    [Senate Hearing 113-680]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 113-680

                     OVERMEDICATION: PROBLEMS AND SOLUTIONS

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

                                    HEARING

                                   BEFORE THE

                         COMMITTEE ON VETERANS' AFFAIRS
                              UNITED STATES SENATE

                        ONE HUNDRED THIRTEENTH CONGRESS

                                 SECOND SESSION

                                   __________

                                 APRIL 30, 2014

                                   __________

           Printed for the use of the Committee on Veterans' Affairs

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

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                         COMMITTEE ON VETERANS' AFFAIRS

                     Bernard Sanders, (I) Vermont, Chairman
    John D. Rockefeller IV, West         Richard Burr, North Carolina,
        Virginia                             Ranking Member
    Patty Murray, Washington             Johnny Isakson, Georgia
    Sherrod Brown, Ohio                  Mike Johanns, Nebraska
    Jon Tester, Montana                  Jerry Moran, Kansas
    Mark Begich, Alaska                  John Boozman, Arkansas
    Richard Blumenthal, Connecticut      Dean Heller, Nevada
    Mazie Hirono, Hawaii
                        Steve Robertson, Staff Director
                     Lupe Wissel, Republican Staff Director

                                C O N T E N T S

                                  ----------

                                 April 30, 2014
                                    SENATORS

                                                                       Page
    Sanders, Hon. Bernard, Chairman, U.S. Senator from Vermont.......     1
    Burr, Hon. Richard, Ranking Member, U.S. Senator from North
      Carolina.......................................................     3
    Blumenthal, Hon. Richard, U.S. Senator from Connecticut..........     5
    Isakson, Hon. Johnny, U.S. Senator from Georgia..................     5
    Begich, Hon. Mark, U.S. Senator from Alaska......................    53

                                   WITNESSES

    Petzel, Robert, M.D., Under Secretary for Health, Veterans Health
      Administration, U.S. Department of Veterans Affairs;
      accompanied by Tracy Gaudet, M.D., Director, Office of Patient
      Centered Care and Cultural Transformation and Peter Marshall,
      M.D., Director of Primary Care Pain Management, Minneapolis VA
      medical center:
        Impromptu question/answer....................................     7
        Oral statement...............................................     8
        Prepared statement...........................................     9
        Response to posthearing questions submitted by:
          Hon. Bernard Sanders.......................................    19
          Hon. Mark Begich...........................................    23
          Hon. Richard Blumenthal....................................    24
    Coots, BG Norvell V., USA, Deputy Commanding General (Support),
      U.S. Army Medical Command and Assistant Surgeon General for
      Force Projection, Office of the Surgeon General, U.S. Army;
      accompanied by COL Kevin T. Galloway, Director, Army Pain
      Management Program, Rehabilitation and Reintegration Division..    24
        Prepared statement...........................................    26
        Response to posthearing questions submitted by:
          Hon. Bernard Sanders.......................................    32
          Hon. Richard Blumenthal....................................    34
          Hon. Mark Begich...........................................    35
    Briggs, Josephine, M.D., Director, National Center for
      Complementary and Alternative Medicine, National Institutes of
      Health.........................................................    36
        Prepared statement...........................................    38
        Response to posthearing questions submitted by:
          Hon. Bernard Sanders.......................................    40
          Hon. Mark Begich...........................................    42
        Additional information.......................................    44
    Kahn, Janet, Ph.D., Research Assistant Professor, Department of
      Psychiatry, University of Vermont and Senior Policy Advisor,
      Consortium of Academic Health Centers for Integrative Medicine.    60
        Prepared statement...........................................    63
    Edlund, Mark, M.D., Ph.D., Senior Research Public Health Analyst,
      Behavioral Health Epidemiology Program, RTI International......    97
        Prepared statement...........................................    99

                                    APPENDIX

    American Legion, The; prepared statement.........................   109
    Ilem, Joy J., Deputy National Legislative Director, Disabled
      American Veterans (DAV); prepared statement....................   112
    Maffucci, Jacqueline A., Ph.D., Research Director, Iraq &
      Afghanistan Veterans of America (IAVA); prepared statement.....   115
    Citizens Commission on Human Rights International (CCHR); report.   117

                     OVERMEDICATION: PROBLEMS AND SOLUTIONS

                                  ----------

                           WEDNESDAY, APRIL 30, 2014

                                           U.S. Senate,
                                Committee on Veterans' Affairs,
                                                        Washington, DC.
        The Committee met, pursuant to notice, at 10:05 a.m., in
    room 418, Russell Senate Office Building, Hon. Bernard Sanders,
    Chairman of the Committee, presiding.
        Senators present: Senators Sanders, Rockefeller, Begich,
    Blumenthal, Burr and Isakson.

              OPENING STATEMENT OF HON. BERNARD SANDERS,
                  CHAIRMAN, U.S. SENATOR FROM VERMONT

        Chairman Sanders. Let us get to work. Let me thank our
    panelists for being with us for a really important discussion
    about a significant issue.
        Within the veterans' community--and in fact, throughout our
    Nation both in the public sector and the private sector--we
    face a very serious problem of overmedication.
        The result of that overmedication is significant numbers of
    people treated in the Department of Defense facilities, VA
    facilities, and in the private sector become dependent upon
    those medications intended to help them and ease their pain.
    Pain is a huge problem in the country and how we treat that
    pain in the most effective way is really what we are discussing
    today.
        Some people who are treated with a whole lot of medication
    become addicted, and I think we all know what happens when
    people become addicted, in the worst cases some may end up
    losing their lives due to overdoses. In my State and throughout
    this country, this is a huge problem.
        This is a major issue that has been discussed on this
    Committee during the last year, and we are so glad we have such
    a distinguished panel with us today to help us examine this
    problem.
        But, before we get to this issue at hand, I did want to say
    a very brief word about another issue that has attracted a lot
    of attention in this country, and that is the developing
    situation at the VA medical center in Phoenix.
        As I think everyone in this room knows, some very, very
    serious allegations have been made regarding delays in health
    care access and, as a result, the possible deaths of veterans.
    I just want to make it very very clear that I take and this
    Committee takes these allegations extremely seriously; and we
    are going to do everything we can to get to the bottom of this
    story and get to the truth.
        Yesterday I spoke to the VA's acting inspector general,
    Richard Griffin. There is a thorough investigation being
    conducted by the VA IG in Phoenix and I have been assured by
    Mr. Griffin that he has the resources he needs to thoroughly
    investigate that situation.
        I expect that the inspector general's office will conduct
    its investigation thoroughly and provide this Committee with an
    objective analysis of these very serious allegations. And as I
    indicated the other day, it is my intention to hold a hearing
    on this issue once the inspector general's inquiry is complete.
        I want to make two brief points on this issue. First, we
    will get to the bottom of what has happened in Phoenix. We will
    reach conclusions based on an objective investigation of the
    facts, not TV reports but an objective investigation of the
    facts.
        Second, we should not let these allegations impugn the
    excellent work done throughout this country by hundreds of
    thousands of VA doctors, nurses, administrators, and staff at
    all levels, many of whom are veterans themselves or are closely
    related to veterans.
        I have been all over this country. I just came back from
    the VA facility in Minneapolis, MN, and my assessment is that
    we have some great people there doing great work.
        Additionally, a recent survey by the American Consumer
    Satisfaction Index, an independent consumer service survey,
    pointed out patient satisfaction is incredibly high within VA--
    higher, perhaps, than the private sector. And I can tell you in
    Vermont--and I think this story is true all over this country--
    that when veterans walk into the VA, they feel very good about
    the quality of care they get.
        And I do not want anything that is happening or may have
    happened in Phoenix to impugn the very good work done by people
    throughout this country.
        Getting back to the issue at hand, as a Nation, we must
    remember that for many veterans, chronic pain is a part of
    their daily life. According to VA data, the most common
    diagnosis among post-
    9/11 veterans is musculoskeletal ailments, including joint,
    neck, and back disorders. Chronic pain is a common symptom of
    this cluster of conditions.
        VA research demonstrates greater than 50 percent of male
    veterans using VA primary care report instances of chronic pain
    and the prevalence of chronic pain may be even higher among
    women veterans.
        Therefore, options for managing chronic pain among our
    veteran population are paramount to improving quality-of-life
    and reintegration.
        Additionally, PTSD, along with other mental health
    diagnoses, such as depression and anxiety, are frequently
    diagnosed among our veterans. According to the most recent data
    from VA, more than 55 percent of our post-9/11 veterans have
    been diagnosed with some type of mental health disorder.
        Just as with chronic pain, it is critical these veterans
    receive the treatment they need and deserve. Oftentimes,
    opioids are used to treat both chronic pain and certain mental
    health disorders. While opioids can be quite effective in
    treating these conditions, they also come with significant risk
    which is what we are going to be discussing today.
        Therefore, it is critical that these medications are
    prescribed to the right patients, with careful monitoring and a
    clear understanding of proper usage.
        I would point out that Senator John Boozman of Arkansas has
    been one of those Senators here who has raised this issue and I
    think, as we all know, John has been in the hospital with a
    heart issue. I think I speak for the whole Committee in wishing
    him the very best of luck and returning to us as soon as
    possible.
        Senator Burr.

            STATEMENT OF HON. RICHARD BURR, RANKING MEMBER,
                    U.S. SENATOR FROM NORTH CAROLINA

        Senator Burr. Well, thank you, Mr. Chairman, and let me
    report for my colleagues that Senator Boozman is home. He did
    not have a heart attack. He had a problem with his aorta. It
    was not an aneurism. It was a genetic flap that had he not
    caught it and had they not been able to do a surgical graft on
    his aorta, he would not have survived like many Americans.
        But the report is good. He is home. He will be back with us
    hopefully soon with a few synthetic parts but I think that by
    all accounts those synthetic parts work every bit as good as
    the original.
        Mr. Chairman, thank you for this hearing and, as important,
    thank you to our witnesses for being here.
        Since the Chairman has talked about Phoenix, let me just
    say this. This is not the first issue on quality of care that
    faces the department, and one veteran death related to delays
    in care is one too many.
        I strongly believe that this Committee needs to hold
    aggressive oversight hearings into these issues that the
    department continues to struggle with, including long wait
    times for specialty care appointments, the misuse of wait
    lists, and the issues documented in the health care inspections
    conducted by the inspector general which, by my count, is now
    over 50 since January 2013.
        Even with all of these issues being publicly reported or
    included in the reports by the IG, this Committee has yet to
    hold a single oversight hearing on the quality of care veterans
    are receiving at the VA facilities.
        Mr. Chairman, I would fully support and urge you to hold
    those hearings.
        I say as it relates to Phoenix, I think the Chairman is
    right. Let us get as many of the facts as we can and not rely
    on what is publicly printed.
        But again, I point to the IG investigations from the past
    and suggest that it is the responsibility of this Committee to
    respond to some of the problems and to work with the VA, Dr.
    Petzel, as a partner. And I have never seen the agency shy away
    from trying to solve those quality of care issues.
        Now, turning to today's subject matter, the United States
    is facing an epidemic of prescription drug abuse. That is why
    it is important that we are here today to conduct oversight
    over the care of veterans who have chronic pain. It is critical
    that we ensure that VA is taking the necessary steps to address
    the overuse of certain medications and the potential risk of
    misuse and dual prescriptions.
        It has been estimated that as many as 50 percent of male
    veterans and as high as 75 percent of female veterans--OEF and
    OIF veterans--struggle with pain.
        The prevalence of chronic pain will likely increase as more
    servicemembers transition into the VA system. These numbers
    demonstrate the need for VA to provide quality pain management
    services to ensure veterans with chronic pain are able to live
    productive and healthy lives.
        According to the Centers for Investigative Reporting,
    between 2001 and 2012 the number of VA prescriptions within
    four opiate categories--including hydrocodone, oxycodone,
    methadone, and morphine--surged 270 percent. Additionally,
    during 2012, VA providers wrote more than 6.5 million
    prescriptions within those opiate categories.
        I found these numbers alarming, in combination with recent
    media reports that describe veterans with known and documented
    drug addictions who were still being prescribed these types of
    medications.
        I would just like to highlight a couple of stories. A
    veteran with PTSD who self-medicated using oxycodone and heroin
    who later struggled to become clean and sober, who is still
    struggling with PTSD and his addiction, now faces a new battle
    with the VA system which continues to prescribe him opiates
    even though his electronic health record documents his
    addiction and the subsequent detox provided by VA.
        Another veteran, while still on active duty, says he was
    injecting himself with an anti-inflammatory drug prescribed by
    military doctors. When he was treated by VA, they only
    responded to his pain by, ``loading him up on narcotics.'' This
    veteran goes on to make the following statement, ``There were
    better options to treat my pain, and those were not presented
    to me. The priority was treating me the fastest, seemingly
    least expensive way, and it was the most detrimental.''
        Now, I am not sure that this is the patient-centered or
    veteran-centric care that we constantly hear VA describing.
    Even in today's testimony from the Department we will hear,
    ``care is increasingly personalized, proactive and patient
    driven.''
        If these stories reflect what VA believes is personalized,
    proactive, and patient driven, we have more problems to address
    than just the quality of care and long wait times.
        When it comes to the care we are providing to those who
    have sacrificed so much for our Nation, we cannot afford to get
    it wrong. This Committee needs to hold VA accountable to ensure
    they are providing world-class care.
        Right now, with the media reports and even VA's own
    research, I am not sure we are. Today VA will describe their
    policies, directives, and initiatives to ensure opiate
    therapies are prescribed to veterans in a safe manner. It is
    our obligation to hold VA accountable and to ensure that they
    are providing the highest standard of care to those who are
    already in the system.
        Mr. Chairman, I thank you for calling this hearing. I look
    forward to the witnesses' testimony which will enlighten us and
    the opportunity to follow up with questions.
        Chairman Sanders. Senator Burr, thank you very much.
        Senator Blumenthal.

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

        Senator Blumental. Thank you, Mr. Chairman.
        I want to thank our witnesses for being here and for your
    dedicated and hard work to the service of our veterans and our
    Nation; and thank you, Mr. Chairman and Ranking Member Burr for
    your comments.
        I want to join in expressing my very strong alarm about the
    reports from Arizona. If true, these reports indicate not only
    a betrayal of trust but also, very bluntly, violation of our
    criminal laws in shredding documents and obfuscating evidence
    that is important to protect the public trust.
        So, I hope that the inspector general will complete his
    report as quickly as possible to restore that trust and
    confidence in the integrity of our system.
        I want place in the record, Mr. Chairman, if I may, a
    request that we be informed as to what the time table is for
    completing that investigation because I very much share the
    Chairman's concern that this Committee has a obligation
    separately and independently of the inspector general, which
    has been articulated by the ranking member as well, that we
    uncover whatever the facts are here and make sure that we
    fulfill our responsibility. And I believe that if the inspector
    general's investigation lags that we should proceed
    independently.
        I agree that we should make use of the inspector general's
    investigation if it proceeds promptly but I think that we
    should require some kind of preliminary report to us as to what
    the claims are and what the preliminary findings are because
    the reports about a secret waiting list, and about neglect of
    care, and about disregard of the responsibility to provide that
    care are beyond alarming. They are truly angering.
        I want to also express my interest and concern about the
    subject matter of this investigation. I have seen in
    Connecticut, as we have around the country, an epidemic of
    overuse and abuse of these powerful pain killers and other
    prescription drugs. They are not only deeply concerning
    themselves, but they are potentially a gateway to other abuse
    such as heroin.
        We have seen in Connecticut and Vermont as well, Mr.
    Chairman, how these prescription drugs can be a gateway to
    heroin use and other drug abuses; and so, particularly when it
    comes to our veterans, we need to make sure that we do whatever
    possible to prevent this kind of overuse and abuse. I know that
    alternate care, which we will discuss today, is integral to
    that effort.
        Thank you very much, Mr. Chairman.
        Chairman Sanders. Thank you, Senator Blumenthal.
        Senator Isakson.

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

        Senator Isakson. Well, Chairman Sanders, thank you for
    calling this hearing. I want to echo the words of Ranking
    Member Burr, yourself, and Senator Blumenthal that the Arizona
    situation is troubling for all of us.
        I am glad we are going to get to the bottom of it. I hope
    we will do so as expeditiously as possible, and then I hope we
    can take action to help support VA in finding out where there
    is a problem, if there is one, and then correcting it.
        Dr. Petzel and I have become close friends over the last 8
    to 9 months because of incidences that neither one of us wish
    would have happened. His quick response in Atlanta has been
    greatly appreciated. His response at the VA hospital in Augusta
    has been greatly appreciated, and the fact that he is going to
    be visiting in the next week, I think this weekend, again is
    very much appreciated and his attention to those matters.
        The VA situation we had in Augusta 2 or 3 years ago: the
    concern about, sterilization of colonoscopy and endoscopy
    equipment, the difficulty that we had in Atlanta with the
    suicide situation and the postponement or untimely following of
    mental health patients; and now what has happened in Arizona
    should be a warning call for all of us.
        I believe we have 340,000 great employees at VA. They do a
    tremendous job; and as the Chairman and Ranking Member said, I
    am very proud of what they do. But if there is a growing
    culture that believes it does not matter or it is not as
    important or our care is not as important as we think it should
    be, we need to nip that in the bud and see to it VA is to every
    veteran and to this country what it was promised to and what it
    must be.
        I think it is important and incumbent upon this Committee
    to get to the bottom, wherever the facts lead us, and to get
    the leadership of VA to go with us so that hand-in-hand we can
    correct the inequities that are going on.
        My last point is this. Pharmaceutical therapy is a godsend
    in terms of pain, in terms of management of disease and other
    chronic ailments. But it also can interact inappropriately with
    other drugs for other ailments. It can also be overprescribed.
    It also can mask a greater problem, particularly with regard to
    mental health.
        This is a terribly important hearing today. I am not a
    person of medicine nor a person of science but I am familiar
    enough with what goes on in terms of drug abuse and one drug
    leading to another, that we cannot allow ourselves to take the
    easy way out in terms of pain management or therapy for our
    veterans.
        We need to always be looking for the long-term benefit of
    that veteran, not just the short-term easing of pain when we
    are prescribing the power opiates that we are talking about
    today.
        Thank you for calling this hearing, Mr. Chairman.
        Chairman Sanders. Senator Isakson, thank you very much for
    your very apt and important remarks. I agree with virtually
    everything you said.
        What I want to do now, if it is alright with the Committee,
    is to introduce our panelists, but I did want to give Dr.
    Petzel a minute or two to address concerns about Arizona. I
    want the main focus of this hearing to stay on overmedication
    while there is interest about what is happening in Arizona.
        Dr. Petzel, could you briefly give us your understanding of
    the situation there?
        Dr. Petzel. Thank you very much, Chairman Sanders.
        First of all, it is important to state that we do care very
    deeply about the care of every single veteran that we are
    privileged to serve. They have earned and they deserve the
    absolute highest quality care that we can provide.
        We take these allegations, as all of you do, very
    seriously. That is why we have asked the independent office of
    VA's IG to go there and do an objective, independent, complete
    review as to exactly what has occurred.
        We also sent, from VHA, a team to Phoenix early to review
    the appointment and scheduling processes, and I need to say
    that to-date we found no evidence of a secret list and we have
    found no patients who have died because they have been on a
    wait list.
        We think it is very important that the inspector general be
    allowed to finish their investigation before we rush to
    judgment as to what has actually happened in Phoenix.
        The other important point is that when an incident like
    this occurs, as with colonoscopies and mental health consults
    that were mentioned earlier, we conduct a thorough systemwide
    look which we are in the process of doing now with scheduling
    and wait lists, seeing if the alleged practices are not
    occurring at any one of our other 150 medical centers.
        If the allegations are true, they are absolutely
    unacceptable and we--if the inspector general does confirm and
    substantiate these claims--we are going to take swift and very
    appropriate action.
        The last point is that the veterans deserve to have full
    faith in their VA health care system. VA facilities are
    committed to transparency. We undergo multiple external and
    independent reviews and every year we are committed to ensuring
    our veteran community and the public that VA hospitals are safe
    and that the quality of care there is high.
        Finally, as has been mentioned by several of you, we do
    appreciate the hard work and the dedication of all of our
    employees. These people are committed to the person to
    providing, again, the best care possible to these veterans who
    have earned and who deserve that care.
        Thank you.
        Chairman Sanders. OK. Thank you very much, Dr. Petzel.
        I thought it was important we deal with that issue briefly.
    Now, let us focus on the issue at hand which is overmedication
    problems and solutions. In order to address that issue, we have
    two excellent panels.
        Our first panel will include Dr. Petzel, who is the Under
    Secretary for Health, Veterans Health Administration,
    Department of Veterans' Affairs; accompanied by Dr. Tracy
    Gaudet, who is the Director, Office of Patient Centered Care
    and Cultural Transformation. Dr. Peter Marshall, Director of
    Primary Care Pain Management at the Minneapolis VA medical
    center.
        Brigadier General Norvell V. Coots, Deputy Commanding
    General, U.S. Army Medical Command and Assistant Surgeon
    General for Force Projection, Office of the Surgeon General;
    and he is accompanied by Colonel Kevin T. Galloway, Program
    Director, Army Pain Management Program.
        We also have Dr. Josephine Briggs, Director of the National
    Center for Complementary and Alternative Medicine, National
    Institutes of Health.
        So, thank you all very much for being with us; and Dr.
    Petzel, you may begin.

     STATEMENT OF ROBERT PETZEL, M.D., UNDER SECRETARY FOR HEALTH,
      VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS
    AFFAIRS; ACCOMPANIED BY TRACY GAUDET, M.D., DIRECTOR, OFFICE OF
      PATIENT CENTERED CARE AND CULTURAL TRANSFORMATION AND PETER
       MARSHALL, M.D., DIRECTOR OF PRIMARY CARE PAIN MANAGEMENT,
                     MINNEAPOLIS VA MEDICAL CENTER

        Dr. Petzel. Good morning, Chairman Sanders, Ranking Member
    Burr, and the Members of the Committee.
        I want to thank you for the opportunity to participate in
    this hearing to discuss the Department of Veterans Affairs'
    pain management and opioid safety programs, our use of
    complementary and alternative medicine, and psychotropic drug
    safety. I am accompanied today by Dr. Gaudet as was mentioned
    earlier and by Dr. Peter Marshall.
        Before I begin, I want to express my joy at hearing that
    Senator Boozman is recuperating well. We wish him a speedy
    recovery and look forward to him participating again in the
    affairs of this Committee.
        Let me begin today by acknowledging all of our Nation's
    veterans who suffer from chronic and acute pain. The burden of
    pain on veterans is considerable. Studies say that more that 50
    percent of all veterans receiving care at the VA are affected
    by some type of chronic pain, much of it being musculoskeletal.
        Six elements of effective pain control include the safe and
    effective use of pain care to enhance the quality of life and
    the satisfaction of veterans that are living with chronic pain.
        VA's concept of safe and effective pain care follow these
    six essential elements. Education of veterans and family
    members about good pain care. Education of the treatment teams
    about good pain care. Developing non-pharmacological and self-
    management approaches. Safe and evidence-based use of all
    interventions and medications including opioids. Developing
    effective modalities for bringing pain care, especially
    expertise, to the veteran when needed. And finally, monitoring
    pain care efficacy at both the individual veteran level and at
    the system level.
        VA recently developed and implemented an innovative opioid
    safety program. This program uniquely combines feedback to
    providers at facilities on their prescribing practices with
    education and training to ensure opioid pain medications are
    used safely, effectively, and judiciously across our entire
    system.
        The purpose of the initiative is to help ensure that pain
    management is addressed thoughtfully, compassionately, and
    safely. This initiative holds considerable promise for
    mitigating the risks of harm among veterans receiving long-term
    opioid therapy, for promoting provider competence and safe
    prescribing of opioids, and in promoting veteran-centered,
    evidence-based, coordinated, disciplined, multi-disciplinary
    pain care for chronic pain.
        For cases where veterans have developed problems with
    opioid abuse and addiction, VA offers effective evidence-based
    treatments for opioid use disorder. Intensive treatments
    consisting of options for evidence-based psychotherapy and
    effective pharmacological therapy for opioid use disorder is
    available at all of our VA medical centers to help facilitate
    veterans' recovery.
        Recognizing that psycho-pharmacological treatments for
    mental health conditions require on-going efforts in quality
    improvement, VA is implementing a psychosocial drug safety
    initiative.
        It addresses pharmacological treatments across the range of
    mental health conditions including PTSD, depression,
    schizophrenia, bipolar disorder, substance abuse disorder, and
    many other mental health conditions.
        This psychotropic drug initiative is designed to identify
    overuse, underuse, and inappropriate use of these drugs by
    reviewing provider prescribing habits, patient use, and
    providing feedback to providers about their use of these
    medications and education about the appropriate use when we do
    find that the use is inappropriate.
        Key leadership has identified as its number 1 strategic
    goal to provide veteran patients with personalized, proactive,
    patient-driven health care. This approach to health prioritizes
    the veteran and their values and partners with them to
    personalize the strategies to optimize their health, healing,
    and sense of well-being.
        Many of the strategies that may be of benefit extend beyond
    what we conventionally address or provide by the health care
    system. Integrative medicine, which includes complementary and
    alternative medicine, provides a framework that aligns with
    this goal of personalized, proactive, patient-drive care.
        There is a growing evidence for the effectiveness of non-
    pharmacological approaches as part of a comprehensive plan for
    chronic pain. These include acupuncture, massage, chiropractic
    care, mindfulness meditation, exercise therapy, relaxation
    therapies, and yoga. These are all being increasingly made
    available to our veteran patients.
        Mr. Chairman, we know our work to improve veteran care
    through accessible, safe, and effective pain management service
    is an ongoing task and is not yet finished.
        However, we are confident that we are developing and
    implementing programs that are responsive to veteran needs. We
    appreciate your support in identifying and resolving these
    challenges as we find new ways to care for America's veterans.
        Mr. Chairman, this concludes my testimony. My colleagues
    and I are prepared to answer your questions.
        [The prepared statement of Dr. Petzel follows:]
     Prepared Statement of Dr. Robert Petzel, Under Secretary for Health,
       Veterans Health Administration (VHA), U.S. Department of Veterans
                                    Affairs
        Good morning, Chairman Sanders, Ranking Member Burr, and Members of
    the Committee. Thank you for the opportunity to participate in this
    hearing and to discuss the Department of Veterans Affairs' (VA) pain
    management programs and the use of complementary and alternative
    medicine. I am accompanied today by Dr. Tracy Gaudet, Director of
    Office of Patient Centered Care & Cultural Transformation, and Dr.
    Peter Marshall, Director of Primary Care Pain Management.
        The challenges related to living with chronic pain and providing
    safe and effective pain care are by no means unique to Veterans and the
    VA health care system. As described in the 2011 Institute of Medicine
    (IOM) report, ``Relieving Pain in America: A Blueprint for Transforming
    Prevention, Care, Education, and Research,'' \1\ pain is a public
    health challenge that affects millions of Americans and is increasing
    in prevalence. Pain contributes to morbidity, mortality, and disability
    across our Nation and the costs of pain can be measured both in terms
    of human suffering as well as economic impact. The IOM estimated that
    chronic pain alone affects 100 million United States citizens and that
    the cost of pain in the United States is at least $560-$635 billion
    each year, which is the combined cost of lost productivity and the
    incremental cost of health care.
    ---------------------------------------------------------------------------
        \1\ Institute of Medicine. 2011. Relieving Pain in America: A
    Blueprint for Transforming Pain Prevention, Care, Education and
    Research. Washington, DC: The National Academies Press.
    ---------------------------------------------------------------------------
                            chronic pain in veterans
        The burden of pain on the Veteran population is considerable. We
    know that Veterans have much higher rates of chronic pain than the
    general population, with more than 50 percent of all Veterans enrolled
    and receiving care at VA affected by chronic pain.\2\ Chronic pain is
    the most common medical problem in Veterans returning from the last
    decade of conflict (almost 60 percent).\3\ Many of these Veterans have
    survived serious and at times catastrophic injuries frequently a result
    of road-side bombs and other blast injuries. These events can result in
    multiple physical traumas including amputations and spinal cord
    injuries as well as concomitant psychological trauma which can compound
    chronic pain concerns. Often these Veterans require a combination of
    strategies for the effective management of pain, which may include
    treatment with opioid analgesics. That makes pain management a very
    important clinical issue for VA. Further, the treatment of pain is
    highly complex, and in the recent past, health care providers have
    often been accused of undertreating the pain that patients suffer.
    Getting the balance right is a challenge that we continue to work
    toward.
    ---------------------------------------------------------------------------
        \2\ Gironda, R.J., Clark, M.E., Massengale, J.P., & Walker, R.L.
    (2006).. Pain among Veterans of Operations Enduring Freedom and Iraqi
    Freedom. Pain Medicine, 7, 339-343.
        \3\ Veterans Health Administration (2013). Analysis of VA health
    care utilization among Operation Enduring Freedom (OEF), Operation
    Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Washington,
    DC: Department of Veterans Affairs.
    ---------------------------------------------------------------------------
        In 2010, VA and the Department of Defense (DOD) published evidence-
    based Clinical Practice Guidelines for the use of chronic opioid
    therapy in chronic pain. The guidelines reserve the use of chronic
    opioids for patients with moderate to severe pain who have not
    responded to, or responded only partially to, clinically indicated,
    evidence-based pain management strategies of lower risk, and who also
    may benefit from a trial of opioids to improve pain control in the
    service of improving function and quality of life.
        We also know that the long-term use of opioids is associated with
    significant risks, and can complicate health care for Veterans with
    Posttraumatic Stress Disorder (PTSD), depression, Traumatic Brain
    Injury (TBI) and family stress--all common in Veterans returning from
    the battlefield, and in Veterans with substance use disorders. Chronic
    pain in Veterans is often accompanied by co-morbid mental health
    conditions (up to 50 percent in some cohorts) caused by the
    psychological trauma of war, as well as neurological disorders, such as
    TBI caused by blast and concussion injuries. In fact, one study
    documented that more that 40 percent of Veterans admitted to a
    polytrauma unit in VHA suffered all three conditions together--chronic
    pain, PTSD, and post-concussive syndrome.\4\
    ---------------------------------------------------------------------------
        \4\ Lew, H.L., Otis, J.D., Tun, C., Kerns, R.D., Clark, M.E., &
    Cifu, D.X. (2009). Prevalence of chronic pain, Post Traumatic Stress
    Disorder, and post-concussive syndrome in OEF/OIF veterans: The
    polytrauma clinical triad. Journal of Rehabilitation Research and
    Development, 46, 697-702.
    ---------------------------------------------------------------------------
        In addition to these newly injured Veterans suffering from chronic
    pain conditions and neuropsychological conditions, VA cares for
    millions of Veterans from prior conflicts, who along with chronic pain
    and psychological conditions resulting from their earlier combat
    experiences, are now developing health concerns related to aging, such
    as cancer, neuropathies, spinal disease, and arthritis, all of which
    may be accompanied by chronic and at times debilitating pain. All of
    these Veterans deserve safe and effective pain care that may include
    the use of opioid analgesics when clinically appropriate.
        Thus, VA cares for a population that suffers much higher rates of
    chronic pain than the civilian population, and also experiences much
    higher rates of co-morbidities (PTSD, depression, TBI) and
    socioeconomic dynamics (family stress, disability, joblessness) that
    contribute to the complexity and challenges of pain management with
    opioids.\5\ So even as more Veterans have the kind of severe and
    disabling pain conditions that require stronger treatments such as
    opioids, so do more of them have increased risk for overdose
    complicated by depression, PTSD and substance use disorders.
    ---------------------------------------------------------------------------
        \5\ See citations 3 and 4.
    ---------------------------------------------------------------------------
        In recognition of the seriousness of the impact of chronic pain on
    our Veterans' health and quality of life, VHA was among one of the
    first health systems in the country to establish a robust policy on
    chronic pain management and to implement a system-wide approach to
    addressing the risks of opioid analgesia.
        I would like to at this time outline our approach to this pain care
    transformation. I will highlight VA's current pain management
    strategies as well as actions being taken to improve the management of
    chronic pain, including the safe use of opioid analgesics, the
    prevalence and use of opioid therapy to manage chronic pain in high
    risk Veterans, the challenges of prescription drug diversion \6\ and
    substance use disorders among Veterans, and efforts being made to
    broaden non-pharmacological approaches to pain care. I will also
    describe some of the best pain care practices across the VA health care
    system.
    ---------------------------------------------------------------------------
        \6\ Diversion is the use of prescription drugs for recreational
    purposes.
    ---------------------------------------------------------------------------
                             va's pain care mission
        VA's mission relative to pain care is simple: safe and effective
    pain care to enhance the quality of life and satisfaction of all
    Veterans living with chronic pain.
        VA's concept of safe and effective pain care includes the following
    six essential elements:

        1. Education of Veterans and family members about good pain care;
        2. Education of the treatment teams about good pain care;
        3. Developing non-pharmacological and self-management approaches;
        4. Safe and evidence-based use of all interventions and
    medications, including opioids;
        5. Developing effective modalities for bringing pain care specialty
    expertise to the Veteran; and
        6. Monitoring pain care efficacy at the individual and system
    level.

        As a blueprint for implementing these principles throughout the
    system,\7\ VHA Pain Management Directive 2009-053 \8\ was published in
    October 2009 to provide uniform guidelines and procedures for providing
    pain management care. These include standards for pain assessment and
    treatment, including use of opioid therapy when clinically appropriate,
    for evaluation of outcomes and quality of pain management, and for
    clinician competence and expertise in pain management. Since
    publication of the Pain Management Directive, a dissemination and
    implementation plan has been enacted that supports the following:
    ---------------------------------------------------------------------------
        \7\ The overall objective of the national strategy is to develop a
    comprehensive, multicultural, integrated, system-wide approach pain
    management that reduces pain and suffering and improves quality of life
    for Veterans experiencing acute and chronic pain associated with a wide
    range of injuries and illnesses, including terminal illness.
        \8\ www.va.gov/vhapublications/viewpublication.asp?pub_id=2781

         Comprehensive staffing and training plans for providers
    and staff;
         Comprehensive patient/family education plans to empower
    Veterans in pain management;
         Development of new tools and resources to support the pain
    management strategy; and
         Enhanced efforts to strengthen communication between VA's
    Central Office (VACO) and leadership from facilities \9\ and Veterans
    Integrated Service Networks (VISN).
    ---------------------------------------------------------------------------
        \9\ The term ``facilities'' or ``facility'' refers to VA's 151
    medical centers, hospitals, or health care systems.

        Following the guidance of the VHA National Pain Management
    Strategy, and in compliance with generally accepted pain management
    standards of care, the Directive provides policy and procedures for the
    improvement of pain management through implementation of the Stepped
    Care Model for Pain Management (SCM-PM), the single standard of pain
    care for VHA, central to ensuring Veterans receive appropriate pain
    management services. The Directive also requires tracking opioid use
    and implementing strong practices in risk management to improve
    Veterans' safety.
        To establish the six essential elements of good pain care listed
    above, numerous modalities have been recently implemented or are in the
    process of implementation throughout the VHA, including: pain schools,
    tele-pain schools, apps and web based modules for patient and family
    education; case based audio conferences, Rural Health Initiative and
    VeHU trainings, Nation-wide community of practice calls and numerous
    other training initiatives to educate and train teams; developing
    Cognitive Behavioral Therapy (CBT) in primary care, tele-CBT, self-
    management strategies and complementary and integrative medicine
    modalities; a number of initiatives to address opioid prescribing which
    I will discuss shortly; e-consultation, Specialty Care Access Network-
    Extension for Community Healthcare Outcomes (SCAN-ECHO), and
    telemedicine to bring pain care expertise to all settings; and pain
    dashboards to monitor care at the individual and populations levels.
        VA facilities are now increasingly leveraging their video
    conferencing capabilities to reach Veterans in the community based
    outpatient clinics (CBOC) both rural and highly rural to provide group
    and individual visits for pain schools, evidence based CBT, smoking
    cessation, and weight loss through the MOVE program all important for
    the self-care and self-management skills needed as part of a chronic
    pain care plan.
        A particularly exciting initiative is the development of a pain
    management application for smart phones that will be used by Veterans
    and their care partners to develop pain self-management skills. This
    tool, called VA Pain Coach, will eventually interface with VHA's
    Electronic Health Record (EHR), with appropriate privacy protections,
    allowing Veteran-reported information about pain, functioning, and
    other key elements in a secure mobile application environment to be
    securely stored and accessible to clinicians. VA Pain Coach, which is
    part of a suite of VA applications called ``Clinic in Hand,'' has just
    finished a one-year pilot test phase with 1150 Operation Enduring
    Freedom/Operation Iraqi Freedom/Operation New Dawn Veterans and their
    caregivers and is now being converted to HTML 5 and will be available
    for smart phones, tablets and as a web based application. In the
    future, a complementary initiative will build a clinician-facing
    application that will enhance the capacity of clinicians and Veterans
    to share in monitoring, decisionmaking, treatment planning, and
    reassessment of pain management interventions.
      the patient aligned care team (pact): the core of the stepped care
                                     model
        The VA approach to pain care mirrors its approaches to all health
    care concerns: care is increasingly personalized, proactive and patient
    driven. Chronic pain, as is the case with all chronic health
    conditions, is most safely and effectively addressed using a
    biopsychosocial model in which all aspect of the Veterans health and
    well-being are included in both the assessment and management of the
    condition: physical health, psychological health and social health. The
    basic platform for providing such care is the Veteran's PACT, or
    patient aligned care team, supported by pain and other specialists.
    PACT is a partnership between the Veteran and the health care team,
    which emphasizes prevention, health promotion, and self-management.
    Veterans are the center of the care team and the PACT teamlet, which
    includes at its core a primary care provider, nurse care manager,
    clinical associate, and clerical associate. Core pain teams in PACT
    often add a behavioral health clinician and pharmacist to help address
    the complexity of pain management.
    the pain medicine specialty team: specialty care access supporting pact
        PACT access to consultation and collaborative care with
    interdisciplinary pain specialty teams is critical. VHA's Pain Medicine
    Specialty Team Workgroup, chartered on January 26, 2012, provides
    standards for pain specialty care services and support of PACT pain
    management in the Stepped Care Model. Key areas of focus include the
    development of collaborative care models and participation in provider
    and team education through telehealth, e-consults, and SCAN-ECHO. VA
    SCAN-ECHO pain experts provide didactics and case-based learning to
    PACT members using videoconferencing technologies to strengthen the
    competencies of providers in pain management. More than 95 percent of
    VHA facilities have specialty pain clinics with documented yearly
    increases in use and capacity.
           vha pain management centers: developing and promulgating
                                strong practices
        The complexity of managing chronic pain may require a more
    intensive and structured approach to care than can be provided in the
    primary care or specialty pain medicine clinics. To address the need
    for tertiary care pain services, on December 15, 2010, the VHA charted
    the Interdisciplinary Pain Management Workgroup to assist Veterans
    Integrated Service Network (VISN) Directors in determining the need for
    tertiary pain care and pain rehabilitation services. As of
    January 2014, VA has ten sites in seven VISNs with Commission on
    Accreditation of Rehabilitation Facilities (CARF)-accredited tertiary
    care pain rehabilitation programs, an increase from only 2 programs in
    2009, with 11 more sites in active preparation or actually applying for
    CARF status. These Centers have the capacity for providing advanced
    pain medicine diagnostics, surgical and interventional procedures, and
    in addition provide intensive, integrated chronic pain rehabilitation
    for Veterans with complex, co-morbid, or treatment refractory
    conditions.
        VHA is in process of greatly expanding access to such Chronic Pain
    Rehabilitation Centers. Pursuant to the expectation that every VISN
    shall have at least one CARF-accredited tertiary, interdisciplinary
    pain care program no later than September 30, 2014, the long-standing
    CARF Center at the James Haley Veterans Hospital in Tampa, one of only
    two multidisciplinary pain management centers that has been twice
    recognized by the American Pain Society as a Clinical Center of
    Excellence (the other being a program at Stanford University), has
    provided direct training to VISN teams from across VHA who wish to
    start CARF programs. Some VISNs may eventually have 2 or more such
    programs. In addition, there is an ongoing system-wide education
    effort, using the expertise at these Centers and in other facilities,
    to educate physicians in Primary Care PACT and other providers taking
    care of Veterans with chronic pain conditions about Chronic Pain
    Rehabilitation approaches.
                   implementing the stepped care model in vha
        To help manage the implementation of the Stepped Care Model, VHA's
    National Pain Management Program Office (NPMPO) works closely with
    other VHA national offices such as pharmacy, mental health, and primary
    care. Other collaborations include NPMPO's partnership with Women's
    Health Services to develop a strategic plan to strengthen the capacity
    for women Veteran pain management services. NPMPO also relies on
    consultation with the interdisciplinary National Pain Management
    Strategy Coordinating Committee, consisting of members of all relevant
    clinical offices/programs in VHA, and meets regularly with all VISN
    Pain Points of Contact (POC). VISN POCs in turn meet regularly with
    Facility POCs in their VISN.
        The role of the Pain POCs, at the VISN and at the facility level,
    is primarily to coordinate efforts in regard to pain management from an
    administrative side. The Pain POCs are expected to work closely with
    the Pain specialists at each facility within the facility Pain
    Management Committee. This structure creates a two-way communication of
    successful `best practices' in the field, which are then communicated
    nationally, as well as advice and support on policy implementation. The
    Pain POCs are not the point of contact for clinical issues regarding
    individual patients. With regards to evaluation and treatment, a
    Veteran's clinical point of contact for their individual pain needs is
    their primary care provider within the PACT. As necessary, the pain
    medicine specialty team at the facility would work in collaboration.
                     stepped care model for pain management
        As mentioned earlier, SCM-PM is the single standard of pain care
    for VHA to ensure Veterans receive appropriate pain management
    services. Specifically, SCM-PM provides for assessment and management
    of pain conditions in the primary care setting. This is supported by
    timely access to secondary consultation from pain medicine, behavioral
    health, physical medicine and rehabilitation, specialty consultation,
    and care by coordination with palliative care, tertiary care, advanced
    diagnostic and medical management, and rehabilitation services for
    complex cases involving co-morbidities such as mental health disorders
    and TBI.
        In FY 2012, VHA made several important investments in implementing
    the SCM-PM. Major transformational initiatives support the objectives
    of building capacity for enhanced pain management in the primary care
    setting, including education of Veterans and caregivers in self-
    management, as well as promoting equitable and timely access to
    specialty pain care services.
        There are other important efforts contributing to the
    implementation of SCM-PM in VHA facilities. Current initiatives focus
    on empowering Veterans in their pain management, and expanding capacity
    for Veterans to receive evidence-based psychological services as a
    component of a comprehensive and integrated plan for pain management.
    For example, during FY 2012, the VHA National Telemental Health Center
    expanded its capacity to deliver face-to-face, psychological services
    to Veterans remotely via high-speed videoconferencing links. This
    initiative not only emphasizes the delivery of cognitive behavior
    therapy for Veterans with chronic pain, but also promotes pain self-
    management, leading to reductions in pain and improvements in physical
    functioning and emotional well-being.
        Additionally, a Primary Care and Pain Management Task Force is
    developing a comprehensive strategic and tactical plan for promoting
    full implementation of the SCM-PM in the Primary Care setting, and it
    continues to work on several products in support of this effort. For
    instance, the Task Force is continuing to expand its network of
    facility- level Primary Care Pain Management points of contact (Pain
    Champions) who meet monthly, via teleconference, to identity and share
    strong practices that have led to improved pain care in primary care
    settings.
        VA's pain management initiatives are designed to optimize timely
    sharing of new policies and guidance related to pain management
    standards of care. Of particular importance are VHA's continuing
    efforts to promote safe and effective use of opioid therapy for pain
    management, particularly those initiatives designed to mitigate risk
    for prescription pain medication misuse, abuse, addiction, and
    diversion.
                               opioid prescribing
        While opioid medications, due to their high risk to benefit ratio
    in chronic pain, will be playing a less prominent role in chronic pain
    management in the future, they are a primary focus currently due to the
    attendant risk of their use, particularly in individuals with some of
    the co-morbid conditions mentioned above.
        To monitor the use of opioids by patients in the VA health care
    system, VA tracks multi-drug therapy for pain in patients receiving
    chronic or long-acting opioid therapy for safety and effectiveness.
    This includes tracking of use of guideline recommended medications for
    chronic pain (i.e., certain anticonvulsants, tricyclic antidepressants
    (TCA), and serotonin and norepinephrine reuptake inhibitors (SNRI)
    which have been shown to be effective for treatment of some chronic
    pain conditions), and tracking of concurrent prescribing of opioids and
    certain sedative medications (e.g., benzodiazepines and barbiturates)
    which can contribute to over sedation and overdose risk when taken with
    opioids and the other medications for pain listed above.
        The prevalence of Veterans using opioids has been measured for
    Veterans using VHA health care services. For FY 2012, of the 5,779,668
    patients seen in VA, 433,136 (7.5 percent) received prescriptions for
    more than 90 days supply of short-acting opioid medications and 92,297
    (1.6 percent) received at least one prescription for a long-acting
    opioid medication in the year. Thus, since more than 50 percent of
    Veterans enrolled in VHA suffer from chronic pain, the most common
    condition in all Veterans, a relatively small percentage of those
    Veterans are receiving chronic opioid therapy, consistent with the DOD/
    VA Clinical Practice Guidelines which limit their use to patients with
    moderate to severe persistent pain that has not responded to other
    safer alternatives that are clinically appropriate. Of these 525,433
    patients that received chronic or long-acting opioid therapy, 79,025
    (15 percent) were also prescribed a TCA, 90,066 (17 percent) were also
    prescribed an SNRI, and 178,361 (34 percent) were also prescribed an
    anticonvulsant some time in FY 2012.
        The co-prescription of either TCAs and SNRIs with opioids is first
    line therapy for the more severe cases of pain related to nerve damage
    from disease (e.g., diabetes, cancer) or from injuries (e.g.,
    battlefield blast and projectile injuries with or without limb
    amputation and spinal cord injury). The numbers above suggest that
    clinical teams are using medically indicated combinations of
    medications that are specifically needed for these more severe
    conditions, which themselves are often co-morbid with musculoskeletal
    pain such as injuries to joints, spine and muscles. Of note, these
    prescriptions may or may not have overlapped with the opioid
    prescription during the year.
        Notably, 272,719 (52 percent) of patients on chronic or long-acting
    opioid therapy received non-medication-based rehabilitative treatments
    as part of their treatment plan (e.g., physical therapy (32 percent),
    chiropractic care (1 percent), programs to encourage physical activity
    (9 percent) or occupational therapy (17 percent), and 241,465 (46
    percent) also received behavioral or psychosocial treatment for chronic
    pain or co-morbid mental health conditions.
        These data, showing the use of non-medication treatments, suggest
    that Veterans are benefiting from VHA's efforts to create access to
    additional pain treatment modalities besides medication. This is
    consistent with VA's commitment to transform pain care to a
    biopsychosocial model \10\ that addresses all the factors that by
    research are demonstrated to affect Veterans' success in chronic pain
    treatment. Pursuant to this aim, a multimodality, team-based, stepped
    care model, per VHA Directive 2009-053, is being implemented widely
    throughout VHA, and in coordination with DOD.
    ---------------------------------------------------------------------------
        \10\ The Biopsychosocial Model takes the position that the causes
    and outcomes of many illnesses often involve the interaction of
    physical and pathophysiologic factors, psychological traits and states,
    and social-environmental factors. Effective treatment planning accounts
    for the salience of these factors in the precipitation and perpetuation
    of illness and illness-related disability.
    ---------------------------------------------------------------------------
        Opioid analgesics may help many patients manage their severe pain
    when other medications and modalities are ineffective or are only
    partially effective. However, there may be risks to both individual
    patients as well as to the surrounding community when these agents are
    not prescribed or used appropriately. VA has embarked on a two-pronged
    approach to addressing the challenge of prescription drug diversion and
    substance use disorders among Veteran patients. One approach is to
    improve the education and training in pain management and safe opioid
    prescribing for clinicians and the interdisciplinary teams that provide
    pain management care for Veterans. A complementary approach involves
    improving risk management through two systems initiatives.
                            opioid safety initiative
        VA recently developed and implemented an Opioid Safety Initiative
    (OSI) program to ensure opioid pain medications are used safely,
    effectively and judiciously. The Opioid Safety Initiative Requirements
    were issued to the VISN's on April 2, 2014. The purpose of the
    initiative is to ensure pain management is addressed thoughtfully,
    compassionately and safely. The nine goals are summarized below:

         Goal One: Educate prescribers of opioid medication
    regarding effective use of urine drug screening
         Goal Two: Increase the use of urine drug screening
         Goal Three: Facilitate use of state prescription databases
         Goal Four: Establish safe and effective tapering programs
    for the combination of benzodiazepines and opioids
         Goal Five: Develop tools to identify higher risk patients
         Goal Six: Improve prescribing practices around long-acting
    opioid formulations
         Goal Seven: Review treatment plans for patients on high
    doses of opioids
         Goal Eight: Offer Complementary and Alternative Medicine
    (CAM) modalities for chronic pain at all facilities
         Goal Nine: Develop new models of mental health and primary
    care collaboration to manage opioid and benzodiazepine prescribing in
    patients with chronic pain

        To do this, the initiative leverages the VHA's Electronic Health
    Record, making visible the totality of opioid use at all levels,
    patient, provider and facility, in order to identify high-risk
    situations. The OSI 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 dosage per day of
    opioids such as hydromorphone, methadone, morphine, oxycodone, and
    oxymorphone. Patients at risk for adverse events from use of opioids
    are identified through the use of administrative and clinical databases
    using pre-determined parameters based on published evidence and expert
    opinion. Providers whose prescribing practices are not aligned with
    medical evidence/strong practices are provided with counseling,
    education and support for to improve their care of Veterans with pain.
    Several aspects to measure the implementation of the Opioid Safety
    Initiative upon opioid use were underway at the time of the October 10,
    2013 hearing and suggested positive impacts:

         Despite an increase in the number of Veterans who were
    dispensed any medication from a VA pharmacy, (i.e., all pharmacy users)
    in October 2012 compared to November 2013, 39,088 fewer Veterans
    received an opioid prescription from VA during that time period.
         Performing urine drug screens is a useful tool to assist
    in the clinical management of patients receiving long-term opioid
    therapy. As of November 2013, urine drug screens were performed on
    80,294 more patients than in October 2012.
         Whenever clinically feasible, the concomitant use of
    opioid and benzodiazepine medications should be avoided. In
    November 2013, 9,609 fewer patients were receiving these drugs at the
    same time than in October 2012.
         Last, the average dose of selected opioids has begun to
    decline slightly in VA, demonstrating that prescribing and consumption
    behaviors are changing.

        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, Columbus), and
    are being studied as strong practice leaders.
        The second system-wide risk management approach to support the
    Veterans' and public's safety is promulgation of new regulations that
    enable VHA to participate in state Prescription Drug Monitoring
    Programs (PDMPs). 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. 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 that
    can be gathered 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.
           leveraging strong practices to change opioid prescribing:
                    the minneapolis va medical center (vamc)
        In summary, there is growing evidence of the successful
    implementation of a Stepped Care Model for Pain Management in VHA.
    Importantly, Veterans receiving long term opioid therapy for management
    of chronic pain are increasingly likely to be receiving this therapy in
    the context of multidisciplinary and multimodal care that often
    incorporates physical and occupational therapy and mental health
    services. All VISNs provide specialty pain clinic services, and the
    number of Veterans who receive these services has grown steadily for
    the past five years. Ten facilities now provide CARF accredited pain
    rehabilitation services, a rapid increase in the availability of these
    higher specialized pain rehabilitation services for our most complex
    Veterans with debilitating chronic pain and comorbid mental health
    disorders.
        VA learns from VISNs and VAMCs that are early adopters of
    implementing evidence-based guidelines and best practices. The
    Minneapolis VAMC has had great success with decreasing over utilization
    of opioid pain medications and developing a full range of pain
    management services. These efforts began with the Minneapolis VA Opioid
    Safety Initiative in 2011. Strong medical center leadership support led
    to the development of systems to identify patients on high risk opioids
    and provide team-based support from pharmacy, primary care, and mental
    health to develop individualized care plans to decrease high risk
    opioid use and improve patient safety. Implementing this best practices
    approach, Minneapolis has seen a nearly 70 percent decrease in high-
    dose opioid prescribing for chronic non-cancer pain patients. This
    early success lead to a coordinated effort between Minneapolis VAMC and
    VISN 23 to expand support for PACT team-based pain management, Step 2
    pain consultation services, and rehabilitation focused
    multidisciplinary pain specialty services. The Minneapolis pain
    specialty services are now developing state-of-the-art, evidence-based
    interdisciplinary pain management programs and services, and also
    providing leadership, guidance, and support for primary care pain
    management throughout VISN 23 and VHA.
        VA is working aggressively to promote the safe and effective use of
    long-term opioid therapy for Veterans with chronic pain for whom this
    important therapy is indicated. VA's Opioid Safety Initiative holds
    considerable promise for mitigating risk for harms among Veterans
    receiving this therapy, for promoting provider competence in safe
    prescribing of opioids, and in promoting Veteran-centered, evidence-
    based, and coordinated multidisciplinary pain care for Veterans with
    chronic pain. VA's Opioid Safety Initiative Tool provides monthly
    reports to all VISNs and facilities as to overall opioid prescribing an
    average dose per day of opioid therapy, which informs facilities of
    Veterans who are at risk for adverse outcomes and enables remedial
    steps to reduce those risks as described earlier by the Minneapolis
    VAMC. Interventions include VISN level, facility level and committees
    that provide support and education to improve the appropriate opioid
    risk mitigation for individual providers and facilities. Early evidence
    of success in reducing overall opioid prescribing and average dose per
    day of opioid therapy is encouraging.
                     complementary and integrative medicine
        VHA leadership has identified as its number one strategic goal ``to
    provide Veterans personalized, proactive, patient-driven health care.''
    Integrative Health (IH), which includes CAM approaches, provides a
    framework that aligns with personalized, proactive, patient-driven
    care. There is growing evidence for effectiveness of non-
    pharmacological approaches as part of a comprehensive care plan for
    chronic pain which includes acupuncture, massage, yoga and spinal
    manipulation. These are all being increasingly made available to
    Veterans.
        In 2011, VA's Healthcare Analysis and Information Group published a
    report on Complementary and Alternative Medicine in VA. At that time,
    89 percent of VHA facilities offered some form of CAM/IH; however,
    there was extensive variability regarding the degree, level, and
    spectrum of services being offered in VHA. The top reasons for offering
    CAM/IH included the following:

         Promotion of wellness;
         Patient preferences; and
         Adjunct to chronic disease management.

    The most commonly offered CAM/IH modalities in VHA facilities were:
    Meditation, Stress Management/Relaxation Therapy, Progressive Muscle
    Relaxation, Biofeedback, and Guided Imagery. The conditions most
    commonly treated with CAM/IH include: Stress management, Anxiety
    Disorders, PTSD, Depression, and Back Pain.
        In VA, chiropractic care is part of the standard medical benefits
    and is administratively aligned under Rehabilitation and Prosthetic
    Services. The number of Veterans receiving chiropractic services in VA
    has expanded form under 4,000 in FY 2004, to over 26,000 in FY 2013. In
    addition to clinical services, Rehabilitation and Prosthetic Services
    is working to develop innovative approaches to foster chiropractic
    inter-professional education strategies and research projects.
        VA recognizes the importance and benefits of recreational therapy
    in the rehabilitation of Veterans with disabilities. Currently, over 30
    VA medical centers across the country participate in therapeutic riding
    programs. These programs use equine assisted therapeutic activities to
    promote healing and rehabilitation of Veterans with a variety of
    disabilities and medical conditions (e.g. Traumatic Brain Injury,
    polytrauma). VA facilities participating in such programs utilize their
    locally appropriated funds to support their participation. Facilities
    can also request supplemental support through the VA Secretary's
    General Post Fund, a trust fund administered by the Department to
    support a variety of recreational and religious projects and national
    rehabilitation special events.
        A monthly Integrative Health (IH) community of practice conference
    call provides VHA facilities national updates, strong practices, and
    new developments in the field and research findings related to IH.
        A key development is a Joint Incentive Fund DOD/VA project to
    improve Veterans' and Servicemembers' access to CAM, the ``Tiered
    Acupuncture Training Across Clinical Settings'' (ATACS) project. ATACS
    represents VHA's initiative to make evidence-based complementary and
    alternative medicine therapies widely available to our Veterans
    throughout VHA. A VHA and DOD network of medical acupuncturists are
    being identified and trained in Battlefield (auricular) Acupuncture by
    regional training conferences organized jointly by VHA and DOD. The
    goal of the project is for them to return to their facilities and VISNs
    with the skills to train local providers in Battlefield Acupuncture,
    which has been used successfully in DOD front-line clinics around the
    world. This initiative ultimately aims to provide all Veterans with
    access to this intervention, and a wider array of pain management
    choices generally, when they present with chronic pain.
                      integrative health--the way forward
        In late 2012, the Under Secretary for Health appointed a Team to
    review the organizational structure to support implementation of
    integrative health strategies in VHA. The Team recommended the
    expansion of the VHA Office of Patient Centered Care and Cultural
    Transformation's (OPCC&CT) capacity to develop and implement
    integrative health strategies in clinical activities, education, and
    research. OPCC&CT is now serving as the lead office in this work,
    expanding on existing efforts and with active partnerships across the
    organization. An Acting Director of VHA's Integrative Health
    Coordinating Center (IHCC) has been named and recruitment for core
    staff is in process. Additional staffing is being vetted now and that
    will continue until the program is fully developed.
        OPCC&CT has deployed a number of clinical, research, and education
    strategies to begin developing a more coordinated approach. This
    includes clinical pilots, work within the existing Centers of
    Innovations, and close alignment with the Office of Research and
    Development, as well as creating curricula and expanding education in
    these areas. VA's Evidence Synthesis program, in conjunction with
    OPCC&CT and Patient Care Services, is examining the scientific
    literature on various CAM modalities and presenting the findings in the
    form of an evidence map. At the present time, reviews are being done on
    Yoga, Tai Chi, and mindfulness meditation and a review was recently
    completed on acupuncture. The evidence map on acupuncture showed a
    positive effect of acupuncture on headaches, migraines, and chronic
    pain as well as a potential positive effect in multiple domains
    including depression and insomnia. The information from these reviews
    will help guide decision on how to best use CAM modalities within VA.
        The Whole Health Clinical Education Program, which includes an
    integrative health focus, launched last year, has received outstanding
    evaluation feedback from the clinicians and leadership who have taken
    the course. An online curriculum is under development and will have
    greater than 40 modules. These have been co-created with VA and the
    University of Wisconsin, leaders in the field of Integrative Medicine.
        Finally, the DOD/VA Health Executive Council (HEC) Pain Management
    Work Group (PMWG) was chartered to develop a model system of
    integrated, timely, continuous, and expert pain management for
    Servicemembers and Veterans. The Work Group participates in VA/DOD
    Joint Strategic Planning (JSP) process to develop and implement the
    strategies and performance measures, as outlined in the JSP guidance,
    and shares responsibility in fostering increased communication
    regarding functional area between Departments. The Group also
    identifies and assesses further opportunities for the coordination and
    sharing of health related services and resource between the
    Departments. A key development is the HEC PMWG's sponsoring of two
    Joint Incentive Fund projects to improve Veterans' and Servicemembers'
    access to competent pain care in the SCM-PM: the Joint Pain and
    Education Project (JPEP), and the ``Tiered Acupuncture Training Across
    Clinical Settings'' (ATACS) projects.
                          oversight and accountability
        Several key responsibilities are articulated in the Pain Management
    Directive. The Directive establishes a National Pain Management Program
    Office (NPMPO) in VACO that has the responsibility for policy
    development, coordination, oversight, and monitoring of VHA's National
    Pain Strategy. The Directive further authorizes the establishment of a
    multidisciplinary VHA National Pain Management Strategy Coordinating
    Committee that supports the Program Office in achieving its strategic
    goals and objectives. The Committee is comprised of 15 members to
    include: anesthesiology, employee education, geriatrics and extended
    care, mental health, neurology, nursing, pain management, patient
    education, pharmacy benefits management, primary care/internal
    medicine, quality performance, rehabilitation medicine, research, and
    women Veterans' health.
        The Directive requires VISN Directors to ensure that all facilities
    establish and implement current pain management policies consistent
    with this Directive. The NPMPO maintains records of VISN and facility
    compliance, along with other key organizational requirements contained
    in the Directive. All VISNs and facilities have appointed National Pain
    Office pain management points of contact, established multidisciplinary
    committees, and implemented pain management policies as required by the
    Directive. Health Care Provider Education and Training
        First, as recognized by the IOM in its extensive 2011 review,
    ``Pain in America'' and the American Medical Association in its 2010
    Report on Pain Medicine \11\, and as articulated in VHA's Pain
    Management Directive in 2009-053, a formal commitment to pain
    management education and training for all appropriate clinical staff is
    required.
    ---------------------------------------------------------------------------
        \11\ Lippe P.M., Brock C., David J.J., Crossno R., Gitlow S. The
    First National Pain Medicine Summit--Final Summary Report. Pain Med
    2010;11(10):1447-68.
    ---------------------------------------------------------------------------
        The Joint Pain and Education Project, JPEP, mentioned earlier, has
    proposed training faculty in all VA training sites to pursue the
    implementation of such a curriculum; new generations of providers and
    other clinicians will themselves ultimately become the practitioners
    and teachers of good pain care. JPEP will target all levels of learner:
    the Veteran and his/her family and caregiver; the public; clinicians
    from all disciplines; specific providers and clinicians in practicing
    at each level of the SCM-PM: primary care, pain medicine specialty
    care, and other specialty care. VA is providing national leadership in
    developing interdisciplinary and discipline-specific competencies for
    pain management, in developing a system-wide approach to trainings, and
    in providing leadership roles in national projects to improve pain
    education and training.
                                   conclusion
        Mr. Chairman, I would be the last person to say that we are now
    right where we want to be with our pain care in VA, but I will be the
    first person to say that we are well along in the process of getting
    there. I am confident that we will be setting standards for pain care
    nationally in the coming years. We are confident that we are building
    more accessible, safe and effective pain care that will be responsive
    to the needs of our Veterans and will better serve to enhance the
    quality of their lives. VA is committed to providing the high quality
    of care that our Veterans have earned and deserve, and we appreciate
    the opportunity to appear before you today. My colleagues and I are
    prepared to respond to any questions you may have.
                                     ______

    Response to Posthearing Questions Submitted by Hon. Bernard Sanders to
       Robert A. Petzel, MD, Under Secretary for Health, Veterans Health
           Administration (VHA), U.S. Department of Veterans Affairs
                            opioid safety initiative
        Question 1.  How does VA plan to implement the Opioid Safety
    Initiative system-wide?
        Response. The Veterans Health Administration (VHA) has been
    vigorously pursuing implementation the Opioid Safety Initiative (OSI)
    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 this end, VHA has embarked
    on a system-wide program of education and training in pain management,
    opioid safety, access to alternative medical and non-medical treatments
    for pain, and patient education in self-management. These programs are
    manifestations of the core principles and policies outlined in the 2009
    Directive and are emphasized in the new draft Directive which is in
    development. In the meantime, Directive 2009-053 remains as VHA policy
    until replaced with the new Directive. 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.
        a. What is the timeline for full implementation?
        Response. While The Opioid Safety Initiative (OSI) was launched in
    October 2013, it is an on-going endeavor, comprised of multiple inter-
    disciplinary approaches, which will be constantly evaluated, modified
    and/or introduced to effective pain management and decrease the risks
    for complications due to both over- and under-treatment with opioids
    and other therapies. As an example, VHA OSI Task Force assembled a 15
    module, peer-reviewed OSI Toolkit that is continually updated as new
    information becomes available, including new evidence-based practices.

        Question 2.  What are the implications of the Opioid Safety
    Initiative beyond pain care, such as reducing the reliance of
    medications to treat mental health conditions?
        Response. VHA original response: The Opioid Safety Initiative
    addresses the risks of opioid analgesia comprehensively through a
    system-wide program with the following aims that include management of
    Veterans with co-morbid pain and mental health conditions:

         To reduce risks, such as high opioid doses, co-prescribing
    of benzodiazepines, close monitoring of Veterans with urine drug
    screens and Veterans with risks such as substance use disorders
    (addiction) and PTSD.
         To encourage the use of psychological, physical and
    complementary and alternative medicine (CAM) therapies such as
    acupuncture and yoga in pain management.
         To provide feedback and educational support for our
    clinical teams caring for patients with co-morbid pain and mental
    health disorders.

        Question 3.  How does VA plan to publicize this initiative--
    particularly to veterans who may have avoided seeking treatment in the
    past because of concerns regarding medication?
        Response. VHA has embarked on a system-wide program of education
    and training in pain management, opioid safety, access to alternative
    medical and non-medical treatments for pain, and patient education in
    self-management. These programs are manifestations of the core
    principles and policies outlined in the 2009 Directive and are
    emphasized in the new draft Directive which is currently in
    concurrence. In the meantime, Directive 2009-053 remains VHA policy
    until replaced with the new Directive.

        Question 4.  One of the goals of the Opioid Safety Initiative is to
    facilitate use of state prescription databases. In which state
    prescription databases is VA able to participate? Is VA currently
    participating in all of the databases where it is able?
        Response. As of the date of this response, Prescription Drug
    Monitoring Program (PDMP) deployment is completed in 29 states, and is
    scheduled for completion in 6 more states by the end of August 2015.
    Please note that in 2 of these 6 states--Florida and Oregon--PDMP
    deployment is very near completion. In Florida, 4 of 6 sites are
    transmitting and in Oregon, 2 of 3 sites are transmitting. Deployment
    will occur in 13 other states by December 2016. The longer
    implementation period for these 13 states is due to their individually
    customized PDMP requirements that VA is working to satisfy. One state--
    New Mexico--has advised the Department that it needs to purchase and
    install new software to support a PDMP, and that its timeline to
    accomplish this purchase is not yet determined. This issue affects all
    dispensing pharmacies within New Mexico. VA stands ready to activate
    the transmission of prescription drug data to New Mexico's PDMP system
    as soon as the state is ready. Missouri is the only state that has not
    enacted a PDMP law. The District of Columbia is currently developing
    its recently enacted PDMP. A complementary effort to PDMP deployment is
    the issuance of the VHA Directive, Querying State Prescription Drug
    Monitoring Programs, which we are planning to publish in the coming
    months. This Directive would establish policy requiring VHA health care
    provider participation in state PDMPs, consistent with applicable state
    laws. The Directive would assign responsibility to each facility
    Director to ensure that local policy and processes are established to
    support the Directive. Specifically, the Directive would outline when a
    query is needed, the frequency of a query, and any exclusions.
    Specifically, the draft would exclude any controlled substance
    prescription that is a 5 day supply or less without refills and any
    patient who is enrolled in Hospice care, unless required by state law.
                  complementary and alternative medicine (cam)
        Question 5.  VA offers a number of CAM therapies, but they are not
    necessarily evenly distributed across the system and veterans are not
    always aware of what's available to them. What is VA doing to more
    evenly distribute access across the system? What is VA doing to inform
    veterans their options for CAM therapies? What is VA doing to encourage
    providers to offer these therapies and how is this being tracked?
        Response. VA is committed to offering Veterans more personalized,
    proactive and patient driven care. This entails better understanding of
    the needs and desires of Veterans and addressing their health care
    goals in a more holistic fashion. VHA has established an Integrative
    Health Coordinating Center whose mission is to help evaluate and where
    appropriate help integrate Complementary and Integrative Health (CIH)
    services into VA. In addition, the Office of Patient Centered Care and
    Cultural Transformation (OPCC&CT) has developed education on Whole
    Health, which is being disseminated throughout VA. These courses
    educate providers on how to approach healthcare in a more holistic
    fashion and educates them on CIH practices and how these may be able to
    play a part in Veterans healthcare. This education on CIH practices
    will expand the resources available to providers when they engage their
    patients in identifying their healthcare goals and the strategies they
    wish to embark on to attain these goals. As VA offers personalized,
    proactive, patient-driven care it is through educating providers that
    we work to ensure that Veterans have a discussion with their provider
    and discuss the best treatment option including all appropriate
    therapies including indicated CAM/CIH which is unique to the Veteran
    and their circumstance. VHA's educational programs for clinical staff
    are being disseminated in the field. These clinical courses educate
    providers on how to approach health care in a more holistic way and
    educates them on CAM therapies available. Other efforts are underway to
    provide information to Veterans. One example is that OPCC&CT developed
    an internet site as the focal point for messaging, resource delivery,
    and community engagement for the patient centered care body of work and
    the Veteran-facing products developed to educate and communicate with
    Veterans. Through the Health for Life site, we are providing products
    that enable Veterans to achieve their greatest health and well-being.
    OPCC&CT has also trained field implementation teams that are being
    deployed around the country to work with local leadership to create a
    culture that supports a whole health, patient-centered model inclusive
    of CIH services. They have developed an education campaign that
    includes both internal and external customer facing modules describing
    the new models of care and services that focus on putting the patient
    at the center of their care to create a personalized, proactive,
    patient-driven model.

        Question 6.  What factors limit VA from further broadening CAM
    therapies across the VA Health Care System?
        Response. The medical benefits package states that VA may offer
    those services that are in accord with generally accepted standards of
    medical practice. There are a vast number of Complementary and
    Integrative Health (CIH) practices, but the evidence base for many of
    them is limited. Questions remain about the efficacy of many of these
    practices, who responds to them, how they should be used, and for how
    long. Although no CIH practice is the gold standard for care, several
    practices show promise as adjuncts to care. In addition, many CIH
    practices lack standardized education, training, certification and
    licensure standards. These factors, combined with a lack of
    occupational classes for CIH practitioners within VA, pose significant
    barriers to the hiring of such providers within VA.
                              dod/va collaboration
        Question 7.  What benefits has VA seen from the standardization of
    the prescription medication between VA and DOD available to both
    servicemembers and veterans? Are servicemembers able to continue their
    existing course of treatment as they transition to VA health care?
        Response. Yes, Servicemembers are able to continue their existing
    course of treatment as they transition to VA health care, unless a
    change would be warranted based on a VA provider's clinical assessment
    (i.e., drug is no longer effective, patient's changing medical
    condition warrants a change, drug is no longer safe given clinical
    circumstances, etc.). There have been widespread anecdotal reports of
    Servicemembers' mental health and pain medications being switched due
    to differences between the VA and DOD drug formularies. However, these
    anecdotes were not substantiated in a medication continuity pilot
    evaluation of over 2,000 Servicemembers recently conducted by VA. In
    this pilot evaluation, VA found that 99% of patients receiving a mental
    health or pain medication were able to continue those medications
    despite differences between the VA and DOD formularies. The data from
    VA's pilot evaluation validates VA's long standing practice of
    continuing medication therapy started by Department of Defense
    prescribers. See (http://www.pbm.va.gov/PBM/
    vacenterformedicationsafety/othervasafetyprojects/DOD--VA--Medication--
    Continuation--Report.pdf).

        Question 8.  What other efforts have DOD and VA taken to
    collaborate and standardize treatment options for servicemembers and
    veterans for the treatment of chronic pain and mental health
    conditions?
        Response. The DOD/VA Health Executive Council's Pain Management
    Work Group ( HEC PMWG), which meets monthly, was chartered in 2010 to
    ``actively collaborate in supporting the development of a model system
    of integrated, timely, continuous, and expert pain management for
    Servicemembers and Veterans.'' The HEC PMWG has articulated 6
    objectives for its present work:

        Objective 1--Standardize Pain Measurement. The PMWG has sponsored
    the development of the Defense and Veterans Pain Rating Scale to
    improve the measurement of pain. The tool has been validated and
    published, is in use in multiple military facilities and in civilian
    hospitals. Additional validation studies continue in DOD and VHA.
        Objective 2--Develop a clinical pain support tool and pain data
    registry. The PASTOR tool, incorporating the NIH ``PROMIS'' patient
    report outcome measures and computer adaptive testing, is under
    development and is being piloted in a collaboration between Madigan
    Army Hospital, NIH, and the University of Washington.
        Objective 3--Standardize Suboxone (buprenorphine and naloxone)
    Prescribing Practices. A common guidance document is developed and VHA
    and DOD working implementation in each organization.
        Objective 4--Develop Medical Drug Testing guidance. The PMWG
    developed DOD/VHA core guidance and have developed and share clinical
    education and training in JPEP modules and in the Opioid Safety
    Initiative Toolkit.
        Objective 5--Develop Acupuncture Credentialing guidance. The PMWG
    developed shared DOD/VHA core guidance for VHA and DOD clinicians and
    is working implementation of core guidance within their respective
    organizations
        Objective 6--Develop Informed Consent for Long-term Opioid Therapy.
    The VHA developed and approved a patient education document, ``Taking
    Opioids Responsibly,'' to assist in the informed consent process, and
    the DOD is evaluating the VHA document for implementation in DOD.

        Currently there are two Joint Investment Fund (JIF) supported
    projects to improve the competencies of our workforce across both
    systems:

         The Joint Pain Education and Training Project (JPEP).
             - Has developed 35 optional evidence-based training modules in
            pain management for use in its multiple pain education programs
            to help standardize pain management education and training
            across the two health systems and to support and educate
            clinicians and Veterans about safe and effective stepped pain
            management, including use of opioids.
             - JPEP modules are being used for primary care residency
            training and for practicing clinicians and clinical teams being
            trained by the Pain Mini-residency, Pain SCAN ECHO,
            asynchronous web-based courses, and Community of Practice
            conferences.
             - All these programs reach across the VHA to train primary
            care providers in all settings in the assessment and treatment
            of pain and in the use of patient education in self-management,
            the use of multiple modalities such as behavioral, integrative
            medicine, and physical therapies and the use of consultant
            specialists in pain, mental health, and CAM.
             - On the topic of opioids safety, for example, 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
            prescription monitoring programs, and safe tapering.

         The Tiered Acupuncture Training Across Clinical Settings
    (ATACS)
             - Has trained more than 1290 front-line providers in the VA
            and DOD in Battlefield Acupuncture as well as dozens of
            physicians in medical acupuncture.
             - Represents VHA's initiative to make evidence-based
            complementary and alternative medical therapies widely
            available to our Veterans throughout VHA.
             - Provides Veterans with a wider array of pain management
            choices when they present with chronic pain.
                              acupuncture training
        Question 9.  How would the Joint Incentive Fund Project to
    implement a standardized acupuncture training and sustainment model
    across DOD and VA medical facilities improve acupuncture services VA
    provides veterans? When can we expect system-wide implementation of
    this joint model?
        Response. By providing standardized training in the short course
    for Battlefield (auricular) Acupuncture (BFA) to hundreds of providers
    across the system, and by credentialing trainees to add BA to their
    pain management toolbox, these providers will be able to use this
    treatment as one of many they have to offer Veterans with pain. The
    physicians being trained in Medical Acupuncture will also be trained as
    BFA Faculty, so they can train their local facility providers in BFA to
    sustain the program's development system-wide.

        Question 10.  How many providers are trained in acupuncture already
    working in the VA Health Care System? How many of these providers are
    exclusively providing acupuncture? What is the average number of hours
    each provider trained in acupuncture offers this therapy each week?
        Response. We do not have information on the number of providers
    based at facilities who provide acupuncture or how many hours a week
    therapy is provided. However, from the 2015 Healthcare analysis and
    information group survey on VA Complementary and Integrative Health
    practices, we do know that 79 facilities offer acupuncture services
    primarily performed by physician-trained acupuncturists as a part of
    their duties at least a half day per week up to several times a week.

        Question 11.  What efforts are being made to ensure an adequate
    number are available to treat veterans once the joint model is
    implemented?
        Response. At the current time, physicians and chiropractors are the
    only VHA occupations with scopes of practice that include acupuncture.
    As a result, the availability of trained acupuncture providers within
    VA is limited. VA continues to support the training of physicians in
    acupuncture, but is also pursuing the development of a licensed
    acupuncturist occupational class within VHA. The addition of licensed
    acupuncturists to VHA occupations will expand VHA's ability to hire
    trained acupuncture providers.
                           pain management directive
        Question 12.  On October 28, 2009, VA issued the Pain Management
    Directive to improve VHA's processes for treating and managing chronic
    pain. How has system-wide implementation of the National Pain
    Management Strategy--as required by the Pain Management Directive--
    improved VA's approach to pain management?
        Response. The implementation of Stepped Care has increased
    resources for primary care pain management, such as behavioral health
    clinicians, access to CAM, access to multidisciplinary pain specialty
    clinics, and access to tertiary care Commission on Accreditation of
    Rehabilitation Facilities (CARF) rehabilitation programs.

        Question 13.  Does VA plan to extend the Pain Management Directive?
    If not, please explain why not. If so, please explain whether it will
    be extended in its current form or if changes will be made.
        Response. Yes, a new Directive has been drafted and is undergoing
    VHA Concurrence. Until which time the new Directive is approved, the
    current Pain Management Directive will remain in effect.
                                     ______

      Response to Posthearing Questions Submitted by Hon. Mark Begich to
       Robert A. Petzel, MD, Under Secretary for Health, Veterans Health
           Administration (VHA), U.S. Department of Veterans Affairs
        Question 14.  My office has received casework from veterans who
    have severe PTSD issues that affect their day to day life, and say I
    quote ``I'm pretty much done with medications.'' They have asked for
    Hero Dogs, who raise and train service dogs and places them free of
    charge with our Nation's Veterans to improve quality of life and
    restore independence. Veterans with disabilities have given enough.
        Tell me what the VA is doing with expanding service/therapy dogs; I
    think this would be a cheaper option and a safer option rather than
    treating with opioids and other drugs.
        Response. Veteran preference is an important consideration when
    choosing a therapeutic approach to treat PTSD. Effective cognitive
    behavioral therapies are made available to every Veteran who seeks VA
    care for PTSD. VA is currently attempting to find ways to increase
    Veteran engagement with these treatment modalities and increase the
    likelihood that Veterans remain in treatment until remission or
    significant clinical improvement is accomplished. While dogs and other
    animals can provide great comfort and companionship, and we do not
    disagree with Veterans' subjective accounts that service dogs have
    improved the quality of their lives. At this time, there is not
    sufficient evidence that animals are effective in the treatment of
    mental health conditions, including Post Traumatic Stress Disorder
    (PTSD). Consequently, VA does not provide service dog benefits for
    mental health service dogs. VA is currently evaluating the efficacy of
    mental health service dogs pursuant to a congressionally mandated study
    to learn whether service dogs and/or emotional support dogs can be
    effective in treating or rehabilitating persons with PTSD. The study,
    expected to take several years to complete, is currently ongoing at
    three sites (Atlanta, GA; Iowa City, IA; and Portland, OR) and has
    begun pairing enrolled Veterans with dogs.

        Question 15.  The following is from a veteran in Kenai: ``I'm on
    ten different types of medications that deal with sleep, back pain,
    depression, anxiety, blood pressure, and inflammation * * *. I've
    really lost count of what I'm taking. I'm sick of it. I don't want to
    take any more medications. I would like to see if we can make a push
    for the VA to fund holistic style medical treatments. I believe in
    these, and I believe that they are cheaper rather than pushing big
    pharma on us. I for one am sick of it and would rather live in a state
    of depression and anxiety as opposed to taking 10+ pills a day. I'm
    also battling with the VA for an increase in VET benefits. They have
    turned down request for shoulder pain connected disability; they've
    turned down requests for increase in ringing in my ears but will give
    me pills!''
        I am glad the VA and the Committee is addressing this, it is very
    real, and how would you respond to this veteran?
        Response. Thank you for raising this important point. The problems
    you mention affect our entire nation and this is an issue we are
    challenged to manage effectively for our Veterans as well. The VA is
    actively addressing these problems in multiple ways, as well as
    contributing to the national effort, outlined in the National Pain
    Strategy, to improve the education and training of all health
    professionals, including those who eventually will care for our
    Veterans and military. The potential for side effects and toxicity
    increases when medications that affect the central nervous system (the
    brain and spinal cord) are prescribed together for symptoms of
    different, but sometimes related, conditions such as sleep disorders,
    chronic pain conditions, anxiety and depression disorders, Traumatic
    Brain Injury (TBI) and PTSD. To help combat this problem the VA can
    take advantage of its unique combination of assets, such as its
    electronic medical record and its Veterans Health Administration (VHA)-
    wide communication and education systems which reach all facilities and
    providers.
        VHA has developed a new tool, the Opioid Therapy Risk Report
    (OTTR), which is available now to all VHA Primary Care clinicians when
    treating a Veteran with opioid therapy for chronic pain. This report
    provides information about the dosages of opioid analgesics and other
    centrally active medications such as benzodiazepines, significant
    medical and psychiatric problems that could contribute to an adverse
    drug reaction, and monitoring data to aid in the review and management
    of complex patients. OTTR is right on the dashboard of the electronic
    medical record, which enables VA providers to review this pertinent
    clinical data related to pain treatment all in one place while actually
    talking to patients about their symptoms and medications. As a result,
    Veterans are afforded a comprehensive Veteran-centered and more
    efficient level of pain management not previously available to Primary
    Care providers. VHA is actively deploying training aids to providers
    and facilities to familiarize them with how to utilize this tool in
    their daily practice.
        VHA has formalized several education and academic detailing
    projects that provide all VA prescribers and facilities guidance and
    education on safe symptom management. One program is the OSI, which
    monitors reductions in potential risks such as prescribing opioids and
    benzodiazepines together or high doses of opioids, monitors how
    facilities are increasing the use of evidence-based alternative
    treatments such as cognitive behavioral therapies and integrative
    medicine (CAM) (which are now required to be available in all
    facilities as alternatives to medication), and also provides feedback
    and support for providers whose prescribing profiles do not meet
    acceptable clinical standards. An OSI Toolkit with detailed education
    and guidance for both providers and patients is available on the VA's
    Pain Management Intranet and Internet sites and has been widely
    presented throughout the VHA in multiple educational formats and
    communications. For example, the Toolkit has detailed instructions
    about guiding safe medication tapers when clinically indicated.
        Programs such as the ATACS are presently training physicians in
    medical acupuncture and providers in ``battlefield (auricular)
    acupuncture'' across both systems. Already 1,293 Providers have been
    trained in battlefield acupuncture in military treatment facilities VA
    hospitals across the country.
                                     ______

    Response to Posthearing Questions Submitted by Hon. Richard Blumenthal
     to Robert A. Petzel, MD, Under Secretary for Health, Veterans Health
           Administration (VHA), U.S. Department of Veterans Affairs
        Question 16.  I have heard from one of my constituents that it is
    difficult for some veterans to obtain their VA Identification Card,
    which is required to obtain VA health benefits. Can you please provide
    information about the process a veteran needs to follow and what are
    the criteria to obtain these benefits?
        Response. The Veterans Health Identification Card (VHIC) is for
    identification and check-in at VA appointments. It cannot be used as a
    credit card or an insurance card, and it does not authorize or pay for
    care at non-VA facilities. To receive a VHIC, a Veteran must be
    enrolled. If the Veteran is not enrolled, the Veteran may apply for
    enrollment online at www.va.gov/healthbenefits/enroll, by calling 1-
    877-222-VETS (8387), or apply for enrollment in person at his or her
    local VA medical facility.
        In February 2014, VA began issuing the VHIC to newly enrolled
    Veterans and enrolled Veterans who were not previously issued the old
    VIC but requested an identification card. Enrolled Veterans who were
    not issued the old VIC may contact their local VA medical center
    Enrollment Coordinator to arrange to have their picture taken for the
    new VHIC, or they may request a new VHIC at their next VA health care
    appointment.
        Veterans who are already enrolled should ensure the address VA has
    on file is correct so you can receive your VHIC in a timely manner. For
    more information, please visit http://www.va.gov/HEALTHBENEFITS/vhic/
    index.asp.

        Chairman Sanders. Dr. Petzel, thank you very much.
        General Coots.

     STATEMENT OF BRIGADIER GENERAL NORVELL V. COOTS, USA, DEPUTY
      COMMANDING GENERAL (SUPPORT), U.S. ARMY MEDICAL COMMAND AND
     ASSISTANT SURGEON GENERAL FOR FORCE PROJECTION, OFFICE OF THE
      SURGEON GENERAL, U.S. ARMY; ACCOMPANIED BY COLONEL KEVIN T.
        GALLOWAY, USA, DIRECTOR, ARMY PAIN MANAGEMENT PROGRAM,
               REHABILITATION AND REINTEGRATION DIVISION

        General Coots. Chairman Sanders, Ranking Member Burr, and
    distinguished Members of this Committee, thank you for the
    opportunity to appear before you to discuss some of the Army
    Medicine's initiatives to address health and pain management
    needs of our servicemembers. I am accompanied by Colonel
    Galloway, who is the director for Army Medicine's Pain
    Management Program.
        On behalf of the over 150,000 dedicated soldiers and
    civilians that make up Army medicine, I want to extend our
    appreciation to Congress for the support given to military
    medicine which provides the resources we need to deliver
    leading-edge health services to our warriors, families, and
    retirees.
        The Army has been engaged over the last 13 years in combat
    operations and related activities that have challenged the
    bodies and spirits of our soldiers and their families. Army
    medicine has worked with our sister services and the Veterans'
    Health Administration to meet the emerging medical needs of our
    servicemembers and veterans.
        Our initiatives which are detailed further in my written
    testimony are aimed at improving outcomes, increasing safety,
    and enhancing the transition of care to the VA.
        Treating pain is one of medicines oldest and more
    fundamental responsibilities. Yet modern medicine continues to
    struggle in its efforts to understand pain mechanisms and to
    relieve pain and suffering of our patients. These complex
    issues impact patients, providers, leaders, and organizations
    across the military, the VA, and in the civilian sector.
    Effective solutions must involve innovative strategies,
    comprehensive solutions, and collaborative efforts.
        While the complicated nature of pain management and
    overmedication is not unique to the military or military
    medicine, we do face some unique challenges. We provide medical
    care on the battlefield and across an 8,000-mile medical
    evacuation chain that moves injured servicemembers from remote
    locations to U.S. hospitals with lightening efficiency.
        I have been there receiving our wounded warriors during my
    time in Afghanistan as well as at Walter Reed when I was the
    hospital commander. I know that for military medical providers,
    we begin pain management on the battlefield at the point of
    injury and continue throughout evacuation, treatment, and
    recovery.
        Army medicine initiative aimed at non-opioid medications
    and regional nerve blocks to provide local relief are important
    to expanding opioid sparing strategies at the earliest moments
    of care.
        In 2010, the Army-led pain management task force was
    chartered to develop a comprehensive, holistic, and multi-
    disciplinary pain management strategy for the DOD. The Army has
    been working to implement the task force recommendations
    through the Army pain management campaign and while continuing
    to build collaborations both inside and outside of the
    Department of Defense.
        Current Army initiatives are aimed at improving pain
    management, patient care and safety, and reducing adverse
    outcomes related to prescription drugs. These are all a part of
    comprehensive strategy that includes establishing a network of
    standardized pain management capabilities, developing the DOD
    pain assessment screening tool, and outcomes registry by
    leveraging previous NIH investment in research, comprehensive
    medication reviews, and pharmacy screening tools within the
    medical home which is our primary care model to identify active
    duty servicemembers at increased risk, expanding the role of
    clinical pharmacists by embedding them in the medical home as a
    member of the comprehensive care team, improving pain
    management specialty support to primary care providers through-
    out pain ECHO tele-mentoring initiative, expanding our
    understanding and utilization of effective integrative medicine
    modalities such as acupuncture, yoga, medical massage, and
    biofeedback through our collaborative partnerships and
    collaboration with the National Center for Complementary and
    Alternative Medicine and the Defense and Veterans' Center for
    Integrative Pain Management on research studies of non-
    medication complements or alternatives to standard pain
    management therapies.
        There efforts have been associated with fewer adverse drug-
    related events, reduced hospital admissions, improved patient
    outcomes, and overall cost avoidance.
        Finally, I would like to mention ongoing work with the VA
    to endure the smooth transition of care as servicemembers enter
    the VA system. The overarching pain management task force
    objective is to provide a standardized DOD and VA approach to
    optimize the care for warriors and their families.
        Our providers and patients benefit from a standardized
    approach to pain management while they are in uniform and as
    they transition to the VA health care system.
        I want to thank my partners in the DOD, the VA, and our
    colleagues testifying here today for the efforts made and our
    shared goals.
        I also want to thank Congress and the Committee for your
    continued support and I look forward to your questions. Army
    medicine is serving to heal and honored to serve.
        [The prepared statement of General Coots follows:]
       Prepared Statement of Brigadier General Norvell V. Coots, Deputy
     Commanding General (Support), U.S. Army Medical Command and Assistant
     Surgeon General for Force Projection, Office of the Surgeon General,
    United States Army and Colonel Kevin T. Galloway, Army Pain Management
    Program Director, Rehabilitation and Reintegration Division, Office of
                    the Surgeon General, United States Army
        Chairman Sanders, Ranking Member Burr, and Distinguished Members of
    this Committee--thank you for the opportunity to appear before you to
    discuss some of the Army Medicine's initiatives to address healthcare
    needs of our Soldiers, specifically as they relate to the challenges
    the entire Nation is facing with pain management and the use of
    opioids. On behalf of the over 150,000 dedicated Soldiers and civilians
    that make up Army Medicine, I want to extend our appreciation to
    Congress for the support given to military medicine, which provides the
    resources we need to deliver leading edge health services to our
    Warriors, Families and Retirees. I'm accompanied today by Colonel Kevin
    Galloway, Director for Army Medicine's Pain Management Program.
        The Army has been engaged over the last 13 years in combat
    operations and related activities that have challenged the bodies and
    spirits of our Soldiers and their families. Throughout this intensive
    period of military operations, Army Medicine, along with our Sister
    Services and the Veterans Health Administration (VHA), have been
    evolving and adapting to meet the emerging medical needs of our
    wounded, ill, and injured Servicemembers and Veterans. While some of
    the medical challenges facing Servicemembers and Veterans are unique to
    the military and military medicine, the challenges related to pain
    management and the potential overuse, abuse, and diversion of pain
    medications are shared by the Nation at large. These complex issues
    impact patients, providers, leaders and organizations across the
    military health system, the VHA, and civilian medicine. Consequently,
    effective solutions and strategies will involve patients, providers,
    leaders and organizations across military, VHA and civilian medicine. I
    would like to share some of our innovative strategies, comprehensive
    solutions, and collaborative efforts with you today as well as
    emphasize our commitment to continuous improvement and research
    efforts.
                                pain management
        First, I'd like to place the challenges of pain management in some
    context. Treating pain is one of medicine's oldest and most fundamental
    responsibilities, yet modern medicine continues to struggle in its
    efforts to understand pain mechanisms and to relieve pain and suffering
    for our patients. Pain is an enigmatic issue for medicine that places
    significant burdens on patients, families, medical providers, and
    employers. Pain is the most frequent reason patients seek medical care
    in the United States. A 2011 Institute of Medicine (IOM) Report noted
    that more than 116 million Americans suffer from chronic pain. The
    annual cost of chronic pain in the U.S. is estimated at $560 billion,
    including health care expenses, lost income, and lost productivity. The
    Centers for Disease Control identified prescription medication abuse as
    an ``epidemic'' in the United States. The military is not immune to
    these challenges.
        In 2010, the Army-led Pain Management Task Force was chartered to
    develop a comprehensive, holistic, multidisciplinary, and multimodal
    strategy utilizing state-of-the-art/science practices in the field.
    Comprised of representatives from the Uniformed Services and VHA, the
    Pain Management Task Force examined staff education, clinical practice,
    and the structure of pain management in military medicine, the VHA, and
    in civilian medicine. I would like to emphasize that the Task Force
    benefited immensely during this analysis from the VHA's previous and
    ongoing initiatives to develop and implement pain management
    strategies.
        The 2010 Pain Management Task Force Report has been widely
    circulated and recognized across U.S. Medicine and abroad. The American
    Academy of Pain Medicine recognized the Pain Management Task Force with
    its Presidential Commendation. One year after the release of the
    report, the IOM released its own report entitled, ``Relieving Pain in
    America,'' which acknowledged and referenced the work of the Pain
    Management Task Force. More importantly, the IOM report's findings and
    recommendations largely paralleled those contained in the Pain
    Management Task Force Report. When the IOM report was released in
    June 2011, the Army was already operationalizing the Pain Management
    Task Force's recommendations through the Comprehensive Pain Management
    Campaign Plan. Since the release of the IOM report, the Army has been
    representing the Department of Defense on the National Institutes of
    Health (NIH) Interagency Pain Research Coordinating Committee, the
    Federal advisory committee created by the Department of Health and
    Human Services to enhance pain research efforts and promote
    collaboration across the government.
        The Comprehensive Pain Management Campaign Plan provides a roadmap
    for this holistic, multimodal, multidisciplinary pain management
    strategy. Army Medicine's pain strategy includes several lines of
    effort: first, to implement a culture of pain awareness, education, and
    proactive intervention; second, to provide tools and infrastructure
    that support and encourage practice and research advancements in pain
    management; and last, to build a full spectrum of best practices for
    the continuum of acute and chronic pain, based on a foundation of the
    best available medical evidence.
        The foundation of the MEDCOM pain management program is developing
    a tiered or ``Stepped Care'' strategy that provides the appropriate
    level of pain management capability, provider education and access to
    consultative/referral support at each level of care (i.e. from Primary
    Care to Specialty Care). Interdisciplinary Pain Management Centers
    (IPMC) are being established at each of the Army's eight medical
    centers. IPMCs provide the highest tier of pain management delivered by
    a multidisciplinary team of providers working together to provide
    consultation, care, and expertise for interventional pain medicine. Our
    goals are rehabilitation and functional restoration through these
    integrative medicine modalities.
        The Army Pain Management Extension for Community Healthcare
    Outcomes (ECHO) tele-mentoring initiative leverages the model developed
    by the University of New Mexico (UNM) Project ECHO initiative. The Army
    is completing a two-year collaboration with UNM to adapt this best
    practice for use in the Army's pain program. ECHO's objective is to
    complement the capacity, competence and confidence of remote primary
    care providers. Utilizing weekly video teleconferencing to create
    regional communities of practice, ECHO links the IPMC specialty teams
    (i.e. hubs) with their designated Patient Centered Medical Homes (i.e.
    spokes). This improves provider knowledge, increases care coordination,
    and decreases the need for continued specialty referrals to the direct
    and purchased care systems.
                 complementary integrative medicine modalities
        As recommended by the Pain Management Task Force, the integrative
    medicine modalities in our IPMCs include acupuncture, movement therapy/
    yoga, medical massage, and bio-feedback. The use of these modalities in
    our IPMCs provides our patients with non-medication pain management
    options. The Army has been collaborating with several organizations
    with a common interest in expanding the utilization of complementary
    integrative medicine modalities. The National Center for Complementary
    and Alternative Medicine at NIH, the Bravewell Collaborative, and the
    Samueli Institute have all been extremely helpful in this effort.
        Army clinicians are participating with the Air Force, Navy, and VHA
    in a $5.4 million Joint Incentive Fund Project to field a standardized
    basic acupuncture training and sustainment model across DOD and VHA
    medical facilities. Training teams have already started traveling to
    Army, Navy, Air Force, and VHA medical facilities to deliver this
    training. The response from providers and patients has been
    overwhelmingly positive.
        Army Medicine, along with the Navy and Air Force, is collaborating
    through the Defense and Vet Center for Integrative Pain Management on
    research studies related to the use of acupuncture and yoga as non-
    medication complements/alternatives to standard pain management
    therapies. Initial evidence indicates these can be effective
    complements and sometimes an alternative to medications.
                           pain outcomes measurement
        In response to the 2010 National Defense Authorization Act and the
    recommendations in the Pain Management Task Force Report, the DOD began
    development of the Pain Assessment Screening Tool and Outcomes Registry
    (PASTOR). PASTOR was designed as a tool to reduce the burden of
    questionnaires during clinical contact through modern information
    technology, make use of well-established pain assessment tools already
    available, and provide a framework for development of new assessment
    tools. Furthermore, PASTOR is envisioned as a critical first step in
    realizing the vision of outcomes driven pain care across the DOD and
    VHA health care systems.
        The PASTOR prototype results in a clinician report, displaying
    alerts for concerning responses to questions covering PTSD, depression,
    anxiety, and alcohol use. These alerts are intended to prompt further
    individualized evaluation by the clinician. Areas of greatest pain are
    mapped on an image of a body, and self-reported pain values are tracked
    over time. When these scores are analyzed in concert with validated
    measures of emotional (anxiety, depression, anger) and physical (sleep,
    physical function) health domains, trends are easily identified.
    Additionally, each patient has an opportunity to list and rate ability
    on activities that are important to that individual. This functional
    data provides practical indicators of pain management success. A new
    set of opioid use measures are also under development and will be field
    tested in both civilian and military setting later this year.
        A significant advantage in the PASTOR development program is its
    collaborative partnership and development strategy with the NIH Patient
    Reported Outcomes Measurement Information Systems, or PROMIS. PROMIS
    represents an existing Federal investment of approximately $100
    million, over 8 years of research and development, and the product of
    150 scientists at 15 primary research sites. PROMIS created more than
    80 royalty free instruments which can be used to capture numerous
    components of health related quality of life including physical health,
    mental health and social health. Computerized adaptive testing (CAT)--
    enables computer-based delivery of measures which can obtain clinical
    accuracy in five items or less. Scientists at Northwestern University
    have teamed with the military to integrate brief PROMIS measures with
    the needs of military personnel and their families who require pain
    management. This reduction in patient burden, without loss of clinical
    reliability, enables PASTOR to frequently assess multiple facets of
    pain and opioid use.
        Thus far, a working prototype has been constructed, pain threshold
    values for appropriate initiation of PASTOR have been identified, and a
    pilot test of the system has begun in two military treatment
    facilities, with more to follow in the coming months.
        Army Medicine is adopting the Defense and Veterans Pain Rating
    Scale (DVPRS). Something as simple as changing how we ask our patients
    about their pain can impact the prevalence of medication use. The scale
    was developed by the Pain Management Task Force and validated through
    DOD/VHA research studies. It recalibrates the pain discussion along the
    lines of: ``How is pain affecting your function and quality of life?''
    The scale includes supplemental questions on pain's effect on sleep,
    mood, stress and activity. The Army is integrating DVPRS into the
    Patient Centered Medical Home workflows.
                       pain management transition to vha
        Another area I'd like to highlight with regard to pain management
    is our ongoing collaboration with the VHA to ensure the smooth
    transition of care for Soldiers who will be receiving care in the VHA
    health system. Prominently positioned on the Pain Management Task Force
    Report cover is the overarching Task Force objective: ``Providing a
    standardized DOD and VHA vision and approach to pain management to
    optimize the care for Warriors and their Families.'' Army Medicine has
    continued to engage with the Air Force, Navy and VHA to move our
    organizations in that direction. The Army Pain Management Program's
    incorporation of the VHA's Stepped Care approach synchronizes provider
    education with the expectations of our patients. Not only do our
    military providers and patients benefit from a standardized approach to
    pain management while they are in uniform, but this also makes the
    transition to VHA care far less disruptive.
        DOD and VHA collaboration has also resulted in standardized
    prescription medication formularies to ensure Soldiers with chronic
    pain are able to continue effective care plans after their transition
    to the VHA. Last, military and VHA providers are engaged in a project
    to develop and implement a common pain management education curriculum
    for both providers and patients. The curriculum will be fully developed
    within the next twelve months, and will be implemented across VHA and
    DOD within the next eighteen months. These initiatives will take us
    closer to the standardized DOD and VHA vision and approach to pain
    management referenced by the Pain Task Force.
        In addition to the Pain Management Campaign, Army Medicine is
    addressing the potential overuse, abuse and diversion of opioids
    through a comprehensive strategy that integrates several other
    initiatives including Polypharmacy, Substance Abuse, Behavioral Health,
    and Warrior Transition Care.
                                  polypharmacy
        Soldiers with complex injuries often require the use of multiple
    medications (i.e. polypharmacy) which can place them at greater risk
    for medication-related adverse events. The Army seeks to reduce risk,
    enhance safety and optimize care by including the Soldier, Family
    members, healthcare providers, pharmacists and commanders as part of
    the healthcare team. Army policies also establish procedures to
    identify polypharmacy trends that could lead to misuse by Soldiers and
    Wounded Warriors.
        Army Medicine uses best practices that are comparable to, or
    exceed, civilian programs, such as prescription drug monitoring to
    identify polypharmacy cases. Positive interventions include
    comprehensive medication reviews, sole provider programs, limiting the
    dispensed supply of medication, restricting high-risk patients to the
    utilization of one pharmacy, informed consent, use of non-drug
    treatment options, clinical pharmacist referrals, and patient and
    provider education.
        The Army trains its providers on the risks of prescription opioid
    overuse and ways to prevent medication misuse. The US Army Public
    Health Command and the Uniformed Services University of the Health
    Sciences developed an interactive storyline-based training aimed at
    increasing the knowledge and skills health professionals need to better
    interact with Soldiers in a clinic setting. Army Medicine has
    implemented systems and procedures our clinicians regularly use to
    prevent and detect issues of opioid overuse. These tools include the
    ability for our clinicians to review all prescriptions paid for by the
    Defense Health Agency (DHA) pharmacy benefit regardless of the point of
    service (Military, Home Delivery or Retail Pharmacy). The DHA
    Pharmacoeconomic Branch Web site allows clinicians to identify
    concerning use of opioids dispensed under the TRICARE Pharmacy Benefit
    through the use of prescription screening tools such as the Medication
    Analysis and Reporting Tools.
        Army Medicine is expanding the role of clinical pharmacists to
    address national concerns with polypharmacy and adverse drug events
    that lead to hospital admissions. The Army Surgeon General supports
    evidence-based enhancements drawing on the expertise and contributions
    of pharmacists embedded in Patient-Centered Medical Homes. The addition
    of clinical pharmacists to the patient care team translates into
    decreased overall costs, fewer adverse drug-related events, reduced
    hospital admissions, and improved medication-related patient outcomes
    and appropriate adherence to medications. Clinical pharmacists improve
    readiness of the force through policy and practice, systematically
    identifying Soldiers with polypharmacy risk and communicating these
    concerns to health care providers. The Army uses an automated
    polypharmacy screening tool to screen all Active Duty Servicemembers
    monthly to identify Soldiers prescribed different combinations of high
    risk medications. These reports are provided to the medical team for
    review and follow-up. Clinical pharmacists embedded in Army medical
    homes optimize patient adherence to appropriate drug therapy by
    conducting medication reviews, resolving medication problems and
    recommending cost effective treatment alternatives.
        Current Army initiatives aimed at reducing adverse outcomes and
    harm due to prescription drug abuses include informed consent for
    polypharmacy, sole provider program, limiting authorized use of
    prescriptions to six months following the prescription fill date,
    adjusting the panel of drugs in random urine drug testing to include
    prescription drugs and polypharmacy education for healthcare providers
    and patients.
        Healthcare providers must review identified risks and potential
    interactions with the Soldier, provide education on detection and
    management of interactions, and must document informed consent in the
    medical record. Informed consent includes a brief description of
    discussed risks and whether or not the indication for which the
    medication is being used is a Food and Drug Administration (FDA)
    approved indication or the medication is used off-label.
        The Army policy instructs healthcare providers to have a low
    threshold for referring patients to Behavioral Health resources and the
    Sole Prescriber Program. Healthcare providers enroll Soldiers at
    increased risk of adverse effects, drug interactions, or inappropriate
    medication use in the Sole Prescriber Program to optimize care. Once
    enrolled, only a Soldier's designated provider or alternate provider is
    authorized to prescribe controlled substances for the Soldier. If
    necessary, the Soldier may be restricted to a specific pharmacy or
    pharmacies by activating the Prescription Lock-out Program.
        In addition to Soldiers who are identified as having intentional or
    unintentional risk for medication overdose, healthcare providers will
    refer Soldiers who present with polypharmacy-related concerns to a
    clinical pharmacist. The pharmacist will identify medication-related
    problems, develop a medication action plan, and provide medication
    education to the patient. Clinical pharmacists document patient
    encounters and consultations for medication therapy management in an
    electronic medical record template to improve communication with
    providers.
        Army policy limits authorized use of prescriptions to six months
    following the prescription fill date. In addition, Army medical
    providers may prescribe only the minimum quantity of controlled
    substances necessary to treat an acute illness or injury, and
    quantities of controlled substances used to treat acute conditions are
    dispensed as a 30-day supply. Prescribers and pharmacists inform
    Soldiers that, per Army policy, controlled substance prescriptions have
    an expiration date of six months from the dispensed date, and that a
    positive urinalysis test for the drug after six months from dispensing
    may result in a ``no legitimate use'' finding.
        Polypharmacy education and training is available to healthcare
    providers and beneficiaries to improve appropriate prescribing and use
    of medications, respectively. Patient-specific training is available to
    Warrior Transition Units (WTU) to improve awareness of safe medication
    use, proper medication disposal, and promotion for the bi-annual drug
    take back events.
        Army Medicine has participated in all Drug Enforcement Agency (DEA)
    National Prescription Drug Take Back Day events since their inception
    in 2010. Thirty-six Army Military Treatment Facilities participated in
    the Take Back Day on 25 and 26 October 2013, with over 2,000 patients
    participating and 7,491 pounds of unused medications collected. The
    Army will continue to participate in bi-annual Take Back events in an
    effort to maintain attention on the importance of appropriate disposal
    of medications that are no longer needed. Army Medicine provides
    support through coordinated public affairs communications and education
    directed at medical staff, patients, Families and military leadership,
    to include on-site presence at every designated event.
                            substance abuse programs
        The Army continues to synchronize clinical care and processes
    provided through the Army Substance Abuse Program and Army Medical
    Command's primary care providers, pain specialists, and behavioral
    health specialists. The Army uses the DOD's drug testing program to
    test not only for illegal drugs, but also for prescribed medications
    taken inappropriately (that is without an active prescription).
    Identified Soldiers are referred to the Army Substance Abuse Program
    where they are assessed and enrolled for treatment. Commanders and
    clinicians support this treatment process regardless of the Soldier's
    disposition, because we recognize that we have an obligation to ensure
    our Soldiers remain effective on active duty or make their transition
    from active service with drug use properly managed.
                           behavioral health program
        Army Medicine's Behavioral Health Service Line is an interconnected
    group of standardized programs delivering a wide variety of Behavioral
    Health services to Soldiers and beneficiaries. For the treatment of
    substance abuse disorders, the Army has five Addiction Medicine
    Intensive Outpatient Programs. There are currently 187 beds designated
    for long-term Substance Use Disorder treatment in the Military Health
    System, 22 of which are in the Army. These Military Health System
    facilities have consistently had 85% or higher utilization rates for
    the past 18 months. Purchased care inpatient substance use disorder
    treatment accounts for approximately 70 Soldiers per month. Demand for
    network inpatient substance use disorder treatment has decreased
    sharply with the implementation of the NDAA 2010, Section 596, but
    continues to remain high enough to justify increases in capacity in the
    coming years to recapture inpatient substance use disorder care going
    to the network.
        Army Medical Command conducted an analysis of all health care and
    pharmacy records involving Army Active Duty Servicemembers, reflecting
    an annual average population of 657,000 Soldiers from 2007 to 2012.
    This analysis showed a 65% increase in the number of Soldiers seeking
    behavioral health services (151,620 in 2007 to 250,410 in 2012), and a
    corresponding 44% increase in the number of Soldiers prescribed any
    medication within the broad psychiatric category (101,914 in 2007 to
    147,197 in 2012). In other words, there has not been any
    disproportionate increase in medication use. There are multiple
    safeguards in place to ensure that psychiatric medications, including
    antipsychotic medications, are prescribed safely and judiciously
    according to accepted clinical practice guidelines and nationally
    recognized standards of care.
                  medical home and warrior transition clinics
        Optimizing the use of medications through pharmacist interaction as
    part of a Patient Centered Care Team is best exemplified by their work
    within the Wounded Warrior Clinics. Of the 22 Warrior Clinics in
    support of Army Medicine Warrior Transition Units, 21 Clinics are
    currently supported by approximately 25 clinical pharmacists and 5
    pharmacy technicians. These Warrior Clinics are consistent with the
    Medical Home model, where pharmacists manage complex medication
    regimens and mitigate risks for Wounded Warriors.
        The Risk Assessment Management within the Warrior Care and
    Transition Program enables WTUs to monitor the safety of Soldiers. WTU
    Commanders, in coordination with the Soldiers' interdisciplinary team,
    conduct risk assessments for every Soldier. The initial risk assessment
    occurs within 24 hours of the Soldier's arrival at the WTU, ongoing
    assessments are regularly made throughout the Soldier's stay, and
    additional assessments occur during key events such as during quarterly
    scrimmages as directed by the Soldier's personalized Comprehensive
    Training Plan. Risk assessments focus on therapy adherence, behavioral
    health history, substance abuse history, and access to care patterns.
    The intent is to assess whether Soldiers on these medications need
    additional monitoring and assistance with medication management. If a
    Soldier is identified as needing additional monitoring and assistance,
    the interdisciplinary team determines what risk mitigation strategies
    are needed to maintain the Soldier's safety. If needed, the Soldier is
    entered into the Army Medical Department's Sole Provider Program.
    Soldiers enrolled in the Sole Provider Program may only receive
    medications from their assigned provider, and receive no more than a 7-
    day supply of narcotics or psychotropic medications. Clinical
    Pharmacists also provide oversight as they review the medication
    profiles of all Soldiers in a WTU, who are determined to be at high
    risk. These reviews occur at least weekly.
        Army Medicine has engaged in a comprehensive campaign to address
    the pain management needs of Soldiers and their Families. Our strategy
    involves developing and implementing solutions with our DOD, VHA, and
    Civilian Medicine partners. Thank you again for the opportunity to
    testify before the Committee and for your support to our Soldiers and
    Veterans.
                                     ______

    Response to Posthearing Questions Submitted by Hon. Bernard Sanders to
      BG Norvell V. Coots, USA, Deputy Commanding General (Support), U.S.
         Army Medical Command and Assistant Surgeon General for Force
              Projection, Office of the Surgeon General, U.S. Army
                  complementary and alternative medicine (cam)
        Question 1. How can the Army improve access to CAM therapies among
    servicemembers? How can it help improve what information is available
    to servicemembers and their providers about CAM services?
        Response. In Army Medicine, perhaps the single greatest application
    of Complementary and Alternative Medicine (CAM) has been seen in pain
    management. Initially, Servicemembers were often the ones who
    identified integrative medicine treatments to their medical providers
    as uniquely effective in restoring and maintaining their health with
    minimal side effects. In response to this call to action and as a
    result of increasing medical evidence, Army Medicine has deliberately
    expanded its experience and utilization with integrative medicine as
    part of the Army's Comprehensive Pain Management Program.
        The Army Pain Program has been moving toward a more multi-
    disciplinary, multi-modal pain management strategy that leverages
    selected CAM modalities alongside more conventional pain management
    treatments such as medications and interventional procedures such as
    injections, nerve blocks, and surgeries. In addition to chiropractic
    care, the Army's Interdisciplinary Pain Management Centers are
    employing modalities such as acupuncture, massage therapy, movement
    therapies to include yoga, and biofeedback. These are all proving to be
    effective complements and sometimes alternatives to medications.
        Army Medicine will continue to expand the utilization and
    collection of evidence regarding the efficacy of integrative medicine
    modalities alongside more conventional therapies.

        Question 2. What factors currently limit DOD from further
    broadening CAM therapies across the Army and other branches?
        Response. Of the many treatment strategies addressed in the Army's
    Comprehensive Pain Management Campaign Plan, the use of CAM therapies
    has been one of the most challenging. As noted in the Army's 2010 Pain
    Task Force Report, there are an increasing number of reports in medical
    literature regarding the safety and efficacy of these treatment
    modalities, and their use is becoming more widespread across medicine.
    It is believed that the use of the various CAM modalities can lead to
    an improved sense of being, health status or functional outcome through
    pain reduction, lower medication usage or increased quality of life.
    However, there is still a paucity of evidence-based scientific
    literature on the precise role for these modalities in the overall
    management of acute and chronic pain.
        Per the Code of Federal Regulations, Section 199.4(g)(15), TRICARE
    is unable to pay for healthcare in the purchased care sector that has
    not been proven to be both safe and effective in the treatment of the
    underlying condition. While there have been an increasing number of
    articles published on the use of CAM for the treatment of acute and
    chronic pain, there have been no evidence-based clinical practice
    guidelines published or other evidence based protocols developed that
    incorporate the general use of CAM, or specific types of CAM.
        However, within the DOD, Military Treatment Facilities (MTFs) are
    allowed, under very specific conditions and specifications, to offer
    certain types of services that would otherwise not be covered benefits
    under TRICARE. That is the case with certain CAM therapies. Under these
    circumstances, the MTF Commander is responsible for ensuring that all
    existing community standards of care are met, to include any
    credentialing requirements of practitioners if they are not otherwise
    considered to be TRICARE authorized providers. Army Medicine is working
    with the Navy and Air Force to develop credentialing guidelines and
    oversight provisions to provide appropriate, standardized credentialing
    of practitioners who will employ CAM at our MTFs.
        One notable exception can be seen in the military's expanded use of
    chiropractic care. Unlike the other CAM modalities, chiropractic care
    was originally offered in 1995 as a demonstration program and later
    expanded as directed under Section 702 of the National Defense
    Authorization Act (NDAA) for Fiscal Year 2001. Three subsequent NDAA's
    allowed for expansion of the program, resulting in chiropractic
    services now being offered at 62 MTFs but still limited to Active Duty
    Servicemembers.
                              acupuncture training
        Question 3. How would the Joint Incentive Fund Project to implement
    a standardized acupuncture training and sustainment model across DOD
    and VA medical facilities improve acupuncture services the Army
    provides servicemembers? When can we expect system-wide implementation
    of this joint model?
        Response. The variances in acupuncture integration, utilization,
    reimbursement, and practice in health systems are not limited to
    Federal/military medicine. The absence of universally accepted
    protocols, credentialing, and clinical practice guidelines have
    inhibited more aggressive implementation across the DOD and VHA health
    systems. The $5.4 million, Joint Incentive Fund (JIF) acupuncture
    project will develop, pilot, evaluate and implement a uniform tiered
    acupuncture education and training program for Military Health System
    (MHS) and Veterans Health Administration (VHA) providers in order to
    provide initial and expanded access to this modality across MHS and VHA
    treatment facilities.
        The acupuncture JIF provides a pathway to uniform implementation
    and integration of this modality across military and VA healthcare
    systems through a proven practical program of training and
    certification for providers. It drives adoption and further development
    of acupuncture best practices across the MHS and VHA. The two-year
    acupuncture JIF project is scheduled to be completed by 2016. In
    progress reviews are provided to the Health Executive Council on a
    quarterly basis.

        Question 4. How many providers trained in acupuncture already
    working in the Army? How many of these providers exclusively offer
    acupuncture services? On average, how many hours per week do these
    offer acupuncture to servicemembers?
        Response. U.S. Army Medical Command (MEDCOM) providers, including
    physicians, physician assistants, nurse practitioners and dentists who
    wish to use acupuncture in their practice are required to document
    their acupuncture training and competency in their facility
    credentialing file. As of April 2014, 46 MEDCOM providers have added
    acupuncture to their credentialing files. None of these providers are
    exclusively offering acupuncture services but use acupuncture as a
    complementary modality in their practice.
        The number of hours per week where acupuncture is offered is not
    possible to calculate. However, the Army does capture the number of
    acupuncture procedure performance. In FY 2012, over 23,000 acupuncture
    procedures were performed in Army medical treatment facilities. The FY
    2013 numbers for acupuncture utilization is currently unavailable but
    should trend upwards.
        The Army pain management program has been working to integrate
    licensed acupuncturists in the eight Army interdisciplinary pain
    management clinics. These individuals are being hired with a primary
    responsibility to provide acupuncture. At this time, the Army Pain
    Program, along with the Air Force, Navy, and VHA are working to
    standardize coding, treatment protocols, and credentialing for licensed
    acupuncturists.

        Question 5. Is the current amount of acupuncture offered within the
    Army sufficient to meet the demand for this therapy? If not, what
    efforts are being made to ensure an adequate number are available to
    treat veterans once the joint model is implemented?
        Response. The current capacity within the Army direct healthcare
    system is insufficient to support the perceived demand for acupuncture.
        While the Joint Incentive Fund acupuncture project to field a
    standardized basic acupuncture training and sustainment model across
    DOD and VHA will greatly improve access to basic acupuncture
    techniques, there will likely be a need for additional organized
    efforts to increase the enterprise wide training, availability, and
    utilization of acupuncture and other complementary integrative
    modalities.
                              dod/va collaboration
        Question 6. What benefits has DOD seen from the standardization of
    the prescription medication between VA and DOD available to both
    servicemembers and veterans? Are servicemembers able to continue their
    existing course of treatment as they transition to VA health care?
        Response. Ongoing efforts to harmonize formularies are aimed at
    improving continuity of care for DOD beneficiaries transitioning to the
    VA. The VA has established policy that supports the continuation of DOD
    prescribed medications upon transfer whether or not the drug is listed
    on the formulary or if its use is consistent with VA prescribing
    guidelines. The VA provider is permitted to change previously
    prescribed medications to allow consistency with prescribing guidelines
    after careful consideration and implementation to prevent avoidable
    problems.

        Question 7. What other efforts have DOD and VA taken to collaborate
    and standardize treatment options available to servicemembers and
    veterans for chronic pain?
        Response. Phased implementation of the Comprehensive Pain
    Management Campaign Plan is ongoing across Army Medicine and Tri-
    Service/VA implementation of Task Force recommendations continues as
    part of Health Executive Council Pain Management Work Group. In FY
    2013, Army, Air Force, Navy, and the VA demonstrated increased interest
    and activity in synchronized implementation of Pain Task Force
    Recommendations. Uniformed Services and the VA will focus on executing
    several joint pain management projects as listed below. These projects
    will provide information to Defense Health Agency and Uniformed
    Services in order to facilitate re-evaluation and possible revisions of
    policies.

        a. Pain Management Outcome Tool
        b. Tiered Acupuncture Course for Primary Care Providers
        c. Development/Implementation of DOD/VHA education curriculum
        d. Synchronized DOD/VA transition policies for medications

        One specific project that highlights DOD/VA collaboration is the
    basic acupuncture training course. Army clinicians are participating
    with the Air Force, Navy, and VHA in a $5.4M Joint Incentive Fund
    Project to field a standardized basic acupuncture training and
    sustainment model across DOD and VHA medical facilities. Training teams
    have already started traveling to Army, Navy, Air Force, and VHA
    medical facilities to deliver this training. The response from
    providers and patients has been overwhelmingly positive.
                                     ______

    Response to Posthearing Questions Submitted by Hon. Richard Blumenthal
    to BG Norvell V. Coots, USA, Deputy Commanding General (Support), U.S.
         Army Medical Command and Assistant Surgeon General for Force
              Projection, Office of the Surgeon General, U.S. Army
        Question 8. Do you have any further breakdown as to the usage for
    each of the branches of the Armed Forces?
        Response. Yes. Information is available on the usage of opiates for
    all branches of the Armed Forces. Question #9 and #10 responses provide
    information for Army Servicemembers.

        Question 9. How much of the opioid use is for acute conditions and
    for chronic conditions?
        Response. For acute conditions, the proportion of Active Duty Army
    Servicemembers prescribed an opiate medication at least once in a year
    for the last 10 years is as follows:

                    2004--21%
                    2005--22%
                    2006--25%
                    2007--26%
                    2008--26%
                    2009--26%
                    2010--27%
                    2011--29%
                    2012--29%
                    2013--27%

        Chronic opioid use is defined as cumulative use of 90 or greater
    days of use in a six-month period. Information on chronic use is
    provided in the response to question #10.

        Question 10. How much opioid use is for >90 days in duration?
        Response. Chronic opioid use is defined as cumulative use of 90 or
    greater days of use in a six-month period. The proportion of Active
    Duty Army Servicemembers with any chronic opiate use in a year is as
    follows:

                    2004--1.27%
                    2005--1.54%
                    2006--1.76%
                    2007--1.96%
                    2008--1.95%
                    2009--1.97%
                    2010--2.09%
                    2011--2.36%
                    2012--2.57%
                    2013--2.34%
                                     ______

     Response to Posthearing Questions Submitted by Hon. Mark Begich to BG
     Norvell V. Coots, USA, Deputy Commanding General (Support), U.S. Army
      Medical Command and Assistant Surgeon General for Force Projection,
                    Office of the Surgeon General, U.S. Army
        Question 11. PTSD, depression, TBI, family stress, disability, and
    joblessness plague our veterans' community and increase the risk of our
    veterans overmedicating to soothe chronic pain. How are you addressing
    growing mental health issues in conjunction with pain management? How
    does this initiative take into account rural and remote locations that
    may not have Behavioral Health professionals or telehealth?
        Response. In the past several years, the Army has vastly expanded
    and completely overhauled its system of behavioral healthcare and pain
    management program to address complex co-morbidities and co-occurring
    conditions.. The Army's Behavioral Health Service Line is comprised of
    11 interconnected standardized programs that provide consistent and
    ready access to behavioral health services covering all behavioral
    health conditions across our supported beneficiary population.
        The 2010 Army-led Pain Management Task Force was chartered to
    develop a strategy that is comprehensive, holistic, multidisciplinary,
    and multimodal, utilizing state-of-the-art/science practices in the
    field resulting in the Comprehensive Pain Management Campaign Plan.
    Army Medicine's pain strategy includes three primary lines of effort:
    1) implement a culture of pain awareness, education, and proactive
    intervention, 2) provide tools and infrastructure that support and
    encourage practice and research advancements in pain management, and 3)
    build a full spectrum of best practices for the continuum of acute and
    chronic pain, based on a foundation of the best available medical
    evidence. This includes incorporating behavioral health care as part of
    pain management solutions and ensuring pain management for Soldiers and
    pain management training for providers outside of the main area of
    care.
        Soldiers with complex injuries often require polypharmacy, or the
    use of multiple medications, which place them at greater risk for
    medication-related adverse events. The Army seeks to reduce risk,
    enhance safety and optimize care by including the Soldier, Family
    members, healthcare providers, pharmacists and commanders as part of
    the healthcare team. Army policies establish procedures to identify
    polypharmacy trends that could lead to misuse by Soldiers and Wounded
    Warriors.
        Army Medicine also uses best practices that are comparable to, or
    exceed, civilian programs, such as prescription drug monitoring to
    identify polypharmacy cases. Positive interventions include
    comprehensive medication reviews, sole provider programs, limiting the
    dispensed supply of medication, restricting high-risk patients to the
    utilization of one pharmacy, informed consent, use of non-drug
    treatment options, clinical pharmacist referrals, and patient and
    provider education.
        The Army trains its providers on the risks of prescription opioid
    overuse and ways to prevent medication misuse. Army Medicine has
    implemented systems and procedures our clinicians regularly use to
    prevent and detect issues of opioid overuse. These tools include the
    ability for our clinicians to review all prescriptions paid for by the
    Defense Health Agency (DHA) pharmacy benefit regardless of the point of
    service (Military, Home Delivery or Retail Pharmacy).
        The Army policy instructs healthcare providers to have a low
    threshold for referring patients to Behavioral Health resources and the
    Sole Prescriber Program. Healthcare providers enroll Soldiers at
    increased risk of adverse effects, drug interactions, or inappropriate
    medication use in the Sole Prescriber Program to optimize care. Once
    enrolled, only a Soldier's designated provider or alternate provider is
    authorized to prescribe controlled substances for the Soldier. If
    necessary, the Soldier may be restricted to a specific pharmacy or
    pharmacies by activating the Prescription Lock-out Program.
        In addition to Soldiers who are identified as having intentional or
    unintentional risk for medication overdose, healthcare providers will
    refer Soldiers who present with polypharmacy-related concerns to a
    clinical pharmacist.
        Army Medicine is expanding the role of clinical pharmacists to
    address national concerns with polypharmacy and adverse drug events
    that lead to hospital admissions. The Army Surgeon General supports
    evidence-based enhancements drawing on the expertise and contributions
    of pharmacists embedded in Patient-Centered Medical Homes.
        Army Medicine has participated in all Drug Enforcement Agency (DEA)
    National Prescription Drug Take Back Day events since their inception
    in 2010. Thirty-six Army Military Treatment Facilities participated in
    the Take Back Day on 25 and 26 October 2013, with over 2,000 patients
    participating and 7,491 pounds of unused medications collected. The
    Army will continue to participate in bi-annual Take Back events in an
    effort to maintain attention on the importance of appropriate disposal
    of medications that are no longer needed. Army Medicine provides
    support through coordinated public affairs communications and education
    directed at medical staff, patients, Families and military leadership,
    to include on-site presence at every designated event.
        Specific to Telehealth, the Army has developed and vastly expanded
    a comprehensive Telehealth system over the past several years that now
    enables the Army to cross-level clinical care capacity across the
    globe. In fiscal year 2013, Army clinicians offered care across 18 time
    zones and in over 30 countries and territories, to include remote
    locations where Soldiers serve. In fiscal year 2013, Army clinicians
    provided over 34,000 patient encounters and provider-to-provider tele-
    consultations in garrison; approximately 85 percent of these encounters
    were related to outreach via Tele-Behavioral Health.
        The Army's Pain Management Task Force recommended the Army ``Expand
    telemedicine capabilities to incorporate pain management initiatives''
    (Pain Management Task Force, 2010). The Army Pain Management Extension
    for Community Healthcare Outcomes (ECHO) tele-mentoring initiative
    leverages the model developed by the University of New Mexico (UNM)
    Project ECHO initiative. The Army is completing a two-year
    collaboration with UNM to adapt this best practice for use in the
    Army's pain program. ECHO's objective is to complement the capacity,
    competence and confidence of remote primary care providers. Utilizing
    weekly video tele-conferencing to create regional communities of
    practice, ECHO links the IPMC specialty teams (i.e. hubs) with their
    designated Patient Centered Medical Homes (i.e. spokes). This improves
    provider knowledge, increases care coordination, and decreases the need
    for continued specialty referrals to the direct and purchased care
    systems. Army Pain ECHO will be available to Providers supporting
    Community Based Warrior Transition Units (CBWTU). Additionally, the
    Army is collaborating with the Air Force, Navy, and Veterans Health
    Administration on development and utilization of a common DOD/VHA Pain
    ECHO education curriculum.

        Chairman Sanders. General Coots, thank you very much.
        Dr. Briggs.

    STATEMENT OF JOSEPHINE BRIGGS, M.D., DIRECTOR, NATIONAL CENTER
    FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE, NATIONAL INSTITUTES
                               OF HEALTH

        Dr. Briggs. Good morning, Chairman Sanders, Ranking Member
    Burr, and Members of the Committee. I want to add my well
    wishes to Senator Boozman.
        Thank you very much for inviting me. I am the Director of
    the National Center for Complementary and Alternative Medicine
    at the National Institutes of Health. NCCAM is the leading
    Federal agency responsible for research on the usefulness and
    safety of complementary and integrative health practices.
        The most common reason Americans turn to these health
    approaches is for treatment of pain. Pain is a major health
    problem affecting over 100 million Americans. It is one of the
    main drivers of our horrific national epidemic of prescription
    drug abuse.
        As a physician, I am well aware that drugs, including
    opioids, are absolutely essential for the management of pain
    but also of their serious side effects including overmedication
    dependency and even death.
        As a Nation, we need to find the appropriate balance
    between the substantial benefits of these medications and the
    risks. Deaths from opioids exceed those attributed to cocaine
    and heroin combined. Every day over 100 Americans die of drug
    overdoses, mostly from prescription painkillers.
        Opioids are particularly deadly when combined with Post
    Traumatic Stress Disorder; and as this Committee knows well,
    pain and PTSD is a common and tough combination faced by many
    veterans, also a very common problem in civilian populations.
    So, finding better alternatives for pain management is an
    absolutely critical national need.
        Concern about research on better strategies for pain
    management is shared by leadership across the NIH. I serve as
    one of the co-directors of the Trans-NIH Pain Consortium and a
    member of the Federal Interagency Pain Research Coordinating
    Committee. Together with other Federal leaders, we are
    partnering to develop a cooperative research strategy to meet
    these important needs.
        Some of the very active areas of NIH research include the
    development of better pain measures including some of the
    measures that have been incorporated by the DOD, the PASTOR
    PROMIS measures, for example, understanding why acute pain
    sometimes turns into chronic pain, and the development of pain
    medications with less abuse potential.
        NCCAM's particular focus is strengthening non-
    pharmacological treatment and self-management of pain. The
    evidence that some complementary approaches are of value in
    pain management is reflected in evidence-based guidelines from
    the American College of Physicians and the American Pain
    Society.
        Select practices including meditation, acupuncture, spinal
    manipulation, massage, and hypnosis are increasingly part of
    the kind of integrative care being offered in some of our
    health care settings, including hospitals, nursing homes,
    hospices, and most notably, health facilities in the Veterans'
    Administration and Department of Defense.
        Integrative practitioners place particular emphasis on a
    patient-centered approach that identifies patient goals and,
    when appropriate, minimizes the use of drugs.
        Research on the mechanism and efficacy and safety of these
    approaches is the highest priority for NCCAM. We hope to learn
    how they work, who they help, and how they can be strengthened
    to better help people with chronic pain.
        As part of this effort, we have established a new
    intramural program that will study the biologic underpinnings
    of pain using state-of-the-art neuroscience methods to study
    the brain.
        We are particularly delighted to be embarking on an
    important partnership with the DOD and VA to support the value
    of these approaches to address the needs of military personnel
    and veterans for improvement non-pharmacological management of
    pain together with conditions such as PTSD, depression, and
    anxiety.
        We are funding new studies in partnership with the DOD, VA,
    National Institute on Drug Abuse, and the National Institute on
    Alcohol Abuse and Alcoholism on these important problems.
        We have created a working group of members of NCCAM's
    advisory council to advise us on this research agenda. The
    working group includes distinguished DOD and VA officials such
    as former Army Surgeon General Eric Schoomaker and the VA's Dr.
    Tracy Gaudet. It is chaired by Dr. Lloyd Michener, Director of
    Family Medicine at Duke University.
        In summary, Mr. Chairman, NIH and NCCAM are committed to
    partnerships with the VA and the DOD to strengthen research to
    understand pain, to improve pain management, and reduce
    overmedication and opioid dependency.
        Thank you. I am very happy to be here and happy to answer
    any questions.
        [The prepared statement of Dr. Briggs follows:]
    Prepared Statement of Josephine Briggs, M.D., Director, National Center
      for Complementary and Alternative Medicine, National Institutes of
              Health, U.S. Department of Health and Human Services
        Chairman Sanders, Ranking Member Burr, and Members of the
    Committee, thank you for inviting me to be here today to discuss the
    need to improve pain management strategies to reduce overmedication and
    opioid dependency. My name is Josephine Briggs, M.D., and I am the
    Director of the National Center for Complementary and Alternative
    Medicine (NCCAM) at the National Institutes of Health (NIH), the
    Federal Government's lead agency for supporting scientific research on
    complementary practices and integrative health interventions. Our
    mission at NCCAM is to define the usefulness and safety of
    complementary and integrative health practices and their role in
    improving health through rigorous scientific investigation. Our
    research priorities are driven by scientific promise and public health
    need. We support the study of complementary interventions, approaches,
    and disciplines across the continuum of basic, translational, efficacy,
    and effectiveness research.
        Complementary, alternative, and integrative health practices are
    defined as having origins outside of mainstream conventional medicine.
    They include both self-care practices like meditation, yoga, and
    dietary supplements, and health care provider administered care such as
    acupuncture, and chiropractic, osteopathic, and naturopathic medicine.
    As these modalities are increasingly integrated into mainstream health
    care, NCCAM is committed to developing the evidence needed by the
    public, health care professionals, and policymakers to make informed
    decisions about their use and integration into medical practice. In
    addition to supporting the research, we disseminate the latest
    evidence-based information on these approaches to scientists, health
    care providers, and the general public through an information-rich Web
    site (www.nccam.nih.gov) and other media.
        According to the Centers for Disease Control and Prevention,
    approximately 30 percent to 40 percent of Americans use complementary
    and integrative health practices, spending some $34 billion in 2007.\1\
    This represents 1.5 percent of total health expenditures and 11 percent
    of out-of-pocket costs. These practices are increasingly being offered
    in hospitals and hospice settings. The most common reason cited for use
    of complementary and integrative health practices is for the
    alleviation of pain.
    ---------------------------------------------------------------------------
        \1\ Nahin RL, Barnes PM, Stussman BA, et al. Costs of complementary
    and alternative medicine (CAM) and frequency of visits to CAM
    practitioners: United States, 2007. CDC National Health Statistics
    Report #18. 2009.
    ---------------------------------------------------------------------------
        Pain is a public health problem of substantial impact. It affects
    more than 100 million Americans each year--more than the total affected
    by heart disease, cancer, and diabetes combined--and is estimated to
    cost the Nation $560-$635 billion each year in medical costs and lost
    productivity.\2\ While an important part of pain management,
    pharmaceutical approaches may provide incomplete relief and can carry
    serious side effects, including overmedication and opioid dependency
    and, in some cases, addiction. Commonly prescribed opioid pain
    relievers can be dangerous as even a single large dose can cause severe
    respiratory depression and death. Deaths from opioid pain relievers
    exceed those attributed to cocaine and heroin combined. Finding
    alternatives for pain management is needed.\3\
    ---------------------------------------------------------------------------
        \2\ IOM (Institute of Medicine). 2011. Relieving Pain in America: A
    Blueprint for Transforming Prevention, Care, Education, and Research.
    Washington, DC: The National Academies Press.
        \3\ Drug Facts: Prescription and Over-the-Counter Medications,
    National Institute on Drug Abuse, National Institutes of Health,
    May 2013. http://www.drugabuse.gov/publications/drugfacts/prescription-
    over-counter-medications, accessed April 28, 2014.
    ---------------------------------------------------------------------------
        In 2011, after examining pain as a national public health problem,
    the Institute of Medicine (IOM) released a Consensus Report in 2011,
    entitled ``Relieving Pain in America: A Blueprint for Transforming
    Prevention, Care, Education, and Research.'' The IOM report encourages
    Federal and state agencies and private organizations to accelerate the
    collection of data on pain incidence, prevalence, and treatments, and
    to take steps to develop integrative pain management strategies. The
    report notes that ideally, most patients with severe persistent pain
    would obtain care from an interdisciplinary team using an integrated
    approach that would target multiple dimensions of chronic pain--
    including disease management, reduction in pain severity, improved
    functioning, and emotional well-being and health-related quality of
    life.
        In addition, the Federal Government created an Interagency Pain
    Research Coordinating Committee (IPRCC) to enhance pain research
    efforts and promote collaboration across the government, to advance our
    fundamental understanding of pain, and to improve pain-related
    treatment strategies. Members include representatives of the
    Departments of Health and Human Services, Veterans Affairs (VA), and
    Defense (DOD), the scientific and medical communities, the public, and
    stakeholder groups. I serve as one of the NIH representatives. The
    IPRCC is developing a comprehensive population health level strategy
    for pain prevention, treatment, management, and research. One of the
    first efforts of the IPRCC was a thorough analysis of pain research
    across Federal agencies, resulting in the recently released ``2011
    IPRCC Federal Pain Research Portfolio Analysis Report'' \4\ which
    revealed many areas of shared research interests between and across
    Federal entities, but no notable redundancies.
    ---------------------------------------------------------------------------
        \4\ National Institutes of Health, National Institute of
    Neurological Disorders and Stroke, Office of Pain Policy. 2011 IPRCC
    Federal Pain Research Portfolio. Analysis Report. Available at
    iprcc.nih.gov/news/CC_Pain_Portfolio_Analysis_Report.pdf. Accessed
    April 28, 2014.
    ---------------------------------------------------------------------------
        NCCAM participates in the NIH Pain Consortium to enhance and
    increase the coordination of pain research across NIH. The Consortium's
    efforts include targeted initiatives such as the development of the
    first clinically-based data registry to help identify pain management
    interventions that are most effective for specific patient-types with
    chronic pain, led by the National Institute on Drug Abuse (NIDA), and
    the creation of standard research measures to assess chronic low back
    pain, which was spearheaded by NCCAM.
        To improve pain education in health professional schools, the Pain
    Consortium established 12 Centers of Excellence in Pain Education to
    advance teaching and provide comprehensive curricula about the
    pathophysiology of pain, its assessment, diagnosis, management, and
    treatment. The curricula include the latest research results in
    complementary and integrative pain management, factors that contribute
    to both under- and over-prescribing of pain medications, and how pain
    manifests itself differently by gender, by age, and in diverse
    populations. In addition, NIDA, Medscape Education, and the White House
    Office of National Drug Control Policy developed two continuing medical
    education courses on practical guidance for physicians and other
    clinicians in screening pain patients for substance use disorder risk
    factors before prescribing, and in identifying when patients are
    abusing their medications. The courses use videos that model effective
    communication about sensitive issues, without losing sight of
    addressing the pain. To date, more than 80,000 health care
    professionals have completed these courses.
        At NCCAM, an increasing proportion of our research budget is
    dedicated to studies examining promising non-pharmacological approaches
    for pain management, including mindfulness meditation, spinal
    manipulation, massage, acupuncture, and exercise forms, such as yoga
    and Tai chi. Some of these approaches are already being recommended by
    the American College of Physicians and the American Pain Society in
    their guidelines for the diagnosis and treatment of low back pain.
    NCCAM is interested in better understanding how these interventions
    work, for what type of pain conditions, and the optimal methods of
    practice and delivery. We also support Centers of Excellence for
    Research on Complementary and Alternative Medicine that bring a
    multifaceted interdisciplinary approach to research on pain. In
    addition, NCCAM recently established a new intramural research program
    that focuses entirely on pain using state-of-the-art neuroimaging and
    other advanced technologies to study the mechanisms of pain including
    the role of emotions and attention on the modulation of pain.
        Last year, NCCAM joined NIDA, the National Institute on Alcohol
    Abuse and Alcoholism, and DOD in a joint initiative to conduct research
    on prevention and health promotion interventions to prevent alcohol and
    other drug abuse and associated physical and psychological health
    problems in Veterans and military personnel. NCCAM also issued a
    solicitation, along with NIDA and the VA, specifically focused on
    complementary and integrative approaches to managing pain and other
    symptoms such as posttraumatic stress, Traumatic Brain Injury,
    substance use disorders, anxiety, and sleep disturbances often
    experienced by Veterans and military personnel. The initiative
    requested research approaches to study (a) mind-body interventions such
    as mindfulness- or meditation-based stress reduction approaches, (b)
    yoga, (c) acupuncture, (d) art therapy, (e) massage, and (f) cognitive-
    behavioral interventions. Grant applications are currently under
    review, and we look forward to funding multiple studies later this
    year. Research findings from these initiatives are expected to lead to
    enhanced patient care and improved pain and symptom management through
    better integration of evidence-based complementary approaches.
        At my direction, a special Working Group of the National Advisory
    Council on Complementary and Alternative Medicine was recently formed
    to explore ways to foster rigorous research that will inform the use
    and incorporation of complementary approaches in military and veteran
    populations and promote collaboration among the VA, DOD, and NCCAM. The
    Working Group, chaired by Lloyd Michener, M.D., of Duke University,
    includes current and former VA and DOD officials. The group is charged
    with defining a research agenda for mind/body interventions for pain
    and symptom management, including identifying the most promising
    therapies and the next steps for development of large clinical trials.
    Experts will present perspectives of patients, Veterans, military
    personnel, and clinicians to help shape the Working Group's
    recommendations.

        In summary, NIH and NCCAM are committed to improving understanding
    and treatment of pain and related conditions for all Americans
    including military personnel and Veterans. We expect research results
    to provide information to the public and health care providers and
    policymakers. I appreciate the opportunity to appear before this
    Committee, and I look forward to answering any questions. Thank you.
                                     ______

    Response to Posthearing Questions Submitted by Hon. Bernard Sanders to
    Josephine Briggs, M.D., Director, National Center for Complementary and
              Alternative Medicine, National Institutes of Health
                  complementary and alternative medicine (cam)
        Question 1. What can be done to increase long-term programmatic
    research to help better understand CAM therapies and their impact on
    servicemembers and veterans?
        Response. As the Federal Government's lead agency for scientific
    research on complementary practices and integrative health
    interventions, the National Center for Complementary and Alternative
    Medicine (NCCAM) is committed to greater understanding of the
    usefulness and safety of complementary and integrative health practices
    and their role in improving health and health care. Since 2010, NCCAM
    has been working with the Departments of Defense (DOD) and Veterans
    Affairs (VA) to explore opportunities for partnerships and
    collaborations.
        After participating in workshops on complementary interventions for
    pain management with DOD and Post Traumatic Stress Disorder with VA,
    NCCAM issued a Funding Opportunity Announcement (FOA) in 2012, to
    encourage collaborations with DOD and VA researchers and clinicians to
    study integrative approaches to pain and symptom management in military
    and Veteran populations. Under this initiative, seven collaborations
    were funded to study modalities such as massage, acupuncture and
    chiropractic for musculoskeletal pain and post-traumatic headache, as
    well as Tai Chi and mindfulness for treating stress disorders, anxiety,
    and depression. In 2013, NCCAM participated in a FOA with the National
    Institute on Drug Abuse (NIDA) and DOD, to promote research on
    interventions to prevent alcohol and other drug abuse and associated
    physical and psychological health problems in military personnel and
    Veterans. NCCAM funded two research projects under this FOA, both
    involving the study of innovative interventions for pain management and
    to reduce substance abuse.
        Last year, NCCAM issued three FOAs, along with NIDA and VA, to
    encourage research on the non-pharmacological management of pain and
    co-morbid conditions in military personnel and Veterans. NCCAM has
    committed two million dollars in Fiscal Year 2014, and hopes to fund
    studies exploring a variety of complementary interventions for pain
    management, including combined interventions for treating pain and
    substance abuse, bright light treatment, mindfulness training, and the
    use of mobile neurofeedback applications for pain management.
        To guide future collaborative efforts with DOD and VA, NCCAM
    recently established a special Working Group of the National Advisory
    Council on Complementary and Alternative Medicine. The Working Group is
    charged with advising NCCAM on potential collaborations, opportunities
    and strategies for integrative health research within DOD and VA health
    care settings. Invited experts will present perspectives of patients,
    military personnel and Veterans, clinicians, researchers, and
    policymakers to inform the Working Group in shaping its final
    recommendations. The Working Group is expected to submit a report to
    the National Advisory Council for Complementary and Alternative
    Medicine in early 2015.
        NCCAM looks forward to building on current collaborations and
    continuing to partner with other NIH Institutes and Centers, DOD, and
    VA to further investigate the usefulness and safety of complementary
    and integrative health interventions for servicemembers and Veterans.

        Question 2. A challenge of medical research is the length of time
    it takes for research to move from bench to bedside. What is the
    National Center for Complementary and Alternative Medicine doing
    specifically--and NIH more generally--to expedite this process?
        Response. NCCAM is committed to improving the translation of
    research findings into improved public health. At NCCAM's core is a
    vision in which rigorous scientific evidence about complementary health
    practices informs both the decisions Americans make regarding the use
    of these health practices and their potential integration into health
    care. As such, NCCAM funds research across the continuum of basic,
    translational, efficacy, and effectiveness research. As part of our
    translational portfolio, NCCAM supports research required to design and
    implement definitive clinical research and ``real-world'' outcomes and
    effectiveness research that capitalizes on the reality that many
    complementary health interventions are in widespread public use. This
    research includes identifying and validating biomarkers or other
    signatures of biological effect; developing and validating measures of
    outcome; validating treatment algorithms and measures of quality
    control; and developing preliminary clinical evidence.
        Additionally, NCCAM is leading the Health Care Systems Research
    Collaboratory, an NIH Common Fund initiative. This program is engaging
    health care delivery organizations as research partners, with the goal
    of strengthening the national capacity to conduct rigorous large-scale
    clinical trials in ``real-world'' settings. Through the Collaboratory,
    NIH is pioneering the development of approaches to conduct large-scale,
    cost-effective clinical research studies in the setting where patients
    already receive their care. Ultimately, this program could help
    increase the number and types of health care systems engaged in
    clinical research and enhance the relevance of research results to
    health care practice.
        At the bedside-end of the continuum, NCCAM ensures that research
    results are widely disseminated to help the public make informed
    decisions about the use of complementary health practices and to enable
    health care providers to better manage patient care. NCCAM provides
    reliable, objective, and evidence-based information through a variety
    of approaches including emerging technology and platforms (i.e., video,
    social media, and mobile applications). Specifically for health care
    professionals, NCCAM's web site features a portal with links to
    scientific literature on complementary health practices, including
    reviews from the Cochrane Collaboration; clinical practice guidelines
    issued by third-party organizations; and online continuing education
    modules. In addition, NCCAM's monthly e-newsletter, NCCAM Clinical
    Digest, summarizes the state of the science on complementary health
    practices for specific health topics.
        Across the NIH, many NIH Institutes and Centers and trans-NIH
    initiatives are also focused on expediting the process of turning
    observations in the laboratory and clinic into effective interventions
    that improve the health of the individual and the public--from
    diagnostics and therapeutics to medical procedures and behavioral
    changes. For example, the newest Center at NIH, the National Center for
    Advancing Translational Sciences (NCATS) was established to transform
    this process by catalyzing the generation of innovative methods and
    technologies that will enhance the development, testing, and
    implementation of diagnostics and therapeutics across a wide range of
    human diseases and conditions. Advances from NCATS are aimed at
    enabling researchers throughout the public and private sectors to more
    efficiently develop treatments for diseases, demonstrate effectiveness
    in improving health, and accelerate the pace at which new treatments
    are delivered to patients.
                                  opioid usage
        Question 3. How can collaborative efforts, such as the Interagency
    Pain Research Coordinating Committee, be leveraged to reduce the
    American health care system's dependency on high-dose medications to
    reduce chronic pain and mental health conditions?
        Response. Collaborative efforts across the National Institutes of
    Health (NIH) and the Federal Government to increase the understanding
    of pain are helping to enable the development of novel therapies,
    including non-pharmacological approaches to treat those who suffer from
    pain conditions. Better strategies for the management of chronic pain
    may also reduce symptoms associated with some mental health conditions,
    such as depression and anxiety that are often comorbid with pain.
        The Interagency Pain Research Coordinating Committee (IPRCC) was
    created to enhance pain research efforts and promote collaboration
    across the Federal Government, with the ultimate goal of advancing
    fundamental understanding of pain and improving pain-related treatment
    strategies.\1\ The Committee comprises seven Federal members and 12
    non-Federal members, six drawn from the scientific and medical
    communities and six from public and stakeholder groups. Six Federal
    Agencies are involved in this effort.\2\ NCCAM is one of the NIH
    representatives.
    ---------------------------------------------------------------------------
        \1\ http://www.iprcc.nih.gov
        \2\ DOD, VA, and within HHS, NIH, the Agency for Healthcare
    Research and Quality, the Centers for Disease Control and Prevention,
    and the Food and Drug Administration.
    ---------------------------------------------------------------------------
        The IPRCC conducted a thorough analysis of the Fiscal Year 2011
    Federal pain research portfolio and released a report that identified
    areas for potential collaboration among the IPRCC- represented
    agencies. The analysis and accompanying report provide important tools
    to assist in sharing resources across the pain research community and
    for enhancing pain research efforts. For example, the Office of Pain
    Policy at NIH's National Institute on Neurological Disorders and
    Stroke, under the auspices of the IPRCC, launched the Federal
    Government's pain research database on May 27, 2014. This resource
    provides the public and the research community with an important tool
    to learn more about the breadth and details of pain research supported
    across the Federal Government.
        The IPRCC is also charged with developing the National Pain
    Strategy, a comprehensive population health level strategy for pain
    prevention, treatment, management, and research. One objective of the
    strategy is to describe how efforts across Government agencies,
    including public-private partnerships, can be established, coordinated,
    and integrated to encourage population-focused research, education,
    communication, and community-wide approaches that can help reduce pain
    and its consequences. The development of the National Pain Strategy
    will involve coordination between the IPRCC and the NIH's Pain
    Consortium, as well as private-sector participants.
        Within the NIH, the NIH Pain Consortium helps coordinate and
    support a number of pain research initiatives and activities across the
    NIH. Importantly, the Pain Consortium is cosponsoring a workshop with
    the NIH Office of Disease Prevention to address several issues related
    to pain management, including the long-term effectiveness of opioids
    for treating chronic pain and the use and effectiveness of opioid
    management strategies in minimizing opioid addiction, abuse, and
    misuse, maximizing pain relief, and improving patients' quality of
    life. Based on the evidence presented, an independent panel of experts
    will release a comprehensive report in early 2015 on the state of the
    evidence, identifying research gaps and proposing research priorities.
        The efforts of the Pain Consortium have already made an impact. On
    May 21, 2014, NIH announced that the NIH Pain Consortium's first pain
    care curriculum--part of the 12 ``Centers of Excellence in Pain
    Education''--showed significant improvements in medical student
    clinical skills.\3\ The educational materials are designed to advance
    the assessment, diagnosis, and safe treatment of pain, while minimizing
    risks of abuse and addiction. The curricula include the latest research
    results in complementary and integrative pain management, factors that
    contribute to both under- and over-prescribing of pain medications, and
    how pain manifests itself differently by gender, by age, and in diverse
    populations. In addition, NIDA, Medscape Education, and the White House
    Office of National Drug Control Policy developed two continuing medical
    education courses on practical guidance for physicians and other
    clinicians in screening pain patients for substance use disorder risk
    factors before prescribing, and in identifying when patients are
    abusing their medications. The courses use videos that model effective
    communication about sensitive issues, without losing sight of
    addressing the pain. To date, more than 80,000 health care
    professionals have completed these courses. These efforts will help
    current and future health care professionals build clinical skills to
    better support, manage and treat patients with pain.
    ---------------------------------------------------------------------------
        \3\ http://www.nih.gov/news/health/may2014/nida-21.htm
    ---------------------------------------------------------------------------
                                     ______

      Response to Posthearing Questions Submitted by Hon. Mark Begich to
    Josephine Briggs, M.D., Director, National Center for Complementary and
              Alternative Medicine, National Institutes of Health
        Question 4. I know I hear from Veteran's in my state that ask for
    more alternative methods for pain, PTSD and with our large native
    population, many native veterans rely on native healers, in the Native
    Health Care system, they are called doctors. Have you researched the
    use of Native healing and if not will you be looking at this effective
    method of healing?
        Response. NCCAM is committed to studying the usefulness, safety and
    efficacy of complementary and integrative health approaches, many of
    which have origins in traditional healing practices. Although a wide
    variety of these practices are used by the American public, better
    information is needed on how or whether they work.
        According to the Centers for Disease Control and Prevention, over
    50 percent of American Indian/Alaska Native (AI/AN) adults use
    complementary therapies--greater than any other ethnic group.\4\ Given
    the prevalence of complementary therapies among this population,
    research on native healing practices is important, and NCCAM takes a
    number of approaches to encourage such research. For example, NCCAM is
    interested in research projects utilizing systems of healing and health
    practices outside the conventional medical care and those studying the
    extent and use of self-care and integrative health practices,
    conventional medical care, or a combination of the two. Examples of
    NCCAM funded research projects include:
    ---------------------------------------------------------------------------
        \4\ Barnes PM, Bloom B, Nahin R. CDC National Health Statistics
    Report #12. Complementary and Alternative Medicine Use Among Adults and
    Children: United States, 2007. December 2008.

         ``Drum-Assisted Recovery Therapy for Native Americans,''
    Daniel Lee Dickerson, D.O., MPH, University of California, Los Angeles.
    Dr. Dickerson' grant focused on developing and pilot testing a
    treatment approach that included Drum Circles and the 12-steps of
    Alcoholics Anonymous within the conceptual framework of the Native
    American Medicine Wheel.
         ``Chemopreventative Properties of Medicinal and Food
    Plants of the Lumbee Tribe,'' Tracie Locklear, Ph.D., University of
    Illinois, Chicago. Dr. Locklear's grant supported her research on the
    development and testing of natural agents isolated from medicinal and
    food plants of the Lumbee Tribe. The long term goal of the project was
    to develop new and novel natural agents for the chemoprevention of
    breast cancer.

        In addition, NCCAM participates in the Native American Research
    Centers for Health (NARCH),\5\ which is a partnership between the
    Indian Health Service and NIH. The goal of the NARCH program is to
    provide opportunities for tribes and tribal organizations to conduct
    research, research training, and faculty development that meet the
    needs of AI/AN communities.
    ---------------------------------------------------------------------------
        \5\ http://www.nigms.nih.gov/Training/NARCH/Pages/default.aspx
    ---------------------------------------------------------------------------
                                     ______

       Additional Information from Josephine P. Briggs, M.D., Director,
      National Center for Complementary and Alternative Medicine, Public
                 Health Service, National Institutes of Health

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairman Sanders. Dr. Briggs, thank you very much.
        Let me begin with Dr. Petzel. Dr. Briggs, I think
    appropriately, talked about this issue as an epidemic. We have
    a horrific problem in Vermont but I think it is shared in
    States throughout this country. People overdosing, getting
    addicted, turning to crime, self-destruction. It is an awful
    issue.
        As we know, as bad as this problem is for the civilian
    population, it is likely even worse among our military and
    veteran population, largely because of the nature of the
    injuries and conditions they experience.
        Dr. Petzel, first, how serious is the problem you are
    addressing and second--Dr. Gaudet and maybe Dr. Marshall might
    want to join in--tell me the role that you think complementary
    and alternative medicine can play in addressing those problems.
        Dr. Petzel. Thank you, Mr. Chairman.
        First of all, in terms of the magnitude of the problem,
    several have mentioned it. We estimate that 50 percent of
    veterans that are coming to us seeking care have some sort of
    pain. Much of it is musculoskeletal, back injuries, et cetera,
    associated with the work that a soldier, sailor, airman, and
    Marine may be doing.
        We are prescribing opioids for somewhere around 650,000
    veterans at the present time which is a large number of people,
    and we recognize the fact that this is an issue that has to be
    addressed very directly.
        I would like to just take a minute before I turn to the
    other panel members to describe the opioid safety program that
    we are involved in to try and get a grip on and reduce the use
    of opiates which, by the way, has reduced the number of
    patients receiving opioids in the last 18 months by 50,000.
    Still, there are a lot of people getting it but----
        Chairman Sanders. So, 50,000 fewer veterans are now
    receiving opioids?
        Dr. Petzel. That is correct.
        The five things that are the central part of the pain
    management program are: one, every medical center has to have a
    pain management clinic; two, every medical center has a pain
    consultation service. VA requires the use of integrative CAM
    approaches.
        The details of this--we require the use of the step care
    model which was developed in the VA and I think has been
    adopted by the Department of Defense now which begins with, in
    the primary care clinic, self-management and management in
    primary care of pain. If needed, it moves to the secondary pain
    clinic; and then finally, there are tertiary pain services
    available.
        The centerpiece of this, though, is the opioid dashboard,
    monthly report to the facilities, to the providers in the
    facility, and to the pain management point of contact about
    people that are prescribing outside of the standard and
    patients that are taking medication outside of the standard.
        That is followed by education and discussion and
    consultation with the providers to bring their use of opioids
    into the standard.
        Chairman Sanders. OK. If I can interrupt you, we will take
    a little bit more time for everybody, because we only have four
    of us here. But I wonder--if it is OK with you, Dr. Petzel, I
    wanted to shift over to Dr. Gaudet and Dr. Marshall.
        What are you doing with complementary and alternative
    medicine and is it, in fact, working?
        Dr. Gaudet. Thank you, Chairman Sanders.
        I think you are aware that the vision for health care, as
    Ranking Member Burr referenced, is personalized proactive
    patient-driven; central to that are strategies that are
    inclusive of complementary approaches that empower the veteran
    to take into their own hands whether they have pain issues. Of
    course, this expands far beyond pain to the many, many
    conditions facing veterans and the public, complex conditions
    where a simple fix does not exist.
        So, I think that these areas, particularly pain, are
    phenomenal places where the VA is committed to bringing more
    holistic approaches to veterans. The veterans are finding them
    very empowering, very much an asset to the complement of what
    they can do to address their issues of pain as well as other
    issues. Yes sir.
        Chairman Sanders. In English.
        Dr. Gaudet. Yes, sorry.
        Chairman Sanders. What are you offering the patient? So,
    somebody walks in. They have chronic pain. They are concerned
    about overmedication. You are concerned. What therapies are you
    offering and are they, in fact, working?
        These are fairly radical ideas in a certain sense, yes? Or
    not?
        Dr. Gaudet. I do not know how radical they are, but I think
    that the therapies that are most promising and most often
    utilized right now in the VA are very parallel to the DOD and
    the public.
        So, they tend to be mind-body approaches such as
    meditation, acupuncture, movement therapies such as, yoga, tai
    chi, spinal manipulation. These are the general approaches that
    seem to have the greatest promise--relatively noninvasive and
    at low risk.
        Chairman Sanders. Now, I have been impressed. I have been
    to VA facilities all over the country and I have been to a
    couple of DOD facilities and I am amazed. You know, 20 or 30
    years ago I think it is fair to say that if we were talking
    about this list of therapies, people would have thought there
    were a few folks in California or certain other places
    utilizing them, not the U.S. Department of Defense or VA.
        So, in terms of treatments like acupuncture, are they
    working? What can you tell us about your success rates? Does it
    work?
        Dr. Gaudet. I think the most evidence actually exists for
    acupuncture as it relates to pain. Our research office of
    evidence-based synthesis just finished a comprehensive look at
    all the evidence related to acupuncture. It is a very useful
    document because it basically says where is there evidence for
    the use of acupuncture, do we know, and is it of benefit or do
    we know it is not of benefit or there is a category where we
    just do not know yet, we do not have research.
        The areas where there is the best and strongest evidence
    for acupuncture are pain, chronic pain, headaches, and
    migraines. So, it is a rational place to start.
        Chairman Sanders. All right. Dr. Marshall, if I walk into
    your beautiful facility in Minneapolis, and I was just there a
    few days ago, and I am in pain, what are my options other than
    drugs?
        Dr. Marshall. Mr. Chairman, thank you for that question.
        I would say at Minneapolis we view pain management as a
    full-spectrum opportunity to engage with a patient and move
    them toward a healthier and more functional life.
        So, we have deployed various complementary and alternative
    modalities at different levels of our facility. For instance,
    nurses, we trained 900 nurses in January of this year; a 4-hour
    training in complementary and alternative medicine with
    integrative nursing.
        Modalities that we trained specifically to those nurses
    included acupuncture, relaxation breathing, meditation, and
    essential oils or aroma therapy.
        Chairman Sanders. When you tell your patients these
    therapies are available, do they say, hey, I would like to try
    that? What do they say?
        Dr. Marshall. There is a lot of variability. Some patients,
    you know, express a strong desire for opioid pain medications.
    Many patients, though, are very open once they learn that these
    alternatives are a standard part of our medical treatment
    armamentarium at Minneapolis VA. I think many patients are
    gravitating toward these kind of services.
        Chairman Sanders. Can you tell us some success stories? Are
    there people who have lived with pain, who were heavily
    medicated but because of complementary and alternative medicine
    have been able to get rid of medication? Dr. Marshall, do you
    have stories?
        Dr. Marshall. Yes, I would like to talk briefly about a
    program that we have just started. This is part of the VA's
    efforts to have Council for Accreditation of Rehabilitation
    Facilities, CARF, pain rehab center at each VISN. So, we
    started one in January of this year.
        We recruited the Director of the Mayo Clinic Pain Rehab
    Program who is now leading our efforts. So that program which
    is just starting at Minneapolis VA had seven veterans, four of
    them were on opioids, three of them were tapered off, and one
    was tapered down.
        And a cornerstone of that program is a 3-week intensive
    residential program and a cornerstone of that program is
    activating patients' innate healing abilities through use of
    primarily complementary and alternative modalities, including
    cognitive behavioral therapy, meditation, relaxation breathing,
    tai chi, yoga, and other active forms.
        Chairman Sanders. So, you have some specific indications
    that these therapies are working?
        Dr. Marshall. Yes.
        Chairman Sanders. OK. I have exceeded my time.
        Senator Burr.
        Senator Burr. Thank you, Mr. Chairman.
        Dr. Petzel, just one follow-up to this hope that we get a
    pathway on Phoenix to some facts. When we had one death at the
    Columbia VA medical center that was related to delays, when the
    medical center and the VISN leadership became aware of that
    problem there were four outside reviews, specifically the task
    force, the Office of Medical Inspector, and the IG.
        Are you confident that we have the sufficient focus on
    Phoenix for this Committee and for the VA to understand what,
    if anything, went wrong?
        Dr. Petzel. Senator, I am. I think that the IG's presence,
    the inspector general, with their independent look, and they
    have a huge collection of manpower that they are focusing.
        Senator Burr. What would trigger so many components for
    Columbia on one death versus just the IG on this?
        Dr. Petzel. I really cannot answer that. I do not know. We
    sent our team in. I think the IG actually went in twice. I
    really cannot speak specifically to what they did. But I am
    confident that the IG has the resources and has them present in
    Phoenix to get to the bottom of what has occurred there.
        Senator Burr. OK. Dr. Gaudet, let me ask you. Is it easier
    to write a prescription or to try a CAM approach?
        Dr. Gaudet. It is easier to write a prescription.
        Senator Burr. Yes. Can you envision, any of you from the
    VA, that it would be appropriate to prescribe an opiate to
    somebody who, in their medical records, has an opiate
    addiction?
        Dr. Gaudet. I am probably not the best person to answer
    that, not being a pain doctor.
        Senator Burr. Dr. Marshall?
        Dr. Marshall. I think the indications would be extremely
    rare. It would be very unusual to do that, but it might be done
    in certain situations, especially situations around acute pain
    from trauma after an operation.
        Senator Burr. So, for a veteran with an opiate addiction
    being treated by VA and sent home for the weekend with 19
    prescriptions, including 12 tablets of oxycodone, and 3 hours
    later he dies of a drug overdose; that would be an unusual
    circumstance?
        Dr. Marshall. I would concur with your previous statement
    that one death too many. It should not happen.
        Senator Burr. Dr. Petzel, VA issued a pain management
    directive in 2009 and in a House Veterans' Affairs Committee
    hearing last fall on the issue, Dr. Jesse said that all VISNs
    and VA facilities have implemented a pain management directive.
    Yet data obtained by the Center for Investigative Reporting
    shows, ``VA doctors are prescribing more opiates than ever and
    the data suggests adoption of the directive varies widely.''
        This is not the only time we have heard problems about
    regulations and programs being executed inconsistently across
    the VA. What oversight does the VA central office perform to
    make sure that the new programs and directives issued are
    implemented as intended?
        Dr. Petzel. Thank you, Senator Burr.
        One, the opioids safety initiative is intended to
    standardize the way we approach. Two, we have demonstrated that
    opioid prescribing in the VA has actually decreased, as I
    mentioned earlier, by 50,000 in the last approximately 18
    months; and we expect to see that plummet. Number 3----
        Senator Burr. We put this management plan into effect in
    2009 and we had an upward spike. You will agree to that?
        Dr. Petzel. Yes.
        If I could digress for a minute. In this country in
    general, not just the VA, there was 10-15 years ago a feeling
    that pain was not being adequately managed, and an effort was
    made to educate doctors about using opioids and other things to
    adequately manage pain, and I think in this country there was
    an overreaction to that phenomenon. And that is part of why we
    are involved in this effort to try and get a grip on opioid
    prescribing and to aggressively pursue other approaches to
    managing pain. While I was not here at the time, my suspicion
    is that that was part of what was going on within the VA.
        Senator Burr. Well, I think Dr. Gaudet reinforced, I think,
    our belief, and I think it is the fact that it is easier to
    write a prescription than it is to go through a CAM process;
    and I think Dr. Briggs would probably agree with me.
        There are some medical conditions that we probably will not
    be able to use an alternative for. The pain is real. It is
    consistent. It can only be addressed with some type of opiate
    medication or alternative to an opiate. For those people, they
    usually fall into a category of a specific illness that they
    have. Certainly, we do have some servicemembers that fall into
    that category.
        Here is my concern, Dr. Petzel, and my question is this,
    when people do not follow the guidelines set by VA--be it a
    doctor, nurse, whoever--what tools do you have to hold them
    accountable?
        I mean, we have seen difficulty with sterilization of
    medical devices. You and I have seen where insulin injection
    pens--multi-use injection pens--that we have now made a
    determination that we are not going to use them at the VA
    anymore because we----
        Dr. Petzel. No, they are not used in-patient. They are
    very, very deeply used as outpatients. They are great.
        Senator Burr. Why do we not use them in-patient?
        Dr. Petzel. Because of the possibility that there might be
    confusion, as we talked about.
        Senator Burr. Because we cannot with certainty believe that
    it is being executed by those guidelines, which means you
    cannot stick a different person with the same pen.
        So, if something that simple is tough to do, what gives us
    confidence that we can carry out a pain management directive
    successfully or any other directive within the health care
    system?
        Dr. Petzel. Senator Burr, I would point out that the opioid
    dashboard is our tool for monitoring the prescriber's use of
    opioids. And the first step when somebody is not using these
    appropriately is to educate them about the way that it ought to
    be done properly.
        So, do we have the tools to correct behavior that we think
    needs to be modified? Absolutely yes.
        Senator Burr. OK, Mr. Chairman. Thank you.
        Chairman Sanders. Thank you.
        Senator Begich.

                    STATEMENT OF HON. MARK BEGICH,
                        U.S. SENATOR FROM ALASKA

        Senator Begich. Mr. Chairman, thank you very much. I know
    earlier you talked about the issue in Arizona so I just want to
    know that--assuming that as soon as the IG report comes, and I
    know, Mr. Chairman, you noted that we will have some sort of
    process here. Obviously, we will look forward to that.
        The question that I am going to be very interested in, and
    it can be answered now or later, and that is the issue of the
    information that the Arizona VA was sending to the national,
    whatever the information was on appointment status; in other
    words, how long it took people to come through their
    appointments--that information. Was that correct or were there
    issues with it. That is going to be my question.
        There are a lot of details of deaths and so forth. What I
    want to know is did the information that came from the VA in
    Arizona to the national--who keeps track of successes at the
    different VAs and the amount of backlog and appointment
    scheduling--on those metrics, will that report or other reports
    confirm accuracy in the delivery of that information. That is
    going to be my fundamental question.
        Dr. Petzel. Senator Begich, as I mentioned earlier, we had
    a team down there looking in a preliminary fashion at the
    circumstances in Phoenix, and to date we have not found that
    there is any discrepancy between the information that we were
    aware of and were getting and the information as it actually
    existed in Phoenix.
        We have found no evidence for a secret list and we have not
    found any evidence to-date that anybody died while sitting on
    the waiting list.
        Senator Begich. Understood. And the IG is looking at all
    those questions I am assuming?
        Dr. Petzel. Yes, they are; as near as I know, yes.
        Senator Begich. OK. And I apologize. I know this part was
    answered. What is their timetable? Do you know?
        Dr. Petzel. They have not shared that with us, so I do not
    know.
        Senator Begich. OK. We will probably hear details as time
    moves on.
        Dr. Petzel. I hope.
        Senator Begich. OK. Thank you. I missed one meeting--I
    cannot remember if I was here or at the Appropriations
    Committee--but I wanted again to commend you all for working on
    and reviewing the NUKA model in Alaska.
        We think this is--as we talk about overmedication and many
    other things--I think they have really capitalized on a very
    unique model that is looking at the whole body and all people
    engaged in health care. One of the things that I want to ask
    is, I am assuming in this issue today that we are talking
    about, overmedication, as you look at the NUKA model you will
    be also looking at this piece of the equation.
        For example, I know they use not only alternative medicines
    but they also use through the native health care, native
    healing methods. Is that also something as you look at the NUKA
    model you can be examining because I want to make sure that is
    part of the equation.
        Dr. Petzel. My understanding, Senator Begich, is the
    central feature of the NUKA model is listening to the patient's
    story and then crafting the therapy around that individual
    patient's story and their circumstance. Since it is an Alaskan
    native program, those medicines, et cetera, are woven
    intimately into the way they deliver care.
        In the Native community here in the States where the VA is
    dealing, we also employ native healers, et cetera, and those
    concepts in dealing with that particular patient population.
    But I think Dr. Gaudet can maybe comment briefly on the fact
    that that is a tone that goes through our program.
        Dr. Gaudet. Yes, thank you, Senator. I would certainly just
    underscore the importance of this holistic approach which I
    appreciate your question actually brings to the surface.
        I think the challenge before us really--truly not just in
    VA health care but nationally in the model of health care that
    is dominant in this country--it is so much easier to write a
    prescription, as Ranking Member Burr said.
        The system is designed to do that. We as physicians are
    trained to find it-fix it. I can operate and I can write you a
    prescription and anything outside of that--and this is a slight
    exaggeration--but I am not actually trained to think about or
    understand.
        So, this transformation is a huge system change, and it
    does as you have described and as Dr. Petzel has described,
    begin with understanding the person. If we are in a situation
    such as Senator Boozman, thank goodness we have the high-tech
    approach. Perfect. They can go in. We can sew you up. We can
    fix the problem.
        Senator Begich. Right.
        Dr. Gaudet. But in the myriad of things like pain, like
    obesity, like PTSD, those find it-fix it cures do not exist.
    So, this holistic approach starting with the individual,
    understanding their cultural beliefs and creating a
    personalized approach for and with them is absolutely
    essential.
        Senator Begich. Very good. Let me proceed, if I can,
    because I have limited time here. General, I know the Army and
    TRICARE have recently required mental health counselors to our
    veterans be credited through the Council for Accreditation of
    Counseling Related Educational Programs.
        Here is the challenge in Alaska. We do not have the
    capacity to meet those standards because of the uniqueness of
    Alaska. It is not offered in Alaska, so it makes it difficult;
    and with huge gaps in mental health professional numbers, how
    can we go with this when in reality we have vacancies that we
    should fill which can easily be filled with qualified
    counselors. But how are we going to meet this in Alaska?
        I mean, I know everyone likes a one-size-fits-all solution.
    Those do not work in Alaska. I will tell you there is no better
    health care as what the VA is looking--Indian Health Services--
    no better health care delivery system in the country. So, we
    figured out how to do it and it does not come from a national
    model. It does not come from the standards that people sit
    around and make up.
        I mean, we deal with reality. That is why we have a great
    dental program in the Indian Health Services. You know, the
    dental community does not necessarily like it totally,
    nationally, but it works in Alaska because we have remote areas
    and we have huge tooth decay and other things that we have been
    able to accomplish through dental therapists.
        So, how are we going to handle this?
        Chairman Sanders. In 24 seconds.
        General Coots. Yes, sir. Alaska is known for its use of
    tele-medicine initiatives, and I think that for the military
    utilizing tele-behavioral health is probably one of the biggest
    initiatives that we have in serving areas that are remote or
    where we do not have those health care providers.
        We are looking at some different ways of attracting
    additional behavioral health providers. We are also looking at
    training some of our own. As we draw down the military, we have
    a large core of physicians assistants that we are looking at
    retrainings some of them as behavioral health physicians'
    assistants.
        Senator Begich. Very good. Let me say, Mr. Chairman, I have
    a couple of cases which I am going to send to Dr. Petzel and
    maybe some very specific questions on how we would respond to
    these kind of individuals that deal with medication.
        Thank you very much.
        Chairman Sanders. Thank you, Senator Begich.
        Senator Isakson.
        Senator Isakson. General Coots, first of all, thank you for
    your service particularly at Walter Reed. You all performed
    miracles on a daily basis in rehab for our servicemen. We
    appreciate it very much.
        I know Colonel Galloway's responsibilities are
    rehabilitation and reintegration of DOD active duty troops back
    into society I take it or back into the military?
        General Coots. Both.
        Senator Isakson. Which tells me that opiate
    overprescription is probably as big a problem in DOD as it is
    in veterans' health care. Is that correct?
        General Coots. Sir, I would say we have statistics that
    show that up until about 2011, about 26 percent of all active
    duty were on some level of opioid medications, either one
    single opioid or multiple opioids.
        The Army is traditionally a little bit higher, 2 or 3
    percentage points higher, I think, by the nature of what we do
    and the pain that our servicemembers have from repeated combat
    tours in remote areas.
        But all the statistics are showing now that with a big push
    for cultural change, with integration of these alternative
    medical modalities, that we are seeing a downturn in opioid use
    across the military, particularly across the Army, and then a
    large upswing from 10 percent up to 28 percent now, utilizing
    alternative medicine.
        Senator Isakson. Which is my point because, you know, we
    use DOD for all kinds of medical research: breast cancer,
    prostate cancer, things like that because you have a controlled
    environment. You have people who are not necessarily
    voluntarily participating but they are participating because it
    is their job. We get a lot of medical data.
        I guess we have learned from addiction and opioid overuse
    that the ``settled science'' is there in terms of what
    constitutes an addiction or an overuse. What we are trying to
    do is find out how we deal with it, and once it happens, to
    prevent it from happening again. Is that right?
        General Coots. Yes, Senator, that is correct.
        Senator Isakson. Then that brings me to my question.
    Seamless transition from DOD health care to veterans health
    care, which by the way General Schoomaker did a remarkable job
    of improving in his service at Walter Reed and in the military.
        What is DOD doing as these active duty military personnel
    go into veteran status? What is the transition like
    particularly with regard to opiates and then opiates having
    been prescribed, of them having been addicted? Is there a
    program or do they go into a black hole and the VA just has to
    discover the problem all for themselves?
        General Coots. Senator, that is a good question. I will
    answer it in two parts.
        First, we have a shared formulary where we have lined up
    the formulary so that any medications that a military member
    might be on, as they transition into the veterans health care
    system, that same medication or modality is available to them
    in the transition.
        We also are working on improving our warm handoff such that
    our military servicemembers have a lead coordinator. There is a
    corresponding lead coordinator on the VA side so that their
    information is transmitted directly in a handoff from that
    military lead coordinator to the VA system so that all of the
    associated and ancillary modalities that have treated them for
    whatever their problems are, be it opiate, be it anything else,
    all of those will transfer over so there is a knowledge
    transfer.
        So, there is no falling off in the cracks or going into a
    black hole.
        Senator Isakson. Good. Good.
        Dr. Marshall, the opioid safety initiative started in
    Minneapolis, is that right?
        Dr. Marshall. That is correct, Senator.
        Senator Isakson. If you uncover a provider who is not
    following the proper safety administration of opioid
    prescriptions, what training or what follow-up do you require
    to make sure that they do not do it again, or is there a
    prescription for doing that?
        Dr. Marshall. Well, first of all, Senator, thank you for
    that question because I think it is an integral part of what is
    happening at Minneapolis. So, we are building a standard of
    care and a cultural change in how we prescribe opioids.
        Part of it is building the prescribing of opioids into a
    team setting so we are using the providers who are doing the
    prescribing, the pharmacists who bring their unique skill set
    to the primary care team to help monitor for adverse effects
    or, you know, dosage problems, and also mental health. So, a
    lot of the control happens at that point working with the
    patient and the primary care team.
        Another phase of the accountability process is that we have
    transparent data--the dashboard that Dr. Petzel mentioned. So,
    we are using that to understand who are the outlying
    prescribers who need more help with changing their prescribing
    patterns.
        And the final stage of accountability rests with the chief
    of staff who, at our facility, has been very involved in
    providing specific direction to providers who are outside of
    the standard of care.
        So, it is a supportive system but there are levels of
    accountability.
        Senator Isakson. Dr. Petzel, you are familiar with our
    question with regard to suicide in the Atlanta VA, and I
    appreciate very much your attention to the ongoing initiative
    there.
        But it occurred to me that in the Atlanta VA situation
    where there were four instances now taking place over the last
    year, two of those were non-drug addicted Vietnam-era,
    noncombat veterans, meaning that they were veterans who served
    during the Vietnam era--my age group, in their late 60s or
    early 70s. They were not in combat. They did not transition
    from DOD to VA health care recently. They did it over a long
    period of time.
        I worry sometimes that prescribing opiates to mental health
    patients who come in for their first encounters at VA
    prescribing opiates might mask a greater problem or might
    accelerate a problem that exists.
        Is there any disciplinary requirements within the VA as far
    as mental health encounters are concerned in terms of
    prescribing opiates?
        Dr. Petzel. Senator Isakson, that is an excellent question.
    There are certain antecedents that are frequently found in
    patients who have either attempted suicide or actually
    committed suicide. Depression, PTSD, sleep disorders, and pain.
    Pain is often an antecedent to suicide, particularly chronic
    pain.
        So, the mental health provider is attuned to the fact that
    when they see somebody who is new to them that they need to be
    evaluated for those antecedents to be sure that they are taken
    into account when they begin to write prescriptions.
        So, anybody who has mental health problems who then also
    presents with a pain problem requires and gets very special
    attention.
        Senator Isakson. Thank you.
        Thank you, Mr. Chairman.
        Chairman Sanders. Thank you, Senator Isakson.
        Senator Blumenthal.
        Senator Blumenthal. General Coots, you mentioned a
    statistic before which I missed as to the percentage of use of
    opioids. I think that was the percentage in the Army or the
    military. Could you repeat that?
        General Coots. Yes, Senator. Up to 2011, the number was
    about 26 percent of all active duty had been prescribed at
    least one opioid medication.
        Senator Blumenthal. And that could be in the course of the
    individual soldier's entire service? Or over what period of
    time?
        General Coots. We are actually tracking that on a year by
    year basis, watching it; and over time, say, from 2007 to 2011,
    you saw a steady increase up to that 26 percent point. After
    about 2011 over the last 2 years, going on almost 3 years, we
    have seen a steady drop off, either stabilization or decline in
    the numbers that are using it.
        Senator Blumenthal. So, let us take 2013. Over 2013, what
    percentage of active duty Army soldiers were prescribe some
    form of opioid?
        General Coots. Senator, I do not have that exact number.
        Senator Blumenthal. What is the last year for which you
    have a number?
        General Coots. Sir, actually I do. It looks like about 24
    percent or so, about 24 percent in 2013. So, down from 26
    percent in 2011.
        Senator Blumenthal. 26 percent in 2011 to 2013, 24 percent?
        General Coots. Yes, Senator.
        Senator Blumenthal. So, it is a pretty small difference.
        General Coots. It is a small difference but I think it
    still represents a big cultural change and a move ahead because
    over the war years you saw a steady increase in it and the war
    is not yet over. We are still getting casualties although
    fewer; but over those last few years, we have been able to use
    these alternative modalities to include battlefield
    acupuncture. We use intranasal ketamine on the battlefield now
    which decreases the amount of morphine that you have to use.
        So, I think all of that is contributing as well in those
    complex casualties, and then translate that to our primary care
    clinics and our interdisciplinary pain management centers where
    we are implementing these alternative medications. I think all
    of that has been contributing to it.
        So, we are right at the beginning of this cultural shift
    and this cultural change.
        Senator Blumenthal. Let me just make sure that I understand
    that number. That is total active duty soldiers.
        General Coots. That is total active duty.
        Senator Blumenthal. 26 percent were prescribed some form of
    opioid in 2011 and 24 percent in 2013. That is not injured
    soldiers. It is all soldiers.
        General Coots. That is all soldiers. This is all soldiers
    sailors, airmen, and Marines. That is all DOD.
        Senator Blumenthal. OK. Let me ask you. You mentioned the
    warm handoff from active duty service to separation and VA
    treatment. As you probably know, many of us on this Committee
    have been concerned about the lack of interoperability of the
    Army medical records with the VA records in terms of the
    electronic medical record systems that each has.
        Do you see an effect of the lack of complete compatibility?
    I do not know what exactly the technical term would be, but I
    know that everybody is talking about trying to make it work
    better but still do not have an interoperable system.
        Do you see an effect of that?
        General Coots. Actually, no, Senator. We are very
    compatible and very interoperable when it goes to that. There
    may be narrow pipelines between the two electronic health
    records but it still allows us to transition and transfer that
    critical information on complex patients and patients on----
        Senator Blumenthal. Is there an automatic re-evaluation
    when a soldier or an airman or Marine, or sailor goes from
    active duty to veteran status; re-evaluation of the
    prescription opioids?
        In other words, does somebody say, well, you have been
    getting this medication or that, let us have a look here. Maybe
    we need to do something different.
        General Coots. To my understanding, there is an intake.
    Anytime you do a handoff or handover of a servicemember's care
    into the veterans' system, there is going to be an intake
    process.
        We transition all of that information from that one lead
    coordinator to the next. But certainly when they get in and
    they have a new provider, a new team who is taking over, there
    is a re-evaluation of everything that has happened in that
    servicemember's medical history now than they have become a
    veteran.
        That does not necessarily mean there is a change in
    therapeutic approach or a change in modalities but it certainly
    could mean that.
        Senator Blumenthal. It could mean it for an individual
    case.
        Let me ask Secretary Petzel whether he has any
    observations.
        Dr. Petzel. Thank you, Senator Blumenthal.
        A comment on a couple of things. First of all, we have
    ready access to everything that is electronic in the DOD
    records. The interoperability part, we are working toward being
    sure that things mean the same in each kind of record. So, that
    is improving. It is definitely improving.
        Also the transition is improving with TAP, the Transition
    Assistance Program. We present to each one of the exiting
    servicemembers about what is available in DOD. People are often
    identified now in that program that need to have a warm
    handoff. We are seeing much more of the at-risk patients being
    handed off to VA in a warm fashion.
        Senator Blumenthal. Just so I understand, I use the term
    but what does that mean?
        Dr. Petzel. That means there is a specific call to a VA
    medical center, this patient, John Jones, is transiting into
    the VA health care system. This is who he is. Here is what it
    means. We need an appointment for him. That is a warm handoff.
        What happens when they come to the VA--not all of them do,
    by the way. We need to understand that unfortunately we do not
    see as many people as we would like to see. They are evaluated.
    Our perspective as an organization is that we want to use the
    least risky, effective way of managing a patient's pain.
        So that my hope would be and the expectation would be that
    their pain is evaluated. The medications that they are
    evaluated on, a plan is developed with that patient for the
    management of their pain that would again lead to the least
    risky, most effective way of managing their pain.
        Chairman Sanders. I want to thank all of our panelists.
    This Committee considers the issue of overmedication to be a
    serious national problem, a problem within the VA and a problem
    within the DOD. We appreciate your focusing on it and the good
    work you are doing. So, thank you all very much.
        At this time I want to introduce our second panel. First, I
    am pleased to welcome Dr. Janet Kahn, who is a member of the
    Department of Psychiatry at the University of Vermont and
    Senior Policy Adviser for the Consortium of Academic Health
    Centers for Integrative Medicine. That is a mouthful.
        Then we have Dr. Mark Edlund, who is the Senior Research
    Public Health Analyst in the Behavioral Health Epidemiology
    Program at RTI International.
        Thank you both very much for being with us.
        Dr. Kahn, let us begin with you.

     STATEMENT OF JANET KAHN, Ph.D., RESEARCH ASSISTANT PROFESSOR,
      DEPARTMENT OF PSYCHIATRY, UNIVERSITY OF VERMONT AND SENIOR
       POLICY ADVISOR, CONSORTIUM OF ACADEMIC HEALTH CENTERS FOR
                          INTEGRATIVE MEDICINE

        Ms. Kahn. Chairman Sanders, Ranking Member Burr, Members of
    the Committee, I want to thank you for the honor of testifying
    before this distinguished body on what we all agree is a really
    critical issue, the issue of overmedication, particularly
    overuse of opioids for pain management.
        I have been asked to share my understanding of what
    integrative health care approaches could offer to people in
    pain and people treating them.
        So, by way of background, I am a medical sociologist and
    for the past 30 years my work has focused on issues of
    integrative health care. I am also a clinician. I am a massage
    therapist and instructor of meditation and somatic awareness
    training. So, in that capacity in the treatment room what I
    have spent the last 30 years doing is trying to understand how
    people can move from illness to wellness, from pain and ease,
    and how a nervous system that has gotten stuck in a flight or
    fight or freeze state can reset itself for optimal functioning.
        For the past 5 years, almost all of my work has been with
    veterans of OEF, OIF, and OND and their partners. I have seen
    them in my private practice; and with my research partner,
    William Collinge, we utilize a program called Mission
    Reconnect.
        This is a self-directed, home-use Web- and app-based
    program that offers instructions to help veterans and their
    partners learn various mind-body techniques that we know to
    support mental, physical, and relationship health.
        Preliminary research that was conducted with veterans of
    the Vermont and Oregon National Guard units showed 8 weeks of
    this program to be effective in decreasing pain, decreasing
    anxiety levels, and decreasing people scores on PTSD checklist
    measurements.
        We are now conducting a randomized clinical trial of
    Mission Reconnect in San Diego, Dallas, Fayetteville, North
    Carolina, and New York to understand the regional differences
    and to cover all branches of the military.
        The term ``integrative medicine'' has been used with
    various meanings, so, I want to be clear that when I speak of
    integrative health care, I use the term to refer to team-based,
    coordinated use of the most appropriate evidence-based
    interventions from across the full conventional, complementary,
    and alternative medicine spectrum, including preventive efforts
    and a particular focus on interventions that educate and engage
    the patient and his or her family members in their own care
    and, therefore, hopefully leaving them with skills for a
    lifetime.
        I think we all know the relevant reports from the Army Pain
    Management Task Force and the IOM, and I would like to echo
    those reports in calling for a comprehensive change not only in
    how we treat pain but literally how we think about pain so that
    it can guide the treatment beginning with understanding that we
    do not actually treat pain, we treat people in all their
    complexity, and pain is part of what they bring to the picture.
        So many of the men and women returning from these wars have
    multiple wounds. They have injuries to their bodies, to their
    brains, to their hearts, to their minds, to their spirits, to
    their relationships; and we need to find a way to deal with
    that complexity as we treat them because they need more than
    just having their symptoms quieted. They actually need help
    learning to heal and to lead fulfilling lives in the many
    decades, being young, that they have ahead of them.
        Our current approach to pain management can too easily lead
    to prescribing a drug for each identified problem and that in
    turn, as we know, can lead to a poly pharmacy problem that we
    may not have the capacity to actually manage.
        These veterans have already been asked to carry and
    maneuver with more weight in their packs than their bodies were
    designed for. They have been exposed to more stress than their
    nervous systems can manage as we see absolutely every day. So,
    over medicating them is no solution and no gift.
        There are evidence-based, non-pharmaceutical ways to
    address pain. In this kind of complexity, I suggest that we
    reorient toward a positive vision of health and wellness for
    our veterans; try to come up under them.
        We know that lack of sleep, emotional stress, inability to
    take a deep breath, these things exacerbate pain. They
    literally make pain hurt more. They change the experience of
    it.
        So, addressing the building blocks of wellness can reduce
    the need for pain medication, and research clearly indicates
    that massage, acupuncture, yoga, and other mind-body therapies
    can significantly enhance sleep quality as well as duration,
    can help the nervous system rest down and thus reduce the
    experience of physical and emotional pain and alter the
    treatment needs for it.
        Educational interventions that include family members or
    groups of veterans can impart needed skills at the same time
    that they build community; and loss of community is an
    important element of a veteran's pain.
        So, on top of all that they have already offered this
    country, veterans are offering us, I believe, the opportunity
    to embrace a wellness approach to the care of people who have
    incurred complex trauma, to kick our pharmaceuticals-only
    habit, come up with something more complex and interactive, and
    learn to collaborate across disciplines on their behalf. We
    should recognize this as one more gift they are giving us and
    move toward it quickly.
        [The prepared statement of Ms. Kahn follows:]
         Testimony of Janet Kahn, Ph.D., Research Assistant Professor,
       Department of Psychiatry, University of Vermont and Senior Policy
    Advisor, Consortium of Academic Health Centers for Integrative Medicine

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairman Sanders. Thank you very much, Dr. Kahn.
        Dr. Edlund.

     STATEMENT OF MARK EDLUND, M.D., Ph.D., SENIOR RESEARCH PUBLIC
      HEALTH ANALYST, BEHAVIORAL HEALTH EPIDEMIOLOGY PROGRAM, RTI
                             INTERNATIONAL

        Dr. Edlund. Good morning. Thank you for inviting me. My
    name is Mark Edlund, and I am a health services researcher at
    RTI International and a practicing psychiatrist.
        For the past 10 years my colleagues and I have researched
    patterns of opioid painkiller prescribing in Blue Cross/Blue
    Shield, Arkansas Medicaid, and more recently the VA.
        Our research involves analyzing administrative data and
    pharmacy records. Most recently, our research has focused on
    national patterns of opioid prescribing in the VA, supported by
    a grant from the National Institute of Drug Abuse.
        The VA data come from the years 2009 to 2011. My testimony
    today will provide initial findings from our NIDA-funded work.
    This work examined three aspects of opioid prescribing in the
    VA.
        One, rates of opioid prescribing in VA patients with
    chronic non-cancer pain. Two, factors associated with
    discontinuation of chronic opioid therapy. And, three, factors
    associated with heavy utilization of opioids among VA patients
    with chronic pain.
        Rates of opioid prescribing in VA patients with chronic
    pain. Many VA patients have chronic pain, most commonly back
    pain and arthritis. Our results suggest that, among VA patients
    with chronic non-cancer pain who are using VA services at least
    twice per year, a little over half receive at least one
    outpatient opioid prescription in that year.
        Although comparing rates of opioid use between health care
    systems can be imprecise, this rate is approximately the same
    rate as found in other health care systems and in other health
    care plans.
        VA patients with chronic pain who receive opioids have a
    median of about 120 days of use in a year, that is, they used
    opioids about one 1 of 3 days--the median individual. This is
    generally higher than in other health care systems.
        In this same VA cohort, the median daily opioid dose is
    modest, about 21 milligram morphine equivalents. So, morphine
    equivalents are the way we standardize all these different
    opioids, and 21 milligrams is fairly low. High would be thought
    of as, say, 120 to 200. So, the median dose is generally lower
    in the VA than in other health care systems.
        Of the VA chronic pain patients prescribed opioids, the
    percentage who receive high doses of opioids is relatively
    small, about 5 percent. This is also lower than in other health
    care systems. This is important because high dose is an
    important predictor of adverse outcomes.
        The opioid use of OEF/OIF VA patients has been the subject
    of scrutiny. We found that, among VA patients with chronic
    pain, OEF/OIF patients were less likely to be prescribed
    opioids as compared to other VA patients; and among VA patients
    with chronic pain who were prescribed opioids, OEF/OIF veterans
    were less likely to be heavy utilizers of opioids.
        Rates of opioid discontinuation. Among VA patients who
    received at least 90 days of VA opioids within a 180-day period
    in 2009, we looked at rates of discontinuation where
    discontinuation was defined as 6 months with no opioid
    prescription.
        We found that among these VA patients nearly 80 percent
    will receive years of opioid therapy. This is consistent with
    what we have found in analyses of other health care plans.
    While high daily doses is not common among VA patients, both
    high daily doses and use of long-acting opioids were strong
    predictors of opioid discontinuation, or excuse me,
    continuation.
        Individuals with substance abuse disorders and mental
    health disorders were more likely to discontinue opioids in the
    VA. This is important because these patients are those who are
    at increased risk for opioid abuse.
        Factors associated with heavy opioid utilization among VA
    patients. In analyses of data from other health systems show
    individuals with substance abuse disorders are at a high risk
    for heavy utilization of opioids.
        However, in an analysis of VA patients with chronic pain
    known to be using the VA at least twice in a fiscal year,
    individuals with substance abuse were less likely to be heavy
    utilizers of opiates.
        In summary, while comparing health care systems can be
    imprecise, we found, one, among chronic pain patients rates of
    any opioid use is approximately the same in the VA and non-VA
    systems.
        However, among chronic pain patients in VA who receive
    opiates, the number of days for which they received opioids in
    a given year is generally higher than in non-VA systems.
    However, median daily dose in the VA is lower than in other
    health care systems.
        Finally, it appears that the VA does a better job of
    screening out individuals with substance abuse and mental
    health disorders from heavy utilization of opioids which is
    also very important because those are the people who are most
    likely to go on to abuse.
        [The prepared statement of Dr. Edlund follows:]
      Prepared Statement of Mark J. Edlund, M.D., Ph.D., Senior Research
      Public Health Analyst, Behavioral Health Epidemiology Program, RTI
                                 International
        Good morning, thank you for inviting me. My name is Mark Edlund. I
    am a health services researcher at RTI International, and a practicing
    psychiatrist. For the past 10 years my colleagues and I have researched
    patterns of opioid painkiller prescribing in different health care
    systems. Our research involves analyzing administrative data and
    pharmacy records. Most recently, our research has focused on national
    patterns of opioid prescribing in the VHA, supported by a grant from
    the National Institute of Drug Abuse (NIDA).
        My testimony today will provide initial findings from our NIDA-
    funded work. This work examined three aspects of opioid prescribing in
    the VHA: rates of opioid prescribing in VHA patients with chronic
    noncancer pain; factors associated with discontinuation of chronic
    opioid therapy; and, factors associated with chronic opioid use among
    VHA patients.
        Our research used VHA administrative and pharmacy data from years
    2009 to 2011. We have thus far conducted three different analyses of
    this data. The results from those analyses were reported at the
    Addiction Health Services meetings held October, 2013 in Portland,
    Oregon and the American Academy of Pain Medicine meetings held March,
    2014 in Phoenix, Arizona.
        While some of the research methods were the same for all three
    studies, some methods varied in each study, as did the VHA patient
    sample.
                            methods for all analyses
    Data Source
        We used data from three VHA Sources

         Pharmacy Benefits Management Service (PBM)
         VHA Corporate Data Warehouse
         OEF/OIF roster

        Opioid Use Variables. Data included all opioid prescriptions
    (including date, daily dose, and type of opioid), other than injectable
    opioids and opioid suppositories (due to lack of conversion factors).
    We recorded the total number of opioid prescription fills for each
    patient within the fiscal year and calculated the number of days
    supplied for each patient in the year, as recorded by the dispensing
    pharmacist. The mean dose in morphine equivalents per day supplied for
    each patient was calculated by summing the morphine equivalents for
    each prescription filled during the year, and dividing by the number of
    days supplied.
        Other Variables. We used International Classification of Diseases-
    9th Revision (ICD-9) codes from VHA Corporate Data Warehouse to
    construct variables for mental health diagnoses and substance use
    disorders. Chronic non-cancer pain conditions were also identified
    through ICD-9 codes and grouped into five broad categories encompassing
    the most common chronic noncancer pain conditions. These groupings
    included neck pain, back pain, arthritis/joint pain, headache/migraine
    and neuropathic pain, which are common to VHA patients. Demographic
    information such as age, race, gender and marital status were also
    extracted from the VHA Corporate Data Warehouse.
        IRB Approval. All analyses were approved by the Institutional
    Review Boards of The Central Arkansas Veterans Healthcare System and
    the University of Arkansas for Medical Sciences. A data use agreement
    was executed with each data repository.
         analysis 1--patterns of opioid use for chronic noncancer pain
    Study Sample
        The study sample consisted of VHA patients in years 2009 to 2011
    who met the following criteria. Inclusion Criteria: 1) chronic
    noncancer pain diagnosis, as defined by two clinical encounters for the
    same chronic noncancer pain condition (neck pain, back pain, arthritis,
    headache/migraine, or neuropathic pain) at least 30 days apart, but no
    more than 365 days apart, 2) Received at least one opioid prescription
    during the year of chronic noncancer pain diagnosis, 3) Age 18 or
    older. Exclusion Criteria: 1) Cancer diagnosis at any time in 2008-12
    other than non-melanoma skin cancer, 2) resident of VHA nursing home or
    living in VHA domiciliary, 3) enrolled in VHA hospice benefits, 4)
    incomplete opioid prescription data, or 5) a prescription for a
    parenteral, suppository, or trans mucosal opioid. These criteria allow
    us to focus on VHA patients likely receiving opioids for the treatment
    of chronic noncancer pain.
                        key results from first analyses
        Many VHA patients have chronic pain, with the most common sources
    being back pain and arthritis. Our results suggest that, among VHA
    patients with chronic noncancer pain who are using the VA at least
    twice per year, a little over half receive at least one outpatient
    opioid prescription in that year. VA patients with chronic pain who
    receive opioids have a median of 120 days of use in a year, or about
    one out of three days. In this same VHA cohort the median daily opioid
    dose is modest, about 21 milligram morphine equivalents. 21 milligram
    morphine equivalents is fairly low, equivalent to about 2 Vicodin
    tablets. In our analyses the percentage of VHA patients who received
    high doses of opioids was relatively small--about five percent. Among
    VHA patients with chronic noncancer pain, 44% of all opioids were used
    by just 5% of patients; 1% of patients accounted for 17% of all opioids
    utilized.
        The opioid use of OEF/OIF VHA patients has been the subject of
    scrutiny. We found that, among VHA patients with chronic noncancer
    pain, OEF/OIF patients were less likely to be prescribed opioids
    compared to non OEF/OIF VHA patients, and less likely to be heavy
    utilizers of opioids.
        Conclusions: About half of all VHA patients with chronic noncancer
    pain receive opioids, and among those who receive opioids, the median
    days of use is 120 days. The median daily dose is modest. Total opioid
    use is heavily concentrated among a relatively small proportion of the
    VHA population with chronic noncancer pain.
    Second Analysis:
        Our second set of analyses focused on discontinuation from chronic
    opioid therapy.
            analysis 2--discontinuation from chronic opioid therapy
    Study Sample
        The study sample consisted of all adult VHA patients receiving 90
    days or greater supply of non-parenteral opioids with less than a 30-
    day gap in supply within a 180-day period between January 1, 2009 and
    December 31, 2011. We refer to individuals who met these inclusion
    criteria as receiving chronic opioid therapy. The index date was
    defined as the first day of this 90-day period. A minimum of two prior
    encounters in the year preceding the index date were required to
    document routine use of VHA care. The year preceding the index period
    was used to identify additional exclusionary criteria and relevant co-
    variables. Veterans with an ICD-9 cancer diagnosis (with the exception
    of non-melanoma skin cancers) and administrative codes for VHA nursing
    home use, hospice or palliative care services in the 360 days before
    and after the index date were excluded. Additionally, veterans with
    incomplete opioid prescription data (unknown dosages or types) or
    enrollment in a methadone maintenance program or receiving
    buprenorphine at any time were excluded.
        Given high rates of interrupted or episodic use among chronic
    opioid users and to maintain consistency in definitions,
    discontinuation was defined as the first run-out day of a minimum 180-
    day period with no opioid prescriptions. In order to distinguish
    clearly between disenrollment from VHA and opioid discontinuation,
    participants without any VHA services use in the 90 days after
    discontinuation were excluded.
        If any two prescriptions overlapped by greater than 20% or greater
    than ten days, the overlapping portions of the prescription were
    assumed to be taken concurrently and the overlapping days were only
    included once in the opioid days calculation. If the overlap was > 20%
    and > 10 days the second prescription was shifted and the overlapping
    days from both the first and second prescription were included in the
    opioid days calculation. A dichotomous variable for the presence of
    multiple opioids defined as two or more types of opioids that
    overlapped by more than 30 days in any 40-day period was created as a
    surrogate for potential opioid misuse.
        VHA service utilization during the period of chronic opioid therapy
    was calculated as the total number of mental health encounters,
    substance use encounters and all other VHA encounters abstracted from
    Current Procedural Terminology (CPT) codes in the 90 days post-index.
       key results from analysis 2--discontinuation from chronic opioid
                                    therapy
        We identified 814,311 VHA patients who met our criteria for chronic
    opioid therapy. After exclusions were applied, 550,548 (67.6% of
    chronic opioid users) were eligible for analysis and 542,843 were
    entered into the statistical models. (We excluded 7,705 (1.4%) of the
    sample due to missing data, primarily the absence of reliable rural/
    urban coding). The sample was primarily male (93%), white (74%) and
    urban-dwelling (68%), with a mean age of 57.8 years and 52% were
    married. At one year after their index prescription date, only 7.5% of
    the sample had discontinued chronic opioid therapy.
        The majority of the sample suffered from at least one chronic
    noncancer pain condition (82.3%); just over a quarter of the sample had
    two chronic noncancer pain conditions (26.7%). Similarly, 62.3% of the
    sample had a mental health diagnosis, the most common being depressive
    disorder (29.7%). Only 14.5% of the sample had a substance use
    disorder, while 25.6% of the total sample used tobacco. The mean number
    of total clinical encounters in 90-days post-index was almost 9 (mean
    8.92, SD 11.01).
        The mean daily morphine equivalent dose was 40.7 mg (SD 61.67 mg)
    among the VHA patients in this analysis though the median was 26 mg and
    only 7% received greater than 100 mg daily morphine equivalent. Nearly
    all received short-acting opioids (97.1%). Only 12.3% received multiple
    concurrent opioid prescriptions, usually a long-acting plus a short-
    acting opioid, and over half (57%) had received greater than 90 days
    total opioid supply in the year preceding their index date.
        We conducted analyses to examine factors associated with
    discontinuation from long-term opioid therapy. The maximum time
    available for follow-up was 1,279 days (3.5 years), and of those who
    discontinued (20%, N=110,460), the mean time to discontinuation was 530
    days (SD 298.15, median: 465). The majority of the sample continued use
    through the end of the follow-up period. Demographic characteristics
    associated with higher rates of discontinuation of long-term opioid
    therapy included being younger or older than VHA patients aged 50-65
    (0-30 years HR=1.52, 95% CI 1.47 to 1.57 and > 65 years HR=1.34, 95% CI
    1.32 to 1.36), non-married status (HR 1.06, 95% CI 1.05 to 1.08) and
    African American race (HR 1.04, 95% CI 1.02 to 1.06). Compared with VHA
    patients living in an isolated rural setting, those in an urban setting
    were significantly more likely to discontinue long-term opioid therapy
    (HR 1.08, 95% CI 1.05 to 1.10).
        VHA patients who were receiving higher average daily doses of
    opioids were less likely to discontinue chronic opioid therapy. Those
    taking long-acting opioid formulations had roughly 6% lower rates
    discontinuation of chronic opioid therapy compared with those taking
    short-acting opioid medications. (HR 0.94, 95% CI 0.90 to 0.98 VHA
    patients). Those receiving multiple opioid prescriptions concurrently
    had about a 20% lower rate of discontinuation compared with VHA
    patients receiving only one opioid medication (HR 0.80, 95% CI 0.78 to
    0.82). Finally, VHA patients with significant use of opioids in the
    year prior to the index date had almost a 30% lower rate of opioid
    discontinuations (HR 0.69, 95% CI 0.68 to 0.70). VHA patients who had
    multiple types of pain or who had greater level of medical comorbidity
    were more likely to continue chronic opioid therapy.
        For the cohort of VHA patients in this analysis, mental health
    diagnoses were associated with greater likelihood of discontinuation of
    chronic opioid therapy, with schizophrenia and bipolar diagnoses
    associated with nearly 20% greater hazard of discontinuation (HR 1.20,
    95% CI 1.16 to 1.25 for schizophrenia and HR 1.20, 95% CI 1.16 to 1.23
    for bipolar). Alcohol use disorder (HR 1.10, 95% CI 1.07 to 1.12),
    opioid use disorder (HR 1.09, 95% CI 1.06 to 1.13) and non-opioid use
    disorders (HR 1.22, 95% CI 1.19 to 1.25) were all significantly
    associated with higher rates of discontinuation. In contrast to other
    mental health and substance use predictors, tobacco use disorders were
    associated with higher rates of continued long-term opioid therapy
    (HR 0.96, 95% CI 0.94 to 0.97).
        Conclusions: Among VHA patients who had received at least 90 days
    of opioids within a 180 day period in 2009, nearly 80% went on to
    receive years of opioid therapy. This is similar in other health care
    plans. However, in other health care plans we studied, individuals who
    were at high risk for opioid abuse, namely those with substance use
    disorders and mental health disorders, were more likely to receive high
    dose opioids and less likely to discontinue opioids. We generally did
    not find this in the VHA. As noted above, VHA patients with mental
    health diagnoses, diagnosed disorders related to alcohol use as well as
    opioid and non-opioid substance use disorders were more likely to be
    discontinued from long-term opioid therapy. Thus, it appears that VHA
    does better than other health care systems previously studied in terms
    of discontinuing patients from chronic opioid therapy.
    Third Analysis:
        Our third analysis examined factors associated with chronic opioid
    use among VHA patients who regularly used VHA care in FY 2011.
     analysis 3--chronic opioid use among all vha patients with or without
                            chronic non cancer pain
    Study Sample
        To be included in the cohort for the third analysis we identified
    all Veterans who had at least one outpatient opioid prescription in FY
    2011 using data from the VHA Pharmacy Benefits Management Service.
    Similar to our 2nd analysis we used secure mechanisms to link the data
    from the Pharmacy Benefits Management Service to that of the Corporate
    Data Warehouse to identify VHA patients who used VHA care at least
    twice in FY 2011. VHA patients with an ICD-9 cancer diagnosis (with the
    exception of non-melanoma skin cancers) and administrative codes for
    VHA nursing home use, hospice or palliative care services, had codes
    for methadone maintenance or were receiving buprenorphine were also
    excluded from the sample. In addition, VHA patients receiving
    outpatient opioid prescriptions for injectable opioids, opioid
    suppositories or trans mucosal opioid preparations were also excluded
    from the analysis. VHA patients were not required to have a chronic
    pain diagnosis to be included in this sample. Based on these inclusion
    and exclusion criteria, we identified a total of 1,127,955 VHA patients
    who were using opioid medications in FY 2011. Almost 52% (584,765) of
    VHA patients in this analysis were using opioids for 91 or more days
    during that fiscal year.
    key results from analysis 3--chronic opioid use among all vha patients
                     with or without chronic noncancer pain
        In unadjusted results, chronic opioid users were slightly older
    than non-chronic users (59 years vs 57 years), were more likely to be
    white (72.9% vs 65.9%), and were less likely to be OEF/OIF/OND Veterans
    (5.9% vs 11.1%).
        We used a logistic regression model to identify factors associated
    with chronic opioid use in this cohort in FY 2011 (adjusted results).
    In this cohort, opioid use was most common in VHA patients ages 56 to
    65 years; patients in other age groups were less likely to have chronic
    opioid use. The difference was most noticeable in the youngest age
    group. VHA patients ages 18-25 were almost 62% less likely than VHA
    patients ages 56-65 years to receive chronic opioid therapy (OR=0.38,
    95% CI=.36-.39). Non-white VHA patients were approximately 28% less
    likely than white VHA patients to receive opioid medications
    chronically (OR=.72, 95% CI=.71-.73). VHA patients in whom race was
    unknown were also less likely to receive chronic opioid medications
    although the difference was less pronounced with these patients being
    8% less likely to receive chronic opioid therapy compared with white
    patients (OR=.92, 95% CI=.90-.93). In this cohort women patients were
    22% less likely to receive chronic opioid therapy compared with male
    patients (OR=.78, 95% CI=.77-.79). VHA patients who were identified as
    OEF/OIF Veterans were 34% less likely to receiving chronic opioid
    therapy compared with non-OEF/OIF Veterans (OR=.66, 95% CI=.65-.67).
        In this cohort having PTSD or a depressive disorder was associated
    with receiving chronic opioid therapy. VHA patients in this cohort with
    a PTSD diagnosis were 16% more likely to receiving chronic opioid
    therapy compared with VHA patients without PTSD (OR=1.16, 95% CI=1.15-
    1.18). VHA patients in this cohort with a diagnosis of a depressive
    disorder were 25% more likely to receive chronic opioid medications
    (OR=1.25, 95% CI=1.24-1.26).
        In this model, likelihood of chronic opioid use was most strongly
    associated with opioid dose, use of long-acting opioid medications and
    receiving multiple opioid medications concurrently. VHA patients in
    this cohort who were receiving 100MG morphine equivalent dose or more
    each day were 68% more likely to receive opioids chronically (OR=1.68,
    95% CI=1.60-1.76. VHA patients who were receiving long-acting opioid
    medications were almost four times as likely to receive opioids
    chronically compared to those receiving short-acting medications
    (OR=3.77, 95% CI=3.6-3.8) while those receiving multiple opioid
    medications concurrently were more than 30 times more likely to receive
    opioids chronically (OR=30.8, 95% CI=29.4-32.3).
        Conclusions: Of VHA patients who use opioids, about half use them
    chronically (at least 89 days per year). VHA patients who were non-
    whites, OEF/OIF, or female were less likely to receive chronic opioid
    therapy. Individuals with mental health disorders were more likely to
    receive opioids chronically, but the magnitude of this effect was
    small. Higher opioid dose, use of multiple opioids concurrently and use
    of long-acting opioid medications were strongly associated with chronic
    opioid use.
                                    caveats
        Our results should be interpreted with 4 factors in mind. First, we
    had access only to VHA records, and do not know about opioids VHA
    patients may be receiving outside the VHA system. Second, the
    definition of chronic pain is inherently subjective. In our first
    analysis we used a definition that is relatively strict. With less
    strict definitions, the percentage of VA chronic pain patients
    receiving opioids would likely be lower, as would the number of days of
    opioids used in a year. Third, the definition of high dose opioids is
    also subjective. We used a measure of high dose opioids that is on the
    low side. If we had used a measure that was higher, then our estimate
    of the percentage of VA patients with chronic pain who received high
    dose opioid therapy would have been lower. Fourth, although we reviewed
    records of all VHA patients in various years we included only specific
    patients in our analyses because we wanted to identify Veterans that
    were known to be using VHA care regularly.

        Thank you.

        Chairman Sanders. Dr. Edlund, thank you very much for your
    testimony.
        Let me start with Dr. Kahn and just ask you a pretty simple
    question. Let's say there is a veteran who is coming back from
    Iraq and Afghanistan dealing with pain issues, back pain or
    whatever it may be, he or she has difficulty sleeping, maybe
    the marriage is in trouble, they have difficulty holding on to
    a job.
        You said the issue here is not to deal with pain but to
    deal with the person. In the real world, somebody walks into
    your door with the issues I have described, the easy path is to
    medicate. Historically, we have done a lot of that. You have
    got pain; here are some drugs.
        You are proposing a different way. In English and maybe
    some concrete examples, what does that mean? What do you do
    with that individual who walked in your door?
        Ms. Kahn. So, I hope I made it clear that I am not
    suggesting an either/or approach.
        Chairman Sanders. No. We understand absolutely.
        Ms. Kahn. OK. And I want to state clearly that I am not a
    physician.
        Chairman Sanders. Right.
        Ms. Kahn. OK. So, that said, yes. I assume a physician
    would address issues of pain directly but at the same time
    because people's experience of pain and their capacity to
    handle and to cope with pain and manage whatever level of pain
    they are experiencing, is influenced by these other things like
    their general state of anxiety or whether or not they are sleep
    deprived and, therefore, on edge in a different way, we want to
    come up under them in terms of those elements of life at the
    same time as addressing the pain directly. That is what I am
    suggesting.
        Chairman Sanders. Give me some examples, if you can, of the
    effectiveness of the approach you are utilizing. Does it work?
    Do you have some examples of people who have walked in the door
    who have been able to get effective treatment, see real
    improvements in their lives with minimal use of heavy drugs?
        Ms. Kahn. I think I am actually not in a position to answer
    that yet because in my own practice of offering Mission
    Reconnect to people the first trial with that program was not
    done in a VA context or in a medical context, thus I did not
    have access to medical records to be able to assess changes in
    medication prescription or use.
        We have been approached by psychologists at the Tampa VA,
    and they are in the process of preparing a proposal to look at
    exactly that, to apply Mission Reconnect with other care for
    people who are both high PTSD and high pain.
        Chairman Sanders. OK. Dr. Edlund, do you have some thoughts
    on that?
        Dr. Edlund. I think that these strategies are
    underutilized. I think that they hold promise. I think that
    they are particularly attractive in that they are noninvasive
    and they do not involve medication.
        I think that ultimately they are going to be an important
    part of the puzzle and there is no one piece of the puzzle that
    is dominant. So, I agree that all of these elements need to be
    brought to the fore.
        Chairman Sanders. In your opinion, Dr. Edlund, has VA been
    aggressive in exploring these new approaches?
        Dr. Edlund. I would say that the VA has been more
    aggressive than the rest of the American health care system and
    that the level of aggressiveness has markedly increased in the
    last 2 or 3 years.
        Chairman Sanders. So, if you walked into a VA facility you
    would be more likely to have the option of looking at these
    approaches than in a private-sector hospital. Is that what you
    are saying?
        Dr. Edlund. Yes, almost certainly.
        Chairman Sanders. OK. Dr. Kahn, do you have anything to add
    to that?
        Ms. Kahn. Well, only that because in the non-governmental
    world, in the world of private insurance, most complementary
    and alternative medicine forms have not been and continue not
    to really be fully reimbursed. Then the patient is faced with a
    tougher choice if they are going to have to pay for it
    themselves in a private hospital than in the VA. So, I would
    imagine there would be greater use in the VA.
        Chairman Sanders. Well, that is an interesting observation.
    So, because insurance companies do not cover many of these
    complementary or alternative approaches, the private hospital
    is constrained about what kind of therapies it can offer.
        Ms. Kahn. Not necessarily what ones they offer but how they
    offer them. An increasing percentage of private hospitals do
    offer them, sometimes paid for philanthropically. Sometimes the
    hospital itself will pay and often it will be a fee that the
    patients themselves have to absorb.
        Chairman Sanders. OK. Thank you very much.
        Senator Burr.
        Senator Burr. Mr. Chairman, thank you.
        The one thing that I hope I will not fall prey to is trying
    to practice medicine from this side of the dias.
        Chairman Sanders. Give it a try.
        [Laughter.]
        Senator Burr. The truth is that the VA is a medical home
    and not everybody that prescribes in the private sector is
    necessarily that patient's medical home. They are referred to
    that pain specialist by their medical home and I think a
    medical home is more apt to look at all the conditions that
    surround an individual before they make a determination as to
    which course to follow, and I think that is why maybe in the
    private sector there are options.
        I think the Chairman's intent was to say that they are not
    all paid for by their insurance company where we have expanded
    it greatly in the VA.
        Dr. Kahn, I am fascinated to look at the studies once you
    have completed them in these multi-geographical areas with a
    variation of our active duty forces to see if we find
    variations between the Army and others. I look forward to that.
        But you testified that the VA needs to change from a
    problem-fixing mentality to a more rounded approach toward
    health care, and I think you alluded to the fact that this is a
    big organization. There are a lot of people, and that makes it
    challenging.
        What do you see as those challenges?
        Ms. Kahn. Well, first of all, any big boat takes a while to
    turn. So, size is simply one problem. I do not know exactly
    what the level of acceptance right now is among providers
    across the VA so that would have to be assessed.
        In general, I would say in the field of health care across
    all health care professions--complementary, alternative,
    conventional, I would say many of us are fairly arrogant about
    our own approach and not necessarily even well informed about
    other approaches.
        Senator Burr. What do you see as the biggest impediment for
    VA making this transition?
        Ms. Kahn. I do not see anything insurmountable. I think if
    the will is there it can absolutely be done. I think in general
    we have not seen large-scale use of integrative health care. It
    has been sort of an almost boutique form, but I think the
    single largest civilian health system that is integrating
    across the whole system is Allina Health, which is in Minnesota
    and Wisconsin. It is not the 150 medical centers and 1,500
    clinics that the VA has. It is 12 hospitals and 150 clinics.
    But it begins to show the scalability, and I think the VA could
    do it.
        Senator Burr. Dr. Edlund, tremendous research comes out of
    RTI, and we are grateful for that, and thank you for your work
    on this. Your testimony discusses several research studies you
    conducted regarding the patterns of opiate prescribing in VA
    facilities.
        Let me ask you, does RTI plan to conduct further research
    in that area?
        Dr. Edlund. I am hoping to submit another grant, yes; and
    we have submitted grants in the past that have not been funded.
    So, yes, it is an active area of research.
        Senator Burr. Can you describe for us what you see that
    next research project structured like, that you would submit
    that grant for?
        Dr. Edlund. Yes. The most recent grant that I have is
    actually not a VA grant. It is outside of the VA. Well, we will
    also be using VA physicians.
        We are looking at what goes into or how do physicians
    arrive at the decision to prescribe an opiate. Opiates are a
    two-edged sword, and the question is always how do you balance
    the risks and benefits.
        I am interested in understanding how they do that and what
    makes them decide along with the patient, OK, we are going to
    prescribe an opiate in this case or we are not going to
    prescribe an opiate in this case or we are going to escalate
    the opiate.
        So, these kind of fundamental decision-making processes
    that the physicians have to make along with the patient, we
    really do not understand at all and our next grant is to go in
    and try to better understand that.
        Senator Burr. Well, maybe, I can persuade Dr. Briggs for
    the Committee to answer that question that I believe she has
    probably looked at and it is a fascinating thing because I
    think we are making a big assumption that there is a tremendous
    amount of thought put into that determination.
        My observation would be opiates are prescribed a lot of
    times because that is what the patient came in and asked for,
    and doctors feel compelled to send them out with what, in fact,
    they requested. That may be part of our problem.
        I thank the Chair.
        Chairman Sanders. Thank you, Senator Burr.
        Senator Blumenthal.
        Senator Blumenthal. Thank you, Mr. Chairman.
        Dr. Edlund, this number may have been in your testimony but
    I have trouble seeing it highlighted there. Is there an average
    for the amount of time or the amount of drugs, opioids that are
    taken when they are prescribed?
        Dr. Edlund. I am sorry. I am not understanding. Is there
    what?
        Senator Blumenthal. Is there an average either period of
    time or amount of drugs over a period of time? In other words,
    someone who is prescribed an opioid takes it on average for 6
    months, 2 weeks, a year.
        Is there any data on how long the average prescription
    lasts?
        Dr. Edlund. Yes. Well, what we know is that--we
    differentiate between acute opiate use and chronic opiate use.
    So acute use would be you hurt your ankle and that is not what
    we are talking about.
        But with chronic use, what we know is that once an
    individual has been on chronic opioids for about 90 days, then
    most of those individuals will go on to use opioids for years.
    Really, you know, we cannot figure out and an average because
    at the end of 5 years, 75 percent of them will still be on
    opiates.
        Senator Blumenthal. Is there any data on whether the
    prescription for chronic users increases over time? In other
    words, does the amount of opioids prescribed have to increase
    to, in effect, take care of the same level of pain or for some
    other reason?
        Dr. Edlund. No. That is a very good question and that is
    poorly understood, meaning whether or not in what percentage of
    cases the opioid dose can be stable.
        Definitely in some cases you have to increase the dose over
    time because the patient develops a tolerance and that is the
    whole problem with opiate use is that, you know, it is a spiral
    that is always going upward. But we do not know how many people
    are in a spiral going upward and how many people are relatively
    stable.
        Senator Blumenthal. Is that not an important question?
        Dr. Edlund. Yes. There are a lot of fundamental important
    questions in opioids that have not been answered.
        Senator Blumenthal. I apologize for interrupting you but my
    time is limited; to follow up on Senator Burr's excellent
    question, it may well be that the patient comes in and says I
    need more, Doc.
        Dr. Edlund. It may very well be and I agree that a lot of
    times probably not a lot of thought is put into these
    decisions.
        Senator Blumenthal. And is there a way, for example, to
    have trip wires, for a lack of a better word? In other words,
    after 6 months there has to be a complete review by some
    independent medical professional or panel or some kind of
    authority to say, you know, there is a pattern here, increasing
    use over 6 months or, in other words, some kind of independent
    review.
        Dr. Edlund. Yes. Obviously that could be done easily, but
    to my knowledge it is fairly rarely done.
        Senator Blumenthal. And in your experience, to talk about
    Post Traumatic Stress--and I would ask this question of Dr.
    Kahn as well--Post Traumatic Stress, is that condition
    addressed therapeutically by opioid use or does opioid use
    address other conditions that, as Secretary Petzel said, may be
    found accompanied with Post Traumatic Stress, pain along with
    Post Traumatic Stress; is there an affect on the Post Traumatic
    Stress of using opioids either good or bad?
        Dr. Edlund. I am not familiar with that research. I do know
    that a lot of people with PTSD receive opioids, but I cannot
    speak to the finding.
        Senator Blumenthal. There is no research so far as you are
    aware----
        Dr. Edlund. Not that I am aware of.
        Senator Blumenthal [continuing]. Showing the effects on
    Post Traumatic Stress, minus of opioid use?
        Dr. Edlund. No, not that I am familiar with.
        Senator Blumenthal. Dr. Kahn, are you aware of any such
    research?
        Ms. Kahn. No, I am not.
        Senator Blumenthal. I would welcome--since I cannot ask the
    past panel whether they are aware of such research, if they
    are, please make me and perhaps the Committee aware of it.
        I thank you, Mr. Chairman. Just one footnote here which I
    have said before. I refer to Post Traumatic Stress as Post
    Traumatic Stress rather than Post Traumatic Stress Disorder,
    and I had said it to others who have testified here including
    Secretary Shinseki.
        You may agree or disagree but I think it is important to
    remove the stigma of Post Traumatic Stress by not referring to
    it as a disorder. I may be clinically and medically out in left
    field but so be it. Thank you.
        Thank you Mr. Chairman.
        Chairman Sanders. Senator Blumenthal, thank you very much
    and, Dr. Kahn, Dr. Edlund, thank you very much for helping us
    out on this very important issue.
        Ms. Kahn. Thank you.
        Chairman Sanders. And with that, the hearing is now
    adjourned.
        [Whereupon, at 11:53 a.m., the Committee was adjourned.]
                                A P P E N D I X

                                  ----------

                   Prepared Statement of The American Legion
              By the time Justin Minyard discovered the video of himself
            stoned, drooling and unable to help his daughter unwrap her
            Christmas presents, he was taking enough OxyContin, oxycodone
            and Valium every day to deaden the pain of several terminally
            ill cancer patients.
              ``Heroin addicts call it the nod,'' the former Special Forces
            soldier says of his demeanor in that video. ``My head went
            back. My eyes rolled back in my head. I started drooling on
            myself. My daughter was asking why I wasn't helping her, why I
            wasn't listening to her.''
              Seeing that video jolted Minyard out of a two-year opiate
            stupor. He asked a Fort Bragg pain specialist to help him get
            off the painkillers his primary care physician had prescribed.
            ``I was extremely disappointed in myself,'' he says. ``I knew I
            couldn't do that to my family again.''\1\
    ---------------------------------------------------------------------------
        \1\ Excerpt ``On the Edge'' The American Legion Magazine story by
    Ken Olsen, April 1, 2014.

        The preceding story is just one of many recent anecdotal accounts
    of veterans struggling with over-prescription of medications. In the
    best cases, the veteran in question has been able to pull themselves
    back from the brink, regroup, and work toward a different mode of care
    that doesn't have the same devastating effect on the veteran and their
    families. In the worst cases, veterans have died from accidental
    overdose, or attempted suicide in a medication-induced haze.
        In September 2013, CBS news reported the tragic tale of 35 year old
    Army SPC Scott McDonald, who tragically perished from the accidental
    overdose brought about by the cumulative effects of the lengthy list of
    medications he had been prescribed.\2\ The American Legion believes
    these risks increase the importance of exploring Complementary and
    Alternative Medicine (CAM) therapies \3\ that can reduce the
    overreliance on prescription drugs and help bring these veterans back
    from the brink of the abyss.
    ---------------------------------------------------------------------------
        \2\ http://www.cbsnews.com/news/veterans-dying-from-overmedication/
        \3\ Resolution #108: Request Congress Provide the Department of
    Veterans Affairs Adequate Funding for Medical and Prosthetic Research
    ---------------------------------------------------------------------------
        The American Legion has continued to be concerned with the
    unprecedented numbers of veterans returning from the wars in Iraq and
    Afghanistan suffering from TBI and PTSD, categorized as the ``signature
    wounds'' of these conflicts. The American Legion believes that all
    possibilities should be explored and considered in an attempt to
    finding treatments, therapies, and cures for TBI and PTSD to include
    alternative treatments and therapies, and they need to make them
    accessible to all veterans. If these alternative treatments and
    therapies are deemed effective they should be made available and
    integrated into the veterans' current health care model of care.
        As a result The American Legion established the TBI and PTSD
    Committee in 2010 comprised of American Legion Past National
    Commanders, Commission Chairmen, respected academic figures, and
    national American Legion staff. The Committee is focused on
    investigating existing science and procedures as well as alternative
    methods for treating TBI and PTSD that are not being employed by the
    Department of Defense (DOD) and VA for the purpose of determining if
    such alternative treatments are practical and efficacious.
        During a three year study the Committee met with leading
    authorities in the DOD, VA, academia, veterans, private sector mental
    health experts, and caregivers about treatments and therapies veterans
    have received or are currently receiving for their TBI and PTSD
    symptoms. Last year the Committee released their findings and
    recommendations in a report titled ``The War Within.'' ``The War
    Within'' report highlights these treatments and therapies and also
    identifies findings and recommendations to the DOD and VA.
                   key highlights and findings of the report:
        Some of the critical findings of The War Within included:

         Most of the existing research for the last several years
    has only validated the current treatments that already exist--VA and
    DOD research is not pushing the boundaries of what can be done with new
    therapies, merely staying within an environment of self-confirmation
    bias.
         There seems to be a lack of fast track mechanisms within
    DOD and VA to employ innovative or novel therapies--a standardized
    approach to these therapies could help servicemembers and veterans gain
    access to care that could help them.
         While some VA medical centers (VAMCs) do offer
    complementary alternative medicine (CAM) therapies, they are not
    offered in a consistent or uniform manner across all 152 VAMCs
    nationwide--VA struggles with consistency and needs better guidance.

        In addition to those findings, the TBI and PTSD Committee made some
    recommendations for the way forward:

         Congress needs to provide oversight and funding to DOD and
    the VA for innovative TBI and PTSD research that is being used
    successfully in the private sector healthcare systems such as
    hyperbaric oxygen therapy, virtual reality exposure therapy, and non-
    pharmacological treatments and therapies.\4\
    ---------------------------------------------------------------------------
        \4\ Resolution #108: Request Congress Provide the Department of
    Veterans Affairs Adequate Funding for Medical and Prosthetic Research
    ---------------------------------------------------------------------------
         Congress needs to increase DOD and the VA research and
    treatment budgets in order to improve the research, screening,
    diagnosis, and treatments for TBI and PTSD.
         DOD and VA need to accelerate their research efforts in
    order to effectively and efficiently diagnose and develop evidence-
    based TBI and PTSD treatments.
                               continued efforts:
        The American Legion's efforts to assess the care and treatments
    available for veterans suffering from TBI and PTSD are not limited to
    the efforts of the TBI and PTSD Committee. In 2003, The American Legion
    established the System Worth Saving Task Force to conduct ongoing, on-
    site evaluations of the Veterans Health Administration (VHA) medical
    system. Annually, System Worth Saving visits provide Legionnaires,
    Congress and the public with an in-depth, boots on the ground view of
    how veterans are receiving their healthcare across the country.
        Over the last several years, the System Worth Saving reports have
    examined the full spectrum of VHA care, but specifically have noted
    several things about how VHA delivers on complementary and alternative
    medicine (CAM) in their facilities.
        VA medical centers throughout the VA healthcare system are
    committed, dedicated, and compassionate about treating veterans with
    TBI. Many medical centers throughout the country have found successful
    complementary and alternative methods for the treatment of TBI and PTSD
    such as hiking, canoeing, nature trips, equine, and music therapy.\5\
    While some systems like the El Paso VA Healthcare System offer several
    CAM solutions, such as yoga, guitar lesions, sleep hygiene and other
    practices, other locations such as the Pittsburgh VA and Roseburg VA
    Healthcare System are more limited, offering only acupuncture in
    Pittsburgh, and acupuncture for pain management through the fee basis
    program in Roseburg.\6\
    ---------------------------------------------------------------------------
        \5\ 2011 SWS--``Transition of Care from DOD to VA''
        \6\ 2014 SWS--``Past, Present and Future of VA Health Care''
    ---------------------------------------------------------------------------
        In addition to the ongoing System Worth Saving Task Force visits,
    The American Legion is taking the lead for veterans by aggressively
    pursuing the best possible treatment options for veterans on multiple
    fronts.
                  hearing from veterans about their treatment:
        On February 3, 2014, The American Legion launched a TBI and PTSD
    survey online in order to evaluate the efficacy of the veterans' TBI
    and PTSD care, treatments, and therapies and to find out if they are
    receiving and benefiting from CAM treatment offered by the DOD and VA.
    The survey, conducted in coordination with the Data Recognition
    Corporation (DRC), Dr. Jeff Greenberg, Ph.D., and the Institute for the
    Advancement of Military and Veteran Healthcare, was to assist The
    American Legion to better understand the experiences of veterans who
    receive care throughout the VA healthcare system.
        William Detweiler, Past National Commander and Chairman of the TBI
    and PTSD Committee has stated about the survey, ``The American Legion
    is very concerned by the unprecedented number of veterans who suffer
    from these two conditions * * * We firmly believe that both VA and DOD
    need to act aggressively in adopting all effective treatments and
    cures, including alternatives being used in the private sector, and
    make them available to our veterans nationwide * * *. By completing
    this survey, veterans across America will have the opportunity to tell
    the true story of the types of care and treatments that they are
    actually receiving for PTSD and TBI. The survey will greatly help The
    American Legion in its efforts to advise the Administration, Congress,
    DOD, VA on the best possible care and treatments for these injuries.''
        The full survey results will be released and discussed in detail at
    the upcoming American Legion TBI and PTSD Symposium, June 2014, however
    two key data points emerged which bear special significance to this
    testimony.

         Medication appears to be the front line treatment reported
    by respondents.
         A sizable proportion of respondents reported prescriptions
    of up to 10 medications for PTSD/TBI across their treatment experience.

        Both of these data points should raise concerns about whether
    veterans are getting the right treatment for these signature wounds of
    the past decade's wars.
                                   symposium:
        On June 24, 2014 in Washington, DC, The American Legion is hosting
    a TBI and PTSD Symposium entitled ``Advancing Care and Treatment for
    Veterans with TBI and PTSD.'' The symposium aims to discuss the
    findings and recommendations from the TBI and PTSD veteran's survey,
    and will hear directly from servicemembers, veterans, and caregivers on
    their TBI and PTSD experiences, treatments and care. The symposium will
    also help us determine how the Administration, Congress, DOD and VA are
    integrating complementary and alternative treatments and therapies into
    current models of veterans' health care.
                                  conclusion:
        After a decade of war, America is still grappling with an evolving
    understanding of the nature of the wounds of warfare. Veterans must be
    reassured that the care they receive, whether serving on active duty in
    the military, or through the VA Healthcare system in their home town,
    is the best treatment available in the world. To combat the physical
    and psychological wounds of war, sometimes the old treatments are not
    going to be the most efficacious.
        Just as new understanding about the nature of these wounds emerges,
    so too must the new understanding about the best way to treat these
    wounds continue to adapt and evolve. Veterans are fortunate to have
    access to a healthcare system designed to treat their wounds, but that
    system must recognize that different treatments will have differing
    levels of effectiveness depending on the individual needs of the
    wounded veteran. There is no silver bullet. There is no single
    treatment guaranteed to cure all ailments. With a national policy that
    respects and encourages alternative therapies and cutting edge
    medicine, veterans have the best possible shot to get the treatment
    they need to continue being the productive backbone of society their
    discipline and training prepares them to be.
        Consider the following condensed version of one of the many veteran
    stories in The American Legion's The War Within:

                Tim Hecker joined the Army at 18 and soon decided to make a
            career of it. He served 22 years in all, in and out of combat,
            rising to the rank of master sergeant. In the summer of 1990,
            he married his high school sweetheart, Tina, and the couple had
            three children.
              Then Tim couldn't remember having married Tina. He couldn't
            tell his sons apart. Their names escaped him. Injuries suffered
            in two separate roadside-bomb explosions in a span of two
            months in Iraq in early 2008 left him with a Traumatic Brain
            Injury and severe post-traumatic stress. He was no longer the
            man Tina had married.
              Frustrated with her husband's descent and the lack of
            progress with traditional care, Tina went online and found
            information about hyperbaric medicine. Following a phone call
            and an initial interview, Tim was selected to be part of a
            pilot study on the use of hyperbaric oxygen therapy (HBOT) for
            Traumatic Brain Injury (TBI) and Posttraumatic Stress Disorder
            (PTSD). He claims the treatments have given him back most of
            his pre-injury life.
              ``By the fourth treatment, I started feeling like a new
            person,'' he says at his home in West Edmeston, N.Y. ``I was
            more aware. I could see things. The deeper I got into the
            treatments, my cognition started to come back--my motor skills
            and my balance. My vision started to improve. The biggest
            benefit was my emotional control.''
              ``We're talking a 180-degree turn around,'' Tina says.
            ``There are days when he's almost back to normal with his
            personality.''\7\
    ---------------------------------------------------------------------------
        \7\ http://www.legion.org/publications/217301/war-within-treatment-
    traumatic-brain-injury-and-post-traumatic-stress-disorder

        Ultimately, that is why it's so important to ensure VA solves the
    over medication puzzle. The veterans have already returned home from
    war. This is about helping the veterans to finally return home to their
    families.
        The American Legion looks forward to working with the Committee, as
    well as VA, to find solutions that work for America's veterans. For
    additional information regarding this testimony, please contact Mr. Ian
    de Planque at The American Legion's Legislative Division, (202) 861-
    2700 or ideplanque@legion.org.
                                     ______

        Prepared Statement of Joy J. Ilem, Deputy National Legislative
                      Director, Disabled American Veterans
        Chairman Sanders, Ranking Member Burr and Members of the Committee:
    DAV (Disabled American Veterans), an organization of 1.2 million
    wartime veterans who were wounded, injured or made ill due to their
    military service, appreciates this opportunity to offer testimony for
    the record of your hearing to examine overmedication and its problems
    and solutions in the Department of Veterans Affairs (VA).
        Less than a month ago, VA formally directed its 21 Veterans
    Integrated Service Networks (VISN) to launch a new and intensive opioid
    safety initiative. The stated goals are to reduce harm to veterans from
    unsafe medications and dosages, but to adequately control veterans'
    pain. While DAV offers no opposition to this initiative, our experience
    in recent years in several local instances with VA physicians who
    decided to abruptly discontinue prescribed opioids for our members
    without offering them alternatives does not lend confidence that this
    initiative will be carried out with sensitivity to the needs of
    veterans to tolerably manage their pain in absence of such drugs. Some
    of our members who contacted DAV had been prescribed these drugs for
    decades, and were tolerating their pain well, but were offered little
    to no alternatives when VA physicians decided to abruptly end such
    prescribing. In situations such as these, we are concerned that these
    veterans will turn to alcohol or illicit drugs in search of pain
    relief, or will be left to needlessly suffer.
        As we understand it, VA's opioid safety initiative contains nine
    goals. The initial goals (to be accomplished within six months,
    according to the directive) would establish systems to educate VA
    prescribers about safely and effectively prescribing opioids; increase
    the usage of urinalysis to detect presence of opioids in veterans'
    urine; provide VA prescribers potential access to state prescription
    databases to identify veterans who are in receipt of opioids from
    private prescribers; and establish ``tapering programs'' for certain
    veterans using opioids along with other drugs.
        The second set of VA goals, to be achieved over the next nine
    months, includes central development of a ``risk stratification
    toolkit'' to be deployed locally in VA facilities to enable physicians
    to assess veterans using opioids who should not be treated with them,
    or identify those who can be given reduced doses at a safer level.
    Another goal calls for each VISN to implement a uniform tapering
    program for certain ``high-risk'' opioids, with an overall objective of
    VA's achieving a 75 percent reduction in the use of certain opioids by
    not later than December 15, 2014.
        The third set of VA goals, to be achieved over a year or possibly
    longer, requires all VA facilities to identify veterans who are
    prescribed opioids above a stated dosage ceiling (200 milligrams of
    morphine equivalents per day). VA Central Office will collate this data
    and provide it to VISNs and facilities, which will be required to
    conduct appropriateness reviews with prescribers who are identified as
    providing veterans dosages higher than the dosage ceiling. Another goal
    is for all VA facilities to provide at least two unspecified
    complementary and alternative medicine (CAM) modalities in the
    treatment of chronic pain. These modalities are to be put in place by
    March 15, 2015.
        The last goal is to establish a mental health component within the
    Patient Aligned Care Team approach to delivering VA care to veterans
    with a history of prescribed opioid use, focusing on establishing a
    three-facility trial of deploying ``interdisciplinary medication risk
    management teams,'' to identify ``strong practices that can be
    operationalized across the VHA Healthcare System,'' to achieve further
    reductions in the use of prescribed opioids.
        The above description of VA's initiative is oversimplified and
    summarized for the Committee's use, but constitutes our understanding
    of its purpose based on our review of the directive and information we
    have received from VA practitioners who remain concerned about this new
    program's effectiveness and its impact on veterans in pain. To our
    knowledge neither DAV nor the remainder of the veterans service
    organization community have had a comprehensive briefing by VA on this
    new program, its purpose and justification, and how it will be
    implemented and monitored. It is also our understanding that, although
    already issued to VISNs and facilities, the directive is being
    reconsidered based on numerous concerns that have arisen since, and may
    be amended.
        While we have not received a national resolution from our
    membership on the topic of opioid reduction in VA health care, as
    indicated above, many of our members who were wounded, injured or made
    ill due to military service during wartime suffer from chronic pain
    from numerous causes other than malignancy (the only stated exception
    to this initiative), and presumably will be targeted by this new
    policy. The directive suggests that the use of CAM combined with
    integration of a specialized, and as yet untested, new mental health
    treatment model can substitute for existing prescribing practices by VA
    physicians who are dealing over time in primary and specialty care with
    veterans suffering from chronic pain and chronic pain syndrome.
        In a confounding countertrend, the Veterans Benefits Administration
    recently announced in the Federal Register that it has determined
    justification is sufficient to award service-connected ratings to
    veterans suffering from chronic pain and chronic pain syndrome, as
    discrete disabilities. DAV fully supports this broader authority to
    recognize that chronic pain is real, damaging and even debilitating.
    Also, this decision on rating veterans with chronic pain would suggest
    that chronic pain is a significant disabling condition from the vantage
    point of the VA division that awards disability compensation, whereas
    based on this new opioid reduction directive, another division of VA
    may see it quite differently.
        DAV is also concerned about VA's potential participation in state
    drug monitoring programs. Many of these activities were stimulated by
    law enforcement, not public health authorities, in a search for illicit
    prescribing practices by private physicians, and trafficking in
    controlled substances by people who defraud physicians. While we
    appreciate VA's legitimate interest in protecting against abuse and
    overuse of opioids, we are concerned about potential unintended
    consequences of VA's approach to these state monitoring programs and
    recommend close oversight by the Committee to ensure its purposes are
    limited to the health and safety of veterans and of their health care.
        DAV would never advocate for broad use of narcotics as a first
    line, or only line, of treatment for wounded, injured and ill veterans
    with chronic pain or chronic pain syndrome; however, the intent of VA's
    new initiative seems dedicated first to a drastic reduction in the use
    of painkiller drugs over other purposes, and may not keep uppermost the
    needs of veterans who suffer from chronic pain as a clinically
    legitimate treatment population.
        DAV strongly supports bringing significant CAM treatments into VA
    health care, particularly for younger veterans who do not want
    traditional health care, prescription medications or typical mental
    health treatments; however, if VA intends to use CAM as a substitute
    for, or replacement of, legally prescribed opioid medications in a
    known and older population, we urge VA to ensure the effects of
    shifting veterans away from these medications is closely followed in
    clinical care, lest these veterans resort to the abuse of alcohol or
    other drugs to compensate for the loss of painkillers that actually
    work for them. Additionally, VA facilities' selection of CAM models may
    not have the desired effect intended by this directive. For example, a
    study in the Journal of the American Medical Association (``Acupuncture
    for the Treatment of Cocaine Addiction: A Randomized Controlled
    Trial,'' January 27, 2010) that followed treatment of a large group of
    cocaine users diverted to acupuncture therapy as a substitute did not
    demonstrate effectiveness in reducing the use of cocaine in that
    population. In fact, the study ``does not support the use of
    acupuncture as a stand-alone treatment for cocaine addiction or in
    contexts in which patients receive only minimal concurrent psychosocial
    treatment.'' Numerous other published studies replicate this finding on
    acupuncture, and are reported on VA's Health Services Research and
    Development web page, http://www.hsrd.research.va.gov/publications/esp/
    acupuncture.cfm. In our view, VA health care officials should carefully
    study the efficacy of CAM modalities as exchanges for prescribed
    opioids for pain to ensure they can accomplish the results intended,
    and that CAM modalities selected by facilities are efficacious for
    these purposes, are evidence-based, and are accompanied by appropriate
    other treatment resources.
        Mr. Chairman, perhaps most important to the purposes of this
    hearing, DAV is concerned that the required rapid implementation of
    this new directive will not be standardized and uniform across the vast
    VA system. In fact, the directive itself allows for local deviations
    and modifications, by ``providing opportunity for customization to meet
    local needs.'' The alternative approaches that are offered in the
    directive are vague, and may lead to wide variations, or only limited
    local implementation. In DAV's view, the directive should mandate
    interdisciplinary pain management teams be established at each
    facility, and ensure these teams are functional, before launching such
    an aggressive tapering program. The structure and function of such
    teams should be specified and mandatory. Without more specificity, a
    ``pain management team'' may simply become a single provider designated
    in a facility whose primary (or imposed) clinical role would be to
    reduce the prescribing of opiates to veterans, without providing viable
    alternatives to address their pain.
        We believe any alternative treatments accompanying this plan should
    be specified and required in the directive. This availability should
    include psychological pain management treatments and other alternative
    treatments, including but not limited to specialized counseling,
    chiropractic care, and CAM approaches that are evidence-based. Even
    when some of these services are made ``available,'' a veteran with
    chronic pain may only be given a limited course of treatment, or be
    made to choose one or the other but not both to meet pain care needs.
    This would be an unfortunate and unsafe way to deal with opioid
    reduction due to its impact on the health of individual veterans. As an
    advocate for these veterans, especially those who were wounded, injured
    and ill due to military service, such an outcome would be unacceptable.
        During VA's initiative to implement a national formulary 15 years
    ago, many prescribers complained that they were disallowed from
    prescribing preferred, standard medications they had used for years in
    their practices because they were not a part of the then-new national
    formulary. In order for VA physicians to procure off-formulary drugs
    under the policy, VA established a national procedure in which the
    prescriber had to submit an explicit justification for use of a
    particular drug in an individual veteran's case, before a local or VISN
    VA pharmacy prescribing board, to gain approval of the deviation. This
    process at the time was seen as time consuming, a dampening influence,
    an interference of professional practice, and a difficult bureaucratic
    barrier. The formulary change accomplished the VA's goal of producing
    cost savings, but it came at the expense of many veterans who needed to
    adjust to new medications without warning and in some cases against the
    interests of their prescribing physicians. We hope and trust this new
    initiative will not carry similar consequences for the veterans it is
    going to affect.
        Finally, also about 15 years ago, it is helpful to recall that VA
    took the national and even international lead on establishing pain as
    the ``fifth vital sign.'' Hospitals and physician practices all over
    the world now use this concept in evaluating patients' pain level and
    developing interventions for pain as an important treatment goal on its
    own merit. Pain is the number one reason people, including wounded,
    injured and ill veterans, seek health care. DAV hopes VA will be able
    to carry out this new initiative to reduce opioid prescribing recalling
    its stewardship of pain management in western medicine, without rushing
    to judgment that veterans under VA care are atypically overprescribed
    narcotic medications. We understand from practitioners in VA facilities
    that, already, the pressure on, and monitoring of, providers to
    decrease their prescribing of opioids in pain management is leading to
    significant reductions in such prescribing, with no good alternatives
    available for affected veterans who are suffering from chronic pain.
    This is a troubling development, and we hope the Committee will
    thoroughly review this situation, not only during this hearing but on a
    recurring basis, to ensure that veterans experiencing pain remain VA's
    primary focus.

        Mr. Chairman and Members, this concludes DAV's statement. Again,
    DAV appreciates the indulgence of the Committee in permitting the
    submission of this testimony.
                                     ______

       Prepared Statement of Jacqueline A. Maffucci, Ph.D.,\1\ Research
                Director, Iraq & Afghanistan Veterans of America
    ---------------------------------------------------------------------------
        \1\ Dr. Jackie Maffucci, IAVA's Research Director, holds a Ph.D. in
    neuroscience from the University of Texas at Austin. She previously
    worked with the Provost Marshall General and other senior leaders at
    the Armed Forces Services Corporation to develop, implement, and
    monitor research programs and opportunities to address the health and
    wellness needs of servicemembers.
    ---------------------------------------------------------------------------
        Chairman Sanders, Ranking Member Burr, and Distinguished Members of
    the Committee: On behalf of Iraq and Afghanistan Veterans of America
    (IAVA), I would like to extend our gratitude for being given the
    opportunity to share with you our views and recommendations regarding
    overmedication, an important issue that affects the lives of thousands
    of servicemembers and veterans.
        As the Nation's first and largest nonprofit, nonpartisan
    organization for veterans of the wars in Iraq and Afghanistan, IAVA's
    mission is critically important but simple--to improve the lives of
    Iraq and Afghanistan veterans and their families. With a steadily
    growing base of nearly 270,000 members and supporters, we aim to help
    create a society that honors and supports veterans of all generations.
        In partnership with other military and veteran service
    organizations, IAVA has worked tirelessly to see that veterans' and
    servicemembers' health concerns are comprehensively addressed by the
    Department of Veterans Affairs (VA) and by the Department of Defense
    (DOD). IAVA understands the necessity of integrated, effective, world-
    class healthcare for servicemembers and veterans, and we will continue
    to advocate for the development of increased awareness, recognition and
    treatment of service-connected health concerns.
        A recent report from the Center for Investigative Reporting found
    that over the last 12 years, there has been a 270 percent increase in
    Veterans Health Administration (VHA) prescriptions for four powerful
    opiates.\2\ There has also been an increase in psychiatric medication
    prescriptions as well.\3\
    ---------------------------------------------------------------------------
        \2\ Glantz, A. (2013, September 28). VA's opiate overload feeds
    veterans' addictions, overdose death. Center for Investigative
    Reporting. Retrieved from http://cironline.org/node/5261
        \3\ Government Accountability Office. (2012, November 14). DOD and
    VA Healthcare: Medication Needs during Transitions May Not Be Managed
    for All Servicemembers. Retrieved from http://www.gao.gov/products/GAO-
    13-26
    ---------------------------------------------------------------------------
        Given the last 12 years of conflict and the very physical and
    psychological demands on our troops, it is no surprise that veterans
    are seeking care at the VA for a multitude of needs. The use of
    medication to treat certain physical and mental conditions is a valid
    treatment option, but the VA must continue to develop a comprehensive
    and multidisciplinary approach to treatment.
        The need for comprehensive treatment is particularly prevalent in
    polytrauma cases, which are among the most complex medical cases to
    address. Pain often presents in consort with other conditions, such as
    depression, anxiety, PTSD, or TBI. Providers can be challenged to treat
    such polytrauma cases because of the challenge of managing multiple
    conditions. Some of these conditions may limit the drugs available to
    the patient, making treatment options limited.
        These issues constitute major challenges for providers. Certainly
    part of a treatment program for chronic pain or mental health issues
    may include strong medication, including opioids and psychiatric
    medications; but a schedule of treatment should not be limited to
    pharmaceutical treatment and should integrate a host of other proven
    therapies. This is why a stepped case management system can be very
    helpful. In this type of system, a primary care physician has the
    support of an integrated, multi-disciplinary team of providers to
    design and implement a comprehensive treatment plan for the patient.
        With approximately 22 veterans dying by suicide every day, and more
    attempting suicide,\4\ reducing instances of overmedication and
    limiting access to powerful prescription medications that can be used
    to intentionally overdose must be included in a comprehensive approach
    to addressing the issue. Particularly considering that overdosing is a
    common mechanism for suicide attempts, with over half of all non-fatal
    suicide events among veterans resulting from overdose or intentional
    poisoning.\5\
    ---------------------------------------------------------------------------
        \4\ Kemp, J. and Bossarte, R. (2012). Suicide Data Report 2012.
    Department of Veterans Affairs. Retrieved from http://www.va.gov/opa/
    docs/suicide-data-report-2012-final.pdf
        \5\ Ibid.
    ---------------------------------------------------------------------------
        The VA's 2012 Suicide Data Report also showed that between 74-80
    percent of servicemembers and veterans sought care from a provider
    within four weeks of attempting suicide.\6\ This evidence shows the
    critical need for providers to not only provide access to timely mental
    health services, but also to ensure that the risk of overdose and
    overmedication are minimized through the use of state prescription
    monitoring programs and the creation of formulary take-back programs.
    ---------------------------------------------------------------------------
        \6\ Ibid.
    ---------------------------------------------------------------------------
        Given the challenging nature of understanding the medical and
    mental health needs of veterans, the VA and the DOD have made laudable
    initiatives to meet these needs. But the challenge remains to uniformly
    and effectively translate all of these efforts to practice. Too often
    we hear the stories of veterans who are prescribed what seems like an
    assortment of psychiatric medications and/or opioids with very little
    oversight or follow-up. On the flip side, there are also stories of
    veterans with enormous pain and doctors who won't consider their
    requests for stronger medication to manage the pain.
        One IAVA family member has expressed frustration and concern in
    regards to the VA's current opioid drug usage. Her husband, who was
    prescribed nine different medications to address a range of health
    issues related to pain, anxiety, and depression, tragically passed away
    from what was labeled an accidental overdose by the corner. Since then,
    his widow has been fighting for overmedication by the VA to be included
    on his death certificate.
        In a similar case highlighted by CBS, a veteran with 5 tours of
    duty in Iraq and Afghanistan received a treatment plan from the VA with
    a total of eight prescriptions. When he was prescribed a ninth drug by
    the VA he took the medicine as instructed. The next morning he was
    found by his wife. His death was classified as an accidental death due
    to overmedication. His widow plans to sue the VA for his death.
        It is not our job to second-guess the judgment of the doctors
    treating these patients, but it is our job to question the system that
    is providing overall care to our veterans and tracking this care. The
    VA has established practices and policies aimed at providing quality
    care to veterans, but it won't do our veterans any good if VHA cannot
    efficiently and effectively integrate these findings into their
    management practices and have a plan in place to continually improve
    upon accepted practice with evidence-based findings. While the VA has
    made great strides to recognize the need for comprehensive and
    multidisciplinary support, clearly there is still a lot of room for
    improvement in implementing these procedures.
        In part, some of the challenges may be in the inherent differences
    between the VA and DOD systems of care, whether it be in their
    available formularies, uniformity of record keeping and medical
    terminology used, or the interoperability, or lack thereof, of the
    medical record systems, care for our military and veteran population
    should be one integrated approach. A comprehensive treatment plan
    requires the VA and DOD have an integration of medical records such
    that receiving doctors are clear on the history of the patients that
    they intake. But beyond that, once the veteran is received into the VHA
    system, it's not just about putting out policies, clinical practice
    guidelines, and funding research. At the end of the day, the success
    will be seen in how those products are implemented into practice and
    how they are continually assessed for effectiveness. The key will be in
    education, integration, and assessment.
        Again, we appreciate the opportunity to offer our views on this
    important topic, and we look forward to continuing to work with each of
    you, your staff, and this Committee to improve the lives of veterans
    and their families.

        Thank you for your time and attention.
                                     ______

         A Report by Citizens Commission on Human Rights International
                                   April 2014

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