[Senate Hearing 114-850]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 114-850

                       OPIOID USE AMONG SENIORS:
                       ISSUES AND EMERGING TRENDS

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

                                HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS


                             SECOND SESSION

                               __________

                             WASHINGTON, DC

                               __________

                           FEBRUARY 24, 2016

                               __________

                           Serial No. 114-20

         Printed for the use of the Special Committee on Aging
         
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]         

        Available via the World Wide Web: http://www.govinfo.gov
        
                                __________

                                
                    U.S. GOVERNMENT PUBLISHING OFFICE                    
48-242 PDF                 WASHINGTON : 2023                    
          
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                       SPECIAL COMMITTEE ON AGING

                   SUSAN M. COLLINS, Maine, Chairman

ORRIN G. HATCH, Utah                 CLAIRE McCASKILL, Missouri
MARK KIRK, Illinois                  BILL NELSON, Florida
JEFF FLAKE, Arizona                  ROBERT P. CASEY, JR., Pennsylvania
TIM SCOTT, South Carolina            SHELDON WHITEHOUSE, Rhode Island
BOB CORKER, Tennessee                KIRSTEN E. GILLIBRAND, New York
DEAN HELLER, Nevada                  RICHARD BLUMENTHAL, Connecticut
TOM COTTON, Arkansas                 JOE DONNELLY, Indiana
DAVID PERDUE, Georgia                ELIZABETH WARREN, Massachusetts
THOM TILLIS, North Carolina          TIM KAINE, Virginia
BEN SASSE, Nebraska
                              ----------                              
               Priscilla Hanley, Majority Staff Director
                 Derron Parks, Minority Staff Director
                        
                        
                        C  O  N  T  E  N  T  S

                              ----------                              

                                                                   Page

Opening Statement of Senator Susan M. Collins, Chairman..........     1
Opening Statement of Senator Joe Donnelly, Member of the 
  Committee......................................................     3
Opening Statement of Senator Tim Kaine, Member of the Committee..     4

                           PANEL OF WITNESSES

Sean Cavanaugh, Deputy Administrator and Director, Center for 
  Medicare, Centers for Medicare and Medicaid Services, U.S. 
  Department of Health and Human Services........................     6
Ann Maxwell, Assistant Inspector General, Office of Evaluation 
  and Inspection, Office of Inspector General, U.S. Department of 
  Health and Human Services......................................     7
Steven Diaz, M.D., F.A.A.F.P., F.A.C.E.P., Senior Vice President 
  and Chief Medical Officer, Maine General Health................     9
Jerome Adams, M.D., M.P.H., Commissioner, Indiana State 
  Department of Health...........................................    11
Sean Mackey, M.D., Ph.D., Redlich Professor, Departments of 
  Anesthesiology, Perioperative and Pain Medicine, Neurosciences 
  and Neurology, Chief, Division of Pain Medicine, Director, 
  Systems Neuroscience and Pain Lab, Stanford School of Medicine, 
  California; and Member of Institute of Medicine's Committee on 
  Advancing Pain Research, Care, and Education...................    13

                                APPENDIX
                      Prepared Witness Statements

Sean Cavanaugh, Deputy Administrator and Director, Center for 
  Medicare, Centers for Medicare and Medicaid Services, U.S. 
  Department of Health and Human Services........................    39
Ann Maxwell, Assistant Inspector General, Office of Evaluation 
  and Inspection, Office of Inspector General, U.S. Department of 
  Health and Human Services......................................    48
Steven Diaz, M.D., F.A.A.F.P., F.A.C.E.P., Senior Vice President 
  and Chief Medical Officer, Maine General Health................    57
Jerome Adams, M.D., M.P.H., Commissioner, Indiana State 
  Department of Health...........................................    60
Sean Mackey, M.D., Ph.D., Redlich Professor, Departments of 
  Anesthesiology, Perioperative and Pain Medicine, Neurosciences 
  and Neurology, Chief, Division of Pain Medicine, Director, 
  Systems Neuroscience and Pain Lab, Stanford School of Medicine, 
  California; and Member of Institute of Medicine's Committee on 
  Advancing Pain Research, Care, and Education...................    68

 
                       OPIOID USE AMONG SENIORS:
                       ISSUES AND EMERGING TRENDS

                              ----------                              


                      WEDNESDAY, FEBRUARY 24, 2016

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 2:30 p.m., Room 
562, Dirksen Senate Office Building, Hon. Susan M. Collins, 
Chairman of the Committee, presiding.
    Present: Senators Collins, Donnelly, Casey, Blumenthal, 
Warren, and Kaine.

                 OPENING STATEMENT OF SENATOR 
                   SUSAN M. COLLINS, CHAIRMAN

    The Chairman. The Committee will come to order. Good 
afternoon.
    I would note today that our Ranking Member, Senator Claire 
McCaskill from Missouri, is unable to be with us today. I know 
I speak on behalf of the entire committee in wishing her a very 
speedy recovery, and I am certain that she will be rejoining us 
very soon.
    In the meantime, it is a great pleasure to have acting as 
our Ranking Minority Member today Senator Joe Donnelly from 
Indiana. At the request of Senator McCaskill, and with my 
strong concurrence, Senator Donnelly has agreed to step in and 
fill the role of Ranking Member today. He has had a very strong 
interest in the issue that we are exploring and, indeed, has 
invited one of the witnesses who will be testifying today, so 
thank you, Senator.
    Senator Donnelly. Thank you, Madam Chair.
    The Chairman. Millions of older Americans experience pain 
associated with conditions such as bone fractures, cancer, 
post-surgery recovery, and end-of-life illnesses. In fact, 
studies have shown that as many as 50 percent of older adults 
living at home and 85 percent of older adults living in 
residential facilities may suffer from chronic pain. For these 
older Americans, prompt delivery of pain control is a medical 
imperative.
    For many years, patients faced unacceptable barriers to 
effective pain management for debilitating symptoms and 
illnesses and their treatment was often needlessly less than 
optimal. More recently, however, the pendulum appears to have 
swung too far in the other direction. Physicians now face the 
complicated task of treating pain in an environment where abuse 
of prescription pain killers is one of the foremost public 
health challenges facing our Nation. Prescription opioid abuse 
has become a national epidemic and is having devastating 
effects on our families and our communities across America.
    Health care providers can play an important role in 
preventing inappropriate access, but Federal reimbursement 
policies may challenge their best efforts. The government's 
current practice of linking certain quality measures to patient 
satisfaction with the control of their pain may inadvertently 
reward opiate prescribing, even when it is not warranted. 
Prompt and effective pain management is a critical component of 
quality patient care, but hospitals should not have to fear a 
penalty when medical providers, using their best medical 
judgment, decide not to prescribe opioid pain relievers.
    I am also concerned by several emerging trends. In the year 
2012, 12.3 million Medicare beneficiaries filled more than 76 
million opioid prescriptions at a cost of more than $3 billion. 
Yet, nearly 90 percent of these individuals did not have any 
hospice stays during the year and were not being treated for 
cancer.
    Another disturbing trend is described in the recent Agency 
for Health Care Research and Quality Study, which reported that 
hospital stays resulting from opioid overuse among adults over 
age 65 increased more than fivefold between 1993 and 2012.
    A 2011 Government Accountability Office study revealed that 
about 170,000 Medicare recipients acquired frequently abused 
drugs of the same category from five or more health care 
providers. Now, it is possible that these beneficiaries may 
have received prescriptions from multiple providers for 
entirely legitimate reasons. For example, they may be seeing a 
number of specialists. GAO, however, did find evidence of 
doctor shopping among some of these beneficiaries, a powerful 
indicator of diversion and misuse. In fact, the GAO identified 
approximately 600 beneficiaries who received prescriptions from 
between 21 and 87 different providers in a single year.
    Seniors in need of substance abuse disorder treatment may 
also face serious challenges accessing care due to a shortage 
of geriatric mental health professionals. I know that is a big 
problem in my State and in many rural areas.
    Older Americans are more likely than their younger 
counterparts to visit a doctor for pain, take multiple 
medications to manage complex medical issues, and to be 
prescribed opioids that they may keep in their home medicine 
cabinets. According to the Substance Abuse and Mental Health 
Services Agency, more than 70 percent of prescription drug 
abusers report obtaining these pills from family members' 
medicine cabinets. Diversion is, thus, a major source fueling 
addiction.
    I am saddened by stories about younger individuals who are 
breaking the law and breaking into older adults' homes in order 
to steal prescriptions to feed their own addictions. In some 
cases, it is even the grandchildren stealing pills from their 
own grandparents.
    Funeral directors in Maine have told me that they sometimes 
advise grieving families not to cite the cause of a loved one's 
death in obituaries because the obituary may inadvertently 
advertise what prescription medications may be in the home and 
when the home may be vacant for ransacking. In one tragic 
example, thieves broke into a home in northern Maine and stole 
prescription medications while the family was attending the 
funeral of a loved one.
    Our committee is holding this hearing to examine one of the 
facets of a complicated and vexing public health crisis. I hope 
that our conversation today is a constructive contribution to 
addressing this sad and serious epidemic of addiction.
    I look forward to hearing from our witnesses, and I now 
turn to Senator Donnelly for his opening statement.

                 OPENING STATEMENT OF SENATOR 
             JOE DONNELLY, MEMBER OF THE COMMITTEE

    Senator Donnelly. Thank you, Madam Chair, and I also join, 
as I know Senator Warren does and Senator Kaine does, in 
sending out our respect, our affection to our colleague, Claire 
McCaskill, who will be back with us soon.
    Chairman Collins, thank you for holding this incredibly 
important hearing. As too many Hoosiers and too many Americans 
have come to know firsthand, opioid addiction and heroin 
addiction is devastating families and communities across this 
country. It has impacted communities large and small, urban and 
rural, working class and wealthy. It has touched our families, 
friends, and neighbors, and far too many children.
    In my home State of Indiana, like so many other parts of 
the country, we have seen there are no boundaries to this 
crisis, and today we are here to learn how it is impacting our 
Nation's seniors.
    In Scott County, Indiana, we experienced an HIV outbreak, 
as Dr. Adams, one of our witnesses, knows. More than 185 people 
in a town of 4,200 have tested positive for HIV, and it is 
largely driven by injection drug users who shared needles. This 
crisis has gripped Scott County and Austin, Indiana. This has 
not only been hit hard by HIV, by also by other drug addiction, 
as well. We learned from the CDC this was an inter-generational 
epidemic, where youth, parents, and grandparents were all 
addicted to the same prescription painkiller.
    We must utilize and leverage every possible tool to address 
the opioid abuse and heroin use epidemics. That is the approach 
we have taken, working on legislative solutions, collaborating 
with Federal partners, our State law enforcement, public health 
officials, prescribers, and community stakeholders.
    For more than 2 years, I have been working to combat the 
opioid abuse and heroin abuse epidemics in Indiana. I 
reintroduced a bipartisan bill with Senator Ayotte last spring 
that would take a multi-pronged approach to help communities 
devastated by this epidemic. Our bipartisan bill focuses on 
several key areas, including enhancing training and education 
for prescribers.
    I am eager for the Senate to take up the Comprehensive 
Addiction and Recovery Act that was introduced by our fellow 
committee member, Senator Whitehouse. I am proud to support 
this legislation and was pleased to see that the committee-
passed version includes provisions to update prescribing best 
practices and raising awareness of this epidemic, similar to 
some of those areas we have worked on with Senator Ayotte.
    I am encouraged that both the Obama administration and the 
State of Indiana have announced their intention to adopt or act 
on a number of the policy recommendations that have been 
suggested and that the President mentioned the drug epidemic as 
a place for bipartisan cooperation in the coming year, and our 
Chairwoman has helped to lead this effort by holding this 
hearing, as well as many others. We could not agree more with 
the President on the bipartisan nature of this and we want to 
thank you for taking a lead in all of this effort.
    We are beginning to see some good steps being taken. 
However, it takes all of us to continue to work to reverse this 
tide.
    Where I have learned the most is from Hoosiers back home on 
the ground, from moms and dads, brothers and sisters. My 
colleague, Congresswoman Susan Brooks, and I held a roundtable 
in Indiana to bring together health officials, doctors, and 
pharmacists to get as many perspectives out on the table as we 
could. What I have learned from those conversations is we have 
a lot of work to do, particularly in raising awareness on this 
growing public health crisis, enhancing prescriber best 
practices, expanding access to treatment, and increasing access 
to overdose reverse options like naloxone for emergency 
personnel.
    There is a lot of wisdom out there. We appreciate all you 
are bringing to us today. I want to thank our witnesses who 
came to testify and I want to thank our Chair for holding this 
incredibly important hearing. Thank you.
    The Chairman. Thank you very much.
    Given the interest in this issue, I am going to see if any 
of our members want to make brief opening statements before we 
turn to our panel.
    Senator Warren, I know that you said you might not want to, 
but I want to give you an opportunity.
    Senator Warren. Thank you. I just want to say thank you 
very much for holding this hearing. It is powerfully important. 
As you rightly point out, this is a bipartisan issue. We are 
all deeply engaged in it.
    I also want to add my good wishes for the speedy recovery 
of our very well respected and beloved colleague, Claire 
McCaskill, and we look forward to having her back on this 
Committee, and I will just yield my time so that we can go 
straight to the witnesses and the questions. Thank you.
    The Chairman. Thank you.
    I suspect that our colleague, Senator McCaskill, is 
watching on C-SPAN from Missouri.
    Senator Warren. Yes.
    Senator Donnelly. We are afraid on this side that she is 
grading us, so we hope to do a good job.
    The Chairman. Senator Kaine.

                 OPENING STATEMENT OF SENATOR 
               TIM KAINE, MEMBER OF THE COMMITTEE

    Senator Kaine. Great. Thank you, Madam Chair, and again, my 
similar thoughts to my Mizzou alumni colleague, Senator 
McCaskill.
    I have been traveling around the Commonwealth since I came 
into the Senate in 2013, and everywhere I go, this is what 
people want to talk about. I started to go into meetings early 
in my time in the Senate where I wanted to talk about something 
else and I did not get to talk about the reason I came because 
people wanted to talk about this opioid problem and the 
connected heroin problem that is affecting communities in all 
regions. It is not a respecter of race or region or demography. 
It is devastating.
    The crisis has a particular impact on older populations. 
The CDC in 2013 said that more than 12,000 Baby Boomers died of 
accidental drug overdoses, and that is more than the number who 
died from auto accidents or from pneumonia and influenza 
combined.
    I think Mr. Cavanaugh is going to talk about Medicare 
mapping data, and we pulled up and looked at that data as it 
affects Virginia and it is just shocking. There are some 
counties in southwest Virginia where there are two to five 
times the number of opioid prescriptions written in Medicare 
than there are the entire population of the county, so a 
Medicare prescription is not the private insurance pay 
prescription. It is not other prescriptions. It is just two to 
five times the number of opioid prescriptions paid for by 
Medicare than the entire population of the county. It is 
staggering, and it is a problem that--you know, it seems unlike 
any other of a major epidemic. It began in the medicine 
cabinet. This is not street corner stuff that is being sold. 
Eighty percent of the heroin deaths in the United States last 
year were people who got hooked on opioids and then went to 
heroin because it was cheaper, so the problem starts in the 
medicine cabinet.
    I look forward to dialoguing about solutions today, those 
my colleagues have mentioned. I have introduced two bills, one, 
the Co-Prescribing Saves Lives Act with Senator Shelley Moore 
Capito dealing with the co-prescription of naloxone in Federal 
health centers, VA, and DOD facilities, and then, second, 
Stopping Medication Abuse and Protecting Seniors Act, which 
would apply some of the Medicaid lock-in prescriptions to 
Medicare, and we probably will want to dialog with you a little 
bit about those, but thank you for being here, and to the 
Chairwoman and Ranking for setting this hearing up on a very 
important topic.
    The Chairman. Thank you very much.
    We will now turn to our panel of witnesses. First, we will 
hear from Sean Cavanaugh. Mr. Cavanaugh is the Deputy 
Administrator and Director of the Center for Medicare at the 
Centers for Medicare and Medicaid Services.
    After his testimony, we will hear from Ann Maxwell, the 
Assistant Inspector General of the Office of Evaluation and 
Inspections in the Office of the Inspector General at the U.S. 
Department of Health and Human Services. Everyone has a long 
title.
    We will then hear from one of my constituents, Dr. Steven 
Diaz. Dr. Diaz is the Chief Medical Officer and an emergency 
medical physician at MaineGeneral in Augusta, Maine. I want to 
thank you for taking your time out of what I know is a very 
busy schedule serving patients to fly down from Maine and be 
with us today.
    I am now going to ask Senator Donnelly to introduce our 
next witness before I introduce our last witness.
    Senator Donnelly. Our next witness is Dr. Jerome Adams, who 
has served as the Indiana State Health Commissioner since 
October 2014. In his role as Commissioner, Dr. Adams has played 
an integral role in the state's response to the opioid and 
heroin abuse crisis, and Dr. Adams was on the very front line 
of the emergency we faced in the town of Austin, the county of 
Scott County, where we have over 185 HIV cases in a town of 
4,200, and he worked together to try to coordinate the response 
to that effort.
    The Chairman. Thank you.
    Our last witness, last but certainly not least, is Dr. Sean 
Mackey. He is the Chief of the Division of Pain Medicine and 
the Redlich Professor of Anesthesiology at Stanford University. 
He, too, traveled a long distance, even further than from 
Maine, to be with us today, and we very much appreciate that.
    We will start with Mr. Cavanaugh.

              STATEMENT OF SEAN CAVANAUGH, DEPUTY

               ADMINISTRATOR AND DIRECTOR, CENTER

               FOR MEDICARE, CENTERS FOR MEDICARE

             AND MEDICAID SERVICES, U.S. DEPARTMENT

                  OF HEALTH AND HUMAN SERVICES

    Mr. Cavanaugh. Thank you, Chairman Collins and members of 
the Committee, for inviting me here today to discuss CMS's work 
to prevent prescription drug abuse.
    We appreciate the continued efforts by this Committee to 
reduce opioid misuse and combat the overutilization of 
prescription drugs. We also thank the Office of the Inspector 
General for their work and their recommendations to improve the 
Medicare Part D program.
    Combating non-medical prescription opioid use, overuse, 
dependence, and overdose is a priority for Secretary Burwell 
and the administration. The Secretary has launched an evidence-
based opioid initiative that focuses on three targeted areas: 
One, informing opioid prescribing practices; two, increasing 
the use of naloxone; and three, expanding the use of medication 
assisted treatment. At CMs, we recognize our responsibility to 
be part of the solution, too, by ensuring appropriate 
safeguards are in place to prevent overuse and misuse of 
opioids.
    Since 2006, the Medicare Part D prescription drug benefit 
program has successfully expanded access to prescription drugs 
to over 40 million Medicare beneficiaries, leading to 
improvements in health outcomes. As we celebrate that success, 
however, we face new challenges from the nationwide epidemic of 
opioid abuse. CMS has taken important steps to reduce potential 
fraud and drug abuse by making sure Part D sponsors implement 
effective safeguards and provide coverage for drug therapies 
that meet safety and efficacy standards. We believe that 
reforms that improve care coordination and oversight can 
protect beneficiaries from the harm associated with 
prescription drug abuse.
    The centerpiece of our strategy is an opioid 
overutilization policy. The Medicare Part D Overutilization 
Monitoring System, or OMS, was implemented in 2013 to 
strengthen our monitoring of Part D plan sponsors' drug 
utilization management programs. Through OMS, we identify 
beneficiaries with potentially dangerous opioid utilization. We 
share the lists of these beneficiaries with Part D plan 
sponsors so they can target strategies, like case management 
and point-of-sale edits, to prevent continued overutilization. 
We also facilitate plans' ability to share information about 
beneficiaries engaged in potentially dangerous opioid use, 
actions that can prevent beneficiaries from changing plans to 
avoid detection. From 2011 to 2015, the number of potential 
opioid overutilizers by the criteria we use in OMS fell by 
approximately 47 percent.
    We have also improved data sharing with law enforcement. 
CMS utilizes the Medicare Drug Integrity Contractor, or MEDIC, 
to identify potential fraud and abuse, allowing us to develop 
cases for referral to law enforcement agencies. In 2013, at the 
recommendation of the Inspector General, we directed the MEDIC 
to increase its focus on proactive data analysis in Part D.
    CMS has also developed high-risk pharmacy and prescriber 
assessments which we provide to the Part D plan sponsors. These 
reports are generated by a sophisticated analysis that 
identifies a list of high-risk pharmacies and prescribers. Plan 
sponsors use this information to initiate investigations and 
conduct audits and ultimately terminate pharmacies or 
prescribers from their networks. We have also implemented a 
system that allows plan sponsors to report actions they have 
taken to address issues posed by pharmacies and prescribers.
    CMS has also created new tools to take action against 
problematic prescribers and pharmacies. We are requiring 
prescribers of Part D drugs to enroll in Medicare, just as they 
would enroll in Part A or Part B of the program. In 2015, we 
enrolled 75,000 new prescribers of Part D drugs, and we are 
conducting targeted outreach to high-volume prescribers who 
remain unenrolled. During the enrollment process, prescribers 
will be subject to the same risk-based screening requirements 
that have already contributed to the removal of more than 
700,000 providers and suppliers from the Medicare program since 
the enactment of the Affordable Care Act. Requiring prescribers 
to enroll in Medicare helps CMS make sure that Part D drugs are 
prescribed by qualified individuals and prevents prescriptions 
ordered by excluded and revoked prescribers from being filled.
    CMS has also established the authority to remove 
problematic prescribers from the Medicare program for abusive 
prescribing behaviors. Together, these new policies will help 
prevent bad actors from taking advantage of the Part D program 
and potentially harming beneficiaries.
    In conclusion, CMS is dedicated to providing the best 
possible care to beneficiaries while also ensuring taxpayer 
dollars are spent on medically appropriate care. We have 
incorporated a new focus on ensuring that Part D sponsors 
implement effective safeguards to prevent over-prescribing of 
opioids. Although there is still work to be done, we are 
confident our initiatives will contribute to the reduction in 
the rate of opioid addiction and overdoses in the Medicare 
population.
    Thank you.
    The Chairman. Thank you.
    Ms. Maxwell.

              STATEMENT OF ANN MAXWELL, ASSISTANT

            INSPECTOR GENERAL, OFFICE OF EVALUATION

          AND INSPECTION, OFFICE OF INSPECTOR GENERAL,

          U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Ms. Maxwell. Good afternoon, Chairman Collins, Acting 
Ranking Member Donnelly, and distinguished members of the 
Committee. Thank you for focusing attention on opioid abuse 
among seniors.
    Opioids, if prescribed and used correctly, play an 
important role in managing and relieving pain from surgery, 
illness, or injury. On the other hand, overutilization of these 
powerful drugs can have devastating consequences, as your two 
previous field hearings chillingly demonstrated.
    Today, I am here to talk about OIG's work on opioids in the 
Medicare Part D program, the prescription drug program for 
seniors and the disabled. Our work raises concerns that there 
may be overutilization of opioids in Medicare.
    Specifically, Medicare spending for opioids with the 
highest potential for abuse was $3.9 billion in 2014, a 156 
percent increase in just 8 years. Additionally, spending for 
commonly abused opioids grew at a faster rate than Medicare 
spending for all drugs. This rate of growth appears to be 
driven primarily by the fact that more Medicare beneficiaries 
are receiving opioids, and they are receiving more opioids. 
Nationwide, 32 percent of Medicare patients receive at least 
one prescription for a commonly abused opioid in 2014. This has 
almost doubled since the inception of the program.
    Sadly, even though opioids dispensed by Part D have 
increased, the CDC reports there has been no overall change in 
the amount of pain reported by Americans. One explanation for 
this discrepancy, based on our investigations and analysis, is 
that Medicare may be paying for some medically unnecessary 
opioids and may, in fact, be paying for opioids that end up 
inflicting harm on seniors and others, as some opioids paid for 
by Medicare find their way onto the street and then back in the 
homes across the country.
    OIG analysis uncovered over 1,000 retail pharmacies and 
physicians associated with extremely high billing of opioids 
compared with their peers. In one example, a Detroit area 
pharmacy billed for opioids for 93 percent of its Medicare 
patients. In another case, an OIG investigation led to the 
conviction of a doctor for the illegal distribution of over 
700,000 opioid pills and one patient death.
    As a Nation, we need a multifaceted approach to ensure we 
are protecting our seniors and the Medicare program while still 
ensuring that patients receive the necessary pain relief.
    OIG has offered numerous recommendations to do just that, 
and CMS has made important changes in response, such as 
proactively identifying pharmacies and prescribers with 
questionable billing patterns. Nonetheless, we urge CMS and 
Congress to pursue the following two recommendations that have 
yet to be implemented.
    First, allow to use a monitoring tool currently used in 46 
State Medicaid programs, a patient review and restriction 
program, sometimes called lock-in. This program limits certain 
at-risk beneficiaries to specific pharmacies or prescribers. 
This tool allows for better coordination of services to prevent 
at-risk beneficiaries from overutilizing drugs that may harm 
them or from diverting those drugs for illegitimate use. 
Currently, CMS does not have the authority to implement this 
program in Part D.
    Second, we recommend that CMS expand its drug utilization 
review of opioids to include certain non-controlled drugs 
susceptible to abuse. Some non-controlled drugs, like HIV and 
antipsychotic drugs, can be combined with controlled drugs to 
enhance the euphoric effect. It may feel better, but it also 
increases the chance of an overdose, so to protect seniors, we 
should also be tackling the misuse of those non-controlled 
drugs linked to opioid misuse.
    For our part, we remain committed to working with you, CMS, 
and other Federal and State partners to address the issue of 
opioid overutilization. A problem of this magnitude requires 
everyone's help. The OIG stands ready to assist in finding 
solutions to this challenging problem, and I am happy to be of 
assistance today in answering any of your questions.
    Thank you for your continuation of this very important 
conversation.
    The Chairman. Thank you for your testimony.
    Dr. Diaz.

          STATEMENT OF STEVEN DIAZ, M.D., F.A.A.F.P.,

          F.A.C.E.P., SENIOR VICE PRESIDENT AND CHIEF

             MEDICAL OFFICER, MAINE GENERAL HEALTH

    Dr. Diaz. Chairman Collins, Ranking Member Donnelly, 
members of the Committee, thank you for your leadership 
convening us today and for the opportunity to share my 
perspective on one of the most urgent public health matters to 
confront our State in recent memory.
    Maine is in the midst of an opioid epidemic that affects 
all ages and socioeconomic groups. In Maine, opioid overdose 
cases handled by EMS increased 4 percent in 2014 over the 
previous year and 8 percent in 2015, for a total of 3,202 
incidents in our State. Most patients were between 25 and 54 
years of age, but 12 percent were between 55 and 65, and 12 
percent were older than 65.
    In our emergency department at MaineGeneral, we have also 
seen an increase in both the number and the average age of 
those patients affected by this epidemic. On average, we see 
four opioid overdoses per year in the 65-and-older age group, 
but in 2015, we saw ten. The total subset has not grown. It is 
still 20 per year 65 and older, but now half of those are from 
opiates.
    For treatment of patients with chronic pain, this is a 
significant contributor to the epidemic. The establishment of 
pain as a fifth vital sign in the 1990's, coupled with the 
query on the Hospital Consumer Assessment of Health Care 
Providers and Systems, or HCAHPS, of how hospitals manage 
patients' pain has resulted in an exponential increase in the 
prescribing of opiates. The HCAHPS query is publicly reported 
and part of Medicare's value-based purchasing. Financial 
incentives to do well on rankings for pain queries along with 
pain tool kits proposing that medications for pain can be used 
ubiquitously and safely has created an untenable conflict.
    As a result, physicians now prescribe more opiates and 
treat more opiate diversion, addiction, and overdoses, and this 
is increasingly a problem for the elderly. We must develop and 
implement a plan to help seniors who have chronic pain needs. 
Pain is a complex phenomenon for which one modality will not be 
the single source solution.
    One central issue is the current physician shortages in 
primary care, physiatry, and psychiatry. These three medical 
subspecialties are key for work on the treatment of pain, and 
the national shortages of each are amplified in rural areas, 
such as Maine. Persons who are addicted require medication-
assisted treatment through intensive outpatient programs for 
stabilization followed by the support of primary care 
providers, or PCPs, to help keep them at steady State.
    Further, PCPs must have immediate access to addiction 
specialists who can help if a patient is failing their steady 
State regimen. Such addiction specialists are typically 
physicians who train in psychiatry, physiatry, anesthesiology, 
or primary care with extended specialty education. Significant 
progress would be achieved if providers who prescribe 
medication-assisted therapy are allowed to prescribe more for 
patients. Currently, they are capped at 100 in total. 
Additionally, allowing advanced practice registered nurses and 
physician assistants to prescribe medication-assisted therapy 
in the form of Suboxone would help meet the urgent needs of 
many communities.
    If the medical specialty most apt and necessary to assess 
and offer treatments for those with chronic pain is physiatry. 
These specialists receive broad training, yet the number of 
physiatrists practicing in chronic pain is neither sufficient 
nor distributed well geographically, especially in rural 
states. At MaineGeneral, our physiatry clinic serves our 
primary and secondary service areas, Kennebec County, and the 
surrounding immediate area, but we also have significant number 
of patients from far rural Northern Maine.
    Opiates for non-terminal chronic pain, especially in the 
elderly, should not be the first-line treatment. This is 
because chronic use of opiates may produce dependence, 
confusion, sleepiness, impaired breathing, constipation, and 
death. When used as prescribed under the direction of an 
appropriate medical team, impaired breathing and death may be 
mitigated, but not if diversion is part of the equation.
    In the elderly, side effects are increasingly problematic, 
as adult routine dosing may elicit significant untoward side 
effects. It is sad that we have a pharmaceutical company 
prominently advertising today a new medication to relieve 
opiate-induced constipation, yet we have few, if any, public 
messages on avoiding opiates in the first place.
    To address an individual's chronic pain is 
multidisciplinary in nature. However, such an evaluation is not 
always readily available nor consistently reimbursed by public 
or private insurers. Additionally, wellness and self-care 
exhibited through exercise, diet, yoga, meditation, 
acupressure, acupuncture, and other alternative medical 
therapies are key components of helping those with chronic 
pain, but because insurers do not typically cover these 
modalities, the out-of-pocket costs for the senior citizen is 
untenable in many cases.
    Further, the complex issue of chronic pain and its relation 
to behavioral health must be noted. Either initially or in the 
course of chronic illness, many patients experience mental 
health disease as a comorbid condition. It is of paramount 
importance to have a multidisciplinary team that includes 
behavioral health to identify and treat coexisting mental 
health disorders, such as depression.
    As a practitioner, I am encouraged by the tremendous 
interest at the Federal level in addressing opiate diversion 
and addiction, both by Congress and the administration, and I 
am grateful for the willingness being shown by you,
    Chairman Collins and members of the Committee on Aging, to 
tackle this unique challenge that this epidemic brings to bear 
in the Nation's elderly, and I am pleased to take your 
questions.
    The Chairman. Thank you very much, Doctor.
    Dr. Adams.

            STATEMENT OF JEROME ADAMS, M.D., M.P.H.,

        COMMISSIONER, INDIANA STATE DEPARTMENT OF HEALTH

    Dr. Adams. Madam Chair, Senator Warren, Senator Kaine, and 
my own Senator Donnelly, thank you so much for having me here 
today to testify.
    Again, my name is Jerome Adams and I am the Indiana State 
Health Commissioner as well as a practicing physician 
anesthesiologist. I was in the hospital yesterday dispensing 
pain medications. On behalf of Governor Mike Pence and the 
people of Indiana, it is my honor to discuss with you the 
effects on seniors of the national opioid epidemic.
    Now, I want to be honest with you. I am not here just 
because of my role as Health Commissioner. It is also personal 
to me. In past congressional testimony, I shared that my own 
brother suffers from addiction. It is so bad that my elderly 
parents, who live just a few hours south of here in Maryland, 
are prisoners in their own home. They are afraid to visit my 
kids, their grandchildren, in Indiana for fear of what might be 
stolen when they are gone, or out of concern that my brother 
might be dead when they get back home. My mother has severe 
chronic back pain, but chooses to suffer through it rather than 
agonize about the temptation of keeping her own pain meds 
around the house.
    In terms of what is going on in Indiana, over the past 
year, we faced the very real consequences of our national 
opioid epidemic in rural Scott County. Senator Donnelly hit the 
high points. A rural community, never had more than three cases 
of HIV in the past 4 years combined, now we have 189 HIV-
positive people in a little over a year, 91 percent of whom are 
coinfected with Hepatitis C.
    The causes of this type of opioid misuse are 
multifactorial, as we know, but it is increasingly apparent 
that the actions by and for our country's aging population play 
a significant role. As Senator Collins mentioned in her opening 
remarks, seniors are inextricably and often unwittingly linked 
to increased availability of prescription opioids. Easy access 
has led to one in five high schoolers in Indiana to report 
trying a prescription pain killer for non-medical reasons. You 
say the number one source for pills is an older relative's 
medicine cabinet, and unfortunately, grandparents or other 
older relatives often have these surplus pills, in part because 
of initiatives that were originally designed to help seniors 
manage their pain.
    In 1999, the VA unveiled the concept of pain as the fifth 
vital sign as a national institutional initiative. This was 
done in a noble attempt to address untreated pain in our mostly 
senior VA population, but experts say it has not improved 
outcomes. Doing little to solve the current problem, the 
increased prescribing was, however, effective in leading to our 
current epidemic of opioid misuse and overdose deaths.
    Prescribing habits have been further impacted by CMS 
surveys linking pain management to patient satisfaction scores, 
as Dr. Diaz alluded to. I will not go into my comments on that 
other than to say that CMS has said they are addressing the 
problem. I do want to say that CMS's response in the webinar--
and this is not picking on CMS, we are all part of this 
together--CMS said in their response that HCAHPS does not 
encourage opioid prescriptions. I will tell you that that is 
not what doctors and prescribers and hospitals are telling me 
as we go around the State.
    I also think it is important that everyone in this room 
hear the question on the HCAHPS survey. During this hospital 
stay, how often did the hospital staff do everything they could 
to help you with your pain? That is the question we as doctors 
are being asked. In a country that has 5 percent of the world's 
population but consumes 80 percent of the world's opioids, and 
where we have a patient base that expects pain management to be 
equated to opioid prescribing, you can see how doctors feel 
little choice but to continue to prescribe.
    Indiana has taken numerous steps to address elements of our 
epidemic. Our Governor, Mike Pence, established a 
multidisciplinary task force on drug enforcement, treatment, 
and prevention. We traveled throughout the State, oftentimes 
with Senator Donnelly, hearing stories about what has led to 
the opioid epidemic, what the fallout has been, and what 
communities are doing to turn the tide.
    The task force heard stories about doctors prepared to 
prescribe opioids to little old ladies, only to discover 
through our prescription drug monitoring program that the 
patient had recently visited several other providers seeking 
pain meds. With a street value of up to $160 for a single pill, 
a 30-day supply of Opana is worth almost $5,000 on the street, 
compared to the average Social Security check of $1,300 a 
month, so you can see how seniors are set up for not only 
diverting to supplement their own incomes, but being taken 
advantage of by unscrupulous folks.
    Neither are seniors immune from drug overdoses, which are 
at an all-time high in Indiana. Prescribers are commonly giving 
elderly patients both an opioid and a benzodiazepine, two 
addicting and sedating drugs. Public health officials are 
currently petitioning the FDA to issue a black box warning 
about the overdose dangers of coprescribing these drugs.
    Further regarding overdose, our task force heard from a 
police officer who was an admitted naloxone skeptic--naloxone, 
as you know, is a drug that can reverse an overdose--because 
the officer thought it would enable drug use. His first 
administration of naloxone was actually to an elderly patient 
who accidentally overdosed on legitimately prescribed pain 
meds.
    The work of the Governor's task force has resulted in 
recommendations that include increasing access to naloxone 
amongst first responders--recent stats tell us Indiana 
administered over 5,000 doses of naloxone in the last year. 
Governor Pence has also directed our task force to increase 
awareness about naloxone for lay providers. We have worked on 
improving our State prescription drug monitoring program, 
developing guidelines for prescribing acute pain medications, 
increasing substance abuse treatment options, including 
medication-assisted treatment, and increasing options for 
proper disposal of unused pain meds. Steps like these will 
ensure pain medications are more appropriately prescribed and 
help prevent diversion of surplus meds.
    In closing, we must continue to take steps to change 
prescribing habits, examine pain as the fifth vital sign, and 
the use of pain management as a metric to determine provider 
reimbursement, and we have to get naloxone in the hands of 
those who need it. There is much to do, but together, we are 
making progress in Indiana. We must persist to protect seniors, 
seniors like my parents and all who have fallen victim to the 
opioid epidemic.
    I am happy to take your questions. Thank you.
    The Chairman. Thank you very much for your compelling 
testimony.
    Dr. Mackey.

             STATEMENT OF SEAN MACKEY, M.D., PH.D.,

       REDLICH PROFESSOR, DEPARTMENTS OF ANESTHESIOLOGY,

         PERIOPERATIVE AND PAIN MEDICINE, NEUROSCIENCES

        AND NEUROLOGY, CHIEF, DIVISION OF PAIN MEDICINE,

          DIRECTOR, SYSTEMS NEUROSCIENCE AND PAIN LAB,

            STANFORD SCHOOL OF MEDICINE, CALIFORNIA;

        AND MEMBER OF INSTITUTE OF MEDICINE'S COMMITTEE

        ON ADVANCING PAIN RESEARCH, CARE, AND EDUCATION

    Dr. Mackey. Thank you very much, Chairman Collins, Ranking 
Member Donnelly, and members of the Committee. It is an honor 
to be here with you today, and I am grateful for your 
leadership in this important area.
    I am a professor and Chief of the Stanford University 
Division of Pain Medicine, where I care for a very large number 
of older adults with pain. I also direct an NIH-funded lab that 
researches pain and its treatment, and I will also share with 
you that I have two parents who both suffer from chronic pain, 
one who is well within the health care community and uses it 
effectively, my father, who will not go anywhere near a 
physician and will not even talk to me about his pain. He is 
very stubborn. I also have a family that has been absolutely 
destroyed by addiction. It runs on both sides deeply and I get 
it. I have seen both sides of this.
    Today, I would like to share with you some of the 
conclusions and recommendations from, first, the IOM Committee 
I served on that developed the ``Relieving Pain in America'' 
report, and second, the NIH task force that I was honored to 
co-chair with Dr. Linda Porter from the NINDS that developed 
the National Pain Strategy.
    From the IOM Pain Report, we noted that the magnitude of 
pain in the United States is absolutely astonishing. More than 
100 million Americans have chronic pain, with a total cost to 
our country exceeding half-a-trillion dollars per year. This is 
higher than the cost of cancer, cardiovascular disease, and 
diabetes combined, and the number is increasing with our aging 
population. We noted that there are many disparities in pain 
care that also disproportionately affect older adults, that 
include the prevalence of pain, its seriousness, and its 
undertreatment.
    Unfortunately, the data quality on older adults is lacking. 
Older adults also have higher rates of medication side effects. 
They have concurrent problems that further complicate diagnosis 
and treatment, and we desperately need better research, as they 
are often excluded from clinical trials based simply on their 
age.
    In the IOM report, the Committee concluded that relieving 
pain will require a cultural transformation in how pain is 
perceived and judged, both by people with pain as well as 
clinicians. Our committee's report offered a blueprint for 
achieving this transformation, including 16 recommendations, 
just a few of which I will highlight.
    One of the first recommendations to be achieved was that 
the NIH designate a single institute to oversee pain research. 
That has been accomplished. That is NINDS under the 
directorship of Dr. Walter Koroshetz.
    Another key recommendation was for the Secretary of HHS to 
create a comprehensive population-level strategy for pain 
prevention, treatment, and research. That recommendation led to 
the National Pain Strategy, which I am now going to turn 
attention to.
    Following the release of the IOM report, the Assistant 
Secretary for Health asked the NIH to oversee the creation of 
the NPS. Whereas the IOM report was a blueprint, a 30,000-foot 
view of both where we are and where we want to go, the NPS took 
that blueprint and turned it into a document of action, a 
specific tactical report with time lines, measurable outcomes, 
and identified key stakeholders who are to be accountable for 
the execution of these goals.
    In developing the NPS, we brought together 80 national 
experts from a wide range of the biopsychosocial aspects of 
pain, including expertise from clinical and public health, 
legal, ethical, and payment. I will note that Sean Cavanaugh 
served admirably and I enjoyed my time with him on the NPS, 
representing CMS. We included both traditional and 
complementary medicine, and we had representation from both the 
private and Federal agencies.
    We formed working groups that aligned with the IOM 
recommendations, and then we developed 17 tactical goals. We 
than subsequently released the draft NPS report for public 
commentary. Just a few of those 17 objectives included to 
improve the quality of the data on pain, its treatment and 
costs, including vulnerable populations such as older adults. 
To improve access to high-quality pain care for vulnerable 
populations, including older adults. To incentivize 
comprehensive and cost-effective care through a whole person 
approach, not just looking at them as a single pain problem or 
using a single tool. To improve pain knowledge and skills for 
all clinicians, and to develop a public education campaign on 
the seriousness of pain and also on the safe medication use, 
especially opioid use.
    We received hundreds of public comments with overwhelming 
support. The final version is pending final edits and release 
by Secretary Burwell.
    These recommendations of the IOM, as well as the objectives 
of the National Pain Strategy, serve to create a comprehensive 
population-level strategy for pain prevention, management, and 
research.
    The problems that we face in pain management are 
formidable. The limitations in the knowledge and the skills of 
health care professionals are just glaringly obvious. To 
achieve the necessary transformation is going to require 
collaboration of the health care community, the people who are 
suffering from pain, as well as professional medical 
associations, patient advocacy groups, State, and, of course, 
the Federal Government. We need to address pain at the public 
health level while still recognizing each individual's source 
of suffering.
    Successful implementation of these strategic goals will 
ultimately create the cultural transformation in pain 
prevention, care, education that we so desperately need for the 
American public.
    I appreciate the opportunity to appear before you today and 
look forward to responding to any questions you have. Thank 
you.
    The Chairman. Thank you very much for your testimony.
    Mr. Cavanaugh, we have heard two of the physicians here 
today and I have heard repeatedly in Maine that one of the 
factors, one of the many, many factors that is encouraging an 
over-prescription--an over-prescribing of opioids is the survey 
that is done by CMS as part of the value-based purchasing 
program. That is an important part of our efforts to reward 
Medicare providers for high-quality care that is based on the 
quality rather than the volume of services, but listen, and I 
am going to repeat two of the questions that are actually asked 
on this survey. One is, during this hospital stay, how often 
was your pain well controlled? The second is, during this 
hospital stay, how often did the hospital staff do everything 
they could to help you with your pain? And what physicians tell 
me and what we have heard today is that puts pressure on 
providers to over-prescribe. They do not want to get dinged on 
those questions because that translates in a lower 
reimbursement to the hospital for which they may well work.
    As a result, 26 Senators signed a letter that I spearheaded 
with Senator Heidi Heitkamp to Secretary Burwell asking CMS to 
take a look at the results of those well-intentioned questions. 
Even if they were reworded to say, was your pain attended to or 
managed, rather than being worded in the way they are, I think 
it would help.
    I know CMS is taking a look, but as Dr. Adams pointed out, 
the webinar that was recently done, which was brought to my 
attention by my staff, suggests that CMS does not perceive a 
link here. Where are you on your analysis, and are you going to 
change this survey?
    Mr. Cavanaugh. Senator, thank you for that question, and 
thank you for your letter, because it did spark a lot of 
introspection at CMS and rethinking of it. As you heard from 
Dr. Mackey, this survey was developed at a time when we have 
this huge disconnect, as we have heard from several witnesses, 
which is there is an enormous amount of pain that is not 
properly treated and there is an over-prescribing of opioids, 
that somehow, those two worlds have not connected.
    The survey was clearly meant to solve, or contribute to the 
problem of under-treated pain. What you heard from the webinar 
and other places were it was not designed to encourage over-
prescription, never our intent, we do not see a link, but, you 
know, with your letter, with talking to enough physicians, 
clearly, we need to rethink this. We do have research currently 
underway to see whether there are better ways to phrase the 
question.
    In your opening statement, you said you hoped this could be 
a constructive contribution, this discussion, so one of the 
things I thought of while my colleagues here were testifying 
was we do a lot of these testing of our questions on 
beneficiaries to see how they will react, but clearly, the 
reaction that we did not anticipate was physicians and 
hospitals, so I had a light bulb that we are going to do some 
testing of--when we come up with possible alternatives of how 
to phrase this, see how physicians say they would react to it. 
Is it consistent with good prescribing practice?
    I think we can make progress. The work is underway. I 
apologize if the webinar suggested otherwise. We are absolutely 
studying whether there is better phrasing in these questions.
    The Chairman. That is very good to hear, and I think you 
are right, that you need to test it on physicians, and there 
are three right here who I am sure would be glad to be part of 
that test panel.
    Dr. Diaz, it is so alarming that Americans consume opioids 
at a greater rate than any other nation, including twice as 
many opiates per capita as Canada, our neighbor to Maine. I am 
concerned that we have this kind of disparity. When you look at 
Canada, the provinces most close to Maine, their populations 
are very similar to our population, so what is it that we are 
doing differently, in your opinion, in the United States that 
results in such a huge disparity in prescribing practices?
    Dr. Diaz. I think Dr. Mackey hit the nail on the head when 
he said we have a cultural problem in the United States on pain 
perception and treatment. I think we have set ourselves up both 
with pain as a fifth vital sign and then the HCAHPS survey 
unfortunately hard-wired to compensation for doing well on 
those questions, that pain is an abnormal finding, and actually 
not to be insensitive, but I would challenge everybody in this 
room that you probably had some pain today, and I am not making 
light of this, but pain is an actual neurologic response to 
something. It can be triggered in many different ways. Much of 
pain has a behavioral health overlay, and because of the way we 
approach this systemically as a culture, we have given credence 
to the fact that you should not have pain.
    I think the step you have to take here is not simply 
tightening up the prescriptions, getting Narcan on the streets 
so we do not have any more deaths. It is also a cultural 
awareness that we have some skin in the game, that we need to 
walk more--did everybody get their 10,000 steps in today? Your 
diet, you should not--you know, we have an obesity issue which 
contributes to pain in many areas, orthopedic pain, spine pain. 
Have we done well in talking about the other substance abuse 
issues, alcoholism?
    Because pain can be triggered from all those issues, it is 
a cultural awareness that wellness should be step one to 
mitigate what we perceive as having a pain epidemic. The real 
epidemic is that we have not culturally done well with this, 
and because we have that in a wealthy nation, I think that is 
what shows you the gap between Canada and other countries.
    The Chairman. Thank you.
    Senator Donnelly.
    Senator Donnelly. Thank you, Madam Chair.
    I think one of the most stunning statistics we have heard 
is the United States has 5 percent of the population and 80 
percent of the opioids that are used in the entire world.
    Dr. Adams, you mentioned you have heard from prescribers 
who say that prescribing guidelines or best practices are a 
helpful tool because they empower prescribers to decide not to 
prescribe opioids when they feel opioids are not the best or 
safest option for a patient. In your experience, how do we best 
engage the prescriber community to ensure they are actually 
adopting existing guidelines or best practices over opioid 
prescribing?
    Dr. Adams. Thank you for that question, and I would like to 
hitch on to the CMS conversation. As you are looking at the 
questions and changing them and the pay-for-performance, I 
would suggest that you incorporate in those looking at 
hospitals and determining whether or not prescribers are 
abiding by guidelines. Does the hospital have acute pain 
prescribing guidelines? Because one of the things the 
Governor's task force has charged us with is developing and 
propagating acute and chronic pain prescribing guidelines. 
JCAHO could do that, also, and so, to your point, engaging the 
provider community, making it part of standard practice, both 
we pay you for it and we evaluate you based on how you are 
responding to this opioid epidemic and are you prescribing 
appropriately. Integration of prescription drug monitoring data 
into routine workflow. Doctors want to do the right thing. We 
have just got to make it easy for them to do the right thing 
and not have to log into five different computers to find out 
whether or not this patient is prescribing. Prescriber report 
cards, which give feedback to providers, and also linking 
overdose death back to prescribers. You would not believe how 
many prescribers we talk to who had no clue that the patient 
they had been prescribing to died and died because of the 
opioids that they prescribed. There is no feedback loop in 
there.
    As we talk about prescription drug monitoring programs, we 
need to talk about making them easy and meaningful for 
providers to use and giving them feedback on a regular basis, 
because a lot of times, they think they are doing the right 
thing. They just do not know. They really do not know.
    Senator Donnelly. Dr. Adams, we both frequently hear about 
the shortage of addiction treatment providers and behavioral 
health counselors, especially in the more rural areas of our 
State.
    Dr. Adams. Absolutely.
    Senator Donnelly. What do you think a State like ours can 
do to incentivize people to go into these much needed fields?
    Dr. Adams. Well, I tell you, we are doing a couple of 
things. We are trying to leverage technology, telehealth and 
remote presence psychiatry, to be able to provide access to 
folks in rural areas. I think you could provide funding for 
addiction treatment fellowship programs for primary care 
providers. There are a lot of doctors out there who would like 
to learn more. They just need the opportunity to learn more.
    There is a project called Project ECHO where doctors can 
interact in a group with other doctors in a learning 
environment while they are participating in addiction and 
recovery services, providing those for their patients, and 
then, fund hospital-based recovery programs that include wrap-
around services. What we found in our rural areas, and Senator 
Donnelly, you know this, is that oftentimes, the hospital, and 
especially now that many physicians are hospital employed, 
leads all efforts in the community not just for health, but for 
public health, and we need to get them engaged in responding to 
this epidemic in a treatment capacity.
    Senator Donnelly. You also mentioned about the VA, and, you 
know, this is of concern to----
    Dr. Adams. You are going to get me in trouble, Senator 
Donnelly.
    Senator Donnelly. I am sorry?
    Dr. Adams. You are going to get me in trouble.
    Senator Donnelly. That is one of my jobs.
    You mentioned that several State VA hospital systems, 
including ours, do not currently participate in the State 
prescription drug monitoring programs. I know that progress is 
being made toward integrating Indiana's VA pharmacies into the 
INSPECT program that we have in our State. Could you tell us 
some of the lessons you learned from the process of trying to 
get Indiana's VA pharmacies to participate in INSPECT that 
could help other states around the country?
    Dr. Adams. Well, there are security barriers with the VA 
electronic health record system that has been a barrier, but 
really, when--there are other states that have overcome it, so 
the bottom line is that people do what you mandate that they 
do, and the Federal exemption right now for VAs not to 
participate means that if someone has an option and it is going 
to be extra work or extra money to integrate, they are not 
doing it.
    That is why Governor Pence, one of the first things we 
heard at our task force meetings were concerns about the VA not 
participating in PDMPs. In a lot of communities, the VA is the 
major source for the pills that are getting out on the streets, 
and many of the people who are suffering from substance use 
disorder are veterans and we just do not have that feedback. 
The same thing for methadone programs, which are federally 
regulated and not required to report to a prescription drug 
monitoring program, so it is really just someone being aware, 
saying, we are not going to take this anymore. You guys sit 
down and figure it out, and there are obstacles, but we can 
overcome those obstacles. Several states have.
    Senator Donnelly. Thank you.
    Ms. Maxwell, the last question I want to ask right now is 
in your role as Inspector General, you talked about a number of 
issues that you were looking at. Have you been concerned about 
the number of pills in each prescription? Instead of four or 
five, that we have 30 or 40 or 50, and that is, in effect, the 
fallback prescription that comes up. Somebody hurts their 
shoulder and two or 3 days of pain, they wind up with 30 pills 
in their prescription, and number one, it is devastating to our 
communities, but number two on the Inspector General side, it 
does not seem to make much sense, either.
    Ms. Maxwell. Absolutely. As I mentioned, one of the 
drivers, we believe, behind the increase that we saw, the 156 
percent increase over the 8 years, was the fact that more 
beneficiaries were getting opioids, but also that there are 
more scripts per beneficiary. We believe both of those are the 
drivers, and that is a concern about whether or not Medicare is 
paying for drugs that are not, in fact, medically necessary, 
and that that is in some way fueling the supply of the drugs 
that go beyond the borders of the Medicare population into the 
general population and fuel some of this public health crisis.
    Senator Donnelly. Thank you. Thank you, Madam Chair.
    The Chairman. Senator Warren.
    Senator Warren. Thank you, Madam Chair.
    In 2013, CMS reported that more Medicare beneficiaries 
received prescriptions for generic Vicodin, a powerful opioid, 
than any other drug, more than the most popular blood pressure 
medication, more than the most popular cholesterol medication, 
and more than the most popular acid reflux medication. These 
prescriptions are everywhere, and many patients do not use all 
the pills that they take home, so where do those unused pills 
end up? The National Institute on Drug Abuse estimates that 
over 70 percent of adults who misuse prescription opioids get 
them from friends or relatives, those leftover pills that are 
tucked away in the medicine cabinet.
    States like Massachusetts are currently considering changes 
to State law to help reduce the number of pills in circulation. 
Instead of filling, for example, 30 days' worth of pills at a 
time, so-called partial fill policies would let doctors or 
patients request that pharmacies dispense only part of these 
opioid prescriptions, providing a few days of supply at a time 
so that patients do not end up with more drugs than they need.
    Dr. Adams, could you say a word about how the adoption of 
partial fill policies could help prevent opioid abuse.
    Dr. Adams. Well, Senator Warren, thank you for the 
question. The devil is always in the details, but I think it is 
a wonderful idea. I think we need every tool in our tool chest. 
That will certainly help some folks.
    I had my wisdom teeth pulled. My wife and I both did.
    Senator Warren. Bless your heart.
    Dr. Adams. We both got 90 Vicodin. My wife has had several 
C-sections. She got 90 Vicodin for those.
    Senator Warren. Ninety?
    Dr. Adams. I looked in my--I keep my pills in my safe to 
keep them away from kids. I went in there and looked a little 
over a year ago. I had probably over $5,000 worth of narcotics 
in my safe under my bed, A, because they were given to me and 
we did not need them, and B, because there were not proper ways 
to dispose of them that were easily accessible to us.
    I think partial fill, as long as it passes legal muster, I 
think we should certainly explore that, and we should also 
explore new and better and more opportunities for people to be 
able to safely dispose of unused medications, whether it is at 
pharmacies or police stations or in hospitals.
    Senator Warren. Thank you, Dr. Adams. You know, partial 
fill policies make a lot of sense, but current Federal 
regulations are unclear on whether partial fills are allowed 
for most opioid prescriptions.
    Dr. Adams. Exactly.
    Senator Warren. States like mine are stuck, and that is why 
Senator Capito and I are introducing bipartisan, bicameral 
legislation today, along with my colleague from Massachusetts, 
Congresswoman Clark, that would allow partial fill opioid 
prescriptions if the doctor or patient requests it. This helps 
get the Federal Government out of the way of the states that 
are looking to pursue additional prescribing policies that are 
the right local response to these dangerous drugs. By reducing 
the number of extra pills in circulation, we can take tangible 
steps toward fighting back against this crisis.
    Now, another option to tackle the opioid crisis is to 
invest in more research on alternative pain therapies, 
including physical therapy and new drugs that do not have abuse 
potential. Medical marijuana might also be a viable 
alternative, but the truth is, we just do not know. Twenty-
three states have enacted laws permitting the use of marijuana 
for medicinal purposes, which means it is being prescribed for 
pain right now today, but serious research on the potential 
benefits and drawbacks of medical marijuana is largely blocked 
by outdated Federal laws and policies.
    I have sent multiple letters to HHS, to DEA, to ONDCP, 
asking that they reduce these barriers, but so far, these 
agencies have taken virtually no action to expand research 
opportunities. I also recently asked the CDC to step up with 
more information about how legalized medical marijuana might 
specifically impact the opioid epidemic.
    Dr. Diaz, if I could just ask you very quickly, could you 
just explain how we could benefit from better research on the 
health effects of medical marijuana.
    Dr. Diaz. That is a great question and thank you, Senator. 
The real answer is that we do not know, so the medical 
marijuana states--Maine is one of them--have allowed the use 
because it has--there are gaps in what we can provide already 
in the current armamentarium. The opiate epidemic has shown 
that there is no free lunch, that every medication has a toxic 
side effect, depending on the dose, and that we have well 
identified that opiates meet the criteria for being very 
dangerous.
    Marijuana is not without its side effects. We all know 
that. I do not use medical marijuana, so I can say this without 
having bias, but we do not know whether or not that would be a 
better alternative for many conditions, including that of 
chronic pain, so I think all research, whether it be 
acupuncture, acupressure, other modalities and/or medications 
that perhaps have less serious side effects should be 
investigated so we have a good answer. Right now, the critical 
evidence on this is unknown.
    Senator Warren. Thank you, Dr. Diaz.
    I am out of time, but if I could ask you just very quickly, 
Dr. Mackey, do you agree with this?
    Dr. Mackey. The short answer is yes. I would take it just 
one step further and say--I am speaking here personally that--
and on behalf of several professional medical associations--we 
have called multiple times for the FDA rescheduling to Schedule 
2. Right now, with the Schedule 1 of it, it makes it very 
challenging to research marijuana. Some colleagues up the road 
at UCSF did one several years ago. The marijuana cigarettes 
were delivered in a Brinks armored truck with guys carrying M-
16s.
    Senator Warren. Oh, my gosh.
    Dr. Mackey. That is kind of silly.
    Senator Warren. Mm-hmm.
    Dr. Mackey. Get it as a Schedule 2. Allow--fund NIDA. Let 
them do the research that we desperately need, and I would 
agree with the CDC. We are running this incredible social 
experiment throughout this country and we need to better 
understand the results of that social experiment. I say that 
not pro or con, but just, we are doing it. Let us monitor what 
is happening and find out, is medical marijuana having an 
impact.
    Senator Warren. Right.
    Dr. Mackey. Then just to follow on, we absolutely need to 
be using other non-pharmacologic means. Pain psychology, 
physical therapy, complementary alternative medicine approaches 
have all been shown to be effective.
    Senator Warren. Thank you. You know, many states are 
expanding access to medical marijuana, and in some 
circumstances, marijuana may provide safer, more effective pain 
relief than opioids, or it may not, but the problem is, without 
better research, we just do not know and we never will know, so 
whatever you think of the merits of this therapy, it is 
irresponsible not to study the science. We cannot be afraid of 
conducting basic medical research. Thank you.
    Thank you, Madam Chair.
    The Chairman. Senator Kaine.
    Senator Kaine. Thank you, Madam Chair, and thanks to the 
witnesses.
    We have a lot of hearings on this Committee where we 
basically look at scams that are perpetrated against the 
elderly. That is one of the things that we do, and I will just 
start off and say, there is an element of scam about this. That 
phrase has not been used in this hearing, although we use it 
all the time in others. These powerful drugs were generally 
developed to help people with palliative care at the end of 
their life or people who were recovering from acute pain 
following surgery or dealing with cancer. That was the sort of 
general development of these drugs.
    The population base was just not large enough, and so a 
whole lot of the companies that developed these drugs have paid 
hundreds of millions of dollars in fines because they basically 
decided, that is too few patients. We have got a drug we can 
make a lot of money with, and so, we would like to prescribe it 
to a whole lot more people, and that is every bit as much a 
scam as the hearing that we had in the last 2 weeks about 
people trying to convince seniors to be drug couriers and carry 
packages overseas. It was a scam, and it has been a scam that 
has wrecked lives by the tens of thousands in this country.
    It coincided with the creation of the pain is the fifth 
vital sign and inartfully worded survey questions, and it 
coincided with people reporting pain and not knowing how to 
treat it, but you have got to lay some of the fault of this at 
the development of drugs and then a marketing decision. This is 
marketing, a decision to go way beyond the way they were used.
    You alluded to this, Dr. Diaz, briefly in your testimony. I 
was stunned. I was watching the AFC playoff game and there is 
an ad, and the ad--and there are all kinds of medical ads on 
TV, but there is an ad for if you have opioid-induced 
constipation, we have a new product for you, and it was in the 
NFC playoff game, too, and it kind of passed by just like every 
other ad, but then I thought about it.
    If we use so many prescription opioids that we have had to 
develop a separate drug to deal with the constipation effect of 
opioids, and if the marketing potential of this drug is so 
massive that we will pay the ads for the NFC and AFC 
championship game--these are, like, next to the Super Bowl, the 
most expensive ads you run all year--this is a marketing scam 
that has been a huge part of this problem, and it just sickens 
me, and even your testimony, 90 Vicodin for a wisdom tooth 
extraction? I mean, this is craziness, and so, that is why we 
have to be about solutions, and it is not going to be one or 
two things, but just a couple on which I think maybe there is 
consensus.
    Do all of you see the value, if we put it together 
correctly, of a Medicare lock-in program that would be similar 
to Medicaid lock-in programs that most states have? Does that 
generally seem like a positive, if we do it right?
    I am assuming all of you see the value, also, of expanded--
again, under appropriate conditions--of expanded naloxone 
access. The worry that you are enabling a drug user is really 
once you get into it not a worry that we need to weight too 
heavily against the live-saving benefit of this product, so 
again, it is going to be according to guideline, but if we 
should make access more generally available, according to 
appropriate guideline. Does everybody agree with that?
    Dr. Adams. I agree. You do not ask someone whether or not--
we do not make a decision whether or not we are going to 
defibrillate someone who is having a heart attack----
    Senator Kaine. Yes, or give them an EpiPen if they got a 
bee sting. Exactly, and finally, do you all generally agree 
that we ought to get these prescriber guidelines out into the 
public realm so that the solo practitioner or the hospital 
chain can all have some sort of best practice that they can 
utilize when deciding whether to prescribe opioids rather than 
other some pain management technique?
    Dr. Adams. Now, Senator Kaine, I think you will find that 
all of us as physicians agree that we should have prescriber 
guidelines. I do want to point out that who is writing those 
guidelines may be something that we differ on and I think is a 
critical point, because we have lots of rural hospitals in our 
area. They do not have the same resources, the same electronic 
health record system integration as, for instance, my hospital 
down at IU Medical Center.
    I think acute pain prescribing guidelines are important for 
everyone who is going to write an opioid, but I think they need 
to be determined at as local a level as possible with some big 
guard rails that we can help establish. What we do not want 
are, no offense to you all, but a bunch of people here in D.C. 
trying to tell the local doctor in Southern Indiana how to 
practice and creating rules that that doctor cannot possibly 
comply with.
    Senator Kaine. Any guideline has the challenge of is it too 
hot or too cold or just right. We have been way over on the too 
cold side, and so, you know, hopefully, we can find the right 
balance in these guidelines, which I hope will come out soon.
    Dr. Adams. Yes.
    Senator Kaine. I want to ask a particular question about 
opioids and seniors in my just remaining seconds, which is 
seniors often take a lot more medications than other people do. 
Talk about the opioid impact with a senior population that is 
just taking more medication and how these kind of co-
prescription effects can compound the problem for our seniors.
    Dr. Mackey. Sure. I will take that one on. It runs the 
spectrum. Seniors are on a lot more medications and more prone 
to the side effects from those multiple medications, which 
requires good monitoring. Also, you put into the effect more 
likelihood for falls and then also the cognitive impairments 
that can be associated with it and they are more at risk.
    At the same time, I just did a 13-hour clinic just right 
before coming out here and spent some time Leslie. She is 73 
years old. She has got nerve pain. She takes a couple opioids a 
day, one in the morning, one in the evening, to help her sleep, 
and her message to me, knowing I was coming out here, is, 
please do not let them take away these medications that are 
helping me to function without giving me something else to use.
    I hear the problems with the people who are taking the 
multiple meds and the side effects. It is real. We need to do 
better, and then I also see Leslie and people like Leslie every 
day and we need to make sure that we are addressing both sides 
of this.
    Senator Kaine. Thank you, Madam Chair.
    The Chairman. Senator Casey.
    Senator Casey. Madam Chair, thank you very much.
    I have a statement I would ask consent to put in the 
record.
    The Chairman. Without objection.
    Senator Casey. Well, thanks very much.
    I was going to start with, Dr. Mackey, where you left off. 
I just have a question for you and maybe one other, but there 
are a lot of ways to outline how grave this problem is. Every 
State, every community has some metric or some horror story. 
Here is just one headline. This is actually the Washington 
Post, but it is about Washington, Pennsylvania, which is a town 
in Southwestern Pennsylvania, in Washington County. It is kind 
of a small town community, only about 200,000 people in the 
whole county, but here is the headline from earlier this--this 
is a headline from 2015. Quote, ``The Heroin Epidemic's Toll: 
One County, 70 Minutes, Eight Overdoses.'' In 70 minutes, eight 
overdoses. Then it goes on to catalog what happened in that 
timeframe, and then they expand it from 70 minutes to 24 hours, 
so the overdose deaths went up to 16 in the 24 hours and 25 
over 2 days, so in 48 hours, 25 overdoses.
    Not an unusual story, unfortunately. Happening all across 
our State. We have had rankings in--or we have been achieving, 
or being placed in rankings that we do not want to be in. We 
are third in heroin deaths. We are ninth in overdose, in the 
number of overdoses.
    I guess the challenge is getting the policy right. There is 
a whole series of good bills that we are all working on. Part 
of it is to make sure that we do not come up with some new 
Federal solution but to invest in proven strategies at the 
local level.
    The only good news here, maybe, is that we have learned a 
lot the last quarter-century. We know exactly how to treat 
these conditions. We know exactly what to do. It is just a 
question of resources and access. I hear a lot from folks in 
rural communities where this is a huge problem, that all they 
want is to provide--is us to provide more access, more 
treatment clinics and more opportunities.
    The difficulty here--that is why I start with you, Dr. 
Mackey--is making sure that we take the right steps, but do not 
take away the opportunity for people to get pain relief. My 
staff just visited a company in Pennsylvania--I have not been 
there yet for a visit, but where they are using, among other 
strategies, low-dose non-steroidal anti-inflammatory drugs, I 
guess known as the NSAIDs. Tell me what you know about that, 
about this pain management field itself, but in particular, is 
there a way to get this right? In other words, is there a way 
to ensure that people with pain are given appropriate care but 
in a manner that will not lead to some of the horrific 
headlines we just outlined.
    Dr. Mackey. Thank you for that. Great question. The short 
answer is, absolutely, sir. Absolutely. This is what started 
with the Institute of Medicine report, to outline and catalog 
this problem and then to define that blueprint, and then what 
we took forward with the National Pain Strategy. If we can all 
get behind the 17 goals of that and put those into play, it 
will have an incredible impact on pain in this country, and I 
would also submit to you it would make a huge dent--a major, 
major dent--in this epidemic that we are facing, because the 
right patient would get the right treatment for the right 
situation and we would be raising public awareness about the 
issues of the opioids.
    We would be getting the messages out there about your 
medications are your medications, and we would be appropriately 
incentivizing the types of care that we know work, that not 
only include the pharmacologic, but all of the other aspects of 
care that, quite frankly, we do not incentivize right now.
    My team does team conferences with 20 people in the room 
around complex patients just about every day at Stanford. I 
have not been paid for one of those team conferences in over 20 
years, but we support it because it is the right thing to do. I 
have five faculty. They are pain psychologists on our staff. I 
hemorrhage money on all of them, but we do it because it is the 
right thing to do.
    We do need to bring this team-based approach together. This 
is part and parcel of the National Pain Strategy.
    Did I answer your question, sir?
    Senator Casey. You did. Thank you.
    I guess, in terms of the science of it, what is the science 
behind being able to treat the condition or relieve the pain, 
but do it in a manner that--because just looking at some of the 
basic descriptions of how this company approaches it, using 
nanotechnology to break down a particular drug into smaller 
components that are more easily processed by the body, 
providing appropriate analgesic effects faster and much lower 
doses, what can you tell us about that?
    Dr. Mackey. I can tell you that there is a lot of 
medications and other treatments that are in the pipeline, that 
we need to do a better job in supporting research into 
understanding the mechanisms of how the drug that you have just 
mentioned works at low doses, translating that mechanistic 
information into safer and effective treatments and then doing 
the followup to figure out which of those treatments are going 
to work for which patient and why.
    The challenge that we have as physicians is, you know, to 
use a baseball metaphor, if I am batting .300, I am making 
millions of dollars, but I will tell you, having done this for 
15 to 20 years, I bat about 40 percent, about .400 right now, 
so it is this very laborious trial and error process to figure 
out what works for which patient. It is frustrating for the 
patients. It is frustrating for us.
    We are in an era of big data where we can bring together 
the information technology to better understand how to develop 
this space of precision or personalized health care.
    Dr. Adams. Senator, just to be frank in response to your 
question, we do that every day. We offer NSAIDs. We offer 
alternative treatments. One of the problems is--and I work at 
an inner city hospital. Dr. Diaz can speak to this. The 
patients say, I do not want it. I am allergic to an NSAID. I am 
allergic to Tylenol and that does not work for me. We have to 
deal with this expectation that folks have that the only way to 
treat pain is with an opioid if we are going to move in the 
direction of moving patients to non-opioid alternatives. It is 
just a huge problem that started with marketing to the point 
that Senator Kaine brought up, and you said marketing. Well, 
every drug has to be FDA approved, so we can blame it on the 
pharmaceutical companies, but at some point, we have got to 
look at who is getting approved for what, and I am not big on 
blame. I want to talk to folks and say, what can we do to solve 
the problem? I think we need to enlist the pharmaceutical 
companies to fund research, to fund take-back programs, and to 
fund awareness campaigns about the dangerous of opioids so that 
we can move forward and get rid of this expectation that 
opioids are the only answer, and then we can look at some of 
these alternatives that you have brought up.
    Senator Casey. Thank you. I am over time. Thank you.
    The Chairman. Thank you.
    Dr. Adams, actually, you have gone exactly to an issue that 
I wanted to ask you about, because you are in the role of the 
Health Commissioner for a State, and that is we have talked a 
lot about health care providers today, hospitals, even 
pharmacists, CMS's role, but what about patients and patients' 
expectations. How do we educate patients that there may be a 
better approach?
    When did heroin lose its stigma? When I was growing up, I 
remember vividly a recovering heroin addict coming to our 
junior high and giving us a lecture, and I will tell you, I do 
not think anybody who heard that would have ever thought of 
trying heroin, and yet, now we see this progression from 
opiates to heroin use because heroin is often cheaper, but what 
can we do to reach the consumer of these drugs so that they 
realize that just because a drug is prescribed and legal does 
not mean that it is safe, and how can we reintroduce the stigma 
attached to trying heroin?
    Dr. Adams. Well, Dr. Diaz and others can weigh in here. I 
will tell you, the stigma went away when the suburban mom who 
no longer could get her Vicodin decided that she would rather 
move on to heroin than to deal with withdrawal. That is when 
the stigma went away. We have to address the prescription 
opioid epidemic and the fact that it is pervasive. It is in our 
suburbs. It is in our schools.
    I told a story the last time I gave congressional testimony 
about a high school quarterback who received Vicodin for a knee 
sprain. Back in the day, the coach would have told me to put 
some dirt on it and suck it up, but he got Vicodin for it, and 
within 2 years was an HIV-positive person down in our State.
    It is a tremendous problem that we face, but if we are not 
serious about increasing awareness about the dangers of opioids 
amongst our youth and then going aggressively after the 
marketing--the folks who told us for years, it is okay, it is 
okay, it is all right, this is not addictive--and stop the 
approval of these drugs, which further insinuate that it is 
safe, then we are not going to stop that transition of folks 
from opioids into heroin, but Dr. Diaz in the ER sees it every 
day.
    The Chairman. Dr. Diaz and Dr. Mackey, I would like both of 
you to comment, as well.
    Dr. Diaz. Right. The cultural changes taking place has 
really been in the forefront with the heroin adoption, and one 
of the other issues around using Vicodin and other oral 
medications, then going to heroin, is the euphoria associated 
with opiates. So, we can treat pain, but one of the problems 
with opiates is not only is your pain treated, now you also 
feel euphoric, and so, non-steroidals, the NSAIDs and other 
pain medicines or injections do not give you euphoria. You do 
not want to conquer the world, and so, once you are hooked on 
that, it is true addiction, so the withdrawal symptoms of going 
off opiates is now magnified by no longer feeling euphoric.
    When Vicodin and other pills became more available and then 
people can afford that and then go to heroin, which is 
ubiquitous in Maine, as well, now, now you have the problems 
with Hep B, Hep C, and HIV, and then you have they cannot 
afford anything more because of the economics, and now you take 
it away. We will control your pain. We will put you on 
Suboxone. There is no more euphoria. They are not going to be 
happy about that.
    When we address this problem, not only do we have to have a 
concerted mind amongst all of us and the patients, we have to 
be honest about it. You are not going to feel as good. The pain 
will not be there, but you will not feel as good. You have to 
be clear in the messaging and we have to be able to take that 
feedback.
    The Chairman. Dr. Mackey. Thank you.
    Dr. Mackey. I would agree with my two colleagues here, with 
everything that they have said. There is no question that the 
prescription opioids have, in some cases, led to a gateway to 
heroin, and that by solving that problem, reducing some of that 
diversion or a large part of that diversion, we are going to 
take a big chunk out of this heroin problem that has occurred.
    Additionally, there are some solutions to this, but it 
needs to be a public health approach to this. I am reminded of 
the public health approaches that have worked very well with 
other addictive substances, such as smoking. You know, in the 
State of California, we have driven smoking down to such a 
small amount because we made it, quite frankly, socially 
unacceptable to smoke, and we got the young people involved in 
those public health campaigns and made it socially 
unacceptable. That is part of the solution.
    I think what you have heard are other components to this, 
and we need to work together to enact that.
    The Chairman. Thank you.
    Senator Blumenthal.
    Senator Blumenthal. Thanks, Madam Chair. As usual, another 
really profoundly important hearing and I want to thank you for 
focusing on this topic.
    I have been holding roundtables around my State, 
Connecticut, on this issue of opioid and heroin and the link 
between them, which for me at this point seems irrefutable. I 
do not have numbers. You would be better able to provide 
statistics, but hardly a roundtable passes--in fact, hardly a 
day passes when I do not hear about a young person who has 
broken an ankle and has surgery and is given a month's supply 
of Percocet or Vicodin or Oxycontin, when I do not hear about 
someone who has had wisdom teeth pulled and, again, a month's 
supply, and it seems to me that one of the real needs here is 
to provide some education for the prescribers, the health care 
providers.
    In fact, Senator Markey and I have a bill which I hope will 
be added to the Comprehensive Addiction and Recovery Act that 
was approved by the Judiciary Committee where I sit--I offered 
it there, but it was regarded as outside the jurisdiction--to 
provide for mandatory education, and it is no disrespect to any 
of the doctors or health care professionals in our country to 
say that we are learning about the powerful addictive effects 
of these pain killers.
    When I first became involved in this issue more than a 
decade ago, it was heresy to say that these pain killers could 
be addictive. No, that is not true, people would tell me. They 
create possibly a dependence, but addiction? No. I think that 
word has acquired much more powerful meaning now as applied to 
these drugs.
    Likewise, the FDA has continued to approve even more 
powerful drugs. In fact, I voted against the nominee for FDA 
Commissioner precisely because I think the FDA has failed in 
its mission, and again, reflecting perhaps lack of awareness or 
education on the part of certain people in the medical 
profession.
    Having talked longer than I intended about this issue and 
perhaps revealing more of my ignorance than anything else, let 
me open it to you to comment on whether we do need, in fact, 
more education, better training, not only in medical school, 
but for those thousands of doctors who are out there now 
prescribing pain killers to young people with broken bones, or 
dentists who are prescribing it for wisdom teeth, or whatever.
    Dr. Mackey. Diving right into that, thank you for that 
question. Education was a cornerstone for the Institute of 
Medicine Pain Report as well as for the National Pain Strategy. 
We devoted two of the six working groups to education, one on 
professional, one on public education. Everybody needs to be 
better educated, from, obviously, the public, but then also 
from the person who is just starting off their training, 
whether it be medical school, dentistry, pharmacy, all the way 
through the practicing physicians.
    I will share with you that the Federal Government has been 
taking efforts on this, one through NIDA, through their Centers 
of Pain Excellence, in developing web-based materials to 
educate providers. Another one, Linda Harris out of the CDC, 
who also came up with an interactive program.
    We have put together a strategic plan, a set of strategic 
plans within the National Pain Strategy to better educate 
across that whole continuum of education, and it is not just 
about the physicians, as we have talked about. It is the 
nurses. It is the pharmacists, the dentists. It is everybody 
who cares for the person in pain. Absolutely critical.
    Dr. Adams. Exactly. You hit on a point, Dr. Mackey, that I 
think is very important for us to remember, and that is that 
doctors are easy to go after, and we bear a lot of 
responsibility for this epidemic. Let me be clear about that, 
but there are many other folks involved in the prescribing 
chain. There are nurse practitioners and PAs who prescribe, so 
if you attach as a condition of medical licensure or 
certification training, then you are leaving out a lot of folks 
who are part of the problem.
    One of the things I think we should do is use JCAHO, use 
CMS to go to hospitals and say, we have got an epidemic here, 
folks. What are you doing to turn the tide within your 
hospital? We are going to survey you based on this. If we found 
folks had high infection rates in terms of urinary tract 
infections, CMS said, okay, hospitals, we are going to start 
seeing what you do to stop urinary tract infections. Why are we 
not saying, what are you doing to stop over-prescribing 
throughout your hospital, and not just the doctors, but 
everyone who is involved.
    Dr. Diaz. I just want to echo my support for my colleagues' 
comments, and one more thing to really hammer home. Physicians 
are not afraid of education. We know that every year, things 
change. We are actually told in medical school that half of 
what we are teaching you is wrong. In 30 years, you will know 
what half that is, but we do not know what half that is today.
    We are used to being wrong, but to make this town, this 
prescribing town intact, it has got to be with hard and fast 
rules that are propagated and supported so that people are not 
getting mixed messages or different messages, so I think all 
medical professions would welcome the education so we knew 
where we stood.
    Dr. Mackey. May I make one quick followup to that? Senator 
Blumenthal, there is basically three types of doctors out there 
in this space. There is the big group that is doing the right 
thing for the right reasons. We need to leave them alone, let 
them care for the patients.
    There is a much smaller group that is doing the wrong thing 
for what they perceive as the right reasons, and these people 
in particular need education, and they will respond to 
education, and then there is a small group of doctors that are 
just bad doctors. They are doing the wrong thing for the wrong 
reasons. Those are the ones that need to be policed.
    What I just want to caution is that we do not apply 
policing policy, you know, that covers everyone, and then take 
the good doctors and just give them fewer tools or make it 
harder for them to care for the patients they need to.
    Mr. Cavanaugh. Just briefly, Senator, from the Medicare 
perspective, one part of education is simply feedback, and we 
have been providing feedback reports. When we look at 
prescribing patterns and we see prescribers who are real 
outliers, we have been sending them feedback reports to see if 
that will change their behavior, and I think it speaks to that 
group that is doing the wrong thing but is willing to change if 
they knew it, so it is not the whole problem, it is a piece of 
it, and we are still learning whether feedback reports are 
effective, but it is something we are testing at CMS.
    Senator Blumenthal. Did you have anything you wanted to 
add? I do not want to leave you out.
    Ms. Maxwell. Why, thank you. Yes, and again, in the context 
of Medicare, we have identified through our analysis of 
Medicare billing data prescribers who are over-prescribing 
opioids, and it was our recommendation that they be provided 
this feedback and we were pleased that CMS took that 
recommendation and are hopeful that that is part of the 
education. As was mentioned earlier, some of them do not know 
the impact of their prescribing or do not know that they are 
extreme in comparison to their peers.
    Senator Blumenthal. I want to--thank you very much, and I 
do think that the Office of Inspector General can play a very 
important role on this issue.
    Let me emphasize a couple of points. First of all, the bill 
that I have introduced applies to physician assistants and 
nurse practitioners. Anything I have said today, or at any 
other time in my life, is not an attack on the medical 
profession or the doctors. My brother is one and never tires of 
telling me how little I know about health care, and most of the 
time, he is right, but finally, I think that the medical 
profession and all of us are learning, as we make mistakes, 
learning, hopefully, from our mistakes, and part of what I was 
told when I first began talking about Oxycontin and the defeat 
of the time-release mechanism and the use for improper purposes 
was that pain killers can play an enormously positive role in 
dealing with chronic pain, and the third caveat that I want to 
express is in no way am I criticizing the use of pain killers 
properly by the group of doctors, and they are probably the 
vast majority, who are doing the right thing. It is just they 
may be doing the right thing without proper supervision 
afterward as to how those extra pills are used, and these are 
potentially enormously disruptive. I have seen their 
destructive effect on families, on communities, on our society, 
so thanks very much for your insights today.
    The Chairman. Thank you.
    Senator Donnelly.
    Senator Donnelly. Thank you, Madam Chair, and I know that 
this is a concern of Senator Collins, as well, and we have 
talked about it.
    In regards to medical school, Dr. Adams, when we had our 
roundtable in Indiana, we heard a pretty shocking statistic, 
and this is not to be negative, but it is just an indication of 
how this has almost been a forgotten thing. They were talking 
about over the entire time our doctors were in medical school, 
they talked about 5 hours about prescribing practices. Is that 
pretty much what you have come across?
    Dr. Adams. Do you remember the response I gave you? That is 
much more than what I got.
    Senator Donnelly. Right.
    Dr. Adams. I mean, unfortunately, that is the reality in 
medical school.
    Senator Donnelly. Yes.
    Dr. Adams. To your point, Madam Chair, about stigma, the 
problem is that--is awareness. It is largely awareness. I mean, 
there are many different facets to it, but there is not an 
awareness at the training level, at the administration level, 
at the treatment level afterwards of the severity of this 
problem, and so, I do think that we are having some success, 
particularly in Indiana with the task force. We are involving 
folks from the educational communities in the task force 
meetings and getting the word out, but there is only so much 
you can stuff into training, and I think it is to the level now 
where we have to say, look, guys, you may have to push 
something else out, but this is killing not only our seniors, 
but citizens across the country and we need to better educate 
doctors in terms of how to properly prescribe.
    Senator Donnelly. Yes.
    Dr. Mackey. I teach the medical school classes at Stanford 
on pain, on opioids, some substance abuse, and others, and we--
they get more than five, but I would continue to argue they 
need to get much, much more. The deans have been responsive and 
we are incrementally improving it. I think it is going to have 
to be at some level at the individual medical school level and 
how are they influenced, in part, by board exams. The board 
exams test their knowledge, and I have to give credit to Dr. 
Scott Fishman of U.C.-Davis. He recently led a task force for 
us to go to the USMLE where we all sat down and they opened up 
their vault and we could look at all of the pain questions that 
they were being asked, and I am not going to steal his thunder, 
but I will tell you, he is preparing a paper that I think will 
be very enlightening at a national level that will outline what 
we really need to do at the medical student level to better 
improve pain education, opioid education, and the care of 
patients with pain, and I just say, stay tuned for that paper 
that should hopefully be released soon.
    Senator Donnelly. Dr. Mackey, I know you have also worked 
with NIH. One of the things that I have heard rumblings of is 
non-opioid-based pain medication research that is going on. 
Could you fill us in on that a little bit?
    Dr. Mackey. Could I ask you to reframe that in the context 
of non-opioid-based--there is a tremendous amount of interest 
in non-opioid-based research into pain.
    Senator Donnelly. Do you see on the part of whether it is 
our pharmaceutical companies or researchers that the space that 
is being occupied by the opioids right now will be in X number 
of years or X number of time replaced by medications that can 
be a strong assistant on the pain part, but without the opioid 
addiction?
    Dr. Mackey. Oh, I certainly hope so. That is one of my 
dreams. You know, one of the challenges in the NIH budget is 
that despite 100 million Americans, half-a-trillion dollars a 
year, we spend a little over 1 percent of the NIH budget on 
pain--only a little over 1 percent. We have a great opportunity 
to shift some of that, not a whole lot, but some of that into 
these type of non-opioid therapies that you are describing, 
into the mechanisms of pain, and discover new molecules, new 
treatments, whether they be pharmaceutical or even non-
medication, mind/body approaches, physical approaches, that are 
going to have a huge impact on our population, and we 
desperately need it, because the population is getting older, 
and as we have already pointed out, it is increasing the amount 
of pain, so we desperately need more of that funding.
    Dr. Adams. I would say, the patient-centered medical home, 
which is an initiative that many of you have heard about, and 
the perioperative surgical home, which is an American Society 
of Anesthesiologists initiative to care for patients from the 
time that they decide they need surgery all the way through to 
recovery, and efforts to integrate behavioral health with all 
aspects of care, will help us as we move down that pathway to 
providing other alternatives.
    One of the problems is, you reach someone when they are 
getting ready to go out the door and you have got one person 
there and, okay, I have got to deal with your pain. Here is a 
script, but if you start addressing the factors that are 
leading into that pain and stop that pain cycle from occurring 
up front, or limit that pain cycle up front and provide 
options, talk to the patient, a lot of times, we are 
prescribing pain medications for reasons that have nothing to 
do with pain. We are prescribing them because of untreated 
behavioral health and mental health issues that coexist in that 
patient.
    Senator Donnelly. This addiction has been--I will finish 
with this. This addiction has been so powerful, so destructive 
in our town of Austin in Indiana, where we have 189 HIV cases. 
The CDC came in, and in doing interviews found multi-
generational situations, where at the same table the 
grandmother, the mom, and the daughter were sitting there 
passing a needle from one to the other to the other because of 
the power of this, and some of these needles, in the way we 
wound up with 189 HIV cases, and some of these needles were 
used over 300 times, and it is almost impossible to not have an 
outbreak of Hep C and HIV in those cases.
    To all of you, thank you very much.
    The Chairman. Thank you.
    Senator Kaine.
    Senator Kaine. Very briefly, and again, thanks to all the 
witnesses.
    We try to do public education through these hearings, and 
one of the things that I think is important for laypeople is to 
know about naloxone training, so my State has a program, 
Project REVIVE! I give credit to Governor McAuliffe and his 
health team for putting this together. It started as a pilot 
project to train laypeople, mostly family members or folks who 
work in offices, you know, assuming that first responders are 
trained and assuming medical professionals are trained, trying 
to broaden the universe of folks who know how to administer 
naloxone.
    I signed up and took one of the classes in Lebanon, 
Virginia, which is in Southwest Virginia, two summers ago. It 
was about 90 minutes long. I learned a lot about pain, about 
the management of pain, about opioids, but especially about the 
use of naloxone, and I would encourage Virginians, certainly, 
if you have a chance, just like you take a first aid class or 
learn to do the Heimlich maneuver, this would be a worthwhile 
thing to do because of the prevalence of opioid use and 
overdoses.
    I am sure if Virginia has a Project REVIVE!, they must have 
modeled it on other states doing something similar, so to 
laypeople who are concerned about this, there is something you 
can do that may help you save the life of somebody who goes 
into an opioid OD.
    Dr. Adams. The city of Baltimore has a great website, and 
in Indiana, at the Governor's direction, we have a site called 
Opt In, www.optin.in.gov, which connects folks to resources 
where they can learn more about naloxone and pick up naloxone, 
which lay providers can get prescribed in the State of Indiana.
    Scary statistic. In the time we have been sitting here in 
this hearing, three people have died related to overdose in 
this country. There is someone dying every 25 minutes from an 
opioid overdose in our country, and if we can get naloxone into 
the hands of more folks, then we can help turn that tide. It is 
a band-aid, mind you, because if we do not get them connected 
to care after they overdose, then they are going to keep coming 
back over and over and over again, but the first step is to 
make sure they do not die, and then the second step is to 
connect them to care.
    The Chairman. Thank you.
    Senator Blumenthal, I gave you an extra 5 minutes first 
round, but if you have another question you would like to ask, 
please proceed.
    Senator Blumenthal. Ever observant, Madam Chair.
    I will not overstay my good luck.
    The Chairman. No, seriously, you are welcome to ask another 
question if you would like.
    Senator Blumenthal. I just have one sort of broader 
question, and I do not want to put you on the spot. To what do 
you think that this problem is the result, and epidemic, I 
think is not too strong a word, is the result of marketing 
practices, sales techniques of the pharmaceutical companies 
that make these products?
    Dr. Adams. I think the other doctors can certainly weigh 
in, and we said earlier, I do think that they play an important 
role in the origin of this epidemic. I think that medical 
schools are taking steps to remove the influence of the 
pharmaceutical industry from the medical training process, but 
again, every drug has got to be FDA approved, so you have a 
mechanism to deal with marketing. I am not picking on them by 
any means, but we cannot just blame it on the pharmaceutical 
industry, and I think the real question right now is what can 
we ask the pharmaceutical industry to do in terms of being a 
partner to help us reverse this epidemic.
    Senator Blumenthal. I did not mean to blame them, in 
quotes, ``blame them,'' because every one of these----
    Dr. Adams. I have blamed them before, but I am a happier 
person now and I want us all to be on the same page-----and 
come up with solutions.
    Senator Blumenthal. I have blamed them. In fact, I have 
sued at least one----
    Dr. Adams. I have not sued anybody, Senator, not yet.
    Dr. Diaz. Well, the landmark drug was Oxycontin. I think 
that was the turning tide on the pharmaceutical companies being 
mass marketing, but to that end, the move to get pharma out of 
medical education, out of continuing medical education, out of 
offices, has been the first step, again, not so much mass 
marketing, but detailing to physicians. Stopping that is the 
key to not just opiates, by the way, all medicines. We overuse 
the wrong medicines based on people getting detailed in their 
offices and everyone is trying to stop that.
    Senator Blumenthal. Thank you. Thanks very much.
    The Chairman. Thank you, Senator.
    I want to give Ms. Maxwell the last word today, since I 
know many of the questions were directed to others. Do you have 
any final advice to us as we seek to address this epidemic?
    Ms. Maxwell. I think your holding hearings like this today 
are critical to continue the focus on this issue and continue 
to look for constructive solutions. We are supportive of a 
multi-faceted approach that goes across departments and across 
Federal and State governments into private associations, as 
well.
    As I said in my oral, the IG stands ready to assist. We 
have a full array of professionals at our disposal and all of 
them are focused on Part D as a priority and opioids, in 
particular. We have seen a 134 percent increase in our Part D 
cases, and we continue to have investigations and legal actions 
related to the fraud associated with this issue, but beyond 
that, we have evaluators and auditors that bring a more 
holistic approach, looking at the systemic issues and trying to 
devise solutions, and the two that we think are really critical 
that I would mention are the lock-in. We think it is a really 
important piece of the larger policy discussion, and then also 
thinking about this a little bit more broadly and expanding 
some of those DUR programs to think about the non-controlled 
drugs that are tied up in this misuse of opioids.
    The Chairman. Thank you very much.
    I want to thank all of our witnesses for being here today. 
This was truly an extraordinarily good panel with very 
constructive suggestions and analysis and insights for all of 
us.
    I am sure, Mr. Cavanaugh, that you found it very valuable, 
as well, and I hope you will take back to CMS many of the 
excellent suggestions and recommendations that were made by 
your fellow panelists today.
    I want to thank the members of our committee for 
participating and tell Senator Donnelly that he was an 
excellent Ranking Minority Member, and----
    Senator Donnelly. Thank you. I am sure Claire is grading me 
at the moment.
    The Chairman. Well, I think she will give you an A, though 
obviously we look forward to her prompt return.
    Committee members will have until Monday, March 9, to 
submit questions for the record, so you may be receiving 
additional questions from us.
    I want to thank our staffs for working very hard on a very 
complex issue, and a special thank you to the three physicians 
who traveled great distances to be with us today.
    With that, this concludes the hearing. The hearing is 
adjourned. Thank you.
    [Whereupon, at 4:17 p.m., the Committee was adjourned.]   
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                               APPENDIX
  
      
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                      Prepared Witness Statements

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