[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

                               __________

[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

                              ----------                              

                           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

                              ----------                              


                       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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \26\ https://www.cdc.gov/mmwr/volumes/68/wr/
mm6839a1.htm?s_cid=mm6839a1_e&delivery
Name=USCDC_921-DM10135.
---------------------------------------------------------------------------
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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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-
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.

---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                               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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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, 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \22\ SAMHSA, ``Recovery Housing: Best Practices and Suggested 
Guidelines'' (Rockville, MD: 2018).
---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------
    \23\ See GAO-18-315.
---------------------------------------------------------------------------
                              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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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

                                   [all]