[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
---------------------------------------------------------------------------
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]