[Senate Hearing 114-339]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 114-339
 
     EXAMINING HEROIN AND OPIATE ABUSE IN SOUTHWESTERN PENNSYLVANIA

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

                                HEARING

                               before the

                      SUBCOMMITTEE ON HEALTH CARE

                                 of the

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                            (PITTSBURGH, PA)

                               __________

                            OCTOBER 15, 2015

                               __________
                               
                               
                               
                               
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                                 

                                     
                                     

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                          COMMITTEE ON FINANCE

                     ORRIN G. HATCH, Utah, Chairman

CHUCK GRASSLEY, Iowa                 RON WYDEN, Oregon
MIKE CRAPO, Idaho                    CHARLES E. SCHUMER, New York
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   BILL NELSON, Florida
JOHN THUNE, South Dakota             ROBERT MENENDEZ, New Jersey
RICHARD BURR, North Carolina         THOMAS R. CARPER, Delaware
JOHNNY ISAKSON, Georgia              BENJAMIN L. CARDIN, Maryland
ROB PORTMAN, Ohio                    SHERROD BROWN, Ohio
PATRICK J. TOOMEY, Pennsylvania      MICHAEL F. BENNET, Colorado
DANIEL COATS, Indiana                ROBERT P. CASEY, Jr., Pennsylvania
DEAN HELLER, Nevada                  MARK R. WARNER, Virginia
TIM SCOTT, South Carolina

                     Chris Campbell, Staff Director

              Joshua Sheinkman, Democratic Staff Director

                                 ______

                      Subcommittee on Health Care

               PATRICK J. TOOMEY, Pennsylvania, Chairman

CHUCK GRASSLEY, Iowa                 DEBBIE STABENOW, Michigan
PAT ROBERTS, Kansas                  MARIA CANTWELL, Washington
MICHAEL B. ENZI, Wyoming             ROBERT MENENDEZ, New Jersey
RICHARD BURR, North Carolina         BENJAMIN L. CARDIN, Maryland
DANIEL COATS, Indiana                SHERROD BROWN, Ohio
DEAN HELLER, Nevada                  MARK R. WARNER, Virginia
TIM SCOTT, South Carolina

                                  (ii)
                                  
                                  
                                  
                                  
                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Toomey, Hon. Patrick J., a U.S. Senator from Pennsylvania, 
  chairman, 
  Subcommittee on Health Care, Committee on Finance..............     2
Casey, Hon. Robert P., Jr., a U.S. Senator from Pennsylvania.....     4

                               MODERATOR

Farah, Tony, M.D., chief medical officer, Allegheny Health 
  Network, Pittsburgh, PA........................................     1

                               WITNESSES

Ling, Shari M., M.D., Deputy Chief Medical Officer, Centers for 
  Medicare and Medicaid Services, Department of Health and Human 
  Services, Baltimore, MD........................................     6
Capretto, Neil A., D.O., F.A.S.A.M., medical director, Gateway 
  Rehab, Aliquippa, PA...........................................    13
Vittone, Eugene A., II, District Attorney, Washington County, PA.    15
Kabazie, A. Jack, M.D., system director, Division of Pain 
  Medicine, Allegheny Health Network, Pittsburgh, PA.............    17
Potts, Ashley, team leader, Crisis Stabilization and Diversion 
  Unit, Southwestern Pennsylvania Human Services, Inc., 
  Charleroi, PA..................................................    19

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Capretto, Neil A., D.O., F.A.S.A.M.:
    Testimony....................................................    13
    Prepared statement...........................................    35
Casey, Hon. Robert P., Jr.:
    Opening statement............................................     4
Kabazie, A. Jack, M.D.:
    Testimony....................................................    17
    Prepared statement...........................................    39
Ling, Shari M., M.D.:
    Testimony....................................................     6
    Prepared statement...........................................    41
Potts, Ashley:
    Testimony....................................................    19
    Prepared statement...........................................    45
Toomey, Hon. Patrick J.:
    Opening statement............................................     2
    Prepared statement...........................................    47
Vittone, Eugene A., II:
    Testimony....................................................    15
    Prepared statement...........................................    48

                             Communications

American Association for the Treatment of Opioid Dependence 
  (AATOD)........................................................    53
American Psychiatric Association et al...........................    55
Beacon Health Options............................................    58
Clark, Allan W., M.D.............................................    61
Conemaugh Memorial Medical Center................................    69
Gateway Health Plan..............................................    70
Geary, Karen, RPh, MHA...........................................    73
Hospital and Healthsystem Association of Pennsylvania (HAP)......    75
Kmiec, Julie, D.O................................................    76
National Association of Chain Drug Stores (NACDS)................    79
Partsch, Deborah.................................................    84
Pennsylvania Medical Society.....................................    85
Pew Charitable Trusts............................................    86
Pfizer...........................................................    88
Pinnacle Treatment Centers.......................................    90
Pittsburgh Tribune-Review........................................    93
Positive Recovery Solutions (PRS)................................    94
Western Psychiatric Institute and Clinic of the University of 
  Pittsburgh Medical Center and Addiction Medicine Services......    96
Wong, Kevin M., M.D., CMD, FAAFP.................................    97



     EXAMINING HEROIN AND OPIATE ABUSE IN SOUTHWESTERN PENNSYLVANIA

                              ----------                              


                       THURSDAY, OCTOBER 15, 2015

                               U.S. Senate,
                       Subcommittee on Health Care,
                                      Committee on Finance,
                                                    Pittsburgh, PA.
    The hearing was convened, pursuant to notice, at 2:13 p.m., 
in the McGovern Auditorium, Allegheny General Hospital, 320 
East North Avenue, Pittsburgh, PA, Hon. Patrick J. Toomey 
(chairman of the subcommittee) presiding.
    Also present: Senator Casey.

    Dr. Farah. Good afternoon. On behalf of Allegheny Health 
Network, I would like to welcome Senator Toomey, who sits on 
the Senate Finance Subcommittee on Health Care, and Senator 
Casey, who sits on the Senate Health, Education, Labor, and 
Pensions Committee. And a special welcome to our friends from 
CMS--Dr. Ling, thank you--Gateway Rehab, and Washington County, 
who have agreed to testify today. Nobody understands the 
complexity and severity of this issue more than our medical 
professionals and our law enforcement community. Thank you, 
Senator Toomey and Senator Casey, for your leadership on this 
issue.
    Senator Toomey and others have introduced the Stopping 
Medication Abuse and Protecting Seniors Act. This is the act 
which is meant to prevent inappropriate access to opioids for 
Medicare patients, and the law would identify medical 
beneficiaries with a history of drug abuse and lock them into 
one prescriber and one pharmacy to reduce physician and 
pharmacy shopping.
    Just a few days ago, Senator Casey visited an addiction 
treatment center in Norristown, PA. Senator Casey supports the 
Treatment and Recovery Investment Act, which would increase 
funding for prevention and treatment programs, including 
recovery programs for teenagers and pregnant women.
    Both of these laws could help ease the drug abuse problem, 
and both our Senators understand the gravity of the opioid 
epidemic. The epidemic is growing in Appalachia, in 
Pennsylvania, and our own region. Pennsylvania now has the 
seventh-highest drug overdose death rate in the United States, 
West Virginia nearby has the highest overdose death rate, and 
Ohio has the eighth-highest rate. In our own State, we have 
more than 2,400 overdose deaths per year, and most of them are 
related to prescription painkillers. We now lose more people in 
Pennsylvania to overdose deaths than to car accidents.
    This is a battle on multiple fronts. Painkiller abuse is 
linked to heroin abuse. A 2014 study found that 80 percent of 
the people who now use heroin were addicted to opioid 
painkillers first. The Attorney General's office says that 
Pennsylvania has about 40,000 heroin users, and that number is 
growing every year.
    It is growing nationally too. Laws to restrict prescription 
shopping and to prevent painkiller abuse can work, but then 
some of those people who can no longer find painkillers are 
switching to heroin. You stop one, and the other then doubles.
    We are trying to do our part here at Allegheny Health 
Network, and what we are doing is training our emergency room 
physicians, nurses, social workers, and dentists to spot the 
early signs of abuse and to know more about pain medications. 
And more than a year ago, we became one of the first health 
networks in the State to help equip law enforcement with 
Narcan, the generic then being naloxone. This is a life-saving 
heroin overdose drug. We have already seen the benefits of 
that.
    Obviously these are serious problems that require serious 
leadership and a thoughtful response, not just from the medical 
and law enforcement communities, but from policymakers as well, 
which is why we are here today. I would like to thank Senator 
Toomey for convening this hearing and also thank Senator Casey 
for attending. And we thank you both for allowing Allegheny 
General Hospital and the Allegheny Health Network to be your 
host today.

  OPENING STATEMENT OF HON. PATRICK J. TOOMEY, A U.S. SENATOR 
   FROM PENNSYLVANIA, CHAIRMAN, SUBCOMMITTEE ON HEALTH CARE, 
                      COMMITTEE ON FINANCE

    Senator Toomey. Thank you very much, Dr. Farah. I 
appreciate that. I appreciate you joining us today. I want to 
also thank John Paul and the Allegheny Health Network for 
making this terrific facility available to us. I also want to 
thank my fellow Finance Committee member, Senator Casey, for 
joining me today. I know that he and I both care very, very 
deeply about this very, very pressing problem that is occurring 
all across the Commonwealth and, in fact, across our country.
    The fact is, as Dr. Farah mentioned, more Pennsylvanians 
will die this year from overdoses and misuse just of heroin and 
prescription painkillers than from influenza or homicide. And 
unlike past drug epidemics that tended to skew towards younger 
populations and were concentrated in specific locales, today 
heroin and prescription drug overdoses are spread across all 
races, regions, demographics, and ages.
    As the Senate Finance Subcommittee on Health Care will hear 
today from our witnesses, sadly southwestern Pennsylvania has 
been hit particularly hard by this epidemic. It seems to me 
that stopping this epidemic and healing our communities will 
require at least a three-pronged approach, and I am trying to 
pursue that as chairman of the Senate Finance Subcommittee on 
Health Care. One element of this approach is to stop the 
illegal diversion of prescription painkillers, a second is 
reducing the overuse of opioids for treating long-term pain, 
and a third is to help those battling with addiction to receive 
the appropriate treatment.
    Our witnesses today will discuss these issues and other 
issues that they will bring up, and I want to really thank all 
of our witnesses for taking the time to be with us today and 
for sharing their expertise and helping to shed light so that 
we can hopefully develop policies that will be helpful for our 
communities.
    Our first panel will consist of Dr. Shari Ling. Dr. Ling is 
the Deputy Chief Medical Officer from the Centers for Medicare 
and Medicaid Services at the United States Department of Health 
and Human Services. After Dr. Ling testifies, Senator Casey and 
I will ask her some questions, and then we will proceed to a 
second panel.
    And the second panel will consist of Dr. Neil Capretto--Dr. 
Capretto is the medical director of the Gateway Rehabilitation 
Center; Mr. Gene Vittone, who is the district attorney for 
Washington County; Dr. Jack Kabazie, who is the system director 
for the Division of Pain Medicine here at the Allegheny Health 
Network; and Ms. Ashley Potts, who is the team leader in the 
Crisis Stabilization and Diversion Unit for Southwestern 
Pennsylvania Human Services. I also want to point out that 
joining us this afternoon is U.S. Attorney David Hickton, who 
has provided outstanding leadership in this and many other 
areas. So, David, thank you for joining us.
    I would like, just for a moment though, to consider how we 
arrived at this point. It seems to me the seeds of this crisis 
may well have been planted 2 decades ago with the advent of 
readily available painkillers like hydrocodone and oxycodone. 
And while these drugs no doubt produce immediate pain relief, 
they are easily abused. They are highly addictive, and they can 
be frequently diverted. The data that I have seen suggests that 
something on the order of 80 percent of heroin users previously 
abused prescription opioids.
    And despite the crackdown on many of the so-called ``pill 
mills'' where unethical physicians intentionally prescribe very 
large amounts of powerful opioids in exchange for cash, the 
problem of diversion and over-prescribing still does exist. In 
fact, the nonpartisan Government Accountability Office has 
found that there are more than 170,000 Medicare enrollees who 
are actively engaged in doctor shopping--shopping for 
physicians who will unknowingly write redundant opioid 
prescriptions.
    Now, when insurance plans, including Medicaid, spot this 
kind of fraud, the insurer will then limit or, as we say, lock 
in the individual to a single doctor or pharmacy in order to 
stop the pill diversion and help control access to the 
addictive medication. But unfortunately, Medicare does not have 
that tool, and that is why I have introduced bipartisan 
legislation, the Stopping Medication Abuse and Protecting 
Seniors Act. This legislation, which Senator Casey has co-
sponsored--which I appreciate--will not only help individuals 
battling addiction to get treatment, but it will also save 
taxpayers something on the order of $79 million by stopping the 
illegal diversion of pain pills.
    I think Medicare and other insurers also need to work with 
physicians to stop the medically unnecessary use of opioids to 
treat pain. This year about 260 million painkiller 
prescriptions will be filled--260 million. That is enough for 
every adult American to have their own bottle of pills, and, 
while opioids can certainly help control intense pain 
immediately after surgery or a visit to the dentist or a 
traumatic event, the medical community has become concerned 
that long-term opioid use becomes less effective over time and 
is associated with higher rates of substance abuse, emergency 
room visits, accidental overdoses, and falls, especially in 
senior citizens.
    Now, fortunately medical specialty societies have begun 
developing new guidelines that reduce both the dosage and the 
length of time that prescription opioids can be safely taken. 
For instance, the American Academy of Neurology now says that 
the risk of opioid abuse outweighs any benefits for treating 
headaches, lower back pain, and fibromyalgia. And when opioids 
are used in combination with other narcotics like Valium or 
Xanax, that combination can be deadly.
    To help providers know the panoply of medications a patient 
is taking, I think there needs to be broader usage of robust 
prescription drug monitoring programs. Making them 
interoperable across State lines is particularly important for 
people who live near State lines. And it will help physicians 
as well as law enforcement to spot diversion and abuse, and 
that is why I have introduced with our colleague, the 
Democratic Senator from New Hampshire, Jeanne Shaheen, the 
reauthorization of the National All Schedules Prescription 
Electronic Reporting Act. NASPER is a Federal grant program 
that provides grants to States to develop interoperable 
prescription drug monitoring programs.
    Finally, I think we need to explore ways to improve access 
to and the quality of care for people who are suffering from 
addiction. While addiction to an opioid, or alcohol for that 
matter, often has been viewed as a moral failing, in many ways 
it is a chronic disease like diabetes or heart disease. And 
while the medical profession continues to debate the optimal 
treatment approaches, I think everyone agrees that opioid 
addiction can be treated with professional help. So Congress 
and my subcommittee are closely examining a number of 
legislative ideas in this area.
    Ending the epidemic of heroin addiction will require 
changes in the practice of medicine, government regulations, 
and societal views. There are steps we can and should take 
today that end diversion, reduce non-medical use of opioids, 
and approach this addiction like a treatable disease. So I want 
to thank everyone who is here today. This turnout, I think, 
shows the extent to which this tragedy affects so many people 
across southwestern Pennsylvania. I appreciate the passion with 
which you approach this issue to find solutions. By working 
together at the Federal, State, and local levels, with health 
care, law enforcement, and others coming together, I am 
confident that we can defeat this scourge.
    [The prepared statement of Senator Toomey appears in the 
appendix.]
    Senator Toomey. I would now like to recognize Senator Casey 
for his opening remarks.

        OPENING STATEMENT OF HON. ROBERT P. CASEY, JR., 
                A U.S. SENATOR FROM PENNSYLVANIA

    Senator Casey. Senator Toomey, thank you very much, and I 
am honored to be here, and I am grateful that Senator Toomey 
called this hearing. We are both members of the Finance 
Committee, but I am not a member of his subcommittee, so I am 
here by special permission or designation. So I am grateful to 
have that opportunity because, as he said, this is a problem 
and a challenge for our country that knows no geographic or 
political boundaries. This affects all of us, all of our 
communities, in one way or the other.
    We are so grateful that Allegheny General Hospital has us 
here, and we are grateful for our witnesses, and we will be 
getting to our witnesses shortly. I will try to be as brief as 
I can. I want to thank David Hickton for being here, someone 
who has been in the trenches on this at the Federal level--and 
every level of government has to work on this problem.
    We are here today because of a problem our country 
confronts, which might be described as the dark night of 
addiction and death that comes from the problems people have 
ultimately with painkillers, opioids, and often, unfortunately, 
the related abuse of heroin. And that dark night, I think, 
requires some light, and one of the reasons we gather and have 
a hearing like this is to hear from experts to consider 
different perspectives on how to confront this, and hope that 
together we can bring some of that light.
    The numbers and the data points are almost endless. There 
are so many ways you could describe the problem. One has 
already been mentioned, the idea that in Pennsylvania today we 
can report sadly that the number of people who will die from 
overdose is higher than the number of people who would die from 
auto accidents. It is hard to comprehend that that is true, but 
that is what we are told.
    Another way to look at it is, over 5 years, 3,000 people in 
this State have died either by way of opioid problems or 
heroin. If you look at it over a longer period of time, over 20 
years, there has been a 470-percent increase in overdose 
deaths. Twenty years, Pennsylvania, 470-percent increase. The 
Coroners Association--maybe the most graphic number of all--
tells us that just between 2009 and 2014, about 5 years, the 
number of overdose deaths went from 47--47--to 800. So no 
matter what number you use--we could go on and on with the 
numbers, and I will not--there is almost no way to adequately 
describe the horror that this has brought to our communities 
and to our families.
    So what do we do about it? Well, if you are a legislator--
and Senator Toomey outlined that we have a number of 
legislative proposals. The bill that he worked on and has 
sponsored with Senator Brown is one of those. I will just 
highlight very quickly a few others. Senate bill 1410 would 
increase the block grant funding, the so-called Substance Abuse 
Prevention and Treatment Block Grant. That particular block 
grant helps our States with planning, with implementing and 
evaluating efforts to prevent and treat substance abuse, and is 
funded now at about $1.45 million. I believe, and others 
believe, that number should go up.
    Secondly, a piece of legislation that I have worked on 
deals with a segment of this problem as it relates to newborns. 
Senator McConnell, the majority leader, and I have a bill, 
Senate bill 799. The neonatal abstinence syndrome problem is 
the focus of this bill. That occurs when infants are born 
addicted to opioids, and what we would do with our bill is very 
simple. We direct the Department of Health and Human Services 
to develop a strategy to fill in the gaps, whether they are 
research gaps or program gaps, and also at the same time 
require that HHS develop recommendations for preventing and 
treating this condition, so-called neonatal abstinence 
syndrome, among other things we can do.
    Finally, as Senator Toomey mentioned, there have been 
legislative efforts. I do not think we are there in terms of 
progress yet when it comes to establishing requirements for 
DEA-registered prescribers and that interoperability that 
Senator Toomey mentioned. That is also part of the problem. 
Sometimes the first line of defense is a pharmacist, among the 
most trusted people in a community, and they can help us 
enormously in terms of pointing out problems.
    I have been to a couple of places in this State over the 
last couple of months where we are seeing the manifestation of 
what a lot of advocates and a lot of experts in this room would 
tell us over and over again: good treatment works, but it has 
to be good treatment, and it has to be sustained, and we have 
to make sure we have the resources to sustain it.
    So we are grateful that, on a day like today when we will 
focus on much of the horror, on much of the tragedy, much of 
that darkness, that so many people in this room, by way of your 
work, by way of your presence here, or by way of your 
testimony, starting with Dr. Ling, can bring some light to that 
darkness. And I want to thank Senator Toomey for gathering us 
today.
    Senator Toomey. Thank you, Senator Casey. We will now hear 
from our first witness. Dr. Shari Ling is currently the Deputy 
Chief Medical Officer serving in the Center for Clinical 
Standards and Quality at the Centers for Medicare and Medicaid 
Services. Dr. Ling is a geriatrician and rheumatologist who 
received her medical training at Georgetown University School 
of Medicine, Georgetown University Medical Center, and Johns 
Hopkins University. She also is a researcher and staff 
clinician at the National Institutes of Health's National 
Institute on Aging, studying human aging and age-associated 
chronic diseases with attention to musculoskeletal conditions 
and mobility function.
    Dr. Ling, thank you very much for joining us. Please 
present us a summary of your testimony.

STATEMENT OF SHARI M. LING, M.D., DEPUTY CHIEF MEDICAL OFFICER, 
   CENTERS FOR MEDICARE AND MEDICAID SERVICES, DEPARTMENT OF 
            HEALTH AND HUMAN SERVICES, BALTIMORE, MD

    Dr. Ling. Good afternoon, and, Chairman Toomey, Senator 
Casey, please accept my sincere thanks for the invitation to 
discuss the Centers for Medicare and Medicaid Services' work to 
ensure that all Medicare and Medicaid beneficiaries are 
receiving the medications that they need while also reducing 
and preventing prescription drug abuse.
    As you have heard already, opioid addiction is taking a 
real toll on communities, families, and individuals, both here 
in Pennsylvania and across our Nation. And as a practicing 
rheumatologist and geriatrician, I understand the challenges of 
effectively managing frail, older adult patients with 
debilitating chronic pain. It begins with identifying the 
underlying source or cause of painful symptoms, particularly in 
older adult patients where it can be challenging to decide 
which condition is the problem.
    It then proceeds with understanding all of the medical, 
psychological, social, and other issues that must be addressed 
in every patient's plan of care. Intervention that addresses 
the underlying cause will improve symptoms; that is, it will 
alleviate pain if addressed effectively. However, when pain 
persists despite conservative management attempts and threatens 
the quality of life and function, chronic pain management 
should include non-pharmacologic as well as medicinal agents, 
but each time with clear and precise treatment goals. There 
will be patients for whom opioid medications are necessary, but 
oftentimes other pain management strategies can be as effective 
and more appropriate.
    Combating non-medical prescription opioid use, overuse, 
dependence, and overdose is a priority for the Department of 
Health and Human Services, Secretary Burwell, and the 
administration at large. As part of that commitment, the 
Secretary has launched an evidence-based opioid initiative that 
focuses on three targeted areas: that is, informing opioid 
prescribing practices, increasing the use of naloxone as a 
second point, and the third being expanding the use of 
medication-assisted treatment to treat the opioid use disorder 
itself.
    As part of our role in these efforts across HHS, CMS has 
released guidance to help States implement comprehensive 
evidence-based service delivery approaches to Substance Use 
Disorder treatment. Overall, CMS recognizes our responsibility 
to protect the health of Medicare and Medicaid beneficiaries 
here in Pennsylvania and across the Nation by putting 
appropriate safeguards into place that prevent non-medical use 
and abuse of opioids, while ensuring that beneficiaries access 
the needed medications that are appropriate for them.
    Since its inception, the Medicare Part D prescription drug 
benefit program has made medications more available and more 
affordable for Medicare beneficiaries, leading to improvements 
in access to prescription drugs, better health outcomes in 
general, and greater beneficiary satisfaction with their 
Medicare coverage. But despite these successes, Medicare Part D 
is not immune from the nationwide epidemic of opioid abuse. The 
structure of the program, in which Part D plan sponsors do not 
have access to Part D prescriber and pharmacy data beyond the 
transactions that they manage for their own enrollees, makes it 
more difficult to identify prescribers or pharmacies that are 
outliers in their prescribing or dispensing patterns relative 
to the entire Part D program.
    CMS has taken several steps to protect beneficiaries from 
the harm and damaging effects associated with non-medical 
prescription drug use, and to prevent and detect fraud related 
to prescription drugs. To prevent overutilization of opioid 
medications through strengthening CMS's monitoring of Part D 
plan sponsors, CMS has implemented the Medicare Part D 
Overutilization Monitoring System, or abbreviated as OMS. OMS 
requires Part D sponsors to implement effective safeguards to 
deter overutilization while maintaining a commitment to provide 
coverage for appropriate drug therapies that meet safety and 
efficacy standards. Through this system, CMS provides quarterly 
reports to sponsors' drug plans on beneficiaries with potential 
opioid overutilization, and sponsors are expected to utilize 
various drug utilization monitoring tools if necessary to 
prevent overutilization.
    We believe this Part D overutilization policy has played a 
key role in reducing opioid utilization in the program. That 
is, from 2011 through 2014, the number of potential 
overutilizers decreased by approximately 26 percent, or said 
another way, 7,500 beneficiaries over that 3-year period of 
time did not become overutilizers. So there was a significant 
reduction, but as we have heard from the numbers shared today, 
we have a long way to go.
    CMS has also used and has available new tools to take 
action against problematic prescribers. CMS issued a regulation 
that both requires prescribers of Part D drugs to enroll in 
Medicare, and establishes a new revocation authority for 
abusive prescribing patterns. CMS is actively working to enroll 
over 400,000 prescribers in Part D by January of 2016. 
Requiring prescribers to enroll in Medicare will help CMS make 
sure that Part D drugs are prescribed by qualified individuals 
and will prevent prescriptions from excluded or already revoked 
prescribers from being filled.
    Additionally, CMS has established its authority to remove 
prescribers from Medicare when they demonstrate irresponsible 
prescribing patterns, have their DEA certificate of regulation 
suspended or revoked, or if any State has suspended or revoked 
the physician's or eligible professional's ability to 
prescribe. These new revocation authorities provide CMS with 
the ability to remove problematic prescribers from the Medicare 
program and prevent them from treating people with Medicare.
    In addition to these initiatives, the President's budget 
includes several proposals that would provide CMS with 
additional tools to prevent inappropriate use of opioids. One 
proposal to prevent prescription drug abuse in Medicare Part D 
would give CMS the authority to establish a program, commonly 
referred to as ``lock-in,'' that would require high-risk 
beneficiaries to only utilize certain prescribers and/or 
pharmacies to obtain controlled substance prescriptions similar 
to the requirement in many States in Medicaid programs.
    So in conclusion, CMS is dedicated to providing the best 
possible care to beneficiaries while also ensuring taxpayer 
dollars are spent on medically appropriate care. CMS has 
broadened its focus from ensuring beneficiaries have access to 
prescribed drugs to ensuring that Part D sponsors implement 
effective safeguards and provide coverage for drug therapies 
that meet the standards for safety and efficacy.
    Although there is still a great deal of work that needs to 
be done, CMS is confident that our initiatives will help to 
reduce the rate of opioid addiction and overdoses in the 
Medicare population. Thank you.
    [The prepared statement of Dr. Ling appears in the 
appendix.]
    Senator Toomey. Thank you very much, Dr. Ling. I am going 
to begin the questions, and I will try to keep to the 5-minute 
guidelines that we have established. Then I will yield the mic 
to Senator Casey.
    I just want to confirm, though, and I think you stated it 
clearly, that it is both your view and the position of CMS that 
the lock-in approach to a single provider and a single pharmacy 
for high-risk beneficiaries and beneficiaries who are abusing 
prescription opioids would likely reduce the diversion of pain 
pills. And so, you and CMS are supportive of that approach for 
Medicare, correct?
    Dr. Ling. So, if I may expand on it just a bit----
    Senator Toomey. Sure.
    Dr. Ling. CMS is supportive of the principle of lock-in 
because what it does achieve is, it provides some guarantee of 
continuity of a source of that prescribing, and it is one 
measure that can complement the tools that are already in 
place. And we believe that that would result in better outcomes 
in general.
    Senator Toomey. Okay, great. Thank you. Doctor, now you are 
a geriatrician. Maybe you could share with us just briefly some 
comments on vulnerabilities that might be greater among the 
older population, senior citizens, specifically with risk to 
either accidental misuse or other adverse effects from the use 
of opioids. Could you share with us your thoughts on that?
    Dr. Ling. Certainly, I would be delighted to. The older 
adult population not only has a higher prevalence of chronic 
conditions, including those chronic conditions that can cause 
painful symptoms--many of which can be managed without the use 
of opioid medications--but likely secondary problems.
    We actually know from the Medicare data that among people, 
as an example, who have arthritis, which is a common reason 
that one would seek treatment from painful symptoms, the 
majority of those people also have competing other medical 
conditions, some of which may be related to the painful 
symptoms that they have; that is, they may have difficulty 
sleeping or sleep disturbance. They actually also may have 
kidney impairment, so their kidneys may not be functioning 
quite correctly.
    And so, you can see how not only they may be at risk of a 
temptation to overuse prescription medications that could be 
potentially harmful, but taken together with the management of 
other competing conditions that may be associated, such as a 
sleep disorder, they may also be at increased risk of adverse 
events occurring. And those adverse events could include 
unintentional overdose from opioid medication. It could, as you 
alluded to earlier, Senator, increase the risk of falls, of 
confusion--and the cycle continues.
    Senator Toomey. Thank you. I want to ask a question about 
the Overutilization Monitoring System, which sounds like it 
might indeed be helpful in spotting excessively high 
consumption of opioids. My understanding is that CMS tells plan 
sponsors when they identify a patient, a beneficiary, exceeding 
the equivalent of 90 milligrams of morphine per day. But I have 
seen some data suggesting that even at levels lower than that, 
maybe as low as 50 milligrams, there could be a significant 
risk of overdose, deaths, emergency room visits, accidental 
falls, and other unintended bad outcomes.
    So my question is, is CMS able to track the outcomes for 
individuals who receive opioids at that lower threshold, and is 
it your view that we have to consider the consequences that are 
occurring at those lower thresholds, or do you think 90 
milligrams is all we need to know?
    Dr. Ling. I will answer it in a couple of ways. Thank you 
for your question, first of all, because it actually gives me 
an opportunity to talk about some of the balance in the system. 
We still want to maintain access for people who have painful 
symptoms, so it becomes an issue of threshold and what 
threshold to set in a monitoring program.
    Indeed it is true that CMS provides plans with prescription 
drug event data. Some of the data can include dosing. 
Obviously, we have dosing as part of the data and a great deal 
of other data, but we provide that data on a quarterly basis. 
And then the plans are expected to review those data and to 
look at those data and to try to understand and work with 
prescribers as well as pharmacies looking for those 
overutilizers and, if necessary, put in place some case 
management efforts to try to curb that prescribing pattern.
    Mind you, it is very safety-focused, so reaching a safety 
threshold, that is where we started. It is also a preventive 
action, so it is expected that the plans would put in place 
strategies to monitor and prevent future events from occurring. 
But it is a starting place, and the data do exist that would 
permit us to look further than what is currently utilized as a 
threshold.
    Having said that, we believe that it is an effective method 
of monitoring, and in support of the Secretary's initiative in 
delivery system reform whereby information is used--that is, 
the Part D data being available to plans--it is an important 
step to achieving the reductions that we are hoping to achieve.
    Senator Toomey. Okay. Thank you very much. Senator Casey?
    Senator Casey. Thanks very much, Doctor. Thanks for your 
testimony.
    I want to ask you a question that relates to the position 
CMS is in as a payer, the Federal Government entity that 
oversees and has to operate both Medicare and Medicaid in 
addition to other programs, and this connection, which I think 
you began to focus on in your written testimony as well as the 
summary you provided. At the bottom on page 1 of your 
testimony, you said, ``The monetary costs and associated 
collateral impact to society due to Substance Use Disorder,'' 
so-called SUD, ``including opioid use disorder, are high.'' You 
go on to say, ``In 2009, health insurance payers spent $24 
billion treating Substance Use Disorder, of which Medicaid 
accounted for 21 percent. The Medicare program itself through 
Medicare Part D spent $2.7 billion on opioids in 2011.''
    What I am getting at is the connection between the two 
where you literally have a connection between two activities 
that relate to the Federal Government. What can you tell us, if 
anything, about whether or not CMS can use its leverage as a 
payer and encourage prescribers to scrutinize their activities 
or prescriptions more generally?
    Dr. Ling. Let me answer this in a couple of ways, and 
please let me know if I do not address your question fully.
    Senator Casey. Sure.
    Dr. Ling. So, as a payer, as you know, we are amidst 
delivery system reform, and part of that effort is to pay for 
high-value health care. That means quality health care or cost 
relative to quality. It is also a reform that requires that we 
practice differently, so how we actually deliver that care is 
more and more coordinated, it is better coordinated to be able 
to deliver the high value of care.
    Now quality, as a focus, is an important factor because 
misuse of opioids, overuse of opioids, death from opioid use, 
are some of many undesirable events that we would think of as 
low-value health care. So, I think there is incredible 
opportunity to think about this problem in the context of 
delivery system reform and how we can go about placing the 
pieces that are necessary to improve the outcomes for medical 
care. Now, having said that, I do want to mention though, since 
you mentioned Medicare and also Medicaid, they are two distinct 
programs and authorities, but common to both is the need to 
improve how we deliver care.
    I did want to mention that, within the Medicaid space, we 
have provided letters of guidance to State Medicaid Directors 
on the construct and the composition of comprehensive care 
services that are needed to address addiction and abuse. And 
there are also additional proposals in the President's 2016 
budget that go further to expect or require States--many States 
monitor their prescription drug use patterns already, but it 
actually proposes to require States to do that, but also to use 
those data to adjust their planning and their strategies to 
meet the needs of the population.
    Now, they can choose to focus on prescription drugs or 
opioids, they can choose something else, but the opportunity 
exists. And I will conclude by also saying that there are two 
new programs--that is, the section 1115 waiver through the 1115 
waiver authority, as well as a Medicaid innovation accelerator 
program--that will support new care and payment models for 
States in this space with addiction and opioid overuse as a 
focal point. So there are new demonstration authorities that 
can support us in figuring out how we provide better care and 
deliver that care that meets the needs of the population and 
contributes a solution to this problem.
    Senator Casey. And I appreciate what you are trying to get 
to in that answer, but I just hope you use that leverage as a 
payer. And I know that is a startling number, Medicare through 
Part D spending $2.7 billion on opioids in 1 year, but that is 
a lot of leverage.
    My last question--I know I am probably over my time. I will 
just be really brief. Naloxone is a remarkable advancement. 
Here you can literally, at the scene of an overdose, be able to 
reverse that horrific consequence. It is a lifesaver. It is a 
wonderful innovation. The problem we are having is--one problem 
among several, I guess, is kind of a patchwork where some 
States are using it, some communities are using it, others not 
as much.
    There are no Federal standards. I am not sure there need to 
be. But what can you tell us about what HHS, CMS, can do to 
advance the use of naloxone, or what they are doing currently?
    Dr. Ling. Yes. So, as you know, increasing the availability 
and access to naloxone is the second prong in the Secretary's 
proposal to address this problem, the first being, of course, 
providing the education and information to providers so that 
they are aware of their prescribing practices and how to 
improve on them.
    If I can go into a little detail, naloxone is available, 
and it is covered in specific instances. So, as part of the 
Part B service or benefit, it is coverable if it is incident to 
a physician's care services under Part B of Medicare. Now, that 
is important because physician services are also what are 
needed for comprehensive addiction management, so it is not 
just a prescription, but it is actually much more than that.
    So the medication is available. There are other medications 
that are also available through Part D, pretty much medications 
such as methadone for pain. And buprenorphine and naloxone for 
any medically accepted indication are also available through 
Part D. So those are available.
    Senator Casey. I hope we can work on that so we make it 
more readily available. Thank you.
    Dr. Ling. Yes.
    Senator Toomey. I have just one quick follow-up for a 
second round, Dr. Ling, if I could, and that is, it is my 
understanding that there is a widespread view in the medical 
community that opioids may not be a suitable treatment for 
long-term chronic pain management, episodes lasting 60 and 90 
days and longer. And in light of that, my understanding is that 
in Massachusetts, Massachusetts Blue Cross and Blue Shield has 
adopted a policy of requiring prior authorization for any 
prescription that exceeds 30 days for opioids.
    And I am just wondering whether you think that is an 
approach that has some merit or not. My understanding is it has 
reduced the frequency of these longer-term prescriptions. What 
are your thoughts on that, Dr. Ling?
    Dr. Ling. So my thoughts are, there are many approaches 
that need to be taken. It is also a proposal to require 
additional clinical information on prescriptions so that there 
is a means of identifying and knowing about off-label uses 
beyond what would be medically indicated perhaps. Prior 
authorization is one such mechanism.
    I will also remind you that, as part of the Overutilization 
Monitoring System, the authority that we have is to encourage 
certain desirable plan behaviors. And so, plans have the 
ability in their toolbox to implement formulary edits, such as 
a maximum number that can be dispensed at a given time, and 
other safety edits. Those can all be put in place and should be 
used by plans when appropriate.
    So there are many different mechanisms that can achieve the 
same outcome, but really the outcome that we want and that we 
remain focused on is, how do we actually improve the outcomes, 
reduce these events of harm, improve safety, and still make 
available the treatment and services that the populations need 
to improve their own health?
    Senator Toomey. Senator Casey, anything else?
    Senator Casey. No. Thank you very much.
    Dr. Ling. Thank you.
    Senator Toomey. All right. Dr. Ling, thank you very much.
    Our second panel can now take their seats. Let me start 
with the introductions of the people on our second panel here, 
and then I will recognize them individually to give their 
testimony.
    First, Dr. Neil Capretto is the medical director of Gateway 
Rehabilitation Center in Beaver County. He is certified by the 
American Board of Psychiatry and Neurology with qualifications 
in addiction psychiatry, and is a medical review officer and 
fellow of the American Society of Addiction Medicine. He is 
frequently consulted in both local and national press on 
addiction and treatment, and has served on the U.S. Attorney's 
Working Group on Drug Overdose and Addiction.
    Mr. Gene Vittone is the District Attorney for Washington 
County. Prior to being elected, Mr. Vittone served as 
prosecutor for more than a decade and supervised the Elder 
Abuse Prosecution Unit. He has prosecuted numerous crimes, 
including violent felonies, sex crimes, child abuse, drug 
trafficking, and financial crimes. He is active in his local 
community as a volunteer firefighter and EMT.
    Dr. Jack Kabazie is the system director, Division of Pain 
Medicine, for the Allegheny Health Network. Overseeing the 
operations of all Allegheny Health Network pain physicians, Dr. 
Kabazie is often called on to provide expert commentary in the 
media on addiction and opioid abuse. He is a member of the 
American Society of Addiction Medicine and received his medical 
doctorate from the Medical College of Pennsylvania. Dr. Kabazie 
also served in the military for the U.S. Special Forces as a 
Green Beret from 1972 to 1975.
    And finally, Ms. Ashley Potts is a team leader for the 
Crisis Stabilization and Diversion Unit of Southwestern 
Pennsylvania Human Services in Washington County. Ashley 
started using OxyContin when she was 13 years old, then became 
addicted to heroin by 17. She was lucky to finally get help and 
has been clean since September 11, 2006. She is a graduate of 
California University of Pennsylvania, is currently pursuing a 
masters degree, and had previously worked at the Washington, PA 
Drug and Alcohol Commission in Prevention Services.
    Dr. Capretto, you may begin with your testimony.

   STATEMENT OF NEIL A. CAPRETTO, D.O., F.A.S.A.M., MEDICAL 
             DIRECTOR, GATEWAY REHAB, ALIQUIPPA, PA

    Dr. Capretto. Thank you. Thank you very much, Senators 
Toomey and Casey, for inviting me here to speak with you today 
about the opioid epidemic in southwestern Pennsylvania.
    I have now been at Gateway full-time practicing addiction 
medicine for 26 years. And during that time, I have been 
directly involved in treating well over 15,000 individuals in 
our community struggling with prescription, opioid, and heroin 
addiction. I have really personally witnessed the evolution of 
this epidemic on a day-by-day basis starting in the mid- to 
late-90s, and it has devastated the lives of thousands of 
individuals and families in our community.
    The sad news is, as of today, there are more people in our 
region addicted to prescription opioids and heroin than at any 
time in our lives. And most signs indicate that if this problem 
is not addressed adequately, it is likely to continue to grow. 
It has also led to record numbers of overdose deaths.
    When I finished my residency at St. Francis in Pittsburgh 
in 1985, there were 22 drug overdose deaths in Allegheny 
County, and there was outrage about that, and it was considered 
an inappropriate, tragic loss of life that must be corrected. 
But as this new opioid epidemic started coming in in the 90s, 
in 1998 Allegheny County reached over 100 with 104. We thought, 
would we ever see that again? Well, it stayed over 100. In 
2002, it went over 200. It has been over 200 a year every year 
since then. Last year we set a record with 307, going from 22 
to 307.
    The other news is, surrounding counties are now actually 
seeing higher rates based on their populations. You know, the 
Centers for Disease Control last year described this as the 
worst drug overdose epidemic in U.S. history. Well, how did we 
get there? I talk about the perfect storm, and I often give 
lectures for many hours, but you have summarized it.
    In a nutshell, it has been this dramatic rise of 
prescription medicine starting in the 1990s. We absolutely have 
to treat pain, but how to do that properly is open for debate. 
There was heavy marketing by pharmaceutical companies. There 
was a dramatic rise in prescriptions of opioids. Western 
Pennsylvania was hit particularly hard because of our 
demographics. There was over a 500-percent increase in 
oxycodone.
    Thousands of people in our area became addicted. It spilled 
onto the streets, and at the same time this was occurring, the 
new heroin was coming in. Old heroin from Asia was about 10-
percent pure. New heroin coming from Colombia and Mexico was 
well over 50-percent pure. You could now snort that, avoid 
using a needle. And by the thousands, people who got addicted 
to prescription opioids who could no longer afford them 
switched over to heroin, and it spread through every community. 
It is everywhere, in every town, rural and suburban. You cannot 
get away from it at this point. In the last probably 5 to 10 
years, the last several thousand new heroin users I have talked 
to in our area, probably easily 90 to 95 percent of them all 
started with prescription medicines.
    So what should we do about it? I mean, obviously we have to 
focus on safe and proper use of opioid pain medications. Dr. 
Ling gave some suggestions. I mean, we definitely have to 
educate our medical community, and we are starting to do that. 
I mean, there are efforts going on. The medical community is 
making progress. The Pennsylvania Medical Society has some good 
guidelines. But, goodness, we have a long, long way to go. I 
mean, these prescription drugs in our community did not come 
from Afghanistan or Colombia. They came from our medical 
system, and we have to come out of denial that that is the 
reality.
    We need things like Prescription Drug Monitoring Programs. 
The good news is, our legislature in Pennsylvania passed one 
last fall. The bad news is, it is not funded yet. We are 
desperately waiting for that to become available. Such programs 
work, and as you said, Senator Toomey, we really need this to 
be regional and national to make it very effective.
    The Stop Medication Abuse and Protecting Seniors Act to me 
is a very good thing. You identify people who are already drug 
diverters and drug seekers, and you direct them to particularly 
a healthcare professional, to one pharmacy. And what you end up 
doing is, you are going to provide medical care to that person. 
You are going to protect them from devolving into their 
addiction. You are going to reduce drug diversion on the 
street. You are going to protect the community, and you are 
going to save money. That seems like a pretty common-sense no-
brainer to me, you know.
    And obviously we have to provide treatment. As we restrict 
prescription medicines, we have to be careful about people 
converting over to heroin, which is happening. We have to make 
sure that it is adequate, available, and of enough duration of 
time. The National Institute of Drug Abuse suggests a minimum 
of 90 days of treatment for people with addition. That is the 
minimum. Few people really get that over time. We also have to 
have adequate availability of naloxone to save lives. That is 
evolving, and I want to see that continue to expand.
    And finally, when we look at all these numbers and data of 
thousands of thousands, it is important that we just not get 
numb to those numbers. And it is important that we never, ever 
forget that behind every number is a real life, a real family 
struggling, like 16-year-old Billy, whom I met back in 2001. 
Great kid. Great sense of humor. Good student. I had a son 
about the same age. He had an infectious laugh. He won an award 
for drafting and talked about his dreams to be an architect one 
day.
    Like many kids, he was at a party and somebody offered him 
this new drug called OxyContin. He liked it, quickly became 
addicted to it, escalated his use, could not afford it, 
switched over to heroin use, and Billy died of a heroin 
overdose 2 days before his 17th birthday. And I talked to his 
mother on what would have been his birthday, and I will never 
forget her words. She said, ``Today I just bought the last 
birthday present I will ever buy for my son, and it was a 
casket.'' Those words continue to haunt me.
    But since Billy died in 2001, there have been nearly 5,000 
other people in western Pennsylvania who have died from this 
condition. It is really a major epidemic, and I thank you, 
Senators, for addressing it and for inviting me today to speak 
on the issue. Thank you.
    [The prepared statement of Dr. Capretto appears in the 
appendix.]
    Senator Toomey. Thank you, Dr. Capretto. I appreciate that.
    Mr. Vittone?

     STATEMENT OF EUGENE A. VITTONE II, DISTRICT ATTORNEY, 
                     WASHINGTON COUNTY, PA

    Mr. Vittone. Thank you, Senator. Good afternoon. Thank you, 
Senator Toomey and Senator Casey, for the honor and opportunity 
to provide testimony to this committee. I met Senator Toomey 
last year when he convened a working panel in Washington 
County, and I appreciate your efforts to fight the increasing 
problem with addiction in our country.
    I would also like to thank our local United States 
Attorney, David Hickton, for his leadership and help on this 
immense national problem of opioid abuse. Mr. Hickton is a 
champion and a great partner for law enforcement as we fight 
this epidemic.
    It is no secret that our Nation is in the midst of an 
epidemic of drug-related deaths caused by prescription drug 
abuse. This is a public health and a public safety crisis. 
Nationally, tens of thousands have died due to overdoses caused 
by opioid drugs. We in Washington County are not immune. Since 
2011, we have had more than 230 Washington County residents 
lose their lives due to accidental poisoning caused by opioid 
drugs. In August of this year, we had a string of overdoses 
caused by fentanyl-laced heroin, which claimed several lives 
and placed Washington County in the national news.
    This epidemic, however, goes beyond the overdoses. It 
significantly impacts the area where I work, which is the 
criminal justice system. I reviewed our criminal case filings 
for 2014 and found that at least 30 percent of our criminal 
cases were directly linked to opioid abuse coming from both 
pills and heroin. This is roughly equivalent to the exact 
number that we are running into with alcohol. Based upon my 17 
years of working in the Washington County District Attorney's 
Office, I can assure you this is a new phenomenon. Not too long 
ago, it was rare to see a heroin case in our court. Now it is 
rare not to have a case involving heroin or prescription 
medication.
    Our coroner in Washington County, Tim Worco, does a very 
good job of documenting the deaths, and his data reveals that 
this is not just a problem for young people. This data reads 
that 41 percent of our deaths since 2011 were people over the 
age of 40, and 46 percent were a combination of two or more 
drugs, and 57 percent were from prescription medications.
    Now, the connection between opioid medication abuse and 
heroin is well established. As local law enforcement officials, 
we have had to respond to this, and we have developed an 
evolving plan to deal with it. We conduct local drug 
educational seminars at local schools to warn children of the 
dangers of the abuse of pharmaceuticals. We have drop boxes in 
our police stations for unwanted medications. We have embedded 
a Federal prosecutor in my office to aggressively go after the 
dealers who are distributing these drugs, and we have 
heightened and promoted, in connection with our local SCA, 
treatment for nonviolent criminal offenders.
    What we are trying to do is work on both the supply side 
and demand side of the problem. While I am proud of what we 
have done thus far, I feel that these measures will not be 
sufficient alone to eliminate the problem. Dr. Capretto talked 
about the Prescription Medication Monitoring Program. I second 
what he said. We did get that established last October. 
However, the funding did not come through. I have learned from 
our State representative, Brandon Neuman, that some funding has 
come through from the Federal side, but we really do need to 
get that program in place. And, Senator Toomey, your bill on 
NASPER is certainly going to be helpful in helping us with 
interstate medication diversion.
    Now, Washington County geographically is close to Maryland, 
Ohio, and West Virginia. Due to our location, we are an easy 
drive for those looking to acquire medications, either using 
forged prescriptions or through doctor shopping. An example of 
this is, in 2013, we arrested 12 individuals who were operating 
as far to the east as Chambersburg and as far north as Warren 
County.
    What is interesting is that they were not going into other 
States to get the medications. They were staying in 
Pennsylvania because they could get the diversion. They 
obtained Opana, OxyContin, and other opioids from various 
pharmacies. They would not have been able to do this had there 
been a lock-in provision with our health insurance plans. We 
have also seen Suboxone starting to be diverted. We have had 
increased criminal activity near Suboxone clinics, and we have 
made arrests of people selling Suboxone on the street.
    In 2012, the United States Attorney's Office arrested Dr. 
Oliver Herndon, who was dispensing powerful oxycodone and 
oxymorphone in the area. He was one of the largest suppliers of 
diverted medications on the eastern seaboard. His parking lot 
frequently had cars from out of State in his lot. During one 
visit by an undercover officer, he actually told the undercover 
officer that you need to get these prescriptions filled as far 
away from here as you can because the pharmacies were on to 
him. He was also medical director for a hospice organization 
and two nursing homes. He was successfully prosecuted in 
Federal court for Drug Act violations.
    So as I said, over 50 percent of the people who die from 
accidental overdoses are over the age of 40. These facts 
emphasize the need for the legislation Senator Toomey is 
requesting on a lock-in for medication, and I would like to 
second that also.
    In closing, I am thankful for the opportunity to address 
the committee today. In the 4 years I have been District 
Attorney, I have had to learn a great deal about this, both on 
the medical end and on the law enforcement end. We need to help 
at all levels of government to make this happen. I am just one 
District Attorney in one county in Pennsylvania, but there are 
many more facing the same crisis, and we would like to continue 
to serve, and do our job, and do the best we can to fight this 
epidemic.
    Thank you.
    [The prepared statement of Mr. Vittone appears in the 
appendix.]
    Senator Toomey. Thank you very much, Mr. Vittone.
    Dr. Kabazie?

 STATEMENT OF A. JACK KABAZIE, M.D., SYSTEM DIRECTOR, DIVISION 
   OF PAIN MEDICINE, ALLEGHENY HEALTH NETWORK, PITTSBURGH, PA

    Dr. Kabazie. Senator Toomey, Senator Casey, thank you for 
shining a spotlight on this devastating epidemic that we have 
in our region and across the country.
    In the 1980s and 1990s, multiple factors contributed to a 
change in opioid prescribing for chronic non-malignant pain. 
Based on scant and faulty medical data, the risk of addiction 
was touted as rare, end organ toxicity non-existent, and 
incidence of tolerance extremely low. Armed with this 
information, physicians became less reluctant to prescribe 
opioids. Patient advocacy groups demanded better treatment for 
chronic pain, and pharmaceutical companies began reformulating 
opioids into extended-release preparations. This brought about 
a dramatic increase in analgesic prescribing for chronic non-
malignant pain that coincided with the rise in opioid-related 
morbidity and mortality.
    Currently, we in this Nation consume more opioids than the 
rest of the world combined. Primary care physicians and 
internal medicine physicians prescribe the majority of opioid 
preparations in this country, but most were not trained in 
addiction or pain management. While most doctors prescribe 
opioids with good intent, once they move down that path, it is 
an extremely difficult path to reverse. This can lead to 
disgruntled patients. It can lead to frustrated physicians. In 
addition, physicians who have compensation or employment tied 
to patient satisfaction scores may feel pressure, if you will, 
to prescribe opioids in response to patient pain complaints.
    Nationally, there are major disparities in prescribing 
opioids for chronic pain. In some regions, including 
southwestern Pennsylvania, this has resulted in ``pill mills'' 
for profit. There are also physicians who tacitly prescribe 
opioids to continue patients on a long path of procedures that 
financially benefit the physician with little long-term benefit 
to the patient. In some circles, these are known as ``pills for 
pokes'' practices. This is a very small--very, very small--but 
difficult practice pattern to detect without close oversight.
    While much attention has been focused on opioid abuse, 
addiction, and mortality, there is also the issue of 
unintentional overdose from misuse and subsequent adverse 
events. This is an issue especially in the elderly population, 
who are at extreme risk for falls and fractures, cognitive 
impairment, and unintentional overdosing. Many of these seniors 
forget that they took one dose, and they take another dose, and 
this places them in significant danger. These adverse events 
result in increased emergency room visits, hospital admissions, 
and length of stay, adding strain to the healthcare costs in 
the United States.
    To curb the prescription opioid epidemic, State medical 
boards have published guidelines on the use of opioids to treat 
chronic, non-malignant pain. However, studies show that many 
providers do not follow these guidelines even with high-risk 
patients. Prescription drug monitoring programs are useful. 
However, they are significantly underutilized when they are not 
mandatory.
    To further address inappropriate opioid prescribing, 
Physicians for Responsible Opioid Prescribing, or PROP for 
short, has petitioned for a mandatory limit on the amount and 
duration of opioids that can be prescribed to a patient with 
chronic non-malignant pain. This has resulted in condemnation 
from patient advocacy groups who fear absolute rules will leave 
many chronic pain patients without help.
    We cannot address the opioid epidemic by painting this with 
a broad brush of absolutes, mandating dosing and time limits. 
There is, in fact, a small subset of patients who will require 
large doses of opioids for extended periods of time, and with 
monitoring they do very well. They should not be denied this 
therapeutic option. However, this should be a treatment of last 
resort. When all other attempts to control their pain have 
failed, they can be, in fact, candidates--if they have a well-
defined pain generator--for opioids on an ongoing basis. 
However, most patients with chronic pain can be treated with 
satisfactory results using a multidisciplinary approach without 
the use of long-term opioid therapy.
    We need more than published guidelines that are either 
ignored or underutilized. It has already been shown that if 
there are guidelines, they do not necessarily have to be 
followed. One group of physicians that I asked about the 
published guidelines stated to me, ``They are only 
guidelines.''
    The Risk Evaluation and Mitigation Strategy, or REMS for 
short, is a voluntary program using extended-release and long-
acting opioids. Rather than a voluntary program, why not 
develop a mandatory REMS coupled with obtaining a DEA number to 
prescribe opioids for chronic pain for longer than 3 months? 
This might be one strategy. You should also include short-
acting opioids, as they are widely associated with abuse. Pill 
mill laws should be enacted in every single State in this 
Nation and adhered to, and offenders should be prosecuted.
    A prescription monitoring program, easily accessible and 
user-friendly, should be mandatory across the Nation, but it 
should be mandatory every time a prescription is written and 
every time a prescription is filled in a pharmacy. Referral to 
a multidisciplinary pain program should be made in a timely 
fashion for evaluation and treatment, and, to curtail this 
prescription opioid epidemic, all stakeholders need to come 
together to solve this problem.
    Senators, thank you very much.
    [The prepared statement of Dr. Kabazie appears in the 
appendix.]
    Senator Toomey. Thank you, Dr. Kabazie.
    Ms. Potts?

 STATEMENT OF ASHLEY POTTS, TEAM LEADER, CRISIS STABILIZATION 
 AND DIVERSION UNIT, SOUTHWESTERN PENNSYLVANIA HUMAN SERVICES, 
                      INC., CHARLEROI, PA

    Ms. Potts. Yes. First, I want to thank Senator Toomey and 
Senator Casey for giving me the opportunity to testify before 
you today. It is an honor to be able to be here before you.
    My name is Ashley Potts, and I currently work for 
Southwestern Pennsylvania Human Services. I am the team leader 
for the Crisis Diversion Unit. Before working there, I worked 
for 3 years at the Washington County Drug and Alcohol 
Commission on their Drug Court program. However, it is 
important to understand that 9 years ago, I found myself 
homeless, facing a State prison sentence, and addicted to 
heroin.
    A few things about my story that I think are prevalent to 
understand are the impact of stigma, the importance of 
treatment, and that recovery is possible. I took my first drink 
of alcohol when I was 9 years old. My mother has addiction 
issues, so culturally I did not really understand the fact that 
it was wrong and it was not something that I should be doing. 
As Senator Toomey said, I took my first OxyContin when I was 13 
years old, and despite the fact that it physically made me ill, 
I had fallen in love with that feeling. I started having 
behavioral issues in school, I started acting out, and my 
addiction just continued to progress.
    It is also important to understand that I always said, ``I 
am never going to be a heroin addict.'' That was something that 
I was never going to do. But just because these prescription 
pain pills are approved by the FDA, that does not make them 
safe.
    I kept having behavioral issues. When I was 15, I was 
expelled from school. I started using crack cocaine at the age 
of 16, and I started running away. I ran away multiple times. I 
got arrested several times. And when I was 17 years old, again, 
despite the fact that I said I was never going to be a heroin 
addict, I found myself an IV drug user.
    When I was 18, it was the first time I decided that I was 
going to try to stop using drugs, and I remember I had not 
talked to my father for quite some period of time because I was 
a runaway. And I called him, and I begged him. I said, ``Dad, 
if you do not come get me, I am going to kill myself.'' I was 
only 18. He came, he got me, I moved back into his house, and I 
went through the physical withdrawals of heroin. And despite 
the fact that with every agonizing breath I said, ``I am never 
going to use again,'' I still did not go to treatment. I still 
did not have any supports. I still did not participate in a 12-
step fellowship.
    After moving in with my father, I found out that I was 4 
months pregnant. I was able to remain abstinent for the 
remainder of my pregnancy. I gave birth to a child on May 20, 
2005. Her name is Riley. Shortly after having Riley, I thought 
that I could just drink alcohol. Me thinking I could just drink 
alcohol led me to just snorting bags of heroin, which 
ultimately led to me being in the same position that I was when 
I started: back to being an IV drug user.
    I moved out of my father's home. I moved into a house, and 
my addiction just continued to escalate. My father had knocked 
on the door one day, and he begged me to give him temporary 
custody of my daughter and for me to go to rehab, which I did. 
I spent 20-some days in rehab, and despite the fact that my 
family had begged them to keep me, I refused a halfway house, 
and I returned home to my father's house.
    I got out of rehab on May 13th, and Riley would have been 
one on May 20th. And despite the fact that I was determined to 
be the best mom that I could be, on May 17th I was using, and I 
missed her first birthday. I was kicked out of my father's 
home, told if I ever stepped foot on his property again that I 
would be arrested. I was homeless. I was living in my car. I 
lost the ability to function as a normal human being. I did not 
shower. I did not brush my teeth. I was living on the street.
    I moved back in with my mother for a period of time, after 
which ultimately I was walked out of her home in handcuffs. I 
wrote fraudulent checks. I robbed an innocent person's house. I 
did things that I said that I would never do because I was a 
slave to a needle. And again, I always said that this was 
something I was never going to do, and I woke up one day and 
realized that that is exactly what I had become.
    I was 20 years old, and I remember I never thought that I 
would live to see my 21st birthday. The time came down where I 
decided that my daughter deserved another chance, and I was 
either going to get clean and really try this thing, or I was 
going to commit suicide. So I decided to go to treatment, and 
this time I did long-term treatment. And I truly believe in 
long-term treatment wholeheartedly.
    I spent 216 days in treatment. I did 7 days of detox, 29 
days in inpatient, and then 6 months in a halfway house. When 
they offered me a halfway house this time, I jumped on the 
opportunity. While I was in the halfway house, I was testing at 
a 6th grade education level. I turned myself in because I had 
multiple warrants out for my arrest, and I just continued to do 
what they do. For the first time in my life, I was willing to 
try something different because I did not want to live that way 
anymore, because I knew if I went back out there, I would 
become another statistic of what we are talking about today.
    In April of 2007, as I was supposed to go to State prison, 
my life truly changed forever, when the judge granted me 216 
days time served and immediate parole. But something also 
happened on that day. I became a convicted felon. I have two 
felony convictions on my record, and this is where stigma 
really comes into play.
    So at 13, when I took my first OxyContin, I did not 
understand the gravity of how being a convicted felon would 
impact the rest of my life, because I did not even think I 
would live to see the rest of my life. So it is important to 
understand that recovery is possible, because 9 years ago I was 
homeless. I was on my way to State prison. Today I am on a 
management team with Southwestern Pennsylvania Human Services. 
We are an organization that provides treatment to individuals 
all the way from adolescence, all the way up to the Area Agency 
on Aging, and everybody in between.
    I am in graduate school. I went from testing at a 6th-grade 
level to being in graduate school. I went through some of the 
programs in the halfway house; I now sit on the board of 
directors.
    You know, my felonies have affected my life in many ways. I 
have been kicked out of college and laughed at by landlords 
when applying for housing. I have been hired and fired in the 
same day, and it has impacted every decision that I have ever 
made with my life. But it is important to understand that, 
despite the fact that society tried to bring me down, I never 
gave up, you know. I just continued to do everything that I 
could to stand up for a purpose and let everybody know that 
recovery is possible.
    And despite all this stuff I have on my record, today I am 
relatively successful, and today I do everything that I can in 
order to try to give back and let everybody know that recovery 
is possible and that treatment works. Thank you. [Applause.]
    [The prepared statement of Ms. Potts appears in the 
appendix.]
    Senator Toomey. Ms. Potts, thank you so much for having the 
courage to share your testimony with us, and for being the 
inspiration that you are to so many people, and for your 
leadership. We are very, very grateful.
    I will begin the questions now of our second panel 
witnesses. Thank you all for your testimony. I would like to 
start with Dr. Capretto. You have been in the trenches of 
fighting addiction for a long time.
    Dr. Capretto. Yes.
    Senator Toomey. Could you just briefly summarize for us the 
demographic changes you have seen from the time you first got 
into addiction medicine to what you are contending with today?
    Dr. Capretto. In terms of opioid addiction, when I started 
at Gateway full time in 1989, we averaged four people in detox. 
Three were alcohol and one was maybe opioid. And usually almost 
all those came from the city, usually the inner city, the poor, 
impoverished areas. As this has spread, right now we have 28 
detox beds. We still have three alcohol, and the rest are 
opioids with usually a dozen people waiting to come in every 
day.
    The demographics--it is everyone. It is every community, 
and it is actually mainly disproportionately Caucasians, middle 
and upper middle class right now, in terms of the pills and the 
heroin. And it is all age groups. We certainly see the young 
age group, but I am starting to see newer people over 40, over 
50, even over 60 using heroin for the first time, and usually 
because they got on pain medicine and were given a lot.
    The community is different. You know, 20 years ago, if you 
got on these medicines, you took them for a few days; your 
doctor gave you a limited supply. Now you are likely to get a 
larger supply, but then your neighbors or co-workers are going 
to say, what did you get, we will give you some money for that, 
you know, stay on it, that is some good stuff. So the culture--
it is definitely everybody and all age groups. In fact, one of 
the leading groups of overdose deaths is the over-50 group 
right now.
    Senator Toomey. Thank you. My understanding is, the FDA 
recently approved an indication for the use of OxyContin to 
treat severe pain in patients age 11 to 16 who may suffer from 
cancer or other very serious and painful conditions. What are 
your thoughts on the suitability of providing a drug like that 
to people of that age?
    Dr. Capretto. Well, for the poor kids who have cancer and 
are terminal, which is a small number, we absolutely have to 
help them. Okay. My concern is that the headlines are, 
OxyContin for kids, so if it is safe for kids, then people 
think well, it is approved, it is safe, so kids are more likely 
to take it. Adults are more likely to take it because it is 
safe for kids, though it is intended to be for pain specialists 
giving it to terminal kids.
    My concern will be--what we saw with regular OxyContin is--
maybe it is going to be given for kids with a sprained ankle 
from soccer or an infected tooth. And again, we have seen this 
with adults. So I do have concerns about that. We certainly 
need to educate the medical profession and the public about 
this.
    Senator Toomey. Yes, that seems very, very important. Thank 
you. Mr. Vittone, you talked about, and we have heard a lot 
about, pill mills that have been closed down and where bad 
physicians have been successfully prosecuted.
    Mr. Vittone. Yes, sir.
    Senator Toomey. Is it your view, though, that prescription 
painkiller diversion is still a serious problem despite this?
    Mr. Vittone. Very much so. As I indicated, just from 
Coroner Worco's data, 57 percent of the deaths we have had have 
been due to prescription drugs. So we are still seeing the 
diversion. I checked with the head of my drug task force the 
other day to see what the effect is, and he confirmed for me 
that diversion is still a big problem in Washington County.
    Senator Toomey. Yes, hence the need for the legislation 
that might----
    Mr. Vittone. Exactly.
    Senator Toomey [continuing]. Help to impede this. Thank you 
very much. Dr. Kabazie, in your testimony you mentioned 
something that you called ``pills for pokes.'' Could you 
explain exactly what that is, and why is it worrisome?
    Dr. Kabazie. It is an underground term that patients use as 
they discuss with each other diversion and abuse in obtaining 
pills. What it refers to--and again, it is a very small problem 
in regards to the numbers of physicians who do this, but it is 
still a real problem. Physicians may, in fact, see an 
opportunity to do a procedure on a patient in exchange for 
giving the patient opioids.
    In other words, the patient will come into the office and 
have a complaint of low back pain, and the physician may say, 
well, I think we need to do a procedure that may help you with 
your low back pain. I am not sure it will, but it might. And in 
turn the patient says, yes, but I was thinking more along the 
lines of some pain pills. Could you give me some pain pills?
    And the doctor will think about that for a second and say, 
sure, I will give you some pain pills, but I still think I need 
to do that procedure. And if I give you the pain pills, we 
should do this procedure, and then it seems to roll on and on 
and on.
    And I have seen this at least in the southwestern 
Pennsylvania area, and in some cases in other States, and what 
this rolls into is an ongoing cycle of bringing the patient 
back, doing a procedure that may give the patient some 
temporary relief, if that, followed by another procedure in 
exchange for medications that continue to escalate in quantity 
and dose.
    Now, it is a very hard thing to track because most of the 
physicians--and again, the small amount of physicians--who do 
this, they document as best they can to cover their tracks in 
that regard.
    Senator Toomey. And you pointed out, I am sure correctly, 
that this is a tiny percentage of physicians who are doing 
this. What is their motivation?
    Dr. Kabazie. It is purely--well, the motivation is this. 
With physicians, it is the state of affairs. Physicians get 
paid to do procedures. That is what we get paid to do at 
present. We get paid to do procedures. We typically do not get 
paid as much money if we sit and talk to a patient or handle 
routine problems. So doing a procedure in exchange for 
medications generates money for the physician.
    Senator Toomey. Yet another reason why it would be good to 
get away from the fee-for-service payment model that we 
generally have, but that is another topic. [Laughter.]
    Ms. Potts, I wonder if you could--and I am going over 
slightly, Bob. Thank you. Do you have some advice for people 
who might be currently struggling with addiction and looking 
for a way out?
    Ms. Potts. Absolutely. My advice would be that there is 
help, that even if people say that you are not worth it or you 
are not going to make it, I am living proof of that, because I 
was told I was never going to make it. But long-term treatment 
does work, individualized treatment works, and we need to just 
wrap them around with supports and let them know there are 
peer-to-peer supports. We have been there before. We can jump 
in there and help pull you out of that hole.
    Senator Toomey. Thank you very much. Senator Casey?
    Senator Casey. Thanks very much. Ms. Potts, I will start 
with you and pick up where Senator Toomey left off. You said in 
your testimony--you said 216 days of treatment?
    Ms. Potts. Yes.
    Senator Casey. Tell us about it, because we often will say 
good treatment works, but you have to sustain it. We all say 
that, but I am not sure those of us who are not professionals 
or have experience with it fully understand what we are saying 
or the meaning of it. And I guess I would ask you to look at 
the treatment question in two ways, and I am assuming in my 
question that both were essential for you, both duration and 
quality.
    But tell me if you can, and I know this is difficult 
because cases vary. But you were in a severe circumstance, as 
difficult as it gets, I guess, based upon your testimony. Walk 
us through those 216 days. What was it about the quality or the 
nature of the treatment that was effective in your case other 
than the necessary duration of it?
    Ms. Potts. Okay. Other than the length of being there----
    Senator Casey. Right.
    Ms. Potts [continuing]. I think it is important to 
understand that when I first walked in the doors, I had nothing 
but the clothes that I had on, just dirty clothes. I was not 
living as a normal person would. I had no idea how to write a 
job resume. I had no idea how to interact with people in the 
community. I had no idea how to speak to people. In my case, I 
was literally that stereotypical street junkie, so that was the 
level that I was at.
    So the importance of that is, when I went to my first court 
hearing, I had on a hoodie and ripped-up jeans and all that, 
and by the time I went to sentencing court, I was dressed like 
a professional, and I had letters that I had been volunteering, 
and that I had a job, and that I was employable. So I went from 
not understanding the importance of having a job or being 
employed to being able to have that.
    You know, statistics say the longer that we are in 
treatment, the better success that we have, so it takes time 
for our brains to start going back to normal. And Dr. Capretto 
could probably speak more on the brain and the brain 
functioning on drugs. It takes at least 90 days just for that 
normal chemistry to come back in the brain. And I just think 
that the longer--you know, you learn life skills. You learn all 
of these things that in my case I missed growing up along the 
way.
    Senator Casey. What would you recommend in terms of the 
structures we have in place now for the kind of quality 
treatment that you are talking about? I hope that your case was 
not unique in the sense that you had the benefit of programs 
that others often do not.
    Ms. Potts. No, there are plenty of me's out there.
    Senator Casey. In other words, if you were designing the 
ideal treatment course, what would be the elements of it?
    Ms. Potts. The ideal treatment course to me would be 
opioids detox, long-term treatment, halfway house, partial 
hospitalization, intensive inpatient treatment, and then 
outpatient, and you are in that continuum for up to 2 years. I 
did outpatient after I was in the halfway house, so I stayed 
connected to those services. I stayed in therapy, and I stayed 
doing the things that were suggested to me because I was not 
going to fix 20 years of trauma in 6 months, if that makes 
sense.
    Senator Casey. Yes, that is very helpful. [Applause.]
    It is important for us to hear the nature of it, but also 
the duration of it, and we have to figure out ways to support 
that. Dr. Capretto, in your testimony in the recommendations, 
you quoted a study--this is on page 4 of your testimony, and I 
am quoting from the summary of the study and your testimony. 
You say, ``Physicians who check the PDMP,'' the management 
program for prescriptions, ``change their original decisions 
about the prescribed medication more than 40 percent of the 
time.'' Tell us about that.
    Dr. Capretto. Right. There was a study of physicians who 
use it, and Dr. Kabazie said it is important that they use it. 
It found that they actually changed their original decision 
about 41 percent of the time. About 70 percent was to prescribe 
less because they found out information, but about 30 percent 
of it was to prescribe more because somebody that they were 
worried about, they saw that they were not involved with 
diversion, so they could build trust with the legitimate 
patient. And we need to do this.
    I have a colleague in another State who has a big pain 
practice, and he was only using it for the patients who really 
looked suspicious, and somebody challenged him to do everybody 
in his practice. And he said if he were to pick the least 
likely five in his practice--and the number-one least likely 
guy, he was a CPA, banker, always came in with a suit, never 
missed an appointment in a year. He checked the database, and 
that person was going to five different physicians for opioids. 
So you cannot judge a book by its cover. So it is a useful 
tool, and it gives us information. It is one piece of the whole 
puzzle, as many of these pieces are.
    Senator Casey. Just one question for the panel. I know we 
may go to a second round, which is helpful, I think. But just 
one question about this, the price dynamic of this. I heard 
testimony recently just in the last 2 weeks from someone who 
had been addicted and had a real problem for years. He was 
saying that the price of heroin----
    Two things on heroin. Number one, the strength of it, the--
what is a better word?
    Dr. Capretto. The potency.
    Dr. Vittone. The potency.
    Senator Casey. Potency. ``Potency'' is a better word. The 
potency of it is much greater.
    Dr. Capretto. Absolutely.
    Senator Casey. And the price, according to this 
individual--and now he was talking about the market that he was 
living in then--but the price is literally the same price as 
the early 1970s, at least according to his testimony. Even if 
he is off by a little bit----
    Dr. Capretto. It is actually less than that.
    Senator Casey. Yes. And so, that is the heroin problem. So 
how do you deal with that price dynamic where, if you are 
aggressive on opioids and the price goes up, they will turn to 
heroin and start there as opposed to starting with opioids? And 
I know it is both a medical and a healthcare issue, but also a 
long-term issue.
    Dr. Capretto. Well, two ways. Number one, you want to limit 
or minimize new people getting addicted to opioids with all the 
things we have talked about it, but, number two, you want to 
have adequate treatment safety nets. You want to have adequate 
naloxone to keep people from dying. You want to have adequate 
access and availability of treatment. They say with this 
disease, only around 10 percent of people who have the problem 
ever get any type of legitimate treatment for it.
    So we need to reach out to them because, if we do not, it 
costs us. Even if you do not care about these people, and look 
at the wonderful turnaround with Ashley, it is a good 
investment in reducing crime, improving jobs, taxes, 
everything. It is a good human investment, and signs indicate 
that the purity is going to continue as cartels are getting 
more aggressive, and the price may come down. So we absolutely 
have to hit this head-on.
    Mr. Vittone. Senator, if I can follow up on that, we have 
always had heroin in Washington County, though not to the 
extent we have it now. So the difference has been the 
prescription pills that came out in the 1990s that really added 
fuel to that fire. So it is cross-cultural, and now it is all 
over the area because of that. So I do not know that you are 
going to ever eliminate completely that heroin baseline, but it 
certainly was not at this level. Do you agree, Doctor?
    Dr. Capretto. Oh, absolutely, nowhere near it.
    Mr. Vittone. You know, this is several years ago, so----
    Senator Casey. Thank you.
    Senator Toomey. Dr. Capretto, so we have discussed how, I 
think you indicated, a vast majority of heroin addicts actually 
were initially addicted to prescription opioids.
    Dr. Capretto. Yes.
    Senator Toomey. Could you share with us a little bit, how 
does that initial addiction occur? Is it people who had surgery 
and then get hooked on the medicine that was prescribed post-
surgery? Is it kids that raid the medicine cabinet? Is it both? 
Is it others? How does it happen?
    Dr. Capretto. It is all of the above. You know, back in the 
1990s when this was being marketed, they were trying to tell 
doctors this will never occur if you give it to your pain 
patients, less than 1 percent. We now know that is not true.
    I would say of the people whom I see, probably about 30 
percent of them, it started with going to a physician who kept 
them on it too long, and it evolved into an addiction. Another 
group gets it recreationally. It is diverted. And then there is 
the in-between. They might have had a pain problem, and I hear 
this, and they were on it for a while. They kind of liked it, 
and they got away from it, but now they go to their local bar 
or sporting event, and there are people using it. These are 
very much part of our culture and available, so they get back 
on it. But it all comes back to their original source, which is 
our medical community.
    Senator Toomey. Yes. Dr. Kabazie, this might be difficult 
to generalize, but I am wondering if you can give us any sense 
of how long a period of time it is safe for most people to be 
consuming a prescription opioid. Is it possible to generalize? 
Is there a point beyond which the risk of addiction becomes 
much greater than a shorter duration, or is it too specific to 
the individual?
    Dr. Kabazie. It is. It is very specific to the individual. 
We know addiction is a biopsychosocial disease, and Dr. 
Capretto knows this quite well. If you are genetically 
predisposed to addiction, to a substance, and you are never 
exposed to that substance, you have absolutely zero chance of 
becoming addicted to it. But if you are genetically predisposed 
and you are exposed to even a small amount, then you are off to 
the races.
    So keeping in mind that this is a disease, there is a bio, 
a psycho, and a social component. And so, it is people, places, 
and things. It would be too generalized to say that there is a 
discrete time period at which the incidence or risk of 
addiction goes up. We just cannot say that. We do know that we 
continue to monitor for that. We also know that the higher the 
dose, the more likely addiction will occur.
    People who have an addiction issue many times, and I am 
sure Dr. Capretto has seen this, do not take the medication, 
the opioid, the heroin, to get high anymore. They are so far 
along that they are taking it just to function. On the street 
it is called ``dope sick.'' They are deathly afraid of getting 
dope sick, and they will do anything they possibly can to keep 
from getting dope sick.
    Without their medication, without their prescription drugs, 
without their heroin, they will get violently ill. They cannot 
function. Once they get it, they can function as normal human 
beings, and you would never know that they have a problem 
because they need that just to function. It is a scary 
proposition to anyone who has an addiction issue.
    Alcoholics can be the same way. You can have a functioning 
alcoholic and never know it. As long as they are drinking, they 
are completely straight and they are functioning, and without, 
they do not do a very good job.
    We know that the longer you are on an opioid, the more 
likely you are to become tolerant. You are certainly going to 
be dependent, and then the long-term effect can be endocrine 
dysfunction. We certainly know that now. We probably knew it 
back in the 80s and 90s, and we just sort of ignored it. And we 
know that opioids over time can actually cause pain, and that 
is called opioid-induced hyperalgesia, which causes a 
significant problem if a patient goes to surgery and the pain 
is extremely difficult to control because they are on high-dose 
opioids.
    We have a patient who is on an opioid--and I think my 
orthopedic colleagues have seen this. If they are on opioids 
and going in, for instance, for a joint replacement, it could 
be extremely difficult to control their pain and get them 
through the rehab that they need. So our job is to try to get 
them off the opioids if we can so that they do not suffer in 
that regard.
    Senator Toomey. Thank you very much, Doctor. My last 
question is for Ms. Potts. Dr. Kabazie described this addiction 
as a biopsychosocial issue or problem. Could you give us a 
sense--I think we intuitively understand that there is a 
chemical problem here. There is a biological problem that has 
to be solved. But what about the social problems? What about 
the behavioral issues? How important are they for someone 
recovering from an addiction like this?
    Ms. Potts. Absolutely. He mentioned people, places, and 
things, and individually, for me, I had to make a geographical 
change. I live 75 miles now from where I used to live because I 
know that going back to the same people, to the same problems, 
to the same situations, and not knowing anything different, I 
would ultimately end up with the same issues. So for me, I had 
to move away and start a whole new life.
    Senator Toomey. Thank you very much. My understanding is, 
that is a really important part of the curing process. Senator 
Casey, did you have any other questions?
    Senator Casey. I did, but just maybe I will do it by way of 
a lightening round because I took more than my time last time. 
Maybe starting with Dr. Capretto and going down the panel, if 
you had to, in a little more than a sound bite, kind of itemize 
steps you hope we would take on a whole range of issues, 
whether it is healthcare legislation, or legislation in 
Washington, local law enforcement, more resources, more 
treatment options, what would be your top three?
    Dr. Capretto. We need to really make sure there are 
adequate treatment options that are available to people in a 
timely fashion and in a long enough period of time that is 
overseen by people who really understand how to treat 
addiction, not just manage funds. And we also need greater 
emphasis on education of our medical community, starting in 
medical school residencies, to treat this. This condition is so 
prevalent, yet the medical community gets minimal, and 
sometimes very little to no, education on this issue. And we 
have to worry about our kids.
    I mean, one of the things I did not mention with OxyContin 
is the developing brain. We know that the younger kids start 
using it--I mean, nobody questions the logic of a pregnant 
female abstaining from use of alcohol or drugs because of the 
developing brain. At birth, is the brain done developing? 
Absolutely not. It continues to develop until the mid-20s. The 
earlier you expose that brain to drugs of abuse, whether it be 
opioids, alcohol, marijuana, the greater likelihood addiction 
will develop, and it will derail their life in so many ways. 
So, a comprehensive approach.
    Senator Casey. Thanks.
    Mr. Vittone. A prescription medication database is a huge 
asset. We need to know who is getting what. Also, law 
enforcement needs access to that, where prescribing patterns 
become criminal. The second thing I would advocate, as Dr. 
Capretto indicated, is education for the medical professionals, 
law enforcement, and the community as to the dangers.
    And lastly, treatment. In speaking with Secretary Gary 
Tennis of the Pennsylvania Department of Drug and Alcohol 
Programs--I have asked him, ``Why are people dying in 
Washington County?'' He said it is because they are being 
under-treated. They are not getting enough treatment. They need 
to get, as Ashley said, that full panoply of treatment, and 
that needs to be available. Thank you.
    Senator Casey. Thank you. Doctor?
    Dr. Kabazie. I will leave the treatment and the law 
enforcement to my two colleagues to the left here. I think we 
need mandatory, mandatory, mandatory prescription monitoring. 
We need to monitor the drugs in the United States, and it has 
to be mandatory. In other words, we need a Prescription Drug 
Monitoring Program that is nationwide, or at least one in which 
the States will exchange information. And that needs to be 
mandatory, so we need physicians to use it every time they 
write a prescription, and we need pharmacists to use it every 
time they fill a prescription.
    We already know that voluntary guidelines do not work. They 
do not work. We have plenty of guidelines out there that nobody 
follows, so we need to make those things mandatory. I know I 
will get pushback from some of the people in the medical 
community, but without making these mandatory, they will not 
work. We need to have a mandatory REMS project, a Risk, 
Evaluation, and Mitigation Strategy, that is mandatory for 
physicians to take if they want to prescibe opioids across the 
class, not only for extended-
release medications, but for short-acting medications. I think 
those two things will go a long way to cutting down at least on 
the prescription drug problems that we have right now and the 
epidemic that we have right now with physicians writing 
inappropriate prescriptions.
    Senator Casey. And, Ms. Potts, I know--now that we know 
something about you, we are calling you ``Ashley.'' Is that all 
right?
    Ms. Potts. Absolutely. Absolutely. [Laughter.]
    I agree with what everybody said. You know, I think that we 
should not put a limit on treatment. If we take, for example, 
two 20-year-olds both addicted to heroin, one has been using 3 
months, one has been using since the age of 10, one is going to 
need a little bit longer treatment than the other one. So I 
think it is important to have an individualized treatment 
approach with a comprehensive support team--and what everybody 
else said, of course.
    Senator Casey. Thank you very much.
    Senator Toomey. Thank you. At this time, I would like to 
ask our panelists to stay here if they would, and I would like 
to use this opportunity to give the audience a chance to ask 
questions or make some comments. They can direct it at any of 
our witnesses, or myself, or Senator Casey as they see fit, but 
we only have a few minutes.
    I want to ask anybody who would like to ask a question or 
make a comment to approach the mics on either side of the room. 
Please state your name and any affiliation that you have that 
would be relevant, and then please try to ask your question as 
succinctly as you can so that we can get to multiple questions. 
And we will start with the gentleman on the left.
    Dr. Wong. Hi. My name is Kevin Wong. I have been a family 
physician in Westmoreland County for over 33 years, and I 
appreciate the Senators' efforts to help as well as our 
panelists'.
    We have heard over the years how people like Dr. Kabazie 
help family physicians try to prescribe appropriately. We do 
need the PDMPs in this State. As you know, that is locked up, 
and that is why the Federal Government needs to get after every 
State that does not have one. And it needs to be interoperable 
immediately, because otherwise, as you just said, we are a 
terrible State. We have West Virginia next to us, and Ohio is 
just as bad, and drug abusers can all go back and forth over 
the waters as they see fit.
    The PDMPs also need the pharmacists, who are our line of 
defense when somebody is prescribing, to not have fear of a 
HIPAA violation, to call a physician and say, you just 
prescribed somebody a prescription and another physician had 
just prescribed recently. The pharmacists are very afraid or do 
not want to get involved.
    As Dr. Kabazie said, the pills for pokes are something we 
see as family physicians. I have had many patients go to some 
of these places, be there a year, 15 months, finally get kicked 
out for breaking the pain contract. They come back to me with 
two to three times the amount of pain meds we sent them to the 
clinic with in the first place. We need legitimate pain clinics 
that are treating people. As we said, we need to think and not 
poke. Thank you very much.
    Senator Toomey. Thank you very much. Unless there is a 
response to that----
    Dr. Capretto. We agree.
    Senator Toomey. I think that was more a recommendation, 
which I think the panel is probably sympathetic to. The 
gentleman on the right.
    Dr. Fuller. Hi. I am Dr. Mark Fuller. I am the CEO of Value 
Behavioral Health. We are a Medicaid managed care program. We 
help administer the Pennsylvania Health Choices Program in 
western Pennsylvania. So the first thing I want to say is, 
thank you to both Senators for your advocacy, for dragging this 
problem out in the light of day where we can have this kind of 
discussion.
    The second thing I want to say is, as a payer, we are fully 
committed to doing whatever we need to do to crush this 
epidemic. We are all in, so anything we can do, we are there 
for. Thank you.
    Senator Toomey. Thank you.
    Senator Casey. Thank you.
    Senator Toomey. Yes, ma'am?
    Ms. Besick. My name is Pat Besick. I am the manager of the 
Behavioral Health Unit at Saint Clair Hospital. And I really 
appreciate everyone's expertise today, but there was something 
that nobody really talked about, which is really a barrier. 
Drug treatment is voluntary unless you are in drug court. So we 
get families involuntarily committing people to our psych unit 
just to get them in treatment, thinking they are going to take 
care of their drug problem. And once we have done the 
evaluation and have them a few days, maybe the doctor started 
an antidepressant for the depression/anxiety, which, of course, 
you would have when you are abusing drugs or alcohol. We get to 
a point where, if a patient does not want to go for treatment, 
it stops there.
    So it is voluntary. You can have all the treatment centers, 
but how do you get to the next level where people will go into 
treatment? At some point, Ms. Potts, you had the insight to put 
things together, but it took a while to say, ``My life is not 
going too well, I need to change something.''
    But this is a huge barrier with most people. They will not 
take that step, and families can be upset. Smart families will 
say, ``Well, you cannot come back home,'' and they kind of 
force the issue, but that is pretty much what we have to do 
with people to get them into treatment. So what are we doing to 
address the issue of people who just will not go into 
treatment?
    Senator Toomey. Anybody?
    Dr. Capretto. That is clearly an obstacle. You cannot, in 
mental health, commit somebody to addiction treatment. There 
can be leverage in the legal system. Drug court is a wonderful 
thing. Families can put pressure, and sometimes families 
themselves, I recommend they reach out to a therapist, maybe an 
interventionalist, to try to help raise the bar.
    Those who are working with them in hospital, I encourage 
you to get trained in motivational interviewing to kind of help 
move them along. I would welcome any leverage or help from 
legislature in getting people in. But it is an obstacle, 
absolutely.
    Ms. Potts. I also think it is important to understand that 
addiction is a family disease, so families are struggling along 
with that individual. And just because they are showing up 
again, and again, and again, at least they are showing up, and 
at least we still have the opportunity to try to save that 
person's life.
    Senator Toomey. Mr. Vittone, did you have something you 
wanted to add?
    Mr. Vittone. Yes. The drug courts do work. We have had one 
since 2005 in Washington County. You use the leverage of the 
criminal justice system to get these people to reform, but it 
is a very intense process. It is very time-consuming. It is 
well worth it, and we have been able to get people to reform 
and get into recovery, so it does work.
    Senator Toomey. Great points. Thank you. The gentleman on 
the right.
    Dr. Pierce. Thank you. It has been a very informative day, 
and I would like to thank the Senator for all your efforts as 
far as helping with this problem. I would like to thank the 
expert panel witnesses for your testimony. I learned a lot 
personally. My name is Dr. Pierce. I am the regional medical 
director in Pennsylvania overseeing four methadone clinics. I 
also do buprenorphine therapy in my office. This is a passion 
and a calling for me.
    I would just like to say, without taking up too much time, 
one of the things that I noticed--and I do the initial 
evaluation of a lot of patients, in fact, most of the patients 
at the methadone clinics. And a lot of times what you see is 
that really people are predisposed to getting this disease 
process. It is a chronic relapsing disease of the brain. And 
really there is not much we can do to stop them from getting 
this disease once they become exposed to the drug itself.
    I mean, when you look at people who have--when they are 
younger, we call them adverse childhood events, which means 
traumatic events that children are exposed to during the 
developmental years: the physical abuse, the sexual abuse, the 
verbal abuse, parents that divorce, and abandonment issues. 
These are one part of the environmental insults that contribute 
to a person getting or being predisposed to this disease.
    Also, you have the adolescent exposure to substances of 
abuse, but then you look at tobacco, and alcohol, and 
marijuana, which will probably be legalized in this State, and 
those three major substances in themselves, when used during 
the adolescent years, actually contribute to predisposing a 
person to entering this process. Now, you add to that the 
undiagnosed and untreated mental health disorders, which can be 
as little as social anxiety or mild depression--it does not 
have to be a full-blown bipolar disorder.
    But these are the three conditions that predispose people 
to getting this disease process, so by the time they take the 
opioid pill, they are set up to get it. And it really does not 
matter if you give them 30 milligrams, 60, or 100, they are 
probably going to get the disease process. So I think what we 
have to really focus on is the treatment component of it.
    And what I am seeing now is that we have the buprenorphine, 
different companies are making it now. But the problem is that 
when you get this disease process, about one out of 10 can go 
to detox, can go to rehab, and be successful. But there are 
another 90 out of 100 people who, no matter how long you keep 
them in rehab, they are not going to be able to stop the cycle 
of this disease.
    Part of this disease process is that the part of the brain 
responsible for controlling behavior is now compromised. It is 
not functioning. So therefore, the simple act of choosing to do 
something or not to do it has been taken away. It is robbed 
from the patient. Their brain has essentially been hijacked. So 
what we have to do is have a medication that can help them to 
be in the state of mind where they can actually now get the 
therapy that they need.
    And these different medications--one of them is methadone, 
which is used very successfully. Another one is the 
buprenorphine. And basically what these medications are is, 
they are relapse prevention medication. It stops the patient 
from relapsing so they can get the therapy that they need in 
order to make the cognitive and behavioral changes that will 
allow them to be successful as far as getting off the 
medication once and for all.
    So my point is that we have this limit on physicians as far 
as, they can only treat 100 buprenorphine patients at one time, 
and that is limiting our ability to help patients who have this 
disease process. Granted, only 20 percent of the people who 
have this disease process are actually in medical treatment, 
but if you do not have the physicians available outside of a 
methadone clinic--not everyone wants to go to a methadone 
clinic. Not everybody needs to go to a methadone clinic.
    We have to have individualized treatment for these 
different patients. I mean, not everybody needs to go to detox 
and rehab. That is like taking every depressed patient and 
telling them you are going to put them into a confined setting 
and give them a rehab and not give them any medication. It just 
does not work.
    So I think we need to eliminate that limit of 100 patients 
and allow some physicians, maybe the ones who are board 
certified in addiction medicine, to be able to increase the 
number of people they could treat. I think that would go a long 
way to helping this situation.
    Senator Toomey. Well, thank you very much for that thought. 
Senator Casey, you had a comment?
    Senator Casey. I know we have to move on, but there is a 
new bill that speaks to this, Doctor. I hope you can take a 
look at it, Senate bill 1455, which would lift that cap. But 
1455 is the bill.
    Dr. Pierce. Thank you.
    Senator Toomey. Could I ask the panelists, does everyone on 
the panel agree that that cap should be lifted?
    Dr. Capretto. I agree, but you have to be careful about how 
you do it. I would recommend a first step, making it for 
addiction specialists, those who could provide kind of 
wraparound services and not just open it up to everybody. We 
certainly do not want to create pill mills in that direction.
    Dr. Pierce. I agree, and certainly only those board 
certified by the American Board of Addiction Medicine. That 
would be the criterion to do that.
    Senator Toomey. Dr. Kabazie, did you want to respond?
    Dr. Kabazie. Well, I think we need to be very, very 
careful. I think everyone who prescribes Suboxone has seen 
Suboxone prescribers who are not doing it appropriately. And, 
if we open up that cap, that will open up the floodgates. And 
again, I am going to harp on physician reimbursement here. It 
is very easy to see a Suboxone patient in very quick fashion, 
sign your name to that prescription, and send them out the 
door. And just as I have seen very, very bad pain physicians, I 
have seen very, very bad Suboxone providers. And that Suboxone 
either ends up on the street or in the hands of someone who 
should not have it. And we need to look at that very, very 
carefully.
    You know, I may speak out of turn here, but I do not 
understand an obstetrician, an OBGYN, prescribing more than a 
hundred Suboxone prescriptions or patients, a pediatrician, 
orthopedic surgeon, prescribing Suboxone to more than a hundred 
patients or even a hundred patients, simply because they sat 
through a course for 8 hours. That is a problem.
    So in the right hands, it would be an appropriate thing to 
do, but only in the right hands, and I think we need to look at 
that more closely.
    Senator Toomey. Thank you very much. We only have time for 
two more questions, so I want to let the gentleman who has been 
waiting patiently over here and then the lady at the other mic 
ask their questions. And then I am going to see if Dr. Farah 
wants to wrap things up here.
    Mr. Bacharach. I will be relatively short. My name is Paul 
Bacharach. I am the CEO at Gateway Rehab. I work with Dr. 
Capretto every day. In western Pennsylvania, we have an elderly 
population, and one of the impediments to--and this may be more 
directed to Dr. Ling. One of the impediments to treatment is 
the fact that Medicare does not cover non-hospital residential 
treatment for addiction, so there are very limited resources 
when it comes to hospitals providing short-term rehab and 
detox. We are unable to provide services to Medicare patients 
because it is not currently a covered service--that is the 
short-term detox, and 28-day.
    So I think one of the things that needs to be looked at to 
provide access to that elderly population that obviously is 
vulnerable also is to at least open up coverage for that group.
    Senator Toomey. Great. Thank you very much. The lady on the 
right.
    Ms. Bell. Hi. Thank you. My name is Alice Bell, and I am 
the overdose prevention project coordinator for Prevention 
Point Pittsburgh, which provides harm reduction-based services 
in southwestern Pennsylvania. A large part of my job is making 
sure that naloxone is available to people who might be at risk 
of an overdose or who might witness an overdose. And I 
appreciate Senator Casey's support of those efforts and his 
comments regarding that.
    The one thing that I feel is missing in the conversation 
today is the dramatic increase that we have seen in heroin use. 
And I would agree that doing a better job of more careful 
opioid prescribing is part of that, that if we do not have 
young people starting to get involved with prescription opioid 
misuse and abuse, then we are going to see less heroin use.
    I do have a real fear that at this point we are seeing such 
a high level of heroin use that we are going to have young 
people starting on heroin because they have friends who are 
already doing heroin, and that we have to look at that as a 
problem in its own right. And a big issue that we are seeing is 
a dramatic increase in injection-related blood-borne diseases, 
like hepatitis-C and HIV.
    And so I feel like, to address that problem, we really need 
to look at the need for access to sterile injection equipment 
for people who are already injecting. That is a small piece of 
the large problem that is being discussed here, but it is an 
important piece. When we look at lives and we look at costs as 
well, the cost to treat hepatitis-C, to treat HIV, that could 
easily be prevented if people have greater access to sterile 
injection equipment. Thank you.
    Senator Toomey. Does anybody want to react to that?
    Dr. Capretto. I totally agree, and I also share Alice's 
concern that now that there is so much heroin out there, even 
though historically it has been prescription medicines leading 
to heroin, as it is out there and available, that is definitely 
something that we may see that may also harm reductions.
    I really want to personally thank--Alice has done more to 
champion the cause of overdose prevention and harm reduction in 
our area than anybody, so thank you very much, Alice. 
[Applause.]
    Senator Toomey. And on that note, I want to thank everybody 
who came out today, and thank the audience members who made 
comments or asked questions. I thought that was a very 
thoughtful contribution to this process. I really want to thank 
the witnesses for all of your time, including Dr. Ling, and 
your very helpful testimony. [Applause.]
    And, Dr. Farah, as our host this afternoon, do you want to 
wrap things up?
    Dr. Farah. Sure. Senator Toomey, thank you very much for 
chairing this session. I think everyone in this audience would 
more than agree that this has been invaluable, not only in 
accomplishing the goals that you have set out to achieve, but 
also to educate us. I think a big part of what we heard today, 
from the panelists especially, is the educational piece that we 
can all use whether we are medical professionals or not.
    I also want to thank Senator Casey. Thank you for 
participating here at Allegheny General Hospital. All the 
panelists, Dr. Ling, U.S. Attorney David Hickton, thank you for 
attending this.
    I think we would all agree that this has been a remarkable 
show of bipartisan leadership here in western Pennsylvania on 
an issue that is impacting not only friends and families, but 
our patients as well. And on behalf of Allegheny Health 
Network, I would like to thank both of the Senators. We are 
very proud to have you represent us here in Pennsylvania and 
the United States. Thanks again. [Applause.]
    Senator Toomey. Thank you very much, Dr. Farah. The hearing 
is adjourned.
    [Whereupon, at 4:10 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


       Prepared Statement of Neil A. Capretto, D.O., F.A.S.A.M., 
                    Medical Director, Gateway Rehab
                              introduction
    Mr. Chairman and members of the committee, thank you very much for 
inviting me to speak with you today about the epidemic of opioid abuse 
in southwestern Pennsylvania, which has devastated the lives of 
thousands of individuals and families, and has led to record numbers of 
overdose deaths in our region.

    I am an addiction psychiatrist and the medical director at Gateway 
Rehab, which is our region's largest nonprofit addiction treatment 
provider. Our mission is to help all affected by addictive diseases to 
become healthy in body, mind and spirit. With 20 locations throughout 
western Pennsylvania and eastern Ohio, Gateway Rehab treats more than 
1,500 patients daily.

    I have worked full time at Gateway since 1989 but started in the 
field of addiction in 1981 at St. Francis Hospital in Pittsburgh. I am 
board certified in general psychiatry, addiction psychiatry, and 
addiction medicine, and I am a fellow of the American Society of 
Addiction Medicine.

    I served as a co-chair of the Western Pennsylvania U.S. Attorney's 
Working Group on Drug Overdose and Addiction, and currently serve on 
the board of directors of the Pennsylvania Society of Addiction 
Medicine, the Allegheny County Overdose Prevention Coalition, and the 
Beaver County Prescription Drug Abuse Coalition. I also consult with 
many professional and grassroots groups focused on addressing the 
addiction problem in our community.

    During my career at Gateway Rehab, I have directly been involved in 
treating more than 15,000 individuals in our region with prescription 
opioid and heroin addiction. I have personally witnessed, on a day-by-
day basis, the evolution of our current opioid epidemic, which began in 
the late 1990s. The sad reality is that, today there are more people in 
our community with addiction from opioid pain pills and heroin than at 
any other time in our history and, if this problem is not addressed 
adequately, it will continue to worsen.
                      our region's opioid epidemic
    When I finished my residency in psychiatry in 1985, there were 22 
accidental drug overdose deaths in Allegheny County, which, at that 
time, appropriately was viewed as an unacceptable tragic loss of lives 
that must be corrected.

    With a rising opioid problem beginning in the late 1990s, Allegheny 
County saw triple-digit overdose deaths for the first time in 1998 with 
104. This number remained over 100 for the next 3 years and then 
reached more than 200 in 2002, remaining such every year since. 
However, in 2014, Allegheny County set a new record with 307 accidental 
drug overdose deaths (OverdoseFreePA 2015).

    Moreover, based on population, most surrounding counties are now 
seeing higher overdose death rates than Allegheny County. Drug overdose 
deaths are now the leading cause of accidental death in our region, far 
exceeding traffic fatalities.
                                 causes
    Several factors have contributed to our current opioid epidemic; 
however, by far, the primary factor in our region leading new 
individuals into opioid addiction is prescription opioid pain pills.

    In the mid to late 1990s, the medical profession came under 
increasing criticism for not adequately treating pain, and there was a 
greater national emphasis to treat non-cancer pain with opioids. 
However, much of this emphasis was coming from pharmaceutical companies 
who sold opioid pain medications. Also, many physicians declared that 
abuse and addiction of opioid medications was essentially a non-issue 
(Van Zee 2009). Then, in 2000, the Joint Commission declared pain as 
``The Fifth Vital Sign.'' These circumstances resulted in a very quick 
and dramatic rise in the medical community prescribing opioids for 
pain.

    From 1999 to 2011, consumption of hydrocodone more than doubled and 
consumption of oxycodone increased by nearly 500 percent (Jones 2013). 
Unfortunately, during that same time, we saw the rate nationally of 
unintentional death from prescription opioids nearly quadruple (Chen, 
Hedegaard, Warner 2014), and the Centers for Disease Control and 
Prevention in 2014 described this as the ``worse drug overdose epidemic 
in U.S. history'' (Paulozzi 2010).

    Historically, most drug trends would start in other parts of our 
country and then reach southwestern Pennsylvania several years later. 
However, with the prescription opioid abuse problem, southwestern 
Pennsylvania was one of the first and hardest hit areas of our country. 
This was largely due to the demographics of our region, which included 
an older population and a large blue collar, working population that 
both have higher rates of medical problems resulting in pain. This led 
to heavy marketing of physicians in our area by pharmaceuticals to 
prescribe more opioids.

    In March of 1999, I saw my first patient come to Gateway with 
OxyContin addiction. By July 2000, I had seen more than 300. By the end 
of 2005, I had seen more than 2,000 people in our region with OxyContin 
addiction. OxyContin significantly accelerated and expanded the opioid 
addiction problem in our regional at a level never seen before.

    By the end of 2001, we were seeing large numbers of people, of all 
ages and from all social economic levels, coming into treatment with 
opioid addiction from virtually every community in our region. As many 
of these people continued to use more opioid pain pills, over time they 
developed tolerance, which resulted in them needing larger daily 
amounts to keep from going into opioid withdrawal and getting sick. The 
average person we were seeing was using more than 150 mg of Oxycodone 
per day, and some more than double that amount.

    The price of Oxycodone on the street at that time was approximately 
70 cents to a dollar per milligram. It was costing most people hundreds 
of dollars a day to support their opioid pill addiction. We then 
started to see a growing number of people who could no longer afford 
their opioid pills switch to a ``new'' heroin that would give them a 
similar and often stronger effect than opioid pills for about a quarter 
of the daily cost. This trend continues today and has created thousands 
of new people in our region addicted to heroin.

    Of the several thousand heroin users that I have interviewed since 
2000, well over 90 percent have told me they started with opioid pain 
pills. This is the primary reason why, 20 years ago in 1995, heroin use 
was essentially unheard of in the vast majority of communities in our 
region, especially the suburbs and the rural communities. Now, today, 
fueled by opioid pill addiction, heroin addiction has spread like an 
infectious disease into every community in our region.

    We first started seeing this ``new'' heroin in the mid-1990s. Most 
heroin in our region prior to that point, I am told, averaged about 10 
percent purity. That was still strong enough to cause severe addiction 
and death from an overdose, but the only way to get an appreciable 
effect from 10 percent heroin was to inject it intravenously. However, 
fears over contracting HIV in the late 1980s led to an increased 
reluctance by many to use a drug intravenously. In the mid-late 1990s, 
we starting seeing people come into treatment reporting they were using 
this ``new'' type of heroin, which would give a very strong effect by 
simply snorting intranasally.

    This ``new'' heroin was much stronger, usually greater than 40 
percent purity, and often, in our area, reached levels of 70-90 percent 
purity. Besides just giving a much more powerful opioid effect, this 
stronger heroin allowed people to get an appreciable effect from 
snorting intranasally, without injecting intravenously. However, almost 
all new heroin users that I have seen in the past 20 years that started 
out by snorting heroin, well over 80 percent switched over to 
intravenous use within 6-12 months because, as they developed tolerance 
to heroin, they learned that using heroin intravenously gives a quicker 
and stronger effect. As large numbers of individuals addicted to heroin 
switched from snorting it to injecting it, several thousand new people 
in our community developed Hepatitis C.

    Two other destructive trends we are seeing, which have magnified 
the opioid problem in our region, include adding fentanyl to heroin and 
opioid enhancement with sedatives.

    Although heroin is very potent and results in high rates of 
addiction, and it alone is very capable of causing an overdose death, 
in what is believed to be an effort to create greater demand for their 
product, some drug traffickers are adding fentanyl to heroin. Fentanyl 
is about 70-100 times stronger than morphine per milligram and is much 
stronger than heroin alone. Due to its high opioid potency, fentanyl-
laced heroin generally leads to a greater street demand and, 
unfortunately, spikes in overdose deaths because it is more lethal. I 
have talked to people who were using more than 20 bags of heroin per 
day who went unconscious with the needle still in their arm after only 
using one or two bags of fentanyl-laced heroin. We have seen several 
spikes in overdose deaths in our community in the last several years 
due to fentanyl-laced heroin.

    Another growing trend, which I believe is largely unrecognized and/
or neglected by much of the medical community, is the growing number of 
people with opioid addiction to pain pills or heroin who also take 
large amounts of sedatives to boost the effects of their opioids. The 
majority of these sedatives are benzodiazepines, drugs such as Xanax, 
Ativan and Klonopin. Adding these sedatives to opioids will definitely 
boost the effect, but it also increases the danger of an overdose 
death.

    A significant proportion of overdose deaths we are now seeing in 
our area are showing a combination of opioids and sedatives. Over the 
past 2 years, approximately 50 percent of the individuals coming to 
Gateway to seek treatment for abusing opioids also are addicted to 
sedatives and, if not detoxed properly, sedative withdrawal can result 
in seizures and possible death.

    Some have referred to our current opioid epidemic crisis as a 
``perfect storm'' that resulted from the dramatic rise in opioid pain 
pills at the same time the ``new'' and stronger heroin was introduced. 
These factors, along with the enhancing effects of fentanyl and 
sedatives, have continued to fuel this storm of opioid addiction in our 
community to now the highest level ever seen.
                            recommendations
    Unfortunately, there is not one easy, clear solution to this 
problem. It is clear that properly addressing this problem will require 
a large, multidimensional collaborative effort from many parts of our 
community. The Western Pennsylvania U.S. Attorney's Working Group on 
Drug Overdose and Addiction, under U.S. Attorney David Hickton, which I 
co-chaired along with Dr. Michael Flaherty, released a comprehensive 
51-page report in September 2014, which discussed this issue in detail 
and offered many recommendations (U.S. Attorney's Working Group on Drug 
Overdose and Addiction 2014).

    One other obvious and important area of focus is the proper and 
safe use of opioid pain pills. There is consensus within the medical 
community that it is important to treat pain properly, and that no 
individual with legitimate pain should be neglected. The challenge, 
though, is to treat pain adequately while minimizing the potential for 
addiction, not only in the patient but also in the community. This will 
require several measures, including better education of the medical 
community and the public, along with better management and monitoring 
of opioid pain medications. This would include not only an assessable 
State prescription drug-monitoring program (PDMP) for health 
professionals, which we hope to soon have in Pennsylvania, but, also, a 
national monitoring program for all scheduled prescriptions to minimize 
interstate drug diversion, which is a significant problem in our tri-
state region.

    Use of PDMPs by a health professional is an integral part of 
practicing responsible medicine. A responsible physician would not 
order antihypertensive medication for a patient without first checking 
their blood pressure or order insulin without first checking blood 
glucose. Therefore, in light of our current opioid epidemic, a 
responsible physician should not order powerful opioids without first 
checking a prescription database.

    One study (Baehren 2010) showed that physicians who check a PDMP 
changed their original decision about the prescribed medication more 
than 40 percent of the time. The majority of these changes were to 
prescribe less medications, but in some cases more because it helped 
build trust with legitimate patients. Another study (Feldman, Williams, 
Coates 2012) found that use of a PDMP increased physician confidence 
that the medications they prescribed were medically warranted.

    In light of the significant problem we have with prescription 
medicine abuse in our community, I believe the actions called for in 
Stopping Medication Abuse and Protecting Seniors Act [S. 1913] or lock-
in bill are very much needed. The patient would continue to have 
adequate access to necessary medical care and medications in a manner 
that would likely improve the quality of their medical treatment, and 
reduce the likelihood of them progressing into addiction. It would also 
help to protect the public safety by minimizing the possibility of drug 
diversion in the community. In addition, it would likely result in 
saving taxpayer dollars.

    For those individuals currently struggling with addiction, it is 
very important to offer them evidenced-based, comprehensive treatment 
of adequate intensity, and for a significant period. For those seeking 
help, comprehensive treatment should be readily available and not 
difficult to access. This would include reducing or removing the 
barriers that restrict Medicare patients from non-hospital, addiction 
treatment programs, which would not only improve their access to 
treatment but would also save taxpayer dollars

    It also will be very important to increase professional and public 
overdose prevention training, and increase the availability and use of 
naloxone to help decrease the tragic number of overdose deaths.

    I believe that over time such efforts can not only improve our 
ability to better treat patients with legitimate pain but, also, help 
reduce the problem with opioid addiction in our community.

    Thank you, again, for your time and for inviting me to discuss this 
important topic.
                               references
    Baehren, D. et al. A statewide prescription monitoring program 
affects emergency department prescribing behaviors. Annals of Emergency 
Medicine, 2010 Jul; 56(1): 19-23. Available at http://
www.ncbi.nlm.nih.giv/pubmed/20045578.

    Centers for Disease Control and Prevention. National Vital 
Statistics System, 1999-2008; Automation of Reports and Consolidated 
Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 
1999-2010; Treatment Episode Data Set, 1999-2009 Centers for Disease 
Control and Prevention. Rates of prescription painkiller sales, deaths 
and substance abuse treatment admissions (1999-2010). Available at: 
http://www.cdc.gov/vitalsigns/painkilleroverdoses/infographic.html.

    Chen L.H., Hedegaard H., Warner M. 2014. Drug-Poisoning Deaths 
Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief 
No. 166. Hyattsville, MD: Natl. Cent. Health Stat.

    Feldman, L., Williams, K.S., Coates, J. Influencing controlled 
substance prescribing: attending and resident physician use of a state 
prescription monitoring program. Pain Medicine, 2012, 13: 908-914. 
Available at: http://www.ncbi.nlm.nih.gov/pubmed/22681237.

    Jones C.M. 2013. Trends in the distribution of selected opioids by 
State, U.S., 1999-2011. Presented at Natl. Meet. Safe States Alliance, 
June 6, Baltimore, MD.

    OverdoseFreePA. Available at: http://www.overdosefreepa.pitt.edu/
overdose-data/.

    Paulozzi L.J. 2010. The epidemiology of drug overdoses in the 
United States. Presented at Promis. Leg. Responses to the Epidemic of 
Prescr. Drug Overdoses in the U.S., Maimonides Med. Cent. Dep. 
Psychiatry, Dec. 2, Grand Rounds, Brooklyn.

    U.S. Attorney's Working Group on Drug Overdose and Addiction: 
Prevention, Intervention, Treatment and Recovery. Final Report. Sept. 
2014. Available at: http://www.justice.gov/sites/default/files/usao-
wdpa/legacy/2014/09/29/US%20
Attorney%27s%20Working%20Group%20on%20Addiction%20Final%20Report.pdf.

    Van Zee A. The promotion and marketing of oxycontin: commercial 
triumph, public health tragedy. Am J Public Health. 2009 Feb;99(2):221-
7. doi: 10.2105/AJPH.2007.131714. Epub 2008 Sep 17. Available at:
    http://www.ncbi.nlm.nih.gov/pubmed/18799767.

                                 ______
                                 
Prepared Statement of A. Jack Kabazie, M.D., System Director, Division 
of Pain Medicine, Allegheny Health Network, and Program Director, Pain 
                          Medicine Fellowship
                              introduction
    Mr. Chairman and committee members, thank you for the invitation 
and opportunity to address you on this important issue that has 
contributed to the staggering increase in abuse, diversion, addiction 
and overdose deaths in our region and the country.

    I am the Medical Director for the Allegheny Health Network Division 
of Pain Medicine, board certified in anesthesiology and pain medicine 
by the American Board of Anesthesiology and American Board of Medical 
Specialties. My responsibilities include oversite of both employed and 
independent pain medicine physicians in the Allegheny Health Network, 
developing policy and procedures and direct patient care. During my 
career I have been invited to lecture on pain medicine at national, 
regional and local meetings.

    In addition to my role as medical director, I am also the Program 
Director for the Multidisciplinary Pain Medicine Fellowship, Allegheny 
General Hospital/Western Pennsylvania Hospital Medical Education 
Consortium. The fellowship involves multiple medical disciplines, 
including psychiatry, neurology, physical medicine and rehabilitation 
and anesthesiology. Since starting the fellowship in 2000, I have 
trained 51 fellows and countless residents.

    My medical career began at the Western Pennsylvania Hospital. After 
completing my fellowship, I started a pain medicine program to serve 
patients in the community, and assist my medical colleagues with their 
chronic pain patients. Around that time Purdue launched Oxycontin and a 
small but nationally influential group of physicians in positions of 
prominence were extolling the virtues and safety of opioids for chronic 
nonmalignant pain. Since that time I have observed a dramatic increase 
in opioid prescribing in southwestern Pennsylvania by physicians, many 
of which were ill equipped and under trained to deal appropriately with 
chronic pain patients.
                    the prescription opioid epidemic
    One of the major contributors to the current opioid epidemic in the 
United States is the over prescribing of opioids for chronic pain. As a 
Nation, we consume approximately 99 percent of the hydrocodone, 80 
percent of the oxycodone and 58 percent of the methadone produced in 
the world (Institute of Addiction Medicine). This has contributed to a 
dramatic increase in opioid abuse, addiction and deaths due to 
overdose. In addition to the tragic personal toll, the direct and 
indirect economic cost associated with opioids places a significant 
burden on health care dollars (Birnbaum HG).
                    multiple drivers of the epidemic
    In the 1980s and 1990s, multiple factors contributed to a change in 
opioid prescribing for chronic nonmalignant pain. Based on scant and 
faulty medical data, the risk of addiction was touted as rare, end 
organ toxicity nonexistent and the incidence of tolerance low (Portenoy 
RK). Armed with this information, physicians became less reluctant to 
prescribe opioids, patient advocacy groups demanded better treatment 
for chronic pain, and pharmaceutical companies began reformulating 
opioids into extended release preparations (1996 Purdue launches 
Oxycontin). This brought about in a dramatic increase in analgesic 
prescribing for chronic nonmalignant pain that coincided with the rise 
in opioid related morbidity and mortality (Braden JB). Little has been 
done to effectively address and curtail the over prescribing of 
opioids.

    Primary care physicians and internal medicine physicians prescribe 
the majority of opioid medications in the United States, and most were 
not trained in addiction or pain management (Volkow ND). While most 
doctors prescribe opioids with good intent and to treat their patients' 
pain with compassion, once that treatment path is started, it is often 
times very difficult to reverse. This can lead to disgruntled patients 
and frustrated physicians. Physicians who have compensation or 
employment tied to patient satisfaction scores may feel pressure to 
prescribe opioids in response to patient pain complaints.

    Nationally, there are major disparities in prescribing opioids for 
chronic pain (Paulozzi LJ). In some regions, including southwestern 
Pennsylvania, this has resulted in ``pill mills'' for profit. They prey 
on those with the disease of addiction out of greed. This has been 
addressed by legislation and law enforcement. Ten States have enacted a 
pill mill law as of May 2013. There are also physicians who tacitly 
prescribe opioids to continue patients on a long path of procedures 
that financially benefit the physician with little long term benefit to 
the patient, in some circles known as ``pills for pokes.'' This is a 
very small but difficult practice pattern to detect without close 
oversite.

    While much attention has been focused on opioid abuse, addiction, 
and mortality, there is also the issue of unintentional opioid misuse 
and subsequent adverse events. This is an issue especially in the 
elderly population who are at increased risk of falls and fractures 
(Miller M), cognitive impairment and unintentional overdosing. These 
adverse events result in increased emergency room visits, hospital 
admissions and length of stay adding strain to the health care costs in 
the United States (Birnbaum HG).

    To curb the prescription opioid epidemic, State medical boards and 
physician groups have developed and published guidelines on the use of 
opioids to treat chronic nonmalignant pain (Hughes MA). The Center for 
Disease Control and Prevention is currently drafting guidelines as 
well. Where treatment strategies do exist to aid providers, studies 
show that some providers do not follow them, even for high risk 
patients (Gupta A). When queried about inappropriate opioid prescribing 
in light of published guidelines, one group of physicians responded, 
``they are only guidelines.'' While opioid prescribing has slowed, it 
still remains at problematic levels. The CDC found that in 2012, United 
States physicians wrote 82.5 prescriptions for opioids for every 100 
people.

    A promising tool to combat prescription drug abuse are State 
Prescription Drug Monitoring Programs (PDMPs). As of July 2013 there 
are 47 States with operational PDMPs, however they are significantly 
underutilized when not mandatory. To further address inappropriate 
opioid prescribing, Physicians for Responsible Opioid Prescribing 
(PROP) has petitioned for a mandatory limit on the amount and duration 
of opioids that can be prescribed to a patient with chronic 
nonmalignant pain. This has resulted in condemnation from patient 
advocacy groups, fearing absolute rules will leave many chronic pain 
patients without help.
                   recommendations for consideration
    We cannot address the opioid epidemic by painting with a broad 
brush of absolutes, mandating dosing and time limits. There is a small 
subset of patients who will require large doses of opioids for extended 
periods of time and do well (Kalso E). They should not be denied this 
therapeutic option. However, this should be a treatment of last resort, 
when all other attempts to control chronic pain have failed. Most 
patients with chronic pain can be treated with satisfactory results 
using a multidisciplinary approach without the use of long term opioid 
therapy (Flor H).

    To engage physicians in this endeavor we will require more than 
published guidelines that are either ignored or underutilized. Many 
physicians have opted out of the Risk Evaluation and Mitigation 
Strategy (REMS) for extended release and long acting (ER/LA) opioids as 
it is voluntary. Mandatory REMS coupled with obtaining a DEA number to 
prescribe opioids for chronic pain of longer than 3 months might be one 
strategy. This should include short-acting opioids as well as they are 
widely associated with abuse (MMWR). The REMS would require physicians 
to discuss with and educate the patient about potential risks, possible 
benefits, outline goals, and develop an exit strategy. This would not 
interfere with a physicians' ability to treat acute pain with opioids 
for a short period of time when appropriate.

    Enacting pill mill laws in all States may be a promising modality 
to help curb abuse, diversion and overdose.

    There needs to be in place in every State, and on the Federal 
level, a prescription drug monitoring program, easily accessible and 
user friendly that is available to physicians and pharmacies. The use 
of this program should be mandatory before prescribing or dispensing 
controlled substances.

    Referrals to multidisciplinary pain programs should be made in a 
timely fashion for patients on opioids for chronic pain for evaluation, 
treatment recommendations and if necessary, reasonable medication 
management and monitoring.

    To curtail the prescription opioid epidemic, all stakeholders need 
to come together and act quickly to address this national health 
crisis.

    Thank you for your invitation and the opportunity to discuss this 
important issue.
                               references
     (1) Institute of Addiction Medicine. February 22, 2013. 2p2.
     (2) Physicians for Responsible Opioid Prescribing. 
www.responsibleopioidpre-scribing.org.
     (3) Flor H et al. Pain. Vol 49, Issue 2, may 1992, pg. 221-230.
     (4) Bureau of Justice Assistance, Office of Justice Programs. U.S. 
D.O.J.
     (5) Birnbaum HG et al. Pain Med 2011;12(4):657-667.
     (6) Paulozzi LJ et el. Morb Mortal Wkly Rep 2014; 63(26).
     (7) Miller m et al. J Am Geriatr Soc. 2011;59(3):430-438.
     (8) Hughes MA et al. J Mange Care Med. 2011;14(3):52-58.
     (9) Kalso E et al. Pain Vol 112, Issue 3 Dec 2004, pp 372-380.
    (10) Volkow ND et al. JAMA. 2011;305(13):1346-1347.
    (11) Braden JB et al. J. Pain. 2008;9(11):1026-1035.
    (12) Portenoy RK, Foley KM. Pain. 1986 May;25(2):171-86
    (13) Prescription Drug Monitoring Programs: an Assessment of the 
Evidence for Best Practices. Sep 20, 2012.
    (14) Gupta A et al. Pain Physician. 2011;14:383-389.
    (15) MMWR Morb Mortal Wkly Rep. 2010;59(23):705-709.

                                 ______
                                 
    Prepared Statement of Shari M. Ling, M.D., Deputy Chief Medical 
  Officer, Centers for Medicare and Medicaid Services, Department of 
                       Health and Huamn Services
    Chairman Toomey and members of the subcommittee, thank you for 
inviting me to discuss the Centers for Medicare and Medicaid Services' 
(CMS) work to ensure that all Medicare and Medicaid beneficiaries are 
receiving the medicines they need while also reducing and preventing 
non-medical prescription drug use.

    Opioid addiction is taking a real toll on communities, families and 
individuals both here in Pennsylvania and across the Nation. Deaths 
from drug overdose have risen steadily over the past two decades and 
have become the leading cause of injury death in the United States. 
Prescription drugs, especially opioid analgesics--a class of 
prescription drugs such as hydrocodone, oxycodone, and morphine used to 
treat both acute and chronic pain--have increasingly been implicated in 
drug overdose deaths over the last decade. From 1999 to 2013, the rate 
for drug poisoning deaths involving opioid analgesics nearly 
quadrupled. Deaths related to heroin also have increased sharply since 
2010, with a 39-percent increase between 2012 and 2013.\1\ It is 
estimated that 12 percent of all Medicaid beneficiaries ages 18-64 and 
15 percent of uninsured individuals who could be eligible for Medicaid 
coverage have a Substance Use Disorder. Given these alarming trends, it 
is time for a smart and sustainable response to prevent non-medical 
prescription opioid use and overdose and to treat people with opioid 
use disorder. The monetary costs and associated collateral impact to 
society due to Substance Use Disorder (SUD), including opioid use 
disorder, are high. In 2009, health insurance payers spent $24 billion 
for treating SUDs, of which Medicaid accounted for 21 percent of 
spending.\2\ The Medicare program, through Part D, spent $2.7 billion 
on opioids overall in 2011, of which $1.9 billion (69 percent) was 
accounted for by opioid users with spending in the top 5 percent.\3\
---------------------------------------------------------------------------
    \1\ National Center for Health Statistics/Centers for Disease 
Control and Prevention, National Vital Statistics Report, Final death 
data for each calendar year (October 2014).
    \2\ Centers for Disease Control and Prevention. Drug Overdose in 
the United States: Fact Sheet, Home and Recreational Safety, accessed 
on October 28, 2013 from http://www.cdc.gov/drugoverdose/index.html.
    \3\ Suzuki, Shinobu. Potentially Inappropriate Opioid Use in 
Medicare Part D. MEDPAC. October 9, 2014, http://www.medpac.gov/
documents/october-2014-meeting-presentation-potentially-
inappropriate-opioid-use-in-medicare-part-d-.pdf?sfvrsn=0.

    Combating non-medical prescription opioid use, dependence, and 
overdose is a priority for Department of Health and Human Services 
(HHS) Secretary Burwell and the administration at large. As part of 
that commitment, the Secretary launched an evidence-based opioid 
initiative that focuses on three targeted areas: informing opioid 
prescribing practices, increasing the use of naloxone (a drug that 
reverses the deadly respiratory effects of opioid drug overdose), and 
expanding the use of medication-assisted treatment to treat opioid use 
disorder. As part of our role in these efforts across HHS, CMS released 
guidance \4\ to help States implement comprehensive, evidence-based 
service delivery approaches to Substance Use Disorder treatment. CMS is 
establishing a new Medicaid demonstration opportunity for States 
seeking to undertake significant improvements in the delivery of care 
to individuals with Substance Use Disorder.
---------------------------------------------------------------------------
    \4\ State Medicaid Director Letter, ``New Service Delivery 
Opportunities for Individuals with a Substance Use Disorder,''
    http://www.medicaid.gov/federal-policy-guidance/downloads/
SMD15003.pdf.

    Moving forward, CMS has a responsibility to protect the health of 
Medicare and Medicaid beneficiaries, here in Pennsylvania and across 
the Nation, by putting appropriate safeguards in place to help prevent 
non-medical use and abuse of opioids, while ensuring that beneficiaries 
can access needed medications and appropriate treatments for SUD.
   preventing overprescribing and abuse of opioids in medicare part d
    Since its inception in 2006, the Medicare Part D prescription drug 
benefit program has made medicines more available and affordable for 
Medicare beneficiaries, leading to improvements in access to 
prescription drugs, better health outcomes, and more beneficiary 
satisfaction with their Medicare coverage.\5\
---------------------------------------------------------------------------
    \5\ In 2013, more than one million distinct health care providers 
collectively prescribed $103 billion in prescription drugs under the 
Part D program. In all, Part D spent $3.9 billion on prescription 
opioids in 2013, https://www.cms.gov/Newsroom/MediaReleaseDatabase/
Fact-sheets/2015-Fact-sheets-items/2015-04-30.html.

    Despite these successes, Part D is not immune from the nationwide 
epidemic of opioid abuse. Based on input from the Department of Health 
and Human Services' Office of the Inspector General (HHS OIG), the 
Government Accountability Office (GAO), and stakeholders, over the past 
several years, CMS has broadened from the initial focus of 
strengthening beneficiary access to prescribed drugs to also address 
prescription drug abuse and fraud. CMS is aware of potential fraud at 
the prescriber and pharmacy levels through ``pill mill'' schemes. This 
is a term used by local and State investigators to describe a 
physician, clinic, or pharmacy that is prescribing or dispensing 
opioids for non-medical and inappropriate purposes. The structure of 
the program, in which Part D plan sponsors do not have access to Part D 
prescriber and pharmacy data beyond the transactions they manage for 
their own enrollees, makes it more difficult to identify prescribers or 
pharmacies that are outliers in their prescribing or dispensing 
patterns relative to the entire Part D program. We believe that broader 
reforms that result in better-coordinated care will help address 
several issues with the complex health care delivery system, including 
non-medical use of prescription drugs. CMS has, however, taken several 
steps to protect beneficiaries from the harm and damaging effects 
associated with non-medical prescription drug use and to prevent and 
detect fraud related to prescription drugs.
Initiatives to Strengthen Medicare Part D and Reduce Opioid 
        Overutilization
    A centerpiece of our strategy to reduce the inappropriate use of 
opioid analgesics in Part D is the adoption of a policy and guidance by 
which CMS encourages case management of Part D enrollees who have 
potential opioid overutilization that may present a serious threat to 
patient safety. To strengthen CMS's monitoring of Part D plan sponsors 
and to prevent overutilization of these medications, the Medicare Part 
D Overutilization Monitoring System (OMS) was implemented in 2013. The 
OMS requires Part D sponsors to implement effective safeguards to deter 
overutilization while maintaining a commitment to provide coverage for 
appropriate drug therapies that meet safety and efficacy standards. 
Through this system, CMS provides quarterly reports to sponsors on 
beneficiaries with potential opioid overutilization identified through 
analyses of Prescription Drug Event (PDE) data and through 
beneficiaries referred by the CMS Center for Program Integrity (CPI). 
Sponsors are expected to utilize various drug utilization monitoring 
(DUM) tools, including: formulary-level controls at point of sale (such 
as safety edits and quantity limits); a review of previous claim and 
clinical activity to identify at-risk beneficiaries, case management 
outreach to beneficiaries' prescribers and pharmacies, and beneficiary-
level point of sale claim edits, if necessary to prevent continued 
overutilization of opioids. Lastly, sponsors that have concluded such 
point of sale edits are appropriate are expected to share information 
with a new sponsor when the beneficiary moves to another plan in 
accordance with applicable law. To support additional monitoring by the 
new sponsor, the CMS Medicare Advantage and Prescription Drug System 
(MARx) notifies a sponsor when a beneficiary targeted for an opioid 
point of sale edit changes plans.

    We believe this Part D overutilization policy has played a key role 
in reducing opioid overutilization in the program. From 2011 through 
2014, the number of potential opioid overutilizers, based on the CMS 
definition in the OMS,\6\ decreased by approximately 26 percent, or 
7,500 beneficiaries.\7\
---------------------------------------------------------------------------
    \6\ OMS defines overutilization as the use of opioids with 
cumulative daily morphine equivalent dose (MED) exceeding 120mg for at 
least 90 consecutive days with more than three prescribers and more 
than three pharmacies contributing to their opioid claims.
    \7\ There were 29,404 potential opioid overutilizers, (or 0.29 
percent of all Part D opioid users) in 2011 and there were 21,838 
potential opioid overutilizers, (0.18 percent of all Part D opioid 
users) in 2014.

    CMS has new tools to take action against problematic prescribers. 
CMS issued a Final Rule on May 23, 2014, that both requires prescribers 
of Part D drugs to enroll in Medicare or have a valid opt-out affidavit 
on file and establishes a new revocation authority for abusive 
prescribing patterns. CMS is actively working to enroll over 400,000 
prescribers of Part D drugs by January 2016, and will enforce the 
requirement that plans deny Part D claims that are written by 
prescribers who do not meet the necessary requirements by June 2016. 
These prescribers will be subject to the same risk-based screening 
requirements that have already contributed to the removal of nearly 
575,000 provider and supplier enrollments from the Medicare program 
since the enactment of the Affordable Care Act. Requiring prescribers 
to enroll in Medicare will help CMS make sure that Part D drugs are 
prescribed by qualified individuals, and will prevent prescriptions 
from excluded or already revoked prescribers from being filled. 
Currently CMS is monitoring Part D claims data to identify provider 
types with a disproportionate number of unenrolled prescribers, such as 
dentists, and focusing our outreach strategy to target them. As we 
approach the implementation date, CMS and Part D sponsors will begin to 
target individual high volume prescribers that remain unenrolled. Upon 
enforcement of the enrollment requirement, CMS will require Part D 
plans to use point of sale edits to stop filling and paying for 
prescriptions from unenrolled prescribers after the affected 
beneficiaries have received a 3 month provisional supply and written 
---------------------------------------------------------------------------
notice from their plans.

    Additionally, CMS has established its authority to remove 
physicians or eligible professionals from Medicare when they 
demonstrate abusive prescribing patterns. A revocation for abusive 
prescribing would be based on criteria that demonstrates a pattern of 
improper prescribing and would address situations where the prescribing 
was not in compliance with Medicare requirements or where there were 
patient safety issues involved. CMS may also revoke a prescriber's 
Medicare enrollment if his or her Drug Enforcement Administration (DEA) 
Certificate of Registration is suspended or revoked, or the applicable 
licensing or administrative body for any State in which a physician or 
eligible professional practices has suspended or revoked the physician 
or eligible professional's ability to prescribe drugs. These new 
revocation authorities provide CMS with the ability to remove 
problematic prescribers from the Medicare program and prevent them from 
treating people with Medicare.
Proposals to Further Fight Opioid Overutilization in Medicare Part D
    In addition to these initiatives, the FY 2016 President's Budget 
\8\ includes several proposals that would provide CMS with additional 
tools to prevent inappropriate use of opioids. One proposal to prevent 
prescription drug abuse in Medicare Part D would give the Secretary of 
Health and Human Services (HHS) the authority to establish a program 
that would require high-risk Medicare beneficiaries to only utilize 
certain prescribers and/or pharmacies to obtain controlled substance 
prescriptions, similar to requirements in many State Medicaid programs. 
The Medicare program would be required to ensure that beneficiaries 
retain reasonable access to services of adequate quality. Currently, 
CMS requires Part D sponsors to conduct drug utilization reviews, which 
assess the prescriptions filled by a particular enrollee. These efforts 
can identify overutilization that results from inappropriate or even 
illegal activity by an enrollee, prescriber, or pharmacy. However, 
CMS's statutory authority to take preventive measures in response to 
this information is limited.
---------------------------------------------------------------------------
    \8\ Fiscal Year 2016 Budget in Brief, http://www.hhs.gov/budget/
fy2016-hhs-budget-in-brief/hhs-fy2016budget-in-brief-overview.html.

    In addition to CMS's existing authority, the FY 2016 President's 
Budget also proposes to provide the Secretary with new authorities to: 
(1) suspend coverage and payment for drugs prescribed by providers who 
have been engaged in misprescribing or overprescribing drugs with abuse 
potential; (2) suspend coverage and payment for Part D drugs when those 
prescriptions present an imminent risk to patients; and (3) require 
additional information on certain Part D prescriptions, such as 
diagnosis and incident codes, as a condition of coverage. While Part D 
sponsors have the authority to deny coverage for a prescription drug on 
the basis of lack of medical necessity, there are currently no 
objective criteria to inform the medical necessity determination, such 
as maximum daily dosages, for some controlled substances, especially 
opioids. Therefore, the only basis for establishing medical necessity 
in these cases is prescriber attestation. If the integrity of the 
prescriber is compromised, the finding of medical necessity is 
compromised as well. If the Secretary had clear authority to intervene 
in these patterns suggestive of abusive prescribing or harmful medical 
care, the incidence of coverage and payment of such questionable 
prescribing could be reduced in Medicare.
Data Analysis Conducted by the Medicare Drug Integrity Contractor 
        (MEDIC)
    CMS also contracts with the National Benefit Integrity (NBI) MEDIC, 
which is charged with identifying and investigating potential fraud and 
abuse, and developing cases for referral to law enforcement agencies. 
In September 2013, CMS directed the MEDIC to increase its focus on 
proactive data analysis in Part D, including producing, at a minimum, 
quarterly reports to plan sponsors on specific data projects, such as 
high risk pharmacies assessments.

    These assessments contain a list of pharmacies identified by CMS as 
high risk and provide plan sponsors with information to initiate new 
investigations, conduct audits, and ultimately terminate pharmacies 
from their network. For example, one Part D plan sponsor terminated 51 
pharmacies from its network as a result of the March 2015 Pharmacy Risk 
Assessment. Another Part D plan sponsor opened investigations on 16 
pharmacies as a result of the September 2014 Pharmacy Risk Assessment. 
The NBI MEDIC also conducts data analysis and other work to support 
ongoing law enforcement activities. Examples of the assistance that the 
NBI MEDIC provides includes: data, data analysis, impact calculations, 
clinical review of claims and medical records, and prescription drug 
invoice reconciliation reviews.
Data to Identify Outlier Prescribers
    CMS used prescription drug event (PDE) data to identify 1,525 
prescribers as outliers of Schedule II controlled substances in the 
95th percentile for the number of prescriptions and the number of 30-
day equivalent prescriptions. Using this information, CMS developed 
reports that clearly identified the differences in prescribing patterns 
for the identified outliers. Similar to CMS's comparative billing 
report initiatives, the goal is to: (1) proactively educate providers 
about aberrant prescribing practices; (2) act as a deterrent by making 
providers aware of the Government's monitoring of their prescribing 
practices; and (3) reduce inappropriate prescribing. CMS then sent 
these reports to half of the providers, alerting them about their 
status as outliers. CMS also shared the list of outlier prescribers 
with Part D plan sponsors in an effort to augment their current 
utilization management program. We are further developing this and 
other approaches, using a similar analysis related to prescribing of 
atypical antipsychotics.
                               conclusion
    CMS is dedicated to providing the best possible care to 
beneficiaries while also ensuring taxpayer dollars are spent on 
medically appropriate care. CMS has broadened its focus from ensuring 
beneficiaries have access to prescribed drugs to ensuring that Part D 
sponsors and State Medicaid programs implement effective safeguards and 
provide coverage for drug therapies that meet standards for safety and 
efficacy. Although there is still work that needs to be done, CMS is 
confident that our initiatives will help to reduce the rate of opioid 
addiction and overdoses in both Medicare and Medicaid.

                                 ______
                                 
 Prepared Statement of Ashley Potts, Team Leader, Crisis Stabilization 
   and Diversion Unit, Southwestern Pennsylvania Human Services, Inc.
    My name is Ashley Potts and I currently work for Southwestern 
Pennsylvania Human Services (SPHS) as a Team Leader for the Crisis 
Diversion Unit. I am currently pursuing my Master's Degree in Social 
Work, I have a Bachelor's Degree of Arts, and an Associate's Degree in 
Science. Before accepting my position at SPHS, I worked for the 
Washington Drug and Alcohol Commission (WDAC) as a case manager for 
Washington County's Restrictive Treatment Program, Drug Court, for 3 
years. However, 9 years ago my life was completely different. At 20 
years old I found myself homeless, addicted to heroin, and suicidal. I 
was facing a State prison sentence and no one in my family wanted to be 
around me. Telling you about my history will help you understand the 
importance of treatment, the impact of stigma, the need to have 
awareness on preventing addiction, and recovery is possible.

    I took my first drink of alcohol when I was 9 years old. My mother 
suffers from addiction issues of her own, so culturally I did not 
process that it was wrong. When I was 12 years old, I started smoking 
marijuana and drinking on a more regular basis. At 13, I was given my 
first Oxycontin. This is where my love for prescription pain pills 
started. I started having behavioral issues in school, getting 
suspended on a regular basis, receiving multiple fines, and eventually, 
I was expelled from high school in the ninth grade. This is the first 
time I thought that maybe I should stop using drugs. I quit abusing 
cocaine and prescription pain pills; however, I still did not seek 
treatment or therapy for the issue. I was able to remain abstinent from 
these substances for the remainder of my ninth grade year.

    At the beginning of my sophomore year of high school, I was allowed 
to return to my old school. Things were going well in the beginning, 
but eventually I fell back into old habits. This is the year I began 
using crack. My life started to spiral out of control and I began 
running away from home. I was apprehended by the police several times, 
yet I still continued to run away. Eventually, I assumed they were no 
longer looking for me. I quit going to school and just continued to use 
drugs. Someone once told me, ``Ashley if you play with fire long 
enough, eventually you will get burned.'' I did not understand what 
that meant at that moment but later it all made sense. My entire life I 
was determined never to be a heroin addict, I hated heroin addicts, I 
was better than them. The price of prescription pills were very 
expensive. The price for Oxycontin on the street was $1.00 a milligram; 
an 80 milligram pill was $80.00. I could not financially support this 
habit despite a life of crime, and eventually I gave into heroin; it 
was only $10.00 a bag. I was 17 years old.

    After breaking into my father's home and stealing some of his 
belongings, I was sentenced to juvenile probation for 6 months. During 
this time I was ordered to an outpatient program and my probation 
officer would come to school to visit me. I had moved in with my 
mother. I was able to graduate from high school despite my drug abuse 
and lack of attendance. The summer after high school graduation, I was 
18 years old, and I had not spoken to my father in quite some time. I 
called him repeatedly and told him if he did not pick me up that I was 
going to kill myself.

    My father came to pick me up. I returned to his house and went 
through the physical withdrawals of heroin. With every agonizing breath 
I said to myself, ``I am never going to use again.'' At this time, I 
still had not received any inpatient treatment; therefore, none of my 
behaviors were changing. After a short time of living there, I found 
out that I was pregnant and I was able to remain abstinent the duration 
of my pregnancy. Once I had my daughter Riley, everything changed. I 
was determined to be the best mom I could be; everything was going to 
be great.

    A few weeks after I had my daughter, I thought I could just drink 
alcohol. This lead to just snorting bags of heroin, which ultimately 
led to me having a needle in my arm again. Things were worse this time, 
worse than ever before. I took my daughter and left my father's house. 
A few weeks later, there was a knock at the door where I was staying 
with my daughter, it was my father. He begged me to let him have 
temporary custody of Riley and for me to go to rehab. I agreed. This 
was the first time I was going to go to an inpatient rehabilitation 
facility. I remember the car ride there, laying in the back seat, too 
sick to even sit up, the agonizing pain was back and with every breath 
I said, ``I am never going to use again.'' The rehabilitation stay was 
short, only 24 days, even though my family begged them to keep me. I 
refused a halfway house and returned home; it was May 13th. Riley had 
her first birthday party on May 20th, but on May 17th I was using, 
nowhere to be found. All the dreams I had of being the best mother I 
could be were shattered and enslaved to a needle. My father informed me 
to never step foot on his property again or I would be arrested.

    I was living in my car. I started selling all the things I had that 
were worth any amount of money: clothes, cell phone, and eventually my 
car. I had nowhere to stay. I moved in back in with my mother. I began 
writing fraudulent checks to support my drug habit. I stole my mother's 
checkbook and wrote fraudulent checks in her name. I broke into an 
innocent person's home and stole their belongings. I had become the 
exact thing I hated most in this world. I felt like a zombie, a hollow 
corpse. My mother had me walked out of her home in handcuffs. Everyone 
was done with me. I had several warrants out for my arrest and no 
desire to live anymore. In my head, there were only two options: go to 
treatment and stop using or kill myself.

    I decided to try treatment one more time. Again, going through the 
physical withdrawals and with every agonizing breath saying, ``I am 
never going to use again.'' I spent 7 long days in a detoxification 
unit and then 29 days in an inpatient rehabilitation program. The time 
came again where they offered me a halfway house, this time I said yes. 
This time I was homeless and had no place to return to. I transitioned 
to a halfway house in Washington, Pennsylvania; it was October 16, 
2006. Making the decision to go to a halfway house was the best 
decision I had ever made. I spent 216 days in treatment; those were the 
best days of my life because those 216 days saved my life.

    When I arrived at the halfway house, the first thing I did was turn 
myself into all the municipalities that were searching for me. They 
told me to stay where I was, and the court process would be started. I 
listened. For the first time in my life, I listened. While I was there, 
I was encouraged to participate in the Intensive Vocational 
Rehabilitation Program (IVRP), a program to assist with job 
development. I took an I.Q. test and scored at a sixth grade level; I 
was 20 years old. Several months went by and it was time for me to go 
to my sentencing court hearing. I had 7 months clean at the time and 
was prepared to face my consequences and go to jail that day. However, 
when I stood in front of the judge, he granted me 216 days time served 
and immediate parole. I finally felt like I had a second chance at life 
and was ready to take full advantage of it. Something happened this 
day, though; I became a convicted felon.

    I returned to Washington and continued with my recovery process. I 
had decided I wanted to go to college. Due to my low education scores, 
I first attended Careerlink to take some refresher courses. I enrolled 
at Community College of Allegheny County (CCAC), I still had to take 
prerequisite courses; however, I was just so excited to be in college. 
It was surreal, the girl everyone said couldn't make it, the girl that 
was told she was not college material. I was in college. I transferred 
to a technical school as I wanted to pursue a career in the medical 
field. I attended 6 hour classes, 4 days a week. It became time to 
participate in an internship; however nowhere in Ohio, Pennsylvania, or 
West Virginia would accept me due to my criminal record. I was forced 
to quit the program.

    This was my first true encounter with stigma. The decisions that I 
had made during my active addiction would haunt me for the rest of my 
life. It was a hard internal battle to continue to pursue a college 
education. I took a year off from school, but then I decided to go 
back. I returned to CCAC to finish my associate's degree and then I 
decided to go further. I enrolled at California University to obtain a 
bachelor's degree. I was sure to select a program that did not require 
an internship, so I would not have to face that stigma again. I was 
able to move forward with my career and obtain a job at the Washington 
Drug and Alcohol Commission. An employee there had vouched for my 
character due to my record. This had happened several times while 
employed there. To be able to work with the Restrictive Treatment 
Program and complete assessments at the jail, the executive director 
had to speak with people individually and let them know that I was not 
the person that I had appeared to be on a piece of paper.

    While assessing individuals for the Restrictive Treatment Program 
applications for Medicare/Medicaid would be completed. Most of these 
individuals were eligible to receive Medicaid to assist with treatment 
for their addictions. It is important to have policies in place to 
continue to assist these individuals to gain access to the treatment 
that they need. It is also important to have policies in place that 
monitor the distribution prescription pain pills. Speaking from 
personal experience having easy access to prescription pain pills can 
have a devastating impact on one's life.

    During my 3 years of employment with WDAC, I had the opportunity to 
learn about the individuals on the Restrictive Treatment Program and 
what had led them to the criminal justice system. In some cases their 
stories began by receiving a ``harmless'' prescription from their 
doctor for pain. These scenarios could include a sports injury or even 
child birth, either way they had the same outcome, drug court. Despite 
the fact that prescription painkillers are approved by the Food and 
Drug Administration, it is important to understand that does not make 
them safe. While working for WDAC, I also learned that medically 
assisted treatments such as Suboxone were being identified by 
individuals as a drug of choice rather that a treatment method. The 
Restrictive Treatment Program had individuals who were utilizing 
Vivitrol as a medical assisted treatment and they were diligently 
working to create more specialty tracks to include other medical 
assisted treatments and address the various issues attached to them.

    During my recovery process, I have had several encounters with 
stigma. My felony convictions have affected every decision I have made 
from employment, to housing, to schooling. I have not been hired for 
several positions due to my criminal record: laughed at by landlords 
when seeking rental properties; and forced out of school. No matter how 
hard society tried to bring me down, I was determined not to let it. I 
have spent several years rehabilitating my life and I never gave up on 
my dreams. I went from testing at a sixth grade education level to 
being enrolled in graduate school maintaining a 3.8 GPA. I went from 
being a client in the IVRP to sitting on their Board of Directors. I 
went from volunteering at the Washington Drug and Alcohol Commission to 
being an employee. Recently I was promoted within SPHS to be a team 
leader for their crisis diversion unit and join their management team. 
I have filed for a Governor's Pardon for my felony convictions and have 
devoted my life to helping others. I am proof that treatment works, I 
am proof of being a good person with much to offer beyond my history of 
addiction, and finally, I am proof that recovery does happen.

                                 ______
                                 
             Prepared Statement of Hon. Patrick J. Toomey, 
                    a U.S. Senator From Pennsylvania
    Thank you to John Paul and Allegheny Health Network for hosting 
this field hearing, and thank you for my fellow Finance Committee 
member, Senator Casey, for being here, too. He and I care deeply about 
how an epidemic of prescription opioid and heroin abuse is affecting 
Pennsylvania's families.

    More Pennsylvanians will die this year from overdoses and misuse of 
heroin and prescription painkillers than from influenza or homicide. 
And unlike past drug epidemics that skewed younger and were felt in 
specific locales, today, heroin and painkiller abuse are spread across 
all age, demographic groups, and regions.

    As the Senate Finance Subcommittee on Health Care will hear today 
from our witnesses, sadly, southwestern Pennsylvania has been hit 
severely hard by this epidemic.

    Stopping this epidemic and healing our communities will require a 
three-prong approach that I am pursuing as chairman of the Senate 
Finance Subcommittee on Health Care:

      1.  Stopping the illegal diversion of prescription painkillers;
      2.  Reducing the overuse of opioids for treating long-term pain; 
and
      3.  Helping those battling addiction receive appropriate 
treatment.

    Our witnesses will discuss those issues. Joining us are: Dr. Shari 
Ling, Deputy Chief Medical Officer, Centers for Medicare and Medicaid 
Services at the United States Department of Health and Human Services; 
Dr. Neil A. Capretto, Medical Director, Gateway Rehabilitation Center; 
Mr. Gene Vittone, District Attorney for Washington County; Dr. Jack 
Kabazie, System Director, Division of Pain Medicine, Allegheny Health 
Network; and Ms. Ashley Potts, Team Leader, Crisis Stabilization and 
Diversion Unit, Southwestern Pennsylvania Human Services.

    First, let's consider how we arrived at this point. The seeds of 
this crisis were planted 2 decades ago with the advent of readily 
available painkillers like hydrocodone and oxycodone. While these drugs 
can help produce immediate pain relief, they are also easily abused, 
highly addictive, and commonly diverted.

    Nearly 80 percent of heroin users previously abused prescription 
opioids.

    Despite the crackdown on many so-called ``pill mills'' where 
unethical physicians prescribed large amounts of powerful opioids in 
exchange for cash, the problems of diversion and overprescribing still 
exist.

    In fact, the nonpartisan Government Accountability Office has found 
there are more than 170,000 Medicare enrollees who are actively engaged 
in ``doctor shopping'' for physicians who will unknowingly write 
redundant opioid prescriptions.

    When other insurance plans, including Medicaid, spot this kind of 
fraud, the insurer limits or ``locks'' the individual to a single 
doctor or pharmacy to stop pill diversion and help control access to 
the addictive medication.

    Unfortunately, Medicare doesn't have this tool. That's why I've 
authored the bipartisan Stopping Medication Abuse and Protecting 
Seniors Act. My legislation, which Senator Casey has cosponsored, will 
not only help individuals battling addiction get treatment, it will 
also save taxpayers $79 million by stopping the illegal diversion of 
pain pills.

    Medicare and other insurers must also work with physicians to stop 
the medically unnecessary use of opioids to treat pain. This year, 
about 260 million painkiller prescriptions will be filled, enough for 
every American adult to have their own bottle of pills. While opioids 
can help control intense pain immediately after a surgery or a visit to 
the dentist, long-term opioid use becomes less effective in most 
patient populations, and is associated with higher rates of substance 
abuse, emergency room visits, accidental overdoses, and falls, 
especially in senior citizens.

    Medical specialty societies have begun developing new guidelines 
that reduce both the dosage and the length of time prescription opioids 
can safely be taken. For instance, the American Academy of Neurology 
now says that the risks of opioid use outweighed any benefits for 
treating headaches, lower back pain, and fibromyalgia.

    And, when opioids are used in combination with other narcotics like 
Valium or Xanax, the combination is deadly. To help providers know the 
panoply of medications a patient is taking, there must be broader usage 
of robust prescription drug monitoring programs. Making them 
interoperable across State lines will also help physicians, as well as 
law enforcement, to spot diversion and abuse.

    Finally, we must also explore ways to improve access to, and the 
quality of care. While addiction to an opioid or alcohol is often 
viewed as a moral failing, in many ways it is a chronic disease like 
diabetes and heart disease. The medical profession continues to debate 
the optimal approach, but everyone agrees that opioid addiction can be 
treated with professional help. Congress and my subcommittee are 
closely examining a number of legislative proposals in this area.

    Ending the epidemic of heroin addiction will require changes in the 
practice of medicine, government regulation, and societal views. There 
are steps we can and should take today that end diversion, reduce non-
medical use of opioids, and approach addiction like a treatable 
disease.

    I thank all of you for being here today. It shows there is a 
commitment and desire in southwestern Pennsylvania to end this 
epidemic. By working together at the Federal, State and local level, I 
am confident that opioid abuse is an enemy we can defeat.

                                 ______
                                 
   Prepared Statement of Eugene A. Vittone II, M.B.A., M.H.A, J.D., 
                District Attorney, Washington County, PA
                              introduction
    Good afternoon. I would like to thank the chairman, Senator Pat 
Toomey, for the honor and opportunity to provide testimony to the 
committee. I first met the Senator last year when he convened a working 
panel in Washington County to address the increasing problem of 
addiction in our country. He is truly a champion in this area, and I 
thank him for his recognition and dedication to resolving this deadly 
national problem.

    I would be remiss if I did not also thank our local United States 
Attorney, David Hickton, for his leadership and assistance on the 
problem of opiate abuse. Mr. Hickton is also a champion and a great 
partner for law enforcement, who are on the front lines fighting the 
epidemic of opiate drug abuse.

    It is no secret that our Nation is in the midst of an epidemic of 
drug-related deaths caused by prescription drug abuse. This is both a 
public health and a public safety crisis. Many thousands have died due 
to overdoses caused by opiate drugs and heroin. Washington County is 
not immune from this peril. Since 2011, more than 230 Washington County 
residents have lost their lives due to accidental poisoning caused by 
opiate drugs. In August of this year, we had a spate of drug overdoses 
caused by fentanyl-laced heroin which claimed several lives and placed 
Washington County in the national news. This epidemic however goes 
beyond the overdose deaths caused by opiate abuse. The epidemic also 
significantly impacts the area where I work, which is the criminal 
justice system.

    I recently conducted a statistical review of the criminal case 
filings for 2014 and discovered that at least 75 percent of the filed 
cases had a connection to drugs and alcohol. Thirty percent of our 
cases were directly linked to opiate abuse, both pills and heroin. This 
is roughly equivalent to the number of cases that we have arising from 
alcohol, including driving under the influence. From my 17 years 
working in the Washington County District Attorneys Office, I can 
assure you that this is a new event. Not too long ago, it was rare to 
see a heroin case in court--now it is rare not to have a case involving 
heroin or someone in opiate addiction.

    Our coroner, Tim Warco, has been very good about documenting the 
toll arising from this epidemic. A review of his data about the deaths 
over the past 5 years indicates that this is a problem not just for 
young people but for all age ranges. Forty-one percent of our deaths 
were people over the age of 40. Forty-six percent were from a 
combination of two or more drugs and, why we are here today, 57 percent 
were from prescription medications.

    The connection between opioid medication abuse and heroin is well 
established. As local law enforcement professionals, we have had to 
become educated in many different areas of the law--which were not 
known to us--in order to fight the abuse of these medications. We have 
responded in Washington County with numerous drug educational summits 
at local schools to warn children of the dangers of abuse of 
pharmaceuticals. We have drop boxes for unwanted medications in our 
police stations, we have embedded a Federal prosecutor in our office to 
aggressively go after drug dealers, and we have heightened and promoted 
treatment for non-violent criminal offenders. These measures are 
designed to work on both the supply side and demand side of the 
epidemic. While I am proud of what we have done thus far, I fear that 
these measures will not be sufficient alone to eliminate the problems 
of rampant opiate addiction.

    Last fall, the Pennsylvania General Assembly enacted legislation 
providing for an improved Prescription Drug Monitoring Program (PDMP). 
This legislation was sorely needed as our old system was inadequate to 
inform health care providers of who was receiving what opiod 
medications. Since that legislation was passed, the PDMP has not come 
into being largely due to the fact that no money was set aside for its 
development. State Representative Brandon Neuman has indicated to me 
that some Federal funding has become available to initiate the work of 
development of the PDMP. S.B. 480, which reauthorizes the National All 
Schedules Prescription Electronic Reporting Reauthorization Act would 
help Pennsylvania's PDMP. This would also provide for improved 
communication with neighboring States to prevent prescription 
medication diversion. It is imperative that this be done as soon as 
possible as Pennsylvania has become a source location for those coming 
from other States looking to acquire opioid medications through 
diversion.

    Washington County sits in the southwestern corner of Pennsylvania 
and is close to Maryland, Ohio, and abuts West Virginia along its 
western edge. Due to our geographical location we are an easy drive for 
those looking to acquire medications, whether they are looking to use 
forged prescriptions or prescriptions acquired through doctor shopping. 
In 2012, my office in combination with other law enforcement agencies 
arrested 12 individuals who were acquiring pills in 7 different 
Pennsylvania Counties. They were traveling as far north as the New York 
State line and to the east as far as Chambersburg. That scheme wasn't 
too sophisticated--they would simply go to different physicians--claim 
pain and obtain prescriptions which they would then alter. They were 
also manufacturing prescriptions utilizing a scanner and computer. They 
operated for at least a year and acquired tens of thousands of pills of 
Opana, OxyContin and other medications before they were arrested. There 
is no doubt that they would had been detected sooner had a PDMP been in 
place. They also would not have been able to utilize third-party 
insurance to pay for the medications if a ``lock'' had been in place to 
prevent them from doctor shopping.

    There is also an emerging trend we are seeing in the diversion of 
Suboxone which is a drug utilized in medication-assisted treatment of 
people with opiate addiction. Traditionally, methadone was utilized to 
wean people off of heroin. Suboxone is also an opiate but is prescribed 
to people in an attempt to lessen the effects of withdrawal and help 
them in recovery. I have heard reports of increased criminal activity 
near Suboxone clinics, and recently we have made arrests of individuals 
selling Suboxone on the street.

    In 2012, a physician, Oliver Herndon, was arrested and charged with 
dispensing powerful opiate drugs, oxycodone and oxymorphone. According 
to DEA Agents who investigated, Dr. Herndon was one of the largest 
suppliers of diverted Opana in the eastern United States. His parking 
lot had cars from many different States and individuals came from out 
of State to get prescriptions filled. Many pharmacies independently 
refused to fill the large prescriptions that were written. During one 
visit by an undercover agent, when asked where his prescription could 
be filled, he was told by Herndon the further away that he could get 
the prescription filled the easier it would be. Investigators learned 
that many of the pills were being sold on the street and were surprised 
to learn that once Herndon was arrested the price of Opana doubled on 
the street. Herndon provided a letter to his patients denying that he 
was under DEA investigation and indicating that he was the medical 
director for a hospice organization and two nursing homes. Herndon was 
successfully prosecuted in Federal Court for the Drug Act violations 
and also for insurance fraud from the hundreds of thousands of dollars 
that were fraudulently submitted as claims.

    I indicated earlier that over 50 percent of the people who die from 
overdoses are over the age of 40. I just spoke about a doctor who was 
supplying pills to people of all ages and was also medical director for 
two nursing homes and a hospice organization. These facts emphasize the 
need for a lock provision in health insurance policies, particularly 
Medicare, which require a patient with a drug abuse medical history to 
``lock in'' with a particular physician and pharmacy. This would help 
eliminate diversion of medications, and the prescribing patterns may be 
clearly evaluated. This would reduce Medicare fraud attributable to the 
filing of false claims and diversion of medications. This lock-in 
provision is the centerpiece of S.B. 1913 entitled the Stopping 
Medication Abuse and Protecting Seniors Act sponsored by Chairman 
Toomey.

    In closing, I am thankful for the opportunity to address the 
committee today and talk about this important challenge which is facing 
Washington County and our Nation. In the 4 years during which I have 
been learning about the epidemic and attempting to develop the means to 
fight this problem, I have learned many things. Much of what we have 
learned has been put into practice as an ever-evolving plan of action. 
I have had to accept that as a law enforcement professional, I cannot 
make this problem go away by myself. I cannot stop the accidental 
overdose deaths and devastation caused by the addiction sweeping our 
Nation. I need the help of all levels of government in combating this 
problem. I pray for consistency in the various regulatory agencies 
involved with the regulation of these powerful medications, and I look 
for a faster response to problems once they are identified. I am just 
one district attorney in a county in Pennsylvania, but there are many 
more like me facing the same crisis, and we need the ability to do our 
jobs and maintain the criminal justice system in the wake of the 
increased demands created by the opiate epidemic. Those of us in law 
enforcement, who are on the front lines of the opiate epidemic, will 
continue to enforce the law and do our best to protect the public we 
serve.

    Thank you.
    statistical review of criminal case filings in washington county
    Study Design--A statistical sample representing a 95 percent 
confidence interval was taken from the 3,377 criminal cases filed in 
Washington County in 2014. The goal was to determine within a measure 
of certainty the number of cases driven by drugs and the specific drugs 
which drove the criminal case. The sample size was 345 cases. 345 
numbers were drawn randomly from an Internet randomization service and 
criminal complaints and affidavits of probable cause for each of the 
specific cases corresponding to the randomly generated numbers were 
reviewed. Note was made of the charges filed, the police department and 
any mention of a drug in the original criminal complaint. These results 
were tallied and are given below.

    Limitations--In many cases, a specific drug may not be named in the 
criminal complaint as the use of a drug may not be relevant to the 
crime charged. For example, in a possession case the type of drug would 
be relevant; in a theft case, the fact that the offender had a drug 
problem would not be an element of the crime charged. This limitation 
on the study design would mean that the results demonstrated are more 
likely than not higher than indicated below.

    Results--A tabulation of a statistically valid sample of criminal 
case filings for Washington County in 2014 yielded the following 
results:

 
 
 
    Offenders use of a      74.78 percent of the   (258/345)
     drug--                  cases
 
Type of drug
 
    Prescription            7.25 percent of the    (25/345)
     medication--            cases
    Heroin                  22.61 percent of the    (78/345)
                             cases
    Cocaine                 2.9 percent of the     (10/345)
                             cases
    Alcohol                 32.17 percent of the   (111/345)
                             cases
    Cannabis                9.86 percent of the    (34/345)
                             cases
 


    Discussion: The results demonstrate that alcohol is still the most 
commonly abused drug resulting in criminal charges. DUIs and alcohol 
based crimes account for almost a third of the criminal cases filed in 
Washington County. Heroin is the second most commonly implicated drug 
in criminal cases. Use of an illicit drug other than alcohol resulted 
in 42.6 percent of the criminal cases filed in Washington County. The 
correlation between offender drug use and criminal activity has been 
well documented and the data produced in this statistical review of the 
filings in Washington County serves to support this correlation.


 
 
 
Other results:
    Felony charge filed           25.79 percent       (89/345)
    Misdemeanors                  74.21 percent       (256/345)
 
Domestic violence crime           5.5 percent         (19/345)
Child Abuse                       3.18 percent        (11/345)
 



                                 ACCIDENTAL OVERDOSE DEATHS IN WASHINGTON COUNTY
                                                    2011-2015
 
                    Year                       2011     2012     2013     2014     2015     Total
 
Total deaths                                     46       40       58       36       50        230
Combined drugs                                   29       22       12       19       25        107      46.52%
Prescription meds                                33       22       26       27       23        131      56.96%
 
Number of drugs found on toxocology
1                                                17       22       46       17       19        121      53.07%
2                                                14        7        6        9       18         54      23.68%
3                                                15        7        0        5        6         33      14.47%
4                                                 0        4        6        4        1         15       6.58%
5 or more                                         0        0        0        1        0          1       0.44%
 
Gender
Male                                             30       23       36       23       35        147      65.04%
Female                                           16       13       22       13       15         79      34.96%
 
Age
<19                                              14        2        1        2        1         20       9.09%
<29                                               0        3       25        5       10         43      19.55%
<39                                              10       12       10       12       15         59      26.82%
<49                                              13       13       16        6       10         58      26.36%
<59                                               7        5        5        8        8         33      15.00%
>60                                               2        1        1        3        0          7       3.18%
 
 
Source:
Washington County Coroners Office
Timothy Warco, Coroner
http://www.co.washington.pa.us/index.aspx?NID=386.


                                 ______
                                 

                             Communications

                              ----------                              


               American Association for the Treatment of 
                       Opioid Dependence (AATOD)

  225 Varick Street, 4th Floor, New York, NY 10014  Phone: (212) 566-
                       5555  Fax: (212) 366-4647

                 E-mail: [email protected].  www.aatod.org

Recommendations on Increasing Access to Effective Treatment for Opioid 
Addiction from the American Association for the Treatment of Opioid 
Dependence (AATOD)

My name is Mark Parrino, and I am writing on behalf of the American 
Association for the Treatment of Opioid Dependence (AATOD), which 
represents 1,000 Opioid Treatment Programs throughout the United 
States, treating 340,000 patients on any given day. These are the 
treatment programs that treat opioid addiction under certification 
through the Substance Abuse and Mental Health Services Administration. 
All of these programs must comply with SAMHSA's operating requirements, 
which were promulgated during 2001. All of the Opioid Treatment 
Programs (OTPs) must also comply with the Drug Enforcement 
Administration's security requirements. Finally, all of the OTPs are 
regulated by the State Opioid Treatment Authorities, which have 
different and at times more stringent, standards of regulation.

The Senate Finance Subcommittee on Health Care and its members 
understand that our country is experiencing a public health crisis of 
untreated opioid addiction. It is useful to reference a recent article 
on this topic, which was published in the New England Journal of 
Medicine on January 15, 2015, ``Trends in Opioid Analgesic Use and 
Mortality in the United States.'' Dr. Richard Dart is the lead author 
in this article, which made the following point: ``Whatever the 
measure, the past few decades have been characterized by increasing use 
and diversion of prescription drugs, including opioid medications, in 
the United States. An estimated 25 million people initiated non-medical 
use of pain relievers between 2002 and 2011.''

As the subcommittee knows, there have been a number of national reports 
from the Substance Abuse and Mental Health Services Administration 
(SAMHSA) and the Centers for Disease Control and Prevention (CDC), 
documenting the increase in the use of prescription opioids. SAMHSA has 
also documented the fact that 80% of new heroin addicted individuals 
report using prescription opioids as a gateway drug.

Need for Public Education

One of AATOD's primary recommendations, which has been made to the 
representatives at the Department of Health and Human Services and 
other federal agencies which have jurisdiction in this area, is the 
need to provide a meaningful and clear public education campaign for 
Americans, underscoring the dangers of opioid abuse and addiction. 
There has been a loss of intergenerational knowledge given the fact 
that people do not understand how they can get into trouble when 
abusing prescription opioids. Additionally, Americans need to 
understand that heroin use is not a safe alternative when they do not 
have access to prescription opioids. We recommend that the Department 
of Health and Human Services (HHS), in conjunction with its agencies, 
work with the White House Office of National Drug Control Policy in 
developing these clear messages to the American public. This would need 
to be a sustained campaign, since it took years for the American people 
to get to the current place of prescription and heroin abuse.

AATOD supports a number of the elements in Congressman Bucshon's 
legislation, especially in providing guidance to medial practitioners 
who work under the aegis of the Drug Abuse Treatment Act of 2000. Such 
practices need to provide greater education to their patients about the 
available medications to treat their illness.

Recommended Policy Initiatives

At the present time, 49 states have either enacted or implemented 
statewide Prescription Drug Monitoring Programs (PDMPs). These programs 
need to be utilized by physicians in general practice in addition to 
dentists and substance abuse treatment providers. It is understood that 
not all of these PDMPs are easy to use and should also be utilized by 
other clinical/administrative support personnel in a medical 
practitioner's office. Ultimately, medical practitioners must utilize 
these databases as a method of treating their patients with a greater 
margin of safety. Increasing such utilization of PDMPs will help in 
better treating individuals who are abusing opioids. However, it is 
part of a solution, not the only solution.

The Use of Medications to Treat Chronic Opioid Addiction

There are three federally approved medications to treat chronic opioid 
addiction in the United States: methadone, buprenorphine, and Vivitrol/
Naltrexone. It is recommended that all three medications be used in 
conjunction with other clinical support services, including counseling. 
Methadone is primarily offered through OTPs, while buprenorphine is 
primarily offered through DATA 2000 practices. Injectable Naltrexone 
products may be used in any medical setting including OBOTs and OTPs.

The National Institutes on Drug Abuse (NIDA) has funded numerous 
studies in support of the use of these medications in treating chronic 
opioid addiction. There are guidelines for the use of such medications 
through the Treatment Improvement Protocol series, published by SAMHSA, 
in addition to recently released guidelines for the use of medications 
in treating opioid addiction through the American Society of Addiction 
Medicine. Physicians need to be trained in how such medications are 
used and when opioid addicted people would benefit from each of the 
three medications, as stated above.

Opioid Overdose Prevention Toolkits

AATOD agrees with the recommendations of ONDCP and HHS in increasing 
the utilization of opioid overdose prevention tool kits. We have 
already seen the benefits of widespread availability through emergency 
responders and police forces in different cities of the United States. 
The key recommendation is to ensure that individuals who receive such 
overdose prevention tool kits get access to emergency room care once 
they have been revived. The Vermont Hub and Spoke model provides even 
more support in how such treatment is coordinated once the individual 
is saved, brought to an emergency room, and then referred to treatment 
through the available resources.

Recommendations to Increase Access to Medication Assisted Treatment for 
Opioid Addiction

Congress passed the Drug Abuse Treatment Act of 2000 and subsequently 
amended it so that physicians who are DATA 2000 waived could treat up 
to 100 patients per practice. It is understood that a few congressional 
offices and HHS are considering how to increase access to such care 
under the aegis of DATA 2000. For the record, our Association has 
opposed the elimination of this patient limit as proposed by the TREAT 
Act.

  Before federal agencies and congressional offices proceed with 
recommendations to increase access to such treatment options, there 
needs to be a better understanding of what treatment is offered through 
DATA 2000 practices at the present time.
  If there is going to be any consideration in adjusting this patient 
number, there should be clear conditions placed on practices that wish 
to treat a greater number of patients. Illustratively, physicians 
should be offering counseling services and conducting toxicology 
profiles on patients to better guide success in treatment.
  Such practitioners also need to be accessing PDMP databases before 
and during the patient's care.
  The practitioner needs to assess the patient for their clinical 
needs, which may include counseling and other ancillary support 
services to treat co-morbidities such as infectious diseases (Hepatitis 
C) or psychiatric co-morbidity (depression, anxiety).
  Patient outcomes need to be followed as a method of better 
understanding the success of such treatment interventions. In this 
case, physicians need to be able to provide information about the 
length of time a patient remains in treatment and relapse rates.

Increasing Access to the Use of Medications in Opioid Treatment 
                    Programs

At the present time, SAMHSA has certified approximately 1,300 OTPs, 
which operate in 49 states. Approximately 350,000 patients are treated 
through theseOTPs at any given point in time. AATOD has identified the 
lack of Medicaid reimbursement for OTP services as a major impediment 
in l7 states in this country. AATOD has also learned that utilization 
of such services increases by a factor of 25 percent when Medicaid 
reimbursement is available. Accordingly, AATOD is working with a number 
of policy partners to address this impediment.

If the experience of OTPs provides any guidance to Congress and this 
Subcommittee in its deliberations, the following illustration provides 
an important reference. OTPs expanded quickly in the late 1960s without 
any operating requirements. Congress passed legislation that created a 
regulatory oversight structure for these OTPs in 1972. The House Select 
Committee on Narcotics Abuse and Control directed the United States 
General Accounting Office to develop a report on Methadone Maintenance 
Treatment. This report was published in March 1990: ``Methadone 
Maintenance--Some Treatment Programs Are Not Effective; Greater Federal 
Oversight Needed.'' SAMHSA published its first Treatment Improvement 
Protocol in 1993 ``State Methadone Treatment Guidelines'' as a method 
of responding to the recommendations of the GAO report. The FDA asked 
the Institute of Medicine to evaluate the federal regulation of 
methadone treatment. The IOM released its findings in 1995, laying the 
foundation for the FDA to end its oversight of the OTPs and transition 
the oversight to SAMHSA. This was finalized in 2001. SAMHSA also 
published more detailed guidelines for OTPs in 2007 and these were 
revised during March 2015. The point in siting these references is to 
advise Congress that it took these interventions to improve the quality 
and practices of OTPs.

Conclusion

In summary, AATOD is pleased to work with members of Congress on the 
best methods of increasing access to treatment for opioid addiction and 
in educating America about the dangers of opioid abuse. This will take 
a sustained and coordinated effort so that federal policy and 
legislation need to be based on evidence and what is known to be 
effective. We have learned a great deal over the past 50 years of the 
most effective methods of treating opioid addiction. It is clear that 
our nation got into this problem in major part as a result of the 
improper and unsupervised prescribing of opioids for pain management. 
The way out is not to provide a different medication without 
appropriate supervision and the provision of essential services, which 
must be used in support of opioid addicted individuals. This explains 
our opposition to the element of the TREAT Act which completely 
eliminates the existing 100 patient restriction. Additionally, we are 
asking Congress to expand access to OTPs through Medicaid and Medicare 
to remove the existing impediments as stated above. We look forward to 
working with the House and other members of the legislature as these 
issues move forward.

                                 ______
                                 
                    American Psychiatric Association
                American Academy of Addiction Psychiatry
           American Osteopathic Academy of Addiction Medicine
The Honorable Sylvia M. Burwell
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Secretary Burwell,

We are writing on behalf of three of the foremost nationally recognized 
addiction medical specialty associations, representing more than 60,000 
physicians, to express our concerns regarding proposals to raise the 
patient limits currently reflected by the Drug Addiction Treatment Act 
of 2000 (DATA 2000). Because our organizations are entrusted by the law 
to train prescribers and health professionals on the front lines of 
treating this public health crisis, we are in eager to work with the 
Department of Health and Human Services in order to develop 
recommendations.

As you are well aware, addiction to prescription drugs and heroin is a 
public health crisis. Yet, as the number of people addicted to these 
opioids increases, there continues to be a shortage of physicians who 
are appropriately trained to treat them. The shortage severely 
complicates and impairs our ability to effectively address the 
epidemic, particularly in many rural and underserved areas of the 
nation.

We sincerely value and appreciate your interest in addressing this 
growing and complex problem. While we are aware of proposals to raise 
patient limits, the potentially adverse consequences of increased 
patient limits are of significant concern, including:
      proliferation of ``pill mills'' and the erosion of evidence-
based treatment;
      inadequate safety monitoring to protect against diversion; and
      underutilization of evidence-based mental health and substance 
abuse counseling services.

As organizations authorized to train physicians to treat opioid use 
disorders, we strongly believe that all aspects of the problem and 
possible solutions should be fully evaluated and considered before 
moving forward with any proposed policy changes.

We believe that:
      There is a need to address this public health matter as a 
priority.
      The real complexities of addressing this issue go beyond 
increasing the patient limit.
      Simply increasing the per-prescriber patient limit is 
problematic even for addiction specialists; handling 100 buprenorphine-
maintained patients in a clinically adequate manner is challenging. 
There must be frank discussions of multidisciplinary and other models 
that might better address the issue without adding undue risk for 
patients, or increasing regulatory scrutiny for all providers, which is 
against the spirit of DATA 2000.
      The right balance between patient volume and clinical 
responsiveness must be determined.

Our members are among the leading clinical experts in the treatment of 
opioid use disorders and are uniquely positioned to address these 
issues. We are currently formulating more specific recommendations and 
welcome an opportunity to work with you on how to effectively confront 
this public health crisis.

Sincerely,

Saul Levin, MD, MPH
CEO and Medical Director
American Psychiatric Association

Laurence M. Westreich, MD
President
American Academy of Addiction Psychiatry

Margaret Kotz, DO
President
American Osteopathic Academy of Addiction Medicine

Cc:  Pamela Hyde, J.D., Administrator, SAMHSA
    Elinore McCance-Katz, M.D., Ph.D., Chief Medical Officer, SAMHSA
     H. Westley Clark, M.D., J.D., M.P.H., Director, Center for 
Substance Abuse Treatment
    Michael Botticelli, Acting Director, ONDCP

                         Recommendations of the

                   American Psychiatric Association,

           American Academy of Addiction Psychiatry, and the

         American Osteopathic Academy of Addiction Medicine on

         Revisions to the Drug Addiction Treatment Act of 2000

1. Replace practice limits of 30/100 patients with a 3 tiered system:

      Tier 1: Small Primary Care or Psychiatry practices: physicians 
can follow up to 30 patients at one time, as with the present system. 
There will be NO DEA INSPECTIONS unless DEA or single state agency 
review of state PDMP data suggests the 30 patient limit has been 
exceeded (or other violations of standard clinical practice regulations 
have occurred).

      Comment: DEA inspections are frequently mentioned as a reason for 
            physicians not prescribing. This change should expand the 
            number of small prescribers. Data groups and SAMHSA should 
            notify all individuals who have taken waiver training of 
            this new option and widely publicize the change.

      Tier 2:
        OPTION ONE_SOLO PRACTICE MODEL (this practice can occur in 
a group setting, or multiple physicians can practice within the same 
system)
        After 1 year of practice, physicians can apply to go up 
from the 30 patient limit to 150 patients.
        Prescribers in this group would be required to:

      1. take 3 hours of approved addiction related CME annually,
      2.  certify that they follow a nationally recognized set of 
            standard evidence-based guidelines for the treatment of 
            patients with substance use disorders, and
      3. would be subject to occasional DEA inspections as in the 
            current system.

      Comment: This tier is comparable to the current system. The 
            increase to 150 patients would immediately address 
            identified need for additional services but not increase 
            the numbers in individual practices to a range that is 
            incompatible with good clinical practice.

        OPTION TWO_MULTIDISCIPLINARY PRACTICE
        After 1 year of practice, a physician can apply to go from 
the 30 patient limit to a range of up to 340 patients with the addition 
of up to three physician extenders to the practice (Physician 
Assistant, Nurse Practitioner). The physician would be capped at 100 
patients, each physician extender would be capped at 80 patients, with 
the total practice capped at 180 to 340 patients depending on the 
number of physician extenders in the group. This group of practitioners 
would be required to:

      1.  take 3 hours of approved addiction related CME/CEU annually,
      2.  certify that they follow a nationally recognized set of 
            standard evidence-based guidelines for the treatment of 
            patients with substance use disorders, and
      3.  be subject to occasional DEA inspections as in the current 
            system.

    Physicians in this type of practice would be required to be 
        certified in Addiction Psychiatry by the ABPN or in Addiction 
        Medicine by ABAM or ASAM, or have subspecialty board 
        certification in addiction medicine from the American 
        Osteopathic Association (AOA), unless SAMHSA grants an 
        exemption for non-specialists practicing in high-need rural 
        areas.

      Comment: In this type of multidisciplinary practice the physician 
            would be required to supervise the physician extenders. To 
            allow for the time for required supervision, should the 
            physician be capped at 80 patients? This would drop the 
            total maximum number for the practice to 320.

      Tier 3: Practices that are over 340 patients would require 
separate registration as a specialized Opioid Treatment Program, and 
would be monitored accordingly with varying staffing requirements 
related to the number of patients being treated, much more specific 
regulation of practice, and would be subject to periodic reviews by DEA 
and CARF or The Joint Commission. Physicians working in such a setting 
would be required to be certified in Addiction Psychiatry by the ABPN 
or in Addiction Medicine by ABAM or ASAM or have subspecialty board 
certification in addiction medicine from the American Osteopathic 
Association (AOA). SAMHSA/CSAT should call a meeting of the DATA 
groups, the DEA, CARF, The Joint Commission to work out the details of 
regulations for this class of OTP. Practices of this type could be 
staffed by one or more physicians and a mix of RNs, MSWs, PhDs, 
Pharmacists and drug counselors comparable to the staffing in a 
methadone maintenance program, or they could follow the staffing 
guidelines described for Tier 2/Option Two above.

      Comment: While this model is inconsistent with the intent of DATA 
            2000, it recognizes the need for expanded services and 
            protects the integrity of the DATA 2000 system, which is 
            much better suited for providing services that are 
            integrated into standard mental health and primary care 
            settings under the ACA.

2.  Permit buprenorphine prescribing by Physician Assistants and Nurse 
Practitioners in those states or jurisdictions where such practice is 
permitted. Prescribers will be required to take a standard 8 hour face-
to-face waiver course, practice under the supervision of a physician 
certified in Addiction Psychiatry by the American Board of Psychiatry 
and Neurology (ABPN) or Addiction Medicine by the American Board of 
Addiction Medicine (ABAM) or the American Society of Addiction Medicine 
(ASAM) or have subspecialty board certification in addiction medicine 
from the American Osteopathic Association (AOA), (unless exempted by 
SAMHSA for non-specialists working in high-need, rural areas), and take 
3 hours of approved addiction related CME/CEU annually. See Tier 2/
Option Two above.

3.  Explore options under telemedicine that would permit delivery of 
buprenorphine services in rural or underserved areas. Those 
telemedicine programs treating more than 340 patients will be held to 
Tier 3 standards.

4.  Additional Federal funds are needed for buprenorphine training for 
physicians and physician extenders, and for ongoing CME programs to 
enhance the clinical skills of treatment providers. Additionally, set-
aside funding is recommended for residency training programs to provide 
training in Medication Assisted Treatment and would also provide 
physician training in MAT through funding additional ABPN-approved 
addiction psychiatry fellowships, as well as general practice addiction 
medicine fellowships.

5.  Funds are also needed to cover the costs for an expanded treatment 
system for uninsured individuals with opioid use disorders, as well as 
those covered under Medicaid programs.

6.  This program should be enacted for a trial period and re-evaluated 
in three years to determine if it is successful in expanding treatment 
capacity and whether increasing the number of patients treated by each 
waivered physicians has a negative impact on the quality of treatment, 
or a negative impact on public health associated with increased 
diversion of buprenorphine or other unanticipated negative 
consequences.

                                 ______
                                 
                         Beacon Health Options

                Senate Finance Health Care Subcommittee

                Investigation into opiate abuse epidemic

                             Field Hearing

                       Thursday, October 15, 2015

            Allegheny General Hospital--Magovern Auditorium

                320 E North Avenue, Pittsburgh, PA 15212

Testimony of Steve Bentsen, MD, MBA, DFAPA, Regional Chief Medical 
Officer, Board Certified in Addiction Medicine, Beacon Health Options.

Senator Toomey and members of the Subcommittee, my name is Steve 
Bentsen, MD, DFAPA, and I serve as Beacon Health Options' Regional 
Chief Medical Officer and I am certified by the American Board of 
Psychiatry and Neurology in Addiction Psychiatry. Thank you for the 
opportunity to testify before the Subcommittee today to discuss actions 
we are taking to address the opioid crisis.

About Beacon Health Options (Beacon).

Beacon is the largest mental health specialty company in America. We 
operate in 13 counties in western Pennsylvania as Value Behavioral 
Health of Pennsylvania in the HealthChoices managed Medicaid program. 
Overall the company serves 47 million people across all 50 states and 
the United Kingdom, including more than 13 million Medicaid and other 
publicly funded members across 26 states and the District of Columbia 
through direct-to-state contracts and 50 health plan partnerships.

Substance abuse is a chronic illness and should be treated through a 
chronic care model.

Beacon proposed in a recent White Paper that a chronic disease model of 
care is required to treat opioid addiction. This framework has been 
applied to other chronic conditions, such as diabetes and cancer. The 
White Paper is available online at http://beaconlens.com/wp-content/
uploads/2015/07/Confronting-the-Crisis-of-Opioid-Addiction.pdf. The six 
tenets set forth in the paper are as follows:

      1.  Increase community resources and policies: To really have 
impact, providers need to create partnerships with local groups 
including state agencies, courts, schools etc. to link resources and 
promote better health.

      2.  Increase collaboration between payers and providers: The 
relationship between purchasers and providers must prioritize chronic 
care over episodic care through alternative payment methods.

      3.  Improve access to resources for self-management: Promote 
verbal and written explanation of treatment options, alternatives, 
risks and benefits of all evidence-based treatments including 
Medication-Assisted Therapies (MAT)

      4.  Improve design of delivery system: Build a continuum of care 
based on the chronic care model; including ASAM's 10 levels of care and 
pain management services.

      5.  Increase decision support: Apply evidence-based clinical 
practice guidelines to MAT, including real time support for prescriber 
such as the MCPAP model for adults with substance use disorders.

      6.  Implement clinical information systems: Improve care 
coordination through EHRs. Create registries of MAT recipients and 
prescribers.

These tenets are summarized in chart below:


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]  


Accepting opioid addiction as a chronic illness provides an evidence-
based framework for a chronic care model that includes changes at all 
levels--clinical, social, legislative etc. We strongly support the 
increased use of evidence based practices in the treatment of substance 
abuse, such as cognitive-behavioral therapy, medication assisted 
therapy and contingency management interventions. Additional steps need 
to be taken to recruit, train and retain a strong workforce of 
treatment professionals to provide needed therapies for substance abuse 
treatment. At Beacon, we are working with various stakeholders to turn 
chaos into order in an organized, step-by-step fashion.

Scope of the substance use disorder problem in Pennsylvania.

We are in the midst of a national ``Substance Abuse'' crisis. The 
United States averages 110 overdose deaths from legal and illegal drugs 
every day. The heroin death toll has quadrupled in the decade that 
ended in 2013, according to the Centers for Disease Control and 
Prevention. By all accounts, it has only grown worse since. In 
Washington County, Pennsylvania there have been more than 50 fatal 
overdoses this year with a number occurring in a single 24 hour period, 
according to local news accounts. Unfortunately there are similar 
stories in other counties in Pennsylvania as well as nearby states.

Opioids, both in prescription drug form as well as illicit sources such 
as heroin, are taking an enormous toll on all of our communities. A 
recent report published by the Trust for America's Health and the 
Robert Wood Johnson Foundation showed that Pennsylvania is near the top 
in the nation for drug overdose deaths. In fact, death from drug 
overdoses now exceeds death from car accidents in Pennsylvania (and 35 
other states). No socio-demographic group is being spared. We see 
reports of young, middle-aged and older people dying of these drugs. 
The demand for substance abuse services in the communities we serve has 
sky-rocketed. And unfortunately, many of the people who need treatment 
are still not seeking it due to a lack of information about treatment 
or the negative stigma that is still attached to drug abuse and 
addiction. We are working closely with local counties, providers, 
oversight groups, state officials, law enforcement, education and 
consumer advocates to help confront this crisis. We believe that a 
concerted and cooperative effort is one of our strongest weapons.

One example of a successful initiative we undertook involved helping 
people stay in treatment once they were admitted. We have seen a number 
of people leaving rehabilitation programs without the ongoing 
transitional services or resources in place to sustain recovery or 
leaving before program completion due to lack of engagement. This can 
lead to early relapse and readmission or death. Through a cooperative 
effort with counties, oversight bodies and providers, an innovative 
series of initiatives were implemented including: the use of 
motivational interviewing, focusing more on individuals early in 
treatment when the against medical advice (AMA) rate is high, improving 
weekend programming, better matching with therapists, better use of 
peers, family members, and other social supports to name just a few. 
Our work showed improvements in treatment retention with significant 
decreases in individuals leaving against medical advice including: a 
39% decrease in premature discharges from short term residential 
treatment, a 46.5% decrease on long term residential treatment and a 
50% decrease in premature discharges among individuals in short term 
dual diagnosis residential treatment programs. This demonstrates that 
we can make a difference when we focus on specific areas in need of 
improvement and when we work cooperatively. We have also provided 
substance abuse trainings to emergency departments and mental health 
units. In addition, we have recently completed a best practice 
guidelines for Suboxone prescribers.

Recommendations for federal action.

Increasing access to treatment--including MAT services.
There are currently three FDA-approved medications for the treatment of 
opioid dependence and relapse prevention. Scientific research has shown 
that these medications are an effective component of treatment, 
decrease the risk of future overdose and should be made available to 
all patients as part of a comprehensive treatment plan that includes 
counseling and behavioral interventions. In addition we support 
availability of rescue naloxone. Congress has already taken some steps 
to increase the use of MAT, appropriating $12 million in the FY 2015 
budget for states to expand access to opioid treatment services where 
MAT is an allowable use. SAMHSA has already released a Request for 
Application for this grant, and states have applied. The Administration 
has proposed doubling this funding to $25 million in FY 2016. I 
encourage Congress to consider appropriating this additional funding 
given the serious challenges that states face in responding to this 
epidemic.

Better Physician training, member awareness, and increased efforts that 
promote alternative pain strategies to opioid prescription for pain 
management.

We need to focus on function (rather than pills), cognitive and 
behavioral approaches, and non-opioid medications and devices. 
Physicians receive little to no training about substance use disorders 
during medical school. As a result, it is reasonable to believe that 
this lack of understanding has likely contributed to the significant 
increases we've seen in prescriptions for opioid pain relievers during 
the last decade despite their significant risks. We need to include 
primary care physicians in the screening of individuals and educate 
them on recognizing the signs of addiction. Members should also be 
messaged regarding the appropriate non-opiate treatments available for 
acute pain. Providers who say no to opiate medications should not risk 
negative patient satisfaction ratings. Beacon proposes that addiction 
be deemed a primary care specialty. In addition, there needs to be 
better training in the areas of diagnosis, treatment and referral of 
individuals with opioid dependence. Moreover, Beacon recommends that 
changes be made to the 42 CFR Part 2 confidentiality regulation to 
allow sharing of addiction-related information about patients for the 
purposes of care management and coordination.
Linkage to treatment.
In many cases identification of substance use does not result in 
treatment engagement. Use and provision of rescue naltrexone is an 
opportunity for engagement but rarely occurs. Frequently health care 
providers are unsure how to refer a member for substance use treatment 
when overuse is identified. In addition, as mentioned above, a 
significant number of patients who complete detoxification services do 
not engage in recommended treatment post discharge. We have found in 
pilot programs provision of case management and/or community peer 
supports significantly increases engagement and retention in treatment 
with resulting decrease in hospital readmissions. Due to fragmentation 
in the current substance use treatment system, Beacon recommends use of 
case management and peer support services for treatment engagement. 
Case management services can also enable care linkages for medical and 
psychiatric co-morbidities which are common in members with substance 
use conditions.

Innovating in reimbursement models that focus on quality, rather than 
quantity, of service.

Relative to the treatment of hypertension or diabetes, there is a 
significant disparity in the provision of best practice care for those 
receiving substance use services. Reimbursement models can improve this 
disparity. The specifications for provider performance would target 
outcomes, member engagement and movement along the continuum to less 
restrictive, intensive, community-based services, and ultimately, 
maintenance treatment. An ``episode bundle'' would pay a provider a 
flat set amount for a continuum--for example, detox, rehabilitation 
step-down and two months of outpatient treatment, followed by a year of 
follow-up care. Over that continuum, the provider would be held to 
quality outcomes, such as detox readmission, therapy completion and 
self-reports by members. Beacon would like to see the use of more 
flexible payment strategies used to support better treatment and 
outcomes.

Conclusion

We commend Senator Toomey for identifying the opioid issue as a top 
priority and appreciate Congress' commitment to holding this hearing to 
continue this important dialogue. Our current health care system needs 
to recognize the chronic disease of opioid addiction and combat the 
opioid crisis with solutions like those set forth above. Support by all 
stakeholders is required to confront and address this crisis. Thank 
you.

                                 ______
                                 
                  Letter Submitted for the Record by 
                          Allan W. Clark, M.D.
                                                    October 7, 2015
The Honorable Pat Toomey
Chairman, Senate Committee on Finance
Subcommittee on Health Care
248 Russell Senate Office Building
Washington, DC 20510

The Honorable Debbie Stabenow
Ranking Member, Senate Committee on Finance
Subcommittee on Health Care
731 Hart Senate Office Building
Washington, DC 20510

Dear Chairman Toomey and Ranking Member Stabenow,

I submit this statement for the record on behalf of the patients and 
families in southwestern Pennsylvania, northern West Virginia, and 
eastern Ohio. I have been providing psychiatric care to adults, 
children and their families in this small part of our country for 30 
years. As a result of the current epidemic in opiate drug misuse and 
overdose deaths, I have focused my medical practice to treatment of 
Opiate Use Disorders and the other mental health problems frequently 
associated with substance use disorders for the last 8 years.

Through the determined work of our patients, dedicated physicians, and 
legislators in the House and Senate, these patients are recovering the 
quality of life lost. It reminds me that Americans have always overcome 
national crises through their selflessness and unity of purpose.

The passage of the DATA 2000 Act delivered an effective, evidenced-
based and accessible treatment (buprenorphine products) for Opiate Use 
Disorders to the medical office. The position paper I submit to the 
Subcommittee describes a model of care for these patients informed by 
current research, practical experience in service delivery and patient 
response to interventions. I suggest that this model which minimizes 
the problems that have arisen with the use of buprenorphine in the 
medical office while keeping those interventions which have shown great 
promise. It is my intent, through submission of this paper, to do my 
part as a citizen and expert in the treatment of addiction, in 
providing the Senate Subcommittee on Health Care with testimony which 
may assist members in the important decisions which lie ahead in the 
area of the treatment of Opiate Use Disorders and resolution of the 
current opiate misuse crisis.

In the spirit of disclosure, I attest that I receive no money from any 
company, agency or insurance group which may or may not benefit from 
the model of treatment for Opiate Use Disorder described. As an Air 
Force veteran, I believe service to country is its own reward.

Respectfully submitted,

Allan W. Clark, M.D.

Quality and Outcomes Management in the Treatment of Opiate Use Disorder 
                      with Buprenorphine Products

                       Allan William Clark, M.D.

ABSTRACT

In the U.S. we face yet another public health crisis. Although smoking 
and obesity related deaths far surpass all other causes of death in 
this country, death rate due to prescription opiates increased 3-fold 
from 2001 to 2013, and heroin overdoses increased 5-fold during the 
same time period.

At the same time, recent legislative actions (Affordable Care Act 2010, 
Mental Health Parity and Addiction Act of 2008) are reshaping they way 
in which mental health care and addiction treatment are delivered in 
the U.S.

The Mental Health Parity and Addiction Act of 2008 ``requires group 
health plans and health insurance issuers to ensure that financial 
requirements (such as co-pays, deductibles) and treatment limitations 
(such as visit limits) applicable to mental health or substance use 
disorder (MH/SUD) benefits are no more restrictive than the predominant 
requirements or limitations applied to substantially all medical/
surgical benefits. MHPAEA supplements prior provisions under the Mental 
Health Parity Act of 1996 (MHPA), which required parity with respect to 
aggregate lifetime and annual dollar limits for mental health 
benefits.''

The Affordable Care Act 2010 (ACA) empowered the Department of Health 
and Human Services (HHS), under Congress oversight, to develop a 
National Quality Strategy (NQS) to better meet the promise of providing 
all Americans with access to health care that is safe, effective, and 
affordable.

The author will review current efforts and strategies developed thus 
far by SAMSHA as part of a NQS as they may apply to the use of 
buprenorphine products in treatment of Opiate Use Disorder. 
Specifically, the author suggests a quality management strategy that 
links providers with these national strategies.

INTRODUCTION

Opiate Use Disorder is defined in the DSM-V as ``a maladaptive pattern 
of substance use leading to clinically significant impairment or 
distress'' as manifested by 2 or more symptoms from a list of 11 core 
symptoms. Buprenorphine and buprenorphine/naloxone for the treatment of 
DSM-V Opiate Use Disorder in the outpatient medical office has been 
controversial. Despite promising data regarding efficacy and safety, 
concerns about misuse, diversion, and quality of care persist. Clinics 
that specialize in the care of patients with Opiate Use Disorder are 
viewed with suspicion (New York Times 2013). Insurance companies, 
private and public, concerned over the cost of treatment, restrict dose 
or duration of the buprenorphine treatment in an effort to control 
costs and increase profit. Pharmacists feel new pressures to verify 
prescriptions in the wake of legal consequences faced by Wallgreens and 
other pharmacies sanctioned for their role in the development of 
Florida ``pill mills'' (Wall Street Journal, April 2012). Physicians 
and hospitals are reluctant to use buprenorphine in the outpatient 
setting due to the requirement for DEA inspections without ``probable 
cause.'' The DATA 2000 amendment requires physicians to comply with 
random inspections by agents of the DEA to verify compliance with the 
law. Normally, law enforcement would not be allowed to inspect a 
physician's practices unless they were able to obtain a warrant by a 
judge.

Quality of service management and outcome assessments could provide the 
relevant clinical information needed to address the current dilemmas. 
In fact, the development of quality delivery measures and strategies 
for outcomes research form the foundation of the current U.S. 
healthcare reform. In 2010, the Patient Protection and Affordable Care 
Act (PPACA--or ACA) charged the U.S. Department of Health and Human 
Services (HHS) with developing a National Quality Strategy (NQS) to 
better meet the promise of providing all Americans with access to 
health care that is safe, effective, and affordable. The Secretary of 
HHS reported to Congress in March 2011 on a National Strategy for 
Quality Improvement in Health Care. Over the last 2 years, the 
Substance Abuse and Mental Health Services Administration (SAMHSA), 
using the National Strategy for Quality Improvement (NQS) as a model, 
has developed the National Behavioral Health Quality Framework (NBHQF). 
The NBHQF has been noted in the NQS Report to Congress as an important 
effort in development of credible research on the critical concern over 
availability and safety of current treatments for mental health and 
substance use disorder.

In this draft, SAMSHA, ``recognized that relatively few acceptable 
outcome measures exist that are endorsed through NQF or other relevant 
national entities for mental health disorders.'' The current leadership 
in behavioral health care quality encourages a collaborative 
relationship between all stakeholders in the development of new 
measures as evidence accrues. They add, ``over time, it is expected 
that a rich catalog of behavioral health outcome, process, and 
structural measures will be endorsed and/or accepted as achieving the 
appropriate level of evidence by the field and payers.''

By contributing to development of new quality measures in our treatment 
of patients with Opiate Use Disorder, we add much needed clinical 
expertise to the critical process of ``achieving the appropriate level 
of evidence'' acceptable to all stakeholders.

REVIEW

Medication-Assisted Treatment of Opiate Use Disorder with buprenorphine 
is an emerging treatment born out of the DATA 2000 Act allowing 
buprenorphine and buprenorphine/nalaxone combination use in outpatient 
medical practice. Led by an unusual public/private partnership between 
SAMSHA and Reckitt Benckiser (drug manufacturer), this project's aim 
was to improve accessibility and decrease stigma for patients seeking 
treatment of Opiate Use Disorder. Twenty-four randomized controlled 
trials (RCTs) comparing buprenorphine to methadone in the maintenance 
treatment of opioid dependence with a total number of 4,497 
participants were included in a 2008 Cochrane systematic review and 
meta-analysis. The main outcome measures were treatment retention and 
suppression of illicit opioid use. Results indicate buprenorphine is 
more effective than placebo and as effective as methadone with both 
drugs being more effective at higher doses. As part of a comprehensive 
treatment program, MAT (medication-assisted treatment) has been shown 
to: \1\
---------------------------------------------------------------------------
    \1\ See reference number 1.

         Improve survival.
         Increase retention in treatment.
         Decrease illicit opiate use.
         Decrease hepatitis and HIV seroconversion.
         Decrease criminal activities.
         Increase employment.
         Improve birth outcomes with perinatal addicts.

An analysis of French overdose deaths between 1995 and 1998 found an 
average annual death rate of 0.47% for patients taking methadone, 
compared with 0.05% for buprenorphine. In the United States, the danger 
of overdose was addressed by the addition of nalaxone to the 
formulation. When injected, buprenorphine/naloxone may cause an initial 
dysphoria due to brief opiate receptor blockade. Buprenorphine/naloxone 
combination was the preferred formulation to avoid problems with 
intravenous use and death found in Europe.

Physicians who use these medications in the office for opiate 
dependence must follow specific protocols in the course of treatment. 
For example, the DATA 2000 Act acknowledges the importance of 
psychosocial interventions in the treatment of addiction. DATA 2000 
states, ``the physicians must attest that they have the capacity to 
refer addiction treatment patients for appropriate counseling and other 
non-
pharmacologic therapies.'' The ``assisting'' treatments typically 
include substance abuse counseling, group therapy, 12 Step self-help 
groups, and other social supports. The guidelines for the use of 
buprenorphine for Opiate Use Disorder published by the World Health 
Organization states, ``psychosocial interventions can add to the 
effectiveness of treatment.'' Further, they recommend that psychosocial 
services should be made available to all patients, although patients 
who decline these services should not be denied access to medication.

The NBHQF framework has identified six NQS health priorities or goals 
(evidence-based practice, person-centered care, coordinated care, 
reduction of adverse events, and cost reductions) that will be tracked 
via a set of core behavioral health quality measures. SAMSHA 
specifically intends that this document be a ``guiding document'' for 
the delivery of behavioral healthcare. SAMHSA has been working with the 
HHS Assistant Secretary for Policy and Evaluation, CMS (Center for 
Medicare and Medicaid Services) and NQF to develop measure concepts and 
to vet and validate measures or instruments for measure development.

The NQF (National Quality Forum) is a non-profit, non-partisan public 
service organization. NQF reviews, endorses and recommends use of 
standardized healthcare performance measures. Performance measures, 
also called quality measures, are essential tools used to evaluate how 
well healthcare services are being delivered. NQF endorsed measures 
that ``are often invisible at the clinical bedside but quietly 
influenced the care delivered to millions of patients everyday.'' The 
participation by groups such as the NQF, representing a wide range of 
stakeholders, insures outcome measures can fulfill the stated 
expectation of this collaborative group to ``seek meaningful, real life 
outcomes for people who are striving to attain and sustain recovery; 
build resilience, and work, learn, and participate fully in their 
communities.''

At this early phase of behavioral health quality measurement 
development, it is understood that the available measures are 
insufficient to provide meaningful information in all behavioral health 
care settings.

Most of the currently approved NBHQF quality measures are ``process 
measures.'' ``Processes'' are specific patient interventions performed 
by health care professionals that result in an particular outcome. 
Process measures are frequently used in performance measurement. 
Process measures are generally much easier to construct, require less 
data collection and analysis to produce, and are easier for both 
clinicians and non-clinicians to understand. Many performance 
measurement systems, such as the Health Plan Employer Data Information 
Set (HEDIS), are primarily measures of process of care. Process 
improvement, when linked to processes proven by randomized clinical 
trials to improve outcomes, is an important part of continuous quality 
improvement (CQI). Implementation of CQI programs based on process 
improvement can reduce variation and enhance patient care.

Practice guidelines for the treatment of illness were developed for 
this purpose. Many practice guidelines (Federation of State Medical 
Boards, American Psychiatric Association, American Society of Addiction 
Medicine) use a grading system to link the strength of the empirical 
data to the specific guideline. Recommendations to initiate and monitor 
a process (intervention) are made based upon the strength and quality 
of the research linking the intervention to desired outcome.

In these systems, an ``I'' (Roman numeral I) or ``A'' is given to those 
guidelines, or process measures, that are recommended ``with 
substantial confidence'' to produce desirable outcome based upon large 
randomized clinical trials. For example, one of the NBHQF process 
measures looks at the percentage of patients diagnosed with a new 
episode of major depression, treated with an antidepressant medication, 
and who remained on an antidepressant medication treatment for 6 
months. Several large random clinical trials support this strongly 
indicates quality outcome defined as reduction of depressive symptoms.

A ``II'' (Roman numeral II) or ``B'' rating is given to guidelines, or 
process measures, that have support from observational studies or small 
randomized clinical trials. An example of this type of guideline is the 
Management of Substance Use Disorder published in 2009 by the VA/DoD. 
They recommend that identifying and addressing other biopsychosocial 
problems may be more effective than increasing the intensity of 
addiction focused treatments when a patient has a lapse or minor 
``slip.''

Finally, a ``III'' rating denotes those guidelines or process measures 
that are developed from expert opinion but which have little scientific 
evidence to support the process indicators (e.g., the Agency for 
Healthcare Policy and Research's low back pain guidelines, most of 
which is supported by expert opinion). Essentially, practice guidelines 
such as those described above and the NBCQF constitute a outcome 
management strategy.

In his classic article, Ellwood coined the term outcomes management as 
``a technology of patient experience designed to help patients, payers, 
and providers make rational medical care-related choices based on 
better insight into the effect of these choices on the patient's 
life.'' Further, he states that this technology ``consists of a common 
patient-understood language of health outcomes; a national data base 
containing information and analysis on clinical, financial, and health 
outcomes that estimates as best we can the relation between medical 
interventions and health outcomes, as well as the relation between 
health outcomes and money; and an opportunity for each decision-maker 
to have access to the analyses that are relevant to the choices they 
must make.''

Further guidelines have been published by SAMSHA to aid in the 
development of relevant measures. To the extent possible, measures 
included in the NBHQF will:

1. Be endorsed by NQF or other relevant national quality entity where 
possible;

2. Be relevant to NQS and NBHQF priorities;

3. Address ``high-impact'' health conditions;

4. Promote alignment with program attributes and across programs, 
including health and social programs, and across HHS;

5. Reflect a mix of measurement types: outcome, process, cost/
appropriateness, and structure;

6. Apply across patient-centered episodes of care; and

7. Account for population disparities.

With the above background, we now may begin to consider useful measures 
for the outpatient medical office using buprenorphine products for the 
treatment of Opiate Use Disorder. I will organize this discussion 
around the five health care priorities designated by the U.S. 
Department of Health and Human Services.

The first priority is to ensure healthcare interventions are effective. 
The goal specifically aims to ``promote the most effective prevention, 
treatment, and recovery practices for behavioral health disorders.'' 
SAMSHA places a heavy emphasis on the inclusion of interventions shown 
to be effective in large randomized clinical trials. Measures within 
this group focus on processes or clinical interventions strongly linked 
to substantial empirical evidence for quality outcome. An example of 
outcomes management in action is the currently approved COMS process 
measure involving treatment of major depression. There is substantial 
clinical evidence that proper use of an antidepressant results in a 
desirable outcome for patients suffering from major depression. In all 
practice guidelines, this recommendation is categorized as I or A. As 
such, given the high prevalence and impact of major depression, this 
was chosen and approved as a process measure. In this case, the NBHQF 
targets percentage of patients diagnosed with major depression who 
receive antidepressant treatment.

Several different accrediting bodies have developed practice guidelines 
for use of buprenorphine in the office using the above described 
grading system. These guidelines organize current empirical evidence 
demonstrating reduction of opioid use, reduction of opioid-related 
health and social problems, and better engagement and retention in 
treatment with the use of buprenorphine. As with the use of 
antidepressants for Major Depressive episodes, a patient who presents 
with depression may choose cognitive behavioral therapy or other 
treatments which have been shown empirically to reduce depressive 
symptoms instead of an antidepressant. Other patients may chose to take 
an antidepressant and engage in one of theses other psychosocial 
treatments. The point is not that every patient suffering from Opiate 
Use Disorder take buprenorphine, but that they are given a choice of 
interventions based upon empirical evidence. The ability to provide 
buprenorphine treatment to any patient for which it is indicated is a 
measure of quality care.

A second ``high impact'' and well researched process is the 
identification and treatment of co-morbid psychiatric diagnosis in 
persons suffering from Opiate Use Disorder. Coexisting psychiatric 
disorders are present in 20% to 60% of the persons entering addiction 
treatment, especially older individuals, those living in urban areas, 
patients who are incarcerated, or patients of a lower socioeconomic 
status. Presence of major depression is linked to poor outcome in 
patients suffering from Opiate Use Disorder, as well as many other 
indicators of health (heart disease, stroke).\2\ Regularly monitoring 
of depressive and anxiety disorders in patients with Opiate Use 
Disorder allows the providers to identify and address these potential 
obstacles to satisfying recovery. Unless comorbidity is taken into 
consideration, measures of the outcome of treatment for opiate 
addiction will fail to tease apart the possibility of better outcomes 
of patients with no comorbidity, thereby compromising a fair test of 
treatment effects. The identification, monitoring, referral and/or 
treatment of comorbid conditions signals quality of care in the 
treatment of Opiate Use Disorder for the above reasons as delineated in 
the practice guidelines.
---------------------------------------------------------------------------
    \2\ See reference number 2.

As we have discussed, the NQF has challenges providers to develop 
outcome measures which ``seek meaningful, real life outcomes for people 
who are striving to attain and sustain recovery; build resilience, and 
work, learn, and participate fully in their communities.'' Several 
promising surveys to measure this concept are being developed by the 
WHO (World Health Organization). The WHO Quality of Life instruments 
define health as ``a state of complete physical, mental, and social 
well-being, not merely the absence of disease.'' WHO, with the aid of 
15 collaborating centers around the world, has developed 2 interments 
for measuring quality of life (the WHOQOL-100 and the WHOQOL-BREF), 
that can be used in a variety of cultural settings while allowing the 
results from different populations and countries to be compared. Both 
instruments show good discriminant validity, content validity, and 
test-retest reliability. The routine use of the QOLBREF in the 
treatment of Opiate Use Disorder and comorbid conditions provides 
crucial data with which to ensure that the interventions which the 
---------------------------------------------------------------------------
patients chooses are effective.

In summary, under the priority of effective care, we attach measures to 
processes which have substantial clinical evidence supporting our 
outcome goals.

        Percent of patients diagnosed with Opiate Use Disorder offered 
buprenorphine as part of their overall treatment.

        Percentage of patients presenting for Opiate Use Disorder who 
receive a comprehensive psychiatric evaluation to identify comorbid 
diagnosis.

        Monthly assessment using PHQ-9 and GAD-7 to monitor for these 
syndromes as treatment progresses.

        Monthly urine drug analysis.

        QOL BREF every 6 months.

The second healthcare goal identified is person-centered care. Morris 
Chavez, M.D. in the 1950s at the Massachusetts General Hospital 
Alcoholism Clinic was able to dramatically improve engagement and 
retention in treatment of alcoholics presenting to the MGH emergency 
room using novel interventions considered patient-centered. He 
concluded that these patients achieved better outcome when they 
received ``caring and organized'' treatment. The concept of person-
centered care has gained considerable momentum in current healthcare 
reform. This has become a key determinate of quality care. Large 
randomized clinical trials have shown that engagement and retention are 
crucial to the recovery process from mental illness and substance use 
disorders.

SAMSHA's Working Definition of Recovery from Mental Disorders and 
Substance Use Disorders revised in 2011 describes 10 Guiding Principles 
of Recovery. These person-centered concepts were vetted by SAMSHA with 
consumers, persons in recovery, family members, advocates, policy-
makers, administrators, providers and others. In this manner, concept 
validity was established for this dimension of quality care. The 
Patient Assessment of Care for Chronic Conditions published by Group 
Health (PAIAC) measures patient engagement in care. It is a self-
administered assessment asking questions about were they given a 
written list of things they could do to improve their health, were they 
encouraged to go to a group to help them cope better with a their 
chronic condition, and asked how the chronic condition effects their 
life. It consists of 20 questions answered on a Likert scale. Higher 
scores signify better engagement. The problem with this measure is that 
it is designed to be scored by an independent agency for reasons of 
confidentiality and candor. As an alternative one could gather this 
extremely useful data while preserving confidentiality. This would 
allow for outside agency review in an HIPAA compliant manner when 
requested.

The inclusion of a competent family/social network assessment at onset 
of treatment is recommended in the NBHQF draft. Again, this is an 
evidenced based process indicator strongly linked to better outcome in 
several large randomized trials and has been included as a 
recommendation in two practice parameters addressing buprenorphine use 
for Opiate Use Disorder.\3\ The stronger the link between family/social 
network assessment and targeted intervention aimed to strengthen 
resiliency and mitigate vulnerabilities the better the outcome. 
Thereby, presence of this assessment in the EHR signals a quality 
process linked to quality outcome.
---------------------------------------------------------------------------
    \3\ See reference number 3.

Recommended measures targeting the evidence base currently available 
---------------------------------------------------------------------------
would include:

       PAIAC every 6 months.

        Presence of competent family/social network assessment at 
onset of treatment in the EHR.

The third priority is ``to encourage effective coordination within 
behavioral health care, and between behavioral health care and 
community-based primary care providers, and other health care, 
recovery, and social support services.''

One process in the treatment of those with Opiate Use Disorder that we 
may chose to monitor relates powerfully to this aspect of care is 
ensuring that those suffering from addiction is ensuring that care is 
coordinated with other mental healthcare providers. With high 
percentages of co-occurring psychiatric disorders, these patients often 
seek and are engaged in mental health treatment which may include 
prescription of potentially abusable medications. For example, patients 
may fear telling the physician prescribing buprenorphine of their 
alprazolam prescription because they think the doctor will take it away 
abruptly. At times of crisis, patients may see their PCP for 
``emergency'' medication contraindicated in the treatment of the Opiate 
Use Disorder. For these reason, the following process measures appear 
to have the most support.

        Percent of patients who have had co-treating physicians 
notified of their ongoing treatment for Opiate Use Disorder.

The fourth priority is to ``assist communities to utilize best 
practices to enable healthy living.'' One of the NBHQF measures 
involves the presence of an assessment of tobacco use and, if 
indicated, a tobacco cessation intervention. These measures are 
included to promote preventive care across the broad spectrum of health 
care services. Body mass index at onset of treatment and at regular 
intervals has also been included in the NBHQF under this goal for 
similar reasons. Obesity is the major preventable cause of illness in 
the U.S.\4\ Regular monitoring of weight in behavioral health care is 
quite common given the propensity of many psychiatric medications to 
cause weight gain. Patients seeking treatment for Opiate Use Disorder 
with buprenorphine often come with a long list of psychiatric 
medication, and have trouble maintaining a healthy weight. One could 
debate the wisdom of initiating treatment for Tobacco Use Disorder, 
Obesity, and Opiate Use Disorder at the same time. However, assessment 
and monitoring of these high impact problems allows for the discussion 
to be postponed until the patient may be better equipped or motivated 
to address these health concerns. The recommended measures under this 
priority would be:
---------------------------------------------------------------------------
    \4\ See reference number 4.

        Presence of screening or intervention/treatment for tobacco 
---------------------------------------------------------------------------
use in EHR.

        Body Mass Index on intake and every 6 months.

The fifth priority is safety. The goal aims to ``make behavioral 
healthcare safer by reducing harm caused in the delivery of care.'' 
NBHQF measures include presence of suicide risk assessments, patients 
discharged on multiple psychiatric medications, and percentage of 
patients engaged in behavioral health treatment hospitalized for 
overdose.

Diversion and misuse of buprenorphine is a major safety concern in the 
treatment of Opiate Use Disorder to individuals and the community. Some 
patients attempt to use buprenorphine intravenously. This practice may 
lead to the addition of intravenous benzodiazepines, overdose and 
death. Another danger of buprenorphine treatment is diversion. Patients 
who falsely present for treatment of Opiate Use Disorder with the 
intention of selling this medicine for profit and fund further illicit 
drug use. One could make an argument for inclusion of pill counts into 
the treatment process. Pill counts can aid in determining compliance 
with medications in the absence of reliable blood levels. Pill counts 
are a reasonable method to detect diversion of medication prescribed to 
a patient. This allows for investigating suspicions in higher risk 
patients and routine monitoring of the patient population as well. Pill 
counts can go along way to reassure partners in the treatment of our 
patients that diversion is being effectively addressed. Pill counts 
done at the pharmacy dispensing the prescription for buprenorphine is 
particularly helpful in reassuring pharmacists the provider is 
responsible addressing diversion.

Should all patients enrolled in a clinic be given regular random pill 
counts? Until further information is available perhaps we may track the 
percentage of patients in the practice receiving pill counts in a 
month. Standardizing pill count practices and procedures would give the 
practitioner and other stakeholders critical data in the quest for 
safely delivered care. For example, a written office protocol where in 
clinic staff members ask the patient to go to their pharmacy for the 
count within a short period of time (1 hour). We take into 
consideration factors like the patient needing to go after work, 
distance to pharmacy and other related obstacles. We have found it 
essential to verify claims that a patient must wait until after work to 
comply with the pill counts. We have found instances where the patient 
was not at work as they said. This process, in conjunction with patient 
cross referencing to State Prescription Monitoring Programs, provides a 
formidable defense against diversion. In the absence of vetted and 
validated measures, the following is recommended:

        Percentage of active patients pill counted per month.

        Use of State Prescription Monitoring programs.

Although listed as the last criterion, the importance of affordability 
is critical. The NBHQF goals' stated purpose is to ``foster affordable 
high-quality behavioral healthcare for individuals, families, 
employers, and governments by developing and advancing new and 
recovery-oriented delivery.'' Methadone treatment studies since 2006 
have shown cost-effectiveness when compared with other treatments, and 
cost effectiveness for HIV prevention. Buprenorphine has been studied 
much less, but available studies are very encouraging as this 
medication appears to be cost-effective as well.\5\ With the 
development and wide spread use of outcome measures which better 
capture the quality of life outcomes achieved via different 
interventions, cost/benefit data will become increasingly relevant. 
Until that time, aggregated data regarding the cost per patient per 
month or year maybe the most useful and easily provided data that can 
be shared with all stakeholders.
---------------------------------------------------------------------------
    \5\ See reference number 5.
---------------------------------------------------------------------------

CONCLUSIONS

Wisely chosen quality measures as part of an outcome management 
strategy can guide us through the treacherous waters of health care 
reform. SAMSHA and other thought leaders have developed the NBHQF as a 
way to coordinate efforts nationally in this arena. This framework 
allows for the development of a common language or method to report 
data satisfying to all stakeholders. The current efforts in behavioral 
health care reform are designed to be a cooperative process. We have a 
choice between focusing on the current controversies in the use of 
buprenorphine in the medical office, and perhaps abandon efforts to 
increase access and availability of this promising approach, or we may 
use the legitimate questions posed by stakeholders as a stimulus to 
find workable solutions. In either case, we must recognize that we have 
an critical role in healthcare reform. Joining the current efforts 
appears to be the way forward in the second decade of use of 
buprenorphine in the outpatient medical office.

REFERENCES

1. National Center for Health Statistics 2013.

2. United States Department of Labor.

3. Availability Without Accessibility? State Medicaid and Authorization 
Requirements for Opioid Dependence Medications. The Avisa Group, June 
2013.

4. Buprenorphine maintenance versus placebo or methadone maintenance 
for opioid dependence.
Mattick RP1, Kimber J, Breen C, Davoli M.

5. Department of Health and Human Services, Substance Abuse and Mental 
Health Services Administration, Center for Substance Abuse Treatment, 
Division of Pharmacologic Therapies. (n.d.). Pharmacotherapy for 
Substance Use Disorders.

6. Am. J. Addict. 2004;13 Suppl 1:S17-28. French field experience with 
buprenorphine. Auriacombe M, Fatseas M, Dubernet J, Daulouede JP, 
Tignol J.

7. Paul M. Ellwood (June 9, 1988). ``Outcomes Management.'' New England 
Journal of Medicine 318 (23): 1549-1556.

8. Effect of buprenorphine dose on treatment outcome.
Fareed A, Vayalapalli S, Casarella J, Drexler K.

9. Robins et al., 1991; Kessler et al., 1994; Room, 1998; Sacks and 
Ries, 2005.

10. Kessler et al., 1994; Dausey and Desai, 2003.

11. Practice Guidelines for the Treatment of Patients With Substance 
Use Disorders Second Edition, 2010, Clinical Guidelines for the Use of 
Buprenorphine in the Treatment of Opioid Addiction 2010.

12. Average annual number of deaths 2000-2004. Source: CDC SAMMEC, MMWR 
2008;57(45):1226-1228.

                                 ______
                                 
                   Conemaugh Memorial Medical Center

                          1086 Franklin Street

                        Johnstown, PA 15905-4398

                              814-534-9000

                           www.conemaugh.org

Tuesday, October 13, 2015

Senator Pat Toomey
C/O Katelyn King Lamm
Regional Manager for Southwest Pennsylvania
Landmarks Building
100 W. Station Square Drive, Suite 225
Pittsburgh, PA 15219

Dear Senator Toomey:

Thank you for hosting the Senate finance Subcommittee on Health Care 
Field Hearing in Pittsburgh. I would like to take this opportunity to 
address the opiate addiction epidemic in western Pennsylvania and 
specifically the Greater Johnstown region.

I am a family physician and serve as Chair of the Department of Family 
Medicine and direct the Conemaugh Memorial Medical Center Family 
Medicine Residency. Within our office, we provide a Ryan White funded 
HIV clinic and a suboxone program.

Each day I see our patients suffering from the ravages of opiate abuse. 
As I rounded today, a patient wanted to make sure she could be 
discharged tomorrow to attend the funeral of a friend's son who just 
died of an overdose. This is becoming ever-more-common. Within our 
practice we are frequently admitting patients with infected injection 
sites. One patient had her finger amputated as the infection traveled 
to her bone.

In our Level 3 NICU, generally 60% or more of the babies are being 
treated for methadone or heroin withdrawal. These children are so 
jittery. Parenting a newborn is always a challenge; I cannot imagine 
how these parents struggling with their own addiction now try to parent 
these extremely fussy newborns. From a health care utilization 
perspective, the cost of treating these babies is enormous.

As physicians are trying to limit prescription drug access we are 
seeing patients turn to cheaper heroin. It is not uncommon that users 
of heroin share needles or engage in unprotected sex. These practices 
may result in transmission of HIV or hepatitis C. Such practices could 
result in an epidemic in our region similar to the ongoing situation in 
Austin, Indiana where a drug fueled outbreak has led to 153 confirmed 
HIV cases. As you are likely aware, the Centers for Disease Control and 
Prevention recently issued a health advisory alerting states, health 
departments, and doctors nationwide to be on the lookout for clusters 
of HIV and hepatitis C among intravenous drug users and take steps to 
prevent them. Our region has little access to hepatitis C treatment. We 
are seeing many young people who are infected and likely spreading the 
infection to their peers. We are also seeing Hepatitis C in our 
pregnant mothers.

We need help to combat this problem. Our drug treatment facilities are 
overburdened. Even law enforcement struggles to keep up. Needle 
exchanges are not legal in our state.

I thank you for the opportunity to share my experiences and concerns.

Sincerely,

Jeanne Spencer, MD, FAAFP, AAHIVS
Chair of Family Medicine
Program Director, Family Medicine Residency Program
Johnstown, PA 15905

                                 ______
                                 
                          Gateway Health Plan
                Cindy Pigg, BS Pharmacy, Vice President

                          Four Gateway Center

                     444 Liberty Street, Suite 2100

                          Pittsburgh, PA 15222

                      [email protected]

                               TESTIMONY

                               Before The

                          UNITED STATES SENATE

                          COMMITTEE ON FINANCE

                      SUBCOMMITTEE ON HEALTH CARE

                             FIELD HEARING

                                   On

               OPIATE ABUSE IN SOUTHWESTERN PENNSYLVANIA

                                   On

                            OCTOBER 15, 2015

Mr. Chairman and committee members, I would like to thank you for the 
opportunity to speak with you about opioid addiction. My name is Cindy 
Pigg. I am a Pharmacist and Vice President of Pharmacy at Gateway 
Health Plan and serve on the Board of the Academy of Managed Care 
Pharmacy. Headquartered in Pittsburgh, PA. Gateway Health is a Managed 
Care Organization that has served the Commonwealth's Medicaid and 
Medicare Advantage population for over 20 years. Our mission embraces 
quality, innovation, and financial soundness. We are the second largest 
participating plan in the statewide Medicaid HealthChoices Program 
delivering quality care to more than 300,000 PA Medicaid beneficiaries 
in 40 counties. Gateway Health's SM robust provider network 
encompasses more than 9,000 physicians and 100 hospitals. We also serve 
over 50,000 Pennsylvanians in 32 counties who are qualified for 
Medicare Advantage Special Needs Plans (SNPs). These individuals are 
those who are either dually eligible for Medicare and Medicaid or have 
chronic conditions such as diabetes, cardiovascular disorders or 
chronic heart failure. Many have physical disabilities as well as 
behavioral health issues.

AMCP is a national professional association of 7,000 pharmacists and 
other health care practitioners who serve society by the application of 
sound medication management principles and strategies to assist 
patients in achieving positive therapeutic outcomes. In Pennsylvania 
alone, we have over 480 active members. AMCP's members develop and 
provide a diversified range of clinical, educational and business 
management services and strategies on behalf of the more than 200 
million Americans covered by a managed care pharmacy benefit.
Studies and reports document the opioid abuse problem in Pennsylvania 
        and 
        nationwide
According to the Centers for Disease Control and Prevention (CDC), 
deaths associated with prescription medications have increased more 
than 300 percent since 1998, while prescribing rates for these drugs 
quadrupled between 1999 and 2010. Deaths connected to prescription drug 
misuse now exceed those from heroin and cocaine combined.\1\ The 
Pennsylvania Medical Society reports that more Pennsylvanians die from 
drug overdoses than from any other type of injury, including car 
accidents.\2\ In 2014, that's 2,400 deaths attributed to drug 
overdoses, or 7 people a day in Pennsylvania.\3\ Moreover, the economic 
costs of prescription drug abuse are substantial. The nonmedical use of 
controlled substances amounts to $73 billion annually in unnecessary 
costs, including lost productivity, increased costs to the criminal 
justice system, and health care expenditures.\4\, 
\5\, \6\
---------------------------------------------------------------------------
    \1\ CDC. Vital Signs: Overdoses of Prescription Opioid Pain 
Relievers--United States, 1999-2008. MMWR 2011; 60: 1-6.
    \2\ http://www.pamedsoc.org/opioids.
    \3\ Pennsylvania Medical Society, August 11, 2015: http://bit.ly/
1PguMyI. Accessed October 6, 2015.
    \4\ Centers for Disease Control and Prevention. Prescription 
painkiller overdoses in the U.S. November 2011. Available at: http://
www.cdc.gov/vitalsigns/painkilleroverdoses/. Accessed on August 25, 
2015.
    \5\ Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and 
comorbidities associated with opioid abuse in managed care and Medicaid 
beneficiaries in the United States: a comparison of two recently 
published studies. J Pain Palliat Care Pharmacother. 32010;24(3):251-
58.
    \6\ Hansen RN, Oster G, Edelsberg J, Woody GE, Sullivan SD. 
Economic costs of nonmedical use of prescription opioids. Clin J Pain. 
2011;27(3):194-202.

Rates of prescription drug abuse related to emergency department visits 
and treatment admissions have reached epidemic levels in the United 
States. All too often, many of us know someone who is battling drug 
addiction. There is a definite need for action on many fronts to 
address this growing concern. Patients, providers, patient family 
members, health plans, community based organizations, employers, and 
government must all work together to formulate and implement solutions.
S. 1913--a solution that addresses a program where abuse has been 
        documented
One area where change can be affected is in the Medicare Part D 
program. That Program does not currently permit the use of a drug 
management program (DMP) by prescription drug plans (PDPs) and Medicare 
Advantage prescription drug plans (MA-PD) to limit patients with a 
history of abuse, misuse or diversion to a single prescriber and/or 
pharmacy.

In terms of the impact to beneficiaries, a 2012 CMS study found that 
less than 1% of beneficiaries would be directed into a DMP. The study 
further found that only 0.7% of Medicare Part D beneficiaries received 
opioids from at least 4 prescribers and 4 or more pharmacies, signaling 
a high-risk patient.\7\ (Those beneficiaries in hospice or those with a 
diagnosis of cancer were excluded from the study.) In essence, DMP 
programs help to mitigate the issues associated with doctor or pharmacy 
shopping and may reduce the number of inappropriate controlled 
substance prescriptions.\8\ The limited number of beneficiaries that 
may be included in the DMP is encouraging because it is an indicator 
that the majority of beneficiaries in the Program will not have any 
change in their prescriber or pharmacy. On the other hand, that small 
group of beneficiaries that are at-risk, will have an opportunity to 
receive better coordination of care by the prescriber, pharmacy and PDP 
working together through the DMP.
---------------------------------------------------------------------------
    \7\ Announcement of Calendar Year (CY) 2013 Medicare Advantage 
Capitation Rates and Medicare Advantage and Part D Payment Policies and 
Final Call Letter. Centers for Medicare and Medicaid Services, April 2, 
2012. Available at
    http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=15078. Accessed 
September 4, 2015.
    \8\ Peirce GL, Smith MJ, Abate MA, Halverson J (2012). Doctor and 
Pharmacy Shopping for Controlled Substances. Medical Care 50:7. http://
bit.ly/1i3C8Zm. Accessed September 11, 2015.

Senator Toomey's bill S. 1913, Stopping Medication Abuse and Protecting 
Seniors Act of 2015, would allow PDPs and MA-PDs to proactively 
identify individuals at risk for controlled substance abuse, misuse or 
improper utilization. The Secretary of Health and Human Services (HHS) 
would determine the criteria for the ``at risk'' designation. The plans 
would work with a beneficiary's prescriber and give the beneficiary 
notice that they had been identified as a potential participant for 
enrollment in a drug management program (DMP). The beneficiary has 
appeal rights and can submit their preference of a specific prescriber 
and pharmacy. The use of DMPs may improve continuity of care among at-
risk plan beneficiaries, while ensuring beneficiaries with legitimate 
medical needs have continued access to effective pain control. 
Furthermore, at risk beneficiaries are still able to receive non-
controlled prescriptions at other pharmacies and from other 
prescribers. Another advantage of a DMP is that it works as prospective 
identification program allowing the plan to act in real time; as 
opposed to a retrospective program which combs through past data to 
find anomalies.
Prospective Drug Management Programs (DMPs) are more beneficial to the 
        patient
In 2013, CMS launched a federal initiative called Medicare Part D's 
Overutilization Monitoring System (OMS) to partner with PDPs and MA-PDs 
to identify Medicare beneficiaries who may be misusing or abusing 
controlled substances. OMS uses a retrospective approach, whereby a 
contractor is utilized to identify beneficiaries who receive certain 
quantities of controlled substance prescriptions on a monthly basis. 
Reports are then provided to Part D plans on a quarterly basis. While 
OMS has been successful in reducing inappropriate controlled substance 
utilization, plans must rely on reports from the contractor to identify 
beneficiaries and then assign case managers to work with the 
beneficiary.

The DMPs we are talking about today, such as the one defined in Senate 
bill 1913, is a prospective program and allows Part D plans to directly 
identify beneficiaries, provide notice to enroll and select a 
prescriber and pharmacy, and then take additional actions necessary to 
reduce the risk of inappropriate controlled substance utilization. This 
type of program is proactive and highly desirable. In addition, the 
plans must provide the beneficiary with information on other 
organizations that can provide them with contact information regarding 
drug management programs. The prospective approach allows the 
identification of at-risk beneficiaries earlier and PDP and MA-PD's can 
offer them assistance sooner.

DMPs have been successfully utilized by state Medicaid programs. On the 
state level, 46 state Medicaid programs have successfully implemented 
DMPs with positive results.\9\ An evaluation of state Medicaid DMPs, 
performed by a CDC expert panel, concluded that these programs have the 
potential to reduce opioid usage to safer levels and thus save lives 
and lower health care costs.\10\
---------------------------------------------------------------------------
    \9\ Roberts AW, Cockrell Skinner A. Assessing the Present State and 
Potential of Medicaid Controlled Substance Lock-in Programs. J Manag 
Care Pharm. 2014;20(5):439-46.
    \10\ CDC; National Center for Injury Prevention and Control. 
Beneficiary review and restriction programs. Lessons learned from state 
Medicaid programs (2012),
    http://www.cdc.gov/homeandrecreationalsafety/pdf/
PDO_beneficiary_review_meeting-a.pdf. Accessed on August 25, 2015.

---------------------------------------------------------------------------
A few examples from other states:

      In 2012, the State of North Carolina, announced $5.2 million in 
savings from their state Medicaid DMP program.\11\
---------------------------------------------------------------------------
    \11\ North Carolina Department of Health and Human Services. 2.3 
million pills off the streets, $5.2 million saved by narcotics lock-in. 
May 14, 2012.
---------------------------------------------------------------------------
      In 2009, the Oklahoma Medicaid department found that its lock-in 
program reduced doctor shopping, utilization rates of controlled 
substances, and emergency room visits with a savings of $600 per person 
in costs.\12\
---------------------------------------------------------------------------
    \12\ SoonerCare Pharmacy Lock-in Program Promotes Appropriate Use 
of Medications. September 9, 2009 [press release], http://okhca.org/
about.aspx?id=10973. Accessed on August 25, 2015.
---------------------------------------------------------------------------
      Florida reported 1,315 individuals had been placed into their 
Medicaid PRR between October 2002 and March 2005. During this time 
period, cumulative savings for medical and pharmaceutical expenses 
topped $12.5 million.\13\
---------------------------------------------------------------------------
    \13\ Centers for Disease Control and Prevention; National Center 
for Injury Prevention and Control. Patient review and restriction 
programs. Lessons learned from state Medicaid programs (2012), http://
1.usa.gov/1UJuEag. Accessed on August 25, 2015.
---------------------------------------------------------------------------
Prescription Drug Monitoring Programs
Another area that we believe would assist PDPs and MA-PDs to help an 
at-risk beneficiary is to allow pharmacists in those plans access to 
information in the Prescription Drug Monitoring Program (PDMP). In 
order for a DMP to be successful, AMCP recommends real-time data 
sharing of information compiled in PDMPs with prescribers, pharmacies, 
managed care organizations, and pharmacy benefit management companies 
(PBMs). In Pennsylvania, where access was recently amended, data in 
PDMPs is generally available to prescribers, pharmacists and other 
health care providers, and law enforcement personnel, but not PDPs, and 
MA-PDs and PBMs. Congress could help to encourage PMP data sharing by 
passing legislation to require states to adopt this practice and 
increase funding of existing PDMP programs.

Many inappropriate controlled substance prescriptions are purchased 
through cash-based transactions and not adjudicated to a private 
insurance plans, Medicare Part D, or Medicaid.\4\ This means that PDPs, 
MA-PDs or PBMs may be unaware of certain controlled substance 
prescriptions for some individuals and thus do not have all the 
information necessary to establish a basis for inappropriate 
utilization or abuse. Allowing access by PDPs, MA-PDs and PBMs could 
help to reduce inappropriate utilization or abuse by implementing 
systems to flag inappropriate utilization and provide other 
interventions to ensure appropriateness of the prescription prior to 
dispensing.

Managed care pharmacists are well-positioned to help reduce 
prescription opioid abuse, misuse, and diversion in two distinct ways. 
First, we have been managing programs on the commercial side and in 
state Medicaid programs. Through specific modeling tools unique to the 
industry, we have been able to identify beneficiaries at-risk for 
abuse, misuse or diversion and offer them the help they need. Secondly, 
through these same tools, the long-term results of having fewer at-risk 
beneficiaries involved in the misuse, abuse, or diversion of controlled 
substances will ultimately result in reduced costs to the overall 
health care system.

On behalf of Gateway Health Plan and AMCP, we strongly support S. 1913 
and your tireless efforts to address this important societal problem. 
In our opinion, S. 1913 strikes the appropriate balance by preserving 
the beneficiaries' rights to be notified, submit their preferences for 
prescriber and pharmacy and exercise appeal rights. On the other hand, 
the PDPs and MA-PDs will have the authority to identify at-risk 
beneficiaries in a prospective manner and help them obtain the 
necessary treatment sooner and improve their ability to address their 
addictions. Earlier this year, legislative language contained in 
another bill creating a drug management program in Medicare Part D for 
at-risk beneficiaries received a score from the Congressional Budget 
Office as saving $115 million over 9 years. Prescribers and pharmacies 
will also be aware of the at-risk beneficiaries' need for assistance. 
This concludes my testimony. Thank you again for inviting me to speak 
here today. Please feel free to contact me, or my colleagues at AMCP as 
a resource in tackling this very important issue. We will continue to 
work with you to enact this legislation.

                                 ______
                                 
                         Karen Geary, RPh, MHA

                             99 Sever Lane

                            West Newton, PA

                            [email protected]

                               TESTIMONY

                    Submitted for the record of the

                      UNITED STATES SENATE FINANCE

                        HEALTH CARE SUBCOMMITTEE

                             FIELD HEARING

                                   On

               OPIATE ABUSE IN SOUTHWESTERN PENNSYLVANIA

                                   On

                            OCTOBER 15, 2015

Mr. Chairman and committee members, I would like to thank you for the 
opportunity to submit comments for the record of the field hearing on 
opioid abuse. My name is Karen Geary. I am a Pharmacist, a life-long 
resident of western Pennsylvania and a member of Academy of Managed 
Care Pharmacy.

AMCP is a national professional association of 7,000 pharmacists and 
other health care practitioners who serve society by the application of 
sound medication management principles and strategies to assist 
patients in achieving positive therapeutic outcomes. In Pennsylvania 
alone, we have over 480 active members. AMCP's members develop and 
provide a diversified range of clinical, educational and business 
management services and strategies on behalf of the more than 200 
million Americans covered by a managed care pharmacy benefit.

Opioid abuse is a problem in Pennsylvania and nationwide and needs to 
be addressed

According to the Centers for Disease Control and Prevention (CDC), 
deaths associated with prescription medications have increased more 
than 300 percent since 1998, while prescribing rates for these drugs 
quadrupled between 1999 and 2010. Deaths connected to prescription drug 
misuse now exceed those from heroin and cocaine combined.\1\ The 
Pennsylvania Medical Society reports that more Pennsylvanians die from 
drug overdoses than from any other type of injury, including car 
accidents.\2\ In 2014, that's 2,400 deaths attributed to drug 
overdoses, or 7 people a day in Pennsylvania.\3\
---------------------------------------------------------------------------
    \1\ CDC. Vital Signs: Overdoses of Prescription Opioid Pain 
Relievers--United States, 1999-2008. MMWR 2011; 60: 1-6.
    \2\ http://www.pamedsoc.org/opioids.
    \3\ Pennsylvania Medical Society, August 11, 2015: http://bit.ly/
1PguMyI. Accessed October 6, 2015.

Rates of prescription drug abuse related to emergency department visits 
and treatment admissions have reached epidemic levels in the United 
States. All too often, many of us know someone who is battling drug 
addiction. Moreover, the economic costs of prescription drug abuse are 
substantial. The nonmedical use of controlled substances amounts to $73 
billionannually in unnecessary costs, including lost productivity, 
increased costs to the criminal justice system, and health care 
expenditures.\4\, \5\, \6\
---------------------------------------------------------------------------
    \4\ Centers for Disease Control and Prevention. Prescription 
painkiller overdoses in the U.S. November 2011. Available at: http://
www.cdc.gov/vitalsigns/painkilleroverdoses/. Accessed on August 25, 
2015.
    \5\ Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and 
comorbidities associated with opioid abuse in managed care and Medicaid 
beneficiaries in the United States: a comparison of two recently 
published studies. J Pain Palliat Care Pharmacother. 32010;24(3):251-
58.
    \6\ Hansen RN, Oster G, Edelsberg J, Woody GE, Sullivan SD. 
Economic costs of nonmedical use of prescription opioids. Clin J Pain. 
2011;27(3):194-202.

There is a definite need for action on many fronts to address this 
growing concern. Patients, providers, patient family members, health 
plans, community based organizations, employers, and government must 
all work together to formulate and implement solutions. One area where 
change can be affected is in the Medicare Part D program. That Program 
does not currently limit patients with a history of abuse, misuse or 
diversion to a single prescriber and/or pharmacy. The use of a drug 
management program (DMP) by prescription drug plans (PDPs) and Medicare 
Advantage prescription drug plans (MA-PD) is a managed care pharmacy 
---------------------------------------------------------------------------
solution to control access to addictive medicines.

Senator Toomey's bill S. 1913, Stopping Medication Abuse and Protecting 
Seniors Act of 2015, would allow PDPs and MA-PDs to proactively 
identify individuals at risk for controlled substance abuse, misuse or 
improper utilization. The Secretary of Health and Human Services (HHS) 
would determine the criteria for the ``at risk'' designation. The plans 
would work with a beneficiary's prescriber and give the beneficiary 
notice that they had been identified as a potential participant for 
enrollment in a drug management program (DMP).

The beneficiary has appeal rights and can submit their preference of a 
specific prescriber and pharmacy. The use of DMPs may improve 
continuity of care among at-risk plan beneficiaries, while ensuring 
beneficiaries with legitimate medical needs have continued access to 
effective pain control. At risk beneficiaries are still able to receive 
non-controlled prescriptions at other pharmacies and from other 
prescribers. In essence, DMP programs help to mitigate the issues 
associated with doctor or pharmacy shopping and may reduce the number 
of inappropriate controlled substance prescriptions.\7\
---------------------------------------------------------------------------
    \7\ Peirce GL, Smith MJ, Abate MA, Halverson J (2012) Doctor and 
Pharmacy Shopping for Controlled Substances. Medical Care 50:7. http://
bit.ly/1i3C8Zm Accessed September 11, 2015

In terms of the impact to beneficiaries, a 2012 CMS study found that 
less than 1% of beneficiaries would be directed into a DMP. The study 
further found that only 0.7% of Medicare Part D beneficiaries received 
opioids from at least 4 prescribers and 4 or more pharmacies, signaling 
a high-risk patient.\8\ (Those beneficiaries in hospice or those with a 
diagnosis of cancer were excluded from the study.)
---------------------------------------------------------------------------
    \8\ Announcement of Calendar Year (CY) 2013 Medicare Advantage 
Capitation Rates and Medicare Advantage and Part D Payment Policies and 
Final Call Letter. Centers for Medicare and Medicaid Services, April 2, 
2012. Available at
    http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=15078. Accessed 
September 4, 2015.

The limited number of beneficiaries that may be included in the DMP is 
encouraging because it is an indicator that the majority of 
beneficiaries in the Program will not have any change in their 
prescriber or pharmacy as a result of S. 1913. On the other hand, that 
small group of beneficiaries that are at-risk, will have an opportunity 
to receive better coordination of care by the prescriber, pharmacy and 
PDP working together through the DMP.
Managed care pharmacists are prepared to work with at-risk Medicare 
        beneficiaries
Managed care pharmacists are well-positioned to help reduce 
prescription opioid abuse, misuse, and diversion in two distinct ways. 
First, we experience with DMPs on the commercial side and in state 
Medicaid programs. Through specific modeling tools unique to the 
industry, we have been able to identify beneficiaries at-risk for 
abuse, misuse or diversion and offer them the help they need. Secondly, 
through these same tools, the long-term results of having fewer at-risk 
beneficiaries involved in the misuse, abuse, or diversion of controlled 
substances will ultimately result in reduced costs to the overall 
health care system.

On behalf of myself and AMCP, we strongly support S. 1913 and your 
tireless efforts to authorize a program that will address this 
important societal problem. In our opinion, S. 1913 preserves the 
beneficiaries' rights to be notified, to submit preferences for 
prescriber and pharmacy and to exercise appeal rights. However, the 
PDPs and MA-PDs will be able to identify at-risk beneficiaries sooner 
and help them obtain the necessary treatment and improve their ability 
to address their addictions. Prescribers and pharmacies will also be 
aware of the at-risk beneficiaries' need for assistance.

I unfortunately will be out of town during the October 15th field 
hearing but this is an important issue to me and I wanted to provide 
input for the record. Thank you the opportunity to be included. Please 
feel free to contact me, or my colleagues at AMCP as a resource in 
tackling this very important issue. We will continue to work with you 
to enact this legislation.

                                 ______
                                 
               The Hospital and Healthsystem Association 
                         of Pennsylvania (HAP)

                            4750 Lindle Road

                             P.O. Box 8600

                       Harrisburg, PA 17105-8600

                           717-564-9200 Phone

                            717-561-5334 Fax

                       https://www.haponline.org/

                Testimony of Michael J. Consuelos, M.D.

             Senior Vice President for Clinical Integration

    The Hospital and Healthsystem Association of Pennsylvania (HAP)

                  The U.S. Senate Committee on Finance

                      Subcommittee on Health Care

                  ``Examining Heroin and Opiate Abuse

                     in Southwestern Pennsylvania''

                            October 15, 2015

Chairman Toomey, Ranking Member Stabenow, and members of the 
Subcommittee, my name is Michael J. Consuelos, M.D., and I am the 
senior vice president for clinical integration for The Hospital and 
Healthsystem Association of Pennsylvania (HAP). HAP represents and 
advocates for the nearly 240 acute and specialty care hospitals and 
health systems across state. We appreciate the opportunity to describe 
how HAP and Pennsylvania hospitals are working to reduce opioid 
addiction and opioid related deaths.

Opioid abuse is a terrible problem in Pennsylvania, and only 
coordinated efforts across sectors of public and private stakeholders 
can increase the chance of stemming what has become a public health 
epidemic. In 2014, in the State of Pennsylvania, approximately 2,500 
people died from drug overdoses, more than double the 1,200 people who 
died from motor vehicle accidents.

HAP has joined the Pennsylvania Medical Society (PAMED), the 
Pennsylvania Department of Health (DOH), the Pennsylvania Department of 
Drug and Alcohol Programs (DDAP), and other stakeholders on the Safe 
and Effective Prescribing Practices and Pain Management Task Force. 
This taskforce has prepared three guidelines for providers who 
regularly prescribe opiate pain medications. These include prescribing 
guidelines for:

     emergency departments;
     dental practices; and
     the treatment of chronic non-cancer pain.

We are now working on guidelines for geriatric patients and obstetrical 
patients.

The taskforce is also collaborating on providing professional 
continuing education programs for physicians, nurses, and pharmacists. 
This important education supports the written prescribing guidelines 
and promulgates the use of naloxone under Pennsylvania Act 139. Act 139 
provides liability protections for first responders administering life-
saving opioid reversal medication.

Individual hospitals are assessing the impact of opioid dependency and 
related deaths in the communities they serve. Many are identifying 
opioid abuse as a major community health issue as they develop their 
most recent Community Health Needs Assessments. Emergency departments 
are seeing a growing number of opioid overdoses and working closely 
with local emergency medical services personnel and police on the 
proper use of naloxone by first responders.

Lastly, the HAP Behavioral Health Taskforce is evaluating 
Pennsylvania's existing laws, policies, and regulations addressing the 
treatment of drug abuse. Hospitals primarily rely on DDAP and country 
treatment and prevention programs. Better alignment between medical and 
behavioral health regulations can provide better transitions to, and 
adherence with, treatment services.

This activity is just a start and requires sustained support and 
additional resources to truly make an impact on this public health 
problem. HAP supports the following:

      Implementation of Pennsylvania's Achieving Better Care by 
Monitoring All Prescriptions (ABC-MAP) Prescription Drug Monitoring 
Program (POMP) to improve safe prescribing practices and identification 
of drug-seeking patients so they can receive the proper treatment.

      Federal legislation, such as S. 480, the National All-Schedules 
Prescription Electronic Reporting (NASPER) Reauthorization Act of 2015, 
introduced by Senators Shaheen (D-NH) and Toomey (R-PA), could support 
Pennsylvania in implementing ABC-MAP. Importantly, NASPER goes beyond 
providing grant support to states to establish prescription drug 
monitoring programs, but also ensures interoperability between state 
monitoring programs and within health information technology systems.

      Increasing the use of naloxone and supporting the development 
and distribution of the life-saving drug, to help reduce the number of 
deaths associated with prescription opioid and heroin overdose. S. 707, 
the Opioid Overdose Reduction Act, would expand important liability 
protections for the emergency administration of an opioid overdose 
drug.

      Expanding the use of Medication-Assisted Treatment (MAT), a 
comprehensive way to address the needs of individuals, which combines 
the use of medication with counseling and behavioral therapies to treat 
substance use disorders.

      Proliferating drug take-back programs, which provide safe and 
efficient means to destroy prescribed pain medications, thereby 
removing them from the streets.

      Assessment and evaluation of prenatal opioid abuse and neonatal 
abstinence syndrome, as outlined in S. 799, the Protecting Our Infants 
Act, introduced by Senators McConnell (R-KY) and Casey (D-PA), will 
initiate positive steps to decrease the number of infants suffering 
from opioid dependency.

In conclusion, HAP and Pennsylvania hospitals are working diligently 
with other stakeholders to address the epidemic of opioid abuse and 
overdose deaths. This good work requires continued support and 
collaboration to fully make an impact on the future health and 
wellbeing of Pennsylvanians.

                                 ______
                                 
          Letter Submitted for the Record by Julie Kmiec, D.O.

                              125 Avenue F

                          Pittsburgh, PA 15221

                              412-992-8529

                            [email protected]

Senator Pat Toomey
100 W. Station Square Dr.
Suite 225
Pittsburgh, PA 15219

October 14, 2015

Dear Senator Toomey,

I am an addiction psychiatrist and treat patients primarily who are 
addicted to opioids. Today's opioid epidemic stems back to the mid 
1990s. In 1995, Purdue Pharma released OxyContin, which is an extended 
release oxycodone tablet, which was initially billed by the 
pharmaceutical company to have low abuse potential. Around the same 
time, there was a focus developing on assessing and treating pain. A 
joint consensus statement from two pain societies published in 1996 
stated that development of addiction is low when opioids are used for 
pain and withholding opioids based on concerns about respiratory 
depression is unwarranted. Judicious use of opioid pain medications was 
encouraged to alleviate suffering. As you are aware, prescribing of 
opioid pain medications increased. From 1991 to 2013, the number of 
opioids prescribed in the United States went from 76 million to 207 
million per IMS Health, Vector One prescription records.i In 
that same period of time, deaths from prescription opioids 
tripled.ii

Today, it is estimated 1.9 million Americans abuse or are 
addicted to pill opioids.iii In Allegheny County, the SAMHSA 
National Survey on Drug Use and Health found that the prevalence of 
pill opioid use from 2010-2012 was 4.05%.iv About 75% of 
those using opioid pills will go on to use heroin due to cost.v 
My patients tell me that they buy pills for $1 per milligram, whereas 
heroin costs $10 per stamp bag. Patients usually start out using heroin 
intranasally, then as their tolerance grows, they need to use more and 
more to get the same effect, so they switch to injecting it in order to 
use less and get a greater effect. However, with time, they become 
tolerant to the effects of the injected heroin as well, and again start 
using more and more. Currently, there are 517,000 Americans addicted to 
heroin.iii Each day, 46 Americans die from prescription 
opioid overdoses vi and 22 die from heroin 
overdoses.vii In 2014, there were 299 overdose deaths in 
Allegheny County alone.viii

I see patients in all phases of their addiction, actively using, 
in detoxification, and in recovery. Sadly, I have treated several 
patients who have overdosed on opioids and died. About 50% of my 
patients have survived or witnessed an accidental overdose at some time 
in their lives.

To address the opioid epidemic, addiction physicians have recognized to 
effectively treat this opioid and overdose epidemic, we need to take a 
multifaceted approach. We need to:

1.  Emphasize prevention. Encourage patients to discard of all unused 
medications, especially narcotic medications, by returning them to 
participating take-back pharmacies, police departments, or utilizing 
drug take-back days so unused drugs are not used by unintended 
recipients.
2.  Educate medical students, residents, and physicians about addiction 
and proper opioid prescribing. An organization, Physicians for 
Responsible Opioid Prescribing (www.supportprop.org) provides 
continuing medical education on responsible opioid prescribing. In 
addition to physicians, dentists, advance practice nurses, and 
physician's assistants also need basic and continuing education on 
proper opioid prescribing. All healthcare professionals need more 
training in recognizing signs and symptoms of addictive disorders and 
effectively working with patients with addictive disorders. I am a 
member of The Coalition on Physician Education in Substance Use 
Disorders (COPE) and we are working on encouraging the integration of 
increased education on addiction into allopathic and osteopathic 
medical school curricula.
3.  Use prescription drug monitoring databases to ensure we have as 
much data available to us as possible to make sound clinical decisions. 
Of note, Pennsylvania's prescription drug monitoring database which was 
signed into law on October 27, 2014, and anticipated to take effect 
June 30, 2015, is still not available due to budget constraints. Hence, 
physicians in Pennsylvania still do not have this resource available to 
possibly inform prescribing.
4.  Use FDA-approved medications to treat opioid use disorder, 
including methadone, buprenorphine, and naltrexone. These medications 
are effective in reducing opioid use, preventing relapse, reducing 
transmission of HIV and hepatitis C from injection drug use, and 
reducing emergency room visits and hospitalizations.ix These 
medications, however, are underutilized currently.
5.  Provide overdose prevention training and co-prescribe naloxone when 
prescribing opioids in case of accidental overdose.

Opioid use disorder, also known as opioid addiction, is a chronic, 
relapsing, life-threatening, but treatable disease of the brain. 
Addiction is not a choice or lack of willpower. It is not a time-
limited illness. Yet, the patients I see each day are given these 
messages by their friends, family, the media, healthcare workers, and 
insurance providers.

Patients with addictive disorders face barriers when trying to seek 
medications for treatment of opioid use disorder, including wait-lists 
to get into methadone maintenance programs and buprenorphine clinics, 
difficulty finding physicians who accept Medicaid who will prescribe 
stabilizing medications,x difficulty getting into 
rehabilitation programs, rigorous prior-authorization requirements 
xi which set up barriers to patients being able to afford 
medications.

Eleven states have implemented lifetime limits for how long their 
Medicaid programs will pay for buprenorphine,xii 14 states 
have implemented buprenorphine dose limits,xiii and one 
state (i.e., Maine) has implemented a 2-year lifetime limit for 
Medicaid payment for methadone. These limits have restricted patients' 
access to treatment and put them at risk for relapse and overdose, and 
there is no evidence behind these practices.xiv

Fortunately, Pennsylvania has not instituted a lifetime limit for 
buprenorphine treatment but Pennsylvania Medicaid does have a dose 
limit of 16 mg daily. Patients on buprenorphine treatment need their 
treating physician to submit prior authorizations documenting 
participation in psychosocial therapy, urine drug testing, relapse 
status, every 6 months. Some managed care companies require patients 
who want to use extended release naltrexone for treatment to use the 
immediate release naltrexone first, as part of a step therapy 
requirement. The patient is required to ``fail'' this treatment in 
order to be approved for the more expensive treatment. This puts the 
patient at risk for relapse and overdose. In fact, I had one patient 
for whom the insurance company refused to authorize the extended 
release naltrexone and required him to take the naltrexone tablets 
first. The patient took the tablets for a short time and relapsed on 
heroin and then overdosed. Fortunately he survived the overdose, 
underwent detoxification again, and then started the extended release 
naltrexone and began a long period of recovery.

Despite The Mental Health Parity and Addiction Equity Act of 2008, 
there are still private insurers in the southwest Pennsylvania region 
that do not pay for outpatient detoxification. These patients who have 
this insurance company who come to the program have to pay out-of-
pocket or try to find an inpatient detoxification facility.

In Pennsylvania, patients with opioid use disorders have to complete 
several hurdles in order to get lifesaving medications authorized by 
their insurance companies as described above. These same patients could 
get prescriptions for most immediate release (e.g., oxycodone) and 
several extended release opioids (e.g., oxymorphone ER, Fentanyl 
patch), without any step therapy requirements, prior authorizations, 
and/or requirements for additional treatment such as physical therapy.

In closing, patients with addiction need to be treated as all other 
patients with chronic diseases. A patient with high blood pressure is 
not expected to stop blood pressure medications once his/her blood 
pressure is stabilized or to maintain the gains made by medication 
through lifestyle changes (e.g., diet and exercise) if these haven't 
been successful treatments previously. Likewise, limits on medications 
to treat opioid and other addictions should not be time limited. Once 
patients stabilize on methadone or buprenorphine, they should not be 
expected to stop the medications and maintain their recovery with 
therapy alone. Patients with opioid addiction should not need to 
``fail'' a treatment before their insurance will pay for a more 
expensive medication, especially since ``failure'' could be a matter of 
life and death.

I am hopeful that you will find my comments helpful in understanding 
the opioid epidemic and barriers those with the disease of opioid 
addiction are facing in Allegheny County, Pennsylvania, and also in the 
greater United States.

Respectfully submitted,

Julie Kmiec, D.O.
Addiction Psychiatrist

______________________________

    i IMS Health, Vector One: National, Years 1991-1996, 
Data Extracted 201. IMS Health, National Prescription Audit, Years 
1997-2013, Data Extracted 2014.
    ii Mack, K.A. Drug-induced deaths--United States, 1999-
2010. MMWR Surveill Summ. 2013 Nov 22;62 Suppl 3:161-3. CDC.
    iii In 2013, the National Survey on Drug Use and Health 
(NSDUH) estimated that 1.9 million Americans live with opioid pain 
reliever addiction and 517,000 are addicted to heroin. http://
www.samhsa.gov/data/sites/default/files/NSDUH-SR200-RecoveryMonth-2014/
NSDUH-SR200-RecoveryMonth-2014.htm.
    iv http://www.samhsa.gov/data/sites/default/files/
substate2k12-StateTabs/NSDUHsubstate
StateTabsPA2012.htm.
    v Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The 
changing face of heroin use in the United States: a retrospective 
analysis of the past 50 years. JAMAPsychiatry. 2014 Jul 1;71(7):821-6. 
doi: 10.1001/jamapsychiatry.2014.366. PubMed PMID: 24871348.
    vi According to the Centers for Disease Control and 
Prevention (CDC), 46 Americans die every day from opioid prescription 
drug overdoses: that translates to almost 2 deaths an hour and 17,000 
annually. CDC Vital Signs, July 2014 (http://www.cdc.gov/vitalsigns/
opioid-prescribing/).
    vii According to the Centers for Disease Control and 
Prevention (CDC). more than 8,000 Americans die annually from heroin 
overdoses. http://www.cdc.gov/nchs/data/databriefs/db190.htm.
    viii http://www.achd.net/pr/pubs/2015release/
052115_nalaxone.html.
    ix http://www.asam.org/docs/default-source/2015-
conference-epk/asam-impact_cce-4-02-14.pdf?sfvrsn=4#search=``proven 
clinical and cost effectiveness opioid use''.
    x A shortage of Medicaid-eligible physicians or 
organizational providers who prescribe addiction medications has 
developed--one state has only one Medicaid-eligible methadone clinic. 
This can be especially harmful when low-income opioid addiction 
patients are unable to find/access Medicaid-eligible providers in their 
area, according to The Avisa Group (Availability without accessibility? 
State Medicaid coverage and authorization requirements for opioid 
dependence medications; Rinaldo, S. and Rinaldo, D. 2013).
    xi Rigorous prior-authorization requirements for 
continued use of medications, sometimes within as little as 6 months. 
Prior authorization requirements can also change substantially over 
time, without notice, and severely restrict or deny access to 
medication, according to research conducted by The Avisa Group 
(Availability without accessibility? State Medicaid coverage and 
authorization requirements for opioid dependence medications; Rinaldo. 
S. and Rinaldo, D., 2013).
    xii Eleven states impose preset ``lifetime'' medication 
limits on buprenorphine, according to The Avisa Group (Availability 
without accessibility? State Medicaid coverage and authorization 
requirements for opioid dependence medications; Rinaldo, S. and 
Rinaldo, D. 2013).
    xiii http://www.asam.org/docs/default-source/2015-
conference-epk/asam-impact_barriers4-02-
14.pdf?sfvrsn=4#search=``medications for the treatment of opioid use 
disord''.
    xiv Stabilizing medications for patients living with 
chronic opioid addiction disease are uniquely controlled, with 
insurance limitations not supported by medical knowledge, according to 
Treatment Research Institute findings (FDA approved medications for the 
treatment of opiate dependence: Literature reviews on effectiveness and 
cost effectiveness; Chalk, M. et al., 2013).

                                 ______
                                 
           National Association of Chain Drug Stores (NACDS)

                      1776 Wilson Blvd, Suite 200

                          Arlington, VA 22209

                              703-549-3001

                             www.nacds.org

                               Statement

                                   Of

             The National Association of Chain Drug Stores

                                  For

                          United States Senate

                          Committee on Finance

                      Subcommittee on Health Care

                           Field Hearing on:

             ``Opiate Abuse in Southwestern Pennsylvania''

                            October 15, 2015

The National Association of Chain Drug Stores (NACDS) thanks Chairman 
Toomey, Ranking Member Stabenow, and members of the Senate Finance 
Subcommittee on Health Care for the opportunity to submit a statement 
for the hearing on Opiate Abuse in southwestern Pennsylvania. NACDS and 
the chain pharmacy industry are committed to partnering with federal 
and state agencies, law enforcement personnel, policymakers and others 
to work on viable strategies to prevent prescription drug diversion and 
abuse. Our members are engaged daily in activities aimed at preventing 
drug diversion and abuse. Since our members operate pharmacies in 
almost every community in the U.S., we support policies and initiatives 
to combat the prescription drug abuse problem in southwestern 
Pennsylvania and nationwide. We believe that holistic approaches must 
be implemented at the federal level.

NACDS represents traditional drug stores and supermarkets and mass 
merchants with pharmacies. Chains operate more than 40,000 pharmacies, 
and NACDS's 115 chain member companies include regional chains, with a 
minimum of four stores, and national companies. Chains employ more than 
3.2 million individuals, including 179,000 pharmacists. They fill over 
2.9 billion prescriptions yearly, and help patients use medicines 
correctly and safely, while offering innovative services that improve 
patient health and healthcare affordability. NACDS members also include 
more than 850 supplier partners and nearly 60 international members 
representing 22 countries. For more information, visit www.nacds.org.

Background

First enacted in 1970, the federal Controlled Substances Act (CSA) 
regulates the manufacture, importation, possession, use, and 
distribution of prescription drugs that have a potential for diversion 
and abuse and are collectively known as ``controlled substances.'' The 
CSA creates a closed system of distribution for controlled substances; 
the Drug Enforcement Administration (DEA) often refers to this as 
``cradle-to-grave'' control over controlled substances. DEA has 
implemented a very tight and comprehensive regulatory regime pursuant 
to the CSA. States have followed this lead and have implemented 
similar, sometimes duplicative regimes. This matrix of regulation has 
created a multi-layered system of checks and balances to protect 
Americans from the dangers of prescription drug abuse. Pharmacists and 
other pharmacy personnel are all trained to understand and comply with 
this complex regulatory matrix.

Chain Pharmacy Initiatives

To comply with DEA's ``cradle to grave'' regulatory regime, chain 
pharmacies have created a variety of loss prevention and internal 
security systems that are in place from member prescription drug 
distribution centers right down to the point of dispensing to the 
patient. Our members undertake initiatives to ensure that prescription 
drugs are accounted for throughout every step along the way. Some of 
those initiatives could include conducting background checks before 
hiring personnel who have access to prescription drugs, training 
employees on controlled substance laws and regulations within 30 days 
of hire, maintaining electronic inventories of controlled substances 
and conducting random audits. Our members work closely with law 
enforcement to see that perpetrators of crimes relating to controlled 
substances are brought to justice.

Specifically at the pharmacy level, examples of NACDS-member 
initiatives include training pharmacy personnel on how to handle 
suspect prescription drug orders, and exception reporting, in which 
exceptionally large or unusual orders of controlled substances will 
trigger an internal investigation. Chain pharmacies also may maintain 
perpetual inventories of controlled substances that are randomly 
audited by internal security personnel. Pursuant to DEA and state 
regulations, pharmacy and chain distribution centers are required to be 
highly secured with physical barriers and utilize heavy duty safes, 
secure cages, and complex alarm systems. Some pharmacy chains also 
utilize cameras and closed-circuit television surveillance to ensure 
compliance with policies and procedures. Some pharmacies require 
employees to read and sign ``codes of conduct,'' which commits them to 
compliance and some will conduct drug testing, including random, for 
cause, and pre-employment testing.

Chain pharmacies are committed to ensuring that prescription drugs 
remain under tight control for the purposes of providing care to their 
patients, and are not diverted for nefarious purposes. Our members' 
efforts are evidence of this commitment.

Legislative Initiatives

NACDS shares the goals of policymakers to curb the incidence of fraud 
and abuse and appreciates the work that has been done over the last 
year, such as with the 21st Century Cures Initiative. NACDS believes 
that any potential programs aimed at ``locking-in'' a beneficiary to a 
certain pharmacy or pharmacies--such as the one included in the 21st 
Century Cures Initiative or in S. 1913, the Stopping Medication Abuse 
and Protecting Seniors Act of 2015--must ensure that legitimate 
beneficiary access to needed medications is not impeded. Policies to 
reduce overutilization must maintain access to prescription medications 
by the beneficiaries who need them most.

While the use of a single pharmacy could decrease incidents of fraud, 
waste and abuse as well as provide the potential for better care 
coordination, a lock-in provision may actually be a barrier to care as 
supply chain issues exist around these medications which are beyond the 
pharmacy's control. Also, patients often legitimately see multiple 
doctors representing different specialties in different locations. In 
addition, there are instances due to location and/or services offered 
(e.g., compounded or specialty drugs) that a single pharmacy may not 
meet all the needs of a specific patient.

In order to protect legitimate patient access while combatting 
prescription drug abuse and diversion, mechanisms must be included in 
any legislation that would allow a pharmacy, in consultation with the 
prescriber, to fill legitimate prescriptions without needlessly 
delaying treatment for beneficiaries. This includes ensuring that back-
up systems are in place which would allow a beneficiary to obtain 
needed medication in the event their ``locked-in'' pharmacy is unable 
to supply the medication. Without this, the potential for harm from 
unnecessary delay in obtaining medication is possible.

Additionally, NACDS believes a beneficiary should be able to select a 
pharmacy location, or number of locations that are under common 
ownership and that electronically share a real time, online database. 
The ability to share real-time data will ensure that beneficiaries are 
only obtaining the necessary prescriptions while protecting beneficiary 
access and health.

The Role of DEA

According to DEA regulations, the responsibility for the proper 
prescribing and dispensing of controlled substances is upon the 
prescribing practitioner, but a corresponding responsibility also rests 
with the pharmacist who fills the prescription. An order purporting to 
be a prescription that is not issued in the usual course of 
professional treatment is not a prescription within the meaning and 
intent of section 309 of the CSA (21 U.S.C. 829), and any person 
knowingly filling such a purported prescription, as well as the person 
issuing it, is subject to the penalties provided for violations of the 
CSA.

Community pharmacists are front-line healthcare providers and are one 
of the most accessible members of a healthcare team. As such, the CSA 
requires pharmacists to take on diverse and sometimes conflicting 
roles. On the one hand, pharmacists have a strong ethical duty to serve 
the medical needs of their patients in providing neighborhood care. On 
the other hand, community pharmacists are also required to be 
evaluators of the legitimate medical use of controlled substances.\1\ 
As briefly mentioned above, the CSA requires that a pharmacist, prior 
to dispensing any controlled substance, make the following 
determinations-whether the prescription complies with all legal and 
regulatory requirements, and whether the prescription has been issued 
for a ``legitimate medical purpose'' ``by a prescriber acting in the 
usual course of his or her practice.'' \2\ The former obligation is 
called ``corresponding responsibility,'' and if the two elements are 
not met, the prescription is not valid. DEA interprets a pharmacist's 
corresponding responsibility ``as prohibiting a pharmacist from filling 
a prescription for a controlled substance when he either `knows or has 
reason to know that the prescription was not written for a legitimate 
medical purpose.' '' \3\
---------------------------------------------------------------------------
    \1\ In order for a prescription for a controlled substance to be 
valid, federal law (21 CFR Sec. 1306.04(a)) requires that the 
prescription be issued for a legitimate medical purpose by a prescriber 
acting in the usual course of his or her practice. The rule places a 
corresponding responsibility upon the dispensing pharmacist to 
establish the validity of the prescription by ensuring the prescription 
is written for a legitimate medical purpose.
    \2\ 21 CFR 1306.04(a).
    \3\ East Main Street Pharmacy, 75 FR 66149, 66163 (Oct. 27, 2010).

Pharmacies fully understand that controlled substances are subject to 
abuse by a minority of individuals who improperly obtain controlled 
substance prescriptions from physicians and other prescribers. 
Pharmacies strive to treat medical conditions and ease patients' pain 
while simultaneously guarding against the abuse of controlled 
substances. The key is to guard against abuse while still achieving our 
---------------------------------------------------------------------------
primary goal of assisting patients who need pharmacy services.

The Role of FDA

In 2007, Congress passed the Food and Drug Administration Amendments 
Act of 2007 (FDAAA), which provided FDA the authority to impose risk 
management plans on prescription drugs; this program is known as Risk 
Evaluation and Mitigation Strategies (REMS). A REMS will be imposed if 
FDA finds that a REMS is necessary to ensure that the benefits of a 
drug product outweigh the risks of the drug product. Among the numerous 
REMS that FDA has implemented is a REMS for extended release and long-
acting opioid products (``ER/LA opioid drugs''). These are pain 
relieving medications that have an elevated potential for abuse. The 
central component of this ``Opioid REMS'' is an education program for 
prescribers (e.g., physicians, nurse practitioners, physician 
assistants) so that ER/LA opioid drugs can be prescribed and used 
safely. NACDS agrees that prescribers should be properly educated about 
the risks and benefits of prescription drugs, including those that have 
elevated abuse potential like ER/LA opioid drugs. It is critical that 
all prescribers understand the nature of addiction and abuse before 
issuing prescriptions for these medications. NACDS supports FDA's 
Opioid REMS.

In 2011, FDA announced a REMS for another class of drugs with elevated 
abuse potential: transmucosal immediate-release fentanyl (TIRF) 
products. NACDS and other industry stakeholders worked closely with FDA 
to design and implement this REMS. We are appreciative of this 
collaborative effort spearheaded by FDA, and believe such a 
collaborative effort should serve as a model for similar programs to 
address prescription drug abuse.

The GAO Report

Numerous groups and state and federal entities are working to reduce 
the problem of prescription diversion and abuse. Unfortunately, in 
their efforts to combat prescription drug abuse, federal agencies have 
not been effectively coordinating their efforts to assure access to 
prescription controlled substances for patients who legitimately need 
these medications. In GAO's recent report that examines shortages of 
prescription drugs that contain controlled substances, GAO found that 
DEA and FDA have not established a sufficiently collaborative 
relationship to ensure an adequate supply of controlled substance 
medications.\4\ GAO found that the barriers to coordination prevent DEA 
and FDA from preventing or alleviating shortages.\5\ Although critical 
to their efforts, a memorandum of understanding (MOU) between the two 
agencies has not been updated in 40 years.\6\
---------------------------------------------------------------------------
    \4\ ``Drug Shortages: Better Management of the Quota Process for 
Controlled Substances Needed; Coordination between DEA and FDA Should 
Be Improved;'' Government Accountability Office; February 2015; pp. 43-
51.
    \5\ Ibid.
    \6\ Ibid., at 46.

---------------------------------------------------------------------------
Specific to DEA, GAO found that:

  DEA does not meet its requirements due to lack of internal controls 
for data reliability, performance measures, and performance monitoring; 
\7\
---------------------------------------------------------------------------
    \7\ Ibid., at 29.

  Insufficient internal DEA controls lead to errors in its data 
system; \8\
---------------------------------------------------------------------------
    \8\ Ibid., at 47.

  DEA has not met required time frames for more than a decade; \9\ and
---------------------------------------------------------------------------
    \9\ Ibid.

  DEA is not prepared to respond to future prescription drug 
shortages.\10\
---------------------------------------------------------------------------
    \10\ Ibid.

Considering the patient harm that occurs due to prescription drug 
shortages, the concerns identified by GAO about lack of federal agency 
coordination, and serious DEA deficiencies, we believe that Congress 
should act. Federal agencies must come together behind a comprehensive 
approach and pursue drug abuse prevention policies that are 
strategically designed to target enforcement efforts while still 
maintaining access to prescription controlled substances for patients 
---------------------------------------------------------------------------
who legitimately need these medications.

Since NACDS and our members are focusing our energies on real, workable 
solutions that will address the problem of prescription drug abuse 
while also ensuring that legitimate patients are able to receive their 
prescription pain medications, we support the ``Ensuring Patient Access 
and Effective Drug Enforcement Act of 2015,'' which has been introduced 
in the Senate as S. 483, sponsored by Sen. Orrin Hatch (R-UT) and Sen. 
Sheldon Whitehouse (D-RI). This legislation would promote cooperation 
among key government agencies, such as DEA and FDA, to jointly identify 
obstacles to legitimate patient access to controlled substances, issues 
with diversion of controlled substances, and how collaboration between 
law enforcement agencies and healthcare stakeholders can benefit 
patients and prevent diversion and abuse of controlled substances.

S. 483 also facilitates open dialogue on issues related to prescription 
drug diversion and abuse by directing key federal agencies to consult 
with patient groups; pharmacies; drug manufacturers; common or contract 
carriers and warehousemen; hospitals, physicians, and other healthcare 
providers; state attorneys general; federal, state, local, and tribal 
law enforcement agencies; health insurance providers and entities that 
provide pharmacy benefit management services on behalf of a health 
insurance provider; and wholesale drug distributors.

We believe that bringing together stakeholders to address the problems 
associated with prescription drug abuse in this manner would provide 
better solutions than have been developed to date. Improved 
collaboration and coordination among federal agencies and other 
stakeholders would benefit all, including the patient, whose legitimate 
access to medication must be preserved in order for any potential 
solution to be successful.

Additional DEA Recommendations

Although the GAO report focuses on the quota process for prescription 
drugs, we have a number of additional concerns about DEA processes and 
functions that should be brought to light. DEA's enforcement activities 
include conducting inspections of the entities that are subject to its 
regulatory oversight. Although such enforcement activities are 
essential to its mission, DEA has been criticized for an alleged lack 
of transparency in its inspection and other enforcement actions, and 
even inconsistency among the actions of its numerous field offices. 
Such opaqueness and inconsistency impose challenges on the compliance 
efforts of DEA registrants.

To help address the problems of DEA opaqueness and inconsistency, we 
support efforts to promote accountability and transparency with respect 
to DEA's inspection and enforcement programs. The following 
recommendations, drawn from FDA transparency and oversight and 
enforcement initiatives, could serve as a model for DEA:

1.  Development of a Comprehensive DEA Investigation Program, 
Corresponding Inspector Manual and Compliance Policy Guides: 
Specifically, DEA would set forth guidance for its oversight of 
regulated facilities inspections that provide clear and firm direction.

2.  Accountability and Consistency Among Field Offices: DEA would 
ensure the uniformity and effectiveness of its inspection program and 
oversight over field offices. DEA would provide public training for 
inspectors and develop an audit process to ensure that inspections are 
carried out consistently across field offices.

3.  Transparency and Communication--DEA Inspection Observations: DEA 
would provide substantive and timely feedback to inspected regulated 
facilities regarding agency observations and facility compliance. 
Specifically, DEA would provide regulated facilities with substantive 
written feedback upon completion of an inspection when an 
investigator(s) has observed any conditions that in their judgment may 
constitute violations of the CSA and implementing regulations. Without 
receiving such information, it is difficult for regulated facilities to 
implement requisite facility and process improvements and take 
corrective actions where necessary.

4.  Public Disclosure--Oversight of Inspections: An important mechanism 
of accountability is public disclosure of information. Disclosure of 
final inspection reports of regulated facilities would provide the 
public with a rationale for DEA enforcement actions and the industry 
with transparency into agency decision-making, allowing them to make 
more informed actions to enhance facility compliance.

5.  Ombudsman Office: An ombudsman office would address complaints and 
assist in resolving disputes between companies and DEA regarding 
interactions with the agency on inspections and compliance issues.

We believe these recommendations would greatly increase predictability 
and transparency in DEA regulation. The adoption of such 
recommendations would greatly enhance the compliance efforts of DEA 
registrants, thus leading to more effective DEA regulation and 
oversight. Enhanced compliance efforts by DEA registrants and more 
effective DEA regulation and oversight would have highly beneficial 
impacts on efforts to combat prescription drug diversion and abuse.

Conclusion

NACDS thanks the Subcommittee for consideration of our comments. We 
look forward to working with policymakers and stakeholders on these 
important issues.

                                 ______
                                 
         Statement Submitted for the Record by Deborah Partsch

  Written testimony relative to Senate bill 1913: Stopping Medication 
   Abuse and Protecting Seniors Act of 2015 to prevent inappropriate 
 access to opioids and improve patient care for at-risk beneficiaries.

Mr. Chairman and committee members, my name is Deborah Partsch, and I 
am a Pharmacist who has lived and practiced professionally in western 
Pennsylvania for over 16 years. I respectfully submit a written 
testimony as an individual and as a member of the Academy of Managed 
Care Pharmacy. I think it is also important to note that I am an 
employee of Highmark Inc. a Pittsburgh-based Blue Cross and Blue 
Shield-affiliated health insurance company. I have held various 
positions within Highmark which has afforded me the opportunity to 
develop expertise on insurance-related aspects of pharmacy and health 
care policy. Briefly:

      Substance abuse has been a problem in this country for decades, 
and has expanded from illegal to legal substances (prescription 
medications). I support bill S. 1913, Stopping Medication Abuse and 
Protecting Seniors Act of 2015, which would allow prescription drug 
plans and Medicare Advantage prescription drug plans to proactively and 
prospectively identify individuals at risk for controlled substance 
abuse, misuse or improper utilization. Many prescription drug plans 
covering non-Medicare eligible individuals utilize a Designated 
Pharmacy Program. The program's intent is to deter drug-seeking members 
from doctor shopping, which is the practice of seeking the same type of 
prescriptions from multiple physicians. Additionally, the Controlled 
Substance Act provides the pharmacist an affirmative obligation to only 
fill prescriptions that are ``issued in the usual course of 
professional treatment,'' i and prescriptions that do not 
meet this requirement are considered improper.
---------------------------------------------------------------------------
    i SOURCE: ``Substances Act.'' Revised 2010.
    http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/
pharm_manual.pdf. Accessed June 28th, 2013.

      Relative to concerns you may hear of limiting access to a 
designated pharmacy, I would highlight the pivotal model to reform the 
health care industry is the creation of Patient Center Medical Home 
programs and Accountable Care Organizations. Stimulated by Health Care 
Reform, these centralized health care partnerships seek to better 
manage an individual's care in a streamlined manner. For the intent of 
the bill to be successful, I recommend real-time data sharing of 
information compiled in Prescription Drug Management Programs with key 
stakeholders including prescribers, pharmacies, managed care 
---------------------------------------------------------------------------
organizations, and pharmacy benefit management companies (PBMs).

      Lastly, patients, providers, patient family members, health 
plans, community based organizations, employers, pharmaceutical 
companies and government must all work together to formulate and 
implement solutions. As an employee of Highmark, I wanted to share with 
you one initiative that Highmark has taken to address the issue of 
opioid abuse. As a health insurer with over 5 million members, the 
issue of opioid abuse is certainly of importance to Highmark. Earlier 
this year, Highmark, through its Foundation, provided a grant of 
$50,000 to support a state initiative that provides grants to first 
responders to purchase naloxone, a drug that reverses heroin and opioid 
overdoses. These grants enable first responders to administer the drug 
to individuals experiencing an overdose. According to the Pennsylvania 
Department of Drug and Alcohol Prevention Programs, results to date 
have been positive--289 drug overdoses have been reversed statewide 
since the implementation of this initiative. I am proud of my employer 
and other health insurers for supporting initiatives such as this one 
and I would like to encourage the drug industry to be a part of the 
solution by ensuring that the price of treatments like Naloxone remain 
reasonable.

Thank you again for accepting my written testimony. Please feel free to 
contact me at 412-544-2489 or [email protected], or my 
colleagues at AMCP as a resource in tackling this very important issue. 
We will continue to work with you to enact this legislation.

AMCP is a national professional association of 7,000 pharmacists and 
other health care practitioners who serve society by the application of 
sound medication management principles and strategies to assist 
patients in achieving positive therapeutic outcomes. In Pennsylvania 
alone, we have over 480 active members. AMCP's members develop and 
provide a diversified range of clinical, educational and business 
management services and strategies on behalf of the more than 200 
million Americans covered by a managed care pharmacy benefit.

                                 ______
                                 
                    The Pennsylvania Medical Society

                           Written Testimony

                        By Karen Rizzo, MD, FACS

                            October 16, 2015

          Stopping Medication Abuse and Protecting Seniors Act

The Pennsylvania Medical Society thanks you for the opportunity to 
present this written testimony regarding the Stopping Medication Abuse 
and Protecting Seniors Act.

Our nation is unquestionably facing an opioid abuse crisis. According 
to a report by the Centers for Disease Control (CDC), there were 16,007 
opioid overdose deaths in the U.S. in 2012, the most recent year for 
which statistics were available. Pennsylvania's death rate exceeds the 
national average, and in 2011 we ranked 21st per capita among the 
states in opioid prescriptions written. Nationally and in Pennsylvania 
overdose deaths now exceed motor vehicle deaths. Magnifying the 
situation, prescription opioids can become gateway drugs to heroin. 
Indeed, up to 80 percent of heroin addicts started on opioids.

While there is a clear need to act aggressively in response to this 
epidemic, we must also act prudently, because prescription opioid 
medications are an essential tool for physicians who treat their 
patients who are living with chronic pain.

Reducing opioid abuse requires a comprehensive effort, and the 
Pennsylvania Medical Society has initiated a multi-pronged approach to 
the problem:

      Our ``Pills for Ills, not Thrills'' campaign provides physicians 
with a wide range of information and resources they can use in their 
practices;

      We secured a grant to host a six-credit Risk Evaluation and 
Mitigation Strategies Continuing Medical Education (CME) program on 
extended release and long acting opioids;

      We actively promote Pennsylvania's medication drop box program. 
Several tons of medications have been turned in since the program was 
initiated less than 2 years ago;

      We were early advocates for the recently enacted statewide 
controlled substance database legislation, where prescribers will be 
able to look to identify patients who might be scammers or have an 
abuse problem;

      We were strong supporters of Senate bill 1164, now Act 198 of 
2014, which provides Good Samaritan protection to those who aid persons 
who experience a drug overdose, and expands the prescribing of life-
saving naloxone to first responders as well as friends and family 
members of persons at risk of experiencing an overdose.

      Additionally, we initiated a process to create opioid 
prescribing guidelines, giving prescribers clear, concise guidance as 
to best practices when utilizing these pain medications. We merged our 
effort with that of the Commonwealth's own task force, and the chronic, 
non-cancer pain prescribing guidelines that resulted from that 
collaboration have been viewed more than 10,000 times on PAMED's 
website.

      Finally, we actively participated in the Joint State Government 
Commission's examination of the state's drug laws and regulations, 
which produced recommendations for further actions.

Of course, much remains to be done. We are currently coordinating an 
effort by key provider organizations, including the PA Department of 
Health and the PA Department of Drug and Alcohol Programs, to develop 
four new continuing education programs focusing on the opioid 
prescribing guidelines, the new naloxone/Good Samaritan law, the 
forthcoming ABC-MAP controlled substances database, and ``warm hand-
offs,'' to better direct overdose survivors and abusers to appropriate 
treatment programs.

While we continue our efforts to combat opioid abuse, we also wish to 
offer a word of caution. Overzealousness in the campaign to eliminate 
opioid abuse can also lead to negative consequences. According to 
published reports, new laws aimed at eliminating Florida's pill mills 
have left many legitimate chronic pain sufferers scrambling to find 
pharmacies that have controlled substances, like Oxycodone, and are 
willing to dispense them.

Additionally, well-meaning legislation which would require physicians 
and patients to follow a rigid, one-size-fits-all protocol, may be 
detrimental to patient care by impeding the individualized treatment 
that is the hallmark of the physician-patient relationship. In that 
regard, we are concerned that the one prescriber/one pharmacy 
provisions of the Stopping Medication Abuse and Protecting Seniors Act 
would create a bureaucratic impediment to that needed clinical 
flexibility.

There is no question that limiting the number of prescribers and 
pharmacies from which a patient obtains scheduled drugs is a key 
element of the campaign to eliminate prescription opioid abuse, and we 
commend Senator Toomey and his co-
sponsors for identifying that need. However, we believe this objective 
can be accomplished without placing additional governmental 
restrictions on prescribers, patients, and pharmacies.

Pennsylvania's new ABC-MAP controlled substance database will allow 
prescribers and pharmacies to quickly identify patients who have an 
abuse problem or are trying to scam the system. One of the system's 
primary purposes is to flag patients who are obtaining scheduled drugs 
from multiple prescribers and multiple pharmacies.

Additionally, the legislation authorizes the ABC-MAP board to aid 
prescribers in identifying those individuals and direct them to 
treatment programs. Further, the state attorney general's office will 
have unrestricted access to Schedule II prescribing and dispensing 
data, and can access Schedule III-V data with a court order.

It should also be noted that Pennsylvania's new opioid prescribing 
guidelines for chronic, non-cancer pain recommend the use of patient 
agreements, which typically include restrictions on multiple 
prescribers and pharmacies, as well as compliance checks involving 
urine and saliva screening and pill counts.

We believe these new tools will have a major impact on the opioid abuse 
crisis without reducing practitioners' clinical treatment options or 
limiting patient access.

Again, we wish to thank you for your leadership on this important 
public health issue, and for offering us the opportunity to comment on 
the Stopping Medication Abuse and Protecting Seniors Act.

The Pennsylvania Medical Society is committed to continuing its 
campaign to eliminate opioid abuse. We look forward to working with the 
Congress, Governor Wolf, the General Assembly, and other stakeholders 
in that ongoing endeavor.

                                 ______
                                 
                       The Pew Charitable Trusts

                           Testimony for the

        Senate Committee on Finance, Subcommittee on Health Care

                          United States Senate

                     Field Hearing on Opiate Abuse

                            October 15, 2015

       Cynthia Reilly, Director, Prescription Drug Abuse Project

Chairman Toomey, Ranking Member Stabenow, and members of the Senate 
Committee on Finance, Subcommittee on Health Care, I am submitting 
testimony on behalf of The Pew Charitable Trusts. Pew is an independent 
nonpartisan research and policy organization dedicated to serving the 
public. Pew's prescription drug abuse project works to develop and 
support policies that will help reduce the inappropriate use of 
prescription drugs while ensuring that patients with legitimate medical 
needs have access to effective pain management. Pew encourages Congress 
to pursue policy solutions to address the nation's prescription drug 
abuse epidemic. The Stopping Medication Abuse and Protecting Seniors 
Act of 2015 is one such proposal that has been introduced in by 
Senators Toomey (R-PA), Brown (D-OH), Portman (R-OH), Kaine (D-VA), and 
Casey (D-PA). Pew supports this bill, which authorizes the use of drug 
management programs in Medicare.

Our testimony makes two key points:

      The use of opioids for non-cancer pain among Medicare 
beneficiaries is common, with some patients obtaining these 
prescription from multiple prescribers and pharmacies--a factor that 
places these individuals at increased risk for overdose and other 
adverse events, and
      Medicare beneficiaries would benefit from drug management 
programs that allow plan sponsors to prevent inappropriate access to 
controlled substances that are susceptible to abuse and better 
coordinate patient care.

The drug management programs described in the legislation, which are 
also known as patient review and restriction programs (PRRs), can play 
an important role in preventing prescription drug abuse by assigning 
patients who are at risk for drug abuse to pre-designated pharmacies 
and prescribers to obtain these drugs. Through this mechanism, PRRs 
allow plan sponsors and providers to improve care coordination and 
prevent inappropriate access to medications that are susceptible to 
abuse. The effectiveness of PRRs has led to their adoption in the 
public and private sector, with major insurers operating these programs 
in their Medicaid managed care and employer-based plans. In addition, 
46 state Medicaid programs currently operate PRRs.i An 
evaluation of state Medicaid PRR programs performed by a Centers for 
Disease Control and Prevention expert panel concluded that these 
programs have the potential to reduce opioid usage to safer levels and 
thus save lives and lower health care costs.ii
---------------------------------------------------------------------------
    i Roberts AW and Skinner AC. Assessing the present state and 
potential of Medicaid controlled substance lock-in programs. J Manag 
Care Pharm. 2014;20(5):439-46c.
    ii Centers for Disease Control and Prevention; National 
Center for Injury Prevention and Control (2012). Patient review and 
restriction programs. Lessons learned from state Medicaid programs. 
Available at http://www.cdc.gov/homeandrecreationalsafety/pdf/
PDO_patient_review_
meeting-a.pdf.

The need for these programs in Medicare is highlighted by the growing 
concern about potential overuse of opioids among these beneficiaries. 
Analyses conducted by the Medicare Payment Advisory Commission 
(MedPAC), the Centers for Medicare and Medicaid Services (CMS) and the 
Government Accountability Office (GAO) have sought to quantify the 
extent of opioid overuse in this population. A MedPAC analysis of 2012 
prescription drug event data found that 10.7 million (87 percent) of 
the roughly 12 million Medicare Part D beneficiaries who were 
prescribed prescription opioids received these therapies for conditions 
not associated with cancer treatment or hospice care. Among 
beneficiaries with the highest expenditures for opioids used for these 
indications, 32 percent obtained these prescriptions from four or more 
prescribers and 32 percent used three or more pharmacies. MedPAC also 
found that these beneficiaries accounted for 68 percent of the 
program's total gross spending on opioids for non-cancer, non-hospice-
related care. On average, these patients filled 23 opioid prescriptions 
at a cost of $3,500 per beneficiary.iii
---------------------------------------------------------------------------
    iii  Medicare Payment Advisory Commission (2015). Medicare 
and the Health Care Delivery System, Report to the Congress. Chapter 5. 
Available at http://www.medpac.gov/documents/reports/june-2015-report-
to-the-congress-medicare-and-the-health-care-delivery-system.pdf?sfvrsn
=0.

Evaluations by CMS and GAO found similar trends in the use of opioids 
for non-cancer, non-hospice-related care and instances in which 
multiple prescribers and pharmacies were used to obtain these 
therapies, respectively.iv Further, the CMS analysis 
identified approximately 225,000 beneficiaries who received potentially 
unsafe opioid dosing, which was defined as doses that exceeded 120 mg 
daily morphine equivalent dose for 90 or more consecutive days.v
---------------------------------------------------------------------------
    iv Centers for Medicare and Medicaid Services (2013). 
Supplemental guidance related to improving drug utilization controls. 
Correspondence from Cynthia G. Tudor, director, Medicare Drug Benefit 
and C and D Data Group dated Sept. 6, 2012. Available at http://
www.cms.gov/Medicare/Prescription-Drug-Coverage/
PrescriptionDrugCovContra/Downloads/HPMSSuppleme
ntalGuidanceRelated-toImprovingDURcontrols.pdf.
    v Government Accountability Office (GAO) (2011). 
Medicare Part D: Instances of questionable access to prescription 
drugs, Report to Congressional Requesters. Available at http://
www.gao.gov/assets/590/585424.pdf.

The Stopping Medication Abuse and Protecting Seniors Act of 2015, which 
would authorize the use of PRRs in Medicare, would help reduce 
prescription drug abuse in this population. In addition, the 
legislation has strong beneficiary protections to ensure that patients 
with legitimate medical needs have access to effective pain management. 
Beneficiaries have the right to appeal their identification as at-risk 
and subsequent enrollment in a PRR. Patient input on the selection of 
prescribers and pharmacies will also ensure reasonable access, 
including consideration of geographic location, cost-sharing, travel 
time, and multiple residencies. Furthermore, patients receiving hospice 
care, those residing in long-term care facilities, and other 
beneficiaries the Secretary elects to treat as exempt would be excluded 
from enrollment in a PRR. This mechanism can be used to avoid 
enrollment of patients with medical diagnoses that require high doses 
---------------------------------------------------------------------------
or combinations of controlled substances to manage their pain.

There is substantial support to advance this policy as an effective 
tool to decrease opioid abuse. The policy has been proposed in the FY 
2016 Budget request for the Department of Health and Human Services. A 
proposal similar to the Senate bill is part of the 21st Century Cures 
Act, which passed the House of Representatives with broad bipartisan 
support on July 10, 2015.

We urge the Senate to help address the nation's prescription drug abuse 
epidemic by passing legislation that would authorize the use of PRRs in 
Medicare. We look forward to working with Congress to refine the 
Stopping Medication Abuse and Protecting Seniors Act of 2015 and other 
legislative proposals that would expand use of the PRRs to ensure that 
these programs work as intended to prevent prescription drug abuse in 
Medicare.

                                 ______
                                 
                                 Pfizer

                      Testimony of Mr. Ken W. Cole

     Senior Vice President, U.S. Government Relations, Pfizer Inc.

           Before the Senate Finance Subcommittee on Health 
                        Hearing on Opiate Abuse

                            October 15, 2015

Mr. Chairman and members of the subcommittee,

Thank you for the opportunity to submit testimony for the Senate 
Committee on Finance Subcommittee on Health Care Field Hearing, 
``Examining Heroin and Opiate Abuse in Southwestern Pennsylvania.'' We 
are including Pfizer's comments, dated January 9, 2015, submitted to 
the FDA addressing the agency's ``Development and Regulation of Abuse-
Deterrent Formulations of Opioid Medications; Public Meeting [FDA-2014-
N-1359]'' for your reference. Further, we appreciate your commitment 
and attention to the prescription drug epidemic and welcome your 
request for policy proposals for Congress to consider for addressing 
this crisis.

Pfizer is a global leader in healthcare, helping change lives for the 
better by providing access to safe, effective, and affordable medicines 
and related healthcare services. Pfizer is one of the world's largest 
research-based biopharmaceutical companies. As part of our mission, we 
believe we can best ensure that people everywhere have access to 
innovative medicines and quality healthcare by working in partnership 
with all stakeholders, including patients, healthcare providers, 
managed care organizations, governments, and non-governmental 
organizations.

As you know, abuse of prescription opioids continues to take a 
devastating toll on individuals, families and communities across the 
nation. According to the Centers for Disease Control and Prevention 
(CDC), every day in the United States, 44 people die as a result of 
prescription opioid overdose. Deaths from overdose of prescription 
opioid painkillers have tripled since 2001, killing more than 16,000 in 
the United States in 2013. The rising prevalence of chronic pain and 
the increasing use and abuse of opioid analgesics have created an 
epidemic of distress, disability, and danger to a large percentage of 
Americans.

As you examine potential policy proposals to address the prescription 
drug crisis, we respectfully request that the subcommittee consider the 
role that abuse-
deterrent opioids (ADOs) can play in reducing opioids misuse and abuse. 
Pfizer is well aware of the urgent need for new, powerful analgesics 
that are safer than opioids, and we are working to develop them. 
However, until powerful yet safer alternatives to opioids become 
available, and possibly even after they become available, opioid 
analgesics are likely to remain an indispensable component of pain 
therapy. Pfizer shares the vision of the future articulated by the Food 
and Drug Administration (FDA) in which most or all opioid analgesics 
are available to pain patients who need them in formulations that are 
less susceptible to abuse than the majority of currently available 
opioids. While no ADO to date can entirely eliminate the risk of abuse, 
ADOs are an important part of a comprehensive strategy to reduce 
prescription opioid-related abuse, misuse and overdose.

We are concerned however, that current policies restricting access to 
these new technologies as they become available could stifle 
innovation, limit patient access, and only perpetuate the prescription 
drug abuse crisis. Existing payment structures help illustrate system-
wide barriers at both the formulary and provider level to the adoption 
of new pain therapies and treatment modalities and, more importantly, 
to the appropriate management of patients with pain. For example, non-
opioid analgesics are uniformly recommended as first-line treatments by 
chronic pain and opioid use guidelines; however, patient access to the 
branded non-opioid analgesics is often restricted by prior 
authorization/step-edits and/or higher patient co-pays/co-
insurance.\1\ In contrast, patient access to currently available, 
largely generic, and largely non-abuse-deterrent opioid analgesics is 
unrestricted as they are placed on preferred formulary tiers with lower 
patient out-of-pocket expenses.\2\ These policies, which disadvantage 
appropriate first-line therapies--either non-opioid alternatives or 
ADOs--and provide preferential access to the currently available non-
ADOs, contribute to opioid overprescribing, and are likely to delay, if 
not prevent, the adoption of ADOs.
---------------------------------------------------------------------------
    \1\ NIH Pathways to Prevention Workshop: The Role of Opioids in the 
Treatment of Chronic Pain, September 29-30, 2014, Draft Statement.
    \2\ http://www.fingertipformulary.com//. Accessed October 2014.

To help ensure patient access for Medicare beneficiaries, Pfizer 
recommends that the Centers for Medicare and Medicaid Services (CMS) 
propose a requirement that ADOs be placed in each drug class where ADOs 
exist. Per the Medicare Prescription Drug Benefit Manual, CMS requires 
that formularies contain at least two drugs for each category/class, 
but ``may require more than 2 drugs for particular categories or 
classes if additional drugs present unique and important therapeutic 
advantages in terms of safety and efficacy, and their absence from the 
sponsor's formulary would substantially discourage enrollment by 
---------------------------------------------------------------------------
beneficiaries with certain disease states.''

In addition to proposals to address prescription opioid abuse and 
misuse through CMS, we would also urge you to consider ways in which 
policies and programs at other federal agencies could be strengthened. 
In particular, you may wish to consider how the Food and Drug 
Administration's regulatory authorities can be utilized to encourage 
health care providers to consider prescribing ADOs, as appropriate, 
before prescribing opioids without abuse-deterrent properties, and to 
not approve new opioids that lack meaningful abuse-deterrent 
properties, except under limited circumstances.

We have recently seen strides made in the development of ADOs. Since 
2010, four such products have been approved by FDA. And in April of 
this year, FDA issued final guidance establishing a pathway for the 
development of ADOs, clarifying the types of data required for abuse-
deterrent labeling.\3\ In Pfizer's view, the labeling of these opioid 
products should support and guide appropriate opioid prescribing.
---------------------------------------------------------------------------
    \3\ http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf.

We appreciate FDA's actions in 2013 mandating new labeling for 
extended-release/long-acting (ER/LA) opioids. The changes clarified 
that these products should only be used for pain severe enough to 
require daily, around-the-clock, long-term opioid treatment for 
patients for whom other, lower-risk pain medications are inadequate. 
These critical labeling changes were an important first step to help 
ensure that providers are fully aware of the risks posed by these 
---------------------------------------------------------------------------
products and, ultimately, they will help save lives.

Yet currently, the labels of extended release opioids fail to provide 
guidance to physicians that opioids without abuse-deterrent properties 
should only be prescribed when an abuse-deterrent version is not 
available, or when an ADO is not appropriate for the patient. Similar 
to the new safety labeling mandated in 2013, such labeling could have a 
significant, positive impact on provider knowledge of ADO options and 
could help ensure that payors, including CMS, are providing access to 
ADOs.

Additionally, Pfizer recommends that FDA not approve opioids or opioid 
formulations lacking meaningful abuse-deterrent properties unless the 
new medicine fulfills an unmet need or provides a unique therapeutic 
benefit. In fact, FDA should encourage and support, through the 
development of guidance documents, a transition of all opioid 
medications, both immediate release and extended release, toward abuse 
deterrence (since both IR and ER opioids formulations can be abused)--
similar processes, guidances, and expectations to those currently in 
place for extended release opioids should be followed for IR opioids, 
when and where there is evidence that developing such technologies is 
feasible.

Pfizer also recommends that FDA implement prominent labeling to 
distinguish between abuse-deterrent and non-abuse deterrent products, 
in order to inform patients, providers, and federal and private payers, 
and to encourage innovation. Please see the attached for Pfizer's full 
comments to the docket for FDA's October, 2014, public workshop 
entitled, ``Development and Regulation of Abuse-Deterrent Opioid 
Medications.''

Finally, we would respectfully request that you consider ways to ensure 
a coordinated policy response to the role of ADOs in helping to address 
the prescription drug abuse epidemic across federal agencies, including 
CMS, CDC, the National Institutes of Health (NIH) and the Substance 
Abuse and Mental Health Services Administration. Pfizer would also 
welcome appropriate recognition and reference updates incorporating the 
important concepts outlined in the FDA final guidance on the evaluation 
and labeling of ADOs in policy guidance and educational documents 
addressing opioids. For example, CMS should acknowledge FDA's final 
guidance establishing labeling standards for ADOs and levels of abuse 
deterrence in its 2017 call letter and discuss the potential role of 
ADOs in reducing the growing problem associated with opioid misuse. 
Similarly, the NIH's National Pain Strategy, the National Drug Control 
Strategy, and the Department of Health and Human Services recent 
initiative on opioid abuse should recognize the importance of ADOs as 
an emerging treatment option for clinicians and should integrate the 
concepts in FDA's recent guidance into relevant clinical, policy and 
research objectives.

Mr. Chairman, thank you again for the opportunity to submit testimony 
and for your efforts to address this critical public health threat. We 
look forward to working with you to turn the tide of this epidemic.

                                 ______
                                 
                       Pinnacle Treatment Centers

                              U.S. Senate

                          Committee on Finance

                      Subcommittee on Health Care

       Field Hearing on Opiate Abuse in Southwestern Pennsylvania

            Allegheny General Hospital--Magovern Auditorium

                            October 15, 2015

                        Statement for the Record

October 14, 2015

The Honorable Pat Toomey
Chairman
U.S. Senate
Committee on Finance
Subcommittee on Health Care
248 Russell Senate Office Building
Washington, DC 20510

The Honorable Debbie Stabenow
Ranking Member
U.S. Senate
Committee on Finance
Subcommittee on Health Care
731 Hart Senate Office Building
Washington, DC 20510

Dear Chairman Toomey and Ranking Member Stabenow,

I appreciate the opportunity to submit a statement for the record to 
this important hearing.

I am Joe Pritchard, CEO of Pinnacle Treatment Centers. Pinnacle 
currently operates 29 treatment centers in Pennsylvania, Kentucky, 
Michigan, New Jersey, and Virginia. On behalf of the Opioid Treatment 
Program (OTP) Consortium, of which Pinnacle is a member, I would like 
to thank you for holding this important hearing today. The OTP 
Consortium is a group of over 300 opioid treatment centers located in 
39 states.

As you and your colleagues seek to address our nation's growing opioid 
abuse epidemic, I want to express our strong opposition to S. 1455, The 
Recovery Enhancement for Addiction Treatment (TREAT) Act.

OTP clinics provide comprehensive treatment to patients suffering from 
prescription opioid and heroin addiction via Medication-Assisted 
Treatment (MAT). MAT emphasizes patient-focused care in an 
individualized and integrated approach that includes counseling, 
behavioral therapies, drug testing, and the use of medication. OTP 
clinics are highly regulated by the states and federal government and 
have very low drug diversion rates. The National Institutes of Health 
(NIH) finds that our treatment protocols--which involve providing 
medications including methadone, buprenorphine and vivitrol, medical 
services, and psychosocial services including counseling for all 
patients--have ``the highest probability of being the most effective of 
all treatments for opioid addiction.'' \1\
---------------------------------------------------------------------------
    \1\ ``Confronting an Epidemic: The Case for Eliminating Barriers to 
Medication-Assisted Treatment of Heroin and Opioid Addiction,'' Legal 
Action Center, March 2015.

The TREAT Act seeks to remove the limit on the number of opioid 
addicted patients that a Drug Addiction Treatment Act (DATA) 2000-
waivered physician can treat. Under current law, DATA 2000 physicians 
can treat 30 patients in the first year and apply for a waiver after 
the first year to treat up to 100 patients. These caps were put in 
place in exchange for the lax regulations governing the DATA 2000 
program. In order to receive a DATA 2000 waiver, physicians only need 
to take an 8-hour online course, which focuses primarily on the 
medication (buprenorphine) that they would be allowed to prescribe to 
patients. DATA 2000 patients are not required to provide MAT. They are 
not required to provide counseling or behavioral therapy (or to refer 
it out), they are not required to administer random testing to 
determine illicit drug use or guide clinical decision making, they are 
not required to reference Prescription Drug Monitoring Program 
databases, and, as a result, most do not. Instead, DATA 2000 patients 
often receive a 30-day supply of buprenorphine and are told to return 
in another month or more for a refill. Prescribing more medication is 
not the answer and it certainly is not MAT. In our opinion, DATA 2000 
practices that begin to exceed 100 patients become unregulated 
addiction treatment services, opening the door for poor practices to 
---------------------------------------------------------------------------
set back the gains achieved by highly regulated MAT services.

Medications like methadone and buprenorphine help to stabilize the 
patient--that's when the real work begins. These medications allow the 
patient to receive the treatment and services needed to address the 
underlying issues that led to their addiction in the first place. These 
patients need counseling and their providers need to be conducting 
random drug testing to help inform clinical decisions. Providers should 
be required to consult PDMP databases to prevent diversion. Seeing 
patients once per month and simply filling out a prescription once 
every 30-90 days will not address the opioid epidemic. That is why 
additional requirements should be placed on DATA 2000 physicians who 
want to treat more than 100 patients for opioid addiction.

The OTP Consortium strongly recommends expanding access to treatment as 
a key component of addressing the opioid epidemic. However, there is no 
evidence to suggest that existing DATA 2000 physicians have reached 
their patient capacity. According to a June 2015 HHS study, through 
2012, just 27.5% of DATA 2000 physicians had a waiver to prescribe to 
as many as 100 patients.\2\ If just one-quarter of DATA 2000 physicians 
have applied for and received a waiver to go beyond the initial 30-
patient limit, it's unlikely that lifting the cap will have an impact 
on access. Those who want to go above 100 are essentially drug 
treatment centers rather than a general medical practice and should be 
regulated as such to ensure their patients suffering from opioid 
addiction are receiving the evidence-based care they need. Worse yet, 
without regulation, these practices run the risk of becoming ``pill 
mills.''
---------------------------------------------------------------------------
    \2\ Jones, Campopiano, Baldwin, and McCance-Katz, ``National and 
State Treatment Need and Capacity for Opioid Agonist Medication-
Assisted Treatment,'' American Journal of Public Health, June 2015, 
page e3.

Additionally, before considering whether to increase the DATA 2000 
patient cap, Congress and HHS should seek information about the type of 
care being provided and patient outcomes in DATA 2000 practices. 
---------------------------------------------------------------------------
Specifically, Congress and HHS should measure:

      The number of patients in treatment within each DATA 2000 
practice relative to its cap;
      Patient level outcomes and practice performance measures;
      The percentage of practices offering counseling on-site;
      The percentage of physicians referring patients for counseling 
and other services; and
      The percentage of practices offering toxicology testing to guide 
therapeutic dosing and decision making and to avoid the widespread 
diversion of this drug in the general community.

If the cap on DATA 2000 facilities were to be lifted, Congress and HHS 
should adopt patient safeguards and reforms that have proven to work in 
the OTP setting. Specifically, DATA 2000 practices should:

      Conduct a minimum amount of counseling per patient, per month;
      Employ prescription drug diversion control strategies;
      Perform drug testing to make sure patients are taking their 
prescribed medications, are not using illicit drugs, and to guide 
treatment decisions (e.g., increase or decrease intensity);
      Use Prescription Drug Monitoring Programs to ensure patients are 
not getting opiates elsewhere; and
      Provide each patient with a comprehensive ASAM Patient Placement 
Assessment.

These reforms would ensure that raising the cap does not result in 
significant unintended consequences like greater diversion, drug use, 
crime, and higher health care spending. Such reforms should be adopted 
through an open process that engages stakeholders before increasing the 
patient cap.

At a minimum, these important patient protections should be added to 
the TREAT Act and apply to any waivered physician seeking to treat more 
than 100 patients.

We strongly recommend that Congress and HHS expand and increase the 
availability of treatment to overcome the opiate epidemic via OTPs as 
OTPs are required to adopt and implement evidence-based MAT. In fact, 
one study found that those who receive MAT are 75% less likely to have 
an addiction-related death than those who do not receive MAT.\3\ A 
recent HHS report stated that increasing the number of OTPs would 
``help address treatment gaps'' and that ``OTPs are important . . . 
because they offer onsite medical care for those receiving methodone.'' 
\4\ The same report found that 82% of OTPs nationally operated at 80% 
capacity in 2012.\5\ Increasing OTP availability would truly increase 
access. Specifically, Congress should:
---------------------------------------------------------------------------
    \3\  Miller, T. and Hendrie, D. Substance Abuse Prevention Dollars 
and Cents: A Cost-Benefit Analysis. DHHS Pub. No. (SMA) 07-4298. 
Rockville, MD: Center for Substance Abuse Prevention, SAMHSA, 2008.
    \4\ Jone et al., page 6.
    \5\  Ibid.

      Expand Medicaid coverage of prescription drugs to treat opioid 
addiction. (Currently, just 28 states cover all three \6\);
---------------------------------------------------------------------------
    \6\ AK, AL, AZ, CA, CT, DE, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, 
NH, NM, NV, NY, OH, OR, PA, UT, VA, VT, WA, and WI.
---------------------------------------------------------------------------
      Allow Medicare to pay for methadone to treat opioid addiction; 
and
      Enforce parity by requiring private insurance to provide 
methadone as a treatment option.

If Congress or HHS chooses to examine lifting the DATA 2000 patient 
cap, it should first reform DATA 2000 practices for the first time in 
15 years to ensure that these physicians who seek a larger addiction 
practice are, at a minimum, providing counseling, employing anti-
diversion programs, and conducting random drug testing.

Thank you for your attention to this important matter. Again, the OTP 
Consortium and its 300+ treatment centers strongly opposes S. 1455 and 
instead strongly supports expanding access to treatment that has proven 
to be the most effective for decades--MAT. The Consortium looks forward 
to working with you to combat this crushing disease.

Sincerely,

Joe Pritchard
CEO
Pinnacle Treatment Centers

                                 ______
                                 
                       Pittsburgh Tribune-Review 
                            October 15, 2015

  Senate Health Care Subcommittee Explores Ways of Stopping Addiction

                            (By Ben Schmitt)

At 13, Ashley Potts popped her first OxyContin pill and immediately 
fell in love.

Her life spiraled out of control as she became addicted, stole money, 
got arrested several times, got expelled from high school and graduated 
to crack cocaine.

Although she made a pact with herself never to inject heroin, she was 
shooting up by 17. Heroin was much cheaper: $10 a bag instead of $80 
for a street prescription pill. Potts found it much easier to obtain.

``I felt like a zombie, a hollow corpse,'' she said. ``In my head, 
there were only two options: Go to treatment and stop using or kill 
myself.''

Potts, 29, of Washington told her story to a crowd of more than 300 
people who packed Allegheny General Hospital's Magovern Auditorium on 
Thursday for a Senate health care subcommittee field hearing on the 
national and regional heroin and opioid addiction crisis. U.S. Senator 
Pat Toomey, a Republican from Lehigh Valley, convened the hearing along 
with Senator Bob Casey, a Democrat from Scranton.

She described herself as a full-on street junkie, who had cleaned up 
and relapsed several times by 2006 with a young daughter and not much 
hope. She contemplated suicide often but decided to try one more stint 
in detoxification and long-term treatment.

Potts eventually got clean and went to college. She works as a team 
leader for the crisis diversion unit of Southwestern Pennsylvania Human 
Services. When she finished her story, the crowd heartily applauded.

Still, Toomey, Casey and a panel of experts pointed out that while 
Potts' tale inspires, there are many people of all ages, races and 
demographics losing their battles with heroin and painkillers such as 
OxyContin, Vicodin and Percocet at startling rates.

Pennsylvanians are more likely to die from an opiate overdose than an 
auto accident, according to a report from the Trust for America's 
Health and the Robert Wood Johnson Foundation. A contributing factor is 
the over-prescribing of addictive painkillers to seniors and others. 
The Government Accountability Office estimates 170,000 Medicare 
beneficiaries nationwide may be battling addiction to pain medication, 
Toomey said.

``Ending the epidemic of heroin addiction will require changes in the 
practice of medicine, government regulation and societal views,'' he 
said.

As chairman of the Senate Committee on Finance Subcommittee on Health 
Care, Toomey described possible solutions as threefold: halting illegal 
diversion of prescription painkillers, reducing overuse of opioids for 
treating long-term pain and helping addicts receive proper treatment. 
He introduced bipartisan legislation to prevent inappropriate access to 
opioids and improve patient care for at-risk seniors.

One of the panelists, Neil Capretto, medical director of Gateway 
Rehabilitation Center, testified that OxyContin, the brand name for 
oxycodone, is a morphine-like drug that accelerated the opioid 
addiction problem in the region ``at a level never seen before.''

``Of the several thousand heroin users that I have interviewed since 
2000, well over 90 percent told me they started with opioid pain 
pills,'' he said.

Dr. Jack Kabazie, system director of Allegheny Health Network's 
Division of Pain Medicine, said Americans consume more opiate 
painkillers than the rest of the world combined.

``While most doctors prescribe opioids with good intents, once they 
move down that path, it is an extremely difficult path to reverse,'' he 
said. ``In addition, physicians who have compensation or employment 
tied to patient satisfaction scores may feel pressure to prescribe 
opioids in response to patient pain complaints.''

As the hearing was underway, Drug Enforcement Administration officials 
told the Tribune-Review they plan to hire drug diversion investigators 
for their Pittsburgh office. The investigators plan to focus on rogue 
pharmacies and doctors who write prescriptions for narcotic painkillers 
without cause, said Special Agent in Charge Gary Tuttle, who in July 
was promoted to head the agency's Philadelphia Field Division, which 
covers Pennsylvania and Delaware.

The beginning of a statewide prescription-drug database will help DEA 
agents keep tabs on the distribution of prescription painkillers from 
doctors and pharmacies, Tuttle said.

The DEA plans to combat the heroin and opiate drug problem through 
education, outreach and treatment, Tuttle said.

``I'm not saying we have a silver bullet,'' he said. ``But we have to 
move people away from use, from that disease.''

Potts, the recovering heroin addict, said the large turnout at the 
hearing moved her but highlighted the devastation caused by opiate 
abuse.

``We're not just statistics--we're real live people,'' she said. ``The 
problem is astronomical. Every day I wake up grateful to be alive.''

Dr. Tony Farah, chief medical officer for AHN, concurred.

``I think everyone saw today the passion and the interest in the 
audience not only from the medical professionals but from the lay 
audiences as well,'' he said. ``This really underscores the incredible 
need for people not only to be educated on this problem but also to 
understand the role that each of them can play in addressing this major 
issue.''

Ben Schmitt is a staff writer for Trib Total Media. He can be reached 
at 412-320-7991 or [email protected]. Staff writer Jason Cato 
contributed to this report.

                                 ______
                                 
                   Positive Recovery Solutions (PRS)

                           730 Brookline Blvd

                          Pittsburgh, PA 15226

                         Office (412) 207-8874

                           Fax (412) 892-9404

October 7, 2015

The Honorable Pat Toomey
Chairman
U.S. Senate
Committee on Finance
Subcommittee on Health Care
248 Russell Senate Office Building
Washington, DC 20510

The Honorable Debbie Stabenow
Ranking Member
U.S. Senate
Committee on Finance
Subcommittee on Health Care
731 Hart Senate Office Building
Washington, DC 20510

Dear Chairman Toomey and Ranking Member Stabenow,

Good afternoon. I would like to thank you for giving me the opportunity 
to speak to you on behalf of Positive Recovery Solutions (PRS). My name 
is Amanda Cope. I am a registered nurse and have developed my career to 
specialize in addiction medicine. I celebrated 9 years sober on May 
6th. Addiction medicine has been a passion for me since starting my own 
journey on the road to recovery. I am so grateful to be a part of this 
process to reach those in need of help. I have always strived to be an 
example of sobriety to each of our patients at PRS.

PRS is a private physician group dedicated to helping those with 
alcohol and opiate dependence. We have two physical locations, one in 
Pittsburgh, PA and one in Washington, PA. We started out as a suboxone 
clinic dedicated to helping those suffering from opiate addiction. 
Through our expansion over the past 20 months we have incorporated 
Vivitrol to help battle the horrific epidemic of heroin overdose that 
is taking place in Pennsylvania. We are on the front lines of this 
battle and work diligently to reach as many underserved populations as 
possible. Through our suboxone treatment we set into place practices 
and policies that reduce the rate of diversion and misuse of the 
medication. Patients are required to have weekly office appointments 
where they are urine drug screened at each appointment and given a 7 
day prescription. The patient will be seen weekly for a minimum of 12 
weeks until they have reached 12 consecutive clean urine drug screens. 
Patients are required to provided monthly verification from their 
behavioral entities that they are compliant with their drug and alcohol 
counseling sessions. We stand firmly on the belief that medication 
alone is not the answer. We also are an insurance based clinic. We do 
not charge patients cash for their office visits. We have a maxium dose 
of 16 mg per day of suboxone. After a patient has reached 12 
consecutive clean urine drug screens they may then graduate to a 
biweekly program at the physicians discretion. Month long prescriptions 
are not given at PRS. Patients are not discharged for positive urine 
drug screens. PRS makes every possible attempt to get the patient the 
appropriate level of care. If a patient has 3 positive UDS they will be 
recommended to receive drug and alcohol counseling at a higher level. 
We will elevate a patients level of care all the way back into 
inpatient rehabilitation in an effort not to discharge. We employ every 
means possible to keep a patient active in treatment and on the road to 
recovery.

Approximately 1 year ago I had a meeting with a Vivitrol representative 
named Joanne Kommer. Joanne explained the Vivitrol medication to me and 
its valuable use in the fight against opiate dependence. PRS 
immediately incorporated Vivitrol treatment into our practice. We were 
very excited in the complete abstinence model that it supported. The 
success stories from people that were already on Vivitrol was a cause 
of great excitement for us. We added PRS onto the provider locater 
website for Vivitrol and that is where the idea for a mobile Vivitrol 
unit formed. Through our addition to the provider locater site one 
thing became rapidly clear to us. Patients were traveling from very far 
distances in order to be followed on the medication. Sometimes as far 
as 4 hours away. We quickly realized that providers were either unable 
or unwilling to provide follow-up care for these patients. A lot of 
patients were induced in an inpatient setting then could not follow up 
with their monthly injections due to lack of providers or the providers 
that would do the 
follow-up care would charge a large cash amount to receive their 
injection. We immediately started researching our idea of a mobile 
unit. PRS had meetings with local SCA in surrounding counties to 
establish that they did in fact have a need in their community. 
Specifically Kami Anderson of Indiana, Armstrong, and Clarion and Judy 
Rosser of Blair county. These ladies were pivotal in the formation of 
our pilot program. As mentioned earlier, PRS believes firmly that 
patients need the whole picture of recovery, not just medication. It is 
with that philosophy that we have created relationships with local 
behavioral health entities in order to give the patient the best chance 
of recovery. Gateway rehab, Cove forge, Pyramid, The Open Door, Arc 
Manor, Blairdap are just a few of the entities that we work with to 
provide the patient the appropriate level of care. Our program is 
designed that when a patient is referred to our services they must 
consent to allow open lines of communication between PRS and the 
behavioral health entity. PRS is strictly the medical aspect of 
treatment. We do not provide drug and alcohol counseling. With that in 
mind, that is why our program is so enticing to programs that have no 
ability to provide medication assisted therapy. We work together to 
complete the picture of a successful road to recovery.

Our mobile unit launched the first week of July 2015 and has been a 
success from day one. Our mobile unit functions in the exact fashion as 
our brick and mortar locations. The unit is equipped with a private 
waiting area, a restroom for urine specimen collection, a private 
assessment room, and a private injection room. We have contracted with 
Blair, Indiana, Clarion, and Armstong counties to be able to provide 
services to unfunded patients. Once a patient has flipped to Medicaid 
coverage we then bill the appropriate insurance. Of the 67 counties in 
Pennsylvania, 37 of those have expressed interest in having our 
services made available to them. More will be revealed when the budget 
is passed. PRS had the capability and intention to provide services to 
the entire state of Pennsylvania. We have applied to programs such as 
``Pay for success'' and up to this point have been privately funded for 
the purchase of the mobile unit. We look forward to expand and service 
as much as the patient population as possible.

Current challenges to our program include the Prior authorization 
process. We have attended meetings in Harrisburg with Secretary Tennis 
and Secretary Dallas who are working with us to make this mobile unit a 
success. Currently we are trying to have an agreement similar to the 
one with the Department of Corrections where we can get a verbal 
authorization and bypass the faxing of documents which then leads to a 
wait from anywhere between 24 hours to 3 weeks. Our desire to get these 
patients safe as soon as possible relies on the ability to be able to 
administer the medication as soon as the treatment team deems it to be 
medically appropriate. Our unit is currently available to each county 
on a biweekly schedule. The first appointment will include their ``New 
patient assessment'' where we do a complete drug history, past medical 
history, medication check, UDS, confirmation of drug and alcohol 
counseling and other pertinent information is obtained. PRS would like 
the ability to give the injection at the first assessment when 
medically appropriate. We continue to work on a daily basis to find new 
ways to help stop the devastating effects of overdoses in our 
communities. We appreciate immensely your interest in learning about 
our innovative program. Together we can help stop this horrific 
epidemic and assist in bringing back together families, loved ones and 
communities. I thank you for your time today. God Bless.

Amanda Cope, RN
Positive Recovery Solutions

                                 ______
                                 
            Western Psychiatric Institute and Clinic of the 
                University of Pittsburgh Medical Center
                      Addiction Medicine Services

                       Oxford Building, Suite 900

                           3501 Forbes Avenue

                          Pittsburgh, PA 15213

                             T 412-246-5910

                             F 412-246-5858

October 12, 2015

U.S. Senator Pat Toomey
248 Russell Senate Office Building
Washington, DC 20510

Dear Senator Toomey:

We appreciate your legislative efforts to address the problem of 
prescription opioid addiction, which is a significant issue in western 
Pennsylvania as well as other areas of the U.S. We are writing to share 
our ideas as we both have worked in the field of addiction treatment 
and research for several decades and have seen firsthand the havoc that 
opioid addiction creates for affected individuals, families, and 
society. Here are some of our thoughts about this problem and potential 
solutions from the perspectives of education and treatment.

The U.S. Attorney in Pittsburgh published a final report and 
recommendations on prevention, intervention, treatment, and recovery 
related to drug overdose and addiction (September 29, 2014). Dr. 
Douaihy served on the committee that generated this report.

Key elements of this report that we believe are relevant to what you 
wish to accomplish with your legislation include:

1. Education, prevention and family intervention:

      a.  Develop a public awareness and education plan to reduce 
overdose deaths.

      b.  Coordinate websites containing information on overdose 
prevention and links to recovery-based resources.

      c.  Assure access to and promote a regional hotline dedicated to 
OD prevention.

      d.  Promote physician education and intervention programs.

      e.  Educate buprenorphine providers on the best practice 
guidelines (Community Care Behavioral Organization in PA published 
excellent guidelines on ``best practices'' for treatment of opioid 
addiction).

2. Treatment:

      a.  Promote efforts to increase the availability of naloxone in 
the community as a safe antidote to opioid overdose.

      b.  Support Good Samaritan Laws and Prescription Drug Monitoring 
Programs.

      c.  Support measures to increase capacity for treatment of 
addiction.

      d.  Implement screening and referral interventions for early 
identification of drug problems (e.g., in medical settings).

Treatment needs to be long-term since opioid addiction is a chronic 
condition. Presently, many treatment resources focus on the acute phase 
of illness (detoxification, rehabilitation, intensive outpatient) and 
not on long-term or ``continuation'' treatment.

Recovery from addiction must be emphasized as this is the best antidote 
for relapse. Engagement in community mutual support programs helps many 
sustain long-term recovery. Treatment can help prepare an individual 
for recovery, but is not a replacement for it.

Family involvement in treatment and recovery needs to be emphasized. 
Many treatment programs DO NOT include families or offer services to 
them. There is a significant research and clinical literature 
documenting the adverse impact of opioid addiction on family units and 
individual members, including children. Addiction contributes to higher 
rates of family break-up, abuse and neglect, dependence on welfare, and 
involvement in criminal justice and other social services. Addiction 
creates a huge emotional and financial burden for families who spend an 
incredible amount of time, energy and money on their addicted loved 
one. Children of opioid addicted parents are at higher risk for 
psychiatric and substance use disorders, behavior problems, and 
academic problems.

Addressing addiction requires considering multiple perspectives. We 
wish you well in your attempts to help addicted individuals, families 
and communities.

Sincerely,

Dennis C. Daley, Ph.D.              Antoine Douaihy, M.D.
Professor of Psychiatry and Social 
Work                                Professor of Psychiatry
Director, Regional Research and     Medical Director
Training Center of Clinical Trials  Addiction Medicine Services
Network of the National Institute
on Drug Abuse

                                 ______
                                 
          Letter Submitted by Kevin M. Wong, M.D., CMD, FAAFP
October 14, 2015

The Honorable Pat Toomey
Chairman
U.S. Senate
Committee on Finance
Subcommittee on Health Care
248 Russell Senate Office Building
Washington, DC 20510

The Honorable Debbie Stabenow
Ranking Member
U.S. Senate
Committee on Finance
Subcommittee on Health Care
731 Hart Senate Office Building
Washington, DC 20510

Dear Chairman Toomey and Ranking Member Stabenow,

S. 1913--Stopping Medication Abuse and Protecting Seniors Act of 2015 
is a laudable effort to help reduce the narcotic abuse. As a practicing 
family physician for over 33 years, I have always tried to treat 
patients to the best of my ability following the adage, ``First do no 
harm.'' Even with clinical indications for appropriate use of long term 
narcotics and prescribing, an experienced clinician will eventually be 
``beaten'' by a patient seeking narcotics for inappropriate reasons. If 
we don't prescribe to some of these patients because they don't fit the 
typical pattern, we will inadequately treat someone who has a true 
medical need.

    A few years ago, I had an 80 year old frail female patient with 
documented severe arthritis who had been on a stable regimen of long 
acting narcotics for her chronic pain. I never suspected that she might 
be diverting her medications and was greatly surprised to receive a 
call from the pharmacist saying, ``we have a problem!'' When we filled 
Mrs. T's prescription today, she stood at our counter, made us count 
out the tablets, stating she had been shorted last month. After she was 
satisfied the count was correct, the bottle was placed in a bag and she 
left. As soon she walked out to the parking lot, we saw her on our 
security camera hand the same bag to a man, who handed her cash, which 
she held up in the sunlight to count each bill (she had poor eye 
sight). The pharmacist said they wouldn't report her if she didn't show 
up there again! When I called her family to tell them I would not be 
prescribing her narcotics anymore, they were livid, claiming I was 
abandoning her. After I explained she would not be withdrawing from 
narcotics, since she handed over her entire amount, they calmed down. 
After that, she transferred to another physician and I eventually found 
out she continued to get narcotics, until I happened to see that 
physician and he mentioned her name, saying she came to see him as I 
had been too busy. After I told him the story, he stopped writing the 
prescription and she moved onto another doctor.

    This bill would eliminate this specific scenario. However there are 
many more reasons it needs to pass. Even with the current guidelines 
proposed by organizations to help physicians (American Academy of 
Family Physicians, American Academy of Pain Medicine, AMA, CDC) without 
support from the federal and state agencies, the problem of narcotic 
abuse will continue to grow as witnessed by the current trends. State-
based Prescription Drug Monitoring Programs (PDMPs) have been 
successful in aiding physicians decrease narcotic diversion, however 
the programs are NOT fully functional in all states (currently 49 
states, District of Columbia, and Guam). Even in states where PDMPs 
have been created, they are NOT all helpful to physicians--Pennsylvania 
is a perfect example. The registry is currently accessible only to law 
enforcement. Many states have been happy with the PDMPs, but the next 
step requires federal help--link all the state PDMPs to prevent 
migration from state to neighboring states that either don't have a 
physician accessible database or don't share data.

Other significant improvements for PDMPs:
    (1)  Require the data be reported by the pharmacist, live to ensure 
the patient didn't get a narcotic recently from another physician and 
report it to BOTH physicians, if a concern is discovered, BEFORE 
filling the prescription.
    (2)  Require photo IDs for anyone prescribed and picking up a 
narcotic prescription.

Physicians who are trying to do the best for their patients need as 
much support as possible. Family doctors find it very hard to follow 
these appropriate guidelines when they are constantly held to a 
different standard of care compared to pain clinics who will prescribe 
narcotics and tranquilizers concurrently, even though there is strong 
evidence against concurrent use of this combination of medications 
which can lead to fatalities.

The good news is that there is some preliminary evidence that an 
insurer in western Pennsylvania trying to aid physicians care for their 
Medicare patients has found that only 0.13% (~200/150,000) for the 
first 2 Quarters of this year hit the high dose narcotic threshold. It 
is hoped with further measures as outlined previously to minimize 
inappropriate use and diversion, this number can continue to drop.

Thank you for your efforts to protect our vulnerable patients and help 
doctors care for them appropriately.

Kevin M. Wong, M.D., CMD, FAAFP

Past President, Pennsylvania Academy of Family Physicians

Resources:

http://www.aafp.org/news/health-of-the-public/20150408hhsopioids.html

http://www.aafp.org/news/health-of-the-public/20150408hhsopioids.html

http://www.ama-assn.org/ama/pub/advocacy/topics/preventing-opioid-
abuse/opioid-abuse-task-force.page

http://www.pdmpassist.org/content/prescription-drug-monitoring-
frequently-asked-questions-faq

http://www.aafp.org/news/health-of-the-public/
20150729opioidtaskforce.html

http://www.cdc.gov/drugoverdose/prescribing/guideline.html

http://www.aafp.org/news/health-of-the-public/
20150128nihopioidstudy.html

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