[Senate Hearing 116-455]
[From the U.S. Government Publishing Office]
S. Hrg. 116-455
TREATING SUBSTANCE MISUSE IN AMERICA: SCAMS, SHORTFALLS, AND SOLUTIONS
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HEARING
BEFORE THE
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 24, 2019
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[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
__________
U.S. GOVERNMENT PUBLISHING OFFICE
44-731 PDF WASHINGTON : 2021
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COMMITTEE ON FINANCE
CHUCK GRASSLEY, Iowa, Chairman
MIKE CRAPO, Idaho RON WYDEN, Oregon
PAT ROBERTS, Kansas DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming MARIA CANTWELL, Washington
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
TIM SCOTT, South Carolina MARK R. WARNER, Virginia
BILL CASSIDY, Louisiana SHELDON WHITEHOUSE, Rhode Island
JAMES LANKFORD, Oklahoma MAGGIE HASSAN, New Hampshire
STEVE DAINES, Montana CATHERINE CORTEZ MASTO, Nevada
TODD YOUNG, Indiana
Kolan Davis, Staff Director and Chief Counsel
Joshua Sheinkman, Democratic Staff Director
(ii)
C O N T E N T S
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OPENING STATEMENTS
Page
Grassley, Hon. Chuck, a U.S. Senator from Iowa, chairman,
Committee on Finance........................................... 1
Wyden, Hon. Ron, a U.S. Senator from Oregon...................... 2
WITNESSES
Adams, Hon. Jerome M., M.D., MPH, Surgeon General, Office of the
Secretary, Department of Health and Human Services, Washington,
DC............................................................. 4
Denigan-Macauley, Mary, Ph.D., Director, Health Care, Government
Accountability Office, Washington, DC.......................... 7
Cantrell, Gary, Deputy Inspector General for Investigations,
Office of Inspector General, Department of Health and Human
Services, Washington, DC....................................... 8
Mendell, Gary, founder and chief executive officer, Shatterproof,
New York, NY................................................... 10
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Adams, Hon. Jerome M., M.D., MPH:
Testimony.................................................... 4
Prepared statement........................................... 35
Responses to questions from committee members................ 53
Cantrell, Gary:
Testimony.................................................... 8
Prepared statement........................................... 71
Responses to questions from committee members................ 78
Daines, Hon. Steve:
Letter from the Federal Law Enforcement Officers Association
to Senators Grassley and Wyden, October 24, 2019........... 88
Denigan-Macauley, Mary, Ph.D.:
Testimony.................................................... 7
Prepared statement........................................... 89
Responses to questions from committee members................ 95
Grassley, Hon. Chuck:
Opening statement............................................ 1
Prepared statement........................................... 103
Mendell, Gary:
Testimony.................................................... 10
Prepared statement........................................... 104
Responses to questions from committee members................ 107
Wyden, Hon. Ron:
Opening statement............................................ 2
Prepared statement........................................... 114
Communications
Association for Behavioral Health and Wellness................... 117
Avery, Trudy..................................................... 119
Center for Fiscal Equity......................................... 123
Coalition for Office-Based Outpatient Treatment.................. 127
Hazelden Betty Ford Foundation................................... 130
SAFE Project US.................................................. 132
Voices for Non-Opioid Choices.................................... 134
TREATING SUBSTANCE MISUSE IN AMERICA: SCAMS, SHORTFALLS, AND SOLUTIONS
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THURSDAY, OCTOBER 24, 2019
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 9 a.m., in
Room SD-215, Dirksen Senate Office Building, Hon. Chuck
Grassley (chairman of the committee) presiding.
Present: Senators Crapo, Thune, Toomey, Scott, Cassidy,
Lankford, Daines, Young, Wyden, Stabenow, Cantwell, Menendez,
Cardin, Brown, Bennet, Casey, Warner, Hassan, and Cortez Masto.
Also present: Republican staff: Nicholas Bartine, Detailee;
Kolan Davis, Staff Director; Evelyn Fortier, General Counsel
for Health and Chief of Special Projects; John Pias, Detailee;
and Jeffrey Wrase, Deputy Staff Director and Chief Economist.
Democratic staff: David Berick, Chief Investigator; Shana
Deitch, Detailee; Anne Dwyer, Senior Health Counsel; Peter
Gartrell, Investigator; and Joshua Sheinkman, Staff Director.
OPENING STATEMENT OF HON. CHUCK GRASSLEY, A U.S. SENATOR FROM
IOWA, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. Good morning. I want to welcome our panelists
to today's hearing on the one-year anniversary of the SUPPORT
Act. This landmark statute, which many of us had a hand in
developing, responded to the opioid epidemic on multiple
fronts. That crisis has affected every corner of our Nation,
with 130 Americans, on average, dying from an overdose every
single day.
We have devoted a lot of Federal resources to tackling this
crisis, and I look forward to hearing from the Surgeon General
on this administration's efforts to implement the SUPPORT Act
over the last year. I also commend Dr. Adams for launching his
own unique initiatives to help raise public awareness about the
risks of opioid misuse.
Challenges remain, however, because roughly 20 million
Americans still struggle with substance abuse disorder.
Addiction to other drugs, including meth and heroin, pose an
equal, or even greater, challenge for some communities,
especially in rural areas.
Another issue is that few battling addiction actually seek
or receive treatment. Yet another issue is that even those who
do seek help lack the expertise to distinguish the good
treatment providers from the bad. Solving that last issue,
which is the second focus of our hearing, is easier said than
done.
The treatment sector includes not just extremely good and
extremely bad providers, but also many others who fall
somewhere in the middle. Some, for example, have not updated
their methods to incorporate the latest research about what
works best for recovering people.
Also, State requirements for addiction counselors and
recovery homes vary. For example, some States require licensing
of recovery home operators, while others might only use
voluntary certification. That is why we have invited two
government watchdog agencies and an addiction treatment
advocate to our committee to share their expertise with us
today.
We welcome back Dr. Denigan-Macauley of the GAO, who
testified before this committee last year. We have all seen the
media reports about so-called ``sober homes'' in Florida,
Pennsylvania, Massachusetts, and a few other States that
exploited recovering addicts with private insurance benefits.
We look forward to hearing from her on that subject of GAO's
work there.
I also extend a warm welcome to Gary Cantrell, who heads
the Inspector General's investigating team. His investigators
worked on a recent high-profile case involving a treatment scam
in Ohio. That investigation, in partnership with the FBI and
law enforcement generally, led to the indictment of six people
this year. All six pled guilty to Medicaid fraud.
Some have called for development of more uniform,
measurable addiction treatment standards by which the public
could evaluate the effectiveness of substance abuse treatment
programs.
Our last witness, Gary Mendell, has gone a step further in
not only identifying eight core standards he believes are key
to any successful program, but also launching a quality rating
system. This is an uncharted area in the treatment sector, and
we look forward to hearing from him about the progress that has
been made there with his nonprofit organization, Shatterproof.
We are here today because too many Americans have lost too
many loved ones to addiction and overdose deaths. America's
opioid crisis has left a trail of broken hearts and homes
across the country. We are here to help communities get on a
path towards health and wellness. Millions of Americans are
desperately seeking a path forward. Working together, we can
save tax dollars and save lives.
Senator Wyden?
[The prepared statement of Chairman Grassley appears in the
appendix.]
OPENING STATEMENT OF HON. RON WYDEN,
A U.S. SENATOR FROM OREGON
Senator Wyden. Thank you very much, Mr. Chairman.
Mr. Chairman, I want to thank you because this is an
exceptionally important issue, and I think we do need to have
our committee tackle it in a bipartisan way. And I also want to
thank you for moving this morning's start time to 9 a.m.,
because we both know there are members who want to attend the
memorial service for Chairman Cummings.
Today's hearing is going to spotlight the pitfalls
Americans face when they try to find quality treatment for
substance use disorder. An American battling this disease is
often jostled and pushed around from one end of the health-care
system to the other. The last thing you need when you're
suffering from this disease is yet more obstacles, rip-off
artists, empty promises, or just out-and-out abuse. The last
thing you need is that, when all you want to do is get better.
Too often people travel across the country expecting to
arrive at a legitimate treatment facility, only to find that
they have fallen prey to a scheme, the goal of which is to
drain their bank accounts and just milk their insurance for
everything it is worth.
In some instances, unscrupulous operators are working to
lure patients by paying for plane tickets and promising free
rent. Once the patients arrive, what they end up getting is
lousy care, or no care at all. And then the fraudsters just go
out and bill the insurance companies for health-care services
that may never have even been performed.
One of the biggest problems involves facilities that
allegedly treat substance abuse disorders but are actually set
up to rip off taxpayers. The fraudsters illegally recruit
patients using bribes and kickbacks, and then they bilk the
taxpayer by billing the patient's health plan for medically
unnecessary drug tests and schemes like this. And we are very
pleased to have this really terrific group of witnesses today.
They are going to outline these schemes in detail. And of
course these schemes also cost Medicare, Medicaid, and private
insurance hundreds of millions of dollars every year. Just this
month, six people operating a network of fraudulent treatment
centers in Ohio pled guilty to submitting 130,000 Medicaid
claims that totaled more than $48 million for medication-
assisted treatment and other services that were never
legitimately provided.
Part of the reason this type of fraud is so common is
because there is no way for a patient and their family to learn
about the quality of a treatment facility before they enroll.
But today we are going to hear from an organization that is
saying, ``Hey, wake up, everybody. This has got to change.''
Shatterproof is currently developing public databases in
multiple States that, if successful, will allow the public to
identify, evaluate, and compare substance use treatment
programs. This kind of database and transparency is the type of
information that American families deserve to have, and they
deserve to have it now because it will be a key tool to find
quality treatment and avoid sham operators trying to make a
quick buck.
One other point that occurred to me as we were preparing
for this hearing is, it is particularly important now to set in
place the kind of concrete policies to make sure that the
programs are not ripping off, and the patients are not taken
advantage of. Because when you read the morning newspaper, the
fact is that States and communities may now be on the cusp of
receiving tens of billions of dollars from the companies that
helped feed the epidemic.
I could kind of look down the road, because I have heard
about this from virtually all of my colleagues. So if you are
talking about a fund of tens of billions of dollars, a sum of
that size is going to be a magnet for the fraudsters and the
ripoff artists.
This hearing is going to highlight these to make sure that
there are rules of the road and vigorous oversight so that
those dollars actually go to help patients get proper care, and
all that new money does not just find its way to the ripoff
artists.
I thank the witnesses and you, Mr. Chairman, again for your
leadership. And we are going to work on this in a bipartisan
way, and I look forward to hearing from the witnesses and our
colleagues.
[The prepared statement of Senator Wyden appears in the
appendix.]
The Chairman. The Senator from Maryland is here to
introduce the Surgeon General.
Senator Cardin. Thank you, Mr. Chairman. I thank you for
giving me this courtesy.
It is a real pleasure to welcome all of our witnesses
today, but particularly I welcome the Surgeon General of the
United States, Dr. Jerome Adams. He hails from Mechanicsville,
MD, a proud son of Maryland, and has had a glowing career, Mr.
Chairman, first winning the prestigious Meyerhoff Scholarship
of the University of Maryland, Baltimore County, where he
received both a bachelor of science in biochemistry and a
bachelor of arts in biopsychology.
I say that because we had a conversation before. Dr.
Freeman Hrabowski, who is the president of UMBC, called Dr.
Adams his most successful failure. That's because the Meyerhoff
Scholarship program is a program that has been extremely
successful in African Americans attaining their Ph.D.s and
going on to extraordinary, successful lives.
Well, Dr. Adams does not have a Ph.D., but he does have a
masters degree and an M.D. degree, and of course has had a
very, very successful career.
I want to congratulate him for his leadership in our
country, his service to our Nation. He attended Indiana
University School of Medicine, an Eli Lilly and Company
scholar.
Before serving as the United States Surgeon General, Dr.
Adams was appointed as the Indiana State Health Commissioner.
As the U.S. Surgeon General, Dr. Adams has spent his time
focusing on combating the opioid epidemic.
He has been an advocate on behalf of public health in our
country, and we are just very proud of his service, and we are
proud to claim him as hailing from our State of Maryland.
The Chairman. For the other three of you, if you just go
through the testimony, I hope you will not feel bad if I do not
introduce you because of the time constraints. I talked about
all of you in my opening statement.
I want to start with the Surgeon General. So would you
start? And then what we will do is go in the order that you are
sitting there at the table, and then we will have questions
after you all get done.
STATEMENT OF HON. JEROME M. ADAMS, M.D., MPH, SURGEON GENERAL,
OFFICE OF THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Dr. Adams. Fantastic. Well, good morning, Chairman
Grassley. My wife Lacey says to tell Barbara ``hi'' and that we
cannot wait to bring the kids out to the farm. I hope she told
you about that. [Laughter.]
The Chairman. Everybody knows about my wife. Does anybody
know about me? [Laughter.]
Dr. Adams. Senator Wyden, distinguished members of the
committee, if you will allow me just 20 extra seconds, I want
to acknowledge the flag flying at half-mast over the Capitol
and lift up the example and accomplishments of Representative
Cummings.
His life was the very definition of public service, and my
condolences go to his family and to all who were blessed to
know him.
For my testimony today I would like to begin by thanking
all of you and your colleagues, Mr. Chairman, for passing the
SUPPORT Act, which has enabled HHS and our country to make
progress in its fight against the opioid epidemic. And I am so
pleased to be here today on the one-year anniversary.
America's overdose and addiction crisis is one of our most
daunting and complex public health challenges ever. Recognizing
its scale and scope, HHS launched the five-point strategy in
2017, and under this strategy we are achieving better
addiction, prevention, and treatment services; better data;
better team management; better targeting of overdose-reversing
drugs; and better research.
I have been engaged on this problem as an anesthesiologist
involved in acute and chronic pain management and, as you heard
from Senator Cardin, as head of a State health department
dealing with an unprecedented opioid-fueled HIV outbreak. But
my work on the opioid epidemic is also very, very personal.
My younger brother Philip struggled with the disease of
addiction. His struggle began with untreated depression,
leading to self-medication and opioid misuse. And like many
with co-occurring mental health and substance use disorders, my
brother has cycled in and out of incarceration. He is currently
serving a 10-year prison sentence for crimes committed to
support his addiction.
This epidemic is blind to color, geography, and class, as
addiction can happen to anyone, even the brother of the United
States Surgeon General. And when stigma keeps people in the
shadows, it impedes our collective recovery.
To address this opioid epidemic, my office released the
``Spotlight on Opioids,'' a digital postcard which you can find
at surgeongeneral.gov--and which you have in front of you,
Senators--and an advisory on opioid overdose and naloxone.
I want to leave you with five key messages that I detail in
these publications.
Number one: early intervention is critical. Evidence-based
prevention and intervention programs work, but they need to be
initiated early in life. We cannot wait until someone is in
high school or in college before we start talking to them about
the dangers of opioid misuse.
Number two: treatment is effective, but it must be
integrated into mainstream health care. As an example,
medication-assisted treatment is the gold standard, but in the
course of a year, only one in four people with opioid use
disorder received specialty treatment.
Number three: having naloxone can save a life and serve as
a bridge to treatment and recovery. And I hope all of you know
about this and carry it. I carry it with me everywhere we go.
It's literally that easy to save a life. Since my naloxone
advisory was published, almost 3 million two-dose units have
been distributed to communities, but too many still needlessly
die.
Fourth: comprehensive community-based recovery support
services are essential. And I saw this first-hand when Second
Lady Pence and I visited Belden Industries in Indiana. Belden
developed a unique pilot project called ``Pathways to Recovery
and Employment'' in which potential employees who fail drug
tests are offered drug counseling. And participants who stay in
the recovery program are then assured jobs. Recovery support
services are also vital to Greyston Bakery in New York. And the
bakery provides employment and support services without
judgment--no resume, no work history, no background check is
required. The bakery's motto, which I love, is, ``We don't hire
people to bake brownies. We bake brownies to hire people.'' At
present, more than 60 percent of Greyston Bakery's employees
were formerly incarcerated.
My fifth point is that, when it comes to opioid use
disorders, society must continue to move from a criminal
justice-based approach to a public health and partnership-based
one. Stigma and judgment are keeping people with the disease of
addiction, people like my brother, from getting the help they
need. And this, in my opinion, is killing more people than
overdose.
In conclusion, under this administration and through your
support, a historic investment has been made in combating the
opioid crisis. By the end of 2019, HHS will have awarded over
$9 billion in grants to States, tribes, and local communities
to combat addiction. This includes nearly $1 billion across 375
projects in 41 States as part of NIH's Helping to End Addiction
Long-term, or HEAL, initiative. It also includes more than $1.8
billion in SAMHSA and CDC funding to States announced last
month. These funds expand access to treatment and strengthen
data and surveillance.
Since the start of this administration, we have seen the
amount of opioids nationally drop 31 percent in terms of
prescriptions. We have seen the number of Americans receiving
treatment grow. Now nearly 1.27 million Americans are receiving
medication-assisted treatment, and we have doubled the number
of providers who have their data waiver to prescribe MAT.
Monthly, naloxone prescriptions have risen 378 percent, and
provisional drug overdose deaths have dropped by 5 percent, the
first drop in over 20 years. We are making progress, but
challenges remain, including the resurgence of methamphetamines
and the need to increase support for comprehensive syringe
service programs and to support emergency department
medication-assisted treatment programs with warm hand-off to
care.
And we also, finally, must expand the behavioral workforce.
And Senator Stabenow and I talked about that before the
hearing. I promise you--I promise you--that HHS and my office
will continue our commitment and our focus on this critical
public health issue.
I thank you for the opportunity to testify, and I look
forward to your questions.
[The prepared statement of Dr. Adams appears in the
appendix.]
The Chairman. Doctor, before you begin, with all your
background in animal science, how did you end up at GAO?
Dr. Denigan-Macauley. Well, as you probably are aware,
there is quite a nexus between animal health and public health,
and I think GAO recognizes that.
The Chairman. Okay. Well, I needed that explanation.
[Laughter.]
Proceed, please.
STATEMENT OF MARY DENIGAN-MACAULEY, Ph.D., DIRECTOR, HEALTH
CARE, GOVERNMENT ACCOUNTABILITY OFFICE, WASHINGTON, DC
Dr. Denigan-Macauley. Chairman Grassley, Ranking Member
Wyden, and members of the committee, I am pleased to be here
today to discuss GAO's recent report on the oversight of
recovery homes.
Substance abuse--and illicit drug use--is a persistent
problem that has ruined families and taken lives. The DEA
reports that, since 2011, drug overdoses alone have been the
leading cause of death by injury in the United States, out-
numbering deaths by guns, car crashes, suicide, and homicide.
Recovery homes can offer safe and supportive housing.
Unfortunately, bad actors have used these homes to take
advantage of individuals during their time of need.
Today, I would like to highlight two key findings from our
report.
First, GAO found that all five States in our review had
received complaints of potential fraud related to recovery
homes, and four of the five--Florida, Massachusetts, Ohio, and
Utah--had conducted, or were in the process of conducting
investigations.
For example, officials told GAO that fraud was extensive in
southeastern Florida. A task force found that operators were
luring individuals to homes using deceptive marketing
techniques, such as promises of free airfare and rent.
Recruiters then brokered these individuals to providers who
billed their insurance for hundreds and thousands of dollars in
unnecessary drug testing. Home operators were then paid $300 to
$500 or more per week for every patient that they referred. At
the time of our report, some arrests had been made.
In Massachusetts, the Medicaid Fraud Control Unit found
that some laboratories owned recovery homes and were self-
referring residents to their own labs for drug testing. Other
labs were paying kickbacks to homes for patient referrals for
testing that was not medically necessary. And between 2007 and
2015, the State settled with nine labs for more than $40
million in restitution.
At the time of our report, Ohio was investigating fraud at
the Braking Point Recovery Center. This month, as Senator Wyden
mentioned, the U.S. Attorney's office reported that six people
from Braking Point pled guilty to health-care fraud conspiracy
for billing Medicaid more than $48 million in drug and alcohol
recovery services that were not provided or not medically
necessary.
To increase oversight, Florida, Massachusetts, and Utah
established either licensure or voluntary certification
programs that included incentives for recovery homes to
participate. Our other two States, Ohio and Texas, did not have
similar programs but were providing resources such as training
to recovery homes.
Despite such efforts, though, fraud continues. For example,
the Pennsylvania Attorney General and U.S. Attorney's offices
recently completed an 18-month investigation looking into
insurance fraud in treatment centers. Charges included, once
again, kickbacks for unnecessary drug testing and billing
insurance companies at exorbitant rates.
Those charged also directed patients to live in company-
owned, unlicensed recovery homes where the housing was
sometimes unsafe, employees and patients were engaged in sexual
relationships, and there were opportunities to relapse. And
this is the case of the bad guys getting caught. That's what
leads me to my second point.
We do not know the total number of recovery homes, so
therefore, we don't know the extent to which this is happening.
In addition, no Federal agency oversees the operations of these
homes to provide a nationwide perspective.
In closing, when run properly, recovery homes are an
important part of a patient's path to sobriety and combating
the opioid crisis. Our work on recovery homes is part of GAO's
broader work on drug misuse. Recent GAO reports have explored,
for example, Federal oversight of opioid prescribing in
Medicare. We also have ongoing work identifying barriers
Medicaid beneficiaries may face accessing important medications
to treat opioid misuse.
Much of our current work is the result of mandates from the
SUPPORT Act, which was signed into law 1 year ago from today.
We highlight this and other work in our latest high-risk
report, where we identify Federal efforts to prevent drug
misuse as an issue requiring very close attention.
Thank you, Chairman Grassley, Ranking Member Wyden, and
members of the committee, for holding this important hearing
and continuing your oversight on this issue. This concludes my
remarks. I am happy to respond to any questions you may have.
[The prepared statement of Dr. Denigan-Macauley appears in
the appendix.]
The Chairman. Now, Mr. Cantrell.
STATEMENT OF GARY CANTRELL, DEPUTY INSPECTOR GENERAL FOR
INVESTIGATIONS, OFFICE OF INSPECTOR GENERAL, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Mr. Cantrell. Good morning, Chairman Grassley, Ranking
Member Wyden, and other distinguished members of the committee.
I am Gary Cantrell, the Deputy Inspector General for
Investigations at HHS OIG. I appreciate the opportunity to
appear before you to discuss OIG's efforts to combat the opioid
crisis. Our ongoing work is taking a multi-faceted approach,
looking at a variety of issues on both the prescribing and
treatment dimensions of this crisis.
OIG is addressing the crisis through expanded law
enforcement activities, audits, evaluations, and data briefs.
Our efforts to combat opioid-related fraud, waste, and abuse
while ensuring both substance use disorder treatment and
continuity of care continue are a top priority for OIG.
For example, we have expanded enforcement efforts to
address the opioid crisis significantly over the past several
years, resulting in an increase of over 100 percent of open
investigations at our office from 2015 to 2019. Just this year,
the newly launched Appalachian Regional Prescription Opioid
Strike Force, a joint initiative between DOJ, OIG, DEA, FBI,
and our State Medicaid Fraud Control Unit partners took down 73
individuals, 64 of them medical professionals, for their
alleged participation in the illegal prescribing and
distribution of opioids and related health-care fraud schemes.
Opioid fraud encompasses a broad range of criminal
activities from prescription drug diversion to addiction
treatment services and billing schemes. A growing concern is
fraud involving medication-assisted treatment, sober homes, and
ancillary services such as counseling and urine drug test
screening. As the number of treatment facilities and sober
homes operating across the Nation continues to increase in
conjunction with increased demand and availability of Federal
funds to support new services, we have seen the commensurate
increase in elicit schemes involving fraudulent billing and
diversions.
As our enforcement and oversight efforts to address the
opioid crisis have expanded, we have also come to understand
the impact our enforcement work can have on the patients that
we serve. We recognize that when a clinic whose patients are
prescribed opioids or MAT is shut down due to law enforcement
efforts, access to care can and will be disrupted. Rather than
leaving these patients to potentially turn to another
fraudulent provider or street drug to meet their needs, we
believe it is vital that they have the access to quality
treatment and pain management services with minimal disruption
to care.
But this is not something that law enforcement can do
alone. Ensuring these patients have continuity of care requires
a collaboration with our Federal, State, and local public
health service officials. As part of the ARPO Appalachian
takedown, OIG and our law enforcement partners worked in close
collaboration with HHS's Office of the Assistant Secretary for
Health, the Centers for Disease Control and Prevention, the
U.S. Public Health Service, and State public health agencies to
deploy Federal and State-level strategies and resources to
provide assistance to patients impacted by our law-enforcement
operations.
OIG will continue to work hand-in-hand with our public
health partners to help ensure access to treatment and
continuity of care for patients impacted by our efforts.
Beyond our enforcement efforts, OIG continues to grow our
robust portfolio of work related to the crisis with new and
ongoing work that identifies opportunities to strengthen
program integrity and protect at-risk patients across the
prescribing and treatment dimensions of this crisis.
OIG currently has several opioid treatment-related audits
and evaluations underway, examining issues such as access to
medication-assisted treatment and advancement and deployment of
oversight of State treatment grants. We look forward to sharing
the results of this work with the committee when it is
complete.
OIG's recent data brief on opioid prescribing in Medicare
shows significant declines in opioid prescribing. At the same
time, it also showed that the number of patients receiving
buprenorphine and naloxone in Medicare is increasing. And this
is a very positive sign. However, there is still much work to
be done to reduce illegal prescribing of opioids and sham
treatment schemes, which only detract from the efforts of those
who seek to provide the help these patients truly need.
OIG will remain vigilant in identifying and investigating
emerging opioid treatment fraud schemes and working to improve
HHS's efforts to provide quality treatment services.
Thank you for allowing me the opportunity to discuss this
important topic, and I look forward to any questions you have.
[The prepared statement of Mr. Cantrell appears in the
appendix.]
The Chairman. Before you start, I realize what little bit I
said about you in my opening statement. I need to recognize
your success in the private sector, and now, bringing that to
the nonprofit organizations, you are able to help us accomplish
this goal. I should have said that, and I did not. So proceed.
STATEMENT OF GARY MENDELL, FOUNDER AND CHIEF EXECUTIVE OFFICER,
SHATTERPROOF, NEW YORK, NY
Mr. Mendell. Chairman Grassley, Ranking Member Wyden, and
members of the committee, thank you for holding this hearing on
treating substance misuse in America. My name is Gary Mendell,
and I am the founder and chief executive officer of
Shatterproof, a national nonprofit organization dedicated to
reversing the addiction crisis in America.
For nearly a decade, my son Brian struggled with substance
abuse disorder. Despite our family working tirelessly to find
my son the best possible care at eight different treatment
programs, on October 20, 2011, we lost my son Brian to the
disease of addiction.
In the months that followed, I was destroyed all over again
when I learned that research existed proving the types of
interventions that would have significantly improved the
outcome for Brian and millions of others who were in treatment
for addiction, if only we had known what to look for. That is
why I founded Shatterproof, the first national nonprofit
organization dedicated to reversing the addiction crisis in
America.
To accomplish this, we developed a five-point plan to
transform the addiction treatment system in the United States.
Number one: a core set of science-based principles for care
for treating addiction.
Number two: a quality measurement system.
Number three: payment reform.
Number four: treatment capacity.
And number five: ending stigma.
My remarks today will focus on the second of these five,
treatment quality measurement. Addiction is a chronic brain
disease. But despite the fact that there are clear clinical
best practices, the use of these practices varies widely across
the addiction treatment field, and some facilities are still
employing tactics based on ineffective and outdated
methodologies.
Unlike other health-care services, comprehensive,
standardized data on the quality of addiction treatment just
simply does not exist. Even worse, because consumers, payers,
and State regulators do not have access to quality measures,
market forces have not been aligned to support these best
practices.
In 2006, in a landmark report by the Institute of Medicine,
it called for the development and dissemination of a common,
continuously improving set of measures for the treatment of
substance use disorder to drive quality improvement.
Shatterproof is seizing upon this longstanding
recommendation to develop a public platform known as ATLAS,
with three aims.
Number one: providing patients and family members the
information they need to identify evidence-based treatment for
their loved ones.
Number two: equipping providers with data to advance the
use of evidence-based practices.
And number three: ensuring policy and payment decisions are
data-driven.
The tool builds upon our eight national principles of care,
which were developed with experts in the field to establish
that addiction should be treated like any other chronic
illness.
We are currently in phase one of that list and are working
with treatment facilities, payers, and other stakeholders in
six States: Delaware, Louisiana, North Carolina, West Virginia,
Massachusetts, and New York. So far, this phase has included
measure identification and refinement through the National
Quality Forum expert panel's strategy session and public
comment periods, feasibility testing of survey items and claims
measures, and a pilot of the Patient Experience Survey across
50 treatment facilities in the State of New York.
Quality data will be collected and triangulated from three
sources--claims data, Patient Experience Survey, and Treatment
Facility Survey--and reported back to providers, to the public,
the payers, and to States. And when I say ``the public,'' I
mean the families.
Following evaluation of phase one, Shatterproof will work
with other States to bring this resource to serve more than 21
million Americans with a substance use disorder.
ATLAS is part of Shatterproof's strategic goal in
transforming the addiction treatment system in the United
States to reverse the addiction crisis that has taken such a
severe and tragic toll on far too many, and for which the
impacts can absolutely be averted for so many others.
Thank you for the opportunity to testify today, and I look
forward to your questions. Thank you.
[The prepared statement of Mr. Mendell appears in the
appendix.]
The Chairman. We will have 5-minute rounds of questioning.
We will start with the Surgeon General.
First of all, I know and thank you for the top priority you
have given as Surgeon General, and even probably as an
individual, to addressing opioids and addiction as a top
priority. And I also thank the administration for its efforts
to prioritize carrying out the enactment of this legislation.
Section 70.31 of the new law calls for the development of
best practices. Has the administration appointed working group
members to develop such best practices, or identified the
factors that should be used to identify potentially fraudulent
recovery housing operators, as required by SUPPORT, and if not,
could you give us a timetable when that might happen?
Dr. Adams. Thank you for that question, sir, and I want to
recognize that Iowa has led the way in the country with a 14.7-
percent decrease in overdose rates over the past year that's
been recorded. And so we need to share more of what's working
in Iowa with the rest of the country, including connecting
people with treatment and recovery services.
I will tell you very specifically, in the ``Spotlight on
Opiods,'' which I highlighted--this came out last year--there
wasn't much fanfare. A lot is going on in DC nowadays, and
folks do not always notice when the Surgeon General puts
something out. But I highlighted what to look for in a
substance use disorder treatment program: personalized
diagnosis assessment and treatment planning; long-term disease
management.
As we learned in Indiana, it is not just substance use
disorders; in many cases it is HIV, it is hepatitis, it is
sexually transmitted diseases, it is co-occurring mental
illnesses. So, access to FDA-
approved medications; effective behavioral interventions;
coordinated care for other co-occurring diseases and diagnoses;
and recovery support services.
So my role is to help give the public the information they
need to make informed decisions. We have put that out. We also
have the SAMHSA treatment finder, 1-800-662-HELP. And beyond
that, in terms of vetting good from bad, I would turn it over
to my friend, Mr. Cantrell, from OIG. I hate to put you on the
spot, sir, but----
Mr. Cantrell. Vetting good from bad is, unfortunately,
where we only encounter the bad. And what we see is that our
institutions have no intent to provide the services that they
are billing for. Individuals do not receive the type of
counseling that they are supposed to receive. Sometimes we have
seen prescription pads just left behind for staff, nonqualified
medical staff at the facility just writing prescriptions as
people walk through the door.
There is zero, in most of these cases we are involved in,
actual interest in the care of these patients in treatment. So
they are not getting the services that they need and deserve,
and oftentimes that we are paying for.
The Chairman. Dr. Denigan-Macauley, I wanted to ask you a
question. You referred in your testimony about not knowing how
many homes there are, or where those recovery homes are. Do you
have any way of telling us what obstacles exist to obtaining
this information? Because it seems like we need this
information.
Dr. Denigan-Macauley Yes, it is difficult to obtain this
information because, as I mentioned, there is no Federal
oversight of these homes. It is left up to the States, and the
States have varying practices.
For example, some States require homes to be licensed.
Other States offer a voluntary certification. NARR * offers
voluntary certifications, and some homes fly under the radar.
So there are many obstacles to identifying the number of
recovery homes that we have.
---------------------------------------------------------------------------
* National Alliance for Recovery Residences.
---------------------------------------------------------------------------
Dr. Adams. Sir, I would highlight--and this ties into your
question--today Medicare, CMS, is going to be releasing a
substance use disorder data book. And that is a direct request
from the SUPPORT Act, which you all passed a year ago, and this
will highlight the people and States that are getting recovery
and treatment services through Medicaid. And that will be a
first important step to figuring out who is getting what, where
are they getting it, and will better allow us to then assess
the good from the bad.
The Chairman. Mr. Mendell, obviously we did not--I did not
recognize that you lost your son, and obviously that is a
terrible loss for you. And I hope you know it is not only your
son, but everybody else that we are trying to help in this
regard.
So I would like to ask you this question, and this will
have to be my last one. Tell us more about what led you to
develop the national standards of care.
Mr. Mendell. Sure. What I saw in the industry was literally
about 45 evidence-based practices that treatment programs
should be following, each with multiple published articles.
Clinical trials showing that they worked--if you do X, the
patient does better; you do A, B, C, the patient does better.
But there were 45 of these, approximately. And they were not
all in one place. They were all in different peer-reviewed
medical journals.
There is not a business in America that bonuses anybody on
45 things. Most businesses that are successful narrow it down
to less than 10 core things that will really move for success.
So I knew what we needed was less than 10 core principles
of care, number one, that could be readily understood. The
Surgeon General just mentioned many of those. And our lists are
fairly close.
Less than 10 core principles of care, number one, that
could be easily understood. But number two, most importantly,
able to be measured. You cannot measure 45 things, but you can
measure less than 10. And we purposely selected, working with
the leading researchers in the field--in fact, many of the
researchers who drafted the 2016 Surgeon General's Report,
which was followed up on in the ``Spotlight''--working with
them to draft 8 principles of care that could be easily
measured that were the most impactful to treatment, whether it
is in-patient, out-patient, opioids, alcohol, adolescent, or
adult.
The Chairman. Senator Wyden?
Senator Wyden. Thank you, Mr. Chairman. This has been an
excellent panel. We thank you all for your commitment and
compassion to the patients. And let me tell you what is
foremost on my mind this morning.
Every morning now, we wake up to these news reports that
there is this effort with the States and the communities to
work with the pharmaceutical companies to come up with a
settlement that deals with the opioid drug addiction and the
overdose epidemic that the drug companies contributed mightily
to that we are facing in this country.
If these court settlements go forward, it is almost certain
that a significant portion of that money is going to go to
substance abuse treatment. And it ought to. But based on the
fraud and the ripoffs that you are already describing to us
today, it seems to me that this lack of oversight could mean
that with a potential influx of more money, we are creating a
perfect storm for more fraud.
So I think what I would like you to do, Dr. Denigan-
Macauley, is tell us, going forward, what should the Federal
Government, working with the States and the private sector, do
to make sure that--if that settlement takes place and there are
billions of dollars coming in for substance abuse treatment,
what should the Federal Government, working with the States and
the private sector, do to make sure the dollars go to reputable
operators and not more fraud?
Dr. Denigan-Macauley Thank you. And it is a big question.
However, our work would show that the certification programs,
the licensing programs, the NARR certifications, the charter
houses, have oversight. So it would be good if we could ensure
that the funds could at least go to those homes that have some
form of oversight.
Senator Wyden. What are the gaps in those areas? My
understanding is, you all have already identified some gaps
today in the oversight of some of those key areas.
Dr. Denigan-Macauley. The gaps are numerous. As I mentioned
before, there is no Federal oversight to help us with this
program.
Senator Wyden. So who would you make the point person on
the Federal side? Would it be the Centers for Medicare and
Medicaid Services? Who would you make the point person, given
the fact that you say there is nobody coordinating this?
Dr. Denigan-Macauley. We did not look at that directly.
However, we do know that SAMHSA is providing grant money, and
so that could be one way to tie it to what the States are
doing.
Senator Wyden. Would that be the most cost-effective? Based
on your work, what would be the most cost-effective way,
starting on the Federal side, to fill the gap? So SAMHSA would
be better than----
Dr. Denigan-Macauley. And unfortunately, we have not looked
at it all to be able to say which is better. However, clearly
CMS and SAMHSA could be involved.
Senator Wyden. Okay; what are the other gaps?
Dr. Denigan-Macauley. The other gap is that we just really
do not have an understanding. And the States are able to do
various things. It is not one-program-fits-all. This is
grassroots level. One State that we interviewed did not want to
establish State regulations for recovery homes, because they
are afraid it would result in fewer recovery homes.
Senator Wyden. What would be the two most serious gaps? I
mean, in other words, we have to start somewhere. We have to
have somebody at the Federal level coordinating it, then they
are going to say, what are the two most serious gaps that if
you do not deal with them, more money is going to get ripped
off?
Dr. Denigan-Macauley. I wish I could answer that, but I do
not know the answer to that. I know there are gaps.
Senator Wyden. Who would? Who would be able to tell us,
with all this money coming in, what the biggest gaps are?
Dr. Denigan-Macauley. I think that is an excellent
question, because, when you look at the number of individuals
that we had to interview just to get an understanding of the
oversight of these homes----
Senator Wyden. Let me go to Mr. Mendell, because I think
you guys have already started us on the way to answering this,
because you found some problems with the accrediting
organizations and the like. I gather you would say that was a
gap?
Mr. Mendell. Correct. I suspect many in this room would
agree that it is difficult for the Federal Government to get
down to regulating at the local level. But what the Federal
Government can do is condition all the grants it is giving to
States on States doing
evidence-based practices.
For example, SAMHSA is going to be giving out billions of
dollars to States. SAMHSA could--could--condition that money
going to States on States doing the following five or six
things.
Senator Wyden. Yes, but my point is, number one--Senator
Stabenow has been a leader in working on these kind of
behavioral issues right now. We are not talking about the
Federal Government taking this over.
Mr. Mendell. Correct.
Senator Wyden. We are talking about the fact that the
Federal Government--if we are talking about substance abuse,
there are significant amounts of dollars that the Federal
Government has been involved with, and the Federal Government
needs to be a partner with the accrediting organizations and
with the States and the private sector and the like.
We will hold the record open--the chairman has had to go--
and I would be very interested in hearing from each of you what
you think the biggest gaps are right now, and your ideas for
helping to fill them. I would also like to throw a bouquet to
my seat-mate here for doing good work on this, and being part
of the bipartisan coalition that is coming up with an actual
plan to deal with it. Thank you.
Dr. Adams. Senator Wyden, you asked for two things--and 20
seconds, 20 seconds?
Senator Wyden. Yes.
Dr. Adams. Two big things. One of the HHS pillars is better
data. I used to run a State health department. Again, the
substance use disorder data book is a big, big deal because it
will give States better information about what is going on
where, so they can make better choices about who to lift up and
who needs to be investigated. So better data is one.
Number two, again, as Gary mentioned, as Mr. Mendell
mentioned, we need to let the consumers at the local level know
what to look for in a good treatment center. So, please, look
at what Shatterpoof has put out. Look at what we have put out.
And use your bully pulpit as Senators to push that information
out to individuals who are making those decisions, to those
parents who are going to treatment center after treatment
center after treatment center and do not have a checklist to
tell good from bad.
We have those checklists available. We need you to help us
push those out.
Senator Wyden. We will keep the record open, if you can get
it to us. The chairman wants to move quickly, within the next
10 days. We would like to have recommendations to make sure
that, if we see this influx of money, we are not going to see
it used for more fraud.
The Chairman. I would just like to recognize that this is
exactly why we are having this hearing, and this has been a
very constructive conversation.
Senator Daines?
Senator Daines. Thank you, Mr. Chairman. Drug overdose is
now the leading cause of death for those under the age of 50 in
the United States. We will let that sink in for a moment. It is
a sobering fact.
No doubt our country is in the middle of a major opioid and
meth crisis, and we absolutely must do more to combat this drug
epidemic. In fact, in my home State of Montana, it is meth that
destroys families and communities.
In fact, from 2011 to 2017 there was a 415-percent increase
in meth cases in Montana, with meth-related deaths rising 375
percent during those same years. And unfortunately in my State
of Montana, the meth crisis is disproportionately impacting
Native American tribes.
That is why we had a debate up here that included a piece
of legislation called ``The Mitigating Meth Act.'' It helped
strengthen Indian tribes' ability to combat drug use in the
SUPPORT Act, which was signed into law by the President last
year.
It was a good first step, but there is a lot more to do. We
need to put an end to the tragic stories we are seeing in the
news. No more babies being born addicted to meth. No more
stories of meth breaking up families, overwhelming our foster
care system in Montana. No more stories of individuals being
taken advantage of who are desperately seeking substance abuse
treatment.
I know I can speak on behalf of Montanans: we have had
enough.
Dr. Adams, thanks for being here. First, I would like to
invite you and other HHS administration officials to come to
Montana to see first-hand how this meth crisis--it is Mexican
cartel meth that is affecting our communities.
While the opioid epidemic has certainly been felt in
Montana, one of the greatest challenges we are facing, though,
is meth use.
Dr. Adams, can you speak to how meth is the next wave of
the opioid crisis?
Dr. Adams. Thank you for that, sir, and you are right. In
Montana, your overdose rates have gone up 26 percent in the
last year from all substances, and we know that, while we have
seen a 5-percent decrease in opioid overdose rates nationwide,
we have seen a 23-percent increase in overdose deaths due to
meth and stimulants. So you are exactly right.
And I would loop back to the HHS strategy points: number
one, better prevention, treatment, and recovery; and number
two, better research on pain and addiction.
I want you to know that about a third of my Commission
Corps officers--the Surgeon General heads the Public Health
Service Commission Corps--work at IHS facilities, Indian Health
Services facilities. We see this firsthand.
I have visited tribes and reservations all over the Nation.
And what I want you to know is, this opioid crisis is not a
problem so much as it is a symptom. It is a symptom of our
failure to recognize untreated behavioral health issues. It is
a symptom of our failure to build resilience into communities.
It is a failure of our recognition to see that there is massive
untreated and under-treated pain in our country, both
emotional, mental, and physical.
And so we really need to lean in to truly better
prevention, treatment, and recovery services that include all
those things. Otherwise, we are just going to keep playing
whack-a-mole over and over again. And we will put out the
opioid fire, but a meth fire will pop up again in our country.
And we are seeing it happen particularly, like you said, in
Montana and on the West Coast.
Senator Daines. And if we look at the meth crisis in
Montana, once upon a time the home-grown meth that used to be
the source of meth had purity levels of about 25 percent.
Today, the Mexican cartel meth has purity levels north of 95
percent. So it is much more potent. The prices have come down
because there is so much more being produced, and the
distribution has certainly become much more sophisticated,
where literally it takes a couple of days from the time it
crosses the southern border until it gets to a reservation in
Montana. I saw that firsthand.
Dr. Adams. I could not agree more, sir. We actually work
with ONDCP to bring together public safety and public health.
We need to work on the supply side. And you talked a lot about
the supply side, but I will tell you, if we do not deal with
demand, if we do not deal with people self-medicating away
their pain and their mental health issues, there is always
going to be a supply.
Senator Daines. Right.
Dr. Adams. Someone is going to find a way.
Senator Daines. I completely agree with you as well.
Lastly, I do believe we need this multi-faceted approach--
you alluded to that, Dr. Adams--to combat this epidemic. And
that is why I have been pressing the NIH to develop medication-
assisted treatment, or MAT, to treat meth addiction. While MAT
exists for opioids, alcohol, and other drugs, there is no MAT
for meth.
Dr. Adams, are you familiar with NIH's work to develop MAT
for meth?
Dr. Adams. I absolutely am. I had about a 10-minute
conversation with Dr. Nora Volkow yesterday specifically on
this topic. And I will tell you what she told me.
Unfortunately, the research out there right now is not
promising in terms of developing MAT for meth. They have spent
millions of dollars on it, and they will continue to spend more
money to try to develop it, but our best solution right now is
prevention.
It is trying to get upstream. It is trying to deal with
these problems before they turn into the next wave of a meth
epidemic. But we still will continue to devote research to
trying to find solutions for people who need to recover.
Senator Daines. Last statement. Would you commit to working
with me to advance these efforts to assist Montanans overcoming
the meth epidemic?
Dr. Adams. Absolutely, sir. Again, the parts of our country
where our Native American and tribal folks reside are very,
very personal to me. And it is where I have tried to make a
point of getting out and visiting, and I and HHS commit to you
that we will not forget about those individuals. They are
citizens of our country, and they should not be forgotten.
Senator Daines. Thank you, Dr. Adams.
Dr. Adams. Thank you.
Senator Daines. I ask unanimous consent to enter a letter
from the Federal Law Enforcement Officers Association and
others into the record. It helps us to see the devastating
effects of substance abuse on our local communities. Without
objection, so ordered.
[The letter appears in the appendix on p. 88.]
The Chairman. Senator Stabenow?
Senator Stabenow. Thank you, Mr. Chairman, for you and the
ranking member. Thank you so much for holding this hearing. And
to each of you on the panel, thank you very much. This is an
incredibly important topic that affects all of us in some way.
And, Mr. Mendell, I am so sorry to hear about your son
Brian. And I am sure that is part of the effort that you have
put in to moving us forward and making a meaningful difference
for so many other families.
I have heard, like everyone else, so many horrifying
stories of individuals and families struggling to get substance
abuse help, as well as mental health help. Those are very much
together. We know many times in mental illness that people are
self-medicating with alcohol and drugs, and underneath there is
a mental illness as well. So these are very much tied together.
And people are trying to do the right thing to get the best
possible treatment, families are, and ultimately, as you have
shown, people can be taken advantage of. And unfortunately, I
believe that this is happening in part because, structurally,
we treat behavioral health, addiction and mental health,
differently for reimbursement.
It is the quality standards. It is evidence-based care. But
also we predominantly do this in grants rather than
reimbursement, like we do for health care. So we have Federally
Qualified Health Centers, where we have set high standards,
that get full reimbursement if you are a physician, a nurse,
and so on. For health centers, we do not yet fully have that on
behavioral health, which is what we are working very hard on
right now.
So we know right now, based on the eight-State
demonstration project, there is a right way to do things, and
we can spend Federal dollars much more wisely with high
standards. In fact, a couple of years ago--and I am so grateful
for Senator Roy Blunt's leadership on this with me as well. But
around this table we have people--we have Oklahoma, Oregon,
Pennsylvania, Nevada, New Jersey, where we now have 2 years of
data of what happens when you have quality standards on
addiction treatment and mental health, and then see how it
plays out. Are people going to jail? Are more people getting
the treatment that they need?
And I want to thank the chairman and ranking member and so
many people here for giving us the opportunity now, through
additional legislation, to actually take the next step for more
services, more States to actually be able to put this in place.
So we have seen in just a short amount of time that this is
transformative. We are also grateful this was in the
President's budget, and SAMHSA has been a lead in making sure
that we are doing grants to begin to step up these structures.
So, General Adams, Dr. Adams, can you provide an update on
the administration's work related to implementation of what we
have called ``The Excellence in Mental Health and Addiction
Treatment Act,'' as well as the Certified Behavioral Health
Center grants that are beginning to move this structure
forward?
Dr. Adams. Thank you for that question. And again, this is
very personal to me. My brother, as I mentioned, sits in jail
right now due to crimes he committed to support his addiction.
And his pathway started with unrecognized, untreated anxiety
and depression.
We know that many of these substance use disorders are co-
occurrent with behavioral health issues, and it is a priority
for us to make sure that folks who are being treated for
substance use disorders are having their behavioral health
issues taken into account, but also that we are recognizing
them before they turn into substance misuse and self-
medication.
You asked for an update. I know you have spoken with
Secretary Azar, and he shares your excitement about what is
happening. I will tell you that at HRSA, we have Behavioral
Health Workforce Education and Training grants, $50 million in
2017. We had mental health and substance use disorder co-
occurring treatment expansion, over $550 million distributed to
1,200 health centers across our country, and then the pilot
grants that you mentioned.
So far the results look good. So I just want to say,
succinctly, that we share your concerns. I want to thank you
for your support for this in Michigan. You all have seen a 10-
percent decrease in your overdose rates there, and I think it
is because you have looked at this as both a mental and
behavioral health issue, and a substance use disorder issue,
and not separated out the two.
I want to say, quickly, I often tell folks that a long time
ago, unfortunately, we cut off the head from the rest of the
body. And what I mean by that is, we said, ``Anything that
happens from here up--oral health, vision health, and mental
health--here is a card. Go see somebody. Good luck. Anything
that happens from here down, we will take care of it at your
primary care visit.''
As Surgeon General, I am talking to providers and
professional organizations and encouraging them to integrate
behavioral health back into primary care and mental health.
Senator Stabenow. Well, thank you. We know that, with the
addiction and mental health, it is a brain disease, and so that
is a very important part of the body, and we should treat it as
we treat every other part of the body. And I know my time is
up, so I will just indicate that in the areas now where we have
certified community behavioral health centers, we actually have
medication-
assisted treatment. We have specialists, real trained people
with evidence-based treatment options, who are working with
people. And in each of these centers is also 24-hour, 7-day-a-
week access to services, crisis services.
So folks are not going to jail. They are not going to
emergency rooms. They are actually able to talk to someone who
is trained to help them.
The Chairman. Senator Cardin?
Senator Cardin. Thank you, Mr. Chairman. Again, I thank all
of our panelists.
I certainly agree with the points that have been made by
Senator Wyden and others that we need more information for
consumers, more transparency, in order to prevent fraud. And I
also agree that we have to get the metrics for that. And that
is not as easy. And we have to narrow it to where consumers can
use that information most effectively in making decisions. I do
think that Shatterproof does provide some ability to look into
these issues.
I want to go on to a point that Dr. Adams made when you
talked about the five key messages for addressing the opioid
crisis, specifically mentioning recovery support services. In
Maryland, we have found that peer support has worked well in
our community.
I included a provision in the SUPPORT Act that deals with
studying the Medicaid program peer support. In Arundel County,
in Garrett County, they are working to increase their capacity
for peer support in emergency rooms. In Baltimore County, they
are looking at nontraditional hours to make sure that we have
peer support programs. In Dorchester County, there are on-call
peer support programs that are available.
I would like to get your view as to how effective you think
peer-support programs have been, and what we can do to try to
encourage more opportunity for peer support, particularly in
nontraditional hours and in emergency rooms and things like
that.
Dr. Adams. So, quickly, I have been all over the country.
And the communities I have seen that have been able to turn
around their opioid overdose reversal rates have done four key
things.
Number one, they have saturated their communities with
naloxone, because you cannot get into treatment and recovery if
you are dead.
Number two, they have had a warm handoff, usually through
some sort of peer recovery type program.
Number three, they have provided medication-assisted
treatment, because that is the gold standard.
And number four, they have had strong public safety and
public health cooperation, so that again, we can shift from
criminalizing the problem to medicalizing the problem.
You asked what we can do. I will tell you that I am very
proud of the fact that, during this administration, we have
increased the number of Medicaid 1115 waivers substantially; 22
have been approved during this administration, and that has
given States the flexibility to pay for things that they feel
are appropriate to improve success rates in treatment and
recovery, including peer recovery, including housing, including
child care, including transportation. We need to provide those
wrap-around services, but you are right, Senator. Peer recovery
is one of the key tenets in making sure you can stop your
overdose reversal rates and get people on the pathway to
becoming productive citizens again.
Senator Cardin. Thank you.
Dr. Denigan-Macauley, some States have implemented peer
support under their Medicaid program. Do you have any
information as to the effectiveness of the peer support
programs under the Medicaid program?
Dr. Denigan-Macauley. So it is good that you mentioned the
SUPPORT Act, because GAO is getting ready to begin a review
that is going to look at Medicaid's use of the peer support in
States. So I do not have an answer for you now, but we do have
work that is beginning that will provide those answers.
Senator Cardin. Well, I am pleased to see that. If you
would keep us informed on that, I would very much appreciate
it.
Dr. Denigan-Macauley. Will do.
Senator Cardin. I would like to get to one other issue, if
I might. In Maryland we are looking at stabilization centers.
Two counties have started stabilization centers to get those
who are on OD out of the emergency room.
I certainly agree, Dr. Adams: you want them alive. So the
medication is important. The emergency services are important.
But emergency rooms are not good places for people needing
care.
So the current reimbursement structure sort of works
against the stabilization center. If you go to the emergency
room, the full cost is usually covered. What can we do to
encourage that type of care that a person who is stressed
needs, usually in nonconventional hours during the middle of
the night--and allow for the funding of programs such as
stabilization centers in communities?
Dr. Adams. Well again, I would highlight giving States the
flexibility to fund these types of programs, such as we have
done through the 1115 waivers. But this is a good one to kick
to Mr. Mendell because he can speak from personal experience
about the struggles of bringing his son in over and over and
not having a place for him to go that would help him.
Mr. Mendell. Absolutely. And I think it comes back to
quality measures, as far as measuring--defining--through
science, what are the most effective methods to treat people
and having a transparent set of quality measures where the
information is published on a regular basis. We have talked
about consumers seeing the information, where they can learn to
send their family members. But it is also for payers, for
payers to understand which providers are most appropriate in
their networks and which ones are not.
And it is also for State regulators. And it is also
information that providers can learn from each other. We have
talked a little bit here about the unscrupulous providers out
there, but there are a lot of good people in the provider
community who are not unscrupulous. But they do not have the
information about what programs are most effective, and which
tactics are most effective.
And if we have transparent, quality information without
even having to regulate, they will learn from each other and
have the information they need to improve. So it is not just
ratings; it is quality measurement. It is quality improvement
and providing the resources to do so.
The Chairman. You brought up, Dr. Adams, my wife, so here
is what I found out---- [Laughter.]
Your wife sat beside my wife at the International Club. We
had lunch at the Indian Museum, and she was a hostess at the
International Club meeting at the Children's Inn at NIH. Is
your wife really that active?
Dr. Adams. My wife is, and she shared her story. Many of
you know this. My wife actually just finished treatment for
metastatic melanoma at the National Institutes of Health, and
we are cancer-free based on the last PET scan, but she shared
her story. And your wife was so incredibly kind to my wife. She
was nervous telling her story. She is not a public speaker, and
you can tell I am pretty nervous talking in public too, but she
did a great job and appreciated the support from Barbara.
The Chairman. Well, my wife is a 33-year survivor of breast
cancer.
Dr. Adams. Exactly. She shared that. Thank you.
The Chairman. Senator Hassan?
Senator Hassan. Thank you, Chairman Grassley and Ranking
Member Wyden, for holding today's hearing. I want to thank all
of our distinguished witnesses for being here today.
But, Dr. Adams and Mr. Mendell, I particularly want to
thank you both for sharing your family stories. Because in
doing that, you really do help combat the stigma that is such a
part of this disease and undermines our capacity to treat it.
So thank you.
As many have mentioned today, a year ago today the SUPPORT
for Patients and Communities Act was signed into law. The
passage of this legislation was a critical step in addressing
the opioid crisis. But the crisis did not happen overnight, and
we know that it will take a continuous and sustained investment
at the Federal level to curb and ultimately reverse the tide of
what is truly a horrible epidemic. I look forward to continuing
to work on a bipartisan basis to adequately fund the SUPPORT
Act, build on the SUPPORT Act, and expand access to prevention,
treatment, and recovery services.
I wanted to start with a question to Dr. Adams and Dr.
Denigan-Macauley about services, and access for women in
particular. The HHS Office on Women's Health estimates that 70
percent of women entering substance use disorder treatment have
children. And many residential treatment programs do not allow
children to be present when their mother is receiving
treatment. This is obviously a real barrier.
We have some good examples of what works. Residential
recovery homes that offer services for pregnant and postpartum
moms like Hope on Haven Hill in Rochester, NH have proven to be
really effective. And data shows that when pregnant women and
new moms have access to long-term evidence-based treatment,
outcomes improve for the entire family.
Unfortunately, recovery homes like Hope on Haven Hill are
few and far between. It is one of only a handful available to
women in New Hampshire. Moreover, reporting from news outlets
throughout New England, as well as the GAO report we are
discussing today, have shown that some recovery homes are
scamming patients and they are not using the evidence-based
treatments we need them to use.
One of the best means to recovery for many women is
residency in an Oxford House, which is an evidence-based
recovery home model that addresses addiction. Yet according to
the GAO report, only 29 percent of Oxford Houses in the United
States provide recovery housing for women.
So, Dr. Adams, what is HHS doing to expand access to long-
term evidence-based treatment for moms that allows them to
remain with their children in a safe environment? And how can
Congress support those efforts? That is the question I want you
to answer.
And then to Dr. Denigan-Macauley, after Dr. Adams, how do
we ensure that we are providing access to the increasing number
of women in need of treatment and recovery services, especially
given the relatively limited number of high-quality recovery
homes for women?
Dr. Adams. Well, quickly, I have visited New Hampshire many
times. Few places have suffered as much from the opioid
epidemic, but also few places have had as much success in
overcoming the opioid epidemic. You have decreased your
overdose rates by 10 percent. And a lot of that has been due to
your focus on NAS. I have been to hospitals in New Hampshire
and learned about the work they are doing there.
What are we doing? Well, ACL has a Neonatal Abstinence
Syndrome national training initiative, listing best practices,
including keeping moms and babies together.
I have partnered with Dr. McCance-Katz, the head of SAMHSA,
to write an article calling on more OBGYN providers to become
trained at MAT so that we are not playing hot potato with a mom
who has substance use disorder, and that we can take care of
her.
And then two other models I mentioned, very quickly, the
Maternal Opioid Misuse Model will increase access to effective
substance use disorder treatment through a focus on improving
the quality of care for pregnant and postpartum patients.
And then the Integrated Care for Kids Model through CMS is
a child-centered service delivery program that again emphasizes
providing those supports. So I could not agree with you more,
and we are trying to do all we can to provide that flexibility.
New Hampshire also has an 1115 waiver which can provide
some flexibility.
Senator Hassan. Thank you. Dr. Denigan-Macauley?
Dr. Denigan-Macauley. Thank you. Yes, GAO is similarly
concerned, and we have looked at reports on Neonatal Abstinence
Syndrome. We also have ongoing work on maternal mortality,
which unfortunately does relate to the opioid crisis.
And we have a report that is coming out looking at Medicaid
and opioid abuse disorder services for pregnant and postpartum
women as a part of the SUPPORT Act. I think it is actually
being released today. So there will be some more information
there.
Senator Hassan. Thank you. I know I am running out of time.
I will follow up with you, Dr. Adams. Senator Murkowski and I
have a bill to remove the waiver necessary right now for
physicians to be able to do medication-assisted treatment. I am
concerned that people do not understand that it is the gold
standard and how important it is. I am concerned about the
stigma attached to MAT still. And so I will have a question for
the record for you to follow up on that, because we really need
to get the word out there how important it is.
Dr. Adams. Absolutely. Happy to follow up.
Senator Hassan. Thank you.
The Chairman. Senator Menendez, I apologize for passing
over you. I forgot.
Senator Menendez. Thank you, Mr. Chairman. Thank you for
calling together a very important hearing on a major health
crisis in our country.
Dr. Adams, I recently spoke with a constituent whose son is
grappling with a substance-based problem, and she mentioned
that there is a disconnect between what she has been told by
experts is the appropriate time for her son to be in a
treatment center, and what her insurance will cover. So now he
has cycled through treatment a couple of times--and this is not
the first time I have heard this, which drives me to the
question: do you think there is a disconnect between what we
know are evidence-based best practices for substance use
disorder treatment and the coverage of such programs?
Dr. Adams. Yes. I cannot say it any plainer than that. We
think that, if you put someone in a treatment program, in 4 to
6 weeks they are going to be magically cured. We know that
recovery is a lifetime, and it is one of the reasons that HHS
is focusing on trying to emphasize treatment and recovery, and
provide that flexibility for States to be able to provide those
wrap-around services, that transition for recovery moving
forward.
Senator Menendez. So what would you recommend to close the
gap between what is paid for and what is recommended?
Dr. Adams. Well, again I can only speak on best practices,
not on regulation or legislation, but I will say that it is
important that folks look at the fact that you are not going to
solve this problem with a short 4-week, 6-week treatment and
that we need to fund that spectrum.
And again, we are trying to use the flexibility we have
within CMS through 1115 waivers to give States the ability to
do that.
Senator Menendez. Well, it seems to me that this is more
consequential, the way it is operating now, more consequential
to the life of the individual, more consequential when we
rotate people in and out, and then they get paid for different
segments of services, instead of having an outcome.
Dr. Adams. Certainly not a good practice, Senator.
Senator Menendez. Would an outcome-based payment system for
rehab treatment ensure best practices are followed?
Dr. Adams. Outcome-based payment is something that we are
certainly pushing towards within HHS in a broad array of areas.
The whole fee-for-service world, I think, needs to be looked at
very closely. We need to make sure we are paying people to
actually create health and wellness and not paying people to do
procedures or to keep someone as an in-patient until their
funding runs out.
And again, HHS is committed to providing that flexibility,
but also to incentivizing new payment models. If you look at
what we are doing through CMMI, we are trying to help States
and local entities figure out what works best for them, but to
show proof of concept so that we can scale it up.
Senator Menendez. Mr. Mendell, first of all, you have my
deepest sympathy for the loss of your son, and none of this is
easy.
You previously stated you do not support heavy Federal
regulation but an approach akin to how highway funds are tied
to speed-limit changes, for example. What should the Federal
Government tie funds to in the addiction space? What laws
should all States have on the books? And what, if any, laws
should the Federal Government lead on to ensure national
uniformity and protection for individuals in recovery?
Mr. Mendell. Sure. Before I answer that, let me just add,
there is one Federal law that I think is very important, which
many members of Congress are working on right now, which is to
require, as part of their DEA license, all doctors in the
field, and psychiatrists, as part of their DEA license for
prescribing controlled substances, to tie it to education.
And if that is done, there will be a huge improvement in
the system. Because doctors right now can prescribe Oxycontin,
Vicodin, Percocet, all opioids, without having any training.
And to have as part of their license to be able to do so, to be
trained in basic prevention and treatment of addiction, would
be a huge lift to this country. So that is number one what the
Federal Government can do.
Then the answer to your question as far as what leverage
the government can do, for your example with the 55 mile per
hour speed limit, number one, conforming. State medical
societies conforming to the CDC prescribing guidelines would be
a huge lift. Requiring States to follow a quality measurement
system like ours--ours is the only one out there right now, but
there could be others, not specific to us.
Tying it to State funding that is coming from the
government only going to evidence-based treatment programs, or
following
evidence-based practices. Again, that relates to a quality
measurement system so you can determine which treatment
programs are following evidence-based practices.
Requiring medical schools in their States to have basic
training on prevention and treatment of addiction. I mean there
are three right there that would be significant improvements to
the system.
And if I could add one more, Federal legislation to
eliminate DATA 2000, which requires any doctor in this country
who wants to prescribe buprenorphine to go through a
significant process with the DEA: licensing, hours of training,
oversight by the DEA.
Doctors can prescribe Oxycontin without any additional
training. Why do they have to go through this whole process to
prescribe buprenorphine? The result of that is less than 5
percent of the doctors in this country can prescribe
buprenorphine. Less than 50 percent of the counties in the
United States have even one doctor who can prescribe
buprenorphine.
There is legislation in Congress right now to eliminate
DATA 2000. I would highly recommend that.
Senator Menendez. Thank you, very much.
The Chairman. Thank you, Senator Menendez.
Senator Young?
Senator Young. Dr. Adams and other witnesses, welcome.
Dr. Adams, we are really proud of you in the State of
Indiana, and we think you are doing the country proud in your
current capacity. I was really glad to see you highlight the
important work of Belden Industries in Richmond, IN in your
testimony. They are really making a difference as well.
Dr. Adams, Dr. Todd Graham, a South Bend physician with
over 3 decades of service, was senselessly killed on July 26,
2017, for refusing to prescribe an opioid to a patient. Tragic.
And in his memory, I worked with then-Senator Donnelly to pass
a provision in the SUPPORT Act that aims to reduce the over-
prescribing of opioids by examining ways to expand the use of
non-opioid alternatives within the Medicare program.
How is HHS working on increasing the utilization of these
non-opioid pain management approaches?
Dr. Adams. Well, I have to tell you, this is a major point
of emphasis for us. It is part of our five-point strategy of
better research on pain and addiction, and it cannot happen
fast enough.
What folks do not realize is back 20, 25 years ago, when I
was in medical school and they told me pain was a vital sign,
it came from a good place. We did and still do have an epidemic
of untreated and under-treated pain in this country, and we
threw opioids at the problem, foolishly. Now we are pulling
them back. We got a significant decrease in opioid prescribing.
But what I say to folks is that if we are not also measuring
what we are substituting in their place to treat pain, and then
folks are going to continue to self-medicate, they are going to
continue to be angry when they do not get their pain treated,
and we are going to continue to chase our tails and play whack-
a-mole.
So the NIH HEAL initiative awarded $945 million in the form
of grants, contracts, and collaborative agreements across 41
States to increase research and practices in terms of pain and
addiction.
We have also gone around the country and lifted up these
different payment mechanisms. CMS has done a lot to make sure
we are paying for the right things. And I have actually worked
with businesses, because we put a lot on CMS and we have to
remember that the other gorilla in the room is the employer-
based insurers. We need to make sure they are paying for
alternatives and not being the first drug dealer. Many of them
will pay for 60 Vicodin but will not pay for one of those
alternatives for their covered lives.
Senator Young. Well, thank you. I think that is really
important. And there is a lot of emphasis, appropriately so, on
increasing access to treatment.
We also need--and I know you agree with this--to make sure
that people are in treatment services that are actually
working. And this is something I placed great emphasis on
during the HELP Committee hearings pertaining to the opioid
crisis last Congress.
In your testimony, Dr. Adams, you say we have amassed a
mass of evidence on effective prevention, early intervention
treatment, and recovery strategies. Can you elaborate on the
evidence you are referring to, especially in terms of
treatment? Because, as I travel around the great State of
Indiana and talk to different service providers, doctors, and
others, I have to say there is heterogeneity. There are
oftentimes varying perspectives on what works and what does not
work.
Dr. Adams. You mentioned a couple of things there, and I
will work backwards. I highlighted Greyston Bakery and Belden
because we need to make sure that, when someone is done with
treatment, they can be reintegrated back into society. Stigma
is killing more people than overdoses, and it causes people to
relapse when they cannot find a job, when they cannot be
integrated into society.
So work is a very important part of this, both training and
then taking a look at the scarlet letter we attach to people
when they come out of a treatment center that prevents them
from getting a job.
As far as substance use disorder treatment centers, you are
right. There is way too much heterogeneity. And I would
actually turn it over to Mr. Mendell to highlight some of the
key aspects of what we should look for in a treatment center.
Mr. Mendell. Absolutely. In a treatment center, we have
identified seven principles that every treatment program should
have.
Number one, a full and complete assessment not just of
addiction issues, but also mental health issues and any
physical issues. It needs to be complete with all three, with
an evidence-based instrument that is proven to be reliable and
valid, delivered by someone who has the credentials to ask the
questions in the right way and understand it.
Number two, once you have that assessment, to be
continually reassessed and your care adjusted via checking pain
and going to the hospital. They will not tell me, based on the
first 15 minutes of questions, here is what your treatment is
going to look like for the next 28 days. They will tell me what
my treatment is going to look like for the next 2 days, or for
1 day, and then they will test me again and readjust it all
along the way. Many treatment programs do not do that. So
continual reassessment and care adjustment.
Number three, evidence-to-evidence-based medications, not
just for opioids but also for alcohol. There are evidence-based
medications.
Number four, access to behavioral therapies that are
evidence-based. There are only seven that were in the Surgeon
General's report, both originally in 2016 and highlighted in
the Spotlight, that have randomly controlled trials, are tested
and proven to work. They have to have those. I can go on and
on, but it is all on our website. But they exist, and they are
easily measured.
Senator Young. That is encouraging. And I would also note,
it takes 17 years on average for evidence to actually reach the
field. That is going to be unacceptable. So I would welcome
future dialogue about things we might be able to do at the
Federal level to compress that time frame, sir.
Dr. Adams. I highlight again, use your bully pulpit to
share the Surgeon General's ``Spotlight on Opioids,'' which
lists the steps, the criteria to look for in evaluating the
treatment center, that we worked with Shatterproof to help
develop, but we need you all to help share that.
The Chairman. Senator Cassidy will be the last one. And
will you close the meeting, Senator Cassidy, because I have to
go to a meeting in my office? And so I thank all the panel, as
chairman of this committee, for this very fruitful meeting.
Senator Cassidy?
Senator Cassidy. Thank you. And at the outset, the chair
will grant himself as much time as is needed. [Laughter.]
Thank you for being here.
First, let me highlight something, Dr. Adams, that HHS has
done. You all had a task force on pain management which was
really good, because your statement earlier said that there is
still untreated pain, and yet we have people who are dying from
addiction. That is the tension. And as you know, Dr. Vanila
Singh headed this up. But they differentiated between the
patient with chronic pain on stable dose for many years, never
escalating, working in society, versus a person who is breaking
into a car to steal a purse to buy drugs.
And so there is the distinction we have to make as a
physician. Let us not turn our backs, if you will, on the
person who has that stable dose who is contributing to society,
which includes people in this room, and differentiate that
person from those.
Secondly, to my two GAO folks in the middle, you all have
been kind of ignored, but I have been thinking about you. I
hear that private insurance companies are very capable of
looking at pain management, looking longitudinally at the
outcomes--okay, who is released and then immediately goes back
into a situation requiring more care for addiction versus those
who have a sustained response?
And yet, we continue to hear that Medicaid does a poor job
of that. Now, it seems like this would be something that could
be done with a supercomputer in terms of, if you look at
diagnostic codes, okay, if somebody has a billing for admission
to a pain management center, and then they had a readmission
for something which plausibly is related to drug overdose
within a period of time, you compare everybody against
everybody and you sort out who is doing a good job, who could
perhaps employ science-based methods and improve their work,
and who should just be kicked out.
Now what is the obstacle to doing so? Either of you.
Mr. Cantrell. I will start. From OIG's perspective, we do a
lot of analysis similar to what you just described in the
Medicare space. We have great access to Medicare claims data.
But on the Medicaid side, we do not have that same level
of----
Senator Cassidy. So let me ask. So we do have the Transform
Medicaid Statistical Information System, or TMSIS. Is TMSIS not
ready for prime time?
Mr. Cantrell. Not quite ready for prime time. Improving,
but not quite ready for prime time.
Senator Cassidy. But it is rapidly improving, which makes
me think that some States are ahead of the curve, and some
States are perhaps still coming on. I think I know that 48 are
currently participating, obviously two not. So can we take
those as proof of concept that are already submitting adequate
data and then create a system which scales as other States come
on board?
Mr. Cantrell. That is something we could explore.
Senator Cassidy. Well, why not something we do?
Mr. Cantrell. Well, sir, I work for the Investigations
Office, so I do not want to commit our auditors and evaluators
yet, but it is something we are very interested in. I will take
it back, and we can follow up with you.
Senator Cassidy. Okay. Ma'am?
Dr. Denigan-Macauley. So, similarly, the work that we have
done that I am familiar with would be related to Medicare,
because the data is there.
Senator Cassidy. By the way, can I insert one thing? I have
actually spoken to people who work for clearing houses. And so,
when somebody changes a Medicaid plan, they have to do data.
And these clearing houses are actually better than TMSIS
because they have it all. And it has to be with a unique
identifier because it is transmitting, you know, Bill Cassidy's
claims data from plan A to plan B.
And so these folks actually have it. I would just point
that out as a point of information.
Dr. Denigan-Macauley. So as GAO, we actually work for you,
and we would welcome a conversation to have a discussion about
what work we can do in this area.
Senator Cassidy. Let me ask it one more time, because GAO
always does a wonderful job. But roughly in the time it takes
you to complete a study, an elephant is born. So it takes a
little while.
We actually need something in real time.
So, Dr. Adams, is it possible for HHS to stand up something
in real time to do this analysis, maybe getting a system from
one of these two folks, but that which you can employ so that
we do not have to wait for a year and a half for an excellent
study when, by that time, the situation on the ground perhaps
has changed?
Dr. Adams. Well, that is definitely something I will take
back. And you know, sir, that I will follow up with you, and I
appreciate your leadership as one of the few physicians in
Congress, and I think you bring up a very important question
and issue.
Senator Cassidy. Let me ask you one more thing. I have done
a lot of work in jails. You mentioned your brother, and thank
you for your openness about that. And I think the statistic I
read is that 15 percent of males entering a jail have a mental
health issue, 30 percent of females. If you add addiction to
that, you are going to be even higher.
Current law is that if you are jailed, even before you were
adjudicated, you lose your VA and Medicaid benefits. Okay, so I
have been arrested but I am not--you know, sometimes you spend
6 months in jail before you go to court, and I am mentally ill,
but I have lost my benefits even though subsequently I am
declared to be not guilty, right?
This is a fairly common scenario. I am not making things
up. There is a score associated with this, but as a physician I
know that, if the formulary in the jail does not include the
psychotropics which have stabilized me on Medicaid out in the
free world, my care becomes disrupted and my condition may
decline.
So I am begging the question, but can you give your
thoughts? And maybe I can kick it over to you, sir, as to,
whatever the score, the wisdom of allowing Medicaid and VA
benefits to continue with someone who is incarcerated in a jail
at least prior to the point of being declared guilty or not
guilty?
Dr. Adams. So you bring up two important points.
Number one, jails and prisons have become our de facto
mental health and substance use disorder providers in this
country, and we need to flip that script if we are going to dig
our way out of this.
And number two, when I saw this first-hand in Scott County,
we actually had to work very closely with the jails to solve
our HIV outbreak that was related to prescription opioid
misuse--because we know that so many folks who would cycle on,
cycle off, cycle on, cycle off, is a significant problem.
Senator Cassidy. So what you are telling me is that they
would be admitted for HIV, and their regime would be disrupted
so they develop resistance because they are getting off the one
that controlled it and whatever strain was there, et cetera, et
cetera, right?
Dr. Adams. It is certainly not optimal care, sir. And we
need to look at how we can transition that system. But I will
also say very plainly and frankly to you, sir, that I learned
in Indiana that we did not have a lot of flexibility at the
State level. Some of that is because of the law as written
currently.
And so we need to take a look at that. We need to take care
of the person and the patient, because it has implications
beyond that individual and on society.
Senator Cassidy. Well, I am glad that Senator Brown is here
from Ohio, because I am going to need a bipartisan colleague. I
think the score is $10 billion over 10 years to allow those
Medicaid benefits to continue when someone is, as I have
described, put in jail but before they are adjudicated.
Sir?
Mr. Mendell. Thank you. I would like to add something.
Throughout the last hour we have talked about different
components of the opioid epidemic and solutions. And as we have
talked about each, we have talked about how to remedy each of
these individually. But I think it would be really helpful if
we could go back to--Surgeon General Adams has mentioned three
times in the last hour something else that I do not think has
gotten the air time here, which is ``stigma,'' which the
Surgeon General has called the biggest killer out there.
He has not talked about any of the specific issues being
the biggest killer; it is stigma. And why has he said that? He
said that because stigma reaches everything we have been
talking about for the last hour.
If there are policies in jail where people lose their
insurance, why is that? That is because most people in America
think that it is bad people doing bad things who cannot make
good decisions--when science shows that is not the case.
Why is our payment policy not equal to other physical
diseases? Because we have grown up in a health-care industry
that believes it is their fault, that we should not pay for
treatment.
Twenty percent of doctors in this country--excuse me, in
the State of Massachusetts in a recent study that we did, which
I suspect is relevant to the rest of the country--do not want
people who are addicted in their waiting rooms. It might affect
their practice.
Eighty percent of Americans in a recent poll--80 percent of
Americans in a recent poll--said, ``I am uncomfortable
associating with someone addicted to prescription opioids as my
friend, my co-worker, or my neighbor.''
So let us say that we get through all the hurdles we have
been talking about in the last hour, and someone gets to
treatment, even though 20 percent of Americans have reported
one of the key reasons they do not go to treatment is they do
not want anybody to know. But let us say they get past that
hurdle and their parents force them in. They get to treatment.
And then they find a provider, even though there are very
few providers that treat it today for the reasons we have been
talking about. And then they get to a provider who delivers
quality care, through all the hurdles we have heard about
today, and they are successfully treated.
But then they enter a society where 80 percent of Americans
do not want you working next to them. They do not want you
living in their neighborhood. They do not want you to be their
friend, do not want you marrying their daughter, or dating
their daughter.
I am sure my son did not see those statistics--this is not
just opioids--nor did the 20 million Americans who were
addicted to drugs or alcohol see that survey, but they feel it.
They feel it every day.
Senator Cassidy. So I thank you and Dr. Adams for being so
honest with your experience, because that helps fight that
stigma.
Senator Brown?
Senator Brown. Thank you, Senator Cassidy. Thank you all
for being here. And, Mr. Mendell, thank you for coming to my
office several months ago. I know there is a lot of pain on
this panel and among a lot of us who have had deaths in our
families that we think should not have happened, or
incarcerations, or just difficult times.
But thank you for making it a mission of your lives to step
up and help others so they do not have to experience the pain
that some of you, and many of us in this room, have had.
I want to start, Dr. Denigan-Macauley, with a couple of
questions for you first. In the course of GAO's work on this
report, how many instances--I will ask a couple of questions
together--how many instances of substance abuse disorder
treatment recovery-related Medicare/Medicaid fraud did you
investigate across these five States? And of that total, what
percent involved a case where a patient was the perpetrator of
that fraud?
Dr. Denigan-Macauley. Thank you for the question. So we are
a little different than the IG. We did not actually do the
investigation of any cases. That would be a better question,
perhaps, for Mr. Cantrell.
However, we did talk with a sample selection of five
States, and we found that all five States had received reports
of potential fraud. We spoke with various actors involved,
including the Medicaid Fraud Control Units. To our knowledge--
and again we did not investigate cases--for example, in
Florida, individuals were lured to recovery homes and then
brokered to substance use disorder treatment providers.
Senator Brown. Mr. Cantrell, I want to ask you--and you can
respond to that too--based on your work, is it your opinion
that individuals with a substance use disorder diagnosis
seeking treatment are generally the culprits in these cases of
fraud? Or are they more likely the victims?
Mr. Cantrell. In the cases we see, they are the victims.
They are not----
Senator Brown. Overwhelmingly?
Mr. Cantrell. Overwhelmingly. Certainly in our fraud
schemes, we have some participating patients who are often--you
know, maybe they are a patient but they are also a patient
broker, where they are trying to solicit other individuals to
come into a fraud scheme. But generally speaking, they are the
victims of these crimes.
Senator Brown. Do you both, the two of you, believe that
States are doing a good job of addressing fraud, when you say
they have in their hands the tools and authorities necessary to
police this kind of fraudulent behavior committed much less
often by the victim than the perpetrator?
Mr. Cantrell. Right. I think, you know, certainly on the
health-care fraud space where we have the Medicaid Fraud
Control Units, they are very active in this space. Our office
is very active.
But where I think there has been maybe a need for
additional oversight is not in the law enforcement space but in
the oversight of these treatment facilities and quality
standards, as we discussed here today, to ensure that there are
quality treatment centers that are receiving Federal funding
and are delivering the product and the treatment that we all
expect.
Senator Brown. Did you want to add, Dr. Denigan-Macauley?
Dr. Denigan-Macauley. And clearly we also found that, in
our States, that Florida, Massachusetts, and Utah had all
started certification or licensure programs. And Texas and
Ohio, while they did not have such programs, they were
providing training and other services to the operators of the
homes. They were concerned and wanted to take steps.
Senator Brown. Thank you. And this question--I will start
with Dr. Adams, but each of you answer, if you would. And I
preface it by I think every one of us on this committee in both
parties thinks we just simply are not doing enough with
prevention education, upscaling treatment, and all that. And I
applaud Dr. Cassidy for his interest--and I know Senator Markey
and others--on the pretrial incarcerated, to keep them on
Medicaid. It is just upside down thinking that you take away
their Medicaid when they need it most at that point.
We are clearly not doing enough to provide the kind of
treatment options to everyone who needs them. But as we all
know, the overall number of non-elderly adults with a substance
use disorder who receive treatment is low; we know that those
with Medicaid are significantly more likely to receive
treatment than those with private coverage.
For instance, thousands of Ohioans are receiving addiction
treatment right now because of Medicaid. I was at a substance
abuse clinic in Cincinnati, and a man put his hand on his adult
daughter's arm and sort of gently said, ``My daughter would not
be alive if it were not for Medicaid.''
We know those stories. So my question for each of you is--
and you can answer as close as you can to a ``yes'' or ``no''--
are we putting additional burdens on beneficiaries that make it
harder for them to access and maintain coverage that could
compromise efforts to address the addiction treatment and limit
access to substance use disorder? Are those additional burdens
helpful, or are they not?
Dr. Adams. Well, sir, are you talking about Medicaid?
Senator Brown. Yes.
Dr. Adams. Okay. Well, I would say that we want to make
Medicaid as effective and as easy to access as we possibly can,
and you frame it as a burden. I do not know which particular
provisions you are referring to, but I do believe that we
should make Medicaid more available. And we have tried to give
States the flexibility through a record number of 1115 waivers
to craft their Medicaid programs in a way that works for their
citizens and their constituents.
Senator Brown. Dr. Denigan-Macauley?
Dr. Denigan-Macauley. So we currently have work looking at
beneficiaries of Medicaid and their access to medication-
assisted treatment, for example.
Senator Brown. Mr. Cantrell?
Mr. Cantrell. We have looked into Medicaid eligibility, but
I do not have--I am not the expert in that, so we would have to
get back to you on what that work entailed.
Mr. Mendell. I would completely agree with the comments
earlier, of the Surgeon General specifically, that any barriers
for those who do not have insurance to get Medicaid,
absolutely, create a lot more loss of life and cost to our
system--so ER rooms and prisons, et cetera, et cetera. We need
to keep as few barriers as possible so more people can be on
Medicaid who need it, who are qualified for Medicaid, without
the barriers. Absolutely, 100 percent.
Senator Brown. Thank you. I appreciate the responses of all
four of you. I would just close, Senator Cassidy, with this:
that the imposition of work requirements in State Medicaid
programs will have a chilling effect on access to treatment.
This hearing underscores the absolute ludicrousness, if that is
a word, and the hard-heartedness of far too many people in this
body and the Trump administration who are trying to repeal the
Affordable Care Act. They could not do it here. They tried very
hard. They could not do it here.
They want to do it through the courts. And it is hard-
hearted, it is stupid, and it will mean a lot more people die
with this assault on the Affordable Care Act. In my State,
900,000 people have insurance who did not have it before the
Affordable Care Act. We know what it means to young people on
their parents' plan. We know what it means for the expansion.
We had a Republican Governor in Ohio who showed more
courage than most of his party members around the country and
expanded Medicaid and saved thousands of lives. And it is just
an absolutely cruel and stupid policy to think repealing the
Affordable Care Act can possibly be good for our country.
So, thank you.
Dr. Adams. Senator Cassidy, can I make one quick comment? I
would just very quickly say that I ran the State Department of
Health in Indiana when we expanded coverage to several hundred
thousand citizens.
As Surgeon General, I want everyone to hear me say that
access to quality, affordable health care is critically
important. This administration believes that we should give
States the flexibility and the opportunity to do it the way
that works best for them, as has occurred in Indiana.
Again, the record number of 1115 waivers shows a commitment
to that flexibility, in giving States that flexibility. And in
my opening statement, I talked about both Belden Industries and
about Greyston Bakery in Indiana and in New York. And I think
it is important that when we talk about work, we understand
that one of the biggest predictors of whether someone is going
to be successful in long-term recovery is whether or not they
can get back to work. And so I will be the first to admit that
the idea of work requirements is a hot-button political topic,
but I do not want us to lose the strong data that says that we
need to think about ways that we can help people reintegrate
back into society and get a job.
And what I am focused on as Surgeon General is how can we
lower the barriers to people getting back to work and help to
bring people together so that folks can truly recover?
And thank you so much for the opportunity to testify today.
This is a critically important period. And I also want to give
you a shout-out, Senator Brown, for the work you all are doing
in Ohio. I know you know Sam Quinones. You all have been able
to drive down your overdose rates there in that State by over
10 percent. And it is because of the partnerships you brought--
--
Senator Brown. Dr. Adams, it is in large part because we
expanded Medicaid, and the President of the United States wants
to take it away. So I appreciate who appointed you. I
appreciate--I do not know your political philosophy, it does
not matter--I appreciate your comments on work requirements.
But the fact is, the President of the United States wants to
wipe off the books the Affordable Care Act with no replacement
on Medicaid. And the fact that we have driven down, not very
far yet, but driven down the death rate in Ohio and the
addiction rate in Ohio is because we have that very, very, very
important public health tool.
Senator Cassidy. Well, with that, that will be the final
rule. The chair will thank you all for your testimony. We leave
the record open for 2 weeks for submissions of questions for
the record. The hearing is now adjourned.
[Whereupon, at 10:45 a.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Hon. Jerome M. Adams, M.D., MPH, Surgeon General,
Office of the Secretary, Department of Health and Human Services
introduction
Thank you, Chairman Grassley, Ranking Member Wyden, and
distinguished members of the committee. As the U.S. Surgeon General, it
is an honor and privilege to be before you today and have the
opportunity to discuss the opioid crisis, the Department of Health and
Human Services' (HHS or Department) five-point strategy \1\ to address
this crisis, and my office's contributions to combating the epidemic.
From the start of his administration, President Trump has made
addressing the opioid crisis a top priority. The Department and the
Office of the Surgeon General share the President's commitment.
---------------------------------------------------------------------------
\1\ Substance Abuse and Mental Health Services Administration.
(2019). Key substance use and mental health indicators in the United
States: Results from the 2018 National Survey on Drug Use and Health
(HHS Publication No. PEP19-5068, NSDUH Series H 54). Rockville, MD:
Center for Behavioral Health Statistics and Quality, Substance Abuse
and Mental Health Services Administration. Retrieved from https://
www.samhsa.gov/data/.
On October 26, 2017, at the request of President Trump and
consistent with the requirements of the Public Health Service Act, the
Acting Secretary of HHS declared a nationwide public health emergency
regarding the opioid crisis, and on March 19, 2018 in New Hampshire,
the President announced his ``Initiative to Stop Opioid Abuse and
Reduce Drug Supply and Demand.'' The Department has made addressing the
crisis a top clinical priority and is committed to using our full
expertise and resources to combat the epidemic. The SUPPORT Act, Pub.
L. 115-271 (October 24, 2018) and the Fiscal Year 2019 Consolidated
Appropriation Act, which provide HHS new funding to address the opioid
epidemic, will allow HHS agencies to continue to invest resources in
expanding opportunities for evidence-based prevention, treatment and
recovery support services, surveillance and data collection, and
research on pain, new non-addictive pain medications, and to enhance
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our understanding of addiction and overdose.
Over the past 15 years, communities across our Nation have been
devastated by increasing prescription and illicit opioid misuse,
addiction, and overdose. According to the Substance Abuse and Mental
Health Services Administration's (SAMHSA) National Survey on Drug Use
and Health, in 2018, approximately 10.3 million Americans misused
opioids; of that population, 9.9 million people misused prescription
pain relievers, 808,000 people used heroin, and 2 million people had an
opioid use disorder (OUD).\1\ While the number of individuals who
misused opioids is down 3.7 percent from 2015, almost 400,000 Americans
died of an opioid overdose over the past 20 years.\2\ Most alarming is
the rapid increase in overdose deaths involving illicitly made fentanyl
and other highly potent synthetic opioids. According to provisional
drug overdose death counts from the Centers for Disease Control and
Prevention (CDC), predicted overdose deaths due to synthetic opioids
rose approximately 10.4 percent between March 2018 and March 2019.\3\
OUD and opioid-related overdose and death remain major issues that
require a broader understanding of intersecting medical and public
health factors.
---------------------------------------------------------------------------
\2\ Centers for Disease Control and Prevention, National Center for
Health Statistics. Multiple Cause of Death 1999-2017 on CDC WONDER
Online Database, released December, 2018. Data are from the Multiple
Cause of Death Files, 1999-2017, as compiled from data provided by the
57 vital statistics jurisdictions through the Vital Statistics
Cooperative Program.
\3\ Ahmad FB, Escobedo LA, Rossen LM, Spencer MR, Warner M, Sutton
P. Provisional drug overdose death counts. National Center for Health
Statistics. 2019. Designed by LM Rossen, A Lipphardt, FB Ahmad, JM
Keralis, and Y Chong: National Center for Health Statistics. https://
www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
Between 1999 and 2017, more than 399,000 people have died of
overdose involving any opioid, including prescription and illicit
opioids, such as heroin and illegally trafficked fentanyl. Overdoses
involving opioids killed more than 47,000 people in 2017.\4\
---------------------------------------------------------------------------
\4\ Centers for Disease Control and Prevention, National Center for
Health Statistics. Multiple Cause of Death 1999-2017 on CDC WONDER
Online Database, released December, 2018. Data are from the Multiple
Cause of Death Files, 1999-2017, as compiled from data provided by the
57 vital statistics jurisdictions through the Vital Statistics
Cooperative Program.
Overall, opioid overdoses appear to plateau when comparing 2017 and
2018 data, which is notable given how aggressively the increases in all
prior years over the past decade had been and suggests some success in
reducing deaths from synthetic opioids and methadone; the preceding
paragraph appropriately calls out illicit fentanyl, given deaths
continue to accelerate for this category.
hhs's five-point strategy to combat the opioid crisis
In April 2017, HHS outlined its five-point Opioid Strategy, which
provides the overarching framework to leverage the expertise and
resources of HHS agencies in a strategic and coordinated manner. The
comprehensive, evidence-based Opioid Strategy aims to:
Improve access to prevention, treatment, and recovery
support services to prevent the health, social, and economic
consequences associated with opioid addiction and to help
individuals to achieve long-term recovery;
Target the availability and distribution of overdose-
reversing medications to ensure the broad provision of these
drugs to people likely to experience or respond to an overdose,
with a particular focus on targeting high-risk populations;
Strengthen public health data collection and reporting to
improve the timeliness and specificity of data and to inform a
real-time public health response as the epidemic evolves;
Support cutting-edge research that advances our
understanding of pain and addiction, leads to the development
of new treatments, and identifies effective public health
interventions to reduce opioid-related health harms; and
Advance the practice of pain management to enable access to
high-quality, evidence-based pain care that reduces the burden
of pain for individuals, families, and society while also
reducing the inappropriate use of opioids and opioid-related
harms.
To date, the Department has taken significant steps to advance the
goals of our Opioid Strategy. This statement addresses my personal
commitment to address the opioid epidemic, and the unique role that the
Office of the Surgeon General serves in combating this crisis. In order
to provide a more comprehensive overview of the Department's
coordinated strategy, it also highlights efforts within the Centers for
Medicare and Medicaid Services (CMS) and across HHS.
my work is personal
In the case of substance use disorders (SUDs) and OUD, my office's
work is quite personal as my family and I are among the millions of
Americans affected by it. My younger brother, Philip, has struggled
with this disease, which started with untreated depression and led to
opioid misuse. Like many with co-occurring mental health and SUDs, my
brother has cycled in and out of incarceration. Philip is currently
serving a 10-year prison sentence for crimes committed to support his
addiction. I share his story to illustrate that addiction can happen to
anyone--even the brother of the U.S. Surgeon General.
Just as the opioid crisis has touched my life, it has also touched
the lives of most Americans. This epidemic is blind to color,
geography, or class and has affected every corner of our country. Quite
simply, this crisis affects all of us.
tackling opioid use disorder and other substance use disorders
While the opioid epidemic continues to be our most pressing public
health crisis, there is evidence that the administration's commitment
to the epidemic and HHS's five-point response strategy have had a
substantial effect.
1. First, we have experienced a nationwide decrease in opioid
prescribing and use. From January 2017 to June 2019, we've seen
a 31-percent reduction in the total morphine milligram
equivalents dispensed monthly by retail and mail order
pharmacies.\5\ We've seen a 52.4-percent decrease in the number
of first-time heroin users from 2016 to 2017.\6\ And, between
2017 and 2018, approximately 1 million fewer Americans reported
misusing opioids in the preceding year.\7\
---------------------------------------------------------------------------
\5\ IQVIA National Prescription Audit. Retrieved October 2018 and
August 2019. Note: These data are for the retail and mail service
channels only and do not include the long-term care channel.
\6\ Substance Abuse and Mental Health Services Administration.
(2018). Key substance use and mental health indicators in the United
States: Results from the 2017 National Survey on Drug Use and Health
(HHS Publication No. SMA 18-5068, NSDUH Series H-53). Rockville, MD:
Center for Behavioral Health Statistics and Quality, Substance Abuse
and Mental Health Services Administration. Retrieved from https://
www.samhsa.gov/data/.
\7\ Substance Abuse and Mental Health Services Administration.
(2019). Key substance use and mental health indicators in the United
States: Results from the 2018 National Survey on Drug Use and Health
(HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD:
Center for Behavioral Health Statistics and Quality, Substance Abuse
and Mental Health Services Administration. Retrieved from https://
www.samhsa.gov/data/.
2. There is also evidence of fewer drug overdose deaths. As of
March 2019, the 12-month rolling count of predicted overdose
deaths remained below 70,000 for fourth month in a row. This
represents a decrease of approximately 2 percent from the
corresponding 12-month period. During that period, 28 States
reported a reduction in drug overdose deaths and many
experienced substantially larger decreases than the national
average. For example, between February 2018 and February 2019,
there was a 14.7-
percent reduction in Iowa, a 12.4-percent reduction in Ohio, an
11.5-percent reduction in Pennsylvania, an 8.2-percent
reduction in Kentucky, and a 9.7-percent reduction in New
Hampshire.\8\
---------------------------------------------------------------------------
\8\ Ahmad FB, Escobedo LA, Rossen LM, Spencer MR, Warner M, Sutton
P. Provisional drug overdose death counts. National Center for Health
Statistics. 2019.
Designed by LM Rossen, A Lipphardt, FB Ahmad, JM Keralis, and Y
Chong: National Center for Health Statistics. https://www.cdc.gov/nchs/
nvss/vsrr/drug-overdose-data.htm.
3. Furthermore, we have seen progress in making both
medication-assisted treatment (MAT) and overdose-reversing
medications more available. From January 2017 to June 2019, the
number of patients receiving buprenorphine and naltrexone
monthly increased by 28 percent and 55 percent,
respectively.\9\ Availability of naloxone, an opioid antagonist
that is used to temporarily reverse the effects of an opioid
overdose, has increased dramatically, as evidenced by a 378
percent increase in the number of prescriptions dispensed
monthly by retail and mail order pharmacies since 2017.
---------------------------------------------------------------------------
\9\ IQVIA National Prescription Audit. Retrieved October 2018 and
August 2019. Note: These data are for the retail and mail service
channels only and do not include the long-term care channel.
4. Consensus has now been achieved reached on how to best
address pain. In May 2019, the Pain Management Best Practices
Inter-Agency Task Force released its final report, which
provides a best practices roadmap for managing acute and
---------------------------------------------------------------------------
chronic pain.
Of course, these indicators are only a fraction of the available
statistics that illustrate our progress.
office of the surgeon general's response to the crisis
The Office of the Surgeon General has been fully engaged in the
Department's response and has made important contributions to the
achievements I have described. In 2018 alone, the office released the
``Spotlight on Opioids,''\2\ a digital postcard \3\ showing the five
actions everyone can take to prevent opioid misuse, and a Surgeon
General's Advisory on Naloxone and Opioid Overdose.\4\ These
publications convey effective strategies to prevent and treat OUD and
support the successful recovery of those affected. I want to leave you
with five key messages based on this scientific information:
1. First, prevention, screening, and early intervention are
critical.
Evidence-based prevention, screening, and intervention programs
are effective and need to be initiated early in life. Traumatic
experiences in childhood, sometimes referred to as adverse
childhood experiences (ACEs), have been repeatedly linked to
increased risk of substance misuse and SUD. So interventions
must begin during childhood and continue throughout the
lifespan to prevent or delay the initiation of substance use
and stop the progression to SUD. To support these early
interventions, the Administration for Children and Families
(ACF) is working on implementation of the Family First
Prevention Services Act, which provides Federal funding for
services to help families remain safely together, preventing
the need for foster care. As Surgeon General, I am committed to
preventing opioid addiction before it starts by promoting: (1)
safe prescribing practices according to the CDC Guideline for
Prescribing Opioids for Chronic Pain, (2) the benefits of
opioid alternatives, and (3) safe storage and disposal.
2. Second, treatment is effective but must be integrated into
mainstream health care. Addiction is a chronic disease of the
brain, which must be treated with skill, compassion, and
urgency. And as with other chronic diseases, we have evidence-
based treatment that works, and we know that recovery is
possible. Medications can successfully treat the chronic
disease of addiction. MAT, the combination of FDA-approved
medications for the treatment of OUD with psychosocial
therapies and community-based recovery supports, is the gold
standard for treating opioid addiction; yet, in the course of a
year, only one in four people with OUD receives any treatment
at all. For this reason, care models that integrate SUD
services using medications and MAT into primary care hold
tremendous promise and have the potential to greatly expand
access to effective, evidence based OUD care.
3. Third, knowing how to use naloxone and keeping it within
reach can save a life and serve as a bridge to treatment and
recovery. As described in my advisory, increasing the
awareness, availability, and targeted distribution of naloxone
is a critical component of our efforts to reduce opioid-related
overdose deaths. Since the advisory was published, more than
2.7 million 2-unit doses of naloxone have been distributed to
States and local communities.\10\ As the Surgeon General, I am
focused on putting naloxone in the hands of first responders
and community members.
---------------------------------------------------------------------------
\10\ Data provided by Emergent BioSolutions.
4. Fourth, there are many pathways to recovery--a term that is
expansive and goes beyond the remission of symptoms to include
a positive change in the whole person. Recovery support
services include mutual aid groups, housing, childcare,
recovery coaches, and community services that provide
---------------------------------------------------------------------------
continuing emotional and practical support.
I saw the benefits of these services, first-hand, when I
visited Belden Industries in Richmond, IN. Belden has developed
a unique pilot project--called Pathways to Employment--in
response to community needs and the labor market. Specifically,
in collaboration with its local health department and community
colleges, the technology company offers potential employees who
fail drug tests opportunities to participate in drug
counseling. Participants who stay in the recovery program are
assured jobs. Belden is connecting those suffering from drug
addiction to care with the goal of helping them become
employment-ready.
Recovery support services are also vital to Greyston
Bakery's workforce development strategy. The bakery, which is
located in Yonkers, NY, began its Open Hiring model in 1982.
Under this model, Greyston provides employment opportunities
without judging applicants or asking questions--no resume, work
history, or background check are required--while providing a
range of social support services including case management,
life-skill building, and workforce training. This approach
creates jobs for people who have traditionally been
marginalized and considered ``unemployable''-- people with past
felony convictions, persons who are homeless or have
disabilities, and people with addiction. The bakery's motto is,
``We don't hire people to bake brownies; we bake brownies to
hire people.'' At present, more than 60 percent of Greyston's
bakers were formerly incarcerated.
I applaud these companies and others that are investing in
their communities to improve health and create economic
opportunities. While people will choose their own recovery
pathway based on their cultural values, psychological and
behavioral needs, and life circumstances, community-based
recovery support services like those embraced by these
innovative companies are instrumental in helping individuals
resist relapse and rebuild their lives.
5. Fifth, when it comes to addiction, society is moving from a
primarily criminal justice-based model to a more balanced
approach that better accounts for public health. I believe that
this shift cannot happen quickly enough. I'll return to my own
family. Had my brother's addiction been treated like a disease
rather than a moral failing, he might be significantly closer
to recovery than he is today. The stigma associated with SUDs
keeps many sufferers from speaking about their troubles and
seeking help. Nowhere is stigma more prevalent than in the
communities of color. The way we as a society view and address
OUD and other SUDs must change; individual lives and the health
of our Nation depend on it.
cms role in addressing the opioid crisis
As a payer, CMS plays an important part in HHS efforts by working
to make sure clinicians are providing the right services to the right
people at the right time. Medicare, Medicaid, and CHIP beneficiaries
are CMS's top priority across all of its programs, and CMS works hard
to protect their safety and put them in the driver's seat of their
care. CMS is keenly focused on three areas--preventing and reducing OUD
by supporting access to pain management using a safe and effective
range of treatment options that rely less on prescription opioids,
including non-pharmacological approaches; increasing access to
evidence-based treatment for OUD; and leveraging data to target
prevention and treatment efforts and to support fraud, waste, and abuse
detection.
Preventing Overprescribing and Misuse of Opioids
CMS is taking a number of steps to identify and stop inappropriate
prescribing to help prevent the development of new cases of OUD that
originate from opioid prescriptions while balancing the need for
continued access to prescription opioids to support appropriate,
individualized pain management. To ensure that balance is maintained,
CMS will provide quality improvement technical assistance to those
communities hit hardest by the opioid epidemic, particularly small,
rural communities' physician practices and hospitals.
Improved Opioid Safety Reviews in Medicare Part D. Due to
the structure of the Medicare Part D program, Medicare
Advantage Organizations (MAOs) and Medicare Part D sponsors
have a primary role in detecting and preventing potential
misuse of opioids. CMS's job is to oversee Medicare Part D
plans to ensure that they are in compliance with requirements
that protect beneficiaries, ensure access to opioids when
needed, and can help prevent and address opioid
overutilization. Medicare Part D plans are expected to use
multiple tools, including better formulary management, case
management with beneficiaries' clinicians and pharmacists for
coordinated care, and safety edits at the point of dispensing.
Medicare Part D sponsors are required to have concurrent drug
utilization review (DUR) systems in place to ensure that a review of
the prescribed drug therapy is performed before each prescription is
dispensed to an enrollee in a sponsor's Part D plan, typically at the
point of sale (POS). Since 2013, CMS has incrementally adopted
successful opioid policies in the Part D program to appropriately
address opioid overutilization, while preventing interruption of
medically necessary drug therapy. These policies incorporate prescriber
involvement through pharmacist and payer efforts to give providers
additional clinical information to better coordinate care.\11\
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\11\ CY 2020 Final Call Letter, p. 225.
CMS recently finalized a series of additional changes in 2019
to further the goal of preventing OUD. Part D sponsors are now expected
to implement improved opioid safety edits at the POS that alert a
pharmacist of possible overutilization.\12\ In real time, the alerts
can flag for a pharmacist that they should conduct additional review
and/or consultation with the plan sponsor or prescriber to ensure that
a prescription is appropriate.
---------------------------------------------------------------------------
\12\ CMS, Announcement of Calendar Year (CY) 2019 Medicare
Advantage Capitation Rates and Medicare Advantage and Part D Payment
Policies and Final Call Letter (April 2, 2018), available at https://
www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads
/Announcement2019.pdf.
Second, to reduce the potential for chronic opioid use or
misuse, beginning in 2019, CMS expects all Part D sponsors to limit
initial opioid prescription fills for the treatment of acute pain to no
more than a seven days' supply.\13\ This policy change is consistent
with the CDC Guideline for Prescribing Opioids for Chronic Pain that
States that opioids prescribed for acute pain in primary care settings
and outside post-surgical pain should be limited to the minimal dose
and amount necessary and, as a rule, three days or fewer unless
otherwise clinically indicated.
---------------------------------------------------------------------------
\13\ Id. at p. 237.
Beginning in 2019, CMS also expects all sponsors to implement
an opioid care coordination safety edit.\14\ This new edit alerts
pharmacists when a beneficiary's average daily opioid dose reaches high
levels. When this occurs, plan sponsors are expected to direct
pharmacists to consult with the prescriber to confirm their intent. If
the pharmacy cannot fill the prescription as written, the pharmacist
will give the beneficiary a notice explaining how the beneficiary or
their prescriber can call or write to the Medicare drug plan to ask for
a coverage decision, including an exception, about a drug they think
should be covered. If their health condition requires, beneficiaries
have the right to ask their plan for a fast decision or a decision even
before they get the prescription filled at the pharmacy. The prescriber
only needs to attest to the Medicare drug plan that the cumulative
level or days' supply is the intended and medically necessary amount
for their patient.
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\14\ Id. at p. 235-236.
Non-Opioid Pain Relief Options in Medicaid. Pursuant to
section 1010 of the SUPPORT Act, CMS issued an Informational
Bulletin in February of 2019 about Medicaid Strategies for Non-
Opioid Pharmacologic and Non-Pharmacologic Chronic Pain
Management. The Bulletin expands on earlier guidance issued by
CMS by providing information to States seeking to promote non-
opioid options for chronic pain management. In addition to
meeting the requirements of the SUPPORT Act, this Bulletin
supports the goal of reducing the use of opioids in pain
management included in the President's Initiative to Stop
Opioid Abuse and Reduce Drug Supply and Demand and is
consistent with the HHS Five-Point Strategy to Combat the
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Opioid Crisis.
Additional State Reporting. Additionally, pursuant to
section 1004 of the SUPPORT Act, CMS issued an Informational
Bulletin in August 2019 that States will be required to report
on their policies related to reducing opioid-related misuse and
abuse in Medicaid. Implementation of these provisions includes
requirements regarding opioid prescription claim reviews at the
POS and retrospective reviews; the monitoring and management of
antipsychotic medication in children; identification of
processes to detect fraud and abuse; and mandatory DUR report
updates; as well as requirements for Medicaid MCOs. In order to
comply with these new requirements, States must submit a State
Plan Amendment by December 31, 2019.
Drug Management Programs for Medicare and Medicaid. For
years, States have been establishing and augmenting effective
``lock-in'' programs that require Medicaid enrollees who are
``at-risk'' for opioid misuse or addiction to use only one
pharmacy and/or get prescriptions from only one medical office.
The Comprehensive Addiction and Recovery Act of 2016 (CARA),
Pub. L. 114-198, provided CMS with the authority to allow
Medicare Part D plans to implement similar programs. For both
Medicaid programs and Medicare Part D plans, these programs
provide additional tools to promote better coordination between
providers and for beneficiaries who meet the guidelines for
lock-in.
Under current law, States are able to implement lock-in
requirements for enrollees who have utilized Medicaid services at a
frequency or amount that is not medically necessary, according to
guidelines established by the State. These limitations may be imposed
for ``a reasonable period of time.'' Almost all Medicaid agencies have
a Lock-In or Patient Review and Restriction Program in which the State
identifies potential fraud or misuse of controlled drugs by a
beneficiary.
In April 2018, as required by CARA, CMS finalized the
framework under which Part D plan sponsors may adopt drug management
programs (DMPs) beginning with plan year 2019.\15\ DMPs allow Part D
sponsors to limit certain beneficiaries to a specific opioid prescriber
and/or dispensing pharmacy within their prescription drug benefit plan.
The final rule incorporated input gathered from various stakeholders,
including beneficiary advocates, clinicians, pharmacists, pharmacy
benefit managers, and plan sponsors.\16\ The rule also incorporated and
codified many aspects of the prior retrospective DUR Policy and the
Overutilization Monitoring System (OMS), which identifies and reports
beneficiaries who are potentially at risk of misusing or abusing
opioids to Part D plan sponsors. These beneficiaries meet OMS criteria
established under the final rule, which take into account the
beneficiary's use of multiple opioid prescribers and dispensing
pharmacies and their level of opioid use. Part D sponsors also have
some leeway to identify additional potential at-risk beneficiaries in
their plans.
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\15\ CMS, Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, the Medicare Prescription Drug Benefit Programs, and the
PACE Program, 83 Fed. Reg. 16440, 16440 (April 16, 2018).
\16\ Id.
Under DMPs, after case management with the beneficiary's
prescribers and written notice to the beneficiary, Part D plan sponsors
may determine that a beneficiary is an at-risk beneficiary and limit
the beneficiary's access to coverage of opioids and/or benzodiazepines.
To ensure care coordination, and depending on the specific coverage
limitation the sponsor puts in place, at-risk beneficiaries receive
their opioid medications from a specific prescriber and/or pharmacy
that the beneficiaries may generally select. At-risk beneficiaries may
also be subject to individualized POS claim edits that limit their
coverage of opioids. Sponsors report to CMS the outcome of their case
management review for each case, including whether the sponsor
implemented a coverage limitation or not. It is important to note that
most OMS cases are managed without a sponsor implementing a coverage
limitation, which CMS views as the more desirable result for providers,
their patients and Part D plans. Also important is that beneficiaries,
and their prescribers on their behalf, also have the right to appeal
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these decisions.
Furthermore, provisions in the SUPPORT Act of 2018 provided
CMS with the authority to implement additional policies in Medicare
Part D to address the opioid epidemic. Section 2004 of the SUPPORT Act
requires all Part D sponsors to have a drug management program for plan
years beginning on or after January 1, 2022, although CMS notes that
the majority of sponsors have already adopted DMPs in 2019. In
addition, section 2006 requires that Part D enrollees with a history of
opioid-related overdose, as defined by the Secretary, be included as
potential at-risk beneficiaries under Part D drug management programs
beginning on or after January 1, 2021.
The Medicare Part D opioid policies have been designed to
promote improved communication between the pharmacy, doctor, and
Medicare drug plan, and give providers additional tools to safely
manage their patients' opioid use. The Medicare Part D opioid safety
edits and DMPs generally do not apply to patients with cancer, patients
receiving hospice, palliative, or end-of-life care, or patients who
live in a long-term care facility. They also should not impact patient
access to medication-assisted treatment (MAT) for OUD, such as
buprenorphine.
Tools for State Medicaid Agencies. While the Federal
Government establishes general guidelines for Medicaid, States
design, implement and administer their own programs. CMS takes
this partnership seriously and, because Medicaid is the single
largest payer for behavioral health services, has been working
under the current statutory framework to ensure that States
have the tools they need and to share best practices to improve
care for individuals with mental illnesses or SUD.
To reduce opioid misuse while ensuring access to treatment for
acute and chronic pain, Medicaid programs can utilize medical
management techniques such as step therapy, quantity limits, and
morphine milligram equivalent (MME) limitations. Additionally, to
increase oversight of certain prescription opioids, States have the
option of amending their Preferred Drug Lists and Non-Preferred Drug
Lists to require prior authorization for certain opioids.
States have long been required to develop a DUR program aimed,
in part, at reducing inappropriate prescribing of outpatient
prescription drugs covered under the State's Medicaid Program. Medicaid
DUR is a structured, ongoing program that interprets patterns of drug
use in Medicaid programs and includes prospective drug review,
retrospective drug use review, data assessment of drug use against
predetermined standards, and ongoing educational outreach activities
conducted by Medicaid State agencies, managed health care systems,
pharmacy benefit managers (PBMs), academic institutions and/or other
applicable stakeholders. The Medicaid DUR Program promotes patient
safety through State-administered utilization management tools and
systems that interface with the claims processing systems.
Additionally, CMS requires any MCO that includes covered outpatient
drugs to operate a DUR program that is as comprehensive as the States
fee-for-service (FFS) program.
Ensuring Access to Evidence-Based Treatment
A critical part of tackling this epidemic is making sure that
beneficiaries with OUD have access to effective treatment options.
Through its networks of health quality experts and clinicians, CMS
advocates sharing best practices for pain management and substance use
disorders, including OUD.
Medicare Parts A and B cover substance use disorder services in
multiple ways. Inpatient treatment in a hospital is covered if
reasonable and necessary; treatment in a partial hospitalization
program, such as an intensive outpatient psychiatric day treatment
program, may also be covered when the services are furnished through
hospital outpatient departments and Medicare-certified community mental
health centers. Medicare currently pays for substance use disorder
treatment services provided by physicians and other practitioners on a
service-by-service basis under the Medicare Physician Fee Schedule
(PFS), such as counseling services provided by a psychiatrist or other
Medicare practitioners and an annual depression screening. Medicare
Part B pays for medications used in physician offices or other
outpatient settings that require a physician/practitioner to
administer, including injections like extended-release formulations of
naltrexone or buprenorphine or implants of drugs like buprenorphine
used in medication-assisted treatment. CMS recently made changes to the
Medicare PFS that help support the fight against the opioid epidemic,
such as establishing separate coding and payment for the insertion and
removal of buprenorphine implants, a key drug used in treatment for
OUD, and improving payment for office-based behavioral health services.
For 2020, CMS also proposed to create new coding and payment under the
PFS for a bundled episode of care for management and counseling for
OUD. The new proposed codes describe a monthly bundle of services for
the treatment of OUD that includes overall management, care
coordination, individual and group psychotherapy, and substance use
counseling.
Medication-Assisted Treatment (MAT). MAT is the use of FDA-
approved medications, in combination with counseling and
behavioral therapies, to treat SUDs, including OUD. MAT is a
valuable intervention that has been proven to be the most
effective treatment for OUD, particularly because it helps
sustain long-term recovery and has been shown to reduce
morbidity and mortality.\17\
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\17\ Sordo, L, Barrio, G, Bravo, MJ, Indave, BI, Degenhardt, L,
Wiessing, L, . . . Pastor-Barriuso, R. (2017). Mortality risk during
and after opioid substitution treatment: Systematic review and meta-
analysis of cohort studies. BMJ, 357. https://doi.org/10.1136/
bmj.j1550.
To increase access to MAT, CMS requires that Medicare Part D
formularies include covered Medicare Part D drugs used for MAT. In
addition, CMS issued guidance on best practices in Medicaid for
covering MAT in a joint informational bulletin with SAMHSA, the CDC,
and the National Institute on Drug Abuse. CMS also released an
informational bulletin with SAMHSA on coverage of treatment services
for youth with SUD and guidance on the co-prescribing of opioids and
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benzodiazepines.
While Medicaid programs vary greatly by State, all 50 States
currently offer some form of MAT. Section 1006(b) of the SUPPORT Act
requires State Medicaid programs to provide coverage for MAT for OUD
beginning October 1, 2020, and ending September 30, 2025. In addition,
section 5022 of the SUPPORT Act makes behavioral health coverage a
mandatory benefit for children and pregnant women covered under the
Children's Health Insurance Program (CHIP) and requires that child
health and pregnancy related assistance ``include coverage of mental
health services (including behavioral health) necessary to prevent,
diagnose, and treat a broad range of mental health symptoms and
disorders, including substance use disorders.''
Additionally, section 2005 of the SUPPORT Act established a
new Medicare Part B benefit for OUD treatment services, including MAT
utilizing methadone, which can only be furnished by opioid treatment
programs. CMS proposed to implement this new benefit for 2020 with
flexibility to deliver the counseling and therapy services furnished as
part of OUD treatment services via two-way interactive audio-video
communication technology as clinically appropriate and zero beneficiary
copayment for a time limited duration.
Increasing the Use of Naloxone to Reverse Opioid Overdose.
CMS is promoting improved access to the opioid overdose
reversal drug naloxone by requiring that it appear on all
Medicare Part D formularies. CMS is also encouraging sponsors
to include at least one naloxone product on a generic or Select
Care tier beginning in 2020.\18\ The percentage of Part D plans
that included at least one naloxone product on a non-branded
tier for each of the past three plan years are: 42.4 percent
for Calendar Years (CYs) 2018 and 2019 and 99.4 percent for CY
2020. Of all naloxone products on formulary, the percentage of
products included on non-branded tiers are: 27.5 percent for CY
2018; 28.4 percent for CY 2019 and 63.3 percent for CY 2020.
CMS recognizes that it is very important for Medicare
beneficiaries and those who care for them to understand that
these options are available to them under Medicare, so CMS is
also working to educate clinicians, health plans, pharmacy
benefit managers, and other providers and suppliers on services
covered by Medicare to treat beneficiaries with OUD. In a
number of cases, this includes education on naloxone products.
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\18\ CMS, Announcement of Calendar Year (CY) 2020 Medicare
Advantage Capitation Rates and Medicare Advantage and Part D Payment
Policies and Final Call Letter (April 1, 2019), available at https://
www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads
/Announcement2020.pdf.
In addition, all Medicaid programs include forms of naloxone
on their Medicaid Preferred Drug Lists. Many State Medicaid programs
also have pharmacist protocols for dispensing naloxone through
collaborative practice agreements, standing orders, or other
predetermined guidelines. CMS has also issued guidance to States on
improving access to naloxone.\19\ States can offer training in overdose
prevention and response for providers and members of the community,
including family members and friends of opioid users.
---------------------------------------------------------------------------
\19\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib011717.pdf and https://www.medicaid.gov/federal-policy-guidance/
downloads/CIB-02-02-16.pdf.
SUD Treatment and Demonstrations in Medicaid. Under section
1115 of the Social Security Act, the Secretary of HHS may
approve experimental, pilot, or demonstration projects that, in
the judgment of the Secretary, are likely to assist in
promoting the objectives of certain programs under the Act,
including Medicaid. In November 2017, CMS announced that it was
using this authority to provide a streamlined process for
States interested in increased access to treatment for
individuals who are primarily receiving treatment or withdrawal
management services for SUD. This opportunity allows coverage
services to beneficiaries who are short-term residents in that
meet the definition of an institution for mental diseases
(IMD), provided that coverage is part of a State's
comprehensive OUD/SUD strategy as long as the State is working
to improve access to OUD and other SUD treatment in outpatient
settings as well. In addition, States are expected to take
certain steps to improve the quality of care for individuals
with SUD, including OUD, particularly in residential treatment
settings, including by requiring these settings to offer MAT as
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a treatment choice onsite or facilitating access offsite.
This initiative offers a more flexible, streamlined approach
to accelerate States' ability to respond to the national opioid crisis
while enhancing States' monitoring and reporting of the impact of any
changes implemented through these demonstrations. In addition to being
budget neutral, demonstrations must include a rigorous evaluation based
on goals and milestones established by CMS. Information on the progress
and outcomes of these demonstrations and evaluations will be made
public in a timely and readily accessible manner on Medicaid.gov so
that other States can learn from these programs; this cycle of
evaluation and reporting will be critical to informing our evolving
response to the national opioid crisis. To date, CMS has approved these
section 1115 demonstrations in more than in 25 States.
The Medicaid Innovation Accelerator Program (IAP), a project
of the Center for Medicare and Medicaid Innovation, provides technical
assistance to Medicaid agencies across a variety of topics, including
SUD, aimed at moving forward Medicaid delivery and payment reforms. IAP
works with States on designing, planning, and implementing strategies
that improve their SUD delivery systems through technical assistance in
areas such as: creating data dashboards; identifying individuals with
an SUD; understanding which options are available to expand coverage
for effective SUD treatment; and designing payment mechanisms for SUD
services that incentivize better outcomes.
Another tool States have to improve access to treatment
through their Medicaid programs is the implementation of a health home
benefit focused on improving treatment for beneficiaries with opioid
use disorder. Health homes are an optional Medicaid benefit through
which States can improve care coordination and care management for
individuals with chronic conditions, including substance use disorders.
States can receive 90-percent Federal matching funds for their
expenditures on Medicaid health home services for the first 8 fiscal
year quarters that the health home State plan amendment is in effect.
Under the SUPPORT Act, States with a SUD-focused health home State plan
amendment approved on or after October 1, 2018, may request that the
Secretary extend the enhanced Federal match period beyond the first 8
fiscal year quarters, for the subsequent two fiscal year quarters, for
a total of 10 fiscal year quarters from the effective date of the State
plan amendment.
Improving Access to Coordinated Care for Vulnerable
Populations. CMS announced a funding opportunity for a 5-year
model that is designed to address fragmentation in the care of
pregnant and postpartum Medicaid beneficiaries with opioid use
disorder. The primary goals of the Maternal Opioid Misuse (MOM)
Model are to improve quality of care and reduce costs for
pregnant and postpartum women with OUD and their infants;
expand access, service-delivery capacity, and infrastructure;
and create sustainable coverage and payment strategies that
support ongoing coordination and integration of care. Up to
$64.5 million will be provided to up to 12 State Medicaid
agencies who will collaborate with local care-delivery
partners, which could include health systems, hospital systems,
or payers, such as a Medicaid managed care plans, to transform
the care-delivery system for affected mothers and their
infants. The MOM model will require awardees and their care-
delivery partners to provide integrated physical and behavioral
healthcare services, such as MAT, maternity care, relevant
primary care services, and mental health services, as well as
wraparound services like coordination, engagement and referrals
to community and social supports. Primary care centers can be
integrated into this care model in a number of ways including
as an MAT prescribing site. States and care-delivery partners
will have the flexibility to develop the care delivery
structure that best fits their local context.
Leveraging Data to Enhance Prevention and Treatment Efforts
Data are a powerful tool and CMS is utilizing the vast amounts of
data at our disposal to better understand and address the opioid
crisis. CMS is working with its partners to ensure that they have the
data and information they need to make changes and improvements to help
address the crisis.
Utilizing Medicare Data to Address Overutilization. Through
the OMS referred to above, CMS identifies and reports potential
at-risk beneficiaries to Part D sponsors that have DMPs, and
sponsors report to CMS the outcome of their case management
review for each case. Starting this year, beneficiaries are
identified as potentially at-risk and reported to plans if, in
the most recent 6 months, their daily dose of opioids exceeds
90 MME; and if they have received opioids from three or more
opioid prescribers and three or more opioid dispensing
pharmacies, or from five or more than five prescribers,
regardless of the number of opioid dispensing pharmacies.
These criteria are called the minimum OMS criteria. Part D
sponsors also have the flexibility to apply supplemental OMS criteria
to identify potential at-risk beneficiaries with any level of opioids
and received opioids from seven or more opioid prescribers and/or
opioid dispensing pharmacies.
In the 2019 Final Call Letter, CMS finalized additional
enhancements to the OMS including revised metrics to track high opioid
overuse and to provide additional information to sponsors about
beneficiaries who take opioids and ``potentiator'' drugs, such as
benzodiazepines, (which when taken with an opioid increase the risk of
an adverse health event).\20\ To help identify and prevent opioid users
from taking duplicate or key ``potentiator'' drugs, in 2019 CMS also
expects sponsors to implement additional safety edits to alert the
pharmacist about duplicative opioid therapy and concurrent use of
opioids and benzodiazepines.
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\20\ CMS, Announcement of Calendar Year (CY) 2019 Medicare
Advantage Capitation Rates and Medicare Advantage and Part D Payment
Policies and Final Call Letter, at p. 235 (April 2, 2018).
CMS utilizes the National Benefit Integrity Medicare Drug
Integrity Contractor (NBI MEDIC) to conduct data analysis that is
shared with plan sponsors to help them identify outlier prescribers or
pharmacies. For example, plans receive Quarterly Outlier Prescriber
Schedule II Controlled Substances Reports, which provide a peer
comparison of prescribers of Schedule II controlled substances. This
report now provides a separate analysis of just Schedule II opioids.
Plans also receive quarterly pharmacy risk assessment reports, which
contain a list of pharmacies identified by CMS as high risk; plan
sponsors can use this information to initiate new investigations,
conduct audits, and potentially terminate pharmacies from their
network, if appropriate. CMS has also sent letters to prescribers that
include educational information and comparative prescribing data to,
and held a webinar, for prescribers whose opioid prescribing patterns
were different as compared with their peers on both a specialty and/or
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national level.
In May, CMS sent letters to providers of opioid-naive
beneficiaries that received one or more selected procedures. Providers
received the letters if 10 or more of their patients' average daily MME
were in the 90th percentile or higher when compared to their peers, for
a given procedure. CMS will monitor the prescribing patterns of those
surgeons/prescribers who are in the subsequent 10 percentiles of
prescribers as a comparison group. In addition, CMS intends to evaluate
the prescribing of the two groups approximately 12 months after the
issuance of the letters.
The SUPPORT Act includes further measures designed to address
overprescribing and misuse of opioids. Section 6065 of the Act requires
annual notification of outlier prescribers of opioids. Currently, CMS
is deciding on the method for selecting outliers. CMS expects to mail
the first set of letters in January 2020. Section 6063 of the Act
requires the Secretary to establish a secure Internet website portal to
enable the sharing of data and referrals of ``substantiated or
suspicious activities'' related to fraud, waste, and abuse between plan
sponsors, CMS and CMS's program integrity contractors. It also requires
plan sponsors to submit information on the corrective actions taken
against those identified as over-prescribers. This would include
information on investigations and any credible evidence of suspicious
activities in plan sponsors' possession as well as information on other
actions taken by plan sponsors related to inappropriate prescribing of
opioids.
To assist clinicians in assessing their own opioid-prescribing
practices while continuing to ensure patients have access to effective
acute and chronic pain treatment, CMS released two interactive online
mapping tools that display the Medicare Part D opioid prescribing rate
and the Medicaid opioid prescribing rate for 2017. The Medicare Part D
Opioid Prescription Mapping Tool \21\ allows users to quickly compare
Part D opioid prescribing rates in urban and rural areas at the State,
county and ZIP code levels. The Medicaid Mapping Tool \22\ allows users
to review Medicaid opioid prescribing rates at the State level and
compare prescribing rates in fee-for-service and managed care. The
mapping tools also offer spatial analyses to identify ``hot spots'' or
clusters in order to better understand how this critical issue impacts
communities nationwide.
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\21\ https://www.cms.gov/Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/
OpioidMap_Medicare_PartD.html.
\22\ https://www.cms.gov/Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/
OpioidMap_Medicaid_State.html.
CMS is working with the National Quality Forum, the HHS
Secretary's
consensus-based entity, to review quality measures and measure concepts
related to opioids and opioid use disorders. NQF's technical expert
panel will review quality measures in this area, summarize and
prioritize gaps in measurement, provide for revision of existing
measures, address the need for development of new measures, and make
recommendations for measure inclusion in certain health-care quality-
based programs. Measures of opioid use and disorder from State and
Federal surveys vary considerably and are often drawn from questions
asked in clinical or diagnostic settings, raising concerns regarding
the accuracy and comparability of the information and resulting
estimates. As part of an ongoing effort to develop a standardized
battery of opioid questions, NCHS has conducted cognitive testing and
evaluation of opioid measures for use on national population health
surveys and surveillance systems to inform measurement strategies for
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use in different settings and populations.
In response to recommendations from the President's Commission
on Combating Drug Addiction and the Opioid Crisis, and in compliance
with the SUPPORT Act and to avoid any potential unintended
consequences, CMS has updated the Hospital Consumer Assessment of
Healthcare Providers and Systems patient experience of care survey by
removing three pain communication questions, removing the quality
measure based on these questions, and no longer publicly reporting on
this measure on the Hospital Compare Internet website.
Modernizing Medicaid Data Collection. CMS has been working
with States to implement changes to the way in which
administrative data are collected by moving from the Medicaid
Statistical Information System (MSIS) to the Transformed-MSIS
(T-MSIS). More robust, timely, and accurate data via
T-MSIS will strengthen program monitoring, policy
implementation, and oversight of Medicaid and CHIP programs.
CMS had transitioned all States to T-MSIS as of 2018. Together
with our partners in all 50 States, the District of Columbia,
Puerto Rico, and the U.S. Virgin Islands, CMS has made
tremendous progress in preparing T-MSIS data for program
oversight, evaluation, research, and program integrity. CMS
continues to work with States to improve the quality of their
data and to stay current with T-MSIS data submissions.
CMS is now using T-MSIS data for program integrity and other
purposes and used T-MSIS data to prepare a Substance Use Disorder data
book, as required by the SUPPORT Act. The data book will be published
this fall and will present nationwide T-MSIS data for the first time.
CMS has begun to develop tools for T-MSIS users, as well as work with
States to improve the quality of data submitted. For example, CMS is
developing data quality information, which aggregates data quality
findings in topical areas as well as by State. This information will
help users of the T-MSIS data, which CMS plans to use for program
oversight efforts. T-MSIS includes data on prescription opioids, and
CMS looks forward to working with States to fully utilize this data in
innovative ways that will augment efforts to combat opioid misuse.
the role of acf, samhsa, cdc, nih, fda, and
hrsa in addressing the opioid crisis
ACF
The Regional Partnership Grant Program:
Since 2007, the Regional Partnership Grant (RPG) Program has been a
cornerstone to the ACF Children's Bureau's efforts to improve outcomes
for children and families affected by parental substance use. The
intent of the RPG program, authorized under sections 436 and 437 of the
Social Security Act as part of the Promoting Safe and Stable Families
program, is to increase the well-being, improve permanency outcomes,
and enhance the safety of children and families in the child welfare
system who are affected by parental substance use. The grants are
funded to build system-level capacity to support families through
collaborative partnerships among child welfare, substance use disorder
treatment, court systems, and other family support systems and
organizations to implement evidence-based, evidence-informed and
promising programs and strategies with children and families. To date,
there have been five rounds of RPG projects, consisting of 101 grants,
in 36 States. The RPG Program was reauthorized in February 2018. Under
this reauthorization, ACF anticipates awarding RPG Round 6, consisting
of eight grants in eight States, awarded in September 2019.
Regional Partnership Grants Round 2 (2012-2017) Interim Findings
The RPG national cross-site evaluation has resulted in several
significant, interim findings from RPG Round 2 that will be formally
shared in a forthcoming Report to Congress. These interim findings
represent the work of RPG Round 2 projects that operated from September
2012 to September 2017. Findings from RPG Round 3 projects, will be
identified and disseminated following the conclusion of their grants
this September, and the completion of data analysis by the national
cross-site evaluator. In June 2019, the national cross-site evaluation
for RPG projects in Round 4 and 5 was officially launched and findings
from this evaluation will be shared at appropriate intervals in the
future.
From October 2012 to April 2017, the 17 RPG Round 2 grantees
enrolled 11,416 adults and children--55 percent of whom were children,
the majority under 5 years old. The strategies and services provided by
the RPGs included: expanded and timely access to comprehensive family-
centered treatment; creation or expansion of family treatment drug
courts; in-home services; case management and case conferencing; and
use of evidence-based and evidence-informed practice approaches, such
as recovery coaches, mental health, and trauma-informed services;
parent-child interventions; and strengthening of cross-system
collaboration. Most RPG Round 2 families received at least one
evidence-based program.
Interim findings demonstrate many adult and child outcomes improved
significantly following entry into RPG. These findings include a
significant decrease in adult drug and alcohol use between program
entry and exit, and adult mental health and parenting attitudes
improved significantly with fewer attitudes about parenting that placed
their children at risk of maltreatment. Additionally, there was a
significant reduction in rates of substantiated maltreatment. Thirty-
six percent of children in RPG had an instance of substantiated
maltreatment in the year before RPG, and this decreased to just seven
percent of children in the year after RPG enrollment. Removals of
children from the home were also less common: 29 percent of children
experienced a removal in the year before RPG enrollment, and only 6
percent of children were removed from the home after entering RPG.
Reunifications with the family of origin or other permanent placements
were also more common in the year after RPG entry than in the year
before. The cross-site evaluation also completed analysis of the adults
in RPG Round 2 that indicated at program entry they were opioid users.
As a result of participation in RPG program, opioid use in particular
appears to be an area of significant improvement. Approximately 16
percent of adults were recent prescription opioid users at program
entry, and only four percent of adults indicated at program exit that
they were recent prescription opiate users.
National Center on Substance Abuse and Child Welfare's (NCSACW) Work to
Address the Impact on the Opioid Crisis on the Child Welfare
System
The National Center on Substance Abuse and Child Welfare (NCSACW)
is a HHS initiative jointly funded by SAMHSA's Center for Substance
Abuse Treatment and the Administration for Children and Families'
Children's Bureau and administered by SAMHSA. The mission of the NCSACW
is to improve family recovery, safety, and stability by advancing
practices and collaboration among agencies, organizations and courts
working with families affected by substance use and co-occurring mental
health disorders and child abuse or neglect. The NCSACW provides
training and technical assistance (TA) to families affected by
substance use disorders, including opioid use disorders, and involved
with the child welfare system. The NCSACW saw a dramatic and sizable
increase in TA responses related to opioids from 2009 to 2018. Since
that time, the most common technical assistance topics continue to be
related to the opioid epidemic, and more specifically have been on the
Child Abuse Prevention and Treatment Act (CAPTA) Plans of Safe Care,
working with pregnant and parenting women, and infants with prenatal
substance exposure. TA responses included sharing of information on
related topics such as best practices in the treatment of opioid use
disorders during pregnancy and collaboration to support infants with
prenatal substance exposure and their families. The NCSACW also creates
written materials that support communities in addressing the opioid
epidemic. In 2016, the NCSACW released A Collaborative Approach to the
Treatment of Pregnant Women with Opioid Use Disorders. This publication
continues to be one of the most-downloaded resource from the NCSACW
website. Web-based tutorials are also provided to train substance use
disorder treatment, child welfare, and court professionals. The content
of these tutorials includes information on opioid use disorders, CAPTA,
and Plans of Safe Care. The website receives approximately 60,000
visitors per year. Additionally, in September 2019, the NCSACW released
their updated Child Welfare Training Toolkit, which includes specific
training modules on considerations for families in the child welfare
system affected by opioids, methamphetamines, and understanding
prenatal substance exposure and child welfare implications.
NCSACW also provides a limited amount of in-depth TA to State,
tribal, and local agencies to assist in developing cross-system
partnerships and the implementation of best practices to address the
needs of this population. The NCSCAW's Infants with Prenatal Substance-
Exposure In-Depth Technical Assistance (IPSE-IDTA) program continues
working to advance the capacity of agencies to improve the safety,
health, permanency, and well-being of infants with prenatal substance
exposure and the recovery of pregnant and parenting women and their
families.
SAMHSA
As HHS's lead agency for behavioral health, SAMHSA's core mission
is to reduce the impact of substance abuse and mental illness on
America's communities. SAMHSA supports a portfolio of activities that
address all five prongs of HHS's Opioid Strategy.
SAMHSA administers the State Opioid Response (SOR) grants to
provide flexible funding to State governments to increase access to
medication-assisted treatment using medications approved by the Food
and Drug Administration (FDA), reduce unmet treatment needs, and reduce
opioid overdose related deaths through the provision of prevention,
treatment and recovery activities for Opioid Use Disorder in the ways
that meet the needs of their State.
In FY 2018, a total of $930,000,000 (including a 15 percent set-
aside for the 10 States with the highest mortality rate related to drug
overdose deaths) was awarded among all 50 States and seven territories.
In FY 2019 SAMHSA awarded an additional total of $1.4 billion in
supplemental and continuation funds. Other funding, including $50
million for tribal communities under the Tribal Opioid Response (TOR)
grant program, has been awarded separately.
Previously, SAMHSA awarded $485 million to States and U.S.
territories in FY 2017 and an additional $485 million in FY 2018
through the Opioid State Targeted Response (STR) grants, a 2-year
program authorized by the 21st Century Cures Act (Pub. L. 114-255).
This program allows States to focus on areas of greatest need,
including increasing access to treatment, reducing unmet treatment
need, and reducing opioid overdose related deaths through the provision
of the full range of prevention, treatment and recovery services for
opioid use disorder. SAMHSA also has several initiatives aimed
specifically at advancing the utilization of medication-assisted
treatment (MAT) for opioid use disorder, which is proven effective but
is highly underutilized. SAMHSA's Medication Assisted Treatment for
Prescription Drug and Opioid Addiction (MAT-PDOA) program expands MAT
access by providing grants to States with the highest rates of
treatment admissions for opioid addiction. Twenty-two States are
currently funded by MAT-PDOA, and in September 2017, SAMHSA awarded $35
million dollars over 3 years in additional MAT-PDOA grants to six
States.
SAMHSA is also implementing section 3201 of the SUPPORT Act, which
broadened the eligibility requirements needed to prescribe
buprenorphine, and thus should result in greater access to treatment
for individuals with opioid use disorder.
CDC
As the Nation's public health and prevention agency, CDC is
applying scientific expertise to understand the epidemic, conduct
surveillance, and use data to inform evidence-based interventions to
prevent further harms, including the spread of infectious disease,
neonatal abstinence syndrome, and overdose death. CDC continues to be
committed to the comprehensive priorities outlined in the HHS strategy
and to saving the lives of those touched by this epidemic. CDC's work
falls into five key strategies to address opioid overdose and other
opioid-related harms: (1) conducting surveillance and research; (2)
building State, local, and tribal capacity; (3) supporting providers,
health systems, and payers; (4) partnering with public safety; and (5)
empowering consumers to make safe choices.
CDC tracks and analyzes data to improve our understanding of this
epidemic. According to the most recent provisional data, there were
69,096 drug overdose deaths predicted in the 12-month period ending
March 2019. This is a slight decrease from 70,924 drug overdose deaths
when compared to the 12-month period ending in March 2018.\23\ CDC's
data indicate that the epidemic continues to be driven by synthetic
opioids, including illicitly manufactured fentanyl. Additionally, in
March 2019, there were approximately 145,000 predicted drug overdose
deaths involving cocaine, representing an increase from March 2018, and
nearly 14,000 drug overdose deaths involving psychostimulants, a 24-
percent increase from March 2018.\24\ Given the evolving nature of this
epidemic, it is essential that we continue to track and analyze data to
target prevention efforts.
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\23\ https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
\24\ https://www.cdc.gov/mmwr/volumes/68/wr/mm6817a3.htm?s--
cid=mm6817a3_e.
Data are crucial in driving public health action. Timely, high-
quality data can help public health, public safety, and mental health
experts better understand the problem, focus resources where they are
needed most, and evaluate the success of prevention and response
efforts. With the passage of the SUPPORT Act and continued support from
the Administration and Congress, CDC is investing in strengthening the
capacity of States to monitor the opioid overdose epidemic and target
their prevention activities. CDC's Overdose Data to Action (OD2A) is a
3-year cooperative agreement that began in September 2019 and focuses
on the complex and changing nature of the drug overdose epidemic and
highlights the need for an interdisciplinary, comprehensive, and
cohesive public health approach. CDC has awarded $301 million in new
funding for the first year of a 3-year cooperative agreement to
Washington, DC, 16 localities, and two territories to advance the
understanding of the opioid overdose epidemic and to scale-up
prevention and response activities. These funds will support State,
territorial, county, and city health departments in obtaining high
quality, more comprehensive, and timelier data on overdose morbidity
and mortality and using those data to inform prevention and response
efforts. This cooperative agreement builds upon CDC's OPIS Initiative
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and the OPIS Surge Support emergency funding.
Over 3 years, recipients will gather and rapidly report data that
includes the substances, circumstances, and locations leading to
overdoses and deaths. In addition, recipients will work to strengthen
prescription drug monitoring programs, improve State-local integration,
establish links to care, and improve provider and health system
support.
CDC is also collaborating with SAMSHA on an evaluation of MAT to
improve the evidence base, with the intent of scaling up MAT to achieve
population-level impact. The purpose of this effort is to assess the
type of MAT and the contextual, provider, and individual factors that
influence implementation and improved patient well-being. CDC will be
following 3,500 patients over the next 2 years. This evaluation will
address the gaps that currently exist about MAT treatment, including:
What are the features of programs that make MAT work?
Who does it work for and which MAT works best for whom?
What are the long-term risks and benefits associated with
the different types of MAT medications?
Finally, CDC developed the CDC Training Series Applying CDC's
Guideline for Prescribing Opioids, a web-based training to help
providers gain a deeper understanding of the CDC Guideline for
Prescribing Opioids for Chronic Pain and implement it into primary care
practice. One of the trainings, ``Assessing and Addressing Opioid Use
Disorder'' provides education to providers on methods for assessing and
addressing an opioid use disorder when it is suspected.
Following the Centers for Disease Control and Prevention (CDC)
Guideline for Prescribing Opioids for Chronic Pain in 2016, the medical
and health policy communities have largely embraced its
recommendations.\25\
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\25\ https://www.nejm.org/doi/full/10.1056/NEJMp1904190. Tamara M.
Haegerich, Christopher M. Jones, Pierre-Olivier Cote, Amber Robinson,
Lindsey Ross. (2019) Evidence for State, community and systems-level
prevention strategies to address the opioid crisis. Drug and Alcohol
Dependence 204, 107563.
CDC is also taking the lead in preventing opioid-related harms such
as the spread of infectious disease and the impact of opioids on
mothers and babies. The number of new hepatitis C infections has more
than tripled since 2010, with an estimated 44,000 people newly infected
and 17,253 associated deaths in 2017. One of the greatest successes in
HIV prevention has been among people who injection drugs, with an 80-
percent decrease in injection drug use associated infections over time.
Since 2011, our progress preventing new infections has stalled, and we
are at risk of reversing our success, as seen by multiple outbreaks of
injection drug use associated with HIV throughout the country just in
the last year. In 2015, the rate of hepatitis C among U.S. women giving
birth was more than five times higher than it was 15 years prior (in
2000).\26\ Further, both new infections and deaths associated with
hepatitis C and hepatitis B are largely underreported. Infectious
disease surveillance is essential in order to understand epidemics and
facilitate more effective State and local responses. Moreover,
evidence-based, prevention programs such as syringe services programs--
sometimes referred to as needle exchanges--are proven effective in
preventing infectious disease among people who use drugs. People who
access syringe service programs are three times more likely to stop
injecting drugs. In addition to access to and disposal of sterile
syringes and injection equipment, syringe service programs can provide
a range of services or referrals to services such as substance use
disorder treatment, including medication assisted therapy; testing, and
linkage to care for infectious diseases; Naloxone distribution to
prevent overdose; and vaccination for hepatitis A and B.
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\26\ https://www.cdc.gov/mmwr/volumes/68/wr/
mm6839a1.htm?s_cid=mm6839a1_e&delivery
Name=USCDC_921-DM10135.
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National Institutes of Health (NIH)
NIH is the lead HHS agency providing support for cutting-edge
research on addiction, mental health, pain and opioid misuse, opioid
use disorder, and overdose. Drug addiction and pain are complex
neurological conditions, driven by many biological, environmental,
social, and developmental factors. Continued research will be key to
understanding the opioid crisis, informing future efforts, and
developing more effective, safer, and less addictive pain treatments.
Over the last year, NIH has continued its work with stakeholders
and experts across scientific disciplines and sectors to identify areas
of opportunity for research to combat the opioid crisis. These
discussions have centered on ways to reduce the over prescription of
opioids, accelerate development of effective non-opioid therapies for
pain, and provide more flexible options for treating opioid addiction.
The result of these discussions is the awarding of over 375 grants,
contracts and cooperative agreements across 41 States for a total of
$945 million in FY 2019 funding for the second year of the NIH Helping
to End Addiction Long-term (HEAL) Initiative. The Trans-NIH research
initiative aims to improve treatments of opioid misuse and addiction
and to enhance pain management. The six specific areas of focus this
year are (1) translation of research to practice for the treatment of
opioid addiction, (2) new strategies to prevent and treat opioid
addiction, (3) novel medication for opioid use disorder, (4) enhanced
outcomes for infants and children exposed to opioids, (5) clinical
research in pain management, and (6) preclinical and translational
research in pain management.
The HEAL Initiative will also prevent addiction through enhanced
pain management. A longitudinal study will explore the transition from
acute to chronic pain, non-addictive pain medications development
efforts will be enhanced by data sharing, and a clinical trials network
for pain therapeutics development will be developed. Best practices for
pain management will be further explored, including non-drug and
integrated therapies. Finally, innovative neurotechnologies will be
used to identify potential new targets for the treatment of chronic
pain, and biomarkers that can be used to predict individual treatment
response will be explored and validated.
The NIH HEAL Initiative will build on extensive, well-established
NIH research that has led to successes such as the development of the
nasal form of naloxone, the most commonly used nasal spray for
reversing an opioid overdose; the development of buprenorphine for the
treatment of opioid use disorder; and the use of nondrug and mind/body
techniques to help patients control and manage pain, such as yoga, tai
chi, acupuncture, and mindfulness meditation.
Advances that NIH is working to promote may occur rapidly, such as
improved formulations of existing medications, longer-acting overdose-
reversing drugs, and repurposing of medications approved for other
conditions to treat pain and addiction. Others may take longer, such as
novel overdose-reversal medications, identifying biomarkers to measure
pain in patients, and new non- addictive pain medications.
A large component of the HEAL Initiative with the potential for
rapid impact is the HEALing Communities Study, a multisite
implementation study testing an integrated set of evidence-based
practices across health care, behavioral health, justice, and other
community-based settings. The goal of the study is to reduce opioid-
related overdose deaths by 40 percent over the course of 3 years in
communities highly affected by the opioid crisis. Sixty-seven such
communities are partnering with research sites in four States to
measure the impact of these efforts.
Finally, NIH is engaged in efforts to advance the HHS Opioid
Strategy pillar of advancing the practice of pain management. NIH
worked with HHS and agencies across government to develop the National
Pain Strategy, the government's first broad-ranging effort to improve
how pain is perceived, assessed, and treated, and is now working with
other Departments and Agencies and external stakeholders to implement
this Strategy. NIH is also involved in implementing the Federal Pain
Research Strategy, a long-term strategic plan developed by the
Interagency Pain Research Coordinating Committee (IPRCC) and the
National Institutes of Health to advance the Federal pain research
agenda.
FDA
Reducing the number of Americans who are addicted to opioids and
cutting the rate of new addiction is one of the FDA's highest
priorities. This may be achieved by ensuring that only appropriately
indicated patients are prescribed opioids and that the prescriptions
are for durations and doses that properly match the clinical reason for
which the drug is being prescribed in the first place. FDA's efforts to
address the opioid crisis are focused on encouraging ``right size''
prescribing of opioid pain medication as well as reducing the number of
people unnecessarily exposed to opioids, while ensuring appropriate
access to address the medical needs of patients experiencing pain
severe enough to warrant treatment with opioids. The SUPPORT Act,
enacted by Congress in 2018, allows FDA to require special packaging
for opioids and other drugs that pose a risk of abuse or overdose.
Earlier this year, FDA opened a public docket to solicit feedback on
potential use of this new authority to require that certain immediate-
release opioid analgesics be made available in fixed-quantity, unit-of-
use blister packaging. The availability of these new packaging
configurations could help prescribers to more carefully consider the
amount of opioid pain medication they prescribe. Reducing the amount of
unnecessary opioid pain medication prescribed will lead to fewer pills
left in medicine cabinets that could be inappropriately accessed by
family members or visitors, including children, and could potentially
lower the rate of new opioid addiction.
Opioid analgesics present unique challenges: they have benefits
when used as prescribed yet have very serious risks and can cause
enormous harm when misused and abused. Our goal has been to ensure
product approval and withdrawal decisions are science-based and that
the agency's benefit-risk framework considers not only the outcomes of
prescription opioids when used as prescribed but also the public health
effects of inappropriate use. The agency recently issued a new draft
guidance which describes the application of the benefit-risk assessment
framework that the agency uses in evaluating applications for opioid
analgesic drugs and summarizes the information that can be supplied by
opioid analgesic drug applicants to assist the agency with its benefit-
risk assessment, including considerations about the broader public
health effects of these products in the context of this crisis. In
addition, FDA held a public meeting to further discuss the agency's
benefit-risk assessment of opioid analgesics, including the manner in
which risks of misuse and abuse of these products factor into the
benefit-risk assessment and whether an applicant for a new opioid
analgesic should be required to demonstrate that its product has an
advantage over existing drugs in order to be approved.
Given the scale of the opioid crisis, with millions of Americans
already affected, prevention is not enough. We must do everything
possible to address the human toll caused by opioid use disorder and
help those suffering from addiction by expanding access to lifesaving
treatment. FDA is supporting the treatment of those with opioid use
disorder and promoting the development of improved, as well as lower
cost, forms of medication-assisted treatment. FDA is also working to
increase availability of all forms of naloxone, an emergency opioid
overdose reversal treatment. Among other actions, FDA has approved the
first generic naloxone hydrochloride nasal spray, granted priority
review to all generic applications for products that can be used as
emergency treatment of known or suspected opioid overdose, and for the
first time proactively developed and tested a Drug Facts label to
support development of over-the-counter naloxone products.
FDA plays an important enforcement role when it comes to the
illicit market for diverted opioids and illegal drugs. One of those
roles is collaborating with U.S. Customs and Border Protection (CBP) on
interdiction work on drugs being shipped through the mail. Earlier this
year, FDA implemented new authority granted by Congress to treat
imported articles as drugs when they meet certain requirements, even in
the absence of certain evidence of intended use. This allows FDA to
more efficiently apply its existing authorities to appropriately
detain, refuse, and/or administratively destroy these articles if they
present significant public health concern. FDA also signed a Letter of
Intent with CBP that addresses information sharing, operational
coordination for better targeting of higher risk parcels, and
collaborative strategies more specific to each agency's respective
regulatory enforcement requirements. In addition, FDA continues to
target illegal sales of opioids online and work with Internet
stakeholders to advance a proactive approach to cracking down on
Internet traffic in illicit drugs to address this public health
emergency.
Health Resources and Services Administration (HRSA)
HRSA investments in community health centers, rural communities,
and workforce programs establish and expand access to opioid and other
substance use disorder (OUD/SUD) services. These programs work toward
integrating behavioral health services into primary care to better meet
the needs of communities across the country.
In FY 2019, through the Integrated Behavioral Health Services
(IBHS) Program, HRSA awarded more than $200 million to 1,208 health
centers across the Nation to increase access to high quality,
integrated behavioral health services, including the prevention and
treatment of OUD/SUD. Health centers are using this funding to hire
behavioral health providers, train health center staff to support the
delivery of OUD/SUD and mental health services in primary care
settings, deliver OUD/SUD and mental health services via telehealth,
and improve awareness of and facilitate access to services through
outreach, partnerships, and community integration efforts.
This new funding builds on the success of HRSA health center
program investments in recent years. In FY 2017 and FY 2018, HRSA
awarded more than $550 million to expand behavioral health services and
increase access to critical OUD/SUD treatment. The impact of these
programs is evident in the expansion of MAT in primary health care
settings. Overall, the number of health center providers eligible to
provide MAT increased nearly 190 percent (from 1,700 in 2016 to 4,897
in 2018) and the number of patients receiving MAT increased 142 percent
(from 39,075 in 2016 to 94,528 in 2018).
In FY 2018, HRSA launched the multi-year Rural Communities Opioid
Response Program (RCORP) to support OUD/SUD prevention, treatment, and
recovery services in high-risk rural communities. Through RCORP, in FY
2018 and FY 2019, HRSA awarded $43 million to 215 rural grantees to
establish partnerships with stakeholders and develop plans for
addressing the treatment and recovery needs in their communities. In
August 2019, HRSA awarded $111 million to 96 rural organizations across
37 States to implement comprehensive OUD/SUD programs, and expand
access to MAT in eligible hospitals, health clinics, or tribal
organizations in high-risk rural communities. HRSA also established
three Centers of Excellence on Substance Use Disorders to identify and
disseminate evidence-based best practices.
HRSA workforce programs expand and enhance the OUD/SUD treatment
and recovery workforce. In FY 2019, HRSA awarded over $87 million in
funding for programs that, over the course of the 3-year project
period, will add approximately 7,860 behavioral health professionals
and paraprofessionals working in the provision of OUD/SUD prevention
treatment and recovery services. These workforce investments support
training across the behavioral health provider spectrum including
community health workers, social workers, psychology interns and post-
doctoral residents. Central to these programs is an approach to
training that builds on academic and community partnerships, enabling
clinicians to provide integrated behavioral health care and treatment
services in underserved communities.
HRSA also supports the National Health Service Corps (NHSC) which
awards scholarships and loan repayment to primary care providers to pay
off their student loan debt in exchange for service to underserved
communities. In FY 2019, HRSA established the NHSC Substance Use
Disorder Workforce Loan Repayment Program to improve recruitment and
retention of providers and expand access to quality opioid and
substance use treatment in underserved areas nationwide. This new
initiative broadened the NHSC to include SUD counselors, pharmacists,
and registered nurses, and approximately 1,100 awards were made. Also
in FY 2019, as part of the new NHSC Rural Community Loan Repayment
Program, an additional 100 awards were made to providers working to
combat the opioid epidemic in the Nation's rural communities. In
addition to these new programs, the NHSC now offers $5,000 incentive
awards to practitioners who obtain DATA 2000 Waivers and demonstrate
that they provide MAT at NHSC-approved clinical sites. Nearly 200
providers received these incentive awards when they continued their
service in 2019.
future directions and conclusion
As my testimony has highlighted, there is cause for optimism in
addressing OUD. Under this administration, an historic investment has
been made in combating the crisis. For example, as mentioned
previously, the NIH recently awarded nearly $1 billion across 375
projects in 41 States as part of its HEAL Initiative, to support
research in key areas where we need better tools to treat or prevent
opioid addiction. In fact, between FYs 2016-2019, HHS has awarded over
$9 billion in grants to States, tribes, and local communities to
address this public health issue.
We have amassed a wealth of evidence on effective prevention, early
intervention, treatment, and recovery strategies. Implementation of
HHS's five-point strategy, along with the efforts of other Federal
Government agencies, has resulted in reductions in opioid use and drug
overdose deaths , increased access to medication assisted treatment,
and increased the availability and distribution of overdose-reversing
medications.
Even so, challenges remain. To that end, HHS's immediate priorities
include addressing the surge of methamphetamine use and overdose, the
introduction of new and highly lethal fentanyl analogues and other
synthetic opioid analogues, and improving, demonstrating, and expanding
the integration of Federal, State, local, and non-governmental efforts
at the community level. Among these initiatives are comprehensive
syringe services programs, Emergency Department MAT programs with warm
hand-offs following overdose, and efforts to expand the behavioral
health workforce. Ultimately, we need to pay attention not just to
addiction, but also to mental health, ACEs, and the social determinants
that exist in all communities.
Although we are making tremendous progress in our fight against the
opioid epidemic, no one is declaring victory at this time. Indeed, we
have only begun the public health fight against SUDs in our country.
The Department will continue to devote its resources to solving this
critical public health issue. And, as U.S. Surgeon General, I echo that
pledge.
Thank you for the opportunity to testify on this important issue.
References
1. HHS Opioid Five-Point Strategy. https://www.hhs.gov/opioids/sites/
default/files/2018-09/opioid-fivepoint-strategy-20180917-
508compliant.pdf.
2. Surgeon General's Spotlight on Opioids. https://
addiction.surgeongeneral.gov/sites/default/files/
OC_SpotlightOnOpioids.pdf.
3. Digital Postcard. https://addiction.surgeongeneral.gov/sites/
default/files/SG-Postcard.jpg.
4. Surgeon General's Advisory on Naloxone and Opioid Overdose.
______
Questions Submitted for the Record to
Hon. Jerome M. Adams, M.D., MPH
Questions Submitted by Hon. Chuck Grassley
Question. Medication-Assisted Treatment (MAT) for opioid addiction
typically involves regular use of methadone, buprenorphine or
naltrexone (accompanied by individualized counseling). In addition, a
monthly buprenorphine injection for the treatment of opioid addiction
was approved by the Food and Drug Administration 2 years ago. What
challenges exist for patients in accessing these products, and what
strategies might we adopt in this area?
Answer. Chapter 5 of the recent National Academies consensus study
report, Medications for Opioid Use Disorder Save Lives, noted several
barriers to use of medications for treating OUD.\1\ The report
concluded that high levels of misunderstanding and stigma toward drug
addiction, individuals with OUD, and OUD medications contribute to
their underutilization. One study cited in the report that found that
high levels of stigma were associated with greater public support for
more punitive policy responses to the opioid epidemic and lower support
for public health-oriented policy responses. Lack of provider training
was also identified as a barrier, with ``few among the broad range of
providers who may treat patients with addiction . . . trained in or
knowledgeable about evidence-based practices in addiction prevention
and treatment,'' as well as inconsistent treatment approaches for
patients. A lack of supporting infrastructure also contributes to the
underutilization of OUD treatment. The National Academies report
pointed to the lack of integration of OUD treatment with other medical
care, gaps in insurance coverage for OUD medications, and regulatory
barriers related to the prescribing of methadone and buprenorphine such
as waiver policies, patient limits, and restrictions on settings where
medications are available. Despite these challenges, we cannot keep
losing people from avoidable deaths and instead, we must work together
to mitigate these challenges.
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\1\ https://www.nap.edu/read/25310/chapter/7.
As I have mentioned previously, although Medicaid programs differ
by State, all States currently offer some form of MAT. Overall,
although there is need for continued progress, approximately 1.28
million individuals are now receiving MAT, increased 39 percent from
2016. This represents significant progress we have made in advancing
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evidence-based treatment.
Question. To what extent has the Department of Health and Human
Services (HHS) recently updated its programs and policies to reflect
the latest brain and other research on what works best with those
struggling with addiction? For example, are there certain performance
measures or addiction treatment standards that HHS incentivizes through
its grant making policies? What other programs or policies has HHS
embraced to ensure the government is allocating its resources to
support access to the most effective products and treatment services
available?
Answer. HHS continues to support research on understanding opioid
misuse and addiction to further inform our programs and policies.
Through the NIH HEAL (Helping to End Addiction Long-termSM)
Initiative, NIH awarded $945 million in Fiscal Year (FY) 2019 to
institutions across 41 States. By leveraging expertise from almost
every NIH institute and center to approach the crisis from all angles
and disciplines, this research effort aims to improve treatments for
chronic pain, curb the rates of opioid use disorder (OUD) and overdose
and achieve long-term recovery from opioid addiction. The Initiative
has six overarching research priorities: (1) translation of research to
practice for the treatment of opioid addiction, (2) new strategies to
prevent and treat opioid addiction, (3) enhanced outcomes for infants
and children exposed to opioids, (4) novel medication options for
opioid use disorder and overdose, (5) clinical research in pain
management, and (6) preclinical and translational research in pain
management.
As part of the NIH HEAL Initiative,SM NIH and SAMHSA
have awarded grants to four academic institutions working in
partnership with 67 communities highly affected by the opioid crisis to
conduct research as part of the HEALing Communities Study. The awards,
totaling approximately $354.1 million, will support research on the
effectiveness of a comprehensive, data-driven, community-engaged
intervention designed to increase the adoption of an integrated set of
evidence-based practices to reduce opioid-related overdose deaths and
associated outcomes.
The State Opioid Response (SOR) program aims to increase access to
MAT using the three FDA-approved medications for the treatment of
opioid use disorder, reduce unmet treatment need, and reduce opioid
overdose related deaths through the provision of prevention, treatment
and recovery activities for opioid use disorder (OUD) (including
prescription opioids, heroin, and illicit fentanyl and fentanyl
analogs). Grants were awarded to States and territories via formula
based on overdose death rates and treatment need. The program also
includes a 15 percent set-aside for the 10 States with the highest
mortality rate related to drug overdose deaths.
Grantees are required to develop and implement comprehensive
systems of prevention, treatment, and recovery support services to
address the opioid crisis. The SOR Program specifically emphasized the
use of MAT as a requirement of the program. Grantees are required to
ensure that FDA-approved medications are coupled with clinical
psychosocial interventions and community recovery supports to address
opioid use disorder. Currently, there are 57 active SOR grants funded
for a total of $933 million per year for up to 2 years. SOR was funded
at $1.5 billion in FY 2019.
In addition to the grant program, SAMHSA supported a robust
technical assistance and training effort to enhance education across
the country to address the opioid crisis. This $12 million effort is
premised on the concept that the opioid crisis will best be addressed
if local needs are addressed in a tailored fashion. As such, SAMHSA has
placed local teams of experts on the ground in every State. These teams
are comprised of clinicians, preventionists, and recovery specialists
to provide training and education not just to practitioners but also to
individuals and families.
SAMHSA has encouraged drug court and reentry program grantees for
the past several years to provide MAT as it is an evidence-based
practice and an important part of a comprehensive treatment plan. FY
2018 and FY 2019 grantees were encouraged to use up to 35 percent of
their annual grant award to pay for FDA-
approved medications (e.g., methadone, buprenorphine, naltrexone,
disulfiram, acamprosate calcium) when the client has no other source of
funds to do so. MAT is an evidence-based SUD treatment protocol for
alcohol and opioid use disorders and SAMHSA supports the right of
individuals to have access to FDA-approved medications. Drug court
grantees must affirm that they will not deny access to the program to
any eligible client for his/her use of FDA-approved medications for SUD
treatment. Any providers of substance use disorder services who are
eligible by law to obtain what is commonly referred to as a Drug
Addiction Treatment Act (DATA) waiver and receiving funding from this
grant program must obtain the DATA waiver and certify their willingness
to provide, when clinically indicated, FDA-approved medications on
Schedule III, IV or V to treat opioid use disorder.
In all cases that MAT is utilized, MAT must be permitted to be
continued for as long as the prescriber determines that the medication
is clinically beneficial. Recipients must assure that a drug court
client will not be compelled to no longer use MAT as part of the
conditions of the drug court if such a mandate is inconsistent with a
licensed prescriber's recommendation or valid prescription. Under no
circumstances may a drug court judge, other judicial official,
correctional supervision officer, or any other staff connected to the
identified drug court deny the use of these medications when made
available to the client under the care of a properly authorized
prescriber and pursuant to regulations within an opioid treatment
program (OTP) or through a valid prescription by an authorized
Buprenorphine prescriber and under the conditions described above. A
judge, however, retains judicial discretion to mitigate or reduce the
risk of misuse or diversion of these medications.
SAMHSA's services grants are intended to fund services or practices
that have a demonstrated evidence base and that are appropriate for the
population(s) of focus. An evidence-based practice (EBP) refers to
approaches to prevention or treatment that are validated by some form
of documented research evidence. Both researchers and practitioners
recognize that EBPs are essential to improving the effectiveness of
treatment and prevention services in the behavioral health field. While
SAMHSA realizes that EBPs have not been developed for all populations
and/or service settings, application reviewers closely examine proposed
interventions for evidence base and appropriateness for the population
to be served. If an EBP(s) exists for the types of problems or
disorders being addressed, the expectation is that EBP(s) will be
utilized.
SAMHSA has created the ``Evidence-Based Practices Resource Center''
to provide communities, clinicians, policy-makers and others with the
information and tools to incorporate evidence-based practices into
their communities or clinical settings. It can be accessed at: https://
www.samhsa.gov/ebp-resource-center.
SAMHSA's Medication-Assisted Treatment for Prescription Drug and
Opioid Addiction (MAT-DOA) program addresses treatment needs of
individuals who have an opioid use disorder (OUD) by expanding and
enhancing treatment system capacity to provide accessible, effective,
comprehensive, coordinated, integrated, and evidence-based MAT and
recovery support services.
MAT refers to the use of the FDA-approved pharmacotherapies (i.e.,
buprenorphine products, methadone, and naltrexone products) in
combination with evidence-based psychosocial interventions for
treatment of OUD. MAT is a safe and effective strategy for decreasing
the frequency and quantity of opioid misuse and reducing the risk of
overdose and death. Recovery support services include linking patients
and families to social, legal, housing, and other supports to improve
retention in MAT to increase the probability of positive outcomes.
In FY 2017, SAMHSA funded five multi-year State grants and funded
one new annual State grant, 23 continuations and one continuing
technical assistance contract. In FY 2018 SAMHSA funded 11 continuation
MAT-PDOA State grants; and in FY 2019 funded 6 continuations. In FY
2018, SAMHSA expanded its funding (TI-18-009) to States, political
subdivisions in States, nonprofit organizations within States, and
tribes by funding 128 new MAT-PDOA grants, 20 of which were tribes, to
support program implementation and provided supplemental funding for
direct technical assistance to the new FY 2018 grantees. SAMHSA's
services grants are intended to fund services or practices that have a
demonstrated evidence base and that are appropriate for the
population(s) of focus. In selecting an EBP, the grantee must be
mindful of how the choice of an EBP or practice may impact disparities
in service access, use, and outcomes for the population(s) of focus.
While this is important in providing services to all populations, it is
especially critical for those working with underserved and minority
populations.
HRSA also recently awarded $20 million to three Rural Centers of
Excellence on SUD through its Rural Communities Opioid Response Program
(RCORP). This program supports practitioners in rural communities
across the country to find and implement evidence-based interventions
that work best for rural populations. RCORP-Rural Centers of Excellence
will facilitate access to the most effective products and treatment
services available in communities often disproportionately affected by
the opioid crisis.
Question. Engaging overdose survivors in the hospital, when they
are at their most vulnerable, and therefore inclined to commit to
addiction treatment, is a strategy that some communities across the
country have pursued. Is there research to suggest the effectiveness of
emergency room initiated support services, and if so, what more could
we do to promote greater awareness of this approach?
Answer. Emergency Departments (ED) can play an important role in
preventing overdose and treating engaging persons with opioid use
disorder. EDs can provide naloxone to everyone who presents with an
overdose or risk for an overdose. An additional important, evidence-
based intervention is the initiation of MAT in the ED, with linkage to
follow up services. CMS has recently proposed additional payments to
incentivize both MAT initiation and linkage to care directly from the
ED.
Additionally, a growing body of research supports the initiation of
treatment with buprenorphine in the emergency department for opioid
overdose survivors and other emergency department patients with opioid
use disorder. Research is also beginning to suggest that peer workers,
individuals who are in recovery from addiction themselves and have
received specialized training, can be effective in engaging overdose
survivors and other patients with opioid use disorder or other
substance use disorder in emergency departments, distributing naloxone,
linking with specialty treatment, providing ongoing support, and
improving outcomes.\2\
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\2\ Carey, C.W., Jones, R., Yarborough, H., Kahler, Z., Moschella,
P., and Lommel, K.M. (2018). 366 Peer-to-Peer Addiction Counseling
Initiated in the Emergency Department Leads to High Initial Opioid
Recovery Rates. Annals of Emergency Medicine, 72(4), S143-S144.
doi:10.1016/j.annemergmed.2018.08.371.
Samuels, E.A., Baird, J., Yang, E.S., and Mello, M.J. (2019).
Adoption and Utilization of an Emergency Department Naloxone
Distribution and Peer Recovery Coach Consultation Program. Academic
Emergency Medicine, 26(2), 160-173. doi:10.1111/acem.13545.
Waye, K.M., Goyer, J., Dettor, D., Mahoney, L., Samuels, E.A.,
Yedinak, J.L., and Marshall, B.D.L. (2019). Implementing peer recovery
services for overdose prevention in Rhode Island: An examination of two
outreach-based approaches. Addictive Behaviors, 89, 85-91. doi:https://
doi.org/10.1016/j.addbeh.2018.09.027.
Welch, A.E., Jeffers, A., Allen, B., Paone, D., and Kunins, H.V.
(2019). Relay: A Peer-Delivered Emergency Department-Based Response to
Nonfatal Opioid Overdose. Am J Public Health, 109(10), 1392-1395.
doi:10.2105/ajph.2019.305202.
HHS recognizes this as an important strategy for connecting persons
with opioid use disorder to treatment services and will continue to
invest in research (e.g., through SAMHSA's Drug Abuse Warning Network
and studies within the National Institute on Drug Abuse's (NIDA's)
Clinical Trials Network, including the Emergency Department Connection
to Care with Buprenorphine for Opioid Use Disorder (ED-CONNECT) trial
and the Emergency Department-INitiated bupreNOrphine and VAlidaTIOn
Network (ED-INNOVATION) trial) which aims to better understand this
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area.
In 2018, CDC released its resource ``Evidence-Based Strategies for
Preventing Opioid Overdose: What's Working in the United States.'' This
resource consolidates the best evidence currently available for opioid
overdose prevention strategies with demonstrated feasibility in the
United States. It offers community leaders, local and regional
organizers, non-profit groups, law enforcement, public health, and
members of the public relevant research and examples of use in the
field. One of the strategies included in this resource is initiating
buprenorphine-based MAT in emergency departments.
In 2019, CDC also funded 47 States, Washington, D.C., Puerto Rico,
Northern Mariana Islands, and 16 localities under its Overdose Data to
Action (OD2A) funding opportunity, which builds on the previous
Overdose Prevention in States (OPIS) work. Funded jurisdictions will
work to collect high quality, more comprehensive, and timelier data on
overdose morbidity and mortality and use those data to inform
prevention and response activities. A required strategy under OD2A is
linkage to care, under which all funded jurisdictions must implement
activities to ensure a systems-level approach to link individuals in
need of care to providers. Potential activities can include emergency
department based buprenorphine induction, peer navigators, warm hand-
offs, pre-arrest diversion, and community health workers, all of which
can help to increase awareness of and help connect persons with OUD to
care.
Further, because trained peer workers with lived experience with
substance use and recovery can effectively build a rapport with people
presenting in the ED with substance use issues, HRSA is working to
expand the number of peer support specialists trained and available to
be placed in the ED setting. These trained support specialists can help
bridge patients to SUD treatment. HRSA recently awarded grants for
training paraprofessionals. First, HRSA's Behavioral Health Workforce
Education and Training (BHWET) Program increases access to treatment by
increasing the number of professionals and paraprofessionals trained to
deliver integrated behavioral health and primary care services in
interprofessional teams. Second, HRSA's Opioid Workforce Expansion
Program (OWEP) offers community-based experiential training for
students preparing to become behavioral health paraprofessionals with a
focus on opioid use disorder (OUD) and other SUD prevention, treatment,
and recovery services. HRSA expects to train 4,309 paraprofessionals
over the 3 years of the grants which began September 1, 2019.
Question. Are there sufficient mechanisms in place to ensure a
coordinated, cohesive approach to treatment of pregnant women with
substance use disorders? Or do barriers still exist for pregnant women
in accessing affordable prevention and treatment services and
interventions? If so, what steps do you recommend to eliminate such
barriers?
Answer. Progress is being made in ensuring such an approach to
treatment of pregnant women with SUD. HHS is addressing the 39
recommendations in the HHS Protecting Our Infants Act (POIA) strategy,
per the HHS Status Report on POIA Implementation Plan.\3\ CMS announced
a funding opportunity for a 5-year model that is designed to address
fragmentation in the care of pregnant and postpartum Medicaid
beneficiaries with opioid use disorder (OUD).\4\ The primary goals of
the Maternal Opioid Misuse (MOM) Model are to improve quality of care
and reduce costs for pregnant and postpartum women with OUD and their
infants; expand access, service-delivery capacity, and infrastructure;
and create sustainable coverage and payment strategies that support
ongoing coordination and integration of care. On December 19, 2019, CMS
awarded MOM Model funding to 10 States to collaborate with local care-
delivery partners, which could include health systems, hospital
systems, or payers, such as a Medicaid managed care plans, to transform
the care-delivery system for affected mothers and their infants. The
MOM Model has a 5-year period of performance, which began on January 1,
2020, and three different types of funding, approximately $50 million
in total.\5\
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\3\ https://aspe.hhs.gov/system/files/pdf/260891/POIA.pdf.
\4\ https://www.cms.gov/newsroom/press-releases/cms-model-
addresses-opioid-misuse-among-expectant-and-new-mothers.
\5\ https://www.cms.gov/newsroom/press-releases/cms-awards-funding-
combat-opioid-misuse-among-expectant-mothers-and-improve-care-children-
impacted.
The Child Abuse Prevention and Treatment Act requires that
providers report illicit substance use including RX misuse by mothers
to child welfare authorities if a State defines such use to constitute
child abuse or neglect. This, as well as ongoing judicial and
prosecutorial bias against MAT, and the lack of facilities willing to
treat pregnant women (or who believe they can treat them safely) are
among the major barriers to the treatment of pregnant women that HHS
and DOJ need to overcome if pregnant women are going to get into
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prenatal care and SUD treatment in a timely manner.
Since 2018, the HHS Office on Women's Health and HRSA have
collaborated on the Regional Opioids Coordination Initiative, which is
developing a family-centered care coordination model for women who
misuse opioids who are served by HRSA-funded care settings. In 2018 OWH
and HRSA hosted three regional stakeholder consultations (in Regions
III, VII, and IX), which brought together a diverse group of public and
private sector stakeholders to identify best practices for care and
treatment coordination in diverse clinical and social service settings.
One of these meetings (in Region VII) specifically focused on the needs
of pregnant women. The project will conclude in late 2020 with the
development and release of a toolkit that will include resources for
providers, and will feature a section focused specifically on the needs
of pregnant women.
HHS established an implementation plan in response to the
Protecting Our Infants Act strategy that is focused on preventing
prenatal opioid exposure, providing evidence-based treatment for both
mother and infant, increasing the accessibility of family-friendly
services for pregnant and parenting women with OUD, supporting
continuing education for healthcare providers, and determining optimal
family and developmental support services for children who have
experienced prenatal opioid exposure. Reporting to Congress about this
is ongoing.\6\
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\6\ https://aspe.hhs.gov/report/status-report-protecting-our-
infants-act-implementation-plan.
The SUPPORT Act contains more than 20 Medicaid-related provisions,
and CMS is working expeditiously to implement this law. Two such
provisions are sections 1012, Help for Moms and Babies, and 1007,
Caring Recovery for Infants and Babies. Section 1012 creates a limited
exception to the Institutions for Mental Diseases (IMDs) payment
exclusion in Medicaid, and allows payments to States for medical care
provided outside IMDs to pregnant or postpartum women receiving
treatment for SUD in IMDs. Section 1007 permits States to include
residential pediatric recovery centers (RPRCs) as providers in their
Medicaid programs for infants with Neonatal Abstinence Syndrome (NAS),
permits payments for room and board to RPRCs for treating such infants,
and permits RPRCs to offer certain services to mothers and other
appropriate family members and caretakers that are for the benefit of
such infants, including counseling or referrals for services,
activities to encourage caregiver-infant bonding, and training on
caring for infants with NAS. CMS issued guidance to States on these
---------------------------------------------------------------------------
provisions on July 26, 2019.
Moreover, in November 2017, CMS launched an opportunity through
section 1115 demonstration projects for States to demonstrate and test
certain Medicaid flexibilities to improve the continuum of care for
beneficiaries with SUD. CMS has approved more than 25 States' SUD
demonstrations to date.
The National Center on Substance Abuse and Child Welfare (NCSACW)
is an HHS initiative to improve family recovery, safety and stability
for those affected by substance use. This initiative also creates
written materials that help those impacted by opioid epidemic. NCSACW
developed publications and web-based tutorials to train professionals
and the site receives 60,000+ visits per year.
HRSA/MCHB's State Legislation on Substance Use During Pregnancy
Guide \7\ developed by the Healthy Start Technical Assistance Center,
highlights the following barriers adapted from an American College of
Obstetricians and Gynecologists (ACOG) toolkit.
---------------------------------------------------------------------------
\7\ https://www.healthystartepic.org/wp-content/uploads/2019/05/
JSI-SU-and-Pregnancy-Resource-Guide.pdf.
Policies that penalize pregnant or parenting women for substance
use leads to adverse consequences for both mother and baby. Research
shows that State laws and policies that penalize women for substance
---------------------------------------------------------------------------
use during pregnancy lead to a host of negative consequences including:
Deterring women from seeking the care they need to reduce
their substance use.
Discouraging women from disclosing substance use to health-
care providers who could help them access treatment and care.
Pressuring women to end their pregnancies in order to avoid
arrest if they do not feel they can successfully stop using
substances.
Limiting health-care providers' ability to provide the best
possible care to women, including providing appropriate
treatment for pain or substance use disorders.
Regarding barriers for pregnant women in accessing affordable
prevention and treatment services and interventions, adapted from
ACOG's toolkit: (1) Health experts agree that substance use during
pregnancy is best addressed through preventative measures and
treatment. Every leading medical and public health organization that
has addressed this issue has concluded that education, prevention, and
community-based treatment are the best methods for reducing substance
use during pregnancy; (2) Staying connected to the healthcare system is
key to improving birth outcomes. The evidence shows that getting
prenatal care, staying connected to the healthcare system, and
maintaining open communication channels with physicians and healthcare
providers about substance use helps improve birth outcomes, regardless
of whether a woman can successfully stop using substances.
Question. What steps has HHS taken to promote development and use
of alternative, non-opioid medications to treat acute pain, and what
more could the Department do in this area?
Answer. HHS has implemented multiple initiatives to promote
awareness regarding risks of prescription opioid misuse and promote
conversations about effective pain management with their health-care
providers. CDC launched the Rx Awareness communication campaign that
features testimonials from those recovering from opioid use disorder
and of people who have lost loves ones to opioid overdose. The CDC has
also developed promotional materials including a piece titled Non-
opioid Treatment for Chronic Pain that lists options of non-opioid
medications as well as non-pharmacological therapies. We will continue
to promote these options, but I would like to note, there is no ``one-
size-fits-all'' approach to treating pain.
In May 2019, HHS also released a report informed by Pain Management
Task Force meetings, including review and analysis of over 9,000 public
comments and testimonials from patients dealing with chronic pain. Over
165 medical organizations submitted feedback on this report as well.
This report examines best practices for acute and chronic pain
management and is available publicly online.
In addition, a major focus of the NIH HEAL InitiativeSM,
is to accelerate the discovery and development of innovative treatments
for pain including non-opioid pain medications and devices. To learn
more about HEAL Initiative efforts to manage pain, I refer you to:
https://heal.nih.gov/research.
Question. What incentives exist for State governments to adopt
programs that offer a continuum of care for addicts and prioritize use
of evidence-based behavioral treatments and medications? Could we do
more to incentivize such programs (e.g., by making eligibility for
certain HHS grants contingent on the adoption of additional policies
that integrate care for mental health and substance abuse disorders)?
Answer. Of note, to avoid perpetuating stigma and to ensure clear,
consistent, science-based language that aligns with the terminology and
``people-first'' framing used to refer to people with other chronic
conditions or disabilities, HHS refers to people with substance use
disorder. Terms such as ``addict,'' ``alcoholic,'' or ``user'' assign
an implicit identity to those they designate and de-emphasize their
full personhood. Stigma, misunderstanding, and negative attitudes
toward individuals with substance use disorder are still pervasive and
even affect the quality of health care patients with substance use
disorder receive and their health outcomes.\8\ HHS prioritizes
evidence-based treatments and medications among State governments
through the design of our programs. SAMHSA's State Opioid Response
Grants require State agencies to utilize evidence-based implementation
strategies to rapidly and adequately address the gaps in their systems
of care and deliver evidence-based treatment interventions that include
FDA-approved medications.
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\8\ van Boekel, L.C., Brouwers, E.P.M., van Weeghel, J., and
Garretsen, H.F.L. (2013). Stigma among health professionals towards
patients with substance use disorders and its consequences for
healthcare delivery: Systematic review. Drug and Alcohol Dependence,
131(1), 23-35. doi:https://doi.org/10.1016/j.drugalcdep.2013.02.018
In 2019, CDC also funded 47 States, Washington, DC, Puerto Rico,
Northern Mariana Islands, and 16 localities under its Overdose Data to
Action (OD2A) funding opportunity, which builds on the previous
Overdose Prevention in States (OPIS) work. Funded jurisdictions will
work to collect high quality, more comprehensive, and timelier data on
overdose morbidity and mortality and use those data to inform
prevention and response activities. A required strategy under OD2A is
linkage to care, under which all funded jurisdictions must implement
activities to ensure a systems-level approach to link individuals in
need of care to providers. Potential activities include peer
navigators, warm handoffs, pre-arrest diversion, and community health
workers, all of which can help to increase awareness of and help
connect persons with OUD to care. HHS also promotes the integration of
mental health and substance use disorder care services through several
programs and innovative payment models. Through HRSA's Health Center
Program, 1,208 health centers across the Nation, which provide
comprehensive primary health services to medically underserved
communities and populations, received funding in FY 2019 to increase
access to high quality, integrated behavioral health services,
including the prevention or treatment of mental health conditions and/
or substance use disorders, including opioid use disorder.
Additionally, in FY 2019, HRSA awarded 80 grants to rural communities
through its Rural Communities Opioid Response Program (RCORP)-
Implementation. This program requires award recipients to implement a
set of required activities that span the care continuum, including
increasing the number of providers who can provide MAT, supporting
integrated treatment and recovery, and enhancing individuals' abilities
to find, access, and navigate evidence-based and/or best practices for
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affordable treatment and recovery support services for SUD/OUD.
On December 19, 2019, the CMS Center for Medicare and Medicaid
Innovation (Innovation Center) announced the awarding of Maternal
Opioid Misuse (MOM) Model funding to 10 States address fragmentation in
the care of pregnant and postpartum Medicaid beneficiaries with opioid
use disorder through State-driven transformation of the delivery system
surrounding this vulnerable population.\9\ By supporting the
coordination of clinical care and the integration of other services
critical for health, well-being, and recovery, the MOM Model has the
potential to improve quality of care and reduce costs for mothers and
infants. Additionally, the Innovation Center announced that it had
issued eight cooperative agreements for the Integrated Care for Kids
(InCK) Model across seven States, which is a child-
centered local service delivery and State payment model that aims to
reduce Medicaid expenditures and improve the quality of care for
children under 21 years of age enrolled in Medicaid/CHIP through
prevention, early identification, and treatment of behavioral and
physical health needs.
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\9\ https://www.cms.gov/newsroom/press-releases/cms-awards-funding-
combat-opioid-misuse-among-expectant-mothers-and-improve-care-children-
impacted.
HHS recognizes that there is still more work to be done to further
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address the changing landscape of the drug overdose crisis.
Question. To what extent do we have reason to be concerned about
respiratory depression in patients who receive post-operative
intravenous opioid medications, and under what circumstances, if any,
should such hospital patients be closely (or continuously) monitored?
Answer. Opioids have been the cornerstone therapy used for the
management of post-operative moderate and severe pain. But as with all
medications, they are accompanied by potential complications or adverse
reactions. It is well accepted that opioids increase the risk of post-
operative respiratory depression in certain populations (e.g., those
who are obese, or have sleep apnea), but more health-care and training
institutions are promoting opioid sparing anesthesia and analgesia as a
way to reduce complications--including respiratory depression--for all
populations.
This current reality restates the importance of finding different
treatment alternatives to intravenous opioid medications that have
lower risk of complications.
In 2014, CMS issued a Survey and Certification Memorandum to update
guidance for hospital medication administration requirements which
reflect the need for patient risk assessment and appropriate monitoring
during and after medication administration, particularly for post-
operative patient receiving intravenous (IV) opioid medications, to
prevent adverse events. The guidance states that hospitals are expected
to address monitoring for over-sedation and respiratory depression
related to IV opioids for post-operative patients. Hospitals must have
policies and procedures related to the use of high-alert medications,
such as IV opioids for post- operative patients, that include the
process for patient risk assessment, including who conducts the
assessments, and, based on the results of the assessment, monitoring
frequency and duration, what is to be monitored, and monitoring
methods. If surveyors find that a hospital does not have adequate
policies and procedures on the use and monitoring of high-alert
medication, the hospital could be cited for a deficiency under the
survey, and the hospital would be required to address this deficiency.
______
Questions Submitted by Hon. John Thune
Question. Your testimony acknowledged continued challenges with
methamphetamine use, which is a problem in South Dakota. What trends
are you seeing nationwide compared to opioids, and what can the
Department and policymakers do to ensure this does not grow to the size
of the opioid crisis?
Answer. As Assistant Secretary Giroir has termed it,
methamphetamine abuse is now the fourth wave of America's overdose
crisis. Deaths associated with psychostimulants with abuse potential
now outnumber deaths from natural and semi-synthetic opioids; and in 14
States (of 37 which report monthly by category), methamphetamines are
involved in more overdose deaths than are synthetic opioids like
fentanyl.
Methamphetamine is readily available throughout the United States,
and availability is highest in the West and Midwest. It is a
significant problem in American Indian/Alaska Native (AI/AN)
communities. It is increasing in prevalence in new markets, such as the
Northeast, as prices continue to decline throughout the United States.
Meth mixed with fentanyl and fentanyl-related substances has been
seized and is increasingly reported on death certificates.
CDC has provisional mortality data on methamphetamine- and cocaine-
related overdose in 18 States. Methamphetamine and cocaine use are
captured in CDC ESOOS data if ED visits or overdose deaths also involve
opioids.
Today's cohort of methamphetamine users is different from the
population using methamphetamine in the early-mid 2000s in the
following ways:
More co-use of opioids.
Larger percent injecting (including both injection of
methamphetamine and opioids).
More geographically diffuse--some of the largest increases
in treatment admissions and deaths are occurring in the
Northeast, Midwest, and South; the West has always had higher
rates and has increased, but not to the same degree as other
areas of the country. This geographic diffusion correlates
highly with methamphetamine supply data from the Drug
Enforcement Administration and others in law enforcement.
More racial/ethnic distribution--in the treatment admission
data--all race/ethnicity groups have experienced significant
increases in the past decade. Consistent with historical
patterns, AI/AN populations have significantly higher rates,
but some of the largest increases have occurred among
populations that historically have not had much involvement
with methamphetamine, especially non-Hispanic blacks.
All age groups are impacted--treatment data indicate
significant increases across all age groups--both for any
methamphetamine at treatment admission, primary methamphetamine
treatment admission, and heroin treatment admissions also
reporting methamphetamine abuse.
substance use patterns among people using methamphetamine
Poly-substance use is the rule rather than exception among people
using methamphetamine in a number of ways:
Among individuals reporting past-year methamphetamine use in
the National Survey on Drug Use and Health (NSDUH) in 2015-
2017, more than 95 percent reported lifetime use of tobacco,
alcohol, and cannabis use, 84 percent reported lifetime cocaine
use, and 36.7 percent reported lifetime heroin use.
Among past-year users of methamphetamine in 2017, past-year
use of other substances is common: 70.2 percent used cannabis,
37.9 percent misused prescription opioids, 32.3 percent used
cocaine, 28.8 percent misused prescription sedatives/
tranquilizers, 28.0 percent misused prescription stimulants,
and 19.0 percent used heroin. In addition, 42.9 percent had
past-month nicotine dependence and 40 percent reported binge
drinking in the past month.
Among past-year methamphetamine users in 2015-2017, the
average age of initiation for methamphetamine use was 21.9. On
average, among the past-year methamphetamine users reporting
lifetime use of cigarettes, alcohol, cannabis, cocaine, and
heroin, the average age of initiation was earlier for alcohol
(14.0 years), cigarettes (14.1 years), cannabis (14.7 years),
and cocaine (19.5 years). Average age of initiation for heroin
was later than methamphetamine (25.5 years).
Among past year methamphetamine users who also misused
prescription opioids in the past year in 2015-2017, the average
age of first methamphetamine use was 21.6 years and the average
age of first misuse of prescription opioids was 22.3 years.
Among past year methamphetamine users who also misused
prescription stimulants in the past year in 2015-2017, the
average age of first methamphetamine use was 21.5 years and the
average age of first misuse of prescription stimulants was 24.1
years.
Among past year methamphetamine users who also misused
prescription tranquilizers in the past year in 2015-2017, the
average age of first methamphetamine use was 22.2 years and the
average age of first misuse of prescription tranquilizers was
27.1 years.
Among past year methamphetamine users who also misused
prescription sedatives in the past year in 2015-2017, the
average age of first methamphetamine use was 21.2 years and the
average age of first misuse of prescription sedatives was 26.2
years.
In the 2015-2017 NSDUH, among past-year methamphetamine
users, 24.7 percent reported past-year injection drug use, 22.7
percent reported methamphetamine injection, 22.1 percent
reported heroin injection, and 4.8 percent reported past year
cocaine injection.
These findings are consistent with other studies in the
literature using different data sources.
Females are experiencing significant burden.
In addition to co-use of opioids; there is also significant
polysubstance use--this is consistent across the NSDUH and
treatment data.
In the mortality data, there are differences among age and race/
ethnicity populations with respect to opioid-involvement in
psychostimulant-related overdose deaths, with younger age groups more
likely to have opioids involved and non-
Hispanic AI/AN, non-Hispanic black, and Hispanic populations less
likely to have opioids involved in psychostimulant overdose deaths.
There are administration-wide efforts to support prevention,
treatment, recovery, and law enforcement against cartels. We are also
working closely with State, local, and non-government programs as we
expand the healthcare workforce and implement comprehensive services
following overdose.
______
Questions Submitted by Hon. Patrick J. Toomey
Question. How far along is the Department of Health and Human
Services in implementing mandatory electronic prescribing of controlled
substances?
Answer. Section 2003 of the SUPPORT for Patients and Communities
Act (Pub. L. 115-271), signed into Federal law in October of 2018,
includes an electronic prescribing requirement for all controlled
substance prescriptions under Medicare part D. The Centers for Medicare
and Medicaid Services is working on the implementation of this
provision.
Following the Federal mandate, many States have put forth
legislation with similar laws. Today, more than 20 States have EPCS
(electronic prescribing of controlled substances) mandates. Over 15
States have future effective dates. In addition to working toward all
States requiring e-prescribing of controlled substances, we will keep
working with these local, State and Federal departments to find ways to
halt the over-prescription of prescribed opioids and diversion via
forgery of paper prescriptions.
Question. Do any of the States stand out as high performers when it
comes to oversight and regulation of addiction treatment centers?
Please provide examples.
Answer. In general, all States license inpatient and outpatient
addiction treatment centers. State licensure includes a measure of
regulatory oversight and enforcement by the designated State agency.
Two States in particular, have been identified to demonstrate robust
oversight of Medication-Assisted Treatment (MAT) within their
respective jurisdictions. Vermont has been a leader in the field by
creating the Hub and Spoke model, along with creating oversight
requirements for Office Based Opioid Treatment. Connecticut has
incorporated MAT into criminal justice settings and has been a leader
in this area.
Additionally, 26 States, of their own accord have established
certification of addiction recovery residences through formal
affiliation with the National Alliance of Recovery Residences (NARR).
Certification serves to assure adherence to national operating
standards established by NARR. The 26 NARR Affiliates are: CA, IL, PA,
GA, FL, TX, OH, IN, MI, CT, SC, NC, VA, MN, NJ, RI, UT, CO, MO, TN, MD,
ME, WA, VT, and AZ. According to NARR, six States are also in the
process of establishing affiliated certification programs, these are:
OR, DE, NH, WV, NY, and WI. NARR Certification closely aligns with
SAMHSA's newly published Best Practices and Suggested Guidelines for
Recovery Residences (2019), and serves to counter the emergence of, and
potential acquiescence by some to, fraudulent and substandard practices
in the addiction treatment community.
Question. How much money do Federal insurance programs (FEHB,
TRICARE, Medicare, Medicaid, etc.) spend on drug treatment and how much
of it is suspected of being fraud? What, if any, are the challenges in
quantifying this?
Answer. Medicare fee-for-service makes payments for covered items
and services that could be used for drug treatment, such as partial
hospitalization program services and physician services. Beginning
January 1, 2020, Medicare will pay for opioid use disorder treatment
services furnished by Medicare-enrolled Opioid Treatment Programs. Data
on Medicare fee-for-service expenditures can be found at: https://
www.cms.gov/Research-Statistics-Data-and-Systems/Research-Statistics-
Data-and-Systems. States make payments for items and services covered
by Medicaid; the Centers for Medicare and Medicaid Services (CMS) pays
States the Federal share of those payments.
CMS cannot make legal determinations of fraud and thus does not
estimate fraud. CMS refers any suspicious behaviors to law enforcement
partners for determining fraud. CMS annually estimates improper
payments for Medicare and Medicaid. Improper payments are not
necessarily indicative, or measures, of fraud but rather are payments
that did not meet statutory, regulatory, administrative, or other
legally applicable requirements, and which may be overpayments or
underpayments. CMS's most recent improper payment estimates can be
found in the FY 2019 HHS Agency Financial Report.\10\
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\10\ https://www.hhs.gov/sites/default/files/fy2019-hhs-agency-
financial-report.pdf.
______
Questions Submitted by Hon. Tim Scott
Question. I am grateful to the chairman and ranking member for
holding a hearing on the important and challenging topic. We have taken
significant steps over the past few years, both through this committee
and through the HELP Committee, to try to reverse the trends of this
epidemic, and I have no doubt that the myriad bipartisan provisions
that we have seen enacted will continue to aid efforts across the
Nation on this front. That said, while it is too early to assess the
impact of much of our Federal legislation in this area, there are
always opportunities for additional initiatives, and opioids persist in
posing a massive threat to our public health, our workforce, and our
society. In South Carolina, we saw 816 opioid overdose deaths last
year, which marked a 9-percent increase over the year before. In one
county, the increase in opioid-related fatalities was as high as 80
percent. Looking specifically at fentanyl, we saw a 27-percent increase
across the State over the same period.
This is a complex epidemic that unquestionably requires a wide
range of solutions. That being said, given that roughly one quarter of
patients who are prescribed opioids for chronic pain ultimately misuse
them, and that around one in ten develop an opioid use disorder,
ensuring access to viable alternatives for pain management is clearly
one key part of the solution. Fortunately, we are seeing some
groundbreaking work on this front.
In August, Nephron Pharmaceuticals, which is based in South
Carolina, announced a partnership with Infutronix to provide an
affordable alternative to opioids that combines an easy-to-use pain
pump with a non-narcotic, pre-mixed bag of medications. Moreover, in
order to effectively scale up operations on treatments like these ones,
Nephron has also launched partnerships with USC and Clemson to work
alongside faculty and students to enhance advanced manufacturing
capabilities. For patients dealing with chronic pain, these efforts
could be a game-changer.
We are also seeing significant progress when it comes to developing
new non-opioid alternatives to pain relief. Just last month, MUSC
announced an NIH grant worth more than $830,000 through the agency's
HEAL Initiative. This will give MUSC team members across disciplines
the opportunity to engage with networks of front-line researchers
across the Nation to enhance and accelerate clinical trials for
innovative alternatives to opioids. We are seeing similar efforts
across research institutions, as well as industry.
From your perspective, what role can efforts like these play in
combating the opioid epidemic?
Answer. Efforts like these are essential. We need to continue to
fund research, specifically in the development of new and effective
diagnostic, preventive and therapeutic approaches for patients. We must
also work together to implement these novel approaches effectively in
health systems and communities.
Question. What remaining barriers do you see when it comes to
ensuring broad patient access to non-opioid alternatives to pain
management, and what can we do to mitigate those barriers?
Answer. Fifty million adults in the United States have chronic
daily pain, with 19.6 million adults experiencing high-impact chronic
pain that interferes with daily life or work activities. Many of these
patients face significant access to care barriers (i.e., stigma, poor
dialogue with providers, not enough research on effective pain
management approaches, shortages of behavioral pain management
specialists, lack of insurance coverage for pain management services,
etc.) and these need to be addressed in order to optimize the
management of acute and chronic pain. We need to enable patients and
physicians to utilize clinically indicated treatment modalities (opioid
and non-opioid, restorative therapies, interventional approaches or
behavioral approaches) to ensure that patients receive the assistance
they need.
______
Question Submitted by Hon. Bill Cassidy
Question. This hearing highlighted some of the challenges that
families affected by substance use disorder face when trying to find
properly certified treatment centers that use appropriate, science-
based methods. One way that families could be helped is by having
access to an app which directs them to certified treatment centers in
their area. Generally speaking, how has HHS considered ways to direct
families to treatment centers that are certified and use science-based
methods? If not such an app exists, could HHS put forth a challenge
grant to help one be created?
Answer. HHS now offers several mechanisms to find opioid treatment
programs. When a person enters their zip code (anonymously), they will
be taken to the Substance Abuse and Mental Health Services
Administration (SAMHSA) facility finding map. Another option is https:/
/findtreatment.gov, which also includes treatment types, distance from
location and payments accepted. I will continue to work with my office,
and HHS as a whole to improve access to families impacted by OUD.
______
Questions Submitted by Hon. James Lankford
Question. How can treatment plans (particularly MAT plans) ween
addicts off opioid dependence without completely replacing their
addiction with an MAT drug? Can it be standardized to have an end-goal
of no drug intake instead of a different drug intake?
Answer. There is no one-size-fits-all situation when it comes to
combating opioid addiction, but we know that MAT works. A common
misconception associated with MAT is that it substitutes one drug for
another. Instead, these medications relieve the withdrawal symptoms and
psychological cravings caused by chemical imbalances in the body and
changes to brain circuitry caused by opioid addiction. MAT programs
provide a safe and controlled level of medication to overcome the use
of a misused opioid. When provided at the proper dose, medications used
in MAT should not affect a person's mental capability or employability
for most jobs.
Research is underway to determine if and when it may be appropriate
to taper patients off of medications used to treat OUD. Current
evidence clearly shows that rates of relapse increase when medications
are discontinued; relapse where highly potent synthetic opioids are
prominent put patients at especially high risk of fatal overdose and
therefore cessation of these medications should not be a treatment
priority.
Evidence-based strategies such as employing psychosocial supports,
community recovery services and MAT using medicines approved by the FDA
(buprenorphine, extended release naltrexone, and methadone) constitute
the gold standard of treatment for opioid use disorders. HHS has
invested significantly (through SAMHSA and HRSA funding) in efforts to
increase access to MAT in communities across the Nation. It also a
critical component of the Department's 5 point strategy for combating
opioid addiction.
Question. How can we increase access to non-addictive opioid
alternatives?
Answer. In answering this question, it is important to distinguish
addiction (substance use disorder) from physical dependence. Any
individual who takes a sufficient dose of opioids over a sufficient
period of time will become physically dependent on them, meaning that
individual will experience withdrawal if they discontinue or
significantly reduce their use of opioids. This does not mean that this
individual has become addicted to opioids. Addiction is characterized
by ``uncontrollable, compulsive drug seeking and use, and that persists
even in spite of negative health and social consequences. These
behaviors are much more difficult to control than the physical
dependence that underlies withdrawal symptom.'' A patient being treated
for opioid use disorder with buprenorphine or methadone is physically
dependent on the medication, but not addicted to it. Moreover,
treatment that includes one of three FDA-approved medications is the
standard of care for opioid use disorder. Therefore, medication should
be part of the front-line response, just as it is for high blood
pressure, diabetes, or high cholesterol. Medications for the treatment
of opioid use disorder can be more effective when used in combination
with behavioral and/or psychosocial interventions. This combination of
medication and psychosocial interventions is known as medication-
assisted treatment (MAT).
While it is not desirable to reduce the use of medication for the
treatment of opioid use disorder, it is important to complement
medication with behavioral treatment that utilizes evidence-based
approaches, such as cognitive behavioral therapy. In addition, it is
critically important to support the use of non-addictive medications
and non-pharmacological interventions for the management of pain and to
support continued research and development in relation to non-addictive
medication. One way HHS is working to make pain management safer is by
pushing for insurance to cover opioid alternatives whether they are for
pain treatment or for addiction treatment (e.g., extended release
naltrexone).
One of the barriers to use of extended release naltrexone is the
medical requirement for abstinence from opioids for 7-10 days prior to
initiation of the naltrexone injection. Many people simply drop out
prior to starting this medicine for opioid relapse prevention. Coverage
for inpatient detoxification services can help but they must be
followed by ongoing treatment. Additionally, FDA approved lofexidine to
help people endure the withdrawal period so they can initiate extended-
release naltrexone. More payors need to cover lofexidine to enable more
patients the opportunity to start extended release naltrexone.
Question. How can we ensure that early intervention in addiction
treatment is a part of mainstream health care?
Answer. The HHS Five-Point Strategy to combat opioid misuse,
addiction, and overdose supports early intervention. One of the
activities detailed under the first strategy ``Better Addiction
Prevention, Treatment, and Recovery Services'' is: ``Identify
individuals who are at risk of opioid use disorder and make available
prevention and early intervention services and other supportive
services to minimize the potential for the development of opioid use
disorder (OUD).''
It is essential to advocate and support evidence-based practices
with the aim of prevention and early intervention and to promote
screening, assessment, and treatment as part of mainstream health care.
Question. In medical marijuana States, marijuana advocates promote
replacing opioids with marijuana to alleviate opioid addiction. Would
you suggest those with opioid dependence use marijuana as a substitute
for or as a type of MAT?
Answer. HHS would not suggest marijuana as a substitute for FDA-
approved medications for the treatment of opioid use disorder. While
some States have legalized the use of marijuana for recreational or
medicinal purposes, the FDA has not approved marijuana containing THC
as medicine to treat opioid use disorder.
No, marijuana should not be promoted as a replacement treatment for
opioid use disorder. Few scientific studies have addressed whether
marijuana may be an effective or safe treatment for this purpose and
those that have been done have significant limitations. Marijuana use,
particularly long term, has been associated with harmful effects
specifically in adolescents and during pregnancy. Medication-
Assisted Treatments, in combination with behavioral therapies, are
strongly recommended for patients with opioid use disorder given the
robust base of evidence for their safety and effectiveness.
______
Questions Submitted by Hon. Ron Wyden
Question. The lack of access to safe, effective treatment for
addiction is its own health-care crisis. The examples that the
Government Accountability Office has provided are just the tip of the
iceberg when it comes to scam artists trying to take advantage of those
who are desperate for help. You are an accomplished doctor and public
health professional. There are many families like yours who have loved
ones struggling with substance use disorders but they do not have the
same medical expertise or financial resources that you had. For them,
the job is even tougher. How do they find good treatment? What red
flags should they avoid? What should the Finance Committee be doing to
make sure those seeking treatment have access to the high-quality care
they deserve?
There are a variety of factors involved with accessing safe and
effective health care. It's important to have open dialogue with
physicians and other health professionals so they are aware of past
opioid use and whether they should be looking for alternative treatment
options for their patient's pain. When it comes to finding treatment,
HHS now offers several mechanisms to find opioid treatment programs.
When a person enters their zip code (anonymously), they will be taken
to the Substance Abuse and Mental Health Services Administration
(SAMHSA) facility finding map.\11\ Another option is https://
findtreatment.gov, which also includes treatment types, distance from
location and payments accepted. Information on the signs of quality
treatment that patients and their families should be looking can be
found in Finding Quality Treatment for Substance Use Disorders.\12\
NIDA also provides guidance to help individuals seeking treatment know
what to ask at Seeking Drug Abuse Treatment: Know What to Ask.\13\
NIAAA provides guidance on identifying quality alcohol treatment
providers at Find Your Way to Alcohol Treatment.\14\ Additionally, most
specialty substance use disorder treatment facilities treat both
alcohol and other drug use disorders. I will continue to work with my
office, and HHS as a whole to improve access to families impacted by
OUD.
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\11\ https://findtreatment.samhsa.gov/locator.
\12\ https://store.samhsa.gov/system/files/pep18-treatment-loc.pdf.
\13\ https://www.drugabuse.gov/publications/seeking-drug-abuse-
treatment-know-what-to-ask/introduction.
\14\ https://alcoholtreatment.niaaa.nih.gov/.
Stigma plays a huge role in this realm and is a major barrier to
treatment and to recovery. We must help people to not only feel
comfortable having a conversation about addiction, but empower them to
take action when they notice family members are misusing prescribed
medicines or involved with illicit drugs. That's why I am so open about
my family's addiction struggles, and it's why I asked all the Senators
to share my opioid postcard, which lists the steps everyone can take to
better understand, and respond to the opioid epidemic. Additionally,
one of my priorities is to ensure that everyone carries naloxone and
knows how to use it. It only takes a few moments to save a life, and I
ask that you and the other Senators share my naloxone advisory, and
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learn about and carry naloxone yourselves.
In FY 2017, HRSA established the Substance Abuse Treatment
Telehealth Network Grant Program, a 3-year pilot program that uses
telehealth networks to improve access to substance use treatment
services in rural, frontier, and underserved communities. In FY 2017
and FY 2018, HRSA awarded approximately $675,000 to three recipients.
Additionally, HRSA's Evidence-Based Tele-Behavioral Health Network
Program increases access to behavioral health-care services in rural
and frontier communities. Through this program, in FY 2018, HRSA
awarded $524,000 to two recipients that are primarily focused on using
telehealth services for OUD treatment. Support to these programs
continues in 2019.
______
Question Submitted by Hon. Benjamin L. Cardin
Question. Do you know if Federal agencies are collaborating with
State and local governments to inform consumers of the dangers of sober
homes and patient brokering practices?
If not, what could the Federal Government do to educate consumers
about quality treatment programs for their loved ones and how to
identify patient brokering scams?
Answer. In response to the questions above: It is important to
promote and educate the public on the evidence-based practices
supported by HHS and the strategies listed in the HHS 5 point strategy
to combat opioid abuse, misuse, and overdose. One tool that can be used
by the public to find quality treatment is findtreatment.gov; this
website provides the public treatment options close by these
individuals. Some of the publications developed by HHS to help
individuals find quality treatment include: https://store.samhsa.gov/
system/files/pep18-treatment-loc.pdf; https://www.drugabuse.gov/
publications/seeking-drug-abuse-treatment-know-what-to-ask/introduction
and https://alcoholtreatment.niaaa.nih.gov/.
While not a form of treatment, recovery (sober) housing is a
critical component of the service continuum. Therefore it is important
to be able to differentiate quality recovery residences from those that
that exploit patients and payers. Subtitle D of the SUPPORT Act,
Ensuring Access to Quality Sober Living, required the HHS Secretary to
identify or facilitate the development of best practices for operating
recovery housing. In response to this requirement, SAMHSA released
recovery housing best practices and suggested guidelines that can be
found here: https://www.
samhsa.gov/sites/default/files/housing-best-practices-100819.pdf.
Building on existing standards, this guidance can help establish
criteria for quality recovery residences. Elimination of fraudulent
sober homes and patient brokering practices will require coordinated
action involving funders, regulators, and law enforcement at the
Federal, State, and local levels.
______
Questions Submitted by Hon. Sherrod Brown
non-opioid alternatives to pain treatment
Question. Congress has taken several steps over the past few years
to provide additional tools, resources, and authority to the
administration to support and promote the development of non-addictive
pain treatments. Emphasizing the use of non-opioid alternatives should
be a critical part of the Trump administration's strategy to confront
this devastating public health crisis. Senator Young focused on this
issue as part of his remarks during the hearing.
Can you please provide an update on the administration's efforts
thus far to support the development and prioritization of these new
products that help prevent addiction in the first place? Please specify
what each agency tasked with doing more in this space has worked on
(including, at the very least, CDC, FDA, CMS, NIH, DoD, VA).
Answer. While we would be pleased to provide an update on the
activities of HHS agencies and their work with non-HHS departments/
agencies, including DoD and VA, it would not be appropriate for HHS to
comment on other Departments' efforts in this domain as HHS does not
oversee those activities. The Office of National Drug Control Policy
coordinates relevant activities across the departments and agencies
have a role in the Nation's response to drug use and its consequences.
Two tenets of the HHS Five-Point Strategy to address the opioid
crisis support the development and prioritization of non-opioid
alternatives. These strategies are better pain management and better
research. One example of the promotion of non-opioid alternatives in
treating pain was The Pain Management Best Practices Interagency
Taskforce Report. This report was the culmination of a Federal advisory
group that was comprised of 29 private-sector and Federal members
overseen by HHS in cooperation with the Department of Veterans Affairs
(VA) and the Department of Defense (DoD). Another example of the
promotion of non-opioid alternatives is CMS's proposal to cover
acupuncture for Medicare patients with chronic low back pain in
clinical trials supported by the NIH or in CMS-approved studies. In
response to the President's Commission on Combating Drug Addiction and
the Opioid Crisis recommendation as well as stakeholder requests and
peer-reviewed evidence, CMS finalized beginning in 2019 to pay
separately for non-opioid pain management drugs that function as a
supply when used in a covered surgical procedure performed in the
ambulatory surgical center setting. CMS is also continuing to analyze
the issue of access to non-opioid alternatives in the hospital
outpatient department and the ambulatory surgical center settings for
which our payment policy should be revised to allow separate payment as
appropriate. In addition, CMS provided guidance to States seeking to
promote non-opioid options for chronic pain management,\15\ and
encourages Medicare Advantage plans to consider benefit designs for
supplemental benefits that address medically-approved non-opioid pain
management and complementary and integrative treatments.\16\ CMS also
implemented Section 6021 of the SUPPORT Act, by including information
on non-opioid pain management in the 2020 Medicare and You Handbook.
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\15\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib022219.pdf.
\16\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf.
The agency for Health Research and Quality (AHRQ) released a
systematic review on the non-pharmacological treatments for chronic
pain. This review examined many common chronic pain classifications and
non-pharmacologic treatments for them. The NIH HEAL Initiative is
another program that, in part, aims to accelerate the discovery and
pre-clinical development of non-addictive pain treatments, and advance
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new non-addictive pain treatments through the clinical pipeline.
The NIH Helping to End Addiction Long-term (HEAL) Initiative is a
broad effort to address the opioid crisis through evidence-based
strategies. It significantly expands research to discover and
accelerate development of non-addictive pharmacological and non-
pharmacological pain treatments. Through the HEAL initiative, NIH
supports programs to discover and accelerate development of new
medications and devices to treat pain. HEAL established preclinical
screening platforms to test for potential new non-addictive pain
treatments. The platforms will use animal-based and human cell-based
models such as neural tissue chips for rapid screening of molecules or
devices for analgesic relevant biological and behavioral activity.
Through HEAL, NIH also is partnering with academia and industry to
bring in promising new drugs and devices for early phase human testing
of novel therapeutics in the newly established Early Phase Pain
Investigation Clinical research network (EPPIC-NET). Trials in this
network will test the safety and efficacy of novel drugs and devices
and support discovery research on a wide range of pain conditions. NIH
also established the Pain Management Effectiveness Research Network to
support phase 3 effectiveness trials which will support a range of
trials on pharmacological and nonpharmacological therapies for many
different pain conditions. Implementation research to evaluate and
embed effective pain management strategies into large health care
systems also are supported by HEAL.
Under section 3001 of the SUPPORT Act (clarifying FDA regulation of
non-
addictive pain products), FDA has taken the following actions to date.
In November 2018, FDA held an advisory committee meeting to discuss the
assessment of opioid analgesic sparing outcomes in clinical trials of
acute pain. Opioid analgesic sparing is when non-opioid drugs are used
to provide analgesia that would otherwise be provided with opioids.
This can reduce patient exposure to opioids as well as the number of
leftover opioids available for abuse or misuse in the community. FDA
issued a June 2019 draft guidance, Opioid Analgesic Drugs:
Considerations for Benefit-Risk Assessment Framework, which describes
the benefit-risk assessment framework that the agency uses in
evaluating applications for opioid analgesic drugs and summarizes the
information that can be supplied by opioid analgesic drug applicants to
assist the agency with its benefit-risk assessment, including
considerations about the broader public health effects of these
products in the context of the opioid crisis. In September 2019, FDA
held a Part 15 hearing to gain feedback on and further discuss the
agency's benefit-risk assessment of opioid analgesics, including the
manner in which risks of misuse and abuse of these products factor into
that assessment. The agency also requested input on potential new
preapproval incentives aimed at fostering the development of new
therapeutics to treat pain or addiction.
Question. Can we count on you to work with your partners across the
Federal Government to make non-addictive alternatives to pain
management a priority?
Answer. Yes. Throughout my time as U.S. Surgeon General, I have
prioritized the opioid crisis and what we can do to change and
eventually eliminate this issue. In my travels around the country, I
have engaged key stakeholders and gathered experts, community leaders,
and families deeply impacted by opioid use. I issued evidence-based
guidance on opioid treatment and continue to disseminate a digital
postcard detailing five key actions to prevent opioid misuse. I also
emphasize the importance of alternatives to opioids, as well as
reducing barriers to treatment, the need for increased funding, and the
importance of addressing stigma.
The Pain Management Best Practices Interagency Task Force Final
Report was issued in May 2019. This report discussed acute and chronic
pain management best practices and emphasized a balanced,
individualized, patient-centered approach. This Task Force was a
Federal advisory group comprised of 29 Federal and private-sector
members overseen by HHS in cooperation with VA and DoD.
The 2016 CDC Opioid Prescribing Guideline for Chronic Pain, States
that clinicians should ensure that patients are aware of potential
benefits of, harms of, and alternatives, to opioids before starting or
continuing opioid therapy.
the methamphetamine crisis
Question. During the hearing, Senator Daines spoke about the
methamphetamine crisis he has seen in his home State of Montana and
especially within Native American tribes. We are seeing a similar
challenge with methamphetamine in the State of Ohio, and there is a
need to do more. In responding to questions from Senator Daines, you
mentioned that there are no options available to help treat meth
addiction (that are comparable to medication-assisted treatment for
opioid use disorder), so our focus should be on the supply side of this
crisis.
Most experts agree that we need a multi-solution approach for the
addiction crisis. We will never tackle supply if we do not first tackle
demand. What would your strategy be to help prevent addiction in the
first place as a way to address the growing methamphetamine crisis?
Answer. We must continue to get ``upstream'' by recognizing and
addressing the root causes of addiction. These include learning about,
screening for, and addressing Adverse Childhood Experiences (ACEs),
social determinants of health, mental illness, and other challenges
that may lead people to seek relief through illicit drugs. I have
spoken about stigma in relation to drug use but it also operates to
prevent those who are suffering from mental health conditions from
speaking out and seeking care.
A complex interplay exists between supply and demand. Without
efforts to reduce supply, our prevention programs continue to be
challenged. It is critical to have effective prevention and reduction
efforts working simultaneously to make headway against the addiction
crisis.
medicaid coverage for those incarcerated pretrial
Question. During the hearing, Senator Cassidy raised an issue I
have been working on with Senator Markey for several years--the fact
that Medicaid coverage is revoked when an individual is incarcerated
pretrial. According to the National Association of Counties, local
jails admitted 10.6 million individuals in 2017. Approximately 65
percent of these inmates are in pretrial status, meaning that they are
awaiting disposition of charges and have yet to be convicted of any
crime. Some individuals in pretrial status are able to return to the
community while they wait for disposition of their charges. Others may
remain in custody if, for example, they are unable to post bail.
Because of the Medicaid inmate exclusion, Medicaid will not cover
health-care services for a pretrial detainee because the individual is
in custody. But Medicaid would cover the same health-care services for
the same individual in pretrial status if that person awaited trial
outside of custody.
In this country, the law states that you are innocent until proven
guilty. However, the Medicaid inmate exclusion results in the loss of
health insurance coverage before any court makes a determination on
whether or not the individual is guilty. Do you agree that we should be
doing more to remove barriers to care for all individuals, including
justice-involved populations?
Answer. HHS agrees that it is important to prioritize removing
barriers to care for all individuals, including justice-involved
populations. A longstanding provision of the Medicaid statute excludes
Medicaid payment for services provided to inmates of public
institutions. It is an important responsibility of the appropriate
State or local government to provide health-care services to inmates
who are in their custody and HHS would be concerned about simply
shifting financial responsibility of State or local inmates' health
care to Federal taxpayers. HHS maintains its commitment to these
populations and important work is happening in the Department to
implement sections 1001 and 5032 of the SUPPORT for Patients and
Communities Act (Pub. L. 115-271) to better support inmates leaving
jails and prisons and connect them to health care, including Medicaid
coverage when they are eligible, more quickly and seamlessly upon
release.
Question. Will you commit to working with your colleagues across
the administration to solve the Medicaid inmate exclusion and ensure
continuation of coverage for pretrial detainees?
Answer. As previously stated, it is a longstanding provision of the
Medicaid statute that excludes Medicaid payment for services provided
to inmates of public institutions. HHS maintains its commitment to
these populations; however, the Department would be concerned about
simply shifting financial responsibility of State or local inmates'
health care to Federal taxpayers.
______
Questions Submitted by Hon. Maggie Hassan
Question. I am greatly appreciative of your support for expanded
access to evidence-based treatments, including medication-assisted
treatment, for those suffering from opioid use disorder.
Earlier this year I joined with Senator Murkowski to introduce
legislation that would eliminate the waiver requirement that keeps many
health care providers from prescribing buprenorphine.
Can you please identify the clinical benefits of medication-
assisted treatment, and list any specific policies being considered by
Department of Health and Human Services that would address the barriers
that limit access to medication-assisted treatment?
Answer. Medicines involved in medication-assisted treatment
(buprenorphine, naltrexone, and methadone) operate to normalize brain
chemistry, block the euphoric effects of opioids, relieve cravings and
normalize body functions without the negative effects of the misused
drug. These medications have been approved by the FDA and the
overarching MAT programs are clinically driven to meet each patient's
needs.
The law allows coverage and payment for opioid use disorder
treatment and services in a range of settings including in an Opioid
Treatment Program accredited and certified by SAMHSA. Buprenorphine and
naltrexone can also be prescribed in
office-based settings. It is important that health-care providers
receive effective training to safely provide their patients with the
best options available, but unfortunately most clinicians have received
little to no training on addiction. That's why I have co-written a
number of articles and visited numerous clinician training programs
calling on ALL providers to receive training in addiction prevention,
diagnosis, and treatment.
To that extent, for example, SAMHSA continues to provide education
and training to providers on MAT through webinars, workshops,
publications, and research, as well as buprenorphine and opioid
prescribing courses for physicians.
HHS continues to work internally to identify policies and
strategies that can help remove barriers to care for individuals
struggling with addiction. For example, two of our priorities moving
forward include exploring opportunities to enhance emergency room MAT
and warm hand-offs following an overdose, as well as working to improve
MAT during transitions into, and our of, the criminal justice system.
Finally, my office continues to emphasize the importance of
eliminating stigma, a major impediment to seeking treatment and
support. By acknowledging that addiction is a disease and not a moral
failing, we can begin to open up pathways to recovery for millions of
Americans.
Question. A recent report by the Centers for Disease Control and
Prevention illustrates the growing public health threat caused by the
dramatic increase in sexually transmitted diseases and infections
across the United States.
Cases of syphilis, gonorrhea, and chlamydia have reached all-time
high records. Since 2014, primary and secondary syphilis cases have
increased by 71 percent, and cases of gonorrhea have increased by 63
percent.\17\
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\17\ https://www.cdc.gov/std/stats18/default.htm.
Even New Hampshire--a State with historically low rates of sexually
transmitted diseases and infections--has experienced an outbreak of
gonorrhea in recent years. In 2016 alone, the New Hampshire Department
of Health and Human Services saw a 250-percent increase in cases of
gonorrhea.\18\
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\18\ https://www.dhhs.nh.gov/media/pr/2017/01192017gonorrhea.htm.
Data from the Centers for Disease Control and Prevention suggests
that drug use may be a risk factor for contracting sexually transmitted
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diseases and infections.
Please identify the steps that the Department of Health and Human
Services is taking to reduce the rate of sexually transmitted diseases
and infections among individuals suffering from substance use disorder,
including what resources the Department is providing to these
individuals.
Answer. Unfortunately, yes, the CDC estimates that 20 million new
STI cases are seen a year and the 2018 report released on October 8,
2019 indicated that chlamydia, gonorrhea, and syphilis have all
increased for the fifth consecutive year. HHS, specifically the Office
of the Assistant Secretary of Health's Office of Infectious Disease
Policy, will be releasing the first ever STI Federal Action Plan in
2020. This plan includes ways to prevent new STIs, improve the health
of people (reduce adverse outcomes of STIs), reduce STI health
disparities and integrate Federal program efforts to address STI
epidemics.
HHS is also supporting research aimed at reducing at the spread of
sexually transmitted infections associated with drug use. For example,
NIDA partnered with the Appalachian Regional Commission (ARC), CDC, and
SAMHSA to issue eight grants to help rural communities develop
comprehensive approaches to prevent and treat consequences of opioid
injection, including HIV, hepatitis C viral (HCV) infections, and
syphilis. Funded in FY 2017 and continuing into FY 2022, investigators
will work with State and local communities to develop best practices
that can be implemented by public health systems in these regions and
rural areas in other parts of the country. NIDA is also supporting a
separate study aimed at increasing access to treatment for HCV in a
rural Appalachian community in Kentucky and a project studying the
effects of linking treatment for HIV, HCV, and opioid addiction in a
community in rural northern New England. The spread of STI among people
who use methamphetamine is also a concern and area of research focus
for HHS. For example, NIDA is testing the use of mobile applications to
help men who have sex with men reduce methamphetamine use and risky
sexual behavior and to increase adherence to HIV pre-exposure
prophylaxis among men who use methamphetamine.
A common theme deeply rooted within STIs and opioid misuse is
stigma and this needs to be addressed in both instances. Increasing and
normalizing these conversations will help health care providers give
their patients safe and effective treatments.
______
Prepared Statement of Gary Cantrell, Deputy Inspector General for
Investigations, Office of Inspector General, Department of Health and
Human Services
Good morning, Chairman Grassley, Ranking Member Wyden, and
distinguished members of the committee. I am Gary Cantrell, Deputy
Inspector General for Investigations with the Department of Health and
Human Services (HHS) Office of Inspector General (OIG).
I appreciate the opportunity to appear before you to discuss OIG's
enforcement efforts and other work to address the prescribing and
treatment dimensions of the opioid crisis.
OIG is charged with overseeing all HHS programs and operations. We
combat fraud, waste, and abuse in those programs; promote their
efficiency, economy, and effectiveness; and protect the beneficiaries
they serve. To accomplish this, OIG employs tools such as data
analysis, audits, evaluations, and investigations. We are a
multidisciplinary organization comprising investigators, auditors,
evaluators, analysts, clinicians, and attorneys. We depend on our
strong public and private partnerships to ensure coordinated
enforcement success.
The Office of Investigations is the component of OIG that
investigates fraud and abuse involving HHS programs. Our special agents
have full law enforcement authority and effect a broad range of
actions, including the execution of search warrants and arrests. We use
traditional as well as state-of-the art investigative techniques and
innovative data analysis to fulfill our mission. Our office has
investigators covering every State, the District of Columbia, Puerto
Rico, and other U.S. territories. We collaborate with other Federal,
State, tribal, and local law enforcement authorities to maximize our
impact.
introduction
OIG has, for several years, identified curbing the opioid crisis as
one of the Department's Top Management and Performance Challenges, as
well as one of OIG's four priority focus areas.\1\ Key components of
that challenge include addressing inappropriate prescribing of opioids,
improving access to treatment, and stopping the misuse of grant funds.
In addition, combating fraud issues, such as drug diversion and billing
for medically unnecessary prescriptions or services not actually
rendered by providers, presents a significant challenge for the
Department. OIG's ongoing opioids-related work is taking a multifaceted
approach, looking at a variety of issues on both the prescribing and
treatment dimensions of the crisis.
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\1\ The other three priority areas are: (1) promoting patient
safety and accuracy of payments for services furnished in home and
community settings, (2) strengthening Medicaid protections against
fraud and abuse, and (3) ensuring health and safety of children served
by grant-funded programs. For each priority focus area, OIG executives
and senior-level staff develop strategies, drive action, unleash
organizational creativity, and measure impact to provide solutions and
improve outcomes for HHS programs and beneficiaries. OIG's current
priority focus areas were selected based on past and ongoing work, top
challenges facing HHS as identified annually by OIG, ability to collect
data, and ability to influence outcomes.
OIG has a longstanding and extensive history of enforcement and
oversight work focused on prescription drug fraud, drug diversion, pill
mills, medical identity theft, and other schemes that harm patients and
waste taxpayer money. For years, OIG has been acting to address a rise
in fraud schemes involving opioids, as well as associated potentiator
and treatment drugs and ancillary services. In addition to increasing
our investigative efforts to combat prescription drug abuse, we have
responded to the growing severity of the opioid crisis 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-
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related fraud.
Today, I will highlight how OIG addresses both the prescribing and
treatment dimensions of the opioid crisis through expanding law
enforcement activities, led by my Office of Investigations, as well as
new OIG work such as audits, evaluations, and data briefs, to combat
opioid-related fraud, waste, and abuse while ensuring that both
substance use disorder treatment and beneficiary continuity-of-care
needs are met.
oig's efforts to address the opioid crisis are increasing
through expanding law enforcement partnerships
Over the past 2 years, through expansion of Medicare Fraud Strike
Force districts, establishment of the Opioid Fraud and Abuse Detection
Unit Initiative, and establishment of the Appalachian Regional
Prescription Opioid (ARPO) Strike Force, OIG's enforcement efforts to
address the opioid crisis have increased significantly. For example, we
have seen an increase of more than 100 percent in open opioid-related
cases from 2015 to 2019.
Medicare Fraud Strike Force
The Strike Force effort began in Miami, FL in March 2007 and has
expanded to now include a total of 12 districts. Strike Force teams
effectively harness the efforts of OIG and the Department of Justice
(DOJ), including Main Justice, U.S. Attorneys' Offices, the Federal
Bureau of Investigation (FBI), and the Drug Enforcement Administration
(DEA), as well as State and local law enforcement, to fight health-care
fraud in geographic hot spots.
Strike Force partnerships between HHS-OIG, DOJ, U.S. Attorney's
Offices, the FBI, and the DEA are a force multiplier that utilize data
proactively to identify high-risk districts to target the worst
offenders involved in criminal conduct or fraud associated with the
improper prescription, distribution, possession, and use of opioids.
This coordinated and data-driven approach to identifying,
investigating, and prosecuting fraud has produced record-breaking
results, including the June 2018 National Health Care Fraud Takedown,
the 2019 Appalachian Regional Prescription Opioid Strike Force
Takedowns, and most recently, the 2019 Regional Health Care Fraud and
Genetic Testing Takedowns.
Appalachian Regional Prescription Opioid Strike Force
In October 2018, DOJ, in partnership with HHS-OIG, FBI, and DEA,
launched the ARPO Strike Force. The mission of the ARPO Strike Force is
to identify and investigate health-care fraud schemes in the
Appalachian region and surrounding areas, and to effectively and
efficiently prosecute medical professionals and others involved in the
illegal prescription and distribution of opioids. This new Strike Force
is operating out of two hubs based in the Cincinnati-Northern Kentucky
and Nashville, TN areas, and supports the six States and 10 districts
that make up the ARPO Strike Force region: eastern, middle, and western
districts of Tennessee; northern district of Alabama; eastern and
western districts of Kentucky; northern and southern districts of West
Virginia; southern district of Ohio; and most recently, western
district of Virginia. The ARPO Strike Force has spearheaded takedowns
in April and September 2019, resulting in charges against 73
individuals, including 64 medical professionals.
Collaboration With Public Health Partners
As part of the ARPO takedowns, OIG and our law enforcement partners
worked in close collaboration with HHS's Office of the Assistant
Secretary for Health (OASH), the Centers for Disease Control and
Prevention (CDC), the Commissioned Corps of the U.S. Public Health
Service, and the States' respective Departments of Health to deploy
Federal and State-level strategies and resources to provide assistance
to patients impacted by the law enforcement operations with additional
information regarding available treatment programs and where they can
turn for quality assistance. I will further discuss this new effort to
ensure continuity of care and prevent patient harm later in my
testimony.
In addition, OIG also implemented a pilot program providing OIG
special agents in the ARPO region with a nasal spray version of
naloxone--a drug that reverses the effects of an opioid overdose. The
special agents were equipped and trained to treat any law enforcement
officer who came into accidental contact with an opioid or any
individual in medical distress caused by an opioid overdose encountered
as part of the operations. OIG has expanded this program nation-wide to
ensure that we are prepared to address agent and public needs that
could arise as we engage in enforcement efforts.
Health-care Fraud Takedowns
Over the month of September, along with our Medicare Fraud Strike
Force, several U.S. Attorney's Offices, and various other Federal,
State, and local law enforcement agencies, OIG participated in a series
of health-care fraud takedowns across the country. In total, these
coordinated law enforcement activities resulted in charges against over
380 individuals, including 178 medical professionals and 105 defendants
for opioid-related offenses, who allegedly billed Federal health-care
programs for more than $3 billion and allegedly prescribed or dispensed
approximately 50 million controlled substance pills.
Overall, the 2018 National and 2019 Regional and Appalachian
Regional takedown efforts demonstrate OIG's commitment to rooting out
fraud in HHS's opioid prescribing and treatment programs, helping to
protect patients from harmful prescribing and worthless treatment
services.
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 are elaborate, involving multiple co-conspirators
including healthcare professionals such as physicians, nonphysician
providers, and pharmacists, and sometimes even beneficiaries or
patients themselves. These investigations can be complex and often
involve the use of informants, undercover operations, and surveillance.
Of particular concern is fraud involving medication-assisted
treatment (MAT), sober homes, and ancillary services such as drug
screening and urinalysis. Through our oversight of opioid treatment
facilities, we have seen a recent increase in MAT-related prescription
fraud cases, particularly those involving buprenorphine.
Case Examples
The following examples highlight common schemes involving
prescription and treatment opioid-related fraud:
Prescription Fraud
In Maryland, OIG recently worked a joint case with Federal,
State, and several local law enforcement agencies to
investigate allegations that Starlife Wellness Center was
operating as a pill mill, charging patients $400 or more in
cash for each office visit in exchange for unlawful
prescriptions for large quantities of narcotics. Patient deaths
were attributed to the prescribing practices of Dr. Kofi Shaw-
Taylor and Starlife owner/general manager Tormarco Harris.
Ultimately, Dr. Shaw-Taylor and eight co-conspirators were all
indicted and charged with a variety of crimes, pled guilty, and
sentenced to prison. Harris was found guilty at trial and
sentenced to 20 years incarceration without the possibility of
parole, 5 years probation, and a $10,000 fine.
Treatment-Related Fraud
Dr. Rajaa Nebbari and Dr. Chethan Byadgi, owners/operators of a
medical practice in Pennsylvania that operated as an urgent-
care medical clinic and a Suboxone treatment facility, both
pled guilty to one count each of Medicaid Fraud, Theft by
Deception and Insurance Fraud. Dr. Nebbari and Dr. Byadgi
admitted to defrauding Medicaid, Medicare Part D, Medicare Part
B, and various private health insurers of between $100,000 and
$500,000. The doctors admitted to directing unlicensed
``Suboxone coordinators'' to see, treat, counsel and prescribe
Suboxone to opioid-addicted patients. As part of the scheme,
the doctors provided the Suboxone coordinators with pre-signed
prescription pads and let the Suboxone coordinators use Google
to find information on how to treat drug-addicted patients with
Suboxone and how to determine the dosage of Suboxone for the
prescription. Both doctors were sentenced to 9-23 months
imprisonment, 7 years probation, and 1,000 hours of community
service to be directed toward those impacted by drug addiction.
Additionally, both doctors were ordered to pay $198,189.06 in
restitution to the Medical Assistance program, the Medicare
Part B and D programs, and various private health insurance
companies.
Enforcement Actions Against Manufacturers
Since first taking action against executives with Purdue Pharma in
2007, OIG has been at the forefront of enforcement efforts to hold
opioid manufacturers accountable for the illegal marketing and
distribution of opioids. Notably, OIG has been heavily involved with
investigation of Insys Therapeutics, which in June of this year agreed
to a global resolution to settle the government's separate criminal and
civil investigations. Both the criminal and civil investigations, as
well as the conviction of seven former executives (including the
company's billionaire founder and CEO) in May, stemmed from Insys's
payment of kickbacks and other unlawful marketing practices to
illegally promote sales of Subsys, a sublingual fentanyl spray that is
only approved by the Food and Drug Administration for the treatment of
persistent breakthrough pain in adult cancer patients who are already
receiving, and tolerant to, around-the-clock opioid therapy. Many of
these kickbacks allegedly took the form of sham speaker programs
designed to reward high-prescribing physicians with jobs for the
prescribers' relatives and friends, and lavish meals and entertainment.
Insys also is alleged to have improperly encouraged physicians to
prescribe Subsys for patients who did not have cancer and lied to
insurers about patients' diagnoses to obtain reimbursement for Subsys
prescriptions that had been written for Medicare and TRICARE
beneficiaries. This was the first successful prosecution of top
pharmaceutical executives for crimes related to the prescribing of
opioids.
Sentencing for the executives and the plea hearing for the global
resolution have been set for next January. As part of the criminal
resolution, Insys will agree to a detailed statement of facts outlining
its criminal conduct and pay a $2 million fine and forfeiture of $28
million, while its operating subsidiary will plead guilty to five
counts of mail fraud. As part of the civil resolution, Insys agreed to
pay $195 million to settle allegations that it violated the False
Claims Act. Insys also has entered into an unprecented 5-year Corporate
Integrity Agreement and Conditional Exclusion Release with OIG.\2\
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\2\ Because of the extensive cooperation provided by Insys in the
prosecution of culpable individuals and its agreement to enhanced CIA
requirements, OIG elected not to pursue exclusion of Insys at this
time. The CIA includes several novel provisions, including enhanced
material breach provisions, designed to protect Federal health-care
programs and beneficiaries. In addition, Insys admitted to a Statement
of Facts and acknowledged that the facts provide a basis for permissive
exclusion. OIG did not release its permissive exclusion authority, as
it generally does for CIA parties in False Claims Act settlements.
Instead, OIG will provide such a release only after Insys satisfies its
obligations under the CIA (https://www.justice.gov/opa/pr/opioid-
manufacturer-insys-therapeutics-agrees-enter-225-million-global-
resolution-criminal).
OIG has been heavily involved with the indictment of pharmaceutical
company Indivior and subsequent resolution with its former parent
company,\3\ Reckitt Benckiser Group plc (RB Group) this year. In April
2019, a Federal grand jury indicted Indivior for allegedly engaging in
an illicit nation-wide scheme to increase prescriptions of Suboxone.
According to the indictment, Indivior--including during the time when
it was a subsidiary of RB Group--promoted the film version of Suboxone
(Suboxone Film) to physicians, pharmacists, Medicaid administrators,
and others across the country as less divertible and less abusable and
safer around children, families, and communities than other
buprenorphine drugs, even though such claims have never been
established. The indictment further alleges that Indivior touted its
``Here to Help'' Internet and telephone program as a resource for
opioid-addicted patients. Instead, however, Indivior used the program,
in part, to connect patients to doctors it knew were prescribing
Suboxone and other opioids to more patients than allowed by Federal
law, at high doses, and in a careless and clinically unwarranted
manner. The United States' criminal trial against Indivior is scheduled
to begin in May 2020.
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\3\ In December 2014, RB Group spun off Indivior Inc., and the two
companies are no longer affiliated.
In the meantime, in July 2019 RB Group has agreed to pay $1.4
billion to resolve its potential criminal and civil liability related
to a Federal investigation of the marketing of the opioid addiction
treatment drug Suboxone. The resolution--the largest recovery by the
United States in a case concerning an opioid drug--includes the
forfeiture of proceeds totaling $647 million, civil settlements with
the Federal Government and the States totaling $700 million, and an
administrative resolution with the Federal Trade Commission for $50
million. The $700 million settlement amount includes $500 million to
the Federal Government and up to $200 million to States that opt to
participate in the agreement. As I said at the time of the resolution
in July, with the Nation continuing to battle the opioid crisis, the
availability of quality addiction treatment options is critical. When
treatment medications are used, it is essential that they are
prescribed carefully, legally, and based on accurate information, to
protect the health and safety of patients in Federal health care
programs.
Exclusions Actions
OIG protects federally funded health care programs by excluding
certain dangerous or unscrupulous individuals and entities. Excluded
providers cannot receive payment from Federal health-care programs for
any items or services they furnish, order, or prescribe. OIG's criminal
law enforcement efforts are complemented by its efforts to exclude
problem providers from participating in Federal health-care programs.
From the start of fiscal year 2018 through the end of fiscal year 2019,
OIG has issued exclusion notices to 1,348 individuals (doctors, nurses,
other providers, business owners/employees, etc.)--including 161
physicians, 896 nurses, and 87 pharmacists/technicians--and 15 entities
(physicians' practices and other businesses) because of conduct related
to opioid diversion and abuse.
oig's efforts to combat the opioid crisis go beyond enforcement
OIG continues to augment its robust portfolio of work related to
the opioid crisis, with new and ongoing work that identifies
opportunities to strengthen program integrity and protect at-risk
beneficiaries across both the prescribing and treatment dimensions of
the crisis. OIG currently has numerous opioid-related audits and
evaluations underway covering multiple departmental programs, including
questionable opioid prescribing patterns in Medicaid and Medicare;
characteristics of Part D beneficiaries at serious risk of opioid
misuse or overdose; beneficiary access to MAT through SAMHSA's
Buprenorphine Waiver Program; SAMHSA's awarding of Opioid State
Targeted Response (STR) grants; and opioid prescribing practices in the
Indian Health Service.
Prescribing Oversight
In a series of reviews targeting provider oversight, OIG examined
actions that selected States have taken using CDC and SAMHSA funds for
enhancing prescription drug monitoring plans (PDMPs) to achieve program
goals toward improving safe prescribing practices and preventing
prescription drug abuse and misuse. In another series of reviews, OIG
identified actions that selected States took related to their oversight
of opioid prescribing and their monitoring of opioid use. Specifically,
OIG reviewed the States' policies and procedures, data analytics,
programs, outreach, and other efforts.
Treatment Oversight
SAMHSA estimates that 2 million people have an opioid use disorder
related to prescription pain relievers and/or heroin. MAT provided by
opioid treatment programs (OTPs) is a significant component of the
treatment protocols for opioid use disorder (OUD) and plays a large
role in combating the opioid crisis in the United States. SAMHSA issued
final regulations to establish an oversight system for the treatment of
substance use disorders with MAT. These regulations (42 CFR part 8)
established procedures for an entity to become an approved
accreditation body, which evaluates OTPs and ensures that SAMHSA's
opioid dependency treatment standards are met. OIG has an ongoing
review that examines whether SAMHSA's oversight of accreditation bodies
complied with Federal requirements.
Separately, OIG is reviewing potential geographic disparities in
access to MAT through SAMSHA's Buprenorphine Waiver Program, which
enables patients to access MAT through regular doctor's offices--
instead of limiting this service to OTPs. In this review, we are
determining how many providers have received waivers to prescribe
buprenorphine for MAT and whether they are located in counties likely
to have high needs for opioid treatment services.
In July 2019, building on our extensive body of work related to the
opioid crisis, which includes annual data briefs on opioid prescribing
in Medicare Part D, OIG released a data brief on the 2018 Part D data,
Opioid Use Decreased in Medicare Part D, While Medication-Assisted
Treatment Increased. We found that nearly three in 10 Medicare Part D
beneficiaries received an opioid in 2018, a significant decrease from
the previous 2 years. At the same time, the number of beneficiaries
receiving Part D drugs for MAT for OUD and the number of beneficiaries
receiving prescriptions through Part D for naloxone both increased. The
number of beneficiaries at serious risk of opioid misuse or overdose
also decreased, along with the number of prescribers with questionable
opioid prescribing for these beneficiaries. Despite this seeming
progress, concerns remain. About 354,000 beneficiaries received high
amounts of opioids in 2018, with almost 49,000 of them at serious risk
of opioid misuse or overdose. Further, about 200 prescribers had
questionable opioid prescribing for the beneficiaries at serious risk.
The data briefs help OIG and OIG's law enforcement partners
investigate high prescribers for possible fraud. We are also referring
actionable information with program integrity partners including the
Centers for Medicare and Medicaid Services (CMS), States, and the
Healthcare Fraud Prevention Partnership (HFPP), so that they can use
tools at their disposal to address high-risk beneficiaries and
prescribers that have questionable billing.
Data Analysis to Identify Questionable Prescribing, Dispensing, and
Utilization of Opioids
OIG uses data analytics to detect and investigate healthcare 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.
Although OIG's increased utilization of data analytics enhances our
enforcement and oversight efforts, there are still areas where we lack
access to reliable data that hinders our work. For example,
historically, Medicaid data have not been complete, accurate, and
timely, and have not been adequate for national analysis and oversight.
In August 2018, CMS announced that all States were submitting data to
the national Medicaid database, known as the Transformed Medicaid
Statistical Information System (T-MSIS), and that it was prioritizing
T-MSIS data quality. OIG has a history of advocating for complete and
accurate Medicaid data and is now monitoring whether the quality of T-
MSIS is suitable for program enforcement and oversight activities. In
fact, we have recently completed work assessing the completeness of
variables needed to monitor national opioid prescribing in Medicaid.
Complete and accurate T-MSIS data are critical for effective monitoring
of the opioid crisis in Medicaid, as well as general program integrity
efforts.
oig maximizes impact through strong collaboration
with public and private partners
In addition to the Strike Force Operations and Opioid Fraud and
Abuse Detection Unit law enforcement collaborations addressed earlier,
OIG works closely with several HHS agencies on initiatives to prevent
prescription drug and opioid-related fraud and abuse covering both the
prescribing and treatment dimensions of the opioid crisis.
Collaboration With CDC on Opioid Rapid Response Teams
As our enforcement and oversight efforts to address the opioid
crisis have expanded, we have come to understand the impact our
enforcement work can have on the beneficiaries we serve. We recognize
that when a clinic whose patients are prescribed opioids is shut down,
access to care for patients, including many suffering from substance
use disorders, can be disrupted. Rather than leaving these patients to
potentially turn to another fraudulent provider or street drugs to meet
their needs, we believe that it is vital that those struggling with
substance use disorder have access to treatment and that patients who
need pain treatment do not see their care disrupted. The potential
dangers of abrupt opioid withdrawal are well established and thoughtful
dose tapering may help patients discontinue opioid use safely.
Ensuring that these patients have continuity of care requires a
collaborative approach with our Federal, State, and local partners,
which has led OIG to work closely with CDC on standing up their new
Opioid Rapid Response Teams (ORRTs). The mission of this team is to
work alongside law enforcement partners to address disruptions in care
after a clinic closure by providing support to State, local, and tribal
jurisdictions; providing clinicians with resources; conducting targeted
outreach; expanding access to MAT; and building response capacity. OIG
worked closely with CDC in the planning and development of the ORRTs.
We advised them on protocols, connected them with other law enforcement
partners, prepared data and support/educational materials, and continue
to coordinate with them on deployment preparations to help focus their
efforts to maximize impact. As part of the recent ARPO takedowns, OIG
and our law enforcement partners coordinated closely with the CDC to
make sure they were able to share their technical expertise with State
and local officials and ensure that all impacted jurisdictions had
sufficient response capacity to address the impact of takedown
operations. OIG will continue to work hand in hand with our public
health partners at the CDC to ensure access to treatment and continuity
of care for beneficiaries impacted by our opioid-related law
enforcement efforts moving forward.
Other Collaboration With the Department
OIG collaborates with a number of other HHS agencies, including 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.
Additionally, in June 2018 OIG published a data analysis toolkit
that our Federal, State, and private insurance partners can use to
translate opioid prescriptions into a morphine equivalent does (MED)
and identify patients who are at risk of opioid misuse or overdose. The
CDC posted the toolkit to its public website aimed at researchers and
analysts.
The Healthcare Fraud Prevention Partnership and the National Healthcare
Anti-Fraud Association
OIG also engages with private-sector stakeholders to enhance the
relevance and impact of our work to combat health-care fraud. The HFPP
and NHCAA are public-private partnerships that address health-care
fraud by sharing data and information for the purposes of detecting and
combating 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. We also share our expertise in data analytics,
including the aforementioned toolkit and specific data resulting from
takedown operations. Through our partnership in the HFPP and
collaboration with the NHCAA, OIG strives to educate and empower
private-sector insurers to best leverage data analytics and
intelligence from the field to protect their own insured customer
population. Likewise, OIG benefits from hearing directly from private
and public partners about schemes and techniques used by other payers
to combat healthcare fraud.
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 with
law enforcement, the program integrity community, and the Department to
maximize our efforts to address both the prescribing and treatment
dimensions of the crisis. OIG will remain vigilant in identifying and
investigating emerging opioid fraud trends, especially schemes
involving patient harm and abuse.
Thank you for affording me the opportunity to discuss this
important topic with you.
______
Questions Submitted for the Record to Gary Cantrell
Questions Submitted by Hon. Chuck Grassley
Question. What policies does your office recommend that Federal,
State, and local policymakers adopt to help reduce future scams in
addiction treatment and recovery housing?
Answer. The Office of Inspector General (OIG) has not conducted
audits or evaluations that specifically address how to reduce scams in
addiction treatment and recovery housing, and as such we do not have
formal recommendations to offer at this time. However, as we continue
to carry out enforcement actions and identify vulnerabilities in this
space, we will follow up to offer you and your staff a briefing.
Question. I understand that the OIG currently is assessing the
effectiveness of States' efforts to monitor opioid treatment programs'
services and medications in accordance with the Federal guidelines for
opioid treatment programs. Can you share any preliminary findings or
emerging trends that you have observed to date?
Answer. In March 2019, OIG published an audit report (A-02-17-
02009) in which we found that New York failed to trace Substance Abuse
Prevention and Treatment Block Grant (SABG) funds to a level of
expenditure adequate to establish that the funds were used for their
program's intended purpose. Specifically, New York used estimated
expenditure data to advance SABG funds to providers and subsequently
reported these payments as expenditures to the Substance Abuse and
Mental Health Services Administration (SAMHSA). In addition, New York
did not record information (e.g., provider names) needed to effectively
account for or trace the payments to SABG expenditures. By not
implementing procedures for reporting actual expenditures and tracing
payments, New York may have retained unexpended funds and hindered its
ability to ensure that substance abuse prevention and treatment
programs received the funds needed to provide timely interventions to
people at risk for and suffering from substance use disorders. We also
found that New York does not have procedures in place to determine
whether providers accurately report Medicaid revenues. Specifically,
the one opioid treatment provider we reviewed received more than $1.8
million in excess SABG funding from New York because the provider
underreported Medicaid revenue on its fiscal report. This excess
funding occurred because State agency staff who reconciled providers'
fiscal reports did not have access to necessary data.
OIG also reviewed States' oversight of opioid prescribing and
monitoring of opioid use. OIG published State fact sheets and a July
2019 audit report (A-09-18-01005) based on this work. The fact sheets
list actions that States took in five categories: policies and
procedures, data analytics, outreach, programs, and other efforts. The
audit report contains State-by-State comparisons of actions that the
initial eight States took related to the five categories, including
opioid prescribing limits compared with the Centers for Disease and
Control and Prevention's (CDC's) Guidelines for Prescribing Opioids for
Chronic Pain.
______
Questions Submitted by Hon. John Thune
Question. This summer, the Department's Inspector General issued a
report on opioid dispensing at Indian Health Service (IHS) facilities.
The report found that IHS hospitals did not always follow agency
established prescribing and dispensing protocols and had IT
vulnerabilities that could affect patient outcomes.
These problems included failure to complete agency established
treatment follow up and drug testing for opioid patients, and failure
to check medical records before dispensing opioids prescribed by non-
IHS providers.
Can the IG project how widely these problems may be spread outside
of the five facilities studied?
Answer. Our observations were specific to the five IHS-operated
facilities that we visited, although some of our observations could
apply more broadly because they were identified in all five hospitals.
Therefore, we have recommendations for IHS to implement controls,
including policies and procedures that will affect all IHS Federal
facilities.
Question. When will the IG follow up to ensure the recommendations
IHS agreed to are implemented?
Answer. In resolving Federal audit recommendations, IHS must comply
with Office of Management and Budget Circular A-50, which requires
``prompt resolution and corrective actions on audit recommendations.
Resolution shall be made within a maximum of 6 months after issuance of
a final report.'' As a result, IHS is required to prepare an OIG
Clearance Document (OCD) and provide it to OIG within 6 months of the
final report. The OCD is due to the OIG by January 16, 2020. The OCD
will contain IHS's concurrence or non-concurrence decision, along with
any action taken, for each recommendation. Once IHS submits the OCD,
OIG will assess the actions taken, conduct any follow-up, and monitor
the resolution of the recommendations.
______
Questions Submitted by Hon. Patrick J. Toomey
Question. How can the Federal Government coordinate and communicate
better with private health plans in Medicare and Medicaid to ensure
actions are being taken swiftly to root out the fraudulent behaviors of
these addiction treatment facilities?
Answer. The Federal Government can better coordinate and
communicate with private health plans through leveraging relationships
with public-private program integrity partners such as the Healthcare
Fraud Prevention Partnership (HFPP) and the National Healthcare Anti-
Fraud Association (NHCAA).
HFPP and NHCAA are public-private partnerships that address health-
care fraud by sharing data and information for the purposes of
detecting and combating 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. We also share our data analytics
expertise as well as specific data resulting from takedown operations.
Through our partnership in the HFPP and collaboration with the NHCAA,
OIG strives to educate and empower private-sector insurers to best
leverage data analytics and intelligence from the field to protect
their own insured customer population. Likewise, OIG benefits from
hearing directly from private and public partners about schemes and
techniques used by other payers to combat health-care fraud.
We also note the new authorities granted under sections 2008 and
6063 of the SUPPORT [Substance Use--Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities] Act, which
will enhance the ability of CMS and plan sponsors to share data and
information regarding bad actors, take swift action based on such data
and information, and enhance the means for more effective law
enforcement referrals based on plan sponsor reporting.
Question. What impact is illicit fentanyl having on our country
compared to illicit opioids?
Answer. OIG does not specifically investigate illicitly
manufactured fentanyl, such as some types of ``street'' fentanyl that
were illegally imported or smuggled into the United States, and so we
would refer you to the Surgeon General, CDC, and SAMHSA for HHS
information on this issue. OIG does, however, investigate allegations
of fraud and abuse involving prescription fentanyl products that are
legitimate Food and Drug Administration-approved medications, but then
become ``illicit'' when they are prescribed without medical necessity
or diverted from the normal chain of commerce through Federal health-
care programs. For example, our investigators and attorneys have been
heavily involved with the recent criminal and civil investigations of
Insys Therapeutics over allegations involving the unlawful marketing of
Subsys, a sublingual fentanyl spray. In May 2019, seven of Insys
Therapeutics' former executives were convicted. In June 2019, the
company agreed to a global resolution to settle the government's
separate criminal and civil investigations. As part of the criminal
resolution, Insys will agree to a detailed statement of facts outlining
its criminal conduct and pay a $2 million fine and forfeiture of $28
million, while its operating subsidiary will plead guilty to five
counts of mail fraud. As part of the civil resolution, Insys agreed to
pay $195 million to settle allegations that it violated the False
Claims Act.
Additionally, at an operational level, the spread of illicit
fentanyl poses unique safety risks. Given fentanyl's lethality even in
very small doses, OIG now equips our agents in the field with naloxone,
a drug that can be administered to reverse opioid overdoses.
Question. If a drug treatment facility does not have to be
certified, how do consumers, States and the Federal Government and
other payers ensure it is providing the resources it advertises?
Answer. Although we have no ongoing work related to facilities that
have not been certified, we currently have ongoing work on SAMHSA's
Oversight of Accreditation Bodies for Opioid Treatment Programs (W-00-
18-59035). SAMHSA issued final regulations to establish an oversight
system for the treatment of substance use disorders with MAT. These
regulations (42 CFR part 8) established procedures for an entity to
become an approved accreditation body, which evaluates Opioid Treatment
Programs and ensures that SAMHSA's opioid dependency treatment
standards are met. Our objective is to determine whether SAMHSA's
oversight of accreditation bodies complied with Federal requirements.
We will reach out to your office to offer a briefing for you or your
staff as soon as we have findings we can share.
Question. Do any of the States stand out as high performers when it
comes to oversight and regulation of addiction treatment centers?
Please provide examples.
Answer. OIG has no work looking at this specific issue.
Question. How much money do Federal insurance programs (FEHB,
TRICARE, Medicare, Medicaid, etc.) spend on drug treatment and how much
of it is suspected of being fraud? What, if any, are the challenges in
quantifying this?
Answer. OIG has no work looking at this specific issue.
______
Questions Submitted by Hon. Ron Wyden
Question. Prior to the hearing, the Office of Inspector General
(OIG) told my staff that there were numerous examples of drug treatment
providers that OIG had investigated. Your written testimony furthermore
stated that ``[o]f particular concern is fraud involving medication-
assisted treatment (MAT), sober homes, and ancillary services such as
drug screening and urinalysis. Through our oversight of opioid
treatment facilities, we have seen a recent increase in MAT-related
prescription fraud cases, particularly those involving buprenorphine.''
However, your testimony only cited one specific example of such fraud
and provided no statistics to substantiate the claim of increased MAT-
related fraud. In order to gain a more comprehensive understanding of
the changing scope of MAT-related fraud:
Please provide data regarding the OIG's MAT-related caseload on an
annual basis since 2013 that substantiates the ``recent increase in
MAT-related prescription fraud cases,'' referred to in your testimony.
Examples of such data are the number of arrests, convictions,
settlements and convictions related specifically to MAT fraud; the
dollar value of MAT-related fraud schemes; and the dollar value of
restitution paid in relation to settlements and convictions.
Answer. Please find our response to this QFR on the following page.
National Opioid Addiction Treatment Cases
--------------------------------------------------------------------------------------------------------------------------------------------------------
CY 2013 CY 2014 CY 2015 CY 2016 CY 2017 CY 2018 CY 2019 CY 2020 Totals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Complaints Received 6 7 6 14 23 37 34 5 132
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cases Opened 5 5 6 14 20 33 36 7 126
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indictments 0 0 2 9 13 34 47 6 111
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criminal Actions 0 0 0 0 8 9 26 10 53
--------------------------------------------------------------------------------------------------------------------------------------------------------
Civil/CMPL Actions 0 0 5 6 2 5 7 0 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expected Receivables $- $- $12,871,210 $13,039,631 $1,906,052 $20,470,279 $1,430,579,113 $31,400,254 $1,510,266,539
--------------------------------------------------------------------------------------------------------------------------------------------------------
Important Points to Note Regarding This Data:
This data includes all cases where substance use disorder treatment was a primary focus of the investigation. Our criteria for inclusion incorporate
a wide variety of fraud schemes, including medication-assisted treatment (MAT)-related prescription fraud cases, sober homes, false behavioral health
service claims, fraud in ancillary services such as drug screening and urinalysis, and other illicit conduct.
However, it is important to note that since many MAT medications (i.e., buprenorphine) are opioids, OI cases where MAT diversion is present but
secondary to a larger opioid diversion scheme are not captured above and are aggregated under our broader drug-related statistics. For this reason, we
have also included a table providing data for the last 4 fiscal years of our drug related cases below.
OI Drug-Related Stats CY 2016-CY 2020
(using allegations 387-Drug Controlled Substances, 393-Drug Diversion, 320-Drug Trafficking)
----------------------------------------------------------------------------------------------------------------
CY 2016 CY 2017 CY 2018 CY 2019 CY 2020 5-Year Total
----------------------------------------------------------------------------------------------------------------
Complaints 280 404 480 348 58 1,570
Received
----------------------------------------------------------------------------------------------------------------
Cases Opened 214 325 389 337 30 1,295
----------------------------------------------------------------------------------------------------------------
Cases Closed 171 177 215 269 71 903
----------------------------------------------------------------------------------------------------------------
Indictments 153 201 335 271 17 977
----------------------------------------------------------------------------------------------------------------
Criminal 144 118 139 235 39 675
PActions
----------------------------------------------------------------------------------------------------------------
Civil/CMPL 2 11 19 5 1 38
Actions
----------------------------------------------------------------------------------------------------------------
Total Money $383,816,380 $30,259,188 $37,346,644 $56,026,597 $12,827,072 $520,275,881
----------------------------------------------------------------------------------------------------------------
Cases Worked 308 382 544 596 463 2,293
Jointly With
DEA
----------------------------------------------------------------------------------------------------------------
Question. My staff gathered the following examples of fraudulent
substance use disorder treatment schemes. Please confirm whether the
examples gather by my staff are consistent with the types of ``MAT-
related prescription fraud'' referred to in your testimony. Please
provide additional examples of such schemes.
2015
Massachusetts--A physician was sentenced to serve 11 months in
prison and ordered to pay $9.3 million in restitution for
providing kickbacks from Medicaid reimbursements, filing false
Medicaid claims, and larceny. The physician owned 29 medical
branches throughout Massachusetts and engaged in a complex
scheme to pay bribes and kickbacks to sober home owners to have
their residents use his labs for urine drug screenings, even
though these residents were never treated by any of the
provider's offices. The physician billed tens of thousands of
urine drug tests to the Massachusetts Medicaid program
(MassHealth), which generally reimburses providers $100 to $200
per test.
2016
Virginia--Owners of a lab and an addiction treatment practice
were sentenced to 3 years in prison and ordered to pay more
than $1.4 million in restitution for billing the Virginia and
Tennessee Medicaid programs, Medicare, and other insurers
between $120 and $1,800 for medically unnecessary urine drug
screenings. Insurance programs were billed for these tests
twice a week for each patient, and tests were not used to
direct patient care.
2017
Pennsylvania--Two physicians were sentenced to 9 to 23 months
each in county prison and ordered to pay $200,000 in
restitution for felony conspiracy to commit unentitled
reimbursement, theft by deception, and insurance fraud; their
medical licenses were also suspended for 3 years. The
physicians directed untrained, non-physician, staff members to
write prescriptions for Suboxone and submitted false claims to
Medicaid, Medicare, and private insurance showing that the
physicians performed these services.
Florida--A total of 124 defendants were charged with offenses
relating to their alleged participation in various fraud
schemes involving over $337 million in false billings of
Medicaid, Medicare, and other Federal health-care programs for
services including substance abuse treatment and lab testing
fraud, among other charges, as part of the annual Federal
National Healthcare Fraud Takedown. The defendants allegedly
participated in schemes to submit claims to Medicare, Medicaid,
TRICARE, and private insurance companies for treatments that
were medically unnecessary and often never provided. In many
cases, patient recruiters, beneficiaries, and other co-
conspirators were allegedly paid cash kickbacks in return for
supplying beneficiary information to providers, so that the
providers could then submit fraudulent bills to Medicare for
services that were medically unnecessary or never performed.
Collectively, the doctors, nurses, licensed medical
professionals, health care company owners and others charged
are accused of submitting a total of over $2 billion in
fraudulent claims.
2018
Pennsylvania--Four doctors were sentenced to 24 to 48 months in
prison and ordered to pay more than $4.6 million in restitution
for conspiracy to distribute controlled substances,
distribution of controlled substances, and health-care fraud.
The physician owner of a medical clinic and employed physicians
prescribed large doses of Suboxone and Klonopin together to
patients regardless of medical need in exchange for large cash
payments. Expert opinion is that these two medications should
never be prescribed together except in rare cases when
medically necessary. The physician owner also helped his
customers to pay for these illegally prescribed drugs by
providing false information to health insurance companies.
2019
Pennsylvania--A physician operating as the medical director of
a network of addiction treatment centers was sentenced to 37
months in prison and ordered to pay $2,484,864 in restitution.
The sentencing included health-care fraud, signing blank
prescription forms and patient orders and ordering medically
unnecessary testing for patients he never saw. Two other
individuals were also charged in connection with this health-
care fraud scheme. A State grand jury investigation also found
that employees of these treatment centers signed up vulnerable
patients for ``platinum'' insurance policies and paid their
premiums in order to bill private insurance companies about $17
million between July 2015 and early 2018 for treatment that was
substandard, medically unnecessary, or not rendered. Employees
also directed patents to live at facility-owned, unlicensed
sober homes, where they were not permitted to come and go
freely, were subjected to residents' use of drugs and alcohol,
making them susceptible to relapse (and overdose), and subject
to sexual harassment and abuse.
Ohio--A recovery center owner and five employees pleaded guilty
in Federal court to crimes related to a health care fraud
conspiracy. Between January 2015 and October 18, 2017, the
defendants submitted billing to Medicaid for drug and alcohol
services that were coded to reflect a service more costly than
was actually provided without proper documentation or valid
diagnoses, billing for patients whose records did not contain a
physician diagnosis, billing for case management services that
were not provided (clients were working out at the recovery
center owner's gym, and billing for inpatient detox and drug
treatment services that were provided in an outpatient
setting), among other violations. The recovery center submitted
over 100,000 claims to Medicaid for more than $48.5 million in
services it claimed to provide between May 2015 and October
2017, which resulted in Medicaid reimbursements of more than
$31 million.
Answer. The following are additional examples compiled by HHS OIG:
Addiction Specialist, Inc.--A doctor and his wife owned a
behavioral health center through which they fabricated mental
health treatment records for payment and falsified patient
names to get Medicaid to pay for Suboxone. Mental health
``therapy'' was provided to patients by unqualified employees
who had no training in behavioral health. Suboxone and
methadone accounting/control on site was poor, and individuals
who were not actual patients were given prescriptions.
https://www.justice.gov/usao-wdpa/pr/health-care-fraud-
charge-filed-fayette-county-addiction-specialists-inc-
case
Mt. Holly Family Practice, Inc.--A North Carolina physician
who owned, managed, and was sole practitioner of an office-
based opioid treatment practice, treated a large volume of
Medicaid patients for substance abuse and pain management
issues. He coerced patients into sexual encounters in exchange
for controlled substance prescriptions and also fraudulently
billed these sexual encounters as office visits to Federal
health-care programs.
https://www.justice.gov/usao-wdnc/pr/former-north-
carolina-physician-pleads-guilty-drug-distribution-
health-care-fraud-and
LabTox, LLC--This Kentucky lab billed for urine drug screens
that they could not have possibly run because they did not have
the necessary equipment. These services were billed to Medicare
and Medicaid. LabTox agreed to pay $2.1M.
https://www.justice.gov/usao-edky/pr/lexington-
laboratory-agrees-pay-21-million-resolve-allegations-
false-claims-urine-drug
Redirections Treatment Advocates, LLC--The owner, operations
manager, and several doctors practicing at Redirections
Treatment Advocates, LLC, a buprenorphine clinic with offices
in Pennsylvania and West Virginia, received various sentences
for conspiring together to create and submit unlawful
prescriptions for buprenorphine and then unlawfully dispensed
those controlled substances to the clinic's patients. Doctors
at Redirections would routinely pre-sign blank prescriptions
for buprenorphine, which were then given to other medically
unlicensed employees at Redirections who completed the
prescription and provided it to the patients in exchange for
cash. On numerous occasions, the doctors were not physically
present at Redirections and did not exam their patients when
prescriptions bearing their names were issued.
https://www.justice.gov/usao-wdpa/pr/contracted-
physician-operations-manager-redirections-treatment-
advocates-sentenced
https://www.justice.gov/usao-wdpa/pr/former-suboxone-
clinic-doctor-sentenced-illegal-prescribing-and-health-
care-fraud
https://www.justice.gov/usao-wdpa/pr/opioid-treatment-
practice-owner-sentenced-illegal-distribution-
buprenorphine-and-health
https://www.justice.gov/usao-ndwv/pr/pennsylvania-
physician-sentenced-drug-charge
Health and Wellness Medical Center and Health and Wellness
Pharmacy--The owners and managers of Health and Wellness
Medical Center, a Suboxone clinic, and affiliated Health and
Wellness Pharmacy, along with a doctor employed by the center,
conspired to commit a health-care fraud scheme that included
billing Medicaid for compound creams that were not provided or
were not medically necessary, prescribing and distributing
Suboxone without medical necessity, and submitting fraudulent
claims to Medicaid for psychotherapy services that were never
rendered to patients.
https://www.justice.gov/usao-sdoh/pr/jury-convicts-
doctor-health-care-fraud-distributing-controlled-
substances-through-pain
https://www.justice.gov/usao-sdoh/pr/husband-and-wife-
sentenced-prison-health-care-fraud
Cherry Way--The owner/operator and medical director of
Cherry Way, a suboxone clinic, conspired together to create and
submit unlawful prescriptions for Suboxone, Adderall, and
Percocet, and then unlawfully dispensed those controlled
substances.
https://www.justice.gov/usao-wdpa/pr/medical-director-
bridgeville-suboxone-clinic-pleads-guilty-unlawfully-
distributing
SKS Associates--A prescribing physician with SKS Associates,
an opioid treatment facility in Johnstown, PA, pled guilty to
creating and submitting unlawful prescriptions for
buprenorphine, and then unlawfully dispensing those controlled
substances to other persons. This doctor also committed health-
care fraud by submitting fraudulent claims to Medicare for
payments to cover the costs of the unlawfully prescribed
buprenorphine.
https://www.justice.gov/usao-wdpa/pr/suboxone-clinic-
doctor-pleads-guilty-unlawfully-dispensing-controlled-
substances-health
Family Medicine Doctor--A doctor operated an addiction-
medicine practice out of offices in Greensburg and
Connellsville, PA, through which he pled guilty to unlawfully
prescribing buprenorphine to undercover law enforcement
officers, billing Medicare and Medicaid to cover the costs of
fraudulent buprenorphine prescriptions that he wrote for his
patients--even though he did not accept insurance/required his
patients to pay in cash, and money laundering of cash proceeds
from his illicit prescribing at a casino.
https://www.justice.gov/usao-wdpa/pr/greensburg-
physician-pleads-guilty-drug-distribution-health-care-
fraud-and-money.
Advance Healthcare, Inc.--The co-owner of Advance
Healthcare, Inc., a drug treatment center in Weirton, WV,
conspired with two physicians and other employees to illegally
sell/distribute controlled substances, including Suboxone.
https://www.justice.gov/usao-ndwv/pr/two-west-virginia-
physicians-and-business-partner-indicted-illegally-
distributing-drugs
https://www.justice.gov/usao-ndwv/pr/hancock-county-
addiction-center-co-owner-admits-illegally-selling-
suboxone
https://www.justice.gov/usao-ndwv/pr/west-virginia-
physician-convicted-illegal-opioid-distribution-
patients
https://www.justice.gov/usao-ndwv/pr/west-virginia-
physician-sentenced-illegal-opioid-distribution-
patients
https://www.justice.gov/usao-ndwv/pr/west-virginia-
physician-found-guilty-illegally-distributing-drugs
https://www.justice.gov/usao-ndwv/pr/west-virginia-
physician-sentenced-illegally-distributing-drugs
Indivior--In April 2019, a Federal grand jury indicted
Indivior for allegedly engaging in an illicit nation-wide
scheme to increase prescriptions of Suboxone. According to the
indictment, Indivior--including during the time when it was a
subsidiary of Reckitt Benckiser Group plc (RB Group)--promoted
the film version of Suboxone (Suboxone Film) to physicians,
pharmacists, Medicaid administrators, and others across the
country as less divertible and less abusable and safer around
children, families, and communities than other buprenorphine
drugs, even though such claims have never been established. The
indictment further alleges that Indivior touted its ``Here to
Help'' Internet and telephone program as a resource for opioid-
addicted patients. Instead, however, Indivior used the program,
in part, to connect patients to doctors it knew were
prescribing Suboxone and other opioids to more patients than
allowed by Federal law, at high doses, and in a careless and
clinically unwarranted manner. The United States' criminal
trial against Indivior is scheduled to begin in May 2020.
https://www.justice.gov/usao-wdva/pr/indivior-inc-
indicted-fraudulently-marketing-prescription-opioid
RB Group Settlement--In July 2019 RB Group agreed to pay
$1.4 billion to resolve its potential criminal and civil
liability related to a Federal investigation of the marketing
of the opioid addiction treatment drug Suboxone. The
resolution--the largest recovery by the United States in a case
concerning an opioid drug--includes the forfeiture of proceeds
totaling $647 million, civil settlements with the Federal
Government and the States totaling $700 million, and an
administrative resolution with the Federal Trade Commission for
$50 million. The $700 million settlement amount includes $500
million to the Federal Government and up to $200 million to
States that opt to participate in the agreement.
https://www.justice.gov/opa/pr/justice-department-
obtains-14-billion-reckitt-benckiser-group-largest-
recovery-case
As a matter of general policy, HHS Office of Investigations
does not discuss ongoing investigations. Accordingly, it is
important to note that many of our germane case examples are
still open matters that have not been adjudicated so we cannot
discuss any of these in detail at this time. That being said,
our active investigations also touch upon the following types
of schemes:
A sober home flying in patients after being told they
``won'' a scholarship for treatment and then, once
there, patients being encouraged to abuse drugs on the
condition of submitting to multiple drug tests and
mental health therapy sessions per week. This type of
scheme can also involve kickbacks being paid and false
billing to patients' insurance plans. Patients in such
schemes are often allowed to stay as long as they
allowed billing to occur and are given access to high
levels of controlled substances, buprenorphine
products, and benzodiazepines. Patient files in such
cases also typically lack continuity of care and
reflect insurance billings for services like urine drug
screens, despite absence of documentation for such
testing in the medical record.
A lab company stealing the practice identity of
legitimate medical providers and then using the stolen
identities to order medically unnecessary urine drug
tests.
______
Questions Submitted by Hon. Benjamin L. Cardin
state targeted response to opioid crisis grants
Question. Much like the rest of the country, Maryland has been
impacted by the opioid epidemic. In 2017, there were almost 2,000
overdose deaths involving opioids, and Maryland ranks in the top five
States for opioid-related overdose rates.
To help States address the opioid crisis, the Federal Government
created the State Targeted Response to Opioid Crisis Grants. This is a
2-year grant program that helps States supplement their existing opioid
prevention and treatment programs and recovery support activities with
Federal dollars. For Fiscal Year 2019, Maryland received over $32.9
million from this Federal grant program. As you know, States are able
to use this grant funding for treatment programs and recovery housing
like sober homes.
Since some of the sober homes could receive Federal funding under
the State Targeted Grant Program, are there any guardrails in place to
certify grant recipients who are recovery programs or other treatment
programs are effective and safe for patients? If not, what should
Congress consider in ensuring Federal funding for opioid treatment
programs do not unintentionally fund bad actors like these sober homes?
Answer. Although we have no ongoing work related to sober home
facilities, we currently have ongoing work on SAMHSA's Oversight of
Accreditation Bodies for Opioid Treatment Programs (W-00-18-59035).
SAMHSA issued final regulations to establish an oversight system for
the treatment of substance use disorders with MAT. These regulations
(42 CFR part 8) established procedures for an entity to become an
approved accreditation body, which evaluates Opioid Treatment Programs
and ensures that SAMHSA's opioid dependency treatment standards are
met. Our objective is to determine whether SAMHSA's oversight of
accreditation bodies complied with Federal requirements. We would be
happy to brief your staff as soon as we have findings we can share.
investigating patient brokering and educating consumers
Question. Ms. Donna Johnson, a mother of four from Frederick,
detailed in a Baltimore Sun article how her then 21-year-old son was
caught in the sober home cycle scam. Over a 4-year period, her son
cycled through more than two dozen sober homes and treatment
facilities, receiving little actual therapy. It all began with a
patient broker who lured her son to South Florida with the promise of
treatment, and resulted in tens of thousands of dollars in fraudulent
charges to her insurance company for drug testing that her son never
received.
GAO's 2018 report pointed to unnecessary or fraudulent testing as
central to sober home scams; in one instance, an insurance provider was
billed close to $700,000 for urine testing in a 7-month period.
In my State, State representatives from Frederick, MD are
reportedly drafting a bill that would outlaw the practice of patient
brokering for substance use disorder treatment. Also, the SUPPORT for
Patients and Communities Act included a provision based on a Rubio/
Klobuchar bill making patient brokering illegal and subjects those
found guilty to a fine of up to $200,000 or 10 years in prison, or
both.
Since the SUPPORT Act was enacted, have Federal prosecutors been
able to curb patient brokering with the threat of fines and prison
terms?
Has the Department of Justice brought forth an increased number of
cases to prosecute instances of patient brokering?
Are there additional authorities needed to investigate and
prosecute patient brokering?
Answer. Under the Inspector General Act and Health Insurance
Portability and Accountability Act, OIG has authority to conduct
investigations relating to HHS programs and operations, including fraud
relating to the Medicare and Medicaid programs. Although the Affordable
Care Act does provide OIG with the authority for limited oversight of
private insurers (largely those participating in exchanges), HHS OIG
does not have the authority to conduct oversight of private insurance
companies or their executives or for billings by their providers and
suppliers, for example. We refer you to the Federal Bureau of
Investigation and Department of Justice to obtain information about the
investigation and prosecution of cases of private insurance fraud when
such schemes constitute Federal criminal violations under the
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) (18 U.S.C. 220) or
another Federal statute.
Question. Do you know if Federal agencies are collaborating with
State and local governments to inform consumers of the dangers of sober
homes and patient brokering practices? If not, what could the Federal
Government do to educate consumers about quality treatment programs for
their loved ones and how to identify patient brokering scams?
Answer. OIG does not have any work specific to this question.
______
Questions Submitted by Hon. Sherrod Brown
state capacity to address fraud
Question. Testimony from both the Government Accountability Office
(GAO) and the Office of the Inspector General (OIG) presented during
this hearing detailed examples of several States that have rigorously
investigated and taken action against fraudulent providers in their
States.
In your experience investigating substance use disorder (SUD)-
related fraud, do you both believe States are doing a good job of
addressing fraud, and would you say they maintain the tools and
authority necessary to police this fraudulent behavior? What more tools
should Congress consider creating to ensure any fraud is addressed?
Answer. OIG notes that the Federal Government relies on our
partnerships with States in addressing substance use disorder (SUD),
and that State oversight of SUD treatment services varies across the
country. This variance will continue to be a factor in our assessment
of the issues surrounding SUD treatment services to beneficiaries with
SUD, including SUD-related fraud. Although we recognize that States
will vary in their approaches, we recognize the value in strong,
consistent oversight at the State level. A pertinent cautionary example
of this--and a topic raised by Senator Cassidy's question at the
hearing about the Transformed Medicaid Statistical Information System--
is the lack of complete, accurate, and timely national Medicaid data,
which has hampered the ability to combat Medicaid provider fraud at a
national level. Although OIG and the other witnesses on the panel at
the hearing did testify about the challenges in finding a one-size-
fits-all solution, OIG continues to assess these issues to determine
where there is an appropriate link or opportunity for the OIG to look
at Medicaid providers, owners, and affiliations who are offering SUD
treatment services to beneficiaries with SUD (e.g., those who reside in
sober homes) to determine OIG's role in this area.
perpetrators of fraud
Question. During the hearing, I asked both you and Dr. Denigan-
Macauley about who tends to be the perpetrator of fraud in the
situations you have investigated. As you both testified, in the vast
majority of cases, it is treatment providers who are engaging in
troublesome practices at the expense of patients. More often, patients
are the victim.
Do you believe that going after patients as if they are scam
artists is an effective method of preventing this type of fraud?
Answer. In most cases, we do not investigate patients, as they are
most often the victims of such schemes. However, if we uncover evidence
that a patient is diverting drugs or conspiring to commit health-care
fraud, we would pursue an investigation of such conduct as
circumstances warrant.
Question. Given that the culprits in these scenarios are providers/
schemers and the victims are the patients they broker/fail to provide
quality treatment to, would you agree that regulations that may
restrict patient access to addiction treatment is not the appropriate
way to tackle fraud in this space?
Answer. With the caveat that our response should not be interpreted
as commenting on any pending legislation, regulation, or policy
proposal, we recognize the importance of ensuring that beneficiaries
receive appropriate care and note that restricting patient access to
treatment may negatively impact those suffering from SUD. We support
ensuring patients have access to addiction treatment in conjunction
with appropriate oversight to ensure quality of services and prevent
fraud.
______
Submitted by Hon. Steve Daines,
a U.S. Senator From Montana
Federal Law Enforcement Officers Association
7945 MacArthur Blvd., Suite 201
Cabin John, MD 20818
Phone: 202-870-5503
https://www.fleoa.org/
October 24, 2019
The Honorable Chuck Grassley
Chairman
U.S. Senate
Committee on Finance
Washington, DC 20510
The Honorable Ron Wyden
Ranking Member
U.S. Senate
Committee on Finance
Washington, DC 20510
Dear Mr. Chairman and Ranking Member Wyden,
The Federal Law Enforcement Officers Association (www.fleoa.org) is the
Nation's largest non-partisan professional association representing
Federal law enforcement officers. With over 27,000 members from across
all 65 Federal law enforcement agencies, FLEOA's members are on the
front lines of protecting and defending America. As America's experts
on Federal law enforcement, we request this letter be included in the
official hearing record.
The committee's hearing today titled ``Treating Substance Misuse in
America: Scams, Shortfalls, and Solutions'' is aptly titled. Within the
ranks of American law enforcement, one theme is constant and that is,
many drug treatment centers fail at their mission and often have an
inverse effect of creating better addicts and expanding a local drug
distribution network. The end result is often individuals that go in
looking for help, leave and return to a life of addiction and crime.
Federal law enforcement officers across America see these tragic
results every day. They do a tremendous job working to stop the flow of
illicit drugs into America, responding to substance abuse infused
incidents and are often the backstop when treatment fails and these
individuals fall into the criminal justice system. Unfortunately, as
law enforcement professionals we know that addiction is a problem that
can't solve by just arrest and incarceration. It needs to be solved
with proven and validated programs that address an addicts issues and
help that individual become a productive member of society.
FLEOA believes that this is due in large part to a non-existent Federal
regulatory structure, no certification requirements for these
facilities and a patchwork of State licensing requirements that often
fail to even mandate that a facility is actually conducting treatment
for substance abuse.
Within the ranks of FLEOA, it is hard to find an individual whose
family has not been touched by substance abuse. Our new Executive
Director Donald Mihalek lost his sister Denise in July of this year due
to an accidental overdose. The story of his sister Denise is the same
as many American families, in and out of drug abuse treatment centers--
all failing to provide the treatment they advertised. This widespread
fraud is being perpetrated against some of the most vulnerable among
us--those dealing with substance abuse and their families looking for
help.
In our profession, we've identified some key areas that we feel if
focused on, could change the dynamic of substance abuse treatment in
America.
First, there is no clear Federal standard for a substance abuse
treatment center. To date, the States are allowed to self-regulate what
a treatment center looks like. This has created a patchwork where a
treatment center in one State looks markedly different than in another.
Having a clear Federal standard would help States and treatment centers
be able to know exactly what they should be providing. It would also
allow easier cross State treatment as individuals would know, like a
hospital, that they would receive the same standard of treatment
wherever they go.
Second, unlike other medical establishments such as hospitals,
rehabilitation facilities, and nursing homes, there is no certification
requirement for a substance abuse treatment center. Treatment centers
around our Nation are allowed to exist with no mandate of
certification. Every law enforcement agency in our Nation must undergo
a certification process, every hospital and school must--how are we
allowing substance abuse treatment facilities to exist without having
to go through a certification process?
Third, America is paying for inadequate, ineffective, and often
failure-ridden substance abuse treatment. The rate of relapse is high
for substance abuse, arguably because real treatment is not occurring
in many facilities yet they take our insurance dollars as payment. Many
articles have been written about the ``substance abuse treatment for
profit'' situation that exists throughout the country, yet the Federal
Government, the Nation's largest health insurer, is paying for it.
Every Federal insurance plan, from FEHB, TRICARE, Medicaid, Medicare to
all others that are paid for by the Federal Government should be
prohibited from paying for treatment at facilities that don't work.
This one step may fundamentally change treatment in America.
The Congress has an important role to play in reframing the nature of
substance abuse treatment in America. The failure, fraud and farce must
stop and should be addressed in a holistic way that stops this fraud
being perpetrated against people desperate for help and drive substance
abuse treatment to a better place.
We look forward to working with the committee to address this dangerous
issue, support our law enforcement officers and ensure that in every
way, America provides the resources necessary to address the substance
abuse issue that if tackled, can only make America stronger and better.
We are always available to provide our subject matter expertise on this
issue.
Sincerely,
Larry Cosme
National President
______
Prepared Statement of Mary Denigan-Macauley, Ph.D., Director,
Health Care, Government Accountability Office
substance use disorder: prevalence of recovery homes,
and selected states' investigations and oversight
Why GAO Did This Study
Substance abuse and illicit drug use, including the use of heroin
and the misuse of alcohol and prescription opioids, is a growing
problem in the United States. Individuals with a substance use disorder
may face challenges in remaining drug- and alcohol-free. Recovery homes
can offer safe, supportive, drug- and alcohol-free housing to help
these individuals maintain their sobriety and can be an important
resource for recovering individuals. However, as GAO reported in March
2018, some States have conducted investigations of potentially
fraudulent practices in some recovery homes.
This statement describes (1) what is known about the prevalence of
recovery homes across the United States; and (2) investigations and
actions selected States have undertaken to oversee such homes. It is
largely based on GAO's March 2018 report (GAO-18-315). For that report,
GAO reviewed national and State data, among other things, and
interviewed officials from the Department of Health and Human Services,
national associations, and five States--Florida, Massachusetts, Ohio,
Texas, and Utah. GAO selected these States based on their rates of
opioid overdose deaths, their rates of dependence or abuse of alcohol
and other drugs, and other criteria.
What GAO Found
In March 2018, GAO found that the prevalence of recovery homes
(i.e., peer-run or peer-managed drug- and alcohol-free supportive homes
for individuals in recovery from substance use disorder) was unknown.
Complete data on the prevalence of recovery homes were not available,
and there was no Federal agency responsible for overseeing recovery
homes that would compile such data. However, two national organizations
collected data on the prevalence of recovery homes for a subset of
these homes.
The National Alliance for Recovery Residences (NARR), a
national nonprofit and recovery community organization that
promotes quality standards for recovery homes, collected data
only on recovery homes that sought certification by some of its
State affiliates. As of January 2018, NARR told us that its
affiliates had certified almost 2,000 recovery homes, which had
the capacity to provide housing to over 25,000 individuals.
Oxford House, Inc. collected data on the number of
individual recovery homes it charters. In its 2018 annual
report, Oxford House, Inc. reported that there were 2,542
Oxford Houses in 45 States.
The number of recovery homes that were not affiliated with these
organizations was unknown.
In March 2018, GAO also found that four of the five States in its
review--Florida, Massachusetts, Ohio, and Utah--had conducted, or were
in the process of conducting, investigations of potentially fraudulent
recovery home activities in their States. Activities identified by
State investigators included schemes in which recovery home operators
recruited individuals with substance use disorder to specific recovery
homes and treatment providers, and then billed those individuals'
insurance for extensive and unnecessary drug testing for the purposes
of profit. For example, officials from the Florida State attorney's
office told GAO that, in some instances, substance use disorder
treatment providers were paying $300 to $500 or more per week to
recovery home operators for every individual the operators referred for
treatment. Then, in one of these instances, the provider billed an
individual's insurance for hundreds of thousands of dollars in
unnecessary drug testing over the course of several months. Further,
these officials told GAO that as a result of these investigations at
least 13 individuals were convicted and fined or sentenced to jail
time.
To increase oversight, officials from three of the five States--
Florida, Massachusetts, and Utah--said they had established State
certification or licensure programs for recovery homes in 2014 and
2015. Officials from the other two States--Ohio and Texas--had not
established such programs, but were providing training and technical
assistance to recovery homes.
_______________________________________________________________________
Chairman Grassley, Ranking Member Wyden, and members of the
committee:
I am pleased to be here today to discuss our recent report on
recovery homes. Substance abuse and illicit drug use, including the use
of heroin and the misuse of alcohol and prescription opioids, is a
growing problem in the United States. Individuals recovering from
substance use disorder (SUD) face challenges remaining alcohol or drug
free. Recovery homes can offer safe, supportive, stable living
environments to help individuals recovering from SUD maintain an
alcohol- and drug-free lifestyle. The Substance Abuse and Mental Health
Services Administration (SAMHSA) within the Department of Health and
Human Services (HHS) is responsible for promoting SUD prevention,
treatment, and recovery services to reduce the impact of SUD on
communities, which includes some activities to support recovery
homes.\1\
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\1\ SAMHSA activities include issuing best practices and suggested
guidelines, and making some funds available to States for recovery
homes.
We have a growing body of work examining policies and oversight of
SUD-related services, including recovery homes. We reported in March
2018 that some States have conducted criminal investigations into
recovery home operators and associated SUD treatment providers within
their States who have engaged in potential health insurance fraud and
exploited residents for the purpose of profit. These investigations
included potential fraud that involved Medicaid--which is one of the
largest payers of SUD treatment in the United States.\2\
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\2\ Medicaid is a joint Federal-State program that funded medical
and other health-care-related services for an estimated 75 million low-
income and medically needy individuals in fiscal year 2018. According
to SAMHSA, in 2015, total spending on SUD treatment across the United
States was $56 billion, and Medicaid spending on SUD treatment
accounted for 25 percent of this total. See SAMHSA, Behavioral Health
Spending and Use Accounts 2006-2015, HHS Pub. No. (SMA) 19-5095
(Rockville, MD: 2019). While recovery homes are not eligible providers
for the purposes of billing Medicaid, SUD treatment providers may
enroll and bill Medicaid.
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My testimony today focuses on
1. What is known about the prevalence of recovery homes across the
United States; and
2. Investigations and actions selected States have undertaken to
oversee recovery homes.
My statement today is largely based on our March 2018 report
describing information on recovery homes.\3\ For the report, we
reviewed available Federal and State information and interviewed
officials from national organizations that provide or have missions
related to recovery homes as well as Federal agencies, including SAMHSA
and the Centers for Medicare and Medicaid Services--the agency within
HHS that is responsible for overseeing Medicaid. For our March 2018
report, we selected a non-generalizable sample of five States for
review: Florida, Massachusetts, Ohio, Texas, and Utah. We selected
these States based on a variety of criteria, such as the rates of
opioid overdose deaths and rates of dependence on or abuse of illicit
drugs and alcohol, among others. In each State, we interviewed
officials from the State substance abuse agency, State Medicaid agency,
State Medicaid Fraud Control Unit, State insurance department, and
others.\4\ Our March 2018 report includes a full description or our
scope and methodology. Further, this statement reflects the most recent
publicly available data on recovery homes from two national nonprofits
dedicated to recovery homes--the National Alliance for Recovery
Residences (NARR) and Oxford House, Inc.\5\ 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 finding 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.
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\3\ See GAO, Substance Use Disorder: Information on Recovery
Housing Prevalence, Selected States' Oversight, and Funding, GAO-18-315
(Washington, DC: March 22, 2018).
\4\ Medicaid Fraud Control Units investigate and prosecute Medicaid
provider fraud, as well as patient abuse or neglect in health-care and
related facilities.
\5\ NARR is a national nonprofit and recovery community
organization that aims to support individuals in recovery by improving
their access to quality recovery residences through standards,
supportive services, placement, education, research, and advocacy.
Oxford House, Inc. is a national nonprofit corporation that serves as
an umbrella organization to connect individual Oxford Houses.
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background
SAMHSA and other organizations recognize recovery homes--peer-run
and peer-managed supportive homes--as an important step in SUD
treatment and recovery. Definitions of and terms for recovery homes can
vary, and recovery homes may differ in the types of services offered
and resident requirements. Alcohol- and drug-free homes for individuals
recovering from SUD may be referred to as ``recovery residences,''
``sober homes,'' or other terms. For the purposes of our March 2018
report, we used the term ``recovery homes'' to refer to peer-run,
nonclinical living environments for individuals recovering from SUD in
general.
Recovery homes generally are not considered to be residential
treatment centers, are not eligible to be licensed providers for the
purposes of billing private insurance or public programs--such as
Medicaid--and residents typically have to pay rent and other home
expenses themselves. Recovery home residents may separately undergo
outpatient clinical SUD treatment, which is typically covered by health
insurance. In addition, recovery homes may encourage residents to
participate in mutual aid or self-help groups (e.g., 12-step programs
such as Alcoholics Anonymous) and may require residents to submit to
drug screening to verify their sobriety. Residents may be referred to
recovery homes by treatment providers, the criminal justice system, or
may voluntarily seek out such living environments.
nationwide prevalence of recovery homes was unknown
In our March 2018 report, we found that the prevalence of recovery
homes nationwide was unknown, because complete data were not available.
We found these data are not collected at the Federal level to provide a
nationwide picture, in part, because there was no Federal agency
responsible for overseeing them. However, as we reported in March 2018,
two national organizations with missions dedicated to recovery homes
collect data on the prevalence and characteristics for a sub-set of
recovery homes and the number of homes that were not affiliated with
these organizations was unknown.
NARR collected data on recovery homes that sought
certification by one of its 15 State affiliates that actively
certify homes.\6\ As we previously reported, as of January
2018, NARR told us that its affiliates had certified almost
2,000 recovery homes, which had the capacity to provide housing
to over 25,000 individuals.\7\
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\6\ As of January 2018, NARR's membership comprised 27 State
affiliates that work to promote and support NARR's quality standard for
recovery housing and other activities in their States. The remaining 12
affiliates support recovery homes in their States by providing
information about recovery homes to the public and hearing complaints.
\7\ NARR-certified recovery homes include recovery homes across all
four NARR levels. NARR level I and II residences are primarily self-
funded, peer-run, single-family homes where residents have an open-
ended length of stay. Level II residences typically have a paid house
manager or senior resident who oversees the house and its residents.
Level III and IV residences are structured or semi-structured living
environments with paid facility staff, such as case managers, to assist
residents in developing treatment plans and may be licensed by the
State if they offer clinical services (such as level IV residential
treatment centers). Residential treatment centers were outside the
scope of our study; however, the activities of some States in our
review may have included more structured facilities (i.e., levels III
and IV).
Oxford House, Inc. collected data on the prevalence and
characteristics of its individual recovery homes (known as
Oxford Houses).\8\ In its 2018 annual report, Oxford House,
Inc. reported that there were 2,542 Oxford Houses in 45
States.\9\
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\8\ Oxford Houses operate under charters granted by Oxford House,
Inc. and are democratically run, self-supporting homes. According to
the Oxford House Inc. manual and related documents, all Oxford Houses
are rentals and residents are responsible for sharing expenses, paying
bills, and immediately evicting residents who drink or use illicit
drugs while living in the house.
\9\ Of the total number of Oxford Houses in 2018, 69 percent served
men and 31 percent served women. The average Oxford House resident age
was 39 years, and the average length of stay was about 9 months. See
Oxford House, Inc., Annual Report, FY 2018 (Silver Spring, MD: January
30, 2019).
most selected states had investigated potential fraud related to
recovery homes and taken steps to enhance oversight
Four of Five Selected States Had Conducted Investigations of Recovery
Homes
Officials from four of the five selected States we reviewed for our
March 2018 report (Florida, Massachusetts, Ohio, and Utah) told us that
since 2007, State agencies had conducted, or were in the process of
conducting, law enforcement investigations of unscrupulous behavior and
potential insurance fraud related to recovery homes.\10\ According to
the State officials, the outcomes of some of these investigations
included criminal charges and changes to health insurance policies.
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\10\ An official from the fifth State, Texas, told us that the
State had not conducted any recent law enforcement investigations
related to recovery homes. This official told us that the Texas
Department of Insurance received two fraud reports in 2014 and 2016
related to recovery homes and that the State was unable to sufficiently
corroborate the reports to begin investigations.
Across the four States, officials told us that the potential
insurance fraud may have relied on unscrupulous relationships between
SUD treatment providers (including laboratories that perform tests to
check for substance use) and recovery home operators. Officials
explained that recovery home operators establish these relationships,
because they cannot directly bill health insurance themselves due to
the fact that recovery homes are not considered eligible providers for
the purposes of billing health insurance. For example, treatment
providers may form relationships with recovery home operators who then
recruit individuals with SUD in order to refer or require residents to
see the specific SUD treatment providers. This practice is known as
patient brokering, for which recovery home operators receive kickbacks,
such as cash or other remuneration from the treatment provider, in
exchange for patient referrals. The extent of potential fraud differed
across the four States, as discussed below.
Florida
Officials from several State agencies and related entities
described investigations into fraud related to recovery homes in
southeastern Florida as extensive, although the scope of the fraud
within the industry is unknown. In 2016, the State attorney for the
15th judicial circuit (Palm Beach County) convened a task force
composed of law enforcement officials tasked with investigating and
prosecuting individuals engaged in fraud and abuse in the SUD treatment
and recovery home industries. The task force found that unscrupulous
recovery home operators or associated SUD treatment providers were
luring individuals into recovery homes using deceptive marketing
practices. These practices included online or other materials that
willfully misdirected individuals or their family members to recruiters
with the goal of sending these individuals to specific treatment
providers so that the recruiters could receive payments from those
treatment providers for each referral. According to officials from the
Florida State attorney's office, these individuals--often from out of
State--were lured with promises of free airfare, rent, and other
amenities to recover in southern Florida's beach climate. Recruiters
brokered these individuals to SUD treatment providers, who then billed
their private insurance plans for extensive and medically unnecessary
urine drug testing and other services. Officials from the Florida State
attorney's office told us that SUD treatment providers were paying $300
to $500 or more per week to recovery home operators or their staff
members for every individual they referred for treatment. In addition,
these officials cited one case in which a SUD treatment provider billed
an individual's insurance for close to $700,000 for urine drug testing
over a 7-month period. Officials from the State attorney's office noted
that the recovery homes that the task force investigated were not
shared homes in the traditional, supportive sense, but rather existed
as ``warehouses'' intended to exploit vulnerable individuals.
As a result of these investigations, as of December 2017, law
enforcement agencies had charged more than 40 individuals primarily
with patient brokering, with at least 13 of those charged being
convicted and fined or sentenced to jail time, according to the State
attorney's office. In addition, the State enacted a law that
strengthened penalties under Florida's patient brokering statute and
gave the Florida Office of Statewide Prosecution, within the Florida
Attorney General's Office, authority to investigate and prosecute
patient brokering.
Massachusetts
An official from the Massachusetts Medicaid Fraud Control Unit told
us that the unit began investigating cases of Medicaid fraud in the
State on the part of independent clinical laboratories associated with
recovery homes in 2007. The unit found that, in some cases, the
laboratories owned recovery homes and were self-referring residents for
urine drug testing. In other cases, the laboratories were paying
kickbacks to recovery homes for referrals for urine drug testing that
was not medically necessary. According to the Medicaid Fraud Control
Unit official, as a result of these investigations, the State settled
with nine laboratories between 2007 and 2015 for more than $40 million
in restitution. In addition, the State enacted a law in 2014
prohibiting clinical laboratory self-referrals and revised its Medicaid
regulations in 2013 to prohibit coverage of urine drug testing for the
purposes of residential monitoring.
Ohio
At the time of our March 2018 report, Ohio had begun to investigate
an instance of potential insurance fraud related to recovery homes,
including patient brokering and excessive billing for urine drug
testing. Officials from the Ohio Medicaid Fraud Control Unit told us
that the unit began investigating a Medicaid SUD treatment provider for
paying kickbacks to recovery homes in exchange for patient referrals,
excessive billing for urine drug testing, and billing for services not
rendered, based on an allegation the unit received in September 2016.
Officials from other State agencies and related State entities, such as
the State's substance abuse agency and NARR affiliate, were not aware
of any investigations of potential fraud on the part of recovery home
operators or associated treatment providers when we interviewed with
them. According to these State officials, this type of fraud was not
widespread across the State.
Utah
In our March 2018 report, we reported that officials from the Utah
Insurance Department told us that the department was conducting ongoing
investigations of private insurance fraud similar to the activities
occurring in Florida, as a result of a large influx of complaints and
referrals the department had received in 2015. These officials told us
that the department had received complaints and allegations that SUD
treatment providers were
Paying recruiters to bring individuals with SUD who were
being released from jail to treatment facilities or recovery
homes;
Billing private insurance for therapeutic services, such as
group or equine therapy, that were not being provided, in
addition to billing frequently for urine drug testing; and
Encouraging individuals to use drugs prior to admission to
qualify them and bill their insurance for more intensive
treatment.
In addition, insurance department officials told us that they
believed providers were enrolling individuals in private insurance
plans without telling them and paying their premiums and copays.
According to these officials, when doing so, providers may lie about
the individuals' income status in order to qualify them for more
generous insurance plans. Officials found that providers were billing
individuals' insurance $15,000 to $20,000 a month for urine drug
testing and other services. Officials noted that they suspect that the
alleged fraud was primarily being carried out by SUD treatment
providers and treatment facilities that also own recovery homes. The
officials said the department had not been able to file charges against
any treatment providers, because it had been unable to collect the
necessary evidence to do so. However, according to the officials, the
State enacted legislation in 2016 that gave insurers and State
regulatory agencies, such as the State's insurance department and
licensing office, the authority to review patient records and
investigate providers that bill insurers. As we noted in our March 2018
report, this authority may help the insurance department and other Utah
regulatory agencies better conduct investigations in the future.
Three Selected States Have Established Oversight Programs, and Two
Selected States Are Taking Other Steps to Support Recovery
Homes
In addition to actions taken in response to State investigations,
our March 2018 report described steps taken by three of the five
selected States (Florida, Massachusetts, and Utah) to formally increase
oversight of recovery homes by establishing State certification or
licensure programs. Florida enacted legislation in 2015 and
Massachusetts enacted legislation in 2014 that established voluntary
certification programs for recovery homes. Further, Florida established
a two-part program for both recovery homes and recovery home
administrators (i.e., individuals acting as recovery home managers or
operators). According to officials from the Florida State attorney's
office and Massachusetts Medicaid Fraud Control Unit, their States
established these programs, in part, as a result of State law
enforcement investigations. Utah enacted legislation in 2014 to
establish a mandatory licensure program for recovery homes. According
to officials from the Utah substance abuse agency and the State
licensing office, Utah established its licensure program, in part, to
protect residents' safety and prevent their exploitation and abuse.
In our March 2018 report, we found that although State recovery
home programs in Florida and Massachusetts are voluntary, there are
incentives for homes to become certified under these States' programs,
as well as incentives to become licensed under Utah's programs.
Specifically, all three States require that certain providers refer
patients only to recovery homes certified or licensed by their State
program; therefore, uncertified and unlicensed homes in the three
States are ineligible to receive patient referrals from certain
treatment providers.\11\ Further, State officials told us that State
agencies are taking steps to ensure providers are making appropriate
referrals. For example, according to officials from the Florida
substance abuse agency, treatment providers may refer individuals to
certified recovery homes managed by certified recovery home
administrators only and must keep referral records.
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\11\ In Massachusetts, this requirement applies to referrals from
State agencies and State-
funded providers only. In Utah, this requirement applies to referrals
from the criminal justice system, such as drug courts.
To become State-certified or licensed, recovery homes in Florida,
Massachusetts, and Utah must meet certain program requirements,
including training staff, submitting documentation (such as housing
policies and a code of ethics), and participating in onsite inspections
to demonstrate compliance with program standards. However, specific
requirements differ across the three States. For example, while all
three State programs require recovery home operators or staff to
complete training, the number of hours and training topics differ. In
addition, for recovery homes to be considered certified in Florida,
they must have a certified recovery home administrator. Similar to
Florida's certification program for the homes, individuals seeking
administrator certification must meet certain program requirements,
such as receiving training on recovery home operations and
administration, as well as training on their legal, professional, and
ethical responsibilities. Features of the State-established oversight
programs also differ across the three States, including program type,
type of home eligible for certification or licensure, certifying or
---------------------------------------------------------------------------
licensing body, and initial fees.
As we noted in our March 2018 report, the State-established
oversight programs in Florida, Massachusetts, and Utah also include
processes to monitor certified or licensed recovery homes, and take
action when homes do not comply with program standards. For example, an
official from the Florida Association of Recovery Residences--the
organization designated by the State to certify recovery homes--told us
that the entity conducts random inspections to ensure that recovery
homes maintain compliance with program standards. State-established
oversight programs in the three States also have processes for
investigating grievances filed against certified or licensed recovery
homes. Further, officials from certifying or licensing bodies in all
three States told us their organizations may take a range of actions
when they receive complaints or identify homes that do not comply with
program standards, from issuing recommendations for bringing homes into
compliance to revoking certificates or licenses. According to officials
from Florida's certifying body, the entity has revoked certificates of
recovery homes that have acted egregiously or have been nonresponsive
to corrective action plans. Officials from the certifying and licensing
bodies in Massachusetts and Utah told us that they had not revoked
certificates or licenses, but had possibly assisted homes with coming
into compliance with certification standards or licensure requirements.
Officials from Ohio and Texas told us that their States had not
established State oversight programs like those in Florida,
Massachusetts, and Utah, but said their States had provided technical
assistance and other resources to recovery homes in an effort to
increase consistency, accountability, and quality.
Officials from the Ohio substance abuse agency told us that
since 2013 the State has revised its regulatory code to define
recovery homes and minimum requirements for such homes.
Officials also told us that the agency did not have authority
to establish a State certification or licensure program for
recovery homes. According to these officials, the State
legislature wanted to ensure that Ohio's recovery homes
community maintained its grassroots efforts and did not want a
certification or licensure program to serve as a roadblock to
establishing additional homes. However, officials from the Ohio
substance abuse agency told us that the agency encourages
recovery homes to seek certification by the State's NARR
affiliate--Ohio Recovery Housing--to demonstrate quality. In
addition, these officials told us that the State substance
abuse agency also provided start-up funds for Ohio Recovery
Housing, as well as continued funding for the affiliate to
provide training and technical assistance, and to continue
certifying recovery homes. According to officials from Ohio
Recovery Housing, the NARR affiliate regularly provides the
State's substance abuse agency with a list of newly certified
recovery homes, as well as updates on previously certified
homes as part of ongoing efforts to develop a recovery home
locator, under its contract with the agency.
Officials from the Texas substance abuse agency told us that
establishing a voluntary certification program would be
beneficial. However, the State legislature had not enacted
legislation establishing such a program at the time of our
review. At the time of our report, the agency was in the
process of developing guidance for providers on where and how
to refer their patients to recovery housing, which includes a
recommendation to send patients to homes certified by the Texas
NARR affiliate.
Chairman Grassley, Ranking Member Wyden, and members of the
committee, this concludes my prepared statement. I would be pleased to
respond to any questions that you may have at this time.
______
Questions Submitted for the Record to Mary Denigan-Macauley, Ph.D.
Questions Submitted By Hon. Chuck Grassley
Question. Officials in two States that were the subject of the
GAO's study on fraudulent treatment providers indicated that they could
not obtain sufficient evidence to initiate investigations or file
charges against these fraudulent providers. What specific barriers
exist to obtaining such evidence and what options exist for States to
overcome these barriers?
Answer. Recovery homes--peer-run, nonclinical living residences for
individuals recovering from substance use disorder (SUD)--are generally
not considered to be residential treatment centers, and are not
eligible to be licensed providers for the purposes of billing private
insurance or public programs, such as Medicaid. Potential insurance
fraud related to recovery homes has typically relied on unscrupulous
relationships between SUD treatment providers, such as laboratories,
and recovery home operators. As we reported in March 2018, officials
from two of the five States in our review told us they faced barriers
collecting information to investigate or file charges against providers
for potential fraud related to recovery homes.\1\
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\1\ See GAO, ``Substance Use Disorder: Information on Recovery
Housing Prevalence, Selected States' Oversight, and Funding,'' GAO-18-
315 (Washington, DC: March 22, 2018).
An official from the Texas Department of Insurance told us
that the department received two fraud reports in 2014 and 2016
related to recovery homes, but the State was unable to collect
information to corroborate the reports.
Officials from the Utah Insurance Department told us that
they faced barriers collecting necessary evidence to file
charges against providers.
We also reported in March 2018 that officials from two of the five
States in our review told us their State had enacted legislation that
may help them to conduct future investigations of fraud related to
recovery homes. Officials from Utah told us that the State legislature
enacted legislation in 2016 that gives insurers and State regulatory
agencies, such as the State insurance department and State licensing
office, the authority to review patient records and investigate
providers that bill insurers. Similarly, Florida enacted a law that
gives the Florida Attorney General's Office the authority to
investigate and prosecute patient brokering. This law also strengthened
penalties for patient brokering.
Question. What other policies do you recommend that Federal, State,
and local policymakers consider adopting to help reduce future scams in
addiction treatment and recovery housing?
Answer. The Substance Abuse and Mental Health Services
Administration (SAMHSA)--the agency within the Department of Health and
Human Services (HHS) responsible for promoting SUD prevention,
treatment, and recovery--maintains certain resources for locating
treatment providers and understanding the resources available for
treating SUD. In response to the Substance Use-Disorder Prevention that
Promotes Opioid Recovery Treatment for Patient and Communities Act
(SUPPORT Act), SAMHSA published best practices and suggested guidelines
for recovery housing.\2\ We also reported in March 2018 that national
organizations with missions dedicated to recovery homes, such as the
National Alliance for Recovery Residences (NARR) and Oxford House,
Inc., provide support and guidance for recovery home operators.\3\ Such
information could inform policymakers' efforts to develop safeguards to
help prevent or reduce abuses in addiction treatment and recovery
homes.
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\2\ Pub. L. No. 115-271, Sec. 7031, 132 Stat. 3894, 4014-16
(October 24, 2018). SAMHSA, ``Recovery Housing: Best Practices and
Suggested Guidelines'' (Rockville, MD: 2018).
\3\ See GAO-18-315.
Question. Use of evidence-based interventions can reduce the
health-care costs and criminal justice costs associated with substance
abuse, according to a Surgeon General's report. Is the government
allocating funding in a way that best promotes evidence-based
interventions, or is there room for improvement in this area? Please
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explain.
Answer. Our work on recovery homes did not examine whether the
government is allocating funding in a way that best promotes evidence-
based interventions. However, we previously reported that in an effort
to reduce the prevalence of opioid misuse and the fatalities associated
with it, HHS established a goal to expand access to medication-assisted
treatment (MAT).\4\ MAT is an evidence-based approach that combines
behavioral therapy and the use of certain medications, such as
methadone and buprenorphine. We also have ongoing work examining the
Office of National Drug Control Policy, including its responsibility to
assess and certify Federal agencies' drug control budgets to determine
if they are adequate to meet the goals and objectives of the National
Drug Control strategy--which includes expanding access to evidence-
based treatment. We anticipate issuing our report later this month.
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\4\ See GAO, ``Opioid Use Disorders: HHS Needs Measures to Assess
the Effectiveness of Efforts to Expand Access to Medication-Assisted
Treatment,'' GAO-18-44 (Washington, DC: October 31, 2017); and GAO,
``Opioid Addiction: Laws, Regulations, and Other Factors Can Affect
Medication-Assisted Treatment Access,'' GAO-16-833 (Washington, DC:
September 27, 2016).
Question. To what extent is professional education on evidence-
based treatment of substance use disorders widely available for health
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professionals?
Answer. As we noted in our March 2018 report, recovery homes are
generally not staffed by treatment providers, but are intended to
provide drug- and alcohol-free housing to help individuals recovering
from SUD.\5\ While we did not review the education of treatment
providers in our work on recovery homes, our other work has found that
some Federal grant programs support education on evidence-based
practices for health-care providers. For example, in October 2017, we
reported that HHS had four grant programs that focused on expanding the
use of MAT for opioid use disorders, and grant recipients could use
funds for a range of activities, including training providers and
supporting treatment involving MAT.\6\
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\5\ See GAO-18-315.
\6\ See GAO-18-44.
______
Questions Submitted by Hon. Patrick J. Toomey
Question. If a drug treatment facility does not have to be
certified, how do consumers, States and the Federal Government, and
other payers ensure it is providing the resources it advertises?
Answer. In our March 2018 report, we identified actions that States
are taking to oversee recovery homes.\7\ We found that three of the
five selected States (Florida, Massachusetts, and Utah) had established
voluntary certification or mandatory licensure programs to increase
oversight. Recovery homes seeking State certification or licensure must
demonstrate compliance with State program standards. For example, all
three States require recovery home operators or staff to complete
training. Further, State-established oversight programs in Florida,
Massachusetts, and Utah also include processes for monitoring certified
or licensed recovery homes and actions when homes do not comply with
program standards. While participation in state oversight programs
cannot guarantee consumers, the Federal Government, or others that
recovery homes are providing resources as advertised, it can indicate
that homes have met standards.
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\7\ See GAO-18-315.
Our other work has described the laws and restrictions that apply
to drug treatment facilities that administer medication-assisted
treatment (MAT).\8\
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\8\ See GAO-16-833.
Methadone--one medication used for MAT--may generally only
be administered or dispensed within an opioid treatment program
(OTP), as prescriptions for methadone cannot be issued when
used for opioid addiction treatment. As we reported in
September 2016, under the Controlled Substances Act, OTPs must
be certified by the Substance Abuse and Mental Health Services
Administration (SAMHSA) and registered by the Drug Enforcement
Administration. To be eligible for full certification, an OTP
must first be accredited by a SAMHSA-approved accrediting
organization. Accreditation is a peer-review process in which
an accrediting organization evaluates an OTP by making site
visits and reviewing policies, procedures, and practices. Once
accredited, SAMHSA may certify an OTP if it determines that the
OTP conforms with Federal regulations governing opioid
treatment standards. Among other things, Federal opioid
treatment standards set forth patient admission criteria,
record-keeping guidelines, and required services, such as
counseling. Once certified by SAMHSA, the OTP must apply for a
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separate registration from the Drug Enforcement Administration.
Buprenorphine--another medication used for MAT--may be
administered or dispensed within an OTP and may also be
prescribed by a qualifying practitioner who has received a
waiver from SAMHSA. Practitioners who received this waiver are
limited in the number of patients they may treat for opioid
addiction.
Question. Do any of the States stand out as high performers when it
comes to oversight and regulation of addiction treatment centers?
Please provide examples.
Answer. Our March 2018 report focused on recovery homes, which are
different from addiction treatment centers.\9\ Recovery homes are peer-
run, drug- and alcohol-free supportive homes for individuals in
recovery from substance use disorder (SUD). As noted in our report,
three of the five States in our review--Florida, Massachusetts, and
Utah--had established certification or licensure programs for recovery
homes in 2014 and 2015. Officials from the other two States in our
review--Ohio and Texas--said they had not established such programs,
but they were providing training and technical assistance to recovery
homes. We did not evaluate these efforts.
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\9\ See GAO-18-315.
Question. How much money do Federal insurance programs (FEHB,
TRICARE, Medicare, Medicaid, etc.) spend on drug treatment and how much
of it is suspected of being fraud? What, if any, are the challenges in
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quantifying this?
Answer. SAMHSA reported that total spending on SUD treatment was
$56 billion in 2015, and public spending accounted for 57 percent of
total spending.\10\ Among Federal programs, Medicaid accounted for 25
percent of total spending. Other Federal spending accounted for 11
percent of the total. This included SUD block grants from SAMHSA, which
accounted for 2.5 percent of all SUD spending, and Medicare, which
accounted for less than 5 percent. Other State and local government
spending accounted for 17 percent of the total.
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\10\ Substance Abuse and Mental Health Services Administration,
``Behavioral Health Spending and Use Accounts 2006-2015,'' HHS Pub. No.
(SMA) 19-5095 (Rockville, MD: 2019).
Our work on recovery homes did not examine the portion of SUD
treatment spending that is suspected of being fraud. We have reported
in the past that there are no reliable estimates of the extent of fraud
in the health-care industry but fraud continues to be a concern because
Federal health-care programs remain vulnerable.\11\ By its very nature,
fraud is difficult to detect, as those involved are engaged in
intentional deception. For example, a provider submitting a fraudulent
claim may include false documentation to substantiate a service not
provided, and thus the claim may appear valid on its face. Fraud may
also involve payments made to beneficiaries to obtain information for
fraudulent billing purposes.
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\11\ See GAO, ``Medicare Fraud: Progress Made, but More Action
Needed to Address Medicare Fraud, Waste, and Abuse,'' GAO-14-560T
(Washington, DC: April 30, 2014).
______
Question Submitted by Hon. Bill Cassidy
Question. This hearing highlighted some of the challenges that
families affected by substance use disorder face when trying to find
properly certified treatment centers that use appropriate, science-
based methods. One way that families could be helped is by having
access to an app which directs them to certified treatment centers in
their area. Generally speaking, how has HHS considered ways to direct
families to treatment centers that are certified and use science-based
methods? If not such an app exists, could HHS put forth a challenge
grant to help one be created?
Answer. Our March 2018 report on recovery homes did not examine
ways HHS can direct families to treatment that is certified and uses
science-based methods, or possible grants to assist in this. Rather,
our report examined the Substance Abuse and Mental Health Services
Administration's (SAMHSA) funding and how selected States have used
this funding for housing.\12\ As noted in our report, SAMHSA
administers two Federal health-care grants for substance use disorder
(SUD) prevention and treatment that States may use to establish
recovery homes and for related activities. Two of the five States in
our review used a portion of their grant funds for recovery homes.
Further, we reported that SAMHSA was undertaking initiatives related to
recovery homes, including a needs assessment for certifying recovery
homes in the future and holding two meetings to discuss emerging best
practices and other topics on recovery homes.
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\12\ See GAO-18-315.
SAMHSA maintains certain resources for locating treatment
facilities and understanding the resources available for SUD treatment.
According to the SAMHSA website, the agency collects information on
thousands of State-licensed providers who specialize in treating SUD,
addiction, and mental illness. On SAMHSA's website, individuals seeking
SUD treatment or their family members can find treatment facilities,
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including recovery homes, and learn about
Finding quality treatment, the different types of treatment,
and what to expect when starting treatment;
The cost of treatment and payment options; and
Addiction and mental health illness.
______
Questions Submitted by Hon. Ron Wyden
Question. The Government Accountability Office found problems
around the country of programs that claim to be providing housing and
health-care services for people in recovery, but in reality these
programs don't come close to making good on their promises. In many
instances, these recovery home operators are just out-and-out crooks
who are conspiring with treatment providers and drug testing companies
to defraud patients and their families, Federal programs like Medicaid,
and even private insurers. What are the warning signs that patients and
their families should look out for in order to avoid these types of
fraudulent programs? How can we ensure that essential government
programs like Medicaid aren't being defrauded?
Answer. Recovery homes can offer safe, supportive, stable living
environments to help individuals recovering from substance use disorder
(SUD) maintain an alcohol and drug-free lifestyle. However, as we
reported in March 2018, four of the five States in our review conducted
law enforcement investigations of unscrupulous behavior and potential
fraud related to recovery housing.\13\ State officials told us that
instances of fraud may have relied on relationships between providers,
including laboratories, and recovery home operators who exploit
residents for the purpose of profit. State investigations of
unscrupulous behavior and potential fraud included:
---------------------------------------------------------------------------
\13\ See GAO-18-315.
Luring individuals into recovery homes using deceptive
marketing practices, such as promising free airfare or rent;
Billing insurance plans for services not rendered; and
Requiring residents to get frequent and medically
unnecessary drug tests in order to excessively bill insurance
plans.\14\
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\14\ According to the American Society of Addiction Medicine's
April 2017 consensus statement on appropriate use of drug testing in
clinical addiction treatment, drug testing should be tailored to
individual patients' needs and stages of addiction and recovery. For
purposes of verifying or ensuring that residents in recovery housing
remain free from alcohol and illicit drugs, the consensus statement
states that weekly testing may be appropriate using presumptive
testing--that is, lower sensitivity tests, such as using drug tests
that can be purchased over the counter. The statement notes that more
frequent or more sensitive testing (i.e., testing that takes place in a
laboratory) is inappropriate and does not fit in the standard of care.
We also reported that, in response to investigations, three of the
five States in our review established oversight programs for recovery
homes to avoid potential fraud. We found that homes that participate in
State oversight programs must meet certain requirements. Further, we
noted that two national recovery home organizations--the National
Alliance for Recovery Residences (NARR) and Oxford House Inc.--maintain
standards for recovery homes. Recovery homes that are certified by a
NARR affiliate or operate under an Oxford House charter must also meet
certain standards, potentially reducing the risk of fraud.\15\
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\15\ NARR promotes standards for recovery housing, and provides
training and education to recovery home operators and others, among
other activities. NARR's membership is composed of State affiliates
that work to promote NARR's quality standards for recovery housing and
other activities in their State. As of January 2018, NARR had 27 State
affiliates, 15 of which were actively certifying recovery homes. Oxford
Houses operate independently, but must follow procedures laid out in
the Oxford House manual and adhere to charter conditions.
We have a body of work examining fraud in Federal programs,
including some programs that pay for SUD treatment, such as Medicaid.
As part of this work, we developed the Fraud Risk Framework, which is a
comprehensive set of key components and leading practices that serve as
a guide for agency managers to use when developing efforts to combat
fraud in a strategic, risk-based way.\16\ In 2017, we made three
recommendations to the Centers for Medicare and Medicaid Services (CMS)
to better align its efforts with the four components of the Fraud Risk
Framework: commit, assess, design and implement, and evaluate and
adapt.\17\ Specifically, we recommended that CMS (1) provide and
require fraud-awareness training to it employees; (2) conduct fraud
risk assessments; and (3) create an antifraud strategy for Medicare and
Medicaid, including an approach for evaluation. The agency agreed with
these three recommendations and has taken some steps to implement them,
such as initiating the fraud risk assessment for some programs in
Medicare. However, additional actions are needed to fully address these
three recommendations and, as of November 2019, they remain open.
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\16\ GAO, ``A Framework for Managing Fraud Risk in Federal
Programs,'' GAO-15-593SP (Washington, DC: July 28, 2015).
\17\ GAO, ``Medicare and Medicaid: CMS Needs to Fully Align its
Antifraud Efforts With the Fraud Risk Framework,'' GAO-18-88
(Washington, DC: December 5, 2017).
Question. During the hearing, you noted that there is no Federal
oversight of so-called sober homes. What other regulatory gaps has the
---------------------------------------------------------------------------
Government Accountability Office identified in this industry?
Answer. In March 2018, we reported that there was no Federal
oversight and limited State oversight of recovery homes at the time we
did our work.\18\ We also reported that some States are beginning to
increase their oversight of recovery homes operating in their States.
For example, we reported that three of the five States in our review--
Florida, Massachusetts, and Utah--said they had established
certification or licensure programs for recovery homes in 2014 and
2015. Officials from the other two States in our review--Ohio and
Texas--said they had not established such programs, but said that they
were providing training and technical assistance to recovery homes.
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\18\ See GAO-18-315.
______
Questions Submitted by Hon. Benjamin L. Cardin
state targeted response to opioid crisis grants
Question. Much like the rest of the country, Maryland has been
impacted by the opioid epidemic. In 2017, there were almost 2,000
overdose deaths involving opioids, and Maryland ranks in the top five
States for opioid-related overdose rates.
To help States address the opioid crisis, the Federal Government
created the State Targeted Response to Opioid Crisis Grants. This is a
2-year grant program that helps States supplement their existing opioid
prevention and treatment programs and recovery support activities with
Federal dollars. For Fiscal Year 2019, Maryland received over $32.9
million from this Federal grant program.
As you know, States are able to use this grant funding for
treatment programs and recovery housing like sober homes.
Since some of the sober homes could receive Federal funding under
the State Targeted Grant Program, are there any guardrails in place to
certify grant recipients who are recovery programs or other treatment
programs are effective and safe for patients?
If not, what should Congress consider in ensuring Federal funding
for opioid treatment programs do not unintentionally fund bad actors
like these sober homes?
Answer. In 2015, we reviewed aspects of the Substance Abuse and
Mental Health Services Administration's (SAMHSA) grant oversight and
its efforts to ensure that grant funds are spent as intended.\19\ This
review did not cover the State Targeted Response (STR) to the Opioid
Crisis Grant Program. However, similar to the grants covered by our
review, STR has specific requirements intended to make sure grantees
use the funds as they were intended. As we reported in March 2018, the
STR grant is intended to supplement States' existing opioid prevention,
treatment, and recovery support activities.\20\ SAMHSA requires most
grant funding to be used for opioid use disorder treatment services,
such as expanding access to clinically appropriate, evidence-based
treatment. States may also use a portion of their opioid grant funding
for recovery homes and recovery support services--which SAMHSA
recognizes as part of the continuum of care--such as establishing
recovery homes and providing peer mentoring.
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\19\ GAO, ``Mental Health: Better Documentation Needed to Oversee
Substance Abuse and Mental Health Services Administration Grantees,''
GAO-15-405 (Washington, DC: May 12, 2015).
\20\ See GAO-18-315.
Our 2015 work resulted in a recommendation to SAMHSA to take steps,
such as developing additional program-specific guidance, to ensure that
it consistently and completely documents both the application of
criteria when awarding grants to grantees, and its ongoing oversight of
grantees once grants are awarded. In response, SAMHSA developed
program-specific guidance, including standard operating procedures and
additional program specific guidance. SAMHSA incorporated this guidance
into an updated Government Project Officer handbook, which was
finalized in October 2015. SAMHSA's continued adherence to its guidance
for grantee oversight should assist it in ensuring that SAMHSA grant
---------------------------------------------------------------------------
funds are used appropriately.
development of sober home standards
Question.GAO's 2018 report noted, ``the nationwide prevalence of
recovery housing is unknown because there was no Federal agency
responsible for overseeing recovery homes that would compile such
data.'' However, there are two national nonprofit organizations, the
National Alliance for Recovery Residences (NARR) and Oxford House,
which have been dedicated to collecting data on the prevalence of
recovery housing.
In fact, NARR promotes standards for recovery housing. In addition,
Shatterproof, has developed Atlas, a web- and app-based platform that
will allow any individual searching for high-quality addiction
treatment to locate and compare facilities.
As 3.8 million Americans received substance use treatment at any
facility in the past year, it seems prudent and necessary that we have
some standards in place for the health and safety of patients and to
ensure that taxpayer dollars are being appropriately spent.
In the review of the standards that NARR uses to certify recovery
homes, did GAO find a consistent set of quality standards that might be
adopted at the Federal level?
Answer. Our report examined investigations and actions that five
selected States had undertaken to oversee recovery homes.\21\ We found
that three of the selected States had enacted licensure or voluntary
certification programs to enhance oversight. These programs require
recovery homes to meet certain requirements, including staff training,
documentation submissions, and onsite inspections. However, specific
requirements varied across States. In addition, we identified two
national nonprofit organizations that have missions dedicated to
recovery homes that maintain standards for recovery homes--NARR and
Oxford House, Inc.--which you cite above. We included information from
these organizations in our review.
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\21\ See GAO-18-315.
SAMHSA issued best practices and suggested guidelines for recovery
homes.\22\ According to SAMHSA, the agency identified 10 specific
areas, or guiding principles, to assist States and Federal policy-
makers in defining and understanding what comprises safe, effective,
and legal recovery homes. SAMHSA recommends following these Ten Guiding
Principles to guide recovery home operators, stakeholders, and states
in enacting laws designed to provide the greatest level of resident
care and safety possible. These principles include, among other things,
having a clear operational definition, recognizing that a substance use
disorder is a chronic condition requiring a range of recovery supports,
and recognizing that co-occurring mental disorders often accompany
substance use disorders.
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\22\ SAMHSA, ``Recovery Housing: Best Practices and Suggested
Guidelines'' (Rockville, MD: 2018).
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investigating patient brokering and educating consumers
Question. Ms. Donna Johnson, a mother of four from Frederick,
detailed in a Baltimore Sun article how her then 21-year-old son was
caught in the sober home cycle scam. Over a 4-year period, her son
cycled through more than two dozen sober homes and treatment
facilities, receiving little actual therapy. It all began with a
patient broker who lured her son to South Florida with the promise of
treatment, and resulted in tens of thousands of dollars in fraudulent
charges to her insurance company for drug testing that her son never
received.
GAO's 2018 report pointed to unnecessary or fraudulent testing as
central to sober home scams; in one instance, an insurance provider was
billed close to $700,000 for urine testing in a 7-month period.
In my State, State representatives from Frederick, MD are
reportedly drafting a bill that would outlaw the practice of patient
brokering for substance use disorder treatment. Also, the SUPPORT for
Patients and Communities Act included a provision based on a Rubio/
Klobuchar bill making patient brokering illegal and subjects those
found guilty to a fine of up to $200,000 or 10 years in prison, or
both.
Since the SUPPORT Act was enacted, have Federal prosecutors been
able to curb patient brokering with the threat of fines and prison
terms?
Has the Department of Justice brought forth an increased number of
cases to prosecute instances of patient brokering?
Are there additional authorities needed to investigate and
prosecute patient brokering?
Answer. We have not conducted any work on investigating and
prosecuting patient brokering since the SUPPORT Act. We would be happy
to work with your staff to explore potential future work for GAO.
Question. Do you know if Federal agencies are collaborating with
State and local governments to inform consumers of the dangers of sober
homes and patient brokering practices?
Answer. In March 2018, we reported that SAMHSA was undertaking
initiatives related to recovery homes, including a needs assessment for
certifying recovery homes in the future. In 2017, SAMHSA held two
recovery homes meetings that covered such topics as research on
emerging best practices, State recovery housing programs, and
challenges that State entities have experienced regulating recovery
homes in their States. Further, SAMHSA contracted with NARR at the end
of fiscal year 2017 to provide training to recovery homes
organizations, managers, and State officials.
We also reported that SAMHSA administers two Federal health-care
grants for substance use disorder (SUD) prevention and treatment that
States may use to establish recovery homes and related activities, and
two of the five States in our review--Texas and Ohio--used a portion of
their SAMHSA grant funds for recovery homes. For example, Texas used
funds to increase the number Oxford Houses in the State and hire
outreach workers who assist individuals in finding recovery homes,
negotiating leases, and helping individuals or groups that want to open
new homes apply for Oxford House charters.
Since our report, SAMHSA published best practices and suggested
guidelines for recovery homes. According to SAMHSA, the agency
identified 10 specific areas, or guiding principles, to assist States,
among other policy-makers, in defining and understanding what comprises
safe, effective, and legal recovery homes.
Question. If not, what could the Federal Government do to educate
consumers about quality treatment programs for their loved ones and how
to identify patient brokering scams?
Answer. While our work on recovery homes did not examine how to
educate consumers on quality treatment programs and how to identify
patient brokering, SAMHSA's website includes information on finding SUD
treatment, including a blog post and a fact sheet on finding quality
treatment for SUD. Further, SAMHSA maintains web-based tools to help
consumers find State-licensed SUD treatment providers.
______
Questions Submitted by Hon. Sherrod Brown
Mandatory Licensing and Certification Requirements
Question. One of the States GAO interviewed in putting together its
report was Utah, which has mandatory licensing and certification
requirements for recovery homes.
Do you believe that these requirements have stifled the growth of
substance use disorder treatment facilities in the State of Utah?
Answer. Utah enacted legislation in 2014 to establish a mandatory
licensure program for recovery homes.\23\ According to officials from
the Utah substance abuse agency and the State licensing office, Utah
established its licensure program, in part, to protect residents'
safety and prevent their exploitation and abuse. We did not evaluate
the growth of sober homes or substance use disorder treatment
facilities, which were beyond the scope of our report, following the
enactment of the legislation in 2014.
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\23\ See GAO-18-315.
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peer support
Question. During the hearing, you mentioned that the Government
Accountability Office (GAO) is planning a few additional reports in
this space--one report is focused on doing a review of peer support
programs across the Medicaid programs of a few States, and another on
Medicaid and treatment of pregnant and postpartum women (which came out
after the hearing adjourned).
What is GAO's timeline for the peer support program report? Are you
planning to do any other work in this space that wasn't mentioned
during the hearing?
Answer. We plan on reporting on peer support services in Medicaid
on or before the mandated reporting date in the Substance Use-Disorder
Prevention that Promotes Opioid Recovery Treatment for Patient and
Communities Act (SUPPORT Act), October 24, 2020. We have other ongoing
work examining a range of topics related to substance use disorder
(SUD) treatment, including possible barriers in Medicaid to substance
use treatment, Medicare mental and behavioral health services, and
substance use treatment capacity and access. We anticipate issuing
these reports throughout 2020.
perpetrators of fraud
Question. During the hearing, I asked both you and Mr. Cantrell
about who tends to be the perpetrator of fraud in the situations you
have investigated. As you both testified, in the vast majority of
cases, it is treatment providers who are engaging in troublesome
practices at the expense of patients. More often, patients are the
victim.
Do you believe that going after patients as if they are scam
artists is an effective method of preventing this type of fraud?
Answer. We have not examined the effectiveness of investigating
patients as a method for preventing fraud. Our work on combating fraud
has centered on the Fraud Risk Framework, which encompasses activities
in which payers can engage to prevent, detect, and respond to fraud,
with an emphasis on prevention and structural and environmental factors
that influence or help managers achieve their objective to mitigate
fraud.\24\
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\24\ See GAO-15-593SP.
Question. Given that the culprits in these scenarios are providers/
schemers and the victims are the patients they broker/fail to provide
quality treatment to, would you agree that regulations that may
restrict patient access to addiction treatment is not the appropriate
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way to tackle fraud in this space?
Answer. Our work on recovery homes has not examined the impact of
regulations on access to SUD treatment, including regulating recovery
homes, which are included in the continuum of care. We would be happy
to meet with your staff to discuss your concerns about this and the
potential for future work.
______
Prepared Statement of Hon. Chuck Grassley,
a U.S. Senator From Iowa
Good morning. I want to welcome our panelists to today's hearing on
the 1-year anniversary of the SUPPORT Act. This landmark statute, which
many of us had a hand in developing, responded to the opioid epidemic
on multiple fronts. That crisis has affected every corner of our
Nation, with 130 Americans, on average, dying from an overdose every
single day.
We've devoted a lot of Federal resources to tackling this crisis,
and I look forward to hearing from the Surgeon General on this
administration's efforts to implement the SUPPORT Act over the last
year. I also commend Dr. Adams for launching his own unique initiatives
to help raise public awareness about the risks of opioid misuse.
Challenges remain, however, because roughly 20 million Americans
still struggle with substance abuse disorder. Addiction to other drugs,
including meth and heroin, pose an equal or even greater challenge for
some communities, especially in rural areas. Another issue is that few
battling addiction actually seek or receive treatment. Yet another
issue is that even those who do seek help lack the expertise to
distinguish the good treatment providers from the bad. Solving that
last issue, which is the second focus of our hearing, is easier said
than done.
The treatment sector includes not just extremely good and extremely
bad providers but also many others who fall somewhere in the middle.
Some, for example, haven't updated their methods to incorporate the
latest research about what works best with recovering addicts.
Also, State requirements for addiction counselors and recovery
homes vary. For example, some States require licensing of recovery home
operators, while others might only use voluntary certification
programs. That is why we have invited two government watchdog agencies
and an addiction treatment advocate to our committee to share their
expertise with us today.
First, I want to welcome back to the committee Dr. Deagan-Macauley
of the Government Accountability Office, who testified before this
committee last year. We've all seen the media reports about so-called
``sober homes'' in Florida, Pennsylvania, Massachusetts, and other
States that exploited recovering addicts with private insurance
benefits. We look forward to hearing from her about GAO's oversight of
recovery housing.
I also extend a warm welcome to Gary Cantrell, who leads the
Inspector General's investigations team. His investigators worked on a
recent high-profile case involving an addiction treatment scam in Ohio.
That investigation, in partnership with the FBI and other law
enforcement entities, led to the indictment of six people this year.
All six pled guilty to Medicaid fraud this month.
Some have called for development of more uniform, measurable
addiction treatment standards, by which the public could evaluate the
effectiveness of substance use disorder treatment programs. Our last
witness, Gary Mendell, has gone a step further, not only identifying
eight core standards he believes are key to any successful treatment
program, but also launching a treatment quality rating system. This is
an uncharted area in the treatment sector, and I look forward to
hearing from him about the progress he's made since founding his
nonprofit, Shatterproof, the obstacles he's faced along the way, and
the challenges that remain to the successful use of such a rating
system.
We're here today because too many Americans have lost too many
loved ones to addiction and overdose deaths. America's opioid crisis
has left a trail of broken hearts and homes across the country. We're
here to help communities get on the path towards health and wellness.
Millions of Americans are desperately seeking a path forward. Working
together, we can save tax dollars and save lives. Thank you to our
witnesses today for helping us examine best practices and take a look
at what works--and what doesn't work--to help get Americans on the road
to recovery.
______
Prepared Statement of Gary Mendell,
Founder and Chief Executive Officer, Shatterproof
Chairman Grassley, Ranking Member Wyden, and members of the
committee, thank you for holding this hearing on the important topic of
solutions for treating substance misuse in America. My name is Gary
Mendell, and I am the founder and chief executive officer of
Shatterproof, a national nonprofit organization dedicated to reversing
the addiction crisis in this country.
For nearly a decade, my son Brian suffered with a substance use
disorder. During this time, our family worked tirelessly to find Brian
the best possible care, and he went to eight different treatment
programs. Brian and my family took the advice of supposed experts on
how to support him. On October 20, 2011, we lost Brian to the disease
of addiction. In the months that followed, I learned that in the
decades prior to my son's death, the Federal Government had provided
grants of tens of billions to dollars to researchers all across our
country, and those researchers had successfully created a body of
knowledge that had proven to be able to significantly improve outcomes
for those in treatment. But shockingly, all this information was
sitting in peer-reviewed medical journals, and hardly any of it was
being used. It broke my heart to realize that there were options that
could have helped Brian, if only we had known what to look for and who
to trust. It haunted me knowing how many families were being shattered
every day by this disease and how much devastation could be easily
prevented by ensuring research is implemented into practice. This is
why I founded Shatterproof, the first national nonprofit organization
dedicated to reversing the addiction epidemic in America.
To accomplish this, we developed a plan to transform the addiction
treatment system in the United States. This plan includes five
components:
1. A core set of science-based principles of care for treating
addiction.
2. Treatment quality measurement.
3. Payment reform.
4. Treatment capacity.
5. Stigma reduction.
For the purpose of this hearing, I will focus my remarks on
treatment quality and share how Shatterproof is currently implementing
the first phase of ATLAS, an addiction treatment locator, analysis, and
standards tool, in six States. I commend the other witnesses today for
their critical work of uncovering fraud and abuse in the substance use
disorder treatment space. I hope that I complement that testimony by
addressing the problem of slow adoption of evidence-based practices,
which are essential to improving patient outcomes and reversing the
nation's staggering overdose rates. ATLAS seeks to spur transformation
in this space, and quickly.
Addiction is a well-researched chronic brain disease, but despite
the fact that there are clear clinical best practices with demonstrated
efficacy the use of these practices varies widely across the addiction
treatment field, even in the wake of an opioid epidemic. While some
addiction treatment facilities offer clinically effective medical
treatment, others employ tactics based on ineffective and outdated
methodologies that may be harmful to patients. Using the information
currently available, Americans with substance use disorders and their
loved ones find it almost impossible to sort through misinformation and
identify the most appropriate level of addiction care, and, evidence-
based care, Even worse, some addiction treatment facilities capitalize
on the fact that addiction impacts the part of the brain that regulates
decision-making, problem-solving, and stress, making people with
substance use disorders susceptible to schemes like patient-brokering.
Unlike other health-care services, comprehensive, standardized,
accurate data on the quality of addiction treatment does not exist.
Even worse, market forces have not been aligned to support best
practices. This must change. And this can change.
what is atlas?
ATLAS is a web- and app-based platform with a triple aim: (1)
empower and educate patients and family members looking for addiction
treatment with reliable information on the use of evidenced-based best
practices by treatment facilities, (2) equip addiction treatment
providers with data to inform their quality improvement initiatives and
advance the use of best practices, and (3) ensure policy and payment
decisions are data-driven, such as the deployment of technical
assistance resources and modified payment models.
Measurement systems for health-care quality have been used to drive
improvements and reduce costs for decades.\1\ Fueled by increased
consumerism, this trend has grown in scope and sophistication since the
early 1990s, and early supporting research shows that health-care
rating systems positively impact provider quality and patient outcomes.
Hospitals with publicly reported quality metrics have significantly
more quality improvement activities \2\ than those without such
metrics. These systems also bring the power of market forces to
incentivize improvements in the quality of care by informing consumer
and payer decisions that impact the market share of treatment
providers.\3\ With regard to addiction treatment, I would like to
highlight that this approach is consistent with recommendations \4\
made by the Institute of Medicine in 2006, calling for the development
and dissemination of a common, continuously improving set of measures
for the treatment of SUD to drive quality improvement and the public
reporting of the delivery of this care.
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\1\ McIntyre, Rogers, and Heier, ``Overview, History, and
Objectives of Performance Measurement,'' Health Care Financing Review,
Spring 2001, available at: https://www.ncbi.nlm.nih.gov
/pmc/articles/PMC4194707/.
\2\ Hibbard, Stockard, and Tusler, ``Does Publicizing Hospital
Performance Stimulate Quality Improvement Efforts?'', Health Affairs,
March/April 2003, available at: https://www.
healthaffairs.org/doi/full/10.1377/hlthaff.22.2.84.
\3\ Werner, Konetzka, and Polsky, ``Changes in Consumer Demand
Following Public Reporting of Summary Quality Ratings: An Evaluation in
Nursing Homes,'' Health Services Research Journal, June 2016, available
at: https://www.ncbi.nlm.nih.gov/pubmed/26868034.
\4\ Institute of Medicine Committee on Crossing the Quality Chasm:
Adaptation to Mental Health and Addictive Disorders, ``Improving the
Quality of Health Care for Mental and Substance-Use Conditions,''
National Academies Press, 2006, available at: https://www.
ncbi.nlm.nih.gov/books/NBK19830/.
ATLAS will allow the public searching for high-quality addiction
treatment to locate and compare facilities, including trustworthy,
standardized quality data on the services available at addiction
treatment facilities, and to review feedback on the services reported
by other patients. ATLAS fulfills Shatterproof's goal of leveraging
healthcare quality measures to increase transparency in and encourage
improvements to addiction treatment. It is based upon Shatterproof's
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National Principles of Care:
1. Routine screenings in every medical setting.
2. Rapid access to care.
3. A personalized plan for every patient.
4. Long-term disease management.
5. Coordinated care for all behavioral and physical health
conditions.
6. The use of evidence-based behavioral therapies by trained
professionals.
7. Access to FDA-approved medications for addiction treatment.
8. Access to recovery support services, including peer and
community services.
ATLAS will collect facility-level data from three sources:
insurance claims, patient experience surveys, and a validated treatment
facility survey. Data from these sources will be available at the
addiction treatment facility level in a free online dashboard that
allows for easy comparisons among facilities. Individuals may filter
searches based upon facility features that are important to them, such
as location and insurance coverage. Facilities that do not respond to
the survey will still be listed on the public-facing website with an
indication that quality data was not disclosed. This approach creates a
source of trusted information, preventing people looking for care from
falling prey to call centers and fraudulent schemes.
Additionally, ATLAS will promote quality improvement by offering
portals for facilities, payers, and States to view and use the data to
drive innovations such as internal facility improvements, rewards for
facility performance, and data-driven State initiatives such as
addiction treatment technical assistance and policy reform. Without
this system, we are concerned that the funneling of needed resources to
the addiction treatment space may only further support questionable
treatment practices. Instead, with ATLAS, responses can be targeted and
ensure that State and Federal dollars are only being used to support
the delivery of evidence-backed care.
current status
Phase 1 of ATLAS is currently being implemented in select states--
Delaware, Louisiana, Massachusetts, New York, North Carolina, and West
Virginia--over 2 years. States were selected based upon various
criteria, including capacity for successful implementation and
demonstrated potential to scale ATLAS in the future. Shatterproof is
working closely with many addiction treatment stakeholders, including
provider and medical organizations, payers, and recovery advocates, to
ensure a successful and collaborative implementation.
Shatterproof is working with RTI International (RTI), an
independent research institute with national expertise in quality
measurement and substance use disorders, to support ATLAS analytics.
RTI currently supports five national health quality reporting efforts
and one large private rating system and has developed and obtained
National Quality Forum (NQF) endorsements for over 40 quality measures.
RTI leads large-scale quality measure collection efforts with health-
care providers including supporting over 3,000 providers in reporting
measures for the Centers for Medicare and Medicaid Services' (CMS's)
Comprehensive Primary Care Plus (CPC+) project.
Shatterproof received $5 million in funding for the ATLAS pilot,
with majority funding coming from Arnold Ventures and the Robert Wood
Johnson Foundation and the remainder coming from a group of national
health insurance companies.
progress to date
Thus far, the pilot has included measure identification and
refinement through an NQF Expert Panel Strategy Session and public
comment period, feasibility testing of survey items and claims
measures, and a pilot of the patient experience survey approach across
50 facilities in one State. Data collection for the pilot phase is
underway from mid-October to mid-December 2019 from three sources:
insurance claims, treatment facility surveys, and patient experience of
care. Facilities will have the opportunity to review the display of
their quality measure data before public launch.
Claims Data. The four claims-based measures address the concepts of
care continuity, overdose after treatment, evidence of opioid use
disorder (OUD) medication use, and continuity of pharmacotherapy for
OUD. The measures are currently being calculated by participating
Medicaid agencies and commercial health plans across the six phase 1
States.
Patient Experience Survey. The Patient Experience Survey, which
includes questions related to treatment quality, access, patient
improvement in functioning, and facility staff support that are based
on the Agency for Healthcare Research and Quality's (AHRQ) CAHPS
survey, was recently piloted at 50 facilities in New York State with
promising findings. Twenty responses per facility will be needed to
report reliable data to the public. Data collection is now underway
across all of the phase 1 States. Upon the launch of ATLAS, the public
will be able to complete these surveys to leave feedback on facilities
directly on the ATLAS site.
Treatment Facility Survey. Shatterproof and RTI have conducted an
iterative process for finalizing the Treatment Facility Survey
questions based on the result of the NQF Expert Panel. This has
included feasibility testing and formal input processes with treatment
providers, State partners, and the public. Validation measures and
protocol, used to ensure the accuracy of survey data collected, have
also been finalized. The Treatment Facility Survey was distributed to
all 2,444 facilities across the six phase1 States via an online portal
on October 14, 2019. More than 15percent of the facilities have already
submitted a response or are in the process of doing so.
Quality data will be triangulated from these three sources and
reported through the ATLAS site back to providers, to the public, and
to payers and States. Importantly, facility-level composite scores such
as a letter grade or star rating will not be generated during this
pilot; instead, descriptive and quality information will be displayed
as objectively as possible with lay-friendly educational content. ATLAS
is slated to be launched as early as May 2020.
future of atlas
Following the implementation and evaluation of the ATLAS pilot,
Shatterproof will lead the sustained implementation and scale-up of
this resource to serve people with substance use disorders and their
loved ones nationally. Lessons learned from phase 1 will inform further
refinement of the quality measures and improve data collection
techniques for future phases to ensure ATLAS is providing
comprehensive, useful information on addiction treatment and driving
overall quality improvement.
Shatterproof remains committed to using data-based indicators to
catalyze long-term systems- and policy-level changes in addiction
treatment. This is part of our strategic goal of transforming the
addiction treatment system in the United States in order to reverse the
addiction crisis that has had a severe and tragic toll on too many, and
for which the impact can be averted for so many more.
Thank you for the opportunity to testify today, and I look forward
to your questions.
______
Questions Submitted for the Record to Gary Mendell
Questions Submitted by Hon. Chuck Grassley
Question. Research suggests that a low percentage of those
struggling with addiction actually seek treatment. Could you comment on
how peer support services can reduce the stigma associated with seeking
treatment for behavioral health conditions?
Answer. This is not an issue we have focused on at Shatterproof,
but we would be happy to work with you and your staff on it. We do know
that some States have started to pay for peer supports and this is a
signal that there is some basis for their benefit.
Question. Please tell us more about your efforts to partner with
State government agencies to offer guidance on different approaches to
expand evidence-based treatment options for those struggling with
addiction.
Answer. In the absence of a national standard of care for addiction
treatment, Shatterproof, in partnership with a multi-stakeholder
collaborative, released its National Principles of Care. The use of
these evidence-based best practices is known to improve patient
outcomes. Recognizing the gap in transparent information on the quality
of addiction treatment facilities, along with a plethora of
misinformation in this space, Shatterproof then created ATLAS to help
families looking for high-
quality addiction treatment. ATLAS helps people searching for treatment
by displaying trustworthy quality information using multiple data
sources. This quality information will be available on treatment
facility profiles along with educational information to help guide
treatment decisions by individuals and family members.
Having established standards of care, it was incumbent on us to
work with States to remove barriers to that care. Prior authorization
(PA) before receiving medication for addiction treatment (MAT) is one
such barrier. Despite the evidence supporting MAT, treatment use
remains low among individuals with an opioid use disorder (OUD): only
25 percent of the 2.1 million individuals with an OUD are treated with
MAT. Utilization management practices applied to MAT by public and
private health insurers or payors contribute to this gap. PA
requirements and annual limits are associated with decreased MAT
availability.\1\ Providers also rate PA requirements as a significant
barrier to MAT prescribing.\2\ Despite evidence suggesting that PA
reduces MAT use, these policies remain prevalent across public and
private markets. In the 2019 Medicaid managed care organization market,
42 percent of plan sponsors or pharmacy benefit managers imposed a PA
or step therapy requirement on generic MAT products; 53 percent imposed
a requirement on brand products.\3\ Among 2017 marketplace plans, 36.1
percent of plans applied PA to a buprenorphine formulation.
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\1\ Andrews CM, Abraham AJ, Grogan CM, Westlake MA, Pollack HA,
Friedmann PD. ``Impact of Medicaid Restrictions on Availability of
Buprenorphine in Addiction Treatment Programs.'' American Journal of
Public Health. 2019;109(3):434-436. doi:10.2105/AJPH.2018.304856.
\2\ Kermack A, Flannery M, Tofighi B, McNeely J, Lee JD.
``Buprenorphine prescribing practice trends and attitudes among New
York providers.'' Journal of Substance Abuse Treatment. 2017;74:1-6.
doi:10.1016/j.jsat.2016.10.005.
\3\ Avalere Health PlanScape. 2019.
We, along with leading organizations like the American Society of
Addiction Medicine (ASAM) and the American Medical Association (AMA),
have worked in several States to end the practice of requiring PA
before accessing MAT. We are making significant progress with many
States banning the use of prior authorization for MAT. Missouri,
Colorado and Texas each passed laws this year ending that practice to
varying degrees. This followed several other States, including
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Massachusetts and Pennsylvania, that had already done so.
Another issue is ensuring that States require quality treatment as
part of their licensure of treatment facilities. We worked in
California to ensure that residential treatment facilities have quality
standards and are hopeful that they will require the same for
outpatient treatment.
Question. Engaging overdose survivors in the hospital, when they
are most vulnerable, and therefore inclined to commit to treatment for
addiction, is a strategy that some communities have embraced. Do
emergency room initiated support services work, in your opinion, and if
so, under what circumstances are they most likely to succeed? What else
might we do to promote awareness of additional strategies to encourage
addiction treatment?
Answer. According to Dr. Nora Volkow, Director of the National
Institute on Drug Abuse, emergency department (EDs) represent a
critical opportunity for overdose prevention and engagement in
treatment. Those who have overdosed on heroin are four to five times
more likely to suffer a subsequent overdose event and are at higher
risk of death from opioid overdose.\4\ A recent report from the
Delaware Drug Overdose Fatality Review Commission found that half of
the people in Delaware who died of an overdose during the second half
of 2018 had suffered a previous nonfatal overdose. More than half of
these deaths occurred within 3 months of an ED visit. The report
recommended that patients who visit EDs with signs of OUD be linked to
treatment.\5\
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\4\ https://www.acep.org/how-we-serve/sections/trauma--injury-
prevention/news/june-2015/opioid-overdose-prevention-and-response/.
\5\ https://www.drugabuse.gov/about-nida/noras-blog/2019/08/
emergency-departments-can-help-prevent-opioid-overdoses.
Studies show that the time period immediately following an overdose
is a critical time to transition an individual into treatment.
Individuals who are treated for a nonfatal overdose in the ED are at
the highest risk for mortality in the first month, and in particular,
the first two days after the overdose.\6\ Yet, a recent study found
that patients with OUD who were treated with buprenorphine in the ED
were twice as likely to be in treatment after 30 days when compared to
patients who were only given referrals to addiction treatment
specialists.\7\
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\6\ https://www.ncbi.nlm.nih.gov/pubmed/31229387.
\7\ https://jamanetwork.com/journals/jama/fullarticle/2279713.
These studies and anecdotal evidence we hear from States and
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medical practices suggest this is an area that needs urgent attention.
Further, Shatterproof supported the section 7081 ``Preventing
Overdoses While in Emergency Rooms'' provision of the SUPPORT Act to
support coordination and continuation of care for drug overdose
patients. The grant program will support implementation of voluntary
programs for care and treatment of individuals after a drug overdose
based on best practices to be defined by the Secretary of the
Department of Health and Human Services, including on the use of
recovery coaches, better coordination and continuation of care, and the
prescribing of overdose reversal medication. We look forward to the
Secretary's report on long-term health outcomes of the population
served by grantees and remain supportive of providing immediate care
continuation and treatment options after a non-fatal overdose.
______
Question Submitted by Hon. Patrick J. Toomey
Question. Do any of the States stand out as high performers when it
comes to oversight and regulation of addiction treatment centers?
Please provide examples.
Answer. Of the States we work with, Massachusetts in particular
stands out as a leader on addressing addiction issues in a
comprehensive way. The State's licensing for addiction facilities
incorporates the highest level of rigor. They have also led the way on
integrating data systems to expand the knowledge base around opioid use
disorder and overdose deaths with their chapter 55 data. This in turn
allows for more targeted interventions. Lastly, they have been a leader
on increasing education around addiction and treatment among future
healthcare professionals.
______
Question Submitted by Hon. Bill Cassidy
Question. This hearing highlighted some of the challenges that
families affected by substance use disorder face when trying to find
properly certified treatment centers that use appropriate, science-
based methods. One way that families could be helped is by having
access to an app which directs them to certified treatment centers in
their area. Generally speaking, how has HHS considered ways to direct
families to treatment centers that are certified and use science-based
methods? If not such an app exists, could HHS put forth a challenge
grant to help one be created?
Answer. Recognizing the gap in transparent information on the
quality of addiction treatment facilities, along with a plethora of
misinformation in this space, Shatterproof created ATLAS to help
families looking for high- quality addiction treatment. ATLAS helps
people searching for treatment by displaying trustworthy quality
information. In the absence of a national standard of care for
addiction treatment, Shatterproof, in partnership with a multi-
stakeholder collaborative, released its National Principles of Care.
The use of these evidence-based best practices known to improve patient
outcomes are then assessed using multiple data sources. This quality
information will be available on treatment facility profiles along with
educational information to help guide treatment decisions by
individuals and family members.
There may be an opportunity to build upon the current quality
measures and learn from the first round of data collection to implement
a certification-type of program in partnership with the Department of
Health and Human Services (HHS). Additionally, if HHS were to implement
a certification program, that distinction could easily be mobilized in
the ATLAS system to make the information available to families. ATLAS
uses best practices in website design and user experience to maximize
the ease of use for consumers and is poised to integrate additional
metrics to help people locate the best quality care.
______
Questions Submitted by Hon. Ron Wyden
Question. Recent press reports have been critical of accrediting
organizations and State licensing agencies for failing to weed out bad
actors lurking in the substance use disorder rehabilitation industry.
For example, the magazine Mother Jones reported earlier this year on a
chain of substance use disorder rehabilitation facilities in Florida
that had been accredited by the Joint Commission up until the day they
were raided by law enforcement agencies. The owner of the fraudulent
Florida facilities went on to be sentenced to 27 years in jail on
charges of committing health-care fraud and coercing patients into
prostitution. In your view, what should accrediting agencies be doing
differently than they are now to avoid these types of shortfalls? What
should the Federal Government's role be in oversight of the drug
treatment industry?
Answer. States have a critical role to play in improving the
quality of treatment by addressing the licensing requirements for
treatment facilities in their State. At the April 2019 National Academy
of Medicine's Action Collaborative meeting, it was discussed that many
State licensing laws have not been reviewed for decades. It is critical
that this be done to ensure that licensing requirements account for the
evidentiary base that has been developed more recently, specifically
the use of medication-assisted treatment (MAT). For example,
Shatterproof has worked with California to ensure its residential
treatment facilities are licensed with current
evidence-based standards and we expect to continue that effort with the
State's outpatient facilities in the coming year.
While State accrediting agencies play an important role in ensuring
the safety and legitimacy of a facility, they provide little
transparency into the quality of the facility to the average consumer.
A facility's use of best practices may vary based on the services and,
without more nuanced information, it may provide a false sense of
quality for an individual seeking care. Shatterproof's ATLAS tool will
display earned accreditations for facilities that participate, as well
as additional transparency around the use of a multitude of best
practices and patient reviews.
On the Federal level, important steps have been taken which include
the requirement that State Opioid Response grants be spent on expanding
MAT capacity. However, much more should be done such as incentivizing
quality care through adequate payment models and oversight.
Finally, ongoing oversight by the Senate Committee on Finance, the
Government Accountability Office and the HHS Officer of Inspector
General will be essential to ending this crisis of quality treatment.
Question. The Government Accountability Office stated during its
testimony that there is no Federal oversight of so-called ``sober
homes.'' Please provide examples of regulatory gaps in the sober home
industry, or the substance use treatment industry, in general, where
the Federal Government should play a greater role.
Answer. ATLAS does not currently include evaluation of or
information about sober homes, but we agree that this is an area in
need of better oversight and transparency. We are aware of some
licensing groups at the State level for sober homes, including the
Massachusetts Alliance for Sober Housing (MASH).
Question. As we have heard during the hearing, it's a real
challenge for people seeking treatment to find good programs. Your
organization is running a pilot program to try to document how well
treatment programs actually perform for both in-patient and out-patient
facilities that Shatterproof is piloting in Delaware, North Carolina,
Louisiana, New York, West Virginia, and Massachusetts. According to
your testimony, these six States have more than 2,400 treatment
facilities. What is the cost of standing up and running these
databases? What is the penetration rate (i.e., how many facilities you
expect to have participate in the pilot program)? What are barriers to
getting the databases off the ground? How do you expect to expand the
program to other States? What steps can the Finance Committee consider
taking to facilitate an expansion of the program if its pilot proves
successful?
Answer. The cost of standing up ATLAS in each State is roughly
$350,000, with some variation based on State size. This includes costs
to engage addiction treatment providers, raise awareness, deploy and
manage the data collection tools, analyze the data, and build and
manage the ATLAS website. Efficiencies to reduce costs for maintenance
of the system will be realized in subsequent years resulting in cost
savings for running the system once launched. In addition to the cost
of building, launching, and maintaining ATLAS, there is further
opportunity to deploy technical assistance to support provider
improvement and adoption of best practices if funding allows.
During the first phase of ATLAS, we expect roughly one third of
facilities to participate across all six States; however, we expect the
participation rate to range from 20-50 percent by State based on
factors related to engagement in the project and incentives for
participation. Facilities participate by completing the Treatment
Facility Survey, or submitting information on the practices, processes,
and services available at their site. Importantly, even if facilities
do not participate in the Treatment Facility Survey, their site will
still be listed on the ATLAS website and it will clearly indicate that
they did not disclose quality data. If data on quality is available
from the other data sources (e.g., claims-based measures or patient
experience surveys), we anticipate that information will still be
displayed.
Shatterproof has worked to overcome barriers to ensure ATLAS is
successful. The level of provider engagement has varied greatly across
Phase 1 States. In some cases, providers have been hesitant or
unwilling to collaborate on ATLAS, given facilities are being assessed
on the quality of their services. Shatterproof has worked diligently
alongside State partners to understand provider concerns and build
trust in the Phase 1 States through frequent provider roundtables,
advisory committees, and other engagement efforts. These efforts have
been worthwhile as engagement has improved in recent months and survey
response rates are on target.
Shatterproof is also revolutionizing the use of claims measures for
addiction treatment--working with health insurers to identify a
feasible strategy to incorporate these data into ATLAS. This novel
approach has proven difficult to implement due to data differences
across States and organizations, but Shatterproof is continuing to
troubleshoot and refine the data collection and analytics processes
with participating insurers and State Medicaid agencies to determine
the best approach.
Despite these challenges, we have seen early successes in Phase 1
and are preparing to scale ATLAS to the remaining 44 States and the
District of Columbia. Lessons learned from Phase 1 will allow for
increased efficiencies, reduced costs, and the delivery of a responsive
and useful product to users across the country. At this point in time,
we are exploring phased expansion of ATLAS to other States based on
available funding. We welcome conversations with the committee to
determine the best path to reach national expansion and sustained
implementation of ATLAS. Our research has indicated an annual cost of
approximately $15M to run the program once it is launched. We are
exploring philanthropic support to facilitate expanding nationally as
quickly as possible and are also exploring possible revenue streams to
sustain implementation. We would welcome conversations with the
committee on other sources of funding and strategies to expand and
sustain ATLAS.
Question. During the hearing, you stated that the Federal
government could condition treatment-related grants to States on them
funding evidence-based treatment practices. What other steps should the
Finance Committee consider taking to help people connect with good
treatment programs?
Answer. Encouraging States to use Federal grant funding for
treatment quality measurement would be an effective way to incentivize
States to support ATLAS implementation and ongoing management. This
would also be an effective mechanism to ensure that Federal and State
dollars spent on addiction treatment are directed to providers using
evidence-based best practices and supporting the adoption of these
practices, as well as helping families and people with substance use
disorders navigate this complex system.
Question. The lack of access to safe, effective treatment for
addiction is its own health-care crisis. The examples that the
Government Accountability Office has provided are just the tip of the
iceberg when it comes to scam artists trying to take advantage of those
who are desperate for help. Mr. Mendell, you are a successful
businessman. There are many families like yours who have loved ones
struggling with substance use disorders but they do not have the same
resources that you had. For them, the job is even tougher. How do they
find good treatment? What red flags should they avoid? What should the
Finance Committee be doing to make sure they have access to the high-
quality care they deserve?
Answer. For people with substance use disorders and their loved
ones, it is difficult to discern between high-quality addiction care
and inadequate or even fraudulent providers based on the information
currently available. Unlike other health-care services, comprehensive,
accurate, and lay-friendly data on addiction treatment quality does not
exist. In the absence of a system like ATLAS to provide trustworthy and
reliable information on the quality of facilities, patients and family
members should be on the lookout for some red flags, including
treatment providers that offer incentives to begin treatment at their
facilities, such as free flights, money, and even cigarettes. Patients
should expect to receive an individual bio-psycho-social examination
that informs their treatment plan resulting in patient-specific care
and should be concerned if a treatment program funnels patients through
a one-size-fits-all program. It is a red flag if facilities do not
assess and monitor each individual patient. Other red flags include
dehumanizing practices and an unnecessary degree of restriction on
personal freedoms, blanket policies prohibiting the use of medication,
policies that kick someone out of a program for relapsing rather than
providing support and re-engaging to the appropriate level of care,
programs without any trained medical staff, and programs boasting of
unrealistic or unsubstantiated outcomes such as 80 percent or higher
``success rates.'' People looking for addiction treatment can use
Shatterproof's National Principles of Care to identify what elements of
care should be included in every treatment program.
______
Questions Submitted by Hon. Benjamin L. Cardin
Question. Shatterproof has launched a pilot called ATLAS to develop
a platform for individuals to search for and find high-quality
addiction treatment facilities on the web or through an app.
Could you discuss how HHS or CMS could possibly use the
standardized quality data gathered by ATLAS to aid in oversight of
recovery homes?
Answer. ATLAS does not currently include evaluation of or
information about recovery homes, but we agree that this is an area in
need of better oversight and transparency. We are aware of some
licensing groups at the State level for recovery housing, including the
Massachusetts Alliance for Sober Housing (MASH).
Question. Do you know if Federal agencies are collaborating with
State and local governments to inform consumers of the dangers of sober
homes and patient brokering practices?
Answer. ATLAS does not currently include evaluation of or
information about recovery or sober homes, but we agree that this is an
area in need of better oversight and transparency. We would be happy to
work with you and your staff to raise awareness about the dangers of
patient brokering practices. We also submitted comments to the House
Energy and Commerce Committee's effort to continue its ongoing
investigation into patient brokering and other challenges, failures,
fraud, and abuse within the substance use disorder treatment industry.
Question. If not, what could the Federal Government do to educate
consumers about quality treatment programs for their loved ones and how
to identify patient brokering scams?
Answer. ATLAS will educate consumers on the best practices in
addiction treatment and report facilities' use of these practices.
Encouraging States and providers to participate in ATLAS and promoting
the website (https://www.shatterproof.org/atlas) to those looking for
addiction treatment will not only help people avoid potentially harmful
or fraudulent providers, it will realign market forces with the
delivery of high-quality care.
______
Questions Submitted by Hon. Sherrod Brown
mandatory licensing and certification requirements
Question. During the hearing, we heard how it can be difficult for
individuals and their families to obtain information on the quality of
sober homes and treatment facilities because there are no Federal
requirements on these facilities that they provide information relevant
to the public to aid in evaluating potential treatment options. You
expressed support for putting conditions on Federal funding to
incentivize States to establish better quality metrics and reporting to
help improve access to useful information that folks can use when
evaluating treatment options.
In its report, GAO commented that some States have chosen not
establish mandatory licensing standards or certification requirements
for treatment facilities out of fear it would be a ``roadblock'' to
establishing additional sober homes. Do you believe that these
facilities should be required to pass a basic certification/licensing
requirement so consumers have access to basic information regarding the
quality of the facility?
Answer. Licensing requirements are critical and should be
consistent with a reputable evidence-based standard, such as the ASAM
criteria. At the April 2019 National Academy of Medicine's Action
Collaborative meeting, it was discussed that many State licensing laws
have not been reviewed for decades. It is critical that this be done to
ensure that licensing requirements account for the evidentiary base
that has been developed more recently, specifically the use of
medication-assisted treatment (MAT). With regard to how these licensing
standards influence the availability of sober homes, this is not a core
area of expertise for Shatterproof at this time. However, one concern
we should have relates to anecdotes about those in recovery who are not
allowed to take their medications for addiction in a sober home or
other recovery setting. This is an issue that needs to be considered as
the licensing and quality conversation continues.
Question. What would you say to somebody who argues that minimum
standards, quality metrics, and licensure requirements for sober homes
are not worth it because they might create barriers to the existence of
these types of facilities?
Answer. Shatterproof is supportive of ensuring individuals have
access to the appropriate level of quality addiction treatment and
other supportive services. Barriers to access should be taken into
consideration when weighing any new policy decisions, but we also must
find ways to encourage or incentivize treatment providers to meet basic
standards for quality, evidence-based treatment and for other recovery
support services.
atlas
Question. In lieu of any standardized Federal accreditation/
certification system, we appreciate Shatterproof's efforts to create a
standardized rating system for treatment facilities to give individuals
and their families more information and power as they compare treatment
options.
What criteria does Shatterproof use to compile ratings for its
ATLAS program?
Answer. ATLAS will allow the public searching for high-quality
addiction treatment to locate and compare facilities, including
trustworthy, standardized quality data on the services available at
addiction treatment facilities, and to review feedback on the services
reported by other patients. ATLAS fulfills Shatterproof's goal of
leveraging health-care quality measures to increase transparency in and
encourage improvements to addiction treatment. It is based upon
Shatterproof's National Principles of Care:
1. Routine screenings in every medical setting.
2. Rapid access to care.
3. A personalized plan for every patient.
4. Long-term disease management.
5. Coordinated care for all behavioral and physical health
conditions.
6. The use of evidence-based behavioral therapies by trained
professionals.
7. Access to FDA-approved medications for addiction treatment.
8. Access to recovery support services, including peer and
community services.
ATLAS will collect facility-level data from three sources:
insurance claims, patient experience surveys, and a validated treatment
facility survey. Data from these sources will be available at the
addiction treatment facility, or location-based, level in a free online
dashboard that allows for easy comparisons among facilities.
Individuals may filter searches based upon facility features that are
important to them, such as location and insurance coverage. Facilities
that do not respond to the survey will still be listed on the public-
facing website with an indication that quality data was not disclosed.
This approach creates a source of trusted information, preventing
people looking for care from falling prey to call centers and
fraudulent schemes.
Additionally, ATLAS will promote quality improvement by offering
portals for facilities, payers, and States to view and use the data to
drive innovations such as: internal facility improvements, rewards for
facility performance, and data-driven State initiatives such as
addiction treatment technical assistance and policy reform. Without
this system, we are concerned that the funneling of needed resources to
the addiction treatment space may only further support questionable
treatment practices. Instead, with ATLAS, responses can be targeted and
ensure that State and Federal dollars are only being used to provide
evidence-backed care.
Our website will be regularly updated as Phase 1 progresses and
next steps are announced: https://www.shatterproof.org/atlas.
Question. Based on the information your organization has gathered,
are there common characteristics that are shared among recovery homes
that ATLAS considers to be high quality? Are there trends across low-
performing facilities?
Answer. ATLAS does not currently include evaluation of or
information about recovery homes, but this is an area in need of better
oversight and transparency. We are aware of some licensing groups at
the State level for recovery housing, including the Massachusetts
Alliance for Sober Housing (MASH).
______
Question Submitted by Hon. Maggie Hassan
Question. Thank you for sharing your story as a witness during the
Senate Finance Committee hearing on ``Treating Substance Misuse in
America.'' And thank you for the incredible work that you are doing in
your son's memory to improve the lives of so many people.
I am grateful for your work to expand access to information about
recovery homes, including the quality and types of treatment available
at these homes. It is critical that individuals and their families have
this information in order to make informed decisions about their
treatment and recovery options.
But, as you know, stigma can limit access to medication-assisted
treatment, and can also raise individual privacy concerns, including
the risk of employment discrimination, for those in recovery housing.
How does Shatterproof work to address the stigma associated with
medication-
assisted treatment and recovery housing, and how can Congress help?
Answer. Shatterproof has identified nine commonly cited drivers of
the epidemic: overprescribing, increased access to substances, social
isolation, lack of help-seeking, insufficient treatment capacity,
insurance coverage disparities, lack of evidence-based treatment,
criminalization of SUD, and social and structural barriers to recovery.
Seven of these nine drivers are either partially or entirely driven by
stigma.
There are three types of stigma: public, structural, and self.
Public stigma is society's negative attitudes towards a group of
people, creating an environment where those with an addiction are
discredited, feared, rejected, discriminated against, and socially
isolated. In a recent survey, fewer than 20 percent of Americans said
they were willing to associate closely with someone who is addicted to
prescription drugs as a friend, colleague, or neighbor.
Recognizing this gap, Shatterproof, McKinsey and Company, and The
Public Good Projects studied 11 analogous social change movements
(i.e., tobacco, HIV/AIDS, etc.) to determine whether stigma could be
significantly reduced and, if so, the most effective ways to do so. Our
research identified six factors from previous movements that helped
reduce stigma and that we believe will be most impactful in reducing
the stigma associated with addiction:
A well-funded, central actor can coordinate rapid change.
Specific actions included educating, changing policies, and
altering language.
Educational initiatives used contact-based strategies
(messaging between people with OUD and those without OUD) to
humanize the disease and emphasize treatment is effective.
Sequencing can help a movement activate influential
institutions who can trigger broader adoption, ensure
sustainable momentum, and reach a tipping point for mass
adoption.
Positive and negative incentives were employed for the most
impactful stakeholders.
Action was mobilized at both the ``grassroots'' and
``grasstops.''
Our research concluded that the stigma related to OUD can be
significantly reduced. Shatterproof and our partners will be releasing
a plan in the coming months to achieve this.
Congress can and should play a pivotal role in addressing the
stigma associated with addiction. We invite you to join us to help
launch and implement this national initiative and significantly reduce
the devastation of the addiction crisis in our country.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
Today's hearing will spotlight the pitfalls people face when they
try to find quality treatment for a substance use disorder. A person
battling this disease is often jostled around from one end of the
health-care system to the other. The last thing they need is another
obstacle--rip-off artists, empty promises, or outright abuse--when they
are just trying to get better.
Too often, people travel across the country expecting to arrive at
a legitimate treatment facility only to find that they have fallen prey
to a scheme whose goal is to drain their bank account and bilk their
insurance for everything it's worth. In some instances, these
unscrupulous operators lure would-be patients by paying for plane
tickets and promising free rent. Once they arrive, these patients may
receive sub-standard care or no care at all. But the fraudsters are
still billing insurers for health-care services that may have never
been performed.
One of the biggest problems involves facilities that allegedly
treat substance use disorders but are actually set up to defraud
taxpayers. These fraudsters illegally recruit patients using bribes and
kickbacks, and then bilk taxpayers by billing the patient's health plan
for medically unnecessary drug tests. Schemes like these, which our
witnesses will detail this morning, cost Medicare, Medicaid and private
insurance hundreds of millions every year.
Just this month, six people operating a network of fraudulent
treatment centers in Ohio pled guilty to submitting 130,000 Medicaid
claims that totaled more than $48 million for medication-assisted
treatment and other services that were never legitimately provided.
Part of the reason this type of fraud is so common is because there
is no way for a patient or their family to learn about the quality of a
treatment facility before they enroll. Today the committee will hear
from an organization that is working to change that. Shatterproof is
currently developing public databases in multiple States that, if
successful, will allow the public to identify, evaluate, and compare
substance use treatment programs. This kind of database and
transparency is the type of information families need to find quality
treatment and avoid sham operators trying to make a quick buck.
One final point. The recent court settlements in multiple States
with drug makers and wholesale distributors demonstrate that States and
communities may be on the cusp of receiving tens of billions of dollars
from the companies that helped seed this epidemic. A sum of that size
will almost certainly be a magnet for fraud. This hearing will
highlight the need to make sure rules of the road and vigorous
oversight are in place to ensure those dollars go to proper care that
will help heal this national crisis.
I thank the witnesses for joining the committee this morning. This
is an opportunity for bipartisan progress on health care, so let's get
to work.
______
Communications
----------
Association for Behavioral Health and Wellness
1325 G Street, NW, Suite 500
Washington DC, 20005
202-449-7660
https://abhw.org/
November 5, 2019
The Honorable Ron Wyden
Ranking Member
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510
October 24, 2019: ``Treating Substance Misuse in America: Scams,
Shortfalls, and Solutions''
Dear Ranking Member Wyden:
The Association for Behavioral Health and Wellness (ABHW) appreciates
the opportunity to respond to your comments requesting information
about substance use disorder (SUD) treatment during the Finance
Committee's October 24th hearing, ``Treating Substance Misuse in
America: Scams, Shortfalls, and Solutions.''
ABHW is the national voice for payers that manage behavioral health
insurance benefits. ABHW member companies provide coverage to
approximately 200 million people in both the public and private sectors
to treat mental health, SUDs, and other behaviors that impact health
and wellness.
ABHW members have witnessed firsthand the fraud in some SUD treatment
facilities in areas of licensure, accreditation, administrative and
billing practices, quality, and enrollment. Our comments below outline
the problems ABHW members have experienced with fraud and abuse as well
as offer ideas to improve the quality of SUD treatment. These
fraudulent activities usually occur in out-of-network SUD facilities
and the inappropriate care they provide can have dire, and sometimes
fatal outcomes.
Recovery Homes
ABHW supports the notion that recovery housing should have a clear
operational definition that accurately delineates the type of services
offered. While recently released guidelines by the Substance Abuse and
Mental Health Services Administration (SAMHSA) encourage this, we
believe additional oversight needs to be identified to truly hold
unethical treatment centers accountable.
Efforts to address this issue should explicitly state that recovery
homes are not treatment programs and individuals do not receive
treatment at a recovery home. Additionally, it should be made clear
that recovery homes can be a component of an individual's treatment and
recovery and that any necessary treatment will be accessed in other
settings and that all services should be coordinated. This level of
specificity is critical so that recovery homes can be evaluated by
consumers, providers, accrediting bodies, government, and payers. A
clear delineation will help everyone know what to expect.
Licensure and Accreditation
While licensing is a function under state and other local
jurisdictions, efforts are needed to ensure that all facilities are
licensed and fully accredited to provide SUD treatment. ABHW members
have found that some facilities do not have a valid license, a license
does not exist at the address provided, a license is not for services
being advertised, and/or the facility may be providing services for
which they are not licensed.
Additionally, it is critical that facilities adopt quality standards
and be held accountable to those standards through accreditation.
Standards should take into account that there are several levels of
care within the recovery housing model, each with different oversight
needs.
Administration and Billing Practices
As more funding is directed toward treating SUDs it has drawn the
interest of private equity and other profit driven providers. Several
important clinical and billing issues need to be addressed. ABHW
members have identified that fraudulent facilities may bill for the
same diagnosis, same procedures, same units for every member, every
day. Additionally, there is often misrepresentation of billed services
such as an inpatient/hospital bill, but the facility is residential or
intensive outpatient. These providers are often unable to substantiate
billed services and lack adherence to federal and state regulations,
policies, and/or procedures.
Quality
ABHW member companies continue to grapple with fraudulent claims and
identifying deceptive practices. While there are efforts to roll back
prior authorization, these and other utilization review tools are
important to help ensure that patients aren't being preyed upon by
fraudulent providers. These managed care techniques help provide checks
and balances to ensure quality treatment and patient protections. ABHW
member companies have identified improper practices sue as, treatment
not being rendered by a medical professional, in appropriate medical
supervision of SUD treatment programs, clinical information provided
during prior authorization is unclear or vague, excessive use of
medically unnecessary services, unlicensed personnel rendering
services, and facilities billing for levels of care that they are not
licensed to perform.
Quality standards, best practices, and model policies need to be
identified and widely disseminated and adopted to ensure individuals
have appropriate and accurate information to make treatment decisions.
Additionally, this will give payers a full picture of the medically
necessary services rendered under appropriately licensed medical
professionals. This will ensure the appropriate level of care and
treatment needed to produce positive health outcomes and protect
patients struggling with SUDs.
Enrollment
Patient brokering continues to be a part of fraudulent practices in
pockets of the SUD treatment industry. This activity often results in
kickback payments and targeting patients through deceptive marketing
and advertising practices with paid travel and incentives to enroll in
treatment, often outside of their state of residence and out-of-
network. Once an individual is enrolled, facilities often bill for
treatments, tests, and other services or procedures that may or may not
be clinically appropriate and may not even be provided. We encourage
efforts to identify this fraudulent behavior and procedures for law
enforcement to address it in a timely manner.
ABHW is committed to working with Congress, the Administration, health
care providers, and other stakeholders to shed light on this issue,
prevent fraud, and protect patient lives.
Additional SUD Policies
ABHW is fully committed to addressing SUDs. In particular we are
interested in curbing the opioid epidemic and supporting a continuum of
evidence-based, person-centered care to treat individuals with an
opioid use disorder (OUD), including medication assisted treatment
(MAT). Our members work to identify and prevent addiction where they
can; and where they cannot, they help individuals get treatment so that
they can recover and lead full, productive lives in the community. As
you continue your work to address SUDs, we encourage you to consider
the following additional policy and legislative proposals.
42 CFR Part 2
ABHW is committed to aligning 42 CFR Part 2 (Part 2) with the Health
Insurance Portability and Accountability Act (HIPAA) for the purposes
of treatment, payment and health care operations (TPO) to allow
appropriate access to patient information that is essential for
providing whole-person care while protecting patient privacy.
The Protecting Jessica Grubb's Legacy Act, S. 1012, promotes
coordinated care and expanded access to treatment. As you continue your
work to address SUDs, we highlight the importance of including S. 1012
in any legislative health package that is considered on the Senate
floor this year. This legislation would align Part 2 with HIPAA to
allow for the transmission of SUD records for the purpose of TPO as
well as enhance patient privacy and anti-discrimination protections.
Only then can we promote integrated care and heightened patient safety,
while providing health care providers with one federal privacy standard
for all of medicine.
The recent Confidentiality of Substance Use Disorder Patient Records
Notice of Proposed Rulemaking, issued by SAMHSA, proposed some helpful
changes to patient consent, and clarified the ability of non-Part 2
providers to segregate any patient records received from Part 2
programs in order to avoid subjecting their own records to Part 2. The
proposed rule did not address aligning Part 2 with HIPAA for the
purposed of TPO. As a result, it remains important for you to consider
S. 1012.
Expanding Access to Care and Addressing Workforce Shortages
We thank you again for your leadership and efforts to ensure a
sustainable workforce to meet the behavioral health needs in
communities across the country. Expanding access to care by addressing
workforce shortages and barriers that limit available providers to
treat addiction can improve health outcomes, overcome stigma, and
reduce costs. Given that approximately 1 in 5 adults have a mental
illness and 1 in 12 have a SUD, and the fact that there is a growing
shortage of behavioral health providers to respond to this significant
need for services, addressing these barriers is vital to help address
this growing need for ready and timely access to necessary treatment.
Increasing the number of mental health professionals in communities
will help confront the behavioral health workforce shortage that
hinders so many individuals and families from accessing care.
ABHW recommends eliminating the DEA X waiver to prescribe
buprenorphine. It is important to remove regulatory hurdles to help
reduce unmet needs for addiction treatment. In many areas1our members
find it hard to locate a provider willing to provide treatment to the
consumers they serve. Addressing this barrier would allow more
providers to prescribe medication for opioid use disorder and help
individuals overcome addiction.
ABHW also advocates expanding access to treatment by addressing
workforce shortage issues. In particular, we propose expanding the
number of residency positions to treat addiction, increasing access to
a wide variety of behavioral health providers such as licensed
counselors and marriage and family therapists, and incentivizing mental
health professionals to serve in workforce shortage areas. These steps
will improve SUD treatment and help curb the opioid epidemic.
Thank you for the opportunity to comment on this import ant issue. We
look forward to working with you to identify solutions and ensure
quality, evidence-based SUD treatment in communities across our nation.
Please feel free to contact Maeghan Gilmore, Director of Government
Affairs at [email protected] or 202-449-7658 with any questions.
Sincerely,
Pamela Greenberg, MPP
President and CEO
______
Letter Submitted by Trudy Avery
October 23, 2019
U.S. Senate
Committee on Finance
Dirksen Senate Office Building
Washington, DC 20510
RE: ``Treating Substance Misuse in America: Scams, Shortfalls, and
Solutions''
To Whom it May Concern:
I am writing this letter on the eve of the Committee's hearing on
``Treating Substance Misuse in America: Scams, Shortfalls and
Solutions''; thus you will be receiving this after the fact.
I was just made aware of this hearing this morning, but still felt it
imperative to write to the committee. I am the mother of an adult son,
Corey, now 32, who is in long-term recovery from IV heroin use. He
struggled since the age of 14 and got sober at age 28, after four in-
patient programs.
I am enclosing a Cape Cod Times article from 2013 reflecting on my
lawsuit with Blue Cross of Massachusetts, which took place 10 years
ago. I wish I could say that access to treatment has improved, but
unfortunately it has not. Even with legislation on many state and
federal books, such as the 2-week requirement that Massachusetts
insurers must pay. I appreciate all the hard work over the years in
addressing this crisis; however, as I continue to testify (as I have
done so for over 15 years), the single most important factor missing
from strategies is to take the
decision-making process of the medical necessity out of insurer's
hands, and place it into the hands of the primary care physician, of
which the insurers cannot override. The medical necessity piece is the
loophole that still allows insurers to get out from payment and access.
I will continue advocating on behalf of so many in this country who
needs that access. Corey originally received 60 in-patient days through
my lawsuit, which was written into my husband's employer's health
contract, and two more additional 60-day programs with his relapses. He
ultimately attended Caron Treatment Centers for five months back in
2016, which gave him the desperately needed time that launched him into
sobriety.
Thank you.
Trudy Avery
______
From Cape Cod Times, April 8, 2013
Insurance Companies Pushed to Cover Addiction Treatment
By K.C. Myers
Blue Cross Blue Shield of Massachusetts didn't know what it was up
against when it refused to cover the son of Sandwich resident Trudy
Avery for extended treatment for opiate addiction in 2008.
SANDWICH--Trudy Avery's life changed completely when her son became
addicted to opiates while at Sandwich High School.
In 4 years, the mother of four grown sons has joined a host of
volunteer committees related to addiction and spoken on Beacon Hill.
She went from a job fundraising at Massachusetts Maritime Academy to
fundraising for Caron Treatment Centers, which operates in several
states.
But first, Avery learned how to fight insurance companies.
Blue Cross Blue Shield of Massachusetts didn't know what it was up
against when it refused to cover her son Corey's extended treatment for
opiate addiction at the Florida Center for Recovery in 2008.
Corey began abusing oxycodone while in high school.
At 18, he sought treatment for the first time at Gosnold on Cape Cod's
detox hospital in Falmouth. After a 5-day stay, paid for by the
family's Blue Cross Blue Shield policy, he ``begged to be transferred
to a 30-day program,'' Avery said.
But insurance wouldn't cover it.
As Avery soon learned, the insurance policy stated it would allow up to
``60 inpatient days per member per calendar year in a mental hospital
or substance abuse facility.''
But the stays had to be pre-approved by the insurance company. And the
approval came down to whether the insurance company deemed the
treatment ``medically necessary,'' Avery said.
Three years after Corey's first detox treatment, when he was 21, he
overdosed while living with his grandmother in Connecticut in September
2008.
``It was an absolute heartbreak to our family, but I can now look back
at it as our blessing in disguise,'' Trudy Avery said. ``Corey now had
the `medical necessity' for the addiction treatment he had been seeking
all those long years.''
The insurance company approved a 14-day stay at the Florida Center for
Recovery in Fort Pierce. Corey moved next to outpatient treatment at
the Transformations Treatment Center in Delray Beach.
But Blue Cross Blue Shield denied his $23,000 claim for the outpatient
treatment, saying his benefits were used up.
Avery didn't give up.
``My son had a medical overdose and was entitled to those 60 days
stated in our contract,'' she said. Avery appealed the denial. She
contacted Massachusetts Attorney General Martha Coakley, and in the
meantime, told her story publicly to the state's former OxyContin and
Heroin Commission, a group formed to hear testimony from those affected
by opiate addiction and to craft legislation to fight opiate abuse.
In September 2009, she testified at the Statehouse.
After she spoke, state Sen. Steven Tolman, D-Brighton, who was then
chairman of the heroin commission, called a meeting with the president
of Blue Cross Blue Shield of Massachusetts and Avery in his office.
The meeting never happened because ``lo and behold, I got paid in
full,'' Avery said.
``I think they were afraid of the publicity,'' she said. ``I think the
insurance companies hope that the majority of people will accept their
`no' without question, or just give up.''
A Blue Cross Blue Shield representative would not talk about the Avery
case because of patient privacy laws.
The Avery family is hardly alone in its fight to have addiction
treatment covered by private health insurance.
In 2011, only 64 percent of substance abuse treatment facilities
accepted private health insurance, according to the federally funded
Substance Abuse and Mental Health Services Administration.
Private insurance payments were accepted at 85 percent of facilities
with a primary focus on mental health services, the report found. At
facilities that treated mainly substance abuse, only 56 percent
accepted private insurance.
For members of Parents Supporting Parents, the Cape self-help group for
parents of addicts, this isn't news. Many parents have paid $20,000 to
$60,000 at a time to put their children into long-term treatment or
reputable inpatient facilities that don't accept insurance at all.
When parents ask how they can pay for addiction treatment, Mashpee
mother Lisa Murphy, who founded the support group, says, ``Take your
children off your private plan, and tell them to go on MassHealth.''
It's true that MassHealth--publicly funded insurance--pays for a lot of
addiction programs. But that adds a burden to taxpayers and the
treatment centers since MassHealth payments cover only 70 percent of
the cost of services, said Gosnold on Cape Cod President and CEO
Raymond Tamasi.
Gosnold tries to have a mix of patients paying privately, on MassHealth
or receiving free care.
``We have to pay close attention to our `pair mix,' '' Tamasi said.
With the wave of young opiate addicts that followed the U.S. Food and
Drug Administration's approval of OxyContin in 1995, Tamasi hears the
Avery story quite often.
Families read ``60 days'' in their policies, he said. But they soon
discover the insurance company won't approve that much treatment,
particularly for someone seeking help for the first time.
``It's a fail-first policy,'' Tamasi said. ``You have to fail at a
lesser level of care first. . . . It's the worst part of this field.''
Laws in 43 states require commercial group health insurance plans to
provide some level of treatment for alcohol or other drug addiction,
according to Deb Beck, president of Drug and Alcohol Services Providers
of Pennsylvania and a consultant with the National Alliance for Model
State Drug Laws, which was created and funded by a bipartisan act of
Congress.
But many insurance companies and managed-care firms continue to work to
find ways around the laws, she said.
``This is the hidden part of the war on drugs,'' Beck said. ``Everyone
says, `We want to treat addiction.' But the insurance companies make it
very difficult to access the treatment required by law.''
In 2008, Congress passed the Mental Health Parity and Addiction Equity
Act. It requires group insurance plans that already offer mental health
and substance abuse treatment to offer the coverage at the same level
as other medical benefits.
But the equity act hasn't improved coverage, Tamasi said.
In theory, the bill was a victory for treatment because it placed the
disease of addiction on the same plane with physical ailments, he said.
``But the guidelines on how it is implemented and interpreted is a
miasma of confusion,'' he said. ``And we still don't have full
implementation.''
Tamasi has seen insurance coverage become more selective about what it
approves and more restrictive since the 1970s, he said.
Twenty years ago insurance typically approved a 28-day inpatient
treatment stay. Now it's much less, often just a week.
Gosnold has five full-time employees whose sole job is to call
insurance companies arguing for a few more days of treatment for
patients, he said.
As Avery learned last year, the equity act wasn't exactly the answer to
her prayers.
After 3 years of sobriety, Corey relapsed briefly in February 2012 with
prescription stimulants and alcohol while starting his new recovery-
focused business called sobernation.com.
Corey, 25 and still on his family's insurance plan, got himself back
into a treatment program within 2 months of his relapse, he said.
Avery called Blue Cross Blue Shield, seeking coverage again.
This time, the insurance policy couldn't put an annual time limit on
the treatment because of the new requirements of the equity act, she
said.
But everything else about fighting for Corey's treatment was familiar.
Eventually the insurance company paid for about one month of inpatient
treatment, Avery said. That treatment was approved in 5- to 7-day
increments.
``They still strive to give the least treatment necessary,'' she said.
As before, the treatments had to be deemed ``medically necessary'' by
the insurance company, she said. ``I think the parity bill is helping,
but not much,'' Avery said.
Dr. Jan Cook, a medical director at Blue Cross Blue Shield, said the
definition of ``medical necessity'' is broad. She said the actual
degree of treatment that gets approved is determined on a case-by-case
basis after a ``conversation'' between the patient's doctor and the
insurance company's medical staff.
The insurance company, however, does not have to agree with the doctor
or treatment specialist. And the appeals process is incredibly time-
consuming and costly, Tamasi said.
Blue Cross Blue Shield receives more claims for substance abuse
treatment now, but not because of the equity act, said Sharon
Torgerson, the company's Massachusetts director of public relations.
Inpatient substance abuse treatment for Blue Cross Blue Shield clients
rose by 7.6 percent in 2012 and by 5 percent in 2011 because of a rise
in addiction nationally and in Massachusetts, she said.
As Beck says, laws alone don't force change, unless those laws also
come with enforcement.
``States need to move forward to monitor and measure compliance by the
insurance companies,'' Beck said. ``Right now, accountability tools
available to the states are not being used, don't exist or are too
complicated for the average person to decipher.''
Beck said her home state of Pennsylvania has done a lot of work on ways
to hold insurance companies accountable.
In 2009, Pennsylvania's Supreme Court upheld one of the strongest laws
in the nation that requires insurance companies to cover addiction
treatment. The law states that a managed-care plan does not have the
authority to overrule a referral by a doctor or psychologist.
Beck said Pennsylvania's addiction treatment law has been on the books
since 1986. But when managed care came to the state in the early 1990s,
many people were ``unable to access the treatment required under law,''
she said.
In 2004, the insurance companies mounted a legal challenge to
Pennsylvania's addiction treatment law that went all the way up to the
Pennsylvania Supreme Court. Five years later, the court upheld the
state's enforcement efforts, Beck said.
``And Pennsylvanians' access to lifesaving addiction treatment required
under law improved dramatically,'' Beck said.
Before Tolman resigned from the Massachusetts Senate in 2011, he
sponsored a bill modeled on Pennsylvania's that would allow the doctor,
not the insurance company, to determine the type and duration of
treatment.
The bill--House 936, An Act to Further Define Adverse Determinations by
Insurers--was refiled this year by state Rep. Kay Khan, D-Newton.
______
Center for Fiscal Equity
14448 Parkvale Road, Suite 6
Rockville, Maryland 20853
[email protected]
Statement of Michael G. Bindner
Chairman Grassley and Ranking Member Wyden, thank you for the
opportunity to submit these comments for the record to the Committee on
Finance. The name is quite apt. I am assuming that this has to do with
both Prescription Drug pricing and Opioids. I will rely on the
Administration witnesses to outline the current case.
Opioids
This national pandemic has been gaining strength for a long time,
starting in rural America and expanding nationally. Any family can be
victimized by this scourge. It is now magnified by the ability to get
even stronger versions through the Internet from Chinese suppliers.
Recent information lays the blame for much of the opioid crisis on the
manufacturer and its owners. I am sure we all hope that the bankruptcy
judge assigned to the Purdue Pharmaceutical case can find a way to claw
back the funds looted from the company prior to expected legal actions.
Bankruptcy Law
Bankruptcy should not be used to reward the guilty. Allow me to provide
a scenario from comments to the Ways and Means Subcommittee on
Oversight on how the tax code subsidizes hate crimes, held on September
19, 2019.
While the First Amendment precludes content regulation, that does not
prevent the Southern Poverty Law Center from suing them into obscurity.
The problem is that the same characters simply pop up on YouTube
(sometimes literally), overnight. One solution is to change bankruptcy
law to make obligations follow successor companies. This would also be
helpful in labor and tort cases (especially the extant case against
Purdue Pharma).
Mandating Treatment
Treatment modalities need to be improved to fight this crisis. They
should have been long ago. Access to both initial and continuing
treatment is vital to both addition and mental health care, as
addiction can often uncover pre-existing psychiatric conditions. Even
for non-alcoholics, once addiction has been turned on by opioids, the
patient can never drink safely again and even moderate or heavy
drinking previously will have to end, along with any medicinal effect
it had.
For initial treatment, the question is not just access for willing
patients, but mandated treatment for the unwilling. The liberalization
of commitment laws in the 1970s has likely gone too far. Our first clue
was mental patients, especially veterans, living on the street. Even
when forced into treatment, taking a sober breath in a few days,
treatment plan or no, resulted in release and resumption of the
previous lifestyle. This is not freedom or health.
State laws or one overarching federal standard must make it easier for
families, police, doctors and social service agencies to begin
mandatory treatment, with the outcome being assignment to medical care
if required and housing beyond shelter space if not already possessed.
While some will not need the latter, those who do, especially our
nation's seniors, disabled and veterans, should not be sent back to the
cold.
Early addiction after-care with an HMO provided two sessions a week
after partial hospitalization. Medicare and Medicaid should as well. If
relapse is detected during this period, the addiction specialist should
be empowered (and the patient funded) to go back into treatment,
possibly in a more intense setting than originally. The therapist
should be similarly empowered, even with patients with long-term
sobriety.
Synergies Provided by Employee Ownership
Companies who hire their own doctors and pharmacists, whether as part
of a cooperative purchase program or as an offset to a single-payer
program (whether it is Single Payer Catastrophic or Medicare for All)
have an advantage in providing treatment. Their health plans would be
much less likely to prescribe their employees into drug misuse and
could more effectively monitor abuse when it occurred. This purchasing
and monitoring would also include franchise and 1099 employees brought
into employee status. Community is the best solution to recovery. The
community most important to most is work. Please see Attachment One for
more on tax reform and Attachment Two for more on Employee Ownership.
Thank you for the opportunity to address the committee. We are, of
course, available for direct testimony or to answer questions by
members and staff.
Attachment One--Tax Reform, Center for Fiscal Equity, September 13,
2019
Individual payroll taxes. These are optional taxes for Old-Age and
Survivors Insurance after age 60 (or 62). The collection of these taxes
occurs if an income sensitive retirement income is deemed necessary for
program acceptance. The ceiling should be lowered to $75,000 reduce
benefits paid to wealthier individuals and a floor should be
established so that Earned Income Tax Credits are no longer needed.
Subsidies for single workers should be abandoned in favor of radically
higher minimum wages.
Income Surtaxes. Individual income taxes on salaries, which exclude
business taxes, above an individual standard deduction of $75,000 per
year. It will range from 6% to 36%. This tax will fund net interest on
the debt (which will no longer be rolled over into new borrowing),
redemption of the Social Security Trust Fund, strategic, sea and non-
continental U.S. military deployments, veterans' health benefits as the
result of battlefield injuries, including mental health and addiction
and eventual debt reduction.
Asset Value-Added Tax (A-VAT). A replacement for capital gains taxes,
dividend taxes, and the estate tax. It will apply to asset sales,
dividend distributions, exercised options, rental income, inherited and
gifted assets and the profits from short sales. Tax payments for option
exercises and inherited assets will be reset, with prior tax payments
for that asset eliminated so that the seller gets no benefit from them.
In this perspective, it is the owner's increase in value that is taxed.
As with any sale of liquid or real assets, sales to a qualified broad-
based Employee Stock Ownership Plan will be tax free. These taxes will
fund the same spending items as income or S-VAT surtaxes. This tax will
end Tax Gap issues owed by high income individuals. A 24% rate is
between the GOP 20% rate and the Democratic 28% rate. It's time to quit
playing football with tax rates to attract side bets.
Subtraction Value-Added Tax (S-VAT). These are employer paid Net
Business Receipts Taxes that allow multiple rates for higher incomes,
rather than collection of income surtaxes. They are also used as a
vehicle for tax expenditures including healthcare (if a private
coverage option is maintained), veterans' health care for non-
battlefield injuries, educational costs borne by employers in lieu of
taxes as either contributors, for employee children or for workers
(including ESL and remedial skills) and an expanded child tax credit.
The last allows ending state administered subsidy programs and
discourages abortions, and as such enactment must be scored as a must
pass in voting rankings by pro-life organizations (and feminist
organizations as well). An inflation adjustable credit should reflect
the cost of raising a child through the completion of junior college or
technical training. To assure child subsidies are distributed, S-VAT
will not be border adjustable.
The S-VAT is also used for personal accounts in Social Security,
provided that these accounts are insured through an insurance fund for
all such accounts, that accounts go toward employee ownership rather
than for a subsidy for the investment industry. Both employers and
employees must consent to a shift to these accounts, which will occur
if corporate democracy in existing ESOPs is given a thorough test. So
far it has not.
S-VAT funded retirement accounts will be equal dollar credited for
every worker. They also has the advantage of drawing on both payroll
and profit, making it less regressive.
A multi-tier S-VAT could replace income surtaxes in the same range.
Some will use corporations to avoid these taxes, but that corporation
would then pay all invoice and subtraction VAT payments (which would
distribute tax benefits). Distributions from such corporations will be
considered salary, not dividends.
Invoice Value-Added Tax (I-VAT) Border adjustable taxes will appear on
purchase invoices. The rate varies according to what is being financed.
If Medicare for All does not contain offsets for employers who fund
their own medical personnel or for personal retirement accounts, both
of which would otherwise be funded by an S-VAT, then they would be
funded by the I-VAT to take advantage of border adjustability. I-VAT
also forces everyone, from the working poor to the beneficiaries of
inherited wealth, to pay taxes and share in the cost of government.
Enactment of both the A-VAT and I-VAT ends the need for capital gains
and inheritance taxes (apart from any initial payout). This tax would
take care of the low income Tax Gap.
I-VAT will fund domestic discretionary spending, equal dollar employee
OASI contributions, and non-nuclear, non-deployed military spending,
possibly on a regional basis. Regional I-VAT would both require a
constitutional amendment to change the requirement that all excises be
national and to discourage unnecessary spending, especially when
allocated for electoral reasons rather than program needs.
As part of enactment, gross wages will be reduced to take into account
the shift to S-VAT and I-VAT, however net income will be increased by
the same percentage as the I-VAT. Adoption of S-VAT and I-VAT will
replace pass-through and proprietary business and corporate income
taxes.
Carbon Value-Added Tax (C-VAT). A Carbon tax with receipt visibility,
which allows comparison shopping based on carbon content, even if it
means a more expensive item with lower carbon is purchased. C-VAT would
also replace fuel taxes. It will fund transportation costs, including
mass transit, and research into alternative fuels (including fusion).
This tax would not be border adjustable.
Attachment Two
A. Employee Ownership, March 7, 2019
Employee ownership is the ultimate protection for worker wages. Our
proposal for expanding it involves diverting an ever-increasing portion
of the employer contribution to the Old-Age and Survivors fund to a
combination of employer voting stock and an insurance fund holding the
stock of all similar companies. At some point, these companies will be
run democratically, including CEO pay, and workers will be safe from
predatory management practices. Increasing the number of employee-owned
firms also decreases the incentive to lower tax rates and bid up asset
markets with the proceeds.
Establishing personal retirement accounts holding index funds for Wall
Street to play with will not help. Accounts holding voting and
preferred stock in the employer and an insurance fund holding the
stocks of all such firms will, in time, reduce inequality and provide
local constituencies for infrastructure improvements and the funds to
carry them out.
ESOP loans and distribution of a portion of the Social Security Trust
Fund could also speed the adoption of such accounts. Our Income and
Inheritance Surtax (where cash from estates and the sale of estate
assets are normal income) would fund reimbursements to the Fund.
At some point, these companies will be run democratically, including
CEO pay, and workers will be safe from predatory management practices.
This is only possible if the Majority quits using fighting it as a
partisan cudgel and embraces it to empower the professional and working
classes.
The dignity of ownership is much more than the dignity of work as a cog
in a machine.
B. Hearing on the 2016 Social Security Trustees Report
In the January 2003 issue of Labor and Corporate Governance, we
proposed that Congress should equalize the employer contribution based
on average income rather than personal income. It should also increase
or eliminate the capon contributions. The higher the income cap is
raised, the more likely it is that personal retirement accounts are
necessary. A major strength of Social Security is its income
redistribution function. We suspect that much of the support for
personal accounts is to subvert that function--so any proposal for such
accounts must move redistribution to account accumulation by equalizing
the employer contribution.
We propose directing personal account investments to employer voting
stock, rather than an index funds or any fund managed by outside
brokers. There are no Index Fund billionaires (except those who operate
them). People become rich by owning and controlling their own
companies. Additionally, keeping funds in-house is the cheapest option
administratively. I suspect it is even cheaper than the Social Security
system--which operates at a much lower administrative cost than any
defined contribution plan in existence.
If employer voting stock is used, the Net Business Receipts Tax/
Subtraction VAT would fund it. If there are no personal accounts, then
the employer contribution would be VAT funded.
Safety is, of course, a concern with personal accounts. Rather than
diversifying through investment, however, we propose diversifying
through insurance. A portion of the employer stock purchased would be
traded to an insurance fund holding shares from all such employers.
Additionally, any personal retirement accounts shifted from employee
payroll taxes or from payroll taxes from non-corporate employers would
go to this fund.
The insurance fund will save as a safeguard against bad management. If
a third of shares were held by the insurance fund than dissident
employees holding 25.1% of the employee-held shares (16.7% of the
total) could combine with the insurance fund held shares to fire
management if the insurance fund agreed there was cause to do so. Such
a fund would make sure no one loses money should their employer fail
and would serve as a sword of Damocles to keep management in line. This
is in contrast to the Cato/PCSSS approach, which would continue the
trend of management accountable to no one. The other part of my
proposal that does so is representative voting by occupation on
corporate boards, with either professional or union personnel providing
such representation.
The suggestions made here are much less complicated than the current
mix of proposals to change bend points and make OASI more of a needs-
based program. If the personal account provisions are adopted, there is
no need to address the question of the retirement age. Workers will
retire when their dividend income is adequate to meet their retirement
income needs, with or even without a separate Social Security program.
No other proposal for personal retirement accounts is appropriate.
Personal accounts should not be used to develop a new income stream for
investment advisors and stock traders. It should certainly not result
in more ``trust fund socialism'' with management that is accountable to
no cause but short-term gain. Such management often ignores the long-
term interests of American workers and leaves CEOs both over-paid and
unaccountable to anyone but themselves.
If funding comes through a Subtraction VAT, there need not be any
income cap on employer contributions, which can be set high enough to
fund current retirees and the establishing of personal accounts. Again,
these contributions should be credited to employees regardless of their
salary level.
Conceivably a firm could reduce their S-VAT liability if they made all
former workers and retirees whole with the equity they would have
otherwise received if they had started their careers under a reformed
system. Using Employee Stock Ownership Programs can further accelerate
that transition. This would be welcome if ESOPs became more democratic
than they are currently, with open auction for management and executive
positions and an expansion of cooperative consumption arrangements to
meet the needs of the new owners.
______
Coalition for Office-Based Outpatient Treatment
October 24, 2019
Senator Charles E. Grassley
Chairman
Senator Ron Wyden
Ranking Member
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Dear Chairman Grassley and Ranking Member Wyden:
We applaud the Senate Finance Committee for holding today's hearing
entitled ``Treating Substance Misuse in America: Scams, Shortfalls, and
Solutions.'' We appreciate the Committee's work to help stem the opioid
crisis nationally and welcome the opportunity to submit these comments
for the official hearing record. We are glad for the opportunity to
share more information about who we are and the important role that
outpatient addiction treatment programs play in the addiction treatment
landscape. We hope that in sharing this information we can begin to
engage more effectively with lawmakers and key decision makers as they
develop strategies to further mitigate the damage the opioid crisis has
inflicted on our great nation.
The Coalition for Office-Based Outpatient Treatment (``Coalition'')
is an advocacy group dedicated to promoting the role of Office-Based
Outpatient Treatment providers (``OBOTs'') in the fight against
addiction in America. Coalition medical practitioners are all specially
trained and licensed to prescribe buprenorphine (most often Suboxone)
under DATA 2000 waivers administered by the Drug Enforcement Agency
(``DEA''). Coalition outpatient centers focus primarily on treating
patients suffering from opioid use disorder (``OUD'') by deploying an
individualized mix of medication and counseling, but also treat other
substance use disorders (``SUDs'') by similar methods.
Chairman Grassley (R-IA) has expressed concern that the patchwork
of State and Federal enforcement regimes has left holes and
opportunities for fraud and abuse to arise in the treatment space. We
appreciate the concern that exists around how to best distinguish
between quality treatment and the ``fraudsters,'' as Ranking Member
Senator Wyden (D-OR) referred to those who prey on the most vulnerable.
We share these concerns and feel that we are uniquely qualified to
demonstrate what works for patients and for the payors. We believe that
our method of treating patients embodies the quality and value that so
many legislators, policymakers, and patients are seeking.
Medication-Assisted Treatment (``MAT'') is the standard of care for
treatment of OUD. We believe that any OUD treatment program that does
not utilize MAT is not meeting the standard of care for addiction
treatment as defined by the American Medical Association.\1\ MAT in an
outpatient setting, properly applied and managed, is both effective at
treating addiction and cost efficient for payors.
---------------------------------------------------------------------------
\1\ https://www.end-opioid-epidemic.org/wp-content/uploads/2018/02/
180221-AMA-MAT-One-Pager_National-FINAL3.pdf.
During the hearing, and in response to a question from Senator
Cardin (D-MD), the Honorable Jerome Adams, M.D., MPH, Surgeon General,
Department of Health and Human Services, pointed out that successful
communities that have turned around overdose rates have done the
following four things: (1) increased naloxone availability; (2) ensured
a warm handoff from hospital emergency departments; (3) provided MAT;
and (4) received cooperation from public safety officials to prevent
criminalizing addiction. Integration of all of these critical
---------------------------------------------------------------------------
components is fundamental to the addiction treatment provided by OBOTs.
Our comments are intended to provide more detail on the role of
OBOTs in the fight against addiction and why our model offers a
powerful combination of treatment effectiveness and cost efficiency.
What is an OBOT?
The American Society of Addiction Medicine (``ASAM'') defined OBOT
in 2004:
OBOT refers to models of opioid agonist treatment that seek to
integrate the treatment of opioid addiction into the general
medical and psychiatric care of the patient. The foundation of
OBOT is the conceptualization of opioid addiction as a chronic
medical condition with similarity to many other chronic
conditions.\2\
---------------------------------------------------------------------------
\2\ ASAM: Public Policy Statement on Office-based Opioid Agonist
Treatment (OBOT), 2004.
While the concept of OBOT was defined 15 years ago, there is still
confusion as to how practitioners working within OBOTs and prescribing
buprenorphine in outpatient offices are distinguished from Opioid
Treatment Programs (OTPs), which dispense Methadone. The distinction,
however, is simple and clear-given the relative safety of
buprenorphine, DATA 2000 certified practitioners can prescribe
buprenorphine in an office-based setting and patients can pick up their
prescription at a pharmacy convenient for them. Unlike OTPs, OBOTs do
---------------------------------------------------------------------------
not dispense medication.
When the initial DATA 2000 regulations were promulgated, OBOTs were
expected to be primary care physicians who would integrate addiction
treatment into their practices. Many primary care practices have done
so, but treatment in mainstream practices has proven to be more
challenging than originally imagined. It has now become clear that
there is strong patient demand for specialized outpatient addiction
treatment which is not otherwise being met.
What is the role for OBOTs?
OBOTs can provide high quality, effective, and cost-efficient
treatment in an outpatient environment. We believe that high quality
OBOTs should be a central feature of any national treatment policy and
are eager to participate in a process that helps to set the standards
for outpatient addition treatment.
The needs of patients suffering from substance use disorders are
extensive and while many patients' struggles pre-date their addiction,
others are caused and/or exacerbated by addiction. Below are a few
important characteristics of much of the population suffering from
substance use disorders:
1. Poverty--If people with an addiction were not struggling
financially before they became addicted, almost all are
impoverished by the time they reach out for treatment;
2. Co-Occurring Mental Health Disorders--Multiple studies have
shown that at least 50% of those with substance use disorder
also have at least one diagnosable mental illness;\3\ and
---------------------------------------------------------------------------
\3\ NIDA: Common Comorbidities with Substance Use Disorders, 2017.
---------------------------------------------------------------------------
3. Polysubstance Use--Most patients with OUD are also
dependent on other illicit substances (e.g., cocaine,
methamphetamine, etc.) and/or prescription pharmaceuticals
(e.g., benzodiazepines).
Patients in the active throws of addiction require an extreme
amount of attention and effort across a wide spectrum of services. For
every office visit, OBOTs typically receive an average of three times
more incoming phone calls and electronic messages from patients.
Moreover, while 70 percent of OBOT patients are stable enough to visit
with a practitioner just once a month, who those patients are changes
regularly. Unfortunately, relapse is a pervasive part of the disease of
addiction.
Often, as one patient is stabilized another may relapse and require
intensive intervention. To address this challenging patient population,
larger scale OBOTs have built specialty outpatient addiction practices
that we believe represent the most cost-effective method for treating
the majority of people suffering from OUD. Coalition practices are
designed to address the broad needs of this population.
How Coalition practices manage the various phases of addiction
treatment:
Induction--Depending on the severity of how a patient presents at
their first appointment, patients visit with a medical practitioner
between one and three times in their first week of treatment;
Stabilization--As patients stabilize over the first months, the
frequency of visits is reduced;
Maintenance--Once a patient is abstinent from illicit and
unprescribed substances and positive for buprenorphine, the frequency
of appointments is typically decreased to monthly visit s, allowing
patients to live more independent lives;
Relapse--In cases of relapse, patients are asked to come back more
frequently until they are stabilized again. Higher levels of care may
be required in some cases and patients will often leave an OBOT to
receive more intensive treatment than an OBOT can offer. Patients are
always welcome back to Coalition practices once they have become
stabilized; and
Tapering--As patients get their lives back, as evidenced by
successful functioning in the workforce and their family lives, many
are eager to wean themselves off medications. This is a period of
elevated relapse risk and appointment frequency is often increased
until patients are able to work toward tapering entirely off their
medication.
Best practices for drug screening:
Urine drug testing has been abused by many bad actors in the
addiction treatment space and all practitioners need to be aware of the
costs associated with unnecessary testing. It is critical, however, to
appreciate how central routine urine drug toxicology is to providing
high quality and effective treatment. ASAM released a Consensus
Statement in 2017 defining the Appropriate Use of Drug Testing in
Clinical Addiction Medicine \4\ and all Coalition practitioners follow
the ASAM guidelines.
---------------------------------------------------------------------------
\4\ https://www.asam.org/docs/default-source/quality-science/
appropriate_use_of_drug_testing
_in_clinical-1-(7).pdf?sfvrsn=2.
Responsible practitioners only test for substances that will impact
treatment decisions. High quality toxicology is the only way to assess
patient compliance in a comprehensive way and also acts as an early
warning system for OBOTs as different drugs ebb and flow in popularity.
As a result, toxicology is central to treatment and is typically
---------------------------------------------------------------------------
administered in two stages:
Screening--Either through the use of instant point of care
testing or through more accurate immunoassay screening, these
initial tests identify what tests need to be run for definitive
confirmation; and
Definitive Testing--Depending on screening results,
confirmation labs use highly accurate methods to quantitatively
report the levels of drugs and metabolites in a patient's
system.
Key components of staffing an OBOT:
Medical Oversight--Provided by a physician with extensive
clinical addiction treatment experience. Medical Directors are
often board certified in addiction psychiatry or addiction
medicine.
Medical Practitioners--DATA 2000 certified Physicians, Nurse
Practitioners and Physician Assistants focus on the
pharmaceutical needs of the patients. Prescriptions can include
medications to treat addiction including buprenorphine and
naltrexone as well as psychiatric drugs if the practice has
qualified psychiatric practitioners.
Mental Health Practitioners--Substance use and mental health
counselors, whether in house or referred, work with patients
one-on-one and in groups to help them rebuild their lives.
Case Managers/Care Coordinators--Many patients at varying
times in their recovery need additional services or higher
levels of care. Care coordination is necessary to help patients
find outside social services such as housing and psychiatric
services. In circumstances where outpatient treatment is
insufficient in its intensity, staff will work with patients to
find higher levels of care, including inpatient services.
Front-line staff--Often overlooked, this is the group that
interacts with patients most regularly, whether at the front
desk, on the phone, or via other electronic messaging. Front-
line staff must be well-trained and knowledgeable about how to
escalate a wide range of challenging interactions.
During the hearing and in response to a question from Senator Ben
Cardin (D-MD), Gary Mendell, Founder and CEO of Shatterproof, suggested
that transparent quality measures would allow payers to better evaluate
value for payments. We are in total agreement and welcome the
opportunity to share the quality measures that our members have
developed internally to improve patient care.
The Coalition is focused on not only addressing each patient's
individual needs but also on evaluating the impact our treatment has on
the broader patient population. Patient and data-centric management
efforts give great insight into what elements of treatment protocols
are effective and what are less so. Well managed practices are always
adjusting aspects of their protocol to adapt to changes that they see
in their patient population.
We welcome the opportunity to engage with legislators and the
Administration as we work together to combat this crisis and treat
patients most effectively and cost efficiently.
Sincerely,
Enrique Oviedo, M.D.
Board Certified Addiction Psychiatrist
______
Hazelden Betty Ford Foundation
Statement of Nick Motu, Vice President
and Chief External Affairs Officer
Chairman Grassley, Ranking Member Wyden, and members, my name is Nick
Motu, and I serve as Vice President and Chief External Affairs Officer
for the Hazelden Betty Ford Foundation (``Hazelden Betty Ford'').
Hazelden Betty Ford, with its headquarters located at 15251 Pleasant
Valley Road, Center City, Minnesota 55012, has long advocated for
patients who suffer from substance use disorders, including in support
of measures before Congress and within states to ensure that patients
and their families can access quality treatment services.
Since Hazelden Betty Ford CEO Mark Mishek testified last Congress
alongside our partner Marv Ventrell, CEO of the National Association of
Addiction Treatment Providers (NAATP), and the subsequent passage of
the SUPPORT Act, we have seen incremental improvements to addiction
treatment industry practices across the country. This is due in part to
nationwide implementation of NAATP's Code of Ethics, additional
scrutiny by online search engines, and states making concerted efforts
to crack down on predatory behavior. And more needs to be done. Below
are summaries of the priority issues we see--often through patients at
our doorstep--and recommendations for action by Congress.
1. Patient brokering continues to plague the addiction treatment
industry, and the most vulnerable patients and their families suffer
the most severe consequences.
The ongoing brokering of vulnerable people for financial gain remains a
grave concern and a tremendous risk to patients and their families who
are seeking help in their most desperate time of crisis. We see this
practice .across the country, both through solicitation of Hazelden
Betty Ford by those seeking payment for referrals, and through patients
and their families who have fallen victim to these predatory practices
and who seek our care following their exploitation. Virtually every
day, Hazelden Betty Ford receives materials peddling patient referrals
from third-party ``bed brokers'' pursuing our organization as a
``partner.'' Additionally, our patients continue to fall victim to call
aggregators and other deceptive marketing practices.
We also continue to hear stories from our clinicians of unethical
providers seeking out uninsured patients through third-party scouts who
are trolling support meetings for those in the most desperate state,
``assisting'' their enrollment in insurance, admitting them into care,
and then discharging them immediately upon exhaustion of benefits--
regardless of their clinical need--often in an extraordinarily
vulnerable state. Although sometimes this practice can be as blatant as
providing a patient with a gift card for relapsing, often it is more
nuanced--although just as damaging--such as paying a person's rent as
long as they stay under the care of a subpar provider so that their
insurance benefits can be tapped. Both in its most blatant and more
nuanced forms, this brokering of people as commodities is egregious and
is particularly common across all levels of care in states where a
sound and comprehensive regulatory structure does not exist.
To address ongoing concerns with patient brokering, Congress must take
further action. Funding the Department of Justice's Eliminating
Kickbacks in Recovery Act (EKRA) enforcement activities specifically
focused on the addition treatment industry, as well as expanding the
penalties to include civil monetary enforcement, would have a chilling
effect on these predatory activities. Additionally, publishing
guidelines related to anti-kickback and patient brokering issues-
perhaps in the form of Special Fraud Alerts or otherwise--would provide
valuable guidance to providers and to state legislatures as they shape
public policy to enforce the intent of EKRA's expansion found in the
SUPPORT Act, in part through enhanced state regulatory oversight, both
criminally and civilly.
2. States lack comprehensive, quality-based regulatory oversight
of the addiction treatment industry and are not adequately incented to
prioritize adoption of necessary reforms.
As a national system of care, Hazelden Betty Ford sees wide variations
in regulatory oversight requirements at the facility, program, and
individual-practitioner levels. We also see the related consequences
suffered by people with substance use disorders. In no other area of
healthcare is regulatory compliance so frequently accepted as
voluntary, so disconnected from basic quality standards, and so
outsourced to non-governmental, non-transparent entities. We see wholly
unregulated programs purporting to provide the most intense levels of
care in buildings that have not been fire coded, without utilization of
any evidence-based practices, and with care delivered by individuals
with no training or experience as professional clinicians.
The federal government has taken steps to not only highlight these
issues but also to provide some limited guidance to states about
quality. Additionally, pending legislation that incents state adoption
of quality standards through contingent grant funding, if passed, would
require states to prioritize reforms, using access to federal funding
as a powerful incentive. Any guidance related to quality standards, and
legislation requiring those standards to be tied to federal funding
streams, would benefit state legislatures, several of which are
actively pursuing quality-based industry licensing reforms. Quality-
based regulatory guidance should include incentivizing accreditation
from entities such as the Joint Commission or the Commission on
Accreditation of Rehabilitation Facilities, requiring a qualified
workforce, ensuring evidence-based practices, and supporting treatment
for co-occurring disorders. Additionally, efforts to incentivize
professional training and education--not only of addiction counselors,
but also clinicians in other areas of healthcare--on addiction medicine
and treatment best practices will continue to be instrumental to
reforming the industry and ensuring better outcomes for patients across
the country.
3. 42 CFR Part 2 providers lack the regulatory alignment necessary
to facilitate integration and to effectuate true and complete parity
for patients. Separate privacy laws and regulations foster an
environment that is not conducive to quality, coordinated care for
patients and foment ``otherness,'' extending the historical
subordination and stigmatization of the addiction treatment industry
versus other areas of healthcare.
Hazelden Betty Ford has long advocated for alignment of federal privacy
standards as a key component to increasing acceptable standards of care
for the addiction treatment industry. Alignment of the federal
regulations found within 42 CFR Part 2 (Part 2), privacy regulations
which can negatively affect a patient's access to integrated care in
certain settings, with those of the Health Insurance Portability and
Accountability Act (HIPPA), which apply to all health care providers,
would facilitate optimal care while protecting patient confidentiality.
Such alignment is crucial to holding the addiction treatment industry
to the standards we expect of all healthcare providers.
Some of the most challenging issues related to quality of treatment
relate to the lack of care integration and coordination for patients of
substance use treatment providers. Part 2 essentially codifies subpar
care. For example, providers like Hazelden Betty Ford are prevented
from electronic prescribing, limited in implementing available
electronic-health-record capabilities, and, in some cases, statutorily
prevented from being able to collaborate with other providers and
process claims. To facilitate standards that align with the rest of
healthcare, thus improving industry practices and ultimately the
quality of the treatment patients receive, privacy regulations must
support integrated, person-centered care for those suffering from
substance use disorders. Without this alignment, the institutional
quality barriers that have risked compromising care for patients
suffering from substance use disorders across the country will
continue.
4. A lack of industry-wide quality standards enables some
insurance carriers to justify practices that prevent the effectuation
of full parity for patients who suffer from substance use disorders.
Since the passage of the Mental Health Parity and Addiction Equity Act
and the subsequent expansion of coverage found within the Affordable
Care Act, effectuating true parity for those suffering from substance
use disorder has been challenging for a variety of reasons. Most
significantly, a lack of nationally accepted standards of practice upon
which state insurance regulators are able to test legal parity
compliance against has resulted in a wide variation of what is
appropriate management of care. As a provider, we see this in widely
variable medical necessity criteria, discriminatory prior authorization
protocols, and other improper approaches to managing care for people
seeking substance use disorder services versus services for other
healthcare conditions. This practice harms our patients and patients
seeking help across the country, and has the effect of giving payers a
free pass to create their own thresholds for what they deem to be
``enough'' treatment for purposes of complying with parity's
requirements.
A more robust set of guidelines for comprehensive and quality treatment
for what is widely recognized as a chronic disease condition would
incent payers to appropriately manage care for people they insure.
Without agreed-upon national standards, payers will continue to
circumvent parity's intent, and state insurance regulators will be left
in the dark-without guidance to rely on when assessing whether people
seeking treatment for their substance use disorder or other mental
health conditions are appropriately benefiting from insurance coverage
that holds true to the intent of these important federal laws.
In closing, Hazelden Betty Ford stands ready to provide any additional
information and assistance your committee needs to continue to advance
this important work on behalf of the millions of people with substance
use disorders and their families across the country. Thank you.
______
SAFE Project US
3118 Washington Blvd., Box 101734
Arlington, VA 22201-9998
Statement of James and Mary Winnefeld, Co-Founders
Recovery housing is a part of the larger continuum of housing and
continuum of care options available to individuals in recovery from the
disease of addiction, otherwise referred to as substance dependency.
Recovery houses are a critical and often necessary step in the recovery
process and a positive transition for people back into the community
from a residential treatment program. They allow individuals to learn
how to live sober in society, while having a shared supportive
environment in which safe and effective recovery can be fostered if the
right house and environment is chosen.
Recovery housing ranges from independent, peer-run homes to staff-
managed residences where clinical services are provided. These
environments create supportive and connected communities within the
house and within the external community, where individuals achieve a
safe place to improve their overall wellness. In these environments,
additional skills and resources are available for a person in long-term
recovery to sustain it.
These facilities should offer individuals suffering from substance
use disorders a greater chance of achieving long-term recovery because
of the community that exists within the home. Good recovery housing has
been associated with numerous positive outcomes, including decreased
substance use, reduced probability of relapse/reoccurrence, lower rates
of incarceration, higher income, increased employment, and improved
family functioning.
Addiction treatment has become a billion-dollar industry, which has
opened the industry up to abuse. Stories have emerged of recovery
houses with substandard living conditions (including no electricity or
running water). All too often, too many residents are packed in one
room. In some cases, gambling or prostitution rings are allowed access
to the home, and house managers or owners kick people out onto the
streets with no warning. In other cases, residents are kept in the home
by allowing them to relapse in order to maintain relapse insurance
payouts. For many, access to a recovery house and a recovery community
is a matter of life or death.
A misconception exists among some communities that, like treatment
facilities, recovery houses are accredited, closely monitored, operate
equally, and have the best interest of the residents in mind.
Unfortunately, this is often far from the truth. Without oversight and
accountability, unscrupulous businesses will continue to make money on
this disease. In most states, anyone can open up a recovery house;
there is no requirement that the proprietor be in recovery, or work in
the addiction treatment field. There is no national unification of
regulations or standards for these types of homes because they are not
considered ``treatment'' (a license to operate is only required for
facilities providing treatment). While there are some states and
municipalities that have adopted National Association of Recovery
Residences (NARR) standards, these are challenging to enforce since
they are voluntary certifications. Federal laws or regulations do not
exist to regulate how these houses operate.
Moreover, unlike treatment facilities, data on which are captured
by the Substance Abuse and Mental Health Services Agency (SAMHSA),
there is no database or registry for recovery housing. Although some
organizations, such as NARR and Oxford Houses, collect data on the
prevalence and characteristics of recovery housing, the data is only
used for their recovery homes. As such, it is extremely challenging for
individuals seeking recovery housing to find a place that suits their
needs.
Stigma is another challenge for recovery housing. A recent Harris
Poll, SAFE Project Opioid Report, confirms that most Americans believe
that more treatment and recovery resources are needed in order to
address this epidemic, but they do not want them in their back yards.
Unfortunately, a perception has been created that a local recovery home
will devalue a neighborhood and bring in crime. For example, the Not in
My Backyard Movement (NIMBY) has resulted in neighbors putting up anti-
recovery housing signs, knocking on recovery housing doors with
unwelcoming words, and standing up at town halls fighting for their
perceived safety.
In short, the recovery housing landscape resembles the Wild Wild
West, with a soup of ethical recovery homes battling for space to exist
in neighborhoods of need, rogue houses that are only accessible through
word-of-mouth, and no protection available for the individual in
recovery.
Several solutions will help enhance the ability of recovery housing
to better support those on the journey of substance abuse recovery.
First, nationwide collaboration is essential in addressing the
challenges listed above. As such, SAFE Project, a national nonprofit
fighting to stop the addiction epidemic, hopes to bring together a
group of experts through the Recovery Housing Collective. Through the
collective, SAFE Project will have the ability to access key
information to address the complex issues of recovery housing
throughout the nation.
Second, federal regulations requiring recovery houses be permitted
will establish a strong foundation for recovery resources, ensure a
safe and healthy environment for residents, and prevent abuse of the
system. This is desperately needed. We believe that SAMHSA should be
empowered to drive this forward, with the support of the Recovery
Housing Collective.
Third, a trackable database for recovery housing would allow states
to determine what recovery houses exist in their state, accredit and
monitor those houses, and provide better access to recovery housing for
the individual seeking recovery housing. We believe SAMHSA should be
resourced to establish such a database. Such a database would also
allow states to track the ``spin cycle'' of addiction treatment-to
recovery housing kickbacks or insurance fraud that often exist within
communities.
Fourth, recovery residences should be celebrated in all
neighborhoods, including college campuses, cities, townships, and even
military bases. We need recovery houses that meet the needs of the
broad diversity of the populations seeking recovery assistance,
including LGBTQ, people of color, differently abled persons, and those
suffering with co-occurring mental health disorders.
Fifth, although living in a recovery home costs money, it is
cheaper than a relapse. Providing financial support for those in such
housing on an as-needed basis and in a way that enforces ethical
behavior, either directly or through requiring the insurance industry
to step up, would be a cost-effective way of contributing to the
attenuation of the opioid epidemic.
In conclusion, recovery houses should exist to assist those who
have transitioned away from self-destructive demoralizing behaviors to
become responsible thriving members of society, who want to be of
service, who have examined their lives to become a better person, and
who are developing the resiliency required for long-term recovery.
Access to quality recovery housing means less time in treatment, less
likelihood of relapse, and more time for a person to recover within
their own environment. More support and oversight are desperately
needed to bring this critical aspect of reversing the epidemic up to
the capability and promise it provides.
______
Voices for Non-Opioid Choices
October 24, 2019
Senator Chuck Grassley
Chairman
Senator Ron Wyden
Ranking Member
U.S. Senator
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Dear Chairman Grassley and Ranking Member Wyden,
On behalf of Voices for Non-Opioid Choices, we are pleased to submit
this statement for the record of the hearing to be held October 24,
2019, entitled ``Treating Substance Misuse in America: Scams,
Shortfalls, and Solutions.'' We applaud the Senate Finance Committee
for further addressing the epidemic of substance use in the United
States. While we look forward to the focus on high-quality treatment
options for those struggling with substance use disorder, we believe no
discussion of substance use, and the commensurate Congressional
response, is sufficient without including methods of prevention.
Congress, along with the Trump Administration, must tackle the problem
of substance abuse with downstream treatment options as well as
upstream preventive efforts.
Voices for Non-Opioid Choices is a nonpartisan coalition dedicated to
one proven method of preventing substance misuse--ensuring patient and
provider access to safe and effective non-opioid pain management
therapies. Our 30 members include licensed healthcare professionals
such as physicians, nurses, dentists, therapists and related
associations as well as patient advocacy groups, students, individuals
in recovery and retirees. We are united in our belief that it is
crucial to prevent addiction before it starts by increasing the
availability and utilization of non-opioid approaches through
responsible policy changes.
The over-prescription of opioids following an acute pain incident is a
significant contributing factor to the current U.S. opioid epidemic. On
average, patients receive 80 opioid pills to manage pain following a
surgical procedure, which is typically well above what is necessary to
help these patients adequately control their symptoms.\1\ Every year in
our country, three million Americans become persistent opioid users
following surgery.\2\ Unfortunately, some of these users will go on to
develop substance use disorder and never recover.
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\1\ Bicket M., et al. Prescription opioid oversupply following
surgery. Journal of American Pain Society 2017.
\2\ Brummett C.M., Waljee J.F., Goesling J., et al. New Persistent
Opioid Use After Minor and Major Surgical Procedures in U.S. Adults.
JAMA Surg. Published online June 1, 2017, 152(6):e170504, doi:10.1001/
jamasurg.2017.0504
Leading practitioners, researchers and health care experts know how to
reverse this trend without sacrificing quality pain management.
Increased use of non-opioids has been proven in peer-reviewed studies
to reduce unnecessary opioid use after surgery,\3\ and research on the
benefits of multimodal approaches to pain management, which prioritize
non-opioid use and minimize opioids, shows that such approaches provide
better patient outcomes than patients receiving opioids following
surgery.\4\
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\3\ Mont M.A., Beaver W.B., Dysart S.H., Barrington J.W., Del Gaizo
D.J. Local infiltration analgesia with liposomal bupivacaine improves
pain scores and reduces opioid use after total knee arthroplasty:
results of a randomized controlled trial. J Arthroplasty,
2018;33(1):90-96.
\4\ Wang M.Y., Chang H.K., Grossman J. Reduced Acute Care Costs
With the ERAS Minimally Invasive Transforaminal Lumbar Interbody
Fusion Compared With Conventional Minimally Invasive Transforaminal
Lumber Interbody Fusion. Neurosurgery, 2017. [epub ahead of print]
We have made progress on many fronts combatting the opioid epidemic,
including slight decreases in overdose deaths and some modest
reductions in opioid prescribing rates in certain populations. Without
additional action to prevent substance misuse, however, we are at risk
of stalling this progress.Medicare policy continues to prioritize less
expensive opioids over the life-saving potential of nonopioids in the
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surgical setting.
We look to Congress and the Administration to act to prevent opioid
misuse by promoting broad use of non-opioid treatments as a first-line
therapy for acute pain across all treatment settings.
Last year, the Centers for Medicare and Medicaid Services (CMS) wisely
adopted a policy change that would provide separate reimbursement for
non-opioid pain management approaches provided during surgery to
patients treated in an Ambulatory Surgery Center (ASC). This was a
welcomed change that appropriately incentivizes the utilization of non-
opioid therapies. Unfortunately, because most surgeries performed in
the United States every year occur in a hospital outpatient department
(HOPD) setting, CMS has not yet taken sufficient action to ensure that
these patients can access available pharmacologic and non-pharmacologic
non-opioid approaches to alleviate their acute pain. For example, many
common orthopedic procedures take place in the HOPD setting and are not
eligible to be performed in the ASC. The estimated 8 million Medicare
patients who undergo these procedures every year are therefore unable
to reasonably access non-opioid pain management approaches.
Given that most of these procedures--and associated opioid
prescribing--take place in the HOPD setting, we urge Congress to work
with the Administration to adopt reimbursement policies that better
incentivize the utilization of non-opioid approaches for pain
management. We believe that, in doing so, federal leaders will have the
opportunity to safely and effectively alleviate pain with optimal
opioid stewardship and provide all patients with the necessary access
to the plethora of available pharmacologic and non-pharmacologic non-
opioid approaches and therapies.
Congress and the Administration must continue to work hand-in-hand to
solve the substance abuse emergency currently taking place in the
United States, and specifically the issues around opioids. We hope that
commonsense solutions and changes to outdated policies can help
increase access to nonopioid approaches to pain management and
therefore prevent opioid addiction or dependence from ever occurring
after an acute pain incident such as a surgical intervention.
We look forward to your continued work on solving the crisis and stand
available to answer any questions.
Sincerely,
Chris Fox
Executive Director
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