[Senate Hearing 116-313]
[From the U.S. Government Publishing Office]





                                                         S. Hrg. 116-313
 
                 MANAGING PAIN DURING THE OPIOID CRISIS

=======================================================================

                                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

                               __________

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             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

                              ----------                              

                               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

                              ----------                              


                       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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \9\  https://www.ncbi.nlm.nih.gov/pubmed/20104399.

    Despite the impact of pain, we have failed as a country to 
---------------------------------------------------------------------------
effectively address it.

          At present, less than 2 percent of the NIH's budget 
        goes to pain research. \10\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \13\  https://www.ncbi.nlm.nih.gov/pubmed?term=21704872.
    \14\  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3841375/.
---------------------------------------------------------------------------
  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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.]

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