[Senate Hearing 114-278]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 114-278

        VA OPIOID PRESCRIPTION POLICY, PRACTICE, AND PROCEDURES

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

                                HEARING

                               BEFORE THE

                     COMMITTEE ON VETERANS' AFFAIRS
                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 26, 2015

                               __________

       Printed for the use of the Committee on Veterans' Affairs


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                     COMMITTEE ON VETERANS' AFFAIRS

                   Johnny Isakson, Georgia, Chairman
Jerry Moran, Kansas                  Richard Blumenthal, Connecticut, 
John Boozman, Arkansas                   Ranking Member
Dean Heller, Nevada                  Patty Murray, Washington
Bill Cassidy, Louisiana              Bernard Sanders, (I) Vermont
Mike Rounds, South Dakota            Sherrod Brown, Ohio
Thom Tillis, North Carolina          Jon Tester, Montana
Dan Sullivan, Alaska                 Mazie K. Hirono, Hawaii
                                     Joe Manchin III, West Virginia
                       Tom Bowman, Staff Director
                 John Kruse, Democratic Staff Director
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                            C O N T E N T S

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                             March 26, 2015
                                SENATORS

                                                                   Page
Isakson, Hon. Johnny, Chairman, U.S. Senator from Georgia........     1
Blumenthal, Hon. Richard, Ranking Member, U.S. Senator from 
  Connecticut....................................................     2
    Prepared statement...........................................     3
Cassidy, Hon. Bill, U.S. Senator from Louisiana..................    22
Tillis, Hon. Thom, U.S. Senator from North Carolina..............    27
Manchin, Hon. Joe, U.S. Senator from West Virginia...............    29
Boozman, Hon. John, U.S. Senator from Arkansas...................    32

                               WITNESSES

Baldwin, Hon. Tammy, U.S. Senator from Wisconsin.................    24
Johnson, Hon. Ron, U.S. Senator from Wisconsin...................    34
Clancy, Carolyn, M.D., Interim Under Secretary for Health, 
  Veterans Health Administration, U.S. Department of Veterans 
  Affairs; accompanied by Gavin West, M.D., Special Assistant for 
  Clinical Operations; Michael Valentino, Chief Consultant of 
  Pharmacy Benefits Management Services..........................     4
    Prepared statement...........................................     6
    Response to posthearing questions submitted by:
      Hon. Bernard Sanders.......................................    36
      Hon. Mazie Hirono..........................................    36
      Hon. Tammy Baldwin.........................................    38
Daigh, John D., Jr., M.D., C.P.A., Assistant Inspector General 
  for Healthcare Inspections, Office of Inspector General, U.S. 
  Department of Veterans Affairs.................................    10
    Prepared statement...........................................    12
Alexander, G. Caleb, M.D., Co-Director, Center for Drug Safety 
  and Effectiveness, Johns Hopkins Bloomberg School of Public 
  Health.........................................................    41
    Prepared statement...........................................    42
Forster, Carol, M.D., Physician Director, Pharmacy & 
  Therapeutics/Medication Safety, Mid-Atlantic Permanente Medical 
  Group, Kaiser Permanente.......................................    43
    Prepared statement...........................................    45
    Response to posthearing questions submitted by Hon. Tammy 
      Baldwin....................................................    58
Gadea, John, Director, Drug Control Division, Connecticut 
  Department of Consumer Protection..............................    49
    Prepared statement...........................................    50

                                APPENDIX

Van Diepen, Louise R., MS, CGP, FASHP; prepared statement........    61
National Alliance on Mental Illness (NAMI); letter...............    71
Opioid Prescribing: A Systematic Review and Critical Appraisal of 
  Guidelines for Chronic Pain; article...........................    73
The Prescription Opioid and Heroin Crisis: A Public Health 
  Approach to an Epidemic of Addiction; report...................    88
 
        VA OPIOID PRESCRIPTION POLICY, PRACTICE, AND PROCEDURES

                              ----------                              


                        THURSDAY, MARCH 26, 2015

                                       U.S. Senate,
                             Committee on Veterans Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:09 a.m., in 
room 418, Russell Senate Office Building, Hon. Johnny Isakson, 
Chairman of the Committee, presiding.
    Present: Senators Isakson, Moran, Boozman, Cassidy, Tillis, 
Blumenthal, Brown, Hirono, and Manchin.
    Also present: Senators Johnson and Baldwin.

           OPENING STATEMENT OF HON. JOHNNY ISAKSON, 
              CHAIRMAN, U.S. SENATOR FROM GEORGIA

    Chairman Isakson. I would like to call this meeting of the 
Veterans' Affairs Committee to order. I want to thank our 
panelists for coming today to talk about a very important 
subject. Dr. Clancy, particularly, we welcome you again and 
thank you for all the help you have given the Committee and the 
Veterans Administration. We appreciate it very much.
    We have new rules for this Senate Committee this year. The 
Ranking Member and the Chairman will make opening remarks. Any 
members that want to make an opening remark can make it at the 
closing of the hearing, because we came to hear from those 
testifying, not from other members of the Senate. Yet, anybody 
is welcome to file a statement if they would like.
    We have two additional members that will sit in today, 
Senator Johnson and Senator Baldwin from the State of 
Wisconsin, which obviously has been a focal point of the over-
prescription of opiates. I think it is important they have the 
opportunity to participate in the questioning of our witnesses.
    In the absence of opening statements, I will make a brief 
one. I will turn it over to our Ranking Member, Richard 
Blumenthal, then we will go straight to our distinguished 
panelists.
    Let me just say this: one of our panelists was going to be 
Dr. Tom Frieden or his designee from the CDC, which is doing an 
awful lot of work on the over-prescription of opiates. He could 
not be here, but we talked by phone for about 15 minutes prior 
to this hearing. There are two facts that he told me that I 
think make the point as to why this is an important hearing.
    One, 145,000 Americans have died in the last 10 years from 
an over-prescription or over-consumption of opiates, 145,000. 
The rate of prescription has become so great that there were 
enough prescribed last year to provide one in every six 
Americans with a prescription for a year. That is 15 percent of 
the population with a year's prescription. That is how much of 
a supply is coming out.
    Two, the CDC has recognized that it is such a prominent 
problem for health care in America that they have a task force 
working on guidelines for their prescriptions which will be 
published some time at the end of December for public comment, 
and hopefully by April 1 it will become policy of the CDC and 
the United States of America.
    This is a serious problem. Abuse and over-prescription of 
opiates is bad for the recipient, it is bad for the country, 
and it is a bad way to mask problems rather than treat 
problems, which is what we are all about in terms of the 
Veterans Administration.
    With that opening preface and the gravity of the situation, 
as illustrated by the statistics from the CDC, I am happy to 
welcome our Ranking Member for his opening remarks.
    Senator Blumenthal.

         STATEMENT OF HON. RICHARD BLUMENTHAL, RANKING 
             MEMBER, U.S. SENATOR FROM CONNECTICUT

    Senator Blumenthal. Thank you, Mr. Chairman, and thank you, 
our witnesses, all of our witnesses for being here today, and 
thank you to Senator Baldwin for sharing with us. I know of her 
very strong interest in the tragic experience, and very 
responsible involvement in making sure there is proper 
oversight at the Tomah facility in Wisconsin where an instance 
of over-prescription occurred.
    I want to thank the Chairman for having this hearing. I do 
not know of any topic that is more important in our VA health 
care system. We talk a lot about inadequate care in the sense 
of inadequate quantities of care. Here is an instance of 
excessive quantities of a particular drug doing absolutely 
horrific damage to our Nation's heroes.
    We know that 22 veterans every day commit suicide, and many 
of them have suffered from over-prescription of opioids. Plain 
and simple, the current system is abysmally inadequate. It is 
like Swiss cheese, riddled with gaps and holes that permit and, 
in fact, enable, sometime even encourage over-prescription, 
deadly over-prescription of opioids.
    This Committee had a hearing during the last session on 
this very problem and I want this hearing to be different, to 
produce much more adequate action by the VA. We are in this 
issue together and I know that the VA shares our alarm and 
outrage, but action is absolutely necessary because over-
prescription and overdose of opioids is an epidemic and a 
scourge in this country.
    I am going to ask that the remainder of my opening 
statement be put in the record, if there is no objection----
    Chairman Isakson. Without objection.
    Senator Blumenthal [continuing]. Because I do provide some 
of the other background. I just want to say I am grateful to 
John Gadea of our State Drug Control Division as well as 
Jonathan Harris, our Consumer Protection Commissioner for being 
here today. John Gadea and I have worked for many years on this 
topic.
    I helped to lead the initiation in Connecticut of our 
prescription monitoring program which computerized 
prescriptions so as to keep track and prevent over-prescription 
and overdosing. This was in 2006. It was started in 2008. So, 
this problem has been around for a long time. We cannot claim 
that it has snuck up on us or surprised us.
    This epidemic has been with us for years and years, and 
that is one reason, from my anger and astonishment, that the VA 
system is not better than it is. It is a problem that is 
nationwide. It is not limited to Tomah or any other single 
facility.
    I plan to begin efforts in Connecticut to make sure that 
the problem that existed in Tomah is not endemic to Connecticut 
as well. I am going to be commenting later on an invention that 
a young lady from Connecticut, Lily Zyszkowski told me about 
that she initiated, announced, and presented to the White House 
recently at the White House Science Fair called the Pill 
Minder, which is a microchip with touch sensors designed to 
remind people how to take their pills and to alert care givers 
when the pills have not been taken.
    A high school student has a system for helping to stop 
overdoses. Think of it for a moment. A high school student is 
telling us how to stop a problem that has been with us for more 
than a decade and has actually killed people. I am very proud 
of young inventors like Lily. I am grateful to our Chairman for 
having this hearing today and for his commitment.
    Needless to say, it is a bipartisan commitment to make sure 
that we end this scourge and that we make sure that this kind 
of systemwide problem is addressed and stopped and that we all 
take whatever action is necessary to do so. Thanks, Mr. 
Chairman.
    [The prepared statement of Senator Blumenthal follows:]
    Prepared Statement of Senator Richard Blumenthal, Ranking Member
    Prescription drug overdose has become an epidemic in this country.
    According to the Agency for Healthcare Research and Quality, the 
hospitalization rate for overuse of opioids doubled between 1993 and 
2012 and drug overdose death rates in the United States have more than 
tripled since 1990.
    This is a problem that requires the attention of policymakers from 
the local to the Federal levels, law enforcement as well as health care 
providers to come together and come up with creative ways to get ahead 
of the scourge of suffering and addiction that tragically all too often 
leads to death.
    There are few areas when drug addiction is more tragic than when 
veterans who have served our country return home with serious medical 
conditions, and seek treatment but end up in a spiral of pain and drug 
addiction.
    I'm pleased that Chairman Isakson has chosen to have another 
hearing on this important topic. Last year, I participated in then-
Chairman Sanders' hearing that focused on complementary and alternative 
treatments that could serve as an alternative to opioid treatment.
    It's vital that we continue to address this topic within this 
Committee--and especially to discuss the best practices that are 
utilized within VA and throughout the private sector in partnership 
with state agencies.
    I look forward to hearing the testimony from VA as well as the 
Inspector General to inform us on the status of VA's internal efforts 
at avoiding diversion and overprescription of painkillers.
    While the rates of opioid misuse have been steadily increasing, 
this is not altogether a new problem. I led a hearing on Prescription 
Drug Abuse as Attorney General of the state of Connecticut over a 
decade ago as we worked at putting a prescription drug monitoring 
system in place. It took many years to get the system set up, but 
Connecticut now has a very robust system and I am especially looking 
forward to hearing the testimony of John Gadea, Connecticut's Director 
of State Drug Control Division. John and I have worked together for 
years and I value his insight as well as his leadership and partnership 
in developing the Connecticut Prescription Monitoring and Reporting 
System.
    Veterans deserve to have the best systems in place for drug 
delivery as well as information on all options available to them. This 
includes having appropriate access to strong painkillers when 
necessary, but also access to screening systems, prevention tools and 
monitoring programs to ensure that treatment for pain does not lead to 
devastating pain, suffering and possibly death.
    While the problem is nationwide, VA must be at the forefront of 
making sure that its physicians, pharmacists and all of its health care 
team are committed to best practices in the area and each facility must 
be confident that doctors like the so-called ``Candy Man'' at the Tomah 
VA facility are identified and those practice corrected. I am pleased 
that my colleagues from Wisconsin are joining our conversation today to 
lend some insight into what their constituents in Wisconsin experienced 
and to assist us with our oversight in this area.
    I will turn back to the Chairman in a second, but I just want to 
share one last thing with the Committee. Earlier this week, I went to 
the White House for the White House Science Fair. We had two 
representatives from Connecticut there, and one of the young ladies, 
Lily Zyszkowski, was there with three inventions, one of which she 
calls the PillMinder.
    I am probably not doing justice to the invention, but the basic 
idea is that the PillMinder is a microchip with touch sensors designed 
to remind people to take their pills and to alert caregivers when the 
pills had been taken. Now I don't know if Lily was thinking about how 
this could be used to prevent and deter drug overdoses, but that seems 
like a pretty interesting use of her invention to me.
    I bring this up today partially because I am very proud of young 
inventors from my state like Lily, but primarily because this is the 
type of smart, creative thinking that we need from all sectors to be 
able to properly tackle the problem of prescription drug abuse. I hope 
this hearing today will result in implementing more of the good ideas 
that I know are out there.

    Chairman Isakson. Thank you, Senator Blumenthal.
    We have our first panel, which consists of Dr. Carolyn 
Clancy, who is the interim Under Secretary for Health, Veterans 
Health Administration, Department of Veterans Affairs. Thank 
you for being here.
    You are accompanied, I believe, by Dr. West and Mr. 
Valentino. Is that correct? From the Inspector General's 
Office, John--is it Daigh?
    Dr. Daigh. Daigh, sir.
    Chairman Isakson. Daigh. Thank you. Dr. Daigh, is Assistant 
Inspector for Healthcare Inspections, Office of the Inspector 
General, Department of the Veterans Affairs. We will start with 
Dr. Clancy.

STATEMENT OF CAROLYN CLANCY, M.D., INTERIM UNDER SECRETARY FOR 
  HEALTH, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF 
  VETERANS AFFAIRS; ACCOMPANIED BY GAVIN WEST, M.D., SPECIAL 
ASSISTANT FOR CLINICAL OPERATIONS, AND MICHAEL VALENTINO, CHIEF 
      CONSULTANT OF PHARMACY BENEFITS MANAGEMENT SERVICES

    Dr. Clancy. Thank you. Good morning, Chairman Isakson, 
Ranking Member Blumenthal, Members of the Committee. We 
appreciate the opportunity to participate in this hearing and 
to discuss VA's pain management programs and the use of 
medications, particularly opioids, to treat veterans' 
experiencing chronic pain. As the Chairman noted, I am 
accompanied by Dr. Gavin West and Mike Valentino.
    I would like to begin today by addressing the situation at 
Tomah. We are continuing to investigate the accusations at 
Tomah and we will keep you up to date on our findings. We will 
not tolerate an environment where intimidation or suppression 
of concerns occurs and we welcome input from all employees and 
whistle blowers.
    If employee misconduct is identified, we will take the 
appropriate action and hold those responsible accountable. 
These investigations are an opportunity to get to the bottom of 
any issue so that moving forward, these issues are not repeated 
at Tomah or elsewhere in our system.
    Unfortunately, many of our Nation's veterans suffer from 
chronic and acute pain. About 60 percent of returning veterans 
from the Middle East and more than 50 percent of older veterans 
live with some kind of chronic pain. The treatment of veterans' 
pain is often very complex.
    Many of our veterans have survived severe battlefield 
injuries, some repeated, resulting in lifelong moderate to 
severe pain related to musculoskeletal problems and permanent 
nerve damage. This can impact not only their physical 
abilities, but also their emotional health and brain 
structures.
    Our efforts to reduce high dose opioid-prescribing have 
been successful initially in patients with uncomplicated 
chronic pain. However, veterans with complex chronic pain, such 
as those with one or more combinations of Traumatic Brain 
Injury, Post Traumatic Stress Disorder, and so forth may have 
relied on opioids for pain control.
    Tapering their doses to safer levels and instituting more 
comprehensive pain practices must go much more slowly and 
carefully to be both safe and to assure control of their 
suffering and quality-of-life. Veterans are particularly 
challenged by chronic pain, but as the Chairman mentioned, 
having heard from my former colleague, Tom Frieden, chronic 
pain is a national public health program.
    As identified in a study by the Institute of Medicine 
several years ago, 30 percent of the Nation's adult population 
experience chronic pain. This country is now in the midst of an 
epidemic of misuse and overuse, as has been very clearly 
stated. The safe and appropriate use of opioids is particularly 
important for VA due to the number of veterans who have 
musculoskeletal injuries, nerve damage, and other conditions 
associated with their pain.
    Making positive changes in our prescribing practices has 
required providers and veterans to change the ways in which 
pain is managed, including other pain treatments available to 
rely less on opioids. These changes to pain management have to 
be done carefully and in a measured fashion to avoid the 
possibility that veterans will receive inadequate pain care.
    Our data and studies in the medical literature show that we 
are making progress in pain management. We have adopted several 
initiatives to advance the goal of safe, effective pain 
management. One of these is called our Opioid Safety 
Initiative, or OSI, which was first launched in August 2013. 
This combines feedback to providers and facilities on their 
prescribing practices with education and training to ensure 
that these medications are used safety, effectively, and 
judiciously.
    This initiative holds considerable promise for minimizing 
harm among veterans, promoting provider competence in promoting 
of veteran-centered, evidence-based, and coordinated multi-
disciplinary pain care.
    We recently produced a risk report for individual 
clinicians so that they could look at their entire panel of 
patients. Academic detailing, which is another one of our 
programs, combines the expertise of individuals specialized in 
pain management and prescribing. It has been tested in three of 
our networks with pretty big successes.
    Last year we encouraged all of our networks to adopt this 
approach, and about a third did. I am now mandating that all of 
our networks adopt this approach and have it fully implemented 
by the end of June 2015, and that they begin reporting 
quarterly data to the Under Secretary's office by the end of 
September 2015.
    We are also leveraging the capabilities of our telehealth 
to extend specialty expertise in safe, effective pain 
management for clinicians who care for veterans in rural 
communities for whom travel to pain management experts can be 
pretty challenging. It has been particularly successful in 
Ohio.
    While we know our work to improve pain management programs 
and the use of these medications will never truly be finished, 
we believe we have been at the forefront of dealing with pain 
management and will continue to do so to better serve the needs 
of veterans. We appreciate this Committee's support and 
encouragement in identifying and resolving challenges as we 
find new ways to care for veterans.
    On the subject of overdose, I will say that since May, we 
have instituted a program and prescribed 2,700, I believe, 
Narcan-prescribing kits, which we have a couple of samples to 
show you here. These can be administered by a family member, a 
friend, or a clinician to prevent an overdose if they suspect 
that has happened in someone close to them. And since last May, 
41 people have a second chance at life. I wanted to make that 
all clear as well and look forward to your questions.
    [The prepared statement of Dr. Clancy follows:]
Prepared Statement of Dr. Carolyn Clancy, M.D., Interim Under Secretary 
    for Health, Veterans Health Administration (VHA), Department of 
                         Veterans Affairs (VA)
    Good morning, Chairman Isakson, Ranking Member Blumenthal, and 
Members of the Committee. Thank you for the opportunity to participate 
in this hearing and to discuss VA's pain management programs and the 
use of medications, particularly opioids, to treat Veterans 
experiencing acute and chronic pain. I am accompanied today by Dr. 
Gavin West, Clinical Operations, Veterans Health Administration (VHA) 
and Dr. Michael Valentino, Chief Consultant, Pharmacy Benefits 
Management, VHA.
    I would like to begin by saying that clearly we are deeply 
concerned about the allegations of improper opioid prescribing 
practices and retaliatory behavior at the Tomah VA Medical Center 
(VAMC). To deliver high-quality health care, we rely on the integrity, 
observations, and recommendations of VA's front-line staff, who work 
professionally and compassionately with Veterans each and every day. We 
recognize the toll this situation is taking on all involved, and we are 
quickly and thoroughly investigating these issues.
                     chronic pain across the nation
    Chronic pain affects the Veteran population, but this is not an 
issue limited to Veterans. Chronic pain is a national public health 
problem as outlined in the 2011 study by the Institute of Medicine 
(IOM). At least 100 million Americans suffer from some form of chronic 
pain. The IOM study describes in detail many concerns of pain 
management, including system-wide deficits in the training of our 
Nation's health care professionals in pain management; the problems 
caused by a fragmented health care system; the general public's lack of 
knowledge about pain leading to inadequate self-management; and the 
need for care planning that is personalized for the individual patient. 
While about 30 percent of the Nation's adult population experiences 
chronic pain, the problem of chronic pain in VA is even more daunting, 
with almost 60 percent of returning Veterans from the Middle East and 
more than 50 percent of older Veterans in the VA health care system 
living with some form of chronic pain. The treatment of Veterans' pain 
is often very complex. Many of our Veterans have survived severe 
battlefield injuries, some repeated, resulting in life-long moderate to 
severe pain related to damage to their musculoskeletal system and 
permanent nerve damage, which cannot only impact their physical 
abilities but also impact their emotional health and brain structures.
               current vha pain management collaboration
    To implement effective management of pain, VHA's National Pain 
Program office oversees several work groups and a National Pain 
Management Strategy Coordinating Committee representing the VHA offices 
of nursing, pharmacy, mental health, primary care, anesthesia, 
education, integrative health, and physical medicine and 
rehabilitation. Working with the field, these groups develop, review 
and communicate strong pain management practices to VHA clinicians and 
clinical teams. For example, the VHA Pain Leadership Group, consisting 
of Pain Points of Contact for the Veterans Integrated Service Networks 
(VISNs) and facilities, meets monthly with the National Pain Program 
office to discuss policy, programs and clinical issues and disseminate 
information to the field as well as to provide feedback to VACO 
leadership about these programs. Several of these groups are chartered 
to promote the transformation of pain care in VHA at all level of the 
Stepped Care Model: the Pain Patient Aligned Care Team (PACT) 
Initiative Tactical Advisory Group focuses on primary care issues; the 
Pain Medicine Specialty Team Workgroup builds capacity for specialty 
pain services; the Interdisciplinary Pain Management Workgroup focuses 
on developing CARF certified tertiary care pain management programs for 
complex patients. Opioid Safety Initiative (OSI) Toolkit Task Force has 
published and promoted 16 evidenced-based documents and presentations 
to support the Academic Detailing model of the OSI. More information on 
the OSI Toolkit can be found via the follow link: (http://vaww.va.gov/
PAINMANAGEMENT/index.asp). The Department of Defense (DOD)-VA Health 
Executive Council's Pain Management Workgroup (PMWG) oversees joint 
projects with the DOD, including the two Joint Investment Fund (JIF) 
projects, the Joint Pain Education and Training Project and the Tiered 
Acupuncture Training Across Clinical Settings, and other projects that 
aim to standardize good pain care across DOD and VHA.
    Academic Detailing is a proven method in changing clinicians' 
behavior when addressing a difficult medical problem in a population. 
Academic Detailing combines longitudinal monitoring of clinical 
practices, regular feedback to providers on performance, and education 
and training in safer and more effective pain management. Our pain 
management programs, including the Specialty Care Access Network-
Extension for Community Healthcare Outcomes (SCAN-ECHO) and the OSI, 
have been designed to integrate into the Academic Detailing model.
                    va's progress in pain management
    Chronic pain management is challenging for Veterans and 
clinicians--VA continues to focus on identifying Veteran-centric 
approaches that can be tailored to individual needs that may also 
include physician therapy, acupuncture, chiropractic treatments, and 
other modalities in addition to medications. Opioids are an effective 
treatment, but their use requires constant vigilance to minimize risks 
and adverse effects. VA launched a system-wide OSI in October 2013, and 
has seen significant improvement in the use of opioids as discussed 
later in the testimony. Most recently, in March 2015, we launched the 
new Opioid Therapy Risk Report tool which provides detailed information 
on the risk status of Veterans taking opioids to assist VA primary care 
clinicians with pain management treatment plans. This tool is a core 
component of our reinvigorated focus on patient safety and 
effectiveness.
    VA's own data, as well as the peer-reviewed medical literature, 
suggest that VA is making progress relative to the rest of the Nation. 
In December 2014, an independent study by RTI International health 
services researcher, Mark Edlund, MD, Ph.D. and colleagues, supported 
by a grant from the National Institute of Drug Abuse, was published in 
the journal PAIN\1\ the premier research publication in the field of 
pain management. This study, using VHA pharmacy and administrative 
data, reviewed the duration of opioid therapy, the median daily dose of 
opioids, and the use of opioids in Veterans with substance use 
disorders and co-morbid chronic non-cancer pain. Dr. Edlund and his 
colleagues found that:

    \1\ Edlund MJ et al, Patterns of opioid use for chronic noncancer 
pain in the Veterans Health Administration from 2009 to 201. PAIN 
155(2014) 2337-2343
---------------------------------------------------------------------------
     First, half of all Veterans receiving opioids for chronic 
non-cancer pain, are receiving them short-term (i.e.: for less than 90 
days per year);
     Second, the daily opioid dose in VA is generally modest, 
with a median of 20 Morphine Equivalent Daily Dose (MEDD), which is 
considered low risk; and
     Third, the use of high-volume opioids (in terms of total 
annual dose) is not increased in VA patients with substance use 
disorders as has been found to be the case in non-VA patients.

    Dr. Edlund and the other authors concluded ``this suggests 
appropriate vigilance at VA, which may be facilitated by a transparent 
and universal electronic medical record.'' Although it is good to have 
this information, a confirmation of our efforts for several years, 
starting with the ``high alert'' opioid initiative in 2008 and multiple 
educational offerings, by no means is VA's work finished. In fact, 
although we are well along in implementing our plan, VA is also working 
with other Federal agencies and VAMC experts to implement the National 
Institutes of Health-Department of Health and Human Services National 
Pain Strategy, an outgrowth of the IOM study, which recommends a 
transformation in the education of physicians and other health care 
professionals in pain management. By virtue of VA's central national 
role in medical student education and residency training of primary 
care physicians and providers, we will be playing a major role in this 
national effort. But we have already started with our robust education 
and training programs for primary care, such as SCAN-ECHO, Mini-
residency, Community of Practice calls, two JIF training programs with 
DOD, and dissemination of the OSI Toolkit.
The Opioid Safety Initiative
    The OSI was chartered by the Under Secretary for Health in 
August 2012. The OSI was piloted in several VISNs. Based on those 
results of the pilot programs, OSI was implemented nationwide in 
August 2013. The OSI objective is to make the totality of opioid use 
visible at all levels in the organization. It includes key clinical 
indicators such as the number of unique pharmacy patients dispensed an 
opioid, unique patients on long-term opioids who receive a urine drug 
screen, the number of patients receiving an opioid and a benzodiazepine 
(which puts them at a higher risk of adverse events), and the average 
MEDD of opioids. Results of key clinical metrics for VHA measured by 
the OSI from Quarter 4, Fiscal Year 2012 (beginning in July 2012) to 
Quarter 1, Fiscal Year 2015 (ending in December 2014) are:

     91,614 (13%) fewer patients receiving opioids (679,376 => 
587,762);
     29,281 (24%) fewer patients receiving opioids and 
benzodiazepines together (122,633 => 93,352);
     71,255 more patients on opioids that have had a urine drug 
screen to help guide treatment decisions(160,601 => 231,856);
     67,466 (15%) fewer patients on long-term opioid therapy 
(438,329 => 370,863);
     The overall dosage of opioids is decreasing in the VA 
system as 10,143 (17%) fewer patients are receiving greater than or 
equal to 100 MEDD (59,499 => 49,356); and
     The desired results of OSI have been achieved during a 
time that VA has seen an overall growth of 75,843 (2%) patients who 
have utilized VA outpatient pharmacy services (3,959,852 => 4,035,695).

    The changes in prescribing and consumption are occurring at a 
modest pace and the OSI dashboard metrics indicate the overall trends 
are moving in the desired direction. OSI will be implemented in a 
cautious and measured way to give VA time to build the infrastructure 
and processes necessary to allow VA clinicians to incorporate new pain 
management strategies into their treatment approaches. A measured 
process will also give VA patients time to adjust to new treatment 
options and to mitigate any patient dissatisfaction that may accompany 
these changes.
    While these changes may appear to be modest given the size of the 
VA patient population, they signal an important trend in VA's use of 
opioids. VA expects this trend to continue as it renews its efforts to 
promote safe and effective pharmacologic and non-pharmacologic pain 
management therapies. Very effective programs yielding significant 
results have been identified (e.g., Minneapolis, Tampa), and are being 
studied as strong practice leaders.
State Prescription Drug Monitoring Programs
    Another risk management approach to support the Veterans' and 
public's safety is VHA participation in state Prescription Drug 
Monitoring Programs (PDMP). These programs, with appropriate health 
privacy protections, allow for the interaction between VA and state 
databases, so that providers can identify potentially vulnerable at-
risk individuals. VA providers can now access the state PDMP for 
information on prescribing and dispensing of controlled substances to 
Veterans outside the VA health care system. When fully deployed, non-VA 
providers will also be able to identify their patients who may be 
receiving controlled substances from VA. Participation in PDMPs will 
enable providers to identify patients who have received non-VA 
prescriptions for controlled substances, which in turn offers greater 
opportunity to discuss the effectiveness of these non-VA prescriptions 
in treating their pain or symptoms. More importantly, information 
available through these programs will help both VA and non-VA providers 
to prevent harm to patients that could occur if the provider was 
unaware that a controlled substance medication had been prescribed 
elsewhere already.
Opioid Therapy Risk Report
    In conjunction with the OSI, a population-based provider report and 
feedback tool has recently been developed and is now available to all 
primary care providers and their teams. This report, easily accessible 
through a direct link in the electronic health record, assists the 
PACTs to manage their entire panel of patients prescribed 
pharmacotherapy for acute or chronic pain; this tool makes it easy to 
ensure Veterans receiving safe, quality care. This resource provides a 
quick but thorough assessment of their patients' opioid risk for 
adverse outcomes. Included in the report is the current opioid dose, 
concomitant use of benzodiazepines, and presence of associated high-
risk diagnoses such as substance use disorder or Post Traumatic Stress 
Disorder. Urine drug screens, recent mental health and primary care 
visits, and the presence of a signed opioid agreement are also tracked. 
By clicking on the patient's name in the report, the provider can 
immediately pull up graphs showing the relationship between the 
patient's opioid dose and pain score over the past 12 months. This 
tabular and graphical information alerts the provider to situations 
where closer follow up may be needed or to settings where opioid 
withdrawal or dose reduction may be opportune. To better inform 
decisionmaking, links to practical pain presentations and opioid 
clinical guidelines are also embedded.
    This report was developed in late 2014 and released in early 2015. 
A comprehensive training program for primary care was launched in 
February 2015 reaching over 2,000 PACT providers and their teams. This 
tool will also assist in the monitoring of opioid prescribing behavior 
of our primary care workforce over time.
Complementary and Integrative Medicine
    The number one strategic goal of VHA is ``to provide Veterans 
personalized, proactive, patient-driven health care.'' Integrative 
Health includes Complementary and Alternative Medicine approaches, 
provides a framework that aligns with personalized, proactive, patient-
driven care. There is growing evidence in the effectiveness of non-
pharmacological approaches as part of a comprehensive care plan for 
chronic pain which includes acupuncture, massage, yoga and spinal 
manipulation. VA is establishing the Integrative Health Coordinating 
Center (IHCC) within the Office of Patient-Centered Care and Cultural 
Transformation to build the infrastructure (e.g. establishing new 
occupations) to support the delivery of these services.
        cleveland va medical center's success in pain management
    Providing Veterans excellent care in pain management is taking 
center stage at the Louis Stokes VAMC in Cleveland, Ohio. The Cleveland 
VAMC earned the Clinical Center of Excellence Award from the American 
Pain Society for implementing a model of care where Veterans engage in 
using interventional procedures and complementary and alternative 
medicine to lower their reliance on opioids. This model of care 
required cultural change within the pain management staff; they worked 
together to embrace clinical and behavioral services in a multi-
disciplinary fashion to promote physical rehabilitation and self-
management of pain.
    It has taken time, but today, the Cleveland VAMC has dedicated 
support in education for both staff and patients, funding to support 
their programs, dedicated staffing, improved resilience among their 
Veteran population, and a demonstrated reduction in the use of opioids 
among their patients.
    The unique program follows a three-level stepped-care model, based 
on Veteran need:

     Level-I Veterans are managed by primary care providers 
with pain management training. The specialized training is provided 
through advanced video teleconferencing, in which the SCAN-ECHO team 
leads weekly training sessions. Time is protected for the providers to 
attend weekly 90-minute sessions for at least a year.
     Level-II Veterans are referred to outpatient clinics where 
they can be seen by specialists in pain medicine, pain psychology, and 
other allied health professionals to assist them in managing their 
pain.
     Level-III is the Intensive Outpatient Program (IOP) where 
more complex cases are referred. In the IOP, Veterans are enrolled in a 
12-week, 1-day/week rehabilitation program that features psychological 
interventions, aquatic therapy, group exercise, occupational therapy, 
and dietary and vocational rehabilitation.
          hydrocodone rescheduling and the impact on veterans
    The new Drug Enforcement Administration (DEA) rescheduling for 
hydrocodone products became effective on October 6, 2014, and aim to 
improve medication safety and reduce misuse and abuse of opioid 
analgesics. Prior to the DEA rule change, a provider could authorize 
five refills within a 6-month period on hydrocodone combination 
products. These refills did not require Veterans to have monthly 
contact with their providers as the refills were requested by the 
Veteran through the VA Pharmacy. Now that the rule change has gone into 
effect, limitations in the VA electronic health record means Veterans 
must contact their providers, either in person or by telephone, to have 
a new prescription written when their supply is running low before the 
VA Pharmacy can dispense the hydrocodone combination prescriptions. 
Although refills for hydrocodone-containing products are not permitted, 
under the DEA rule change, Veterans do not necessarily always need to 
physically see their provider at a clinic visit. VHA policy requires 
patients on chronic opioid therapy to be evaluated once every 1 to 6 
months, based on provider assessments. Each Veteran's case is different 
and providers may issue a new prescription for Veterans based on 
telephone contact, if that is clinically appropriate.
        va's opioid education and naloxone distribution program
    In certain situations, opioids are the best choice for pain. 
Naloxone is an antidote to respiratory depression which can cause fatal 
overdose. With opioid use, risks are involved, and VA is taking 
precautionary steps to mitigate these risks. In May 2014, a VHA team 
developed and implemented VA's Overdose Education and Naloxone 
Distribution (OEND) program. Although VA's national OEND program is 
less than 1 year old, as of March 8, 2015, over 2,400 naloxone kit 
prescriptions have been dispensed to at-risk Veterans throughout the 
United States. As a result of these efforts, 33 individuals' life-
treatening opioid overdoses were reversed as a direct result of the 
OEND program.
                               conclusion
    In conclusion, we are continuing to investigate the situation at 
the Tomah VAMC and will keep you up-to-date on our findings. If 
employee misconduct is identified, VA will take the appropriate action 
and hold those responsible accountable. These investigations are an 
opportunity to get to the bottom of any issues so that moving forward, 
these actions are not repeated elsewhere.
    While we know our work to improve pain management programs and the 
use of medications will never truly be finished, VA has been at the 
forefront in dealing with pain management, and we will continue to do 
so to better serve the needs of Veterans.

    Mr. Chairman, we appreciate this Committee's support and 
encouragement in identifying and resolving challenges as we find new 
ways to care for Veterans.

    Chairman Isakson. Thank you, Dr. Clancy.
    Dr. Daigh.

   STATEMENT OF JOHN D. DAIGH, JR., M.D., C.P.A., ASSISTANT 
    INSPECTOR GENERAL FOR HEALTHCARE INSPECTIONS, OFFICE OF 
     INSPECTOR GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS

    Dr. Daigh. Thank you. Good morning, Chairman Isakson, 
Ranking Member Blumenthal, and Members of the Committee. Thank 
you for the opportunity to appear before you today on this 
important topic of opioid prescription policies of the 
Department of Veterans Affairs and efforts in combating over-
medication. My written statement references several OIG reports 
and a national review on the dispensing of take-home opioids 
that contain national data from fiscal year 2012.
    In 2010, VA and DOD published an excellent clinical 
practice guideline, The Management of Opioid Therapy for 
Chronic Pain. Our national review demonstrates that in 2012, VA 
providers were, in general, non-compliant with guideline 
requirements.
    Whether it be the use of urine drug screens and follow-up 
visits where they were 37 percent compliant with the guideline, 
whether it be the practice of refilling prescriptions at least 
7 days early 23 percent non-compliance with the guideline, the 
concomitant use of benzodiazepines and narcotic medications 
which occurred in the chronic use population 92 percent of the 
time. Or ensuring that veterans with substance use disorder and 
chronic pain receive concurrent treatment for their substance 
use disorder and urinary drug testing, there was 10.5 percent 
compliance.
    The data and the report make clear that the VA as a system 
of care in fiscal year 2012 that was managing this patient 
population very poorly. Who were these patients? One in 16 
served in Operation Enduring Freedom or Operation Iraqi 
Freedom. One in three was diagnosed with a mood disorder, one 
in five with PTSD, one in seven with substance use disorder.
    Since the publication of this report, I believe the VA has 
made serious efforts and dramatic improvement in the way they 
deliver pain care.
    On another topic, some have claimed that the Office of 
Healthcare Inspections has hidden secret, unpublished reports. 
I dispute this claim. I have always had a policy, upon 
accepting a hotline, of either publishing the report to the Web 
in an unredacted format or administratively closing the report.
    The semiannual has a list, including the number of admin 
closures each 6 months, it is common practice to brief Members 
of Congress on the results of accepted hotlines, whether they 
are admin-closed or published. Going forward, all hotlines will 
be published to the Web and admin closures going back to 2006 
are in the process of being published to the Web. I hope to 
revisit this policy going forward with both the House and 
Senate Committees.
    The admin closure of the Tomah hotline is drawing 
particular attention. On August 31, 2011, my office opened a 
hotline at Tomah that was based upon the receipt of a request 
from Congressman Kind, data from an employee survey that we did 
as part of our routine cap, and allegations that were received 
from out hotline.
    In summary, it was alleged that narcotic medication was 
being used as the primary treatment for PTSD, that specific 
patients were receiving poor quality of medical care, that 
numerous patients were dying of narcotic overdose, that Tomah 
providers were contemplating the amputation of a veteran's leg 
as treatment for his pain syndrome, and that there was 
inappropriate interference with the administration of the 
pharmacy service by Tomah management.
    In the administrative closure on this matter, the first 
four pages, detail the steps that OIG staff took to determine 
if these allegations had factual support. We reviewed numerous 
medical charts and peer reviews. We interviewed many current 
and former employees. We contacted the local Tomah police, the 
Milwaukee police, the Drug Enforcement Agency. We pulled the 
email from 17 employees.
    The Office of Investigations, which is another element of 
the IG, investigated aspects of these allegations. We found 
that the allegations that led us to Tomah could not be 
substantiated. We did find examples of failure to comply with 
the DOD/VA chronic pain guidelines, consistent with the 
national data that I just discussed with you today from fiscal 
year 2012.
    Given that the data we collected did not support the 
allegations that led us to Tomah, and knowing that our national 
report would highlight the many deficiencies in VA providers' 
compliance with these guidelines, and that other projects in my 
office had great demand for OIG psychiatry time, I chose to 
administratively close this report.
    To ensure that the deficiencies we identified were 
corrected by Veterans Health Administration (VHA), my staff met 
with the Director of the Tomah VAMC and with the Veterans 
Integrated Service Network (VISN) Director for Tomah. Both 
gentlemen were familiar with the individuals and issues we 
described at Tomah. These leaders discussed the changes that 
had been instituted and future planned actions to address the 
deficiencies we identified.
    I did not brief Congressman Kind on the admin closure. That 
was a deviation from our practice and I apologized to him for 
this failure. I will be pleased to answer your questions.
    [The prepared statement of Dr. Daigh follows:]
    Prepared Statement of John D. Daigh, Jr., M.D., CPA, Assistant 
   Inspector General for Healthcare Inspections, Office of Inspector 
              General, U.S. Department of Veterans Affairs
    Mr. Chairman and Members of the Committee, Thank you for the 
opportunity to discuss the Office of Inspector General's (OIG) work 
concerning VA's opioid prescription policies and practices. My 
statement will focus on a national review issued on May 14, 2014, 
Healthcare Inspection--VA Patterns of Dispensing Take-Home Opioids and 
Monitoring Patients on Opioid Therapy, as well as other reviews that we 
have conducted since 2011. A listing of those reports is included in 
Appendix A.
                               background
    Adequate management of pain has become a tenant of the 
compassionate delivery of health care. Subjective pain levels are now 
considered to be the fifth vital sign in medicine in addition to body 
temperature, pulse rate, respiration rate, and blood pressure. It has 
been estimated that pain affects 100 million adults in the United 
States. More than 50 percent of veterans enrolled and receiving VA care 
are affected by chronic pain. Servicemembers come to VA with a 
combination of health care conditions: pain resulting from injuries 
during military service, mental health disorders including Post 
Traumatic Stress Disorder (PTSD), and substance use disorders that 
involve alcohol and/or narcotic medications.
    In 1998, the Veterans Health Administration (VHA) initiated a 
National Pain Management Strategy to establish pain management as a 
national priority. In 2009, VHA issued a directive for the improvement 
of pain management consistent with VHA's National Pain Management 
Strategy.\1\
---------------------------------------------------------------------------
    \1\ VHA Directive 2009-053, Pain Management, October 28, 2009.
---------------------------------------------------------------------------
    In 2003, VA and the Department of Defense (DOD) published the first 
Clinical Practice Guideline for Management of Opioid Therapy for 
Chronic Pain (Clinical Practice Guideline) to improve management, 
quality of life, and quality of care for veterans and servicemembers. 
It was last updated in 2010.\2\
---------------------------------------------------------------------------
    \2\ Clinical Practice Guideline--Management of Opioid Therapy for 
Chronic Pain, May 2010, http://www.healthquality.va.gov/guidelines/
Pain/cot/COT_312_Full-er.pdf.
---------------------------------------------------------------------------
    Opioid therapy is intended for patients who suffer from moderate to 
severe chronic pain and who have been previously assessed and treated 
with non-opioid or non-pharmacological therapy with no response or 
limited success or response, and who may benefit from opioid therapy 
for pain control. Opioids are powerful medications that can help manage 
pain when prescribed for the right condition and when used properly. 
However, if prescribed inappropriately or if used improperly, they can 
cause serious harm, including overdose and death. Patient adherence 
with the proper use of opioids is crucial in the delivery of 
appropriate opioid therapy. Patient assessments, follow-up evaluations, 
and urine drug tests (UDTs) are recommended monitoring tools for safe 
and effective use of opioids.
  va patterns of dispensing take-home opioids and monitoring patients 
                           on opioid therapy
    As requested by the U.S. Senate Committee on Veterans' Affairs, the 
OIG conducted a study to assess the provision of VA outpatient (take-
home) opioids and monitoring of patients on opioid therapy (hereinafter 
referred to as opioid patients).
    The objectives of the study were to:

     Describe both the prevalence of VA patients who filled any 
take-home opioid prescriptions at VA in fiscal year (FY) 2012 and their 
baseline characteristics.
     Evaluate VA dispensing patterns of take-home opioids, 
including concurrent (filled) benzodiazepines, filled acetaminophen, 
and early refills of opioids.
     Assess the extent to which VA screens and monitors opioid 
patients in alignment with measures adapted from selected 
recommendations in the Clinical Practice Guideline.
     Define VA patterns of providing psychosocial treatment for 
pain, pain clinic service, and medication management/pharmacy 
reconciliation for take-home opioid patients.
     Determine the prevalence of six selected serious clinical 
adverse effects among VA take-home opioid patients that may reasonably 
be expected to relate to opioid therapy.

    In our May 14, 2014, report, we made six recommendations, and the 
Under Secretary of Health agreed to the findings and recommendations 
and provided an improvement plan. As of March 20, 2015, four 
recommendations are closed:

     We recommended that the Under Secretary for Health ensure 
that the practice of prescribing acetaminophen is in compliance with 
acceptable standards.
     We recommended that the Under Secretary for Health ensure 
that follow-up evaluations of patients on take-home opioids are 
performed timely.
     We recommended that the Under Secretary for Health ensure 
that opioid patients with active (not in remission) substance use 
receive treatment for substance use concurrently with urine drug tests.
     We recommended that the Under Secretary for Health ensure 
that VA's practice of prescribing and dispensing benzodiazepines 
concurrently with opioids is in alignment with acceptable standards.

    As of March 20, 2015, only two recommendations remain open:

     Recommendation 2: We recommended that the Under Secretary 
for Health ensure that VA's practice of routine and random urine drug 
tests prior to initiating and during take-home opioid therapy to 
confirm the appropriate use of opioids is in alignment with acceptable 
standards.
    VA management provided an estimated implementation date of 
February 28, 2015. In its most recent status update dated December 30, 
2014, VA indicated that actions to implement this recommendation remain 
in progress. VA is scheduled to provide another status update to the 
OIG by March 31, 2015.
     Recommendation 6: We recommended that the Under Secretary 
for Health ensure that medication reconciliation is performed to 
prevent adverse drug interactions.

    VA management provided an estimated implementation date of 
December 31, 2014. However, VA indicated in its most recent status 
update dated December 30, 2014, that actions to implement the 
recommendation remain in progress. VA did not provide an updated 
implementation date estimate. VA is scheduled to provide another status 
update to the OIG by March 31, 2015.
Findings
    We integrated and analyzed VA administrative files, as well as the 
Death Master Files of the Social Security Administration, for the 
population of nearly half a million VA patients who filled at least one 
oral or transdermal opioid prescription from VA for self-administration 
at home in FY 2012. We followed retrospectively the 442,544 patients in 
the population who did not receive any hospice or palliative care 
during the fiscal year or within 1 year prior to their first take-home 
opioid prescription for their experience with the provision of VA 
opioid therapy.
            Population
    We found that 7.7 percent of VA patients were on take-home opioids. 
A majority (92.5 percent) of the opioid patients were male, which 
mirrored the gender composition of VA patients. The average and the 
median patient age at their first opioid prescription in FY 2012 was 
59.4 and 61, respectively. Approximately 1 in every 16 patients had 
served in Operation Enduring Freedom/Operation Iraqi Freedom. 
Approximately 87 percent of the opioid patients were diagnosed with a 
primary pain site of non-cancer origin that could result in pain 
serious enough to warrant an opioid medication. Six out of 10 patients 
had been diagnosed with mental health issues, 1 in 3 with mood 
disorders, 1 of 5 with PTSD, and 1 of 7 with substance use. Nearly 94 
percent of the study population had been diagnosed with either pain or 
mental health issues and 58.4 percent with both. About one third of the 
opioid patients were on take-home opioids for more than 90 days 
(chronic users) in FY 2012. Approximately half of the study population 
were new patients in the sense that they were initiated on take-home 
opioid therapy during FY 2012 after not having been on take-home 
opioids for at least more than 1 year. Seven out of 10 of the non-
chronic users were new patients in contrast to 1 in 5 of the chronic 
users. Nearly 41 percent of the study population had been dispensed 
with one prescription. This 41 percent was composed entirely of the 
61.4 percent of non-chronic users because none of the opioids were 
allowed to be prescribed for more than 90 days in one prescription. 
Patients with six or more prescriptions were mainly chronic users, 
which amounted to 69.3 percent of that group.
            Dispensing Patterns and Drug Interactions
    Almost all (98.4 percent) patients received their prescriptions 
from a single VAMC, and three quarters of the patient population had 
all their (filled) prescriptions issued from a single prescriber. Most 
(95.0 percent) of the patients were dispensed with a single type of 
opioid. More than 6 percent of patients received at least one long-
acting opioid product, with the percentage of chronic users being four 
times that of non-chronic users. Opioid dosages with a morphine 
equivalent of at least 200 milligrams (mg)/day were dispensed to 1.2 
percent of the study population. We found that refills of opioids at 
least 7 days early occurred in 23 percent of the population, with 
refills of at least 11 days early in 14 percent of the population.
    The concurrent use of benzodiazepines and opioids can be dangerous 
because opioids and benzodiazepines can depress the central nervous 
system and thereby affect heart rhythm, slow respiration, and even lead 
to death. We found that take-home benzodiazepines were dispensed to 7.4 
percent of the study population, with the percentage of chronic opioid 
users being 1.6 times that of non-chronic users. We determined that 71 
percent of the opioid patients who also received take-home 
benzodiazepines were dispensed benzodiazepines concurrently with 
opioids. The percentage of chronic opioid users with concurrent 
benzodiazepines was 92.6, and the percentage of non-chronic users was 
53.6.
    Acetaminophen poisoning is a leading cause of liver toxicity. We 
determined that take-home acetaminophens were given to 92.3 percent of 
the study patients and that 2.0 percent of them were given an average 
daily dose of 4 g/day or more. The Clinical Practice Guideline calls 
for a urine drug test (UDT) prior to initiating opioid therapy and a 
follow-up contact at least every 2-4 weeks after any change in 
medication regimen. We determined that 6.4 percent of the new patients 
who were initiated take-home opioids in FY 2012 after not having been 
on take-home opioids for at least more than 1 year received both a UDT 
prior to and a follow-up UDT within 30 days.
            Screening and Monitoring
    The Clinical Practice Guideline requires routine and random UDTs to 
confirm the appropriate use of opioids by patients and a follow-up 
contact either in-person or a telephone encounter at least once every 
1-6 months for the duration of opioid therapy. We determined that 37 
percent of the existing opioid patients who were on take-home opioids 
at least from FY 2011 received both an annual UDT and a follow-up 
contact within 6 months of each filled opioid prescription. We found 
that VA conducted an annual UDT for 37.9 percent of the existing opioid 
patients which accounted for 40.9 percent of the chronic opioid users 
and 33.7 percent of the non-chronic users. We observed wide variation 
of VA medical centers' practice on an annual UDT, ranging from 4.4 
percent to 87.6 percent.
    We found that 13.1 percent of the study population was diagnosed 
with active substance use. The Clinical Practice Guideline specifies 
that chronic (for more than 1 month) opioid therapy is absolutely 
contraindicated in patients with active (not in remission) substance 
use disorders (SUD) who are not in treatment. It recommends that active 
substance use patients receive SUD treatment concurrently with urine 
drug testing as an adjunctive tool at regular intervals. For the active 
substance use patients who had at least 90 days available for follow-up 
in FY 2012, we determined that 10.5 percent received both a treatment 
for substance use and a UDT within 90 days of each filled opioid 
prescription.
            Pain Management Requires Multiple Specialties
    Psychotherapy, including cognitive behavioral therapy, is 
recommended to reduce pain and improve function in chronic pain 
patients. We found that 45.2 percent of the opioid patients received at 
least one psychosocial treatment for pain and that 35.1 percent of 
these patients received this treatment after their first filled opioid 
prescription in FY 2012. We determined that 8.7 percent of the opioid 
patients received care from a Pain Clinic. A review of medications by a 
pharmacist or other health care professional can prevent harmful 
interactions between these medications. We found that 38.8 percent of 
the opioid patients received medication management or pharmacy 
reconciliation during the fiscal year.
            Opioid Side Effects
    We determined percentages of opioid patients with evidence of a 
serious adverse effect that may reasonably be expected to be related to 
opioid therapy for the following six serious adverse effects: (1) 
opioid overdose, (2) sedative overdose, (3) drug delirium, (4) drug 
detoxification, (5) acetaminophen overdose, and (6) possible and 
confirmed suicide attempts. We found that less than 1 percent of the 
population experienced any one of these adverse effects during the 
fiscal year, except for the adverse effect of possible and confirmed 
suicide attempts that was evident in 2 percent of the opioid patients.
                           other oig reports
    The OIG has published a number of reports that address aspects of 
the issues when patients are prescribed large doses of opioids. These 
reports have certain themes:

     The use of high dose opioids in patients with a substance 
use disorder and mental illness is a common clinical situation.
     Compliance with clinical guidelines is not routine.
     Primary care providers bear the responsibility for 
managing these complex patients, often with limited support from pain 
management experts and related specialists.
     The use of high dose opioids causes friction within 
provider groups, where opinions on the proper use of these medications 
varies.
     Non-traditional therapies that may offer the benefit of 
less narcotic use are not fully utilized.

    I would like to discuss four reports that highlight these themes.
    In our report, Healthcare Inspection--Medication Management Issues 
in a High Risk Patient, Tuscaloosa VA Medical Center, Tuscaloosa, 
Alabama, we substantiated that facility providers collectively 
prescribed oxycodone, methadone, and benzodiazepines to a high-risk 
patient who died of an accidental multi-drug overdose. Three factors 
contributed to this outcome:

     Providers did not consistently comply with VHA and local 
policies for the management of chronic pain in this high-risk patient. 
Additionally, the patient's primary care provider did not conduct key 
portions of the pain assessment program. These include the requirement 
to address previous pain treatments and their effectiveness, suicide 
risk status, and drug overdose history. The primary care provider did 
not initiate an opioid pain care agreement with the patient or ensure 
adequate patient monitoring and follow-up after prescribing methadone. 
Required patient education regarding the specific dangers of methadone 
was not documented.
     The facility did not ensure access to an interdisciplinary 
pain management team or a pain clinic to provide needed expert services 
to this patient.
     Providers did not ensure communication and coordination of 
care. The primary care provider did not read other providers' progress 
notes reflecting concerns about prescribing opioids and 
benzodiazepines, the primary care and mental health providers did not 
communicate directly about this high-risk patient, and the suicide 
prevention staff did not assist in coordinating this patient's care 
although the patient was on the High Risk for Suicide list.

    We made seven recommendations and as of March 20, 2015, only 
Recommendation 7 that the Facility Director ensure access to 
interdisciplinary plan management care for chronic pain patients who do 
not respond to standard medical treatment remains open. We will 
continue to follow-up until VHA provides documentation that planned 
corrective actions have been implemented.
    In our report, Healthcare Inspection--Alleged Improper Opioid 
Prescription Renewal Practices, San Francisco VA Medical Center, San 
Francisco, California, we addressed several issues related to the group 
practice of primary care, where opinions vary on the use of high dose 
narcotic medications. The OIG substantiated the allegation that 
physicians are tasked with evaluating numerous opioid renewal requests 
for patients with whom they are unfamiliar. VHA policy requires that 
certain opioid prescriptions are restricted to a 30-day supply with no 
refills, which means patients must obtain a new or renewal prescription 
every month. During the course of our inspection, we found that all 
clinic physicians were part-time; therefore, patients requiring opioid 
prescription renewals every 30 days could be subjected to extended 
periods without their opioid medication, if required to see one 
provider. Senior leaders reported that in an effort to avoid such 
situations, a prescription renewal process was implemented for those 
instances when a patient requires a medication renewal but is unable to 
schedule a timely encounter with his or her primary care provider. The 
renewal process, established in 2006, assigned the attending on duty 
the responsibility for evaluating all medication renewal requests, 
including opioids for a period of time. The facility also hired 
clinical pharmacists who were designated to screen all renewal requests 
prior to provider evaluation for refills. The physicians we interviewed 
validated the complainant's allegation that within their on-duty half-
day clinics they evaluated multiple opioid renewal requests for 
patients unknown to them. VHA policy, however, does not prohibit a 
provider from renewing an opioid prescription for a patient he or she 
has not evaluated in person.
    We partially substantiated that providers do not routinely document 
patients' opioid prescription renewal problems in the electronic health 
record. The providers did not consistently document an assessment for 
adherence with appropriate use of opioids and monitor patients for 
misuse. The primary care providers did not consistently complete the 
``narcotic instructions note'' in the health record template
    We substantiated that there have been patient hospitalizations 
related to opioid misuse. Seven clinic patients were hospitalized for 
opioid overdose; however, the primary care provider, Psychiatry 
Service, and/or the facility's Substance Abuse Program appropriately 
assessed and monitored the patients. There were no deaths related to 
opioid overdose.
    The report made two recommendations with which the Veteran 
Integrated Service Network (VISN) and facility directors concurred. We 
closed our report on April 17, 2014, after receiving documentation from 
VA that corrective actions were sufficiently implemented.
    In an August 21, 2012, report, Healthcare Inspection--Management of 
Chronic Opioid Therapy at a VA Maine Healthcare System Community Based 
Outpatient Clinic, we substantiated the allegation that providers did 
not adequately assess patients who were prescribed opioids for chronic 
pain. Although providers performed initial pain assessments of 
patients, reassessments were not consistently documented at the minimum 
required frequency.
    We also substantiated the allegation that providers did not 
adequately monitor patients who were prescribed opioids for misuse or 
diversion of the medications. One provider did not properly follow-up 
on a patient's positive urine drug test, and due to staffing 
constraints at the clinic, patients often obtained prescriptions from 
multiple providers.
    We substantiated the allegation that facility managers asked 
providers to write opioid prescriptions for patients whom the providers 
had not assessed.
    We made one recommendation with which the VISN and facility 
directors concurred. Based on documentation from VA that corrective 
actions were sufficiently implemented, we closed our report on 
February 22, 2013.
    In a June 15, 2011, report, Healthcare Inspection--Prescribing 
Practices in the Pain Management Clinic at John D. Dingell VA Medical 
Center, Detroit, Michigan, we substantiated that providers prescribed 
controlled substances without adequate evaluation of patients and the 
facility did not have a policy outlining requirements for the ongoing 
assessment of patients treated with opioid medications. The Clinical 
Practice Guideline recommends that patients be evaluated every 1-6 
months. We reviewed 20 patients' electronic medical records, including 
those named by the complainant and those with the largest aggregate 
opioid doses identified from among the 4,445 patients who received 
these medications during December 2010. We found that during 2010, five 
patients on chronic opioid therapy had no evaluation and six patients 
had evaluations more than 7 months apart. For 10 of these patients, 
prescriptions were written by one physician.
    We did not substantiate the allegation that clinic supervisors 
coerced providers to prescribe controlled substances to patients not 
under their care. A provider had numerous patients who would require 
medication renewals. Physician coverage for these patients was 
arranged, after some discussion regarding the proper provision of care, 
to this population of controlled substance Users.
    We made two recommendations with which the VISN and facility 
directors concurred. Based on documentation from VA that corrective 
actions were sufficiently implemented, we closed our report on 
November 25, 2011.
                               conclusion
    The use of high dose opioids for the primary treatment of pain 
conditions is all too common within the veteran population. Patients 
with mental health or substance use disorders comprise a particularly 
complex subgroup of patients whose chronic mental health disorders may 
exceed the competence expected of primary care providers. As the 
findings in our national report demonstrate, VA was not following its 
own policies and procedures in six key areas: acetaminophen 
prescription practices; follow-up evaluations of patients on take-home 
opioids; concurrent substance use treatment with urine drug tests; 
prescribing and dispensing of benzodiazepines concurrently with 
opioids; routine and random urine drug tests prior to and during take-
home opioid therapy; and medication reconciliation. We note that VA has 
taken actions to implement a number of the recommendations in this 
report, but VA must be vigilant in monitoring facility compliance with 
opioid prescription policies and in completing outstanding 
recommendations.
    Mr. Chairman, this concludes my statement. I would be pleased to 
answer any questions you or other Members of the Committee may have.
                               APPENDIX A
                     VA Office of Inspector General
               Reporting on Opioid Prescription Practices

 
December 9, 2014           Alleged Inappropriate Opioid Prescribing
                            Practices, Chillicothe VA Medical Center,
                            Chillicothe, Ohio Phttp://www.va.gov/oig/
                            pubs/VAOIG-14-00351-53.pdf
 
July 17, 2014              Quality of Care and Staff Safety Concerns at
                            the Huntsville Community Based Outpatient
                            Clinic, Huntsville, Alabama Phttp://
                            www.va.gov/oig/pubs/VAOIG-14-01322-215.pdf
 
June 25, 2014              Medication Management Issues in a High Risk
                            Patient, Tuscaloosa VA Medical Center,
                            Tuscaloosa, Alabama Phttp://www.va.gov/oig/
                            pubs/VAOIG-13-02665-197.pdf
 
June 9, 2014               Quality of Care Concerns Hospice/Palliative
                            Care Program, Western New York Health care
                            System, Buffalo, New York www.va.gov/oig/
                            pubs/VAOIG-13-04195-180.pdf
 
May 14, 2014               VA Patterns of Dispensing Take-Home Opioids
                            and Monitoring Patients on Opioid Therapy
                            Phttp://www.va.gov/oig/pubs/VAOIG-14-00895-
                            163.pdf
 
November 7, 2013           Alleged Improper Opioid Prescription Renewal
                            Practices, San Francisco VA Medical Center,
                            San Francisco, California  http://www.va.gov/
                            oig/pubs/VAOIG-13-00133-12.pdf
 
August 21, 2012            Management of Chronic Opioid Therapy at a VA
                            Maine Health care System Community Based
                            Outpatient Clinic  http://www.va.gov/oig/
                            pubs/VAOIG-12-01872-258.pdf
 
August 10, 2012            Patient's Medication Management, Lincoln
                            Community Based Outpatient Clinic, Lincoln,
                            Nebraska  http://www.va.gov/oig/pubs/VAOIG-
                            12-02274-244.pdf
 
August 19, 2011            Alleged Improper Care and Prescribing
                            Practices for a Veteran, Tyler VA Primary
                            Care Clinic Tyler, Texas  http://www.va.gov/
                            oig/54/reports/VAOIG-11-01996-253.pdf
 
June 15, 2011              Prescribing Practices in the Pain Management
                            Clinic at John D. Dingell VA Medical Center,
                            Detroit, Michigan  http://www.va.gov/oig/54/
                            reports/VAOIG-11-00057-195.pdf
 


    Chairman Isakson. Thank you, Dr. Daigh. Dr. Clancy, you 
made an interesting statement in your remarks I have to seize 
on for just a second. You were talking about violations of 
policy at VA in terms of over-prescription of opiates, and you 
made the statement that wherever we find that taking place we 
will take the appropriate action, talking about discipline, I 
presume.
    To what extent can you terminate somebody for a continual 
violation in terms of over-prescribing opiates and pain relief 
at the VA?
    Dr. Clancy. In general, there are multiple steps to this 
process and I know that some of your staff have been briefed on 
some recent investigations. If it came up about a single 
patient, the first step would be a peer review where their 
practice is reviewed by their peers. If this came up--and this 
goes on across our system for any kind of clinical deviation, 
if you will.
    We have about 15 to 20 percent of those peer reviews across 
our system routinely re-reviewed by an organization in 
California that works with us under contract for just that 
purpose, mostly to make sure that our clinicians are 
calibrated, because in general, they are rated as one of three 
levels. One is, the vast majority of clinicians would have done 
it exactly this way; three is, almost no one on the planet 
would have done it this way; two is sort of intermediate.
    For repeated deviations from practice, whether that is 
level two or three, or other concerns that come up, we do have 
procedures in place to actually work very closely with that 
clinician to see if the deviations can be corrected. If they 
cannot, then they can be removed from their practice.
    Chairman Isakson. If in that first initial peer review 
there is evidence that the over-prescription was taking place 
and there was a violation of policy, how many hoops do you 
still have to go through to terminate that individual?
    Dr. Clancy. There are a number of steps. The first is to 
discuss that with the individual and counsel them about what is 
the right kind of practice, and so forth, and that is why we 
have all this expertise, to be able to bring to the attention 
of--I mean, this is a part of routine practice across all 
areas.
    Chairman Isakson. And it takes a long time?
    Dr. Clancy. It does, it does.
    Chairman Isakson. The reason I asked the question is, it 
was announced this morning, I believe, at the VA that the 
director of the project in Denver, the construction of that 
hospital, is no longer with the VA and took retirement. Is that 
correct?
    Dr. Clancy. Yes.
    Chairman Isakson. Is it easier to try and induce someone 
who has violated policy to retire or transfer to go somewhere 
else than it is to actually fire them?
    Dr. Clancy. I think that is sometimes the case, yes.
    Chairman Isakson. I appreciate your great service and the 
great information you provided us with. One thing you could do 
for me and the Committee, I think, any counsel you could give 
us on what we could do as legislators to give you statutory 
ability to run your department in a responsive way, not an 
abusive way, but a responsive way, would be greatly 
appreciated.
    I think the VA is being blamed for an action that really 
was not fair because the policies and procedures are so great 
to go from the violation to termination that it is easier to 
try and induce somebody to transfer or somebody to just retire. 
If you have statutory impediments that we could deal with, I 
would love to make your job easier and the justice more swift 
for our veterans in terms of those. If you would do that, I 
would appreciate it.
    Dr. Clancy. Well, I appreciate that, Mr. Chairman. I would 
just call to your attention and those of your colleagues that 
there are really two big issues on the clinical side. One is, 
although it is true for other areas. One is having enough 
evidence that it will stick and not be overturned.
    In the example of strong concerns about a clinician's 
practice, a good lawyer can sometimes actually help us. A 
settlement ends up being that we end up having that person do 
something non-clinical because we have so many concerns we 
would not want to have them seeing patients. That is costing 
the taxpayers. We definitely want to avoid that if we can. For 
other kinds of behaviors, having enough evidence to withstand 
an appeal is a big part of our issue as well.
    The other issue clinically is just always trying to make 
sure that for some reason, in the case of opioids, for example, 
there is not a good reason to think that perhaps a clinician 
selectively saw unusually complex or unusual patients. That is 
really why our clinician investigations have been very, very 
thorough in that regard.
    Chairman Isakson. Thank you for that response. In the 
interest of time, I will not ask another question, but I will 
make a comment. In Dr. Daigh's testimony, he talks about the 
March 14th recommendations of the IG's report and the six 
recommendations of the VA. I want to congratulate you on 
closing four of the six--that is a record--in a short period of 
time, and the two that are open deal with a subject you and I 
talked about yesterday which is urine testing and making sure 
you have the proper testing on these prescription of opiates. 
So, congratulations on your responsiveness to that.
    Dr. Clancy. Thank you.
    Chairman Isakson. I will turn to the Ranking Member for his 
questions.
    Senator Blumenthal. Thank you, Senator Isakson. First of 
all, thank you, Dr. Clancy, for acknowledging the value of a 
good lawyer. Rarely are good and lawyer combined in the same 
phrase in these halls, but I do appreciate your comments. I 
want to say that I appreciate your service to our Nation. You 
are a relatively recent appointee to your current position and 
you have been very cooperative and helpful to the Committee and 
to members individually, and I want to thank Dr. Daigh as well 
for your work in the Inspector General's Office as well as 
members of your team.
    None of the criticisms that we are aiming at you, the 
panel, are meant to be personal to you. As you understand, they 
are institutional. You mentioned that the systemwide or network 
wide reporting will be instituted, I think you said, as of 
June. What will that system then encompass?
    Dr. Clancy. So, that system--and in the interest of time I 
was trying to be succinct in terms of details. This consists of 
every single clinician getting a customized consultation, and 
it is not optional, combined with a review of their prescribing 
practices. And we have seen that this works very well in three 
networks.
    It is called academic detailing because it takes a page 
from a practice that the pharmaceutical industry has used to 
market their products, where they go out and they kind of 
customize their pitch, if you will, to the needs of an 
individual clinician. In their case, they are selling a 
product. This is selling knowledge and skills or marketing, 
communicating.
    Senator Blumenthal. This is a new system that will be going 
nationwide as of June?
    Dr. Clancy. It is not brand new, but what will be new is 
actually that it is going to be nationwide and not optional.
    Senator Blumenthal. That is distinct from the opioid 
therapy prescribing report that was in use earlier or is that 
the same system?
    Dr. Clancy. It builds on it. The Opioid Safety Initiative, 
if you will, is maybe 500 or 1,000 feet off the ground. It is 
all about the knowledge and so forth. This is getting it right 
down to you, the individual clinician personally, and your 
patients.
    Senator Blumenthal. Even under this new system, will the 
prescribing providers in the VA system be compelled to provide 
information to the State prescription monitoring programs, that 
is the State registries?
    Dr. Clancy. Because I have been paying a great deal of 
attention to Wisconsin in response to concerns from Senator 
Baldwin and other members of the delegation, and we have been 
reporting to the Wisconsin State program for some time, I made 
the blithe assumption that we were reporting to all the State 
programs.
    Senator Blumenthal. But that is not true.
    Dr. Clancy. Correct. We are reporting to 20 of them. We 
have identified that we have an internal disagreement among 
some of our IT folks around privacy and security issues, which 
we will be resolving very promptly.
    Senator Blumenthal. In some States, 20 of them----
    Dr. Clancy. Yes.
    Senator Blumenthal [continuing]. Out of the 49 that have 
prescription monitoring programs----
    Dr. Clancy. Yes.
    Senator Blumenthal [continuing]. You are providing this 
information to State systems, but in some 29 of them you are 
not doing so. Connecticut happens to be one where it is not 
occurring.
    Dr. Clancy. That is correct. Now, obviously, resolving the 
difference of opinion here could lead to one of two outcomes. 
One, we immediately report to 49. The other is that we have to 
come up with an alternative solution that fits our standards 
for security and privacy. Either way, this will happen.
    Senator Blumenthal. I understand there are privacy 
concerns. Just to be very clear, if I am a VA patient right now 
in Connecticut, or those 29 other States, I can go to a private 
provider and that private provider has no way of knowing the 
doses of opioids that I am receiving through the VA system?
    Dr. Clancy. Correct.
    Senator Blumenthal. It is a blind one-way source of 
information where it is working now, and if I am reading your 
testimony correctly, where you use the word--and I am quoting--
VA providers can now access the State Prescription Drug 
Monitoring Program (PDMP), it is not compulsory that they do 
so?
    Dr. Clancy. Is it compulsory?
    [Discussion off the record with Mr. Valentino.]
    Dr. Clancy. Not yet, but it will be.
    Senator Blumenthal. When?
    Dr. Clancy. We are saying in the next 3 months.
    Senator Blumenthal. I would like a definite timeline.
    Dr. Clancy. Alright. We will get back to you with a very 
specific date. I will tell you that I am very worried about 
this, particularly since I learned extremely recently that we 
are not reporting to all the State programs, because in the 
context of our buying more care out of network, either through 
our usual non-VA care program or through the Choice program, 
this becomes an even bigger risk for us and for veterans, most 
importantly.
    Senator Blumenthal. My time has expired. I have a raft of 
additional questions relating, for example, to the lack of 
revised guidelines. You and I spoke about this issue yesterday. 
The last guidelines were done in 2010. Even the most, I think, 
permissive of recommendations would say they are well due for 
revision in 2015, 5 years later.
    My questions also relate to the lack of implementation of 
two of the recommendations--Dr. Daigh mentioned them--from his 
report relating to urine tests and medicine reconciliation. I 
am going to be submitting questions for the record because in 
the interest of my colleagues, I do not want to impinge on 
their time.
    I think there are some very urgent inquiries that need to 
be pursued here. Thank you very much.
    Dr. Clancy. Well, let me just assure you we will get you 
responses expeditiously. The other two things I would just note 
is, I had briefly forgotten yesterday that we are participating 
in a broad HHS series of guidelines on pain management and 
adverse reactions to medications and so forth, and we have 
three or four of our experts who are part of that work going 
on.
    I do think we need to close the loop with our own guideline 
that we developed with the Department of Defense and we will be 
reaching out to those folks.
    Senator Blumenthal. The relationship and the coordination 
with the Department of Defense is an entirely other area that I 
was going to pursue, and I hope I will through the written 
questions. I might just close by saying, since you referred to 
a good lawyer, if you need a good lawyer to reconcile privacy 
concerns with access to VA data by State registries, I am 
volunteering, at least as a lawyer, not necessarily a good 
lawyer. If we need legislation to do it, you will have it.
    Dr. Clancy. Thank you.
    Senator Blumenthal. At least you will have my commitment to 
pursue it and I hope it will be a bipartisan initiative because 
this kind of coordination of information is really essential to 
protecting veterans. You make the point, and I think it may be 
one of the most important points in this hearing, that 30 
percent of people in America suffer from chronic pain.
    But more than 50 percent of our veterans, for obvious 
reasons, they have endured the wounds and scars of battle and 
they suffer with them for a lifetime. Providing them with 
responsible pain treatment is one of our obligations and it 
ought to be responsible. Thank you, Mr. Chairman.
    Chairman Isakson. I think Senator Blumenthal's willingness 
to volunteer proves that old adage that if there is a billable 
hour out there somewhere, there is always an attorney. 
[Laughter.]
    Senator Blumenthal. I guarantee that whether I am good or 
not, my rates are very affordable, namely zero.
    Chairman Isakson. We will follow the early bird rule and 
our next questions will be Sen. Cassidy followed by Sen. 
Baldwin, followed by Sen. Tillis.
    Senator Cassidy.

         HON. BILL CASSIDY, U.S. SENATOR FROM LOUISIANA

    Senator Cassidy. Yes, sir. Dr. Clancy, I am not so much 
concerned about the physician or the osteopathic physician (DO) 
having access to the State database, but does your pharmacist 
have access to it? When someone goes out to a private provider, 
sees that provider and gets a prescription, is that 
prescription filled at the VA pharmacy or in a private 
pharmacy? I do not know. I am asking.
    Dr. Clancy. Sorry?
    Senator Cassidy. If someone goes to a private provider and 
gets a prescription for an opioid, would that prescription be 
filled in a VA pharmacy or would it be filled in a community 
pharmacy?
    Dr. Clancy. It would most likely be filled in a community 
pharmacy, in part because these medications are pretty 
inexpensive. So they could get it filled at VA if they were 
enrolled in our system, but they would have to come in and 
actually be seen by someone first, because we are not legally 
authorized to be dispensary.
    Senator Cassidy. I will just echo my friend, the attorney. 
Clearly having physicians involved in that database would be 
important because I, as a physician, have learned that many 
patients who are addicted doctor shop. We all know this. They 
are getting a reasonable prescription here and a reasonable 
prescription there, but in aggregate, it is an unreasonable 
prescription.
    Let me ask second, in your testimony, you mentioned that 
you have decreased the percent of people receiving chronic 
opioid therapy, and I have your review paper from the American 
Academy of Neurology, and I will quote from it. Although there 
is evidence for significant short-term relief with opioid 
therapy, there is no substantial evidence for maintenance of 
pain relief or improved function over long periods of time 
without incurring serious risk of overdose, dependence, or 
addiction.
    Why would anybody be on long-term maintenance for non-
cancer pain? I say that as a doctor. I used to give somebody 
with chronic pancreatitis, I may give them something for break-
through pain, but if you will, that was acute relaxing pain. It 
was not chronic pain. I know that this is not the position 
paper that would state this. Why would anybody be, much less 
370,000 people, on chronic opioids for non-cancer pain? You 
with me?
    Dr. Clancy. Largely because we do not have easy 
alternatives. It is very easy to see the safety and adverse 
affects associated with narcotics, particularly in some case 
for veterans, especially combined with other medications, but 
we do not have a good answer to chronic pain that fits 
everyone.
    Senator Cassidy. I accept that. So, two things about that. 
One, if there is no evidence for long-term benefit, then 
clearly this is not an answer even though it is being used for 
370,000 people. Do you follow what I am saying? Knowing that as 
a doc, believe me, I used to love to refer to pain doctors 
because these are such tough patients.
    The Academy of Neurology says there is no evidence that we 
should use it, which means it is not even a non-answer, it is a 
negative answer. It violates first do no harm. It seems like 
there should be stricter prescriptions, proscriptions against 
doctors providing it. For example, you only get it after 90 
days if you get a waiver from the local pain doctor, sort of 
thing. You follow what I am saying?
    Dr. Clancy. Yes. First, let me just say, starting with your 
last point, that having even more pain expertise into these 
decisions, I think, is only a good thing and I think the 
academic detailing approach will actually accomplish quite a 
bit of that.
    Many of the servicemembers who are transitioning into VA, 
particularly from our most recent conflicts, have substantial 
amounts of morbidity. I mean, it is a great tribute to 
battlefield medicine that the mortality for----
    Senator Cassidy. I accept that.
    Dr. Clancy [continuing]. People who served in Iraq and 
Afghanistan is much, much lower.
    Senator Cassidy. But again, the point is, is that there is 
no evidence that for non-cancer pain longer than 90 days, that 
risk appears to outweigh benefit.
    Dr. Clancy. That is correct. But understand that when they 
come to VA, they have often been treated with narcotics and 
many other----
    Senator Cassidy. I accept that. It seems as if they would 
be immediately entered into a program which would begin to wean 
them from this, because again, American Academy of Neurology 
long-term--and I know you know this. Believe me, people come 
and you want to please them. We both know as physicians 
sometimes the best answer is no. Otherwise, it is addiction, 
dependence, suicide.
    Knowing that it is not efficacious for those with long--
long-term therapy is not efficacious for those with non-cancer 
pain, it does seem like it should not be 370,000. It should be 
closer to 5,000 or something like that.
    Dr. Clancy. I think ultimately, that is probably the right 
answer. The trick is, how do we actually help veterans live in 
a way where they have a quality-of-life that they can maintain. 
I certainly have had patients who, after, are trying many, many 
different things. Together we ended up with a pain contract for 
them to get chronic narcotics because nothing else quite seemed 
to work and they seemed remarkably functional.
    Senator Cassidy. Real quickly, your testimony mentioned 
Cleveland having a good pain clinic, and Dr. West was helping 
me with my back problems even as we started.
    Dr. Clancy. And no narcotics either.
    Senator Cassidy. No narcotics. So I guess the question is, 
how successful have you been in broadening access to pain 
clinic doctors among all your different facilities?
    Dr. Clancy. What happened in Cleveland that was 
particularly exciting, and then I will ask Dr. West to comment, 
is that they formally implemented and tested an approach that 
leverages the expertise of pain management clinicians in a 
multi-disciplinary group working together and used telehealth 
to reach out to doctors practicing in rural areas.
    Many of our facilities have that kind of multi-disciplinary 
approach. This would be the major facilities, but if you live a 
couple of hours away from that, coming in periodically may not 
be all that practical.
    Senator Cassidy. What percent of your facilities would have 
access to expertise such as this?
    Dr. West. I do not have that number right off-hand, but 
we----
    Senator Cassidy. 50 percent, 20 percent, 80 percent? 
Ballpark? Because telemedicine obviously allows you to extend 
this reach to everyone, should you make the decision.
    Dr. West. I would say--the vast majority of our facilities 
have access to telehealth. We are rapidly expanding our access 
to pain medicine programs. It is relatively new. It has been 
rolled out very successfully in Cleveland. It will be a 
published peer reviewed article very shortly.
    You brought up all the very critical points here. We need 
better access to pain physicians through our system of 
technology, through telehealth, which we do a very nice job 
with. We can expand access through our existing networks.
    The problem is, just as you also alluded to, there is not a 
whole lot of pain doctors out there to tap into. So we can use 
technology and leverage the advantages. We have in already 
forming these networks to network those people in and take 
those messages out to the other clinics, rural clinics--we have 
a huge rural population and a rural base--and bring that 
education system.
    The education system, at the end of the day, is so 
important because providers for so long, and mentioned in 
previous testimony, were--the training of the use of opiates 
was, you use opiates. Now we are seeing this horrible epidemic.
    Senator Cassidy. Dr. West, I am way over, so let me just 
finish by summing up. It does seem, instead of 370,000 people, 
we should have 5,000 people because there is always the 
exception, and it does seem like telemedicine has that ability 
to take that reach, knowing your number of doctors is limited. 
Since I have done telemedicine in the past, you can bring it 
across the country. Cleveland can be in Baton Rouge or 
Lafayette or Shreveport, LA.
    Hopefully, 2 years from now, it will be 5,000 because that 
seems to be most consistent with modern medicine. I yield back 
and I apologize for going over.
    Chairman Isakson. Thank you, Sen. Cassidy.
    Senator Baldwin.

        HON. TAMMY BALDWIN, U.S. SENATOR FROM WISCONSIN

    Senator Baldwin. Thank you, Mr. Chairman, and Ranking 
Member Blumenthal. I very much appreciate you and the Members 
of the Committee agreeing to my request to hold this hearing 
and for inviting me to participate as a non-Member of the 
Committee today.
    As you have heard, in my home State of Wisconsin, the Tomah 
VA medical center is currently the subject of multiple 
investigations that I have called for, including the one that 
Dr. Clancy mentioned earlier today being conducted by the 
Department of Veterans Affairs Under Secretary for Health, the 
VA Office of Inspector General, and the Drug Enforcement 
Agency.
    Among other issues, these investigations are looking at 
disturbing allegations of improper opioid-prescribing 
practices, the subject of today's hearing. I am going to have a 
chance next week at a field hearing in Tomah to give a longer 
opening statement, but I briefly wanted to state today that the 
problem of over-prescribing of opioids at the VA has led to 
tragic and real consequences for veterans, their families, and 
entire communities across our Nation.
    We should never lose sight of the central human dimension 
of these issues, which we in Wisconsin have been learning so 
much about. Dr. Clancy, it is my understanding as part of the 
opioid safety initiative that VHA has set up a central database 
that tracks all opioid prescriptions across the network.
    I would like to know if the system also tracks the 
prescribing of dangerous drug combinations, for example, 
opioids concurrently prescribed with benzodiazepines? As we saw 
at the Tomah VA, a former Marine, Jason Simcakoski tragically 
died last August as an inpatient from mixed drug toxicity. At 
the time of his death, he was reportedly on 15 different 
prescription drugs, including anti-psychotics, tranquilizers, 
muscle relaxants, and opioid pain killers. Does the VA's new 
system recognize when these dangerous combinations are being 
prescribed?
    Dr. Clancy. Yes. In fact, the report that we released 
several weeks ago actually makes that available to individual 
clinicians so they can look at one screen and see this for all 
the patients under their care.
    Senator Baldwin. So, can this system alert the providers in 
real time to stop the prescriptions?
    Dr. Clancy. Real time here, I think, is defined as we pull 
the data. I think it is every couple of weeks right now. We are 
trying to see if we can do it daily without blowing up the rest 
of the network. It is pretty close to real time.
    Senator Baldwin. So right now a couple of weeks?
    Dr. Clancy. Yes.
    Senator Baldwin. Who at the VA is tracking this data and 
who has use of it today?
    Dr. Clancy. Our pharmacy benefit management service tracks 
this very carefully, and I know that we had a discussion 
yesterday about would there be some value in making this 
public, and I said, Yes, I just think it would be a little bit 
hard to do that in a way that is comprehensible, which is not 
in any way saying no. It is simply saying that we would have to 
do so thoughtfully, because the quality measures that tend to 
be easiest to understand are those where the right answer is 
100 percent or zero, this is more nuanced.
    Senator Baldwin. Among the allegations that are being 
looked into at the Tomah VA are early refills of prescriptions 
for opioids. Also, refills when a urine analysis indicates that 
a patient is negative for use of the prescribed drugs. Can you 
tell me whether this is easily tracked with the system that you 
are describing?
    Dr. Clancy. The system I am describing is actually focused 
on prescribers, but the system also does tell prescribers which 
of their patients have had a urine drug screen and when, 
because we will be monitoring that much more closely than we 
have been in the past.
    Senator Baldwin. I am reading between the lines that it is 
not an effective tool in real time to help----
    Dr. Clancy. It does not slap your wrist in real time, no. 
It does tell you which of your patients, because some patients 
take these medications intermittently. Part of the idea is to 
get random urine tests as opposed to on a regular prescribed--
--
    Senator Baldwin. It would track the negative urine test, 
but it would not necessarily--I did not get the answer on early 
refills.
    Dr. Clancy. Early refills should not be happening, period. 
I think one of the issues that has been surfaced at Tomah, and 
we are going to be dealing with, just still in the 
investigation phase, is the pharmacist who felt uncomfortable 
about that because their State boards generally make it very, 
very clear to them that this should not be happening, either 
left or they first tried to protest and then left the employ of 
that facility.
    Senator Baldwin. In terms of the opioid safety initiative 
and the tracking system, I have two other questions on this 
topic. Is it acceptable practice to send a prescription to a 
patient at home while they are in inpatient at a VA facility, 
and would you be able to track that with this system?
    Mr. Valentino. Normally no, but a large percentage of our 
prescriptions go through the mail. So I could envision a system 
where a patient requested a refill and it was in the queue, and 
it was sent to them automatically, and perhaps after they 
ordered it and it was in the queue that they were admitted, and 
if the timing was close, there just would not be enough time to 
stop that.
    Senator Baldwin. Maybe on an incidental basis, but if it 
was happening over a long period of time, that prescriptions 
were being sent to a home when somebody was a long-term 
inpatient, that would be----
    Mr. Valentino. That would indicate there is a problem.
    Senator Baldwin. Would the tracking system capture that?
    Mr. Valentino. Not the opioid safety tracking system.
    Senator Baldwin. OK. Last, on this tracking system, does 
this link the prescriptions to the underlying diagnosis of the 
patient? So would it flag, for example, where a patient who is 
being seen for conditions other than chronic pain is receiving 
an opioid prescription?
    Dr. West. Yes, that is a wonderful question. The new tool 
that we have been talking about, the Opiate Therapy Risk 
Report, actually does. OK. So we are making it more easily 
accessible to front line providers. I mean, I am still a front 
line provider. I have a quarter-day clinic a week. And the 
important thing is to be able to get easy access to that 
information.
    With the new Opiate Therapy Risk Report, you can see the 
last primary care visit, last time they may have been in a 
substance abuse clinic visit, last time that they saw mental 
health. It also looks at--you know, you brought it up earlier--
co-morbid illnesses that may be a counter-indicator to contra-
indicated with opiates such as sleep apnea. We kind of are 
covering the whole bases there with our new risk report.
    Senator Baldwin. Mr. Chairman, I have additional questions, 
but I went way beyond my time, so either for the record or if 
you have a second round.
    Chairman Isakson. You owe Senator Cassidy a debt of 
gratitude. I let you go as long as he went.
    Senator Baldwin. I will thank him on the floor.
    Chairman Isakson. We will leave the record open for any 
questions you want to submit, and for the record to reflect, I 
appreciate Senator Baldwin's thanks for calling this hearing. 
Both Senators from the State of Wisconsin requested a hearing 
and both were invited to be here, and I understand Senator 
Johnson is going to come as well. We appreciate your being part 
of the meeting today.
    I am going to have to go to the floor in just a minute, so 
as I recognize Senator Tillis to come forward and ask his 
questions, I am going to also ask him to conduct the rest of 
the hearing until I get back, if that is OK. After Senator 
Tillis, Senator Manchin, and Senator Boozman will be the next 
to question.
    Senator Tillis.

       HON. THOM TILLIS, U.S. SENATOR FROM NORTH CAROLINA

    Senator Tillis [Presiding.]. Thank you, Mr. Chair. I am 
neither a doctor nor a lawyer. I am a management consultant, 
which I am sure is a great baseline for a joke, they walk into 
a bar. My question really relates to trying to reconcile some 
of the numbers. Senator Cassidy, said there are some 350,000 
people on medications today and that realistically that should 
be 5,000. I like getting numbers right.
    If that is even within the realm of possibilities, what are 
we doing? Assuming that the people who are on these 
prescription medications, they are on it for one of two or 
three reasons: they are on it and they should not be; they are 
using it, but it is not the most effective treatment they can 
get, which is there a question about, is there some mis-
prescribed treatment or are there other options that we should 
be providing available; and then some of them are doctor 
shopping and probably not taking the medication and putting it 
out on the market.
    Can you just give me some sense of that challenge we have 
now with this more than 300,000 people? Has there been any 
research done on what a realistic number is for the long-term 
use of opioids?
    Dr. Clancy. To the best of my knowledge, there is not a 
number that comes out of all these efforts. What we know is we 
can continue to make progress and that is exactly what we are 
planning to do. In terms of your breakdown, Senator Cassidy is 
completely correct that there is no evidence that they are 
effective. Unfortunately, there is not any evidence that 
anything else is more effective.
    So, you have got a choice between drugs that do not--or 
other modalities that do not work terribly well. What we do in 
VA is make access to other alternatives more available as much 
as we can. That can be different types of rehabilitation 
services, particularly for musculoskeletal pain, physical 
therapy, sometimes chiropractic. For some types of pain, 
acupuncture and massage treatments like that.
    To be quite honest, to get off opioids, I think people 
should be able to try anything. The trick is whether that works 
or not. Acupuncture tends to be better on more peripheral types 
of pain than it does on more centralized visceral types of 
pain.
    That is the path that we are going down. What is likely? It 
feels like the kinds of models you might have used as a 
management consultant, but I bet--I would like to actually ask 
some of our experts to try to figure out how low could we go. 
5,000 feels possibly a little too ambitious, but I do not think 
we should make it up. I think we ought to figure that out.
    Senator Tillis. I think it is very important because to me, 
unless you have that sort of baseline target, I do not know how 
you develop strategies around achieving the target. It seems to 
me it would be helpful. Dr. West, you looked like you were 
about to say something. Do you have something to add?
    Dr. West. I always look like that.
    Senator Tillis. OK.
    Dr. West. I always have something to add. I am an 
internist, so if you give me a chance, I will talk your ears 
off.
    Senator Tillis. Dr. Daigh, you went back in your opening 
comments and you were talking about compliance numbers. It just 
seemed to be very, very low, and that was a 2012 report?
    Dr. Daigh. It was data from fiscal year 2012.
    Senator Tillis. OK.
    Dr. Daigh. The report is from May 2014.
    Senator Tillis. What does it look like in fiscal year 2014?
    Dr. Daigh. I do not know. We would have to ask VA the data. 
That was a one-time look and we have not gone back to 
regenerate that data.
    Senator Tillis. Is there any, based on the analysis of the 
fiscal year 2012 data, has there been any way to map what 
seemed to be unacceptable compliance numbers to individual 
people who need to be held accountable for achieving higher 
compliance numbers? To the extent the compliance numbers were 
so low in 2012, have there been any consequences or was it 
appropriate to have any consequences for those who were 
responsible at the time?
    Dr. Daigh. For the first question, the methodology of the 
study, was a snapshot in time. It was not a longitudinal study.
    Senator Tillis. OK.
    Dr. Daigh. You cannot get to where you would like to go and 
where we would like to go, too.
    Senator Tillis. Great. That is where you really need to get 
to?
    Dr. Daigh. Absolutely. That study will not take you there, 
unfortunately.
    Senator Tillis. OK. The last question I have is about as 
far off topic as possible, but there is probably not a day or a 
week, at least, that goes by that I do not hear from certain 
veterans organizations I did as Speaker of the House with 
respect to opioids not necessarily being the only source that 
we should look to for palliative care, for pain care, and 
cannabinoids come up and, in fact, we are having the discussion 
here.
    To what extent have you all looked at this as a--of the 
300,000 who are currently depending on opioids, there may be 
some efficacy in consideration of cannabinoids or certain 
extracts for this sort of pain? Because I tend to agree. I do 
not think you get to 5,000 from 350,000. Are there other things 
that you tier into there and to what extent do you all think 
that merits our consideration? Thank you.
    Dr. Clancy. So, our clinicians cannot prescribe that by 
law. As far as I know, there is no federally-funded research--I 
am putting a small caveat on that--that looks at the 
effectiveness of medical marijuana. It has been more of a 
compassionate use sort of approach to make that available in 
some States. Frankly, putting that specific issue aside, which 
has a number of sensitivities, I think we should be willing to 
try anything.
    The other thing I would say that offers some hope for the 
future is actually not starting opioids to begin with. Most of 
the time we are not starting them, and, in fact, Defense has 
some very compelling studies in process right now of actually 
testing acupuncture in the field. I would guess it will not be 
100 percent effective, but if you can delay or actually prevent 
the initiation of opioids, you have completely changed the ball 
game.
    I know that when they launched the studies, they were 
sufficiently optimistic before making a big investment in a 
large study that they went to the researcher and said, Wait a 
minute. Before we cut the check here, you need to include the 
component that talks about the training program. How would we 
train medics, and so forth, in the field to actually administer 
this?
    Senator Tillis. OK. Thank you. I am going to tell myself my 
time has expired.
    Senator Manchin.

       HON. JOE MANCHIN, U.S. SENATOR FROM WEST VIRGINIA

    Senator Manchin. Thank you, Mr. Chairman. Last year the VA 
found that more than half a million VA patients are abusing 
opioids. I think we have gone through all this. I am so sorry I 
am coming in late from another Armed Services meeting. VA 
patient overdose on prescription medication is double the 
national average, from what our statistics have shown.
    I have seen the tragedy first hand in West Virginia. Sadly, 
we have the highest mortality rate in the country, and the 605 
percent increase in deaths since 1999, 605 percent. I have 
worked to reschedule Hydrocodone, combination drugs like 
Vicodin, Lortab, trying to get them from three to two. It makes 
the drugs a little bit harder to get.
    I have heard some alarming stories from my constituents, 
and often they are prescribed one drug after another. I have 
had people stop me on the street coming out of the military. 
When I first got here as a Senator, I started looking at the 
highest unemployment categories we have and it is our veterans.
    I started looking into why that might be. It is drug use. 
Cannot pass a drug test. It is an epidemic all through this 
country, in my State, and I am sure in Wisconsin, everywhere 
else. How well are your doctors trained and how well are they 
basically able to detect these types of dependencies?
    I just had a person stop me on the street Saturday and say 
their husband was given certain drugs, he was complaining; he 
is schizophrenic, he was almost suicidal. They would not change 
them. They kept doubling down. We had to fight to get to 
another clinic that truly specializes in this away from the VA 
to find someone who could cure our problem. Now, thank God, 
they are living more of a normal life.
    So, I can tell you that some of the veterans in the State 
of West Virginia do not believe that the veterans portion of 
medical care is really expertise enough to be able to handle 
this. Do you find that to be--I am not being derogatory at all. 
I am just saying, what can we do to help? Or can we just get 
them to someone who has the expertise?
    Dr. Clancy. What came up before you arrived, Senator--and I 
am sorry we did not get a chance to meet briefly yesterday and 
I know that you all were pulled into many votes--is, I did 
bring some data from West Virginia which I did not bring today, 
but I will make sure that your staff get a copy.
    Senator Manchin. It is quite high, is it not?
    Dr. Clancy. It is, although there has been progress in 
terms of reducing the rates and the doses. One of the biggest 
challenges for veterans is both the severe injuries that many 
have had, musculoskeletal nerve injuries and so forth, as well 
as the associated Post Traumatic Stress and Traumatic Brain 
Injury.
    There are many veterans who get off opioids or down to an 
extremely low dose only needing it sometime who are profoundly 
grateful and appreciative and will say that their lives are 
transformed. There are far, far more who are very hesitant, 
absolutely resistant to even starting that journey. That is the 
sort of broad spectrum of challenges that we are dealing with.
    Senator Manchin. Let me ask you, as a non-medical person, 
it just makes common sense to me that if you gave me one, 
prescribed one, and I come back and I tell you it is not 
working, would you not take the prescription away before you 
gave me another? Does that make sense? It is so common sense to 
me that something did not work so I am going to try something 
else--they are telling me nothing ever gets taken away.
    Dr. Clancy. That may actually be true, and I think an issue 
that we struggle with, as the rest of the country does, is that 
we have a pretty important shortage of pain management 
specialists and we are----
    Senator Manchin. I mean, common sense, remove and replace.
    Dr. Clancy. Well, you would be surprised how many times in 
medicine, actually the reason the drug is not working is they 
got the wrong dose. Giving an ineffective dose is sometimes 
referred to as homeopathic.
    Senator Manchin. You all recognize, I mean, it is a serious 
problem.
    Dr. Clancy. Yes, without question.
    Senator Manchin. Especially, let me tell you, if you go 
down into the age groups, our highest unemployed age group is 
veterans 18 to 24.
    Dr. Clancy. Right.
    Senator Manchin. I can assure you that is where most of 
addiction comes right out, and then it changes as the ages 
change a little bit more. Every indication is that's where the 
problem is. Again, it goes back. Do you require patients 
receive mandatory counseling when being prescribed opiates?
    Dr. Clancy. Yes. They now have to--and this is one of the 
features of the risk report that we were discussing earlier. 
They actually have to sign an informed consent and that is part 
of their record which walks through benefits and potential 
harms of these treatments.
    Senator Manchin. You are saying you are still practicing, 
correct, Dr. West?
    Dr. West. Correct.
    Senator Manchin. Dr. Daigh, are you still practicing?
    Dr. Daigh. No, I am not.
    Senator Manchin. OK. Dr. West, how much training did you 
have in dispensing as far as pain medication?
    Dr. West. It is a wonderful question. When I first came out 
of residency, which was not all that long ago, none. We just 
were not trained in residency. I went to a strong academic 
program here.
    Senator Manchin. Sure.
    Dr. West. Now, it has significantly increased. One of the 
things I talked about earlier as well was getting this 
education to the primary care providers. So now primary care 
providers are getting the information.
    Senator Manchin. What would you say that in the VA--I am so 
sorry, my time, I will just be a second--that basically in the 
VA medical delivery system the doctors that come in, how they 
come, where they come from, would they have that expertise?
    Dr. West. Doctors coming into the system really are not 
being trained on pain management the way they should be. That 
is why they need to be trained. That is why VA has a 
responsibility to train those physicians and get that expertise 
out directly to them.
    Senator Manchin. Do you not think we should get advice from 
those who specialize in----
    Dr. West. Absolutely.
    Senator Manchin [continuing]. Before you start prescribing?
    Dr. West. Absolutely. Getting that information out there is 
critical.
    Senator Manchin. No, I am saying, if I am just deploying 
out, I am 19, 20, 21, 22, and I have chronic pain or whatever 
other ailments I may have, would you not think I should be 
evaluated by someone who specializes in it before you give me a 
prescription?
    Dr. West. It is definitely a reasonable thing to say and 
again, the issue is we do not have a whole lot of pain 
providers out there. We are working through that and we are 
getting the appropriate education programs there.
    Senator Manchin. Thank you.
    Dr. Clancy. One other thing, Senator, two things. One is, I 
do have the information so I will leave that with you, and one 
of your facilities is actually making substantial progress, 
particularly in the proportion of veterans who are on both a 
narcotic and another drug that have a particularly high risk of 
adverse affects. That is modestly good news.
    Senator Manchin. Can you----
    Dr. Clancy. Absolutely, yes. We will get it to you right 
afterwards. Part of the challenge is that oftentimes these 
veterans come to us having been treated for many, many 
different conditions acutely. We are not starting them on those 
drugs to begin with. Many are arriving having been treated with 
them for a few weeks, months, or whatever their period is.
    Senator Manchin. I am not here to blame, I am really not. I 
am just looking for answers to serious problems and we want to 
work together to try to cure these problems.
    Senator Tillis. In the interest of time, we have got 
another panel after this and I know we all have got a place to 
be at noon.
    Senator Boozman.

         HON. JOHN BOOZMAN, U.S. SENATOR FROM ARKANSAS

    Senator Boozman. Thank you, Mr. Chairman. Thank you, all of 
you all, for being here today. I agree with you, Dr. Clancy. 
You mentioned that one of the most important things to prevent 
these problems from happening is to not prescribe them in the 
first place when they are not needed.
    The other thing, though, is that when they are prescribed--
when they are needed--is having adequate follow up, and I think 
in medicine in general these days are getting better at that. 
Sometimes those safeguards have not been in place. That is 
where you get the mail order. My county sheriffs tell me that 
it has become a cottage industry, not only with veterans, but 
others selling pills to get a little extra income.
    So it is a huge problem. One of the things that appears to 
be promising, perhaps, is--is it Vivitrol? There is a drug. Am 
I pronouncing it correctly?
    Mr. Valentino. Yes.
    Senator Boozman. That again blocks, from what I understand, 
blocks the receptors from getting the whatever. It is certainly 
not habit forming. The other drugs that are used, Methadone and 
various other things are all controlled substances and you have 
to worry about them. Can you talk a little bit about that, if 
we are using that, or the effectiveness of that? I know it is 
an expensive drug.
    Mr. Valentino. Yes. We are using that drug. We are also 
using other alternatives to Methadone, Suboxone and Subutex. We 
are using those. They are----
    Senator Boozman. Suboxone, again, you have to worry about 
becoming addicted to that, also.
    Mr. Valentino. Yes. Not quite as much. It has an antagonist 
along with the agonist, so it is----
    Senator Boozman. And again, correct me if I am wrong, the 
preliminary stories seem to be very, very positive about the 
other. Is cost the reason that we are not, perhaps, jumping in 
with both feet?
    Mr. Valentino. Regarding Vivitrol?
    Senator Boozman. Yes.
    Mr. Valentino. It is expensive, but it is not horribly 
expensive. I think it is about $500 per month. So it is not 
like a Hepatitis C drug or other drugs. So no, I do not think 
cost is the issue. When new therapies are introduced in 
medicine, there is a lag. People have to get comfortable with 
how to prescribe, how to monitor.
    We do have guidance out for the drug. It is on our 
formulary. We have seen a pretty dramatic up tick in its 
utilization over the last 6 months.
    Senator Boozman. Good. again, perhaps we can get some 
evidence based on what are the most effective of these. I am 
concerned about the transition. You know, you will have 
individuals in the military, active duty transitioning to the 
VA and these individuals are having problems over a period of a 
great deal of time. Sometimes you finally get them on a 
formulary that works and then you come to the VA and they are 
told we do not have the particular drugs they need.
    Dr. Tuchschmidt was in on Tuesday and said there is the 
opportunity to override that. I guess my question is, how long 
does it take? Are we actually using the ability to override or 
are these individuals basically saying come back in a few 
weeks, we cannot do this?
    Dr. Clancy. We are just arguing about who gets to say yes 
first, but yes.
    Mr. Valentino. Yes.
    Senator Boozman. But that has been a no in the past or a 
difficult yes.
    Mr. Valentino. We have not had a policy in the past, but we 
have actually had a practice in the past of continuing pain 
medication----
    Senator Boozman. I do not mean to interrupt, but the 
practice is such that when we have these families come in, that 
is kind of the common thread in the sense that many times they 
cannot get the medicines that they need and are frustrated.
    Mr. Valentino. Yes, I understand that concern. When 
somebody comes in from DOD, we have to take a look at their 
medications that they are on. For example, in particular with 
what we are talking about here, if somebody comes in on an 
opiate and a benzodiazepine, the VA physician is really 
compelled to take a close look at that and probably stop one or 
the other or both.
    A lot of these drugs in mental health have changed----
    Senator Boozman. Is that because the DOD physician is not 
doing a good job?
    Mr. Valentino. I am not saying that. Patients' conditions 
change over time, and perhaps what was initiated at one point 
is no longer the best therapy because patients' conditions have 
changed, other things have changed.
    Dr. Clancy. Their focus is acute in its short term. Right? 
So opioids usually work great for people in the short term.
    Senator Boozman. No, I understand.
    Dr. Clancy. It is the longer term.
    Senator Boozman. Yes and no. Some of these, they have been 
kind of fiddling with and getting them fine-tuned where they 
can live with whatever they are doing. Would it not make sense, 
with some of these drugs for specific things like that--and I 
do not know what the expense is. Would it not make sense to 
mesh the formulary?
    Dr. Clancy. We have a very clear agreement and commitment 
before transitioning servicemembers, particularly focused on 
those who are on mental health medications, that there will be 
no change until they have had an opportunity to be evaluated.
    We continue those medications, depending on the clinical 
circumstances of the individual, a former servicemember now 
veteran. Some of those drugs may be continued and we can do 
that in our formulary. I think that we prescribe or have the 
opportunity to prescribe about 96 percent of what is in the DOD 
formulary.
    What we are really focusing on is a veteran-centered 
approach at that time of transition, because with all the other 
things you have to deal with, to be told that, Oh, no, thank 
you, we think we will give you different medications now, is 
not actually helpful.
    Senator Boozman. Thank you, Dr. Clancy. Thank you, Mr. 
Chairman.
    Senator Tillis. Thank you.
    Senator Johnson.

         HON. RON JOHNSON, U.S. SENATOR FROM WISCONSIN

    Senator Johnson. Thank you, Mr. Chairman. I would like to 
thank you and the Committee for allowing Senator Baldwin and I 
to come and participate in this because this is, obviously, an 
issue that is striking dear to our hearts here in Wisconsin. I 
would like to thank you, Dr. Clancy, for responding to my 
letter, and certainly starting your own investigation in terms 
of the problems at Tomah.
    Senator Manchin would say, and we all recognize this is a 
serious problem, I guess I just want to ask, how long has the 
VA recognized the potential of opiate overdosing or over-
prescription to be a problem?
    Dr. Clancy. We have recognized it since at least 2012 and 
launched a very serious initiative starting in 2013, and we are 
now upping that. Upping it is probably the wrong way to say it. 
We are renewing the focus on it to get it right down to ground 
level for each individual prescriber and their patient panel.
    Senator Johnson. How long have you been at the VA?
    Dr. Clancy. I have been there for a year and a half.
    Senator Johnson. OK. Dr. Daigh, how long have you been in 
the Inspector General's Office?
    Dr. Daigh. About 12 years.
    Senator Johnson. About 12 years. How long have you been 
aware, or the Inspector General's Office, how long have they 
been aware that opiate over-prescription may be a problem?
    Dr. Daigh. I think if you look through our hotlines for as 
long as I have been at the VA, it has been a problem. And the 
reason that we did the national review in 2012 was that it has 
been my experience that in order to get VA to respond and make 
change, I need national data. We put a tremendous amount of 
effort into providing a national report to demonstrate at least 
what we think the level of the problem is and then encourage 
VHA to move forward.
    Senator Johnson. How long have you been aware, or the 
Office of Inspector General, and/or, been aware of the problems 
at the Tomah facility? When were you first hearing of these 
problems?
    Dr. Daigh. In recent time, that would be the first time 
Tomah has come up to me. We got a hotline allegation in roughly 
2011, and I can give you a timeline, and that allegation of 
improper care to providers at Tomah was sent to the VISN 
director to respond to.
    Historically, I have produced about 60 hotlines a year. I 
write about one hotline a week, is about what I can publish for 
manpower. The OIG gets roughly 50,000 contacts and that 
distills down to, in 2014, 2,400 health care issues. So, in the 
triage process, I sent that to the VISN director and the VISN 
director responded to those allegations, essentially saying 
they found no problems at Tomah.
    About a month or two later, we got another hotline. Again, 
I can provide the data.
    Senator Johnson. OK. Now, I do not want to get into the 
whole thing right now.
    Dr. Daigh. OK.
    Senator Johnson. The Office of Inspector General first 
became aware of problems at Tomah in terms of potential opiate 
over-prescription in 2011? Are you looking in a more robust 
fashion in terms of possibly knowing before that? This is when 
you were first aware of it. Are you checking either the 
Inspector General's Office or within the VA in terms of 
previous reports of problems with Tomah?
    It may be even beyond opiate over-prescription. Allegations 
of intimidation? How long has that been known? Are you 
inspecting that right now? Are you launching an investigation 
in terms of how long this has been known?
    Dr. Daigh. I would say in recent time, roughly 2011 
timeframe, is when we became of those issues.
    Senator Johnson. Are you going to launch an investigation 
to see if this was known sooner to hold people accountable?
    Dr. Daigh. So in order----
    Senator Johnson. Just simply yes or no. Are you going to?
    Dr. Daigh. I am not planning to go back further.
    Senator Johnson. Dr. Clancy, are you going to look into how 
long this has been known?
    Dr. Clancy. Yes. Right now we have got two rigorous 
investigations going on. One is being done by an entity that 
Secretary McDonald and the Deputy set up called the Office of 
Accountability and Review. Historically, VA has 150 facilities 
and many clinics and so forth, so highly decentralized and for 
many policies, including HR, was pretty decentralized or 
federated, if you will.
    The whole purpose of this Office of Accountability and 
Review, fondly known as OAR, is to hold senior leaders in 
particular accountable. Part of that investigation will also 
include any previous allegations or issues that have surfaced.
    Senator Johnson. OK. My time is up. Dr. Daigh, one of the 
things we have been trying to work with the Office of Inspector 
General. Certainly sensitive to the privacy issues, that type 
of thing. We also are conducting our own investigation as part 
of my Committee. That is my responsibility.
    We are going to require some of these files so we can do 
our own investigation to find out how far this went back, when 
it was known, who knew it so we can, first and foremost, the 
number 1 goal here is to make sure these tragedies never happen 
to another veteran or their families, but also to find out who 
knew what when and hold those individuals accountable.
    I am hoping that the Office of Inspector General actually 
cooperates with the Committee as we undertake our 
responsibility to do our own investigation as well. Thank you, 
Mr. Chairman.
    Senator Blumenthal [presiding]. I think that concludes the 
questioning. Just to let you know, both Senator Isakson and 
Senator Tillis are on the floor where they have to be right 
now. So, I have been asked to take over as Chairman.
    In the interest of time since we only have about half an 
hour left, I am going to invite Senator Baldwin to submit any 
additional questions she may have for the record. I want to 
thank her for being here today, as well as Senator Johnson, and 
ask the second panel to please come forward.
Response to Posthearing Questions Submitted by Hon. Bernard Sanders to 
  Carolyn Clancy, M.D., Interim Under Secretary for Health, Veterans 
       Health Administration, U.S. Department of Veterans Affairs
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Hawaii, Washington, Utah, Alaska, Idaho, Kansas, Minnesota and the 
District of Columbia.

    Question 1.  Since naturopathic physicians are trained in a variety 
of diagnostic and therapeutic modalities, is the VHA considering hiring 
certified naturopathic physicians to augment VA medical facilities' 
pain management clinics?
    Response. VA has no legal authority under 38 U.S.C. 7402(b) to 
appoint certified naturopathic physicians unless they otherwise meet 
the degree and licensure requirements of that section. For those that 
do, the problem remains that no mechanism currently exists by which VA 
can credential them to practice within VHA as naturopathic physicians. 
However, alternative medicine strategies are currently being actively 
incorporated into VHA's inventory of treatments for chronic, refractory 
pain syndromes. These emphasize non-pharmacologic approaches and 
include modalities such as acupuncture, massage therapy, and yoga.
                                 ______
                                 
Response to Posthearing Questions Submitted by Hon. Mazie K. Hirono to 
  Carolyn Clancy, M.D., Interim Under Secretary for Health, Veterans 
       Health Administration, U.S. Department of Veterans Affairs
                      va opioid safety initiative
    Question 2.  You mention in your testimony that the Opioid Safety 
Imitative has been in place since 2013. What failed with the program in 
Wisconsin? How can you be sure it is effective across the country?
    Response. The Opioid Safety Initiative (OSI) was not fully 
functional during the time the Tomah events occurred. VA's initial 
focus for the Opioid Safety Initiative (OSI) was to identify and take 
corrective action for Veterans Integrated Service Networks (VISNs) that 
were outliers on the OSI metrics. VA then shifted its focus to identify 
and take corrective action for individual facilities that were outliers 
on the OSI metrics. VA is now focusing on identifying and taking 
corrective action on individual providers who appear to be outliers on 
the OSI metrics. This current focus is complex because administrative 
databases do not lend themselves well to conducting the type of 
analysis that is necessary to accurately identify inappropriate 
prescribing. For example, a pain management specialist, a hospice care 
provider or an oncologist may ``appear'' to be an outlier, when in 
actuality their prescribing may indeed be clinically appropriate. VA is 
working through these issues now to develop a reliable way to identify 
potential cases of inappropriate prescribing practices so that local 
review, validation and intervention, if necessary, can occur.
    Going forward, VA will ensure enhancements to the OSI enable 
identification at the national level of individual provider prescribing 
patterns. The OSI will also become a more useful tool when augmented by 
VA's mandated deployment of the Academic Detailing Program. The 
Academic Detailing program is designed to provide the infrastructure 
and processes needed for VISNs, facilities, and individual providers to 
achieve safe and appropriate opioid prescribing practices and 
consumption. Each VISN will submit its first Academic Detailing Program 
progress report to the Under Secretary for Health by September 30, 
2015.
    Nationally, the Opioid Safety Initiative (OSI) has been effective. 
From Quarter 4, Fiscal Year 2012 (beginning in July 2012) to Quarter 2, 
Fiscal Year 2015 (ending in March 2015) there are: 109,862 fewer 
patients receiving opioids; 33,871 fewer patients receiving opioids and 
benzodiazepines together; 74,995 more patients on opioids that have had 
a urine drug screen to help guide treatment decisions; and 91,760 fewer 
patients on long-term opioid therapy. The overall dosage of opioids is 
decreasing in the VA system as 12,278 fewer patients are receiving 
greater than or equal to 100 Morphine Equivalent Daily Dosing (MEDD). 
The desired results of the OSI have been achieved during a time that VA 
has seen an overall growth of 90,488 patients that have utilized VA 
outpatient pharmacy services.
    We are confident that individual provider-level enhancements to the 
OSI, coupled with the Academic Detailing Program will foster safer and 
more appropriate opioid treatments.
                     va's coordination with states
    Question 3.  While you tout coordination with states that have 
monitoring programs, testimony provided here seems to indicate a lack 
of actual coordination--what reassurances can you offer that the VA is 
actually following through on all of these protocols and efforts and 
not just paying lip service to the very real issue of opioid abuse?
    Response. VA's State PDMP is a new capability to share prescription 
drug information, including opiate prescription data, with the PDMP of 
each state in the country that has a drug monitoring program in place. 
VA is participating with all states with which it is able to. PDMP 
deployment is now complete at 29 states; deployment of the system to 6 
additional states is currently underway; Missouri is the only state 
without a PDMP; and 1 state is not yet ready to accept data from VA 
(New Mexico). Thirteen states have data, communication, or format 
issues that need to be resolved before VA prescription drug information 
can be shared with them (New York, Massachusetts, Illinois, California, 
Indiana, Rhode Island, Iowa, Nebraska, Michigan, West, Virginia, 
Nevada, Texas, and Montana). VA is conducting a state-by-state 
assessment of these 13 states to determine the specific requirements 
for data transfers of VA prescription drug information, and VA is 
working to secure funding and contracts to support the changes needed.
    Additionally, VHA is currently drafting a new directive titled, 
which will establish policy requiring VHA health care provider 
participation in State Prescription Drug Monitoring Programs, 
consistent with applicable state laws.
                  va's policy on prescribing suboxone
    Question 4.  Are you monitoring the Suboxone so it's not being 
misused or untracked?
    Response. Yes. Monitoring of adherence at a minimum involves 
routine urine drug screens for metabolites of buprenorphine/naloxone 
(Suboxone) to confirm recent ingestion of the medication. When 
clinically indicated based on patient symptoms and function, providers 
also use pill counts to determine if patients have possession of doses 
prescribed for future use. Some clinics institute random calls for 
patients to present within 24 hours for medication counts and alert 
patients to this procedure as a standard part of the treatment consent 
process. Patients without the appropriate doses in their possession 
have adjustments to their treatment plan such as more frequent 
monitoring or enrollment in an Opioid Treatment Program with dispensing 
of medication observed daily.
                                 ______
                                 
 Response to Posthearing Questions Submitted by Hon. Tammy Baldwin to 
  Carolyn Clancy, M.D., Interim Under Secretary for Health, Veterans 
       Health Administration, U.S. Department of Veterans Affairs
    Question 5.  VA Prescribing Standards
    Your clinical review findings for Phase 1 of your investigation 
into the Tomah medical facility found that Tomah patients were 2.5 
times more likely than the national average to be prescribed opioids 
greater than 400 morphine equivalents per day and were more likely than 
the national average to be prescribed opioid doses between 200-300 
morphine equivalents per day. With respect to the use of 
benzodiazepines and opioids concurrently, which is discouraged due to 
risks of complications, your team found that Tomah was almost double 
the national average.

    a. In your opinion, are these prescribing practices at Tomah 
appropriate?
    Response. Since the prescribing practices at Tomah are at the core 
of VA's ongoing investigation, we are unable to offer a formal opinion 
on the matter at this time. However, the clinical review findings for 
Phase 1 of the VA investigation found mixed results in the use of 
opioids at the Tomah VAMC. From the fiscal quarter beginning in 
July 2012 to the fiscal quarter ending in December 2014 the percent of 
pharmacy users receiving an opioid decreased 6% (2,124 to 1,994 
Veterans), while the national percentage decreased 13% (679,376 to 
587,762 Veterans). The percent change for this metric must be 
considered within the context that Tomah has a lower percentage of 
Veterans receiving an opioid compared to the rest of the VA. The 
percent of pharmacy users receiving an opioid or tramadol who are also 
receiving a benzodiazepine decreased 9% (611 to 554 Veterans), while 
the national percentage decreased 24% (122,633 to 93,352 Veterans). The 
percent of pharmacy users receiving opioids for longer than 90 days who 
also received a urine drug screen to monitor treatment increased 36% 
(453 to 712 Veterans, while the national percentage increased 31% 
(160,601 to 231,856 Veterans). The percent of pharmacy users who are 
receiving doses of opioids greater than or equal to 100 MEDD has not 
changed (274 Veterans), while the national percentage decreased 17% 
(59,499 to 49,356 Veterans).

    b. Are these prescribing practices at Tomah consistent with VHA's 
clinical practice guidelines for prescribing opioids; for prescribing 
benzodiazepines; and for prescribing both drugs concurrently?
    Response. VA is deeply concerned with and is actively addressing 
the overuse and dependence on opioid medications by Veterans. After 
many years of promoting the aggressive treatment of pain with powerful 
opioid analgesics, the United States is in the midst of an epidemic of 
misuse and abuse of opioid analgesics. The extent and complexity of our 
Nation's Veterans multiple chronic pain conditions, including many 
severe battlefield injuries associated with blasts and co-morbid 
Traumatic Brain Injury and/or psychological conditions such as 
depression and Post Traumatic Stress Disorder, often make effective 
pain management clinically challenging and increase the risks for 
complications due to both over- and under-treatment with opioids and 
other therapies.
    Per VHA clinical practice guidelines, the use of benzodiazepines 
and opioids concomitantly is discouraged due to risks of complications, 
including apnea and death. The clinical review findings for Phase 1 of 
our investigation suggest that Clinical Practice Guidelines (CPGs) for 
chronic opioid therapy may have not been correctly followed. However, 
as previously stated, our investigation is ongoing and we are unable to 
offer a formal opinion on the matter at this time.
    In the months following the clinical review findings for Phase 1 of 
the VA investigation at Tomah VAMC, the medical center has been 
vigorously pursuing implementation of the Opioid Safety Initiative 
(OSI) similar to other VA facilities to ensure optimal pain management 
and to safeguard Veterans from harm inherent in high-risk medications 
such as opioids and benzodiazepines. The objective of OSI is to make 
the totality of opioid use visible at all levels in the organization 
with a particular emphasis on identifying and remediating prescribing 
practices that place Veterans at increased risk for adverse outcomes. 
To assist Veterans, providers and clinical teams in achieving OSI goals 
for safer opioid prescribing practices, an interdisciplinary VHA Task 
Force assembled a 15 module, peer-reviewed OSI Toolkit that is 
continually updated as new information becomes available, including new 
evidence-based practices. The OSI Toolkit is accessible to all VHA 
clinicians and disseminated widely and repeatedly through multiple 
communication channels and educational formats to facilitate safe 
opioid prescribing practices.

         - If yes, do you believe the relevant VHA clinical practice 
        guidelines should be revised?
    Response. We agree that it would be useful to update the guidelines 
with the latest evidence; a Chronic/Long Term Opioid Therapy Clinical 
Practice Guideline Panel is scheduled to begin this work in September/
October 2015. However, considerable work has already been completed in 
developing specific guidance for safe opioid prescribing in the Opioid 
Safety Initiative Toolkit, which has been widely disseminated to VHA 
clinicians. These documents can be found on the VA Pain Management 
Intranet Site, http://vaww.va.gov/PAINMANAGEMENT/index.asp.

         - If no, what actions do you recommend to bring facilities 
        like Tomah into compliance?
    Response. Suggested actions would include a clinical consultation 
by an expert team followed by action plans to establish competent 
stepped clinical care for pain in primary care and in specialty care, 
as articulated in VHA Directive 2009-053.
    The Tomah VAMC and VISN 12 leadership are committed to providing 
the best pain management to Veterans, who need such care. Specific 
steps taken at Tomah in past three months include:

     Implementation of pain resource folder in computerized 
medical record that is easily accessible to providers;
     Provider training on how to better leverage VHA's on-line 
opiate safety tools;
     Hiring a tracking nurse to help monitor and track Urine 
Drug Screen results and actions as part of a continuous monitoring/
monitoring maintenance plan; and
     Provider education: in additional to academic detailing, 
VISN 12 has sponsored a pain management workshop on June 3, 2015.

    c. When was the last time the VHA updated the relevant clinical 
practice guidelines?
    Response. The current VA/DOD Management of Opioid Therapy Clinical 
Practice Guideline (CPG) was updated in 2010. A CPG update kick-off 
meeting is scheduled for August 2015. Dr. Jack Rosenberg (VHA National 
Pain Management Strategy Coordinating Committee) has agreed to be the 
VA's champion for this update. As part of the CPG development/update 
process a thorough evidence review and synthesis will be conducted. 
Inclusion or exclusion of the CDC's updated prescribing guideline will 
be dependent on the evidence synthesis and the work groups 
recommendations at that time.

    d. The Center for Disease Control and Prevention plans to update 
its guidelines for opioid prescribing practices in the near future. 
Does the VHA currently use the CDC's prescribing guidelines and does 
the VHA plan to incorporate CDC's updated prescribing guidelines when 
they are complete?
    Response. The current VA/DOD Management of Opioid Therapy Clinical 
Practice Guideline (CPG) was updated in 2010. A CPG update kick-off 
meeting is scheduled for August 2015. Dr. Jack Rosenberg (VHA National 
Pain Management Strategy Coordinating Committee) has agreed to be the 
VA's champion for this update. As part of the CPG development/update 
process a thorough evidence review and synthesis will be conducted. 
Inclusion or exclusion of the CDC's updated prescribing guideline will 
be dependent on the evidence synthesis and the work groups 
recommendations at that time.

    Question 6.  VA Prescribing Guidance and Continuing Medical 
Education for Providers
    In Dr. Forster's testimony, she notes how Kaiser Permanente 
distributes ``clear and concise protocols'' to providers so they can 
identify and take action to stop inappropriate prescription narcotic 
use, including drug diversion or drug seeking behaviors. Dr. Forster 
also notes that Kaiser offers continuing education to providers on this 
issue. Based on what I've learned from prescribing practices at Tomah 
and from multiple GAO reports on the VHA system, it appears that VHA 
lacks similar ``clear and concise protocols,'' or what it does have is 
not implemented effectively or consistently followed.

     What protocols does VHA distribute to doctors, nurses and 
pharmacists so they can spot and prevent opioid abuse?
     Does VHA have continuing education programs so providers 
can stay up on the latest trends and tools?
    Response. VHA has multiple projects, coordinated under the National 
Pain Program (NPP) Office, to support and educate clinicians and 
Veterans about safe and effective pain management, including use of 
opioids, such as: the Opioid Safety Initiative (OSI), the Joint Pain 
Education and Training Project (JPEP) with the Department of Defense 
(DOD), the Pain Mini-Residency, Pain SCAN-ECHO, asynchronous web-based 
training, and Community of Practice calls which providers may elect to 
take but which are not required. These programs have presentations on 
universal precautions and risk management, including clinical 
evaluation, written informed consent, screening such as urine drug 
monitoring, use of state monitoring programs, and safe tapering.
    In recognition of the clinical challenges to successfully manage 
pain and prescribe medication safely for our Veterans while 
implementing the Opioid Safety Initiative (OSI) Directive and the 
Informed Consent Directive, the NPP Office convened a national task 
force to create an OSI Toolkit (evidence-based to the extent possible) 
to help guide the field. The OSI Toolkit Task Force (Task Force) is 
comprised of experienced experts from pain management, pharmacy, 
primary care, and mental health and is charged to systematically peer-
review and standardize clinical education and patient education 
materials for distribution throughout the VHA in support of OSI goals. 
In developing the OSI Toolkit, completed October 2014, the Task Force 
met in weekly conferences over several months to create content which 
was then merged with Pharmacy Benefits Management Academic Detailing 
Program Office product development. The resulting Toolkit contains 
documents, some in presentation form, that can aid in clinical 
decisions about starting, continuing or tapering opioid therapy and 
other challenges related to safe opioid prescribing. These documents 
can be found on the VA Pain Management Intranet Site, http://
vaww.va.gov/PAINMANAGEMENT/index.asp, or on the Adobe SharePoint Site, 
https://va-eerc-ees.adobeconnect.com/osi/
                     osi toolkit table of contents
     1. Pain Management Opioid Safety--Education Guide (Academic 
Detailing)
          a. Introduction--Chronic Pain Management: Reducing Harm While 
        Helping the Hurting Veteran. pp. 1-2
          b. Chronic Pain Treatment Strategies pp. 3-6
          c. Universal Precautions in Opioid Therapy pp. 4-11
          d. Discussing Pain Management p. 12
          e. High Dose Opioid Therapy pp. 12-14
          f. High risk Medication Combinations p. 15
          g. Opioid Reduction and Discontinuation pp. 16-17
     2. Pain Management Opioid Safety--Quick Reference Guide (Academic 
Detailing)
          a. Tools for Opioid Risk Classification pp. 1-2
          b. Urine Drug Screening pp. 3-9
          c. Opioid dosing p. 10
          d. Methadone p. 11
          e. Opioid Rotation pp. 12-14
          f. Opioid Adverse Effects pp. 15-17
          g. Opioid Dose Reduction or Discontinuation p. 18
          h. Benzodiazepine Dose Reduction or Discontinuation p. 19
          i. Non Opioid Agents for Acute and Chronic pain pp. 20-21.
     3. Clinical Considerations when caring for patients on Opioids and 
Benzodiazepines
     4. Effective Treatment for PTSD--Clinician Handout
     5. Effective Treatment for PTSD--Patient Handout
     6. Helping Patients Taper Benzodiazepines--Clinician Handout
     7. Helping Patient Taper Benzodiazepines--Patient Handout on 
Opioid Dose Reduction. Fact Sheet
     8. Final, IMed Consent Opioid Directive-1005. Rationale
     9. Frequently asked questions (FAQ): Informed Consent for Long 
Term Opioid Therapy Directive (VHA 2014-1005)
    10. Shared Medical Appointment. Taking Opioids Responsibly. 
Education Visit Template--Power Point
    11. Written and Informed Consent for Long Term Opioid Therapy--
Shared Medical Appointment--Power Point
    12. Pain management opioid safety guide 91314--Power Point
    13. Patient Information Guide on Long-term Opioid Therapy for 
Chronic Pain--Power Point

    Senator Blumenthal [presiding]. Let me dispense with 
lengthy introductions in the interest of time. We have votes 
scheduled for noon. Thank you to our staff for so quickly 
arranging for you to come forward.
    We are very pleased and grateful to welcome G. Caleb 
Alexander, who is not only an M.D., but Co-Director of the 
Center for Drug Safety and Effectiveness at Johns Hopkins 
Bloomberg School of Public Health; Carol Forster, also a 
doctor, M.D., Physician Director of Pharmacy and Therapeutics/
Medication Safety at the Mid-Atlantic Permanente Medical Group 
of Kaiser Permanente; and John Gadea, Director of the Drug 
Control Division at the Connecticut Department of Consumer 
Protection.
    We are thankful to all of you. Let us proceed with your 
opening statements. Thank you.

STATEMENT OF G. CALEB ALEXANDER, M.D., CO-DIRECTOR, CENTER FOR 
 DRUG SAFETY AND EFFECTIVENESS, JOHNS HOPKINS BLOOMBERG SCHOOL 
                        OF PUBLIC HEALTH

    Dr. Alexander. Good morning, Ranking Member Blumenthal and 
Senator Baldwin. The opinions expressed here are my own and do 
not necessarily reflect the views of Johns Hopkins University, 
and I thank you for inviting me.
    Doctors of my generation were taught not to worry about the 
addictive potential of opioids if a patient had true pain. 
Although well-intentioned, doctors have contributed to soaring 
opioid use. We have heard some of the statistics. Another one 
is that enough opioids were prescribed last year in the United 
States to provide every adult a 4-week, round-the-clock, 
continuous supply of Vicodin.
    Abuse of opioids has become an epidemic that devastates 
America's families, and we have lost far too many lives from 
this epidemic, more than twice the number of Americans as have 
died in the Vietnam, Iraq, and Afghanistan wars combined. A 
core contributor to this epidemic is that doctors and patients 
continue to over-estimate the benefits and under-estimate the 
risks of these products.
    In my testimony I would like to mention three important 
steps to address this problem, and I also discuss several 
popular ideas that I am concerned may distract us from the 
primary cause of this epidemic.
    First, we need to improve prescribing practices. Best 
practices for opioid use have been described. Doctors need to 
be more cautious with opioid initiation as well as use over 
longer durations and with higher doses. They need to limit the 
use of fentanyl and methadone for pain. They need to use multi-
disciplinary teams that incorporate non-pharmacologic pain 
treatments.
    They need to avoid combining opioids with medicines such as 
benzodiazepines and barbiturates. These approaches are 
especially vital among individuals with mood disorders such as 
depression, Post Traumatic Stress Disorder, Traumatic Brain 
Injury, or substance abuse since we know that high risk use and 
adverse outcomes are both more common among these patients.
    To improve practice, it is also vital to improve the 
measurement and accessibility of data about opioid utilization 
and prescribing at a patient, provider, clinic, and health 
system level. Such measurements allow for bench marking and 
enhance our understanding of practices contributing to opioid 
misuse and overdose deaths.
    Second, we need to help people who are addicted to opioids 
access effective treatment. Treatment with the medicines 
buprenorphine and methadone is the most effective means of 
helping individuals regain control of their lives and avoid 
overdose.
    Yet, despite over five million Americans with opioid 
dependence, fewer than one in five are currently receiving 
available treatments. There is too little provider interest. 
There are too many regulatory and payment barriers to access 
the most effective remedies.
    Third, we need to help people get rid of opiates that they 
do not need. It is stunning that these drugs are so easy to 
get, and yet, so difficult to get rid of. There are millions of 
pounds of unwanted and unused medicines sitting in bathroom 
cabinets and bedroom night stands all over America.
    The DEA recently finalized its rules regarding the disposal 
of controlled substances, and properly implemented, I believe 
that these take-back programs can serve an important role in 
reducing opioid-related injuries and deaths.
    Other tools may be valuable, but I am cautious because the 
scientific evidence to support them is limited. Urine testing, 
for example, may be reasonable to routinely apply in practice, 
but urine tests do not reduce the addictive potential of 
opioids and they do not change the overall unfavorable risk/
benefit balance for many, many current users.
    The FDA and manufacturers are also pursuing so-called abuse 
deterrent formulations to re-engineer medicines to reduce their 
abuse potential. I would also approach this strategy with 
substantial caution. While these re-engineered medicines are 
designed to thwart abuse, their active chemical ingredients are 
no less addictive and most people that are abusing or addictive 
to these medicines swallow them whole.
    Moreover, our research suggests that prescribers may over-
estimate the safety of abuse deterrent formulations. I am not 
convinced that we can engineer our way out of this problem. 
Some have framed efforts to rein in runaway prescribing as a 
threat to quality of care for those with chronic pain. As a 
practicing physician, I can assure you nothing could be farther 
from the truth.
    An overwhelming amount of evidence supports that 
compatibility of effective pain treatment with reducing opioid 
prescribing. High quality care for patients in pain is not 
jeopardized by such efforts. High quality care demands it. 
Thank you for the opportunity to testify today. I look forward 
to your questions.
    [Opioid Prescribing: A Systematic Review and Critical 
Appraisal of Guidelines for Chronic Pain from the Annals of 
Internal Medicine appears in the Appendix.]
    [The Prescription Opioid and Heroin Crisis: A Public Health 
Approach to an Epidemic of Addiction appears in the Appendix.]
    [The prepared statement of Dr. Alexander follows:]
 Prepared Statement of G. Caleb Alexander, MD, MS, Co-Director, Johns 
            Hopkins Center for Drug Safety and Effectiveness
    Good morning Chairman Isakson, Ranking Member Blumenthal and 
Members of the Committee. Thank you for the opportunity to speak today.
    I am a practicing internist and prescription drug expert at the 
Johns Hopkins Bloomberg School of Public Health, where I co-direct the 
Johns Hopkins Center for Drug Safety and Effectiveness. The opinions 
expressed herein are my own and do not necessarily reflect the views of 
Johns Hopkins University.
    Doctors of my generation were taught not to worry about the 
addictive potential of opioids if a patient had true pain. Although 
well intentioned, many doctors have unwittingly contributed to soaring 
opioid use * * * so much so that enough opioids are prescribed each 
year to provide every adult in the United States a 4-week round the 
clock supply of Vicodin.
    I know that you are well aware of the devastating consequences of 
this epidemic on America's families. We have lost far too many lives--
more than twice the number of Americans as have died in the Vietnam, 
Iraq and Afghanistan wars combined--and these deaths are the tip of the 
iceberg. Although there are many contributors to this epidemic, a core 
problem is that doctors and patients continue to overestimate the 
benefits of opioids and underestimate their risks.
    In my testimony, I would like to mention three important steps to 
address this problem. I will also discuss several popular ideas that I 
am concerned may take our eyes off the ball.
    First, we need to continue to improve prescribing practices. Best 
practices for opioid use have been described--including cautious use 
with longer durations or higher doses, limiting the use of fentanyl 
patches and methadone for pain, incorporating multidisciplinary pain 
management teams, and avoiding the combination of opioids with 
medicines such as benzodiazepines. These approaches are especially 
vital among patients with comorbid conditions such as mood disorders, 
Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI) or 
substance use, since high-risk opioid use and adverse outcomes are both 
more common among these patients.
    To improve practices, it is also vital that we continue to improve 
the measurement and accessibility of data about opioid utilization and 
prescribing at a patient, provider, clinic and health system level. 
Such measurements allow for benchmarking and enhance our understanding 
of practices contributing to opioid misuse and overdose deaths.
    Second, we need to help people who are addicted to opiates access 
effective treatment. Treatment with the medicines buprenorphine and 
methadone is the most effective means of helping individuals regain 
control of their lives and avoid death by overdose, yet despite over 5 
million Americans with opioid dependence, fewer than 1 in 5 are 
receiving available treatments due to low provider interest and a 
variety of regulatory and payment barriers.
    Third, we need to vastly expand opportunities for people to get rid 
of opiates that they do not need. It is stunning that these drugs are 
so easy to get, yet so difficult to get rid of. There are literally 
millions of pounds of unwanted and unused medicines sitting in kitchen 
drawers, bathroom cabinets and bedroom nightstands all over America. 
The DEA recently finalized its rules regarding the disposal of 
controlled substances, and properly implemented, I believe that these 
``take back'' programs can serve an important role in reducing opioid-
related injuries and deaths.
    Other risk mitigation methods such as patient contracts, risk 
assessment tools and urine testing are increasingly common. Despite 
their appeal, the scientific evidence to support them is limited. 
Although some of these approaches, such as urine testing, may be 
reasonable to routinely implement in clinical practice, such measures 
do not reduce the addictive potential of these products, nor do they 
change the overall unfavorable risk/benefit balance of them for many 
current opioid recipients.
    The FDA and manufacturers are also pursuing so-called ``abuse 
deterrent formulations'' to reduce the chance a particular product will 
be misused. These formulations should also be regarded with caution. 
While these re-engineered medicines are designed to thwart abuse, their 
active products are no less addictive, and most individuals who abuse 
or are addicted to opioids swallow them whole. Moreover, our research 
suggests that prescribers may have important misconceptions regarding 
their safety. In short, I am not convinced that we can engineer our way 
out of this problem.
    Some have framed efforts to reign in runaway prescribing as a 
threat to quality of care for those with chronic pain. As a practicing 
physician, I can assure you, nothing could be further from the truth. 
An overwhelming amount of evidence supports the compatibility of 
effective pain treatment with reducing opioid prescribing. High quality 
care for patients in pain isn't jeopardized by such efforts, it demands 
it.

    Thank you for the opportunity to testify today. I look forward to 
your questions.

    Senator Blumenthal. Thank you, Doctor.
    Dr. Forster.

STATEMENT OF CAROL FORSTER, M.D., PHYSICIAN DIRECTOR, PHARMACY 
   & THERAPEUTICS/MEDICATION SAFETY, MID-ATLANTIC PERMANENTE 
                MEDICAL GROUP, KAISER PERMANENTE

    Dr. Forster. Good morning, Mr. Chairman. I should say 
Ranking Member Blumenthal and the Committee Members. Thank you 
for the invitation to be here today. I am Dr. Carol Forster, 
Physician Director of Pharmacy and Therapeutics and Medication 
Safety for the Mid-Atlantic Permanente Medical Group, one of 
the regions of Kaiser Permanente which is a national health 
program.
    It is the largest private integrated health care program in 
the United States, a private integrated health care program, I 
should say, providing comprehensive care to over 9.5 million 
members in eight States and the District of Columbia. We have 
over 500 pharmacies, 38 hospitals, and more than 170,000 
employees, and we partner with over 17,000 physicians.
    Our health care organization has been focusing on improving 
overall pain management services and appropriate prescribing 
for several years. The impact of narcotic abuse and over-use is 
felt by every sector of health care in every community. Our 
integrated electronic medical record and targeted prescribing 
reports have allowed us to identify potential non-medical use 
of prescription narcotics, even in those with a history of a 
chronic pain condition.
    I would like to tell a story of a patient named Robert. 
Robert was diagnosed with a spinal injury after a motor vehicle 
accident in 2012. Since that time, he has been referred to 
several specialists and has received treatment, including 
surgery on his spine.
    During the post-op period, Robert was soon identified as 
possibly depressed and drug-seeking. He had requested more 
medication and in higher doses from his surgeon as well as 
several other emergency room physicians. Subsequent involvement 
of his primary care physician and pain management team, as well 
as review of pharmacy reports, led to identifying that Robert 
was actually visiting ERs and multiple providers every week, 
many outside of Kaiser Permanente, and was not being truthful 
about his reasons for requested medications.
    He was quickly referred to our specialist in behavioral 
health and addictionology and weaned off of all narcotics 
safely and received counseling and continued treatment for his 
depression and his chronic pain conditions.
    National statistics showing the direct relationship between 
increasing deaths from narcotic overdose and increasing sales 
of narcotics in the U.S. have helped to motivate Kaiser 
Permanente to develop a national narcotic drug use initiative 
and aggressive monitoring program.
    First, we have supported, developed, and communicated 
comprehensive continuing education programs for our physicians 
on the subjects of pain management, appropriate opioid 
prescribing, narcotic abuse, and diversion. As our physicians 
develop a comprehensive treatment plan for patients with 
chronic pain, they focus initially on alternatives to opioid 
therapy.
    If they do prescribe opioids, it is recommended that a 
narcotic agreement between patient and doctor is used which 
clearly defines goals and conditions of therapy. They will then 
reassess the patient periodically for effectiveness, adverse 
affects, and other risk behaviors. If there is evidence of 
narcotic ineffectiveness or any concerns of misuse, an exit 
strategy is developed to effectively and safely wean the 
patient from the drug. Clear and understandable patient 
education from the beginning as far as expectations of 
treatment is essential.
    Second, using our integrated delivery approach and 
electronic medical record system that provides clinical 
decision support, we generate reports on individual physician 
prescribers patterns and compare them to others in the same 
specialty.
    When physicians and pharmacists understand the bigger 
picture that good data can provide, prescribing behavior often 
does change. We also have started to look at groups of datasets 
known as drug-seeking behavior reports that we believe have 
potential to identify patients at risk using various datasets 
such as those filling prescriptions at multiple pharmacies, 
those having multiple prescribers, those using high doses, and 
those having infrequent in-person visits with their physician.
    Third, we avail ourselves of outside resources, especially 
those of the State prescription drug monitoring programs, that 
allow us to share data and know when Kaiser Permanente patients 
seek prescriptions outside of our system. Our involvement also 
allows us to be part of the larger community in response to 
problems of over-use and abuse.
    Fourth, our entire 75-year history at Kaiser Permanente is 
one of physician leadership and group problem-solving. Our 
regions have developed multi-specialty chronic pain boards to 
review difficult and complex cases and offer recommendations to 
individual physicians. Local Kaiser Permanente physicians and 
pharmacists have also organized interdisciplinary work groups 
to address systematic problems of opioid use and to improve 
care.
    Thank you for inviting me to testify before the Committee 
today. I hope this information will be helpful as you 
understand and address narcotic use and over-use in VA 
hospitals and the communities they serve.
    [The prepared statement of Dr. Forster follows:]
   Prepared Statement of Carol A. Forster, M.D., Physician Director, 
  Pharmacy & Therapeutics/Medication Safety, Mid-Atlantic Permanente 
         Medical Group, Kaiser Permanente Medical Care Program
    Thank you for the invitation to be here today; it is an honor to be 
able to share our experiences with you. I am Dr. Carol Forster, 
Physician Director of Pharmacy and Therapeutics and Medication Safety 
for the Mid-Atlantic Permanente Medical Group at Kaiser Permanente. I 
received a pharmacy degree from Saint John's University College of 
Pharmacy in New York and a medical degree from the State University of 
New York School of Medicine at Buffalo. I also have received training 
as a Patient Safety Officer at the Institute for Healthcare 
Improvement. I have used my background in pharmacy and medication 
safety to develop and augment several programs within Kaiser Permanente 
related to improving the appropriate prescribing of narcotics.
    I am testifying today from my perspective as a clinician and expert 
on medication safety and also on behalf of the national Kaiser 
Permanente Medical Care Program, the largest integrated healthcare 
delivery system in the United States, which provides comprehensive 
healthcare services to over 9.5 million members in eight states 
(California, Colorado, Georgia, Hawaii, Maryland, Oregon, Virginia and 
Washington) and the District of Columbia.
    We hope the information we share today about the programs Kaiser 
Permanente has established will provide additional resources to help 
the Committee further understand and address narcotic overuse and/or 
abuse in VA hospitals and the communities they serve.
           background: the problem of narcotic overuse/abuse
    Controlled substance use has been subject to significant scrutiny 
in recent years, as the mortality from narcotic overdoses has increased 
proportionally to the sales of prescription narcotics.\1\ These types 
of statistics along with the disproportionately high volume of narcotic 
prescriptions in the United States,\2\ and other data showing worldwide 
increases in fraud, addiction, and abuse of narcotics motivated our 
organization to develop aggressive monitoring programs and mechanisms 
to assure that 1) we are providing the most appropriate care to our 
patients with chronic pain; and 2) we are doing whatever we can to 
reduce the likelihood of inappropriate narcotic use in our Program and 
in our communities.
---------------------------------------------------------------------------
    \1\ http://www.cdc.gov/homeandrecreationalsafety/rxbrief/
    \2\ 80% of the world's narcotic use for 5% of the world's 
population
---------------------------------------------------------------------------
    Narcotic medications are most often prescribed to treat chronic 
pain. According to a 2011 Institute of Medicine study, this condition 
is widespread, affecting 100 million Americans.\3\ Forty-two percent 
have pain lasting over 1 year; 33% report their pain as disabling. Pain 
also drives utilization nationally, accounting for up to 20% of 
outpatient visits and representing a $600 billion annual cost.\4\
---------------------------------------------------------------------------
    \3\ Compared to 26 million individuals with diabetes, 16 million 
with coronary heart disease, and 12 million with cancer
    \4\ Includes direct healthcare expenses and indirect costs, such as 
lost income and lost productivity
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                      kaiser permanente: overview
    Standard and established principles for appropriate opioid 
prescribing are used in all Kaiser Permanente regions. These include: 
appropriate patient selection, initial patient assessment, and 
development of a comprehensive treatment plan focusing initially on 
alternatives to opioid therapy when indicated. When opioid medication 
is prescribed, it is important to establish and document effectiveness 
upon reassessment, as well as identifying an exit strategy if therapy 
does not achieve pain reduction within a desired/expected period of 
time. Patient education during this process is critical to success. 
Physicians are encouraged to regularly assess the ``Four A's'': 
analgesia, activity, adverse reactions, and aberrant behavior.
    Program-wide efforts to reduce the volume of patients taking high-
dose narcotics for chronic non-cancer pain and to combat fraud, waste, 
and abuse of controlled substances have been instituted for the past 
several years. These efforts evolve appropriately to incorporate state 
and national laws and clinical guidelines and reflect our own best 
practices. Complex patients who are difficult to manage can usually be 
recognized early in the course of treatment, by exhibiting patterns 
that alert physicians to risks. When there are indications of drug-
seeking behaviors, physicians can also seek additional consultation 
from internal Fraud, Waste, and Abuse Special Investigations Units if 
needed.
    Using our integrated health system we have been able to establish 
baseline data to understand our opportunities for improving narcotic 
use and set specific goals. One region set a goal to decrease the 
percentage of patients receiving chronic high-dose chronic narcotic 
therapy (120mg or more morphine equivalent doses per day or MEDD) by 
25%. Most recent data show a 29% reduction, mostly through providing 
improved feedback to physicians, using other non-pharmacologic pain 
therapies, and establishing a team of regional pain management experts.
    We set more overarching goals: to improve overall management of 
patients with chronic pain, to augment resources internally, and to 
refer chronic high utilizers to appropriate therapy in an effort to 
wean or discontinue narcotics due to lack of effect.
    We also widely communicated clear and concise protocols and 
established multiple education programs to ensure physicians and 
pharmacists were aware of the specific actions they should take when 
they suspect inappropriate prescription narcotic use. These protocols 
are consistent with existing pharmacy policies regarding controlled 
substance dispensing. Requests to refill too soon, multiple requests 
for more medication, missed appointments, multiple prescribers 
(internal and external to Kaiser Permanente), and multiple pharmacy 
locations are patterns and behaviors that alert our staff and 
physicians to investigate further before any drug orders are sent. 
Multiple continuing education programs are offered in all regions to 
refine and reinforce these actions expected of healthcare providers.
    As we work to address medication issues, we have been able to take 
advantage of our integrated delivery system to provide data and 
feedback to prescribers and to understand how patients with chronic 
pain are managed. Most pharmacy, diagnostic, and laboratory services 
delivered to Kaiser Permanente members are performed within Kaiser 
Permanente. We have also made a significant investment in developing a 
secure Electronic Health Record (EHR) system. The system includes 
functionality that helps to improve medication safety and reduce 
errors, such as automated clinical decision support for adverse drug 
event prevention, drug-allergy checking, and medication adherence 
monitoring. The EHR enables coordination across the care delivery 
spectrum, including primary care, inpatient and specialty care, 
pharmacy, laboratories, etc., providing opportunities to manage drug 
utilization, including being able to closely monitor narcotic use.
    Kaiser Permanente recognizes that several states have also 
established improved monitoring and methods to detect inappropriate 
prescribing. Arizona, Massachusetts, New York, New Jersey, Kentucky, 
and Tennessee are among states that have instituted detailed mechanisms 
to provide feedback to prescribers, and on occasion law enforcement 
and/or licensing boards when state prescription drug monitoring program 
(PDMP) data reveal suspicious prescribing patterns.\5\ For example, 
prescribing large quantities/large volumes of opioids, prescribing 
unsafe combinations, and prescribing more frequently than expected by 
that medical specialty will prompt an investigation in states employing 
this type of monitoring.
---------------------------------------------------------------------------
    \5\ www.pdmpexcellence.org/sites/all/pdfs/Brandeis_PDMP_Report.pdf
---------------------------------------------------------------------------
              clinical leadership and physician education
    Physician leaders and other clinicians in various Kaiser Permanente 
regions have formed local workgroups to address the complex problems 
related to narcotic prescribing for chronic pain. In the Mid-Atlantic 
region, a Chronic Pain Workgroup was convened in May 2012 as part of 
our overall strategy to address narcotic overuse in our local 
communities. This workgroup focused on developing a strategy to further 
enhance our efforts to assure appropriate prescribing and dispensing of 
controlled substances. Interdisciplinary experts came from Pharmacy 
Operations, Clinical Pharmacy, Pain Management, Adult Primary Care, 
Behavioral Health, the Regional Spine Service Behavioral Health, 
Surgical subspecialties, and Addictionology.
    The workgroup met frequently over a period of about six months to 
revise existing protocols and policies, create tools in our EHR related 
to appropriate care of chronic pain, and agree upon appropriate 
reporting to monitor use. The workgroup also revised goals for our 
continuing education programs for physicians and pharmacists.
    Many of our efforts focus on prescriber education and on supporting 
improved management of chronic pain treatment and non-pharmacologic 
pain therapies. We offer continuing medical education (CME) courses 
that cover pain management clinical guidelines as well as detection and 
prevention of abuse, diversion, and fraud. We have developed a 
comprehensive chronic pain order set with clinical references, 
appropriate doses for various medication orders, lab orders including 
urine drug testing, patient instruction sheets, narcotic agreements, 
and multi-specialty referral resources to improve narcotic prescribing 
and management at the point of care.
                           chronic pain board
    A number of Kaiser Permanente regions have established regional 
Chronic Pain Boards to review difficult and complex cases by referral 
as well as cases that meet criteria for review. Such Boards typically 
will have physicians from a number of related specialties, such as Pain 
Medicine, Interventional Pain, Anesthesia, Addictionology, Psychiatry, 
Clinical Pharmacy, Medication Safety, and potentially others including 
primary care providers (PCPs) and any specialists involved in cases 
under review. The Board review process includes discussion of each 
case, developing customized therapy goals, providing recommendations to 
the primary care provider, and documenting a plan for treatment.
                         the importance of data
    Reliable information is also critical to understand and manage 
narcotic pain medication and chronic pain treatment. Our Pharmacy 
Analytics Department is able to generate reports based on specific data 
elements and patient populations. For the last several years, our 
regions have established national and local prescribing reports to 
monitor appropriate use of opioids and controlled substances. 
Prescriber feedback reports give specific information regarding 
individual physician prescribing patterns, including quantities 
prescribed, average MEDD and how one physician's prescribing might 
compare to another in the same specialty.
    We can sort by patient, provider, specialty, facility, and can see 
all filled prescriptions, including external pharmacies if paid for 
using the Kaiser Permanente drug benefit. There are also reports that 
focus on unsafe combinations of drugs used, for example, a ``triad 
report'' was created to detect when carisoprodol (a muscle relaxant), 
oxycodone or hydrocodone (a narcotic), and a benzodiazepine such as 
lorazepam (an anti-anxiety drug) have been prescribed concurrently for 
the same patient.
    More recently, our Program has developed a ``drug-seeking 
behavior'' report for all regions. By using a group of selected data 
sets, we can calculate a score for patients that meet several criteria 
associated with such behaviors. Multiple pharmacies, multiple 
prescribers, high doses, infrequent in-person visits with their doctor, 
etc., are examples of some of the data elements used in scoring. We are 
also able to separately identify and report any patients who meet a set 
of specific criteria, for example: 4 or more prescriptions, 4 or more 
pharmacies, AND greater than 120mg MEDD in a 90-day period. We can also 
look at subgroups, such as Medicare patients.
    In most regions, we have required our prescribing physicians to 
register with their state prescription drug monitoring program (PDMP). 
Kaiser Permanente pharmacies provide the required controlled substance 
dispensing data to the state prescription monitoring programs. The 
PDMPs are invaluable as they allow us to see which patients fill 
external prescriptions even if they are not using their Kaiser 
Permanente drug benefit. These state programs along with our own 
internal reporting have enabled us to review in a comprehensive way all 
the controlled substances the patient may be receiving both inside and 
outside of the Kaiser Permanente facilities.
    Providing actionable data is the key to uncovering and addressing 
suspicious patterns of narcotic use. Feedback is given to physician 
leadership when indicated, with individual messaging to prescribers if 
their patients have been identified as high-utilizers or suspected of 
drug seeking.
                   centralized information resources
    Making information available in one place is also important. We 
have established an online secure site to post important references for 
the Chronic Pain Workgroup as a single site resource, where documents 
and presentations, including those from other Kaiser Permanente regions 
and external sources are posted. These resources can be accessed by 
members of group and other interested parties. We are also developing a 
KP Program-wide Chronic Non-Cancer Pain web page, accessed through our 
National online Clinical Library, to contain resources for all 
healthcare providers.
                               conclusion
    In summary, we continue to take specific steps, as we have 
described here today, to combat the increased problem of narcotic 
overuse and abuse in our communities.
    We are committed to aligning ourselves with other institutions that 
face problems of narcotic overuse and abuse. Our efforts to date that 
have helped us achieve reductions in use include:

     Implementing recognized, well-established national, state 
and local principles and clinical guidelines throughout our program;
     Engaging our prescribers in PDMP registration in their 
states;
     Maintaining a continued focus on education and awareness 
for pharmacists and physicians;
     Supporting clinical leadership and community engagement in 
addressing problems of narcotic overuse;
     Monitoring targeted prescribing and drug-seeking behavior 
reports, based on pharmacy analytic data and our EHR system; and,
     Establishing expert consultative Chronic Pain Boards for 
review of difficult cases and making referrals to recommended 
subspecialists when necessary to improve the care of the patient.

    Through these internal programs, we have achieved improvements in 
managing narcotic prescribing and limiting the use of unsafe 
combinations of medications. We will continue to work closely with our 
local, state, and national organizations as we strive to decrease the 
morbidity and mortality associated with narcotic overuse and abuse in 
the U.S.

    Thank you to the Committee for the opportunity to provide this 
testimony. I would be happy to respond to questions.

    Senator Blumenthal. Thanks, Dr. Forster.
    Mr. Gadea.

   STATEMENT OF JOHN GADEA, DIRECTOR, DRUG CONTROL DIVISION, 
         CONNECTICUT DEPARTMENT OF CONSUMER PROTECTION

    Mr. Gadea. Good morning, Ranking Member Blumenthal, Senator 
Baldwin. My name is John Gadea. I am the Director of State Drug 
Control. I am also a pharmacist. For you who do not know what 
we do, we monitor the entire pharmaceutical industry from 
manufacturer to the patient. We do that through various 
compliance inspections, and when something goes away from that 
route, we also investigate it.
    We have been doing that for over 40 years. I personally 
have been involved in it for over 30. In addition to that 
responsibility, the Division is also home to the Connecticut 
Prescription Monitoring program, the Connecticut Medical 
Marijuana program, and we are also home to the board 
administrator for the Commission of Pharmacy.
    We are going to primarily focus in on the Prescription 
Monitoring program. With the backing and help of, at the time, 
Attorney General Blumenthal, and the Commissioner at the time, 
we went live in July 2008 with our Prescription Monitoring 
program and we require all pharmacies and hospital outpatient 
pharmacies to be uploading data into the system.
    We gave them between 3 and 4 months to have their system in 
order to be able to upload that data. We followed a sequence of 
access. The access was primarily, and first, given to 
physicians to access the system, followed by pharmacists and 
eventually followed by law enforcement. This was in keeping 
with the program's goal of having the actual Prescription 
Monitoring program be, first and foremost, a health care tool, 
and we wanted them to have that access.
    The third major group is law enforcement as well as the 
folks in my unit and they came on board substantially sometime 
further down the road.
    I would like to underscore that fact, that physicians and 
prescribers are key to it, and that is that the system is there 
to provide better health care, and in order to provide that 
better health care, you have patients that, unfortunately, as 
part of their treatment, have to receive certain regimens that 
include controlled substances.
    What happens is, what we started learning is that various 
groups on both sides of the issue identify that because you 
have a large quantity of drugs, you are a drug abuser. What we 
found is that you are not really a drug abuser, most of the 
time. You are a drug misuser and you have been placed in a 
situation that, either between your own actions as a patient or 
because of problems in drug management or health care 
management, you now have this problem.
    I would also point out that working with addictionologists 
in the course of our investigations that many times that is the 
symptom of the problem and not so much the problem in and of 
itself. After hearing this issue discussed today and in other 
times where this issue has come up, not just with the VA, but 
with any health care system we must ask of the problem we are 
talking about is the addiction of the patient or is the 
prescribing of those products the symptom of a greater issue 
that is not really going to be addressed? If it is not 
addressed, all the efforts you put into correcting what you are 
going to try and correct may not really give us a solution that 
we want.
    We find that the program works best when it is tied to a 
robust educational program and we have done several things to 
increase that usage of the program through education. We 
recently included morphine milli-equivalents on our program 
reports that give a good benchmark to physicians based on 
Substance Abuse and Mental Health Services Administration 
(SAMHSA) data, whether they are approaching the high end of 
prescribing.
    The problem in Connecticut is that we have a VA that does 
not upload data into our system. It provides relatively a Swiss 
cheese approach to data. It does not help anybody. We have 
tried having these discussions at the request of physicians in 
the VA system, and at one point, we went down to speak to those 
physicians and were told by the privacy officer, who is no 
longer there, to never discuss that with their physicians, 
leave the premises immediately and do not return.
    Since then, physicians have been given access to the 
system, which is very, very, good. But currently, we do not 
have their data being uploaded and that presents a problem 
because we are a small State and sometimes patients from the VA 
wind up in emergency rooms or getting health care outside of 
there and it is not beneficial to, at that point, look up a 
patient that you are trying to take care of and you do not know 
the complete picture.
    I have submitted written testimony. I would like to thank 
you for the time to present this information and I look forward 
to answering any of your questions or comments. Thank you.
    [The prepared statement of Mr. Gadea follows:]
 Prepared Statement of John Gadea, Jr., Director of State Drug Control 
   Division, Department of Consumer Protection, State of Connecticut
    I am John Gadea, Jr., RPh, Director of State Drug Control Division, 
Department of Consumer Protection for the State of Connecticut. I am 
honored to appear before this Committee.
    The Drug Control Division oversees the entire pharmaceutical 
industry from manufacturer to patient and includes wholesalers, 
pharmacies, prescribers, dispensers and any location where drugs may be 
purchased, dispensed or stored. This involves performing compliance 
inspections. The Division also investigates the loss and diversion of 
all drugs, including controlled substances from the state's registrants 
and healthcare professionals. This is all accomplished with 12 agents, 
all of whom are pharmacists, and two of whom are supervisors.
    In addition to the described responsibilities, the Division also is 
home to the Connecticut Prescription Monitoring Program, the 
Connecticut Medical Marijuana Program, and the Board Administrator to 
the Commission of Pharmacy.
    The Connecticut Prescription Monitoring Program, also known as the 
Connecticut Prescription Monitoring and Reporting System (CPMRS), went 
live on July 1, 2008. Shortly after going live, pharmacies and hospital 
outpatient pharmacies began uploading data into the system. All these 
entities were afforded three months to modify their systems to be able 
to upload their controlled substance data into the CPMRS.
    Soon after the upload process was completed by the pharmacies, 
access was afforded to prescribers, pharmacists and law enforcement 
under certain conditions. We followed the sequence of authorized access 
to the system by allowing prescribers access to the system first, 
followed by pharmacists. This was in keeping with the program's goal of 
providing better care to patients by enabling health care professionals 
to have access to their patients' controlled substance history. Law 
enforcement was the last of the major user groups to be given access to 
the system.
    I would like to underscore that first and foremost this system can 
attain the most by encouraging the prescribers and pharmacists to use 
the system to provide better healthcare to their patients. Many 
patients being treated for a condition may, as part of the treatment, 
use controlled substances. Some patient profiles may display large 
quantities of medications or the use of several different prescribers 
or pharmacies; that alone may appear to be indicative of some type of 
fraudulent activity. Often, we find that these patients are categorized 
as drug abusers when, in reality they are misusers of the medications. 
Their misuse is either a result of their own actions or that of the 
prescribers, through lack of proper medication management or lack of 
total healthcare management.
    The end result of this increase in the pool of `drug abusers' is 
that it creates an increased workload on law enforcement and strains 
the criminal justice system, when in fact, many of these cases could 
have been handled as a healthcare event. Law enforcement should not 
have to use their valuable resources to manage the result of poor 
healthcare.
    We believe the Connecticut Prescription Monitoring Program is at 
its best when combined with a robust education program. The education 
is directed at prescribers and pharmacists on the use of the system; 
and on prescribers, pharmacists and the public on prescription drug 
abuse. Collaborations with associations such as the Connecticut Medical 
Society and the Connecticut Pharmacists Association are critical to the 
program's educational completeness.
    Knowing the type of disastrous situations that can arise from 
prescription drug abuse and misuse we believe that it is critical for 
the prescribers and pharmacists to have accurate, timely and complete 
information at their disposal that allows them to make those needed 
decisions affecting their patients' well-being. This is what we try to 
achieve with the CPMRS. There are times though, when we are not able to 
provide this program in the form that we believe it should be.
    The problem of not providing a complete data set to both 
prescribers and pharmacists on their patients can be illustrated by the 
lack of data being uploaded into the CPMRS by the U.S. Veterans 
Administration (``VA''). The VA out-patient pharmacies and the VA mail-
order pharmacies perform a valuable function in the care of our 
veterans. While a number of veterans receive the bulk of their 
healthcare from within the VA, many of these same veterans have 
physicians both in the VA system and in their communities. They also 
have some prescriptions dispensed from their local pharmacies. Only 
recently have the prescribers in the VA been allowed to access the 
CPMRS and, while this is a desirable situation, it is incomplete 
because it does not contain the uploaded controlled substance 
information from within the VA Healthcare system. That VA system 
prescription information would be extremely beneficial to the community 
prescribers and pharmacists. It should be further noted that any 
admittance to a non-VA hospital or emergency room without this 
information being included in the patient's controlled substance 
history could be detrimental to the health of the veteran.
    In the past, physicians in the VA Healthcare system have resorted 
to gaining access to the CPMRS by using their own computers or 
performing the patient reviews from an off campus location. Being 
invited on to the VA campus to explain the CPMRS resulted in the 
program manager and me being instructed to leave the campus, not to 
discuss our system with VA practitioners and not to return. Although 
Federal law was eventually changed allowing VA Healthcare system 
prescribers to access the system, it was not until in 2013 that we 
received a call from the VA in Connecticut indicating that 
practitioners were allowed to register in the CPMRS and the VA Central 
Office in Washington, DC, would perform the uploading of data. As of 
today, no uploads into the CPMRS have occurred. It is of great concern 
that the state of Connecticut can access the data from 17 other states 
in addition to the 684 in-state and 872 out-of-state pharmacies but it 
cannot access the data from two campuses located within the boundaries 
of the state.
    To this point in this testimony I have described the system as a 
healthcare tool for both prescribers and pharmacists, but there are 
those individuals who go beyond what healthcare care providers can 
correct or control and it becomes a law enforcement matter. The CPMRS 
is a valuable tool for certain members of local, state and Federal law 
enforcement that have been specifically authorized by my agency to use 
the system. Many of the comments regarding prescription-monitoring 
programs revolve around the detection of ``doctor shopping.'' While 
this is a major problem, doctor shopping is only one form of diversion. 
Forgeries and false call-ins of controlled substance prescriptions can 
only be detected by the prescriber who supposedly prescribed the drugs; 
therefore we encourage prescribers to review their own prescribing 
history using this system. Prescription monitoring programs also offer 
an invaluable tool in the detection of economic fraud committed by 
prescribers, pharmacist, pharmacies and patients. As a result, agencies 
such as the Connecticut Department of Social Services and the U.S. 
Department of Health and Human Services have recouped fraudulent 
claims. Additionally, my agency along with the Connecticut Department 
of Public Health and the U.S. Drug Enforcement Administration have just 
completed a case against a midlevel practitioner that has resulted in 
the surrender of Federal and state controlled substance registrations. 
The same practitioner was recently identified as one of the top ten 
prescribers of controlled substances in the country. Other agencies 
utilizing the system include the FBI, the Office of the Connecticut 
Chief State's Attorney, the Connecticut State Police, and numerous 
local police departments.

    Thank you for providing me this opportunity to present this 
information to you. I would be happy to respond to any questions you 
have today.
    Following that, please feel free to contact me or Commissioner 
Jonathan Harris if you have any additional questions or comments.

    Senator Blumenthal. Thanks, Mr. Gadea. Before I turn the 
gavel back to Senator Isakson, let me just say all of your 
written testimony, if you wish, will be made a part of the 
record without objection. Senator Isakson.
    Chairman Isakson. In order for Senator Isakson to get re-
organized, I am going to leave the gavel with you for just a 
minute, sir, for your questions first.
    Senator Blumenthal. Thank you. Mr. Gadea, let me begin by 
asking you about the real life consequences of the Swiss 
cheese, as you have aptly described it, and I described it in 
the same way earlier, in terms of the gaps between the State 
Prescription Monitoring program and the Federal VA system for 
tracking and monitoring prescriptions.
    You mentioned the potential emergency room visit where the 
emergency room doctor would have no knowledge about what the 
prescriptions were from VA doctors. There are also law 
enforcement consequences, are there not?
    Mr. Gadea. Yes. Law enforcement has access to our system 
for specific cases. They have to have an open case number. 
Because we are a small State and there are a lot of patients 
that are outpatients in the VA system, they are in the 
community and they are receiving products, medications from 
both inside the VA and outside the VA.
    They are filling those prescriptions in pharmacies. 
Pharmacies are the first trip wire to identify that something 
is not right. It becomes extremely difficult if that trip wire 
has been cut, in this case, and that dovetails into the first 
thing that the pharmacy will do is contact local narcotics 
division, Statewide narcotics, and they are at a loss because 
you then have to go and search manually.
    We have 684 pharmacies in the State. It becomes very 
difficult, even by phone call, to do that search. It is not 
very efficient to have a system which is only being fed 
partially.
    Senator Blumenthal. As I know because I was Attorney 
General and did a number of these cases. There have been both 
civil and criminal prosecutions resulting from the excellent 
work done by your program.
    Mr. Gadea. The Department of Social Services combined with 
the U.S. Health and Human Services, use the system to recoup 
fraudulent claims. We work closely with the U.S. Drug 
Enforcement Administration and the compliance folks. And we 
recently had a case where we used this system to identify 
someone, conduct a case, and we have just received the 
surrender of their controlled substance registration, both at 
the State and Federal level.
    That case was rather important because they were also 
identified on Centers for Medicare and Medicaid Services (CMS) 
listing as one of the top ten prescribers in the country.
    Senator Blumenthal. Uploading this information from the VA 
to the State system, in other words, complete connectivity 
would aid not only better treatment, but also law enforcement 
that would save taxpayer dollars?
    Mr. Gadea. Oh, absolutely. Even at the health care level, 
we can currently share data with 17 other States. We have 
uploads of data from approximately 800 out of State pharmacy 
providers and over 600 in-state pharmacy providers. We do not 
have the Newington VA and we do not have the West Haven VA able 
to complete the picture.
    Senator Blumenthal. Dr. Alexander, there was a question 
earlier, and I think you were here, about possible alternative 
ways of treating pain. Could you comment on the potential 
alternatives for treating Post Traumatic Stress and pain 
associated with it or other means of alternative treatments for 
pain that might be as effective or more so and far less 
dangerous in terms of the potential side effects of addiction 
and dependence?
    Dr. Alexander. Thank you for the question. There are lots 
of different treatments for both post-traumatic stress disorder 
as well as pain, and these treatments include both 
pharmacologic and non-pharmacologic approaches. Unfortunately, 
at times prescribers over rely on prescription drugs and 
underutilize non-pharmacologic approaches that, in the case of 
pain, may include physical therapy, massage, biofeedback and 
acupuncture.
    To some degree the optimal approach depends upon the type 
of pain, since different treatments work variously well for 
different types of pain. There was a comment earlier regarding, 
for example, the difference between visceral and non-visceral 
pain. I think that these are important to keep in mind and 
these alternative approaches tend to be under-used.
    It is also important to note that we have less information 
than we would like about the long-term safety and effectiveness 
of some of the pharmacologic treatments and alternatives to 
opioids. But given the well-demonstrated serious adverse events 
associated with opioids, I think that overall, their risk/
benefit balance is unfavorable for many, many current users.
    Senator Blumenthal. Thank you. Unfortunately, my time has 
expired and since Senator Isakson is here and since he is the 
Chairman, I am going to yield to him and just say I have many 
more questions. I am going to submit them. I apologize, Dr. 
Forster, that I did not get to my questions for you. I have 
other questions for the additional witnesses.
    This panel is extraordinarily useful and expert and I 
really want to thank you for being here today. We are just kind 
of denting the surface of the immense resource in terms of 
knowledge that you have to help us, and I really am very 
grateful to you for being here and your continuing help to the 
Committee. Mr. Chairman.
    Chairman Isakson. Thank you, Senator Blumenthal, and I 
appreciate very much the panelists being here and apologize 
that I had to go to the floor to present an amendment. That was 
part of the process I could not avoid today.
    Maybe I will cover Dr. Forster's question that you had 
anyway, because in reading the testimony, one of your regions 
at Kaiser-Permanente realized a 29 percent reduction in the 
prescription of opioids, and in your remarks, you pay credit to 
that. You say this was primarily a result of improved feedback 
to physicians. What does your feedback system entail and how 
are providers kept accountable, held accountable should they be 
over-prescribing opiates at a much higher rate than normal?
    Dr. Forster. Thank you for the question. I actually will 
correct that. We just got our newest report yesterday and it is 
now 33 percent.
    Chairman Isakson. It is the right direction.
    Dr. Forster. Thank you for asking. This region specifically 
is actually the Mid-Atlantic region, which is my region. What 
we do have is, I think, a really amazing level of reporting 
regarding narcotic use. We have been using it since the end of 
2011.
    I helped work on getting it to the right level of reporting 
that would be useful to a physician and actionable to a 
physician so we are able to see, you have already mentioned, 
the morphine equivalent doses per day which is very important 
as far as severity or risk severity as well as the amount of 
drug they are taking across all different types of drugs.
    We have MEDs on our report. We also have the days supply 
that is being given. We have, of course, the physician, the 
prescriber, and who the primary physician is. We have also done 
combination reports. We call it a ``triad report.'' We look at 
the combinations of benzodiazepines, narcotics, and 
Carisoprodol which is a muscle relaxant that on the street is 
actually part of the ``trinity'' or ``holy trinity,'' as it is 
called, used to achieve the best ``high.''
    These kinds of combinations are very important for us to 
know about and our physicians may not be aware that there is 
concurrent prescribing. Of course, now more physicians are 
using the Prescription Monitoring Program (PMP) as another 
aspect of the report that is tied into the prescriber feedback.
    We also have a new report which is almost a year old now, 
and that is a drug-seeking behavior report. It is not meant to 
put any blame on the patient, but it is meant to identify 
behaviors that seem to be or have a potential to be drug 
seeking.
    It shows us that, for instance, a patient may not have had 
a visit with their provider for many months, as well as have 
had multiple providers prescribe a narcotic or have had visited 
multiple pharmacies, both inside and outside of Kaiser, to get 
that prescription. Those are hallmarks or red flags to us that 
there is a problem.
    These types of reports are--I mean, I can go into much more 
detail about it, but it would take a long time. I have 
presentations on these types of reports. We really feel that 
they really have helped all of us, the pharmacists, the 
physicians, and even our patients understand that appropriate 
monitoring is the best way to really take care of the patient.
    I think it has already been mentioned before, our 
physicians are also receiving a lot of education as well. In 
addition to receiving those reports, they are receiving much 
education on appropriate prescribing. You cannot give just a 
report. You need to educate as well.
    From the very beginning, we have been adding education 
along with giving that report and have initiated mandatory 
training, and mandatory registration for the state PMPs. I 
think all States except one, I believe, now have PMPs in place. 
I think D.C. is about to start theirs at the end of this year. 
So pretty soon we will be able, in all of our regions, we will 
be able to have PMP access for everyone.
    Chairman Isakson. If, by virtue of the information you are 
collecting, you find one of your providers prescribing at a 
much higher rate than others, what do you do to hold them 
accountable?
    Dr. Forster. Well, that is one of my roles. I work with 
that physician and their chief of service or their leader in 
their local facility and give them the data they need to show 
that there has been variant prescribing and we try to take 
action along with them, help them identify resources for the 
patient.
    Part of the electronic medical record we use has what they 
call ``smartsets'' which provide decision support at the point 
of care. We encourage the physicians to understand all the 
resources that are available for treating pain, and that 
includes the many referrals that we have already mentioned on 
the panel, the various lab tests, and other resources that we 
can use other than drug treatment to take care of that patient.
    We make sure that that physician understands the concerns 
so that he can start the weaning process. One of those 
referrals, of course, is also to pain management. We have pain 
management specialists.
    Chairman Isakson. Let me ask you a question. Is hydrocodone 
an opiate?
    Dr. Forster. Yes.
    Chairman Isakson. The reason I ask that question is, more 
information--information is power and that is what you are 
really talking about and the better the information you have, 
the better tracking. I had back surgery in October and was 
prescribed hydrocodone for, I guess for pain or whatever, and 
it worked.
    Dr. Forster. They can work.
    Chairman Isakson. I did not work after taking it. My point 
I want to get to and I do not want to take any more time is, 
the pharmacy that I filled that prescription at, when my 
prescription time had run out, I got a letter from them telling 
me that my prescription could not be renewed and that if I had 
any leftover hydrocodone pills, they would be happy to destroy 
them for me, which I was very impressed with, because I think a 
lot of that stuff is getting into the secondary market or the 
black market or the kid market.
    Dr. Forster. Yes.
    Chairman Isakson. I think the more information you have and 
the more awareness you have, the better results you are going 
to have.
    Dr. Forster. I totally support that.
    Chairman Isakson. Thank you for what you are doing.
    Dr. Forster. Thank you.
    Chairman Isakson. Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman. Dr. Alexander and 
Dr. Forster, in your testimony, you both highlight a focus on 
avoiding the unsafe combination of opioids with medicines such 
as benzodiazepines, and also focus on, Dr. Alexander in 
particular, when you are treating patients with co-morbid 
conditions such as mood disorders, Post Traumatic Stress 
Disorder, Traumatic Brain Injury, and substance abuse, these 
are both issues that were very apparent when we started 
learning of problems at the Tomah VA facility. That sort of 
dangerous combination had tragic results at that facility.
    It also motivated me to work with this Committee to ensure 
strong report language with regard to a bill, and I do want to 
give the Chairman and Ranking Member a big shout out and thank 
you for all of your work on the Clay Hunt SAV Act, a suicide 
prevention act that was passed by Congress and signed into law 
last month.
    I thank the Chairman and Ranking Member for working with me 
to include report language that requires that the third party 
evaluation of VA mental health and suicide prevention programs 
that are required by the Clay Hunt SAV Act includes a review of 
opioid use by patients in those programs.
    I do, Mr. Chairman, want to submit for the record a letter 
from the National Alliance on Mental Illness, also known as 
NAMI, in support of including opioid prescribing practices in 
the Clay Hunt third party evaluation.

    [The letter referred to is in the Appendix.]

    Senator Baldwin. Dr. Alexander, please talk a little bit 
more about why these combinations of opioids and 
benzodiazepines and other strong prescription drugs are so 
dangerous, and also, with regard to the treatment of patients 
not with, necessarily, chronic pain, but with mental illness or 
PTSD.
    Dr. Alexander. Sure. Thank you for the question. As you 
have identified, these are particularly high risk patients and 
I think it is really important that they are prospectively 
identified and carefully managed throughout the continuum of 
their care. Multi-disciplinary teams, which ideally would be 
involved in the management of virtually every patient that is 
on opioid therapy for chronic pain, are particularly important 
for these types of patients, as are especially vigilant efforts 
to decrease opioid use among them.
    Some of the medicines that we are talking about are 
considered psychotropic drugs. They have specific targeted 
effects on the central nervous system. Benzodiazepines, for 
example, have effects not dissimilar from alcohol within the 
brain, and they can compound or act synergistically with 
opioids and increase the magnitude of adverse effects from 
opioids, ranging from sedation and impaired cognition to 
respiratory depression and death.
    So, although many risk factors for high risk prescribing 
have been identified, the presence of these co-morbid 
conditions, I think, is of particular concern and warrants 
particular focus.
    Senator Baldwin. Dr. Forster, the same question.
    Dr. Forster. Yes. The combination is definitely unsafe and, 
as I mentioned, there is also a combination using Carisoprodol 
which is a muscle relaxant and that actually adds to this 
euphoria that a person who is misusing narcotics may seek. We 
are trying our best to not use narcotics in patients with co-
morbid conditions knowing the potential is there, and there is 
a concern that they are a relatively high risk population.
    In cases where a short-term narcotic is needed, they have 
to be watched very closely. Again, as I mentioned, we have 
addiction medicine specialists, behavioral health specialists, 
and pain management specialists that are there for us. As a 
primary care physician myself, I would probably, if I had a 
patient that was a difficult or more complex patient with 
multiple co-morbidities, I probably would seek their advice and 
recommendation much earlier than later, in fact, almost at the 
outset.
    Senator Baldwin. Thank you.
    Chairman Isakson. Thank you, Senator Baldwin.
    Senator Blumenthal has one additional question.
    Senator Blumenthal. Yes. I want to ask Mr. Gadea about 
sources of funding for the Prescription Monitoring program. Can 
you tell us how Connecticut system is funded and whether that 
same system or source of funding is used for other PMPs in the 
49 States that have them around the country, if you know?
    Mr. Gadea. It is a little haphazard around the country. I 
can tell you what we have done. We initially had implementation 
grants and execution grants from the Bureau of Justice 
Assistance. Those grants eventually, as more States came on, 
became more difficult to obtain. We were very fortunate in 
having your office as part of restitution to the State would 
provide us with funding to keep us afloat.
    We have been able to do that since the onset and have never 
used, to this date, any funding from the State, general funds.
    Senator Blumenthal. Just for the record, your reference to 
my office was to the Office----
    Mr. Gadea. The Attorney General.
    Senator Blumenthal [continuing]. Of Attorney General in the 
settlement that was done with Perdue Farmer in the case that we 
did jointly with the U.S. Department of Justice.
    Mr. Gadea. Yes.
    Senator Blumenthal. Just so that is clear in the record. To 
state it succinctly, you receive no Federal or State funds for 
the operation of your office?
    Mr. Gadea. No. At this point we do have in the proposed 
budget that one more position--we currently operate the entire 
system with just one person and we are hopeful that if the 
budget passes in the format that we like, that we do get 
funding for that, for the program, the maintenance, as well as 
one more individual. Around the country, it is some grants, 
some funding, partial funding. It is kind of all over the 
place.
    Senator Blumenthal. To again try to state it succinctly, 
for systems that are critically and profoundly important to law 
enforcement, for effective treatment for addition abuse 
prevention, the system right now is, at best, haphazard----
    Mr. Gadea. Yes.
    Senator Blumenthal [continuing]. Funding?
    Mr. Gadea. Yes.
    Senator Blumenthal. My view is that fact ought to be 
changed. So thank you for your testimony----
    Mr. Gadea. Thank you.
    Senator Blumenthal [continuing]. Mr. Gadea, Dr. Forster, 
Dr. Alexander.
    Chairman Isakson. I want to thank our witnesses for their 
participation today and their leadership. Thanks, Senator 
Baldwin, for being here, Senator Johnson for making time. The 
record will be left open for 5 days for additional questions to 
be submitted or opening statements or closing statements to be 
made. If there is no other business to come before the 
Committee, we stand adjourned.
 Response to Posthearing Questions Submitted by Hon. Tammy Baldwin to 
   Carol Forster, M.D., Physician Director, Pharmacy & Therapeutics/
   Medication Safety, Mid-Atlantic Permanente Medical Group, Kaiser 
                               Permanente
                alternative treatments for chronic pain
    VHA is trying to expand the use of complementary and alternative 
medicine to treat patients with chronic pain, recognizing that there's 
growing evidence of the effectiveness of these approaches. Furthermore, 
when I speak with veterans, I consistently hear a desire for more 
acupuncture, massage, yoga, aqua-therapy, and other techniques. I would 
like to see VA more rapidly expand the use of these techniques.

     What types of alternative and complementary approaches are 
used by Kaiser specifically, and private health providers generally?
    Response. Recent research findings indicate growth in Americans' 
use of complementary and alternative practices for a variety of health 
conditions, including pain.\1\ The goal of integrating these practices 
is to improve functioning and reduce the need for pain medicines that 
can have serious side effects.\2\
---------------------------------------------------------------------------
    \1\ https://nccih.nih.gov/news/press/02102015mb
    \2\ Chronic pain is a common problem among active-duty military 
personnel and veterans. NCCIH, the U.S. Department of Veterans Affairs, 
and other agencies are sponsoring research to see whether integrative 
approaches can help. For example, NCCIH-funded studies are testing the 
effects of adding mindfulness meditation, self-hypnosis, or other 
complementary approaches to pain management programs for veterans. 
https://nccih.nih.gov/health/integrative-health
---------------------------------------------------------------------------
    KP offers its members certain complementary and alternative 
medicine (CAM) therapies. The most consistently available, program-
wide, is mindfulness training (e.g., biofeedback, meditation, guided 
imagery). We also offer some movement-based CAM interventions (e.g., 
Feldenkrais, Tai Chi) through Health Education departments as health 
promotion activities at a cost for members outside of the traditional 
healthcare benefit. Other treatments, like acupuncture, may be 
available to some patients as a covered service, depending on an 
individual's plan benefits.
    Kaiser Permanente employs CAM specialists to manage various 
conditions, including pain. CAM can encompass a very broad spectrum of 
different therapies and techniques, from health education resources to 
alternative treatments, such as acupuncture, chiropractic or 
osteopathic treatment. Some CAM approaches fall outside the typical 
services offered or covered by health care systems, for instance, 
herbal remedies, exercise or movement therapies (e.g., yoga) or 
massage; some approaches, like lifestyle changes, depend primarily on 
self-motivation and individual action, rather than external 
interventions.
    The uptake for CAM therapies across the overall population of 
chronic pain patients may vary. There can be several barriers to CAM 
adoption for pain management, including the timing of CAM (i.e. whether 
CAM is offered as initial therapy) and the investment and commitment 
required of patients and providers. For the right patients, CAM may be 
a beneficial component of pain management.
    The ability to aggregate and analyze electronic clinical data can 
allow providers to flag certain prescribing/utilization patterns. 
Applying these analytics successfully is enhanced within integrated 
care delivery systems, like KP and the VA, where it is possible to 
coordinate care across care settings (both in- and out-patient primary 
and specialty care and pharmacy).
    Within KP, we have used this approach for managing members who are 
receiving long-term opioids, applying population care strategies. While 
we have tried to target these members to the CAM modalities, the 
pharmacy analytics approach was more successful: in promoting 
``universal precautions'' such as: tracking early refills, emergency 
room/urgent care dispensed medications, annual urine toxicology 
screenings, documented medication agreements, etc.

     How would you rate their effectiveness?
    Response. While the evidence of CAM's safety and effectiveness in 
chronic pain management is not overwhelming, certain modalities may 
help patients motivated to integrate CAM into their treatment plan. One 
of the challenges to determining clinical effectiveness is that the 
goals of CAM therapies focus on feelings of well-being and mastery of 
the illness, outcomes that are harder to define and measure than 
objective primary endpoints typical to research involving traditional 
medicine.\3\
---------------------------------------------------------------------------
    \3\ See http://www.ncbi.nlm.nih.gov/pubmed/23126534; see also 
http://www.ncbi.nlm.nih.gov/books/NBK83795/; see also www.va.gov/RAC-
GWVI/docs/Minutes_and_Agendas/Presentations _Feb2011

    [Whereupon, at 12:04 p.m., the hearing was adjourned.]

                            A P P E N D I X

                              ----------                              


       Prepared Statement of Louise R. Van Diepen, MS, CGP, FASHP
    Mr. Chairman and Members of the Committee: Thank you for this 
opportunity to testify today on United States (US) data and strategies 
on opioid overprescribing to put into context VA opioid prescription 
policy, practice and procedures. I am a retired Veterans Health 
Administration (VHA) executive and clinical pharmacist who served in a 
number of Federal and private sector health care executive and clinical 
roles, most in direct support of high quality health care for Veterans 
(e.g., VHA National Chief of Clinical Pharmacy/Quality Management; 
Director of Clinical [Pharmacy] Services, PharmMark Corporation; Vice 
President for Clinical [Pharmacy] Services for AARP Pharmacy Services; 
VHA Chief of Staff).
    I will frame my testimony around six questions to ensure that 
Committee has adequate context for its discussions today:

    1. What is the magnitude of the opioid abuse problem in the United 
States?
    2. Which are the higher-risk opioids and where are they being 
prescribed?
    3. What are the major recommendations to address overprescribing of 
opioids?
    4. What major actions actually have been taken nationally to 
address opioid overprescribing?
    5. Are VHA's actions, as a system, adequate and consistent with the 
national momentum on this issue?
    6. What more could VHA do to improve opioid prescribing?

                     the first question to ask is 
   ``what is the magnitude of the opioid abuse problem in the united 
                               states?''
According to the CDC: \1\

    \1\ CDC: NCHS Health E-Stat: Trends in Drug-poisoning Deaths 
Involving Opioid Analgesics and Heroin: United States, 1999--2012. 
Margaret Warner, Ph.D., Division of Vital Statistics; and Holly 
Hedegaard, M.D., M.S.P.H., and Li-Hui Chen, M.S., Ph.D., Office of 
Analysis and Epidemiology
---------------------------------------------------------------------------
     From 1999 through 2012, the age-adjusted drug-poisoning 
death rate nationwide more than doubled, from 6.1 per 100,000 
population in 1999 to 13.1 in 2012 (Table 1).
     During the same period, the age-adjusted rates for drug-
poisoning deaths involving opioid analgesics more than tripled, from 
1.4 per 100,000 in 1999 to 5.1 in 2012 (Figure 1). Opioid-analgesic 
death rates increased at a fast pace from 1999 through 2006, with an 
average increase of about 18% each year, and then at a slower pace from 
2006 forward. The 5% decline in opioid-analgesic death rates from 2011 
through 2012, is the first decrease seen in more than a decade.
     Also from 1999 through 2012, the age-adjusted rates for 
drug-poisoning deaths involving heroin nearly tripled, from 0.7 deaths 
per 100,000 in 1999 to 1.9 in 2012. The rates increased substantially 
beginning in 2006. Between 2011 and 2012, the rate of drug-poisoning 
deaths involving heroin increased 35%, from 1.4 per 100,000 to 1.9.
     In 2012, 14 states had age-adjusted drug-poisoning death 
rates that were significantly higher than the overall U.S. rate of 13.1 
per 100,000 population (Figure 2). The states with the highest rates 
per 100,000 population were West Virginia (32.0), Kentucky (25.0), New 
Mexico (24.7), Utah (23.1), and Nevada (21.0).
     In 2012, there were 41,502 deaths due to drug poisoning 
(often referred to as drug-overdose deaths) in the United States (Table 
1), of which 16,007 [38.6%] involved opioid analgesics and 5,925 
involved heroin.
 the second question relates to the prescribing patterns. ``which are 
     the higher-risk opioids and where are they being prescribed?''
    CDC recently studied 2012 prescribing patterns of 57,000 
pharmacies, which dispense nearly 80% of the retail prescriptions in 
the United States. Prescriptions included in the study were dispensed 
at retail pharmacies and paid for by commercial insurance, Medicaid, 
Medicare, or cash. The study examined prescribing patterns for opioid 
pain relievers (OPRs), long acting/extended release (LA/ER) OPRs, high 
dose OPRs, and benzodiazepines.\2\ According to CDC, LA/ER OPRs are 
more prone to abuse, and high-dose formulations were more likely to 
result in overdoses, so they deserved special focus; Benzodiazepines 
were often prescribed in combination with OPR, even though this 
combination increases the risk for overdose.\3\
---------------------------------------------------------------------------
    \2\ Benzodiazepines are antianxiety drugs like alprazolam (Versed), 
diazepam (Valium), and chlordiazepoxide (Librium). The class includes 
approximately 39 unique agents.
    \3\ In September 2013, FDA announced labeling changes for these 
products. The updated labeling states that ER/LA opioids are indicated 
for the management of pain severe enough to require daily, around-the-
clock, long-term opioid treatment and for which alternative treatment 
options are inadequate.
---------------------------------------------------------------------------
    The updated labeling further clarifies that, because of the risks 
of addiction, abuse, and misuse, even at recommended doses, and because 
of the greater risks of overdose and death, these drugs should be 
reserved for use in patients for whom alternative treatment options 
(e.g., non-opioid analgesics or immediate-release opioids) are 
ineffective, not tolerated, or would be otherwise inadequate to provide 
sufficient management of pain; ER/LA opioid analgesics are not 
indicated for as-needed pain relief.
    CDC found that State prescribing rates varied for all drug types 
(See Table 2) with rates that were 2.7fold for OPR and 22fold for one 
type of OPR, oxymorphone. Overall, prescribing rates varied widely by 
state for all drug types (See table 2). When looking for patterns by 
Region, the southern US had the highest rate of prescribing OPR and 
benzodiazepines. The Northeast had the highest rate for high-dose OPR 
and long acting and extended release OPR, although high rates also were 
observed in individual states in the South and West. In the Northeast, 
17.8% of OPR prescribed were LA/ER OPR. States in the South ranked 
highest for all individual opioids except for hydromorphone, fentanyl, 
and methadone, for which the highest rates were in Vermont, North 
Dakota, and Oregon, respectively.\4\
---------------------------------------------------------------------------
    \4\ CDC Vital Signs (Weekly): Variation Among States in Prescribing 
of Opioid Pain Relievers and Benzodiazepines--United States, 2012. MMWR 
July 4, 2014/63(26);563-568
---------------------------------------------------------------------------
 the third question is ``what are the major recommendations to address 
                     overprescribing of opioids?''
In the general US population, Center for Disease Control recommends:

     Use of prescription data combined with insurance 
restrictions to prevent ``doctor shopping'' and reduce inappropriate 
use of opioids.

         - Users of multiple providers for the same drug, people 
        routinely obtaining early refills, and persons engaged in other 
        inappropriate behaviors can be tracked with state prescription 
        drug monitoring programs or insurance claim information.
         - Public and private insurers can limit the reimbursement of 
        claims for opioid prescriptions to a designated doctor and a 
        designated pharmacy. This action is especially important for 
        public insurers because Medicaid recipients and other low-
        income populations are at high risk for prescription drug 
        overdose. Insurers also can identify inappropriate use of 
        certain opioids for certain diagnoses (e.g., the use of 
        extended-release or long-acting opioids like transdermal 
        fentanyl or methadone for short-term pain).

     Improving legislation and enforcement of existing laws.

         - Most states now have laws against doctor shopping, but they 
        are not enforced uniformly. In contrast, only a few states have 
        laws regulating for-profit clinics that distribute controlled 
        prescription drugs with minimal medical evaluation. Laws 
        against such ``pill mills'' as well as laws that require 
        physical examinations before prescribing might help reduce the 
        diversion of these drugs for nonmedical use.
         - In addition, a variety of other state controls on 
        prescription fraud are being employed. For example, according 
        to the National Alliance for Model State Drug Laws, 15 states 
        required or permitted pharmacists to request identification 
        from persons obtaining controlled substances as of March 2009.

     Improve medical practice in prescribing opioids.

         - Care for patients with complex chronic pain problems is 
        challenging, and many prescribers receive little education on 
        this topic. As a result, prescribers too often start patients 
        on opioids and expect unreasonable benefits from the treatment. 
        In a prospective, population-based study of injured workers 
        with compensable low back pain, 38% of the workers received an 
        opioid early in their care, most at the first doctor visit. 
        Among the 6% who went on to receive opioids for chronic pain 
        for 1 year, most did not report clinically meaningful 
        improvement in pain and function, even though their opioid dose 
        rose significantly over the year.
         - Evidence-based guidelines can educate prescribers regarding 
        the under-appreciated risks and frequently exaggerated benefits 
        of high-dose opioid therapy. Such guidelines especially are 
        needed for emergency departments because persons at greater 
        risk for overdose frequently visit emergency departments 
        seeking drugs. Guidelines will be more effective if health 
        system or payer reviews hold prescribers accountable for their 
        behaviors.

     Develop a public health approach of secondary and tertiary 
prevention measures to improve emergency and long term treatment.

         - Overdose ``harm reduction'' programs emphasize broader 
        distribution (to nonmedical users) of an opioid antidote, 
        naloxone, that can be used in an emergency by anyone witnessing 
        an overdose. Efforts also are under way to increase the ability 
        of professionals responding to emergencies to administer 
        optimum treatment for overdoses.
         - Substance abuse treatment programs also reduce the risk for 
        overdose death. Continued efforts are needed to remove barriers 
        to shifting such programs from methadone clinics to office-
        based care using buprenorphine. Office-based care can be less 
        stigmatizing and more accessible to all patients, especially 
        those residing in rural areas.\5\
---------------------------------------------------------------------------
    \5\ CDC Grand Rounds (Weekly): Prescription Drug Overdoses--a U.S. 
Epidemic; January 13, 2012/61(01);10-13.

---------------------------------------------------------------------------
    The National Association of Boards of Pharmacy recommends:

     Recognizing ``red flag'' warnings. These warnings are 
based on how the patient presents, how the medication has been taken, 
how the patient is communicating, and how the patient does (or does 
not) participate in the treatment plan.
     Based on patient populations and behaviors, physicians and 
pharmacists should identify situations that indicate whether a patient 
may be more likely to be abusing or diverting prescription drugs.
     When warning signs are present, health care practitioners 
should immediately assess the situation and/or the patient's medical 
and psychological condition and determine the appropriate action (e.g., 
continuation of treatment, intensify monitoring, refer for substance 
use/addiction treatment, refuse to issue/dispense a prescription).

    The Behavioral Health Coordinating Committee of the Prescription 
Drug Abuse Subcommittee of Health and Human Services recommends (in 
addition to activities underway; See Appendix I for details):

     Strengthen surveillance systems and capacity
     Build the evidence-base for prescription drug abuse 
prevention programs
     Enhance coordination of patient, public, and provider 
education programs among Federal agencies
     Further develop targeted patient, public, and provider 
education programs
     Support efforts to increase provider use of Prescription 
Drug Monitoring Programs (PDMPs)
     Leverage health information technology to improve clinical 
care and reduce abuse
     Synthesize pain management guideline recommendations and 
incorporate them into clinical decision support tools
     Collaborate with insurers and pharmacy benefit managers to 
implement robust claims review programs
     Collaborate with insurers and pharmacy benefit managers to 
identify and implement robust programs that improve oversight of high-
risk prescribing.
     Improve analytic tools for regulatory and oversight 
purposes
     Continue efforts to integrate drug abuse treatment and 
primary care
     Expand efforts to increase access to medication-assisted 
treatment
     Expand Screening, Brief Intervention, and Referral to 
Treatment services
     Prevent opioid overdose through new formulations of 
naloxone

 the fourth question is ``what major actions actually have been taken 
            nationally to address opioid overprescribing?''
    The States have taken various actions to control opioid 
prescribing. As automation has improved, States have introduced 
electronic prescription monitoring systems to aggregate data, for use 
by health care providers and enforcement agencies.

     In one example, New York established the Prescription 
Monitoring Program (PMP) on August 27, 2013. Most prescribers are 
required to consult the PMP Registry when writing prescriptions for 
Schedule II, III, and IV controlled substances. The PMP Registry 
provides practitioners with direct, secure access to view dispensed 
controlled substance prescription histories for their patients. The PMP 
is available 24 hours a day/7 days a week. Patient reports include all 
controlled substances that were dispensed in New York State and 
reported by the pharmacy/dispenser for the past six months. This 
information will allow practitioners to better evaluate their patients' 
treatment with controlled substances and determine whether there may be 
abuse or non-medical use.

    Many States and professional associations have published pain 
treatment guidelines to better inform prescribers of evidence-based 
treatment guidelines for pain.

     For example, the Medical Board of California published 
Guidelines for Prescribing Controlled Substances for Pain in 2014 
(http://www.mbc.ca.gov/licensees/prescribing/pain_guidelines.pdf) This 
comprehensive, 90 page document includes information for providers on 
the various types of pain, considerations of treating pain in different 
populations, patient treatment options and risks, and patient contracts 
(which include agreement to urine screening). Similarly, the state of 
Washington has published comprehensive guidelines (http://
www.agencymeddirectors.wa.gov/files/opioidgdline.pdf)
     As an example of a professional association guideline, the 
American Society of Anesthesiologists Task Force on Chronic Pain 
Management and the American Society of Regional Anesthesia and Pain 
Medicine published updated practice guidelines for chronic pain 
management.

    Regulators have taken action to better educate providers and 
improve labeling.

     The Food and Drug Administration (FDA) required 
manufacturers to make educational materials available for prescribers 
and patients based on FDA-approved materials for continuing education 
for prescribers.
     FDA established a Web site to assist providers in quickly 
identifying and accessing educational programs (https://search.er-la-
opioidrems.com/Guest/GuestPage External.aspx)
     FDA changed labeling on long acting opioid drugs. Older 
labeling stated that ''[Name of drug] is indicated for the relief of 
moderate to severe pain in patients requiring continuous around the 
clock opioid treatment for an extended period of time.'' Newer labeling 
states that ''[Name of drug] is indicated for the management of pain 
severe enough to require continuous around the clock opioid treatment 
and for which alternative treatment options are inadequate.''
     FDA required a new boxed warning on long acting opioid 
drugs that increased emphasis on risks, including abuse, overdose, 
death, and Neonatal Opioid Withdrawal Syndrome
     FDA's newer labeling urges prescribers to ``assess each 
patient's risk'' for abuse before prescribing and to ``monitor all 
patients regularly for the development of abuse.''
     FDA has recently approved several ``abuse deterrent'' 
opioids to minimize the risk for prescription diversion or abuse.
     FDA approved a naloxone auto-injectable product for the 
emergency treatment of known or suspected opioid overdose outside of a 
healthcare setting. Naloxone is a medication that rapidly reverses the 
effects of opioid overdose.

    National enforcement agencies have taken action to require more 
frequent prescribing by providers. Previously, opioid combination 
products could be prescribed for up to a 30 day supply with 5 refills 
(e.g., up to a 6 month period between physician visits). That changed 
under new DEA rules:

     Hydrocodone combination products are now in a more 
restrictive category of controlled substances, along with other opioid 
drugs for pain like morphine and oxycodone. After a scientific review, 
FDA made the recommendation that DEA take this step.

         - If a patient needs additional medication, the prescriber 
        must issue a new prescription. Phone-in refills for these 
        products are no longer allowed.
         - In emergencies, small supplies can be authorized until a new 
        prescription can be provided for the patient.
         - Patients will still have access to reasonable quantities of 
        medication, generally up to a 30-day supply.

     In addition, DEA continues its community ``Take Back'' 
programs to assist consumers in the proper disposal of unused 
medication, including opioid prescriptions.
 the fifth question is: ``are vha's actions, as a system, adequate and 
         consistent with the national momentum on this issue?''
     In August 2013, VHA implemented a national opioid 
surveillance program (Opioid Safety Initiative) to monitor utilization. 
The program analyzes data to identify outliers in terms of opioid (and 
benzodiazepine) prescribing and refers that information to VA medical 
centers for more critical evaluation and action, as appropriate. Recent 
VHA prescription dispensing data shows improvement since the 
implementation of the program. For example, VHA has advised that:

         - In Q4 FY 2012, 59,499 patients were dispensed greater than 
        100 MEDD.\6\ By Q1 FY 2015, only 49,356 patients were dispensed 
        greater than 100 MEDD--a 17% reduction.
---------------------------------------------------------------------------
    \6\ VHA defines higher-risk patients as those receiving 
prescriptions of greater than (or equal to) 100 morphine sulfate 
equivalent doses dispensed (100 MEDD).
---------------------------------------------------------------------------
         - From Q4 FY 2012 through Q1 FY 2015, 91,614 fewer patients 
        received an opioid prescription. This reduction was seen 
        despite an overall increase (1.8% -from 3,966,139 to 4,035,695) 
        in the number of pharmacy patients during the same period.
         - From Q4 FY 2012 through Q1 FY 2015, there were 67.466 fewer 
        pharmacy patients on long term opioids. During this same 
        period, urine drug screening (screening essential to detecting 
        potential drug diversion) increased by 71,255 patients.

     In 2014, outside research experts assessed VHA's opioid 
utilization and testified before the U.S. Senate Committee on Veterans' 
Affairs that VHA was exercising appropriate vigilance. ``The research, 
funded by the National Institute on Drug Abuse, showed that the 
percentage of VHA patients with chronic pain who receive higher doses 
of opioids is relatively small and lower than those in other health 
care systems. The amount of days in which chronic pain patients receive 
opioids is typically higher within the VHA; however, the median dose of 
opioids is lower than other health care systems, according to Edlund * 
* * Edlund reported that the VHA, overall, screens out substance abuse 
patients from high use of opioids better than other health care 
systems.'' \7\
---------------------------------------------------------------------------
    \7\ http://www.rti.org/newsroom/news.cfm?obj=01E25DFA-9549-3A9E-
0A638C19F38BDD1E
---------------------------------------------------------------------------
     VHA has published opioid treatment guidelines (with 
education and decision support tools and pocket guides) in 2010, 
updated in 2013 (http://www.healthquality .va.gov/guidelines/Pain/cot/) 
In addition, VHA's treatment guidelines for substance use disorder 
(http://www.healthquality.va.gov/guidelines/MH/sud/) are directly 
linked to and complement the opioid guidelines. These guidelines are 
equally comprehensive to the State and professional guidelines cited 
previously.
     Academic detailing is a model of peer based education 
intended to improve prescribing performance (http://www.narcad.org/) 
where there is a gap between best practice and current treatment 
patterns. VHA conducted a 3 year pilot of academic detailing program to 
change prescribing habits in a variety of practice settings. Based on 
the extraordinary success of VHA's initial pilot, the program will be 
expanded nationwide and include opioid prescribing as one of the focus 
areas.
     VHA has developed software to interact with State 
Prescription Drug Monitoring Programs (PDMPs). This will ensure that 
opioid prescriptions for Veterans receiving purchased care and/or VHA 
care are monitored consistently. (But deployment of the software has 
been problematic. See recommendation below.)
     VHA has expanded its health care model to include 
treatment modalities (e.g., chiropractic care, yoga, acupuncture, etc.) 
that can provide attractive alternatives to opioid treatment.
     In 2014, VHA has instituted a naloxone distribution 
program (http://www.pbm .va.gov/PBM/clinicalguidance/
clinicalrecommendations/Naloxone_Kits_Recommenda 
tions_for_Use_Rev_Sep_2014.pdf) to reverse life-threatening opioid 
overdoses. The program has already literally saved lives.
     VHA has increased its use of injectable naltrexone, a drug 
used to prevent relapse after opioid detoxification.
     VHA has a robust substance use disorder program that can 
support provider and patient efforts to discontinue opioid use when 
addiction and abuse is apparent.
     VHA has a national Pain Management Office that coordinates 
information and programs to ensure that providers have the most current 
information at their fingertips (http://www.va.gov/PAINMANAGEMENT/
Clinical_Resources.asp)
                         the final question is 
       ``what more could vha do to improve opioid prescribing?''
    While overprescribing patterns are improving, there is always more 
that can be done to ensure continued progress. VHA should:

     Resource the national opioid surveillance and academic 
detailing initiatives appropriately to ensure success. Many of the 
initiatives are currently minimally staffed and sustainment is at risk 
if staffing is not adequate.
     Expedite VA's deployment of software to interact with 
State Prescription Drug Monitoring Programs (PDMP). The deployment is 
at risk due to an assessment by the Office of Information Technology of 
a security risk. The Department should be encouraged to report its 
progress on a quarterly basis to drive this to successful resolution.

    In conclusion, I find that the actions of VHA, as a system, are 
consistent with the national momentum on this issue. I reached this 
conclusion based on the review of outside studies, VHA's internal 
surveillance data, and my own evaluation relative to other national and 
State program benchmarks. I believe that this momentum can be sustained 
and improved given adequate resources.

    Mr. Chairman and Members of the Committee, I wish to thank you for 
this opportunity to present this perspective today.

Figure 1. Age-adjusted drug-poisoning death rates: United States 1999-
                    2012
                    
  [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                  
                    
                    
                    
                    
    NOTE: Drug-poisoning deaths may involve both opioid analgesics and 
heroin.
    SOURCE: CDC/NCHS, National Vital Statistics System, Mortality File.

Figure 2. Age-adjusted drug-poisoning death rates, by state: United 
                    States, 2012
                    
                    
       [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]             
                    
          
                    
    SOURCE: CDC/NCHS, National Vital Statistics System, Mortality File.


  Table 1. Number and age-adjusted rate of drug-poisoning deaths involving opioid analgesics and heroin: United
                                                States, 1999-2012
----------------------------------------------------------------------------------------------------------------
                                                                 All         Opioid analgesics       Heroin
                          bYear                          -------------------------------------------------------
                                                            Number     Rate    Number     Rate    Number    Rate
----------------------------------------------------------------------------------------------------------------
1999....................................................    16,849     6.1      4,030     1.4     1,960     0.7
2000....................................................    17,415     6.2      4,400     1.5     1,842     0.7
2001....................................................    19,394     6.8      5,528     1.9     1,779     0.6
2002....................................................    23,518     8.2      7,456     2.6     2,089     0.7
2003....................................................    25,785     8.9      8,517     2.9     2,080     0.7
2004....................................................    27,424     9.4      9,857     3.4     1,878     0.6
2005....................................................    29,813    10.1     10,928     3.7     2,009     0.7
2006....................................................    34,425    11.5     13,723     4.6     2,088     0.7
2007....................................................    36,010    11.9     14,408     4.8     2,399     0.8
2008....................................................    36,450    11.9     14,800     4.8     3,041     1.0
2009....................................................    37,004    11.9     15,597     5.0     3,278     1.1
2010....................................................    38,329    12.3     16,651     5.4     3,036     1.0
2011....................................................    41,340    13.2     16,917     5.4     4,397     1.4
2012....................................................    41,502    13.1     16,007     5.1     5,925     1.9
----------------------------------------------------------------------------------------------------------------
NOTES: Deaths are classified using the International Classification of Diseases, Tenth Revision (ICD--10). Drug-
  poisoning deaths are identified using ICD--10 underlying cause-of-death codes X40--X44, X60--X64, X85, and
  Y10--Y14. Opioid-analgesic drug-poisoning deaths are drug-poisoning deaths with a multiple cause-of-death code
  of T40.2, T40.3, or T40.4. Heroin drug-poisoning deaths are drug-poisoning deaths with a multiple cause-of-
  death code of T40.1. Approximately 25% of drug-poisoning deaths lack information on the specific drugs
  involved. Some of these deaths may have involved heroin, opioid analgesics, or both.
SOURCE: CDC/NCHS, National Vital Statistics System, Mortality File



      Table 2. Prescribing rates per 100 persons, by State and drug type-- IMS Health, United States, 2012
----------------------------------------------------------------------------------------------------------------
                                                         Long-acting/
                                                          extended-          High-dose
                                        Opioid             release             opioid            Benzo-
                State                    pain      Rank  opioid pain   Rank     pain     Rank  diazepines   Rank
                                       relievers          relievers          relievers
 
----------------------------------------------------------------------------------------------------------------
Alabama.............................     142.9       1       12.4       22       6.8       4       61.9       2
Alaska..............................      65.1      46       10.7       31       4.2      26       24.0      50
Arizona.............................      82.4      26       14.5       12       5.5      12       34.3      33
Arkansas............................     115.8       8        9.6       37       4.1      29       50.8       8
California..........................      57.0      50        5.8       49       3.0      42       25.4      47
Colorado............................      71.2      40       11.8       24       4.1      31       28.0      44
Connecticut.........................      72.4      38       14.1       13       5.4      13       46.2      11
Delaware............................      90.8      17       21.7        2       8.8       1       41.5      19
District of Columbia................      85.7      23       13.7       17       5.7      10       38.4      24
Florida.............................      72.7      37       11.3       26       6.6       5       46.9      10
Georgia.............................      90.7      18        8.6       43       4.1      30       37.0      27
Hawaii..............................      52.0      51        8.8       42       3.9      36       19.3      51
Idaho...............................      85.6      24       10.3       33       3.9      34       29.1      42
Illinois............................      67.9      43        5.2       50       2.0      50       34.2      34
Indiana.............................     109.1       9       10.7       30       4.9      20       42.9      17
Iowa................................      72.8      36        7.3       47       2.2      48       37.3      26
Kansas..............................      93.8      16       10.3       34       4.0      32       38.9      23
Kentucky............................     128.4       4       11.6       25       5.0      19       57.4       5
Louisiana...........................     118.0       7        7.8       46       3.6      39       51.5       7
Maine...............................      85.1      25       21.8        1       5.6      11       40.7      22
Maryland............................      74.3      33       16.0        6       5.0      18       29.9      40
Massachusetts.......................      70.8      41       14.9        8       3.5      41       48.8       9
Michigan............................     107.0      10        9.1       40       4.5      22       45.5      14
Minnesota...........................      61.6      48       10.2       35       2.2      49       24.9      48
Mississippi.........................     120.3       6        7.2       48       2.9      43       46.2      12
Missouri............................      94.8      14        9.5       38       3.5      40       42.6      18
Montana.............................      82.0      27       14.0       15       4.4      23       33.7      35
Nebraska............................      79.4      28        7.8       45       2.3      46       35.0      32
Nevada..............................      94.1      15       14.8       10       8.2       3       37.5      25
New Hampshire.......................      71.7      39       19.6        3       6.1       7       41.2      21
New Jersey..........................      62.9      47       11.3       27       5.8       9       36.5      28
New Mexico..........................      73.8      35       12.7       21       3.8      38       31.5      37
New York............................      59.5      49        9.5       39       4.3      24       27.3      45
North Carolina......................      96.6      13       13.7       18       4.3      25       45.3      15
North Dakota........................      74.7      32       10.5       32       2.3      47       31.1      39
Ohio................................     100.1      12       11.2       28       4.2      27       41.3      20
Oklahoma............................     127.8       5       12.8       20       6.0       8       44.5      16
Oregon..............................      89.2      20       18.8        4       5.2      16       31.4      38
Pennsylvania........................      88.2      21       14.9        9       5.4      14       46.1      13
Rhode Island........................      89.6      19       14.0       14       5.2      17       60.2       4
South Carolina......................     101.8      11       11.0       29       3.9      33       52.6       6
South Dakota........................      66.5      45        9.0       41       2.5      45       28.0      43
Tennessee...........................     142.8       2       18.2        5       8.7       2       61.4       3
Texas...............................      74.3      34        4.2       51       1.9      51       29.8      41
Utah................................      85.8      22       12.1       23       5.3      15       35.9      30
Vermont.............................      67.4      44       13.9       16       4.7      21       35.5      31
Virginia............................      77.5      29        9.9       36       3.8      37       36.4      29
Washington..........................      77.3      30       14.6       11       4.1      28       27.1      46
West Virginia.......................     137.6       3       15.7        7       6.2       6       71.9       1
Wisconsin...........................      76.1      31       13.1       19       3.9      35       33.4      36
Wyoming.............................      69.6      42        8.0       44       2.7      44       24.1      49
Mean................................      87.3      --       12.0       --       4.5      --       39.2      --
Standard deviation..................      22.4      --        3.9       --       1.6      --       11.1      --
Coefficient of variation............       0.26     --        0.32      --       0.36     --        0.28     --
Median..............................      82.4      --       11.3       --       4.2      --       37.3      --
25th percentile.....................      71.7      --        9.5       --       3.7      --       31.1      --
75th percentile.....................      96.6      --       14.1       --       5.4      --       46.1      --
Interquartile ratio.................       1.3      --        1.5       --       1.4      --        1.5      --
----------------------------------------------------------------------------------------------------------------

                               Appendix 1
   december 5, 2013 report recommendations of the behavioral health 
 coordinating committee of the prescription drug abuse subcommittee of 
                       health and human services
     Enhance surveillance:

         - Review current surveillance systems to identify ways to 
        better detect changing patterns of abuse and health outcomes, 
        and inform policy decisions and programmatic interventions.
         - Explore the predictive value of potential measures of abuse 
        such as doctor-shopping metrics in claims data and other data 
        sources.
         - Examine the role of prescriber dispensing in prescription 
        drug abuse and overdose.
         - Better understand the relationship of opioid dose and 
        duration that increases the risk of abuse and overdose.
         - Explore risk factors for addiction among patients receiving 
        opioids for legitimate medical purposes.
         - Examine potential unintended consequences that may result of 
        interventions aimed at reducing prescription drug abuse, such 
        as a decrease in legitimate access to pain treatment.

     Enhance drug abuse prevention (through HHS funded 
research)

         - Evaluate the effectiveness of drug abuse prevention programs 
        to reduce prescription drug abuse in order to inform the 
        implementation of evidence-based programs.
         - Conduct social science research to understand the initiation 
        of prescription drug abuse and to identify risk and protective 
        factors to prevent initiation.
         - Evaluate the impact of medication disposal programs on 
        prescription drug abuse and overdose. Evaluations should 
        include sampling to determine the proportion of returned drugs 
        that are controlled substances.

     Enhance patient and public education.

         - Convene Federal agencies to assure that patient education 
        activities and messaging is evidence-based and consistent 
        across agencies.
         - Leverage DEA's National Take Back Days, International 
        Overdose Awareness Day, National Substance Abuse Prevention 
        Month, National Drug Facts Week, and other special occasions as 
        opportunities to highlight the dangers of prescription drug 
        abuse to patients across the U.S.
         - Partner with professional societies, patient education 
        organizations, and others to expand targeted patient education 
        programs, focusing on the addiction risks of medications, the 
        dangers of mixing medications or mixing them with alcohol, and 
        what patients can do to safeguard their medications.
         - Work with public and private insurers and pharmacy benefit 
        managers to include targeted educational information to 
        beneficiaries receiving opioid analgesics and other 
        prescription drugs prone to abuse based on demographics, 
        medications prescribed, and conditions being treated.
         - Conduct research to determine the effectiveness of patient 
        education programs and use the findings to inform future 
        educational programs.

     Enhance provider education.

         - Convene Federal agencies to further coordinate the 
        development and dissemination of provider education programs to 
        ensure maximum reach and benefit.
         - Partner with health professional schools, educational 
        accrediting bodies and professional societies to continue 
        development of targeted educational programs to meet the needs 
        of different types of providers and practice settings.
         - Evaluate educational programs to determine the most 
        effective programs with respect to changing provider behavior, 
        improving prescribing, and reducing abuse and overdose.
         - Conduct research to determine the most effective ways to 
        provide educational programs and training to providers.

     Enhance Clinical Practice Tools

         - Convene professional societies to identify barriers and 
        potential incentives to increase provider use of Prescription 
        Drug Monitoring Programs (PDMPs).
         - Partner with electronic health record (EHR)/Health 
        Information Technology (HIT) stakeholders to expand the ongoing 
        work of the Health eDecisions (HeD) project to identify, 
        define, and harmonize standards to transmit data for use in 
        clinical decision support, including incorporating data from 
        state PDMPs, screening tools such as Screening, Brief 
        Intervention, and Referral to Treatment clinical decision 
        support, and other relevant clinical information.
         - Work with stakeholders to harmonize the data standards 
        necessary for the interoperable exchange of PDMP data with 
        EHRs.
         - Support pilot projects focused on the use of EHRs and health 
        information exchanges (HIEs) to improve clinical decisionmaking 
        through real-time access to intrastate and interstate PDMP 
        data.
         - Support efforts to integrate clinical tools into EHRs and 
        other electronic media to provide just in time information to 
        improve clinical decisionmaking.
         - Convene professional societies and subject matter experts to 
        synthesize information from available pain management 
        guidelines and the published literature to develop a set of 
        prescribing recommendations that can be incorporated into 
        clinical decision support tools.
         - Conduct research to determine the impact of opioid 
        prescribing guidelines on prescribing behaviors and health 
        outcomes such as opioid abuse and overdose.
         - Test the effectiveness of clinical decision support tools 
        designed to improve care and reduce prescription drug abuse and 
        overdose.
         - Partner with health information technology developers and 
        healthcare providers to validate electronic screening tools and 
        clinical decision support tools in EHRs.

     Opportunities to enhance regulatory oversight

         - Convene partners to develop indicators of inappropriate 
        prescribing and patient abuse that can be applied in regulatory 
        and oversight settings.
         - Encourage insurers and pharmacy benefit managers to 
        regularly review claims data and PDMP data, where available, to 
        identify and address healthcare providers prescribing outside 
        of accepted medical standards and patients at high-risk for 
        overdose.
         - Collaborate with state Medicaid programs, other public and 
        private insurers, and pharmacy benefit managers to identify and 
        implement robust programs that improve oversight of high-risk 
        prescribing.
         - Collaborate with stakeholders to research the effectiveness 
        of insurer benefit designs aimed at reducing prescription drug 
        abuse, and pill mill and doctor shopping laws, including 
        unintended consequences of these laws.

     Enhance drug abuse treatment

         - Partner with professional societies to identify barriers and 
        promote the integration of drug abuse treatment, including 
        SBIRT and medication assisted treatment, and primary care.
         - Collaborate with states, national associations, insurers, 
        and PBMS to assure standard benefit packages cover medication-
        assisted treatment and SBIRT, and to develop reimbursement 
        strategies that will increase the number of primary care 
        providers offering such treatment in a variety of medical 
        settings.
         - Partner with public and private insurers to develop and 
        disseminate materials to inform healthcare providers about 
        SBIRT billing codes and other administrative information.
         - Work with researchers and drug manufacturers to develop 
        additional medical treatments for opioid addiction and new 
        medical treatments for addiction to other abused prescription 
        drugs.
         - Support the development and testing of behavioral 
        interventions for screening and treating prescription drug 
        abuse, including interventions targeting youth and pregnant 
        women.

     Enhance overdose prevention

         - Expand efforts to support the development of new 
        formulations of naloxone, such as nasal spray or auto-injector 
        formulations.
         - Partner with national, state and local EMS and other first 
        responder organizations to disseminate information on the use 
        of naloxone.
         - Evaluate naloxone programs to better understand how and 
        under what conditions it is most effectively being used.
         - Examine the impact of immunity from prosecution laws.
                                 ______
                                 
Letter Submitted by Hon. Tammy Baldwin from National Alliance on Mental 
                                Illness
                                
                                
 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                               
                                
                                  ______
                                 
  Article Submitted by G. Caleb Alexander, MD: Opioid Prescribing: A 
Systematic Review and Critical Appraisal of Guidelines for Chronic Pain


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                                 ______
                                 
Report Submitted by G. Caleb Alexander, MD: The Prescription Opioid and 
  Heroin Crisis: A Public Health Approach to an Epidemic of Addiction
  
  
 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 


                                  [all]