[Senate Hearing 116-313]
[From the U.S. Government Publishing Office]
S. Hrg. 116-313
MANAGING PAIN DURING THE OPIOID CRISIS
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING MANAGING PAIN DURING THE OPIOID CRISIS
__________
FEBRUARY 12, 2019
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
41-390 PDF WASHINGTON : 2021
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky TAMMY BALDWIN, Wisconsin
SUSAN M. COLLINS, Maine CHRISTOPHER S. MURPHY, Connecticut
BILL CASSIDY, M.D., Louisiana ELIZABETH WARREN, Massachusetts
PAT ROBERTS, Kansas TIM KAINE, Virginia
LISA MURKOWSKI, Alaska MARGARET WOOD HASSAN, New
TIM SCOTT, South Carolina Hampshire
MITT ROMNEY, Utah TINA SMITH, Minnesota
MIKE BRAUN, Indiana DOUG JONES, Alabama
JACKY ROSEN, Nevada
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, FEBRUARY 12, 2019
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 3
Witnesses
Steinberg, Cindy, National Director of Policy and Advocacy, U.S.
Pain Foundation, Policy Council Chair, Massachusetts Pain
Initiative, Lexington, MA...................................... 6
Prepared statement........................................... 8
Summary statement............................................ 15
Gazelka, Halena, M.D., Assistant Professor of Anesthesiology and
Perioperative Medicine, Director, Mayo Clinic Inpatient Pain
Service, Chair, Mayo Clinic Opioid Stewardship Program,
Rochester, MN.................................................. 16
Prepared statement........................................... 18
Summary statement............................................ 21
Coop, Andrew, Ph.D., Professor and Associate Dean for
Academic Affairs, University of Maryland School Of
Pharmacy, Baltimore, MD.................................... 22
Prepared statement........................................... 23
Summary statement............................................ 26
Rao-Patel, Anuradha, M.D., Lead Medical Director, Blue Cross and
Blue Shield of North Carolina, Durham, NC...................... 27
Prepared statement........................................... 28
Summary statement............................................ 33
QUESTIONS AND ANSWERS
Response by Cindy Steinberg to questions of:
Hon. Patty Murray............................................ 59
Hon. Robert P. Casey......................................... 61
Hon. Elizabeth Warren........................................ 62
Hon. Maggie Hassan........................................... 63
Hon. Lisa Murkowski.......................................... 65
Response by Halena Gazelka to questions of:
Hon. Patty Murray............................................ 66
Hon. Robert P. Casey......................................... 67
Hon. Lisa Murkowski.......................................... 69
Hon. Tina Smith.............................................. 70
Response by Andrew Coop to questions of:
Hon. Patty Murray............................................ 71
Hon. Robert P. Casey......................................... 72
Hon. Lisa Murkowski.......................................... 72
Hon. Richard Burr............................................ 73
Response by Anuradha Rao-Patel to questions of:
Hon. Patty Murray............................................ 74
Hon. Robert P. Casey......................................... 78
Hon. Lisa Murkowski.......................................... 81
Hon. Tina Smith.............................................. 81
APPENDIX A
Additional responses by Andrew Coop to questions of:
Hon. Patty Murray............................................ 82
Hon. Robert P. Casey......................................... 84
MANAGING PAIN DURING THE OPIOID CRISIS
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Tuesday, February 12, 2019
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander,
Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Burr, Isakson,
Collins, Cassidy, Murkowski, Romney, Murray, Baldwin, Hassan,
Smith, Jones, and Rosen.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will please come to order. Senator Murray
and I will each have an opening statement and then we will
introduce witnesses. After their testimony, Senators will each
have a five-minute round of questions. Dan, who is a
constituent of mine in Maryville, Tennessee, recently wrote me
about his wife who has a rare disease that causes chronic pain.
Dan is concerned because it has become more difficult for her
to find, access painkillers. This is what Dan wrote, ``She is
not an abuser, and is doing everything right now; it is harder
for her to get the medicine she needs.'' Dan's wife is 1 of 100
million Americans, who according to a 2011 report by what is
now the National Academy of Medicine, are living with some
pain. That is about 30 percent of Americans--25 million of
those, the Academy said, have moderate to severe pain.
A new report in 2018 by the Center for Disease Control and
Prevention says, about 50 million Americans have chronic pain.
Nearly 20 million of those Americans have high-impact chronic
pain. And here is the reality. We are engaged in a massive
bipartisan effort to make dramatic reductions in the supply and
use of opioids, which is the most effective painkiller that we
have. But on the theory that every action has an unintended
consequence, we want to make sure that as we deal with the
Opioid Crisis, that we keep in mind those Americans who are
hurting. We are holding this hearing to better understand the
causes of pain, how we can improve care for patients with pain,
and where we are on developing new medicines and ways to treat
pain.
We know that pain is one of the most frequent reasons that
people see a doctor. And according to the Mayo Clinic, the
number of adults in the United States with pain is higher than
the number of people with diabetes, heart disease, and cancer
combined. These Americans need more effective ways than
opioids, or other addictive painkillers, to manage pain.
Opioids, which are commonly used to treat pain, can lead to
addiction and overuse. We know that well.
More than 70,000 Americans died from drug overdoses last
year, including prescription opioids, making it the biggest
public health crisis in our country, affecting nearly every
community. Last year, in the midst of the acrimony of the
Kavanaugh hearing, Congress and another part of the Capitol saw
72 different Senators--or 70 Senators offering 72 different
suggestions for a comprehensive opioid legislation, which
passed the Congress, and which President Trump signed and
called the largest single bill to combat a drug crisis in the
history of our country. That legislation, from all those
Senators, included eight Committees in the House and five in
the Senate, included reauthorizing training program for doctors
and nurses who prescribe treatments for pain, increasing access
to behavioral and mental health providers, encouraging the use
of blister packs for opioids such as 3 or 7-day supply, and
safe ways of disposing unused drugs.
We also took steps to ensure our new law would not make
life harder for patients with pain, but now we need to take the
next step to find new ways to help them. First, we gave the
National Institutes of Health more flexibility and authority to
spur research and development of new, non-addictive
painkillers. We also asked the Food and Drug Administration to
provide guidance for those developing new, non-addictive
painkillers to help get them to patients more quickly. I am
pleased to see commissioner Gottlieb's announcement this
morning that the agency is developing new guidance's on how FDA
evaluate the risks and the benefits of new opioid treatments
for patients with pain, and to help the development of non-
opioid treatments for pain.
Sam Quinones, a witness at one of our hearings, called new
addictive--new non-addictive painkillers the ``Holy Grail to
solving the Opioid Crisis.'' We have backed up those new
authorities with substantial funding. Most recently, $500
million to help the National Institutes of Health find a new
non-addictive painkiller.
Second, we included provisions to encourage new pain
management strategies such as physical therapy. And third, the
new law requires experts to study chronic pain and report to
the Director of the National Institutes of Health how patients
can better manage their pain. And fourth, the new law requires
the Secretary of Health and Human Services to report the impact
on pain patients that Federal and state laws and regulations
that limit the length quantity and dosage of opioid
prescriptions.
Now that we have started to turn the train around and head
in a direction that is different on the use of opioids, every
one of us, doctors, nurses, insurers, patients, Senators,
Congressmen, will need to think about the different ways we
treat and manage pain.
There are other things the Federal Government is doing to
understand what causes pain and how we treat and manage it. For
example, the National Pain Strategy, developed by the
Interagency Pain Research Coordinating Committee, which
develops recommendations, prevent, treat, manage, and research
pain. Through the National Institute on Drug Abuse, the
National Institutes of Health HEAL Initiative, researchers are
working to better understand pain and why some people
experience it differently than others. This will help us find
more ways to more effectively treat pain and help get people
the treatment they need. For example, physical therapy or
exercise may be the best course of treatment for some kinds of
back pain.
It may also help us understand why some people can take
opioids or manage their pain for years without becoming
addicted, while others more easily become addicted. Today, I
hope to hear more about how close we are to having non-
addictive painkillers and how doctors and nurse can better
treat Americans who live with pain. Senator Murray.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Thank you very much Mr. Chairman. Thank you
to all of our witnesses for joining us today.
This Committee has done a lot of important work on the
Opioid Crisis that families and communities across the country
are facing. I was glad we were able to come together last year
to take strong bipartisan steps to address some of the root
causes and ripple effects of the Opioid Crisis. I hope we can
continue to build on that work. However, today's hearing does
offer an important opportunity to take a slightly different
perspective on some of the challenges related to the use of
opioids, and I hope it can serve as a reminder that while we
are working to address substance use disorder and help the
families facing it, we cannot forget about the people who are
facing pain, both acute and chronic, and we cannot overlook how
important it is they get the tools they need to manage their
pain and find relief.
For too long, providers were incentivized to think of
opioids as an easy and harmless solution to addressing pain,
and the lack of understanding about pain management and the
risks of opioid prescribing meant health care providers
prescribed opioids far more often than was necessary,
contributing to the tragic increase in opioid misuse. But that
does not mean the solution to the Opioid Crisis is for
providers to stop finding ways to help their patients manage
pain. We have to find responsible, comprehensive solutions for
pain management that ensures opioids are marketed, prescribed,
and used responsibly, but at the same time, or within reach for
people dealing with chronic pain. It is important to remember
that for many people who are elderly, people who have been
seriously injured, people with chronic health conditions, or
undergoing aggressive health treatments, and people who have a
disability, pain seriously impacts their day-to-day lives.
Fifty million people nationwide suffer from pain that
persists for weeks or even years. For almost 20 million people,
this pain can interfere with their work and daily life
activities. Pain management is an absolutely critical quality
of life issue for these people and their families. Acute and
chronic pain can make it harder to keep a job and earn a
paycheck. Even when treated, pain can make it difficult to
travel to and from work, and sit at a desk for long stretches
of time. And pain does not just affect a person's livelihood,
it affects every aspect of their life. Without pain management,
patients may not be able to tackle the tasks they need to live
independently, by getting dressed, or driving a car, or doing
laundry. They may not be able to spend quality time with their
loved ones as their pain can make it hard to enjoy a meal with
friends or family, or attended a grandkid's soccer game, or
even leave the house. Without the right pain management tools,
some patients struggle to get a decent night's sleep.
For people living with pain, the ability to get treatments
that help them manage it can impact their entire life, and I am
very interested to hear from one of our witnesses today to
offer her first-hand perspective on this. We appreciate your
being here.
It is so important we listen to patients about their health
care needs, whether that is finding ways to address that
person's pain, or recognizing when asking for painkillers is a
result of an addiction, which requires an entirely different
form of treatment. Of course, another part of what makes this
issue so challenging is that no two people experience pain the
same way. Where pain is felt, how it is felt, how severe it is,
how long it lasts, and how much it impacts our life, can vary
widely from person to person. Pain is not a one-size-fits-all
and the tools we use to manage it cannot be either. We need to
do more to make sure everyone facing pain is able to get
treatment that works for them.
This means ensuring research is done to better understand
the biological basis of pain and the factors that determine
what might work best for a patient. It means training providers
to recognize pain symptoms, to truly listen to their patients'
needs, and to consider lower risk, less invasive options before
turning to more extreme measures. And it means making sure
insurers policy support access to these options rather than
incentivizing providers to simply write a prescription for an
opioid without taking the time to understand what might work
best for that patient. And for some with severe pain, it may
mean responsible opioid prescribing, but for many others there
are options that will work better and have lower risks of
addiction, from other types of drugs that might fit better
their needs, to service like physical therapy, to treatments
that help address the psychosocial dynamics of pain, like
cognitive behavioral therapy to support for modifying their
lifestyles in ways that might help manage their pain like
through exercise. And it means addressing threats to their
health care like the blatantly partisan legal threat from the
Republican lawsuit that could strike down protections for
people with pre-existing conditions, including people affected
by pain.
During our hearing today, I am interested to see what
inside our witnesses have to offer about these very complex
problems, and what steps we can take to help people get the
support they need to manage their pain. For example, what can
we do to make sure insurers cover pain management options that
patients need, and do so in ways that help them quickly find
the treatments that work best for them? How can we tackle the
workforce shortage and make sure people in pain are able to
find a care provider that can serve them close to their home?
What can we do to address health disparities when it comes to
pain treatment, and how can we make sure employers understand
their obligations to accommodate employees as struggling with
chronic pain under the Americans with Disabilities Act, and
help them learn how best to support those employees?
As we continue our efforts to respond to this Opioid Crisis
and build on the strong bipartisan steps we took last year, I
am really glad that we have this opportunity to take a look at
another very important angle of this challenge. So, thank you,
Mr. Chairman.
The Chairman. Thank you, Senator Murray. And thanks to you
and to your staff for working to create this bipartisan
hearing, which is an important follow-up to our work on the
opioids bill last year. Each witness will have up to five
minutes for his or her testimony. We welcome each of you and
thank you for coming. Our first witness is Cindy Steinberg. She
is the National Director of Policy and Advocacy at the U.S.
Pain Foundation, and Chair of the Policy Council of the
Massachusetts Pain Initiative. She was appointed in May 2018 by
the Secretary of the Department of Health and Human Services,
to serve on the Pain Management Best Practices Interagency Task
Force, and she previously served on the Interagency Pain
Research Coordinating Committee of the National Institutes of
Health. Senator Smith, would you like to introduce the next
witness.
Senator Smith. Thank you, Chairman Alexander. I am really
honored today to introduce Dr. Gazelka from my home State of
Minnesota. Dr. Gazelka's work represents the health care
innovation that is happening in Minnesota and at Mayo Clinic.
Dr. Gazelka is the Director of Inpatient Pain Services in the
division of Pain Medicine at Mayo Clinic in Rochester, and she
is also an Assistant Professor of Anesthesiology at the Mayo
Clinic College of Medicine. And she has dedicated her
professional life to pain medicine and palliative medicine.
Dr. Gazelka has worked extensively in opioid management, as
well as acute and chronic pain management. And most recently,
she was appointed by HHS Secretary, Alex Azar, to serve on the
Pain Management Best Practices Interagency Task Force--a
mouthful and very important work. Dr. Gazelka attended the
University of Minnesota Medical School and completed her
residency and fellowships at Mayo Clinic College of Medicine.
And I think that her professional experience makes her
perfectly suited to testify before us today on pain management
during--with this Opioid Crisis in front of us. And I know that
we are all going to benefit from your expertise, so thank you
so much, Dr. Gazelka. And thank you for taking time away from
your practice and your patients to be with us today.
The Chairman. Thanks, Senator Smith. Dr. Andrew Coop is the
next witness, Professor and Associate Dean for Academic Affairs
of the University of Maryland School of Pharmacy. He is
currently researching a new opioid analgesic that may have less
potential for abuse and diversion. And finally, Senator Burr,
would you introduce our remaining witness.
Senator Burr. Mr. Chairman, thank you for holding this very
important hearing. I welcome all our witnesses today, and I
have the great pleasure, Mr. Chairman, for the opportunity to
introduce Dr. Anu Rao-Patel from Durham, North Carolina. And
her current role is Lead Medical Director at Blue Cross, Blue
Shield of North Carolina. Dr. Rao-Patel is responsible for
making coverage decisions for health care services and
prescription drugs for a number of health benefit plans offered
by North Carolina Blue Cross. She has also spent much of her
career treating patients with chronic and painful conditions,
such as lower back pain and migraine headaches. Dr. Rao-Patel
is board-certified in physical medicine and rehabilitation, an
active member of the American Academy of Physical Medicine and
Rehabilitation and the American Medical Association.
Before moving to North Carolina, Dr. Rao-Patel received her
medical training and a medical degree from Louisiana State
University. She completed her internship in internal medicine
at Earl K Long Hospital in Baton Rouge, and residency training
in physical medicine and rehabilitation at Sinai Hospital
University of Maryland in Baltimore. I was overly impressed
with her background until I found out that her attending
physician in her internship was Dr. Cassidy.
[Laughter.]
Senator Burr. I do know that she had a hard-charging
attending, as she went through that internship. Dr. Rao-Patel,
thank you for all the important work you do on behalf of North
Carolina. I look forward to hearing your testimony before the
Committee today on how we approach pain management in North
Carolina, during a very devastating time of Opioid Crisis in
this country.
The Chairman. Dr. Cassidy, do you have any comment on your
former resident?
Senator Cassidy. It is so gratifying to see someone as a
former student do so well, and so I am incredibly proud that
you are here. So, I will just limit it at that.
The Chairman. Thank you, Senator Cassidy and Senator Burr.
Now, why don't we begin with Ms. Steinberg. And if each of you
would summarize your remarks in about five minutes, we will go
right down the line. Ms. Steinberg, welcome.
STATEMENT OF CINDY STEINBERG, NATIONAL DIRECTOR OF POLICY AND
ADVOCACY, U.S. PAIN FOUNDATION, POLICY COUNCIL CHAIR,
MASSACHUSETTS PAIN INITIATIVE, LEXINGTON, MA
Ms. Steinberg. Thank you. Thanks for your introduction and
thank you for holding this hearing on a really important issue,
on pain management. It is a conversation that is long overdue.
My life changed in an instant two decades ago when I was
crushed in a serious accident that left me with severe back
pain that has never gone away. On an otherwise typical day at
my job as a manager at a technology company, I opened my file
drawer and unbeknownst to me, moving men had stacked cubicle
walls against it. The cabinets and all the walls fell on me,
crushing me and causing extensive damage to my back and spine.
I was suddenly plunged into a search for relief from an
unrelenting, gnawing, burning band of hot coals across my mid-
back and the crushing pressure of clenched muscle spasms.
Chronic pain is very different from acute pain. It is
relentless. It never ends. I often say, it feels like you are a
prisoner in your own body, only you are a prisoner being
tortured 24/7, and there is no escape. After a discouraging,
difficult and at times demeaning five-year journey of searching
for help while trying to hold onto the career that I loved, I
finally found a doctor who helped me. Even so, the pain
eventually forced me to give up my career. Out of my own sense
of loss and isolation, I decided to start a support group for
others living with chronic pain. I was shocked at how many
people started showing up for monthly meetings--all ages, men
and women, all backgrounds.
Eighteen years later, I am still running that group, and
more than 400 people have come to this group in the suburbs of
Boston. I learned that my story is everyone's story with pain
in America. Though the causes of pain vary, each of us has had
the same experience of struggling to find adequate care.
Everyone had to see four or five practitioners and go through
years of discouraging and expensive trial and error treatments
before they could find help.
The scope of chronic pain is enormous. The number of
Americans impacted by pain and the human suffering involved,
and the cost of the health care system in society is
staggering. You have said some of these things yourself. Fifty
million Americans live with chronic pain. Twenty million have
high-impact chronic pain, which is pain that affects their
ability to work, live, socialize on a daily basis. Pain is the
number one reason why Americans access the health care system.
It is the leading cause of disability in the United States.
Pain costs our economy $600 billion a year in lost productivity
and direct medical costs. Despite the impact of pain, we fail
as a country to effectively address it. We have underinvested
in pain research relative to its burden. Less than 2 percent of
the NIH's annual budget has gone to pain research. We still do
not understand the basic nor biological mechanism of pain in
the human body. Medical students receive an average of 9 hours
of pain management training in 4 years. Veterinarians get 87
hours--your pet is getting better pain management often than
people do. And less than 1 percent of physicians are
specialized in pain management.
In the midst of the Opioid Crisis, there has never been a
more important time for policymakers to improve pain
management. Some well-intentioned measures to contain the
crisis have resulted in unintended consequences for chronic
pain patients. We and other groups have heard from thousands of
chronic pain patients who have been forcibly tapered off their
medications or dropped from care completely by their doctors.
This is inhumane and morally reprehensible. Opioids are one
treatment among many. They should not be a first-line treatment
for chronic pain. Patients with providers must work together
closely to carefully balance the benefits and risks for each
person.
Nevertheless, for many pain sufferers, particularly those
with severe pain, opioids can be a lifeline to lessening their
pain. In the near term, we can and must restore balance to
opioid prescribing. In the long term, we must invest in the
discovery of new, effective, and safer options for people
living with pain. There are, however, many steps we can take
now to give people with chronic pain the quality of care they
so desperately need and deserve. Some examples include reducing
insurance cover barriers to ensure that a full range of
pharmacological and non-pharmacological treatments, including
complementary treatments and medical devices and technology.
Promoting reimbursement models that encourage providers to
dedicate the time and resources necessary to treat the
complexities of pain, promoting individualized, integrative
multi-care plans, investing in vital collection and reporting
epidemiological data on pain, increasing research into
understanding pain in the human body, and investing in ongoing
patient support and teaching of self-management skills for
living with a chronic illness.
Fortunately, Congress has an excellent policy blueprint for
implementing these measures. And that blueprint is the report
of the task force that you have mentioned. That report is due
out in May, and it has many excellent suggestions that I hope
you all implement. Thank you.
[The prepared statement of Ms. Steinberg follows:]
prepared statement of cindy steinberg
Introduction
My name is Cindy Steinberg and I have lived with chronic pain for
more than 18 years. I am also a chronic pain support group leader of 18
years, the Policy Council Chair for the Massachusetts Pain Initiative,
and the National Director of Policy and Advocacy for the U.S. Pain
Foundation.
Thank you for holding this critical and timely hearing on the state
of pain management in the United States, and how the opioid epidemic
impacts people living with chronic pain. Our country is facing two
public health challenges that are often conflated as one: chronic pain
and opioid use disorder.
This is the first of what I hope will be many hearings focused on
improving pain management for the tens of millions of Americans who are
suffering. It's a conversation that is long overdue. The opioid crisis
has only underscored our failure to provide adequate, safe, accessible
treatment options for pain relief.
Chronic Pain is an Enormous and Costly Public Health Problem
The number of Americans impacted by pain, the human suffering
involved, and the cost to the health care system and society is
staggering:
50 million Americans suffer from chronic pain, or
pain that lasts most days or every day for 6 months or more.
\1\
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\1\ https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm.
20 million Americans suffer from high-impact chronic
pain, or pain that interferes with basic functioning, including
work, sleep and activities of daily living, like personal
hygiene and household chores. \2\
---------------------------------------------------------------------------
\2\ https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm.
Pain is the number one reason that Americans access
the health care system. \3\
---------------------------------------------------------------------------
\3\ https://report.nih.gov/nihfactsheets/
ViewFactSheet.aspx?csid=57.
Pain is the leading cause of long-term disability in
the United States. \4\
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\4\ https://report.nih.gov/nihfactsheets/
ViewFactSheet.aspx?csid=57.
In 2010, pain cost the United States $560-635 billion
a year in direct medical costs and lost productivity. \5\
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\5\ https://www.jpain.org/article/S1526-5900(12)00559-7/fulltext.
People with moderate pain spend an extra $5,000 a
year on health care expenditures than people without pain;
those with severe pain spend an extra $8,000 a year. \6\
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\6\ https://www.jpain.org/article/S1526-5900(12)00559-7/fulltext.
People with chronic pain are four times more likely
to experience anxiety or depression, \7\ and 10 percent of all
suicide cases involve chronic pain. \8\
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\7\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3000181/.
\8\ https://annals.org/aim/fullarticle/2702061/chronic--pain--
among--suicide--decedents--2003--2014--findings--from--national.
80 percent of veterans returning from Operation
Enduring Freedom and Iraqi Freedom live with chronic pain. \9\
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\9\ https://www.ncbi.nlm.nih.gov/pubmed/20104399.
Despite the impact of pain, we have failed as a country to
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effectively address it.
At present, less than 2 percent of the NIH's budget
goes to pain research. \10\
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\10\ https://www.hhs.gov/about/budget/budget-in-brief/nih/
index.html.
Veterinary students spend 3-4 times as many hours
studying pain management than students in medical school. \11\
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\11\ https://www.ncbi.nlm.nih.gov/pubmed/21945594.
For every 8,700 people with high-impact chronic pain,
there is only one board-certified pain specialist. \12\
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\12\ http://www.abpm.org/faq.
Patients can only expect to achieve, through their
various treatments, an average reduction in pain of only 30
percent. \13\, \14\
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\13\ https://www.ncbi.nlm.nih.gov/pubmed?term=21704872.
\14\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3841375/.
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Chronic Pain is a Disease of the Nervous System Distinct From Acute
Pain
I would like to make an important clarification about chronic pain
before continuing any further. Acute pain serves as a normal and vital
signal, alerting us that something is wrong and protecting us from
further injury, such as the pain of a broken bone or abdominal pain
before a ruptured appendix. But when pain continues past six months--
regardless of the cause--it transitions into chronic pain. Neuroscience
research now shows that chronic pain becomes a disease in and of
itself, with measurable changes in the brain, spinal cord, and
peripheral nervous system.
Chronic Pain Devastates Lives
Think about the last time you experienced pain. Maybe it was
because you whacked your elbow against a cabinet or burned your finger
on a hot pan. Do you remember how it took your breath away and
commanded your attention? You could not do anything else until the pain
subsided.
All of us have experienced physical pain at some point. What is
difficult to imagine is pain that never goes away. But I'd like you to
envision it. Try to imagine how the pain would impact your daily life,
your career, or your relationships.
Chronic pain is relentless agony. It's often described as being
imprisoned in one's body and tortured 24/7 with no means of escape.
Unlike a serious illness such as cancer, where patients can often
receive treatment and resume daily life, victims of chronic pain are
often forced to cease life activities in perpetuity. They cannot work,
care for their families, or engage in social activities.
This loss of function, productivity, and independence is heart-
wrenching. People with chronic pain lose their sense of self. They feel
worthless, helpless, and very, very alone.
We Can, and Must, Improve Pain Care
The need to improve pain care has never been more urgent. We can
and must do a better job in improving pain management by:
Promoting individualized, integrative, multi-modal
care plans.
Breaking down coverage barriers to a full range of
non-pharmacological as well as pharmacological treatments.
Investing in vital collection and reporting of
epidemiological data on pain.
Improving public, patient, and provider education
about pain management.
Breaking down stigma that creates barriers to proper
care.
Investing in ongoing patient support and teaching of
self-management skills for living with a chronic illness and
pain.
Increasing research into understanding the basic
mechanisms of chronic pain in the human body and the
development of novel safe and effective treatments.
My Story: Learning Firsthand About Pain Care in America
More than 18 years ago, on an otherwise typical day at my job as a
manager at a technology company, a stack of unsecured filing cabinets--
and the cubicle walls leaning up behind them--fell on top of me,
crushing me beneath them. The accident left me with severe, unrelenting
back pain that continues to this day.
No matter what therapy or medication I tried, I simply couldn't be
upright for more than a couple of hours at a time without an enormous
increase in pain and muscle spasms. Even aside from my job, it was a
struggle to do basic things I had previously taken for granted: bathe
my young daughter, and cook dinner for her and my husband. Everything
that required being upright was and is still is a challenge. After a
discouraging, difficult, and, at times, demeaning five-year journey of
searching for help for my pain while trying to hold on to the career I
loved, I finally found a doctor who helped me.
Even with a treatment plan, the pain eventually forced me to give
up my career. Out of my own sense of loss and isolation, I decided to
start a support group for others living with chronic pain. I was
shocked at how many people started showing up for my monthly pain group
meetings--all ages, men and women, and diverse racial, ethnic and
socioeconomic backgrounds.
A remarkably common experience is that everyone has had to see at
least four or five health care practitioners before they could find
help for their relentless pain, if they ever do, and many did not.
There was no one-size-fits-all treatment; what worked well for one
person might cause a bad reaction in another. The quest for help was
exhausting and frustrating--each person had dealt with having their
pain dismissed or downplayed by healthcare providers. It was also
expensive: affording treatment could easily drain a family's resources.
Living with severe pain most likely means you struggle to work--combine
that with high health care costs, and you have a potentially ruinous
problem.
It has been 18 years and I am still running this group today. More
than 400 people with chronic pain have come to this local group. I knew
I was helping these individual lives, but I had to do more. Despite my
daily pain and physical limitations, I decided to dedicate all the
energy I could to improving pain care in this country.
In 2009, I became Policy Council Chair for the Massachusetts Pain
Initiative--an all-volunteer organization that is comprised primarily
of healthcare providers who treat individuals with pain and donate
their time to the organization and its mission to improve pain care in
the Commonwealth. Working together with Massachusetts lawmakers and
regulators, I have led our successful efforts to establish pain
education and opioid prescribing continuing education requirements for
physicians, create pain policies with professional licensing boards,
establish a pain specialist consultation service for general
practitioners, and require Massachusetts public and private insurers to
cover a full range of pain management therapies.
In 2013, the U.S. Pain Foundation asked me to work on Federal pain
policy for the organization. U.S. Pain Foundation is a patient
organization with thousands of Ambassador advocates and tens of
thousands of supporters nationwide that educate, support, and advocate
for Americans living with chronic pain. The organization advocates for
common diseases like cancer and arthritis, as well as rare or complex
conditions like Ehlers-Danlos syndrome, migraine disease, and complex
regional pain syndrome; or pain from trauma, like a motor vehicle
accident or my own accident.
In my role with U.S. Pain, I advocate for improvements in pain care
at the national level.
I am honored to have been appointed to a number of key pain policy
committees at the Federal and state level: the Interagency Pain
Research Coordinating Committee, the highest ranking Federal pain
policy oversight committee chaired by the NIH; the HHS Pain Management
Best Practices Interagency Task Force, established by the CARA
legislation; a National Pain Strategy Expert Working Group;
Massachusetts Governor Charlie Baker's Opioid Working Group; and the
Massachusetts Drug Formulary Commission.
Managing Pain During the Opioid Crisis
There has never been a more important time for policymakers to
improve pain management in the United States. The focus on the opioid
crisis, while absolutely necessary, has resulted in unintended
consequences for chronic pain patients, who are being stigmatized for
their disease and in many cases, denied medically necessary treatment.
Too often, well-intentioned reforms have harmed or unfairly penalized
people with legitimate pain.
Conflation of Two Populations
A critical misunderstanding that pervades media coverage of opioids
and pain is the conflation of two largely distinct populations--those
with the disease of chronic pain and those with the disease of opioid
use disorder.
Demographic research on these populations has shown that chronic
pain sufferers tend to be largely female and over the age of forty and
those with opioid use disorder tend to be largely male and under the
age of thirty. These are two largely separate groups with very little
overlap.
Repeated research within the chronic pain population has found the
risk of addiction to be small, on average less than 8 percent \15\ and
in patients with no history of abuse or addiction, studies have shown
the rate of addiction to be between .19 percent to 3.27 percent. \16\,
\17\
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\15\ https://www.nejm.org/doi/full/10.1056/NEJMra1507771.
\16\ https://www.ncbi.nlm.nih.gov/pubmed/18489635.
\17\ https://www.ncbi.nlm.nih.gov/pubmed/20091598.
Speaking from personal experience and from 18 years of helping
hundreds of chronic pain sufferers manage their conditions, opioid
prescription medications are not the enemy, nor the savior, when it
---------------------------------------------------------------------------
comes to chronic pain.
Opioids are one treatment modality among many pharmacological and
non-pharmacological treatments for pain. They should not be a first
line treatment for chronic pain and ideally should be used in
conjunction other therapies. They should primarily be considered in the
case of severe chronic pain, and in the case of moderate pain when
other options have failed. When they are prescribed, patients should be
carefully screened for risk factors for abuse, like a prior alcohol or
other drug misuse or a personal or family history of substance use
disorder, and counseled in safe use and storage.
Opioids do not help all pain sufferers and when they do help, they
do not completely take the pain away. Nevertheless, they are an
important option. For many pain sufferers who take them responsibly and
legitimately, they are a lifeline that allows them to have some quality
of life and lessen their relentless pain.
Treatments like physical therapy, massage, behavioral therapy, and
injections may be helpful, but few insurance plans cover these options
fully, if at all. For a person with severe pain who is struggling to
work part-time, costs for complementary therapies that are not covered
by insurance may cost hundreds of dollars a week, and this is not
affordable. Furthermore, people with pain who live in rural areas or
have physical limitations that impede travel may have difficulty even
physically getting to appointments for non-pharmacological options,
like physical therapy or injections.
For patients without risk factors for abuse and where opioids are
clinically indicated, it is cruel to take away a treatment option
without offering any realistic alternatives.
It is essential that treating clinicians be permitted to evaluate
individual benefits and risks for each patient and that all appropriate
pharmacological, interventional and complementary therapies remain
available.
As a result of well-intentioned measures to contain the opioid
crisis, such as restricting the supply of prescription opioids, intense
regulatory scrutiny of physicians, the establishment of ceiling doses
and day limits on the number of opioids that can be prescribed,
legitimate chronic pain patients are being made to feel like criminals
simply for seeking relief--many of whom have been on long-term stable
doses of their medication for years.
We, and other pain patient groups, have heard from thousands of
chronic pain patients who have been forcibly tapered off their
medications or dropped from care by their doctor. It's easy to
understand why, for many providers, restrictions on opioids have made
it simply too burdensome to prescribe them, even when they may be
beneficial. Some providers are outright leaving the specialty of pain
medicine out of fear, a devastating development given there is already
a dire shortage in the field: less than 1 percent of physicians are
specialized in pain management. Even if a clinician does continue to
prescribe opioids, patients feel like criminals for taking them and are
constantly terrified that the slightest misstep might be misconstrued
as a sign of misuse or addiction.
This has caused tremendous unnecessary suffering and anxiety, and
has led many to contemplate or attempt suicide. As I mentioned earlier,
recent research found that at least 10 percent of suicide cases in
America involve chronic pain. This number may be surprising to the
average person, but not to pain patients, who know the fear and
helplessness all too well.
In the near term, we can and must restore balance to opioid
prescribing with de-politicized, rational and clear-eyed recognition of
the risks and benefits of these medications. In the long term, we must
invest in the discovery of new, effective, and safer options for people
living with pain.
Federal Efforts to Improve Pain Management
Fortunately, the Federal Government has launched several important
policy planning initiatives to improve pain management. HHS has
included improved pain management as one of its Five Pillars to address
the opioid crisis and the FDA has released its Opioid Blueprint and
Innovation Challenge to promote the development and use of approved
medical technology and non-opioid medication, and the development of
new medical devices and non-addictive medications.
In 2016, HHS, under the auspices of the NIH and the Interagency
Pain Research Coordinating Committee, released the comprehensive
National Pain Strategy. The National Pain Strategy emphasizes the need
for patient-centered, integrative pain management practices based on a
biopsychosocial model of care that enables providers and patients to
access a full spectrum of pain treatment options including
pharmacological and non-pharmacological treatments and complementary
therapies.
In 2017, the Interagency Pain Research Coordinating Committee and
the Office of Pain Policy at the NIH released the Federal Pain Research
Strategy, a long-term strategic plan for basic biomedical research to
advance our understanding of the neurobiological basis of pain.
Recent Promising Initiatives
I applaud Congress for initiating two of the most promising
developments in advancing the science and clinical treatment of chronic
pain in 2018. These are the Helping to End Addiction Long-term (HEAL)
Initiative at the NIH and the establishment of the HHS Pain Management
Best Practice Interagency Task Force.
The HEAL initiative will invest in research on addiction and pain.
The goals of the pain research are to understand the process by which
acute pain turns chronic, discover novel targets for pain treatments,
advance previously discarded pharmaceutical assets for reasons other
than safety, develop a pain clinical trials network, and discover
biomarkers for chronic pain.
Congress established the HHS Pain Management Best Practices
Interagency Task Force in the Comprehensive Addiction and Recovery Act
(CARA) with the charter to identify gaps and inconsistencies in best
practices for acute and chronic pain management adopted by Federal
agencies and propose recommendations to address those gaps and
inconsistencies.
Secretary Azar appointed an exceptional group of pain management
and substance use disorder experts, including my fellow witness today,
Dr. Halena Gazelka, whom I am proud to serve alongside on the Task
Force. The Task Force has been ably led by Dr. Vanila Singh, the Chief
Medical Officer of HHS who is a well-qualified board certified pain
management physician. We have worked hard over a seven-month period to
review the literature, discuss and deliberate on each section of the
report, consider all the input we received including that of thousands
of patients and offer the best possible advice we could provide on the
most current consensus on best practices in pain management.
A draft report is currently out for public comment with the final
recommendations report due out at the end of May 2019. I strongly
encourage Congress to formulate an action plan to implement the best
practices recommendations in the report.
Pain Management Policy Recommendations
1. Surveil the national burden of chronic pain through NIH data
collection, analysis, and dissemination.
Despite the enormous human and economic impact imposed by chronic
pain on our Nation, there is no concerted effort within the government
to ascertain and make publicly available high-quality data on chronic
pain. National surveillance efforts are needed to evaluate population-
level interventions, evaluate the impact of changing public policies,
and identify emerging trends and needs. For example, we would expect
that our aging population with age-associated pain-producing conditions
such as cancer, diabetes and arthritis is leading to substantial
increases in the incidence and cost of pain to the Nation. But without
data to understand this trend, how can we effectively plan for and
manage this burden, as well as contain its cost?
It is critical that Congress create and fund a National Chronic
Pain Surveillance System (NCPSS) at NIH to collect epidemiological data
to clarify the incidence and prevalence of various chronic pain
conditions. The NCPSS would enable NIH to collect data that will:
identify trends, subpopulations at risk, and the health consequences of
pain in terms of morbidity, mortality, and disability; clarify the
incidence and prevalence of pain syndromes differentiated by age,
comorbidities, socio-economic status, race, and gender; and assess
direct cost of pain treatment in terms of utilization of medical and
social services and indirect costs such as missed work, public and
private disability and reduced productivity. Simply put, better data
equals better pain policy and better health outcomes.
2. Transform pain treatment through implementation of pain
management best practices.
Pain care across the United States is highly ineffective,
inadequate and inefficient. Integrative, multimodal pain care based on
a comprehensive assessment and an individualized care plan including a
combination of non-pharmacological and pharmacological treatments
developed and guided by a knowledgeable healthcare provider with input
from the patient is best practice, but many barriers prevent access to
such care. These barriers include inadequate insurance coverage for
pain management services, lack of education and training of physicians
and other healthcare providers on core competencies in pain management,
time constraints that deter physicians from managing chronic illness,
shortages of pain management specialists and lack of research and
evidence base on treatment modalities that currently exist, especially
which modalities are best for which type of pain and in what
combination.
Fortunately, as I noted earlier, Congress, HHS, and the NIH have
already authorized and developed two excellent public policy blueprints
for improving pain care in the United States: through the National Pain
Strategy and the HHS Pain Management Best Practices Interagency Task
Force (PMTF). The National Pain Strategy is the Nation's first
interagency strategic plan to implement a system of safe, effective,
evidenced-based care. HHS released the strategy in 2016, after a nearly
two-year period of thoughtful development among six Federal agencies,
along with eighty nominated experts from the medical, scientific,
patient, and advocacy communities.
Through CARA, the PMTF was charged with identifying gaps and
inconsistencies in best practices for acute and chronic pain
management, as well as proposing recommendations to address those gaps
and inconsistencies. The subsequent report was drafted by a panel of 29
pain management and Federal Government health agency experts selected
from an extensive and thorough search throughout the country. The PMTF
report, including its recommendations, is currently out for public
comment, with the final report due at the end of May, at which time
Congress must develop an action plan to implement the recommendations.
3. Invest in pain research at the NIH.
The Federal investment in pain research has been chronically and
grossly incommensurate with its human and societal burdens. Very little
is known about the prevention, causes, and mechanisms of chronic pain.
Substantial initiatives are urgently needed to develop pain treatments
without abuse potential. Further, generating high-quality evidence that
can guide clinicians and patients in making informed decisions about
safe and effective pain management is imperative.
An essential response to the opioid crisis must include an increase
in the Federal pain research investment. The cost savings of
discovering improved chronic pain therapies will far surpass the
increased costs of research. Beyond relieving suffering from both
chronic pain and substance use disorder, development of improved pain
therapies will spur introduction of innovative products with global
markets, increase workplace productivity, and reduce expenditures for
Federal entitlement programs such as Medicaid, Medicare, and Social
Security Disability Insurance. A meager 1 percent reduction of the
United States costs of pain would translate into approximately $6
billion in annual societal savings. .
The recently begun HEAL Initiative is a start, but it is limited in
scope to a few specific areas. The Federal pain research budget
including the HEAL Initiative pain work still only represents 2 percent
of the NIH's annual budget for a disease that affects 50 million
Americans and is the leading cause of disability. The Federal Pain
Research Strategy, released in 2017 under the auspices of the IPRCC and
the NIH Office of Pain Policy, is a comprehensive strategic plan
developed using the same thoughtful, inclusive process of work teams
comprised of the Nation's brightest medical and scientific experts in
the field of pain research. Congress should use this strategy as
blueprint to expand and expedite our investment in pain research.
Other Important Policy Recommendations
Although the National Pain Strategy and the HHS Pain Management
Best Practices Interagency Task Force Report discuss the
recommendations below, among many others, I have chosen to highlight
these as priorities from a patient perspective:
Ensure access to any medically necessary treatment so
long as benefits outweigh risks for that individual patient.
Improve public and private payer coverage for
integrative care based on individualized treatment plans, so
that patients and their healthcare providers can select from a
full range of pain management therapies, including non-
pharmacological complementary treatments, novel medical devices
and innovative non-addictive pharmacological treatments.
Provide grants for patient support group networks
that educate and empower patients to self-manage chronic pain
using a skill-based chronic disease model.
Invest in large-scale efforts to improve public,
patient, physician, and other healthcare provider education in
pain management. This is essential to restoring empathy and
compassion, eliminating damaging stigma and reducing the
tremendous burden of pain and suffering among millions of
Americans living with chronic pain.
Summary and Conclusion
I would like to sincerely thank the HELP Committee for holding this
hearing focused on pain in America. Chronic pain is the most prevalent,
costly and disabling health condition in the United States, yet it
remains largely unknown, poorly treated, and misunderstood relative to
other prevalent diseases such as cancer, diabetes, and heart disease.
It has been called the ``hidden epidemic,'' and rightly so.
The opioid crisis has revealed decades of underinvestment in
research aimed at understanding the mechanisms and treatment of pain,
such that we have no completely effective therapies that will eliminate
chronic pain and only a handful of good ones that substantially help
carefully selected patients. It should come as no surprise that we have
had to rely on imperfect treatments for pain relief. While these
treatments may help those who use them appropriately, they have led to
huge costs for others and society-at-large.
We have also turned a blind eye to the tremendous physical pain of
millions of our fellow Americans. These people are your constituents,
your families, your friends, and your neighbors. We can and must do
better.
As you plan future legislative action, I hope Congress will
consider these key points:
Chronic pain affects 50 million Americans, including
20 million Americans who live with high-impact pain.
The financial and societal burden of chronic pain is
enormous: it costs the United States an estimated $635 billion
annually in terms of lost productivity and health care costs.
It is the leading cause of long-term disability.
Chronic pain is a disease of the nervous system and
brain that can and does last a lifetime. It is distinct from
acute pain, which is time-limited.
There is no one-size-fits-all approach to treatment
for pain. Individualized care is essential. Patients must work
closely with their healthcare providers to weigh the benefits
and risks of each option.
Chronic pain and opioid use disorder are distinct and
separate diseases. Many patients use opioids legitimately and
safely.
We must restore access to care and medically
necessary treatment for tens of thousands of pain patients who
have been dropped from care by fearful and frustrated providers
or who have been forcibly tapered off stable doses of opioids
that have helped them for years and left to suffer with
relentless pain. This is inhumane and morally reprehensible.
A multimodal, multidisciplinary approach to
treatment--that includes both pharmacological and
nonpharmacological options--is essential to effective, long-
term pain relief. Inadequate insurance coverage, high out-of-
pocket costs, and limited availability are significant barriers
to effective care.
Prescribing reform was necessary to address the
opioid crisis. However, we must be cautious to ensure that
these reforms are thoughtful, balanced, and consider the needs
people with opioid use disorder as well as the needs of people
with pain.
Investing in public, provider, patient and
policymaker education about acute and especially chronic pain
is fundamental to progress in the care, well-being and
productivity of millions of Americans.
Expanding research at the NIH into our fundamental
understanding of the mechanisms of pain in the human body is
essential to discovering safer, more effective treatments--and
someday a cure--for chronic pain, and for reducing reliance on
opioids.
The National Pain Strategy and the HHS Pain
Management Best Practices Task Force Report are excellent
public policy blueprints for jumpstarting a national commitment
to pain care improvements. These initiatives must be funded and
implemented.
The American crisis of inadequate treatment of chronic pain demands
congressional attention. We have done the work to determine effective
next steps; it is now the work of Congress to fund these necessary
recommendations. I call on you to commit to an investment commensurate
with the scale of this crisis to once and for all solve the enormous
problem of pain in America.
______
[summary statement of cindy steinberg]
My life changed in an instant two decades ago when I was crushed in
a serious accident that left me with severe back pain that has never
gone away. I was suddenly plunged into a search for relief from an
unrelenting, gnawing, burning, searing band of scorching hot coals
across my mid-back and the crushing pressure of clenched, spasm muscles
tightened like cords running up and down my spine that worsened
whenever I was not lying flat.
I have learned that my multi-year search for help is a common story
for everyone with chronic pain in America. For nearly two decades, I
have led a chronic pain support group, and in recent years I have
become involved in a number of efforts to address the dual crises of
opioid use disorder and chronic pain in America. My years of experience
have taught me that the most vital thing Congress can do is invest in
research and improvements in clinical care, commensurate to the
economic burden, physical pain, and loss of quality of life and even
life itself they can cause.
I call on Congress to consider these key points:
Chronic pain affects 50 million Americans, including
20 million Americans who live with high-impact chronic pain.
The financial and societal burden of chronic pain is
enormous: it costs the United States an estimated $635 billion
annually in terms of lost productivity and health care costs.
It is the leading cause of disability.
Chronic pain is a disease of the nervous system and
brain that can and does last a lifetime. It is distinct from
acute pain, which is time-limited.
There is no one-size-fits-all approach to treatment
for pain. Individualized care is essential. Patients must work
closely with their healthcare providers to weigh the benefits
and risks of each option.
Chronic pain and opioid use disorder are distinct and
separate diseases. Many patients use opioids legitimately and
safely.
We must restore access to care and medically
necessary treatment for tens of thousands of pain patients who
have been dropped from care by fearful and frustrated
providers.
A multimodal, multidisciplinary approach to
treatment--that includes both pharmacological and
nonpharmacological options--is essential to effective, long-
term pain relief. Inadequate insurance coverage, high out-of-
pocket costs, and limited availability are significant barriers
to effective care.
Investing in public, provider, patient, and policy
maker education about acute and especially chronic pain is
fundamental to progress in the care, well-being, and
productivity of millions of Americans.
Expanding research at the NIH into our fundamental
understanding of the mechanisms of pain in the human body is
essential to discovering safer, more effective treatments--and
someday a cure--for chronic pain, and for reducing reliance on
opioid analgesics.
The National Pain Strategy and the HHS Pain
Management Best Practices Task Force Report are excellent
public policy blueprints for jumpstarting a national commitment
to pain care improvements. These initiatives must be funded and
implemented.
The American crisis of inadequate treatment of chronic pain demands
congressional attention. We have done the work to determine effective
next steps; it is now the work of Congress to fund these necessary
recommendations. I call on you to commit to an investment commensurate
with the scale of this crisis to once and for all solve the enormous
problem of pain in America.
______
The Chairman. Thank you so much, Ms. Steinberg, for making
the trip and for being here today. Dr. Gazelka, welcome.
STATEMENT OF HALENA GAZELKA, M.D., ASSISTANT PROFESSOR OF
ANESTHESIOLOGY AND PERIOPERATIVE MEDICINE, DIRECTOR, MAYO
CLINIC INPATIENT PAIN SERVICE, CHAIR, MAYO CLINIC OPIOID
STEWARDSHIP PROGRAM, ROCHESTER, MN
Dr. Gazelka. Thank you. Chairman Alexander, Ranking Member
Murray, and Members of the Committee, thank you for allowing me
to testify today.
My name is Halena Gazelka. I am an anesthesiologist
practicing pain medicine at the Mayo Clinic in Rochester,
Minnesota. Mayo Clinic cares more than 1.3 million patients
annually from all 50 states and from over 140 countries. The
needs of our patients range from primary care to very complex
and serious conditions. I am honored to serve those in need of
both acute and chronic pain care, and palliative care. I am
privileged to share my inside as a provider and a leader in an
organization that is thoughtfully addressing the pain
management needs of our patients.
Pain management is, at its essence, individualized
medicine. No patient is the same as another, and therefore each
condition, treatment, and surgery has a unique impact with
relation to pain. To ensure that patients receive appropriate
pain treatment, Mayo Clinic created the Opioid Stewardship
Program in 2016, which I chair. Through these efforts, we
realized a dramatic reduction in the amount of opioids provided
to our patients. Our program evaluated surgical specialties,
and we surveyed thousands of patients to develop internal
prescribing guidelines, but they are not a replacement for
clinical judgment. Using these guidelines, some of our
departments have realized a reduction in opioid prescribing of
up to 50 percent, all while maintaining a high level of patient
satisfaction.
The goal is not only to provide the best care at Mayo but
to share our work with others. Our experience has helped other
health care organizations improve their pain management, reduce
opioid-related morbidity, and decreased diversion.
Established in 1974 in Rochester, Mayo Clinic's Pain
Rehabilitation Program has helped bring hope and management
strategies to thousands with chronic pain over the past four
decades. Similar centers have been established at our Florida
and Arizona practices. While pain rehab is very effective,
insurance coverage for it is limited. For instance, it is
covered by Medicare but not by Medicaid. Today, I would like to
convey four key points to you.
First, dose limits on opioids, such as three and seven-day
limits, will not satisfy the acute pain requirements for
patients equally. Patients and procedures vary significantly. A
patient recovering from the removal of their wisdom teeth will
have a very different pain management requirement than a
patient recovering from a major orthopedic surgery, or a
trauma. These variations are the basis for our procedure-
specific and patient-specific guidelines. Chronic pain lasting
for months to years typically could be related to cancer or it
could be as common as back pain, for example. As the condition
and the needs of all, physicians should utilize evidence-based
interventions, medical therapy, and restorative therapies to
ensure proper management. Typically, patients with chronic
pain, particularly when it is not cancer-related, may be better
candidates for non-opioid therapies. An individualized approach
to care is paramount, and policy should promote the use of
effective non-opioid treatments.
Further research is needed to determine why some patients
with acute pain develop chronic painful conditions, and to find
a means to interrupt that progression. Second, Federal policy
should embrace multi-faceted approaches to the treatment of
opioid use disorder, including access and prevention. Medicare
and Medicaid must develop additional coverage of and
reimbursement for non-opioid pharmacotherapies and treatment
regimens for chronic pain, to prevent the contact with opioids
that may ultimately lead to addiction, particularly for chronic
pain where little medical evidence exists in support of long-
term opioid use. Other solutions to manage pain may be cost-
prohibitive, time-consuming, and lack appropriate coverage by
insurers.
The basis of chronic pain management was focused on
treating the whole individual with restorative, behavioral,
psychosocial, and medical and procedural elements combined
appropriately to the patient and the condition. There is not
only a paucity of pain management providers and resources but
in cases where opioid use disorder does complicate management,
not enough treatment programs exist to satisfy that need.
Third, the optimization and standardization of prescription
drug monitoring programs should be pursued. While most states
currently utilize them, the existing programs are varied and
the administrative burden is additive. Nationally, there is a
greater need for coordination and consistency across the PDMPs.
Finally, we believe that empowering patients is a major key to
solving the epidemic. We must increasingly engage patients in
shared decision-making and educate them on treatment, risks,
and alternatives. We also believe the role of communities and
local governments are important. Because opioids provided
legitimately by providers are only one facet of this problem,
the epidemic will only be solved with a collective approach.
Thank you for the opportunity to join you today and for
your efforts in ensuring proper pain management amidst the
Opioid Crisis. I am happy to answer any questions.
[The prepared statement of Dr. Gazelka follows:]
prepared statement of halena gazelka
Chairman Alexander, Ranking Member Murray, and Members of the
Committee, thank you for the opportunity to testify before you today.
My name is Halena Gazelka and I am an anesthesiologist practicing at
Mayo Clinic in Rochester, Minnesota. Mayo Clinic is a not-for-profit
health care system dedicated to medical care, research, and education,
where multiple medical experts work collaboratively to find solutions
for patients with the most serious and complex illnesses. Our staff of
more than 60,000 provide and support care for more than 1.3 million
people from all 50 states and 140 countries. The needs of our patients
span the spectrum of care--from primary care in the Mayo Clinic Health
System to serious and complex conditions in our destination practice.
My specialty is in pain medicine where I have the honor of serving
patients who seek pain relief therapies for acute, chronic and
palliative care needs. My clinical practice and research focuses on
pain medicine, palliative medicine, opioid management, acute and
chronic pain management, neuromodulation, intrathecal drug delivery
systems, spine care, and cancer pain management. I am an assistant
professor of anesthesiology and perioperative medicine; am board
certified in anesthesiology, pain medicine, and palliative medicine;
and have the privilege of serving as director of Inpatient Pain
Services at Mayo Clinic Rochester. I also direct Mayo's Opioid
Stewardship Program, which was established in 2016 to oversee
prescribing practices across Mayo's enterprise and identify
opportunities for improvement.
Recently, I have had the pleasure of serving on the Pain Management
Inter-Agency Task Force overseen by the Department of Human Services.
Established by the Comprehensive Addiction and Recovery Act of 2016,
the Task Force was charged with developing best practices for
prescribing pain medication and managing chronic and acute pain. A
draft report with recommendations is currently open for public comment
and will be shared with Congress later this year.
I am privileged to share my insight as both a pain medicine
provider and a leader in an organization that has taken a very
deliberate and thoughtful approach to guarantee the pain management
needs of our patients are met while ensuring responsible prescribing
practices. Mayo has taken a multi-faceted approach to address the drug
abuse and opioid crisis across our own enterprise, drawing upon our
expertise in integrated clinical care, research and education. Our
focus includes embracing a broad range of pain treatment and management
tools in our medical practice, where care delivery methods are put
through scientific rigor to determine whether they improve patient care
and outcomes, as well as developing clinical guidelines that minimize
the risk of addiction and abuse with minimal impact on patient
experience.
As a pain medicine provider, I can say without reservation that
pain management is a very individualized practice of medicine. No
patient is the same as another, and therefore each condition,
treatment, and surgery will also have unique impact. The scope and
length of pain can also vary significantly. To ensure patients
continued to receive appropriate pain treatment, the Mayo Opioid
Stewardship Program uniquely looked at prescribing practices for acute
and chronic pain. This coincided with the development of educational
tools for providers and patients, and increased monitoring of opioid
prescribing behavior across our organization. The resulting ``Mayo
Clinic Guidelines for Acute and Chronic Opioid Prescribing'' are
available to all Mayo care team members and have been shared with
external colleagues as well. These recommendations reflect Mayo
consensus based on review of existing evidence and guidelines, but are
not a replacement for clinical judgment.
The guidelines were developed after extensive research on the
existing prescribing practices of our clinicians as well as the
experience of our patients. This included a number of activities aimed
at better understanding practice behavior and patient experience, such
as surveying thousands of patients to comprehend their prescription
utilization and needs after being discharged. This combination of
examining both clinician and patient behavior was a critically
important component of our work as we aim to balance the need to reduce
reliance on opioid medications while ensuring that patient needs for
pain management are reasonably met. This dyad approach also facilitates
the development of effective and relevant education tools that
recognizes the current behaviors of target audiences and how to adjust
them as necessary.
Early results from the standards developed under our stewardship
program have shown significant results in uniform acute and chronic
care prescribing practices, improved pain management for our patients,
and a drastic reduction in excess opioid availability. As an example,
some departments have seen a reduction in opioid prescriptions of close
to 50 percent in high-volume surgical practice areas, all while
maintaining a high-level of patient satisfaction with pain management.
Mayo researchers continue to study the outcomes of the prescribing
practices, including continued engagement with patients, to help
identify areas for improvements to optimize care. The goal of this work
is to not only provide the best care to patients at Mayo Clinic, but to
broadly share our work and learnings with medical experts, educators,
and communities so that people can benefit from our expertise. To this
effort, we continue to educate future clinicians on responsible and
appropriate opioid prescribing practices for chronic pain, illnesses
and palliative care as part of planned curricula.
Our stewardship experience has already led to a larger effort with
14 other major health care organizations in Minnesota, working together
to improve pain management and treatments for patients, reduce risk of
opioid-related morbidity, and decrease opioids available for diversion.
This work is now taking place at the Institute for Clinical Systems
Improvement (ICSI), in Minneapolis, Minnesota and will yield ongoing
information that can inform broader efforts to address opioid use and
abuse across entire communities beyond just one organization.
While great efforts are underway to standardize the prescribing of
opioids, Mayo Clinic continues to promote non-opioid therapy
treatments. Established in 1974 in Rochester, Minnesota, Mayo's Pain
Rehabilitation Center (PRC) was one of the first pain rehabilitation
programs in the world. The PRC in Rochester has helped thousands of
people with chronic pain management over the past four decades, and
similar centers were established in 2011 at Mayo Clinic's campus in
Jacksonville, Florida, and in 2016 at Mayo's campus in Phoenix,
Arizona.
The PRC is staffed with an integrated team of health care
professionals trained in many areas, including pain medicine, physical
therapy, occupational therapy, biofeedback and nursing. In addition to
pain management, the PRC also addresses the psychological needs of all
our patients with an array of cognitive behavioral and mental health
programs. A major emphasis of the program is the management of chronic
pain without the use of opioids, and patients participate in a three-
week, full-day program that educates them on effective strategies for
addressing their needs with or without prescription medications. We
also operate a similar program designed for teens based upon their
unique clinical and cultural needs. While we have found the PRC
intervention to be a very effective means of addressing patients who
cannot or should not utilize opioid therapies, the insurance coverage
for this program is limited. The program is covered under Medicare, but
it is not covered by Medicaid.
As Congress considers options to address the opioid epidemic that
is impacting individuals, families and communities across the Nation,
Mayo Clinic would encourage Members to not limit access to appropriate
opioid treatment, increase access for patients to alternative pain
management therapies, reduce the burden for providers to access
prescribing data, and promote public awareness and education on the
topic of pain and various treatment options. When considering these
options, it is important to recognize at the outset that the needs of
patients facing short-term pain, such as those recovering from a
surgical procedure, are different than those of patients managing
chronic pain, such as those with cancer or complex injuries. Members
may want to consider different policy approaches for addressing the
challenges associated with these very different populations. For the
prior, opioid use as a result of surgeries, procedures or conditions
require the most flexibility for physicians to manage and monitor
patients. A patient recovering from removal of wisdom teeth will have
different pain management needs than a patient with a major orthopedic
surgery, and physicians should respond accordingly, and have the
ability to do so, to both circumstances.
Chronic pain, however, is generally considered pain that lasts
longer than 45 days to three months. The pain could be the result of an
underlying medical disease or condition such as cancer or chronic back
problem, among many other concerns. These patients can be monitored and
providers can be rewarded by utilizing evidence-based care and other
guidelines to ensure proper utilization of opioid medications. These
patients often present with more complex clinical considerations and
their needs may change as conditions evolve. They also may be better
candidates for alternative non-opioid therapies that are able to
address pain over longer periods of time or offer a cumulative effect
that is negligible for patients needing just a few days or weeks of
pain relief.
While we strongly believe opioids should be prescribed in the
smallest amounts needed, standardized prescribing guidelines and
restrictions may not always meet the individual needs of all surgical
and complex care patients. An individualized approach to care is a core
principle of how Mayo cares for patients. As such, we believe that the
most appropriate policies will encourage responsible behavior, promote
the use of effective non-opioid treatments where possible and
proactively address high-risk prescribing practices. This approach is
the most effective means of addressing the crisis before us without
compromising legitimate patient care needs.
Absolute dose limits on opioid prescriptions, such as three-day or
seven-day limits already implemented in a number of states will not
satisfy the pain requirement for patients equally. Medications,
particularly opioid medications, often have to be dose-adjusted to the
individual and medical state. For example, a 30 year old 80 kg male
recovering from a tonsillectomy will have different pain management
needs than a 75 old 50 kg female recovering from hip replacement
surgery. Additionally, patients appropriately using medication for non-
pain treatment may also be adversely impacted by such policy changes.
In essence, the emphasis of prescribing efforts should be to ensure
providers are proficient in prescribing the right medication, in the
right dose, for the right patient.
Our research on opioid prescribing across a number of specialties
shows that there is no one correct limit for post-surgical prescribing.
Several factors should be considered by the prescribing physician, such
as the degree and complexity of the surgery, rehabilitation
requirements, medical co-morbidities, medication interactions, and
access to follow-up care (among other issues) when determining
discharge prescriptions. Policies considered and implemented should
recognize that no surgery--or patient--is identical to any other. As
such, prescribers must have the flexibility to develop a care plan that
best meets the need of his/her patient while simultaneously prescribing
opioids in a responsible manner.
Additionally, the clinical community, payers, patients and
regulators need to invest additional effort to develop consistent
evidence-based guidelines for opioid prescribing as well as building
out the evidence base for non-opioid pain treatments and therapies.
While some guidelines currently exist, the wide variation in existing
practice patterns demonstrates these guidelines are falling short in
providing necessary information and have not been widely adopted. It is
imperative that clinical standards and best practices be informed by a
strong body of clinical evidence and that stakeholders feel invested in
the process of developing those guidelines. These guidelines, in turn,
can serve as a fair basis for measuring clinician practice and
performance as part of value-based payment for services and other
incentives that encourage broader adoption and utilization of practice
guidelines at the facility or organization level. Existing performance
measurement initiatives, such as the Quality Payment Program, may offer
natural opportunities for utilizing such guidelines effectively in the
future.
To reduce the reliance on cost-effective opioid treatments,
Medicare and Medicaid should develop additional coverage of and
reimbursement for non-opioid pharmacotherapies and treatment regimens.
There is little medical evidence in support of long-term use of opioids
in treating chronic pain, and a number of alternative therapies are not
covered or reimbursed in a meaningful way by the Medicare and Medicaid
programs. Currently, short-acting opioids are often the least expensive
option for pain suffers. But, other solutions preventing Opioid Use
Disorders (OUD) such as non-opioid pharmacotherapies and other non-
invasive treatments are not covered by many insurers or require large
co-payments or cost sharing that is prohibitively expensive for
beneficiaries. Interventional treatment options are restricted, but
these therapies keep many patients not only off of opioids but
contribute to a high functioning status. Understanding that Medicare
and Medicaid coverage should be driven by clinical evidence
demonstrating the effectiveness of treatment, there may be cases where
those standards benefit from greater flexibility. For instance,
Congress could direct CMS to exercise greater flexibility under the
coverage with evidence development process for Medicare in areas where
public health would benefit from broader coverage of emerging
therapies.
Opportunities for optimizing existing prescription drug monitoring
programs (PDMP) at the national level should also be strongly pursued.
Most states are currently utilizing some form of a PDMP to gain greater
visibility into physician prescribing and patient behavior. However,
there is wide variation in how these programs operate as well as who
can access and utilize the information within the program. As an
organization serving patients from all 50 states and with facilities
physically located in several states, we have observed the need for
greater coordination and consistency across programs. Aside from posing
administrative difficulties, this inconsistency also leads to gaps in
the system that diminish the ability of PDMPs to curtail inappropriate
behavior and abuse.
While creating a national PDMP may be one option for reconciling
these differences, we are cognizant of the challenges such a program
may pose across states and are concerned that duplication of state
efforts could actually complicate this issue further. As such, we
encourage the exploration of opportunities to bring some element of
uniformity to PDMP policies and operations without adding an additional
layer of regulation on top of the existing framework. One approach for
undertaking that effort may be to engage with participating Medicare
and Medicaid providers in partnership with states to apply consistent
standards across the programs.
Furthermore, Federal policy under the Medicare and Medicaid
programs should embrace integrated, multi-faceted approaches to
addiction treatment, including access. Many patients continue to seek
pain management, and thus opioids, in the setting of OUD. Currently,
there is not enough availability of treatment programs for opioid
addiction to satisfy demand and the increasing role of pain management
specialists as the opioid epidemic grows is taxing many communities'
available resources. Physician and other referring providers often have
few or limited referral options for evaluation and/or treatment. While
medically assisted therapy (MAT) for OUD has significant evidence to
support its efficacy, the availability of methadone and Suboxone may be
unnecessarily limited in some areas and may be financially out of reach
for patients and their families with limited coverage. Further,
enrolling in the DEA Suboxone program is currently administrative
burdensome and significantly limits practice and patients who may be
enrolled.
While Congress reviews the various policy proposals to address this
crisis, any opportunity to increase public education on the
ramifications of opioid addiction, the science of pain and pain
management, and non-opioid alternatives and solutions may also prove
beneficial by empowering patients. A recent survey conducted as part of
the Mayo Clinic National Health Checkup found that a large majority of
patients would choose an alternative treatment to opioid pain
relievers, but only 25 percent of those surveyed said they have spoken
to their provider about alternative treatments. Mayo continues to look
for opportunities to educate patients and partners on the impact of
various pain management options. Additionally, we engage with local
government leaders and law enforcement partners to identify
opportunities for increased collaboration, and recently entered a
partnership with a public broadcasting partner to develop a public
awareness campaign around the opioid crisis. This epidemic will only be
solved with a collective approach.
Thank you for the opportunity to join you today, and for your
efforts in ensuring proper pain management amidst the opioid crisis. I
would be happy to answer any questions and engage further.
______
[summary statement of halena m. gazelka]
Mayo Clinic is taking a deliberate, multi-faceted approach to
address the drug abuse and opioid crisis across our own enterprise and
in our communities, drawing upon our expertise in integrated clinical
care, research and education. Our efforts embrace a broad range of pain
treatment and management tools in our medical practice, where care
delivery methods are put through scientific rigor to determine whether
they improve patient care and outcomes, as well as development of
clinical guidelines that minimize the risk of addiction and abuse with
minimal impact on patient experience. We recognize that this crisis
will only be solved with a collaborative approach and appreciate the
opportunity to share our experience with you today.
Pain management is a very individualized practice of medicine. No
patient is the same as another, and therefore each condition,
treatment, and surgery has a unique impact. The scope and length of a
patient's pain can also vary significantly. To ensure patients continue
to receive appropriate pain treatment while guarding against
overprescribing, the Mayo Opioid Stewardship Program, which I chair,
was created to review our prescribing practices for both acute and
chronic pain to assess how we could best support our clinicians in
managing the pain needs of our patients. Paired with the development of
educational tools for Mayo Clinic providers and patients and increased
monitoring of opioid prescribing behavior across our organization, this
initiative allowed us to realize a dramatic reduction in the amount of
opioids provided to our patients with minimal complaints.
The resulting prescription guidelines, developed after extensive
research on the existing prescribing practices of our clinicians as
well as the experience and needs of our patients, are available to all
Mayo care team members and are shared externally as well. The
recommendations reflect our consensus based on physician data review,
extensive patient surveys and existing guidelines, but are not a
replacement for clinical judgment. We are continuously talking to the
members of our care teams to adjust our protocols and integrated
effective workflow tools to support adoption of recommended practices
on the Epic EHR platform deployed across all Mayo Clinic sites last
year. Early results from implementation of these efforts demonstrate
more appropriate acute and chronic care prescribing practices, improved
pain management for our patients, and a drastic reduction in excess
opioid availability.
As Congress continues to address the opioid epidemic that impacts
individuals, families and communities across the Nation, I would
encourage Members to increase access for patients to alternative pain
management therapies, refrain from placing one-size-fits-all limits on
clinician prescribing, reduce the burden for providers to access
prescribing data, and promote public awareness and education on the
topic of pain and various treatment options. When considering these
options and opportunities, it is important to recognize at the outset
that the needs of patients facing short-term pain, such as those
recovering from a surgical procedure, are distinctly different than
patients managing chronic pain, such as those with cancer or complex
injuries.
Thank you for the opportunity to join you today, and for your
efforts in ensuring proper pain management amidst the opioid crisis. I
would be happy to answer any questions and engage further.
______
The Chairman. Thank you, Dr. Gazelka. Dr. Coop, welcome.
STATEMENT OF ANDREW COOP, PH.D., PROFESSOR AND ASSOCIATE DEAN
FOR ACADEMIC AFFAIRS, UNIVERSITY OF MARYLAND SCHOOL OF
PHARMACY, BALTIMORE, MD
Dr. Coop. Chairman Alexander, Ranking Member Murray, and
Committee Members, I thank you for the opportunity to testify
today.
My name is Andy Coop. I am the Associate Dean for Academic
Affairs at the University of Maryland School of Pharmacy. But I
am a chemist. I make new drugs. I was trained over the pond by
a guy called John Lewis, who many people have forgotten about.
He was the guy who discovered buprenorphine. He trained me that
academics are here to make discoveries, but unless those
biomedical discoveries are translated to the patient, it is all
for nothing. I applaud the Federal funding agencies for that
focus on translational research. As we have heard, chronic pain
is horrendous. There are figures, there are dollars out there,
but we just owe everybody a better solution. There are
wonderful, outstanding classes of opioids, and we should ensure
the patients that require opioids, get them. But we need to
respect them. Just like a big dog; we need to respect them.
But I have been asked today about the new analgesics coming
down the pipeline, including, in full disclosure, the compound
I am working on. So, opioids, not opioids, there are lots of
other options, but what about opioids. Well, first of all, we
need to define what we are talking about. If we do not define
where we are trying to get, we are never going to get there,
which is the reason I do not use the word addiction--it is very
hard to define on biological mechanisms. I use the terms
dependence and reinforcement.
The two concepts need to be solved when we are developing
new opioid medications. Okay, what other? Dependence is when
you chronically take a drug, your body adapts, so it becomes
normal to have the drug present. You stop taking it, you go
into withdrawal. There is only one surefire way of eliminating
withdrawal and that is taking more drug. That happens in the
clinic to patients. Reinforcement is the high, taking a drug
recreationally. It is acute. It is instant. You get high from
taking the drug. So recreational seeking of a drug is seeking
to get the high. Long-term, chronic is dependence. They are two
very different concepts. We need to address both. So--sorry, I
got ahead of myself, sorry. We need to solve both.
Think about abuse-deterrent formulations. They are designed
so that they cannot be abused on the street. They are used in
the clinic. That is great. They will not be diverted, but they
will still cause dependence. So, discontinuation would still
cause withdrawal. So, what is being done toward this area? We
have biased agonists, which is activating one pathway, not
another. We have approaches where opioids only go to one place
in the body. We have what I am doing and many others--there are
many people doing this--where we actually target two biological
systems, where the second biological system modulates the first
to prevent the dependence under reinforcement.
Many are in development in both academic and industrial
laboratories, and it is important to continue this funding, of
which thankfully NIDA and the NIH have been wonderful. We need
consistent funding. As mentioned by the Chairman, the FDA has a
critical role in addressing these drugs. But not only does the
FDA need to do this rapidly, it needs to be safe. It is safe
and effective. We need to ensure that we do not bring drugs to
the market that make things worse. Non-opioid medications. We
have gone through some of these. Some that were not mentioned.
OTC ibuprofen often works very well for many patients, and we
need to remember that.
We have local anesthetics. We have channel blockers. We
have capsaicin and non-pharmacological treatments. And yes, we
need to do further research, and yes, it is controversial, but
we really should look at the potential of cannabinoids. The
studies are not out there. If we do not have the studies, we
cannot make the decision on the potential of cannabinoids. In
my last two minutes, I just want to talk quickly about my
profession of pharmacy, my Doctorate profession of Pharmacy.
Pharmacist pretty much, often get ignored in this crisis. They
are accessible. They are trained. They are doctors. They are
able to help with counseling patients on the appropriate
medications to use. And one major impact that the Federal
Government could make is to expand the prescribing of
buprenorphine for medication-assisted treatment to include
pharmacists. This is called getting a data waiver, so that the
pharmacists, under collaboration, could prescribe buprenorphine
and provide the buprenorphine in a very accessible pharmacy.
Thank you.
[The prepared statement of Dr. Coop follows:]
prepared statement of andrew coop
Chairman Alexander, Ranking Member Murray and Committee Members, I
want to thank you for the opportunity to testify today on a matter of
critical importance to this country, and I applaud this Committee for
continuing to seek to better understand alternatives for pain
management that will not lead to opioid addiction. I am Dr. Andrew Coop
and I am a Professor of Pharmaceutical Sciences in the University of
Maryland's School of Pharmacy. As many of you know, the school is
located at the University of Maryland, Baltimore in the city of
Baltimore--a densely urban area of this country which has its share of
the many challenges US cities face. The scourge of opioid addiction
continues to be particularly prevalent in Baltimore despite many
relatively successful efforts to lessen its impact. The University,
where I have worked for 20 years, is deeply involved in this fight for
our citizens' lives. I was trained in England by John Lewis, a name
that is not known to many; he was the person who developed
buprenorphine, and I have followed him in my personal research efforts,
focused on developing non-addictive, non-opioid alternatives for pain
management to help diminish the number of individuals addicted to
opioids due to chronic pain.
With this background, I want to briefly outline the current state
of research in finding effective, non-addictive pain compounds, discuss
the promise and to offer suggestions on strengthening the
administration of pain management compounds. In the interest of
transparency, I want to disclose that one of the compounds I will
discuss is being developed by ALT Pharmaceuticals of which I am the co-
founder along with a colleague from the School of Pharmacy, and I serve
as its Chief Scientific Officer.
Let me begin by saying that individuals who suffer from severe and
chronic pain deserve our sincere sympathy. Their discomfort is
debilitating and even life threatening in some cases, and their
addiction to relief brought on by opioids is not by choice in most
cases. We owe these individuals a better solution--one that does not
come with its own complications and one that, while not curing the
condition that brings the pain, enables them to return to a fuller
life.
The number of individuals with chronic pain addicted to opioids is
significant according to recent data. According to the CDC's National
Health Interview Survey (NHIS), an estimated 20.4 percent of U.S.
adults--some 50 million people--had chronic pain and nearly 20 million
had high-impact chronic pain--pain that frequently limits life or work
activities.
Make no mistake, opioids are an outstanding class of drugs for
treating pain when used appropriately. All currently approved opioids
interact with and activate certain receptors in the brain which gives
rise to analgesia (pain relief), and are a gold standard in treating
pain when used appropriately. Unfortunately, they also give rise to all
the associated side effects, including ``addiction'' and respiratory
depression--it is the respiratory depression (slowing of breathing)
that is the major cause of death on overdose. In my work and those of
others in the field, we are searching for a compound that will treat
the threshold of pain like opioids, but without the dependency of
opioids. I attempt to avoid the term ``addiction'' due to the fact that
it is often interpreted differently by different people, and therefore
does not allow a scientific approach to the development of new opioids
lacking such an effect. If we don't know what our goal is, we will
never get there. We need to define terms that can be measured
biologically, namely dependence and reinforcement. They are different
and have different mechanisms.
Dependence: Chronic administration of an opioid causes adaptations in
the brain--specifically to the mu receptors, where they now function as
if the opioid is present. On discontinuation of the opioid, the
receptors are suddenly functioning without the drug that they adapted
to, and this leads to withdrawal. This effect occurs no matter the
reason for taking the opioid (for clinical reasons or for recreational
reasons), so a patient who has received chronic administration of an
opioid to treat pain will have withdrawal just as much as a person
taking illicit opioids. The withdrawal effects are severe (like a bad
case of the flu) and leads to patient seeking opioids to prevent
withdrawal. Both prescription and illicit opioids would attenuate the
withdrawal effects (as both work through mu receptors), leading to a
life of drug use.
Reinforcement: In addition to analgesia, opioids also give rise to
euphoria--commonly referred to as a ``high'', an acute and instant
effect. This effect leads to drug seeking for recreational purposes,
and the drugs are usually administered through snorting or by injection
for optimal reinforcement. Overtime, as the individual takes opioids
chronically, they develop dependence, and drug seeking turns to
preventing withdrawal, rather than for reinforcement. As stated, all
opioids act through the same mechanism, so prescription opioids are
often diverted for recreational use due to their reinforcing
properties.
My research, along with that of several others is focused on the
development of an opioid lacking both reinforcement (like the abuse
deterrent formulations) and dependence. Approaches include biased
agonists, opioids that do not enter the brain (peripheral opioids), as
well as my approach of designing a drug that activates both mu
receptors and an additional biological system that prevents the side
effects from mu. Many are in development in both academic and
industrial laboratories, and it is critical that this research continue
to be funded. The FDA has a critical role in the approval of such
opioids, as we need an approach that will be both rapid in getting the
drug to patients, but ensure that the new opioids are indeed safer than
the current clinically approved ones. For instance, the drug developed
in my laboratory appears to lack dependence in animal tests, but is
reinforcing in larger rodents. Thus, although this compound (UMB425)
appears promising it is not a panacea, is only half-way to the optimal
analgesic, and would almost certainly not be approved by the FDA, due
to the potential for illicit use through its reinforcing properties,
something that has happened recently for other new opioids.
An example of effort to create a drug for pain management without
the complications of reinforcement is loxicodegol under development by
an industrial laboratory.
The efforts to design a drug that would treat the same level of
pain as a traditional opioid but would lack both dependence and
reinforcement characteristics continue in laboratories across the US,
but may take a number of years to reach the prescribing market. Like
you, I wish this were not the case, but the research is intense and
hopeful. A more rapid approach would be the use of drug combinations,
where a lower dose of opioid is combined with another approved drug
leading to lower doses of opioid required.
Research is also ongoing to find ways to potentially reduce
recreational use of opioids, which is of concern to policymakers and
the Nation as a whole as the drug crisis continues. One approach is to
focus on the use of ``abuse-deterrent formulation''. For example, we
can use tablets that prevent removal of the opioid to be diverted for
recreational use and injected or snorted, but when taken orally will
have the desired analgesic effect. The same is true for using a patch
for transdermal drug induction. Taking a drug orally or transdermally
leads to less reinforcing effects, as it is the rate of increase in
levels that is correlated with reinforcement. Abuse deterrent
formulations are a strong step toward the optimal opioid, but, however,
do not prevent the development of dependence as that is due to chronic,
long-term action of opioid on the brain's mu receptors--so not yet
perfect.
As noted above, opioids should continue to be available to patients
for the treatment of severe pain, as they are unsurpassed in their
ability to treat chronic pain. That said, we need to ensure patients
who require opioids are able to have them prescribed. However, their
use should be reduced to a minimum, with education of patients on
appropriate use and misuse. This requires a multi-faceted approach to
pain management, including education of both patients and prescribers
that pain is to be managed, rather than eliminated. This requires a
team-based approach, where one size does not fit all. We all have
experienced pain of some sort, and the first line of defense is to use
aspirin, ibuprofen, acetaminophen or naproxen. When these and other
over-the-counter medicines fail to relieve our symptoms, we turn to our
physicians who may suggest alternative or complementary approaches such
as exercise, physical therapy, weight loss, acupuncture, or cognitive
behavioral therapy. There are local anesthetics and nerve blockers that
are effective for surgical pain, but cost is often an obstacle. Topical
capsaicins work well in many cases. Medical cannabis, controversial as
it is, has potential, but well-designed studies are lacking. However,
these potential sources of relief may not suffice especially for those
with high-impact chronic pain and many require more patience and
dedication than a pain sufferer can manage, and we ask for more. Many
patients have come to expect a prescription of opioids that
unrealistically totally eliminates pain when the appropriate goal is to
reduce pain to a manageable level. Patient education, counseling, and
follow-up care are critical to minimizing the risk of addiction.
I cannot stress enough the importance of prescriber education on
opioid prescribing and would hope that this Committee and other
interested bodies would continue to push for reducing the number of
potentially unneeded opioid prescriptions written. Further, I suggest
that patients need to take more personal responsibility for managing
their pain before asking one's physician ``for something stronger''.
If I might turn to my own adopted profession and how pharmacists
can contribute to reducing addiction. We are behind the counter when a
prescription is filled and our prescription records often tell an
important story about a particular patient. We are on the front line
when opioids are the choice. The opioid epidemic requires an ``all
hands-on deck'' inter-professional team approach to truly combat
opioid-related deaths and adequately treat opioid use disorder. Adding
to the complexity, mental illness and substance use disorders are often
concurrent chronic disorders. We want to make you aware of the unique
expertise that specialized pharmacists can bring to this effort.
Pharmacists are medication experts and one of the most accessible
health care professionals, yet they have been underutilized in fighting
this epidemic. Expanding the prescribing of medications like
buprenorphine/naloxone to include pharmacists would optimize treatment
access and patient care.
Pharmacists are routinely making a difference every day by
dispensing medications like naloxone and educating the public about
this lifesaving antidote for opioid overdose. They receive years of
training to educate patients, manage and monitor medications, including
for side effects and drug interactions, and, in some cases, prescribing
and administering medications. Allowing pharmacists to practice at the
full extent of their education expands access to care. When pharmacists
gained the authority to administer influenza vaccine and other
vaccinations, immunization rates significantly increased. As a result,
280,000 pharmacists are trained to administer vaccines. Pharmacists
also receive specialized training in various practice areas. For
instance, psychiatric pharmacists are uniquely qualified to work with
opioid use disorder patients and are experts in medication use and
abuse/diversion. Psychiatric pharmacists receive graduate pharmacy
degrees and post-graduate residency training in psychiatry and
substance abuse. They are eligible to become board certified
psychiatric pharmacists (BCPP) by completing required prerequisites and
a rigorous national exam.
Most states allow pharmacists to prescribe or adjust patient
medications and monitor medication effects in collaboration with a
physician through laws permitting collaborative drug therapy management
(CDTM) agreements. Patients with substance use disorders and mental
illness often require complicated medication regimens. Collaboration
between prescribers and pharmacists helps to optimize medication
selection, improve safety, and expand access to care, especially in
areas with a shortage of health professionals.
Buprenorphine/naloxone is an effective treatment for opioid use
disorder. Unlike other medications, including prescription opioids,
buprenorphine/naloxone can only be prescribed by a DATA-waivered
prescriber, which limits treatment availability. Lack of institutional,
mental health and psychosocial support has been cited as significant
barriers to prescribing buprenorphine among primary care providers.
Pharmacists are not currently eligible to apply to become DATA-
waivered. We ask your support and petition for Federal legislative
changes which would allow pharmacists participating in CDTM agreements
to prescribe buprenorphine/naloxone collaboratively with physicians to
further expand access to care and improve treatment outcomes. I
strongly recommend that we allow pharmacists to prescribe buprenorphine
as part of an overall management of care for opioid use disorder, and
gain reimbursement from Medicare. We need a long-term solution to the
opioid crisis, but we also need to ensure that current patients have
optimal access to medication-assisted treatment.
In conclusion, we must continue to allow access to opioids for
those individuals with significant pain while we search for alternative
medicines to control pain. Alternatives to opioids are within reach and
research funding into such medications must not be threatened if
progress is to be made. Policies designed to stem illicit drug use must
not jeopardize appropriate health care. Greater efforts into the
development of ``safer opioids'' are warranted. Prescriber and patient
education on the use, and possible misuse of opioids for chronic pain
conditions must continue and be strengthened. Teams addressing the
opioid crisis should include pharmacists.
Thank you.
______
[summary statement of andrew coop]
Severe and chronic pain is debilitating and even life threatening
in some cases, and addiction to relief brought on by opioids is not by
choice in most cases. We owe these individuals a better solution--one
that does not come with its own complications and one that, while not
curing the condition that brings the pain, enables them to return to a
fuller life.
My testimony will focus on four main areas:
1. The need to define the biological mechanisms behind
addiction, specifically the difference between dependence and
reinforcement, and how new opioid analgesics need to address
both.
2. Non-opioid analgesic medications that are available,
including combinations to lower the amount of opioid, non-
pharmacological treatments, and potential new drugs that act
through non-opioid mechanisms.
3. The education of both patients and prescribers on the fact
that pain management should indeed be considered as management,
rather than an elimination of all pain. Opioids should be
available to those patients that require them, but their use
should be kept to a minimum.
4. Pharmacists are medication experts and one of the most
accessible health care professionals, yet they have been
underutilized in fighting this epidemic. Expanding the
prescribing of medications like buprenorphine to include
pharmacists would optimize treatment access and patient care.
______
The Chairman. Thank you, Dr. Coop. Dr. Rao-Patel, welcome.
STATEMENT OF ANURADHA RAO-PATEL, M.D., LEAD MEDICAL DIRECTOR,
BLUE CROSS AND BLUE SHIELD OF NORTH CAROLINA, DURHAM, NC
Dr. Rao-Patel. Good morning. Thank you, Chairman Alexander,
Ranking Member Murray, the distinguished Members of the
Committee and their staffs for providing me with the
opportunity to talk about the management of pain during the
Opioid Crisis--I apologize.
My name is Anu Rao-Patel. I am a Lead Medical Director of
Blue Cross Blue Shield of North Carolina. My background is in
physical medicine and rehabilitation, and prior to joining Blue
Cross four years ago, I was in private practice doing chronic
pain management and some management of addiction. I continue to
remain clinically active. I see patients regularly in addition
to my primary role at Blue Cross. I hope to provide unique
perspective today to the Committee based on my clinical
training and practice as a board-certified physiatrist, my
first-hand management of chronic pain, as well as my
perspective as a Medical Director at Blue Cross, North
Carolina. I have also submitted written testimony, which
further expands on my comments. At Blue Cross, North Carolina,
we serve close to 4 million customers. We are in every zip code
of all 100 counties. The Blue Cross, North Carolina PPO network
of health care providers includes 96 percent of medical doctors
and 99 percent of general acute-care hospitals. Blue Cross,
North Carolina is accredited by the National Committee for
Quality Assurance. We are all aware of the scope of the issues
with the Opioid Crisis, both the human and the financial toll
that it is having.
In North Carolina alone, Attorney General Josh Stein stated
that in 2018, four people died every day from an overdose and
that between 2017 and 2018 the number of fatal overdoses in
North Carolina increased by 33 percent, and that is even with
efforts to reduce overdose death by distributing naloxone to
reverse narcotic effects. Blue Cross and Blue Shield companies
are strongly committed in doing our part to combat the epidemic
of opioid use disorder while ensuring patients living with
chronic pain get access to appropriate evidence-based
treatments. As evidence of this unified commitment, I am
listing several examples of things that we cover.
We provide coverage for non-opioid pharmacologic
alternatives for pain management including, non-steroidal anti-
inflammatories, antidepressants, anticonvulsants, topical
analgesics, alpha-2 agonists, and others. We provide coverage
for non-pharmacologic alternatives for pain, including physical
therapy, occupational therapy, aquatic therapy, chiropractic
care, trigger point injections, biofeedback, steroid joint
injections, interventional pain procedures, including facet
blocks, medial branch blocks, epidural steroid injections,
spinal cord stimulators. We cover TENS units, intra-articular
hyaluronic acid injections for knee osteoarthritis, Botox
injections for migraine and spasticity, as well as others. We
have endorsed the CDC guidelines for prescribing opioids for
chronic pain, and we are working collaboratively with the
prescriber community to implement these, understanding that
there is not a one-size-fits-all approach to managing pain.
We support access to medication-assisted therapy, including
associated counseling and behavioral therapy. We support a wide
availability of naloxone. We support enhanced operability of
prescription drug monitoring systems and encourage providers to
access this data before prescribing. As chronic pain is a
legitimate and debilitating medical issue, there are many
opportunities for physicians to continue to manage pain
effectively with or without the use of opioids. Physicians must
incorporate the universal precautions in the use of pain
medicine for the treatment of chronic pain, including making an
accurate diagnosis, informed consent with a patient, treatment
agreements, pre and post-intervention assessment to assess pain
and function.
The goal of long-term pain management is to support the
patient improvement of their function and quality of life as
much as possible, despite their ongoing pain symptoms. Opioids
are certainly an option to support select patients in managing
symptoms and should be prescribed thoughtfully and judiciously
as part of a broader pain management regimen. In addition,
patients must have realistic and honest expectations of pain
management goals, including understanding that in some
circumstances elimination of pain in its entirety is not a
possibility but certainly a goal.
Providers should continue self-education on appropriate
prescribing and in pain management, as well as participation in
their state and medical licensing boards on continuing medical
education requirements. There must also be increased training
in medical school and residency programs on pain, as well as
addiction, as well as increased research nationally on pain.
Finally, physicians and payers must understand, as
mentioned several times, that there is no one-size-fits-all
approach to manage chronic pain, and must incorporate a
holistic, multimodal, and thoughtful approach similar to any
other chronic medical condition. Thank you again for including
me in this discussion. Blue Cross Blue Shield companies share
your commitment in addressing America's Opioid Crisis, and
ensuring those who are suffering from opioid use disorder, as
well as chronic pain, get the care that they need.
Thank you.
[The prepared statement of Dr. Rao-Patel follows:]
prepared statement of anuradha rao-patel
Good morning and thank you, Chairman Alexander, Ranking Member
Murray, the distinguished Members of the HELP Committee, and their
staff for providing me with the opportunity today to discuss the
management of pain during the opioid crisis. My name is Anuradha Rao-
Patel, and I am a Lead Medical Director at Blue Cross and Blue Shield
of North Carolina (Blue Cross NC). My background is in Physical
Medicine and Rehabilitation and prior to joining Blue Cross NC four
years ago, I was in private practice providing management and treatment
for chronic pain and addiction. I continue to remain clinically active
and see patients regularly in addition to my primary role at the health
plan. I hope to provide a unique perspective to the Committee today
based on my clinical training and practice as a board-certified
physiatrist, my first hand management of chronic pain as well as
addiction, as well as my perspective as a Medical Director at Blue
Cross NC.
Background--Blue Cross Blue Shield Association and Blue Cross NC:
Since 1929, Blue Cross Blue Shield (BCBS) companies have provided
healthcare coverage to members in every ZIP code. Blue Cross Blue
Shield offers a personalized approach to healthcare based on the needs
of the communities where their members live and work. They work closely
with hospitals and doctors in the communities they serve to provide
quality, affordable health care.
We understand and answer to the needs of local communities, while
providing nationwide health care coverage that opens doors for more
than 106 million members in all 50 states, Washington, DC, and Puerto
Rico. Nationwide, more than 96 percent of hospitals and 95 percent of
doctors and specialists contract with Blue Cross Blue Shield
companies--more than any other insurer.
At Blue Cross NC, we serve close to 4 million customers and are in
every ZIP code of all 100 counties. The Blue Cross NC PPO network of
health care providers includes 96 percent of medical doctors and 99
percent of all general acute-care hospitals. Blue Cross NC is
accredited by the National Committee for Quality Assurance (NCQA), a
not-for-profit organization dedicated to improving health care quality.
NCQA is the most widely recognized accreditation program in the United
States. We have partnered with our provider network and continue to
work collaboratively with other key state stakeholders including North
Carolina Department of Health and Human Services (NCDHHS), North
Carolina Medical Board (NCMB), North Carolina Medical Society (NCMS),
and the North Carolina Attorney General's Office.
Scope of the Issue-Opioid Epidemic:
According to the Centers for Disease Control and Prevention (CDC),
from 1999-2017 almost 400,000 people in the United States died from an
overdose involving any opioid, including prescription and illicit
opioids. They also estimate that the total ``economic burden'' of
prescription opioid misuse alone in the United States is $78.5 billion
per year, which includes the costs of health care, lost productivity,
addiction treatment, and criminal justice involvement. The National
Institute on Drug Abuse (NIDA) estimates that roughly 21 to 29 percent
of patients prescribed opioids for chronic pain misuse them and between
8 and 12 percent develop an opioid use disorder. In North Carolina
alone, Attorney General Josh Stein stated that in 2018 four people died
every day from an overdose and that between 2017-2018, the number of
fatal overdoses in North Carolina increased by 33 percent--and that is
even with efforts to reduce overdose deaths by distributing naloxone to
reverse narcotic effects.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Blue Cross Blue Shield Findings:
Blue Cross Blue Shield Association (BCBSA), in collaboration with
Blue Health Intelligence (BHI), examined opioid prescription rates,
opioid use patterns and opioid use disorder among commercially insured
Blue Cross Blue Shield (BCBS) members (excluding members diagnosed with
cancer or who were undergoing palliative or hospice care). In 2017,
BCBSA released a report, The Health of America report, illustrating the
impact of opioid use and opioid use disorder on the health of
Americans.
While progress has been made, there were approximately 241,900 BCBS
members diagnosed with opioid use disorder in 2017.
Specific Findings
Nationally, the total number of opioid medications
filled by commercially insured BCBS members has declined by 29
percent since 2013, with significant variation among states.
Thirty-four states had higher reductions, with Massachusetts
leading at 51 percent.
In 2017, 67 percent of BCBS members filled their
first opioid prescription within the CDC-recommended guidelines
for both dose and duration. Some states did significantly
better than the average, led by Rhode Island at 80 percent,
Mississippi at 74 percent and Vermont and Massachusetts at 73
percent.
When examining total opioid prescriptions for BCBS
members in 2017, not just the first prescription, 45 percent of
members filled prescriptions within the CDC-recommended dose
and duration guidelines, up from 39 percent in 2013.
In 2016, opioid use disorder claims stabilized, with
6.2 in 1,000 BCBS members diagnosed. The rate dipped slightly
to 5.9 in 1,000 members in 2017.
Why Opioids have the Potential for Abuse:
In order to understand why opioid medications have the potential
for abuse, one needs to understand what an opioid is and how these
medications are metabolized in the human body. Opioids are a class of
drugs naturally found in the opium poppy plant. Some prescription
opioids are extracted from the plant directly, while others are
manufactured in laboratories using the same chemical structure. Opioid
medications exert their analgesic effects predominantly by binding to
mu-opioid receptors. These receptors are densely concentrated in brain
regions that regulate pain perception (periaqueductal gray, thalamus,
cingulate cortex, and insula), including pain-induced emotional
responses (amygdala), and in brain reward regions (ventral tegmental
area and nucleus accumbens) that underlie the perception of pleasure
and well-being. Mu-opioid receptors are also located in other regions
such as the gastrointestinal tract which explain other side effects of
opioids such as constipation and in the brainstem which results in the
respiratory depression associated with opioid-overdose incidents and
death. Opioid medications vary with respect to their affinity and
selectivity for the mu-opioid receptor and there is also variability
among the drugs with respect to their pharmacokinetics and
bioavailability.
Chronic Pain:
Chronic pain generally is defined as pain lasting three or more
months or beyond the time of normal tissue healing. According to the
Morbidity and Mortality Weekly Report (MMWR) from the Centers for
Disease Control and Prevention (CDC), approximately 50 million American
adults--20.4 percent of the U.S. adult population--have chronic pain,
defined as pain most days or every day for at least the past six
months. Age and sex do seem to make a difference, with a higher
prevalence among older adults and women. For those with chronic pain, 8
percent (19.6 million adults), report that the pain is bad enough to
frequently limit their daily life or work activities. In addition,
living with chronic pain can also lead to a variety of health issues,
including anxiety and depression. All told, according to estimates
cited by the CDC, the bill in the United States for chronic pain totals
at least $560 billion a year in medical expenses, lost productivity and
disability programs.
Use of Opioids to Manage Chronic Pain:
Opioids emerged into standard management for chronic pain
management in the 1990s. There are many conditions for which opioids
have been prescribed including arthritis, low back pain, fibromyalgia,
musculoskeletal pain, and in dental issues. The recognition of the role
of opioids in the management of acute and end-of-life pain, the
inappropriate adoption of World Health Organization (WHO) analgesic
ladder designed for use in cancer pain at the end of life, the
utilization of pain scales (0-10 scale) to rate level of pain, the
refractory nature of persistent pain, labeling pain as the fifth vital
sign, and the influence of marketing by the pharmaceutical industry
fueled an increase in the popularity of opioids as a treatment for
chronic pain. Early studies seemed to provide sufficient evidence to
support this approach. In 2013, however, it became evident that the
rise in the prescribing of opioids was accompanied by a parallel rise
in opioid-related harms, including addiction, overdose, and death. A
reevaluation of the early clinical trials suggested that opioid use in
clinical practice was neither as safe nor effective as previously
believed.
There are a number of systematic reviews on use of opioid therapy
for chronic pain. However, evidence on the benefits of long-term opioid
therapy is still lacking. There appears to be no data that any one
opioid is more effective than another and minimal evidence that opioids
differ in their propensity to cause harm. An obvious limitation is the
short duration of many clinical trials and the fact that most clinical
trials were monitored and supervised closely and firm conclusions
cannot be extrapolated into the long-term use in a clinical practice
setting.
Evidence is also lacking regarding the relationship between or the
progression from acute to chronic pain, although preoperative chronic
pain is thought to be a risk factor. It has also been proposed that
inadequate management of acute pain may increase an individual's risk
for development of chronic pain.
Alternatives to Opioids to Manage Chronic Pain:
It is important to emphasize and understand that the term ``pain
management'' has not been clearly defined and is generally lacking in
research. Oftentimes, the term is used erroneously to denote solely
pharmacologic tools, most commonly with the use of an opioid. However,
pain management may involve the use of a number of tools--both
pharmacologic and nonpharmacologic--to both relieve pain and improve
function and quality of life. In my personal experience in clinical
practice, patients more often than not equated a referral for pain
management with an automatic prescription for a narcotic. Physicians
fortunately are in a front-line role and have the unique opportunity to
educate their patients on expectations and goals for management of
their pain. As chronic pain represents a complex pathophysiologic
condition that develops over time, its successful management often
requires an equally complex and time-intensive approach. Therefore,
combining multiple therapeutic modalities, nonpharmacologic and
pharmacologic (non-opioid and opioid) and treating pain holistically by
addressing the underlying cause as well as the immediate experience
appears to be the best approach. In addition, redirection and emphasis
on setting reasonable expectations and establishing mutually agreed-
upon goals for the control of chronic pain, with an emphasis on
communication and safety is paramount.
Role of the Payer in Management of Chronic Pain:
Blue Cross Blue Shield companies are strongly committed in doing
our part to combat the epidemic of opioid use disorder while ensuring
patients living in chronic pain have access to appropriate evidence
based treatment. As evidence of this unified commitment, I have listed
several examples below:
We provide coverage for non-opioid pharmacological
alternatives for pain management including nonsteroidal anti-
inflammatory medications, antidepressants, anticonvulsants,
topical analgesics, alpha 2 (a2) adrenoreceptor agonists, and
others
We provide coverage for non-pharmacological
alternatives for pain management including physical therapy,
occupational therapy, aquatic therapy, chiropractic care,
trigger point injections, biofeedback, steroid joint
injections, interventional pain therapies (facet blocks/medial
branch blocks/epidural steroid injections and spinal cord
stimulators), TENS unit, intraarticular hyaluronan injections
for knee osteoarthritis, Botox injections for migraine and
spasticity and others
We endorsed the CDC Guidelines for Prescribing
Opioids for chronic pain and are working collaboratively with
the prescriber community to implement these or similar
guidelines
We support access to Medication Assisted Treatment
(MAT) including the associated counseling and behavioral
therapy
We support wide availability of naloxone
We support enhanced operability of prescription drug
monitoring programs (PDMPs) and encourage providers to access
PDMP data before prescribing
Conclusion:
As chronic pain is a legitimate and debilitating medical issue,
there are many opportunities for physicians to continue to manage pain
effectively with or without the use of opioids. Physicians must
incorporate ``universal precautions'' in the use of pain medicine for
the treatment of chronic pain as excerpted from Gourlay, et al . . .
2005 including the following:
1. Make a Diagnosis with Appropriate Differential
2. Psychological Assessment Including Risk of Addictive
Disorders
3. Informed Consent
4. Treatment Agreement
5. Pre-and Post-Intervention Assessment of Pain Level and
Function
6. Appropriate Trial of Opioid Therapy +/^ Adjunctive
Medication
7. Reassessment of Pain Score and Level of Function
8. Regularly Assess the ``Four A's'' of Pain Medicine:
Analgesia, Activity, Adverse Effects, and Aberrant Behavior
9. Periodically Review Pain Diagnosis and Comorbid Conditions,
Including Addictive Disorders
10. Documentation
The goal of long-term chronic pain management is to support the
patient in improvement of their function and quality of life as much as
possible despite their ongoing pain symptoms. Opioids are certainly an
option to support select patients in managing symptoms, and should be
prescribed with caution if they are effective in low doses and used
intermittently as part of a broader pain management plan. In addition,
patients must have realistic and honest expectations of pain management
goals including an understanding that after an assessment of risk
versus benefit in the use of opioids, that pain elimination may not be
a possibility. Providers should continue self-education on appropriate
and judicious prescribing and in participation in their state medical
and licensing boards continuing medical education (CME) requirements.
There must also be increased training in medical schools and residency
programs on pain and addiction as well as increased research on pain.
Finally physicians and payers must understand that there is no ``one
size fits all'' approach to manage chronic pain and it must incorporate
a holistic, multimodal, and thoughtful approach.
Thank you again for including me in this discussion. Blue Cross
Blue Shield companies share your commitment in addressing America's
opioid crisis and ensuring that those suffering with opioid use
disorder and chronic pain get the care they need.
Sources:
Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain
medicine: A rational approach to the treatment of chronic pain. Pain
Medicine. 2005;6(2):107-112.
Blue Cross Blue Shield Association, The Health of America Report.
Chou R, Turner JA, Devine EB et al. The effectiveness and risks of
long-term opioid therapy for chronic pain: a systematic review for a
National Institutes of Health Pathways to Prevention Workshop. Ann
Intern Med 2015; 162: 276-86.
Els C, Jackson TD, Kunyk D et al. Adverse events associated with
medium-and long-term use of opioids for chronic non-cancer pain: an
overview of Cochrane Reviews. Cochrane Data base of Syst Rev 2017; 10:
CD012509. DOI:10.1002/14651858.CD012509.pub2.
https://healthblog.uofmhealth.org/health-management/accepting-
chronic-pain-strategies-offer-alternative-to-opioids.
Centers for Disease Control and Prevention, 2017. CDC guideline for
prescribing opioids for chronic pain--United States, 2016.
New England Journal of Medicine. Opioid Abuse in Chronic Pain-
Misconceptions and Mitigation Strategies. 3/31/16.
Centers for Disease Control (CDC) website.
National Institute on Drug Abuse (NIDA) website.
Chou R, Fanciullo G J, Fine P G et al. American Pain Society--
American Academy of Pain Medicine Opioids Guidelines Panel. Clinical
guidelines for the use of chronic opioid therapy in chronic noncancer
pain. J Pain 2009; 10: 113-30.
Pedersen L, Borchgrevink PC, Riphagen II et al. Long-or short-
acting opioids for chronic non-malignant pain? A qualitative systematic
review. Acta Anaesthesiol Scand 2014; 58: 390-401.
Stannard C. Where now for opioids in chronic pain? DTB 2018;56:118-
122.
Barclay JS, Owens JE, Blackhall LJ. Screening for substance abuse
risk in cancer patients using the Opioid Risk Tool and urine drug
screen. Supportive Care in Cancer. 2014;22(7):1883-1888.
https://www.ncbi.nlm.nih.gov/books/NBK458655/.
https://www.pcori.org/events/2018/beyond-opioids-evidence-based-
delivery-alternative-treatments-chronic-pain.
https://dtb.bmj.com/content/56/10/118.
______
[summary statement of anuradha rao-patel]
According to the Centers for Disease Control and
Prevention (CDC), from 1999-2017 almost 400,000 people in the
United States died from an overdose involving any opioid,
including prescription and illicit opioids.
In 2017, BCBSA released a report, The Health of
America report, illustrating the impact of opioid use and
opioid use disorder on the health of Americans.
According to the Morbidity and Mortality Weekly
Report (MMWR) from the Centers for Disease Control and
Prevention (CDC), approximately 50 million American adults--
20.4 percent of the U.S. adult population--have chronic pain,
defined as pain most days or every day for at least the past
six months.
There are a number of systematic reviews on use of
opioid therapy for chronic pain. However, evidence on the
benefits of long-term opioid therapy is still lacking.
It is important to emphasize and understand that the
term ``pain management'' has not been clearly defined and is
generally lacking in research. Oftentimes, the term is used
erroneously to denote solely pharmacologic tools, most commonly
with the use of an opioid. However, pain management may involve
the use of a number of tools--both pharmacologic and
nonpharmacologic--to both relieve pain and improve function and
quality of life.
Blue Cross Blue Shield companies are strongly
committed in doing our part to combat the epidemic of opioid
use disorder while ensuring patients living in chronic pain
have access to appropriate evidence based treatment.
The goal of long-term chronic pain management is to
support the patient in improvement of their function and
quality of life as much as possible despite their ongoing pain
symptoms.
There must also be increased training in medical
schools and residency programs on pain and addiction as well as
increased research on pain.
Finally physicians and payers must understand that
there is no ``one size fits all'' approach to manage chronic
pain and it must incorporate a holistic, multimodal, and
thoughtful approach.
______
The Chairman. Thank you, Dr. Rao-Patel. We will now go to
five-minute round of questions. I am going to try to hold
combined questions and answers to five minutes because we have
lots of Senators interested in discussion today.
I will begin with Senator Isakson.
Senator Isakson. Thank you, Chairman Alexander. Ms.
Steinberg, I hate to make you get up off your cot.
[Laughter.]
Ms. Steinberg. It is Okay. I am used to going back and
forth.
Senator Isakson. Well, you can tell that you have the
same--that part we were talking about, and we appreciate all
you are doing to help us learn more about it, and Dr. Coop I
appreciate your pronunciation of all those words. I cannot
pronounce any of them.
[Laughter.]
Senator Isakson. I would like to know the name of the new
one you are working--or have you named the new one you are
working on?
Dr. Coop. It has got a code number at the moment, UMB425.
Senator Isakson. Okay, well that does not help me much.
Dr. Coop. Nope.
[Laughter.]
Senator Isakson. I do numbers better than letters anyways,
so thank you. But thanks to all of you. I lost a grandson to an
overdose and an addiction, and so, this issue is important to
me. And so much of the stuff is on the streets now. It is stuff
gotten out of medicine cabinets in homes. And it may have come
from Mexico, it may have come from Canada, it may have come
from somewhere else, but they got them--kids got it in medicine
cabinets, and take them, and it causes big problems. My first
question, Dr. Patel maybe you would be the best person to ask
this or probably all of you would be. Is hydrocodone the most
prescribed? Is it the most prescribed pain medicine?
Dr. Rao-Patel. Yes, it is.
Senator Isakson. It is an opioid, is it not?
Ms. Steinberg. Yes.
Senator Isakson. The reason I ask that question is, I had a
major back operation 2 years ago, and I mean major, and major
pain. And the surgery worked. I had finally to go to surgery
and had fusion and all that kind of stuff. But I noticed that I
was always getting hydrocodone because I was having dental work
done in terms of implants. I was having a back surgery fusion
done. And I got so much hydrocodone--it just seemed like I had
an excess of it. Is it prescribed more than anything else
because it is less addictive than other types of opioid-based
pain medicines, or is it just the most popular one?
Dr. Gazelka. I think that is probably a culture. It is a
very popular medication because it has always been combined
with acetaminophen and so people have felt that perhaps you
would need less opioid with the combination of acetaminophen.
It has been sort of culture in dental schools and in other
outpatient arenas, particularly to prescribe hydrocodone.
Senator Isakson. It is equally as addictive, is it not?
Dr. Gazelka. It is. Yes.
Senator Isakson. But one of you, and I forgot who did it so
all of you can address this question, but one of you talked
about addiction, and I think that is the problem. I mean I--and
you talked about new, encouraging new development. I think, Dr.
Coop, you said that. How the pharmaceutical companies and
others find replacements for opioid-based painkillers, and to
help with the problem. I think that is exactly it. I mean, I
think that if we could take all the hydrocodone that is
prescribed in America and substitute some new development that
does not use opioids as a base, we would solve a lot of our
problems on addiction, I think.
Do you know how many pharmaceuticals are actually working
on something like that? It may be what Dr. Coop is working on.
I do not know, but is there a lot of work being focused on
trying to find a replacement for that?
Dr. Coop. I have a list actually here of about 12 different
laboratories currently working toward new opioids. But that is
just on the opioid space. They are also working on the non-
opioids space.
Senator Isakson. Yes, the replacement.
Dr. Coop. A non-opioid replacement that does not work
through opioid mechanisms.
Senator Isakson. I think that is the most important thing.
I am convinced opioids--and I am not a physician. I am an
expert in having pain, but I think that----
[Laughter.]
Senator Isakson. I think the opioids is a problem, and I
think that addiction is a problem. If we can find a way to cure
addiction or at least reduce dependence and addiction, we will
be a whole lot better off. And I think that is what you said. I
think that is what you said.
Dr. Gazelka. If I could just make a comment. I think so
much of that legislation and a lot has been concentrated on
treating current addiction, which is obviously incredibly
important. We have a country full of people who have substance
use disorders, but I think that what you touched on is really
important--the prevention of future addiction. The contact,
preventing contact with pain medications the teenagers are
finding in their parents' medicine cabinet or that they are
coming in contact with when they have their wisdom teeth
removed in high school. And I think that is really going to be
essential for future generations.
Senator Isakson. Well, I appreciate it. I think so too and
having three children, and having nine grandchildren, I see
what we get in our medicine cabinet at home for them, and it is
important that be managed as well as possible. It keeps kids
from getting something and getting addicted to it without us
even knowing, and my grandson, who I lost, is a step-grandson,
was not with me all his life, but was with me a lot of his
life, he was addicted before we knew, before anybody in the
family knew what he was getting or where he was getting it
from. But it was a medicine cabinet that got him started and
the peer pressure that kept him on it, and dependence that
caused the problem. So, I appreciate what you said, what all of
you said. I appreciate what you are working on, and God bless
all of you for doing it.
Dr. Gazelka. Well, I am terribly sorry for your loss, sir.
We do know that 80 percent of people who eventually develop
heroin use disorders and other substance use disorders start
with a legitimate prescription that someone received, not
necessarily themselves. I am sorry.
Ms. Steinberg. Senator Isakson, I totally support your
emphasis on research. As I mentioned, the HEAL Initiative is a
great start, but we have underinvested in research. For the
number one reason why people go to the doctor, less than 2
percent of NIH's budget was dedicated toward pain. We still do
not understand the basic mechanism of pain in the body. So, we
really need investment in research commensurate with the burden
of pain. And I think we are going in the right direction, but
we have to keep going there.
Senator Isakson. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Isakson.
Senator Murray.
Senator Murray. Yes, thank you very much to all the panel.
Really, appreciate it. Throughout these Committees, bipartisan
work on the opioid misuse crisis, I have heard from people who
supported our legislative efforts who are very grateful. But I
also heard from some people with disabilities who experience
pain and fear that restricting access to treatment could affect
independent living merely because they were unable to manage
their pain. So, Dr. Gazelka, maybe you can take this on, have
we struck the right balance in our work to reduce misuse but
also making sure that treatments are available, which can be
really vital for people with disabilities?
Dr. Gazelka. That is a very good question, and I worry that
we have gotten ahead of ourselves with wanting to restrict
opioids. A lot of people are now--a lot of providers--are now
scared to provide opioids to patients. They have been
prescribing them for many years, but that does not necessarily
mean that those patients have come in contact with a pain
provider who can help them manage their pain with other means.
Most opioids in the United States that are prescribed
chronically are prescribed by primary care providers, many of
them who do not have any education in managing chronic pain.
They do not have time to go into the detail that it takes to
talk to patients about other options. They do not have access
to pain providers, and I think in some ways--I mean, we have
done what needed to be done, which is to drastically reduce
opioid prescribing, I think, but I worry that we are getting
ahead of ourselves with having available and other options.
Senator Murray. Okay. Thank you. I know people experience
pain in a lot of different ways, but one of the things I am
really concerned about is how bias in the health care system
can affect a patient's treatment for pain. Despite the fact
that women experience pain at higher rates than men, they are
more likely than men to receive sedatives or be diagnosed with
a mental health condition when they seek treatment for pain.
And when it comes to cardiac care, women are less likely to
have their heart attack symptoms recognized, or to receive
painkillers after cardiac surgery. And, when patients are not
listened to, the results can be debilitating, even fatal. So,
Dr. Gazelka, maybe I can ask you, have you seen female patients
being treated differently than male patients?
Dr. Gazelka. I have a patient who has not only giving me
permission to share her story but has encouraged me to do so. A
60-year-old lady in 2017 went to her local provider in a small
town in Minnesota with abdominal pain. She has been very active
running before this. As the year progressed, she became less
functional. Her primary care provider did not know what else to
do for her other than ordering a CT scan of her abdomen and
ruling out any difficulty there. She started presenting to the
emergency room locally.
After multiple presentations, the emergency room physician
sat her down and said Mrs. B, you have chronic pain. You are
going to need to go home and figure out how to manage this. She
was frustrated, so came two hours to the Mayo Clinic emergency
room and eventually ended up on my schedule in the pain clinic.
Now talking about bias, I admit that when I saw that on the
schedule and I read her history--I just felt a little irritated
that morning having to go into the room, but I stood outside of
her room and I told myself you are going to listen to her, like
this is the first time she has told her story. And I went in
and I listened to her, and I ordered an MRI that showed that
she had a metastatic lung cancer eating through her rib and the
nerves that innervate that area in her abdomen. They had been
present for at least a year and ignored because people felt
that she was taking opioids. Bias is a significant problem in
all areas of medicine. It is a problem in research. It is a
problem when we see patients, and it contributes significantly,
I think, to the stigma that surrounds the treatment, not only
of chronic pain, but of addiction and of mental health
disorders. I think it is a significant issue.
Senator Murray. I am not sure how we address that but being
aware of it is certainly a critical part of it.
Dr. Gazelka. I think awareness and I think education both
for patients and providers, and the public as well.
Senator Murray. Yes. And I understand people of color,
same----
Dr. Gazelka. Yes. There are definitely studies that show
that, yes.
Senator Murray. Ms. Steinberg, I wanted to ask you, can you
share your experience in providing a health care provider who
helped you manage your pain, and your thoughts on how Congress
can help make sure that providers have the tools they need to
support patients who live with pain?
Ms. Steinberg. Yes, I think it is a great question because
I have often asked myself after five years, why did it take so
long to find somebody, and what was special about this doctor
that finally helped me? And it was not anything miraculous and
that is, I think, an important message today, which is he
empathized with me. He believed me. A lot of people with pain
do not get believed because it is an invisible disability. He
said, I will work with you to help you find things to manage
your pain, but understand that there is no cure now for chronic
pain. You probably have chronic pain and you are going to need
to learn to live with this, but I will partner with you. He was
honest. He was empathetic, as I said, and he worked with me to
find things that helped me. We often say in pain management
now, if you do a program of several different things, and what
I do is I take medication, I limit the amount of time I am up.
Everybody has different limitations on their activities
with pain. I do a water-based therapy, physical therapy
program, and a land-based program. So, if each thing takes down
your pain 15 or 20 percent, it adds up to maybe a 50 or 60
percent reduction in pain, you can live that way. But it is a
matter of having doctors have the time to do coordinated care.
Our system is so fragmented now that people go from doctor
to doctor. Nothing is coordinated. They try one thing, it does
not work, they go to another person because they are desperate.
But if we had coordinated care--think about cardiac rehab.
Heart disease has been a huge cost for us, right. But we focus
on cardiac rehab and said, we are going to have a rehab program
that puts everything together, and we have had great success
with that. Pain needs something like that. We need that kind of
approach. Where there is an integrated care center, doctors
have time to provide that care, and you can try different
things and have somebody helping you. You are not isolated. It
would go a long way to saving a lot of the wasted cost from
trying different procedures, and different needles, and
different injections--this is what happens to people with pain.
So, that is my suggestion. It is not miraculous. I think we can
do this. If we rethink and realign insurance reimbursement, and
think about models of care that are creative that way.
Senator Murray. Thank you.
The Chairman. Thank you, Senator Murray. I am going to try
to keep the questions and answers to five minutes each since we
have--but let me go back to you, recognizing I have only got
five minutes, Ms. Steinberg. We have 300,000 primary care
doctors in the country. They are the access point for most of
us to--whatever else we need. How do we empower them to do a
better job, as you just described?
Ms. Steinberg. That is a great question because I have been
working in policy in Massachusetts for at least 11 years now,
and I have worked with lawmakers to try some innovative things.
And we just passed the law, something that I worked on, which
was--patients are being dropped from care right now. You have
heard that doctors are afraid to take care of people with pain.
And the bulk of people with pain end up, because we have so
many millions, being taken care of by primary care physicians,
who do not get much training in it. So we try----
The Chairman. I hate to cut you off, but I have got several
questions----
Ms. Steinberg. Okay, so we tried a program where primary
care doctors can call pain management specialist for
consultation, free of charge to them. So the state is going to
pay for specially trained teams of pain management specialist
who can consult with the doctor, so the doctor feels more
comfortable handling that patient, they have a network of
alternative providers and that is really helpful.
The Chairman. Thank you. Dr. Gazelka, does the Mayo Clinic
have such a system to connect with primary care doctors around
Minnesota or other states?
Dr. Gazelka. We do have a system within our electronic
medical record. We allow for eConsults, where a physician or
provider can contact a specialty physician and ask for advice
to treat that patient and ask if a referral might be
appropriate.
The Chairman. Dr. Coop, this hearing, for an obvious reason
is called human nature, you said that one direction is the
right direction, but for sure that something is going to happen
that could cause you to go in the other direction you did not
anticipate, and that is what we are worrying about here today.
Let's say I have a loved one who is about to have a serious
surgery, how do I think about opioid prescriptions in a state
like Tennessee, where the state has said, with our
encouragement, three days per prescription? How should we think
about opioids? Is there something you do not use it all? I
notice that Blue Cross in Tennessee won't reimburse oxycodone,
although I do not think that may be true for other opioids, but
how should one think about that, looking at it from the point
of view of your own family and someone headed toward a painful
surgery?
Dr. Coop. My own family takes opioids and I am fully
supportive of them taking them. If somebody needs opioids, they
should get them. I really do not think--one of the issues is
the pendulum is swung way too back to limiting and people
suffering from pain. We need to get to the middle ground, where
opioids are used in limited quantities, but we also add all the
other approaches that we have had----
The Chairman. What is a limited quantity? Three days or
three weeks?
Dr. Coop. I am not a physician. I cannot answer that, I am
sorry.
The Chairman. Dr. Gazelka, what is a limited quantity?
Dr. Gazelka. That varies by the patient and the procedure.
The Chairman. Well, what would a range be?
Dr. Gazelka. Between--I think three days is very reasonable
for emergency room presentations. That is what we have
instituted at Mayo and actually throughout the State of
Minnesota with other health care organizations cooperating. But
I think for a knee surgery, we know from research, that it is
about 16 days of opioid that a patient takes. What is
appropriate is to educate the patient, perhaps with the
participation of a pharmacist. Educate the patient that you
should take this for the shortest amount of time possible. The
risk for maintaining long-term opioid use increases
dramatically at about 10 days of use.
The Chairman. Dr. Coop, I have about a minute left. What
are the one most promising non-addictive painkiller treatments
or medicines coming down the road? You can mention your own.
[Laughter.]
Dr. Coop. My own would not be approved. It does indeed
cause less dependence and tolerance, but it is reinforcing. So,
that is why I say the FDA needs to fully address all these
drugs. My drug should not be approved. It would be the worst
thing to put onto the market. I am working on the next
generation. The drugs that are coming--I mentioned
cannabinoids. I really do, and I know that is a controversial
topic, but it is great----
The Chairman. Why is it controversial?
Dr. Coop. The states have legalized, the Federal Government
has not legalized. The studies out there have potential, but
the studies have been done with no systematic approach. We need
a systematic approach----
The Chairman. You are talking about medical marijuana?
Dr. Coop. Yes, medical marijuana. Sorry, yes medical
marijuana.
The Chairman. We are laymen, most of us.
Dr. Coop. Sorry, I am really sorry. Medical marijuana, yes.
I think that has great potential.
The Chairman. Thank you very much.
Senator Baldwin.
Senator Baldwin. Thank you Mr. Chairman. As our witnesses
have all noted, pain is a complex issue. It is especially true
for patients who are struggling with serious conditions, such
as cancer, who often need palliative care services to manage
painful symptoms from treatment.
My home State of Wisconsin has embraced palliative care as
a critical component. It focuses on patients' needs, explains
the treatment options, and gives patients and their families a
real voice in their care. Many who need palliative services can
ultimately recover and continue to live meaningful lives. I
have had the honor of working with my colleague, Senator
Capito, on bipartisan legislation, the Palliative Care on
Hospice Education Act, which would help grow and sustain the
palliative and hospice workforce, to help fill the needs and
wishes of patients and their families. Our bipartisan bill
passed the House last session with unanimous support, and I
look forward to continuing to work with my colleagues on this
Committee to advance this measure through Committee this year.
Dr. Gazelka, you stated that Mayo Clinic's clinical
guidelines were developed after extensive research on
prescribing practices among providers, but also with feedback
from patients. I wonder if you could discuss how the Mayo
Clinic continues to refine these guidelines for patients with
palliative care needs, and what else is really needed to
improve the training that palliative care professionals get to
provide the best care possible?
Dr. Gazelka. Well, that is a topic that is near and dear to
my heart. I left my practice to go back and do a palliative
fellowship at the Mayo Clinic several years ago. I think that
palliative care is essential. I think what you said is key.
That not all patients who receive palliative care--they are not
dying. They are people who have serious medical illnesses,
chronic medical illnesses, and often, studies show that they
perform better if they receive those types of services. We have
a robust palliative care service at Mayo. We are training
fellows each year, but it is a new specialty and there is a
paucity of providers--way too few. And so, training is really
important. Most guidelines including the CDC guidelines another
state laws that have been passed, for instance, have exemptions
and exclude cancer patients and patients receiving palliative
care.
At Mayo, we started out in the same vein, but recognizing
that with the treatments for cancer and with a palliative care
measures that we are able to provide to patients, that these
patients are surviving. They are being cured of their cancer or
their cancer is becoming a chronic disease rather than a
terminal illness. And so are their risk of addiction is high.
It is as high as any other patients who take an opioid
medication. And so we have focused efforts on instituting,
essentially, the same guidelines within our palliative care
clinic, as we have elsewhere in our clinics. Appropriate opioid
use, because there are many--I mean opioids, we call it a
stewardship program for a reason. They are vital, important.
They are the best painkillers around. They have been around for
thousands of years and probably will continue. Very important,
but we need to be good stewards of them and teach our patients
to be good stewards as well. I hope I answered your question.
Senator Baldwin. The dangerous misuse of opioids at a VA
facility in Tomah, Wisconsin a few years back resulted in the
tragic death of a marine veteran named Jason Simcakoski. His
story inspired me to author the Jason Simcakoski Memorial and
Promise Act, again with my colleague Senator Capito, which has
been since signed into law. But the law reforms pain management
and safe opioid prescribing practices in the VA system
including, by creating pain teams that incorporate provider
education and expand access to complementary and integrative
health services.
Dr. Coop, you noted that the safe use of opioids requires a
multi-faceted, team-based approach to pain care that includes
patient and provider education. Can you discuss what your
research has shown to be necessary for such comprehensive care
to truly address chronic pain, and describe the important role
that pharmacist play as a part of those teams?
Dr. Coop. The research behind this is that those teams do
not always work together. We need to ensure that those teams do
work together. There are perverse financial incentives not to
work together. So one of the things that we need to do is to
ensure that the financial incentives are there to ensure that
the team works together so that we educate people and put the
money at the frontend, so we are not putting the money at the
backend.
Senator Baldwin. Thank you.
The Chairman. Thank you, Senator Baldwin.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman. Dr. Gazelka, last
year the aging committee held a hearing on opioids and seniors.
I think many of us, when we think of the face of the opioid
addiction, automatically think of a young person, usually a
young male person. However, what our hearing showed is that
this epidemic also affects our older adults. And if you think
about it, it is not surprising, since nearly half of older
Americans do suffer from chronic pain. And the incidence of
chronic pain, it increases with age. The Centers for Disease
Control estimates that the number of people aged 55 or older
treated in emergency rooms for opioid overdoses increased by
nearly a third from 2016 to 2017. Now, some research suggests,
however, that opioids are really not effective in treating
chronic, long-term pain except in cancer patients. First, I
want to ask if you agree with that finding.
Dr. Gazelka. For the most part, yes. However, I have found
in my own practice and with other pain for providers is
commonly we do use opioids for patients who don't have other
options, and many times as patients are aging, they may not
have some of the options, such as surgical interventions,
procedural intervention, implants, etc., that might be
available to a younger patient simply because of their medical
comorbidities.
Senator Collins. Ms. Steinberg.
Ms. Steinberg. Yes, I do want to address your question
because I talked about the doctor that helped me, and when I
went to him, I did not want to take any medication because I
had heard horrible things about pain medication. And he tried
me on a lot of other things first, like gabapentin, which is
common. It made me so tired, I could not function. But he
convinced me to try a hydrocodone, Tylenol combination
medication, and I tried that medicine, and it helped me, and I
never got high from that medicine. I took a relatively low dose
of it, but I took that same medicine. It allowed me to
function. I still had pain, but it allowed me to function and
become the advocate that I could. I took that medicine for 10
years at the same dose. I never had to change my dose. I never
got a high, and most people with pain have that experience.
Unfortunately, people with substance use disorder, it is a
genetic disease. You often start with tobacco or alcohol or
other things, but I want to draw a distinction. I think the
misunderstanding is people think every time you take an opioid,
you get addicted. I want to draw a distinction between two
largely separate populations. People with pain tend to be women
over the age of forty. People with substance use disorder tend
to be men under the age of thirty. We are talking largely about
two separate populations, and Nora Volkow herself wrote a
prominent article that said that people living with chronic
pain, people with pain who take the medication for pain, less
than 8 percent of those become addicted. That means 92 percent
do not.
Unfortunately, it is clear some people do become addicted.
I think that you need to make a distinction and understand that
for some people, they are helpful, and they are the right
thing.
Senator Collins. Right and I am not implying that they are
not, but there is research that says that for long-term use for
chronic pain for many people, that there are better
alternatives to opioids--matches the point I was wanting to
explore. Dr. Coop, very quickly because my time is almost done.
A substance abuse expert has told me that an individual who is
given opioids, who is under age twenty, is far more likely to
become addicted than someone who is older, because of the brain
not being fully developed. Is that accurate?
Dr. Coop. That has been widely studied, yes. And, if you,
for instance, look up when people start experimenting with any
drug, it tends to be at that age group. The brain is still
developing until your early twenties. So, that is why I guess.
Senator Collins. It is interesting because you think of
young people having their wisdom teeth taken out and being
given opioids, and I know that many of the dentists in Maine
have switched to strong doses of ibuprofen followed by Tylenol,
and alternating at every two hours, and have found that the
pain relief is just as effective and safer. And I see two of
you nodding your heads.
Dr. Coop. Yes.
Ms. Steinberg. I think acute pain, particularly in acute
pain is where we have had to cut back and should cut back with
opioids. And for dental procedures, it is usually unnecessary,
and hopefully, they have gotten the message now.
Senator Collins. Thank you.
The Chairman. Thank you, Senator Collins.
Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chairman and thank
you, Ranking Member Murray as well for holding this hearing.
Thank you to all of the witnesses for being here. We really
appreciate not only your presence but your expertise and your
commitment. As you know, New Hampshire has been especially
hard-hit by the opioid epidemic, and we also have many patients
who are suffering from chronic pain. So we need to make sure
that all of our patients have what they need to access care,
including those suffering from pain, as well as people who are
suffering from addiction and mental health conditions.
But provider shortages in all of those areas is a real
issue in my state. For example, Dartmouth-Hitchcock, which is
the largest health care provider in New Hampshire, has between
750 and 800 open positions at any time. And the state's
community mental health centers have more than 175 vacancies
for clinical positions.
This first question is to Dr. Coop and Dr. Gazelka, as
faculty of pharmacy in medical schools, I am interested in what
you see as the greatest workforce challenges, and your views on
the role graduate medical education play in training the next
generation of physicians? And a follow-up to that--you can
answer both--how could additional residency slots, particularly
it feels like pain management, addiction medicine, and
addiction psychiatry, improve access to care for patients? So,
Dr. Gazelka if you would like to start and then Dr. Coop.
Dr. Gazelka. I think, it is probably not a popular thing to
talk about, but I think the cost of medical school and the
loans that students accumulate during the time that they are in
their medical training, are cost-prohibitive, in some cases, if
you are going into some of the primary care practices and some
of the lesser reimbursed practices, which may be such as,
primary care psychiatry, addiction medicine, etc. And I think
that is a real problem.
I remember at the time that I was in medical school at the
University of Minnesota, the Dean came and spoke to our class
and said, so many of you are planning to go into specialties,
you need to go into primary care, we need primary care
physicians in Minnesota. But at the same time, the University
of Minnesota Medical School was the most expensive state
medical school in the United States at that time. And those
considerations have to be taken. And so, I think finding some
way to encourage students to go into specialties that are
needed, will be important in that regard.
Senator Hassan. Thank you.
Dr. Coop.
Dr. Coop. Approaching this, specifically from pharmacy,
pharmacist, as I mentioned, they are often the most
underutilized of health care professionals. They are the
medication experts----
Senator Hassan. Yes.
Dr. Coop. They are. I teach them all about drugs. They are
also taught how to counsel patients--how to appropriately
counsel patients with medications. One of the biggest issues we
have with patients taking medications is actually taking the
medication----
Senator Hassan. Right.
Dr. Coop. Right. If the medication does not get to the
patient, it is not going to do any good. So again part of the
financial model is reimbursement for those cognitive services,
and it is getting those reimbursements for those cognitive
services could bring the pharmacist into the health care team,
which would expand that access you are talking about.
Senator Hassan. Well, thank you. And that brings me really
to my next question, which was about reimbursement. And again,
to Dr. Gazelka, we know it can be a powerful tool to influence
the availability of services as well as providers behavior, and
that the lack of appropriate reimbursement, to Dr. Coop's
point, can create tremendous barriers for patients who need
access to a variety of services.
Insufficient reimbursement policies and Federal programs
like Medicaid and Medicare, as well as in private insurance can
sometimes create barriers to access to therapy and services
that can reduce opioid use, including chiropractic services,
some surgical interventions, acupuncture, behavioral health
programs, and multi-modal pain strategies. We have taken in
Congress some important steps over the last few years, both in
CARA and the Support Act, to help address some of these
barriers and certainly, Dr. Rao-Patel talked about things at
Blue Cross Blue Shield is doing to try to eliminate some of
those barriers. But, Dr. Gazelka, can you give me some
specific, concrete actions that Congress can take related to
reimbursement in order to improve patient access to non-opioid
pain management therapies and services?
Dr. Gazelka. I am an interventional pain physician and so I
do neuromodulation. I am implanting intravehicular drug
delivery systems, spinal cord stimulators, etc. In many cases,
it is very difficult to get those covered. I find that Medicare
is one of the most difficult, when I have a patient on
Medicare, to have access to those therapies. Those therapies
are proven in Europe to be extremely useful for chronic angina,
for instance, so that patients do not have to pursue further
stent placement, etc., or use opioids for chronic headaches,
but the coverage for them is poor.
I also think that I have rarely met a pain patient who
would not benefit from behavioral and psychosocial management.
It is vital that we treat those areas for patients, and they
are not covered. In the hospital, we would like to allow
patients who are having surgery to have access to non-opioid
management. We did a survey recently at the Mayo Clinic showing
at 94 percent of patients would choose something other than
opioids, acutely after surgery if they could, but we cannot
provide acupuncture, we cannot provide massage, we cannot
provide extensive physical therapy at sometimes, and
restorative therapies for those patients.
Senator Hassan. Thank you and thank you Mr. Chairman for
your indulgence.
Dr. Gazelka. Thank you.
The Chairman. Thank you, Senator Hassan.
Professor Cassidy.
[Laughter.]
Senator Cassidy. Thank you. First, Ms. Steinberg, you are
sitting back there, but I remember, and this will set up my
next question, I remember having, when I was first year in
Congress, having a slipped disc in my neck with radiating pain
down my honor distribution, and it was so incredibly painful. I
was imprisoned by the pain and all day long I just waited for
my every 6-hour dose of Motrin, and I staggered it with my
Tylenol, taking something just when I went to bed. And for
three or four months, that is all I did and it just sapped my
emotional energy. Now as eventually helped by epidural
injections, and this sets my next question, Dr. Gazelka, when I
looked at the research on epidural--and for people who are not
in medicine, they put a needle right there, they injected it
and it would give me instant relief that would then wear away--
I looked up the data and said it was no good.
The data says, epidural has no long-term benefit in the
management of chronic pain. But after my third one, it just
went away and never came back. Now, then I looked up the CDC
guidelines for management of chronic pain, and they say, going
back to Senator Collin's question, that there is really just no
evidence of the use of opioids long-term vs. no opioids vs.
etc., etc., etc. So it seems like we have a paucity of
evidence, and which empirically worked in me, you know N is
equal to 1, does not have the evidence to support it. Now
briefly comment on that, because then I am going to go to my
former student, Dr. Rao-Patel, to ask if Blue Cross is covering
things, which have no evidence, but nonetheless empirically do
work in some. So, quickly.
Dr. Gazelka. Dr. Cassidy, I do not have to explain to you
that you can find studies almost to back up whatever you are
looking to back up. You have acute pain. Epidurals very
effectively manage acute pain, radicular pain. Probably for
patients who have spinal stenosis or other types of chronic
radicular pain, they may not be as effective. I could tell you
that anecdotally from my practice. Do we use them? Yes, because
they are helpful to them. Sometimes patients do not have other
options available. But definitely for acute pain, those are
helpful.
Senator Cassidy. Now, of course, mine lasted 3 months. Now
eventually what my neurosurgeon friend told me is that it is
just part of your nerve will die, although I have a little bit
of something. It tingles right there. And then after that
death--that is a great way to look at it, I would feel better.
So, by the way also once read a Mad Magazine as a kid. Give me
statistics and I can prove that Rhode Island is bigger than
Texas----
[Laughter.]
Dr. Gazelka. That is right.
Senator Cassidy. To your point. But Dr. Rao-Patel, will
Blue Cross pay for that which evidence suggests does not work,
number one. Number two, Dr. Gazelka mentioned all these
wonderful things that can be used in lieu of opioids and the,
say, post-surgical study. But then my physician friends tell
me, hey, you are on a bundled payment, or you are on capitated
payment and the insurance company won't give you that bump up
for the more expensive drug, or the more expensive procedure.
And I see Dr. Gazelka over there vigorously nodding your head
yes. So tell us, as it ultimately comes to your decision as you
are the manager for Blue Cross, how does that handle?
Dr. Rao-Patel. Along with her comment, there are studies
that show that for acute pain, injections like epidural steroid
injections work. Again there multiple times of injections for
spinal pain depending on where the pain generator is. And those
are things that Blue Cross Blue Shield does cover. Several of
the things that we have discussed like physical therapy,
occupational therapy, water therapy, chiropractic care,
epidural steroid injections, those are all a multitude of
things that we cover as a plan without any type of prior
authorization. So if a provider feels that this is the
appropriate intervention for the patient for their pain, they
can go ahead and do the procedure, they do not even have to
contact us----
Senator Cassidy. Now, let me ask though because clearly
giving a prescription for opioids would be cheaper than a whole
panoply of that which might be less likely to induce--so and it
seems like that is the rub, right. If you get an x number of
dollars to manage patients, how do you employ that which is
significantly more expensive even though long-term there is a
benefit?
Dr. Rao-Patel. Well, I mean our approach at Blue Cross, is,
again we have participated with multi-stakeholders at our
state-level, including the Medical Board and Specialty
Societies on appropriate management and treatment of pain. And
our approach has always been a multimodal approach.
Senator Cassidy. Let me ask, as amounts at a time, and go
back to the question of a bundled payment, and I do not know if
Blue Cross uses bundled payment but I can imagine in some
place, either you do or you plan to, and again my pain
management physicians say, listen post-surgically, we can do
this or that, but it is more expensive than just giving them a
prescription or giving them an injection of an opioid. So, how
do we manage that? How do we approach, as policymakers, bundled
payments when we know that it may increase the cost to do
something, which would decrease the use of opioids?
Dr. Rao-Patel. Again, the reason that we bundle payments,
for example, is to be more cost-efficient overall. So, again,
we are again not trying to limit the options that providers
have in managing pain, but we are encouraging to use a
multimodal approach in terms of management.
Senator Cassidy. But I am not sure that answers my question
because if your cost basis is just getting a prescription for
opioids, but the alternative is this--and he is lightly tapping
this thing to tell me to shut up, so that will be a question
for the record.
[Laughter.]
The Chairman. Well maybe you could provide some--Senator
Murray would like to know the answer. So, we will extend the
discussion for Senator Cassidy and ask you if you have any
comment on what he just said.
Dr. Rao-Patel. Yes, again like I said, the things that, for
example, that I am aware of that we bundle at Blue Cross in
terms of payment, or for example post-surgery, let's say a
patient has a knee replacement or a hip replacement the
perioperative, the pre-operative period and the postoperative
period is bundled in a payment in terms of management of that
patient. It is more of a payment question that I could get back
to you on, in specifically what we bundle in terms of
interventional pain management procedures, but there are
instances where we do bundle payments in order to contain the
cost.
The Chairman. Thank you, Dr. Cassidy. I think she said she
wants to submit some homework to you.
[Laughter.]
The Chairman. It is terrific to have a United States
Senator who has a former resident student as a witness.
Dr. Rao-Patel. Yes, I feel like I am in his clinic right
now, so.
[Laughter.]
The Chairman. Senator Smith.
Senator Smith. Thank you, Chairman Alexander and Ranking
Member Murray, and I feel a little intimidated following
Senator Cassidy because my knowledge of physiology is
dramatically less than yours. But I really appreciate this
hearing so much and, Ms. Steinberg, I think it is so important
that you are here because in this Committee, we all have our
personal stories and we are focusing on the policy issues, and
some of us have our own experiences with, pain in our families.
But to be able to have you bring it down to the reality is
extremely helpful so thanks. Thanks so very much.
Dr. Gazelka, I know that when I meet with health care
professionals and families all across Minnesota, what I hear
over and over and over again is the need for a coordinated
approach to health problems that are complicated, and cannot
just be resolved in one way with one provider. And this is--
especially when you think of that all the related issues that
relate to whatever that one primary diagnosis is, and this is
particularly true for pain management, and we know that chronic
pain is associated with all sorts of issues like frustration,
and stress and depression, isolation and I know that Mayo
Clinic understands this so well. Mayo is renowned for the
collaborative approach that you bring to all different kinds of
health challenges. Not only this challenge, but this seems to
be particularly appropriate. So I am wondering if you could
just talk a little bit about the connection between pain
management and mental health disorders, and the tools that you
see. I am interested in getting from you kind of what we ought
to be doing at the Federal Government level to encourage that
kind of coordinated approach when it comes to pain management
in mental health disorders.
Dr. Gazelka. It is well known. It is well understood that
anxiety, depression, and other mental health disorders are far
more prevalent in patients who suffer from chronic pain. They
are highly prevalent, and so in treating the whole patient with
pain, you must treat their anxiety, their depression, or other
mental health disorders. I think an excellent example is the
Pain Rehabilitation Center at Mayo. It is an integrative
approach. It is housed within our psychiatry department, but it
involves pain physicians, physical and occupational therapy. It
is a multi-specialty. I think we have gotten away from the pain
clinics of 30 years ago, where patients would come in and they
would essentially see a team. They would see a team that
included a physician, that included a psychologist, typically,
that included perhaps a physical therapist or someone involved
in restorative therapies. And reimbursement for that type of
model, I declined.
It became more interesting to do interventional procedures
for patients, which are sort of our rapid, fix me now, and I
think that a return to that sort of a model of chronic pain
management is essential for caring for patients well. And so I
think integrating those services is very important. And then
addiction medicine. I can tell you, we do so many surgeries a
year. I, could not tell you the number, but a lot of patients
come in on chronic pain medications and they have issues with
addiction. They come in on their buprenorphine, their
methadone. Well, how are we going to treat their pain acutely
while they are hospitalized? Well, that takes some coordination
with our addiction medicine colleagues as well, because just
because you have an addiction does not mean you are not going
to need a surgery, or need chronic pain management at some
point in your life.
Our palliative medicine clinic is full of patients who have
developed cancer or some other chronic, or terminal disease
even, but they also suffer from substance use disorder. And so,
we have had to coordinate care for those patients so that they
can have appropriate management for their pain, but also for
their substance use disorder or mental health issues.
Senator Smith. If we think about what we can do at the
Federal level to encourage that kind of approach, I guess it
gets somewhat to the line of questions that Senator Hassan was
asking about how reimbursements do not support a comprehensive
approach, is that fair to--the way reimbursements happen do not
support a comprehensive approach, would you say that is true?
Dr. Gazelka. I think that is true. It is very hard. For one
thing, about positive addiction medicine, physicians and
providers throughout the United States, beginning with the Mayo
Clinic, we do not have addiction medicine services in our
hospital. Patients have to see those providers as an
outpatient. Reimbursement is poor for that, and at a point
where they could be touched and significantly altered in their
course. They are not able to have that type of contact.
Senator Smith. That leads to some much fragmentation.
Dr. Gazelka. Right.
Senator Smith. Also, in their care, which is bad.
Dr. Gazelka. Even talking about buprenorphine cover, for
instance. There is so much talk about pharmacists providing
buprenorphine, mid-level in NPs, PAs providing buprenorphine.
But you cannot just give a patient buprenorphine. Buprenorphine
can also be a drug of abuse. You have to give a patient the
other addiction management services that they require to be
successful.
Senator Smith. Thank you very much. I know I am out of
time, but I appreciate that very much. Thank you.
The Chairman. Thank you, Senator Smith.
Senator Romney.
Senator Romney. Thank you Mr. Chairman and Ranking Member.
I appreciate very much the comments of the panelists,
particularly Ms. Steinberg, who has made a real sacrifice in
being here. Appreciate your coming here despite that pain. Your
testimony, Ms. Steinberg, reminds me of my experience having
served as the Governor of the state where you now live, and I
once did.
That is, we noted that we were spending a lot of money in
Medicaid psychotropic drugs and we could not quite figure out
why and determined that most of these drugs are being
prescribed by primary care physicians who had very little
experience in really deciding what the most effective
psychotropic drug might be. And after some consultation we
said, we are not going to--Medicaid is going to no longer
reimburse psychotropic drugs to young kids unless the doctor
prescribing it contacts a physician at the University of
Massachusetts Medical School that is a psychiatrist or in that
trained field. That does not mean a psychiatrist had to approve
the prescription, just they had to have a conversation. And by
doing so, we found that the number of prescriptions
dramatically came down, and the quality of care, we believed,
substantially improved.
I think each of you has spoken about the fact that most of
this prescription of opioids is being done by people who are
not specialists in the field. And I wonder whether the lack of
best practices is not something, which is really affecting the
challenges that we are facing, both for those that have chronic
pain and for those that are abusing these products. Should we
have some mechanism, that one gathers data from all over the
country from everybody who is using these drugs to see what the
effect is, but number two, a place where physicians go to get
consult, if you will, before they prescribe for someone that
has chronic pain--prescribe medication for someone with chronic
pain. Do we not need to something of that nature, and how would
something like that be structured at a state or national level?
I am happy to turn to any one of you that would like to comment
on that.
Ms. Steinberg. The program mentioned is one attempt to do
that. We are doing that in a small model, where PCPs can call
for a consultation. I think that is a great idea. One thing
that is not a good idea, I think, that was tried, I think was
in Washington State, so that nobody could get an opioid
prescription without having seen a specialist. And it turned
out there is like a handful of specialists in the state. And so
people with pain who really did need their prescriptions, could
not get their medication. They had to go out of state to get
their medication. And it was a disaster. So, I really encourage
us to think through the way we implement that. Clearly,
education is the other side of what you are talking about, and
there is an absolute dearth of pain education. We are not
training people on what we now know. So medical schools just
absolutely are ignoring this.
Senator Romney. The challenge with that is that if you take
more time on one subject, that means less time on another
subject, and so consult may be a way we need to go. I am going
to ask with regards to Blue Cross Blue Shield, are you able to
get expertise to the people who are backing these
prescriptions?
Dr. Rao-Patel. To answer your question, I will say, one
thing is that often times it needs to be the primary care
physician who is managing the pain. Because, for example, in
North Carolina with a lot of rural areas, access to a primary
care physician can be challenging and access to a pain
management doctor can be even more challenging. So we have
really--we actually just started working with a new company,
Quartet, who is bringing behavioral health and mental health
into primary care areas to empower primary care physician.
There is also something that you might have heard before
Project ECHO, which is a platform that, several Blue Cross
plans are already using, which if anything is sort of a ground
rounds, if you will, where primary care physicians or any type
of physician can call in and seek expertise from people who are
addiction specialist or pain management doctors, and it is
meant not only for a consultative purpose, but also an
educational purpose so that way the physician learns in the
future how to manage a patient that way.
Senator Romney. Yes, thank you. Please, please.
Dr. Gazelka. On that, Senator Romney.
Senator Romney. Yes.
Dr. Gazelka. We have, on a small scale at Mayo, begun
using--we need to leverage telemedicine and electronic medical
records, which are now more and more beginning to speak to each
other. Finally, at Mayo we have a health record that speaks
to--so we can talk anywhere in the country about our patients
and look them up. We have developed a controlled substance
advisory group where a specialist, such as myself, sits and
hears the cases that are brought by primary care physicians. So
they bring forth patients with difficult pain management
problems, patients with a substance use disorder problems,
etc., and we have specialists from all those around, who sit at
the table provided by us and then we enter a note in the
patient's medical record, stating what the decision of the
panel is. And I think I have visions of expanding that because
I think it would be incredibly helpful to primary care
providers. Obviously, there are HIPA, restrictions and things
like that across various states, but I think it would be great.
Senator Romney. Thank you. My time is up, but I do want Dr.
Coop to instruct a system a path forward on cannabis research,
but we will save that for another day.
The Chairman. Thank you, Senator Romney. And of course, if
any of you have additional comments that you would like to make
to Senators, you can submit those in writing after you leave.
Senator Rosen.
Senator Rosen. Thank you, Senator Alexander. Senator Murray
and I really appreciate the panelists here. I hope that my
acute pain from wrist surgery does not turn into chronic pain,
but that is another issue. But what I want to say is before
coming to Congress, I stepped back from my career for several
years, was a caregiver to my parents and my in-laws. During
this time, I became very familiar with the field of medicine
known as palliative care, and the relief from pain symptoms, of
course, and the stress that specialized care can provide.
Palliative care focuses on improving quality of life for those
with often life-limiting illnesses, including those in
significant pain or having a terminal illness, often in that
gap between end-of-cure and end-of-life, like my mother.
Last Congress, I launched a bipartisan Palliative Care Task
Force in the House to bring attention to this type of care. I
am hoping to do that here. So, I have a couple of questions for
you Dr. Gazelka. In your experience, is it common for patients
diagnosed with chronic pain, or possibly terminal diagnosis, to
have those conversations with their doctors about palliative
care as a treatment option, and how can we ensure specifically
with primary care physicians that they understand the needs of
terminal or long chronic pain patients? How do we do that,
possibly maybe requiring ongoing CME for primary care
physicians in this area?
Dr. Gazelka. I think that is a vitally important topic, and
not common enough. I think patients make choices that they do
not want to make, to come in and have treatment for things that
they would not necessarily choose to have treated. 100-year-
olds ending up in the ICU with pneumonia or with a hip fracture
because no one had a conversation with them that it is okay to
be comfortable and to even do this at home, perhaps, on
hospice, to be taken care of, or in another nursing facility.
And so I think empowering patients to have those conversations
with their physicians is vitally important, and training
physicians and other providers to have those conversations is
really----
Senator Rosen. Do you think that we could possibly provide
that by improving the way we use continuing medical education,
maybe requiring this pain management, chronic pain management
as an ongoing CME requirement, especially for primary care
physicians? Do you think this is something that we could help?
Dr. Gazelka. I absolutely. I think it would be helpful. We
have instituted in our medical school, for instance, a
palliative care education program. Very uncommon in medical
schools, but people need to have not only an understanding of
what patients' rights and preferences might be but know how to
have conversations. And it is the skills of having critical
conversations that are vitally important.
Senator Rosen. But you think to retain board certification
possibly in family practice or a primary care physician
required, just like we do for mammograms certain requirements
or hours, this could be a way we could go?
Dr. Gazelka. I do. It is being required for opioid right
now.
Senator Rosen. Thank you. I have a question also for Dr.
Coop about medical marijuana. In Nevada, we have ranked 13th in
the Nation in prescribing opioid painkillers. Our former
Governor took action by forming a new state agency, the Opioid
State Action Accountability Agency. We do have legalized
medical marijuana in Nevada. We have found that using that has
reduced the prescriptions for high potency painkillers, and so
in your experience, what do you think are the barriers into
effective research for the benefits of cannabis treatments, and
how can this possibly be an--or can this possibly be a non-
addictive approach or alternative to chronic pain, just another
tool in the toolbox?
Dr. Coop. I, first of all, think it has great potential to
be another tool in the toolbox. I do not think there is ever
going to be a one-size-fits-all magic bullet because pain is
different in different people. In terms of how to move the
research forward in medical marijuana, one of the issues has
been because of the unusual legal status, shall we say, in the
United States. Research has been limited. There is no
consistency between the different types of marijuana, the
studies done. So, what we need is good--they are going on. Some
are coming but we need more. We need good, consistent, well-
designed clinical studies with good, consistent material so
that we can fully assess the impact, do not get me wrong, also
the potential drawbacks.
Senator Rosen. Right, like everything else.
Dr. Coop. Right.
Senator Rosen. Thank you so much.
The Chairman. Thank you, Senator Rosen.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman, and Ranking
Member. Thank you for this conversation this morning. So
important, and I really appreciated the back and forth there
with Senator Romney, clearly coming from a very, very rural
state. When you are dealing with how you respond to patients'
pain issues and you do not have access to, perhaps, those
alternate pain management technologies, the different therapies
that are available, the quick, and easiest, and cheapest, to
Senator Cassidy's point, is the prescription drug. And so, this
idea of eConsult is really critical. We pioneer a lot in the
telehealth space, but making sure again that there will be
reimbursement for these consoles is important. And Dr. Rao-
Patel, the words that you used where you are empowering the
primary care docs, but translate that to me. Do you cover these
consults then?
Dr. Rao-Patel. Yes, we do. We do cover telehealth, and in
fact, like I mentioned. One of the things that we are doing----
Senator Murkowski. Telehealth specific to these types of
pain management consults?
Dr. Rao-Patel. Correct. And a lot of behavioral health
telehealth as well, as it is used to treat opioid use disorder
as well.
Senator Murkowski. Good.
Dr. Rao-Patel. I guess one of things I was going to mention
is that, that is one of the things that we have really
developed and are expanding on, at least on our Blue Cross
North Carolina program, is increasing access for folks
especially in the rural areas that we talked about, to be able
to access providers that they would not otherwise be able to
through telehealth.
Senator Murkowski. Right. Let me just--I am going to ask
one question for all of you here, so you can probably jump in
on this Ms. Steinberg. The big conversation over the Christmas
and the New Year's holiday back home was what we are seeing
with constituents in our bigger population centers, so out of
the rural areas but in Anchorage and in Fairbanks, they are
being denied prescriptions where the prescription drug is
opioid-based. Some of it goes to the bias issue, but it is the
pharmacists that are refusing to fill the prescription the
doctor has prescribed and we are not--certainly the involvement
that we have had with these constituents, it certainly does not
appear to be abusive situations, but people who have
legitimately been prescribed these pain medications for these
debilitating and long-term pain management issues.
I understand that it relates to the recent guidance coming
out of CDC, recommending, restricting how much a pharmacy can
do and guidance in controlling law, but in an abundance of
caution, the pharmacists are saying no we are not going to do
this. So, you now have the patient in the middle of a
regulatory debate, if you will, and it has caused the lid to be
blown off the discussions in my state, and I cannot imagine it
is just in Alaska. What are we doing to address this tension
now, this conflict between prescriber and the pharmacist? And
then ultimately we want to be helping the patient, but we have
got a struggle going on and I do not know who is addressing
that. Can anyone of you speak to that?
Ms. Steinberg. There is a terrible of fear out there among
all practitioners right now, and they are just--they do not
even want to treat people with pain anymore. That is how it has
gotten. That bad. And, like your example, I had a doctor from
Dana-Farber Cancer Center call me saying pharmacist will not
fill my prescription for patients that I have that have really
bad cancer, and so it has gotten to a point where--it has just
gotten so unreasonable. There is a history out there.
Senator Murkowski. What do we do?
Ms. Steinberg. I think we need to educate everyone better
about this issue. I think we need public education about pain
and the fact that pain is a disease itself, so people
understand that we are not just talking about acute pain here.
Chronic pain is devastating, and for the kinds of things that
you are talking about, pharmacists are not getting proper
training in that. I do not think anyone is getting enough
training in pain.
Senator Murkowski. It is pharmacists who are not getting
the training, but you have also said that the physicians do not
get enough training.
Ms. Steinberg. Correct.
Senator Murkowski. Dr. Coop.
Dr. Coop. I was just going to say that folks do view the
guidance as being like gospel, so I think those guidance on the
quotas, I think they have been taken too far, and that needs to
be rolled back. This is one thing that can be done. Yes, all
health care professionals could certainly benefit from more
education in this area.
Ms. Steinberg. The other thing I wanted to add to this
whole discussion of specialists, and consult, and telehealth,
is that we do not have enough pain management specialists. And
I know Senator Hassan has left here, but she brought that issue
up. There are so few doctors specializing in pain management
that it takes people more than a year, in my pain group, to get
an appointment with a pain specialist. There is a dearth of
them and I do not know in your state, I can just imagine how
few there are. So, we are talking about consults and
telehealth. There are not even specialists to handle the
telehealth. We need to incentivize pain management as a
specialty. There is a board certification and there is a dearth
of physicians.
Dr. Gazelka. I just wanted to comment on the unintended
consequences of some of the use of the CDC guidelines. There is
only number six in the CDC guidelines. It is a very small
section talking about acute pain management, that three days,
at the most seven days, should be considered for acute pain
management. It has been made into law in many states. Many
insurers have used this. It is not a problem of pharmacies at
the Mayo Clinic, it is a problem of our insurance companies.
We literally are keeping patients in the hospital longer
because we cannot get their prescription for discharge pre-
authorized so that they can go home to North Dakota or they can
go home to Montana. They are staying in a hospital because a
physician will give out a prescription for two weeks of
opioids, which is what we have decided on, if that is a certain
procedure that we have decided that on our guidelines. This has
to go too. Their insurance company or pharmacy has to submit
it, a patient cannot get a prescription for that link, so they
stay in the hospital while we work that out. There have been
some significant unintended consequences in multiple of the
pharmacies as well. Larger pharmaceutical companies and I have
spoken to some of them on the phone, have arbitrarily set 7-day
limits on what they will allow patients to have and they cancel
the rest of the prescription from the physician. This means
more trips back to the doctor for the patient, who may have
just had surgery. This means another copay for the patient, who
has already paid one copay for their opioid when they need a
refill. So, it can be a really significant issue. I respect
that.
Ms. Steinberg. The task force has looked at the CDC
guidelines and have some really great recommendations on how
they need to be revised. Picking a dosage level is an arbitrary
decision. It was not scientifically based and it has now become
law, and it has caused all kinds of problems.
Dr. Rao-Patel. Can I just add one thing to that? I will
just say that I think a lot of the issues with the CDC
guidelines are just that, I think, it is a lack of education on
the part of the physician, as well as the pharmacist in
understanding that they are just that, guidelines. That there
are going to be patients who will potentially look like
outliers and go higher than what CDC recommendations are, and
that might be entirely appropriate for that patient population.
So, I just wanted to mention that as well.
Senator Murkowski. Thank you. Mr. Chairman, I know we are
well over, but we have apparently revealed something here.
[Laughter.]
The Chairman. Well, we are all interested in those answers
and I think it is worth saying that we considered and rejected
the idea of a Federal law establishing 3 and 7-day
prescriptions, leaving that to states, and physicians and
caregivers to work out. And I think that is proving to be a
wise decision, although I hear what you say about CDC. Doctor--
not doctor but--
Senator Jones.
Senator Jones. Doctor-Senator would be fine.
[Laughter.]
The Chairman. Senator Jones. We have a Doctorate from Law
School.
Senator Jones. That is right. Thank you, Mr. Chairman and
Ranking Member. Thank you all for being here today. One brief
comment, I appreciate the comments on telehealth and
telemedicine. And we are continuing to have our rural hospitals
and providers leave our rural areas, and I have always thought
that telemedicine and telehealth is one way to try to keep
that. It is only, however, as good as our rural broadband and
access to the internet, and that is something that we are, my
office, are continuing to push forward and I would--any help on
that area to try to get broadband in those areas would be
great.
I do want to follow-up though with an area, and I--a lot of
times when we ask these questions, people think we are going at
it with an agenda. And sometimes we are, sometimes we are not.
This is not one of those. But Senator Rosen asked about the
research and development using medical marijuana and cannabis,
and Dr. Coop, you gave a very good answer. I appreciate that
very much, but I would also like to hear from the other three
of you on this issue. I do think it is an important topic. It
is one that, in the public's mind, it is growing throughout the
country. And so, with each of our physicians as well as Ms.
Steinberg there, if you would.
We will just start with you, Ms. Steinberg. If you could
comment on the pros and the cons of what you see in the
developing of medical marijuana, cannabis. The ability to use
this alternative, but also the research that would be required
to go into it.
Ms. Steinberg. Yes and actually, cannabis has helped a
number of people living with pain. It is another option, as we
talked about, in the toolbox. It has helped a significant
number of people, but it is not legal in a lot of places and
therefore, even where it is legal, as Dr. Coop said, it is not
standardized. Doctors need to be the ones prescribing it, but
they do not know what they are doing with it. They are not
trained with it either. And so without having a real good
research base--we are just flying, blind.
Senator Jones. What prohibits the research base?
Ms. Steinberg. The fact that it is not legal.
Senator Jones. Okay. Just wanted to get that in the record.
It is a scheduled substance so that it limits the amount of
research considerably that can go on with both the pros and the
cons.
Ms. Steinberg. Yes.
Senator Jones. Yes. Okay, thank you. Dr. Gazelka.
Dr. Gazelka. I do not think we do know that marijuana is
not addictive. I have certainly seen patients who have
excessively used marijuana, not medical marijuana perhaps but
the pot, and it is believed to be an addictive substance. You
have said not that many years ago, we heard that opioids were
not addictive, and so I think we have to proceed with caution--
--
Senator Jones. Right.
Dr. Gazelka .----as with anything else. I think that
inconsistency among the products that are produced with the
ratio of CBD to THC, etc., is an important component of this
that will factor in when it is being researched. But I think
the impediment has been that it is a schedule II--a schedule I
substance rather, sorry. It is not permissibly prescribed by
providers, but I do think that there may be some significant
areas where this may be very useful. I have some palliative
medicine patients using it for nausea, appetite, etc. And I
think it can be helpful.
Senator Jones. All right, thank you. Yes, ma'am.
Dr. Rao-Patel. I would agree with that. I think due to
limitations, such as the fact that it is illegal in some states
as well as on a Federal level, make research difficult. I think
a lot of times I have seen patients of mine in the past who
were taking opioids and, we did a urine drug screen on and they
tested positive for marijuana, and they found that seemed to
help more than being prescribed an opioid or any type of
adjunctive medicine to do an opioid.
I do think that there is, from a physician's standpoint, I
think that there is some potential to the utility of medical
marijuana for the management of chronic pain. I will say
putting on my other hat as an insurer hat that we obviously
only cover procedures and drugs that are FDA approved. So, we
would obviously need some clinical evidence to support to be
able to cover those kinds of medications.
Senator Jones. Have any of you got any suggestions? Other
than short of removing it off of schedule I, which I guess you
could do and put some other weird restrictions I guess, what
can we do other than--is there anything other than that, that
we can do to open up the ability to research the pros and the
cons of medical use of cannabis? Or is that the impediment that
we have got to try to figure out how to deal with? Dr. Coop.
Dr. Coop. I was going to go into this and I would say that
this is a decision that the National Institute on Drug Abuse,
with the experts that could know all the confounding factors,
it would be something that I think we should charge those guys
with--coming up with what is the best way forward.
Senator Jones. Okay. Right. Well, thank you all for your
answers and thanks for being here. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Jones. Senator Murray, do
you have additional comments?
Senator Murray. I just would like to thank all of our
panelists for being here today. This has been, I think, really
an interesting, and eye-opening, and important hearing and I
want to thank all of you for your help today.
The Chairman. Well, I agree with Senator Murray's
sentiments, and I only have one question. Several of you have
mentioned, in response to questions from Senators, that what we
could do about this is public education. Well, that is what we
are attempting to do today. I mean the U.S. Senate is a forum
that helps lead the way to recognize opioid abuse and try to
deal with it, and we should at the same time try to lead the
way to determine whether there are some unintended consequences
and whether the millions of Americans who live with pain are
not able to deal with pain as a result of the reaction to the
effort to stem opioid abuse.
We have heard today that reimbursement policies are
important. That primary care doctors and their education is
important. We have talked about the most promising non-
addictive pain medicine. That has been a priority of Senator
Murray in her role as senior Democrat on the Appropriations
Committee that deals with health, and this Committee, where we
have attempted to push more funds into the National Institutes
of Health toward non-addictive treatments and medicines. And
Dr. Collins has been here to testify on that and is working in
a variety of ways to accelerate that.
We have talked today about pharmacists and what their role
might be as we go along, but I wanted to ask one last question
about the CDC, the Center for Disease Control recommendations.
They are not law. They are not rules that anyone has to follow,
but the CDC is enormously respected in states and in the
medical profession, and in this environment, sounds to me like,
Ms. Steinberg, that your experience of using a low dose of
hydrocodone and one other over the counter medicine for 10
years to relieve pain would not fit with the CDC guidelines for
your doctor. So what recommendations--my final question would
be and you can elaborate if you would like to after you leave,
and you can submit it in writing, but each of you, what would
be your recommendations about the existing guidelines of the
Center for Disease Control guidelines for opioid abuse, and how
we can make sure that, while we are dealing with the opioid
epidemic, that we do not make it difficult or impossible for
people who need opioids to relieve their pain to get them.
Let's start with you, Ms. Steinberg.
Ms. Steinberg. Yes, I think the best thing you can do is
have the CDC guidelines revised. They really have been taken as
a law. As the CDC is behind them, people think that those are
based on strong science and they are not.
The Pain Management Task Force that Congress did wisely
create, of pain management experts, is producing a report now
and the report specifically reviews the CDC guidelines and
makes excellent recommendations on how to revise them. I really
think that Congress should ask CDC to revise those guidelines
based on the task force report. Dr. Gazelka and I both serve on
that task force and they really need to be revised. CDC are not
pain experts and they did not use pain experts to create those
guidelines, sadly.
The Chairman. Well the CDC deals with epidemics and
obviously, we had an epidemic, but I hear your suggestion and
maybe that is a subject for another hearing.
Ms. Steinberg. NIH is the best place to put pain. NIH has
an office of pain policy. The CDC has no pain section. I have
done tons of research at CDC to understand why their attitude
toward pain is the way it is. They do not have pain experts.
NIH is the place really, that should decide those things. They
have the office of pain policy. They know about pain research,
and I think they are the best people to make a decision like
that and to pull the experts together. They have done the best
job with the national pain strategy and with everything else. I
really do not think it belongs in the CDC.
The Chairman. Thank you, Ms. Steinberg. Thank you again for
making the effort to come today.
Dr. Gazelka.
Dr. Gazelka. I think the best thing that could happen with
the CDC guidelines is that people understand what they were
intended for. They were intended to advise primary care
providers, they were not intended to provide hard-and-fast
rules. I actually like the CDC guidelines, at the risk of
having tomatoes thrown at me. We use those guidelines to form
our chronic pain management guidelines at the Mayo Clinic. I
think they have a lot of good advice on how you monitor a
patient appropriately when you place them on opioids. The doses
that are mentioned probably are not scientifically based, as we
would prefer that they would be, but they do not say do not use
chronic opioids. They suggest doses where you might kind of
yellow-light, red-light, become concerned with the use. And so
those numbers are concerning somewhat, but I think the basis of
the guidelines was sound, as far as the intention of them.
Where the numbers came from is probably more questionable.
The Chairman. Do you see those guidelines as inconsistent
with say a decision by Mayo team for knee surgery, 16 days of
opioids would be appropriate?
Dr. Gazelka. Yes, I think that there is very little
mention, as I said, of acute pain management. They were not
really intended to address acute pain management as much as
chronic pain management. They do suggest that you limit to 3
days or 7 days unless there is a compelling reason to do
otherwise, and I think that leaves some room for a physician--
--
The Chairman. But that is per prescription, right?
Dr. Gazelka. That is correct.
The Chairman. It is not for everyone.
Dr. Gazelka. For acute prescribing. That is right. For a
one-time incident or surgery, yes. Not for chronic pain--the
guidelines within are different.
The Chairman. Just for the layperson, which most of us are,
what is a short description of a difference between chronic and
acute pain?
Dr. Gazelka. Yes, so we have considered, in the medical
literature, typically three months has been used to describe
the transition to chronic pain. We use 45 days at Mayo just to
allow our surgeons a shorter time that they would be
prescribing. But I think between 45 days and three months.
Anything over that time is typically considered chronic.
The Chairman. Dr. Coop.
Dr. Coop. There is not much I can add that has not already
been add by my learned colleagues, except that it is the law of
unintended consequences and people take these guidelines as
law. So we need to reassess them and we need to remind everyone
that they are indeed education and a place to start. That is
what we need to do.
The Chairman. Thank you.
Dr. Rao-Patel.
Dr. Rao-Patel. Yes, so I will just add this comment and say
that I agree with everything my colleagues have said here, but
what I will say is that the reason that the CDC made these
guidelines, is part of the reason that we have an opioid
epidemic now, is because there was a lack of education and
knowledge on how to prescribe these medications.
I won't pick on any other specialty but my own. I know they
are geared toward primary care physicians, but they can be used
for any specialty. And as a physiatrist, I will say that
physiatrists used to write a lot of opioids. We write a lot of
opioids. A lot of us are interventional pain management
doctors. A lot of us do chronic pain management, which is what
I did. So I think that the goal of what the CDC was doing is
correct, which is that there were not a lot of guidelines on
how to prescribe these medicines, so people would go in to
their physicians on Monday morning after having a flare-up of
their back because they painted their home, and they would come
home with a 30-day prescription of opioids, which is not
necessary. So I think the intentions were correct.
I think like any other guidelines, they are guidelines.
There are going to be people who fall outside of those
guidelines and it is entirely appropriate to prescribe outside
of them. I think that is where the universal precautions come
in, managing chronic pain and making sure that you are
assessing a patient's function, a patient's--how they are
responding to the pain, or are there any other, risk-benefit
ratio, do they have informed consent, etc. And I think like any
guidelines, they are open for revision. Just because something
was written one month ago, three months ago, six months ago,
does not mean that six months from now the guidelines have not
changed.
What I would say is that they are a revolving door of
guidelines. I think there is certainly room to improve them, to
change them, but I do understand the reason that they were
written, and a lot of that is the reason that we are here
today.
The Chairman. Thank you very much. This has been a follow-
up to what the President described as the most important
Federal law to try to fight a public health epidemic. That was
the opioids epidemic. But as I mentioned earlier, this
Committee, which has as you can see from the personalities on
the Committee, has broadly divergent views. Generally left to
state physicians and agencies who write guidelines. These
decisions about limits on prescriptions, rather than try to
write an inflexible Federal law that applied everywhere.
There is plenty of room for discussion and adjustment if
adjustments need to be made. We welcome any follow-up comments
you would like to make. You can tell by the interest from the
Senators today that we are very interested in the topic. The
hearing record will remain open for 10 days. Members may submit
additional information during that time if they would like.
The Chairman. Thank you for being here.
The Committee will stand adjourned.
QUESTIONS AND ANSWERS
Response by Cindy Steinberg to Questions From Senator Murray, Senator
Casey, Senator Warren, Senator Hassan, and Senator Murkowski
SENATOR MURRAY
Question 1. H.R. 6, the SUPPORT for Patients and
Communities Act that Congress passed last year to address the
opioid crisis, includes several specific provisions requiring
CMS and FDA to examine barriers to the development and adoption
of non-opioid alternatives, including payment and coverage
policy. What do you see as the most significant barrier to
further adoption of non-opioid alternatives for pain
management? What can be done to overcome or address these
barriers?
Answer 1. The most significant barrier to the adoption of
non-opioid treatments for chronic pain is cost and the lack of
public and private insurance coverage, limited payer coverage,
elaborate prior authorization hurdles and high deductibles, co-
pays and co-insurance for these therapies. Individuals living
with high impact chronic pain, which the CDC and NIH have
reported to be 19.6 million Americans either are completely
disabled by their pain or can only work part time.
Consequently, they are living on very limited budgets and can
ill-afford these treatment modalities.
To overcome these barriers, payers including CMS and
private insurers should be required to: cover a broader range
of treatment options such as acupuncture, massage therapy,
aquatherapy, chiropractic, relaxation and mindfulness
meditation among others; remove payer limits on physical
therapy and occupational therapy allowing physicians to decide
when these modalities are needed; and, ensure that payers allow
exceptions to lengthy, complicated prior authorization
procedures for non-opioid pharmacological treatments.
Question 2. For some people with chronic pain,
accommodations provided by an employer can make the difference
between staying in the workforce or being forced out. Can you
comment on the importance of accommodations for chronic pain in
the workplace?
Answer 2. This is a very important issue that could greatly
reduce the high rate of disability among those with high-impact
chronic pain. There are a myriad of diseases, conditions and
trauma including accidents and surgery that result in chronic
pain. We now know that when pain continues past 6 months it can
become a disease itself of the nervous system and brain that
can go on for many years or last a lifetime and can be
extremely debilitating. Unfortunately, this information is not
understood by the general public and most employers. Because
pain is an invisible disability, chronic pain sufferers are
often not believed nor accommodated in the workplace. In many
cases, due to stigma, pain sufferers are afraid to come forward
and ask for accommodations. This is all very unfortunate and
wasteful because people with pain want to work, be productive
and earn a regular salary.
If employers were incentivized to make accommodations for
employees with pain and workers were not afraid they would be
penalized for asking for an accommodation, many more people
with pain would be able to stay in the workplace and be
productive. Often the accommodations needed are not that
difficult to implement. For example, individuals with
repetitive strain injuries who are unable to use their hands to
type on a computer can be accommodated with voice recognition
software. People unable to sit for more than a few minutes can
be accommodated with a standing desk or those unable to be
upright can lie down and use a special table to access a
computer. Being able to work virtually from home is another key
accommodation that would enable many people living with pain to
be productive wage earners.
I firmly believe that an awareness campaign to educate
employers and the public about the prevalence of and
debilitating nature of high-impact chronic pain and what could
be done to be more inclusive of and accommodating to people
with such disabilities would more than pay for itself in
reduced disability costs and increased productivity.
Question 3. Similar to other health advocacy groups, the
U.S. Pain Foundation has received significant funding from
pharmaceutical companies and there are multiple open
investigations into how the Foundation spent funds it raised
from pharmaceutical companies under its former CEO.
Why do you think so many health advocacy groups rely on
pharmaceutical funding?
Answer 3. Most patient organizations rely on pharmaceutical
funding because it is one of the only sources of funds for
these groups. It is unclear to me why health insurers and other
industry stakeholders, like medical groups, pharmacies, etc.,
don't offer much if any support to patient groups. In order to
actively raise funds from philanthropic organizations and
wealthy donors, non-profits require development professionals.
These professionals command high salaries that small non-
profits cannot afford. To my knowledge, there is also a
significant lack of public and private grants available for
patient groups.
US Pain Foundation offers a rich array of educational
programs and materials, pain awareness activities and events,
support services and advocacy free to patients. US Pain
Foundation materials do not promote any specific product. It
costs a great deal of money to develop and run these programs.
US Pain Foundation's constituents are mostly people with high-
impact chronic pain who are disabled by their conditions and
have extremely limited funds. They cannot afford to pay
membership dues nor pay for educational materials, access to
events, support groups or other resources or donate money to
the organization.
US Pain Foundation's programs reach thousands of patients
every year and provide them with hope, support and information
to enable them to better cope with their illness, advocate for
themselves and take back control of their lives which many feel
they have lost. US Pain Foundation and similar groups are a
life-line for tens of thousands of Americans. Would it be
better for these organizations to cease to exist rather than
accept funds from pharmaceutical companies?
One suggestion I can make in this regard is for the Federal
Government to make grants available to patient groups
especially for the development of patient education programs
and training programs to train support group leaders to run
networks of patient support groups. Having run a support group
for 19 years as a volunteer, I have seen firsthand how these
programs can provide patients with important self-management
skills that help them live happier, healthier and more
productive lives despite their conditions. Successful groups
save costs in the longrun by helping patients gain control over
their conditions to be able to return to work at least part-
time as well as take an active role in finding and managing the
right set of therapies to keep them functional and engaged,
thereby reducing unnecessary healthcare costs. It is very rare
for leaders to continue to run a group for years as a volunteer
like I have. It costs money to develop training programs,
create materials, find good trainers and potential leaders,
transport them to a training location, rent a facility, provide
meals, etc.
Question 4. Do you think more transparency about where pain
advocacy groups' funding comes from would be beneficial to
patients and families?
Answer 4. It is always good to know where an organization's
funding comes from. US Pain Foundation lists its funders for
every program the organization runs on its website. In
addition, the organization publicly provides copies if its
2016, 2017 and 2018 Form 990 Information Returns as well as its
2018 Audited Financial Statement which can all be found at
(https://uspainfoundation.org/funding/).
SENATOR CASEY
Nationally, more than 70,000 people died of drug overdoses
in 2017, with the large majority of these deaths caused by
opioids. My home State of Pennsylvania had the third highest
rate in the Nation in 2017, resulting in nearly 5400 deaths,
many hundreds of whom were under the age of 25. Given this
ongoing public health emergency, activities to reduce access to
opioids are an essential part of the national, state, and local
response. However, it is also essential that we do not forget
about people who live with chronic pain and that we ensure that
they have access to coordinated pain management approaches that
meet their specific needs and improve their quality of life. It
is also essential that insurers and health care providers both
have the tools for and are held accountable for providing
appropriate care, and utilize best practices regarding acute
and chronic pain relief for adult and pediatric populations.
Last, it is crucially important to support research into
effective, non-addictive alternatives that do not carry the
risks of opioid addiction, overdose, and death.
Response. I appreciate and agree with Senator Casey's
observations about the need for balance in opioid policy--
ensuring that patients with pain who have a legitimate need for
opioids are able to obtain them while at the same time using
risk assessment tools to ensure that those who are likely to
misuse or abuse them do not. As Senator Casey has mentioned, it
is essential that we utilize best practices for managing acute
and chronic pain. Fortunately, the HHS Pain Management Best
Practices Interagency Task Force mandated by Congress in the
CARA Act has recently released a final report that has been
universally praised by stakeholders. The report has many
excellent recommendations that I hope Congress will review and
consider implementing. Finally, I could not agree more about
the need to invest in research at the NIH into our
understanding of pain in the human body and finding effective,
non-addictive alternatives to opioid medications. Sadly,
decades of underinvestment in pain relative to its burden have
contributed to the dearth of truly effective options for those
who suffer the most severe chronic pain.
SENATOR WARREN
Medical marijuana has the potential to provide therapeutic
benefits for patients across the country--including those
experiencing chronic pain. Currently, 33 states, the District
of Columbia, Puerto Rico, and Guam have passed laws providing
for the use of marijuana for medical purposes. This means that
there are patients who are using the drug legally under state
law to treat chronic pain or illness. However, there is still
very limited scientific and population-based research conducted
to help improve our understanding of the potential therapeutic
benefits of marijuana that could in turn help inform patients
and their physicians. In addition, medical marijuana may also
be one tool to help mitigate the effects of the opioid crisis,
as it is a possible alternative treatment to prescription pain
medications. A 2014 JAMA Internal Medicine study showed that in
states that passed legislation allowing for the use of medical
marijuana, the fatal opioid overdose rate is 25 percent lower
than in other states. \1\ Some studies have also shown that
state recreational marijuana laws may also impact the opioid
crisis locally. A 2017 American Journal of Public Health study,
for example, studied Colorado's legalization of adult-use
recreational marijuana and found that it resulted in almost one
fewer opioid overdose death each month and determined that the
``legalization of cannabis in Colorado was associated with
short-term reductions in opioid-related deaths.'' \2\ This is
consistent with other data from states that have developed laws
for medical or recreational marijuana use. As more states pass
laws providing for the use of medical or recreational adult-use
marijuana, it is critical that the Federal Government
facilitate research on the drug and work to support these state
efforts. Doing so could ultimately provide patients struggling
with chronic pain access to a safer, more effective treatment
without the dangerous side effects of opioid medications.
---------------------------------------------------------------------------
\1\ Marcus A. Bachhuber, Brendan Saloner, Chinazo Cunningham et
al., ``Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in
the United States, 1999-2010,'' Journal of the American Medical
Association (October 2014) (online at http://jamanetwork.com/journals/
jamainternalmedicine/fullarticle/1898878).
\2\ Livingston, Barnett, Delcher, Wagenaar, ``Recreational
Cannabis Legalization and Opioid Related Deaths in Colorado, 2000-
2015,'' American Journal of Public Health (October 11, 2017) (online
at: http://ajph.aphapublications.org/doi/abs/10.2105/
AJPH.2017.304059'journalCode=ajph&).
Question 1. How could we benefit from improved scientific
research on the health benefits of marijuana when used to treat
---------------------------------------------------------------------------
chronic pain?
Answer 1. The majority of the research on marijuana
supported by the Federal Government in recent decades has
exclusively focused on assessing the potential harms of
cannabis use. As a result, relatively few studies have
addressed its positive benefits. In its 2017 report on the
state of cannabis research, the National Academy of Sciences
found many promising, but small or limited research projects on
the usefulness of marijuana for treating pain, and these areas
of research certainly merit further study. It's clear that
medical marijuana has positive and therapeutic effects for
those suffering from chronic pain. But doctors and patients
still lack many details about how medical marijuana, with its
many different forms and strains, can be most effectively
utilized for this purpose. Millions of patients suffering from
debilitating pain, not to mention millions of health care
providers, would benefit tremendously from a far more rigorous
research agenda focused on marijuana for the treatment of pain.
Doctors are generally hesitant to encourage their patients
to try cannabis due to the lack of research on pain efficacy
and safety and their own lack of knowledge and experience in
prescribing it. Yet many patients who use medical cannabis for
pain report positive results in reducing pain, improving
function and in some cases, allowing them to reduce other
medications including opiates that they have relied on.
However, without rigorous research these reports remain
anecdotal and are likely to continue to limit more widespread
use of medical cannabis for pain control.
Question 2. Has the U.S. Pain Foundation received any
stories from chronic pain patients who have utilized medical
marijuana as an alternative treatment to opioid medications?
Answer 2. We have heard some patient stories of medical
cannabis use as an alternative to opioids but the more common
stories we hear are patients who have started cannabis as a way
to reduce their opioid use. We frequently get questions about
the best way to do this. This is an area where patients could
really benefit from research on the best way to transition to
medical cannabis for pain relief from other medications.
Question 3. Have there been any efforts to survey patient
outcomes?
Answer 3. We are not aware of any such efforts.
SENATOR HASSAN
Question 1. Public reports and previous investigations show
that the U.S. Pain Foundation has received millions of dollars
from opioid manufacturers. Please provide a table listing all
entities that donated $5,000 or more to the U.S. Pain
Foundation in 2016, 2017, or 2018, including but not limited to
donations received from individuals, companies and tax exempt
organizations. In the table, please list each entity that
donated to the foundation, the amount they donated in each
year, and the purpose of the donations. Please note whether the
donation was unrestricted or restricted; in the case of
restricted donations, please detail any restrictions.
Answer 1. The U.S. Pain Foundation receives funding from a
number of sources, including pharmaceutical companies; this
funding enables U.S. Pain to offer programs free of charge to
its members. The source of any funding U.S. Pain receives does
not influence its mission of educating, supporting, empowering
and advocating for the 50 million Americans who live with
chronic pain. The U.S. Pain Foundation has filed and publicly
provided copies of its 2016, 2017 and 2018 Form 990 Information
Returns as well as the 2018 Audited Financial Statement. These
documents are available on its website: (https://
uspainfoundation.org/funding/).
I am a contractor for the U.S. Pain Foundation. I am not an
officer nor a board member and do not have access to the
detailed financial records you have asked for.
Question 2. For each of the last 3 years--2016, 2017 and
2018--what percentage of the U.S. Pain Foundation's revenue was
generated from payments or donations in excess of $5,000?
Answer 2. U.S. Pain Foundation receives funding from
individual donors, grants, private companies and pharmaceutical
companies. As previously mentioned, the source of any funding
does not influence U.S. Pain's mission of educating,
supporting, empowering and advocating for the 50 million
Americans who live with chronic pain. The U.S. Pain Foundation
has filed and publicly provided copies of its 2016, 2017 and
2018 Form 990 Information Returns as well as the 2018 Audited
Financial Statement, which can be found on its website:
(https://uspainfoundation.org/funding/).
Question 3. Press reports indicate that the U.S. Pain
Foundation's activities are currently being investigated,
including by multiple entities, including the U.S. Attorney's
Office, the Federal Bureau of Investigation, the U.S.
Department of Health and Human Services, the Attorney General
for the State of Connecticut, and the Department of Consumer
Protection for the State of Connecticut. A previous
investigation by the U.S. Senate Homeland Security and
Government Affairs Committees revealed that the foundation
received a $2.5 million payment from Insys to operate a patient
assistance program, which is now subject to investigation by
the U.S. Senate Committee on Finance. Insys has been subject to
Federal criminal and civil prosecution for improper marketing
of Subsys, and its former CEO recently pleaded guilty to
charges of bribing doctors to prescribe opioids. \3\ Please
provide a list that, to the best of the U.S. Pain Foundation's
knowledge, discloses all entities and offices investigating the
foundation, its activities, and any of its current or past
employees.
---------------------------------------------------------------------------
\3\ https://www.reuters.com/article/us-insys-opioids/former-insys-
ceo-pleads-guilty-to-opioid-kickback-scheme-idUSKCN1P312L.
Answer 3. As I stated in my answer to question 1 above, I
am a contractor for US Pain Foundation. I am not an officer nor
a board member and do not know the answer to the questions you
have asked. I contacted Nicole Hemmenway, the Interim CEO, and
---------------------------------------------------------------------------
she has provided the following response:
In April, 2018, USPF's Board of Directors determined that
between 2015 and 2018 its former CEO, Paul Gileno,
misappropriated funds. Mr. Gileno was forced to resign, and the
Board of Directors then assumed leadership of the organization.
USPF immediately reported the suspected fraud to the
appropriate authorities, and has cooperated with law
enforcement throughout the course of their investigation into
Mr. Gileno. The U.S. Attorney's office prosecuted Mr. Gileno
for his misconduct and on June 17, 2019 Mr. Gileno pleaded
guilty to wire fraud and tax evasion; his sentencing is
scheduled for October 29, 2019. USPF is unaware of any other
criminal investigation related to the organization. Regarding
the U.S. Senate Committee on Finance inquiry, USPF has provided
information in response to questions about funding the
organization received from pharmaceutical companies, including
INSYS. The questions posed here are nearly identical to the
ones posed by that Committee.
As a result of ongoing investigations into and lawsuits
against pharmaceutical companies across the country, USPF has
received and responded to subpoenas requesting information
related to its affiliation with those companies. USPF has
cooperated in these investigations, provided requested
information, and has fulfilled financial reporting
requirements. These financial documents have been publicly
filed and the organization has made them available on its
website.
Question 4. Please list all Federal panels, task forces and
committees, in which you have participated, including those in
which you were a member, witness or otherwise provided
testimony. Please include any involvement you had with work
done by the National Academies of Science, Engineering and
Medicine.
Answer 4. Advancing the Understanding of the Safe Use of
Acetaminophen--panelist.
Interagency Pain Research Coordinating Committee--member.
Health and Human Services Pain Management Best Practices
Inter-agency Task Force-member.
Senate HELP Committee Hearing on Pain Managment during the
Opioid Crisis--witness.
I have had no involvement with any work done by the
National Academies of Science, Engineering and Medicine.
SENATOR MURKOWSKI
Question 1. What is your perspective on the reported
increase in counterfeit opioids as reported by the Drug
Enforcement Administration (DEA) and what impact do you think
counterfeit drugs will have on the pain community and/or
potentially the opioid crisis?
Answer 1. Counterfeit opioid pills being shipped or
smuggled into this country are dangerous and we must do all we
can to stop this illicit flow of drugs. The most harmful impact
of these illicit drugs are on those with substance use disorder
who are obtaining these medications on the street. They are
often comprised of illicit fentanyl or illicit fentanyl
combined with heroin and are many times more powerful than
legal opioid medications.
Counterfeit drugs will have less of an effect on legitimate
pain patients who overwhelmingly obtain their medications
through legal channels such as pharmacies or hospitals.
However, given the difficulty legitimate pain patients are
reporting obtaining opioid medications from their physicians
and pharmacists who are too frightened to prescribe or dispense
them, we have heard a few stories (unverified) of patients who
are so desperate for relief from their relentless pain that
they have been driven to the street to obtain illicit opioids.
We are very concerned about these patients.
Quetion 2. As early as 2017, the Alaska Pharmacists
Association has been raising the issue with me that counterfeit
opioids were coming into the country and posing a danger.
Neither the Alaska pharmacists nor the licensed healthcare
groups here today are part of that illegal distribution, and
yet must deal with the consequences. What efforts have you and/
or your organization implemented to educate patients about the
dangers of counterfeits to combat the increasing amount of
opioids being purchased outside of the legitimate distribution
channel or on the street by the pain community?
Answer 2. We have not undertaken any such efforts.
------
Response by Halena Gazelka to Questions From Senator Murray, Senator
Casey, Senator Murkowski, and Senator Smith
SENATOR MURRAY
Question 1. H.R. 6, the SUPPORT for Patients and
Communities Act that Congress passed last year to address the
opioid crisis, includes several specific provisions requiring
CMS and FDA to examine barriers to the development and adoption
of non-opioid alternatives, including payment and coverage
policy. What do you see as the most significant barrier to
further adoption of non-opioid alternatives for pain
management? What can be done to overcome or address these
barriers?
Chairman Alexander, Ranking Member Murray, and Members of
the Committee, thank you for the opportunity to respond to
additional questions for the record following the February 12
hearing on ``Managing Pain During the Opioid Crisis''.
Answer 1. As you noted Senator Murray, thanks to
congressional action, efforts are underway to identify barriers
to the proliferation of non-opioid therapies for pain
management. In response to your two questions, which I will
answer in tandem, the ongoing barriers that I see as most
critical to the adoption of these treatments are related to
education and access. As providers, we must remain diligent in
staying apprised of new discoveries and processes established
by scientific rigor in order to best understand and utilize
non-opioid alternative treatments. We are then able to share
this education with our patients so they are best informed of
their options. Patients must also be better exposed to
information on pain management and expectations for treatments.
Opioids have been largely utilized because they are a ``quick
fix''--meaning pain relief is received in short order, at least
initially. But as we now know, the reward does not exceed the
risk as our country continues to face this crisis. Congress
should continue to promote medical education to ensure proper
understanding of pain and opioid stewardship for providers.
Furthermore, Congress should also continue to pursue
opportunities to increase public education on the ramifications
of opioid addiction, the science of pain and pain management,
and non-opioid alternatives and solutions in order to better
establish expectations for pain management and empower patients
to play a role in their care.
The other primary barrier is access. For some patients,
especially those in rural areas, physical access to pain
specialists can be limited due to the lack of specialty
providers trained in the practice of pain management. In
addition, many patients experience an access barrier to non-
opioid treatments due to lack of health plan coverage. As a
result, the cost of a treatment plan involving opioids may be
less costly and more convenient than a non-opioid treatment
plan. During my testimony I spoke to the benefit of pain
rehabilitation programs, and specifically recognized the impact
of the Mayo Clinic Pain Rehabilitation Center (PRC).
Established in 1974, the PRC has helped hundreds of people
manage their chronic pain without relying on opioids. And while
the program is covered by Medicare, it is not yet covered by
Medicaid. It should be noted that with the growth of
telemedicine, there may also be opportunities to utilize this
innovative care tool to meet the needs of patients with limited
access, but the coverage for telemedicine services continues to
be inconsistent. As non-opioid treatment models and technology
continues to evolve, it will be essential that government
programs also recognize the importance and efficacy of these
options.
SENATOR CASEY
Question 1. Nationally, more than 70,000 people died of
drug overdoses in 2017, with the large majority of these deaths
caused by opioids. My home State of Pennsylvania had the third
highest rate in the Nation in 2017, resulting in nearly 5400
deaths, many hundreds of whom were under the age of 25. Given
this ongoing public health emergency, activities to reduce
access to opioids are an essential part of the national, state,
and local response. However, it is also essential that we do
not forget about people who live with chronic pain and that we
ensure that they have access to coordinated pain management
approaches that meet their specific needs and improve their
quality of life. It is also essential that insurers and health
care providers both have the tools for and are held accountable
for providing appropriate care, and utilize best practices
regarding acute and chronic pain relief for adult and pediatric
populations. Last, it is crucially important to support
research into effective, non-addictive alternatives that do not
carry the risks of opioid addiction, overdose, and death.
Answer 1. I could not agree more with your supplemental
statements, Senator Casey. While actions are needed to address
the opioid and drug abuse crisis that is plaguing our
communities, it is essential that those with chronic pain are
not adversely impacted. That is why the Committee's attention
to this topic is appreciated. As a pain specialist who has the
honor of serving those with acute and chronic pain management
needs, I am happy to serve as a resource to you and fellow
Members of the Committee as you discuss this important topic.
Question 2. Child and adolescent brain physiology is
distinct from that of grown adults, and many research studies
have highlighted the increased risk of ongoing addiction to
substances when exposed to them prior to adulthood.
LIn your organizations, how are current
recommendations for acute and chronic opioid use
different between adults and children/adolescents?
LWhat processes do your organizations have in
place to help ensure that children/adolescents have
reduced exposure to prescription opioids in both the
acute and chronic health care setting?
Answer 2. This is a very important question as patients
young and old experience pain. Best practices for acute and
chronic opioid use between adults and children/adolescents are
distinctly different topics and have been assessed and
addressed individually. In children/adolescents, except in
terminal diagnoses and rare exceptions, standard clinical
practice is to minimize opioid exposure. As a result, it is
very rare to use opioids for children/adolescents.
At Mayo Clinic, we promote that non-opioids be first line
treatment for acute injuries experienced by children/
adolescents, when reasonable. This would include surgeries for
oral and maxillofacial needs, sports injuries, etc. If it is
determined that opioids are appropriate given the patient's
needs, they should be prescribed for the shortest duration
possible. For chronic pain, we have found that adolescent pain
rehabilitation is effective. Mayo's Pain Rehabilitation Center
(PRC) operates a similar program designed for teens based upon
their unique clinical and cultural needs. Like the PRC program
for adults, the adolescent program covers a set of core
components but also includes topics specific to teens from a
relative point of view. Recognizing that chronic pain can
affect entire families, the adolescent program includes
programing for parents and siblings to better understand
chronic conditions and how to respond to those affected.
Question 3. What are current best practices for helping a
chronic pain patient who has received years of opioid
medication transition onto alternative therapies?
Answer 3. As alternative therapies are identified for
chronic pain patients currently receiving opioid treatment, it
is important for patients and providers to explore the various
options and discuss the best course of action. Patients must
understand the reasoning and rationale for weaning off of an
opiate as well as what alternative options may be offered for
treatment. Most transitions require that other non-opioid
options be implemented in parallel with the termination of
opioid therapy. This is very important in order to mitigate a
break in pain management for the patient. As alternative
options are explored, access for and coverage of these is
critical for ensuring a smooth transition prior to the weaning
of the opioids. Alternative therapies may include
interventional therapies, physical therapy, biofeedback,
cognitive behavioral therapy, non-opioid medications, etc., but
access and coverage of these services is not consistent for
every patient. Additionally, pain rehabilitation or inpatient
weaning may be required, but this is also a more time-consuming
and potentially costly process.
Question 4. How can it be determined that this transition
is ``appropriate'' for some patient but not others?
Answer 4. Pain management is a very individualized practice
of medicine. As patients and providers discuss when a
transition from an opioid therapy to a non-opioid therapy is
most appropriate, it may be very beneficial to utilize the
expertise of a pain specialist. These specialists receive
advanced medical training in all aspects of acute and chronic
pain management. The diagnosis for which the opioid is being
given is vitally important, as are the other comorbidities of
the patient in order for the best treatment plan to be
identified.
Question 5. Can you describe what ``success'' in this
process looks like at the Mayo Clinic?
Answer 5. At Mayo Clinic, success of a transition for a
patient from an opioid therapy to a non-opioid therapy will
likely include a few milestones. These milestones may include,
but are not limited to: the patient understanding their
diagnosis and treatment options; a primary care provider
understanding the diagnosis and treatment options; the
patient's pain being managed with interventions, other
medications, surgical procedures, etc.; and psychiatric and
psychological comorbidities are well-controlled. The milestones
may happen entirely within a primary care practice, or with a
pain specialist, or in pain rehabilitation, but it more
typically will require a multidisciplinary effort to ensure the
needs of the patient are met.
SENATOR MURKOWSKI
Question 1. What is your perspective on the reported
increase in counterfeit opioids as reported by the Drug
Enforcement Administration (DEA) and what impact do you think
counterfeit drugs will have on the pain community and/or
potentially the opioid crisis?
Answer 1. While we are taking great efforts to ensure
opioids are prescribed in a responsible manner, the increase of
counterfeit drugs with contaminants such as fentanyl analogs is
contributing to many deaths. Opioids purchased outside of the
United States or through illegal means lack quality control. If
patients are not candidates for opioid therapy yet still seek
them illegally, there may be significant consequences,
including overdose and death. Prescribing opioids properly,
utilizing alternatives whenever possible, and educating
patients appropriately are the best tools providers have to
prevent improper and illegal use of opioids.
Question 2. As early as 2017, the Alaska Pharmacists
Association has been raising the issue with me that counterfeit
opioids were coming into the country and posing a danger.
Neither the Alaska pharmacists nor the licensed healthcare
groups here today are part of that illegal distribution, and
yet must deal with the consequences What efforts have you and/
or your organization implemented to educate patients about the
dangers of counterfeits to combat the increasing amount of
opioids being purchased outside of the legitimate distribution
channel or on the street by the pain community?
Answer 2. As an organization, we strive to provide
appropriate pain management treatments and services. Combatting
the use of counterfeit and other illicit substances requires a
collective community approach. Through the Mayo Clinic Opioid
Stewardship Program, we have constructed provider and patient
education tools on the appropriate use of opioids. We believe
that education on the proper use of opioids will lead to
increased awareness of the risks associated with the
inappropriate use of opioids and, hopefully, less illegitimate
use.
SENATOR SMITH
Question 1. While we work to address the opioid epidemic,
we must not forget that there are millions of Americans who
suffer from chronic pain and depend on opioids to manage their
pain. Mayo Clinic has always been on the forefront of
innovation in healthcare, and their pain rehabilitation
programs are the perfect example. The Mayo Clinic's Pain
Rehabilitation Center was founded in 1974 as one of the first
pain rehabilitation programs in the world. Their pain
rehabilitation programs provide three-work courses that deliver
holistic pain management therapies to adult and pediatric
patients. The Pain Rehabilitation Center created the Mayo
Clinic Opioids Stewardship Program to help bring meaningful
solutions to addressing the opioid crisis. One of the outcomes
of this program was the creation of uniform acute pain and
chronic pain opioid prescribing guidelines.
LIn your research, you describe how you and
your colleagues at the Mayo Clinic worked with multi-
disciplinary teams to inform these opioid prescribing
guidelines. Can you describe the process behind
developing these opioid prescribing guidelines and
explain the benefit of having a whole host of providers
at the table to inform these guidelines?
LCan you contrast the opioid prescribing
guidelines that you developed at Mayo Clinic with the
guidelines developed by the Centers for Disease Control
and Prevention (CDC)?
Answer 1. As an organization, Mayo Clinic recognized the
need to review our opioid prescribing practices. As a result,
the Mayo Clinic Opioid Stewardship Program was established. We
utilized a multidisciplinary team, including clinicians, allied
health personnel, researchers and educators, from across the
organization to develop our guidelines for chronic pain
management as well as acute care. This was vitally important to
ensure that we approached our charge from a wide range of
viewpoints and that Mayo's collaborative culture was a core
foundation of the guidelines.
Once established, our Stewardship Program reviewed current
guidelines (such as those released by the CDC), reviewed
available literature on acute and chronic prescribing, reviewed
the prescribing practices of our providers, surveyed patients
(and continue to do so) to determine their care needs, and
developed evidence-based guidelines. These guidelines have been
made available to all Mayo care team members and have been
shared with external colleagues as well.
Those reviewing our guidelines would find many similarities
to the CDC guidelines in terms of restricting opioid use to
appropriate indications, limiting treatment duration and dose
provided, minimizing risk both with appropriate patient
selection and medication selection and how/when to monitor
patients who are taking opioids. We do encourage adherence to
lowest clinically effective dose and duration of therapy but
differ from the CDC on recommendations for prescribing limits
(such as three days versus seven days) because patients and
procedures vary in requirements for opioid administration. Mayo
Clinic strongly believes that any prescribing guidelines should
not limit provider discretion, as long as the rationale for the
variation is clear and documented.
Question 2. As the opioid epidemic scours the Nation, I
have also heard from communities across Minnesota--particularly
tribal communities--who are struggling with addiction to
methamphetamine.
LWhat is the relationship between illicit use
of methamphetamine and the use of medication assisted
treatment for opioid use disorders or acute and chronic
pain?
LHow is the opioid crisis hiding the rise in
methamphetamine use?
Answer 2. This is a very interesting question and not in my
area of expertise. Senator Smith, I would be happy to connect
you with some colleagues within Mayo who have a greater
understanding of substance abuse to respond to this question.
------
Response by Andrew Coop to Questions From Senator Murray, Senator
Casey, Senator Murkowski, and Senator Richard Burr
SENATOR MURRAY
Question 1. H.R. 6, the SUPPORT for Patients and
Communities Act that Congress passed last year to address the
opioid crisis, includes several specific provisions requiring
CMS and FDA to examine barriers to the development and adoption
of non-opioid alternatives, including payment and coverage
policy. What do you see as the most significant barrier to
further adoption of non-opioid alternatives for pain
management? What can be done to overcome or address these
barriers?
Answer 1. In my role as an educator, I would say that
education of both patients and healthcare providers. As stated
in my written testimony, there are many pharmaceutical and non-
pharmaceutical options, but prescribers require additional
training on the options for treating pain. This could be
accomplished by (1) increasing pain management education in the
curriculums for all healthcare professionals, and (2) education
of patients that opioids are not always the answer. My adopted
profession of pharmacy is the profession that is most focused
on drugs, and utilizing the pharmacists to consult with
patients on the options available, and what to expect, is an
avenue that has gone primarily unexplored. This covered under
the answer for question 2 in appendix A (see page 82).
Question 2. Given your experience as a pharmacist, how can
health care teams better integrate pharmacists into pain
management? Are you aware of any effective team-based care
delivery for pain management used either in practice in the
United States or internationally?
Answer 2. A detailed response is provided in Appendix A
(see page 82).
SENATOR CASEY
Question 1. Nationally, more than 70,000 people died of
drug overdoses in 2017, with the large majority of these deaths
caused by opioids. My home State of Pennsylvania had the third
highest rate in the Nation in 2017, resulting in nearly 5400
deaths, many hundreds of whom were under the age of 25. Given
this ongoing public health emergency, activities to reduce
access to opioids are an essential part of the national, state,
and local response. However, it is also essential that we do
not forget about people who live with chronic pain and that we
ensure that they have access to coordinated pain management
approaches that meet their specific needs and improve their
quality of life. It is also essential that insurers and health
care providers both have the tools for and are held accountable
for providing appropriate care, and utilize best practices
regarding acute and chronic pain relief for adult and pediatric
populations. Last, it is crucially important to support
research into effective, non-addictive alternatives that do not
carry the risks of opioid addiction, overdose, and death.
Answer 1. These are all outstanding points, and an approach
that includes pharmacists is included in Appendix A (see page
82). The need to fund research into new analgesics is close to
my heart, and one that I fully support. The Federal funding
agencies (NH, DOD) are committed to this, and we need to ensure
that their budgets are sufficient to allow the studies to
continue at a rapid pace.
SENATOR MURKOWSKI
Question 1. What is your perspective on the reported
increase in counterfeit opioids as reported by the Drug
Enforcement Administration (DEA) and what impact do you think
counterfeit drugs will have on the pain community and/or
potentially the opioid crisis?
Answer 1. The rise in counterfeit opioids has been well
documented, including in the mainstream media (https://
www.washingtonpost.com/national/counterfeit-opioid-pills-are-
tricking-users-sometimes-with-lethal-results/2017/11/19/
d34edb14-be4b-11e7-8444-
a0d4f04b89eb_story.html?utm_term=.72b7d52b4701). Many are laced
with extremely potent opioids, or a range of other
pharmaceuticals. The DEA requires the resources to ensure that
such tablets are eliminated to the greatest extent possible,
but the DEA cannot be everywhere at once. As such, as access to
prescription opioids continues to be limited to prevent
inappropriate use, more individuals will turn to opioids
purchased from the street. This opens a potential huge public
health crisis, as the individuals have no idea what drugs they
are actually taking. I feel the only approach is a public
information campaign with a focus on:
A. That opioid abuse is a disease, and there are
treatments
B. Opioids have deadly consequences, when taken
inappropriately
C. Individuals should only take opioids that are
specifically prescribed to them. When used
appropriately, they are outstanding medications.
D. Opioids from other mechanisms are of unknown
quality, and the potential to be lethal
Question 2. As early as 2017, the Alaska Pharmacists
Association has been raising the issue with me that counterfeit
opioids were coming into the country and posing a danger.
Neither the Alaska pharmacists nor the licensed healthcare
groups here today are part of that illegal distribution, and
yet must deal with the consequences. What efforts have you and/
or your organization implemented to educate patients about the
dangers of counterfeits to combat the increasing amount of
opioids being purchased outside of the legitimate distribution
channel or on the street by the pain community?
Answer 2. Students groups at the University of Maryland
School of Pharmacy engage the community regarding all aspects
of drug use and misuse. We always stress that medications
should only be obtained from legitimate sources and only to
take those prescribed to you. However, there is always room to
improve our message, I will reassess to ensure that the
communications are clear in regards to opioid specifically.
SENATOR BURR
Question 1. While hemp and marijuana are both species of
the Cannabis plant family, they have different legal statuses
in the United States due to the amount of tetrahydrocannabinol
(THC) in each plant--marijuana has a high concentration of THC
and hemp has a very low concentration. Due to its naturally low
levels of THC, hemp is a legal substance in the United States.
When discussing alternative pain management options, you note
in your testimony that ``medical cannabis, controversial as it
is, has potential, but well-designed studies are lacking.''
Similarly to marijuana, hemp contains cannabidiol (CBD) which
some claim has the potential to help with pain.
Just as researchers believe there is potential in medical
cannabis for treating chronic pain, are researchers looking
into the use of hemp as an alternative treatment? If so, what
type of results and impacts have been observed? If not, what
are the biggest barriers and challenges to this research?
Answer 1. Hemp is indeed now a legal substance, as you
stated, it contains very little (generally less than 0.3
percent) of THC, the psychoactive in marijuana. The agent in
hemp that leads to its actions is indeed proposed to be CBD,
and is under extensive investigation as a medication. That CBD
does not act on the traditional cannabis targets in the body is
a plus in terms of giving rise to no psychoactive effects, but
it is through that receptor that THC yields its pain-killing
effects.
CBD was recently approved as a medication to treat epilepsy
in a medication called Epidiolex. As I stated in my testimony,
much of the research with cannabis is difficult to interpret
due to differences in the materials being studied, with natural
variability in substances from natural sources. In addition,
the type of pain plays a significant role, as it appears that
both THC and CBD have potential for different types of pain. A
very recent paper showed no pain killing activity from one such
source of CBD (http://dx.doi.org/10.1097/
j.pain.0000000000001464), but another paper showed CBD had
activity in treating pain and inflammation of the cornea
(https://doi.org/10.1089/can.2017.0041 ). This is typical of
the literature where THC is controlled, and CBD was until
recently controlled. The actions of CBD are therefore difficult
to fully assess, but it does appear that a main mechanism of
action of CBD is due to its anti-inflammatory actions (https://
doi.org/10.1002/ejp.818). Although anti-inflammatory actions
are almost certainly not the entire story, inflammation is a
major contributor to pain so to CBD has the potential to treat
pain. Only well designed clinical trials with standardized
materials will allow a full analysis of the scope AND
limitations of CBD (and THC) as alternatives to opioids.
------
Response by Anuradha Rao-Patel to Questions From Senator Murray,
Senator Casey, Senator Murkowski, and Senator Smith
SENATOR MURRAY
Question 1. H.R. 6, the SUPPORT for Patients and
Communities Act that Congress passed last year to address the
opioid crisis, includes several specific provisions requiring
CMS and FDA to examine barriers to the development and adoption
of non-opioid alternatives, including payment and coverage
policy. What do you see as the most significant barrier to
further adoption of non-opioid alternatives for pain
management? What can be done to overcome or address these
barriers?
Answer 1. Blue Cross and Blue Shield (BCBS) companies
(Plans) cover a multitude of non-opioid pain treatments and
services, including physical therapy, occupational therapy,
chiropractic care and other evidence-based therapies. BCBS
Plans recommend the following to address barriers to broader
use of non-opioid alternatives for pain.
LAlign 42 CFR Part 2 with HIPAA. The
regulations in 42 CFR Part 2 currently impede the
exchange of treatment information for patients with
substance use disorders (SUD). The policies for sharing
SUD records should align with the Health Insurance
Portability and Accountability Act (HIPAA) for the
purposes of healthcare treatment, payment, and
operations (TPO) to support safety and the appropriate
exchange of information. Today, Part 2 limits the use
and disclosure of SUD records among treating providers
and effectively separates an individual's SUD treatment
record from the rest of his or her physical and mental
health medical records, creating barriers to whole-
person, integrated approaches to care. Therefore,
clinicians face barriers in making complete clinical
decisions regarding choice of medications or whether a
particular patient may need additional services or
supports to address an underlying SUD. Lack of patient
SUD information poses a serious safety threat to
patients, including risks from multiple drug
interactions and co-existing medical problems. To
eliminate this barrier, we recommend the alignment of
42 CFR Part 2 regulations with HIPAA, with appropriate
consumer protections.
LGrant Payers Access to Prescription Drug
Monitoring Programs (PDMPs). In order to protect
patients from overprescribing and protect against
fraudulent activities to obtain controlled substances,
payers should have access to PDMPs at the state level.
Increased information, with appropriate privacy
protections, supports the provision of holistic and
integrated care. Affording plans access to PDMP data
would provide plans with additional information that
can be used to identify at-risk individuals. For
instance, plans do not receive information on
prescriptions paid in cash or by other third-party
payers--even though this data is collected by PDMPs.
With a clear and complete view of the data, plan
sponsors would be better positioned to coordinate care
and mitigation strategies across providers and
suppliers.
LEncourage the evaluation of evidence-based,
non-opioid pain management therapies by Federal
agencies and encourage stakeholders to develop provider
licensing standards and accreditation. Challenges
pertaining to clinical application of non-
pharmacological therapies include a wide heterogeneity
of therapeutic approaches and variations in the skill
levels of the providers of the therapies. (For example:
There are many different approaches to acupuncture,
different kinds of Cognitive Behavioral Therapy and
many different schools of yoga and tai chi that can be
used) with limited information on the efficacy of the
different approaches. There are also unique network
challenges due to the lack of standards for the
licensing of these providers, raising potential quality
of care concerns. Certification of these providers
varies across locations and modalities. For instance,
acupuncture has licensure requirements in most states
in the United States, while yoga typically has no such
certifications.
LSupport the chronic pain management
infrastructure. Due to a lack of accessible pain
medicine specialists, non-specialists and primary care
providers are left to manage some patients with complex
chronic pain and painful conditions. In areas where
specialist access is limited, support should be given
to improving access through telehealth and other
innovative strategies.
LPromote additional pain management education
and resources. More educational and instructional tools
are needed to inform providers, employers, caregivers
and consumers about pain management topics, including:
the risks of SUD/opioid use disorders, living and
working with chronic pain and available treatments. In
addition, greater resources should be dedicated to
research, particularly for understanding chronic pain,
opioid misuse, SUD and the establishment of evidence-
based treatment guidelines for neonatal abstinence
syndrome (NAS).
Question 2. Developing new treatments and team-based
approaches to care for chronic pain are both critical to
improve patient outcomes. However, if insurers do not cover
these treatments and services, patients will be unable to
afford them. In a survey of insurers and providers, researchers
at Georgetown University found that, while insurers are taking
steps to limit inappropriate use of opioids, insurance plans
still do not offer sufficient coverage of alternative
treatments and services that may help pain patients.
What are the most common types of non-opioid pain
treatments and services that Blue Cross Blue Shield of North
Carolina covers for its members?
Answer 2. Chronic pain syndromes are unique to each patient
and complex. A one-size-fits-all approach is not appropriate.
Management of pain often times requires a multimodal and
multidisciplinary assessment and treatment plan.
BCBS of North Carolina covers a multitude of non-opioid
pain treatments and services including physical therapy,
occupational therapy, chiropractic care, aquatic therapy, facet
blocks, medial branch blocks, epidural steroid joint
injections, steroid joint injections, TENS units and trigger
point injections.
Most BCBS Plans cover similar benefits. Some patients need
a variety of pain management treatments and medication to find
relief. Plans take a number of steps to help ensure access to
the best care for their members:
LPlans assess evidence-based strategies
through their medical and pharmacy policies.
LPlans work with providers to look for and
review new technology and medications at least yearly
in order to offer the best options available.
LPlans support coverage of treatments, both
pain relief drugs and nondrug treatments that meet the
best clinical practice guidelines and scientific
evidence.
LPlans follow, and encourage prescribers to
follow, the Centers for Disease Control and Prevention
(CDC) Guideline for Prescribing Opioids for Chronic
Pain.
When deciding which drugs are on the approved list of non-
opioid medications, Plan medical and pharmacy teams consider
which have the best clinical benefit. Other options to manage
pain may include:
LNonsteroidal anti-inflammatory drugs (NSAIDs)
(such as ibuprofen and naproxen)
LAnticonvulsants (such as gabapentin)
LTricyclic antidepressants (TCAs) and
Serotonin norepinephrine reuptake inhibitors (SNRIs)
(antidepressant medications)
LCorticosteroids (steroid injections)
LSkeletal muscle relaxants
LTopical analgesics (cream-and ointment-based
pain medications)
Question 3. What steps has BCBS of North Carolina taken to
ensure providers within its network are aware of the full range
of non-opioid alternatives available to treat pain?
Answer 3. BCBS Plans provide a variety of educational
materials and resources to providers and members on non-opioid
alternatives.
Specifically, BCBS of North Carolina sends out ``Provider
E-Briefs'' and other communications to providers as well as
having case managers reach out to members, especially after
certain elective surgeries for additional education.
As another example, Anthem Blue Cross and Blue Shield has
collaborated with the National Urban League to implement
www.whatsupwithopioids.org which provides educational materials
and toolkits that can be used to discuss SUD.
Question 4. What types of prior authorization, step therapy
and other utilization management protocols are these
alternative treatments and services subject to?
Answer 4. Specific benefits and services and any
corresponding utilization management protocols are dependent
upon the program (Medicare, Medicaid and commercial insurance),
state requirements and benefit plan.
BCBS of North Carolina does not employ utilization
management protocols when treating pain through physical
therapy, occupational therapy, chiropractic care, aquatic
therapy, facet blocks, medial branch blocks, epidural steroid
joint injections, steroid joint injections, TENS units or
trigger point injections. This approach is similar in other
Blue Cross and Blue Shield Plans.
Additionally, Plans routinely examine and update
utilization management protocols as more evidence and data
become available.
Question 5. How does BCBS of North Carolina ensure that
there is an adequate network of providers for the full-range of
treatments?
Answer 5. BCBS of North Carolina takes several steps to
ensure an adequate network of providers for the full range of
treatments.
BCBS Plans routinely use data analytics to identify
provider access needs. For instance, at BCBS of North Carolina,
our contracting department creates geo-access reports to ensure
we meet all regulatory requirements around mileage and number
of providers for primary care and specialties. BCBS of North
Carolina has the largest network of providers in the state.
If a member has trouble finding a provider, our customer
service providers (CSP) or nursing team will assist that
member. In the event a network access issue is identified, our
medical affairs team will work to recruit high quality
providers in that area.
In specific situations, BCBS of North Carolina may approve
coverage for certain services received from non-participating
providers. This includes situations where continuity-of-care or
network adequacy issues dictate the use of a non-participating
provider. Benefits are also available from non-participating
providers for emergent and urgent care services.
Question 6. H.R. 6, the SUPPORT for Patients and
Communities Act, expands the scope of Medicare coverage of
telehealth services for the treatment of opioid use disorder
and substance use disorders generally. Does BCBS of North
Carolina support or cover telehealth services in this fashion?
Why or why not?
Answer 6. Yes, BCBS of North Carolina covers telehealth
services and has even expanded Current Procedural Terminology
(CPT) codes for treating SUDs. Many BCBS Plans also cover
telehealth services for SUD.
It should be noted, however, that BCBS of North Carolina
and other BCBS Plans have experienced poor participation by
providers in providing treatment via telemedicine. One
explanation is that workforce inadequacies mean that SUD and
behavioral health providers are at practice capacity and are
not able to take additional patients.
Question 7. Has BCBS of North Carolina explored providing
telehealth services for other aspects of the opioid crisis,
such as mental health services? Why or why not?
Yes, BCBS of North Carolina covers behavioral health
through telemedicine and has continued to build out the
behavioral health program by supporting primary care physicians
by integrating behavioral health into the overall course of
care.
SENATOR CASEY
Nationally, more than 70,000 people died of drug overdoses
in 2017, with the large majority of these deaths caused by
opioids. My home State of Pennsylvania had the third highest
rate in the Nation in 2017, resulting in nearly 5400 deaths,
many hundreds of whom were under the age of 25. Given this
ongoing public health emergency, activities to reduce access to
opioids are an essential part of the national, state and local
response. However, it is also essential that we do not forget
about people who live with chronic pain and that we ensure that
they have access to coordinated pain management approaches that
meet their specific needs and improve their quality of life. It
is also essential that insurers and healthcare providers both
have the tools for, and are held accountable for, providing
appropriate care and utilize best practices regarding acute and
chronic pain relief for adult and pediatric populations. Last,
it is crucially important to support research into effective,
non-addictive alternatives that do not carry the risks of
opioid addiction, overdose, and death.
In your testimony, you wrote that ``Nationally, the total
number of opioid medications filled by commercially insured
BCBS members has declined by 29 percent since 2013,'' and ``In
2017, 67 percent of BCBS members filled their first opioid
prescription within the CDC-recommended guidelines . . . ''
This appears to be progress. However, it is also important to
ensure that patients with disabilities--who can have ongoing
needs for pain management greater than the general population--
are not inappropriately denied effective medical care as a
result of these changes.
Question 1. How many of the nearly 4 million enrollees of
BCBS of North Carolina are individuals with disabilities?
Answer 1. BCBS of North Carolina does not have that data
readily available. However, when looking at BCBSA system wide
data and employing a broad definition of disability as any
health event that leads to a reduction in healthy living, BCBSA
estimates that 40 percent of members incur a disability due to
an injury or a musculoskeletal condition (conditions clearly
leading to pain) in a given year.
Question 2. What protections or processes did the BCBS of
North Carolina system implement to ensure that ``flexing''
around the CDC guidelines for acute and chronic opioid
prescription is accomplished when appropriate for pain
management?
Answer 2. BCBS of North Carolina and other BCBS Plans align
pharmacy benefit management strategies with the March 2016 CDC
Guideline. Plans maintain robust exceptions for clinically
appropriate circumstances such as for conditions of cancer or
sickle cell anemia.
BCBS Plans use strategies such as pharmacy point-of-sale
edits to target new starts (opioid naive patients) and are not
designed to abruptly alter current pain management regimens
that are working. Plans also utilize the CDC Guidelines as a
tool to educate providers who are continuing regimens for
consumers with chronic pain. The goal for these edits is to
ensure clinically appropriate use of opioids while minimizing
the risk of accidental or inadvertent addiction/dependence.
Plans rely on clinical appropriateness and doing what is
right for each member. For certain consumers with chronic pain
syndrome, opioids are appropriate, allowing the consumer to
remain functional and to control pain. As detailed previously
in this response, BCBS Plans also provide consumers access to
non-opioid options. There are many non-opioid approaches to
pain relief which are covered and are used successfully by
consumers.
Question 3. How many enrollees have let you know their pain
needs are not being met as a result of BCBS of North Carolina
implementation of CDC's guidelines? How are you responding to
these concerns?
We do not have a specific measure to answer this question.
However, in addition to the protections listed above, BCBS
Plans have appeals processes in place if a patient has been
denied service. Further, Plans continue to educate providers
and members on proper opioid use.
Question 4. Child and adolescent brain physiology is
distinct from that of grown adults, and many research studies
have highlighted the increased risk of ongoing addiction to
substances when exposed to them prior to adulthood.
In your organizations, how are current recommendations for
acute and chronic opioid use different between adults and
children/adolescents?
Answer 4. There are conditions in children such as Sickle
Cell disease, cancer and deforming musculoskeletal conditions
for which a child's chronic pain must be appropriately and
adequately managed. Children differ in how drugs affect their
developing bodies, the rate at which the drug is metabolized
and side effects of these drugs. A child's pain must be treated
holistically, similar to treating adult pain, with a goal of
achieving maximum pain relief while preventing the risk of
medication misuse and addiction.
Plans have specific utilization management protocols and
quantity limits in place for children and adolescents and work
closely with network pediatricians to ensure a child's comfort
and safety.
We would also like to draw attention to the increase in
Neonatal Abstinence Syndrome (NAS) diagnoses. Over the last
several years, the United States has seen a significant
increase in the incidence of NAS--from 1.5 per 1,000 U.S.
hospital births in 1999 to 6.0 per 1,000 U.S. hospital births
in 2013. This accounts for a 300 percent increase in infants
born with NAS, a postnatal drug withdrawal syndrome that occurs
primarily among opioid-exposed infants shortly after birth. In
response to opioid use disorders and the associated health
risks, BCBS Plans are developing strategies to address
substance use before, during and after pregnancy. This strategy
includes efforts to optimize pregnancy avoidance or delay for
women using controlled substances, effective identification of
pregnant women using controlled substances, increased capacity
for efficient and effective referral to treatment for pregnant
women, and the promotion of standards and consistency of
treatment for newborns with NAS.
Additionally, BCBSA recommends that the Substance Abuse and
Mental Health Services (SAMHSA) take steps to educate primary
care and obstetrical physicians in the safe use of medication
assisted treatment (MAT) during pregnancy.
Question 5. What processes do your organizations have in
place to help ensure that children/adolescents have reduced
exposure to prescription opioids in both the acute and chronic
health care setting?
Answer 5. BCBS of North Carolina has taken several steps to
reduce childhood exposure to opioids. First, our nurses and
case managers educate members on proper use and storage of
opioid medications. Second, BCBS of North Carolina has specific
utilization management protocols and quantity limits in place
for children and adolescents. We have also partnered with local
pharmacies in the state for drug take-back boxes across and
participate in the annual DEA National Drug Take Back Day.
BCBS Plans continue to encourage providers to educate
adolescent patients and their parents and guardians on proper
use, storage and disposal of unused medications.
SENATOR MURKOWSKI
Question 1. What is your perspective on the reported
increase in counterfeit opioids as reported by the Drug
Enforcement Administration (DEA), and what impact do you think
counterfeit drugs will have on the pain community and/or
potentially the opioid crisis?
Answer 1. BCBS Plans work diligently to ensure members are
safe from opioid misuse, deploying a range of strategies to
identify and address instances of opioid waste, fraud and abuse
as well as diversion including: monitoring of claims for
potential fraudulent or abusive behavior; data mining for top
prescribers; review of pharmacies when identified for high-
volume dispensing of controlled substances; and monitoring
cases of potential ``doctor shopping.''
At a local level, BCBS of North Carolina has donated $1
million and has partnered with the Attorney General's office
and NC Department of Health and Human Services on a public
awareness and education campaign, not just on the opioid
crisis, but also on counterfeit opioids and pain management.
Question 2. As early as 2017, the Alaska Pharmacists
Association has been raising the issue with me that counterfeit
opioids were coming into the country and posing a danger.
Neither the Alaska pharmacists nor the licensed healthcare
groups here today are part of that illegal distribution, and
yet must deal with the consequences. What efforts have you and/
or your organization implemented to educate patients about the
dangers of counterfeits to combat the increasing amount of
opioids being purchased outside of the legitimate distribution
channel or on the street by the pain community?
Answer 2. Please see above response.
SENATOR SMITH
Question 1. Researchers at the Mayo Clinic have found that
hospitals and other providers are often driven toward
prescribing opioids because they're relatively cheap compared
to other options to treat pain.
Dr. Rao-Patel, you mentioned in your testimony that Blue
Cross Blue Shield provides coverage for non-opioid alternatives
for pain management. What are some ways we can drive the market
toward non-opioid therapies for acute and chronic pain
management?
Answer 1. As outlined in our response to Senator Murray's
first questions, BCBS Plans cover and encourage providers and
patients to use non-opioid alternatives for pain relief. In our
experience, physicians and patients would benefit from
increased education on how to manage chronic pain.
Question 2. Has the private sector taken steps in this
direction?
Answer 2. Yes, in addition to the examples offered in
responses to previous questions, BCBS Plans are working in
communities with other local and national stakeholders to
educate consumers and prescribers about the risks associated
with opioid use and regarding coverage for pain-relief
alternatives as well as for the treatment of SUD.
Thank you for allowing me to participate in the hearing and
offer these additional comments for the record.
------
APPENDIX A
Response by Andrew Coop to Questions From Senator Murray and Senator
Casey
senator murray
Given your experience as a pharmacist, how can health care teams
better integrate pharmacists into pain management? Are you aware of any
effective team-based care delivery for pain management used either in
practice in the United States or internationally?
As Associate Dean for Academic Affairs at the University of
Maryland School of Pharmacy, I am acutely aware of the education and
training pharmacists receive. Post-graduate education to obtain a
Doctor of Pharmacy is rigorous but makes these health care providers
uniquely qualified to provide medication-related services, including
medication management, screening and risk-factor reduction. Pharmacists
provide care in a variety of settings, including community pharmacies,
physicians' offices, hospitals, long-term care facilities, community
health centers, managed care organizations, hospice settings and the
uniformed services. The types of activities and services pharmacists
can contribute to optimizing pain management outcomes can vary
depending on the practice setting.
Pharmacist integration into pain management services would be
enhanced by addressing current barriers to their inclusion. There is a
need for better healthcare team provider and patient/caregiver
education and awareness of the enhanced services and expertise
pharmacists can contribute to effective pain management in order to
improve collaborations. \1\, \2\ Promotion of successful models beyond
the efforts currently underway in the pharmacy profession would help in
raising awareness. In addition, integrating community pharmacies into
health information exchanges to better facilitate communications and
data-sharing is an essential component of team-based care. \3\, \4\
Yet, the most significant barrier to widespread adoption of the models
noted is that payers, including Medicare, provide little reimbursement
opportunities for pharmacist-provided patient care services, including
pain management-related services. The lack of payment hinders
organizations from financially supporting the work of pharmacists
within health care teams or contracting with community pharmacies to
provide pain management-related services as part of the team. While
value-based payment models are changing to facilitate integration of
pharmacists, the predominant fee-for-service model remains a barrier to
pharmacist inclusion. Effectively addressing these barriers is crucial
to health care teams seeking to better integrate pharmacists into pain
management.
---------------------------------------------------------------------------
\1\ Fay, A.E., Ferrreri S. P., Shepherd, G., Lundeen, K., Tong,
G.L. & Pfeiffenberger, T. (2018). Care team perspectives on community
pharmacy enhanced services, Journal of the American Pharmacists
Association, 58, S83-S88.
\2\ Doucette, W.R., Rippe, J.J., Gaither, C.A., Kreling, D.H.,
Mott, D.A. & Schommer, J.C. (2017). Influences on the frequency and
type of community pharmacy services, Journal of the American
Pharmacists Association, 57, 72-76.
\3\ See Community Pharmacy Enhanced Services Network, Integrating
Pharmacists into the Medical Home Team, available at: https://
www.communitycarenc.org/what-we-do/supporting-primary-care/pharmacy/
cpesn, last accessed: March 13, 2019.
\4\ See also, Pharmacy Health Information Technology
Collaborative, (2018). Integrating Pharmacists into Health Information
Exchanges--Update Version, available at: http://www.pharmacyhit.org/
pdfs/workshop-documents/WG3-Post-2018-01.pdf, last accessed March 13,
2019.
When these barriers are overcome, integration of pharmacists into
pain management services helps fill gaps in care, enhance treatment
capacity and options, increase cost savings, reduce pain, improve
functionality, improve adherence, reduce adverse events and enhance
patient satisfaction, among other benefits. Coordination and alignment
of the various pharmacists interacting with patients, team members and
caregivers is critical if we are to optimize pain management for the
patients served. Appendix B contains a Department of Veterans Affairs
(VA) overview of how pharmacists can assist in providing pain
management services and addressing the opioid epidemic. VA has an
excellent practice model that fully optimizes pharmacists'
---------------------------------------------------------------------------
contributions to improved patient care.
Pharmacists can work collaboratively with other members of the
patient's health care team in an ``embedded'' model where the
pharmacist sees patients and works at the practice site with other
health care team members. Pharmacists practicing in embedded models are
usually located in physician office practices, hospital outpatient
clinics, and hospitals. Pharmacists in embedded models providing pain
management services have defined roles and responsibilities and often
work under collaborative practice agreements. These voluntary
agreements, permitted in 48 states and the District of Columbia, allow
the prescriber to delegate certain functions to the pharmacists beyond
the pharmacist's normal practice authority, often prescribing (post-
diagnosis), adjusting, or discontinuing medications and ordering
laboratory tests. These agreements allow the pharmacist to manage and
make adjustments to pain medications resulting in improved treatment
outcomes and expanded access to care.
Pharmacists working on pain management teams bring valued expertise
focused on optimizing medication therapies by comprehensively
evaluating all of the medications that the patient is taking, not just
the pain medications. Since patients with pain often have other
conditions, the pharmacist's role in coordinating their medications can
help to avoid problems arising from multiple prescribers. These
pharmacists are also important conduits and coordinators with community
pharmacists and other practitioners caring for patients.
Other activities that pharmacists working on pain management teams
are involved in include working with physicians and others on the team
to provide education on evidence-based guidelines, monitoring pain
medication use, working with the health care team to consider non-
opioid medications/treatments to control pain, providing opioid and
benzodiazepine tapering services, performing risk assessments for
substance use disorder or mental health conditions, and facilitating or
furnishing naloxone. Pharmacists meet regularly with team members,
document in the electronic health record, share information, and
communicate with prescribers and other members of the team. Referral
processes are often in place for other team members to refer patients
to the pharmacist.
Another team-based delivery model involves community pharmacists
working with physician practices in a more ``virtual'' team-based
arrangement for patient care services that go beyond traditional
dispensing. While not as common as the embedded model, these virtual
arrangements often include data sharing and communications agreements
and referrals for patient care services. Medicare's Chronic Care
Management (CCM) Service is an example where virtual team-based service
delivery is occurring that can include aspects of pain management. In
addition, some community pharmacists are also partnering with physician
office practices to offer opioid tapering services, an aspect of pain
management, often using collaborative practice agreements, exploring
how they can assist in monitoring for risk of substance use disorder,
and providing naloxone.
Highlights of effective team-based care delivery for pain
management utilizing pharmacists are noted below:
A systematic review published in the Journal of the
American Medical Association indicated that while up to 92 percent of
patients studied reported they had ``unused'' opioids after surgery,
utilizing pharmacists in the assessment of opioid prescribing can help
minimize the risk of drug diversion. \5\
---------------------------------------------------------------------------
\5\ Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL.
Prescription Opioid Analgesics Commonly Unused After Surgery A
Systematic Review. JAMA Surg. 2017;152(11):1066-1071. doi:10.1001/
jamasurg.2017.0831.
Pharmacists can perform a complete review of a patient's
---------------------------------------------------------------------------
medication regimen to optimize therapy and minimize side-effects.
Y As part of this service, they may recommend non-opioid pain
alternatives and work with prescribers to provide screening,
medication management, monitoring and tapering services.
A study analyzing the economic impact of opioid-related
adverse drug events (e.g. nausea, respiratory complications), estimated
over half experiencing an event would have a longer hospital stay
resulting in 47 percent higher cost of care for that patient. Involving
pharmacists in the process of counseling, discharge, and clinic follow-
up of post-operative patients who are prescribed opioids can help
reduce opioid-related adverse drug events and subsequent health care
costs. \6\
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\6\ E.R. Kessler, M. Shah, S.K. Gruschkus, A. Raju (2013). Cost
and quality implications of opioid-based postsurgical pain control
using administrative claims data from a large health system: opioid-
related adverse events and their impact on clinical and economic
outcomes Pharmacotherapy, 33(4), 383-391.
Pharmacists are involved in pain management programs that
include monitoring and medication tapering services, work in medication
assisted treatment programs, and furnish naloxone where authorized.
Research has demonstrated the value of pharmacists in positively
impacting patients with chronic pain. \7\, \8\
---------------------------------------------------------------------------
\7\ Cox, N., Tak, C.R., Cochella, S.E., Leishman E., & Gunning, K.
(2018). Impact of Pharmacist Previsit Input to Providers on Chronic
Opioid Prescribing Safety.
\8\ https://doi.org/10.1016/j.japh.2017.01.016.
Pharmacists' medication expertise helps inform other care
team members about safer and alternative prescribing options, and
naloxone. \9\, \10\ For example, physicians in community practices and
the U.S. Department of Veterans Affairs medical settings who received
services such as academic detailing from a pharmacist regarding safer
opioid prescribing later reported adopting safer prescribing behaviors.
\11\, \12\
---------------------------------------------------------------------------
\9\ See Trotter Davis, M., Bateman, B. & Avorn J. Educational
Outreach to Opioid Prescribers: The Care for Academic Detailing, Pain
Physician, 2017, 20:S147-S:151. Available at: https://
www.ncbi.nlm.nih.gov/pubmed/28226336.
\10\ Duvivier H., et al., Indian Health Service pharmacists
engaged in opioid safety initiatives and expanding access to naloxone.
Journal of the American Pharmacists Association. 57 (2017), S135-S140.
\11\ Larson, M.J., Browne, C., Nikitin, R.V., Wooten, N.R., Ball,
S., Adams, R.S. & Barth, K. (2018). Physicians report adopting safer
opioid prescribing behaviors after academic detailing intervention,
Substance Abuse, Apr 2:1-to 7. Available at: https://
www.researchgate.net/publication/324172121-Physicians-report-adopting-
safer-opioid-prescribing-behaviors-after-academic-detailing-
intervention.
\12\ Gelland, W.F., Good, C.B. and Shulkin, D.J. (2017).
Addressing the Opioid Epidemic in the United States Lessons from the
Department of Veterans Affairs, JAMA Intern Med. 177(5):611-612.
Pharmacist involvement in MAT for opioid use disorders
helps improve access and outcomes, while reducing the risk of relapse.
\13\, \14\, \15\ Currently, six states explicitly allow pharmacists to
prescribe Schedule II-V controlled substances under a collaborative
practice agreement. Consequently, under certain states' scope of
practice laws, pharmacists are eligible to prescribe Schedule III
controlled substances but are constrained by Federal law, specifically
the Drug Addiction Treatment Act of 2000, from further expanding
patient access to MAT.
---------------------------------------------------------------------------
\13\ DiPaula BA, Menachery E. Physician-Pharmacist Collaborative
Care Model for Buprenorphine-maintained Opioid-dependent Patients. J Am
Pharm Assoc. 2015; 55: 187-192.
\14\ Duvivier H., et al., Indian Health Service pharmacists
engaged in opioid safety initiatives and expanding access to naloxone.
Journal of the American Pharmacists Association. 57 (2017), S135-S140.
\15\ Grgas, M. Clinical psychiatric pharmacist involvement in an
outpatient buprenorphine program, Mental Health Clinician, 2013, 3(6),
Duvivier H., et al., Indian Health Service pharmacists engaged in
opioid safety initiatives and expanding access to naloxone. Journal of
the American Pharmacists Association. 57 (2017), S135-S140 290-291.
---------------------------------------------------------------------------
______
senator casey
Detailed examples of effective team-based care delivery for pain
management:
1. Cox, N., Tak, C.R., Cochella, S.E., Leishman E., & Gunning, K.
(2018). Impact of Pharmacist Previsit Input to Providers on Chronic
Opioid Prescribing Safety.
Y Pharmacist's Role: All adult patients with an appointment
for chronic pain who were prescribed >50 morphine milligram
equivalents (MMEs)/day had charts reviewed by a pharmacist
before each appointment; recommendations were sent
electronically to the provider before the appointment.
Y Results: When comparing outcomes before and after
intervention, the mean MMEs/day decreased by 14 percent (P <
.001), with no change in pain scores (P = .783). Statistically
significant improvements were noted in multiple other secondary
opioid safety outcomes.
Y Conclusion: Clinical pharmacists providing previsit
recommendations was associated with decreased opioid
utilization with no corresponding increase in pain scores and
increased compliance to guideline recommendations.
2. Genord, C., Frost, T. & Eid, D. (2017). Opioid exit plan: A
pharmacist's role in managing acute postoperative pain, Journal of the
American Pharmacists Association, 57(2), S92-S98.
Y Pharmacist's Role: Pharmacist-led opioid exit plan (OEP) for
acute postoperative pain management. OEP is a tool and its
benefits include medication reconciliation review and
prescription drug--monitoring program search before admission,
interdisciplinary rounds with the medical team to provide
optimal inpatient postoperative pain management, clinical
assessment of outpatient prescriptions with opioid discharge
counseling, and medication evaluation of prescribed pain
regimen and opioid discontinuation status at the post-discharge
follow-up appointment. An OEP is a national practice model.
` This paper summarizes the setup of a new pharmacist-
led OEP practice model and the potential role that
pharmacists and students can have before admission,
during inpatient visits, and during transitions of care
for discharge in acute pain management patients.
Y Conclusion: A pharmacy pain management team can be key to
guiding the appropriate prescribing practices of inpatient
opioids and ensure best practices with quantity and quality of
opioid prescriptions written on discharge. Future outcomes-
based evaluations of the success of this practice model are in
progress.
3. Michalets, E., Creger, J. & Shillinglaw, W.R. (2015). Outcomes
of expanded use of clinical pharmacist practitioners in addition to
team-based care in a community health system intensive care unit,
American Journal of Health System Pharmacy, 72(1), 47-53.
Y Pharmacist's Role: Dedicated clinical pharmacist
practitioner (CPP) was made available 5 days per week in
multidisciplinary team (trauma surgeon, bedside nurse, care
manager, pharmacist, respiratory therapist, and nutrition
support professional) rounds in a neurotrauma ICU. A practice
agreement was in place to allow the CPP to initiate, modify, or
discontinue medications on the hospital formulary and to order
pertinent laboratory tests. In addition, the CPP could provide
comprehensive medication management for medications
administered in the ICU.
` The pharmacist was responsible for clinical
services, participation in the multidisciplinary team,
electronic verification of medication orders,
participation in emergency-code responses and
provisions of clinical services. The CPP assisted with
the development of individualized care plans, daily
monitoring of patients and precepting of pharmacy
student and residents.
Y Results:
` Based on the evaluated national benchmarking data,
the estimated cost savings or avoidance associated with
these patient encounters was $2,118,426 over the two-
year period. The ROI increased after the CPP expansion,
from $9 per $1 invested in year 1 to $18 per $1
invested in year 2. This doubling of the ROI reflected
daily consistency in CPP involvement in NTICU care and
provision of more meaningful therapeutic interventions.
` Comparison of the year 1 and year 2 data indicated a
significant increase in the frequency of patient
encounters for therapeutic optimization (p < 0.01)
along with a 29 percent increase in cost savings with
the CPP expansion (Table 3). Thus, the addition of two
CPPs increased the volume of meaningful interventions.
Although not a statistically significant decline,
patient deaths decreased by 5.6 per 1000 ICU days
during the study.
Y Conclusion: With expanded CPP involvement on the NTICU team,
there was a substantial increase in therapeutic optimization
interventions and a clinically notable reduction in preventable
ADEs, as well as an estimated 30 percent increase in associated
cost savings.
4. Mathew, S. Chamberlain, C., Alvarez, K.S. & Shah, M. (2016).
Impact of a Pharmacy-Led Pain Management Team on Adults in an Academic
Medical Center, Hospital Pharmacy, 51(8), 639-645.
Y Pharmacist's role: Pharmacy pain medication management
service (pharmacy pain consult) was provided to certain adult
patients.
Y Results: Eight hundred twenty-one interventions were made by
the clinical pharmacists. Patients displayed a significant
reduction in their pre-and post-consult pain intensity scores
on a 0 to 10 numerical rating scale (6.15 vs 3.25; p < .001).
Likewise, a significant reduction in pain intensity scores was
seen from pre-consult to pre-discharge (6.15 vs 3.6; p < .001).
Overall functional improvement, specifically sleep, mobility,
and appetite, was seen in 86.6 percent of patients.
Y Conclusion: Pain management is an area that provides
opportunities for pharmacotherapy interventions. Pharmacists'
involvement in pain management on an inpatient consult service
had a positive impact on pain scores and improvement in
functionality.
5. Boren, L.L., Locke, A.M., Friedman, A.S., Blackmore, C.C. &
Woolf, R. (2019). Team-Based Medicine: Incorporating a Clinical
Pharmacist into Pain and Opioid Practice Management, PM&R,. doi:
10.1002/pmrj.12127.
Y Pharmacist's Role: A clinical pharmacist was added to a
team-based care model in an outpatient Physical Medicine and
Rehabilitation clinic in a tertiary hospital.
Y Results: A clinically significant reduction in MED with an
average decrease of 207 mg was seen after five or more visits
with the pharmacist. The pharmacist initiated non-opioid
medications at 209 (19.5 percent) unique patient visits. The
pharmacist completed 1,197 visits during the study timeframe,
increasing physician access by at least 2 additional visits per
patient per year. Completion of urine drug screens and
medication agreement reviews improved over time (p < .001).
There was an increase in MED for patients who did not complete
this monitoring, while the MED remained stable in those who did
complete the monitoring.
Y Conclusion: The addition of a clinical pharmacist to an
interdisciplinary team managing COT patients resulted in a MED
reduction after five or more visits with the pharmacist,
improved adherence to best practice standards, optimization of
opioid and non-opioid medication therapy, and increased patient
access.
6. Chen, J., Lu, X., Wang, W., Shen, B., Ye, Y., Jiang, H., Wang,
Q. & Chang, B. (2014). Impact of a Clinical Pharmacists-Led Guidance
Team on Cancer Pain Therapy in China: A Prospective Multicenter Cohort
Study, Journal of Pain and Symptom Management, 48(4), 500-509. (Note:
Chinese study)
Y Pharmacist's Role: Clinical Pharmacist-Led Guidance Teams
provided pre-therapy consultation and drug education to
physicians, monitored prescriptions during treatment, and
conducted patient follow-up.
Y Results: A total of 542 patients were enrolled, 269 in the
CPGT intervention group (CPGT group) and 273 controls.
Standardization of opioid administration was improved
significantly in the CPGT group, including more frequent pain
evaluation (P < 0.001), more standardized dosing titration (P <
0.001), and less frequent meperidine prescriptions (P < 0.001).
The pain scores in the CPGT group were significantly improved
compared with the control group (P < 0.05). The incidences of
gastrointestinal adverse events were significantly lower in the
CPGT group (constipation: P = 0.041; nausea: P = 0.028;
vomiting: P = 0.035), and overall quality of life was improved
(P = 0.032). No opioid addiction was encountered in the CPGT
group. Risk analysis revealed that patient follow-up by
pharmacists and the controlled dosing of opioids were the major
factors in improving treatment efficacy.
Y Conclusion: The CPGTs significantly improved
standardization, efficiency, and efficacy of cancer pain
therapy in China. In a country where clinical pharmacy is still
developing, this is a valuable service model that may enhance
cancer treatment capacity and efficacy while promoting
recognition of the clinical pharmacy profession.
7. Slipp, M. & Burnham, R. (2017). Medication management of chronic
pain: A comparison of 2 care delivery models, Canadian Pharmacists
Journal, https://doi.org/10.1177/1715163517690540 (Note: Canadian
study).
Y Pharmacist's Role: In the pharmacists-physician team model,
the physician did the medical assessment, diagnosis, and
established a treatment plan in consultation with the patient
and pharmacist. The pharmacist then provided the ongoing
follow-up including education, dose titration and side effect
management and consulted with the physician as needed.
Y Results: Both models of medication management resulted in
significant and comparable improvements in pain, disability and
patient perception of medication effectiveness. Patients in the
physician-only group were seen more frequently and at a greater
cost. The pharmacist-physician team approach was markedly more
cost-effective, and patients expressed a high level of
satisfaction with their medication management.
Y Conclusion: The pharmacist-physician team model of
medication management results in significant reductions of pain
and disability for chronic nonmalignant pain sufferers at a
reduced cost and is well accepted by patients.
[Whereupon, at 12:02 p.m., the hearing was adjourned.]