[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]




                          ``THE OPIOID CRISIS: 
                       THE CURRENT LANDSCAPE AND 
                CMS ACTIONS TO PREVENT OPIOID MISUSE''

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

                                HEARING

                               before the

                       SUBCOMMITTEE ON OVERSIGHT

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                     U.S. HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            JANUARY 17, 2018

                               __________

                          Serial No. 115-OS10

                               __________

         Printed for the use of the Committee on Ways and Means







[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]










                                   ______
		 
                     U.S. GOVERNMENT PUBLISHING OFFICE 
		 
33-659                    WASHINGTON : 2019                 





















                      COMMITTEE ON WAYS AND MEANS

                      KEVIN BRADY, Texas, Chairman

SAM JOHNSON, Texas                   RICHARD E. NEAL, Massachusetts
DEVIN NUNES, California              SANDER M. LEVIN, Michigan
DAVID G. REICHERT, Washington        JOHN LEWIS, Georgia
PETER J. ROSKAM, Illinois            LLOYD DOGGETT, Texas
VERN BUCHANAN, Florida               MIKE THOMPSON, California
ADRIAN SMITH, Nebraska               JOHN B. LARSON, Connecticut
LYNN JENKINS, Kansas                 EARL BLUMENAUER, Oregon
ERIK PAULSEN, Minnesota              RON KIND, Wisconsin
KENNY MARCHANT, Texas                BILL PASCRELL, JR., New Jersey
DIANE BLACK, Tennessee               JOSEPH CROWLEY, New York
TOM REED, New York                   DANNY DAVIS, Illinois
MIKE KELLY, Pennsylvania             LINDA SANCHEZ, California
JIM RENACCI, Ohio                    BRIAN HIGGINS, New York
PAT MEEHAN, Pennsylvania             TERRI SEWELL, Alabama
KRISTI NOEM, South Dakota            SUZAN DELBENE, Washington
GEORGE HOLDING, North Carolina       JUDY CHU, California
JASON SMITH, Missouri
TOM RICE, South Carolina
DAVID SCHWEIKERT, Arizona
JACKIE WALORSKI, Indiana
CARLOS CURBELO, Florida
MIKE BISHOP, Michigan
DARIN LAHOOD, Illinois

                     David Stewart, Staff Director

                 Brandon Casey, Minority Chief Counsel

                                 ______

                       SUBCOMMITTEE ON OVERSIGHT

                     LYNN JENKINS, Kansas, Chairman

DAVID SCHWEIKERT, Arizona            JOHN LEWIS, Georgia
JACKIE WALORSKI, Indiana             JOSEPH CROWLEY, New York
CARLOS CURBELO, Florida              SUZAN DELBENE, Washington
MIKE BISHOP, Michigan                EARL BLUMENAUER, Oregon
DARIN LAHOOD, Illinois
TOM REED, New York





















                            C O N T E N T S

                               __________

                                                                   Page

Advisory of January 17, 2018, announcing the hearing.............     2

                               WITNESSES

Gary L. Cantrell, Deputy Inspector General for Investigations, 
  Office of the Inspector General, Department of Health and Human 
  Services (HHS).................................................     6
Elizabeth H. Curda, Director, Health Care, Government 
  Accountability Office (GAO)....................................    18
Kimberly Brandt, Principal Deputy Administrator for Operations, 
  Centers for Medicare & Medicaid Services (CMS).................    35

                        QUESTIONS FOR THE RECORD

Questions from the Hon. Lynn Jenkins, Chairman of the 
  Subcommittee on Oversight of the Committee on Ways and Means, 
  to Kimberly Brandt, Principal Deputy Administrator for 
  Operations, Centers for Medicare & Medicaid Services (CMS).....    80
Questions from Representative Jackie Walorski, 2nd District of 
  Indiana, to Kimberly Brandt, Principal Deputy Administrator for 
  Operations, Centers for Medicare & Medicaid Services (CMS).....    81
Questions from Representative Patrick Meehan, 7th District of 
  Pennsylvania, to Kimberly Brandt, Principal Deputy 
  Administrator for Operations, Centers for Medicare & Medicaid 
  Services (CMS).................................................    87
Questions from Representative Joseph Crowley, 15th District of 
  New York, to Kimberly Brandt, Principal Deputy Administrator 
  for Operations, Centers for Medicare & Medicaid Services (CMS).    88
Questions from the Hon. Lynn Jenkins, Chairman of the 
  Subcommittee on Oversight of the Committee on Ways and Means, 
  to Elizabeth H. Curda, Director, Health Care, Government 
  Accountability Office (GAO)....................................    89
Questions from Representative Joseph Crowley, 15th District of 
  New York, to Elizabeth H. Curda, Director, Health Care, 
  Government Accountability Office (GAO).........................    91
Questions from the Hon. Lynn Jenkins, Chairman of the 
  Subcommittee on Oversight of the Committee on Ways and Means, 
  to Gary L. Cantrell, Deputy Inspector General for 
  Investigations, Office of the Inspector General, Department of 
  Health and Human Services (HHS)................................    92
Questions from Representative Patrick Meehan, 7th District of 
  Pennsylvania, to Gary L. Cantrell, Deputy Inspector General for 
  Investigations, Office of the Inspector General, Department of 
  Health and Human Services (HHS)................................    94
Questions from Representative Joseph Crowley, 15th District of 
  New York, to Gary L. Cantrell, Deputy Inspector General for 
  Investigations, Office of the Inspector General, Department of 
  Health and Human Services (HHS)................................    95

                       SUBMISSIONS FOR THE RECORD

American Association of Nurse Anesthetists (AANA)................    97
Abuse Deterrent Coalition (ADC)..................................   103
Nola, a Concerned American Citizen...............................   109
Halyard Health...................................................   111
Premier healthcare alliance......................................   115
Quest Diagnostics Incorporated...................................   118

 
                          ``THE OPIOID CRISIS: 
                       THE CURRENT LANDSCAPE AND 
                 CMS ACTIONS TO PREVENT OPIOID MISUSE'' 

                              ----------                              


                      WEDNESDAY, JANUARY 17, 2018

             U.S. House of Representatives,
                       Committee on Ways and Means,
                                 Subcommittee on Oversight,
                                                    Washington, DC.

    The Subcommittee met, pursuant to call, at 10:00 a.m., in 
Room 1100, Longworth House Office Building, Hon. Lynn Jenkins 
[Chairman of the Subcommittee] presiding.
    [The advisory announcing the hearing follows:]

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                       SUBCOMMITTEE ON OVERSIGHT

                                                CONTACT: (202) 225-1721
FOR IMMEDIATE RELEASE
Wednesday, January 17, 2018
OS-10

                        Chairman Brady Announces

                   Oversight Subcommittee Hearing on

             ``The Opioid Crisis: The Current Landscape and

                 CMS Actions to Prevent Opioid Misuse''

    House Ways and Means Committee Chairman Kevin Brady (R-TX), 
announced today that the Oversight Subcommittee will hold a hearing on 
``The Opioid Crisis: The Current Landscape and CMS Actions to Prevent 
Opioid Misuse.'' The hearing will focus on efforts by the Centers for 
Medicare & Medicaid Services (CMS) to utilize data to identify 
individuals in the Medicare Part D program who are at risk to abuse 
opioids. The hearing also will examine the extent of the problem as 
well as the tools CMS has available to prevent individuals from 
receiving unnecessary opioids. The hearing will take place on 
Wednesday, January 17, 2018, in room 1100 of the Longworth House Office 
Building, beginning at 10:00 a.m.
      
    In view of the limited time to hear witnesses, oral testimony at 
this hearing will be from invited witnesses only. However, any 
individual or organization may submit a written statement for 
consideration by the Committee and for inclusion in the printed record 
of the hearing.
      

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

      
    Please Note: Any person(s) and/or organization(s) wishing to submit 
written comments for the hearing record must follow the appropriate 
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which you would like to make a submission, and click on the link 
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you have followed the online instructions, submit all requested 
information. ATTACH your submission as a Word document, in compliance 
with the formatting requirements listed below, by the close of business 
on Wednesday, January 31, 2018. For questions, or if you encounter 
technical problems, please call (202) 225-3625.
      

FORMATTING REQUIREMENTS:

      
    The Committee relies on electronic submissions for printing the 
official hearing record. As always, submissions will be included in the 
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    All submissions and supplementary materials must be submitted in a 
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Committee relies on electronic submissions for printing the official 
hearing record.
      
    All submissions must include a list of all clients, persons and/or 
organizations on whose behalf the witness appears. The name, company, 
address, telephone, and fax numbers of each witness must be included in 
the body of the email. Please exclude any personal identifiable 
information in the attached submission.
      
    Failure to follow the formatting requirements may result in the 
exclusion of a submission. All submissions for the record are final.

    The Committee seeks to make its facilities accessible to persons 
with disabilities. If you are in need of special accommodations, please 
call 202-225-1721 or 202-226-3411 TDD/TTY in advance of the event (four 
business days notice is requested). Questions with regard to special 
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materials in alternative formats) may be directed to the Committee as 
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    Note: All Committee advisories and news releases are available at
    http://www.waysandmeans.house.gov/

                                 

    Chairman JENKINS. The Subcommittee will come to order. 
Welcome to the Ways and Means Oversight Subcommittee Hearing on 
the Opioid Crisis, the Current Landscape and CMS Actions to 
Prevent Opioid Misuse.
    Good morning. I want to thank the panel for coming and 
welcome you all to today's hearing, the Opioid Crisis, the 
Current Landscape and CMS Actions to Prevent Opioid Misuse. 
Opioid abuse has devastated communities across America. In 
2016, more than 42,000 Americans died due to opioids, a level 
that is five times what it was in 1999.
    My home State of Kansas is no exception. In 2000, 35 
overdose deaths were attributed to opioids. In 2016, 159 people 
died from opioid abuse in Kansas. Overdose deaths in America 
are on the rise largely due to opioids, which account for three 
out of every five overdose deaths. These numbers are startling, 
and yet many experts believe they are too low. And, 
unfortunately, this epidemic continues to get worse, which is 
why finding ways to address the problem is a high priority for 
this Committee.
    No community is immune to the effects of opioid abuse. 
Rural communities are hit particularly hard, as they often have 
limited access to critical services and resources to support 
those struggling with addiction. The immense cost opioids 
impose on society as a whole cannot be overstated.
    According to the Centers for Disease Control, opioids 
imposed an economic burden of $78.5 billion in 2013. Much of 
this is due to increased substance abuse treatment cost, lost 
productivity, incarceration, and other burdens put on the 
criminal justice system. Last year, the President's Council of 
Economic Advisors estimated the cost to be even higher.
    In order to address the opioid crisis, we need to 
understand what the current state of the problem is. We also 
need to understand what tools are in place to address this 
problem and how they can be improved. Today we will examine how 
the Centers for Medicare & Medicaid Services, or CMS, is 
working to address opioid misuse in the Medicare Part D 
program.
    More than 42 million beneficiaries rely on the program for 
prescription drugs, including opioids. It is critical that 
Medicare and private Part D plan sponsors have the tools they 
need to ensure that opioids are provided only when medically 
necessary. We have a panel of experts that can talk about what 
CMS and the plan sponsors are doing to identify those most at 
risk so that appropriate interventions can be taken.
    Our witnesses today should provide the Committee with 
valuable insights into how things are currently working and 
what can be done to improve them. The Committee plans to do 
more oversight on this issue as we continue to examine other 
ways to reduce opioid abuse.
    Before closing, I want to recognize that a lot of what we 
will be discussing today will be sanitized to some degree, 
simply through the use of numbers and statistics. I would like 
the record to reflect that the Members of this Committee know 
that there are real people, real families, and real experiences 
behind every number. That is why we are here today and we are 
devoting time to such a critical issue.
    With that, I want to thank our witnesses, and I look 
forward to their testimony. I now yield to the distinguished 
Member from Washington, Ms. DelBene, for the purposes of an 
opening statement.
    Ms. DELBENE. Thank you, Madam Chair. And thank you for 
holding this important hearing. I would like to thank our 
witnesses also for taking the time to be with us here today.
    And I would like to acknowledge our Ranking Member, Neal, 
and thank him for being here today and joining us. But I want 
to start by congratulating our new Chair of the Subcommittee on 
Oversight. Clapping is appropriate. No, no, I said that is 
good. I know you are a certified public accountant, and were 
the 37th Kansas State Treasurer, both of which will be valuable 
for this Subcommittee in particular, as we look at IRS reforms.
    I look forward to working with you on this and other things 
that are under the Subcommittee's jurisdiction, and I hope 
we'll continue to work in a bipartisan fashion on issues that 
are important to all of us, just like today's topics. So, thank 
you very much, and welcome to your new role. And I yield back.
    Chairman JENKINS. Thank you. I now yield to the 
distinguished Ranking Member of the Full Committee, Mr. Neal, 
for the purposes of a statement.
    Mr. NEAL. Thank you, Madam Chairperson. Everyone in this 
room has a family member or knows someone directly impacted by 
the opioid epidemic, somebody down the street, a neighbor, or 
we have all witnessed wrenching consequences of what this has 
done to families across the country. In Massachusetts, there 
were 2,094 confirmed opioid-related overdose deaths in 2016. 
Although overdose rates are highest for people 25 to 54, this 
public health emergency also affects Medicare beneficiaries.
    According to a study recently from Altarum in November of 
2017, the economic burden from opioids was estimated to be $95 
billion in 2016, $21 billion of which was attributed to 
healthcare services, direct and indirect cost, and $55.6 
billion lost to earnings and productivity.
    In 2016, one-third of Medicare Part D beneficiaries filled 
a prescription for opiates. For one-third of these 
beneficiaries, we know part of the consequence. This number is 
too high and we need to explore better ways to manage chronic 
pain. I hope that we can work in a bipartisan manner to urge 
the Centers for Medicare & Medicaid Services to move quickly to 
implement recommendations.
    Congress and the Administration need to do more to help 
Americans access necessary treatment for opioid use disorders. 
The Administration's emergency declaration expires next week, 
but nothing at the moment has progressed. Yet, another missed 
opportunity for positive action. The most significant step that 
has been taken in recent years to stem the tide of the opioid 
crisis has been to expand Medicaid under the ACA to low-income 
working Americans who previously could not afford insurance.
    The Medicaid expansion has provided millions of previously 
uninsured adults with access to health insurance, which 
includes coverage for substance abuse and mental health 
services. For Medicare, the specific topic of today's hearing, 
we need to look to beneficiary's ability to access treatment, 
as oftentimes providers aren't available to meet the need. We 
know there are significant groups and gaps in the coverage and 
access under Medicare that need to be acknowledged.
    For example, Medicare does not cover outpatient treatment 
programs that provide comprehensive opiate addiction 
treatments, nor does Medicare cover methadone for addiction, 
which is often the treatment of choice for long term addicts. 
We clearly have our work to do this year, and we need to stop 
undermining the programs that provide coverage and treatment 
for those who need it, instead, strengthening and improving 
access to care and coverage.
    And another reflection, just off the talking points. What 
this has done to labor participation rates across the country 
is an underreported story. When the Department of Labor 
recently indicated that there are six million jobs in America 
every day that go unanswered, and when you consider that there 
are two million people with opiate addictions that are sitting 
on the sidelines who could be working, that is another 
consequence of what has happened.
    A number of people across America, who have opiate 
addictions, who are sitting home in the afternoon playing video 
games rather than in the workforce, ought to alarm all of us, 
and there ought to be something that we can all agree to in 
terms of the treatment needs of those very people. But this has 
a personal consequence for all of us as well, as I indicated in 
the first sentence. We all have a neighbor, friend, or a 
relative who is battling this addiction. And this ought to be 
well beyond the consequence of partisanship in this 
institution. We ought to be trying to find some remedies. And I 
yield back my time.
    Chairman JENKINS. Thank you, Mr. Neal.
    Without objection, other Members' opening statements will 
be made part of the record.
    Today's witness panel includes three experts: Gary L. 
Cantrell, Deputy Inspector General for Investigations at the 
Department of Health and Human Services Office of the Inspector 
General; Elizabeth H. Curda, Director of Health Care at the 
Government Accountability Office; and Kimberly Brandt, 
Principal Deputy Administrator for Operations at the Centers 
for Medicare & Medicaid Services.
    The Subcommittee has received your written testimonies, and 
they will be made part of the formal hearing record. You each 
have 5 minutes to deliver your oral remarks. We will begin with 
you, Mr. Cantrell. You may begin when you are ready.

  STATEMENT OF GARY L. CANTRELL, DEPUTY INSPECTOR GENERAL FOR 
INVESTIGATIONS, OFFICE OF THE INSPECTOR GENERAL, DEPARTMENT OF 
                HEALTH AND HUMAN SERVICES (HHS)

    Mr. CANTRELL. Thank you. Good morning, Chairman Jenkins and 
Ranking Member Neal, and other distinguished Members of the 
Subcommittee. I am Gary Cantrell, Deputy Inspector General for 
Investigations at HHS OIG, and I am excited to be here today to 
discuss efforts by the HHS OIG to combat the opioid epidemic in 
Federal healthcare programs.
    Given a long history of healthcare fraud enforcement, 
program knowledge, and data analytics capabilities, OIG is 
uniquely positioned to help lead this fight against illegal 
opioid prescribing in Medicare and Medicaid.
    My testimony today will highlight our work to prevent 
opioid-related fraud and abuse, detect questionable prescribing 
and billing patterns, and enforce laws and regulations 
governing opioid prescribing.
    Opioid-related fraud encompasses a broad range of criminal 
activity, from prescription drug diversion to addiction 
treatment fraud. Many of these schemes involve kickbacks, 
medical identity theft, and criminal enterprises. Developing 
these investigations is complex, requiring the use of 
confidential informants, undercover operations, and 
surveillance to gather evidence of crimes often committed by 
corrupt doctors, pharmacists, and criminal networks. In the 
worst cases, our special agents uncover evidence of illegal 
prescribing leading to patient deaths.
    Given the complexity and high stakes of these 
investigations, OIG's partnerships with DOJ, FBI, DEA, and 
State Medicare fraud control units is critical to the success 
of these efforts. OIG and our Medicare Fraud Strike Force 
partners led the 2017 national healthcare fraud take-down. This 
take-down was the largest ever healthcare fraud take-down, 
resulting in over 400 individuals charged; 120 of these 
defendants were charged for their roles in illegally 
prescribing and distributing opioids.
    The enforcement operation brought together more than 1,000 
Federal and State law enforcement personnel, including 350 OIG 
special agents. OIG has also shifted resources to support the 
Attorney General's Opioid Fraud and Abuse Detection Unit, a 
multiagency effort capitalizing on data, with dedicated 
prosecutors and agents focused solely on prosecuting opioid 
fraud in the healthcare system.
    OIG uses advanced data analytics to put timely, actionable 
information about prescribing, billing, and utilization trends 
in the hands of investigators, auditors, evaluators, and our 
government partners. A recent report identifying Medicare 
beneficiaries receiving extremely high amounts of opioids and 
questionable prescribing patterns demonstrates the value of 
this approach.
    Of note, the report uncovered that half a million Medicare 
beneficiaries received opioids in excess of CDC guidelines. 
Further, nearly 90,000 beneficiaries are at serious risk of 
opioid misuse or overdose. Some of these received extreme 
amounts of opioids, over 2\1/2\ times the CDC recommended 
amounts, when others appear to be doctor shopping.
    To get to the source of this extreme use, OIG identified 
about 400 prescribers with questionable opioid prescribing 
patterns for these beneficiaries at serious risk. OIG is 
following up on these outlier prescribers, and we have also 
shared this data with our public and private sector partners. 
This is one example of how we leverage our relationships and 
empower our partners to help us tackle this problem.
    Recognizing the growing severity of the opioid epidemic, 
OIG has initiated work beyond Medicare. The work identifies 
opportunities to strengthen program integrity and protect at-
risk beneficiaries across multiple HHS programs. For example, 
OIG audits and evaluations currently underway address the broad 
range of opioid-related funding and activity at HHS, including 
opioid prescribing in Medicaid, transfer prescription drug 
monitoring programs, FDA's oversight of opioid risk management 
program and addiction treatment services.
    OIG's work holds criminals accountable and results in 
impactful recommendations to improve program integrity, save 
tax dollars, and protect HHS beneficiaries from harm. Key 
recommendations to combat opioid-related fraud and abuse are 
outlined in my written testimony.
    In summary, OIG will continue to focus our 
multidisciplinary efforts on the opioid epidemic. We will 
identify opportunities to improve HHS prescription drug and 
treatment programs, share data and educate the public, and 
identify and hold accountable perpetrators of opioid-related 
fraud.
    I appreciate the opportunity to speak with you today, and I 
would be happy to answer any questions.
    [The prepared statement of Mr. Cantrell follows:]


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    Chairman JENKINS. Thank you, Mr. Cantrell. Ms. Curda, you 
are recognized for 5 minutes.

    STATEMENT OF ELIZABETH H. CURDA, DIRECTOR, HEALTH CARE, 
             GOVERNMENT ACCOUNTABILITY OFFICE (GAO)

    Ms. CURDA. Good morning, Chairman Jenkins, Ranking Member 
Neal, and Members of the Subcommittee. I am pleased to be here 
to discuss our report on the Centers for Medicare & Medicaid 
Services oversight of opioid prescribing in the Medicare 
program. Overprescribing and misuse of prescription opioids has 
led to significant increases in opioid use disorder, overdoses, 
and deaths in the United States.
    Recognizing this, CMS developed an opioid misuse strategy 
with a goal to reduce harm from opioid misuse in its programs. 
Today I will discuss how CMS oversees opioid prescribing under 
Medicare Part D, both in terms of the beneficiaries who receive 
opioid prescriptions, as well as the providers who prescribe 
them.
    To oversee beneficiaries, CMS relies on private insurers, 
known as plan sponsors, to monitor and take appropriate action 
to address potential opioid overuse. CMS employs an 
overutilization monitoring system to alert plan sponsors about 
very high-risk beneficiaries. These are beneficiaries receiving 
high doses of opioids from four or more providers and 
pharmacies or from six or more providers regardless of the 
number of pharmacies. Excluding cancer and hospice care, about 
33,000 beneficiaries met these criteria in 2015. Plan sponsors 
are expected to review a quarterly list of identified 
beneficiaries, determine appropriate action, and then respond 
to CMS with information on their actions within 30 days.
    The use of these criteria, along with plan sponsor actions, 
has helped to significantly reduce the number of these very 
high-risk cases.
    However, CMS oversight does not address the over 700,000 
beneficiaries potentially at risk of harm, based on CDC 
guidelines. These guidelines note that long-term use of opioid 
doses over 90 milligrams morphine equivalent per day are 
associated with significant risk of harm and should be avoided 
unless a provider determines that it is necessary.
    This is particularly the case for patients aged 65 and 
older, because the drugs can more easily accumulate in the body 
to toxic levels. We recommended that CMS gather information on 
the total number of these beneficiaries over time to help 
assess progress in reaching the agency's goals related to 
reducing opioid harm and misuse. HHS concurred with our 
recommendation.
    CMS oversees Medicare Part D providers through its 
contractor, NBI MEDIC, as well as through the plan sponsors. 
NBI MEDIC provides oversight by analyzing Medicare prescriber 
data for outliers and determining potential fraud. NBI MEDIC 
conducts its own investigations of potential fraud, waste, and 
abuse by providers, and also refers cases to law enforcement or 
the Office of the Inspector General.
    CMS also requires plan sponsors to prevent, detect, and 
correct prescriber noncompliance, as well as fraud, waste, and 
abuse. However, NBI MEDICS analyses to identify outlier 
providers focused broadly on all drugs at risk of abuse, rather 
than on opioids specifically.
    We recommended that CMS require NBI MEDIC to gather 
separate data on providers who prescribe high amounts of 
opioids. This would allow CMS to better identify those 
providers who are inappropriately and potentially fraudulently 
prescribing high doses of opioids. HHS concurred with this 
recommendation as well.
    CMS also lacks key information necessary for oversight of 
opioid prescribing because it does not require plan sponsors to 
report cases of fraud, waste, and abuse, cases of 
overprescribing, or any actions taken against providers. While 
CMS received some of this information from plan sponsors who 
voluntarily report their actions, it does not know the full 
extent to which plan sponsors have identified providers who 
prescribe high amounts of opioids or take an appropriate 
action.
    We recommended that CMS require plan sponsors to report on 
investigations and other actions taken related to providers who 
prescribe high amounts of opioids. HHS did not concur, noting 
that plan sponsors are responsible for detecting and preventing 
fraud, waste, and abuse, and that CMS reviews cases when it 
conducts audits.
    HHS also stated that it seeks to balance the requirements 
it places on plan sponsors. However, without complete 
reporting, CMS is missing key information that could help the 
agency achieve its goals. We continue to believe that CMS 
should require plan sponsors to report on the actions they take 
to reduce overprescribing.
    In conclusion, having information on the total number of 
beneficiaries receiving potentially harmful levels of opioid 
medication, as well as complete information on providers who 
may be inappropriately prescribing opioids, could help CMS as 
it works to decrease the risk of opioid use disorder, 
overdoses, and deaths.
    This concludes my prepared statement, and I am happy to 
answer the Committee's questions.
    [The prepared statement of Ms. Curda follows:] 
    
    
    
 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
 
    

                                 


    Chairman JENKINS. Thank you, Ms. Curda. Ms. Brandt, you are 
recognized for 5 minutes.

 STATEMENT OF KIMBERLY BRANDT, PRINCIPAL DEPUTY ADMINISTRATOR 
               FOR OPERATIONS, CENTERS FOR MEDI- 
                 CARE & MEDICAID SERVICES (CMS)

    Ms. BRANDT. Thank you. Chairman Jenkins, Ranking Member 
Neal, and Members of the Subcommittee, thank you for inviting 
me to discuss CMS's work to address the misuse of opioids in 
the Medicare Part D program.
    CMS understands the magnitude and impact the opioid misuse 
epidemic has had on our communities and is committed to a 
comprehensive and multipronged strategy to combat this public 
health emergency.
    As Principal Deputy for Operations at CMS, I am charged 
with directing cost-cutting issues that affect all of our 
programs, with the efforts to fight the opioid epidemic being 
one of our agency's biggest priorities. We cover over 58 
million Medicare beneficiaries, and the opioid epidemic affects 
every one of them as a patient, family member, caregiver, or 
community member.
    CMS recognizes that its primary role in the healthcare 
system is that of a payer. And as a payer, we are focused on 
the unique steps we can take to ensure that plans comply with 
requirements that protect beneficiaries.
    For us, all of our efforts are ultimately focused on 
protecting the health and safety of our Medicare beneficiaries. 
Due to the structure of the Medicare Part D program, Medicare 
Advantage organizations and Medicare Part D sponsors are well-
positioned to identify and address improper opioid utilization 
by working with prescribing physicians.
    Our job at CMS is to oversee these efforts and to make sure 
that plan sponsors have the tools and information they need to 
be as effective as possible. We do this in a number of ways. 
First, as my colleague from GAO knows, we use the 
Overutilization Monitoring System, or OMS, to help ensure plan 
sponsors have established systems and programs to help prevent 
overutilization of prescription opioids.
    Through this system, CMS identifies high-risk beneficiaries 
who have visited multiple pharmacies or prescribers. We then 
report these high-risk beneficiaries to plans who conduct case 
management or implement real time alerts at a pharmacy. This 
effort has been very successful, with a 61 percent decline in 
the number of beneficiaries meeting the OMS criteria from 2011 
to 2016, even while Part D enrollment was increasing at the 
same time.
    To improve on these outcomes and to better identify high-
risk beneficiaries, we have improved the criteria used in OMS 
to reflect the Centers for Disease Control's prescribing 
guidelines. This action will allow us to better identify 
potential opioid overutilizers and is just one of the many ways 
we are collaborating with our colleagues in HHS to tackle this 
epidemic and further protect beneficiaries at high risk of 
opioid overutilization.
    Thanks to recent action taken by Congress, CMS now has the 
authority to implement a new Medicare Part D lock-in policy. 
CMS has proposed to integrate this new authority with our OMS 
to expand upon our existing innovative approach to reduce 
opioid overutilization in the Part D program. We believe this 
approach will improve quality of care through enhanced 
coordination while maintaining access to necessary pain 
medications.
    Second, all plan sponsors are using real-time alerts, 
referred to as safety edits, to flag potentially unsafe opioid 
prescriptions at the pharmacy. When these alerts are triggered, 
the pharmacist must take an action, depending on the type of 
safety edit, before the prescription can be dispensed.
    Through this process, prescribers can receive important 
information about their patients, such as a better picture of a 
patient's total opioid dosage and prescription history. 
Ultimately, this helps prescribers make more informed decisions 
about the care that they are providing to their patients.
    Third, CMS tracks and monitors the number of Part D 
beneficiaries who receive high doses of opioid prescriptions 
regardless of the number of prescribers and pharmacies being 
used by the beneficiary. Using this information, CMS sends 
monthly patient safety reports to plan sponsors so they can 
conduct case management. Ensuring that Medicare beneficiaries 
with substance use disorder have access to the most effective 
treatment is a critical component of addressing the epidemic.
    We want to make sure that we cover the right treatment for 
the right beneficiaries in the right setting, and we are 
working to increase access to medication-assisted treatment by 
requiring that Part D formula include MAT drugs as well as 
Naloxone.
    In addition to these efforts to identify and protect 
beneficiaries who are at high risk for opioid overutilization, 
CMS also uses data to identify prescribers and pharmacies with 
questionable opioid prescribing and billing patterns. Plans 
receive quarterly reports on outlier prescribers and pharmacies 
they can use to initiate new investigations, conduct audits, 
and take administration actions like terminating a pharmacy 
from their network.
    Based on a recommendation by the GAO, these reports now 
separate outlier prescribers of opioids from other Schedule II 
prescribers.
    As we move forward with our efforts to curb this public 
health crisis, CMS plans to enact comprehensive strategies from 
all Medicare Part D sponsors on their activities aimed at 
combatting the opioid crisis. This will help CMS better 
understand the approaches sponsors are taking from both their 
Medicare and commercial alliance. Once we receive this 
information, we will conduct an analysis and provide best 
practice guidance to all plans.
    While CMS has taken numerous steps to improve our opioid 
overutilization and monitoring programs, we know there is much 
more we can do. We appreciate the work and recommendations from 
our colleagues at GAO and OIG, and we are continually assessing 
how we can best utilize our tools as a payer to build on their 
recommendations to tackle this crisis.
    Thank you for your interest in our efforts to protect 
Medicare beneficiaries, and I look forward to answering your 
questions.
    [The prepared statement of Ms. Brandt follows:]

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    Chairman JENKINS. Thank you. And I appreciate all three of 
you being here today with your excellent testimony.
    We will now proceed to the question and answer session. And 
I would like to direct my questions to Ms. Curda.
    Ms. Curda, in your testimony, you discussed how the OMS 
tracks only a small portion of the potentially at-risk 
beneficiary population. Can you talk more about what GAO found?
    Ms. CURDA. Sure. We found that the criteria that CMS is 
currently using in its OMS tracked the very high dose--
beneficiaries who are getting very high doses, who are using 
multiple doctors, multiple pharmacies, but they aren't tracking 
the larger number of beneficiaries that are at risk of harm 
because they are receiving higher doses of opioids. These are 
those that are receiving more than 90 milligrams morphine 
equivalent dose per day, which is indicated in CDC guidelines.
    According to a one-time analysis that CMS performed, this 
criterion covered about 700,000 beneficiaries in 2015. So, just 
relatively speaking, we are talking about 700,000 beneficiaries 
taking very, very high levels of opioids, versus the OMS 
criteria, which is in the sort of more tens of thousands range. 
And so, we recommended that they gather that data, not just for 
reporting back to the plan sponsors, but because it has this 
goal of reducing harm from opioid use, to track and monitor 
that information over time to see what is happening with that 
number of beneficiaries, to see is it going up, is it going 
down, and use it to inform its strategy.
    Chairman JENKINS. Right. One of the recommendations that 
GAO made was for CMS to track beneficiaries receiving large 
amounts of opioids, irrespective of the number of pharmacies 
and providers that they used to obtain them. Can you talk about 
why you believe this to be important?
    Ms. CURDA. Sure. CMS does track very useful information 
on--using its overutilization system, and also in its in-
patient quality measures. But neither of those measures track 
the larger number of beneficiaries that are receiving harmful 
doses of--potentially harmful doses of opioid medication. And 
so we think that, in routinely collecting this information, 
they can better inform their strategy and track their goal 
achievements.
    Chairman JENKINS. What specific data do you believe is 
important for CMS to track?
    Ms. CURDA. This would be the patients receiving either 90 
milligram morphine equivalent dose per day or greater through 
Medicare.
    Chairman JENKINS. Okay. How much of that data is currently 
being utilized for CMS for these purposes, and why do you 
believe the current data CMS is monitoring to be insufficient?
    Ms. CURDA. It is basically just a measurement issue. The 
CMS tracks data, but not at that level. And they don't use it 
for the purposes of monitoring this harmful use of opioids over 
time. So we believe that by collecting this information and 
monitoring it, over time they can better track whether they are 
achieving their goals.
    Chairman JENKINS. Okay. Thank you. I would now like to 
recognize Ms. DelBene.
    Ms. DELBENE. Thank you, Madam Chair. The Administration 
recently released guidance indicating that it would allow 
States to implement work requirements to access Medicaid. Ms. 
Brandt, in your testimony to the Committee, you state one of 
the points of the comprehensive evidence-based opioid strategy 
is to ``improve access to treatment and recovery services, and 
to enable individuals to achieve long-term recovery.''
    In the guidance that was put out, the Administration 
requires exemptions for individuals with medical conditions, 
such as substance use disorders, and outlined that medical 
treatment for any--for their substance use may fulfill a work 
requirement.
    My question is, how does a work requirement improve access 
to treatment? And, second, how can an individual who is 
suffering from addiction access treatment to fulfill their work 
requirement if they are not allowed to get Medicaid and can't 
have that to cover such a treatment? So, we end up in this 
circular situation where someone doesn't have coverage, so they 
can't get treatment, but they can't fulfill the work 
requirement because they need to be in treatment to do that. 
Can you explain how we would address that?
    Ms. BRANDT. Thank you for your question. While the work 
requirements and the Medicaid requirements are not my day-to-
day responsibility, I will do my best to sort of answer, to the 
best of my knowledge.
    As part of our issuance last week, as you mentioned, States 
are required to take steps to ensure access to appropriate 
treatment or services. And one of the things that they are 
supposed to do is make reasonable modifications to ensure that 
people who are receiving treatment for substance abuse 
disorders or opioid treatments are able to have reasonable 
accommodations. And so we have worked to provide guidance to 
the States to help them to ensure that balance, and the goal is 
to ensure that the beneficiary who is receiving those 
treatments can hopefully be able to have the appropriate 
accommodations made so they can continue to receive it.
    Ms. DELBENE. So, if a State doesn't come up with a work--
with the work-around, as you describe, how would someone access 
Medicaid so they can get treatment if they can't fulfill their 
work requirement because they can't fulfill--they aren't 
allowed to access treatment?
    Ms. BRANDT. Well, our goal is to work with the States to 
ensure that they would be able to provide those types of 
accommodations as part of what they are supposed to do under 
the mandate of the work requirement. And we would work with 
them to ensure that the beneficiary, hopefully, would be able 
to continue to receive those types of services.
    Ms. DELBENE. Thank you. As CMS moves more providers to 
value-based payments in an effort to improve quality and lower 
healthcare costs, part of the challenge is to properly risk 
adjust for high-needs patients. And because substance use 
disorder is such a complicated condition that demands a 
tremendous amount of coordination of care, this may be one of 
the conditions that warrants a risk adjustment. And, in fact, 
this was done for a managed care demonstration in Massachusetts 
that focused on dual eligible enrollees under 65.
    Ms. Brandt, have you considered how we can better align 
payment to promote coordination and quality care for people 
with substance use disorders in other value-based and managed 
care arrangements like ACOs and Medicare or Medicare Advantage 
Plans, and how is CMS promoting coordination of care between 
providers to mitigate the instances of high amounts of opioid 
prescribing?
    Ms. BRANDT. Thank you for your question. As I mentioned in 
my oral and written testimony, ensuring good access to 
beneficiaries across our payment lines is one of the goals at 
CMS. And one of the things that we have been doing is looking 
across all of our payment types, especially as we begin the new 
payment rules for this year and as we have discussions with 
providers to determine where we can do more and how we can have 
better coordination with them on just these types of issues.
    So it is something that we are currently engaged in as an 
agency, to try to figure out better ways to make sure that we 
are striking that balance and making sure, as I said in my 
testimony, that we have the right treatment, for the right 
people, in the right setting, at the right time.
    Ms. DELBENE. I understand that the--things like the managed 
care demonstration in Massachusetts have been looking at these 
scenarios. Is there something that you have learned from these 
that will better inform us on how best to address more 
complicated situations like substance use disorders?
    Ms. BRANDT. I can't speak specifically to the Massachusetts 
demonstration project because I am not familiar with the 
outcomes of that, but I can tell you that we have been looking 
at all of our demonstration projects, the models we run, and 
our Centers for Medicare and Medicaid innovation, as well as 
across the CMS programs to look at lessons learned and best 
practices, and we are trying to bring all that to bear as we 
try to figure out good solutions for this crisis.
    Ms. DELBENE. Thank you very much. I yield back.
    Chairman JENKINS. Mrs. Walorski is now recognized for 5 
minutes.
    Mrs. WALORSKI. Thank you, Madam Chair. Thank you to our 
witnesses for being here today. Like so many of the parts of 
the country, the opioid epidemic has affected my district in 
Indiana. It has destroyed lives, torn apart families, and put 
stress on first responders, hospitals, the foster care system, 
and other vital community institutions. Unfortunately, last 
year a dear friend of mine, a doctor in my district, was 
murdered for refusing to prescribe opioids.
    Opioids come in many forms: pills, heroin, the emerging 
threat of fentanyl, and others. Unfortunately, this means that 
there are too many fronts in the fight.
    Mr. Cantrell, I just want to ask you, identifying 
overprescribing by providers is incredibly important; however, 
examining at-risk beneficiaries can also help identify 
providers who are potentially overprescribing. The Inspector 
General identified in my State, Indiana, a prescriber who wrote 
an average of 24 opioid prescriptions each for 108 
beneficiaries who received extreme amounts.
    Can you talk about your approach to identifying potentially 
problematic prescribers, and then also, once these prescribers 
are identified, what happens?
    Mr. CANTRELL. Yes, thank you. First of all, in our data 
brief, we used an analysis approach that we hadn't previously 
utilized. We wanted to first focus on the beneficiaries who are 
at greatest risk of harm because of the volume of opioids they 
were receiving. And, instead of just looking at the universe of 
claims, we look then at the individuals, the prescribers who 
were prescribing specifically to a high number of those at-risk 
beneficiaries.
    So, that led us to, in our report, 400 different 
prescribers who were prescribing either to a large number of 
doctor-shopping Medicare beneficiaries, or to a large number of 
patients receiving high amounts of opioids.
    So, when we have this analysis, we use this data--first, we 
report on these results, so that we can inform the public. We 
share this information with CMS, so they can begin engaging in 
administrative or other review to monitor these prescribers, 
and we refer many of these out to our field offices, to our 
partners at the Department of Justice for criminal 
investigation.
    Now, with 400 different prescribers identified, it isn't 
necessarily the case that all are committing fraud, so we sift 
through the data to identify those that appear most likely to 
be committing fraud, send them out to the field, and then, 
ultimately, it takes boots on the ground to investigate these 
matters and bring individuals to justice who have committed 
this fraud.
    And so it is very intensive work, and we work closely with 
DEA, FBI, State agencies, and local law enforcement, and this 
is a huge priority for us to bring individuals who are 
prescribing in the Medicare and Medicaid space these opioids 
illegally.
    Mrs. WALORSKI. And just as a followup, I have heard from 
doctors in my district. They would like to have access to more 
data so they know, and they are a little bit less at risk on, 
you know, falling into some kind of a doctor-shopping kind of a 
network.
    Can you talk about ways you believe we can improve data 
sharing to combat opioid abuse? And then, are there ways to 
improve data sharing really just while working within State 
privacy laws as well?
    Mr. CANTRELL. Well, first of all, we certainly encourage 
the utilization of prescription drug monitoring programs in 
every State. We believe these are an important tool. For us, we 
see Medicare claims data, we have great visibility there. We 
have a little less, slightly less, but some visibility in the 
Medicaid, but we don't see cash-based transactions and other 
transactions like that, which the PDMPs would include.
    And so, we think it is vitally important for prescribers 
and pharmacies to check these PDMPs to make sure that they are 
not dispensing to doctor-shopping patients. And we look for 
other ways to share this information across both the Federal 
Government and with the States and the private sector.
    One of the things I think is most important that we have 
done is share their approach to this analysis, but also the 
underlying data with our private sector program integrity 
partners who we work with, through the Healthcare Fraud 
Prevention Partnership and the National Healthcare Antifraud 
Association. So they are empowered to conduct their own 
analysis, monitor these individuals, and hopefully have a 
broader impact.
    Mrs. WALORSKI. I appreciate it. And, Ms. Brandt, just 
quickly, is--one of the things I have continued to work on here 
is access to non-opioid alternatives. Is CMS developing a plan 
to use more non-opioid alternatives for patients with chronic 
pain?
    Ms. BRANDT. Yes. As I mentioned in my oral testimony, we 
are working to increase access to medication-assisted 
treatments and are looking and working with the CDC and other 
partners to determine----
    Mrs. WALORSKI. On a scale of one to ten, where are we, in 
looking? What have we found? What are we doing?
    Ms. BRANDT. We have done a number of stakeholder listening 
sessions over the past while, where we got a lot of valuable 
input, and we have been having meetings with NIH, CDC, and 
others. So I would say we are probably at about a six; we have 
more to do, but we are definitely moving in the right 
direction.
    Mrs. WALORSKI. Thank you. Madam Chairman, I yield back.
    Chairman JENKINS. Mr. Neal is recognized for 5 minutes.
    Mr. NEAL. Thank you, Madam Chairperson.
    Massachusetts, as I noted in my opening statement, is 
really--we are reeling from the addiction crisis, and your 
testimony was really well done this morning, the three of you. 
The number of opioid-related deaths in Massachusetts is now 
four times higher than it was 15 years ago, and it continues to 
get worse. We certainly owe it to our communities and to our 
families who have been hit by the epidemic to prevent 
addiction; that means earlier intervention and treating those 
afterward as well.
    There is a compelling argument as to the most effective way 
to treat opiate addiction for all of us. Medication-assisted 
treatment, MAT, is the evidence-based standard for treating 
opioid addiction. Medical and substance use disorder experts in 
the President's own Commission point to MAT as a vital tool to 
attack the epidemic.
    Medicare is usually the standard bearer when it comes to 
healthcare coverage, but Medicare does not cover a key MAT 
option, methadone for outpatient service. Ms. Brandt, Ms. 
Curda, you both testified about the importance of MAT in your 
opening statements.
    What is the Administration doing, and what would you 
recommend that it continue to do or should do to expand access 
to medication-assisted treatment?
    Ms. BRANDT. Well, as I mentioned, Congressman, we are 
continuing to look at the wide range of alternate treatments, 
such as Naloxone and others. We are well aware of methadone and 
the statutory impediments to that, but we are open to working--
I know you have legislation on that--we are open to working 
with Congress to provide technical assistance on those issues. 
But we can continue committed at CMS to determine what all we 
can do to increase the access to medication-assisted 
treatments.
    Ms. CURDA. We prepared a couple of reports on the issues 
surrounding access to medication-assisted treatment, not 
specifically in Medicare, but in general. The first report we 
did looked at the sort of regulatory and legal framework for 
access to these drugs, and also looked at some of the barriers 
to access. And there were things like not having enough doctors 
who have the appropriate waivers in order to prescribe this 
medication, and also in some cases, simply attitudinal issues 
where this is viewed as perhaps a substitute for another kind 
of addiction.
    So taking these issues into account, Congress passed 
legislation last year to enhance access to medication-assisted 
treatment, and we did a further report looking at HHS's roll-
out of the grant programs intended to enhance access to 
medication-assisted treatment, and we found that they had a 
strategy for accomplishing this. They were getting the programs 
going. It was a little too early to assess their effectiveness, 
but we did note that they did not have any sort of measures in 
place for their goals for expanding access to MATs, so not 
knowing sort of what the ultimate goal is for that, and that 
they did not have sort of firm timeframes. They had planned an 
evaluation of their efforts, but they did not have any firm 
timeframes for when that would be done.
    Mr. NEAL. Thank you. I hope the Administration and my 
colleagues on the other side, who I know are all sincere in 
their efforts on this, would also be supportive of another 
piece of legislation that I have offered, and that would be to 
hold harmless first responders who administer Naloxone. When 
they show up, oftentimes there is violent reaction as the high 
comes down, and they sometimes have to subdue the individual 
who has just been treated; save their lives, and then are 
attacked for saving their lives.
    So I think holding those individuals harmless would make a 
good deal of sense, and I hope that the--in a bipartisan manner 
we might be able to address that part of this complicated issue 
as well.
    Thank you for your testimony, and thank you Madam 
Chairperson; I yield back.
    Chairman JENKINS. Mr. Schweikert is recognized for 5 
minutes.
    Mr. SCHWEIKERT. Thank you, Madam Chairman.
    My assumption is that everyone in this room has been 
affected by addiction in a family member, a friend, or a 
neighbor. Growing up in a household where my mother was 
actually an addiction counselor, after years of fighting 
through her own demons, you actually just understand how 
complicated this is.
    This is actually an interesting opportunity, as the Ranking 
Member was talking about some of the different pieces of 
legislation he has, and I agree, we should actually start to 
step up and do a package, because there is no golden bullet 
here, no magic bullet.
    But I do want to also touch on--we have a piece of 
legislation, and it is bipartisan, we have Republicans, 
Democrats, and this Committee from E&C, and that is a mechanism 
to standardize the prior authorization process, so the 
electronic mechanism is underneath.
    And Ms. Brandt, I am going to ask you to sort of walk us 
through right now for Part D, how prior authorization actually 
is working today, and then I want to sort of pitch everyone on 
the Committee, the concept of, let's actually put together a 
package of bills, hopefully our prior authorization 
standardization will be one of those. But how does it work 
today for Part D?
    Ms. BRANDT. Well, let me caveat by saying, I am not a Part 
D expert, so I will give you the best of my understanding----
    Mr. SCHWEIKERT. Okay.
    Ms. BRANDT [continuing]. As to how it works. But currently 
the way it works is that the Part D sponsors have formularies 
which have approved drugs on them, and as patients present, 
they see if the drugs that they are looking to receive, that 
are being prescribed to them, are off of that formulary. And 
then they determine whether or not, based on CDC prescribing 
guidelines, they meet the appropriate dosage amounts.
    Some of what the GAO was saying, we have been working to 
incorporate into our Overutilization Monitoring System to 
determine that beneficiaries are not prescribed beyond what are 
acceptable levels in the program.
    And so, using those types of criteria and screening, it is 
then determined what is appropriate to be able to authorize to 
be paid under the person's plan.
    Mr. SCHWEIKERT. For our other witnesses--and thank you for 
that. Any other thoughts, that if I came to you--in reading the 
testimony, it looks like we are doing a much better job in our 
data collection and data modeling and finding bad actors.
    Okay, now that we have the data, how do you move to a 
solution? Is it alternative pharmaceuticals? Is it a 
standardization of the red flashing light for the pharmacy or 
the doctor, saying, this doesn't need to be filled? You have 
the data; what is the next solution, what is the next layer?
    Mr. CANTRELL. One of the things that we are recommending 
and continue to monitor is the beneficiary lock-in program that 
has now been authorized and CMS is working to implement. With 
the number of beneficiaries at risk because of the volumes of 
prescriptions they are receiving, I think this data analysis 
leads us to patients that maybe should be considered for this 
type of lock-in, at least gets us started as to where to focus 
these efforts, and that will help manage the care of these 
individuals who need services.
    Mr. SCHWEIKERT. All right.
    Ms. CURDA. We didn't acknowledge that issue specifically, 
but I think you can sort of take an all of the above approach, 
you can--all of these things working together can help. One 
thing we looked at, a couple of years ago, was more of a 
prevention focus. It gets very costly when it gets to the point 
where someone is addicted to opioids and requires therapy and 
treatment. It is much better to prevent the addiction in the 
first place; to the extent that we can have controls in place 
to flag these individuals who are getting very high doses, it 
is very helpful.
    But we did a--the Comptroller General held a forum that 
talked about prevention and talked about educational healthcare 
and sort of a legal kind of strategy.
    Mr. SCHWEIKERT. That is actually a very rational approach. 
In my last couple of moments, I will pitch our new Chairman, 
which I am elated to have you--I feel so tall next to you. 
There is an opportunity here for us to take a number of the 
pieces of legislation, because we know there are some 
alternative pharmaceuticals out there that actually have less 
addictive effects or more stabilizing effects.
    There is my fixation on taking the data that has been 
collected, building that standardization on the 
preauthorization so we stop--it becomes almost a preventative 
because you don't write the prescription. And the uniqueness of 
this Oversight Committee, and its charter, we have the ability 
to do legislation. Maybe it is time we all get together, figure 
out if we have solutions, bundle them together, and move 
forward.
    And with that, I yield back.
    Chairman JENKINS. Excellent. I yield to Ms. Chu for 5 
minutes.
    Ms. CHU. Thank you. Mr. Cantrell, in your testimony you 
mentioned an example of drug testing or treatment fraud in 
which sober living homeowners were bribed to direct their 
residents to a specific lab for their year-end sample 
screenings. As you noted, this resulted in fraudulent earnings 
at the expense of sober living homeowners and those residents 
who are in recovery.
    I truly appreciate the OIG's attention to this issue, as I 
have heard directly from constituents about the fraud and abuse 
that can occur in sober living facilities. And, in fact, the 
bottom line is we need better oversight, because not only are 
these bad actors preying on vulnerable individuals who have 
just left treatment, but institutions like the OIG are playing 
catch-up to find these nefarious actors, and in the meantime, 
more individuals can be hurt.
    So I believe we should be assisting those who have entered 
and completed treatment and who need support to make a full 
recovery. That is why I introduced the bipartisan H.R. 4684, 
the Ensuring Access to Quality Sober Living Act, and it would 
direct a Substance Abuse and Mental Health Services 
Administration, or SAMHSA, to develop a set of best practices 
for sober living facilities so that individuals and families 
with loved ones just leaving treatment can better identify the 
good actors from the bad.
    So, Mr. Cantrell, can you expand upon the OIG's efforts to 
address fraud and abuse in the sober home industry?
    Mr. CANTRELL. Yes. Thank you. Sober homes have become--we 
used to talk a lot about pill mills, now we have sober homes 
becoming fraud mills. These aren't services that are 
necessarily covered by Medicare or Medicaid, but they are ways 
to attract people at great risk because they are likely 
addicted--have a substance abuse disorder, need treatment, need 
services, but instead corrupt sober home owners are basically 
farming them out for either medically unnecessary services, 
treatment, or testing, or services and treatment that are just 
never provided.
    Sometimes these homes are places where individuals can 
continue to get drugs. And so we have all read about the horror 
stories of individuals going to these homes trying to get 
treatment and ultimately overdosing. So this is a problem that 
is of great concern to us. Largely, it affects us on the 
ancillary services side as they farm them out, pay kickbacks to 
doctors and drug testing labs.
    But it is also through the Healthcare Fraud Provisions 
Partnership, we know it has had an enormous impact on the 
private sector payers as well. So this is definitely a problem 
that we are noticing and we are tackling as it affects Medicare 
and Medicaid.
    Ms. CHU. Well, I thank you for pursuing it.
    And now I would like to address a question to Ms. Curda. We 
know that there is, of course, obviously, an unprecedented 
crisis, and we are going to have to find solutions that work 
for everyone, and that is why I believe we should be expanding 
our treatment options for a vulnerable population to include 
alternative medicines like acupuncture.
    Acupuncture has been the subject of numerous studies by the 
National Center for Complementary and Integrated Health and the 
National Institutes of Health, and it has been found to be 
nonadditive, noninvasive, and can be good for conditions like 
migraines, hypertension, chronic pain, or arthritis.
    And, in fact, no less than 13 independent studies on the 
effectiveness of acupuncture are referenced in NCCIH's web page 
on acupuncture. At a time when there is an over prescription of 
opioids, I believe that we should be opening our doors to 
alternative treatments like acupuncture. And that is why I 
introduced H.R. 2839, the Acupuncture for Heroes and Seniors 
Act, which would ensure that qualified acupuncturist services 
are covered through Medicare.
    It is currently available for individuals who receive their 
health insurance through the Affordable Care Act in States like 
California, as well as in some Medicaid plans, but seniors 
should not lose out.
    So, Ms. Curda, has the GAO ever studied the impact of 
making acupuncture available through traditional Medicare 
plans?
    Ms. CURDA. No, I don't believe that GAO has done that work.
    Ms. CHU. Is it possible for GAO to evaluate the 
effectiveness of offering integrative health alternatives like 
acupuncture to opioid prescribing practices and government 
healthcare programs? Do you foresee any hurdles in such an 
examination?
    Ms. CURDA. Yes. I think GAO could look at that question. 
The hurdle would be the sort of status of the literature and 
evidence in that area. We would probably want to first do a 
review of the literature to see, you know, what does the peer-
reviewed literature say about the effectiveness of that 
treatment. And we could certainly describe, you know, what that 
evidence lays out.
    Ms. CHU. Thank you.
    Chairman JENKINS. Mr. LaHood is now recognized for 5 
minutes.
    Mr. LAHOOD. Thank you, Chairman Jenkins. And it is an honor 
to be part of this Subcommittee and Full Committee, and I 
appreciate the opportunity to have this subject matter before 
us today. And I want to thank the witnesses for your valuable 
testimony here today.
    I represent a district in central and west central Illinois 
that is a rural district, 19 counties. And this is an epidemic 
that continues to rage in a district like mine. And it really 
transcends socioeconomic--all socioeconomic categories, rural, 
urban, and all sectors of society. And over the last 2 years, I 
have held a number of roundtables in my district with first 
responders, law enforcement, judges, treatment center 
providers, and physicians, to try to understand the issue 
better, but also look at how we, from a public policy 
standpoint, what we can do to fix this problem.
    And as I look at the numbers in Illinois, data from 2016 
shows that, in a 3-year period, deaths from overdose increased 
by 44 percent from 2013 to 2016, and over 80 percent of those 
deaths were attributed to opioids. Of those 80 percent of 
opioid-attributed deaths, there was a 70 percent increase from 
those attributed from opioids in that same 3-year period.
    In Adams County, in my district, they have seen a 360 
percent increase in emergency department visits related to 
opioid and heroin overdoses over that 5-year period from 2010 
to 2015. Additionally, the county saw a 300 percent increase in 
overdose mortality rates due to opioids and heroin in the same 
period.
    And looking at what is the solution, obviously, we have 
looked at--from a law enforcement perspective, what do we need 
to do on the criminal justice side? Also looking at how you 
hold doctors accountable, and what we do in that space. We have 
talked a lot about, you know, how we have more resources and 
money for treatment centers.
    And in some ways, when we look at this epidemic and the 
direction we are going, I equate it in some ways to what drunk 
driving was in this country 25 years ago. It was raging out of 
control, so what did we do? We allocated resources, we raised 
awareness, we had a public campaign, and we also had something 
called Mothers Against Drunk Driving that was organic that 
started.
    So I don't necessarily think this is a Federal solution, 
this is going to be solved in Washington, DC, and that we have 
to work with our local stakeholders in our different States and 
local areas that are doing a lot of good work on this. And so 
when I think about the testimony here today, Mr. Cantrell, I 
wanted to ask you, you talked a little bit about prescription 
drug monitoring systems.
    In terms of States that have done a pretty good job on 
that, can you talk about examples of that, which have kind of 
been a model for how to do it, and what they have done to be 
successful?
    Mr. CANTRELL. The OIG hasn't completed any work on 
evaluating PDMPs across the country. But in just talking to our 
staff across the country, our special agents, and hearing from 
individuals who work in different States, there are a couple of 
things that need to happen, I think, to make a PDMP successful.
    One, it has to be--there needs to be some sort of 
requirement that data be entered in a timely fashion. I think 
that, for those that are successful, there is timely data 
entry, there is timely review of that data. Sometimes there 
needs to be interoperability. Some of these PDMP systems don't 
talk from State to State, and we see many fraud schemes, of 
course, that cross State lines.
    So the States that have interoperability with their 
neighboring States, that is a plus. And then we have seen, in 
terms of data access, for us in law enforcement, some States 
restrict access for law enforcement, and other States allow 
that sort of access. From my perspective, of course, I believe 
in that law enforcement access to help identify those 
individuals who may be prescribing or doctor shopping in 
seeking to divert drugs. So those are some of the components of 
what I think can make up a successful PDMP.
    Mr. LAHOOD. And is there an example or a model you can 
point to that has done a pretty good job around the country?
    Mr. CANTRELL. I just heard anecdotally that, as Kentucky 
got started, they were doing a pretty good job; they are one of 
the earlier ones that I was hearing about. I have heard that 
the State of New York, from our agents, is doing a pretty good 
job, but I don't have any data or any statistics to point to 
their success or favor. That is just anecdotally what I have 
heard from some of our agents.
    Mr. LAHOOD. Thank you.
    Chairman JENKINS. Mr. Crowley is recognized for 5 minutes.
    Mr. CROWLEY. I thank the Chair, I thank the Ranking Member 
for holding this hearing today on what has become a devastating 
epidemic for our Nation. My district, like many other districts 
across the country, has been ravaged by the opioid epidemic. 
More Bronx residents die of drug overdoses--more Bronx 
residents died of drug overdoses in 2016 than any other New 
York City borough.
    Out of the 308 overdose-related deaths, 85 percent involved 
opioids generally, and 76 percent involved heroin or fentanyl. 
This devastation is unaccepted anywhere. But there is an aspect 
in my district that is notable, part of the opioid epidemic 
when compounded with other parts of the country.
    The increase in prescription opioids across the country has 
led to a spike in heroin use, which people turn to for a more 
potent high as they run out of their prescription medications. 
Heroin has become even more accessible and cheaply available to 
communities across the country.
    In a community like mine, which is still recovering from 
the aftermath of the failed tough on crime tactics of the 1980s 
and 1990s, residents have not properly dealt with their 
addictions and are more likely to use and abuse newly available 
heroin. That makes opioid-related overdoses a side effect of 
the race-based drug enforcement policies of the past.
    As we work to address the opioid epidemic, I encourage this 
Administration and my colleagues in Congress to work toward a 
more holistic approach that focuses on treatment rather than 
punishment. And I challenge all of us to strive for a better 
understanding of the entirety of the epidemic, which impacts 
different communities on different levels.
    Urban communities, particularly communities of color, must 
be a part of this conversation, and they must be a part of the 
solution to this terrible and growing problem.
    Mr. Cantrell, in the OIG report, Opioids and Medicare Part 
D, there are concerns about extreme use and questionable 
prescribing, and it suggests that prescribers are not checking 
the State prescription drug monitoring databases, or these 
databases do not have current data.
    Can you explain how prescribers are trained or are supposed 
to be trained on how to use their State prescription drug 
monitoring database?
    Mr. CANTRELL. I am sorry, but I don't actually know the 
training requirements for the use of these prescription drug 
monitoring programs. And I would suspect it might vary from 
State to State.
    Mr. CROWLEY. Do you have State-based data on where there 
are vulnerabilities of prescriber use of prescription drug 
monitoring databases?
    Mr. CANTRELL. We do not at this time.
    Mr. CROWLEY. Thank you. What are HHS-OIG's recommendations 
for improving prescriber use of these databases?
    Mr. CANTRELL. Education is certainly one strong component. 
And we, along with the DEA, who goes around the country talking 
to pharmacists and prescribers, participated in these events to 
train and educate individuals in the community about the 
importance of this tool and the fraud schemes that they should 
be looking out for when utilizing these tools. So I think 
education is critical.
    And I, once again, this is not based on any analysis that 
we have done, but I have just heard there are some barriers to 
utilization because it can take a long time to access these 
PDMPs as they are providing patient care.
    I have heard from individuals in the community that 
sometimes just the nature of the system can, maybe it is slow, 
and it can deter you. So I think that obviously any 
improvements that can be made to increase the timeliness of 
these sorts of data checks would be critical to ensuring 
adoption and use.
    Mr. CROWLEY. I think there is one critical area in terms of 
government that can be involved in helping to get a handle on 
what is happening in each of the States. And I would hope that 
we would have a more robust addressing of the monitoring 
databases.
    Mr. Cantrell and Ms. Curda, does the OIG or GAO look at 
race as a factor in collecting data regarding the opioid 
epidemic?
    Mr. CANTRELL. We do not.
    Ms. CURDA. We have not looked at that.
    Mr. CROWLEY. Well, thank you. And I appreciate your time 
here today.
    Thank you very much. I yield back.
    Chairman JENKINS. Mr. Bishop, you are recognized for 5 
minutes.
    Mr. BISHOP. Thank you, Madam Chairman. Thank you to the 
panel for being here today and providing your valuable 
testimony. I appreciate the information that you shared and 
your expertise.
    I am from the State of Michigan. I share all the same 
concerns that the rest of the Committee has on this subject. 
Each of us has our own stories to tell. Over and beyond the 
direct impact on families and individuals who are impacted by 
this scourge of opioid abuse, there is another statistic that I 
find alarming.
    The American Enterprise Institute recently published a 
study looking at the cost of the opioid epidemic. And it did it 
by State. And I was astounded to see that in Michigan, where I 
am from, my home State, the cost of opioid addiction is over 4 
percent of our State's GDP. And yet I look at other States on 
this table that we have been provided, and it shows other 
States that have also been impacted, but not to the extent that 
other States have.
    There is a huge disparity in how much other States have 
been impacted. For example, the White House Council of Economic 
Advisors, it estimates the societal burden to fight the 
fatalities from opioid overdoses, and also estimated the 
nonfatal cost of the opioid epidemic in 2015 to be $72.3 
billion, and the fatal cost to be $431.7 billion. And then you 
look at the State by State, and you see the huge disparity.
    And I am wondering, why does it cost West Virginia, which 
has the highest per capita burden at $4,793 per resident? And 
then you look at Nebraska, which is $465 dollars per resident. 
Why is that? Are there more resources there? Is there some kind 
of demographic there that is more susceptible to this? What 
causes this kind of data?
    Can someone tell me that? Mr. Cantrell.
    Mr. CANTRELL. Just in terms of what we see, what we focus 
on, fraud trends, you know, there is a variety of factors, but 
we definitely see that once a fraud scheme takes root, it 
becomes viral in communities. And that is no different, I 
think, than in the opioid epidemic. And our agents, 
unfortunately, in the Detroit area, see numerous fraud 
investigations related to illegal opioid distribution. And 
sometimes we are told that it is an export area. So that those 
drug schemes are meant to often export those drugs to other 
States where they can get higher reimbursement.
    So this is the intelligence, you know, we hear from the 
ground. Once again, I don't have any analytics available to 
point to reasons why one State is different than the other, 
but, you know, we have continued throughout my career, my 20-
year career, certainly to see South Florida as a hotspot or an 
epicenter of healthcare fraud in general. It has also been a 
point where we have seen lots of fraud related to opioids. 
Certain communities where this has taken root, it is hard to 
get rid of it once it has taken root.
    Mr. BISHOP. But you can identify those areas, those 
demographics where this kind of abuse and fraud happens. You 
have indicated that you have an opioid abuse and fraud program 
that you administer. Can you tell us how that works and what 
the resources are? Who is in charge of it? What is your mission 
in that organization?
    Mr. CANTRELL. So, that is a new unit, established by the 
Attorney General just last year. As it was initiated, they 
rolled out 12 prosecutors in 12 districts around the country to 
focus specifically on this epidemic. And as a partnership, FBI, 
OIG, DEA, we all dedicated agent resources to those 
prosecutors.
    Now, that is just a small, at this point in time, kind of 
effort in comparison to the total effort nationwide in this 
area, but it is an important focus in areas that were not 
necessarily the bigger markets that had the greater resources. 
We focused on smaller markets in these first 12 districts to 
bring resources to various communities that hadn't necessarily 
seen the amount of resources in the past.
    Mr. BISHOP. Thank you for that. You also mentioned there 
were private sector partners as well. I am interested to know 
what the private sector is doing to partner with you.
    Mr. CANTRELL. So we talked, and CMS is an integral part of 
the healthcare fraud prevention partnership, but it provides a 
community of private sector payers, State agencies, as well as 
Federal payers and law enforcement to share, first of all, 
information about trends and schemes, but, also, it is a forum 
where they can safely share data from different resources, 
analyze that data, and come up with answers or identify issues 
across multiple data sources that were previously available to 
be searched across.
    So I think, for me, it is certainly of great value in 
learning about these schemes, because some of these schemes, 
like the sober home scheme that was discussed earlier, I was 
hearing about it from our private sector partners before we 
were seeing it impacting Medicaid or Medicare. And so it is a 
great intelligence tool.
    Mr. BISHOP. Okay. Thank you so much. And I yield back.
    Chairman JENKINS. Mr. Meehan is recognized for 5 minutes.
    Mr. MEEHAN. Thank you, Madam Chairman. I am grateful for 
you allowing us to sit in on this very, very important issue. 
And I want to thank you for the work that you are doing, each 
of the panelists, engaged in what is a remarkable challenge for 
all of us, and particularly back in our communities.
    I want to ask specific questions about the Medicare 
relationship to this, but in my own region of southeastern 
Pennsylvania, we have seen a staggering 83 percent increase in 
drug deaths. That is overwhelming. And when you look at what is 
driving that, the distinguishing issue appears to be fentanyl, 
but it is fentanyl which is tied to its use with, oftentimes, 
opioids. And I know we are dealing with a poly-drug 
environment, and there is no simple solution.
    But if we are going to have an impact on this, we want to 
start by dealing with the opioid abuse in the first place. We 
have worked on some programs here in Congress with things that 
we have done already that have come from recommendations from 
people like you. One of those is the Medicare lock-in. And I 
have listened to each of the panelists describe in various ways 
how individuals have been able to utilize the system, either by 
going to multiple pharmacists, or multiple doctors, or multiple 
plans to get the drugs. And still staggering, that even with 
Medicare, we are talking about people who are later in life--
often, not all the time--but later in life, and we are still 
talking about dependency in that group.
    So the lock-in program, as I understand right now, Mr. 
Cantrell, would allow us to have a designated distributor and a 
much better control over that individual's relationship. Now, 
there have been recommendations and utilization by numbers of 
plans, but CMS itself, or at least the government, hasn't 
created it. Can you tell me where we are on that, where you 
think lock-in may be utilized?
    Mr. CANTRELL. Well, first, I will say we are very 
supportive of lock-in, but I think I would like to defer to my 
colleague from CMS to talk about where it stands.
    Mr. MEEHAN. Is this Ms. Brandt?
    Ms. BRANDT. Yes.
    Mr. MEEHAN. Because I was going to go to you next because 
you----
    Ms. BRANDT. No problem.
    Mr. MEEHAN [continuing]. Mentioned that in your testimony.
    Ms. BRANDT. I am happy to. As I mentioned in my testimony, 
we really appreciate this, this additional tool from Congress. 
We agree with the OIG. We think this is going to be a very 
powerful tool. We are currently in the notice and comment 
period for this. We have to promulgate regulations to implement 
it. In fact, the comment period closed yesterday, so that's 
good timing with the hearing today.
    But we are looking forward to reviewing those comments and 
then implementing those comments as we do the final rule. And 
then, beginning in 2019, we will be able to begin using this 
tool. And we are very excited at the potential that it is going 
to add to our suite of tools to help us address these types of 
issues.
    Mr. MEEHAN. How do you think it is going to make a 
difference?
    Ms. BRANDT. Well, it will make a difference because it will 
allow us, as you said, to limit. We will be able to limit a 
beneficiary to a pharmacy and be able to have them at one 
pharmacy. And that is the only place, or however it works out 
for implementation--we are still working all that out--but 
essentially, they could be limited to one pharmacy, which would 
allow us then to be able to see their billings just related to 
that pharmacy. Right now, they can go to multiple pharmacies, 
multiple prescribers. This limits the scope of that much more 
narrowly.
    Mr. MEEHAN. Okay. If you know, because I am sure the 
comments have come from a variety of places, but I am assuming 
you have been monitoring this as we have been going through the 
comments. Have there been any observations which have 
influenced your thinking on this or any kind of a perspective 
that was shared in the comment period that either opens up a 
new place for us to consider the program or a concern that we 
may not have been thinking about?
    Ms. BRANDT. Well, as the comment period did just close 
yesterday and because it is open rulemaking, I am afraid I 
can't speak to that, sir.
    Mr. MEEHAN. Okay.
    Ms. BRANDT. But as we move forward and have things that we 
can share, we will be happy to do so.
    Mr. MEEHAN. Okay. Well, I appreciate that. May I just ask 
if anybody has a thought on one other problem that I am hearing 
quite a bit about, and it does relate to opioid abuse, but it 
is the abuse of treatment programs in certain States in 
particular, in which people appear to get treatment for a 
period of time, they go off, and there are almost finder's fees 
to get them in, and they walk out.
    And people are targeting them to get them readdicted, 
getting them back into treatment so long as there is a payer, 
they are in, then they pull them out. And some of these things 
appear almost to be scams. Is anybody looking at this issue, or 
does anybody have any thoughts? The OIG.
    Mr. CANTRELL. Unfortunately, we are seeing a great deal of 
fraud relating to the treatment side of this epidemic, where we 
need legitimate services the most.
    We discussed the sober homes where addicted residents are 
sometimes farmed out for lab testing that is either never 
provided or isn't appropriate, and they are billing thousands 
of dollars for these residents, for these tests. They are 
offered counseling, which once again is never provided or isn't 
the quality of counseling that actually these individuals need.
    And unfortunately, we are also seeing, in terms of some of 
the medication-assisted treatment, which, I think, many have 
discussed the importance of increasing access to that, we are 
seeing fraud schemes relating to this, the availability of 
these drugs that are intended to treat this crisis.
    So the fraud has followed this epidemic from source all the 
way to treatment. And that is the unfortunate thing that we are 
seeing around the country right now.
    Mr. MEEHAN. I would love to follow up more with you on 
that, but, Madam Chairman, I yield back.
    Chairman JENKINS. Mr. Blumenauer is recognized.
    Mr. BLUMENAUER. Thank you very much, Madam Chair. And I do 
appreciate our Subcommittee having this hearing. I think this 
is the first time Ways and Means has really dealt with this 
opioid crisis and the impact it has on the things that we are 
responsible for.
    I hope it is not the last. I hope that there is an 
opportunity--I think this is one thing that touches us all that 
we feel strongly about. It certainly impacts our community. It 
makes a difference in terms of employment. What is it, for one-
quarter of the women who are ineligible of being in the 
workforce, there is an opioid problem, I am told.
    I am concerned that, as we are looking at different 
therapies, different options, there is a way to focus on 
something that some of our States have done, the State of 
Washington, the State of Oregon, dealing with medical 
marijuana. And I have some material, Madam Chair, that I would 
like to place in the record that makes it clear that States 
that have worked with medical marijuana prescribe fewer pills.
    [The submission for the Record of 
Hon. Earl Blumenauer follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                                 

    Mr. BLUMENAUER. There is, on average, a 25 percent lower 
rate in terms of overdose deaths. The State that has had it the 
longest, medical marijuana, California, it is a third less. It 
is a cheaper alternative. It is not addictive, the way that we 
see with many of the opioids that have been handed out like Tic 
Tacs.
    It is an area where the public has demanded change. 
Politicians haven't brought medical marijuana to 29 States. It 
has been the public that has voted for--at least--excuse me, I 
guess Vermont is in the process of being the first State that 
does it legislatively. But this has been driven by individual 
voters. It is supported by strong majorities of the American 
public. Florida approved, in 2016, a medical marijuana program 
with 71 percent of the population.
    I would hope, Madam Chair, that we would have an 
opportunity to explore what the impacts are in terms of how 
Cannabis can prevent dose escalation and the development of 
opioid tolerance, which happens with people who are taking 
oxycodone or something like that.
    We have the opportunity to be a viable first-line 
analgesic. We have an opportunity to make a big difference with 
our veteran populations, who, sadly, we have policies in the 
Federal Government now that prevent VA doctors from even 
talking to veterans about the implications of medical Cannabis, 
even in States where it is legal.
    And I think we are missing a huge opportunity to help a 
troubled population, to cut down on the overdose deaths and 
save substantial amounts of money and, while we are at it, 
squeeze the black market, which is fueling a lot of other 
illegal activities.
    I hope, Madam Chair, that my colleagues will have a chance 
to look at the materials. It just happens to be from a 
physician, a researcher from Oregon. I hope you won't hold that 
against it, but the whole second page is documented in terms of 
justifying the points that I am making.
    This is something that we are no longer going to be able to 
avoid. The public is demanding it; 95 percent of the population 
has access to some form of legal marijuana. We have the so-
called Charlotte's Web Law, where it is a low CBD dose that is 
available for children with severe seizure disorders. But when 
you put all that together, it is 95 percent of the population. 
The American Legion has come forward saying let's research 
this, let's look at it. We are hearing from veterans that it 
makes a difference.
    Last month I was at our VA hospital, and we were dealing 
with this precise subject of opioid addiction. And I happened 
to raise, in the course of the meeting, I said we ought to be 
looking at medical marijuana and the impact it has. When I 
walked out of the room, I was followed by a veteran who was on 
the staff, who took my hands and said, ``I am glad you raised 
that. I couldn't survive without medical marijuana.''
    I think we are missing the boat if we don't dive into this. 
And I would commend this to my colleagues for their attention. 
Thank you very much.
    Chairman JENKINS. Mr. Reed is recognized for 5 minutes.
    Mr. REED. Thank you, Madam Chair. And as I was listening to 
some of the exchanges, I wanted to take a moment before I got 
into my prepared questions. My colleague from Washington asked 
about the work requirements for Medicaid, potential issues, and 
somehow that impacts substance abuse providers. And one of the 
things that it reminded me of is often Medicaid, and I know it 
is not the jurisdiction of this Committee, but Medicaid's--I 
seem to get the impression--goal of providing insurance 
coverage is the only metric that a lot of folks here in DC 
gauge its success by.
    By that I mean getting people into Medicare programs, 
therefore, they have health insurance and, therefore, our job 
is done. But I think we can do better than that.
    And, Ms. Brandt, I think your response to that question 
illustrated CMS' point of view that we can go beyond just 
insurance coverage and actually get to making people healthier. 
And so one of the questions I have for you when I want to 
understand the work requirements that are being proposed is: if 
someone is in treatment for drug addiction, I look at drug 
addiction as a disease. It is a medical-related situation. That 
individual, to me, is not an able-bodied individual as those 
work requirements I have advocated for over the years would 
envision.
    If someone is seriously addicted and in in-patient-type 
treatment, is it CMS' position that that individual is able 
bodied as we are trying to define it under the proposed work 
requirements that are being discussed across the country today?
    Ms. BRANDT. Thank you for your question. I am not sure I 
can specifically answer our definition of able bodied because, 
again, the work requirements are outside of the realm of what I 
deal with day-to-day, but I can tell you, as I mentioned 
before, that our goal is to make sure that States have steps 
that they are taking to ensure access to appropriate treatment 
services, particularly for those who have substance use 
disorders or opioid disorders.
    So if there are people with addiction issues, our goal is 
to work with the States to ensure that they are providing 
access to those services and that they are giving appropriate--
--
    Mr. REED. If that addiction is a disease and that prevents 
them from being able bodied, I would hope that our official 
policy position would be that that is not who we are addressing 
with our work requirement.
    The other issue that I would raise on this that I am so 
passionate about, is one of the things that I hear from our 
employers across the country. One of the barriers to 
reemployment--which is empowering to individuals, employment, a 
job, an opportunity, does a lot for, not just earning their 
paychecks, but for their soul and their dignity and mental 
health and their physical health--is being addicted to drugs; 
not being able to pass a drug test.
    So we have a program under Medicaid or Medicare that is 
trying to address opioid addiction; does that not help us to 
try to solve the overall issue, when it comes to the example 
for Medicaid, in regards to getting people empowered to be put 
back into the workforce by getting their addiction under 
control and having the goal of, not just insurance coverage for 
those individuals, but also the services and the treatments 
necessary to get them into a healthy position, which removes 
that barrier to reemployment that I am discussing here today.
    Would you agree with that?
    Ms. BRANDT. Well, as I mentioned, our number one goal is 
the beneficiary. Our goal is to make sure we are getting the 
right treatment for the right people at the right time, to help 
get them to be as able bodied and productive as possible.
    Mr. REED. I appreciate that. And I share that commitment. 
And I hope our policies here at the Federal level achieve that, 
as we set them into a potential future course.
    Now to my more prepared remarks. You know, one of the 
things that I have seen, as all of my colleagues have seen 
across this country, is that opioid addiction is something that 
knows no barriers. It impacts everyone. It doesn't delineate, 
you know, how much money you have, what kind of family you were 
raised in, what race you are, whether you are a man or a woman. 
Addiction is that demon that knows no boundaries, in my humble 
opinion.
    And I am reminded of Vanessa, who we were able to assist 
through our office in the district, who was pretty much written 
off. Her parents pretty much adopted the tough love approach. 
And Vanessa came to us just recently after going through some 
very difficult times. And working with her parents, we were 
able to get her into a rehab situation. And her parents and her 
reunited, and at a town hall they were able to declare that she 
was opioid-free. That is a success story.
    And so when I see the new programs that are coming out of 
CMS--I know I only have 24 seconds left--the Overutilization 
Monitoring System shows that we went from 29,000 in 2011 down 
to 11,000 in 2016, for at-risk beneficiaries. That is a 
significant improvement. How are we going to enhance and 
promote that type of program even further and get that into the 
system?
    Ms. BRANDT. Well, we are continuing to constantly update 
that Overutilization Monitoring System. Most currently, we 
updated it to reflect the newest CDC guidelines. We have been 
very much focused on first-time opioid over-utilizers. And in 
fact, we have seen a 77 percent reduction in those since 2013, 
and we are continuing to use the work of our colleagues at GAO 
and the OIG and their recommendations to further refine our 
approach.
    Mr. REED. I appreciate that. And to all the Vanessas out 
there, I just say we stand ready across both aisles to join 
hands to serve their needs and address their addiction to get 
them into that healthy life.
    With that, I yield back.
    Chairman JENKINS. Mr. Curbelo is recognized for 5 minutes.
    Mr. CURBELO. Thank you, Madam Chairman, for this 
opportunity. And I thank all the witnesses. I am from South 
Florida, so regrettably, I have to raise the issue of 
healthcare fraud in this context, given that, unfortunately, we 
are known throughout the country for that issue.
    Mr. Cantrell, can you describe some of the types of fraud 
schemes that you see out there related to opioids? And if you 
have any examples that are specific or relevant to South 
Florida, I would appreciate those as well.
    Mr. CANTRELL. The fraud schemes, unfortunately, in many 
cases, we see them migrate from South Florida to other parts of 
the country. We found it to be a place where fraud schemes are 
born, in some instances. I know you know this, but that 
continues to be an important area for our work in healthcare 
fraud. But in terms of opioid-related fraud, it runs the gamut.
    We have seen situations where we have bad prescribers who 
are receiving kickbacks, who would write opioid prescriptions 
and also write prescriptions for other noncontrolled, high-
expense drugs and get paid a kickback by a pharmacy. The 
pharmacy will dispense the opioid and never dispense the 
expensive drug, keeping all the profit that is paid by Medicare 
for that drug that was never even dispensed or medically 
necessary. That is one very egregious scheme.
    We have seen examples of physicians who have gone into 
business with known criminal networks, outlaw motorcycle gangs, 
for the sole purpose of illegally distributing Oxy's and 
pairing up with known drug dealers. Sometimes we call them 
marketers or patient recruiters. In this case, in this area of 
fraud, they are simply pairing up someone who wants the drug 
with a pharmacy who is willing to get the drug for a kickback 
in most of these situations.
    In some of these cases, this overprescribing leads to 
overdoses, and, unfortunately, sometimes an overdosed death for 
those who have been overprescribed. And so these schemes are 
not unique to South Florida. These are par for the course, and 
we are seeing these types of schemes around the country.
    Some of the things that we have seen in places like South 
Florida and New York are schemes related to HIV medications, 
which are very expensive. And so we have individuals who have 
HIV, need the medication, but are willing to, in essence, sell 
it back to a pharmacy for a kickback or sell it on the black 
market for a profit.
    So schemes like this, whether they are related to opioids 
or other expensive noncontrolled drugs, are certainly present 
in South Florida, but also in other areas of the country.
    Mr. CURBELO. And do you think that government is doing 
enough to mitigate this, to address this? Do you think that law 
enforcement has the resources to pursue these types of cases?
    Mr. CANTRELL. I will say that I don't think we have the law 
enforcement resources to address all the complaints that we 
have coming through our system. So there is more fraud out 
there than we are certainly able to address, given our 
resources. So what we do is utilize the data that we have 
available to us to maximize the use and the impact of the 
resources that we have.
    So we focus our efforts in places like South Florida, 
whether it is South Florida or somewhere in Indiana, wherever 
the highest impact or the most impactful fraud schemes are, 
where there are potentially patients at risk or where there is 
certainly lots of money being stolen, we will focus those 
resources, utilizing data and also intel from the street, if 
you will, allowing traditional law enforcement methods to focus 
on the right areas.
    There is, I think, more that we can certainly all do. And 
we have discussed some recommendations for CMS and identified 
many areas where they are going to improve their monitoring in 
this area, but it is a huge, enormous issue that requires 
resources and focus from a lot of different agencies.
    Mr. CURBELO. Thank you very much for that response. And I 
would just encourage all of my colleagues--we focus on the 
victims of opioid abuse, and we should because they are the 
ones suffering, but I think we also have to shine the light on 
the criminals and find a way to put a dent in all of these 
fraudulent schemes and operations that really open the door for 
so many vulnerable Americans to this type of addiction.
    So I thank you, and I hope that we can begin in South 
Florida, just a place where a lot of these schemes begin, that 
perhaps we can begin solving the problem there.
    I appreciate it.
    Chairman JENKINS. Mr. Paulsen is recognized for 5 minutes.
    Mr. PAULSEN. Thank you, Madam Chair, for putting this 
hearing together and for our witnesses today.
    We have all heard the stories of tragedies of opioids that 
are impacting real people. These are real families and very 
heartbreaking stories of addiction and death. It is no 
different in Minnesota. I mean, in 2016, the most recent year 
of data that we have, we have seen a 12 percent rise in opioid 
deaths over 2015. So Minnesotans are suffering through this 
epidemic as well, like so many other States.
    And one of the challenges that we have seen and had is that 
the theft of opioids from either pharmacies or even from 
people's trash has been occurring, where it is a problem due to 
outdated disposal techniques or information about how to 
properly dispose of opioids. So many people are now simply 
throwing them away and thinking nothing of it. Safe home 
disposal of unused and unwanted medications is one of the ways 
or tools to prevent theft and abuse from inappropriate access 
to these painkillers or prescription painkillers.
    We know that many people, including younger people, in 
particular, start on this path to addiction and overdose by 
stealing medications that are prescribed to others. So we have 
a company in Minnesota that I toured not long ago, Vertitech, 
that makes a very low-cost, easy-to-use, safe disposal bag that 
properly and completely disposes of opioids, patches and pills. 
It is a little different than going to a senior fair that I 
have hosted where maybe the Hennepin County sheriff comes in 
and they have a proper disposal technique or facility that is 
filled immediately with seniors who come in and dispose of 
their medications.
    So Ms. Brandt, let me just ask you, is CMS considering ways 
to help encourage Medicare and Medicaid beneficiaries to 
dispose of unused and unwanted medications as part of a more 
comprehensive strategy to confront this epidemic that we have? 
Or are you aware of the role that these drug deactivation bags 
can have in this space?
    Ms. BRANDT. Well, one of the interesting aspects of my job 
is that I get to meet with and talk to a lot of people. And as 
I mentioned earlier, one of the things we did last fall was 
have a number of stakeholder meetings. And as part of one of 
those stakeholder meetings, this topic came up, and there was 
actually quite an active discussion about the disposal of 
drugs. And one of the things that we talked about was the types 
of bags that you are describing and how effective those can be 
in environments.
    We also have heard from CVS, Walgreens, and several of the 
other pharmacies about ways that they have been doing things 
within their pharmacy networks to encourage that. So at CMS, 
one of the things we have been looking at is how we can partner 
with our partners at CDC, the Drug Enforcement Agency, and 
others to really work to educate beneficiaries about the safe 
disposal of opioids and other types of drugs and the full range 
of tools available to them to dispose of them.
    Mr. PAULSEN. That is great. I would encourage you to stay 
in touch with us or Members of Congress, obviously, to support 
this work that you are doing now around the safe medication 
disposal strategies that you are looking at, and certainly to 
partner with you. If there are any opportunities to do that, 
please let us know.
    Ms. BRANDT. Absolutely. It is always helpful for us to hear 
about the strategies that you all are seeing in your 
communities and then have that dialogue. And we will definitely 
keep in touch.
    Mr. PAULSEN. Thank you, Madam Chairman. I yield back.
    Chairman JENKINS. I recognize Mr. Kelly for 5 minutes.
    Mr. KELLY. Thank you, Madam Chair. And thank you all for 
being here.
    I think Mr. Reed hit on a lot of different aspects about 
the personal involvement that we all have. And knowing too much 
about it because of going through things personally. And the 
quote that is out there or the saying that says ``where we are 
all involved, we are either dependents or codependents.'' But 
what I wonder about is, I mean, this started, this war on drugs 
actually started back in 1970 with the opium wars, with 
President Nixon. And I think in the early 1970s, with President 
Reagan. Mrs. Reagan said to ``just say no'' and Mr. T said 
``just say no.''
    So I don't think it has been for a lack of concern, and it 
certainly hasn't been for lack of dollars that we have spent. I 
am in the automobile business. I don't want people to confuse 
what I am saying here. I am just saying that we do have the 
ability to track so many things.
    I mean, if you were to come into the dealership today and 
ask me about a car, I can tell you the complete warranty 
history on that car, everything that has been done to it. The 
question then becomes, if we have this ability, why aren't we 
able to incorporate it with people who prescribe drugs? And 
maybe it is because of the HIPPA Act, I don't know, but we have 
so much technology out there today that allows us to really get 
an in-depth look at who it is that we are talking about, what 
they are prescribing, and who is getting the benefits of this.
    So, Mr. Cantrell, I have heard from many healthcare 
providers who were frustrated with the HIPPA law that prevents 
their ability to coordinate care for substance disorder 
patients that are frequent fliers of their emergency 
departments.
    If the law were amended to allow care coordination, does 
HHS have a sense of how much Medicare, Medicaid, and private 
plans, that cost would go down? There is a tremendous--the 
totality of this is just overwhelming. And I think sometimes we 
get confused. If we could just throw more money at it, we could 
get it fixed. We have thrown so much money away and seen 
nothing but an increase. Is there a better way to use this data 
and to coordinate it?
    Mr. CANTRELL. We don't have any estimates of the impact of 
that sort of change, but I absolutely agree that there are more 
opportunities to utilize this data to more effectively manage 
this issue, this crisis. And for Medicare, we have fairly good, 
strong data related to opioid prescribing.
    In Medicaid, it is an area where we still lack visibility 
across the country, and it inhibits, we think, CMS' ability to 
oversee the Federal dollars that go out to Medicaid that relate 
to this opioid crisis, and it doesn't allow us to get a handle 
on the scope of the problem in Medicaid without going, in 
essence, State to State.
    There is a system that CMS is working on to improve the 
access to that Medicaid data, and we think, as they continue to 
improve that data and get timely, full, complete data from all 
50 States, we will have--I don't know what we will see, but it 
will be enlightening as we do the same kind of analytics that 
we are doing in Medicare against the Medicaid.
    Mr. KELLY. I guess that is where I am coming from. Because 
I mean, and I really, I look at the private sector. I mean, if 
you wanted to--again, I am going to go back to what I do. If 
you wanted to find out if a car that you were looking to buy 
was ever involved in an accident, you go to the Carfax, and we 
have all seen this on TV. Why can't we go and find out exactly 
where the problem is? It just has to be there.
    These are prescriptions. And I see the numbers, and we have 
all this tracking of everything we have done, yet we can't 
coordinate it. We can't put the two together to help the people 
that really need it the most. And look, I know it is about the 
money. There is no question. What a huge economic model this 
is. And again, because I am too personally attached to it, it 
is not spending more money. We keep thinking that the idea is 
to spend more money. I think if we are spending more money, it 
is probably going to have to do with personnel, people like you 
that handle these things, that never quit on this. This is not 
a nine-to-five job. This is 24 hours a day that we all worry 
about it.
    I think the frustrating part, when we can separate 
ourselves from this, first of all, there is a huge loss for 
human beings. There is a huge loss in dollars that are being 
wasted because we can't connect the dots. We can't combine the 
information. I just don't know why we can do it so easily in 
the private sector with things that are just inanimate, but we 
can't do it where we are, when we are talking about human 
beings, being able to touch them, get them together and 
actually getting to know how we could serve them. And I don't 
know how much more it would cost because I think we don't have 
enough boots on the ground to see it.
    The other thing is this waste, fraud, and abuse; it is 
incredible what is happening on our watch right now. I wouldn't 
care what the cost was if it was actually going to help a 
patient or a person. I just think it is so sad that we are in a 
situation right now. And the President has declared it a 
national emergency. Pennsylvania has declared it a national 
emergency. We started in the 1800s knowing what the problem 
was. We have gone through this whole process. We are no closer 
to the answer today than we were way back in the opium wars.
    And I think that is the saddest part of it all. Where has 
it led? It is not because of the lack of investment or the lack 
of concern. How do we get to the point where we can actually 
connect this stuff so we don't have to worry about Vanessas or 
Jims or Bills or Marys that are out there today? It is just a 
tremendous loss in human potential and taxpayer cost.
    I thank you so much. Madam Chair, I thank you so much. And 
listen, what you are doing is incredible. I can tell you, I 
coached children's sports a lot in my life. I can't tell you 
the number of times I have been in a funeral home looking at 
some young person in a coffin, and around the room were 
pictures of them when they played for me at the Penn Street 
Cardinals or they played for me at our Little Marlins team. And 
I look at that, and I think, ``what happened to that little 
boy, what happened to that little girl, that they reached this 
point in their life.'' I think it is just so tragic. And it is 
not about the money. It is about the results.
    Please let's find a way to put this together so we can 
track it the right way. Thank you so much. I know I am way over 
my time, but I will tell you what, this is overtime. This goes 
back to the 1870s. And if we are no closer to a cure today than 
we were then, what was the whole purpose and the exercise? 
Thank you for staying on this and not giving up.
    Chairman JENKINS. Mr. Rice is recognized for 5 minutes.
    Mr. RICE. Thank you, Madam Chairman.
    I got a call from a friend of mine a couple of weeks ago 
about his daughter who had been arrested, and she had drugs on 
her person and is probably going to jail. I knew this young 
lady growing up. She grew up with my children. She played with 
my children. She is a fantastic, bright young lady who has 
just, her life is spiraling downward.
    And I read these statistics on South Carolina. Do you know 
the number of deaths from opioid abuse have doubled in the last 
3 years? They surpassed traffic deaths a couple of years ago. 
The national statistics say opioid deaths killed 60,000 people 
last year, which is significantly more than if you combine 
homicides and traffic deaths nationally.
    So, and if you look at the graph, I mean, it goes from flat 
to straight up. It is not leveling off. We haven't peaked. It 
is just accelerating. So whatever we are doing, clearly it is 
failing. We are not doing enough.
    I look at how you, you know, what you guys do is try to 
track where there are problem users and attack that, or problem 
prescribers and attack that, but that is not working. I look at 
your definitions just from this hearing summary today that you 
consider a beneficiary at risk if they receive a daily dose of 
greater than 120 milligrams, get prescriptions from four or 
more providers, and fill prescriptions from four or more 
providers. Good grief. Good grief.
    I mean, clearly, if you have those three conditions 
combined, that is obviously a huge problem. In 2016, despite 
your efforts, despite these programs that you have put in 
place, you tell us a beneficiary in New Hampshire received 134 
prescriptions for opioids from one prescriber, including 13 
months of OxyContin, that is 80 milligrams; 13 months of 
OxyContin, 60 milligrams; 13 months of OxyContin, 40 
milligrams; 14 months of oxycodone, 30 milligrams; and 13 
months of fentanyl patches. You guys didn't catch that? Good 
grief. Whatever you are doing is not working.
    A beneficiary in Washington, DC received prescriptions for 
opioids from 42 different prescribers and filled them at 37 
different pharmacies in a year. In a single month, this 
beneficiary received 2,330 pills from prescriptions written by 
just one prescriber. And we didn't catch that? You know, it is 
just overwhelming and depressing that we are so bad at this.
    One problem I see is what Mr. Kelly was referring to a 
minute ago, is the inability of the Federal Government to bring 
itself into the modern age of technology. I know, talking with 
folks on the IRS in this Subcommittee, talking with folks in 
Social Security, that they are still using Cobol and Fortran in 
a lot of their stuff, and they are using computers that have 
magnetic tape and all that, where everybody else left that 
behind, you know, decades ago.
    The IRS has 52 points of failure where only one person 
knows how to program these old computers. And if this person 
dies or retires, they don't know what they are going to do. Is 
CMS in that condition? Is CMS in such a bad shape, such a bad 
shape that it is impossible for them to accumulate and 
interpret the data that we are talking about?
    Ms. BRANDT. Well, we made numerous strides at CMS over the 
past several years, and particularly in the past 2 years, to 
really try to become more modern with our data.
    As Mr. Cantrell mentioned, one of the big developments that 
we have, which is going to go a long way toward helping us with 
having more of a full picture, is that we were seeing 
comprehensive Medicaid data from all of our States.
    One of the challenges we have----
    Mr. RICE. What does that mean when you say----
    Ms. BRANDT. That means----
    Mr. RICE. You said you will soon have comprehensive 
Medicaid data from all of our States. That is a fascinating 
statement right there. What does that mean?
    Ms. BRANDT. Let me demystify it for you. That means at the 
current point in time we have over 46 States and our goal is to 
have all 50 States----
    Mr. RICE. We have 50 States.
    Ms. BRANDT. Yes. We have 46 out of the 50 States that are 
currently reporting in their Medicaid data. We are working with 
the other four States to get all of that data in. And once we 
are able to have all of the States reporting in data in a 
consistent format, then we will be able to use that data to do 
more of the data analysis----
    Mr. RICE. Okay. Can you do that by regulatory requirement, 
or would that require some legal, some legislation?
    Ms. BRANDT. This is all within our authority. We are using 
our regulatory authority to do that.
    Mr. RICE. And basically, you are going to say ``if you 
don't meet these benchmarks by this date, we are not going to 
pay for the prescriptions anymore,'' I hope?
    Ms. BRANDT. Well, that's true with part of this on the 
Medicaid side. And then on the Part D side of the house, 
Medicare Part D side, we work with the plan sponsors, who are 
the ones who actually receive the data.
    Mr. RICE. So have you given them benchmarks and set forth 
the timelines by which they have to meet those benchmarks?
    Ms. BRANDT. On the Medicaid side, we have. We have been 
working with them. They have deadlines they have to meet. And 
we are working with them to ensure that they are meeting those 
reporting deadlines.
    And on the Medicare Part D side, we consistently work with 
the plans to issue updated guidelines to make sure that they 
are reporting to us with as accurate information as possible.
    Mr. RICE. So what does that mean? That you haven't given 
them the guidelines?
    Ms. BRANDT. No, we have, but we update the guidelines on an 
ongoing basis. So, for instance, we just issued----
    Mr. RICE. Are you getting the Medicare Part D information 
from all 50 States now?
    Ms. BRANDT. Well, that comes from the plan sponsors, not 
from the States. So the States provide us with Medicaid data, 
which is for drugs that are covered under Medicaid----
    Mr. RICE. Okay. So from the plan sponsors, are you getting 
information----
    Ms. BRANDT. Yeah.
    Mr. RICE [continuing]. From all 50 States?
    Ms. BRANDT. Well, the plan sponsors operate in all 50 
States, but they, themselves, are the frontline. They are the 
ones who provide the point-of-sale data.
    Chairman JENKINS. The gentleman's time has expired.
    Mr. RICE. All right. I just want to ask one quick question. 
I know I am over time. Just one quick question.
    Mr. Cantrell, is there any legal impediment to you 
gathering this information from all 50 States? Because if there 
is, we need to fix that. What is that legal impediment, if 
there is one, and how do we fix it?
    Mr. CANTRELL. There is no legal impediment. Given the 
progress that has been made at CMS for doing this, it might not 
make sense for us to independently do it separately.
    So we are hoping to leverage CMS' effort to collect this 
data in all 50 States, but in order to do our work and do it 
independently, we have and continue to get data directly from 
the States----
    Chairman JENKINS. Thank you, Mr. Cantrell. Thank you, Mr. 
Rice. The gentleman's time is expired.
    I would like to recognize the distinguished Member from 
Washington, Ms. DelBene, for a request.
    Ms. DELBENE. Thank you, Madam Chair. Congressman Lewis, the 
Ranking Member of this Subcommittee, was unable to join us 
today. And I would just like to ask unanimous consent to enter 
his opening statement into the record.
    Chairman JENKINS. Without objection, so ordered.
    [The submission for the Record of Hon. Suzan DelBene 
follows:]

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    Chairman JENKINS. I would like to thank our witnesses for 
appearing before us today. Please be advised that Members have 
2 weeks to submit written questions to be answered later in 
writing. Those questions and answers will be part of the formal 
hearing record.
    With that, the Subcommittee stands adjourned.
    [Whereupon, at 11:46 a.m., the Subcommittee was adjourned.]
    [Questions for the Record follow:]

 
    
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