[Senate Hearing 115-708]
[From the U.S. Government Publishing Office]









                                                        S. Hrg. 115-708

                  EXAMINING EFFORTS TO PREVENT OPIOID
                       OVERUTILIZATION AND MISUSE
                        IN MEDICARE AND MEDICAID

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

                                HEARING

                               before the

                      SUBCOMMITTEE ON HEALTH CARE

                                 of the

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 29, 2018

                               __________






              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]




                                     
                                     

            Printed for the use of the Committee on Finance
                               __________

                      U.S. GOVERNMENT PUBLISHING OFFICE
                      
38-217-PDF                 WASHINGTON : 2019 





















                          COMMITTEE ON FINANCE

                     ORRIN G. HATCH, Utah, Chairman

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

                     A. Jay Khosla, 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                  ROBERT MENENDEZ, New Jersey
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN THUNE, South Dakota             THOMAS R. CARPER, Delaware
RICHARD BURR, North Carolina         BENJAMIN L. CARDIN, Maryland
JOHNNY ISAKSON, Georgia              SHERROD BROWN, Ohio
ROB PORTMAN, Ohio                    MARK R. WARNER, Virginia
DEAN HELLER, Nevada                  RON WYDEN, Oregon
BILL CASSIDY, Louisiana              SHELDON WHITEHOUSE, Rhode Island

                                  (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....     1

                         CONGRESSIONAL WITNESS

Fitzpatrick, Hon. Brian K., a U.S. Congressman from Pennsylvania.     1

                               WITNESSES

Denigan-Macauley, Mary, Ph.D., Acting Director, Health Care, 
  Government Accountability Office, Washington, DC...............     6
Dixon, Maureen, Special Agent in Charge, Philadelphia Regional 
  Office, Office of Investigations, Office of the Inspector 
  General, Department of Health and Human Services, Philadelphia, 
  PA.............................................................     7
Snyder, Richard, M.D., senior vice president and chief medical 
  officer, Independence Blue Cross, Philadelphia, PA.............     8
Malone, Heather, person in recovery, Media, PA...................    10
Weintraub, Matthew, District Attorney, Bucks County, Doylestown, 
  PA.............................................................    12

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Denigan-Macauley, Mary, Ph.D.:
    Testimony....................................................     6
    Prepared statement...........................................    25
Dixon, Maureen:
    Testimony....................................................     7
    Prepared statement...........................................    32
Fitzpatrick, Hon. Brian K.:
    Testimony....................................................     1
Malone, Heather:
    Testimony....................................................    10
    Prepared statement...........................................    39
Snyder, Richard, M.D.:
    Testimony....................................................     8
    Prepared statement...........................................    41
Toomey, Hon. Patrick J.:
    Opening statement............................................     1
    Prepared statement...........................................    45
Weintraub, Matthew:
    Testimony....................................................    12
    Prepared statement...........................................    48

                                 (iii)

 
                  EXAMINING EFFORTS TO PREVENT OPIOID 
                       OVERUTILIZATION AND MISUSE 
                        IN MEDICARE AND MEDICAID 

                              ----------                              


                         TUESDAY, MAY 29, 2018

                               U.S. Senate,
                       Subcommittee on Health Care,
                                      Committee on Finance,
                                                      Bensalem, Pa.
    The subcommittee was convened, pursuant to notice, at 1 
p.m., in the Bensalem Township Municipal Building, 2400 Byberry 
Road, Bensalem, PA, Hon. Patrick J. Toomey (chairman of the 
subcommittee), presiding.

    Senator Toomey. Good afternoon, everyone. Before we get 
started, I would like to recognize Congressman Fitzpatrick.

            STATEMENT OF HON. BRIAN K. FITZPATRICK, 
              A U.S. CONGRESSMAN FROM PENNSYLVANIA

    Representative Fitzpatrick. Thank you all for being here 
today.
    Senator Toomey, I speak on behalf of all of our local 
elected officials here: Mayor DiGirolamo, Public Safety 
Director Fred Harran, Commissioner Rob Loughery. We really 
appreciate you choosing Bucks County to have this discussion. 
And as everybody here knows, dealing with the opioid crisis 
requires an ongoing message mission to problems we are having 
here in Bensalem Township-- with close to 60,000 residents--and 
to those who have been on the front lines of this epidemic.
    So, Senator, on behalf of all of Bucks County, we 
appreciate you choosing Bucks to have this hearing. We have a 
fine panel here, and I just wanted to thank you for being here.
    Thanks.

  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, Congressman.
    We will now begin a hearing of the United States Senate 
Committee on Finance Subcommittee on Health Care, a field 
hearing, where we will discuss and examine efforts to prevent 
opioid overutilization and misuse in Medicare and Medicaid.
    First, I want to thank the Bensalem Township Council for 
hosting this field hearing.
    Mayor DiGirolamo, thank you very much.
    A special thank you to the Director of Public Safety here, 
Fred Harran, for his help in pulling this together.
    I want to thank the witnesses for making themselves 
available and for contributing their time and expertise to what 
I am sure will be an illuminating discussion.
    To the various public officials who are here from various 
places around the Commonwealth and around the county, I 
appreciate your dedication to this issue, in particular.
    I want to thank Congressman Fitzpatrick, who has been a 
stalwart in the work that he has done in the House of 
Representatives.
    But I also want to recognize two special guests who are 
with us. One is joining us from the Middle District of 
Pennsylvania, the U.S. Attorney, David Freed. David, thank you 
for joining us. And from the Eastern District, Bill McSwain. 
Bill, thank you for being here.
    If we have time, I hope we might be able to get a couple of 
thoughts from each of you, because I know so much of your work 
is involved in this space.
    Also, to the public who is here--because I know, like all 
of us, we are all interested in how we can make progress and 
eventually defeat this terrible scourge.
    There are many lessons relevant to the current experience 
we are having, believe it or not, from the history of our 
country. This opioid epidemic actually has a precedent of 
sorts. It is not the first time, sadly, that our country has 
found itself in the depths of a public health crisis 
precipitated by the overuse of opium and its derivatives.
    In the 19th and early 20th centuries, medical advances, 
like the development of morphine and the adoption of the 
hypodermic syringe, made a very powerful reliever of pain 
readily available to the masses. The addictive qualities and 
negative effects of opium and morphine use were not fully 
appreciated, not then, not until it was too late for many.
    It is unfortunate that we find ourselves today in a 
predicament with such a clear precedent, but it is not too late 
to learn from the experience. There was no simple solution to 
that public health crisis, and there will be no simple solution 
today.
    Then, the transition away from dependence on opioids was 
enabled in part by developing ways to resolve the underlying 
disease that gave rise to pain, such as improving sanitation. 
It was enabled in part by embracing alternative treatments, 
such as the adoption of aspirin as an analgesic beginning in 
1899. It was enabled in part by improving pharmaceutical 
controls and restricting the importation of opium itself and 
its derivatives. And finally, there was a significant shift in 
medical practice and the culture of medicine to appreciate that 
in many, though not all cases, the dangers associated with this 
particular treatment could outweigh the benefits.
    Then and now, the correlation between an increased 
availability of opioids and very negative societal 
repercussions, such as substance use disorder and overdose, 
cannot be ignored. This correlation is too powerful to dismiss 
it. Opium became the most commonly dispensed medical item by 
1834. From that time until the tide was finally turned in the 
late 1890s, the number of individuals struggling with opiate-
related substance misuse grew six-fold.
    Fast forward to the 21st century and opioids are, once 
again, among the most popularly prescribed class of 
medications. From 1999 to 2016, opioid-related overdoses 
quintupled. This chart created by the Centers for Disease 
Control shows the clear correlation between opioid-related 
sales, the growth of which is depicted on the green line, and 
opioid-related deaths, which is the blue line. By the way, this 
does not include the recent wave of heroin- and fentanyl-
related deaths, but just prescription opioid-related deaths, 
and it shows the first wave of the crisis.
    When we look at this issue in the present day, and we look 
by region, the trends are even more clear. This is another 
chart by the CDC. The size of the yellow circle depicts the 
number of painkillers sold per 10,000 in population. So, 
clearly, the larger yellow circles reflect a greater prevalence 
of opioid prescriptions per number of individuals. The shade of 
blue indicates the drug overdose rate per 100,000, and the 
darker the color blue, the greater the frequency of overdose 
deaths. There is a lot going on in a chart that shows 50 
American States. But one thing that is pretty clear is the 
large yellow circles, the preponderance of prescription 
opioids, correspond to the dark blue, which is where there are 
very high death rates.
    Now we have another chart that illustrates this in an even 
more compelling way, and it is a direct comparison of two 
distinct regions of the country. High prescribing, which is the 
big yellow circles, and high overdose rates, the dark blue, go 
hand in hand throughout much of Appalachia, while at the same 
period of time, much lower prescribing rates, the very small 
yellow circles, and significantly lower overdose rates, the 
light blue color, are the norm in the upper Midwest. Folks, 
this is not a uniform national crisis. It is really several 
intense regional crises.
    Another point of comparison that I think is useful is 
looking at opioid consumption internationally. The data that is 
displayed here comes from the United Nations International 
Narcotics Control Board, and it shows the most recent period of 
time for which we have data, which is 2012 through 2014. And in 
that period of time, the United States, after adjusting for 
population, so this is all on a per-citizen basis, still 
utilizes--look at this graph. This is the United States in a 
bar graph that shows the opioid consumption by prescription, 
and in the United States, we consumed in this period of time 
eight times the rate of opioid prescriptions in Italy, six 
times that of France, four times that of Great Britain, and 
more than 1\1/2\ times the rate of opioid prescriptions of the 
number two country in the world, which is our neighbor, Canada.
    Now, all of that is very discouraging at some level, for me 
anyway, but it is not to say that we have not made significant 
progress in recent years. It appears that the peak of opioid 
prescriptions was in 2011, and there has been a significant 
falloff, as you can see, since then. In fact, the total fall 
has been about 29 percent. That is very significant, and that 
is real progress.
    I think it is attributable in part to increased awareness, 
both throughout the medical profession and the public as a 
whole. I think it has come in part because of developments such 
as the endorsement of guidelines for prescribing opioids for 
chronic pain by the Centers for Disease Control and Prevention. 
These sorts of things have had a profound effect. The adoption 
of prescription drug monitoring programs allows physicians to 
know in a moment what other prescriptions have been prescribed 
for a given patient. This was only recently introduced here in 
the Commonwealth of Pennsylvania, and it has given health-care 
providers a powerful new tool to inform their judgment about 
whether or not to prescribe another opioid.
    But despite all this progress, the amount of opioids being 
dispensed today, after a 29-percent decline from the peak--
today we are still prescribing roughly five times the volume of 
prescriptions as recently as 1992. Let me say that again. 
Today, we are prescribing five times the level that was being 
prescribed in 1992.
    In 2016, there were 215 million opioid prescriptions 
written across the country. In our State of Pennsylvania, there 
are still counties where, in a given year, there are more 
prescriptions for opioids than there are people. Fayette 
County--129 prescriptions in 2016 for every 100 people. 
Lackawanna County--112 for every 100 people. Mercer County--109 
prescriptions for every 100 people. Let me reiterate. That is 
more than one opioid prescription for every man, woman, and 
child in that county.
    I am going to ask our witnesses at the appropriate time 
whether it could possibly make sense that we need to prescribe 
that many opioids throughout the population of our country.
    But another question and a related question that we are 
going to explore today is: what are our Nation's largest payers 
of health care, Medicare and Medicaid, doing to prevent opioid 
overutilization and misuse? With the implementation of the 
Medicare prescription drug benefit in 2006, commonly referred 
to as Medicare Part D, the Federal Government became the single 
largest purchaser of opioids in the world. Let me say that 
again as well so that we are all very clear about this. The 
world's largest purchaser of opioids, by far, is the United 
States Federal Government through these programs.
    This is a chart that ran in the Journal of Health Affairs. 
The dark red--which you can see going from a minute little line 
in the early years to a very large portion of the column in the 
latter years--that is the volume of opioids paid for by 
Medicare alone. Medicaid is the dark blue portion of the 
columns, and Medicaid does not spend as much money on opioids 
as the Federal counterpart for the aged and disabled, which is 
Medicare.
    But Medicaid beneficiaries receive average annual doses 
that are twice as high as those who are privately insured, and 
Medicaid beneficiaries are much more likely than the general 
population to be diagnosed with substance use disorder or 
suffer an overdose. I am not suggesting that I know the cause 
and effect here. I am simply suggesting that these are facts 
that are occurring at the same time.
    So the approaches of Medicare and Medicaid programs to deal 
with this, to prevent opioid overutilization and misuse, have 
been underway for some time, and they have been multifaceted. 
Let me touch on a few of these, because they are important.
    Some examples: Congress worked with the previous 
administration to decouple questions related to pain management 
in patient surveys from Medicare hospital reimbursement. It 
used to be that a hospital would get a bump-up in their 
reimbursements from Medicare if, in patient surveys, patients 
indicated a high level of satisfaction with pain management. It 
really was a mechanism for creating a financial incentive to 
prescribe more opioids. We ended that.
    The Centers for Medicare and Medicaid Services, plan 
sponsors, States, health systems, medical professional 
societies, and other stakeholders have undergone a noteworthy 
campaign of education, especially for prescribers. CMS is 
implementing a 7-day initial fill limit for what they call 
opioid-naive patients. That is a patient who has had no opioid 
prescription for at least the previous year. So a 7-day initial 
fill limit means you do not leave with more than a 7-day 
supply. If you need a greater supply than that, you go back and 
get a prescription refilled.
    Medicare, State Medicaid programs, and plan sponsors have 
utilized drug management programs that incorporate tools like 
prior authorization, point-of-sale edits, and patient review 
and restriction, sometimes referred to as lock-in programs, to 
encourage more appropriate prescribing. Law enforcement has 
aggressively worked to crack down on those working to defraud 
Medicare and Medicaid programs for monetary gain.
    Today, we will hear from witnesses who should give us 
insight into the effectiveness of all of these efforts and how 
we may improve upon them and what other ones we may explore. 
Specifically, we want to explore whether the efforts focus on a 
large enough portion of the total beneficiaries who are at risk 
of harm. Are we doing enough to ensure that when potential 
fraud is identified, appropriate action is being taken? Are we 
doing enough to equip providers with the information that they 
need? Are the efforts currently underway in the Medicare and 
Medicaid programs having any noticeable impact at the local 
level, including with law enforcement? These are some of the 
things we are going to explore during the course of this 
afternoon.
    So again, I want to thank everyone for being here today. I 
look forward to the discussion. I do remain confident that by 
working together at the Federal, State, and local levels and, 
essentially, with health-care providers, insurance, and the 
various plans, that we can continue to make the substantial 
progress we have been making. But it is clear to me we still 
have a very long way to go.
    [The prepared statement of Senator Toomey appears in the 
appendix.]
    Senator Toomey. Our first witness this afternoon is Dr. 
Mary Denigan-Macauley. She is Acting Director of Health Care at 
the U.S. Government Accountability Office, a graduate of the 
University of Delaware with a Ph.D. from Arizona State. Dr. 
Denigan-Macauley has been at GAO since 2001. She had previously 
taught public policy at Sam Houston State University in Texas 
and Troy University in Japan. Her recent work focuses on the 
effectiveness of Federal programs to promote and ensure public 
health and to prevent and respond to public health emergencies 
such as the opioid epidemic.
    We will then turn to Ms. Maureen Dixon. Ms. Dixon is the 
Special Agent in Charge of the Philadelphia Office of the 
United States Department of Health and Human Services' Office 
of the Inspector General. Ms. Dixon graduated from Syracuse 
University and, prior to entering law enforcement, was an 
emergency medical technician. In her current capacity, Ms. 
Dixon manages all Health and Human Services Office of Inspector 
General operations in Pennsylvania, Maryland, West Virginia, 
Delaware, and the District of Columbia.
    She will be followed by Dr. Richard Snyder. Dr. Snyder is 
the senior vice president and chief medical officer of 
Independence Blue Cross. Dr. Snyder is a graduate of Franklin 
and Marshall College and the Medical College of Pennsylvania 
and is board-certified by the American Board of Family 
Medicine. He is the chief clinical spokesperson for 
Independence Blue Cross, the largest provider of health 
insurance in our region. At Independence, Dr. Snyder has 
overall responsibility for medical quality, pharmacy 
management, and all clinical policies and programs.
    Then we will hear from Ms. Heather Malone. Ms. Malone is a 
constituent who joins us from Delaware County. Following a 
traumatic childhood, Ms. Malone was prescribed opioids for back 
pain resulting from a car accident she had at the age of 18. 
She continued to use opioids for the next 2 years. Dependence 
and misuse eventually led to heroin and some very harrowing 
experiences. Ms. Malone has been in recovery for 6 months now. 
We are looking forward to hearing from her.
    And finally, we will hear from Mr. Matthew Weintraub. Mr. 
Weintraub is the District Attorney for Bucks County. A graduate 
of Ursinus College and Temple Law, he previously worked as an 
Assistant D.A. in both Bucks and Lehigh Counties. He has tried 
more than 100 criminal cases, including the successful 
prosecution of four Philadelphia heroin dealers who had sold 
fatal doses to Bucks County residents. D.A. Weintraub has also 
taught criminal justice at Rowan, DeSales, and Delaware Valley 
Universities.
    So thank you to the witnesses. Your full testimony will be 
submitted for the record. I ask you to keep your oral testimony 
this afternoon to approximately 3 minutes each so that we will 
have time for a robust discussion, and I would like to ask Dr. 
Denigan-Macauley to begin.

  STATEMENT OF MARY DENIGAN-MACAULEY, Ph.D., ACTING DIRECTOR, 
 HEALTH CARE, GOVERNMENT ACCOUNTABILITY OFFICE, WASHINGTON, DC

    Dr. Denigan-Macauley. Good afternoon, Chairman Toomey and 
Congressman Fitzpatrick. Thank you for the opportunity to 
testify today on the oversight of opioid prescribing in the 
Medicare program.
    Prescription opioids are critical for treating both acute 
and chronic pain, and it is important we maintain access to 
them for those in need. Unfortunately, misuse of prescription 
drugs has become a serious public health problem, including for 
Medicare and Medicaid beneficiaries. The Centers for Disease 
Control and Prevention reported that from 1999 to 2013, the 
rate of deaths from prescription opioids nearly quadrupled. 
Today, I would like to point out two areas where the Federal 
Government can do more to protect Medicare beneficiaries from 
harm.
    First, the Centers for Medicare and Medicaid Services, also 
known as CMS, do not know how many of their Medicare 
beneficiaries receive doses of opioids that are high enough to 
put them at risk for addiction, overdose, and death. We found 
in 2017 that this is because CMS only monitors the total number 
of beneficiaries who receive prescriptions for high doses of 
opioids if those prescriptions also come from a certain number 
of providers and pharmacies. CMS estimated that in 2015, it 
would have captured more than 20 times the number of 
individuals at risk, from 33,223 to more than 720,000 
beneficiaries, if it did not tie prescription monitoring to 
that number of providers and pharmacies.
    According to the Centers for Disease Control and 
Prevention, long-term use of high doses of opioids is 
associated with significant risk of harm and should be avoided 
if possible. This is particularly the case for patients age 65 
and older, because the drugs can more easily accumulate in the 
body and become toxic. We recommended and CMS concurred that it 
should gather this information.
    Second, we found that CMS lacks key information to ensure 
proper opioid prescribing because it does not require its 
private insurers to report on the actions they take against 
doctors and others who may inappropriately prescribe opioids. 
We recommended that CMS make this a requirement. CMS did not 
concur, noting concerns about overburdening the private 
insurers with new regulatory requirements. We continue to 
believe that this should be a requirement so that CMS has the 
information it needs to assess progress in reducing the over-
prescribing of high doses of opioids.
    In conclusion, it is important that patients receive 
appropriate and safe pain treatment based on benefits and 
risks. Having information on beneficiaries receiving harmful 
levels of these opioids and on providers inappropriately 
prescribing them could help CMS reduce the risk of opioid 
addiction, overdose, and death.
    Chairman Toomey, Congressman Fitzpatrick, this concludes my 
statement, and I look forward to your questions.
    Senator Toomey. Thank you very much.
    [The prepared statement of Dr. Denigan-Macauley appears in 
the appendix.]
    Senator Toomey. Ms. Dixon?

     STATEMENT OF MAUREEN DIXON, SPECIAL AGENT IN CHARGE, 
PHILADELPHIA REGIONAL OFFICE, OFFICE OF INVESTIGATIONS, OFFICE 
   OF THE INSPECTOR GENERAL, DEPARTMENT OF HEALTH AND HUMAN 
                   SERVICES, PHILADELPHIA, PA

    Ms. Dixon. Good afternoon, Chairman Toomey and Congressman 
Fitzpatrick. Thank you for the opportunity to appear before you 
today to discuss OIG's efforts to combat the opiate epidemic in 
Federal health-care programs.
    Given our long history of health-care fraud enforcement, 
program knowledge, and data analytics, OIG is uniquely 
positioned to help lead the fight against illegal opiate 
prescribing in Medicare and Medicaid. My testimony today will 
highlight our work to prevent opiate-related fraud and abuse, 
detect questionable prescribing and billing patterns, and 
enforce laws and regulations governing opiate prescribing.
    Opiate-related fraud encompasses a broad range of criminal 
activity, from prescription drug diversion to addiction fraud 
treatment. Developing these investigations is complex, 
requiring our full range of law enforcement techniques to 
gather evidence of crimes often committed by corrupt doctors, 
pharmacists, and criminal networks. In the worst cases, we have 
uncovered evidence of illegal prescribing resulting in deaths 
from overdose.
    OIG's partnership with DOJ, FBI, DEA, and State Medicaid 
fraud control units is critical to the success of our efforts. 
OIG and our Medicare Fraud Strike Force partners led the 2017 
national health-care fraud takedown, the largest health-care 
fraud enforcement action ever, resulting in over 400 charged 
defendants across the country.
    OIG has also shifted resources to support the Attorney 
General's Opiate Fraud and Abuse Detection Unit, a multiagency 
effort capitalizing on data analytics. Agents in the 
Philadelphia regional office are assigned to support this 
initiative, which focuses solely on investigating and 
prosecuting opiate-related health-care fraud cases.
    OIG uses advanced data analytics to put timely, actionable 
information about prescribing, billing, and utilization trends 
in the hands of investigators, auditors, evaluators, and 
government partners. Our July 2017 data brief uncovered that 
half a million Medicare beneficiaries receive opiates in excess 
of CDC guidelines.
    Further, nearly 90,000 beneficiaries are at serious risk of 
opiate misuse or overdose. To get at the source of this extreme 
use, OIG identified about 400 prescribers with questionable 
opiate prescribing patterns for these beneficiaries at serious 
risk. OIG will release an update to the data brief later this 
summer based on more recent data. OIG will also release an 
analyst toolkit based on the methodology we developed in our 
extensive work on opiates to assist our public- and private-
sector partners with analyzing their own prescription drug data 
to help combat the opiate crisis.
    OIG's work holds criminals accountable and results in 
impactful recommendations to improve program integrity, save 
tax dollars, and protect HHS beneficiaries from harm.
    I appreciate the opportunity to speak with you today, and I 
would be happy to answer any questions you may have.
    Thank you.
    Senator Toomey. Thank you, Ms. Dixon.
    [The prepared statement of Ms. Dixon appears in the 
appendix.]
    Senator Toomey. Dr. Snyder?

 STATEMENT OF RICHARD SNYDER, M.D., SENIOR VICE PRESIDENT AND 
 CHIEF MEDICAL OFFICER, INDEPENDENCE BLUE CROSS, PHILADELPHIA, 
                               PA

    Dr. Snyder. Senator Toomey, Congressman Fitzpatrick, thank 
you for having me. The detailed written testimony that I 
provided has a lot more detail, but I wanted to focus on this 
problem using sort of a physician's disease model approach, 
because I think it may shed some light on what otherwise seems 
like a very large morass of issues that we need to tackle 
simultaneously.
    I think of diseases as manageable if you think of primary 
prevention--that would be like an immunization--secondary 
prevention, which would be identified with screening and then 
treating the patient, and obviously, tertiary, intervening when 
the patient crashes. So if we think about the people who take 
opioids in that light, primary prevention should focus on those 
people who are opioid-naive. You mentioned this, Senator 
Toomey--they have not had opioids in the past. We need to 
prevent that.
    I sat on the Mayor's task force in Philadelphia to address 
this, and one of the stories I heard over and over was young 
people who became addicted to heroin by first encountering 
opioids in a loved one's medicine cabinet--the one room in the 
house that you can enter, lock the door, and no one would think 
different while you are in there looking through the medicine 
cabinet. You need to prevent that. And even here today, a 
couple of people mentioned to me that after minor procedures 
they received 30 oxycontin at the point of discharge. We cannot 
do that. You take one or two, and they end up in a medicine 
cabinet. That is very problematic.
    So we need to educate physicians and patients, the 
beneficiaries, about the risks of opioids and put some kind of 
blockade in place to prevent that arbitrary prescribing of 
opioids for minor procedures--wisdom teeth, minor surgical 
procedures.
    A close friend who is a cardiothoracic surgeon, upon having 
his bladder removed for bladder cancer, received only IV 
Tylenol because of the risk of getting addicted to opioids--did 
not want it, did not need it.
    We can manage things differently and prevent the exposure 
and, more importantly, the lingering of opioids in people's 
possession at home.
    The secondary prevention concept is one that we do not do a 
very good job of as a medical community, and that is screening 
people who are at risk for opioids before we continue to 
administer them. It is very common that physicians will not ask 
about past history, and there are lots of examples where that 
has resulted in perpetuating a problem with patients.
    Screening tools are available, and we at Independence will 
be making a tool available midyear this year online that 
physicians or members can access supported by computerized 
cognitive behavioral therapy to help intervene. If you do not 
want to publicly go out and meet with your physician about that 
issue, you can try to do it on your own.
    In addition to that, one thing we cannot do as a payer--and 
I assume you also are running into that issue in the Office of 
the Inspector General--is use all the data that is available. 
There is a lot of data sitting in PDMPs that I cannot access to 
couple with diagnostic information as well as other prescribing 
information about our members that would allow me to then 
intervene prospectively before they have a crisis and try to 
help them, as we would with any other chronic condition--
medical conditions, heart failure, diabetes, et cetera.
    We would like to be prospective, not wait until the patient 
is in the hospital in crisis, and intervene with a security net 
of services to help them address their chronic problem. We are 
not allowed to do that with opioid use disorder, substance use 
disorder, as a result of HIPAA and 42 CFR part 2 and State laws 
which interfere with that. So if mental health parity is ever 
going to really exist for patient care, we need to somehow 
address that, which would allow us to find people who are at 
risk and treat them and support them through the transition.
    And then, thinking about this from a tertiary prevention 
perspective, obviously, in crisis, patients are identified 
either by a loved one or emergency medical services, and we 
need to make the rescue medications Narcan and naloxone more 
readily available. We have tried to do that by eliminating 
member cost share where possible and encouraging patients to 
have it available if they are dealing with a loved one who may 
be subject to opioid use and abuse.
    Warm hand-off programs are another thing. When people are 
in crisis, it is very effective to have someone who has been 
down that path help the patient to walk into treatment. We, in 
a study commissioned here in this region looking at our own 
data, have identified that with warm hand-off programs in 
place, there is an 89-
percent greater chance that the patient will actually enter 
into treatment. And with treatment, obviously, there is 
recidivism, but we can at least have a fighting chance to 
support them.
    And last, I think there is a big opportunity for payers and 
providers to collaborate more than they do today, if we can get 
past some of the issues with the privacy laws as they stand.
    On behalf of Independence and our CEO, Dan Hilferty, I 
appreciate the opportunity to be here and testify.
    Senator Toomey. Thank you very much, Dr. Snyder.
    [The prepared statement of Dr. Snyder appears in the 
appendix.]
    Senator Toomey. Ms. Malone?

                 STATEMENT OF HEATHER MALONE, 
                 PERSON IN RECOVERY, MEDIA, PA

    Ms. Malone. Thank you, Senator Toomey and Congressman 
Fitzpatrick. Thank you, fellow witnesses, for your testimony.
    Six months ago, I made a decision to better my life for 
myself. For so long, I lived in fear, darkness, and chaos. I 
was using heroin every single day, and it left me lost and 
alone. My family wanted nothing to do with me, and my children 
did not know their mother.
    Looking back, it was really easy to blame my past and how I 
turned out on situations that led up to things. I never learned 
any coping mechanisms on how to deal with all the pain. I came 
from a mother who was an addict, and she was never around. She 
had a lot of live-in babysitters, and, eventually, my aunt and 
her boyfriend filled this role of my mother. My aunt's 
boyfriend molested me, and when he moved out, my aunt committed 
suicide. I then had to move in with my father, who was very 
emotionally and physically abusive, and at age 14, I attempted 
to take my own life.
    At 18, my mother reentered my life, and I thought I would 
be able to grow close to her, but this did not happen. She 
wanted someone to get high with, and after a minor car 
accident, she took me to a doctor, and all I had to do was tell 
the doctor that I had serious back pain and I was prescribed 
medication.
    The first time taking a pill was a memory that I will never 
forget. I thought I had found the answers to all my pain and 
problems. The pill gave me a numbing effect that I fell in love 
with. As time progressed, the strength of medications 
increased, as did my addiction. Pills were so easily 
accessible, and they were legal, so I did not see a problem 
with them.
    Eventually, prescriptions ran out, and pills became too 
expensive, and I graduated to heroin, and that became my new 
best friend. This took me down a dark path with more pain and 
suffering. I was raped, and selling my body was an easy way to 
pay for my next fix. Jails and institutions and running and 
using became my life. There were bouts of sobriety thanks to 
Suboxone and methadone.
    I went back to school and I worked with people like myself, 
and I excelled, and I was admitted to an honor society. I was 
picked to give a speech at a ceremony, and I should have been 
happy and I should have been proud, but I was not. I never made 
it to that speech that night, because that night, I tried to 
take my life once again.
    As years went on, things got worse, and addiction became my 
full-time job. I was consumed with that numbing effect. I did 
not want to live, but if I had to, I did not want to feel 
anything. I lived to use, and I used to live. Eventually, I got 
back into a relationship with a person who was in active 
addiction and very abusive, and I thought that we loved each 
other, because, to me, pain equaled love.
    All the people who were ever supposed to love me ended up 
hurting me, and physical abuse meant that I did not have to 
feel that internal pain.
    Last December 8th, the abuse went to a whole new level. I 
woke up to my girlfriend choking me, and I begged her to end my 
life. She cut my throat, she hit me with a bat, and she hung me 
over a balcony. My father arrived and stopped this, and I 
should have gone right to the hospital because I had black 
eyes, bruises on my neck, and a fractured hip, and all I could 
do was beg him to take me to Kensington to get my next fix so I 
could feel that numbness once again. He took me, and I promised 
that I would go to rehab.
    I showed up at rehab badly physically beaten. I was at an 
all-time low. I was emotionally and spiritually bankrupt and 
broken. After 3 days in rehab, I got up enough strength to look 
at myself in the mirror, and I realized I did not want this 
anymore. I wanted something better. Due to DBT therapy, they 
finally helped me share stories and secrets that I would never 
share with anyone before.
    As my discharge date approached, I agreed, after talking 
with my counselors, to live at MVP--Motivation, Vitality, and 
Perseverance Recovery House. This program is helping me so 
much. It is helping me recognize my defects coming out and how 
to work through them so that I can be a better person. 
Perfecting this process is unrealistic, and I fall short at 
times. But because of MVP and the community that I am in now, I 
am able to work towards being a productive member of society.
    Today, I am accountable for my actions. I am able to be a 
daughter, a friend, and most of all a mother. I am still in a 
lot of pain on a daily basis due to my fractured hip. I need to 
get a partial hip replacement, and I fear the aftermath, 
because to recover, a doctor might write me a prescription for 
pain medication. If I do not notify them ahead of time that I 
am in recovery, it is almost automatic that they will prescribe 
me opiates.
    My demise of addiction all began with a simple script 
written from a doctor.
    I want to recover. I do not want to be defined as a 
statistic, and hopefully, things can change to help implement 
changes to avoid over-prescribing or prescribing to people who 
are at risk.
    In treatment, they asked us what our 5-year goal was in 
life, and people wanted houses and cars and families. When it 
was my turn to share, all I wanted was genuine happiness, 
because I never had that before, and I honestly thought that 
pure happiness was unattainable for a person like myself, and I 
definitely did not think that I would be able to achieve it 
within 5 years. But today, I can tell you I am truly happy, and 
I am truly grateful to be exactly where I need to be.
    Thank you. [Applause.]
    Senator Toomey. Ms. Malone, I just want to thank you for 
having the courage to be here today and share this experience 
and to assure you that it is very likely, in my view, that you 
are encouraging and inspiring other people who are facing the 
kind of circumstances you were in, and you are inspiring them 
by proving that they can recover. So thanks very much.
    [The prepared statement of Ms. Malone appears in the 
appendix.]
    Ms. Malone. Thank you for this opportunity.
    Senator Toomey. We appreciate it.
    Ms. Malone. Thank you.
    Senator Toomey. D.A. Weintraub?

   STATEMENT OF MATTHEW WEINTRAUB, DISTRICT ATTORNEY, BUCKS 
                     COUNTY, DOYLESTOWN, PA

    Mr. Weintraub. Good afternoon. Thank you, Chairman Toomey 
and Congressman Fitzpatrick, for the opportunity to provide 
this testimony to the committee. As Bucks County D.A., I will 
try to focus on the challenges of the opioid epidemic as I see 
them, with a specific focus on why prevention is so important.
    But I want to go off script for just a second and say that 
I applaud Ms. Malone's bravery. But we are surrounded by people 
in recovery every day, and they will help us to destigmatize 
recovery if they will step forward and be brave like Ms. Malone 
has been today.
    Bucks County is particularly challenged because of our 
proximity to Philadelphia, to Allentown, and to Trenton. We are 
fortunate and unfortunate both in that we border these three 
very challenged areas that have been hit hard by the opioid 
epidemic. This makes it easy for those suffering from addiction 
to obtain these drugs. These drugs--we try our best to stop 
them from infiltrating our county, but they are easy to obtain 
with a very short drive, literally minutes, and that is why our 
regional and national response is vital.
    No one county or entity within the county can do it alone. 
We have D.A. Kat Copeland here from Delaware County. We need 
her help, and we work hand in hand. We also have the regional 
law enforcement to help us as well, and we work closely 
together, all as a team. But we need more help. The following 
is a great example of where cross-county collaboration thwarted 
a pill-dealing drug ring.
    In 2018, this very year, the Bucks County Drug Strike 
Force, which we started with the aid of our Commissioners--and 
I will point out that Commissioner Rob Loughery is here today--
conducted an investigation in which 10 people were arrested in 
Berks County, which does not even neighbor Bucks County, for 
making and passing fraudulent prescriptions. Over 106 
fraudulent prescriptions were filled in the Bucks County and 
Philadelphia area, which resulted in these individuals 
obtaining 12,500 oxycodone pills. These pills, unfortunately, 
were then distributed on the streets in Bucks County and 
Philadelphia.
    Our medication take-back program demonstrates the 
overprescribing problem that we face, and it is illustrated by 
the amount of unneeded medication in our community. One of the 
other testifiers stated that we leave our unused, old, expired 
medication in our medicine cabinets, and if we know that, that 
is where somebody who craves these medications knows to look 
for them as well.
    It is a good news-bad news situation. We here in Bucks 
County are number one in the State in medication take-back. We 
have collected over 107,000 pounds since this program's 
inception. That is over 53 tons. This is a lot of medication 
that can no longer be diverted to hurt or to kill somebody ever 
again. That is a lot of medication, period, and that is part of 
the problem, as you pointed out, Mr. Chairman.
    Medicare and Medicaid are two of the largest payers for 
prescription opioids and, therefore, hold a critical role in 
making sure that we reduce the amount of excess opioids in 
circulation in the first place. Congress recently dedicated an 
unprecedented $4.6 billion to combat the opioid crisis in 
fiscal year 2018. I think that is wonderful. We need every 
penny of that.
    It is important to make sure that funding reaches the 
places where it is needed the most through the programs that 
will be the most effective. Such programs that could benefit 
from such funding right here in Bucks County include drug 
recovery programs in our jails that can educate and 
successfully begin to treat our inmates so that they never 
return. That is really the point.
    Another innovative program we are looking to expand is 
Bucks Police Aiding in Recovery. I would love to give a shout-
out. That was started right here in Bensalem as Bensalem Police 
Aiding in Recovery. This helps increase treatment access to 
those who seek it voluntarily.
    Finally, we have spent so much time focused on heroin, 
which is critical, of course, but we have turned our attention 
away from other substances. One phenomenon that we are seeing 
is what we now call a rising twin epidemic, which pairs 
stimulants like methamphetamine and opiates, like oxy or 
heroin. We are finding that many opioid users are also abusing 
meth in order to ease their painful physical withdrawal 
symptoms experienced as they seek their next opioid fix.
    We must also continue to focus on underage drinking and 
marijuana use and educating our youth in the schools, which 
will continue to be issues for our community.
    I appreciate the opportunity to address the committee 
today, Senator Toomey, to talk about the challenges of the 
opioid epidemic as I see them.
    Thank you.
    Senator Toomey. Thank you very much, D.A. Weintraub.
    [The prepared statement of Mr. Weintraub appears in the 
appendix.]
    Senator Toomey. Let me begin questions, and let me begin 
with an issue that both Dr. Denigan-Macauley and Ms. Dixon 
touched on. Dr. Snyder, I think, at least in your written 
testimony, you had something to say about this as well. This is 
the manner in which CMS, the Centers for Medicare and Medicaid 
Services, attempts and to some degree does monitor the 
utilization of opioids by people whom they deem to be at risk. 
Specifically, what I want to get at is the perception of who is 
at risk.
    So the data that I have seen suggests that if you use the 
Centers for Disease Control criteria, specifically, their 
criteria for the daily volume of opioids above which they 
consider someone to be at risk, at risk of a serious adverse 
health consequence and at risk to addiction--if you use CDC's 
criteria, then in 2016, the number may be as high as 1.6 
million Medicare beneficiaries who would be at risk. Yet CMS, 
under the new criteria, which are a little bit looser than 
their old criteria, as I understand it--their overutilization 
monitoring system, which is meant to track these folks, will 
be, when the new system is implemented next year, monitoring 
something on the order of 44,000 people instead of 1.6 million 
people. It is fewer than 3 percent of the people whom the 
Centers for Disease Control believe are at risk based on the 
quantities that they are receiving.
    We have a chart here that might be a little bit tricky to 
follow. Let me just explain this briefly, and then I would love 
to get your thoughts on how we could do this differently. This 
circle is meant to reflect all Medicare beneficiaries. The 
large share in a given year do not get an opioid prescription, 
but a very substantial portion do. This would be represented by 
this slice of this pie--12.6 million in the year for which this 
graph was developed.
    Of those 12.6 million who received opioid prescriptions 
through Medicare, the vast--let me make sure I have this 
right--a substantial portion, this part right here, received a 
quantity that is above the level at which the CDC would say 
that is an at-risk population. It would be the size of that 
green slice of the pie.
    And yet the number who are actually going to be monitored 
by CMS is that little black line, that little tiny, tiny line, 
meaning, to this layman's view of this, that a very large 
number of people who might be at serious risk are not even 
being subject to the monitoring of their consumption that 
Medicare is approving and paying for. I find that surprising 
and disturbing, and I wonder--maybe we could start with Dr. 
Denigan-Macauley and then go on to Ms. Dixon and Dr. Snyder--if 
(a) you agree that my analysis is about right in terms of who 
is being monitored, and why should we believe that the Centers 
for Disease Control got it wrong and CMS got it right, and, if 
not, what should we do about it?
    Dr. Denigan-Macauley. I would be happy to answer that 
question. So basically, the Federal Government, CMS, has an 
overutilization monitoring system program, and they track the 
number of beneficiaries at risk of high dose, even at the 90 
milligrams level, which is the more stringent standard. When 
they track that, they tie that to the number of providers and 
pharmacies rather than tracking that individual number, and, 
therefore, that is why you get to the smaller proportion of 
people whom they are tracking.
    Senator Toomey. Could I just try to put this in a different 
way and see if you agree that I have this right? My 
understanding is what CMS says is, it is not sufficient for you 
to have a high quantity of opioids being prescribed for us to 
choose to monitor your consumption. You must also get it from 
multiple providers and/or multiple pharmacies. Is that about 
right?
    Dr. Denigan-Macauley. That is correct, and we made a 
recommendation in our 2017 report that they need to decouple 
that and to be able to track what you are asking them to track. 
They agreed, and they are working on that.
    Senator Toomey. It seems to me that it is almost irrelevant 
how many doctors--I mean, irrelevant is not the best term--but 
for the purpose of determining whether someone has too much 
opioid going into their system, I do not think it matters how 
many pharmacies you go to. It matters how many prescriptions 
you are getting filled, regardless of the number of pharmacies. 
Is that what you mean?
    Dr. Denigan-Macauley. Correct. We would agree with that.
    Senator Toomey. Ms. Dixon, do you have any thoughts on this 
issue?
    Ms. Dixon. Thank you, sir. As I am not with CMS, I cannot 
comment specifically on CMS's mindset for this. But I can 
assure you that the OIG has shared our programming code and 
methodology with CMS regarding our July 2017 data brief, which 
will allow them to start proactively monitoring patients for 
high risk of opiates.
    Senator Toomey. Thank you.
    Dr. Snyder?
    Dr. Snyder. Yes; I will share a clinical sort of 
perspective and then as well a business perspective as to why 
CMS ought to care about this. First, from a clinical 
perspective, many of the costs that the system incurs can be 
not only related to the actual cost of the opioids but, in 
addition to that, the consequences of taking opioids, such as 
fall risks resulting in hip fractures and other types of 
injuries and, as well, just overdose risk itself. It is 
interesting that CMS separately tracks opioids from the 
potentiators of opioids, the drugs that can lead to a greater 
impact, clinical impact, of the opioids.
    I think one of the opportunities would also be to 
consolidate within OMS opioid prescribing and then the drugs 
that potentiate opioids or put you at greater risk, for example 
benzodiazepines, and I will transition into the business case 
momentarily. If we track them together with the diagnoses of 
patients, we would have a lot more useful information for 
intervening and helping those patients.
    True clinical story----
    Senator Toomey. Could I ask a quick question just for 
clarification?
    Dr. Snyder. Yes.
    Senator Toomey. Are you saying there is a category of drugs 
that makes a person more vulnerable to becoming addicted to 
opioids if they are prescribed opioids in addition to that 
category?
    Dr. Snyder. Or that increases the risks----
    Senator Toomey. Increases the risks----
    Dr. Snyder [continuing]. Of taking the opioids. It could be 
a fall risk or anything else. It could be--the effect on your 
mind and your body of the opioids can be accentuated by certain 
drugs.
    Senator Toomey. Okay.
    Dr. Snyder. True story. One of our executive's father and 
mother were sharing their opioids, both getting them from one 
doctor, one pharmacy, going to ERs in between when they would 
fall short, when their new physician refused to prescribe 
opioids. They were deemed--at least the father was deemed to be 
slightly demented--and when they could no longer get opioids 
prescribed, I assisted in helping them be admitted to a 
facility for detox and rehabilitation.
    The mental health function tests improved dramatically. The 
patient is off opioids, taking non-steroidals at this point in 
time, and was on very large doses, far in excess of 90 
milligrams a day, of opioids. So there is hope. There are a lot 
of people who are senior citizens walking around on large doses 
of opioids who could do very well mentally and physically 
without being on opioids and using alternatives.
    The business case. Why should CMS care? Our average member 
cost is about $5,000 a year across all of our members. That 
would be a little higher for Medicare. The year that a patient 
is diagnosed with opioid use disorder, they roughly cost us 
about $28,000 that year, partially because you have treatment 
that is invoked. And if they stay on medication-assisted 
therapy after that, the cost drops by about $9,000 a year--
reason to get people treated and keep them on medication-
assisted therapy.
    The interesting thing--and the reason I go back to my 
comments about OMS and the need to bring in the information on 
drugs that can potentiate opioids--we actually at one point in 
time had 1,600 people who carried a diagnosis of opioid use 
disorder and still were getting prescription opiates. Why? 
Perhaps because the PDMP was not in effect at the time. But 
that is not clinically sound, and the cost of those people is 
about $45,000 a year.
    Now, you add the potentiator, the benzodiazepines, onto 
it--we are at $68,000 a year. If there is not a business case 
there for treating people and barring people from access to 
those kinds of combinations, I do not know what would be a good 
business case for it.
    Senator Toomey. Thank you, Doctor.
    Just continuing on this topic a little bit here, Ms. Dixon, 
you referred to the June 2017 data brief and described how HHS 
OIG made some disturbing discoveries. My understanding is 
500,000 Medicare beneficiaries received over the 120-milligram 
morphine equivalent dose--MED--daily for at least 3 months--
500,000. Now, mind you, CMS is going to be monitoring 44,000.
    But of that 500,000, 70,000 Medicare beneficiaries received 
over 240--and again, CDC establishes 90-milligram MED, morphine 
equivalent doses, as a threshold above which people are at a 
risk. At 240 milligrams MED for an entire year--first, Dr. 
Snyder, just very briefly, would a large percentage of the 
population who are receiving a 240-milligram MED for an entire 
year already be addicted at that point?
    Dr. Snyder. Yes.
    Senator Toomey. So what Dr. Snyder in his professional 
medical judgment is telling us is that there are tens of 
thousands of Medicare beneficiaries who are simply routinely 
having their addiction satisfied by ongoing prescriptions of 
opioids, and we are not even monitoring--still, nevertheless, 
they do not qualify even to have their situation monitored.
    Ms. Dixon, my understanding is you will be doing a follow-
up analysis, and in the subsequent analysis, will we be able to 
look at, to the extent to which these beneficiaries begin to be 
monitored, whether we have a reduction in the number of people 
who are receiving these very elevated volumes for long periods 
of time?
    Ms. Dixon. Thank you for the question, Senator. Yes, we are 
doing a follow-up study which will, hopefully, be released this 
summer. It will be based on the same methodology and 
programming code as our previous study that we referenced in my 
testimony. This will be updated using 2017 Medicare data, 
prescription drug data.
    We will look to identify the extent to which Part D 
beneficiaries are still receiving high amounts of opiates. 
Additionally, we will be looking for serious risks of opiate 
misuse or overdose as well in our beneficiary population, and 
also looking again to identify, potentially, prescribers who 
are prescribing out of the norm for our beneficiaries as well.
    Based on our study last time, we were also able to get CMS 
to send comparative billing reports to prescribers who appear 
to be billing inconsistent with their peers. So that was a good 
step that came out of our last study.
    Once this new study is released, we will be able to 
determine what those numbers are and make comparisons at that 
point.
    Senator Toomey. Thank you. Still in the category of whether 
CMS is monitoring enough people as they should be, my 
understanding is there was a recent study of Pennsylvania 
Medicaid beneficiaries who suffered a nonfatal opioid-related 
overdose. In 60 percent of those nonfatal overdoses, the people 
had received legal opioid prescriptions before this life-
threatening but nonfatal overdose. But what is truly amazing is 
about 60 percent received a subsequent opioid prescription in 
the following 6 months. This is after having an overdose.
    My question to, really, all three of our experts in this 
area is, should CMS consider a nonfatal overdose as a criterion 
for being in the monitoring system?
    Dr. Snyder, do you have a thought on that?
    Dr. Snyder. Yes, I absolutely think they should. I think it 
is--you know, there is an ethical, a moral, a clinical, and a 
business case for policing the prescribers who would continue 
to prescribe. If they are using the PDMP appropriately, 
obviously, they should know that the patient has been on 
opioids. They may not know about the overdose, which is one of 
the faults that I alluded to earlier. We need to link that 
data. If we link the data, and we know that the patient had an 
overdose previously, then I think most physicians would not 
prescribe additional opioids.
    Senator Toomey. Ms. Dixon, do you have any thoughts on 
that?
    Ms. Dixon. I can assure you that OIG is committed to using 
data to identify areas where we can make improvements as well. 
So any additional data that is accurate and timely that we 
would receive from--whether it was Medicaid programs--would be 
helpful in this area.
    Senator Toomey. Thank you.
    Dr. Denigan-Macauley?
    Dr. Denigan-Macauley. Yes, the GAO works to provide 
support, whether it is Medicare or Medicaid, that CMS needs to 
identify those at risk.
    Senator Toomey. But specifically, do you believe--and if 
you do not have an opinion on it, that is fine. But do you have 
a view as to whether a recent prior nonfatal overdose ought to 
constitute a criterion for being included in that monitoring 
system?
    Dr. Denigan-Macauley. We did not look at that specifically, 
but it falls in the at-risk category.
    Senator Toomey. Thank you.
    A quick question for Dr. Snyder. So we talked earlier about 
the staggering volumes of prescriptions in the United States. 
Based on the data from the UN survey of 2012 through 2014, the 
U.S. could reduce consumption by 40 percent and we would still 
be the number one consumer in the world. If we reduced our 
consumption by 80 percent, we would be roughly on par with the 
rest of the developed world.
    So, Dr. Snyder, it is pretty clear. Either we have it 
right, or the rest of the world has it right. Who do you think 
is more likely to be closer to being in the right ball park in 
terms of the volume of prescribed opioids?
    Dr. Snyder. I think you can probably imagine what my 
position is, and I think it is the rest of the world. I will 
give you a couple of--I mean, you know the story. In 1996, the 
American Pain Society said we should treat pain as a fifth 
vital sign. Shortly thereafter, the Veterans Administration put 
a focus on it with a strategy, and then shortly after that, the 
Joint Commission started the process of including a standard 
around assessing pain and treating pain, and then we rewarded 
the provider community for treating the pain.
    It is easy to see how that cascade resulted in utilization 
levels where they are today.
    The anecdote I want to share with you is sitting in on the 
Mayor's Task Force in Philadelphia and listening to young 
people tell how they encountered medicine in medicine cabinets. 
And just anecdotally, talking to people and understanding that 
many people get 30 tablets, use one or two, and put the rest on 
a shelf, I made the decision to unilaterally just put a limit 
on our members, commercial members, not Medicare, obviously, at 
5 days and 90 MEDs. That went into effect July 1st.
    Several things happened. We had a 22-percent drop in the 
number of patients getting opioids in the second half of the 
year compared to the first and a 26-percent drop in the actual 
number of prescriptions. Not a lot of member noise, some 
appeals for patients who wanted some of the medication. What I 
was really intrigued by was the number of physician calls I got 
who thanked me for putting the target on my back rather than 
their back when they would refuse to write a prescription for 
an expectant patient, someone who wanted and thought they would 
get a script.
    So physicians are creatures of habit, and I think, you 
know, if it worked in the past, it will work now. And we keep 
doing things, but when you really challenge them to think a 
little differently about what they are going to prescribe, they 
can do it, they will do it, they are okay and happy doing it, 
and they actually feel good about it. I have been the recipient 
of those calls from physicians. So I think we are clearly the 
outlier, and the rest of those countries are closer to the 
right answer.
    Senator Toomey. It does look like we may have turned a 
corner, but it certainly seems that we still have a long way to 
go.
    This question is for both Dr. Denigan-Macauley and Ms. 
Dixon. The GAO and the OIG made recommendations that prompted 
me to introduce legislation that is called the Strengthening 
Partnerships to Prevent Opioid Abuse Act, and the idea is that 
this bill would create an online portal that would facilitate 
information sharing on corrective actions by plans, audit 
contractors, and CMS on referred cases of opioid-related fraud 
and abuse. Could you elaborate a little bit on why you think 
that is important and how that would be helpful?
    Dr. Denigan-Macauley. Yes. In our 2017 report, we found 
that CMS did not require the reporting of this information 
either to CMS itself or to the audit contractor, and, 
therefore, they really do not have a complete understanding of 
who the bad actors might be. So we would concur with the idea 
of introducing such legislation.
    Senator Toomey. Ms. Dixon?
    Ms. Dixon. OIG also has a recommendation, an open 
recommendation, right now which is focused on having the 
Medicare Part D sponsors report all incidents of fraud, waste, 
and abuse. This would be very helpful to CMS in order to 
determine how well each plan is doing in preventing fraud, 
waste, and abuse. Additionally, it would be very helpful to my 
office as law enforcement, as it would give us an opportunity 
to possibly identify trends occurring earlier, and we could use 
that to be proactive in our investigations.
    Senator Toomey. One more quick question, and then I want to 
ask Ms. Malone a couple of questions.
    The data analysis that the OIG has done has found a very 
large--hundreds of prescribers with very, very troubling 
prescribing patterns, hundreds of doctors prescribing for 
patients over 240 milligrams MED for an entire year and longer, 
that sort of thing. Here is my question. What is the process by 
which--when you identify physicians who are prescribing at, 
like, really unusually high volumes, what is the process of 
referring them to law enforcement?
    Ms. Dixon. Thank you for the question, Senator. Of the 400 
prescribers that I believe you are referencing from our report, 
OIG shared all that information within all of our components, 
which includes the Office of Investigations, and, additionally, 
we have also spoken with CMS and our partners in other law 
enforcement agencies such as DOJ and DEA and FBI, and we are 
currently working a number of cases--I cannot provide 
specifics--and we have also referred a number of these 
specifically to DOJ, FBI, and CMS.
    We have shared our code, actual programming code, with CMS, 
so that way, they would be able to conduct this type of study 
on an ongoing basis to identify patients who are at risk and 
may be at risk for an overdose or could use some additional 
case management monitoring. We are going to also release our 
code and methodology to the general public as well as our 
private-sector partners later this summer in the form of a 
toolkit so all individual plans--and that includes States--who 
have prescription data information will be able to run the 
exact same report and, hopefully, identify any beneficiaries 
they have who might be in need of additional services.
    Senator Toomey. Mr. Weintraub, are there any challenges 
that you face that are unique to building a case on fraudulent 
opioid prescribing or heroin trafficking that would be useful 
for the Federal Government to deal with, any legislative or 
other changes we could make that would make it easier for you 
to do your job?
    Mr. Weintraub. The one that comes to my mind, I think, has 
been tackled a bit but with not much success, and that is--all 
these transactions occur via cell phone now, and that is how we 
investigate these. When we find, unfortunately, a fatal 
overdose or even when we are trying to investigate a drug 
dealing enterprise, it is all done over the cell phones, and 
sometimes the technology is so advanced in the cell phones that 
we cannot crack it.
    And as you know, some of the cell phone companies are not 
cooperative with law enforcement, and they continue to put out 
new products. We have just recently been beset by a--well, the 
law of the land right now, in the Federal and State law of the 
land, is that the cell phones cannot even be manipulated. They 
cannot even be turned on and be put on an airplane mode without 
a search warrant. That was through the United States Supreme 
Court very recently in a decision that came down.
    So we are that much further behind the bad guy whom we are 
trying to catch when we come upon a cell phone that might have 
that vital information to help us make those connections.
    Senator Toomey. I am not sure there is a Federal 
legislative solution to that, but it is useful information. 
Thank you.
    Ms. Malone, thanks again for sharing your story with us. 
When you were originally prescribed opioids around the age of 
18--you had had a car accident--the doctor that prescribed the 
opioids, did he explain to you the risks that were associated 
with them and sort of have a discussion with you about whether 
or not that was a good idea?
    Ms. Malone. No; no discussion.
    Senator Toomey. No explanation of the possible risk of 
addiction or anything like that?
    Ms. Malone. No.
    Senator Toomey. And during the 2 years when you were 
misusing prescription opioids, did you receive prescriptions 
from multiple doctors?
    Ms. Malone. Correct; yes.
    Senator Toomey. That was part of the strategy, right, to go 
to multiple doctors?
    Ms. Malone. Yes.
    Senator Toomey. So if you had just one or two lessons that 
you would like for Congress to take away from the experiences 
that you have had, what would they be? What would that be?
    Ms. Malone. You just touched base on it--increased 
awareness, you know--and as a mother, more youth education, and 
even to equip the providers with more information for us 
patients walking into a place like that, you know, to give us a 
heads-up that this is what can potentially happen. Maybe if I 
would have had something like that given to me and that 
information, I may not have had to go down this deep dark path. 
I am grateful that I did, but, you know, that is something that 
I definitely would like everyone to take today from me, you 
know, just increased awareness and education on the dangers 
associated with prescription medication, overprescribing, and 
how easy--it is so accessible; so easy.
    Senator Toomey. So you are now 6 months into what certainly 
appears to be a remarkable recovery, and we all wish you all 
the best. Do you have any message for other people who might 
still be struggling with substance abuse disorder and anything 
that you would like to convey to them?
    Ms. Malone. Thank you for that recognition. It means a lot 
to me. I would not be where I am today without you, Mr. Corson, 
and MVP Recovery. You have done so much for my life.
    And the most important thing is, there is this stigma 
placed on us people as addicts. You know, I am a normal person, 
and I have just been through a lot of things, but due to that 
path that I went down, there is this stigma of me as a drug 
addict, and they do not see the other side and that there is 
hope and recovery is possible and it is a beautiful thing, and 
as long as we work for it, we do recover. That is the biggest 
thing.
    We do recover as long as we want it, and it is not easy, 
and it is a fight that I take every single day, but it is worth 
it, and I want to live today, and it is just--life is 
beautiful. They say ``world beyond your wildest dreams,'' and 
that sounds like a cliche, and it is not. It really is. Today, 
I am sitting up here with you, and, you know, the conversation 
we had earlier--never in a million years did I think that I 
would have an opportunity to just be among you people and like 
a part of society and on a positive.
    Yes, recovery is possible in the end, and I am just so 
grateful to be here and grateful for my life today.
    Senator Toomey. Well, we are grateful you are here too. 
[Applause.]
    My last question--and then I think my staff is going to get 
very angry when I turn the mic over to my Federal colleagues in 
law enforcement for a couple of quick thoughts from our U.S. 
Attorneys.
    But, Mr. Weintraub, we have established that the total 
volume of prescription opioids is down a little bit, right? We 
have been making some progress since 2011, and, in addition, 
some communities have launched very aggressive medicine take-
back programs. You alluded to yours. Bucks County has a very 
substantial and, to my understanding, a successful program.
    But here is the $64,000 question. Has it actually resulted 
in any observable or measurable or noticeable reduction in 
prescription opioids on the streets? Is it having an effect 
yet?
    Mr. Weintraub. I would say that, by and large, it has. But 
as you know, Senator, it takes an all-out approach. It takes 
educating the doctors. It takes educating the public.
    But one of the things that we have been successful in doing 
is shifting the mind thought on this issue now. Just like when 
people get in their cars, they know to put their seatbelts on. 
It is the same thing with their unused, old, expired 
medications. People in Bucks County know they have to get rid 
of them, because every pill that is left out of that 30-pill 
prescription can be a potential deadly dose, and people in 
Bucks County have gotten it. We have pretty much assailed them 
on this. We have beaten it into their heads with constant 
marketing and advertising, and we are seeing a difference.
    That is certainly one prong of it, but it is a critical 
prong, because it is going to take an all-out effort for us to 
win this battle that we are in.
    Senator Toomey. Thanks very much.
    I am going to wrap up the formal part of this hearing, and 
in compliance with the very strict rules we have in the Senate 
Finance Committee, we will wrap this up, and then I will 
immediately recognize our two U.S. Attorneys for just a brief 
thought, if they would.
    But first, I do want to once again thank the folks from 
Bensalem Township. I want to thank our witnesses for being 
here. This has been very, very helpful for me.
    A couple of the conclusions that come to my mind are, first 
of all, there are still many, many people getting very large 
quantities of prescription opioids through Federal Government 
programs, and their consumption of these opioids is not being 
properly monitored, in my opinion. It is huge doses. The fact 
that you could have a nonfatal but nevertheless very serious 
overdose on opioids and then promptly get another prescription 
from Medicare is amazing and problematic in my mind.
    We have made progress in overutilization, but clearly we 
are not finished. Some health-care providers and insurance 
plans have made more progress than others. I really appreciate 
the input that we have gotten from Dr. Snyder with Independence 
Blue Cross. It is a very encouraging story about where the 
private sector can and has made progress. But we still have a 
very, very serious problem that manifests itself, and the 
causes are many, and the Federal Government needs to do more 
and to do better.
    So again, this has been very, very helpful testimony, and I 
welcome your ongoing thoughts as we continue to address this.
    So this will conclude the formal part of the hearing, and 
at this point, I would like to ask the U.S. Attorney from the 
Middle District of Pennsylvania, Mr. David Freed, if he would 
like to take the podium and just share--there is a mic right 
here--just share your thoughts as the top law enforcement 
officer in the central part of Pennsylvania.
    Mr. Freed. Sure. Good afternoon, everyone. Senator and 
Congressman Fitzpatrick, thank you for your leadership on this 
issue. I have to say Matt Weintraub, even before he was 
District Attorney in Bucks County, was a leader in fighting the 
heroin and opioid epidemic. I am thinking back to following him 
on Twitter in years past, and he has been really essential in 
getting the word out about this scourge.
    And, Ms. Malone, what a pleasure to be in your presence. 
Congratulations.
    Senator, we are fighting similar battles with our State and 
local colleagues on the Federal side. We have a greater 
opportunity to go after over-prescribers, I think, with the 
resources that we enjoy. We have been tasked--and U.S. Attorney 
McSwain may allude to this issue as well. We have been tasked 
by Attorney General Sessions with reducing deaths. He is 
telling the U.S. Attorneys that we want to reduce deaths.
    One of the ways that we think we can do that is using civil 
proceedings against folks who bill through Medicare, and if it 
works in conjunction with the criminal investigation, using 
civil process, perhaps an injunction or some other civil 
process, to stop them from prescribing right away. It may be 
before DEA can take the license. It may be before a criminal 
case is ready to go. We can institute civil process and stop 
that right away.
    We are working on some of those cases now in the Middle 
District of Pennsylvania, and they are being worked on 
throughout the country. In fact, there is a specific group on 
the civil side of the Department of Justice working on just 
this issue.
    So I think the hearing today is timely. The discussion 
about cooperation is timely. That is one of the things that we 
are doing to try to stop the overprescribing. Providers have 
come a long, long way in the last few years.
    Ms. Dixon and her group--the only thing that limits their 
effectiveness is resources. I can tell you even in the short 
time I have been in the U.S. Attorney's Office that the HHS OIG 
group is great. They are doing great work, not just in 
Pennsylvania but throughout the region.
    So, Senator, again, I thank you for your leadership. Thank 
you for having us here today for this most important hearing.
    Senator Toomey. U.S. Attorney Bill McSwain from the Eastern 
District of Pennsylvania.
    Mr. McSwain. Thank you, Senator, and thank you, everybody, 
for showing up at this hearing today. Just a couple of 
preliminary points and then two observations.
    First, Ms. Malone, again, I wanted to congratulate you for 
having the courage to be here. And I think when we all leave 
here today, the thing that we are going to remember the most is 
your story. So thank you for sharing that with us.
    I wanted to make--there is a lot of bad news here that we 
are talking about: the overprescribing, the problem we have 
with the use of opioids in our country. But there is also some 
good news, in that what I have seen in the first 2 months of my 
job--because I was sworn in on April 6th and have been on the 
job for about 2 months--is tremendous collaboration, among law 
enforcement in particular.
    My office has a great relationship with Dave's office, 
Matt's office. We have a great relationship with Special Agent 
Dixon's office. We have an Opioid Law Enforcement Task Force 
that we stood up in February that meets bi-monthly at the U.S. 
Attorney's office. I attended that meeting in April. We have a 
great relationship with Kat Copeland's office in Delaware 
County, who is also here, and she has attended the Opioid Law 
Enforcement Task Force meetings, as Matt has.
    Philadelphia police, local law enforcement, Federal law 
enforcement--we are all working together, and we have all got 
our oar in the water, pulling in the same direction. So I think 
that is positive.
    But when I think about what we can do as law enforcement--
there are basically three prongs to this problem. There is 
treatment, there is prevention, there is law enforcement. We 
are law enforcement, so that is what I think about the most. 
You know, we are doing a lot of cases. We are attacking it from 
sort of two different directions, dealing with the 
overprescribing, dealing with the doctors' offices, 
essentially, and we are also dealing with what I will call the 
street part of it--the illicit drug organizations--and we could 
use some more tools.
    One tool that has been brought to my attention that we 
really need--again, it is probably not something that your 
committee would deal with, but I want you to be aware of it--is 
we have the ability in law enforcement to do wiretaps on cell 
phones, for example, where we can listen to the conversations 
of drug dealers and figure out what they are doing and then use 
that as evidence in cases in order to dismantle and destroy 
those organizations.
    One thing we do not have the ability to do right now is, we 
cannot monitor Internet-based applications, and that is what a 
lot of these drug organizations are starting to use. They are 
starting to use these Internet-based apps as opposed to cell 
phones, because they know that the cell phones are being 
listened to and the 
Internet-based apps are not.
    So I know that that is a big ask of the legislative branch, 
because there are privacy concerns, there are powerful 
lobbyists, you know, and there are folks who do not necessarily 
want there to be legislation when it comes to Internet-based 
applications. But I think I probably speak for all law 
enforcement here that we really need that, because the 
criminals sometimes are pretty crafty and pretty smart. So I 
would just raise that for your consideration with your 
colleagues, that I think the future of law enforcement is 
really going to need that.
    But that aside, I will say that there is good news in that 
we are all focused on this problem. There is the political will 
to deal with it, as demonstrated by your leadership and being 
here and having this kind of hearing, and there is the will 
among law enforcement, and we will eventually win this battle. 
But we need to do it, hopefully, as quickly as possible.
    Thank you.
    Senator Toomey. Thank you very much. The hearing is 
adjourned.
    [Whereupon, at 2:24 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


 Prepared Statement of Mary Denigan-Macauley, Ph.D., Acting Director, 
             Health Care, Government Accountability Office

 Prescription Opioids: Medicare Needs Better Information to Reduce the 
                     Risk of Harm to Beneficiaries

                             what gao found
    In October 2017, GAO found that the Centers for Medicare and 
Medicaid Services (CMS) provided guidance on the monitoring of Medicare 
beneficiaries who received opioid prescriptions to plan sponsors--
private organizations that implement the Medicare drug benefit, Part 
D--but it lacked information on most beneficiaries at risk of harm from 
opioid use. Specifically, GAO found that:

          CMS provided guidance to plan sponsors on how they should 
        monitor opioid overutilization among Medicare Part D 
        beneficiaries, and required them to implement drug utilization 
        review systems that use criteria similar to CMS's. Prior to 
        2018, the agency's criteria focused on beneficiaries who did 
        all the following: (1) received prescriptions of high doses of 
        opioids, (2) received prescriptions from four or more 
        providers, and (3) filled prescriptions at four or more 
        pharmacies. According to CMS, this approach focused actions on 
        beneficiaries the agency determined to have the highest risk of 
        harm. For 2018, CMS revised the criteria to include more at-
        risk beneficiaries.

          CMS's criteria, including recent revisions, did not provide 
        sufficient information about the larger population of 
        potentially at-risk beneficiaries. CMS estimated that, in 2015, 
        727,016 beneficiaries would have received high doses of opioids 
        regardless of the number of providers or pharmacies, but only 
        33,223 would have met its revised criteria. In 2016, CMS began 
        to collect information on some of these beneficiaries using a 
        higher dosage threshold for opioid use. However, based on 
        Centers for Disease Control and Prevention guidelines, CMS's 
        approach also missed some who could be at risk of harm. As a 
        result, CMS had limited information to assess progress against 
        the goals of the Medicare and Medicaid programs' Opioid Misuse 
        Strategy, which includes activities to reduce risk of harm to 
        beneficiaries.

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
        

    CMS provided oversight on prescribing of drugs at high risk of 
abuse through a variety of projects, but did not analyze data 
specifically on opioids. According to CMS officials, CMS and plan 
sponsors identified providers who prescribed large amounts of drugs 
with a high risk of abuse, and those suspected of fraud or abuse may be 
referred to law enforcement. However, GAO found that CMS did not 
identify providers who may be inappropriately prescribing large amounts 
of opioids separately from other drugs, and did not require plan 
sponsors to report actions they take when they identified such 
providers. As a result, CMS lacked information that it could use to 
assess how opioid prescribing patterns are changing over time, and 
whether its efforts to reduce harm are effective.

    Chairman Toomey, Ranking Member Stabenow, and members of the 
subcommittee, I am pleased to be here to discuss our October 2017 
report on oversight of opioid prescribing in the Medicare program.\1\ 
Misuse of prescription opioids, which are used to treat both acute and 
chronic pain, has become a serious public health problem for the U.S. 
population, including Medicare and Medicaid beneficiaries. The Centers 
for Disease Control and Prevention (CDC), within the Department of 
Health and Human Services (HHS), reported that from 1999 to 2013 the 
rate of drug poisoning deaths from prescription opioids nearly 
quadrupled, and that in 2016, alone, there were more than 17,000 
overdose deaths from prescription opioids.\2\
---------------------------------------------------------------------------
    \1\ See GAO, Prescription Opioids: Medicare Needs to Expand 
Oversight Efforts to Reduce the Risk of Harm, GAO-18-15 (Washington, 
DC: Oct. 6, 2017). In January of 2018, we also testified before the 
Subcommittee on Oversight, Committee on Ways and Means, House of 
Representatives on the findings and recommendations from this report. 
See GAO, Prescription Opioids: Medicare Should Expand Oversight Efforts 
to Reduce the Risk of Harm, GAO-18-336T (Washington, DC: Jan. 17, 
2018).
    \2\ See Department of Health and Human Services, Centers for 
Disease Control and Prevention, Rates of Deaths from Drug Poisoning and 
Drug Poisoning Involving Opioid Analgesics--United States, 1999-2013, 
Morbidity and Mortality Weekly Report, vol. 64, no. 1 (Atlanta, GA.: 
Jan. 16, 2015); and P. Seth, L. Scholl, et. al., Overdose Deaths 
Involving Opioids, Cocaine, and Psychostimulants--United States, 2015-
2016, Morbidity and Mortality Weekly Report, vol. 67, no. 12, Centers 
for Disease Control and Prevention (Mar. 30, 2018).

    The Centers for Medicare and Medicaid Services (CMS), also within 
HHS, administers Medicare and Medicaid, two of the Nation's largest 
health care programs. Medicare is a Federal health insurance program 
for people age 65 and older, individuals under age 65 with certain 
disabilities, and individuals diagnosed with end-stage renal disease. 
Within Medicare is Part D, the program's outpatient prescription drug 
benefit.\3\ Medicaid is a joint Federal-State program that finances 
health care coverage for certain low-income and medically needy 
individuals.\4\ Due to concerns about adequacy of oversight, both 
Medicare and Medicaid are on our list of high-risk programs.\5\
---------------------------------------------------------------------------
    \3\ Medicare consists of Parts A, B, C, and the Part D prescription 
drug program. Parts A and B are known as traditional Medicare or 
Medicare fee-for-service. Medicare Part C, also known as Medicare 
Advantage, is a private plan alternative to traditional Medicare, and 
covers all traditional Medicare services.
    \4\ Within broad Federal requirements, States have significant 
flexibility to design and implement their Medicaid programs based on 
their unique needs, resulting in 56 distinct programs. Medicaid 
programs are administered by the 50 States, the District of Columbia, 
American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, 
Puerto Rico, and the U.S. Virgin Islands. These programs are 
administered at the State level and overseen at the Federal level by 
CMS.
    \5\ See GAO, High-Risk Series: Progress on Many High-Risk Areas, 
While Substantial Efforts Needed on Others, GAO-17-317 (Washington, DC: 
Feb. 15, 2017).

    HHS's Office of Inspector General (HHS-OIG) reported that 14.4 
million people (about one-third) who participated in Medicare Part D in 
2016 received at least one prescription for opioids, and that Part D 
spending for opioids in 2016 was almost $4.1 billion.\6\ We and the 
HHS-OIG have previously reported on inappropriate activities that can 
be associated with such prescriptions, including ``doctor shopping'' to 
receive multiple opioid prescriptions from different providers; the 
diversion of prescription drugs for uses other than what was intended; 
and questionable prescribing practices by providers.\7\
---------------------------------------------------------------------------
    \6\ Department of Health and Human Services Office of Inspector 
General, Opioids in Medicare Part D: Concerns About Extreme Use and 
Questionable Prescribing, OE-02-17-00250 (July 2017).
    \7\ See GAO, Medicare Part D: Instances of Questionable Access to 
Prescription Drugs, GAO-11-699 (Washington, DC: Sept. 6, 2011); and 
Medicare Program Integrity: CMS Pursues Many Practices to Address 
Prescription Drug Fraud, Waste, and Abuse, GAO-15-66 (Washington, DC: 
Oct. 24, 2014). See also Department of Health and Human Services, 
Office of Inspector General, High Part D Spending on Opioids and 
Substantial Growth in Compounded Drugs Raise Concerns, OEI-02-16-0029 
(June 2016).

    The Medicaid program also covers opioid prescriptions for its 
beneficiaries. In our prior work, we have reported on potentially 
inappropriate activities involving Medicaid's prescription drug 
coverage. In 2017, for example, we reported on prescriptions for opioid 
pain medication among Medicaid beneficiaries. In that report, we noted 
that while opioid pain medication can constitute proper medical care 
for beneficiaries suffering from painful conditions, the use of these 
medications among Medicaid beneficiaries with diagnosed opioid abuse or 
dependence raises concerns about potential inappropriate 
prescribing.\8\ In addition, in a July 2015 report, we found indicators 
of potential Medicaid prescription-drug fraud and abuse, such as doctor 
shopping.\9\
---------------------------------------------------------------------------
    \8\ GAO, Medicaid Expansion: Behavioral Health Treatment Use in 
Selected States in 2014, GAO-17-529 (Washington, DC: June 22, 2017).
    \9\ GAO, Medicaid: Additional Reporting May Help CMS Oversee 
Prescription-Drug Fraud Controls, GAO-15-390 (Washington, DC: July 8, 
2015).

    In March 2015, HHS announced plans to make addressing opioid abuse 
a high priority through two broad goals: (1) decreasing opioid 
overdoses and overall overdose deaths, and (2) decreasing the 
prevalence of opioid use disorder.\10\ In 2016, CDC issued guidelines 
with recommendations for prescribing opioids in outpatient settings for 
chronic pain.\11\ The guidelines recommended that providers use caution 
when prescribing opioids at any dose, carefully reassess evidence of 
individual benefits and risks when increasing opioid dosage to 50 mg 
morphine-equivalent dose (MED) per day or more, and avoid or carefully 
justify dosage at 90 mg MED or more.
---------------------------------------------------------------------------
    \10\ Department of Health and Human Services, Office of the 
Assistant Secretary for Planning and Evaluation, Opioid Abuse in the 
U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Death 
(Mar. 26, 2015). Opioid use disorder is defined as a problematic 
pattern of opioid use leading to clinically significant impairment or 
distress as indicated by at least 2 of 11 criteria occurring within a 
12-month period. The criteria include taking opioids in larger amounts 
or over a longer period of time than was intended, persistent desire or 
unsuccessful efforts to cut down or control opioid use, or a strong 
desire or urge to use opioids.
    \11\ Department of Health and Human Services, Centers for Disease 
Control and Prevention, CDC Guideline for Prescribing Opioids for 
Chronic Pain--United States, 2016, Morbidity and Mortality Weekly 
Report, vol. 65, no. 1 (Atlanta, GA.: Mar. 18, 2016).

    CDC guidelines also noted that providers should use additional 
caution in prescribing opioids to patients aged 65 and older, because 
the drugs can accumulate in the body to toxic levels. Further, in 
January 2017, CMS issued its Opioid Misuse Strategy for the Medicare 
and Medicaid programs, including Medicare Part D.\12\ The strategy 
includes the agency's plans to address concerns about beneficiary use 
of opioids and the prescribing of opioids by providers.
---------------------------------------------------------------------------
    \12\ Centers for Medicare and Medicaid Services, Centers for 
Medicare and Medicaid Services (CMS) Opioid Misuse Strategy 2016 (Jan. 
5, 2017).

    My remarks today discuss the findings and recommendations from our 
2017 report on CMS efforts to oversee prescription opioids in 
Medicare.\13\ Accordingly, this testimony focuses on how:
---------------------------------------------------------------------------
    \13\ See GAO-18-15.

        (1)  CMS oversees beneficiaries who receive opioid 
---------------------------------------------------------------------------
        prescriptions under Medicare Part D, and

        (2)  CMS oversees providers who prescribe opioids to Medicare 
        Part D beneficiaries.

    For our report, we reviewed CMS opioid utilization and prescriber 
data, CMS guidance for plan sponsors--private organizations, such as 
health insurance companies, contracted by CMS to provide outpatient 
drug benefit plans to Medicare beneficiaries--and CMS's strategy to 
prevent opioid misuse. We also interviewed officials from CMS, the six 
largest Part D plan sponsors, and 12 national associations selected to 
represent insurance plans, pharmacy benefit managers, physicians, 
patients, and regulatory and law enforcement agencies. More detailed 
information on our objectives, scope, and methodology for that work can 
be found in the issued report. We conducted the work on which this 
statement is based in accordance with generally accepted government 
auditing standards. Those standards require that we plan and perform 
the audit to obtain sufficient, appropriate evidence to provide a 
reasonable basis for our findings and conclusions based on our audit 
objectives. We believe that the evidence obtained provides a reasonable 
basis for our findings and conclusions based on our audit objectives.

     cms delegated monitoring of beneficiaries who receive opioid 
prescriptions to plan sponsors, but did not have sufficient information 
                     on those most at risk for harm
CMS Delegated Monitoring of Individual Beneficiaries' Opioid 
        Prescriptions to Plan Sponsors
    Our October 2017 report found that CMS provided guidance to 
Medicare Part D plan sponsors on how they should monitor opioid 
overutilization problems among Part D beneficiaries. The agency 
included this guidance in its annual letters to plan sponsors, known as 
call letters; it also provided a supplemental memo to plan sponsors in 
2012.\14\ Among other things, these guidance documents instructed plan 
sponsors to implement a retrospective drug utilization review (DUR) 
system to monitor beneficiary utilization starting in 2013.\15\ As part 
of the DUR systems, CMS required plan sponsors to have methods to 
identify beneficiaries who were potentially overusing specific drugs or 
groups of drugs, including opioids.
---------------------------------------------------------------------------
    \14\ Centers for Medicare and Medicaid Services, Announcement of 
Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and 
Medicare Advantage and Part D Payment Policies and Final Call Letter, 
accessed December 21, 2016, https://www.cms.gov/Medicare/Health-Plans/
HealthPlansGenInfo/Downloads/2013-Call-Letter.pdf; and Centers for 
Medicare and Medicaid Services, Supplemental Guidance Related to 
Improving Drug Utilization Review Controls in Part D, accessed April 
25, 2017, https://www.cms.gov/Medicare/Prescription-Drug-Coverage/
PrescriptionDrugCovContra/Downloads/HPMSSupplementalGuidanceRelated-
toImprov
ingDURcontrols.pdf. 
    \15\ In addition to instructing plan sponsors to implement 
retrospective DUR systems, the guidance in the 2013 call letter 
includes information on other mechanisms to control overutilization. 
See https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/
Downloads/2013-Call-Letter.pdf.

    Also in 2013, CMS created the Overutilization Monitoring System 
(OMS), which outlined criteria to identify beneficiaries with high-risk 
use of opioids, and to oversee sponsors' compliance with CMS's opioid 
overutilization policy. Plan sponsors may use the OMS criteria for 
their DUR systems, but they had some flexibility to develop their own 
targeting criteria within CMS guidance. At the time of our review, the 
OMS considered beneficiaries to be at a high risk of opioid overuse 
---------------------------------------------------------------------------
when they met all three of the following criteria:

        1.  received a total daily MED greater than 120 mg for 90 
        consecutive days,

        2.  received opioid prescriptions from four or more health care 
        providers in the previous 12 months, and

        3.  received opioids from four or more pharmacies in the 
        previous 12 months.\16\
---------------------------------------------------------------------------
    \16\ These criteria were in effect through 2017. CMS announced in 
its April 3, 2017 call letter the revisions to the OMS criteria that 
will take effect in 2018. See Announcement of Calendar Year (CY) 2018 
Medicare Advantage Capitation Rates and Medicare Advantage and Part D 
Payment Policies and Final Call Letter and Request for Information, 
accessed April 4, 2017, https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement
2018.pdf. Some of the beneficiaries that meet the OMS criteria may not 
be using the opioids themselves, but rather diverting them by either 
giving or selling them to others.

    The criteria excluded beneficiaries with a cancer diagnosis and 
those in hospice care, for whom higher doses of opioids may be 
---------------------------------------------------------------------------
appropriate.

    We found that through the OMS, CMS generated quarterly reports that 
list beneficiaries who met all of the criteria and who were identified 
as high-risk, and then distributed the reports to the plan sponsors. 
Plan sponsors were expected to review the list of identified 
beneficiaries, determine appropriate action, and then respond to CMS 
with information on their actions within 30 days. According to CMS 
officials, the agency also expected plan sponsors to share any 
information with CMS on beneficiaries that they identified through 
their own DUR systems. We found that some actions plan sponsors may 
take included the following:

          Case management. Case management may include an attempt to 
        improve coordination issues, and often involves provider 
        outreach, whereby the plan sponsor will contact the providers 
        associated with the beneficiary to let them know that the 
        beneficiary is receiving high levels of opioids and may be at 
        risk of harm.

          Beneficiary-specific point-of-sale (POS) edits. Beneficiary-
        specific POS edits are restrictions that limit these 
        beneficiaries to certain opioids and amounts. Pharmacists 
        receive a message when a beneficiary attempts to fill a 
        prescription that exceeds the limit in place for that 
        beneficiary.

          Formulary-level POS edits. These edits alert providers who 
        may not have been aware that their patients are receiving high 
        levels of opioids from other doctors.

          Referrals for investigation. According to the six plan 
        sponsors we interviewed, the referrals can be made to CMS's 
        National Benefit Integrity Medicare Drug Integrity Contractor 
        (NBI MEDIC), which was responsible for identifying and 
        investigating potential Part D fraud, waste, and abuse, or to 
        the plan sponsor's own internal investigative unit, if they 
        have one. After investigating a particular case, they may refer 
        the case to the HHS-OIG or a law enforcement agency, according 
        to CMS, NBI MEDIC, and one plan sponsor.

    Based on CMS's use of the OMS and the actions taken by plan 
sponsors, CMS reported a 61 percent decrease from calendar years 2011 
through 2016 in the number of beneficiaries meeting the OMS criteria of 
high risk--from 29,404 to 11,594 beneficiaries--which agency officials 
considered an indication of success toward its goal of decreasing 
opioid use disorder.

    In addition, we found that CMS relied on separate patient safety 
measures developed and maintained by the Pharmacy Quality Alliance to 
assess how well Part D plan sponsors were monitoring beneficiaries and 
taking appropriate actions.\17\ In 2016, CMS started tracking plan 
sponsors' performance on three patient safety measures that were 
directly related to opioids. The three measures were similar to the OMS 
criteria in that they identified beneficiaries with high dosages of 
opioids (120 mg MED), beneficiaries that use opioids from multiple 
providers and pharmacies, and beneficiaries that do both. However, one 
difference between these approaches was that the patient safety 
measures separately identified beneficiaries who fulfill each criterion 
individually.
---------------------------------------------------------------------------
    \17\ The Pharmacy Quality Alliance is a consensus-based, multi-
stakeholder membership organization that collaboratively promotes 
appropriate medication use and develops strategies for measuring and 
reporting performance information related to medications. The alliance 
developed all but one of CMS's Part D patient safety measures, and that 
one measure is not related to opioid safety.
---------------------------------------------------------------------------
     cms did not have sufficient information on most beneficiaries 
                      potentially at risk for harm
    Our October 2017 report also found that CMS tracked the total 
number of beneficiaries who met all three OMS criteria as part of its 
opioid overutilization oversight across the Part D program. However, 
the agency did not have comparable information on most beneficiaries 
who receive high doses of opioids--regardless of the number of 
providers and pharmacies used--and who therefore may be at risk for 
harm, according to CDC's 2016 guidelines. These guidelines noted that 
long-term use of high doses of opioids--those above a MED of 90 mg per 
day--are associated with significant risk of harm and should be avoided 
if possible.

    Based on the CDC guidelines, outreach to Part D plan sponsors, and 
CMS analyses of Part D data, CMS has revised its current OMS criteria 
to include more at-risk beneficiaries beginning in 2018. The new OMS 
criteria define a high user as an individual:

          Having an average daily MED greater than 90 mg for any 
        duration; and

          Receiving opioids from four or more providers and four or 
        more pharmacies, or from six or more providers regardless of 
        the number of pharmacies, for the prior 6 months.\18\
---------------------------------------------------------------------------
    \18\ According to CMS officials, the changes are partially in 
response to CDC's 2016 guidelines. The CDC guidelines noted that 
patients are at risk of harm above 50 mg MED and that providers should 
generally avoid increasing dosage to more than 90 mg MED of opioids, 
regardless the number of providers or pharmacies.

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Based on 2015 data, CMS found that 33,223 beneficiaries would have 
met these revised criteria. While the revised criteria would help 
identify beneficiaries who CMS determined are at the highest risk of 
opioid misuse and therefore may need case management by plan sponsors, 
they did not provide information on the total number of Part D 
beneficiaries who may be at risk of harm. In developing the revised 
criteria, CMS conducted a one-time analysis that estimated there were 
727,016 beneficiaries with an average MED of 90 mg or more, for any 
length of time during a 6 month measurement period in 2015, regardless 
of the number of providers or pharmacies used. According to the CDC 
guidelines, these beneficiaries may be at risk of harm from opioids, 
and therefore tracking the total number of these beneficiaries over 
time could help CMS to determine whether it is making progress toward 
meeting the goals specified in its Opioid Misuse Strategy to reduce the 
risk of opioid use disorders, overdoses, inappropriate prescribing, and 
drug diversion. However, CMS officials told us that the agency did not 
keep track of the total number of these beneficiaries, and did not have 
plans to do so as part of OMS (see Fig. 1).
    We also found that in 2016, CMS began to gather information from 
its patient safety measures on the number of beneficiaries who use more 
than 120 mg MED of opioids for 90 days or longer, regardless of the 
number of providers and pharmacies. The patient safety measures 
identified 285,119 such beneficiaries--counted as member-years--in 
2016.\19\ However, this information did not include all at-risk 
beneficiaries, because the threshold was more lenient than indicated in 
CDC guidelines and CMS's new OMS criteria. Because neither the OMS 
criteria nor the patient safety measures included all beneficiaries 
potentially at risk of harm from high opioid doses, we recommended that 
CMS should gather information over time on the total number of 
beneficiaries who receive high opioid morphine equivalent doses 
regardless of the number of pharmacies or providers, as part of 
assessing progress over time in reaching the agency's goals related to 
reducing opioid use. HHS concurred with our recommendation.
---------------------------------------------------------------------------
    \19\ Patient safety measures count member-years, which account for 
beneficiaries who are enrolled in a Part D plan for only part of a 
year.

 cms oversees providers through its contractor and plan sponsors, but 
       efforts did not specifically monitor opioid prescriptions
    Our October 2017 report found that CMS oversees providers who 
prescribe opioids to Medicare Part D beneficiaries through its 
contractor, NBI MEDIC, and the Part D plan sponsors.

          NBI MEDIC's data analyses to identify outlier providers. CMS 
        required NBI MEDIC to identify providers who prescribe high 
        amounts of Schedule II drugs, which include but are not limited 
        to opioids.\20\ Using prescription drug data, NBI MEDIC 
        conducted a peer comparison of providers' prescribing practices 
        to identify outlier providers--the highest prescribers of 
        Schedule II drugs--and reported the results to CMS.
---------------------------------------------------------------------------
    \20\ Under the Controlled Substances Act, which was enacted in 
1970, drugs are classified as controlled substances and placed into one 
of five schedules based on their medicinal value, potential for abuse, 
and risk of dependence. Schedule II drugs have the highest potential 
for abuse of any drugs approved for medical use.

          NBI MEDIC's other projects. NBI MEDIC gathered and analyzed 
        data on Medicare Part C and Part D, including projects using 
        the Predictive Learning Analytics Tracking Outcome (PLATO) 
        system. According to NBI MEDIC officials, these PLATO projects 
        sought to identify potential fraud by examining data on 
---------------------------------------------------------------------------
        provider behaviors.

          NBI MEDIC's investigations to identify fraud, waste, and 
        abuse. NBI MEDIC officials conducted investigations to assist 
        CMS in identifying cases of potential fraud, waste, and abuse 
        among providers for Medicare Part C and Part D. The 
        investigations were prompted by complaints from plan sponsors; 
        suspected fraud, waste, or abuse reported to NBI MEDIC's call 
        center; NBI MEDIC's analysis of outlier providers; or from one 
        of its other data analysis projects.

          NBI MEDIC's referrals. After identifying providers engaged 
        in potential fraudulent overprescribing, NBI MEDIC officials 
        said they may refer cases to law enforcement agencies or the 
        HHS-OIG for further investigation and potential prosecution.

          Plan sponsors' monitoring of providers. CMS required all 
        plan sponsors to adopt and implement an effective compliance 
        program, which must include measures to prevent, detect, and 
        correct Part C or Part D program noncompliance, as well as 
        fraud, waste, and abuse. CMS's guidance focused broadly on 
        prescription drugs, and did not specifically address opioids.

    Our report concluded that although these efforts provided valuable 
information, CMS lacked information necessary to adequately oversee 
opioid prescribing. CMS's oversight actions focused broadly on Schedule 
II drugs rather than specifically on opioids. For example, NBI MEDIC's 
analyses to identify outlier providers did not indicate the extent to 
which they may be overprescribing opioids specifically. According to 
CMS officials, they directed NBI MEDIC to focus on Schedule II drugs, 
because these drugs have a high potential for abuse, whether they are 
opioids or other drugs. However, without specifically identifying 
opioids in these analyses--or an alternate source of data--CMS lacked 
data on providers who prescribe high amounts of opioids, and therefore 
cannot assess progress toward meeting its goals related to reducing 
opioid use, which would be consistent with Federal internal control 
standards. Federal internal control standards require agencies to 
conduct monitoring activities and to use quality information to achieve 
objectives and address risks.\21\ As a result, we recommended that CMS 
require NBI MEDIC to gather separate data on providers who prescribe 
high amounts of opioids. This would allow CMS to better identify those 
providers who are inappropriately and potentially fraudulently 
overprescribing opioids. HHS agreed, and in April 2018 reported that it 
is working with NBI MEDIC to separately identify outlier prescribers of 
opioids.
---------------------------------------------------------------------------
    \21\ GAO, Standards for Internal Control in the Federal Government, 
GAO-14-704G (Washington, DC: Sept. 10, 2014). Internal controls is a 
process affected by an entity's oversight body, management, and other 
personnel that provides reasonable assurance that the objectives of an 
entity will be achieved.

    In addition, our 2017 report found that CMS also lacked key 
information necessary for oversight of opioid prescribing, because it 
did not require plan sponsors to report to NBI MEDIC or CMS cases of 
fraud, waste, and abuse; cases of overprescribing; or any actions taken 
against providers.\22\ Plan sponsors collected information on cases of 
fraud, waste, and abuse, and could choose to report this information to 
NBI MEDIC or CMS. While CMS receives information from plan sponsors who 
voluntarily reported their actions, it did not know the full extent to 
which plan sponsors had identified providers who prescribed high 
amounts of opioids, or the full extent to which sponsors had taken 
action to reduce overprescribing. We concluded that without this 
information, it was difficult for CMS to assess progress in this area, 
which would be consistent with Federal internal control standards. In 
our report, we recommended that CMS require plan sponsors to report on 
investigations and other actions taken related to providers who 
prescribe high amounts of opioids. HHS did not concur with this 
recommendation. HHS noted that plan sponsors have the responsibility to 
detect and prevent fraud, waste, and abuse, and that CMS reviews cases 
when it conducts audits. HHS also stated that it seeks to balance 
requirements on plan sponsors when considering new regulatory 
requirements. However, without complete reporting--such as reporting 
from all plan sponsors on the actions they take to reduce 
overprescribing--we believe that CMS is missing key information that 
could help assess progress in this area. Due to the importance of this 
information for achieving the agency's goals, we continue to believe 
that CMS should require plan sponsors to report on the actions they 
take to reduce overprescribing.
---------------------------------------------------------------------------
    \22\ According to CMS officials, the agency's regulations currently 
make reporting inappropriate prescribing and any actions against 
providers voluntary for plan sponsors. See 42 CFR 
Sec. 423.504(b)(4)(vi)(G)(3).
---------------------------------------------------------------------------
                              conclusions
    In conclusion, a large number of Medicare Part D beneficiaries use 
potentially harmful levels of prescription opioids, and reducing the 
inappropriate prescribing of these drugs has been a key part of CMS's 
strategy to decrease the risk of opioid use disorder, overdoses, and 
deaths. Despite working to identify and decrease egregious opioid use 
behavior--such as doctor shopping--among Medicare Part D beneficiaries, 
CMS lacked the necessary information to effectively determine the full 
number of beneficiaries at risk of harm, as well as other information 
that could help CMS assess whether its efforts to reduce opioid 
overprescribing are effective. It is important that health care 
providers help patients to receive appropriate pain treatment, 
including opioids, based on the consideration of benefits and risks. 
Access to information on the risks that Medicare patients face from 
inappropriate or poorly monitored prescriptions, as well as information 
on providers who may be inappropriately prescribing opioids, could help 
CMS as it works to improve care.

    Chairman Toomey, Ranking Member Stabenow, and members of the 
subcommittee, this concludes my prepared statement. I would be pleased 
to respond to any questions that you may have at this time.

                                 ______
                                 
     Prepared Statement of Maureen Dixon, Special Agent in Charge, 
 Philadelphia Regional Office, Office of Investigations, Office of the 
       Inspector General, Department of Health and Human Services
    Good afternoon, Chairman Toomey. I am Maureen Dixon, Special Agent 
in Charge of the Philadelphia Regional Office, Office of Investigations 
with the U.S. Department of Health and Human Services (HHS), Office of 
Inspector General (OIG).

    I appreciate the opportunity to appear before you to discuss how 
OIG is combating the opioid crisis in Federal health care programs.

    OIG's mission is to protect the integrity of HHS programs and the 
health and welfare of the people they serve through prevention, 
detection, and enforcement. To accomplish our mission, OIG uses data 
analytics and real-time field intelligence to detect and investigate 
program fraud and to focus our resources for maximum impact. We are a 
multidisciplinary organization comprised of investigators, auditors, 
evaluators, analysts, clinicians, and attorneys. In addition, we depend 
on strong public and private partnerships to ensure coordinated 
enforcement success. OIG has for several years, identified curbing the 
opioid epidemic as one of the Department's Top Management and 
Performance Challenges. Key components of that challenge include 
addressing inappropriate prescribing of opioids, inadequate access to 
treatment, and misuse of grant funds. In addition, combatting fraud 
issues, such as drug diversion and fraud committed by providers, 
presents a significant challenge for the Department.

    OIG has a longstanding and extensive history of enforcement and 
oversight work focused on prescription drug fraud, drug diversion, pill 
mills,\1\ medical identity theft, and other schemes that put people at 
risk of harm. Several years ago, OIG detected--and began taking action 
to address--a rise in fraud schemes involving opioids, as well as 
associated potentiator drugs.\2\ In addition to increasing our 
investigative efforts to combat prescription drug abuse, we have 
responded to the growing severity of the opioid epidemic by focusing on 
work that identifies opportunities to strengthen program integrity and 
protect at-risk beneficiaries. OIG uses advanced data analytics tools 
to put timely, actionable data about prescribing, billing, and 
utilization trends and patterns in the hands of investigators, 
auditors, evaluators, and government partners. Our goal is to identify 
opportunities to improve HHS prescription drug programs to reduce 
opioid addiction, share data and educate the public, and identify and 
hold accountable perpetrators of opioid-related fraud.
---------------------------------------------------------------------------
    \1\ A pill mill is a doctor's office, clinic, or health care 
facility that routinely prescribes controlled substances--such as 
oxycodone--outside the scope of professional practice and without a 
legitimate medical purpose.
    \2\ Drugs that enhance the high or euphoria when combined with 
controlled substances.

    In my testimony today, I will highlight law enforcement activities 
led by the Office of Investigations and discuss OIG projects currently 
underway to combat opioid-related fraud, waste, and abuse. I also will 
highlight key OIG recommendations that would, if implemented, have a 
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positive impact on the opioid problem.

     oig's office of investigations targets fraud, waste, and abuse
    OIG's Office of Investigations has investigators covering every 
State, the District of Columbia, Puerto Rico, and other U.S. 
territories. We collaborate with other Federal, State, and local law 
enforcement authorities to maximize our impact. Special Agents in our 
Office of Investigations have full law enforcement authority and use a 
broad range of investigative actions, including the execution of search 
and arrest warrants, to accomplish our mission. OIG and its law 
enforcement partners combine resources to detect and prevent health 
care fraud, waste, and abuse. During the last 3 fiscal years (FYs 2015 
to 2017), OIG investigations have resulted in more than $10.8 billion 
in investigative receivables (dollars ordered or agreed to be paid to 
Government programs as a result of criminal, civil, or administrative 
judgments or settlements); 2,650 criminal actions; 2,211 civil actions; 
and 10,991 program exclusions.\3\
---------------------------------------------------------------------------
    \3\ OIG has the authority to exclude individuals and entities from 
federally funded health care programs. The effect of an exclusion is 
that no payment will be made by any Federal health care program for any 
items or services furnished, ordered, or prescribed by an excluded 
individual or entity. No program payment will be made for anything that 
an excluded person furnishes, orders, or prescribes.

    Much of OIG's investigative work involves the Medicare and Medicaid 
programs and is funded by the Health Care Fraud and Abuse Control 
Program (HCFAC). The HCFAC provides funding resources to the Department 
of Justice (DOJ), HHS, and OIG, which are often used collaboratively to 
fight health care fraud, waste, and abuse. Since its inception in 1997, 
the HCFAC has returned more than $31 billion to the Medicare trust 
fund. OIG is a lead participant in the Medicare Fraud Strike Force, 
which combines the resources of Federal, State, and local law 
enforcement entities to fight health care fraud across the country. 
Finally, OIG collaborates with State Medicaid Fraud Control Units 
(MFCUs) to detect and investigate fraud, waste, and abuse in State 
Medicaid programs.
                           the opioid crisis
    Opioid use is a rapidly growing national health care problem, and 
our Nation is in the midst of an unprecedented opioid epidemic.\4\ More 
than 60,000 Americans died from drug overdoses in 2016, of which 66 
percent reportedly involved opioids.\5\ Deaths from prescription pain 
medication remain far too high, and in 2016, there was a sharp increase 
in deaths involving synthetic opioids such as fentanyl and an increase 
in heroin-involved deaths.\6\ According to the Centers for Disease 
Control and Prevention (CDC), approximately three out of four new 
heroin users report having abused prescription opioids prior to using 
heroin. Prescription drug diversion--the redirection of prescription 
drugs for an illegal purpose--is a serious component of this epidemic.
---------------------------------------------------------------------------
    \4\ Centers for Disease Control and Prevention, Prescription 
Painkiller Overdoses at Epidemic Levels [press release], Nov. 1, 2011.
    \5\ Centers for Disease Control and Prevention, Data Brief 294, 
Drug Overdose Deaths in the United States, 1999-2016, December 2017, 
and supplement tables.
    \6\ Ibid.
---------------------------------------------------------------------------
                 oig's opioid fraud enforcement efforts
    Opioid fraud encompasses a broad range of criminal activity from 
prescription drug diversion to addiction treatment schemes. Many of 
these schemes can be elaborate, involving complicit patients or 
beneficiaries who are not ill, kickbacks, medical identity theft, money 
laundering, and other criminal enterprises. Some schemes also involve 
multiple co-conspirators and health care professionals such as 
physicians, nonphysician providers, and pharmacists. These 
investigations can be complex and often involve the use of informants, 
undercover operations, and surveillance.
2017 National Health Care Fraud Takedown
    OIG and our Medicare Strike Force partners led the 2017 National 
Health Care Fraud Takedown. The Takedown was the largest ever health 
care fraud enforcement action, resulting in 412 charged defendants 
across 41 Federal districts, including 115 doctors, nurses, and other 
licensed medical professionals, for their alleged participation in 
health care fraud schemes involving approximately $1.3 billion in false 
billings. Over 120 defendants, including doctors, were charged for 
their roles in prescribing and distributing opioids and other dangerous 
narcotics.\7\ OIG also announced 295 opioid-related exclusions. The 
enforcement operation brought together more than 1,000 Federal and 
State law enforcement personnel, including 350 OIG Special Agents and 
30 MFCUs.
---------------------------------------------------------------------------
    \7\ Department of Justice, National Health Care Fraud Takedown 
Results in Charges Against Over 412 Individuals Responsible for $1.3 
Billion in Fraud Losses, July 2017.
---------------------------------------------------------------------------
Case Examples
    OIG agents have investigated the following cases. These examples 
highlight opioid schemes involving patient harm and prescription and 
treatment fraud:
Patient Harm
          In Philadelphia, Dr. Norman Werther was sentenced to 25 
        years in prison for distribution of a controlled substance 
        resulting in death and more than 300 counts stemming from his 
        operation of a pill mill. Werther was part of a multimillion-
        dollar drug conspiracy involving illegal prescriptions, phony 
        patients, and multiple drug trafficking organizations. The drug 
        traffickers recruited large numbers of pseudo-patients who were 
        transported to Werther's medical office for cursory 
        examinations. The ``patients'' paid an office visit fee, 
        usually $150, by cash, check, or money order, and Werther wrote 
        prescriptions for them to obtain oxycodone-based drugs without 
        a legitimate medical purpose and outside the usual course of 
        professional practice. The phony patients were then driven to 
        various pharmacies to have their prescriptions filled. The 
        drugs were then turned over to drug traffickers so their 
        organizations could sell them to numerous drug dealers who 
        resold them on the street. At one point, Werther knowingly 
        dispensed approximately 150 pills containing 30 milligrams each 
        of oxycodone, and 30 pills containing 15 milligrams each of 
        oxycodone, to a patient for no legitimate medical purpose, 
        ultimately resulting in the individual's death from overdose.
Prescription Fraud
          In Williamsport, Dr. John Terry was sentenced to 20 months 
        in prison for writing fraudulent prescriptions for oxycodone. 
        Along with Terry, Thomas Ray was sentenced to 71 months in 
        prison on charges of possession with intent to distribute a 
        controlled substance. Terry wrote prescriptions for oxycodone 
        and other narcotics for Ray in reckless disregard of the fact 
        that the drugs were not being used by Ray for legitimate 
        medical purposes, but being diverted and sold on the street. 
        Medicaid paid for the fraudulent prescriptions written for Ray. 
        Terry also wrote prescriptions for oxycodone in Stephen 
        Heffner's name knowing that Heffner was not his patient and the 
        drugs would later be diverted to another individual, David 
        Hatch. Because Medicare paid for these drugs, Heffner and Hatch 
        were both sentenced to 6 months of probation for theft from the 
        Medicare Program.

          In Pittsburgh, Dr. Brent Clark was sentenced to 60 months in 
        prison on charges of distribution of oxycodone and amphetamine 
        outside the usual course of professional practice and health 
        care fraud. He was also ordered to pay more than $225,000 in 
        restitution and forfeit $131,000, the building he owned where 
        he conducted his medical practice and where the offenses were 
        committed, his Drug Enforcement Administration prescribing 
        number, his Pennsylvania State medical license, and a vehicle 
        he owned. Clark distributed oxycodone on 13 occasions and 
        amphetamine on 3 occasions outside the usual course of 
        professional practice.
Treatment Related Fraud
          In Philadelphia, Dr. Alan Summers was sentenced to 48 months 
        in prison and ordered to pay over $4.6 million in restitution 
        after pleading guilty to charges of conspiracy to distribute 
        controlled substances, distribution of controlled substances, 
        health care fraud, and money laundering. Dr. Summers ran a 
        clinic that sometimes operated under the business name NASAPT 
        (National Association for Substance Abuse-Prevention and 
        Treatment). Co-defendants Dr. Azad Khan and Dr. Keyhosrow 
        Parsia were employed by Dr. Summers. The defendants executed a 
        scheme in which they sold prescriptions for large doses of 
        Suboxone and Klonopin in exchange for cash payments. Experts 
        testified at trial that Suboxone and Klonopin should never be 
        prescribed together except in rare cases when absolutely 
        necessary. At the clinic, virtually all customers received 
        prescriptions for both Suboxone and Klonopin regardless of 
        their medical need. During the duration of the conspiracy, Dr. 
        Khan and other doctors at the clinic illegally sold more than 
        $5 million worth of these controlled substances. Almost all of 
        the prescriptions for Suboxone and Klonopin were preprinted 
        before the customer met with a doctor. Khan and the other 
        doctors working at the clinic failed to conduct medical 
        examinations or mental health examinations as required by law 
        to legally prescribe these controlled substances. Several 
        customers who frequented the clinic testified that they were, 
        in fact, drug dealers or drug addicts who sold the prescribed 
        medications. Three other doctors involved in the scheme have 
        pleaded guilty and have either already been sentenced or await 
        sentencing.

          In Johnstown, Dr. John Johnson was sentenced to 84 months in 
        prison and ordered to pay more than $3 million in restitution 
        after pleading guilty to charges of paying kickbacks and tax 
        fraud. Johnson owned and operated a group of pain management 
        clinics and entered into an agreement with Universal Oral Fluid 
        Labs (UOFL) and its owner, William Hughes, to refer patients to 
        UOFL in exchange for kickback payments. UOFL was a clinical 
        drug testing and drug screening lab located in Greensburg, 
        Pennsylvania. Johnson received cash payments and monthly checks 
        from Hughes and UOFL in exchange for referring patients, 
        including Medicare and Medicaid beneficiaries, to UOFL. Johnson 
        referred all of his patients to UOFL for drug testing and 
        related services. He received more than $2,300,000 in kickbacks 
        from Hughes and UOFL for these referrals. As a result of 
        Johnson's referrals, UOFL received millions of dollars from 
        third-party payors, including approximately $3,443,528 from 
        Medicare and $1,147,768 from Pennsylvania Medicaid.
   oig's efforts to combat the opioid epidemic go beyond enforcement
Data analysis to identify questionable prescribing, dispensing, and 
        utilization of opioids
    OIG uses data analytics to detect and investigate health care 
fraud, waste, and abuse. We analyze billions of data points and claims 
information to identify trends that may indicate fraud, geographical 
hot spots, emerging schemes, and individual providers of concern. At 
the macro level, OIG analyzes data patterns to assess fraud risks 
across Medicare services, provider types, and geographic locations to 
prioritize and deploy our resources. At the micro level, OIG uses data 
analytics, including near-real-time data, to identify potential fraud 
suspects for a more in-depth analysis and efficiently target 
investigations.

    In July 2017, OIG released a data brief entitled Opioids in 
Medicare Part D: Concerns About Extreme Use and Questionable 
Prescribing \8\ in conjunction with the 2017 National Health Care Fraud 
Takedown. We found the following:
---------------------------------------------------------------------------
    \8\ OIG, Opioids in Medicare Part D: Concerns About Extreme Use and 
Questionable Prescribing, OEI-02-17-00250, July 2017.

          One in three Medicare Part D beneficiaries received opioids 
        in 2016. In total, 14.4 million beneficiaries received an 
---------------------------------------------------------------------------
        opioid prescription that year.

          Approximately 500,000 beneficiaries received high amounts of 
        opioids. Beneficiaries with a cancer diagnosis and those 
        enrolled in hospice were excluded from the analysis. To 
        identify these beneficiaries, OIG looked at the morphine 
        equivalent dose (MED) received by each beneficiary, which 
        equates all of the various opioids and strengths into one 
        standard value. Beneficiaries who received high amounts of 
        opioids had an average daily MED greater than 120 mg for at 
        least 3 months in 2016. A daily MED of 120 mg is equivalent to 
        taking 12 tablets a day of Vicodin 10 mg or 16 tablets a day of 
        Percocet 5 mg. These dosages far exceed the amounts that the 
        manufacturers recommend. Although beneficiaries may receive 
        opioids for legitimate purposes, these high amounts raise 
        concern due to the health risks associated with opioids.

          Within that group, OIG identified nearly 90,000 
        beneficiaries at serious risk of opioid misuse or overdose. OIG 
        identified two groups of beneficiaries at serious risk of 
        opioid misuse or overdose: (1) beneficiaries who received 
        extreme amounts of opioids, and (2) beneficiaries who appeared 
        to be ``doctor shopping.'' \9\
---------------------------------------------------------------------------
    \9\ Other beneficiaries may also be at serious risk of opioid 
misuse or overdose, but they were not the focus of this data brief.

              OIG identified 69,563 beneficiaries who 
        received extreme amounts of opioids. They each had an average 
---------------------------------------------------------------------------
        daily MED of more than 240 mg for the entire year.

              OIG also identified 22,308 beneficiaries who 
        appeared to be doctor shopping. They each received high amounts 
        of opioids and had four or more prescribers and four or more 
        pharmacies for opioids. While some of these beneficiaries may 
        not have been doctor shopping, receiving opioids from multiple 
        prescribers and multiple pharmacies may still pose dangers from 
        lack of coordinated care. Typically, beneficiaries who receive 
        opioids have just one prescriber and one pharmacy.

          OIG identified about 400 prescribers with questionable 
        opioid prescribing for beneficiaries at serious risk. In the 
        data brief, a total of 401 prescribers stood out as having 
        questionable prescribing because they ordered opioids for 
        higher numbers of beneficiaries at serious risk (i.e., those 
        who received extreme amounts of opioids or appeared to be 
        doctor shopping). In total, prescribers with questionable 
        billing wrote 265,260 opioid prescriptions for beneficiaries at 
        serious risk, costing Part D a total of $66.5 million.

    Although some patients may legitimately need high amounts of 
opioids, questionable prescribing can indicate that prescribers are not 
checking State databases that monitor prescription drugs, or that they 
are ordering medically unnecessary drugs that may be diverted for 
resale or recreational use. Another possibility is that the 
prescriber's identification was sold or stolen and is being used for 
illegal purposes. Questionable levels of prescribing also raise 
significant concern that prescribers may be operating pill mills.

    Ensuring the appropriate use and prescribing of opioids is 
essential to protecting the health and safety of beneficiaries and the 
integrity of Part D. Prescribers play a key role in combating opioid 
misuse. They must be given the information and tools needed to 
appropriately prescribe opioids when medically necessary. States' 
prescription-drug-monitoring programs can provide invaluable 
information to prescribers about a patient's opioid prescription 
history. Prescribers must be vigilant about checking the State 
monitoring databases to ensure that their patients are receiving 
appropriate doses of opioids and to better coordinate patient care. At 
the same time, the Department must address prescribers with 
questionable prescribing patterns for opioids to ensure that Medicare 
Part D is not paying for unnecessary drugs that are being diverted for 
resale or recreational use.
Identify Opportunities to Improve HHS Programs
    Across multiple operating divisions and programs, HHS has many 
opportunities to help curb this epidemic. Medicare provides 
prescription drug coverage for 41 million Part D beneficiaries and 
Medicaid for almost 69 million beneficiaries. The U.S. Food and Drug 
Administration (FDA) oversees the approval and safe use of prescription 
drugs. Agencies such as the National Institutes of Health (NIH), the 
Substance Abuse and Mental Health Services Administration (SAMHSA), the 
Health Resources and Services Administration (HRSA), and the CDC award 
grants to support health care providers, researchers, and States in 
their efforts to combat the epidemic.

    OIG audits and evaluations address opioid issues by identifying 
opportunities to strengthen program integrity and protect at-risk 
beneficiaries across HHS programs. OIG currently has numerous opioid-
related audits or evaluations underway. They address the following 
issues:

          Questionable prescribing patterns in Medicaid;
          Medicaid program integrity controls;
          Medicare program integrity controls in the prescription drug 
        benefit;
          CDC's oversight of grants to support programs to monitor 
        prescription drugs;
          FDA's oversight of opioid prescribing through its risk 
        management programs;
          SAMHSA's oversight of opioid treatment program grants;
          Beneficiary access to buprenorphine medication-assisted 
        treatment; and
          Opioid prescribing practices in the Indian Health Service.

    In addition, as part of its strategy to fight the opioid crisis and 
protect beneficiaries, OIG will soon release a new data brief on opioid 
use in Medicare Part D.\10\ It is a follow-up to a previous data brief, 
Opioids in Medicare Part D: Concerns About Extreme Use and Questionable 
Prescribing (OEI-02-17-00250), which was based on 2016 data. The new 
data brief is based on 2017 data and, like the previous one, will (1) 
determine the extent to which Medicare Part D beneficiaries received 
high amounts of opioids, (2) identify beneficiaries who are at serious 
risk of opioid misuse or overdose, and (3) identify prescribers with 
questionable opioid prescribing patterns for these beneficiaries.
---------------------------------------------------------------------------
    \10\ OIG, Opioid Use in Medicare Part D, OEI-02-18-00220, 
forthcoming.

    In conjunction with the new data brief, OIG will also release an 
analysis toolkit.\11\ It is based on the methodology that OIG has 
developed in our extensive work on opioids. The toolkit provides 
detailed steps for using prescription drug data to analyze patients' 
opioid levels and identify those at risk of opioid misuse or overdose, 
such as those who receive extreme amounts of opioids or appear to be 
doctor shopping. The purpose of the toolkit is to assist our public and 
private sector partners with analyzing their own prescription drug 
claims data to help combat the opioid crisis.
---------------------------------------------------------------------------
    \11\ OIG, Toolkit to Identify Patients at Risk of Opioid Misuse, 
OEI-07-00560, forthcoming.

    OIG is also focused on effective public health approaches to 
prevention and treatment. Currently, we are conducting an evaluation to 
examine access to Medication-Assisted Treatment (MAT) for opioid use 
disorder. MAT, including buprenorphine, is a key component of effective 
treatment for opioid use disorder. Congress has taken sustained action 
to support MAT services through broadened prescribing authorities and 
increased Federal funding. However, a treatment gap continues to exist 
where an estimated 10 percent of the people in the United States who 
---------------------------------------------------------------------------
need treatment receive it.

    To address this treatment gap, we are examining access to MAT 
through the SAMHSA buprenorphine waiver program, which permits 
providers to prescribe buprenorphine to patients in office settings 
rather than traditional opioid treatment facilities. We are determining 
the number, location, and patient capacity of providers who have 
obtained buprenorphine waivers from SAMHSA. We will also determine the 
extent to which waivered providers are located in areas with high 
indicators of opioid misuse and abuse (i.e., areas that likely have 
large numbers of residents in need of treatment services), including 
whether any of these areas are without waivered providers. We 
anticipate that this report, when finalized, will highlight counties in 
need of MAT services that do not now have adequate access.
           oig maximizes impact through strong collaboration 
                    with public and private partners

    In addition to Strike Force operations and other government 
collaborations, OIG engages with private sector stakeholders to enhance 
the relevance and impact of our work to combat health care fraud, as 
demonstrated by our leadership in the Healthcare Fraud Prevention 
Partnership (HFPP) and collaboration with the National Health Care 
Anti-Fraud Association (NHCAA). OIG strives to cultivate a culture of 
compliance in the health care industry through various educational 
efforts, such as Pharmacy Diversion Awareness Conferences, public 
outreach, and consumer education.
Medicare Fraud Strike Force
    The Strike Force effort began in Miami in March 2007 and has 
expanded operations to eight additional cities. Strike Force teams 
effectively harness the efforts of OIG and DOJ, including Main Justice, 
U.S. Attorneys' Offices, and the Federal Bureau of Investigation (FBI), 
as well as State and local law enforcement, to fight health care fraud 
in geographic hot spots.

    The Strike Force teams use near-real-time data to pinpoint 
potential fraud hot spots and identify aberrant billing. This 
coordinated and data-driven approach to identify, investigate, and 
prosecute fraud has produced significant results, highlighted by the 
July 2017 National Health Care Fraud Takedown. Since its inception in 
March 2007, the Strike Force has charged more than 3,000 defendants who 
collectively billed the Medicare program more than $10.8 billion.
Collaboration With the Department
    OIG collaborates with a number of HHS agencies, including the 
Centers for Medicare and Medicaid Services (CMS) and the Agency for 
Community Living (ACL), on fraud and opioid-related initiatives. OIG 
collaborates with CMS and ACL to educate providers, the industry, and 
beneficiaries on the role each one plays in the prevention of 
prescription drug and opioid-related fraud and abuse. We share our 
analytic methods and data analysis with CMS and work together to 
identify mitigation strategies and develop follow-up approaches to deal 
with the prescribers and at-risk beneficiaries identified. OIG engages 
ACL's Senior Medicare Patrol and State Health Insurance Assistance 
Program through presentations on the prevention of fraud, waste, and 
abuse.
Opioid Fraud and Abuse Detection Unit
    OIG provided critical support in the establishment of the new 
Opioid Fraud and Abuse Detection Unit established by the Attorney 
General in collaboration with OIG, FBI, and Drug Enforcement 
Administration (DEA). The unit focuses specifically on opioid-related 
health care fraud using data to identify and prosecute individuals who 
are contributing to the opioid epidemic. This collaboration led to the 
selection of 12 judicial districts around the country where OIG has 
assigned Special Agents to support 12 prosecutors identified by DOJ to 
focus solely on investigating and prosecuting opioid-related health 
care fraud cases. Each of the 12 districts is supported by OIG, FBI, 
and DEA.
The Healthcare Fraud Prevention Partnership and the National Healthcare 
        Anti-Fraud Association
    The HFPP and NHCAA are public-private partnerships that address 
health care fraud by sharing data and information for the purposes of 
detecting and combatting fraud and abuse in health care programs. OIG 
is an active partner in these organizations and frequently shares 
information about prescription-drug fraud schemes, trends, and other 
matters related to health care fraud.
Pharmacy Diversion Awareness Conferences
    OIG has collaborated with the DEA to provide anti-fraud education 
at numerous Pharmacy Diversion Awareness Conferences held across the 
United States. The conferences were designed to assist pharmacy 
personnel with identifying and preventing diversion activity. Since 
2013, OIG has presented at conferences in 50 States and Puerto Rico.
      top oig recommendations for cms related to the opioid crisis
    OIG has made numerous recommendations to improve HHS programs to 
better protect beneficiaries at risk of opioid misuse or overdose. 
Specifically, ensuring the appropriate use and prescribing of opioids 
is essential to protecting the health and safety of beneficiaries and 
the integrity of Medicare Part D.

    As a result of OIG recommendations, Part D has strengthened its 
monitoring of beneficiaries at risk of opioid misuse. CMS has expanded 
drug utilization review programs to include non-opioid ``potentiator'' 
drugs. These euphoria-enhancing potentiator drugs are often abused in 
conjunction with opioids and increase the risk of negative outcomes 
including overdose. CMS now identifies beneficiaries with concurrent 
opioid and benzodiazepine prescription drug use and will, beginning in 
2019, identify beneficiaries who receive high doses of gabapentin in 
addition to opioids. CMS also expects that when plan sponsors perform 
case management they would consider the use of these potentiator drugs 
in their own review processes. Further, CMS has committed to perform 
analyses to proactively identify other potentiator drugs, meet 
biannually with OIG to discuss emerging issues, and consider additional 
enhancements to drug utilization review programs in the future.

    Despite the progress made, there are other improvements OIG 
recommends to protect Medicare beneficiaries.

    (1)  Restrict certain beneficiaries to a limited number of 
pharmacies or prescribers.

    OIG recommends that CMS encourage implementation of the new 
Medicare Part D beneficiary lock-in authority under the Comprehensive 
Addiction and Recovery Act of 2016 (CARA). Lock-in would restrict 
certain beneficiaries to a limited number of pharmacies or prescribers 
when warranted and reduce inappropriate use of opioids among Medicare 
beneficiaries and Part D fraud. This policy would provide coordination 
of care for beneficiaries being harmed by overprescribing and address 
beneficiaries who are doctor shopping or intentionally seeking 
unnecessary prescriptions.

    In 2018, CMS promulgated regulations that govern how Part D 
sponsors should implement the new lock-in authority under CARA, 
beginning in 2019. However, the decision of whether to implement this 
program rests with the Part D sponsors.

    (2) Require plan sponsors to report to CMS all potential fraud and 
abuse and any corrective actions they take in response.

    CMS should collect comprehensive data from Part D plan sponsors to 
improve its oversight of their program integrity efforts, including the 
diversion of opioids for illegitimate use. Sponsors serve as the first 
line of defense against opioid fraud, waste, and abuse in Part D as 
they are responsible for paying claims and monitoring billing patterns. 
However, there is currently a lack of transparency on how Part D 
sponsors identify and investigate these matters.

    (3) Improve Medicaid data.

    CMS does not have complete and accurate data needed to effectively 
oversee the Medicaid program, including opioids. Without accurate 
claims data, adequate oversight of the Medicaid program is compromised. 
OIG has a history of work that points to the incompleteness and 
inaccuracy of CMS's national Medicaid database, the Transformed 
Medicaid Statistical Information System (T-MSIS). Without a national 
dataset, CMS, States, and OIG are unable to identify nation-wide trends 
and vulnerabilities. This hampers program integrity efforts because 
fraud does not respect State boundaries. OIG recommends that CMS 
establish a deadline for when national T-MSIS data will be available 
for multistate program integrity efforts.
                               conclusion
    OIG has made combating the opioid crisis a top enforcement and 
oversight priority. We will continue to leverage our analytic, 
investigative, and oversight tools, as well as our partnerships in the 
law enforcement and program integrity communities and with the 
Department to maximize our efforts. OIG will remain vigilant in 
following and investigating emerging opioid fraud trends, especially 
schemes involving patient harm and abuse.

                                 ______
                                 
                 Prepared Statement of Heather Malone, 
                           Person in Recovery
    They say you shouldn't judge a book by its cover. This is true for 
me, as many would be shocked if they read the pages in my book.

    My name is Heather Malone, and almost six months ago, I finally 
made the decision to make a better life for myself. For so long, I 
lived a life of fear, darkness and chaos. I was using heroin on a daily 
basis. At the end, I was lost and alone. My family wanted nothing to do 
with me and my own children didn't know their mother.

    I was living in North Philadelphia with a person who was 
physically, mentally, and emotionally abusive. I accepted this because 
I didn't believe I deserved anything better. Every day I asked myself, 
``How did I end up here?''

    Looking back, it used to be easy to blame my past as for how I 
turned out. I never learned any kind of coping mechanisms to deal with 
pain and would keep my emotions deep inside me.

    My mother was an addict who always had live-in babysitters look 
over my sister and me. She eventually moved my aunt and her boyfriend 
in with us for this purpose. I was four years old when he molested me 
for the first time. This continued for five years until he left my 
aunt. I vividly remember the day he left. My aunt ended up going into 
the bathroom and never coming out. It was hours before I had finally 
went to check on my aunt. When I did, I found her hanging from the 
ceiling. All I could do was make sure my little sister who, was five at 
the time, did not see her.

    When my aunt took her life, my mother was not home. And she didn't 
come at any point during the following three days. I was left, watching 
my sister, while my aunt hung from the ceiling in our bathroom. 
Eventually, the neighbors called the authorities. At this point, my 
father stepped in and took custody of my sister and me. I thought this 
was my chance to finally be a happy and free kid, something I did not 
have a chance to experience to that point. Unfortunately it didn't turn 
out that way, as my father was very abusive. All I wanted was my father 
to love me, I guess he had his own ways of showing it.

    I was fourteen when I tried to escape reality for the first time by 
taking my own life. I was so lost, alone, hurt, and scared. Obviously I 
was not successful, but self-harm, more attempts at suicide, and self-
destruction continued to play a big part in my life.

    My mother came back into my life at eighteen, and this is where 
demise began. I always longed to be mommy's little girl. But when I 
moved in with her, she didn't want to be my mother. All she wanted was 
to have someone to get high with. Like I said, she was an addict and 
after I got into a minor car accident, she brought me to a doctor she 
was seeing who prescribed me medication. All I had to do was tell the 
doctor I had serious back pain and he wrote me a prescription. That 
fist time taking a pill was a memory I will never forget. I thought I 
found the answers to all my pain and problems, it gave me a numbing 
effect that I fell in love with. As time progressed the strength of 
medications increased as did my addiction. Pills were so easily 
accessible and they were legal so I did not see the problem with it all 
at the time.

    Time went on, and eventually prescriptions ran out and pills became 
too expensive and I graduated to heroin, and that became my new best 
friend. This took me down a very deep dark path, with more pain and 
suffering and all my never came true. I was a person that was hurting 
and hurt people. I was raped on numerous occasion; selling my body was 
an easy way to pay for my next fix. Jails, institutions, running, and 
using was my life. There were bouts of sobriety with the help of 
methadone and Suboxone maintenance. And yes, it helped periodically, 
but there was so much pain that I never dealt with which always led me 
back to relapse. I didn't know how to live life on life's terms without 
a substance.

    I tried to be and do better. I even went back to school to work 
with people who were in a similar situation as me at Harcum University. 
In May of 2012, I was inducted into the honors society for receiving 
one of the highest GPA's in the tri-state area. As part of this 
recognition, I was scheduled to give a speech at a ceremony. This is 
where self-sabotage, which is re-occurring thing for me, took place. It 
should have been one of the best nights of my life. My father was so 
proud of me and my family was going to be attending the ceremony. I 
should have been proud and happy, but I wasn't.

    I remember thinking back to how envious I was of my aunt who was 
able to escape reality when she took her own life. I never made it to 
that ceremony. The last thing I remember was walking upstairs to my 
room and getting two scarves, tying them together, and fastening either 
end to my ceiling fan and myself. Days later, I woke up in ICU at 
Crozer Hospital with tubes down my throat hooked up to machines that 
were breathing for me. I was so angry when I woke up--I couldn't even 
successfully kill myself.

    As years went on, things got worse. Addiction became my full-time 
job. I was consumed with the numbing effect. I didn't want to live. But 
if I had to, I didn't want to feel anything. I felt like a soulless, 
empty shell of a person. I used to live and lived to use.

    I eventually got back into a relationship with a person who was 
also in active addiction. I really thought we loved each other. To me, 
pain equaled love because all the people that were supposed to love me 
hurt me, so that is all that I thought I deserved. Physical abuse was 
something I allowed because if someone hurt me physically on the 
outside I didn't have to feel my internal pain.

    Last year, on Friday, December 8th, the abuse went to a whole new 
level. I remember being woken up by my girlfriend choking me. I begged 
her to please just end my life. She proceeded to cut my throat, hit me 
with a bat, and had me hanging over the balcony. I wanted her to drop 
me. My father showed up and stopped her, he carried me to his car and 
took me far away from there. I should've went right to the hospital. I 
was bloody and couldn't walk. I later found out that I had a fractured 
hip, eyes blackened and finger print bruises on my neck.

    But all I could do was beg him to take me to Kensington to get my 
next fix to feel numb once again. After a lot of persuading, he took me 
but he made me promise if he did I would then go into treatment. I 
agreed. I was at my all-time low. I showed up to rehab badly physically 
beaten. Worse though, I was emotionally and spiritually bankrupt and 
broken.

    Detox was not easy, and insanity set in. I started missing my 
girlfriend because, again, pain equals love to me. After the third day, 
I finally found enough courage to look at myself in the mirror and I 
almost fainted. Before bruises get better they get worse. This made me 
take a long look at myself and the life I was living.

    I didn't want to live this way anymore, I needed to figure out how 
to escape the nightmare I had been living for so long. At that moment, 
I truly surrendered and prayed for a new way of life and guidance.

    At Keystone, they had me in a dialectical behavioral therapy (DBT) 
group for people who have experienced trauma and I am so grateful for 
that opportunity. In past treatments, I would act as if I used drugs 
only for the effect and that there was no underlying issues. I never 
shared that I had a very traumatic past which made me feel like my only 
answer was addiction. With the help of DBT, I was able to scratch the 
surface of all my pain. I spoke about my past and secrets that had kept 
me sick for so long.

    As my projected discharge date was approached, my counselors 
suggested I move to a recovery house. At first I was resistant due to 
previous stays at recovery houses that were not conducive to my 
recovery. My counselors explained their suggested recovery house was 
not your average facility. And the more positive things I heard the 
more intrigued I became. I thought maybe this is my chance to actually 
get my act together and live a real life and not just exist.

    I made the decision to go, and it has not been easy by any means. I 
live in a therapeutic community of women that help build me up to be 
the person I can and want so much to be.

    I came through the doors of MVP with so many defects of character. 
I was so used to living a chaotic lifestyle. This program is helping me 
recognize when my defects come out and how to work through them so that 
I can change them and become a better person. Perfecting this process 
is unrealistic and I fall short all the time. However, because of MVP, 
I am able to work on being a productive member of society. Today, I am 
accountable for my actions. I am able to be a daughter, a friend, and 
most of all, a mother. Trust was always a hard thing for me, but today, 
I can trust in others, others can trust in me, and most of all I trust 
in myself.

    I am still in a lot of pain on a daily basis due to my fractured 
hip. I need surgery to get a partial hip replacement and I fear the 
aftermath because to recover, a doctor will just write me a 
prescription for pain medication to help ease the physical pain. If I 
do not notify them ahead of time that I am a person in recovery, it's 
almost automatic for them to prescribe opiates.

    Like I said, that does help with the pain temporarily but this is 
how my demise of addiction all began with a simple script written from 
a doctor. I do not want that to be the way my life has to end, but it 
will because I truly believe I may have another run in me but I do not 
have another recovery. I want to recover. I don't want to be defined as 
a statistic and hopefully things can change to help implement changes 
to avoid over prescribing or prescribing people who are at risk.

    In treatment, they asked us what our five year goal was in life. 
People wanted houses, families, and cars. When it was my turn to share, 
all I wished for was genuine happiness. I honestly thought pure 
happiness was unattainable for a person like me, and I definitely 
didn't think I would be able to achieve it within five years. But 
today, I can truly say that I am so grateful to be exactly where I need 
to be.

                                 ______
                                 
 Prepared Statement of Richard Snyder, M.D., Senior Vice President and 
             Chief Medical Officer, Independence Blue Cross
    Senator Toomey, members of the subcommittee, good afternoon and 
thank you for the invitation to testify at today's field hearing 
examining efforts to prevent opioid overutilization and misuse in 
government health care programs. My name is Dr. Richard Snyder, and I 
am the Senior Vice President and Chief Medical Officer for Independence 
Blue Cross (Independence), based in Philadelphia. Through our parent 
company, Independence Health Group, we serve over 8.4 million people in 
24 states and the District of Columbia, including more than 2.5 million 
people in Southeast Pennsylvania. For almost 80 years, we have been 
enhancing the health and well-being of the people and communities we 
serve.

    We appreciate the opportunity to provide information regarding our 
efforts to address the ongoing opioid crisis. This national epidemic is 
widespread, affecting the American public with no regard for age, 
income, education, or geography. The over-prescribing and abuse of 
prescription opioids in the United States has reached epidemic 
proportions and Philadelphia's unfortunate status as the city with the 
cheapest and purest heroin in the country further exacerbates the 
problem in our region.

    According to local health officials, approximately 1,700 people in 
southeastern Pennsylvania died in 2016 from an opioid overdose. While 
all 2017 data is not yet available, the Centers for Disease Control and 
Prevention (CDC) reports that Pennsylvania had the fastest growing rate 
of drug overdose deaths nationwide from July 2016 to July 2017.

    Independence is not new to this fight. We have been working for 
years with the doctors, hospitals, and community partners in our region 
to refine our medical policies to reduce overprescribing, to protect 
appropriate access to therapy for those who are in need and to work 
collaboratively to make treatment options available for those trapped 
in a cycle of abuse or misuse.
              commercial efforts to reduce overprescribing
    Before discussing overprescribing patterns and policies in 
Medicare, it may be helpful to first walk through our efforts in the 
commercial health insurance space, where we have more discretion to 
implement medical policies that are consistent with the most recent and 
relevant clinical evidence.

          Limiting High-Dose Opioid Prescriptions: Since the beginning 
        of 2015, Independence has required doctors to provide 
        additional clinical documentation to prescribe our members high 
        doses of opioids. In 2016, we updated these policies to reflect 
        the most recent CDC prescribing guidelines.

          Outreach to Outlier Prescribers: We share the CDC's 
        guidelines with our network providers and have specifically 
        focused on the 1,250 prescribers who have exceeded them, 
        providing member-level detail to enable prescriber review and 
        modification. This outreach has resulted in nearly 60 percent 
        changing or decreasing their prescribing habits.

          Systems to Prevent Doctor Shopping and Improper Prescribing: 
        Our ongoing dialogue with local, regional, State, and Federal 
        law enforcement agencies, including the U.S. Attorney's Office 
        for the Eastern District and the Pennsylvania Attorney 
        General's Office, encourages valuable information sharing that 
        can help prevent and deter fraud, such as doctor shopping or 
        inappropriate prescribing practices. In 2017, our 
        Investigations Division used tips and data analysis to review 
        141 cases of improper prescribing and dispensing, resulting in 
        14 individuals being convicted of insurance or prescription 
        fraud.

          Cumulative Five-Day Supply Limit: In 2017, Independence 
        became one of the first insurers in the country to restrict 
        first-time, low-dose opioid prescriptions to a five-day supply 
        limit, with an exemption for patients with cancer or terminal 
        illnesses. During the last six months of 2017, the number of 
        members using opioids dropped 22 percent and the number of 
        prescriptions dropped 26 percent.

    The results are promising. Since 2014, Independence has seen a 
major reduction in members using opioids, opioid prescription claims 
processed, and opioid dosages prescribed. This includes a 45-percent 
reduction in opioid users (45,000 fewer members), a 35-percent 
reduction in opioid prescriptions (100,000 total), and an 18-
percent reduction in morphine equivalent dose.
                     access to effective treatments
    Beyond prescribing guidelines, we know many of our members need 
access to effective treatment services for opioid use disorder (OUD). 
Independence plan designs offer coverage for a range of services, 
including detoxification, rehabilitation, outpatient programs, and 
counseling, as well as medication-assisted treatments (MATs), to treat 
substance use disorder.

    We know that in addition to it being the right thing to do, getting 
our members with OUD into evidence-based treatment is a sound strategy 
for containing health care costs. We have done the analysis and know 
that an Independence member with unaddressed OUD utilizes about $10,000 
more in healthcare services than a member with OUD who is being treated 
with an MAT, like buprenorphine or naltrexone. In other words, for 
every 100 members we can guide into effective treatment, Independence 
can save our members $1 million in claims costs.

    This is why we have become one of the few commercial insurers that 
covers methadone and why we have removed initial prior authorization 
restrictions for common MATs. Our provider network includes 100 
different substance abuse rehabilitation facilities and more than 5,000 
behavioral health providers. We were also the first commercial insurer 
accepted by Caron Treatment Centers, one of the country's premier 
addiction treatment programs located in Pennsylvania.
     how medicare prescribing guidelines work and recommendations 
                        for future improvements
    In the Medicare Advantage (MA) market, we are proud to be the most 
popular plan in Southeast Pennsylvania, including here in Bucks County. 
We share your concerns with the recent Department of Health and Human 
Services (HHS) Office of the Inspector General report that noted that 
one in three Medicare Part D beneficiaries received an opioid in 2016, 
including roughly 500,000 individuals who received opioid scripts of 
greater than 120 mg per day for at least three months.

    Within Independence's MA membership, approximately 11.5 percent of 
beneficiaries utilized opioids in 2017, compared to less than 4.5 
percent in our commercial membership. Approximately 400 members were 
designated as ``at-risk'' for an OUD due to a high daily dose use over 
an extended period of time. A total of 120 Medicare members 
participated in an addiction treatment program in 2017.

    Within the Medicare population, there are differences in how 
Independence and other insurers can address and prevent OUD. It is 
important to keep in mind that HHS, specifically the Centers for 
Medicare and Medicaid (CMS), has established very specific and detailed 
rules that must be followed within the sphere of traditional Medicare 
and MA offerings. At times, this has meant that CMS has prevented 
Independence from putting reasonable limitations on prescribing.

    For example, we recently experienced such a challenge when CMS 
rejected our initial 2018 High Dose Opioid Policy. As part of the 
criteria, Independence wanted the provider community to evaluate 
patients for non-pharmacologic treatment, such as physical and/or 
psychological therapy. In response to that recommendation, CMS stated 
that: ``Criteria cannot require treatment parameters that are not 
managed by Part D. Delete the PA element or remove evaluation for non-
pharmacologic treatment including but not limited to physical and/or 
psychological therapy requirements. Criteria appear too restrictive or 
overly burdensome.''

    While this was unfortunate for the 2018 plan year, CMS made great 
strides in improving prescribing guidelines in the 2019 Final Call 
Letter, which sets annual program policies for MA. Starting in January; 
plans will have to limit initial opioid prescriptions to no more than a 
seven day supply. In addition, for all other MA members previously 
prescribed opioids, CMS will now require a care coordination edit when 
daily prescribing guidelines have been exceeded, forcing plans and/or 
network pharmacists to engage with the prescribing physician. With 
these changes, Independence anticipates further prescribing decreases 
as the 2019 Medicare enhancements are operationalized.

    As CMS works with plans to begin transitioning more MA members off 
of opioids if they do not fit the criteria for initial fills, the 
agency will need to allow and encourage additional flexibility for 
plans. Having seniors evaluated and transitioned to Part B benefits, 
such as physical therapy, is clinically appropriate in many instances 
and the agency should embrace these options as a potential non-
pharmaceutical solution. Other non-opioid pain management therapies, 
such as acupuncture, which the FDA has included in its "blueprint" for 
non medication based therapies, will need to be considered as a covered 
service under Medicare as the next phase of prescribing adjustments 
begin. Along with this greater flexibility in therapy, CMS should also 
consider integrating Pharmacy Quality Alliance performance measures 
(such as the proportion of beneficiaries prescribed more than 120mg for 
90 days or longer) into the Star Rating program. Doing so will tie 
financial incentives to how well plans work with their provider 
partners to reduce unnecessary opioid prescribing, which is beneficial 
for patients, for providers, and for plans.

    Additionally, the future expansion of MA care coordination efforts 
may require updates to Federal privacy statutes. Alerting the primary 
care physicians of Independence members who have been treated for OUD 
at a separate facility is currently prohibited under Federal law by 42 
CFR Part 2. This is not the case for a member who has been treated for 
a heart attack or diabetes in the ER. Care coordination parity, or 
treating OUD records the same way other health records are treated 
under the Health Insurance Portability and Accountability Act (HIPAA), 
is essential in the battle against the opioid epidemic. We all 
recognize the vital need to appropriately share important health 
factors across the provider spectrum, while maintaining a patient's 
right to privacy. Aligning Part 2 with HIPAA is a necessary and 
integral piece of the regulatory framework that we believe will ensure 
providers have the full and accurate understanding of a patient's 
medical history that is necessary for appropriate care at the 
appropriate time at the appropriate level.
    overutilization monitoring and at-risk beneficiaries in medicare
    Independence regularly communicates with CMS on opioid 
overutilization. This is done through the agency's Overutilization 
Monitoring System (OMS) to identify members who may be at-risk of 
diverting and abusing opioids. In the current Level 3 retrospective 
opioid overutilization program, members are identified on a monthly 
basis using a rolling six-month look-back period based on the following 
criteria: (1) use of opioids with an average daily dose greater than or 
equal to 90mg, and (2) either four or more prescribers and pharmacies, 
or six or more prescribers, regardless of pharmacies. Under these 
criteria, very few Independence members are identified annually and 
when they are, the situation is evaluated immediately.

    The prescribers of the identified members are reviewed according to 
specialty to determine appropriate targeting for case management 
communications and interventions. Independence schedules a telephonic 
conversation with the prescribers and the corresponding pharmacists, 
either together or separately.

    The process will result in either prescriber verification of the 
appropriateness of the member's opioid therapy or, more likely, we will 
implement a point-of-sale benefit edit for the member to prevent them 
from continuing to access that level of opioids. The member is notified 
in writing and they are reminded of their ability to appeal the limit. 
CMS requires plans to report back on the outcome of these incidences. 
When necessary, Independence refers cases to our internal Criminal 
Investigations division for potential referral to law enforcement.

    Independence supports CMS's efforts to expand these criteria in 
2019 to include other potentiator drugs (such as benzodiazepines) and 
agrees that these criteria and reporting requirements could be expanded 
further still. We look forward to working with CMS on this endeavor and 
we will be submitting our comprehensive feedback to the agency in the 
coming weeks.
                       treatment gaps in medicare
    In terms of services and treatments that are covered for those who 
have been diagnosed with an OUD, we follow the requirements defined by 
CMS. As a MA plan, we are required to cover the same benefits as 
original Medicare. These are not inclusive of all options made 
available to our commercial members.

    One of the Medicare treatment gaps is the lack of coverage for 
methadone when it is administered in an outpatient setting as part of 
MAT. While not many of our commercial members have utilized our 
coverage for this MAT, it can be suitable and effective for certain 
members. The lack of coverage for sub-acute inpatient services at 
residential treatment centers (RTCs), which can be an appropriate 
setting after detoxification, is another current treatment gap. 
Currently, Medicare members are discharged to a partial hospitalization 
program, an intensive outpatient program, or professional outpatient 
services following their initial detoxification. Beneficiaries may be 
more successful in treatment with the introduction of an interim stage, 
such as a step-down to a RTC, for a discrete period of time.

    On behalf of Independence and our CEO Dan Hilferty, I want to thank 
you for the opportunity to share my thoughts with you today. We are 
committed to finding solutions that will curtail overprescribing, 
protect the appropriate use of opioids, and enable access to effective 
treatment of OUD. We all want to end this epidemic that is ravaging our 
communities and our Nation. We are losing too many of our friends, 
family members, and community to this disease. While we are making 
significant progress, there is much more work to be done. We look 
forward to working with CMS and Congress on finding sensible policy 
solutions to aid in this fight.

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


------------------------------------------------------------------------
              Q1 2015--Q1 2018                 Commercial     Medicare
------------------------------------------------------------------------
Reduction in Opioid Utilizers                        -35%          -16%
------------------------------------------------------------------------
Reduction in Opioid Claims                           -40%          -19%
------------------------------------------------------------------------
* The red bars in the first two graphs indicate the implementation of
  new prior authorization policies on commercial market opioid
  prescribing in 2015 and 2016 as well as the 5-day initial limit
  instituted in 2017.


                                 ______
                                 
             Prepared Statement of Hon. Patrick J. Toomey,
                    a U.S. Senator From Pennsylvania
    Thank you to the Bensalem Township Council for hosting this field 
hearing of the Senate Finance Subcommittee on Health Care, to the 
witnesses for making themselves available for what I hope to be an 
illuminating discussion, to the public officials here for dedicating 
your attention to this important issue, and to the public for your 
interest.

    There are many lessons relevant to our current times buried within 
the annals of history. Today's opioid and heroin epidemic is no 
different. Sadly, this is not the first time even our own Nation has 
found itself in the depths of a public health crisis precipitated by 
the overuse of opium and its derivatives. In the 19th and early 20th 
centuries, medical advances like the development of morphine and the 
adoption of the hypodermic syringe made a powerful reliever of pain 
readily available to the masses. The addictive qualities and negative 
effects of opium and morphine use were not fully appreciated until it 
was too late for too many.

    It is unfortunate that we find ourselves today in a predicament 
with such a clear precedent, but it is not too late to learn from the 
experience. There was no simple solution to that public health crisis 
and there will be no simple solution today. Then, the transition away 
from dependence on opiates was enabled in part by developing ways to 
resolve underlying diseases, such as by improving sanitation. It was 
enabled in part by embracing alternative treatments for pain, such as 
the adoption of aspirin as an analgesic beginning in 1899. It was 
enabled in part by improving pharmaceutical controls and restricting 
the importation of opium and its derivatives. Finally, there was a 
significant shift in medical practice to appreciate that in many, 
though not all, cases the dangers associated with this line of 
treatment outweighed the benefits.

    Then and now, the correlation between an increased availability of 
opioids and negative societal repercussions such as substance use 
disorder and overdose cannot be ignored. Opium became the most commonly 
dispensed medical item by 1834. From that time until the tide was 
finally turned in the late 1890s, the number of individuals struggling 
with opiate-related substance misuse would grow six-fold.\1\ Fast 
forward to the 21st century and opioids are once again among the most 
popularly prescribed class of medications.\2\ From 1999 to 2016, 
opioid-related overdoses quintupled.\3\ When we look at this issue in 
the present day by region, the trends are even clearer. High 
prescribing and high overdose rates have gone hand-in-hand in 
Appalachia, while significantly lower prescribing rates and 
significantly lower overdose rates have been the norm in places like 
Texas and the upper Midwest.\4\
---------------------------------------------------------------------------
    \1\ David T. Courtwright, Dark Paradise: A History of Opiate 
Addiction in America, Harvard University Press, 1982, http://
www.hup.harvard.edu/catalog.php?isbn=9780674005853&content
=reviews.
    \2\ Nora D. Volkow, M.D., and A. Thomas McLellan, Ph.D., ``Opioid 
Abuse in Chronic Pain--Misconceptions and Mitigation Strategies,'' The 
New England Journal of Medicine, March 31, 2016, https://www.nejm.org/
doi/full/10.1056/NEJMra1507771.
    \3\ ``Opioid Overdose,'' Centers for Disease Control and 
Prevention, accessed May 24, 2018, https://www.cdc.gov/drugoverdose/
index.html.
    \4\ Grant Baldwin, Ph.D., MPH, ``Overview of the Public Health 
Burden of Prescription Drug and Heroin Overdoses,'' Centers for Disease 
Control and Prevention, July 1, 2015, https://www.fda.gov/downloads/
drugs/newsevents/ucm454826.pdf.

    Another useful point of comparison is opioid consumption 
internationally. Data compiled from the United Nations International 
Narcotics Control Board shows that from 2012-2014 the United States, 
after adjusting for population size, still utilized eight times as many 
opioids as Italy, six times as many opioids as France, four times as 
many opioids as Great Britain, and over one and one half times as many 
opioids as Canada.\5\ This is despite having a population with an 
average age lower than each of those nations.\6\
---------------------------------------------------------------------------
    \5\ Dr. Keith Humphreys, ``Americans use far more opioids than 
anyone else in the world,'' The Washington Post, March 15, 2017, 
https://www.washingtonpost.com/news/wonk/wp/2017/03/15/americans-use-
far-more-opioids-than-anyone-else-in-the-world/?utm_term=.ee4e2a669229.
    \6\ The World Factbook: Median Age, Central Intelligence Agency, 
accessed May 24, 2018 https://www.cia.gov/library/publications/the-
world-factbook/fields/2177.html.

    This is not to say we have not made some significant progress in 
recent years. Since 2011, the total volume of opioid analgesics 
dispensed has fallen by 29 percent.\7\ Increased awareness both 
throughout the medical profession and the public as a whole, coupled 
with developments such as the endorsement of guidelines for prescribing 
opioids for chronic pain by the Centers for Disease Control and 
Prevention,\8\ have had a profound impact. The adoption of prescription 
drug monitoring programs, such as the one recently implemented by the 
Commonwealth of Pennsylvania,\9\ have given health care providers a 
powerful new tool to help inform the best course of treatment.
---------------------------------------------------------------------------
    \7\ ``Medicine Use and Spending in the U.S.: A review of 2017 and 
Outlook to 2022,'' IQVIA Institute for Human Data Science, April 19, 
2018, https://www.iqvia.com/institute/reports/medicine-use-and-
spending-in-the-us-review-of-2017-outlook-to-2022.
    \8\ ``CDC Guideline for Prescribing Opioids for Chronic Pain,'' 
Centers for Disease Control and Prevention, accessed May 24, 2018, 
https://www.cdc.gov/drugoverdose/prescribing/guideline.html.
    \9\ David Wenner, `` `Doctor shopping' for opioids declines in Pa.; 
new monitoring program gets credit,'' Harrisburg Patriot News, April 
26, 2017, http://www.pennlive.com/news/2017/04/
doctor_shopping_for_opioids_sh.html.

    Despite this progress, the amount of opioids being dispensed today 
is still roughly five times the level we saw in 1992. In 2016, there 
were still 215 million opioid prescriptions written across the 
country.\10\ In our Commonwealth of Pennsylvania, there were still 
counties with more prescriptions than people, such as Fayette (129 
prescriptions per 100 people), Lackawanna (112 per 100), and Mercer 
(109 per 100).\11\ Let me reiterate, that is more than one opioid 
prescription for every man, woman, and child within those counties.
---------------------------------------------------------------------------
    \10\ ``U.S. Prescribing Rate Maps,'' Centers for Disease Control 
and Prevention, accessed May 24, 2018, https://www.cdc.gov/
drugoverdose/maps/rxrate-maps.html.
    \11\ ``U.S. County Prescribing Rates, 2016,'' Centers for Disease 
Control and Prevention, accessed May 24, 2018, https://www.cdc.gov/
drugoverdose/maps/rxcounty2016.html.

    The question we are going to explore today is what are our Nation's 
largest payers of health care--Medicare and Medicaid--doing to prevent 
---------------------------------------------------------------------------
opioid overutilization and misuse.

    With the implementation of the Medicare prescription drug benefit 
in 2006, commonly referred to as Medicare Part D, the Federal 
Government became the single largest purchaser of opioid 
analgesics.\12\ Studies suggest that while Medicaid does not spend as 
much money on opioids as its Federal counterpart for the aged and 
disabled, Medicaid beneficiaries receive average annual doses twice as 
high as those who are privately insured.\13\ Furthermore, Medicaid 
beneficiaries are much more likely than the general population to be 
diagnosed with substance use disorder \14\ or suffer an overdose.\15\
---------------------------------------------------------------------------
    \12\ C. Zhou, C.S. Florence, and D. Dowell, ``Payments for Opioids 
Shifted Substantially to Public and Private Insurers While Consumer 
Spending Declined, 1999-2012,'' Health Affairs (Project Hope), May 
2016, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.1103.
    \13\ M.J. Edlund, B.C. Martin, M.-Y. Fan, J.B. Braden, A. Devries, 
and M.D. Sullivan, ``An Analysis of Heavy Utilizers of Opioids for 
Chronic Non-Cancer Pain in the TROUP Study,'' Journal of Pain and 
Symptom Management, 2010, https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC2921474/.
    \14\ ``Medicaid and the Opioid Epidemic,'' Medicaid and CHIP 
Payment and Access Commission, June 2017, https://www.macpac.gov/wp-
content/uploads/2017/06/Medicaid-and-the-Opioid-Epidemic.pdf.
    \15\ Mark J. Sharp, Ph.D., Thomas A. Melnik, DrPH, ``Poisoning 
Deaths Involving Opioid Analgesics,'' Morbidity and Mortality Weekly 
Report, April 17, 2015, https://www.cdc.gov/mmwr/preview/mmwrhtml/
mm6414a2.htm.

    The approaches of the Medicare and Medicaid programs to prevent 
opioid overutilization and misuse have been, appropriately, multi-
---------------------------------------------------------------------------
faceted. Some examples include:

          Congress worked with the previous administration \16\ to 
        decouple questions related to pain management in patient 
        surveys from Medicare hospital reimbursement,\17\ a system that 
        created a harmful financial incentive to prescribe more 
        opioids;\18\
---------------------------------------------------------------------------
    \16\ Tracie Mauriello, ``Toomey backs change in ACA that ties 
reimbursements to patient satisfaction,'' Pittsburgh Post-Gazette, 
April 21, 2016, http://www.post-gazette.com/news/politics-nation/2016/
04/21/Toomey-backs-change-in-ACA-that-ties-reimbursements-to-patient-
satisfaction/stories/201604210119.
    \17\ ``CMS Finalizes Hospital Outpatient Prospective Payment System 
Changes to Better Support Hospitals and Physicians and Improve Patient 
Care,'' Centers for Medicare and Medicaid Services, November 1, 2016, 
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-
Press-releases-items/2016-11-01.html.
    \18\ Sean Gregory, ``How Obamacare Is Fueling America's Opioid 
Epidemic,'' Time, April 13, 2016, http://time.com/4292290/how-
obamacare-is-fueling-americas-opioid-epidemic/.

          The Centers for Medicare and Medicaid Services (CMS), plan 
        sponsors, States, health systems, medical professional 
        societies, and other stakeholders have undergone a noteworthy 
---------------------------------------------------------------------------
        campaign of prescriber education;

          CMS is implementing a 7-day initial fill limit for opioid-
        naive patients in the Medicare program starting in 2019;

          Medicare, State Medicaid programs, and plan sponsors have 
        utilized drug management programs that incorporate tools like 
        prior authorization, point-of-sale edits, and patient review 
        and restriction (often referred to as ``lock-in'') programs to 
        encourage more appropriate prescribing; and

          Law enforcement has aggressively worked to crack down on 
        those working to defraud the Medicare and Medicaid programs for 
        monetary gain.

    Today we will hear from witnesses who should give us insight into 
the effectiveness of these efforts and how we may improve them. Joining 
us are Dr. Mary Denigan-Macauley, Acting Director of Health Care at the 
United States Government Accountability Office (GAO); Ms. Maureen 
Dixon, Special Agent in Charge at the Philadelphia Regional Office of 
the Office of the Inspector General for the United States Department of 
Health and Human Services (HHS-OIG); Dr. Richard Snyder, senior vice 
president and chief medical officer of Independence Blue Cross; Ms. 
Heather Malone, a constituent in recovery; and Mr. Matthew Weintraub, 
District Attorney for Bucks County.

    Some of the specific questions that will be explored:

          Do these efforts focus on a large enough portion of the 
        total beneficiaries who are at risk of harm? When CMS adopted 
        an opioid overutilization policy to reduce the inappropriate 
        use of opioids in 2013, it established the Overutilization 
        Monitoring System (OMS) to monitor plan sponsor compliance and 
        provide quarterly reports on high-risk beneficiaries. The 
        Government Accountability Office (GAO) last year found the OMS 
        only includes a small subset of the population that is at-risk 
        according to CDC guidelines (individuals receiving a daily dose 
        at or above 90 milligrams morphine equivalent dose).\19\ 
        Furthermore, recent research by the University of Pittsburgh 
        showed that even beneficiaries that have suffered a nonfatal 
        opioid-related overdose often continue to receive legal opioid 
        prescriptions following this life-threatening event.\20\ 
        Currently, our Medicare and Medicaid systems do not alert 
        health-care providers or plans to this potentially dangerous 
        situation.
---------------------------------------------------------------------------
    \19\ GAO-18-15, ``Medicare Needs to Expand Oversight Efforts to 
Reduce the Risk of Harm,'' Government Accountability Office, October 6, 
2017, https://www.gao.gov/products/GAO-18-15.
    \20\ W. Frazier, G. Cochran, W. Lo-Ciganic, et al., ``Medication-
Assisted Treatment and Opioid Use Before and After Overdose in 
Pennsylvania Medicaid,'' JAMA, 2017;318(8):750-752. doi:10.1001/
jama.2017.7818, https://jamanetwork.com/journals/jama/fullarticle/
2649173.

          Are we doing enough to ensure that when potential fraud is 
        identified appropriate action is taken? Both the GAO and the 
        HHS OIG have recommended improving communication between CMS, 
        its contractors, and insurance plans on when potential fraud 
---------------------------------------------------------------------------
        has been identified and what corrective action has been taken.

          Are we doing enough to equip providers with the information 
        they need? The adoption of electronic prescribing for 
        controlled substances, which would provide real time 
        information and reduce fraud associated with forgeries, has 
        been slow. Additionally, Congress is considering adopting 
        legislation that would require CMS to alert providers when 
        their opioid prescribing patterns differ significantly from 
        their peers.

          Are the efforts currently underway in the Medicare and 
        Medicaid programs having any noticeable impact on the local 
        level? Despite a discernable drop in the amount of opioid 
        prescriptions being written, initiatives like the highly 
        successful Bucks County Medication Takeback Program are still 
        seeing record amounts of unused medications taken in.\21\
---------------------------------------------------------------------------
    \21\ Christian Menno, ``Record amounts collected at drug take-back 
events in Bucks, Montgomery Counties,'' Bucks County Intelligencer, 
November 2, 2017, http://www.theintell.com/news/20171102/record-
amounts-collected-at-drug-take-back-events-in-bucks-montgomery-
counties/1.

    I thank you all for being here today. I look forward to the 
discussion, and remain confident that by working together at the 
Federal, State, and local levels, we can continue to make substantial 
progress in our efforts to prevent and overcome opioid and substance 
---------------------------------------------------------------------------
misuse.

                                 ______
                                 
               Prepared Statement of Matthew Weintraub, 
                    District Attorney, Bucks County
    Good afternoon, and thank you, Senator Toomey, for the opportunity 
to provide testimony to this committee. As Bucks County District 
Attorney, I will try to focus my remarks on the challenges of the 
opioid epidemic as I see them, with a specific focus on why prevention 
is so important.

    Bucks County is particularly challenged in its battle against the 
opioid epidemic due to our proximity to Philadelphia (Kensington 
specifically), Allentown, and Trenton which makes it easy for those 
suffering from addiction to obtain drugs. We strive to prevent heroin 
and other drugs from infiltrating our county, but they are easy to 
obtain with a short drive. That is why a regional or national response 
is vital. No one county or entity within the county can do it alone. We 
in Bucks County do work well as a team across systems such as law 
enforcement and health and human services, but we do need more help. 
The following is a great example of a case where cross-county 
collaboration thwarted a pill-dealing drug ring. In 2018, members of 
the Bucks County Drug Strike Force conducted an investigation in which 
ten people were arrested in Berks County for making and passing 
fraudulent prescriptions. Over 106 fraudulent prescriptions were filled 
in the Bucks County/Philadelphia area which resulted in these 
individuals obtaining 12,500 Oxycodone pills. These pills were then 
distributed on the street in Bucks County and Philadelphia.

    Victims of this epidemic not only include the users themselves, but 
the emotional, and often criminal, toll taken on family and loved ones. 
Additionally, in 2017 we had 217 babies born diagnosed with Neonatal 
Abstinence Syndrome (NAS). These innocent newborns are a startling 
reminder that the opioid epidemic does not only affect those who are 
addicted.

    Our medication take-back program demonstrates the overprescribing 
problem we face as illustrated by the amount of unneeded medication in 
our community. In a good news, bad news scenario, we are the number one 
county in the State in medication take-back, having collected over 
100,000 pounds of unused, old, or expired medication since this 
program's inception. That is a lot of medication that can no longer be 
diverted to hurt or kill someone ever again. But, that is a lot of 
unnecessary medication, period. Medicare and Medicaid are two of the 
largest payers for prescription opioids and therefore hold a critical 
role in making sure we reduce the amount of excess opioids in 
circulation in the first place.

    Congress has recently dedicated an unprecedented $4.6 billion to 
combat the opioid crisis in fiscal year 2018, and it is important to 
make sure that funding reaches the places where it is needed most 
through the programs that will be most effective. Such programs that 
could benefit from such funding in Bucks County include drug recovery 
programs in jails that can educate and successfully begin to treat our 
inmates so that they never return. Another innovative program we are 
looking to expand is the Bucks Police Aiding in Recovery, modeled off 
of a similar effort by the Bensalem Police Department, which helps 
increase treatment access to those who seek it voluntarily.

    While Medicaid and Medicare may have responded slowly to implement 
controls aimed at curbing overutilization of opioids in the first 
place, the Behavioral Health (drug/alcohol treatment) Medicaid 
providers have been strong partners in providing treatment supports. 
Unfortunately, part of the challenge we face is that no one wants these 
providers to open up facilities or increase services in their 
community. We must combat this community stigma against those with 
substance use disorders, and we need our elected officials to be 
leaders in this effort.

    Those in recovery cannot be looked at as needing only treatment 
supports. Physical health, housing, nutrition, employment and other 
social determinants of health need to be addressed to help people in 
recovery. That is another part of the challenge that all single county 
authorities must strive to address. Finally, we have spent so much time 
focused on heroin, that we have turned our attention away from other 
substances. Our current concern is a ``twin epidemic'' which pairs 
stimulants (i.e., methamphetamine) and opiates (i.e., oxy or heroin). 
We are now finding that many opioid abusers are also abusing meth in 
order to ease their painful physical withdrawal symptoms experienced as 
they seek their next opioid fix. We must also continue to focus on 
underage drinking and marijuana use which continue to be issues for our 
communities.

    Thank you for the opportunity to address the committee today to 
talk about the challenges of the opioid epidemic as I see them, with a 
specific focus on why prevention is so important in this battle against 
the opioid epidemic.

                                   [all]