[Senate Hearing 115-677]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 115-677

                  TACKLING OPIOID AND SUBSTANCE ABUSE
                    DISORDERS IN MEDICARE, MEDICAID,
                      AND HUMAN SERVICES PROGRAMS

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

                                HEARING

                               BEFORE THE

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             APRIL 19, 2018

                               __________                                 
                                     

            Printed for the use of the Committee on Finance
            
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                    U.S. GOVERNMENT PUBLISHING OFFICE                    
37-709 PDF                  WASHINGTON : 2019                     
          
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                         COMMITTEE ON FINANCE

                     ORRIN G. HATCH, Utah, Chairman

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

                     A. Jay Khosla, Staff Director

              Joshua Sheinkman, Democratic Staff Director

                                  (ii)
                            
                            
                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Hatch, Hon. Orrin G., a U.S. Senator from Utah, chairman, 
  Committee on Finance...........................................     1
Wyden, Hon. Ron, a U.S. Senator from Oregon......................     3

                        ADMINISTRATION WITNESSES

Giroir, Adm. Brett P., M.D., Assistant Secretary for Health and 
  Senior Adviser to the Secretary for Mental Health and Opioid 
  Policy, Department of Health and Human Services, Washington, DC     8
Brandt, Kimberly, Principal Deputy Administrator for Operations, 
  Centers for Medicare and Medicaid Services, Department of 
  Health and Human Services, Washington, DC......................     9

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Brandt, Kimberly:
    Testimony....................................................     9
    Prepared statement...........................................    45
    Responses to questions from committee members................    57
Giroir, Adm. Brett P., M.D.:
    Testimony....................................................     8
    Prepared statement...........................................    45
    Responses to questions from committee members................    57
Hatch, Hon. Orrin G.:
    Opening statement............................................     1
    Prepared statement...........................................   121
Heller, Hon. Dean:
    Letter from Albertsons Companies et al. to Senators Bennet 
      and Heller, April 19, 2018.................................   122
McCaskill, Hon. Claire:
    Homeland Security and Governmental Affairs Committee minority 
      staff reports..............................................   124
Wyden, Hon. Ron:
    Opening statement............................................     3
    Prepared statement with attachments..........................   165

                             Communications

Alliance for the Treatment of Intractable Pain (ATIP)............   189
American College of Osteopathic Family Physicians (ACOFP)........   198
Becker, Kristi...................................................   201
Bransfield, Robert C., M.D., DLFAPA..............................   202
Center for Fiscal Equity.........................................   203
Clark, Kathleen M................................................   206
Coalition of 50 State Pain Advocacy Groups.......................   209
Efaw, Carol......................................................   211
Huber, Sonya.....................................................   212
Ibsen, Mark, M.D.................................................   213
O'Keefe, Cherri..................................................   218
Polson, Elizabeth................................................   219
Smith, Amanda....................................................   220
Tyrell, Reese....................................................   221

 
                  TACKLING OPIOID AND SUBSTANCE ABUSE
                    DISORDERS IN MEDICARE, MEDICAID,
                      AND HUMAN SERVICES PROGRAMS

                              ----------                              


                        THURSDAY, APRIL 19, 2018

                                       U.S. Senate,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 10:04 
a.m., in room SD-215, Dirksen Senate Office Building, Hon. 
Orrin G. Hatch (chairman of the committee) presiding.
    Present: Senators Roberts, Cornyn, Thune, Isakson, Portman, 
Toomey, Heller, Cassidy, Wyden, Stabenow, Cantwell, Nelson, 
Menendez, Carper, Cardin, Brown, Bennet, Casey, Warner, 
McCaskill, and Whitehouse.
    Also present: Republican staff: Brett Baker, Health Policy 
Advisor; Jennifer Kuskowski, Chief Health Policy Advisor; Ryan 
Martin, Senior Human Services Advisor; and Stuart Portman, 
Health Policy Advisor. Democratic staff: Joshua Sheinkman, 
Staff Director; Laura Berntsen, Senior Advisor for Health and 
Human Services; Anne Dwyer, Senior Health-care Counsel; 
Elizabeth Jurinka, Chief Health Advisor; and Matt Kazan, Health 
Policy Advisor.

 OPENING STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM 
              UTAH, CHAIRMAN, COMMITTEE ON FINANCE

    The Chairman. The committee will come to order.
    I would like to welcome everyone to today's hearing on 
tackling opioid and substance abuse disorders in Medicare, 
Medicaid, and human services programs.
    I feel compelled to start with news that we all wish was 
untrue: more than 60,000 Americans died from a drug overdose in 
2016--60,000. The majority of these overdoses involved 
prescription opioids or illicit opioids like heroin or 
fentanyl. These numbers are more than mere statistics. They 
represent our constituents, our friends, and our loved ones.
    My home State of Utah continues to be hard hit. An alarming 
number of Utahans have undergone hospital stays and emergency 
room visits due to opioid overdoses. In 2016 alone, over 450 
Utahans died from an opioid overdose.
    Americans across the country recognize the challenges posed 
by the epidemic and are fighting against it. President Trump 
and Secretary of Health and Human Services Alex Azar have made 
tackling the opioid epidemic a top priority, and I look forward 
to working with them to advance policy solutions.
    Congress continues to support States and communities in 
their efforts and has a record of working in a bipartisan 
manner to identify solutions that can have a meaningful impact 
for struggling individuals and families. I was pleased to work 
with Ranking Member Wyden and other members of this committee 
to lead an effort that makes significant strides to address the 
opioid epidemic: the Family First Prevention Services Act, 
enacted last February.
    This bill will provide States with access to funds to help 
families with substance abuse disorders and allow more children 
to stay safely with their families instead of being placed in 
foster care.
    I am also pleased that Congress wisely opted to build on 
the foundation of the Family First Prevention Services Act in 
the March omnibus law by providing States with additional funds 
to ramp up these services immediately. This will allow States 
to develop more evidence-based services that will make a real 
difference in the lives of families affected by substance use 
disorders.
    The Federal Government cannot solve this crisis alone, but 
my hope is that we can work together to ensure that our Federal 
programs, such as Medicare, Medicaid, and human services 
programs, are innovative and responsive to the needs of 
Americans with chronic pain or opioid use disorders.
    My ranking member, Senator Wyden, and I have successfully 
partnered to make numerous recent improvements in health care. 
And I really appreciate him for this. He has been a great 
partner, and I have really enjoyed working with him.
    We worked together to realize a 10-year extension of the 
Children's Health Insurance Program. We pushed through a 
package of policies, known as the CHRONIC Care Act, that 
improve Medicare for beneficiaries with chronic conditions.
    I would be remiss if I did not point out that none of these 
accomplishments would have been possible without the bipartisan 
engagement of members on this committee.
    Identifying policies to evaluate and improve the Federal 
response to the opioid epidemic will be no different, and the 
success of these efforts will depend upon bipartisan, 
committee-wide support.
    Today, members will have an opportunity to speak with two 
of the administration's leading experts on opioid-related 
policies about how Medicare, Medicaid, and human services 
programs can adapt and be improved to address the crisis, and 
what this administration and Congress can do to save lives 
together.
    It is my hope that members take advantage of this hearing 
and the expertise of our two witnesses to drill down into 
policies that are likely to garner bipartisan support to help 
this committee advance its long record of working together 
collaboratively. Anything less would be a missed opportunity to 
help individuals, families, and communities across the Nation.
    In fact, through outreach to stakeholders and soliciting 
input from each member of the committee, we have already 
identified areas of potential bipartisan support. These include 
the need to evaluate access to and utilization of non-opioid 
treatment options for managing pain, enhancing data-sharing to 
promote appropriate health-care interventions and strengthen 
program integrity, and ensuring evidence-based care is 
available for patients to identify and treat opioid use 
disorders.
    In closing, my view is that the committee must do all it 
can to prevent and relieve opioid-related suffering by 
implementing effective policies in Medicare, Medicaid, and 
human services programs. We have a unique opportunity to do so 
in the near term.
    [The prepared statement of Chairman Hatch appears in the 
appendix.]
    The Chairman. We will hear the ranking member's thoughts on 
this momentarily, but I do hope that he agrees on the need to 
work toward bipartisan solutions that would add to the 
committee's long list of bipartisan health-care 
accomplishments. And I am sure he does.
    The witnesses will get a proper introduction shortly, but I 
would like to briefly say a few words before I have to attend a 
Judiciary Committee markup. I apologize.
    First, I would like to welcome Dr. Brett P. Giroir. His 
recent appointment as Secretary Azar's point person on opioid 
policy speaks highly of his capabilities. I am grateful that 
the Finance Committee will be the first congressional committee 
to hear from him in this capacity.
    I am also delighted to have CMS's Kim Brandt appear before 
the committee today.
    Ms. Brandt likely needs no introduction to my fellow 
committee members, as she served as a senior member of my staff 
for 6 years before assuming the role of Principal Deputy 
Administrator for Operations at CMS last year. I am very proud 
of her.
    I would like to quickly say that, while I certainly gave my 
blessing to Ms. Brandt before she moved on to a CMS leadership 
role, it was really difficult for me to see Kim go. She is the 
greatest person.
    I ask that you all indulge a point of personal privilege to 
allow me to explain why. I no longer get those uplifting visits 
from her puppy, Sherlock. [Laughter.]
    Senator Wyden. And the cookies.
    The Chairman. Yes.
    Senator Wyden. Oh, here they come.
    The Chairman. And those incredible cookies and other 
goodies.
    I do not want this to take away from your expertise. 
[Laughter.]
    She frequently provided all these to members and staff. 
They are much harder to come by now, I have to say. [Laughter.]
    But I am glad to know that Kim is helping to steer the ship 
at CMS. Truly, it could not be in better hands. As we all know, 
Kim served this committee and all of us members of this 
committee on both sides of the aisle with great distinction. I 
am glad to have her here today.
    And with that, I would like to recognize my friend--who has 
worked so well with me and whom I have such great respect for--
the ranking member, for his opening statement.

             OPENING STATEMENT OF HON. RON WYDEN, 
                   A U.S. SENATOR FROM OREGON

    Senator Wyden. Mr. Chairman, thank you. And I know your 
time is short.
    I will just make a couple of points. First, I want to thank 
you for the comments about the bipartisanship. And we are 
definitely going to continue that as we tackle this opioid 
issue.
    I have said to friends in town meetings, if somebody had 
said in January of 2017--in a very polarized Congress--that we 
would get the Children's Health Insurance Program reauthorized 
for a decade, we would transform the foster care system in 
America under Family First, we would begin the transformation 
of Medicare from being an acute care program to a chronic care 
program while updating the Medicare guarantee, Mr. Chairman, if 
somebody had said that was doable in January of 2017, they 
would have been accused of hallucinating. People would have 
said there was no way that this could happen.
    And it took place under your leadership, under your 
chairmanship. I very much appreciated that it allowed us----
    The Chairman. With your help.
    Senator Wyden. Well, we incorporated values from both 
sides. And I want it understood that we are going to work on 
this issue in a bipartisan way as well.
    The Chairman. Right. That is great.
    Senator Wyden. Let me make a comment on an important point 
that many Senators have brought to my attention, and that is, I 
do think it is long past time to get the opioid executives 
before the committee, have them raise their right hands, and 
hold them accountable for their role in creating a public 
health calamity that is killing tens of thousands of Americans 
each year.
    Some years ago, I participated in a House hearing where a 
panel of tobacco executives said under oath that their products 
were not addictive. In my view, there is a clear parallel you 
can draw to the opioid issue today.
    Back then, it was tobacco executives who concealed the 
dangers of their products and denied they were addictive. Now 
it is the opioid companies--including those that manufacture 
the drugs and those that distribute the drugs--that have misled 
the country about the dangers of their products.
    The opioid executives, however, have avoided the spotlight 
that Congress put on the executives of the big tobacco 
companies.
    Colleagues, we have colleagues and friends now from both 
sides of the aisle who are saying that has got to change. The 
executives need to be brought before this committee that pays 
for so much of American health care and be held accountable.
    Flooding American communities with these drugs is big, big 
business. And so-called safer opioid pills have just kept the 
cash registers running. Congress would be derelict in its 
responsibilities if it pretends there is no profit motive or 
corporate scheming behind the addiction crisis.
    In 2015, more than 52,000 Americans died of a drug 
overdose. And I am glad the chairman touched on those 
statistics, because it increased to 64,000 in 2016, and in 2017 
it was 71,000. There is a tragic and well-documented pattern of 
opioid addiction escalating into abuse of heroin and fentanyl.
    Now, an even stronger narcotic called carfentanil is 
spreading. Carfentanil is supposed to be used, colleagues, as a 
sedative for elephants. It is so potent and dangerous, first 
responders apparently around the country have to run around in 
hazmat suits when they are around it. That is the horrifying 
level of danger plaguing our communities as a result of this 
epidemic.
    So on a bipartisan basis, we have already begun the work to 
find answers. And when you get into this, you deal with the 
paradox that cutting down the supply of opioids, depending on 
how you do it, could drive even more people to heroin and other 
drugs, leading to even more overdose deaths. That is obviously 
nothing that any member of this committee could possibly want.
    With that said, I want to stress, as Chairman Hatch has, 
that we have a big-time opportunity for bipartisan action. And 
I am going to touch on just a couple of issues that have been 
important to me. And at the top of my list is addressing what I 
have come to call the prescription pendulum.
    Doctors used to be criticized for prescribing too 
conservatively. Now they are criticized, and I believe fairly, 
for prescribing too much. There has to be a practical approach 
that really meets the needs of our people and strikes a 
responsible balance.
    For me, this all began back in the days--and Chairman 
Roberts has heard some of these stories about the Gray 
Panthers. I ran the legal aid program for the elderly, was 
director of the Gray Panthers. And I remember a fellow called 
and said his 92-year-old dad was in pain and could not get a 
prescription. His father was 92, and the doctor said, ``No, no, 
no, I am not going to prescribe for pain because the risk of 
addiction is too great.'' Compare that with the fact that today 
one in three Medicare patients has a prescription for opioids.
    And of course--I see my friend Senator Isakson--this has 
been part of our effort on chronic care, our bipartisan effort 
on chronic care.
    I have also heard, more recently, agonizing stories from 
parents at home who have lost kids to the epidemic.
    At one of my roundtables, I met Kerry Strickland, who lost 
her son Jordan to an overdose. Jordan was a star athlete in the 
tiny Columbia River town of Knappa. When he suffered an injury, 
he was prescribed opioids, and I guess he may have gone to a 
party, gotten involved with some of his friends, and he started 
using heroin. And for years, he struggled in the battle between 
addiction and recovery.
    Colleagues, I know we have a lot of athletes here. I went 
to school on a basketball scholarship. I was too small, and I 
made up for it by being slow. [Laughter.]
    But nobody, nobody, who threw out their knee--and I think 
Dr. Cassidy, I am sure, knows more about it--back when I was 
coming up suddenly became addicted to painkillers. That was 
unheard of, just unheard of.
    And I am sure my colleagues are all hearing these stories.
    So as Chairman Hatch noted--and I want to come back to it--
we can come up with bipartisan proposals to help make a 
difference. The chronic care legislation that the chairman 
mentioned, I have mentioned, which Senator Isakson joined me 
on--we were kicking off and hardly anybody figured it had a 
chance--began literally to transform Medicare from being an 
acute care program to being a chronic care program, which is 
where most of the money is now being spent.
    And Senator Isakson deserves an enormous amount of credit, 
as does the chairman, because we made it a bipartisan process. 
We can do that again.
    I am looking at the three colleagues on my side here. 
Senator Stabenow has worked hard on this. Senator McCaskill--
nobody has worked harder on the opioid issue than Senator 
McCaskill, in terms of investigating the crisis, holding people 
accountable. So we have colleagues here.
    And I do not want to overlook the fact that I see 
colleagues on the other side of the aisle who have also put in 
a lot of time on this.
    So we can address these issues in a bipartisan way. And I 
think particularly important for us is the vital role that 
Medicaid plays in treatment. Four out of 10 working-age 
Americans suffering from an opioid addiction rely on Medicaid. 
It is the largest source of funding for treatment in the 
country, so it is going to have to be a key part of a solution.
    As the chairman noted, the Family First legislation 
provides a real tool to deal with the epidemic. Family First is 
about keeping the families together wherever you can.
    So under this law--and let us just make sure everybody 
knows what it means for opioids--if a parent is swept up in 
opioid addiction, a grandparent could, for example, step in to 
care for the youngsters while mom or dad got the treatment they 
needed. It would provide support for both the parent's 
treatment and services for the relatives. The end result: you 
have a family that can stay together.
    And now we are in the period where we will be working with 
the Department. We have two of their representatives here to 
help the States to prepare for the major reform.
    But Chairman Hatch and I are determined to see this 
Federal/State partnership through so that Family First gives us 
a fresh new tool for fighting back against opioid addiction and 
keeping the families together in the process.
    Last point: a warm welcome to our witnesses. All of us have 
enjoyed Ms. Brandt's cookies. And that has been referenced. But 
I want it understood that we very much appreciate her 
professionalism. Virtually everybody on this committee has had 
a good experience late at night struggling to try to put 
together the details on an important piece of domestic 
legislation.
    So, Ms. Brandt, Dr. Giroir, we welcome both of you.
    [The prepared statement of Senator Wyden appears in the 
appendix.]
    Senator Wyden. And I guess the Kansans are in charge of the 
committee now, huh?
    Senator Roberts [presiding]. It is a coup. [Laughter.]
    Senator Wyden. All right.
    Senator Stabenow. Is this the Ag Committee? No?
    Senator Roberts. It is a coup.
    I would like to associate myself with the remarks, the 
bipartisan remarks and approach we have to this problem, stated 
by my colleague and friend from Oregon, who did start out in 
Kansas.
    Senator Wyden. My roots. [Laughter.]
    Senator Roberts. And I would like to read the statement by 
the distinguished chairman, Senator Hatch, and to extend a warm 
welcome to our two witnesses here today.
    Our first witness today will be Dr. Brett Giroir, who was 
confirmed by the Senate by a voice vote--something that rarely 
happens--just 2 months ago in February and is currently serving 
as our Assistant Secretary for Health in the Department of 
Health and Human Services.
    Dr. Giroir's confirmation hearing was not in this 
committee, but we are pleased his appointment as Secretary 
Azar's opioid policy lead brings him before us today.
    Prior to his current position, Dr. Giroir was a physician, 
a scientist, and also an innovator. He is a former medical 
school executive, biotech startup CEO, and served in a number 
of leadership positions in both the Federal Government and also 
in academia.
    The rest of Dr. Giroir's professional career is far too 
long to describe here. He is quite a gentleman, but let me 
include just a few highlights.
    He chaired the Veterans Choice Act Blue Ribbon Panel in 
2014 and 2015. He directed the Texas Task Force on Infectious 
Disease Preparedness responses during the Ebola emergency. He 
was CEO of Texas A&M's Health Sciences Center from 2013 to 
2015. He directed DARPA from 2006 to 2008.
    Dr. Giroir has authored or coauthored almost 100 peer-
reviewed scientific publications and holds patents on a number 
of biomedical inventions.
    He holds a bachelor's degree in biology from Harvard and a 
medical degree from the University of Texas Southwestern 
Medical Center in Dallas.
    I am grateful, and I know all the members of this committee 
are, that this committee will be the first congressional 
committee to hear from him in his capacity as Senior Adviser to 
the Secretary on Mental Health and Opioid Policy.
    I am also delighted to have CMS's Kim Brandt appear before 
the committee. I was going to say that we used to refer to CMS 
as ``it's a mess,'' but she has certainly done her best to make 
it ``CMS.'' So we will forget about that remark. [Laughter.]
    Kim also has a lengthy list of credentials. She is 
currently serving as the Principal Deputy Administrator for 
Operations of the Centers for Medicare and Medicaid Services. 
Prior to that, she was here with all of us, serving as the 
Chief Oversight Counsel on the majority staff from 2011 to 
2017. Just prior to that work, Kim was a senior counsel at 
Alston and Bird--so you know Bob Dole--after working for 7 
years as the CMS Director of the Medicare Program Integrity 
Group.
    Prior to that, Kim worked for 5 years at the HHS Office of 
Inspector General as Special Counsel and Director of External 
Affairs.
    Kim holds a bachelor's degree from Valparaiso University, a 
master's degree in legislative affairs from George Washington 
University, and a J.D. with a concentration in health law from 
the DePaul School of Law.
    So, talk about two very qualified witnesses.
    Without further ado, let us get to the meat of this very 
important hearing.
    Dr. Giroir, would you please get us started?

      STATEMENT OF ADM. BRETT P. GIROIR, M.D., ASSISTANT 
 SECRETARY FOR HEALTH AND SENIOR ADVISER TO THE SECRETARY FOR 
               MENTAL HEALTH AND OPIOID POLICY, 
    DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Dr. Giroir. Yes, sir, Senator Roberts. Thank you so much 
for that introduction.
    And I want to first thank Chairman Hatch, Ranking Member 
Wyden, and all the members of the committee for holding this 
important hearing.
    The opioid epidemic is the most pressing public health 
challenge of our time. The data are staggering. Each year, 
nearly 12 million Americans misuse opioids. According to the 
latest CDC statistics, each day 125 Americans die of opioid 
overdoses, predominantly caused by heroin and illicit synthetic 
opioids like fentanyl.
    Behind these statistics, I always see the individual 
patients--always--because I am a pediatric critical-care 
physician by training and fully feel the pain of needless 
suffering and death.
    Last week, I met a remarkable woman named Missy Owen. Four 
years ago, Missy learned that her precious son Davis had been 
found dead in his car due to a heroin overdose. Davis was 
president of his senior class, hall of fame in his high school, 
an honor student, and a community volunteer. But his journey 
with addiction began with use of opioids from the family 
medicine cabinet to address his difficulty sleeping.
    Missy's story is just one example of why the Department has 
made this crisis a priority and is committed to solving it 
through our five-point strategy: first, strengthen public 
health data reporting and collection to inform real-time 
responses; second, advance the practice of pain management to 
decrease the inappropriate use of opioids; third, improve 
access to prevention, treatment, and recovery services; fourth, 
enhance the availability of overdose-
reversing medications; and fifth, support cutting-edge research 
that improves our understanding of pain and addiction, leads to 
new treatments, and identifies effective public health 
interventions.
    Regarding public health data, the CDC currently provides 
funding and scientific support to equip States with tools to 
track and report opioid overdoses and deaths and to implement 
comprehensive prevention programs. States also utilize CDC 
funding to enhance their prescription drug monitoring programs, 
which are an increasingly powerful tool to ensure safe 
prescribing practices and share information from multiple 
sectors.
    CDC has received an additional $350 million in 2018 to 
enhance these initiatives.
    Improving the practice of pain management is also critical 
because, as the chairman pointed out, three of four people who 
used heroin this past year misused prescription drugs first.
    The CDC issued prescribing guidelines recommending no 
greater than 7 days of opioids for use in acute pain and the 
use of non-opioid alternatives whenever possible. This 
guideline and recent educational efforts to raise awareness 
among providers and health systems have resulted in significant 
reductions in opioid prescribing nationwide already.
    To improve access to prevention, treatment, and recovery 
support services, the Substance Abuse and Mental Health 
Services Administration, or SAMHSA, administers the State 
Targeted Response to the Opioid Crisis grants, which enable 
States to focus on areas of their greatest need.
    This program provided $485 million to States and U.S. 
territories in fiscal year 2017. And just last evening, we 
released funding for the 2018 allocation of another $485 
million to States.
    And, because of the unprecedented funding requested by the 
President and appropriated by Congress, SAMHSA will provide an 
additional $1 billion to States this year. And this additional 
billion will likely be awarded to States in September.
    CMS also has a significant role in prevention, treatment, 
and recovery, and my colleague Ms. Brandt will speak to their 
role momentarily.
    Regarding overdose-reversing agents, U.S. Surgeon General 
Vice Admiral Jerome Adams, my colleague, earlier this month 
issued the first Surgeon General's advisory in 13 years, which 
urged more Americans to carry overdose-reversing agents like 
naloxone. In addition, multiple funding streams are now in 
place to assist States, localities, and first responders to 
obtain this agent.
    Finally, HHS is supporting cutting-edge research. Dr. 
Francis Collins has recently announced the Helping to End 
Addiction Long-Term Initiative at the NIH. And as a result of 
new funding recently provided by Congress, NIH will double its 
investment in research on pain and addiction.
    In closing, the current opioid epidemic is enormously 
tragic, dauntingly complex, vastly widespread, and 
scientifically and medically challenging. This epidemic 
respects no age, no gender, no race, no socioeconomic status. 
Victims are our sons and daughters, mothers and fathers, 
brothers and sisters, leaders and colleagues.
    Solving this problem will require a whole-of-government 
approach. I look forward to working with you collaboratively. 
Thank you very much.
    Senator Roberts. We thank you, Doctor, for your most 
comprehensive statement.
    [The prepared statement of Dr. Giroir appears in the 
appendix.]
    Senator Roberts. Ms. Brandt, please.

 STATEMENT OF KIMBERLY BRANDT, PRINCIPAL DEPUTY ADMINISTRATOR 
  FOR OPERATIONS, CENTERS FOR MEDICARE AND MEDICAID SERVICES, 
    DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Ms. Brandt. Thank you. Chairman Hatch, Ranking Member 
Wyden, Senator Roberts, and members of the committee, thank you 
for inviting me to discuss the Centers for Medicare and 
Medicaid Services' work to address the opioid epidemic.
    I am honored to be back in the Finance Committee, though I 
will say it is a little strange to be on this side of the 
witness table.
    Over 130 million people receive health coverage through CMS 
programs. And the opioid epidemic affects every single one of 
them as a patient, family member, caregiver, or community 
member. This theme has been repeated throughout the multiple 
stakeholder listening sessions that CMS has facilitated to 
discuss best practices and brainstorm solutions.
    As a payer, CMS plays an important role by incentivizing 
providers to provide the right services to the right patients 
at the right time. Our work at CMS is focused mainly on three 
areas: prevention, treatment, and data.
    Due to the structure of our programs, Medicare Part D plan 
sponsors and State Medicaid programs are well-positioned to 
help prevent improper opioid utilization by working with 
prescribing physicians. Our job at CMS is to oversee these 
efforts and to make sure that plan sponsors and States have the 
tools they need to be effective.
    Beginning in 2019, CMS expects all Part D sponsors to limit 
initial opioid prescription fills for acute pain to no more 
than a 7-day supply, which is consistent with the guidelines 
issued by the Centers for Disease Control and Prevention.
    Additionally, we expect all sponsors to implement a new 
care coordination safety edit that would create an alert for 
pharmacists when a beneficiary's daily opioid usage reaches 
high levels. Pharmacists would then consult with the prescriber 
to confirm intent.
    Thanks to recent action by Congress, CMS now also has the 
authority to allow Part D plan sponsors to implement lock-in 
policies that limit certain beneficiaries to specific 
pharmacies and prescribers. CMS also recently finalized a 
proposal to integrate lock-in with our Overutilization 
Monitoring System, or OMS, to improve coordination of care.
    The administration also supports legislation which would 
require plan sponsors to implement lock-in policies.
    These new tools will add on to existing innovative efforts 
in Part D to track high-risk beneficiaries through OMS and to 
work with plan sponsors to address outlier prescribers and 
pharmacies.
    We have seen a 76-percent decline in the number of 
beneficiaries meeting the OMS high-risk criteria from 2011 to 
2017, even while Part D enrollment has been increasing.
    We also support States' efforts to reduce opioid misuse. 
Medicaid programs can utilize medical management techniques, 
such as step therapy, prior authorization, and quantity limits 
for opioids.
    In this year's President's budget, CMS proposed 
establishing minimum standards for the Medicaid Drug 
Utilization Review program, a tool that we use to oversee State 
activities in this area.
    In addition to prevention measures, ensuring that Medicare 
and Medicaid beneficiaries with substance use disorders have 
access to treatment is also a critical component to addressing 
the epidemic. Our aim is to ensure the right treatment for the 
right beneficiary in the right setting. And we are working to 
increase access to medication-assisted treatment, or MAT, as 
well as naloxone.
    The President's budget also includes a proposal to conduct 
a demonstration to cover comprehensive substance abuse 
treatment in Medicare through a bundled payment for methadone 
treatment or a similar MAT. Because current statute limits 
CMS's ability to pay for methadone, we are focused on ensuring 
access to other 
evidence-based MAT.
    The administration is committed to increasing treatment 
access for Medicaid beneficiaries as well through our 1115 
waiver authority.
    CMS announced a streamlined process last November providing 
more flexibility for States seeking to expand access to 
treatment. Already, we have approved five State demonstrations, 
which include services provided to Medicaid enrollees in 
residential treatment facilities.
    As this committee knows, ordinarily residential treatment 
services are not eligible for Federal Medicaid reimbursement 
due to the statutory exclusion to institutions for mental 
disease, or IMD. Combined with a full spectrum of treatment 
services, we believe the new residential treatment flexibility 
is a powerful tool for States. And we look forward to reviewing 
more requests.
    Finally, CMS is utilizing the vast amounts of data at our 
disposal to better understand and address the opioid crisis, to 
share with partners, and to ensure program integrity. This 
includes active monitoring of trends, sharing prescribing 
patterns through heat maps, and other various efforts to ensure 
the effectiveness of our prevention and treatment policies.
    While CMS has taken numerous steps to address this national 
epidemic, we know there is more we can do. We appreciate the 
work that this committee is doing to highlight the importance 
of addressing this crisis, and we look forward to engaging with 
you on solutions.
    Thank you for your interest in our efforts to protect our 
beneficiaries. And I look forward to answering your questions.
    Senator Roberts. Thank you very much, Kim.
    [The prepared statement of Ms. Brandt appears in the 
appendix.]
    Senator Roberts. Let us see; in the order of arrival and 
the order of being here, I think Senator Isakson--I beg your 
pardon, it is Senator Portman.
    Senator Portman. Thank you, Mr. Chairman.
    And thank you both for being here.
    Admiral Giroir, we are fortunate to have your expertise 
there. We have enjoyed working with you all on a number of 
issues.
    I want to start, if I could, talking about an issue that 
comes before this committee, which is the STOP Act. Some of you 
know this is legislation that deals directly with the huge 
challenge we face with synthetic opioids coming into our 
country. We know it is coming mostly from China. We know it is 
coming mostly through the U.S. mail system.
    Our Permanent Subcommittee on Investigations did a year-
long study of this. In fact, earlier Senator McCaskill was 
here, who is very involved in that. Senator Carper is the co-
chair of that effort and very involved with it.
    Senator McCaskill. I am still here.
    Senator Portman. We reported back in January something 
shocking, alarming, which is that, if you go online and ask 
about opioids, people say, fine, we are happy to sell you 
synthetic opioids, but we will send it through the U.S. mail 
system, because it is going to get there without any concern 
because the U.S. mail system, unlike the private carriers, does 
not require the advanced electronic data that helps law 
enforcement to identify these packages.
    Sixty percent of the people who died in Ohio of overdoses, 
in the most recent data we have, died of fentanyl overdoses--
carfentanil, fentanyl, other synthetic opioids.
    The county that comprises Columbus, OH just came out with 
their report from last year, showing a 47-percent increase in 
overdose deaths; two-thirds of those were related to fentanyl. 
This is a huge crisis.
    And it is amazing to me that we are allowing our United 
States Post Office to be able to continue not to provide law 
enforcement the data they need to go and find that needle in 
the haystack.
    We introduced this legislation back in February of 2017. It 
has 32 cosponsors, including a number of members of this 
committee on both sides of the aisle.
    And I just am frustrated, as the chairman knows and as the 
staff knows. We cannot get it out of this committee. We cannot 
report it out and get it to the floor for a vote. There is a 
companion bill in the House; it is common-sense legislation.
    Is it the ultimate answer? No. The CARA legislation, which 
Senator Whitehouse and I coauthored--Senator Whitehouse is 
here--is working on treatment and recovery and certainly 
prevention and helping on Narcan, but this is a clear and 
present danger, and we are not addressing it. We are allowing 
people to have access to this fentanyl in our communities, the 
poison is coming in, and at a minimum it would increase the 
cost if we could do more in terms of stopping it coming in from 
China through our U.S. mail system.
    So I would ask you about that.
    And, Admiral, first, are you aware of this issue? And are 
you supportive of the STOP Act? I will tell you, the Customs 
and Border Protection people are, the DEA is, law enforcement 
is. And would you be willing to help us to get this done?
    Dr. Giroir. Thank you for that question. I want to 
reinforce how critical the limitation of importation of 
fentanyl and carfentanil and similar drugs is to our fight.
    In the hospital setting, to use fentanyl would be in ICU 
and anesthesia by trained people. And the thought of this being 
on the street with its deadly potency is absolutely frightening 
and astounding.
    We would be very pleased--we work very closely with Customs 
and Border Patrol, as you know. The FDA has increased its 
enforcement capabilities and the number of import investigators 
that they have in order to stop the importation of fentanyl and 
carfentanil so it does not enter our supply.
    And of course, Senator Portman, we would be very pleased to 
provide technical assistance and to work with you 
collaboratively, because any efforts that we can do to minimize 
fentanyl and carfentanil getting on the streets will greatly 
aid our fight in prevention and treatment.
    Senator Portman. Thank you, Admiral. I hope the staff on 
this committee and the leadership of this committee hears that. 
And I just think it is one of those issues that we should be 
able, on a nonpartisan basis, to address and address quickly.
    With regard to prescribing limits, I noticed that CMS 
recently finalized their Part D call letter which sets a 7-day 
opioid prescribing limit for Medicare beneficiary patients with 
acute pain. Not talking about chronic pain, not talking about 
cancer--we are talking about acute pain.
    As you know, in our CARA 2.0 legislation--Senator 
Whitehouse, again, is here, the coauthor of that bill--we set a 
3-day limit. We do that because of the science and because of 
what CDC has told us, which is that on the fourth day is when 
there is a much higher chance of someone becoming addicted. And 
also, with regard to pain, with regard to acute pain, that 
fourth day is typically not viewed as necessary from a 
scientific point of view.
    How did you choose a 7-day rather than a 3-day limit?
    Ms. Brandt. So thank you for that question, sir. We chose 
it because it was consistent with the CDC guidelines. The 
Centers for Disease Control have a guideline that says a 7-day 
supply limit is what they recommended as the top end. We sought 
public comment on it, and the commenters supported this. And we 
were really trying to strike the right balance.
    We recognize that oftentimes 3 days or less will be 
sufficient, and that is certainly something, so we have 7 days 
as the top end. It does not mean that is what it has to be, but 
that was what we did, consistent with the CDC guidelines.
    Senator Portman. Yes. Ms. Brandt, I would ask you to go 
back and look at that CDC data and look at what they say about 
the fact that during that fourth day, remarkably, because it 
is, you know, based on science--and it might not seem common 
sense to some people--but during that period of time after 1, 
2, 3 days, there is a much less likelihood of an addiction 
during that fourth day; the sixth day there is. So I hope you 
will take another look at that and consider a 3-day limit, 
again, for acute pain.
    And by the way, someone can go back and get another 
prescription, but they have to go back and explain to the 
physician that is prescribing it why that is necessary. And you 
know, if you look at what is happening in my State and States 
around the country, almost everyone who dies of an overdose 
started with prescription drugs.
    And the ranking member, Senator Wyden, has just talked 
about this issue of just the pain of the families going through 
this with regard to prescription drugs being usually the 
gateway to the overdose and the deaths.
    Thank you both for your service. And we look forward to 
continuing to work with you.
    Senator Roberts. I thank the Senator for his very incisive 
comments.
    Senator Wyden?
    Senator Wyden. Thank you very much, Mr. Chairman.
    Let me start with you, if I could, Dr. Giroir.
    I think we all understand we have a public health calamity 
on our hands, thousands of deaths. We have spent something like 
a trillion dollars since 2000 in terms of trying to pick up the 
pieces, you know, financially.
    And I reviewed your written testimony carefully, and it 
almost suggests that the opioid epidemic happened by osmosis.
    Your written testimony completely omits the role of the 
pharmaceutical manufacturers that put a greater emphasis on 
increasing sales rather than protecting the patients. You state 
in your written testimony, quote, ``Well-intentioned health-
care providers began to prescribe opioids to treat pain in ways 
that we now know are high-risk and have been associated with 
opioid abuse addiction and overdose.''
    Now, it is hard to believe that trained physicians would 
just come up with these pervasive over-prescribing practices on 
their own. In your view, who told the physicians that these 
doses and these amounts were acceptable?
    Dr. Giroir. So, thank you for that question. What I can 
tell you is, I was part of the generation where my teachers, my 
professors told me, taught me that prescribing opioids in the 
setting of pain would not be addictive to the patients. We did 
not, within the medical culture at that time, have the 
appropriate information, nor was it transmitted.
    Pain was the fifth vital sign. Opioids were prescribed 
based on what we knew.
    I cannot tell you, sir, how this started and who is 
responsible for it. That is a question or an issue for the 
committee or other components.
    Senator Wyden. So you do not think that the fact that the 
manufacturers bankrolled patient advocacy groups and experts 
who placed an outside influence on these over-prescribing 
practices had anything to do with it?
    I have accumulated evidence showing conflicts on these 
boards. One person has actually been removed. Do you believe 
that that contributed to this problem?
    Dr. Giroir. I am not here to defend or to place blame on 
any singular group. I will say that there was a confluence of 
factors that led to this.
    Clearly, opioids were over-prescribed. They were over-
prescribed by well-intentioned physicians who believed they 
were doing the best for the patients, by other prescribers. And 
we now understand that this problem, which led to heroin and 
fentanyl, really started with prescription over-prescribing.
    Senator Wyden. We are committed here on this Committee--you 
heard the chairman and I talk about it--to being bipartisan. 
But we have to make sure we get the roots of the problem right 
so you can pull them out and get on with the correction.
    And I just want to wrap up this round, and then I have one 
question for you, Ms. Brandt.
    To me, opioid manufacturers--through twisted research, 
deceptive marketing, and bought and paid-for patient advocacy 
groups--had a significant role in fueling the crisis.
    Now, you are going to be the point person for the Trump 
team. Do you share those kind of concerns that I have 
mentioned?
    Dr. Giroir. I am doing everything, and the Department is 
doing everything we can, to limit opioid prescriptions now to 
only when opioid prescriptions are important to the patient. We 
are supporting non-opioid uses. We are supporting alternative 
care.
    So absolutely, I agree with you that opioid prescribing 
needs to be decreased. We need better science, better 
information. A key pillar of what we are doing is trying to 
decrease the unnecessary opioids.
    And again, I do mean this respectfully: how we got here and 
who was responsible, I think is a matter for the committee and 
others to ascertain.
    Senator Wyden. I want you to have the chance to respond in 
writing.
    Dr. Giroir. Yes, sir.
    Senator Wyden. Because I do not think we got here by just 
well-meaning people saying, gee, maybe I do not know how much 
to prescribe. I think there was a strategy with the opioid 
executives, and I laid it out item by item: twisted research, 
excessive hype that downplayed the harmfulness, and stacking 
these advisory committees where they could.
    So we will leave the record open.
    Mr. Chairman, if I could just get one question in for Ms. 
Brandt.
    Ms. Brandt, Medicaid is the largest payer of substance 
abuse disorder services in the country, covering four out of 10 
who suffer. In the States ravaged by the epidemic, Medicaid 
pays for nearly half of the treatments.
    Medicaid expansion is clearly going to be a major tool on 
the ground, and yet I am having trouble squaring the 
administration's commitment to expanding access to treatment 
with the President's budget proposal to drastically cut the 
program and roll back the Medicaid expansion.
    Now, we are not over here saying money is the sole answer. 
But I am going to put into the record some programs that 
dollar-for-dollar are going to make a big difference in 
Michigan and Ohio and the States where my colleagues--and 
Oregon--are fighting this epidemic. And I would just like--
because I am over my time--for you to tell us how, when you 
slash a trillion dollars in Medicaid funding for these lifeline 
programs, we are going to be able to work with the States to 
address the epidemic.
    Ms. Brandt. Well, as I mentioned in my oral testimony, we 
are really committed to working with the States to allow them 
as much flexibility as possible to use their resources to 
maximum benefit so they can provide the right treatment to the 
right people in the right setting.
    We have additional money that has been appropriated to go 
towards the opioid epidemic. The Admiral mentioned some of the 
additional grants that have just gone out. And we are committed 
to trying to continue to get as many resources to put towards 
this problem as possible.
    Senator Wyden. Thank you, Mr. Chairman.
    Senator Roberts. Senator Stabenow?
    Senator Stabenow. Thank you, Mr. Chairman.
    I am used to saying, ``Thank you, Mr. Chairman,'' in the 
Agriculture Committee. So it is nice to see you in this role.
    Welcome to both of you.
    And first, to follow up, Ms. Brandt, we could talk a lot 
about--you know, we already talked about the budget. It is 
great that we were able to get the additional dollars for 
opioid and mental health services.
    One bright light consistent in the President's budget as 
well has been the strong and consistent support for the 
Excellence in Mental Health and Addiction Treatment Services. 
And I thank you for your involvement when you were on this side 
of the table working in a bipartisan way with Senator Blunt and 
myself.
    As part of the opioid crisis, the fiscal year 2019 budget 
for the administration also explicitly endorses the Excellence 
Demonstration and proposed funds to expand the program. And you 
know this is really creating behavioral health center clinics, 
federally qualified clinics, like we do for health centers, so 
that we have permanent structures on the ground. And in the 
eight States where we are doing that now, a lot of what they 
are doing is opioid treatment. So it is a very important, long-
term way to treat this.
    So just a question. As we in the Finance Committee 
contemplate the best approaches for addressing this crisis, 
would the Secretary agree that the expansion of Certified 
Community Behavioral Health Clinics to additional States, as 
the President's budget proposes, is one important way to 
address this?
    Ms. Brandt. Thank you for the question. As you know, we 
have been very supportive of doing innovative approaches. And 
we believe that the Certified Community Behavioral Health 
Clinics are part of that innovative solution. That is why the 
budget proposal includes the extra money.
    And we think that this is an issue where no amount of 
resources, in terms of things like this where you can target 
it, can be ignored. And this is a very valuable tool that we 
think could help with this crisis.
    Senator Stabenow. Thank you. Well, I look forward to 
working with you on this.
    Let me talk specifically about a critical part of the 
question of treating people right now involved with opioid 
addiction, with possible overdoses, with what is happening. And 
this relates to the question of naloxone, and not only 
availability for police and fire and for others, as has been 
suggested, but when we talk about root causes, I just want to 
take a moment to lay out the fact that naloxone was approved by 
the FDA as an opioid overdose reversal drug in 1971--1971. 
Generic versions have been available since 1985. And for a 
while, prices were not an issue.
    In 2005, there were two manufacturers producing a generic 
version of naloxone, and it cost a dollar for a vial--$1 for a 
vial. But by 2013, both companies were selling the drug for 15 
times that amount. As the need went up, the price went up, 
which is very concerning to me.
    And in 2014, Evzio, a naloxone auto-injector, was 
introduced. They introduced an auto-injector, the first product 
approved by the FDA for use by people without medical training.
    And so what happened then? They came on the market with 
$690 for a two-pack. And the price of the generic injectable 
actually went up a little bit that year. So more need, price 
goes up. Not exactly how it should operate when it relates to 
health care and something as serious as this.
    Then less than a year later, the price of Evzio increased 
to $4,500--$4,500. In 2015, Narcan, the nasal spray version of 
the drug, also approved for use by people without medical 
training, came on the market for $150 for a two-pack.
    I just want to stress the actual drug naloxone was approved 
47 years ago. And as recently as 2005, you could get a vial for 
a dollar--a dollar. And now taxpayers, in order to support 
police and fire and medical personnel and others, are going to 
be spending thousands and hundreds of thousands of dollars in 
order to address what is an extremely concerning price 
situation and lack of accountability.
    So I just want to ask--because this month the U.S. Surgeon 
General called for more people to carry naloxone. And you can 
get it without a prescription. And so we go, over and over 
again, and we have this price now skyrocketing.
    So, Dr. Giroir, you are responsible for coordinating HHS 
efforts across the agency to fight the opioid crisis. The 
Commission on Combating Drug Addiction and the Opioid Crisis 
recommended that HHS use its negotiating power to reduce the 
prices, use the negotiating power of our government on behalf 
of our people to be able to bring prices down.
    And so I think we all want to know, will you use that power 
to negotiate what is an uncontrollable situation with no 
accountability where, frankly, I think the drug companies are 
taking advantage of the pain and suffering and loss of life in 
this situation?
    Dr. Giroir. So, thank you, Senator Stabenow. And I 
appreciate the fact that you are helping us highlight the 
importance of naloxone.
    Naloxone does not solve substance abuse disorder.
    Senator Stabenow. Correct.
    Dr. Giroir. It does not get to the root cause, but it is an 
absolutely critical drug that literally brings life back to a 
person on the brink of death. So we certainly support that.
    Let me give you an update of where we are. First of all, 
the State targeted grants that I talked about, the $485 million 
and the extra $485 million yesterday, has increased flexibility 
for the States to use more of that money as needed for 
naloxone.
    Senator Stabenow. And I am only going to interrupt, not to 
be rude, but because I am out of time.
    Dr. Giroir. Yes. Yes.
    Senator Stabenow. My question was bringing the price down. 
It is great we are using taxpayer money to pay for these 
outrageous prices. The question is, something that was on the 
market for a dollar and now we are talking about these huge 
price increases, are you going to use the authority that the 
Commission, the President's Commission, asked you to use to 
negotiate the best prices for Americans and bring the price 
down?
    Dr. Giroir. So if I could, the nasal Narcan, which is 
increasingly the choice reversal agent for first responders, is 
now fairly significantly discounted and is now to the level of 
the GSA schedule. So all States and localities are now getting 
that for $75 for the two-pack, which is consistent with the GSA 
schedule.
    Senator Stabenow. I am sorry, the chairman is telling me to 
stop.
    Dr. Giroir. Okay. Okay.
    Senator Stabenow. But I assume your answer is ``no,'' you 
are not going to be negotiating the best price, because I am 
not hearing a ``yes.''
    Dr. Giroir. So we are now getting that at the GSA schedule. 
The FDA is looking at all aspects to bring naloxone to over-
the-counter and also to increase the generic competition. So 
that is our current strategy right now.
    We have seen the price go down by over 40 percent within 
the last year.
    Senator Stabenow. Well, I would hope so. It started at a 
dollar. It started at a dollar, and look at where we are right 
now. And I think it is really outrageous what is happening and 
what people are having to spend and taxpayers are having to 
spend.
    Thank you, Mr. Chairman.
    Senator Roberts. I would just observe that the Senator 
would never advise the distinguished chairman emeritus of the 
Agriculture Committee to stop with regards to her advice and 
consent on the committee. [Laughter.]
    Senator Stabenow. Thank you, Mr. Chairman.
    Senator Roberts. Senator Cassidy?
    Senator Cassidy. Thank you.
    Thank you both for being here.
    Mr. Chairman, thank you.
    Last week, I was in Lafayette, LA and announced our Safer 
Families, Healthier Communities initiative. And I just would 
speak to folks back home. And what I learned from them will be 
the basis of my questions for you.
    I spoke to the father of a 17-year-old, a young man who 
eventually died, who when he first went into treatment was 
asked by the insurance company to be released 2 weeks after 
treatment began. The fact that he died obviously indicates that 
this was not an effective strategy.
    And then I contrast it with my next conversation, which is 
that, if you are an impaired physician in Louisiana, there is a 
minimum of 3 months' inpatient therapy then 1 month follow-up 
before you are allowed to practice once more.
    So contrast that, which is apparently effective--3 months' 
inpatient with a month of follow-up--with that which clearly 
was not, after 2 weeks they were asked to leave.
    And then lastly, I spoke to another physician who told me 
of the abuse potential of our medication-assisted therapy: 
first, that there are a certain number of people who die from 
methadone overdose, and secondly about the diversion of 
Suboxone.
    So I am going to use that and work backwards for my 
question.
    Dr. Giroir, nice to see a Louisiana guy who does well. Good 
to have you here.
    Dr. Giroir. Thank you, Senator.
    Senator Cassidy. I know how to pronounce your name, even if 
others do not.
    Let me say, as you know, there are some forms of 
medication-
assisted treatment, like buprenorphine injections and implants, 
coming onto the market. Next-gen products are provider-
administered so they never go into the hands of the patient, 
therefore cannot be diverted as I have learned that Suboxone is 
being diverted.
    Now, the law is unclear whether or not the pharmacies can 
dispense this medication directly to the provider, because 
current law says it has to go to the patient.
    Makes sense; you do not want the brother picking it up. But 
DEA has interpreted this as saying that you cannot give it to 
the provider to then do the implant and therefore avoid the 
potential for diversion.
    Senator Bennet and I have legislation in the HELP Committee 
that would address this problem. Can you go back to the 
Department and see if you can get endorsement of our bill?
    Dr. Giroir. Certainly, I will go back to the Department and 
discuss this with the Secretary.
    I want to state, certainly, that medication-assisted 
treatment is our best route going forward, in combination with 
behavioral therapy, to treat patients.
    And yes, sir, I will go back. I am not familiar with the 
specific bill, but we will go back and----
    Senator Cassidy. But we agree that there is certainly abuse 
potential for both the drugs used in MAT.
    Dr. Giroir. There is abuse potential for the drugs used in 
MAT, part of the drugs, right? So there is not so much abuse 
potential for naltrexone, which, of course, is an antagonist, 
but there is potential diversion abuse with drugs, as you 
pointed out, yes, sir.
    Senator Cassidy. Ms. Brandt, let me ask you--I have noticed 
in some localities there are less prescription opioids, but 
there is no decrease in the number of deaths from opioid 
overdose, suggesting that it is illegal drugs replacing or 
backfilling the loss of opioid prescriptions. Is that what your 
data is showing?
    Ms. Brandt. Actually, I am going to defer to the Admiral on 
that one.
    Dr. Giroir. Yes, the prescription opioids have been a 
gateway, if you will, in that three of four people who use 
heroin started that way. But clearly, the deaths now are far 
overshadowed by heroin and fentanyl.
    Senator Cassidy. In those areas that are using MAT more 
extensively, are we seeing fewer deaths related to opioids?
    Dr. Giroir. So, the data we have is that MAT is more 
effective than non-MAT in preventing death and providing long-
term recovery.
    I do not have geographic data that correlates geographic 
use of MAT with a lowering of the death rate within that 
geography. I will go back and----
    Senator Cassidy. Could you get us that?
    Dr. Giroir. Yes, sir, I will go back and see if that data 
is available. Clearly, MAT is associated with improved 
outcomes. So, you know, we would tend to believe that that is 
the case, but we need to verify that those two things go 
together.
    Senator Cassidy. I keep going back to the 17-year-old boy 
who was left, who was asked to be discharged and then is now 
dead. So something is not working.
    And, Ms. Brandt, I thought this question might be for you. 
It may not be; it may be for either of you.
    Do we have a way to track which treatment programs have 
better outcomes versus those which do not?
    If empirically I can say a physician with 3 months' 
inpatient followed up by a year of follow-up as an outpatient 
works, but being discharged 2 weeks after being admitted and 
then ultimately dying maybe does not, do we have best practices 
on this, and are we doing a proactive follow-up to see that, 
oh, yes, program Acme Rehab is doing really well, but Beta 
Rehab not so well?
    Ms. Brandt. Well, speaking for the CMS programs, we are 
starting to accumulate that type of data through our new T-
MSIS, our new Medicaid information system, through results of a 
lot of the demonstration projects we have been doing and 
through testing a lot of our new innovative models. We are 
starting to try to collect that.
    Senator Cassidy. Let me interrupt. Is T-MSIS actually 
getting populated with State data? Because my understanding was 
that States were not as aggressively populating that as they 
should be.
    Ms. Brandt. We are actually getting States. We now have 49 
States, the District of Columbia, and, as of March 26th, Puerto 
Rico actively reporting full data into T-MSIS.
    Senator Cassidy. That is great.
    I am over time. I yield back. Thank you.
    Senator Roberts. Okay. Senator Cardin?
    Senator Cardin. Thank you, Mr. Chairman.
    First, I want to concur with the comments of Senator 
Portman on the fentanyl and Senator Wyden on the misuse of the 
prescription of opioids for the management of pain, and Senator 
Stabenow's point on the costs of medicines. I think all those 
are important aspects of dealing with the opioid crisis.
    I have been around the entire State of Maryland, and we 
have opioid addiction problems in every part of our State, from 
our most rural to our most urban. And they are in desperate 
need of partnerships with the Federal Government.
    So I want to go on. I want to talk about two programs, one 
that is pretty well established and another that is becoming a 
popular option or perhaps an option. Both are impeded by our 
reimbursement structure. We do not have an integrated care 
system that reimburses for integrated care, so you have to find 
creative sources in order to deal with a lot of the treatment 
options.
    One of the more successful options in our State has been 
peer-support services, where those who are recovering from drug 
addiction help get those who are in need to the appropriate 
care center.
    We have those programs in Maryland, and they are extremely 
successful, by the way. The programs are very, very popular. 
The problem is, there is not a reimbursement structure. A lot 
of this you have to find either third-party sources to fund or 
creative ways or hospitals coming in to help us because they 
know this will reduce their emergency room traffic.
    So what I am looking for is whether we can find a way to 
encourage these types of services. So let me start with that 
first.
    What can we do at the national level either in changing our 
reimbursement structures or providing direct funding? Because 
when you look at the grant programs that are available from the 
Federal Government sources, it is really difficult to get 
support for peer-support services.
    Ms. Brandt. I am actually going to take this one, because 
this impacts a lot of the Medicare and Medicaid programs.
    Senator Cardin. Sure.
    Ms. Brandt. We agree with you that peer-support services 
are a key part of the continuum of care. One of the limits--you 
asked about what can be done--one of the challenges here is 
that a lot of these types of services are not covered or not 
considered a provider for purposes of Medicare. So broadening 
the definition of what is a Medicare provider to be able to 
encompass these types of services would give us more 
flexibility, because currently the statute does not recognize 
them as appropriate Medicare providers.
    We have seen some success with this in States. As of 2016, 
there are a few States that are covering peer-support services 
for substance use disorder in Medicaid. That is also something 
that could be encouraged more. It is in a few States right now, 
but at least on the Medicare side we would need to expand the 
provider definition to be able to better cover it.
    Senator Cardin. I look forward to working with you on that, 
because I think that is clearly a very fruitful model.
    The States that are changing it, they do not need a waiver, 
they can just do it under their current authority?
    Ms. Brandt. They can do it under their current authority; 
that is correct. To the extent that they hit roadblocks, we 
will work with them on that.
    Senator Cardin. The other area which is relatively new and 
has some concerns that it is used appropriately is 
stabilization centers that try to get individuals who are 
stressed out of the emergency rooms, where sometimes it is 
affecting access to emergency care, into a facility that can 
refer them to the proper care that they need in a more 
appropriate setting.
    We have now, I believe, two stabilization centers in the 
State of Maryland. Again, the reimbursement structure does not 
provide for this.
    Is there some way that we could try to encourage the 
appropriate placement of those who are in stress so that they 
can get referred to the appropriate care?
    Either one, whoever feels more confident.
    Ms. Brandt. That is something we could work with you on. It 
is not something that I am familiar with directly, but we could 
definitely work with you all to sort of find out more about 
that and see how we could help.
    Senator Cardin. We have had a couple of our communities, 
through the emergency room, saying that they want to take care 
of people, everybody who is in stress and in need of care, but 
there are security issues with people who are coming out of an 
overdose. That requires security, but it also compromises the 
ability of emergency rooms to do their intended purpose, and 
for these individuals, what you really need is follow-up care, 
not so much--their life is no longer being threatened, but they 
need follow-up treatment and care.
    And yes, we need more community-based centers, but we also 
need to get the individual, when we have their attention, the 
appropriate placement.
    Admiral, is there hope for an alternative to using the 
emergency rooms to deal with this?
    Dr. Giroir. We would certainly hope so. The emergency room 
is great for emergencies, but it is not so great for everything 
else. So we certainly support community-based programs. The STR 
grants we have have a large amount of flexibility for States to 
both institute programs and test programs.
    And increasingly, as you suggest, with the numbers that we 
have, with millions of Americans misusing opioids, probably 2.4 
million with substance use disorder, we are going to have to 
change the way we do things. It is going to have to be 
outpatient-based primarily, with the inpatient services 
primarily reserved for people with co-morbidities, severe 
mental illness as well as opioid issues.
    We are going to have to train more behavioral health 
professionals, not just psychiatrists, but levels all through. 
And it has to be community-based.
    And again, we are all on the same page here and would be 
delighted to work with you.
    Senator Cardin. Thank you for that. I look forward to 
removing the roadblocks that we have in the system that prevent 
communities from pursuing innovative ways, less expensive ways, 
and more effective ways to deal with those who are stressed.
    Dr. Giroir. And in my new role, if there is a roadblock, I 
want to hear about it, because part of my job is to make sure 
that HHS is listening and understanding and can be responsive 
to those needs. And I would appreciate that direct feedback. I 
mean that sincerely.
    Senator Cardin. Thank you for that. Thank you.
    Senator Roberts. Senator Menendez?
    Senator Menendez. Well, thank you, Mr. Chairman.
    Ms. Brandt, children whose families have been impacted by 
the opioid epidemic experience trauma when their family 
structure breaks down. One program that is important to New 
Jersey in helping these children is the Family First Prevention 
Services Act, which allows States to draw down funds for 
evidence-based practices, such as mental health, substance use 
treatment, parenting programs, as well as kinship navigators to 
help grandparents.
    Given that these programs span multiple HHS agencies, 
collaboration is critical to them. For instance, New Jersey has 
a Mommy and Me program that allows mothers in treatment for 
substance abuse to get inpatient treatment without giving up 
the custody of their children.
    I believe programs like Mommy and Me help avoid the trauma 
of taking children away from parents and help keep families 
intact.
    The Family First Act allows States to draw down funds 
starting on October 1st of this year, but we are still awaiting 
guidance from ACF and CMS on how to make that work.
    So my question is, can I count on you to work with ACF to 
get that guidance out in time for States like mine?
    Ms. Brandt. Certainly. I'm happy to work with ACF and with 
the Admiral to ensure that we are coordinating to get that 
guidance out.
    Senator Menendez. Okay. In your joint testimony, you talk 
about the role of Medicaid data. Some States have been able to 
take their Medicaid data and analyze it to inform their 
intervention approach.
    Given your statements about the value of Medicaid data to 
address this epidemic, do you see value in these types of 
proactive analyses?
    Ms. Brandt. Speaking for CMS, we absolutely do. In fact, as 
I mentioned in my opening statement, data is one of the three 
main components of the CMS opioid strategy. We now have 49 
States and the District of Columbia and Puerto Rico reporting 
in to our Medicaid Statistical Information System. And we are 
using all of our data across CMS and trying to use it to really 
target how we can better do prevention and treatment and really 
be able to help give feedback to States and others, working 
with their data set.
    Senator Menendez. That was going to be my second question. 
How is CMS working with States like mine to support these types 
of activities?
    Ms. Brandt. So a couple of different ways. We certainly 
coordinate with States on the data that they report on through 
their T-MSIS program. And that allows us to take out, for 
instance, the pharmacy file, which is all of the claims that 
are related to things like prescription of opioids, and really 
be able to help tell them where it is that we see patterns and 
work with their information that they get from their 
prescription drug monitoring programs, PDMPs, to be able to 
really see more detail on how we can do interventions.
    Senator Menendez. Now, I know you also mentioned the 
Medicaid Innovation Accelerator Program. Does CMS have plans to 
provide New Jersey and other States with technical assistance 
in this space?
    Ms. Brandt. We are certainly continuing to offer ongoing 
support to the States, and we think that it is something where 
we want to be able to have more technical assistance and 
technical support to provide on that program.
    Senator Menendez. Do you think additional Federal support 
would be beneficial to better support these types of 
activities?
    Ms. Brandt. We really think that we want to really support 
States' ongoing payment and delivery system reforms. And as I 
said, we are really looking to see how we continue to look at 
different program innovations in it and how we can best support 
them.
    Senator Menendez. Well, we would like to follow up with you 
on that.
    And finally, prescription drug monitoring programs have 
been helpful in curbing the flow of opioids. But according to 
the American Journal of Managed Care, PDMPs are not necessarily 
associated with a reduction in overdoses. And I think this may 
be due to the fact that individuals already addicted to opioids 
will switch to illegal narcotics as their supply of 
prescription painkillers is cut off.
    What opportunities are there to prevent an opioid addiction 
from becoming a heroin addiction?
    Dr. Giroir. Thank you for that. First of all, I want to say 
that PDMPs are rapidly developing, and I think they are a very 
important tool. And the CDC is supporting States to further 
utilize them.
    I think the next level is to not have a PDMP sit on the 
side of the equation, but be integrated in the workflow of 
physicians and other providers, which is sort of the next 
level.
    How to prevent people with opioid use disorder from going 
to heroin? It is a matter of treatment. We have to get people 
into the appropriate treatment. We have to stage them early. We 
do not want to wait until they are on heroin and fentanyl and 
come into the emergency room.
    And again, a lot of the State targeted grants and the 
technical assistance from SAMHSA are really working on that 
question specifically. But I agree with you 100 percent.
    Senator Menendez. Well, I hope what the Congress did in 
this omnibus is going to help us focus a significant part of 
that money towards that exact purpose.
    Dr. Giroir. Yes, sir. The omnibus extra billion dollars 
through SAMHSA, we expect that to be out to the States by 
September, in addition to the $485 million extra from the 
original Cures Act that was released yesterday.
    Senator Menendez. Thank you, Mr. Chairman.
    Senator Roberts. Senator Toomey?
    Senator Toomey. Thank you, Mr. Chairman.
    Ms. Brandt, welcome.
    You know, we all know Medicare is the largest purchaser of 
prescription opioids in the country. I was a little shocked to 
learn that in a typical year, 2016 anyway, one out of three 
beneficiaries received an opioid prescription.
    I am not a doctor, I am not an expert on this, but it is 
just counterintuitive to me that one out of three people needs 
to be given a drug that is so powerful and so dangerous, but 
that is the case.
    It is further even more surprising that Medicare actually 
pays more on a per-patient basis for opioids than either 
commercial insurance or Medicaid, so over $4 billion on opioids 
alone in 2016.
    So I really, really wonder about the total consumption 
levels.
    I know that Medicare and Medicaid have overutilization 
monitoring systems, and I know there has been some progress 
with respect to the people who are being tracked. But I am 
concerned that the overutilization monitoring systems are in 
fact monitoring a tiny percentage of the people who maybe 
should be monitored. And I say that because, in November of 
last year, the GAO identified 727,000 people, Medicaid 
beneficiaries, whom they believe are at particularly high 
risk--727,000.
    The OIG determined 500,000 were receiving high dosages of 
opioids for at least 3 consecutive months, and this excluded 
cancer and hospice patients. But the overutilization monitoring 
system, it is my understanding, covers something on the order 
of 60,000 to 70,000 beneficiaries. And I am wondering if the 
right number would not be 10 times as high, based on the GAO 
and the OIG reports.
    So what do you think of the number of folks who are being 
monitored compared to the number of folks who ought to be 
monitored?
    Ms. Brandt. Well, a couple of things--and I thank you for 
the question, because this is an area where we have really been 
working to improve our oversight and to see how we can address 
the OIG and GAO concerns.
    First of all, the OMS system only covers Part D 
beneficiaries, which are a subsection of our larger Medicare 
and Medicaid population.
    So, as a result of the OIG and GAO feedback, we have 
significantly strengthened and significantly improved our 
ability to do edits and oversight through the OMS system, 
which, when we re-ran at last the OIG beneficiaries that they 
had identified, enabled us to be able to show that we caught 
over 85 percent of them with our new and improved expansion of 
the system and with the additional edits that we put in place.
    We have been continuing to implement the CDC guidelines, 
our new safety edits, and a number of other coordination edits 
to really get at that. But we are looking at how we can expand 
this to cover the rest of the program.
    Senator Toomey. Could you send us the backup documentation 
on that?
    Ms. Brandt. Sure; I would be happy to do that.
    Senator Toomey. Because, from what I have seen, it looks 
like we are falling way, way short of the total goal.
    Let me go to a specific subset of folks. It is my 
understanding anyway that people who experience a nonfatal 
overdose, that that experience alone is not a sufficient 
criteria for being part of the overutilization monitoring 
system, that that is not by itself sufficient. But yet, we have 
had a spike in nonfatal overdoses.
    My understanding is, almost half the time there is a 
nonfatal overdose that preceded a fatal overdose, so it is 
obviously a very, very dangerous event.
    Should a nonfatal overdose in and of itself be sufficient 
criteria for including someone in the overutilization 
monitoring?
    Ms. Brandt. Well, I am not a doctor. I cannot speak to 
whether or not that is an appropriate criterion for us to use, 
but I think it is something that we want to look at, because we 
consider the continuum of care to be very important and we want 
to make sure that there is that coordination.
    Senator Toomey. So do you have the authority to adopt that 
as a criterion? What would it take to adopt--for instance, if 
it turns out that that is an appropriate criterion--what would 
it take to make it the criterion for inclusion?
    Ms. Brandt. I am happy to go back and get to you exactly 
what it would take for us to include that.
    Senator Toomey. Great.
    Admiral, did you have any thoughts on this?
    Dr. Giroir. No, sir. I would be happy to go back and look 
at what authorities would be required. But clearly, a nonfatal 
overdose is a risk factor moving forward, and in a true sense, 
a cry for help, and we need to be attentive to that.
    Senator Toomey. Exactly. But as it stands today, that is 
not a sufficient criterion for being included in 
overutilization monitoring. And so I am not a doctor either, 
but that is extremely counterintuitive.
    Dr. Giroir. We will certainly take that back and provide 
responses.
    Senator Toomey. Thanks very much, Mr. Chairman.
    Senator Roberts. Senator McCaskill?
    Senator McCaskill. Thank you, Mr. Chairman.
    I would, in reference to the ranking member's comments 
about the contributions by the manufacturers of opioids to the, 
quote, unquote, ``public policy groups,'' we have been 
investigating the manufacturers of opioids in the Government 
Oversight Committee, the minority staff. We have issued a 
report that shows, for example, the American Academy of Pain 
Management receiving big money from opioid manufacturers, and 
then, coincidentally, they actually issued the statement that 
said that opioids were not significantly addictive.
    I would like to enter that report into the record. I think 
it is important that the work we have done on that committee be 
added to this hearing record, because it is relevant.
    Senator Roberts. Without objection.
    [The report appears in the appendix on p. 124.]
    Senator McCaskill. There is another report we issued about 
a fentanyl manufacturer. Their internal sales slogan--after we 
got into the documents and started really getting into the 
weeds--their internal sales slogan was ``start them high and 
hope they don't die.''
    They had a fraudulent unit within their company that was 
posing as doctors' offices and actually calling pharmacy 
managers to try to get approval for fentanyl--this was Subsys, 
the fentanyl.
    I would like that report also to be made a part of the 
record.
    Senator Roberts. Without objection.
    [The report appears in the appendix on p. 143.]
    Senator McCaskill. And I am pleased to say that, as a 
result of a lot of work, but after this report was issued, the 
CEO of that company was criminally arrested, which is major 
progress.
    We are continuing to look at the manufacturers, at how they 
have contributed to this problem. The next report we will be 
issuing is on the distribution of opioids.
    Which brings me to opioid misuse and the failure of CMS 
Part D to actually require the plans to submit to you potential 
fraud and abuse. Is there some reason why you are not requiring 
the plans to give you the evidence of fraud and abuse they 
uncover?
    Ms. Brandt. I really appreciate the question, because that 
is something that we have been reexamining. And we are now 
exploring making that mandatory so that there would be 
mandatory reporting of fraud, waste, and abuse.
    Senator McCaskill. Well, I just hope that the exploration 
does not take very long. We have people dropping dead in my 
State every day. You know, talk about common sense. Why would 
this be hard to do immediately? I mean, what studies would you 
need to do?
    If a Part D plan that is making money off our program, that 
the taxpayers support, is not reporting to you the fraud and 
abuse they find, then what chance do we have of really getting 
a handle on this?
    Ms. Brandt. We concur it is a very important part of the 
program integrity. And as I said, we are working to see how we 
can begin to implement that.
    Senator McCaskill. I think you implement it by saying, we 
are going to have a rule that you have to report fraud and 
abuse. Can you do that sometime in the next 30 days?
    Ms. Brandt. I will get back to you. I am not sure that we 
can do a rule in 30 days, but I will get back to you.
    Senator McCaskill. Well, you can certainly announce you are 
doing a rule in 30 days.
    Ms. Brandt. I am happy to get back to you with our----
    Senator McCaskill. Yes; this hands-off approach with these 
pharmaceutical manufacturers and companies--I mean, Senator 
Stabenow said, really, a drug that has been around 47 years, 
that is lifesaving, increases from $690 in 2014 to $4,500 at 
the beginning of 2017, more than 600 percent? Where is the 
outrage? Where is CMS in this?
    This hands-off approach for these incredibly unconscionable 
price increases that are not driven by R&D, they are driven by 
greed, unadulterated greed, in an area where people are dying--
--
    So I think it is great, sir, that you got 75 bucks, but 
what about the family that has a member they know is addicted? 
How much is it costing them to get naloxone or Narcan? How can 
they afford it at a price increase of more than 600 percent?
    Why are we not being more aggressive and going after these 
companies that are doing this? What is their excuse for raising 
these prices? Because they know they can make more money? Is 
there any other excuse they have given you?
    Have you asked them?
    Dr. Giroir. No, I have not asked the companies about 
their----
    Senator McCaskill. Would you ask them? So would you ask 
them why they are raising these prices this high?
    Dr. Giroir. Yes, we will. We want naloxone to be more 
available and affordable. There is absolutely no question about 
that.
    Senator McCaskill. Well, how about----
    Dr. Giroir. And the nasal spray naloxone, the prices are 
going down, as we talked about before, but we are going to do 
everything we can to increase generic competition, to 
potentially have it over-the-counter, to promote competition to 
lower that even further.
    Again, this is the predominant form that is being used by 
States and first responders; $75 for two doses is where we are. 
I would love to see that lower and work on mechanisms to do 
that.
    Senator McCaskill. The Evzio naloxone product jumped from 
$690 to $4,500 in 3 years.
    Dr. Giroir. Right.
    Senator McCaskill. I would really appreciate you either 
telling me ``yes'' or ``no,'' will you write them a letter 
asking them why the price increased by that much? What was 
their justification for that price increase? Would you do that?
    Dr. Giroir. I will get back to you on whether I can write a 
letter. I do not know. But let me just tell you, the $4,000 
doses are not being used primarily by first responders and by 
States.
    Senator McCaskill. I am talking about families that are 
trying to save their family members' lives. Do you know how 
many parents I have talked to who walked into the bedroom and 
their child was overdosing and they had nothing, they cannot 
afford this drug to save their life? I mean, they may need it 
before the first responders get there.
    I just want you all--this hands-off deal about pharma is 
wrong, and I want you to be as mad as I am about it.
    Dr. Giroir. So I am absolutely aware that naloxone needs to 
be with families. And again, the inhaled naloxone, the nasal 
spray naloxone, is generally preferred and useful because it is 
easy to administer; it is a new form. So I agree with you: it 
needs to be less expensive.
    But now we are at $75 for two lifesaving doses.
    Senator McCaskill. For first responders.
    Dr. Giroir. For first responders, you are right. You are 
right.
    Senator McCaskill. Listen, I am going to hold you 
accountable on this. I want you to write the letter. I want 
somebody at CMS to begin to express the outrage towards these 
pharmaceutical companies that I hear from Missourians every 
single day.
    Thank you, Mr. Chairman.
    Senator Roberts. Coop, you are up.
    Senator Thune. Thank you, Mr. Chairman.
    You know, no State is immune from this issue. Our State 
does not have some of the data that other States have in terms 
of prevalence of opioid use disorder, fortunately for us.
    But we do have lots of substance use disorder issues, which 
our Governor is trying to address. And obviously, we are very 
interested in working with the members of this committee and 
others of our colleagues and doing everything we can to take 
this issue head on.
    But I do want to express my appreciation to the chairman of 
this committee and the ranking member for their efforts to help 
ensure that our committee activity addresses not only the 
opioid epidemic, but substance use disorder broadly. And I hope 
that our witnesses and the administration will also keep this 
issue in mind as they continue theirs efforts to coordinate the 
Department's activities.
    In the face of provider shortages, South Dakota's health 
systems have worked to innovate through telehealth. As you may 
be aware, several Senators have been working on the Connect for 
Health Act, which has the broad goal of expanding access to 
telehealth and remote patient monitoring services in Medicare.
    One provision would provide the Secretary of HHS authority 
to waive certain Medicare restrictions in current law where 
telehealth would reduce spending or improve quality of care. 
And we are hopeful that this is something the Department would 
have an interest in, particularly as a means to expand access 
to opioid and substance use disorder treatment.
    Is this something Secretary Azar would support? And are 
there other opportunities that you are looking at 
administratively to expand access via telehealth?
    Dr. Giroir. Yes, sir; thank you for the question. I 
certainly want to reaffirm that telehealth is part of the 
solution. We have to get into an outpatient mentality. We have 
to reach out to where patients are in their community. And I 
think telehealth is a really critical and important tool.
    The one thing I could say that we are exploring and working 
with our DEA partners on now is to be able to expand not only 
telehealth treatment, but telehealth medication-assisted 
treatment so that that can be given by a qualified provider 
across telehealth and monitored by a variety of different 
professionals.
    I think that is really the next step that is really 
important. And again, we are in very active work with DEA now 
to see about how we can make that come about in a very short 
term.
    Senator Thune. Good, good.
    In your written testimony, you highlighted the important 
work being done by the NIH and FDA to advance the research and 
availability of nonaddictive pain medications and devices, 
which I applaud. And I know the HELP Committee is also working 
on further proposals in this space.
    Ms. Brandt, has CMS put in place procedures to ensure 
timely Medicare coverage determination of new therapies once 
they are approved by the FDA?
    Ms. Brandt. Yes; actually, it is a great question. And 
because we know the importance of this, we have been working on 
a parallel process with the FDA. So as the FDA is determining 
whether or not it will be a drug or device that is approved, we 
are looking at coverage and reimbursement on our side so that, 
hopefully, once the FDA approves their piece of it, we can then 
very quickly move in to getting it approved for Medicare.
    Senator Thune. It seems like a big part of the solution to 
this problem.
    Just one last question. Indian Health Service does not fall 
directly into this committee's jurisdiction, but I am sure you 
are aware that many South Dakota tribal members are also 
eligible for Medicaid, which is the single-largest payer for 
behavioral health services.
    Through your efforts to coordinate the Department's 
response, what recent engagement has taken place with the 
tribes and other stakeholders, working with them to address 
substance use disorder in tribal communities?
    Has the National Committee on Heroin, Opioids, and Pain 
Efforts, or HOPE Committee, that was formed last spring made 
any changes or suggestions for improving access to culturally 
appropriate treatment?
    Dr. Giroir. I could say in the 2 weeks that I have had this 
position, I have probably met with the IHS three times, 
including an 8-hour principals retreat at HHS, where the 
Director of the NIH, FDA, IHS and deputies, CDC, myself, 
Secretary, Deputy Secretary, we were all together, working 
together and focusing specifically on what we can do to support 
each other throughout this process.
    And as you know, because of your passing the $1 billion 
that is coming through, the omnibus that will be released in 
September has a specific $50-million allocation to the tribes 
specifically.
    So I think we are highly coordinated and sensitive to that.
    In my other-hat job as the Assistant Secretary for Health, 
our Office of Minority Affairs, which focuses on culturally and 
linguistically appropriate treatment, has, even in the last 
week, done visits to IHS and to multiple tribes to make sure, 
at the grassroots level, that we are reaching them.
    Senator Thune. Very good; thank you. I hope you will 
continue those efforts. I appreciate that.
    Mr. Chairman, thanks.
    Senator Cornyn [presiding]. Thank you.
    Senator Heller?
    Senator Heller. Mr. Chairman, thank you.
    I want to thank you and the committee for putting together 
this particular hearing. It is important. And it is important 
for my State; it is important across the country. And I am 
pleased that we have this opportunity.
    For many Nevadans, substance abuse is an issue that hits 
close to home. It is an issue I read about in constituent 
letters, and I hear about it in calls to my office.
    Like many of my colleagues, I have heard from those who are 
struggling with addiction or, for that matter, those who have 
lost loved ones to this epidemic.
    And in my home State of Nevada, there were 665 drug 
overdose deaths in 2016. And in that same year, opioids were 
involved in over 40,000 American deaths--statistics, I am sure, 
you are well familiar with. So opioid abuse is a major public 
health concern, and more steps need to be taken--I am sure we 
are all in agreement on that--to ensure that our communities 
are equipped to address this crisis. So I am pleased to have 
the panel here before us.
    Ms. Brandt, I want to welcome you back to the committee.
    Ms. Brandt. Thank you.
    Senator Heller. It is great to see you.
    And I want to thank both of our witnesses for taking a few 
moments of your time to be with us today.
    Dr. Giroir, I would like to start with you.
    Dr. Giroir. Yes, sir.
    Senator Heller. I just had a meeting in my office. I met 
with Boys and Girls Clubs of western Nevada. And obviously, 
they were discussing their after-school activities and programs 
that they had that were available to these young adults. And 
they were talking about some of the programs, in particular 
when it comes to trying to prevent students from being involved 
in drugs, and opioids in particular.
    I am just curious as to what--since it was timely--the 
Department has in mind and what the Department of Health and 
Human Services is doing, any work they are doing on early 
prevention.
    Dr. Giroir. So you highlight a very important point, 
because, obviously, prevention is where it is at.
    Senator Heller. Sure.
    Dr. Giroir. Once you are addicted to opioids, it is a long 
road, even with the best therapy and cognitive behavioral 
therapy.
    A couple of things regarding that. Number one, we are in 
the middle of assessing what are the best evidence-based 
practices to reach different communities. And we are going to 
have to reach them specifically based on age, based on where 
they interact. And this is an active, ongoing effort with the 
CDC and other parts of our agency to target information across 
the board.
    Secondly, the State targeted grants that I spoke about have 
a significant component of prevention that could support 
States' activities, because, as you stated, every State is a 
little bit different, has different organizations that need to 
be supported and reached.
    So I absolutely agree with you there is----
    Senator Heller. Who directs those dollars--in other words, 
once it gets down to the State level? If the needs are at the, 
you know, at the school levels, education levels, can the 
dollars or, for that matter, does HHS have a program with the 
educational system to get those dollars down there? I just want 
to know who moves the dollars. And if every State is a little 
bit different, which I know, how do we get those dollars to the 
places that need them most?
    Dr. Giroir. So you may have programs in this as well, but 
these specific grants, they are awarded to the States, and the 
States can subcontract with any variety of organizations they 
want to fulfill their mission with those dollars. And it is 
going to be very similar.
    It is highly flexible funding. We want to make sure there 
is actually prevention and treatment that is covered. But aside 
from that, the States have tremendous flexibility to 
subcontract with whomever.
    Ms. Brandt. Yes, and I would just jump in from the Medicaid 
program side. I am sure you are familiar with the Early and 
Periodic Screening, Diagnostic, and Testing, or EPSDT. It is 
mandated that they provide prevention and other types of 
services for children and adolescents up to age 21. So that is 
another way, through the Medicaid programs and the 
flexibilities that they have and resources there, that they can 
do that.
    Senator Heller. Okay, that is helpful.
    Dr. Giroir. And I just want to emphasize, a couple of weeks 
ago the President issued an executive order on youth sports 
participation. And I look at this as a great opportunity to 
provide opportunities, not just for youth sports participation 
in underserved communities, but to have that as a platform for 
health in general where we could send many messages about 
appropriate nutrition and opioids, et cetera.
    Senator Heller. Thank you.
    Ms. Brandt, I wanted to ask you a little bit about 
electronic prescribing. Senator Bennet and I have introduced 
the Every Prescription Conveyed Securely Act.
    Mr. Chairman, I have a letter I would like to submit for 
the record, from 20 groups and organizations that support this 
particular piece of legislation that Senator Bennet and I have 
introduced.
    Senator Cornyn. Without objection.
    [The letter appears in the appendix on p. 122.]
    Senator Heller. But I guess the question is to you, Ms. 
Brandt. What impact would electronic prescribing have on 
addressing the opioid epidemic?
    Ms. Brandt. Well, there are a couple of things. First of 
all, I would just note we had a number of stakeholder sessions 
last fall with various stakeholders across the spectrum, and e-
prescribing was one of the top four things that came up across 
all those stakeholder sessions.
    So we really think that the data from that is very 
important. It has a lot of benefits to the plans, pharmacies, 
prescribers, and the States. Also, our Part D sponsors are 
required to support electronic prescribing as part of their 
participation in the Part D program.
    So I think it is something that we think has a lot of 
potential, and we are aware of your legislation and we would be 
happy to continue to support technical assistance.
    Senator Heller. Ms. Brandt, thank you.
    And, Doctor, thank you for taking time.
    My time has run out, Mr. Chairman.
    Senator Cornyn. Thank you, Senator Heller.
    Senator Carper?
    Senator Carper. Welcome. We are happy you are here today 
and appreciate your appearance.
    I have been writing down the number of times that the two 
of you have said, well, that is a great question or, I am glad 
you asked that question or, that was an important question, 
like, over 25 times so far. That is a record. And I was just 
wondering, do you ever get questions where you want to just 
say, God, that is a dumb question; why are you asking that 
question? [Laughter.]
    Maybe not here, but maybe some other committees.
    Senator Cornyn. Do not answer that question. [Laughter.]
    Dr. Giroir. I yield to the Senator from Texas. [Laughter.]
    Senator Carper. So I want to talk to you about electronic 
prescribing. I want to talk with you about something that 
sounds like electronic prescribing, but it is quite different. 
It is electronic prior authorization.
    And generally, patients in Medicaid, their providers 
oftentimes wrestle with the prior-authorization requirements 
for medication--this is to treatments for opioid abuse and 
increasing the odds that these patients will relapse and return 
to their use of opioids.
    Would increasing the use of electronic prior authorization 
in Medicaid, in Medicare, and in private health insurance plans 
help improve access to medication-assisted treatment?
    And what do you need from us? What do you need from this 
committee? What do you need from Congress in order to increase 
the use of electronic prior authorization for medication-
assisted treatment?
    I think Senator Roberts, if he were here, would have talked 
about legislation that he and I have actually, I think, 
collaborated on. But let me just ask you: what do you think?
    Ms. Brandt. Well, from our perspective, we think that there 
is great potential for prior authorization. It is something 
that electronic prior authorization----
    Senator Carper. Would you go so far as to say you are glad 
I asked this question?
    Ms. Brandt. Well, I decided not to say that----
    Dr. Giroir. I am glad you asked the question.
    Ms. Brandt [continuing]. But I am glad you asked that 
question, yes, sir; thank you. But it is something that we have 
been looking at and that we think is one of another potential 
good tools that we have along with, as I mentioned, e-
prescribing--anything we can do that helps us to be able to see 
in real time what is happening and what is being requested, and 
especially if it helps us to be able to tell who is requesting 
different types of services. That is very helpful for us from a 
program management perspective.
    Senator Carper. Dr. Giroir, do you agree with what she just 
said?
    Dr. Giroir. I do.
    Senator Carper. Would you go so far as to say you approve 
of this message?
    Dr. Giroir. Yes, sir, I do.
    Senator Carper. Oh, good. And I would say, going back to 
Senator McCaskill's question, I have found that whenever Claire 
McCaskill is after me to do something, make a phone call, write 
a letter, I finally just say I will do it, and it saves us all 
time and trouble. And I think what she is asking is probably 
the right thing to do.
    I have another question. And I am a recovering Governor. 
And when I was privileged to be Governor of Delaware for 8 
years, we established a Family Services Cabinet Council. And it 
included basically half of my Cabinet Secretaries. We met every 
month. We developed a strategy that we pursued for 8 years to 
strengthen families, the basic building block of our society.
    We said, rather than just address the symptoms of problems, 
why don't we go after root causes?
    And several people today have mentioned root causes. But as 
we confront the opioid epidemic, I want to urge you to focus 
not just on treatment, but also to focus on the root causes for 
this crisis. And I know there are several.
    Our child and family experts tell us that individuals with 
mental health conditions and adverse childhood experiences are 
at a greater risk for abusing drugs.
    Let me just ask: what are HHS and CMS doing to ensure at-
risk children and families have adequate access to early mental 
health treatments and intervention that could reduce drug abuse 
and addiction? And how can we make better use of telehealth in 
Medicaid and the CHIP program in order to improve access to 
mental health treatment, especially for at-risk children?
    Ms. Brandt. So I think from our perspective, we absolutely 
agree with you that it is important to get the right services 
to children. As I mentioned, one of our real mantras with the 
opioid epidemic is the right services to the right person in 
the right setting, and making sure, particularly with 
children--as I mentioned to Senator Heller--through our 
Medicaid program, we do the EPSDT program, which allows us to 
do prevention services.
    And we have really been looking at ways to expand the use 
of telehealth, particularly for rural areas and areas where 
they just do not have as great an access, to be able to really 
use that as an important tool as part of our efforts to fight 
this epidemic.
    Senator Carper. Dr. Giroir?
    Dr. Giroir. I agree completely. We are also very actively 
looking at some demonstrations, particularly for children, that 
would co-
locate mental services with physical services and really 
working with our academic and nonprofit partners to do that, 
because I think that is, you know, very, very important, and 
that is one way that we can do that.
    Having been in a children's hospital and working there for 
many years, I understand the importance of that.
    The second issue is, there are degrees of susceptibility. 
And I absolutely agree with you, mental health, adverse 
childhood experiences always make it much more likely. But I 
think the point is, everybody in this room is susceptible to 
addiction.
    If you are on prescription opioids for too long, it is like 
asking yourself not to breathe. After a while, you cannot do 
it.
    So I just want to make it clear that you are absolutely 
right, we need to target the high risks, we need to work on 
adverse childhood experiences, we need to co-locate those 
services. But everybody is at risk.
    Senator Carper. All right; thanks very, very much.
    Senator Cornyn. Admiral, it is good to see you again.
    Dr. Giroir. Thank you, sir.
    Senator Cornyn. Thank you for being here and for your 
distinguished service at two great Texas institutions, Texas 
A&M and the University of Texas, in addition to, of course, the 
United States military.
    Ms. Brandt, it is good to see you.
    I would like to talk about the elephant in the room. Is 
heroin an opioid, Admiral?
    Dr. Giroir. Yes, sir.
    Senator Cornyn. When people cannot get prescription drugs 
for some reason, do addicts frequently resort to heroin?
    Dr. Giroir. Yes, sir.
    Senator Cornyn. Because it is cheaper, right?
    Dr. Giroir. Yes, sir.
    Senator Cornyn. More readily available?
    Dr. Giroir. Yes, sir.
    Senator Cornyn. But the addiction that it produces is just 
as bad, maybe worse than from prescription drugs. Would you 
agree with that?
    Dr. Giroir. The addiction is the addiction; the 
consequences of heroin and fentanyl are much more severe 
because of their potency. Yes, sir.
    Senator Cornyn. And are you aware that one of the major 
sources of heroin into the United States is across our 
Southwestern border?
    Dr. Giroir. It is, sir. That is for sure.
    Senator Cornyn. And along with tons of heroin come tons of 
methamphetamine, tons of cocaine. But I know we are talking 
primarily about opioids.
    I heard it described to me recently by the head of Southern 
Command, the Combatant Commander in charge of that region of 
the world, he said the criminal organizations that traffic in 
drugs, poison if you will, into the United States that addict 
so many Americans, they are commodity-agnostic is the way he 
put it. They will traffic in drugs, they will traffic in 
children, they will traffic in whatever will make them a 
dollar. That is all they really care about. They care nothing 
for the human misery that they cause as a result of their 
illegal activity.
    Which is why it causes me great pain and disappointment to 
see that, when Congress has an opportunity to live up to its 
responsibilities to provide the funds and the means by which to 
provide greater security along our Southwestern border, even 
when it is coupled together with a pathway to citizenship for 
1.8 million young people, people vote ``no,'' we abdicate our 
responsibility when we fail to live up to--I am talking about 
Congress now--our responsibility to deal with this whole 
epidemic.
    And would you agree with me, Admiral, that if we just dealt 
with the prescription drug part, but did not deal with the 
heroin and fentanyl problems, that we would not be able to get 
our arms around this epidemic?
    Dr. Giroir. We absolutely need a comprehensive solution 
that includes prescriptions. But I cannot overemphasize the 
importance of limiting heroin, fentanyl, and carfentanil to the 
solution set.
    Senator Cornyn. Yes. I have heard General Kelly, now the 
Chief of Staff at the White House, formerly head of Southern 
Command, bemoan the fact that many of our military or law 
enforcement who are stationed in places to be able to intercept 
the movement of illegal drugs into the United States, because 
they are inadequately resourced in terms of the equipment, 
airframes and the like, boats, that they have to simply sit 
there and watch it pour into the United States.
    But as we all know, the demand is equally or maybe even 
more important than the supply. And do you have any 
suggestions, either one of you, for what Congress might be able 
to do to deal with the demand side of this terrible problem?
    It seems to me we throw up our hands and give up too 
readily on the demand side. And if we can figure some way to 
dampen the demand side, that would be an important part of 
solving this problem. Would you agree?
    Dr. Giroir. Two comments. First, we know that the demand 
side today, much of that was created by prescription opioids. 
So three out of four users of heroin started on prescription 
opioids. So one of our principal strategies to decrease the 
demand side is to reduce the unnecessary prescribing of 
prescription opioids across the board.
    Senator Cornyn. Absolutely.
    Dr. Giroir. The second comment is, with opioids, the supply 
does create demand, because once you are on it, you cannot get 
off of it. It is a disease; it is an addiction. I fully agree. 
It is like telling someone not to breathe, once you are 
addicted to these drugs.
    So in addition to decreasing the demand, we have to 
understand that we have to decrease the supply and also that 
the supply creates demand. Once you are on heroin, fentanyl, or 
any of these drugs, it is very, very difficult to get off.
    Senator Cornyn. Are there strategies that you think that 
the Federal Government could embrace to try to deal with that 
demand component?
    I hear what you are saying about supply and demand, but if 
we dealt with the supply and did not do anything on the demand 
side, I think we would find ourselves pretty much in the same 
mess we are in right now.
    Dr. Giroir. Yes, sir.
    Senator Cornyn. Are there strategies that the Federal 
Government could embrace to deal with the demand side?
    Dr. Giroir. You know, I think with the unprecedented amount 
of funding and the programs that we have, we need to evaluate 
their effectiveness over the next months. But you know, I do 
believe by decreasing prescription opioids--and we are already 
seeing a very significant decrease nationwide, even more in the 
Medicare population, even more in the VA--that the demand is 
going down. But it has to be coupled with treatment for those 
who are already misusing or have substance use disorder.
    And again, part of the grant process that we are in 
supports medication-assisted treatment; it supports 
comprehensive services.
    But I want everybody to understand that, as good as they 
are, the best MAT and services are still only partially 
effective. We need a tremendous increase in what we look at to 
improve the effectiveness of those programs.
    And we are actually--one of our major thoughts is to work 
with Francis Collins and the NIH to really start looking in a 
way to understand, how do you put all the services together to 
even be more effective?
    Again, most MAT, even with good therapy, is only 50 or 60 
percent effective for 6 months. So that is the state of the 
art, and we need to improve that.
    Senator Cornyn. I agree 100 percent. But I would just 
submit that, unless we come to grips with not just the 
prescription drug side, but the heroin/opioid component, both 
supply and demand, we are going to find ourselves----
    Dr. Giroir. There are tons of heroin literally coming over. 
The problem with fentanyl, among all the problems, is it is 
very cheap, so the profitability is high. And because it is so 
potent, you do not have to carry truckloads of it. Only small 
amounts can have an impact that could kill tens of thousands of 
individuals.
    Senator Cornyn. Senator Cantwell?
    Senator Cantwell. Thank you, Mr. Chairman.
    And thank you for your question, because I think it is a 
good precursor to some of the things that we are interested in.
    I do not know if either one of you knows--I am assuming you 
do--that the Drug Enforcement Administration classified opioids 
as a dangerous substance with a potential for high abuse and 
leading to severe psychological and physical dependence.
    So because of that, that is why we created a strong network 
of laws on distribution. We basically said that substances like 
this needed to be tracked and reported and suspicious orders 
red-flagged and the distribution of these drugs communicated, 
so that the Drug Enforcement Administration, DEA, could work 
through this.
    But despite the fact that that law exists, there have been 
large quantities of opioids flooding our communities, with 
manufacturers filling excessively large orders in distribution.
    In one example, a physician in Everett, WA wrote more than 
10,000 prescriptions of the highly addictive OxyContin, and 
these were 26 times higher than the average for an Everett 
prescriber.
    In another case, an illegal opioid distribution ring in 
California allowed more than 1 million opioids to be 
distributed into a community.
    So my point is, where is the accountability? Where is the 
accountability for drug manufacturers not tracking and using 
that information with the Drug Enforcement Administration to 
work cost-
effectively to try to stop this kind of distribution?
    Currently, the fines for manufacturing are a mere $10,000 
for neglect in reporting on that distribution. So to me, that 
is hardly a deterrent. That is why I am asking legislatively 
for a tenfold increase for not reporting negligent 
distribution.
    And to me, we have to get at this problem of not tracking 
and seeing the signs of that distribution.
    Now, my colleague Senator Harris and I also want to address 
what my colleague Senator Cornyn just mentioned, which is 
giving law enforcement the tools to also deal with the heroin 
epidemic.
    The heroin epidemic is also part of the problem, and we 
want to make sure that they have the resources to deal with 
heroin traffic. And we think that the front line of that is our 
law enforcement entities, and they need that help and support.
    But the question I have about this, on the distribution, 
is, does HHS have a system in place to track prescription 
opioids covered by Medicaid and Medicare and knowing how they 
might be falling into the wrong hands?
    Ms. Brandt. So, speaking for Medicare and Medicaid, we do, 
through our Medicare program, particularly the Part D program, 
have what is called the overutilization monitoring system, 
which allows us to be able to track--for instance, you were 
talking about beneficiaries who receive high amounts of 
opioids. We are able to see if they receive 90 or more morphine 
milligram equivalents for a sustained period of time, say 6 
months, from up to three or more prescribers or three or more 
pharmacies.
    We also have our MEDIC, which is our fraud investigations 
unit, which looks at prescriber data to really be able to work 
with the Inspector General to track those prescribers and to 
really look at pharmacies and prescribers who are high 
overutilizers and hopefully take action against them.
    Senator Cantwell. So you do not work with the Drug 
Enforcement Administration on this?
    Ms. Brandt. We do not work directly with them. Our law 
enforcement partners at the Office of Inspector General and 
Department of Justice do, but we at CMS do not work directly 
with DEA.
    Senator Cantwell. Do you think that we need larger controls 
in place on improper prescribing, billing, and dispensing?
    Ms. Brandt. We are working to try to put as many of those 
controls in place and agree that we need to really watch these 
patterns.
    Senator Cantwell. I think we are beyond watching these 
patterns. I think that is why we are in this problem, because 
that is all we did and we did not penalize the manufacturer for 
failing to notify.
    We should be able to see some problem on distribution, 
whether that is a drug ring or an individual physician who has 
gone awry, whatever the issue is. We should be able to see 
that. That is what the law requires now.
    But there is no penalty severe enough to get people's 
attention. So I would hope that you would look at this 
legislation and give us some feedback on it and think about 
improper prescribing, billing, and dispensing, and what other 
methods we need for Medicare and Medicaid to be part of that 
equation.
    Ms. Brandt. We will definitely take a look at the 
legislation and get back to you.
    Senator Cantwell. And, Admiral, what about giving more 
resources for an anti-heroin enforcement ring with local law 
enforcement?
    Dr. Giroir. You know, I can only comment generally. I think 
we have to be all on the same page to decrease the heroin 
supply. It is heroin and fentanyl that are now killing much 
more than prescription drugs. And we absolutely need to support 
a trans-government approach, including DOJ, local law 
enforcement, et cetera.
    Both of my parents were police officers. I understand how 
important the front line is to this.
    Senator Cantwell. Well, I see my time is expired.
    I would say I hope that we can come together on this 
because, you know, we have toured our State, we have heard 
unbelievable stories of what is happening.
    People are getting opioids just so they can sell them for 
the heroin, because they can get that at three times the rate. 
So we need to combat both. I agree with Senator Cornyn that the 
heroin part of this is critical, but this is why we need law 
enforcement, and they need more resources and tools to do that. 
So I hope you will look at this legislation and give us some 
feedback.
    Thank you, Mr. Chairman.
    Senator Wyden [presiding]. Senator Brown?
    Senator Brown. Thank you, Mr. Chairman.
    Ms. Brandt, I know that you, as a native of Ohio, 
understand how hard this epidemic has hit our State. Eleven 
people died on Tuesday, 11 people died yesterday, 11 people 
will die today, and 11 people will die tomorrow, on the 
average, as you know.
    Eleven is not the only number that matters. Let me give you 
another number: 10,769. According to the American Academy of 
Pediatrics, that is how many Ohio children were placed in 
foster care in 2016, many of them--not all--many of them as a 
direct result of this addiction epidemic.
    As you know, the bipartisan Family First Act just signed 
into law requires the Department to issue guidelines on program 
criteria and provide a list of preventive services authorized 
under title IV-E by October 1st of this year.
    I understand, since I am way down in the list today because 
of the Banking Committee, I understand Senator Menendez asked 
earlier about implementation of Family First. I am pleased to 
hear you all expect the guidance to States will come out in a 
timely manner later this year. Thank you to both of you for 
that. And thanks for your commitment.
    Now, I have a few additional questions I will submit for 
the record on the implementation of Family First, and I 
encourage you to solicit input and feedback--I know I do not 
need to admonish you to do that--from the States as you move 
forward with this guidance.
    Before I get to really my only question, Ms. Brandt, I 
would like to just share some of the things Ohio is doing. We 
do not do well on infant mortality compared to other States. We 
do not do well in education. We unfortunately lead the Nation 
almost in for-profit charter schools abuse.
    But we are doing some really innovative things on babies 
and neonatal abstinence syndrome. I want to talk for a moment 
about it.
    Every 25 minutes, a baby is born suffering from opioid 
withdrawal in this country. Twenty-one hundred babies, six 
babies a day, were admitted to a hospital in Ohio for NAS. Just 
a decade earlier, just 300 cases were reported nationwide, so 
the explosion of numbers you two are all too familiar with.
    Ohio is doing a lot of creative things. Cincinnati 
Children's established a universal screening program that has 
helped to identify babies born with NAS and get them to 
treatment faster.
    In previous Finance Committee hearings, Senator Portman and 
I have talked about our work on the CRIB Act, which would help 
pediatric recovery centers receive reimbursement through 
Medicaid.
    Secretary Azar made the trip to Kettering, OH--I thank all 
of you for that--to see firsthand the work happening in our 
first pediatric recovery center, Brigid's Path. I want to 
continue our work together to pass the CRIB Act to make sure 
that these recovery centers have the funding necessary.
    Another initiative that our State has been working on is 
through the Ohio Perinatal Quality Collaborative NAS project, 
which has developed best practices for treating babies born 
with NAS. Other States are looking to adopt this successful 
model.
    But our providers are overwhelmed, as you know.
    I hosted a conference yesterday for CEOs from a handful of 
Ohio's smaller and rural hospitals. They spoke about NAS 
babies, how hard they are for hospitals to treat. Not all of 
them have NICUs. Some of these smaller hospitals do not have 
providers who are experienced or specialized enough to care for 
these babies. As a result, they transfer these high-need 
infants to other facilities with more resources that are 
already themselves overwhelmed, but they realize the system is 
not sustainable.
    One of the CEOs of these 100-, 200-bed hospitals, smaller 
than that even, shared how his hospital is collaborating with 
another larger system to utilize telehealth technology to keep 
babies closer to home while they undergo treatment. The larger 
system will share their resources and expertise through that 
technology when babies are born with NAS at the smaller 
hospital.
    Their hope is to reduce burden on the regional hospitals 
that currently are caring for those babies. They anticipate a 
savings obviously from cutting back on transfer costs.
    Now, my request is, Ms. Brandt, talk to me about what CMS 
is doing to help NAS babies and improve care for moms and 
babies suffering from the addiction epidemic. What tools do you 
have to improve care options for these individuals? How does 
Congress support additional Federal initiatives in that space 
through multistate demonstrations?
    And then if you would answer that and then commit to 
working, if you would--give us specifically on the record a 
commitment to work with us on these innovative solutions. So, 
thank you.
    Ms. Brandt. Well, thank you for the question. And I 
absolutely recognize the issues back home in my home State of 
Ohio. The county I am from back home is one of the hardest hit, 
and it is a really big issue.
    And at CMS, we have been particularly focused on the issues 
you are talking about in terms of helping mothers and infants 
struggling with their opioid addiction. We have heard a lot 
about it.
    The Secretary spoke very much about his visit at Brigid's 
Path and what he learned in Ohio.
    So one of the things that we have done is, in February of 
this year, we approved a State plan amendment for West 
Virginia, which we hope will be a model for other States to 
use. It is going to provide additional treatment services for 
neonatal abstinence syndrome and NAS treatment centers. It 
basically allows West Virginia to reimburse all medically 
necessary NAS services through an all-inclusive bundled cost 
per-diem rate based on a perspective payment methodology.
    This is a big shift from how we normally would reimburse 
for these services and will allow more services to get covered.
    Some of the services that they can fund through this would 
now include nursing salaries, supportive counseling, and case 
management, which are currently not included.
    What it does not include--and this is part of what Congress 
could potentially take action on--are room and board costs and 
physician treatment services.
    Another thing that we have heard--and that was something 
that was raised when the Secretary was at Brigid's Path--is the 
problem with the limitation on 60 days of coverage for mothers 
who are postpartum and the fact that they do not receive 
services beyond that. So that is another thing that we have 
been looking at at CMS, and we have heard a lot of feedback on, 
and we would love to work with you all, not only on that issue, 
but on all of these issues, because we think they are 
critically important.
    Senator Brown. I spoke at the Cleveland City Club the other 
day about opioids and our government looking at it in a big, 
comprehensive, public health way. And I used a couple of 
examples of when government--and you know, a lot of people here 
do not think there is a role for the Federal Government in a 
lot of health-care issues, when many of us, on this side at 
least, believe there is.
    But I used the example of tobacco. In 1964, when the U.S. 
Surgeon General first came out against it, so first recognized 
tobacco as a public health crisis, 45 percent of American 
adults smoked; last year, it was down to 15.
    You can look at how we treated HIV/AIDS. And at the 
beginning, I mean, we had a President and a bunch of 
politicians and many others who would not acknowledge it.
    My wife writes a weekly newspaper column that is 
syndicated, and she wrote about how Barbara Bush, whatever year 
she did this, when people were so afraid of HIV, you would not 
even want to touch anybody with it, even though there was no 
evidence at all that it was transmissible that way, Barbara 
Bush went into a clinic and held a baby that was HIV-positive. 
And then once we decided that, what we have been able to do in 
that public health arena----
    So we know how to do this as a country. This one looks more 
intractable maybe than the other ones; maybe it is, maybe it is 
not, but we know how to do these things when we really put our 
minds to solving a public health crisis.
    So you two are really on the front lines of that. And your 
whole careers have been dedicated to that kind of fight, so 
thank you both.
    Senator Wyden. Well said, Senator Brown.
    Senator Casey?
    Senator Casey. Thanks very much.
    I know we are at the end and we are all running for time.
    But, Admiral, good to be with you. Thank you for your 
service.
    Dr. Giroir. Thank you.
    Senator Casey. I do not know which title you like better, 
Admiral or doctor. We will use them interchangeably.
    Dr. Giroir. Yes, sir.
    Senator Casey. And, Ms. Brandt, we are grateful you are 
back here. Thanks very much for your service.
    I wanted to just highlight what so many others have 
highlighted and just ask one question, and I will be quick.
    This opioid and, frankly, a larger substance use disorder 
crisis is hitting every State, just as you have heard today.
    In my State, the numbers are, as of 2016, I think 4,624 was 
the number. That number was up 37 percent overall from 2015 to 
2016. I do not think I have a 2017 number yet. But in rural 
areas, it was up more than 37 percent; it was up in the mid-
40s, so higher in rural areas.
    In one rural county I was in back in August kind of on a 
tour of the State, the most graphic metric or scenario was the 
coroner saying we do not have enough places to put the bodies. 
Literally, they did not have enough slabs or places to put 
bodies. So it is horrific on every level.
    And one question I wanted to ask you is about barriers. I 
know that we hear a lot about the barriers to accessing 
treatment being stigma, limited availability of providers, high 
out-of-pocket costs.
    So my only question, because we are all pressed for time, 
is, do you agree that those barriers exist? And what is the 
administration doing to confront those?
    And it could be either of you. I am directing it to Ms. 
Brandt, but either or both.
    Dr. Giroir. I certainly agree those barriers exist and 
particularly for rural populations as well.
    Senator Casey. Yes.
    Dr. Giroir. As I am learning more about this, there is $100 
million by HRSA that is going to be targeted specifically to 
rural areas. The STR funding that we announced yesterday, which 
was, again, the Cures second tranche and plus the billion 
dollars, there is great flexibility for the States to use that 
to support urban or rural, depending on where the needs are.
    We talked about it earlier. I am a big believer in 
telehealth for many issues in distributing health care out of 
the major centers to where the actual need is. And I think that 
is part of the answer.
    And again, we are exploring, with DEA, sort of the next 
iteration of that as to, how can we prescribe, have a 
telehealth prescription of an MAT provider in a rural community 
where there may not be an MAT provider? There are certain 
barriers to that, but we are working on that, because I think 
that is an important component as well.
    I do not want to take up all of your time, so I will stop 
there and let Ms. Brandt reply, but I would be happy to follow 
up on that.
    Senator Casey. That is very helpful; thank you.
    Ms. Brandt. And I will just follow up with what the Admiral 
said.
    At CMS, we agree with you: there are a lot of barriers. One 
of the ways that we are working on those barriers is through 
demonstration projects. We have 1115 waivers based on some new 
flexibilities and guidance we issued last November. We have 
five States that are now using these flexibilities, including 
allowing them to do things like access residential treatment 
facilities which, as you are aware, has prior not been allowed 
under Medicaid reimbursement. So that is something where we are 
very interested to see the results of those five States and 
sort of what is happening there and how we can work with other 
States to provide those flexibilities to help break down those 
barriers.
    Senator Casey. Great. Thanks very much. And thanks for your 
help on Wills Eye Hospital. Thank you.
    Ms. Brandt. Oh, happy to help.
    Senator Wyden. Thank you, Senator Casey.
    So we are going to wrap up here pretty quickly.
    We have a little business left to do, and then I am going 
to just reiterate a couple of points from 2\1/2\ hours ago.
    First, I would like to enter into the record Senator 
Roberts's questions.
    [The questions appear in the appendix.]
    Senator Wyden. When we wrap up, we are going to ask that 
there be a response to questions for the record--and I will do 
this on behalf of the chairman in a minute--by the close of 
business on Thursday, April 26th. So we need responses from the 
administration to Senator Roberts's very good and important 
questions.
    And I am going to--I thought I did it, but perhaps it was 
not clear--put into the record the various documents that 
attest to these very serious conflicts of interest that I 
talked to you about, Dr. Giroir----
    Dr. Giroir. Yes, sir.
    Senator Wyden [continuing]. With respect to these Federal 
advisory boards.
    [The documents appear in the appendix beginning on p. 166.]
    Senator Wyden. In one of these instances already, one of 
our letters led to the removal of an official where the 
conflict was so extraordinarily outlandish. But there is a lot 
of heavy lifting to do here.
    All right. Having said that, let me kind of recap where we 
are.
    First, I want to make clear how strongly I feel, and how 
strongly our side feels, that we tackle this issue in a 
bipartisan way. We are going to do that under the leadership of 
the chairman. This is going to be tackled in the same kind of 
way that we pursued the CHIP bill for 10 years, the historic 
Family First bill, the potentially transformative Medicare 
legislation that we have spoken about. We are going to get this 
bill done, and it is going to be done in a bipartisan way. 
Period, full stop.
    Now, having said that, I want to go back to one of the 
points that I did make earlier with you, Dr. Giroir, and make 
sure you understand my expectation.
    I continue, as I indicated in my opening statement, to be 
exceptionally troubled by the role of the opioid executives, 
the manufacturers, and the distributors. And I do not believe 
we got into this situation, a public health calamity, by 
osmosis. And I do not think it was just because some really 
well-meaning people missed some of the addictiveness.
    I think that the opioid manufacturers, through twisted 
research, deceptive marketing, and bought-and-paid-for advocacy 
groups, had a significant role to play in creating and fueling 
the crisis.
    So I ask for that answer in writing from you. I expect it 
within a week because, if we are going to get at the roots of 
this problem, we have to go at some of what led us to get to 
this political calamity.
    Will you get me an answer to my question within a week?
    Dr. Giroir. Yes, sir. And I just want to be clear that I am 
fully supportive of the Senate looking at the root causes of 
this and understanding it and for whatever DOJ is doing. I 
fully support that.
    The only point I was trying to make is that we got here in 
a multifactorial way. We need to understand the roots so it 
does not happen again. But where we are is going to require the 
kind of activities we are doing right now. So, yes, sir, I will 
provide you that within the time frame.
    Senator Wyden. No one disagrees with the theory that there 
are a variety of factors here. What I was concerned about in 
your written statement is it just completely overlooked--
completely--the role of the manufacturers and the distributors. 
And I think that is a significant part of it.
    I appreciate your cooperation on this. We will look forward 
to your answer.
    As you could hear, there are differences of opinion on this 
committee. And I happen to share the views with respect to the 
role of cost containment. We have to use every effective tool 
to drive down the costs, because you can have really 
transformational health products, but people have to be able to 
afford them.
    And also, as Ms. Brandt knows, it is a taxpayer issue as 
well as an individual issue.
    So the question of costs, the question of urgency, as you 
heard colleagues talk about, is all fundamental.
    But we are going to get a bipartisan bill from the Finance 
Committee, because Chairman Hatch and I have been talking about 
this for some time. There are colleagues with very good ideas 
on both sides of the aisle. That is the way we do it.
    And with that, we will thank you both.
    Always good to see you, Ms. Brandt. You have had a lot of 
good ideas over the years with respect to the other bipartisan 
legislation. That is really principled bipartisanship.
    And with that, the Finance Committee is adjourned.
    [Whereupon, at 12:19 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


 Prepared Statement of Adm. Brett P. Giroir, M.D., Assistant Secretary 
 for Health and Senior Adviser to the Secretary for Mental Health and 
Opioid Policy; and Kimberly Brandt, Principal Deputy Administrator for 
 Operations, Centers for Medicare and Medicaid Services, Department of 
                       Health and Human Services
    Chairman Hatch, Ranking Member Wyden, and members of the committee, 
thank you for holding this important hearing. We appreciate the 
opportunity to communicate and share with the committee the 
Department's ongoing activities, programs, and research directed toward 
responding to the opioid crisis in the United States.

    From the start of his administration, President Trump has made 
addressing the opioid epidemic a top priority, and at HHS we share the 
President's commitment to bringing an end to this crisis, which is 
exacting a heavy toll on individuals, families, and communities across 
the country. On October 26, 2017, at the request of President Trump and 
consistent with the requirements of the Public Health Service Act, the 
Acting Secretary of HHS declared a nationwide public health emergency 
regarding the opioid crisis, and on March 19th in New Hampshire the 
President announced his ``Initiative to Stop Opioid Abuse and Reduce 
Drug Supply and Demand.'' The Department has made the crisis a top 
clinical priority and is committed to using our full expertise and 
resources to combat the epidemic. The Fiscal Year 2018 Consolidated 
Appropriation Act, which provides HHS new funding to address the opioid 
epidemic, will allow HHS's agencies to continue to invest resources in 
expanding opportunities for evidence-based prevention, treatment and 
recovery support services, surveillance and data collection, and 
research on pain, new non-addictive pain medications, and to enhance 
our understanding of addiction and overdose.

    Over the past 15 years, communities across our Nation have been 
devastated by increasing prescription and illicit opioid abuse, 
addiction, and overdose. According to the Substance Abuse and Mental 
Health Services Administration's (SAMHSA) National Survey on Drug Use 
and Health (NSDUH), in 2016, over 11 million Americans misused 
prescription opioids, nearly 1 million used heroin, and 2.1 million had 
an opioid use disorder due to prescription opioids or heroin. While the 
number of individuals who misused opioids is down by one million from 
2015, opioid overdoses and related deaths remain a major issue and one 
that requires a much broader understanding of a complicated problem. 
Over the past decade, the United States has experienced significant 
increases in rates of neonatal abstinence syndrome (NAS), hepatitis C 
infections, and opioid-related emergency department visits and 
hospitalizations. Most alarming are the continued increases in overdose 
deaths, especially the rapid increase since 2013 in deaths involving 
illicitly made fentanyl and other highly potent synthetic opioids. 
Since 2000, more than 300,000 Americans have died of an opioid 
overdose. Opioids were involved in 42,249 deaths in 2016, five times 
more than in 1999.

    The opioid epidemic in the United States can be attributed to a 
variety of factors. For example, there was a significant rise in opioid 
analgesic prescriptions that began in the mid-to-late 1990s. Not only 
did the volume of opioids prescribed increase, but also well-
intentioned healthcare providers began to prescribe opioids to treat 
pain in ways that we now know are high-risk and have been associated 
with opioid abuse, addiction, and overdose, such as prescribing at high 
doses and for long durations. One additional factor is a lack of health 
system and healthcare provider capacity to identify and engage 
individuals with opioid use disorders, and to provide them with high-
quality, evidence-based opioid addiction treatment, in particular the 
full spectrum of medication-assisted treatment (MAT). It is well-
documented that the majority of people with opioid addiction in the 
United States do not receive treatment, and even among those who do, 
many do not receive evidence-based care. Accounting for these factors 
is paramount to the development of a successful strategy to combat the 
opioid crisis. Further, there is a need for more rigorous research to 
better understand how existing programs or policies might be 
contributing to or mitigating the opioid epidemic.

    In April 2017, HHS outlined its five-point Opioid Strategy, which 
provides the overarching framework to leverage the expertise and 
resources of HHS agencies in a strategic and coordinated manner. The 
comprehensive, evidence-based Opioid Strategy aims to:

          Improve access to prevention, treatment, and recovery 
        support services to prevent the health, social, and economic 
        consequences associated with opioid addiction and to enable 
        individuals to achieve long-term recovery;

          Target the availability and distribution of overdose-
        reversing medications to ensure the broad provision of these 
        drugs to people likely to experience or respond to an overdose, 
        with a particular focus on targeting high-risk populations;

          Strengthen public health data reporting and collection to 
        improve the timeliness and specificity of data and to inform a 
        real-time public health response as the epidemic evolves;

          Support cutting-edge research that advances our 
        understanding of pain and addiction, leads to the development 
        of new treatments, and identifies effective public health 
        interventions to reduce opioid-related health harms; and

          Advance the practice of pain management to enable access to 
        high-quality, evidence-based pain care that reduces the burden 
        of pain for individuals, families, and society while also 
        reducing the inappropriate use of opioids and opioid-related 
        harms.

    To date, the Department has taken significant steps to advance the 
goals of our Opioid Strategy. This statement addresses the unique role 
that the Centers for Medicare and Medicaid Services (CMS) and the 
Administration for Children and Families (ACF) are taking to address 
this opioid crisis. In order to provide a more comprehensive overview 
of the Department's coordinated strategy, it also includes a summary of 
activities that may fall outside of the committee's jurisdiction by 
highlighting efforts within the Office of the Assistant Secretary for 
Health (OASH), the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Centers for Diseases Control and 
Prevention (CDC), the National Institutes of Health (NIH), and the Food 
and Drug Administration (FDA).

                CMS Role in Addressing the Opioid Crisis

    As a payer, CMS plays an important part in the HHS efforts by 
working to make sure providers are providing the right services to the 
right patients at the right time. Beneficiaries are CMS's top priority 
across all of our programs, and CMS works hard to protect their safety 
and put them in the driver's seat of their care. CMS is keenly focused 
on three areas--preventing and reducing OUDs by promoting CDC 
guidelines for opioid prescriptions and encouraging non-opioid pain 
treatments; increasing access to evidence-based treatment for OUD; and 
leveraging data to target prevention and treatment efforts and to 
support fraud, waste, and abuse detection efforts.
            preventing overprescribing and misuse of opioids
    CMS is taking a number of steps to reduce overprescribing in order 
to help prevent the development of new OUDs that originate from opioid 
prescriptions while balancing the need for continued access to 
prescription opioids for certain medical conditions and pain 
management.

    Due to the structure of the Medicare Part D program, Medicare 
Advantage Organizations (MAOs) and Medicare Part D sponsors have a 
primary role in detecting and preventing potential misuse of opioids. 
All Medicare Part D sponsors are expected to have a documented, written 
strategy for addressing overutilization of prescription opioids given 
the public health crisis. CMS's job is to oversee Medicare Part D plans 
to ensure that they are in compliance with requirements that protect 
beneficiaries and can help prevent and address opioid overutilization. 
Medicare Part D plans are expected to use multiple tools including 
better formulary management, case management with beneficiaries' 
clinicians aimed at coordinated care, and safety edits at the point of 
dispensing.

    CMS recently finalized a series of additional changes for 2019 to 
further the goal of preventing OUD.\1\ To reduce the potential for 
chronic opioid use or misuse, beginning in 2019, CMS expects all Part D 
sponsors to limit initial opioid prescription fills for the treatment 
of acute pain to no more than a 7 day supply. This policy change is 
consistent with the Centers for CDC Guideline for Prescribing Opioids 
for Chronic Pain \2\ that states that opioids prescribed for acute pain 
in most cases should be limited to 3 days or fewer, and that more than 
a 7-day supply is rarely necessary.
---------------------------------------------------------------------------
    \1\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/
2018-Fact-sheets-items/2018-04-02-2.html.
    \2\ See https://www.cdc.gov/drugoverdose/prescribing/
guideline.html.

    Safety edits alert a pharmacist of possible overutilization at the 
point of sale. In real-time they can flag for a pharmacist that they 
should conduct additional review and/or consultation with the plan 
sponsor or prescriber to ensure that a prescription is appropriate. In 
2018, all plan sponsors are utilizing these safety edits. Beginning in 
2019, we expect all sponsors to implement a new opioid care 
coordination safety-edit. This new edit would create an alert for 
pharmacists when a beneficiary's daily opioid usage reaches high 
levels. When this occurs, plan sponsors are expected to direct 
pharmacists to consult with the prescriber to confirm their intent. 
This new policy aims to strike a balance between addressing opioid 
overuse without a negative impact on the patient-doctor relationship, 
preserving access to medically necessary drug regimens, and reducing 
the potential for unintended consequences.
Lock-In Authority
    For years, States have been establishing and augmenting effective 
``lock-in'' programs that require Medicaid enrollees who are ``at-
risk'' for misusing or abusing opioids to use only one pharmacy and/or 
get prescriptions from only one medical office. The Comprehensive 
Addiction and Recovery Act of 2016 (CARA) provides CMS with the 
authority to allow Medicare Part D plans to implement similar pharmacy 
and prescriber lock-in programs. For both Medicaid programs and 
Medicare Part D plans, lock-in programs are an additional tool to 
promote better coordination between providers and beneficiaries who 
meet the guidelines for lock-in.

    Under current law,\3\ States are able to implement lock-in 
requirements for enrollees who have utilized Medicaid services at a 
frequency or amount that is not medically necessary, according to 
guidelines established by the State. These limitations may be imposed 
for ``a reasonable period of time.'' Almost all Medicaid agencies have 
a Lock-In or Patient Review and Restriction Program in which the State 
identifies potential fraud or misuse of controlled drugs by a 
beneficiary.
---------------------------------------------------------------------------
    \3\ 42 CFR 431.54(e).

    CMS recently implemented the new CARA lock-in requirements in Part 
D to provide an important additional tool to combat the growing opioid 
epidemic that is devastating families and communities across the 
Nation.\4\ CARA requires CMS to establish through regulation a 
framework that allows Part D sponsors to implement drug management 
programs. The policy incorporated input gathered from various 
stakeholders, including beneficiary advocates, clinicians, pharmacists, 
pharmacy benefit managers, and plan sponsors. With a focus on 
addressing opioid misuse, the proposal would integrate our new ``lock-
in'' authority with current CMS programs aimed at curbing the opioid 
epidemic. For example, Part D plan sponsors implementing a drug 
management program could limit an at-risk beneficiary's access to 
coverage of frequently abused drugs beginning in 2019 through a 
beneficiary-specific Point of Sale (POS) claim edit and/or by requiring 
the beneficiary to obtain frequently abused drugs from a selected 
pharmacy(ies) and/or prescriber(s) after case management and notice to 
the beneficiary. In addition, the President's FY 2019 budget \5\ 
includes a proposal that would provide the HHS Secretary with the 
authority to require plan participation in a prescriber and/or pharmacy 
lock-in program to prevent prescription drug abuse in Medicare Part D; 
this proposal would save an estimated $100 million over 10 years.
---------------------------------------------------------------------------
    \4\ https://www.cms.gov/Medicare/Prescription-Drug-Coverage/
PrescriptionDrugCovContra/Downloads/CY2019-Medicare-Advantage-Part-D-
Final-Rule.
    \5\ https://www.whitehouse.gov/wp-content/uploads/2018/02/budget-
fy2019.pdf.
---------------------------------------------------------------------------
Tools for State Medicaid Agencies
    While the Federal Government establishes general guidelines for 
Medicaid, States design, implement, and administer their own programs. 
CMS takes this partnership seriously, and because Medicaid is the 
single largest payer for behavioral health services, and has been 
working under the current statutory framework to ensure that States 
have the tools they need and to share best practices to improve care 
for individuals with mental illnesses or substance use disorders (SUD).

    To reduce opioid misuse without restricting access to legitimate 
services, Medicaid programs can utilize medical management techniques 
such as step therapy, prior authorization, and quantity limits. For 
example, Vermont implemented prior authorization criteria which 
involves step therapy for methadone as a treatment of pain, requiring 
that patients must have documented side effects, allergies, or 
treatment failure to a preferred, long-acting opioid before being 
prescribed methadone for pain. Virginia implemented prior authorization 
criteria which involves additional documentation by both providers and 
beneficiaries before long-acting opioids can be approved for managing 
chronic, nonmalignant pain. As of FY 2016, 37 States have edits in 
place to limit the quantity of short-acting opioids that will be 
covered for a beneficiary and 39 States have similar edits in place to 
limit the quantity of long-acting opioids. Additionally, to increase 
oversight of certain prescription opioids, States have the option of 
amending their Preferred Drug Lists and Non-Preferred Drug Lists to 
require prior authorization for certain opioids.

    States are required to report on their providers' prescribing 
patterns, including prescription opioids, as part of the Medicaid Drug 
Utilization Review (DUR) program. This is a two-phase process that is 
conducted by the State Medicaid agencies. During the first phase, 
(prospective DUR), the State agency's electronic monitoring system 
screens prescription drug claims to identify problems such as 
therapeutic duplication, contraindications, incorrect dosage, and 
clinical misuse or abuse. The second phase (retrospective DUR) involves 
ongoing and periodic examination of claims to identify patterns of 
fraud, abuse, gross overuse, or medically unnecessary care.

    The President's FY 2019 budget includes a proposal that would 
establish minimum standards for Medicaid Drug Utilization Review 
programs. Currently, CMS does not set minimum requirements for these 
programs, and there is substantial variation in how States approach 
this issue. Establishing minimum standards would not only help increase 
oversight of opioid prescriptions and dispensing in Medicaid, but would 
save the program an estimated $245 million over 10 years.
              ensuring access to evidence-based treatment
    A critical part of tackling this epidemic is making sure that 
beneficiaries grappling with OUD have access to the most effective 
treatment options. Through its networks of health quality experts and 
clinicians, CMS advocates the sharing of best practices for OUD 
screening and treatment.

    Medicare Parts A and B cover and pay for substance abuse services 
in multiple ways. Inpatient treatment in a hospital is covered if 
reasonable and necessary; treatment in a partial hospitalization 
program, such as an intensive outpatient psychiatric day treatment 
program, is also covered when the services are furnished through 
hospital outpatient departments and Medicare-certified community mental 
health centers. Medicare pays for substance abuse treatment services 
provided by physicians and other practitioners on a service-by-service 
basis under the Medicare Physician Fee Schedule, such as counseling 
services provided by a psychiatrist. Medicare Part B pays for 
medications used in physician offices or other outpatient settings that 
require a physician/practitioner to administer, including injections 
like naltrexone or implants of drugs like buprenorphine used in 
medication-assisted treatment. In addition, CMS recently made changes 
to the Medicare Physician Fee Schedule that help support the fight 
against the opioid epidemic, such as establishing separate coding and 
payment for the insertion and removal of buprenorphine implants, a key 
drug used in medication-assisted treatment for opioid addiction, and 
improving payment for office-based behavioral health services.
Medication-Assisted Treatment (MAT)
    Medication-Assisted Treatment (MAT) is the use of medications, in 
combination with counseling and behavioral therapies, to treat SUDs, 
including OUDs. MAT is a valuable intervention that has been proven to 
be the most effective treatment for OUD, particularly because it 
sustains long-term recovery and has been shown to reduce opioid-related 
morbidity and mortality.\6\ To increase access to MAT, CMS requires 
that Medicare Part D formularies include covered Medicare Part D drugs 
used for MAT and mandates Medicare Part C coverage of the behavioral 
health element of MAT services. In addition, CMS issued guidance on 
best practices in Medicaid for covering MAT in a joint informational 
bulletin with SAMHSA, the CDC, and the National Institute on Drug 
Abuse.\7\ CMS also released an informational bulletin with SAMHSA on 
coverage of treatment services for youth with SUD.\8\
---------------------------------------------------------------------------
    \6\ https://www.ncbi.nlm.nih.gov/pubmed/24500948.
    \7\ https://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-
07-11-2014.pdf.
    \8\ https://www.medicaid.gov/federal-policy-guidance/downloads/cib-
01-26-2015.pdf.

    While Medicaid programs vary greatly by State, all 50 States 
currently offer some form of MAT. In addition, the President's FY 2019 
budget includes a proposal that would require State Medicaid programs 
to cover all FDA-approved MAT for OUD, including associated counseling 
and other costs. These up-front investments in expanded MAT treatment 
are expected to reduce total Medicaid expenditures over time as more 
individuals recover from OUD; this provision would result in an 
---------------------------------------------------------------------------
estimated $865 million is savings over 10 years.

    Under an additional proposal in the President's FY 2019 budget, CMS 
would conduct a demonstration to test the effectiveness of covering 
comprehensive substance abuse treatment in Medicare. This demonstration 
could be expanded nation-wide if successful in key metrics, such as 
reducing opioid-related deaths among beneficiaries, reducing 
hospitalization for opioid poisoning, and reducing emergency room 
utilization for opioid-related issues. Through this proposal, Medicare 
would provide bundled reimbursement on a per-week-per-patient basis to 
providers for methadone treatment or similar MAT and would recognize 
opioid treatment programs and substance abuse treatment facilities as 
independent provider types; outpatient counseling would be billed 
separately as clinically necessary. The model would be allowed to 
target beneficiaries determined to be at-risk, as defined by the 
Overutilization Monitoring System, to voluntarily receive comprehensive 
substance abuse treatment, including MAT and SUD counseling.
Increasing the Use of Naloxone to Reverse Opioid Overdose
    CMS is also promoting improved access to the opioid overdose 
reversal drug naloxone by requiring that it appear on all Medicare Part 
D formularies.\9\ CMS recognizes that it is very important for Medicare 
beneficiaries and those who care for them to understand that these 
options are available to them under Medicare, so CMS is also working to 
educate clinicians, health plans, pharmacy benefit managers, and other 
providers and suppliers on services covered by Medicare to treat 
beneficiaries with OUD.\10\
---------------------------------------------------------------------------
    \9\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf.
    \10\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLN
MattersArticles/downloads/SE1604.pdf.

    In addition, Medicaid programs in a number of States include forms 
of naloxone on their Medicaid Preferred Drug Lists. CMS has also issued 
guidance to States on improving access to naloxone.\11\ States can 
offer training in overdose prevention and response for providers and 
members of the community, including family members and friends of 
opioid users.
---------------------------------------------------------------------------
    \11\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-02-02-16.pdf and https:
//www.medicaid.gov/federal-policy-guidance/downloads/cib011717.pdf.
---------------------------------------------------------------------------
Substance Use Disorder (SUD) Treatment and Demonstrations in Medicaid
    Under the demonstration authority granted by section 1115 of the 
Social Security Act, CMS can waive certain Federal requirements so that 
States can test new or existing ways to deliver and pay for health-care 
services in Medicaid. Last November, CMS announced that it was using 
this authority to provide for a streamlined process for States 
interested in designing demonstration projects that increase access to 
treatment for OUDs and other SUDs by permitting services to be covered 
in an institution for mental diseases (IMD) as part of a State's 
comprehensive OUD/SUD strategy. Current law prohibits Medicaid from 
making payments to IMDs for services rendered to Medicaid beneficiaries 
ages 21 to 64. Previously, States seeking to cover services otherwise 
subject to the exclusion of coverage for IMD patients had been required 
to meet rigid CMS standards concerning operational details for 
implementation before Medicaid demonstration approvals could be 
granted. The new policy will allow States to begin to provide better 
treatment options more quickly while improving the continuum of care 
over time.

    CMS is encouraging States to apply for approval of a 5-year 
demonstration allowing them to receive Federal financial participation 
for services to treat addiction to opioids or other substances, 
including services provided to Medicaid beneficiaries residing in IMDs, 
as these States work to improve access to treatment in outpatient 
settings as well. In addition, CMS is working with States that operate 
these demonstrations to establish strong quality of care standards, 
particularly for residential treatment settings.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones established by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these programs; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis. To date, CMS have approved these waivers for 5 States--
Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    To further support this initiative, throughout 2018, the Medicaid 
Innovation Accelerator Program (IAP) will be available to States that 
would benefit from strategic design support related to improving their 
treatment delivery systems. The IAP provides States with access to 
national learning opportunities and technical expert resources, 
including strategic design support to States planning targeted 
addiction treatment delivery system reforms and developing 1115 
proposals. In addition, CMS is available to provide technical 
assistance to States on how to meet Federal transparency requirements 
as well as to preview States' draft 1115 proposals and public notice 
documentation to help ensure States successfully meet Federal 
requirements.

    Another tool States have to improve access to treatment through 
their Medicaid programs is the implementation of a health home benefit 
focused on improving treatment for beneficiaries with opioid use 
disorder. Health homes are an optional benefit for which States can 
receive 90 percent Federal match for the first 2 years to improve care 
coordination and care management for individuals with chronic 
conditions including substance use disorders.\12\
---------------------------------------------------------------------------
    \12\ Four States currently focus health home benefits on improving 
treatment for opioid use disorders: VT, MD, RI, and ME.
---------------------------------------------------------------------------
      leveraging data to enhance prevention and treatment efforts
    Data are a powerful tool and CMS is utilizing the vast amounts of 
data at our disposal to better understand and address the opioid 
crisis. CMS is working with its partners to ensure that they have the 
data and information they need to make changes and improvements to help 
address the crisis.
Utilizing Medicare Data to Address Overutilization
    CMS uses the Overutilization Monitoring System (OMS) to help CMS 
ensure that sponsors have established reasonable and appropriate drug 
utilization management programs to assist in preventing overutilization 
of certain prescribed medications, including opioid pain medications. 
CMS has continued to refine and improve the criteria used in OMS. OMS 
identifies and reports on beneficiaries with a high risk of misusing 
opioids and plan sponsors can then use these reports generated by OMS 
to conduct case management and beneficiary-specific edits. Starting 
this year, beneficiaries are now identified as at-risk and reported to 
plans if, in the most recent 6 months, their daily dose of opioids 
exceeds 90 morphine milligram equivalent (MME); and if they have 
received opioids from more than three prescribers and more than three 
pharmacies, or from more than five prescribers, regardless of the 
number of opioid dispensing pharmacies.\13\
---------------------------------------------------------------------------
    \13\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2018.pdf.

    In the 2019 Final Call Letter,\14\ CMS finalized additional 
enhancements to the OMS including revised metrics to track high opioid 
overuse and to provide additional information to sponsors about high 
risk beneficiaries who take opioids and ``potentiator'' drugs, such as 
benzodiazepines, (which when taken with an opioid increase the risk of 
an adverse event). To help identify and prevent opioid users from 
taking duplicate or key ``potentiator'' drugs, in 2019 CMS also expects 
sponsors to implement additional safety edits to alert the pharmacist 
about duplicative opioid therapy and concurrent use of opioids and 
benzodiazepines.
---------------------------------------------------------------------------
    \14\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf.

    CMS utilizes the National Benefit Integrity Medicare Drug Integrity 
Contractor (NBI MEDIC) to conduct data analysis that is shared with 
plan sponsors to help them identify outlier prescribers or pharmacies. 
For example, plans receive Quarterly Outlier Prescriber Schedule II 
Controlled Substances Reports, which provide a peer comparison of 
prescribers of Schedule II controlled substances. This report now 
provides a separate analysis of just opioids. Plans also receive 
quarterly pharmacy risk assessment reports, which contain a list of 
pharmacies identified by CMS as high risk and provide plan sponsors 
with information to initiate new investigations, conduct audits, and 
potentially terminate pharmacies from their network, if appropriate. 
CMS has also sent letters to prescribers that include educational 
information and comparative billing data and held webinars \15\ for 
prescribers whose opioid prescribing patterns were different as 
compared with their peers on both a specialty and/or national level.
---------------------------------------------------------------------------
    \15\ https://www.cbrinfo.net/cbr201801-webinar.

    To assist clinicians, nurses, and other health-care providers to 
assess opioid-
prescribing habits while continuing to ensure patients have access to 
the most effective pain treatment, CMS released an interactive online 
mapping tool. The mapping tool allows the user to see both the number 
and percentage of opioid claims at the local level and offers spatial 
analyses to identify ``hot spots'' or clusters in order to better 
understand how this critical issue impacts communities nationwide.\16\
---------------------------------------------------------------------------
    \16\ https://www.cms.gov/Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/
OpioidMap.html.

    The CMS Quality Innovation Network Quality Improvement Organization 
(QIN-QIO) program, consisting of 14 quality contractors, works to 
improve health-care quality and safety for Medicare beneficiaries. The 
QIN-QIO program \17\ has established a methodology using CMS claims 
data to identify adverse events, hospital admissions, readmissions, 
emergency visits, and observation stays for high-risk Medicare 
beneficiaries who have taken an opioid medication in the outpatient 
setting. QIN-QIOs collaborate with providers and other community 
coalitions, using their reports to support local and national efforts 
to address the opioid epidemic and increase surveillance of adverse 
events.
---------------------------------------------------------------------------
    \17\ http://qioprogram.org/about/why-cms-has-qios.
---------------------------------------------------------------------------
Modernizing Medicaid Data Collection
    CMS has been working with States to implement changes to the way in 
which administrative data is collected by moving from the Medicaid 
Statistical Information System (MSIS) to the Transformed-MSIS (T-MSIS). 
More robust, timely, and accurate data via T-MSIS will strengthen 
program monitoring, policy implementation, and oversight of Medicaid 
and CHIP programs. CMS is working to transition all States to T-MSIS 
and has made significant progress. As of March 8, 2018, 49 States plus 
the District of Columbia and Puerto Rico have begun submitting T-MSIS 
data. These entities represent 98 percent of the Medicaid and CHIP 
population. CMS continues to work with the remaining States to help 
them submit data and expects all States to report T-MSIS data.\18\
---------------------------------------------------------------------------
    \18\ https://www.medicaid.gov/medicaid/data-and-systems/macbis/
tmsis/index.html.

    CMS has begun to develop tools for T-MSIS users, as well as work 
with States to improve the quality of data submitted. For example, CMS 
is developing a data quality assessment for users, which aggregates 
data quality findings in a user-friendly tool. These efforts will help 
States report complete and comparable T-MSIS data, which CMS plans to 
use for program oversight efforts. T-MSIS includes data on prescription 
opioids, and CMS looks forward to working with States to fully utilize 
this data in innovative ways that will augment efforts to combat opioid 
---------------------------------------------------------------------------
misuse.

    The President's FY 2019 budget also includes a proposal to require 
States to monitor high-risk billing activity to identify and remediate 
prescribing and utilization patterns that may indicate abuse or 
excessive utilization of certain prescription drugs in the Medicaid 
program. States are currently authorized to implement prescription drug 
monitoring activities, but not all States have adopted such activities. 
States would have flexibility to choose one or more drug classes and 
must develop or review and update their care plans to reduce 
utilization and remediate any preventable episodes to improve Medicaid 
integrity and beneficiary quality of care.

                     ACF Role in the Opioid Crisis

                 the regional partnership grant program
    Since 2007, the Regional Partnership Grant (RPG) program has been a 
cornerstone to the ACF Children's Bureau's efforts to improve outcomes 
for children and families affected by parental substance use. The 
intent of the RPG program, authorized under sections 436 and 437 of the 
Social Security Act as part of the Promoting Safe and Stable Families 
program, is to increase the well-being, improve permanency outcomes, 
and enhance the safety of children and families in the child welfare 
system who are affected by parental substance use. The grants are 
funded to support collaborative partnerships among child welfare, 
substance use disorder treatment, court systems, and other family 
support systems and organizations to implement evidence-based, 
evidence-informed, and promising programs and strategies with children 
and families. To date, there have been four rounds of Regional 
Partnership Grants, with round 4, consisting of 17 grants in 17 States, 
awarded in September 2017.
    regional partnership grants round 2 (2012-2017) interim findings
    The cross-site evaluation has resulted in several significant, 
interim findings that will be formally shared in a forthcoming Report 
to Congress. From October 2012 to April 2017, the 17 RPG round 2 
grantees enrolled 11,416 adults and children--55 percent of whom were 
children, the majority under 5 years old. The strategies and services 
provided by the RPGs included: expanded and timely access to 
comprehensive family-centered treatment; creation or expansion of 
family treatment drug courts; in-home services; case management and 
case conferencing; and use of evidence-based and evidence-informed 
practice approaches, such as recovery coaches, mental health, and 
trauma-informed services; parent-child interventions; and strengthening 
of cross-system collaboration. Most RPG round 2 families received at 
least one evidence-based program.

    Interim findings demonstrate many adult and child outcomes improved 
significantly following entry into RPG. These findings include a 
significant decrease in adult drug and alcohol use between program 
entry and exit, and adult mental health and parenting attitudes 
improved significantly with fewer attitudes about parenting that placed 
their children at risk of maltreatment. Additionally, there was a 
significant reduction in rates of substantiated maltreatment. Thirty-
six percent of children in RPG had an instance of substantiated 
maltreatment in the year before RPG, and this decreased to just 7 
percent of children in the year after RPG enrollment. Removals of 
children from the home were also less common. Twenty-nine percent of 
children experienced a removal in the year before RPG enrollment, and 
only 6 percent of children were removed from the home after entering 
RPG. Reunifications with the family of origin or other permanent 
placements were also more common in the year after RPG entry than in 
the year before. The cross-site evaluation also completed analysis of 
the adults in RPG round 2 that indicated at program entry they were 
opioid users. As a result of participation in RPG program, opioid use 
in particular appears to be an area of significant improvement. 
Approximately 16 percent of adults were recent prescription opioid 
users at program entry, and only 4 percent of adults indicated at 
program exit that they were recent prescription opiate users.
national center on substance abuse and child welfare's (ncsacw) work to 
  address the impact on the opioid crisis on the child welfare system
    The National Center on Substance Abuse and Child Welfare (NCSACW) 
is a HHS initiative jointly funded by SAMHSA's Center for Substance 
Abuse Treatment and the Administration for Children and Families' 
Children's Bureau and administered by SAMHSA. The mission of the NCSACW 
is to improve family recovery, safety, and stability by advancing 
practices and collaboration among agencies, organizations, and courts 
working with families affected by substance use and co-occurring mental 
health disorders and child abuse or neglect. The NCSACW provides 
training and technical assistance (TA) to families affected by 
substance use disorders, including opioid use disorders, and involved 
with the child welfare system. The NCSACW saw a dramatic and sizable 
increase in TA responses related to opioids from 2009 to 2017. TA 
responses included sharing of information on related topics such as 
best practices in the treatment of opioid use disorders during 
pregnancy and collaboration to support infants with prenatal substance 
exposure and their families. The NCSACW also creates written materials 
that support communities in addressing the opioid epidemic. In 2016, 
the NCSACW released ``A Collaborative Approach to the Treatment of 
Pregnant Women With Opioid Use Disorders.'' This publication continues 
to be the most-downloaded resource from the NCSACW website with 2,148 
downloads to date. Web-based tutorials are also provided to train 
substance use disorder treatment, child welfare, and court 
professionals. The content of these tutorials includes information on 
opioid use disorders, Child Abuse Prevention and Treatment Act (CAPTA), 
and Plans of Safe Care.

    NCSACW also provides a limited amount of in-depth TA to State, 
tribal, and local agencies to assist in developing cross-system 
partnerships and the implementation of best practices to address the 
needs of this population. The NCSCAW's Substance-Exposed Infants In-
Depth Technical Assistance (SEI-IDTA) program is working to advance the 
capacity of agencies to improve the safety, health, permanency, and 
well-being of infants with prenatal substance exposure and the recovery 
of pregnant and parenting women and their families. Currently, 
Delaware, New York, Florida, Maryland, North Carolina, and West 
Virginia are receiving time-limited SEI-IDTA to develop policy and 
protocols on the prenatal substance exposure provisions CAPTA.
 the role of oash, samhsa, cdc, nih, and fda in addressing the opioid 
                                 crisis
    OASH coordinates multiple efforts across HHS and other Federal 
agencies that address cross-cutting issues related to opioids and pain.

          Pain Management Best Practices Inter-Agency Task Force (Task 
        Force)--The Task Force was established by the Comprehensive 
        Addiction and Recovery Act of 2016 to: (1) identify gaps or 
        inconsistencies in pain management best practices, (2) propose 
        recommendations on addressing identified gaps or 
        inconsistencies, and (3) develop a strategy for disseminating 
        information about the Task Force recommendations. The Task 
        Force will include a broad spectrum of stakeholders Task Force 
        representatives will include a variety of Federal and non-
        Federal stakeholders including patients, veteran services, 
        first responders, health-care providers, and experts in pain, 
        addiction, mental health, and other areas of expertise.

          National Pain Strategy (NPS)--OASH and NIH are implementing 
        the NPS, which is a coordinated plan to reduce the burden of 
        chronic pain in the United States; and to achieve a system of 
        care in which all people receive high quality, evidence-based 
        pain care. Areas of focus include population research, 
        disparities, and education and training, among others.

          Behavioral Health Coordinating Council (BHCC)--The Assistant 
        Secretary for Health and the Assistant Secretary for Mental 
        Health and Substance Use co-lead the BHCC, which is a convening 
        body that provides guidance and recommendations on the HHS 
        behavioral health agenda. Areas of focus include prescription 
        drug and opioid abuse, behavioral health and primary care 
        integration, and serious mental illness, among others.

          The Surgeon General is also within OASH. U.S. Surgeon 
        General Jerome M. Adams, M.D., recently released a public 
        health advisory to urge more Americans to carry a potentially 
        lifesaving medication that can reverse the effects of an opioid 
        overdose. The medication, naloxone, is already carried by many 
        first responders, such as EMTs and police officers. The Surgeon 
        General is now recommending that more individuals, including 
        family, friends and those who are personally at risk for an 
        opioid overdose, also keep the drug on hand. Expanding the use 
        of the overdose-reversing drug naloxone is a key part of the 
        public health response to the opioid crisis, and is one of the 
        five components of the HHS Opioid Strategy.

    As HHS's lead agency for behavioral health, SAMHSA's core mission 
is to reduce the impact of substance abuse and mental illness on 
America's communities. SAMHSA supports a portfolio of activities that 
address all five prongs of HHS's Opioid Strategy.

    SAMHSA administers the Opioid State Targeted Response (STR) grants, 
a 2-year program authorized by the 21st Century Cures Act (Pub. L. 114-
255). By providing $485 million to States and U.S. territories in 
fiscal year (FY) 2017, this program allows States to focus on areas of 
greatest need, including increasing access to treatment, reducing unmet 
treatment need, and reducing opioid overdose related deaths through the 
provision of the full range of prevention, treatment and recovery 
services for opioid use disorder.

    In November 2017, SAMHSA announced that it was accepting 
applications for $1 million in grants for Opioid State Targeted 
Response (STR) Supplements. The purpose of this program is to expand 
and enhance prevention, treatment, and recovery support efforts in the 
States hardest hit by the Nation's opioid epidemic. The purpose of the 
supplemental funding is to bolster efforts already being made through 
the STR grant program. On March 19, 2018, SAMHSA awarded grants to 
three States that are among those with the highest overdose death rates 
and greatest increases in death rates. This funding follows the STR 
grants which SAMHSA distributed to States and territories based on 
number of overdose deaths and the number of people needing treatment.

    SAMHSA also has several initiatives aimed specifically at advancing 
the utilization of medication-assisted treatment (MAT) for opioid use 
disorder, which is proven effective but is highly underutilized. 
SAMHSA's Medication Assisted Treatment for Prescription Drug and Opioid 
Addiction (MAT-PDOA) program expands MAT access by providing grants to 
States with the highest rates of treatment admissions for opioid 
addiction. Twenty-two States are currently funded by MAT-PDOA, and in 
September 2017, SAMHSA awarded $35 million dollars over 3 years in 
additional MAT-PDOA grants to six States.

    As the Nation's public health and prevention agency, CDC is 
applying scientific expertise to understand the epidemic and use that 
information to create interventions to prevent further harms, including 
the spread of infectious disease and the impact of opioids on mothers 
and babies. CDC continues to be committed to the comprehensive 
priorities outlined in the HHS strategy and to saving the lives of 
those touched by this epidemic. CDC's work falls into five key 
strategies to address opioid overdose and other opioid-related harms: 
(1) conducting surveillance and research; (2) building State, local, 
and tribal capacity; (3) supporting providers, health systems, and 
payers; (4) partnering with public safety; and (5) empowering consumers 
to make safe choices.

    CDC tracks and analyzes data to improve our understanding of this 
epidemic. Since 1999, more than 632,000 Americans have died from drug 
overdoses. In 2016, the death toll continued to rise. Over 63,600 
deaths resulted from drug overdoses.\19\ More than 42,000 of those 
deaths involved opioids.\20\ According to the most recent provisional 
data, there were 67,344 drug overdose deaths in the 12-month period 
ending August 2017. This is an increase of nearly 8,000 deaths 
attributed to drug overdose compared to the 12-month period ending 
August 2016. CDC's data indicate that these increases were primarily 
driven by synthetic opioids, including illicitly manufactured fentanyl. 
Given the evolving nature of this epidemic, it is essential that we 
continue to track and analyze data to target prevention efforts.
---------------------------------------------------------------------------
    \19\ https://www.cdc.gov/mmwr/volumes/67/wr/mm6709e1.htm.
    \20\ https://www.cdc.gov/mmwr/volumes/67/wr/mm6709e1.htm.

    Data are crucial in driving public health action. Timely, high-
quality data can help public health, public safety, and mental health 
experts better understand the problem, focus resources where they are 
needed most, and evaluate the success of prevention and response 
efforts. During the past few years, CDC has invested in strengthening 
the capacity of States to monitor the opioid overdose epidemic and 
target their prevention activities. CDC currently provides funding and 
scientific support to 45 States and Washington, DC to equip States with 
the tools and technical expertise they need to implement a 
comprehensive prevention program within their communities. States 
utilize their funding to enhance Prescription Drug Monitoring Programs 
(PDMPs) and leverage them as public health tools, improve health system 
and insurer practices for safer opioid prescribing, support community-
level response and prevention activities, and evaluate policies that 
may impact the opioid epidemic (e.g., naloxone distribution and Good 
Samaritan laws). In addition, CDC funds 32 States and Washington, DC to 
improve the timeliness and comprehensiveness of fatal and non-fatal 
opioid-involved overdose reporting and to disseminate data to 
---------------------------------------------------------------------------
stakeholders.

    CDC is also taking the lead in preventing opioid-related harms such 
as the spread of infectious disease and the impact of opioids on 
mothers and babies. The recent threefold increase in hepatitis C and 
the 2015 HIV outbreak in Indiana underscore the urgency of the issue. 
New hepatitis C infections have increased more than 167 percent in 
recent years and States like Kentucky, Tennessee, Virginia, and West 
Virginia reported a 364 percent increase in new hepatitis C infections 
from 2006 to 2012 in persons under 30. Surveillance for viral hepatitis 
is limited. Infectious disease surveillance is essential to know the 
true scale of the epidemic and facilitate more effective State and 
local responses.

    NIH is the lead HHS agency providing support for cutting-edge 
research on pain and opioid misuse, opioid use disorder, and overdose. 
Drug addiction and pain are complex neurological conditions, driven by 
many biological, environmental, social, and developmental factors. 
Continued research will be key to understanding the opioid crisis, 
informing future efforts, and developing more effective, safer, and 
less addictive pain treatments.

    Over the last year, NIH has continued its work with stakeholders 
and experts across scientific disciplines and sectors to identify areas 
of opportunity for research to combat the opioid crisis. These 
discussions have centered on ways to reduce the over prescription of 
opioids, accelerate development of effective non-opioid therapies for 
pain, and provide more flexible options for treating opioid addiction. 
The result of these discussions is the recently launched NIH Helping to 
End Addiction Long-term (HEAL) Initiative. This new Initiative will: 
(1) advance our understanding of the genetic, social, and other factors 
that put patients at increased risk for opioid misuse and addiction; 
(2) expand the therapeutic options available for treating opioid use 
disorder and overdose; (3) explore the effectiveness of medication-
assisted treatment in conjunction with nondrug treatment approaches 
such as cognitive therapy and meditation; (4) develop new treatments 
for OUD, including immunotherapies that can block the effects of 
opioids on the brain; and (5) evaluate treatment options for neonatal 
abstinence syndrome. The HEAL Initiative also will also include a 
demonstration study to test the integration of multiple addiction 
prevention and treatment approaches into health-care and criminal 
justice settings in States with the highest rates of opioid misuse and 
overdose.

    The HEAL Initiative will also prevent addiction through enhanced 
pain management. A longitudinal study will explore the transition from 
acute to chronic pain, non-addictive pain medications development 
efforts will be enhanced by data sharing, and a clinical trials network 
for pain therapeutics development will be developed. Best practices for 
pain management will be further explored, including nondrug and 
integrated therapies. Finally, innovative neurotechnologies will be 
used to identify potential new targets for the treatment of chronic 
pain, and biomarkers that can be used to predict individual treatment 
response will be explored and validated.

    The NIH HEAL Initiative will build on extensive, well-established 
NIH research that has led to successes such as the development of the 
nasal form of naloxone, the most commonly used nasal spray for 
reversing an opioid overdose; the development of buprenorphine for the 
treatment of opioid use disorder; and the use of nondrug and mind/body 
techniques to help patients control and manage pain, such as yoga, tai 
chi, acupuncture, and mindfulness meditation.

    Advances that NIH is working to promote may occur rapidly, such as 
improved formulations of existing medications, longer-acting overdose-
reversing drugs, and repurposing of medications approved for other 
conditions to treat pain and addiction. Others may take longer, such as 
novel overdose-reversal medications, identifying biomarkers to measure 
pain in patients, and new non-addictive pain medications.

    Finally, NIH is engaged in efforts to advance the HHS Opioid 
Strategy pillar of advancing the practice of pain management. NIH 
worked with HHS and agencies across government to develop the National 
Pain Strategy, the government's first broad-ranging effort to improve 
how pain is perceived, assessed, and treated, and is now working with 
other Departments and Agencies and external stakeholders to implement 
this Strategy. NIH is also involved in implementing the Federal Pain 
Research Strategy, a long-term strategic plan developed by the 
Interagency Pain Research Coordinating Committee (IPRCC) and the 
National Institutes of Health to advance the Federal pain research 
agenda.

    The issue of opioid misuse and abuse remains one of FDA's highest 
priorities and the agency has a critical and unique role to play in 
addressing this national crisis. FDA's regulatory oversight of lawfully 
prescribed drugs gives the agency important opportunities to impact 
prescribing in ways that can reduce the rate of new addiction while 
making sure patients with medical needs have access to appropriate 
therapy. FDA also plays an important role in interdiction of unlawful 
drugs, in particular, illegal drugs that are shipped through 
international mail facilities.

    Some percentage of patients who are prescribed opioids will develop 
an addiction to these drugs. Addiction is characterized by a pronounced 
craving for the drug, obsessive thinking about the drug, erosion of 
inhibitory control over efforts to refrain from drug use, and 
compulsive drug taking. This is very different than physical dependence 
on opioids. The repeated administration of any opioid almost inevitably 
results in the development of tolerance and physical dependence. These 
short-term results of physical dependence from repeated opioid 
administration require dose tapering. FDA has taken steps to address 
both the risk of addiction and physical dependence. FDA recently 
announced its plans to expand the risk management plans, known as Risk 
Evaluation and Mitigation Strategies or REMS, to incorporate, for the 
first time, all opioid analgesics that are intended for use in the 
outpatient setting, including the immediate-release formulations. FDA 
has revised the associated Blueprint \21\ for how providers should be 
educated about pain management in general, and prescribing opioid 
analgesics specifically. And we are requiring that this training be 
extended to all providers likely to come into contact with patients who 
are prescribed these medicines, including nurses and pharmacists.
---------------------------------------------------------------------------
    \21\ https://www.regulations.gov/contentStreamer?documentId=FDA-
2017-D-2497-0683&attachmentNumber=1&contentType=pdf.

    FDA also is taking immediate action when needed, as it did with 
FDA's first-of-its-kind request to remove a marketed opioid pain drug 
from sale due to the public health consequences associated with the 
product's abuse. The agency is also looking closely at certain opioids 
that may have a higher abuse potential. This includes oxymorphone, an 
active ingredient in certain opioid drugs. If it is determined, through 
a scientific process, that a particular opioid drug was more prone to 
abuse, and addiction, FDA would consider taking additional regulatory 
---------------------------------------------------------------------------
steps.

    One key to reducing the rate of new addiction is to rationalize 
prescribing to help make sure that patients are prescribed opioids only 
when medically indicated. When a prescription is written, it should be 
for a dose and duration of use that comports closely with the clinical 
purpose. FDA is considering several potential strategies to promote 
proper opioid prescribing and dispensing that involve new measures with 
respect to how opioid products are packaged and labeled, and how 
providers are educated about their proper prescribing.

    On the issue of illegal narcotics, such as illicit fentanyl, that 
are coming into the United States via international mail, FDA has taken 
action to enhance our operations at international mail facilities 
(IMFs). FDA plays an important role related to the interdiction work 
that takes place in the IMFs. When an illegal controlled substance is 
identified in the IMFs, our partners at Customs and Border Protection 
(CBP) will immediately seize it, such that products readily and 
initially identified as controlled substances will not come to the FDA 
investigators in these facilities. Instead, what FDA is tasked with 
opening, inspecting, and sometimes testing include products that are 
perceived to be illegally-imported FDA-regulated drug products; for 
example, if they are products such as kratom and believed to be 
counterfeit drugs or unapproved drug products. But as part of our work 
to examine what initially are believed to be non-opioid drug products, 
we still identify a large amount of controlled substances, in some 
cases because they might be disguised as other kinds of drug products. 
To give you some statistics on the scope of the risk: From the end of 
September 2017 through January 2018, of about 5,800 suspicious packages 
that FDA was tasked with inspecting because they were suspected of 
containing illegal prescription or counterfeit drugs or dietary 
supplements, 376 were controlled substances, including opioids, and 
were referred back to CBP for seizure. In some measure, the FDA 
investigators are a last line of defense in the IMFs, working closely 
with CBP. As the sophistication of those trying to penetrate our mail 
facilities continues to increase, this represents a growing 
vulnerability.

    To address these risks, last year, FDA tripled the number of import 
investigators we have in the IMFs, allowing us to nearly quadruple the 
number of suspicious packages that we're able to open and inspect. This 
has taken our footprint from 8 to 22 full time employees (FTEs), the 
maximum capacity that our space in these facilities allows.
                               conclusion
    HHS is actively engaged in addressing the opioid epidemic and is 
committed to implementing effective tools across our programs. We look 
forward to continuing to work with this committee and the Congress on 
these efforts.

                                 ______
                                 
   Questions Submitted for the Record to Adm. Brett P. Giroir, M.D. 
                          and Kimberly Brandt
               Questions Submitted by Hon. Orrin G. Hatch
    Question. Dr. Giroir, given the focus of the new Family First law 
on helping families with substance abuse issues, how will HHS 
coordinate the implementation of this new law with other efforts across 
the department focused on the opioid epidemic?

    Answer. The Substance Abuse and Mental Health Services 
Administration (SAMHSA) and the Administration on Children, Youth and 
Families (ACYF) are committed to supporting States' efforts to improve 
outcomes for infants and families affected by substance use disorders. 
Through the National Center on Substance Abuse and Child Welfare 
(NCSACW), these agencies build the capacity of States to respond to 
growing concerns about opioid misuse, the increasing number of infants 
with prenatal exposure, and the lack of coordinated and ongoing 
services needed to support infants and families during the critical 
postpartum and infancy period. Technical assistance from the NCSACW is 
available to assist States with implementing plans of safe care for 
infants and their families or caregivers, and develop collaborative 
practices to expand access to family-centered treatment services on a 
system-wide basis. Also, as you know, the statute requires the 
Secretary to develop criteria that interventions must meet in order to 
receive funding under the title IV-E prevention services program. Over 
the course of the next few months, the Administration for Children and 
Families (ACF) will consult broadly across the Department of Health and 
Human Services (HHS) and the field in the development of those 
criteria. Once the criteria are established, ACF will take an equally 
broad approach for identifying interventions that meet the criteria, 
including interventions related to opioid use disorder.

    Question. Given Medicaid's critical role in addressing the opioid 
crisis, Congress needs timely and accurate demographic and payment data 
information to oversee the program. Without better information, we 
won't be able to judge the effectiveness of our policies, including 
those on opioid and substance use disorders. Ms. Brandt, how can CMS 
and Congress work together to improve the accuracy and timeliness of 
information from State Medicaid programs to help address the opioid 
epidemic?

    Answer. CMS understands the importance of having complete, accurate 
data. The Transformed Medicaid Statistical Information System (T-MSIS) 
is a critical data and systems component of CMS's efforts to gather 
information from State Medicaid programs. CMS has made significant 
progress with its Federal T-MSIS information technology (IT) platform, 
and CMS is continuing to work with States on T-MSIS data quality and 
technical compliance as a priority for 2018.

    CMS continues to focus on improving the quality and completeness of 
the State submissions, technical compliance and building the agency's 
Medicaid and CHIP data analytic capacity. We look forward to making 
data more widely available as quality improves.

    Question. The CDC has guidelines for opioid prescribing that are 
meant to prevent against excessive supply. While we shouldn't expect 
every prescription to be consistent with these guidelines, assessing 
the extent to which they are followed could be helpful in identifying 
outliers.

    Ms. Brandt, does CMS have the data to determine prescriber 
adherence to the CDC guidelines?

    Answer. CMS is taking a number of steps to reduce overprescribing 
in order to help prevent the development of new opioid use disorders 
that originate from opioid prescriptions while balancing the need for 
continued access to prescription opioids for certain medical conditions 
and pain management. Due to the structure of the Medicare Part D 
program, Medicare Advantage Organizations (MAOs) and Medicare Part D 
sponsors have a primary role in detecting and preventing potential 
misuse of opioids.

    CMS uses the Overutilization Monitoring System (OMS) to help CMS 
ensure that Medicare Part D sponsors have established reasonable and 
appropriate drug utilization management programs to assist in 
preventing overutilization of certain prescribed medications, including 
opioid pain medications. CMS has continued to refine and improve the 
criteria used in OMS, including recent updates that align with CDC 
guidelines. For example:

          CDC recommends that clinicians should avoid or carefully 
        justify a decision to titrate dosage of opioids to over 90 
        morphine milligram equivalents (MME) per day.\1\ Starting this 
        year, beneficiaries are now identified as at-risk and reported 
        to plans if, in the most recent 6 months, their daily dose of 
        opioids exceeds 90 MME; and if they have received opioids from 
        more than three prescribers and more than three pharmacies, or 
        from more than five prescribers, regardless of the number of 
        opioid dispensing pharmacies.\2\
---------------------------------------------------------------------------
    \1\ https://www.cdc.gov/drugoverdose/pdf/guidelines_at-a-glance-
a.pdf.
    \2\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2018.pdf.

          CDC advises clinicians to avoid prescribing opioids and 
        benzodiazepines concurrently whenever possible to avoid putting 
        patients at greater risk for potentially fatal overdose.\3\ 
        Beginning in October 2016, CMS added a concurrent 
        benzodiazepine use flag to OMS reports to alert sponsors that 
        high-risk beneficiaries have concurrent use of these 
        medications.\4\
---------------------------------------------------------------------------
    \3\ http://www.cdc.gov/drugoverdose/prescribing/guideline.html.
    \4\ https://www.cms.gov/Medicare/Prescription-Drug-coverage/
PrescriptionDrugCovContra/RxUtilization.html.

    In addition, CDC's Guideline for Prescribing Opioids for Chronic 
Pain \5\ States that opioids prescribed for acute pain in most cases 
should be limited to 3 days or fewer, and that more than a 7-day supply 
is rarely necessary. Beginning in 2019, CMS expects all Part D sponsors 
to limit initial opioid prescription fills for the treatment of acute 
pain to no more than a 7 day supply.
---------------------------------------------------------------------------
    \5\ See https://www.cdc.gov/drugoverdose/prescribing/
guideline.html.

    CMS will continue to work with our Federal partners, including CDC, 
along with Medicare Part D sponsors and other health plans, beneficiary 
and advocacy groups, States, clinicians, and other stakeholders to 
---------------------------------------------------------------------------
ensure safe prescribing.

    Question. As an alternative to high doses of oral opioid, some 
patients with severe chronic pain are prescribed an implantable pain 
pump. These pumps deliver medication that is tailored to a specific 
patient and their needs. The method of delivery requires less 
medication, avoids the risk of overdose, and prevents diversion. After 
years of allowing pharmacies to bill and be paid for the medication, 
CMS ruled that claims could only be made by physicians as ``incident 
to.'' This policy reversal has limited the availability of patients to 
access this service. Some physicians are reluctant to take on the 
financial risk to purchase and bill for these drugs, and some States 
prohibit pharmacies from selling products to a physician or a third 
party for sale to a patient, making the arrangement illegal under State 
law.

    Considering these barriers, which diminish the availability of a 
pain management alternative less likely to inflame the opioid epidemic, 
would CMS be willing to correct this issue in the CY 2019 Physician Fee 
Schedule rule and allow for intrathecal medications to be billed by 
pharmacies or physicians in these limited circumstances?

    Answer. Under Medicare statute, Part B covers drugs and biologicals 
furnished ``incident to'' a physician's service. These drugs furnished 
under the ``incident to'' provision are typically injectable drugs that 
are bought by the physician, administered in the physician's office, 
and billed by the physician to Medicare. In the Calendar Year 2013 
Medicare Physician Fee Schedule final rule, CMS clarified a Part B 
payment policy that drugs used by a physician to refill an implanted 
item of durable medical equipment would be considered under the 
``incident to'' benefit. Based on this policy, physicians, but not 
pharmacies, must purchase the drugs used to refill intrathecal pumps 
and bill for them under Medicare Part B. However, these drugs may be 
payable to the pharmacy under Part D if the ingredients that are being 
compounded independently meet the definition of a Part D drug. Medicare 
Part B payment to pharmacies (or suppliers) for drugs used to refill an 
implanted pump can be made under the DME benefit category where the 
drug is directly dispensed to a patient and the implanted pump is 
refilled without a physician's service.

                                 ______
                                 
               Questions Submitted by Hon. Chuck Grassley
    Question. Nonpharmacological alternatives exist for treating 
chronic pain management. What is CMS doing to ensure that evidence-
based, nonpharmacological pain management alternatives are available to 
CMS beneficiaries?

    Answer. The opioid crisis cannot be tackled by CMS alone, and that 
is why we are collaborating with other HHS agencies, such as the 
National Institutes of Health (NIH), to identify services that need 
more evidence to support coverage by Medicare and other health plans.

    Both medicinal and non-medicinal therapeutic alternatives to 
opioid-based pain medications exist; although Medicare coverage and 
payment varies. In general, Medicare covers items and services that are 
``reasonable and necessary.'' This includes several non-pharmacologic 
therapies and other non-opioid pharmaceuticals. CMS uses the national 
and local coverage determination process to evaluate new or promising 
items and services with respect to Medicare Parts A and B, through 
well-delineated processes set forth in statute. Those items and 
services for which evidence demonstrates improvement in health outcomes 
in the Medicare population are more likely to be coverable, while those 
items and services for which such evidence is insufficient or lacking 
warrant further research.

    CMS has partnered with the CDC to develop the Opioid Safety 
Commitment poster campaign,\6\ which promotes the most effective pain 
management treatments and strategies. This campaign emphasizes patient 
engagement, clinician counseling regarding opioid alternative pain 
management strategies, and discussion with patients of the risks and 
benefits of opioids when opioids are prescribed.
---------------------------------------------------------------------------
    \6\ https://www.cdc.gov/drugoverdose/prescribing/posters.html.

    CMS has a number of initiatives underway to increase the use of 
recommended evidence-based practices for pain management. CMS provides 
outreach regarding best practices and technical assistance through the 
Transforming Clinical Practice Initiative's (TCPI's) Practice 
Transformation Networks.\7\ TCPI is designed to use peer-based learning 
networks for information sharing, outreach, and dissemination of 
evidence-based practices to educate prescribers on safe and appropriate 
methods of pain treatment. For example, the TCPI Medication Management 
and Opioid Initiative is mobilizing the existing network of more than 
100,000 clinicians into action to address the opioid crisis, generating 
collaborations with other CMS quality improvement projects, showcasing 
successful strategies in engaging providers and patients on proper 
opioid utilization and spreading the successful strategies throughout 
all CMS communities.
---------------------------------------------------------------------------
    \7\ https://innovation.cms.gov/initiatives/Transforming-Clinical-
Practices/.

    The CMS Quality Innovation Network Quality Improvement Organization 
(QIN-QIO) program, consisting of 14 quality contractors, works to 
improve health-care quality and safety for Medicare beneficiaries. The 
QIN-QIO program has established a methodology using CMS claims data to 
identify adverse events, hospital admissions, readmissions, emergency 
visits, and observation stays for high-risk Medicare beneficiaries who 
have taken an opioid medication in the outpatient setting. QIN-QIOs 
collaborate with providers and other community coalitions, using their 
reports to support local and national efforts to address the opioid 
---------------------------------------------------------------------------
epidemic and increase surveillance of adverse events.

    CMS also promotes free educational materials for health-care 
professionals on CMS programs, policies, and initiatives through the 
Medicare Learning Network (MLN).\8\ The CDC Guidelines for Prescribing 
Opioids for Chronic Pain is featured in the January 12, 2017 \9\ MLN 
Connects newsletter.
---------------------------------------------------------------------------
    \8\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLNGen
Info/Index.html.
    \9\ https://www.cms.gov/Outreach-and-Education/Outreach/
FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2017-01-12-
eNews.html?DLPage=7&DLEntries=10&DLSort=0&DL
SortDir=descending#_Toc471878721.

    Question. For years we have heard problems with the quality of 
Medicaid data. How is the T-MSIS different from previous attempts to 
---------------------------------------------------------------------------
gather information from each of the States and territories?

    Answer. CMS has made significant investments to meet the 
organizational and information technology (IT) infrastructure to 
adequately represent CMS's role in the ever-changing health-care 
marketplace. The Transformed Medicaid Statistical Information System 
(T-MSIS) is a critical data and systems component of the CMS Medicaid 
and CHIP Business Information Solution (MACBIS).

    CMS has been working with States to transform our MSIS system, 
which was used to collect utilization and claims data as well as other 
key Medicaid and CHIP program information, to keep pace with the data 
needed to improve beneficiary quality of care, assess beneficiary 
access to care, improve program integrity, and support States, the 
private market, and other stakeholders with key information.

    The enhanced data available from T-MSIS will support improved 
program and financial management and more robust evaluations of 
demonstration programs. It will also enhance the ability to identify 
potential fraud and improve program efficiency. Ultimately, the 
transformed infrastructure will offer States, CMS, and others the 
ability to do the following at the State and national levels:

          Study encounters, claims, and enrollment data by claim and 
        beneficiary attributes;

          Analyze expenditures by medical assistance and 
        administration categories;

          Monitor expenditures within delivery systems and assess the 
        impact of different types of delivery system models on 
        beneficiary outcomes;

          Examine the enrollment, service provision, and expenditure 
        experience of providers who participate in our programs (as 
        well as in Medicare);

          Observe trends or patterns indicating potential fraud, 
        waste, and abuse in the programs so we can prevent or mitigate 
        the impact of these activities.

    In addition, T-MSIS benefits States in the following ways:

          It will reduce the number of reports and data requests CMS 
        requires of States. T-MSIS will be a main source of Medicaid 
        and CHIP operational data, and CMS intends to use the T-MSIS 
        data to calculate and derive other reports States are currently 
        required to submit, such as Early Periodic Screening, 
        Diagnosis, and Treatment Program (EPSDT) and Children's Health 
        Insurance Program Annual Reporting Template System (CARTS). 
        Availability of T-MSIS will also reduce the number of ad hoc 
        data requests CMS makes of States in the absence of a more 
        robust reporting system.

          States will be able to analyze data in the national 
        repository. Over time, CMS plans to incorporate capabilities 
        for States to conduct their own analyses of data available in 
        the national repository and, eventually, to enable States to 
        bring their own data to analyze alongside the national 
        repository.

          States will have enhanced anti-fraud, waste, and abuse 
        capabilities. They will be able to analyze their data along 
        with other information in the CMS data repositories, including 
        Medicare data, enhancing abilities to better identify potential 
        anomalies for further investigation.

    Question. Will you commit to working with my office on 
implementation and analysis of the data you receive?

    Answer. CMS is committed to transparency across our programs. We 
are always willing to work with stakeholders, including members of 
Congress and their staff, to gain feedback that is critical to our 
efforts to improve our programs.

    Question. I am interested in your time at DARPA and your medical 
inventions. NIH Director Francis Collins recently outlined areas in 
need of accelerated research in terms of the opioid crisis. One area he 
mentioned was the need for non-addictive treatments for chronic pain.

    What are your thoughts about innovation in this area?

    Answer. Over 100 million American adults have painful conditions, 
while over 25 million suffer from daily or chronic pain. The opioid 
crisis highlights the urgent need for novel, non-addictive pain 
medications. This is why supporting cutting-edge research that advances 
our understanding of pain, overdose, and addiction, and leads to the 
development of new treatments is a key part of the comprehensive, five-
point HHS Opioid Strategy. As an element of this strategy, a large-
scale program to accelerate all phases of development of non-addictive 
medications--alternatives to opioids--is underway as part of the NIH 
Helping to End Addiction Long-term (HEAL) Initiative (https://
www.nih.gov/research-training/medical-research-initiatives/heal-
initiative). Through this program, NIH will support research to 
understand how chronic pain develops, making patients susceptible to 
risks associated with opioid use to relieve pain. NIH will work with 
partners from the biopharmaceutical industry to develop a data sharing 
collaborative, new biomarkers for pain and response to pain treatments, 
and a clinical trials network for testing new pain therapies. NIH also 
will expand the pipeline of treatments for pain and enhance clinical 
practice for pain management.

    Development of both non-addictive drugs and devices to better 
assess and to treat chronic pain is a key element to addressing the 
opioid crisis. NIH is pursuing innovative strategies to develop 
technologies and medical devices to monitor and modulate peripheral 
nervous system activity through its Stimulating Peripheral Activity to 
Relieve Conditions (SPARC) project. Because chronic pain is associated 
with abnormal, persistent changes in the peripheral and central nervous 
system circuitry, SPARC is being leveraged to advance new targets and 
innovative technologies for pain relief. For example, SPARC supported 
investigators have developed non-invasive tools to ``silence'' 
peripheral nerves by photo-stimulation and reduce bladder pain. Another 
SPARC investigator explored the effects of noninvasive stimulation of 
the vagus nerve on brainstem activity and associated reduction in 
episodes of migraines. Moving forward, SPARC expects to expand its 
scope on pain and addiction research and to provide a more efficient 
medical device development pipeline.

    The NIH BRAIN initiative is focused on development of technologies 
and knowledge to better understand the central nervous system circuitry 
and to be able to modulate its activity. Pain researchers are 
encouraged to explore the pain circuitry and how modulation of 
maladaptive changes in the central nervous system associated with 
chronic pain can be tapped as a therapeutic strategy. One study uses 
nano-particle based drug delivery to very precise regions of the brain, 
a technology for very targeted delivery of medications for pain and 
other brain disorders. Other studies target a range of approaches such 
as trans-cranial magnetic stimulation, to modulate specific brain 
circuits, which has clinical implications for chronic pain relief.

                                 ______
                                 
                Questions Submitted by Hon. Pat Roberts
    Question. I am interested in the potential for electronic prior 
authorization, or e-prior authorization, within Medicare Part D to 
strike a proper balance between limiting the unnecessary dispensing of 
opioids and avoiding overly burdensome requirements on our providers. 
How can e-prior authorization be used by Medicare Part D or Medicare 
Advantage plans to help uphold responsible dispensing of opioids while 
reducing physician and patient burden?

    Given that the majority of the commercial market already uses e-
prior authorization, what affects can be expected should this practice 
be expanded in Medicare Part D?

    How would streamlining prior authorization affect the way coverage 
issues are resolved at the pharmacy counter?

    Answer. CMS is always interested in finding ways that will improve 
our programs and reduce physician and patient burden. Electronic prior 
authorization is one of many tools currently available to Medicare Part 
D and Medicare Advantage plans as they continue to work with CMS in 
identifying ways to further address the opioid epidemic. Prior 
authorization programs can protect beneficiaries from receiving 
unnecessary services or devices and help providers by ensuring they 
will get paid. Regarding prescriptions, prior authorization allows 
providers and patients to avoid the risk of a future claim denial, as 
well as its subsequent delay in care, by determining a beneficiary's 
eligibility to receive the medication before he or she reaches the 
pharmacy counter. While interoperability is important for the tools 
used by plans and providers to combat the opioid epidemic, we are 
cognizant of the potential for administrative burden and expense for 
providers any time we introduce new requirements. Across our programs, 
we are looking for ways to streamline regulations and reduce provider 
burden to better allow clinicians to focus on their patients.

    CMS is committed to working with plans and making sure they have 
the flexibility they need in order to best serve beneficiaries.

    Question. I understand there is some interest in adding Medicare 
patients who are at-risk for prescription drug abuse to the list of 
eligible beneficiaries for MTM. Additionally, in the recent Part D 
Final Rule, CMS clarified that MTM programs will fall under ``quality 
improving activities'' when calculating medical loss ratio 
requirements. Do you expect this clarification will encourage plans to 
expand access to MTM programs to more beneficiaries?

    Answer. CMS believes that the Medication Therapy Management (MTM) 
programs improve quality and care coordination for Medicare 
beneficiaries. We also believe that allowing Part D sponsors to include 
compliant MTM programs as quality improving activities (QIA) in the 
calculation of the Medicare MLR will encourage sponsors to ensure that 
MTM is better utilized, particularly among standalone Part D plans that 
may currently lack strong incentives to promote MTM. Furthermore, we 
have expressed concern that Part D sponsors may be restricting MTM 
eligibility criteria to limit the number of qualified enrollees, and we 
believe that explicitly including MTM program expenditures in the MLR 
numerator as QIA-related expenditures could provide an incentive to 
reduce any such restrictions.

    Question. What impact would including these at-risk beneficiaries 
to MTM have in addressing the opioid epidemic?

    Answer. CMS hopes that, by removing any restrictions or uncertainty 
about whether compliant MTM programs will qualify for inclusion in the 
MLR numerator as QIA, the proposed changes will encourage Part D 
sponsors to strengthen their MTM programs by implementing innovative 
strategies for this potentially vulnerable population. We believe that 
beneficiaries with higher rates of medication adherence have better 
health outcomes, and that medication adherence can also produce medical 
spending offsets, which could lead to government and taxpayer savings 
in the trust fund as well as beneficiary savings in the form of reduced 
premiums.

    Question. The Great Plains QIN is currently implementing a project 
to combat opioid use and abuse in rural southeast Kansas. This project 
has been successful in engaging providers, hospitals, and community 
organizations to coordinate their efforts in ways that more effectively 
help patients. How is CMS using data from projects like this to inform 
best practices and develop policies that help address substance use 
disorders in rural areas?

    Answer. CMS's Quality Innovation Network Quality Improvement 
Organization (QIN-QIO) program, consisting of 14 quality contractors, 
works to improve health-care quality and safety for Medicare 
beneficiaries. The QIN-QIO program has established a methodology using 
CMS claims data to identify adverse events, hospital admissions, 
readmissions, emergency visits, and observation stays for high-risk 
Medicare beneficiaries who have taken an opioid medication in the 
outpatient setting. QIN-QIOs collaborate with providers and other 
community coalitions, using their reports to support local and national 
efforts to address the opioid epidemic and increase surveillance of 
adverse events.

    Question. I have heard from constituents that cost is a major 
barrier to accessing alternatives to opioids within Medicare. How can 
CMS encourage the use of opioid alternatives to treat both acute and 
chronic pain? What authorities does CMS have to reduce the cost barrier 
for patients to access alternatives to opioids?

    Answer. The opioid crisis cannot be tackled by CMS alone, and that 
is why we are collaborating with other HHS agencies, such as the FDA, 
CDC, and NIH, to identify services that need more evidence to support 
coverage by Medicare and other health plans.

    Both medicinal and non-medicinal therapeutic alternatives to 
opioid-based pain medications exist; although Medicare coverage and 
payment varies. In general, Medicare covers items and services that are 
``reasonable and necessary.'' This includes several non-pharmacologic 
therapies and other non-opioid pharmaceuticals. CMS uses the national 
and local coverage determination process to evaluate new or promising 
items and services with respect to Medicare Parts A and B, through 
well-delineated processes set forth in statute. Those items and 
services for which evidence demonstrates improvement in health outcomes 
in the Medicare population are more likely to be coverable, while those 
items and services for which such evidence is insufficient or lacking 
warrant further research.

    CMS has partnered with the CDC to develop the Opioid Safety 
Commitment poster campaign,\10\ which promotes the most effective pain 
management treatments and strategies. This campaign emphasizes patient 
engagement, clinician counseling regarding opioid alternative pain 
management strategies, and discussion with patients of the risks and 
benefits of opioids when opioids are prescribed.
---------------------------------------------------------------------------
    \10\ https://www.cdc.gov/drugoverdose/prescribing/posters.html.

    CMS has a number of initiatives underway to increase the use of 
recommended evidence-based practices for pain management. In addition 
to the work of the Quality Innovation Network Quality Improvement 
Organization program, described above, CMS provides outreach regarding 
best practices and technical assistance through the Transforming 
Clinical Practice Initiative's (TCPI's) Practice Transformation 
Networks.\11\ TCPI is designed to use peer-based learning networks for 
information sharing, outreach, and dissemination of evidence-based 
practices to educate prescribers on safe and appropriate methods of 
pain treatment. For example, the TCPI Medication Management and Opioid 
Initiative is mobilizing the existing network of more than 100,000 
clinicians into action to address the opioid crisis, generating 
collaborations with other CMS quality improvement projects, showcasing 
successful strategies in engaging providers and patients on proper 
opioid utilization and spreading the successful strategies throughout 
all CMS communities.
---------------------------------------------------------------------------
    \11\ https://innovation.cms.gov/initiatives/Transforming-Clinical-
Practices/.

    CMS also promotes free educational materials for health-care 
professionals on CMS programs, policies, and initiatives through the 
Medicare Learning Network (MLN).\12\ The CDC Guidelines for Prescribing 
Opioids for Chronic Pain is featured in the January 12, 2017 \13\ MLN 
Connects newsletter.
---------------------------------------------------------------------------
    \12\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLNGen
Info/Index.html.
    \13\ https://www.cms.gov/Outreach-and-Education/Outreach/
FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2017-01-12-
eNews.html?DLPage=7&DLEntries=10&DLSort=0&DLSortDir=descending#_Toc47187
8721.

                                 ______
                                 
               Questions Submitted by Hon. Johnny Isakson
    Question. It's estimated that a little over 60 million patients are 
prescribed opioids for post-surgical pain every year. CMS has estimated 
that roughly one out of five patients with non-cancer related pain is 
prescribed opioids. While there are times that opioids may be a 
clinically justified option for the treatment of pain, evidence 
suggests that alternative methods of treating pain are being 
overlooked.\14\
---------------------------------------------------------------------------
    \14\ https://www.cms.gov/Outreach-and-Education/Outreach/
Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf (page 20).

    There are a number of FDA-approved medical devices that are 
designed to manage chronic pain in lieu of opioids. My constituent, 
Halyard Health, located in Alpharetta, GA is one such innovative 
company, with FDA-approved products covered by Medicare. While it's 
critical that we're examining ways to identify individuals at risk of 
abusing opioids and how we might limit unnecessary prescribing, it's 
equally important that we're exploring non-opioid treatments on the 
front end that can effectively address people's legitimate pain before 
---------------------------------------------------------------------------
the first opioid prescription is written.

    In fact, the President's Commission on Combating the Drug Addiction 
and the Opioid Crisis recommended that CMS review and modify rate-
setting policies that discourage the use of non-opioid treatments for 
pain, such as certain bundled payments that make alternative treatment 
options cost prohibitive for hospitals and doctors.\15\
---------------------------------------------------------------------------
    \15\ https://www.whitehouse.gov/sites/whitehouse.gov/files/images/
Final_Report_Draft_11-1-2017.pdf (page 14).

---------------------------------------------------------------------------
    What steps has CMS taken to implement this recommendation?

    Does CMS currently have any payment mechanisms in place that 
incentivize the use of non-opioid treatments that are FDA-approved and 
covered by Medicare?

    Is CMS working to revise existing policies under Medicare Part A 
and B to establish coverage and additional reimbursement for medical 
devices and other non-opioid options for pain management?

    Answer. The opioid crisis cannot be tackled by CMS alone, and that 
is why we are collaborating with other HHS agencies, such as the FDA, 
CDC, and NIH, to identify services that need more evidence to support 
coverage by Medicare and other health plans.

    Both medicinal and non-medicinal therapeutic alternatives to 
opioid-based pain medications exist; although Medicare coverage and 
payment varies. In general, Medicare covers items and services that are 
``reasonable and necessary.'' This includes several non-pharmacologic 
therapies and other non-opioid pharmaceuticals. CMS uses the national 
and local coverage determination process to evaluate new or promising 
items and services with respect to Medicare Parts A and B, through 
well-delineated processes set forth in statute. Those items and 
services for which evidence demonstrates improvement in health outcomes 
in the Medicare population are more likely to be coverable, while those 
items and services for which such evidence is insufficient or lacking 
warrant further research.

    The President's Commission on Combating Drug Addiction and the 
Opioid Crisis recommended that CMS review its payment policies for 
certain drugs that function as a supply, specifically non-opioid pain 
management treatments. Drugs that function as a supply in surgical 
procedures or diagnostic tests are packaged under the Hospital 
Outpatient Prospective Payment System and the Ambulatory Surgical 
Center Payment System. In a proposed rule \16\ released on July 25, 
2018, (subsequent to the date of the hearing) in response to this 
recommendation as well as stakeholder requests, for calendar year 2019, 
CMS proposes to pay separately at Average Sale Price plus 6 percent for 
non-opioid pain management drugs that function as a supply when used in 
a covered surgical procedure performed in an Ambulatory Surgical 
Center. Further, we are seeking feedback on whether other non-opioid 
alternatives for acute or chronic pain have evidence demonstrating that 
they lead to a decrease in opioid prescriptions and addiction and may, 
therefore, warrant separate payment under the Hospital Outpatient 
Prospective Payment System and the Ambulatory Surgical Center Payment 
System.
---------------------------------------------------------------------------
    \16\ https://www.federalregister.gov/documents/2018/07/31/2018-
15958/medicare-program-proposed-changes-to-hospital-outpatient-
prospective-payment-and-ambulatory-surgical.

    Question. What sort of authorization from Congress does the agency 
---------------------------------------------------------------------------
need to continue expanding their role in the opioid space?

    Answer. CMS, along with our State and plan partners, have many 
valuable tools available to assist our efforts to combat the opioid 
epidemic. This issue is a top priority of this administration, and we 
look forward to continuing our partnership with Congress to discuss 
additional changes that could be made to improve our efforts.

    The President's FY 2019 budget included several proposals aimed at 
addressing the opioid epidemic. Within CMS, the budget proposes to:

          Provide the Secretary with authority to establish a 
        mandatory prescriber and/or pharmacy lock-in program in 
        Medicare Part D that all Part D plans will be required to 
        participate in; this is estimated to save $100 million over 10 
        years.

          Allow CMS to conduct a demonstration to test the 
        effectiveness of covering comprehensive substance abuse 
        treatment in Medicare, including methadone.

          Provide the Secretary authority to suspend coverage and 
        payment for drugs when those prescriptions present an imminent 
        risk to patients or when they are prescribed by providers who 
        have been engaged in misprescribing or overprescribing drugs 
        with abuse potential. This proposal would also provide the 
        Secretary authority to require additional clinical information 
        on certain Part D prescriptions, such as diagnosis and incident 
        codes, as a condition of coverage. The proposal is estimated to 
        save $420 million over 10 years.

          Allow the Secretary to work with the Drug Enforcement 
        Administration (DEA) to revoke a provider's DEA Certificate of 
        Registration after CMS revokes a provider's Medicare enrollment 
        based on a pattern of abusive prescribing of controlled 
        substances via a newly established mandatory reporting 
        requirement.

          Require States to monitor high-risk billing activity to 
        identify and remediate prescribing and utilization patterns 
        that may indicate abuse or excessive utilization of certain 
        prescription drugs in the Medicaid program.

          Require State Medicaid programs to cover all FDA-approved 
        medication-
        assisted treatments (MAT) for opioid use disorder; this is 
        estimated to save $865 million over 10 years.

    Question. Has the agency considered adding a pain management 
portion to the Welcome to Medicare visit? It seems like a basic enough 
idea, and a good first step in trying to prevent an opioid issue as 
soon as the beneficiary joins Medicare. Is this something CMS could do 
administratively or would they need congressional authorization?

    Answer. Pain evaluation could be useful in helping to identify 
beneficiary needs for care, and CMS supports beneficiaries in getting 
the pain management they need and providing them access to non-opioid 
treatments. Providers always have the ability to discuss pain 
management during the Welcome to Medicare visit or any other visit, as 
they deem appropriate. We are always looking for ways to improve 
beneficiary education, and we encourage providers participating in our 
programs to educate their patients about pain management, particularly 
regarding the use and potential dangers of opioids.

                                 ______
                                 
                Questions Submitted by Hon. Dean Heller
    Question. In the United States, incident rates of neonatal 
abstinence syndrome (NAS) have increased significantly over the years. 
In fact, according to a 2016 Centers for Disease Control and Prevention 
(CDC) report, overall prevalence of NAS increased by 300 percent in 28 
States, including Nevada. More must be done to address this issue, 
which is why I was pleased that the Comprehensive Addiction and 
Recovery Act of 2016 (Pub. L. 114-198) required the Government 
Accountability Office (GAO) to publish a report on NAS. In its report, 
GAO concluded that ``NAS is a rapidly increasing public health 
problem.'' However, upon evaluating the Department of Health and Human 
Services' (HHS) strategy document to address NAS in an effort to combat 
the opioid crisis, GAO found that HHS had not established a timeline 
for developing an implementation plan.

    Is addressing NAS a priority for HHS?

    Answer. Yes, addressing NAS is a priority for HHS. As just one 
example, in response to the Protecting Our Infants Act (POIA) and the 
subsequent GAO study, HHS developed a POIA Strategy to inform planning 
and policy across the Department. The 39 recommendations range from 
aspirational to practical and include preventing prenatal opioid 
exposure, providing evidence-based treatment for both mother and 
infant, increasing the accessibility of family-friendly services for 
pregnant and parenting women with OUD, supporting continuing education 
for health-care providers, and determining optimal family and 
developmental support services for children who have experienced 
prenatal opioid exposure.

    Question. What steps has HHS taken so far to address NAS?

    Answer. Congress passed the Protecting Our Infants Act of 2015, the 
purpose of which is to address opioid use by pregnant women and 
resultant consequences to newborn infants. The Act tasked the 
Department of Health and Human Services with producing a three-part 
report to include: (1) a review of gaps, overlap, or duplication 
regarding prenatal opioid use and neonatal abstinence syndrome (NAS); 
(2) state of the science and clinical practice; (3) and a strategy and 
set of recommendations. In January 2017, HHS provided the report to 
Congress. The updated Protecting Our Infants Act; Final Strategy--2017 
was published in the Federal Register on May 25, 2017. The strategy was 
revised to reflect public comment on the Report to Congress. 
Subsequently, HHS convened a department-wide workgroup that is 
developing an implementation plan based on the strategy that will 
support decision-making by departmental leadership with regard to 
specific agency priorities.

    In recognition of the need for an organizing framework to guide and 
track implementation of recommendations in the POIA Strategy, the HHS 
Behavioral Health Coordinating Council (BHCC) Opioid and Controlled 
Substances Subcommittee, NAS Workgroup developed an implementation work 
plan. This plan documents the NAS activities that are completed, in 
process, and planned by HHS agencies, targeting activities for research 
and evaluation, programs and services, data and surveillance, and 
education. The work plan shows that HHS is addressing all POIA 
recommendations, with the majority of recommendations being addressed 
through dedicated cross-agency collaboration.

    In addition, SAMHSA developed ``Clinical Guidance for Treating 
Pregnant and Parenting Women with Opioid Use Disorder and Their 
Infants.'' This Guidance, described in the POIA Strategy, outlines the 
optimal management of pregnant and postpartum women with an opioid use 
disorder (OUD) and their infants based on the recommendations of 
experts. In the past 12 months, the document had been downloaded 7,565 
times. The guidance reflects recommendations of an expert steering 
committee and 13 other Federal agencies and offices, and assists 
health-care professionals to determine the most clinically appropriate 
care for a patient. The guide is a patient-focused clinical guide that 
considers the maternal--fetal and maternal--infant dyad as a unit with 
the expectation that the health-care professionals, in consultation 
with the patient, will make individualized treatment decisions for both 
a mother and her infant. The Guidance may be found here: https://
store.samhsa.gov/product/Clinical-Guidance-for-Treating-Pregnant-and-
Parenting-Women-With-Opioid-Use-Disorder-and-Their-Infants/SMA18-5054).

    SAMHSA's Pregnant and Postpartum Women's program (PPW) expands the 
availability of comprehensive substance use disorder treatment, 
prevention, and recovery support services for PPW, their minor 
children, and other family members. In FY 2018, SAMHSA funded 19 new 5-
year residential PPW grants, totaling $9 million annually and 19 
continuing PPW 5-year residential grants, totaling $10.7 million 
annually. The PPW Pilot Program was created under the Comprehensive 
Addiction and Recovery Act (CARA) of 2016 with the first three grants 
funded in FY 2017, totaling $3.2 million annually. SAMHSA funded three 
new 3-year PPW Pilot grants in FY 2018, totaling $3.2 million annually. 
PPW Pilot grants are awarded to State substance abuse agencies to 
increase outpatient treatment and recovery support services for 
substance use disorder, including opioid use disorder, across the 
continuum of care and promote new approaches and models of service 
delivery. In FY 2017, SAMHSA began a 3-year PPW cross-site evaluation 
to examine the effectiveness of the PPW Pilot Program. The evaluation 
results will be used broadly to improve the collective understanding 
about effective components of the continuum of care for pregnant and 
postpartum women with a primary diagnosis of a substance use disorder, 
including whether the PPW Pilot Program is an effective approach to 
increase access to the use of medication-assisted treatment.

    SAMHSA and the Administration for Children and Families (ACF) 
jointly fund the National Center on Substance Abuse and Child Welfare 
(NCSACW), a national resource center providing information, expert 
consultation, training and technical assistance to child welfare, 
dependency court and substance abuse treatment professionals to improve 
the safety, permanency, well-being, and recovery outcomes for children, 
parents, and families. The NCSACW also makes available webinars, 
assessment instruments, training and program toolkits, resource lists, 
and other publications.

    With SAMHSA and ACF support during 2017, NCSACW conducted 12 
presentations and 11 web-based trainings/virtual meetings on opioids. 
During its September 2017 webinar, ``Supporting Families Affected by 
Opioid and Other Substance Use Disorders, Child Abuse and Prevention 
Act, Plan of Safe Care,'' over 1,200 individuals attended. In addition, 
during the same period NCSACW received and responded to over 300 
opioid-related technical assistance requests; produced and disseminated 
the Policy Academy brief, Improving Outcomes for Pregnant and 
Postpartum Women with Opioid Use Disorders and Their Infants, Families, 
and Caregivers; and developed a web-based directory of resources on 
best practices for the treatment of opioid use disorders and neonatal 
abstinence syndrome.

    Question. What is HHS's time frame to complete implementation of 
its strategy related to addressing NAS?

    Answer. The work plan is iterative and demonstrates that there are 
over 400 HHS NAS activities that are completed, in process, or in the 
planning stages. As the opioid epidemic continues to impact women and 
their children, and our communities, the BHCC Opioid and Controlled 
Substances Subcommittee will continue to monitor ongoing implementation 
and coordination of NAS activities to assess progress, evaluate 
effectiveness, and publicize NAS specific programs and tools, 
contingent on funding.

                                 ______
                                 
            Question Submitted by Hon. Benjamin L. Cardin, 
                Hon. Bill Cassidy, and Hon. Bill Nelson
    Question. We believe we need to take a comprehensive approach to 
prevent and treat the opioid epidemic before more lives are lost. 
Medicare Part D covers some, but not all FDA-approved forms of 
medication-assisted treatment (MAT). MAT has been shown to be most 
effective in treating opioid use disorders when coupled with counseling 
and other services. That's why we will be introducing a bill to allow 
Medicare to pay for MATs as a bundled payment to providers at opioid 
treatment centers. In the fiscal year 2019 budget, the Department of 
Health and Human Services (HHS) expressed support for a similar 
proposal.

    What is the administration doing to test the effectiveness of 
covering comprehensive substance abuse treatment in Medicare?

    Does the administration commit to working with our offices on this 
proposal?

    Answer. Medication-Assisted Therapy (MAT) is a valuable 
intervention that has been proven to be the most effective treatment 
for OUD, particularly because it sustains long-term recovery and has 
been shown to reduce opioid-related morbidity and mortality.\17\ To 
increase access to MAT, CMS requires that Medicare Part D formularies 
include covered Medicare Part D drugs used for MAT and mandates 
Medicare Part C coverage of the behavioral health element of MAT 
services. In addition, CMS issued guidance on best practices in 
Medicaid for covering MAT in a joint informational bulletin with the 
Substance Abuse and Mental Health Services Administration (SAMHSA), the 
CDC, and the National Institute on Drug Abuse.\18\ CMS also released an 
informational bulletin with SAMHSA on coverage of treatment services 
for youth with SUD.\19\
---------------------------------------------------------------------------
    \17\ https://www.ncbi.nlm.nih.gov/pubmed/24500948.
    \18\ https://www.medicaid.gov/Federal-Policy-Guidance/downloads/
CIB-07-11-2014.pdf.
    \19\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-01-26-2015.pdf.

     While Medicaid programs vary greatly by State, all 50 States 
currently offer some form of MAT. In addition, the President's FY 2019 
budget includes a proposal that would require State Medicaid programs 
to cover all FDA-approved MAT for OUD, including associated counseling 
and other costs. These up-front investments in expanded MAT treatment 
are expected to reduce total Medicaid expenditures over time as more 
individuals recover from OUD; this provision would result in an 
---------------------------------------------------------------------------
estimated $865 million is savings over 10 years.

    Under an additional proposal in the President's FY 2019 budget, CMS 
would conduct a demonstration to test the effectiveness of covering 
comprehensive substance abuse treatment in Medicare. This demonstration 
could be expanded nation-wide if successful in key metrics, such as 
reducing opioid-related deaths among beneficiaries, reducing 
hospitalization for opioid poisoning, and reducing emergency room 
utilization for opioid-related issues. Through this proposal, Medicare 
would provide bundled reimbursement on a per-week-per-patient basis to 
health-care providers for methadone treatment or similar MAT and would 
recognize opioid treatment programs and substance abuse treatment 
facilities as independent health-care provider types; outpatient 
counseling would be billed separately as clinically necessary. The 
model would be allowed to target beneficiaries determined to be at-
risk, as defined by the Overutilization Monitoring System, to 
voluntarily receive comprehensive treatment, including MAT and SUD 
counseling.

    CMS looks forward to working with Congress to implement these 
budget proposals. CMS is happy to work with the committee and provide 
technical assistance on the legislation you are considering.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
holding manufacturers, distributors, and other stakeholders accountable
    Question. Between 1999 and 2014, sales of prescription opioids 
nearly quadrupled while the number of fatal opioid-related overdoses 
tripled nationwide. As the country comes to grips with this epidemic, 
it remains unclear whether entities that had a financial stake in 
opioid misuse--the manufacturers and distributors of opioids--will be 
held accountable for their culpability in a crisis that led to the loss 
of hundreds of thousands of American lives.

    During your testimony before the committee, I expressed concerns 
regarding the administration's efforts to investigate these 
stakeholders for their actions. As I stated, ``To me, opioid 
manufacturers, through twisted research, deceptive marketing, and 
bought and paid for patient advocacy groups had a significant role in 
fueling the crisis.'' When I asked whether you shared my concerns, you 
stated that rising numbers of opioid prescriptions occurred in part due 
to a misunderstanding in the medical community about the addictive 
nature of these drugs. These drugs, you stated, ``were overprescribed 
by well-intentioned physicians who believed they were doing the best 
for the patients.''

    This misunderstanding was no doubt true for many health-care 
providers. However, attention must be paid to how manufacturers, 
distributors, physicians, and advocacy organizations deliberately 
conspired to mislead the American public, influence medical education, 
shape standards of practice, and suppress information on the risks 
associated with these drugs.

    Does the administration believe opioid manufacturers and 
distributors bear some responsibility in the spread of the opioid 
epidemic?

    If yes, how does the administration plan to hold these entities 
accountable?

    If not, why not?

    If other stakeholders are found to have willfully deceived or 
misled the American public on the addictiveness of opioids, how does 
HHS plan to hold these entities accountable?

    Answer. The Department of Health and Human Services (HHS) has spent 
considerable time seeking to understand how this crisis developed, an 
issue I believe to be of paramount importance. Without understanding 
the root causes and learning the lessons of history, there will be no 
way to prevent similar problems in the future. However, as with most 
complex genetic-socio-behavioral-cultural problems, the etiology of the 
opioid crisis is complex and multi-factorial, and correlated with many 
individual events, some of which were causal and some of which were 
not. Specifically, your question whether manufacturers or distributors 
may have had a negligent role in driving the crisis is one that the 
Department of Justice (DOJ) is examining as that question arises in the 
context of ongoing litigation among parties other than the Federal 
Government.

    Alongside DOJ, HHS is now implementing solutions to the crisis--
solutions that will be effective despite the etiologic complexities. We 
are engaging all potential stakeholders and interest groups--from drug 
manufacturers, to health professionals, community and faith-based 
organizations, and family members--to assist in reversing the epidemic.
            ongoing conflicts of interest among stakeholders
    Question. Ongoing financial arrangements suggest that opioid 
manufacturers may still be bankrolling advocacy groups and others to 
undermine the Federal response to the opioid epidemic.

    In 2016, I sent a letter to HHS after learning that certain members 
of the Interagency Pain Research Coordinating Committee (IPRCC) had 
attempted to undermine CDC efforts to develop guidance on opioid 
prescribing practices.\20\ As described in that letter, some members of 
the IPRCC had financial relationships with major opioid manufacturers, 
including Purdue Pharma, the maker of OxyContin. In 2017, I wrote again 
to HHS regarding a workshop hosted by the Food and Drug Administration 
on safe opioid prescribing when it was revealed that some participants 
shared financial ties with Purdue Pharma and other prominent 
manufacturers.\21\ Most recently, in February 2018, an investigation 
led by Senator McCaskill through the U.S. Senate Homeland Security and 
Governmental Affairs Committee reported that manufacturers of the top 
five prescription opioids in worldwide sales gave more than $10 million 
to 14 advocacy groups and affiliated doctors between 2012 and 2017.\22\ 
Purdue accounted for nearly half of the $9 million in funding granted 
to advocacy groups alone.
---------------------------------------------------------------------------
    \20\ Letter from Ranking Member Ron Wyden to HHS Secretary Sylvia 
Matthews Burwell (February 5, 2016), https://www.finance.senate.gov/
imo/media/doc/Wyden%20Letter%20to%20HHS
_Opioid%20Conflicts.pdf.
    \21\ Letter from Ranking Member Ron Wyden to HHS Secretary Sylvia 
Matthews Burwell (May 5, 2017), https://www.finance.senate.gov/imo/
media/doc/050817%20corrected%20Senator%20
Wyden%20to%20Secretary%20Price%20re%20FDA%20Opioid%20Prescriber%20Workin
g%20
Group%20(5%20May%202017).pdf.
    \22\ ``Fueling an Epidemic: Exposing the Financial Ties Between 
Opioid Manufacturers and Third Party Advocacy Groups,'' U.S. Senate 
Homeland Security and Governmental Affairs Committee, Office of the 
Ranking Member (February 2018), https://www.hsgac.senate.gov/media/
minority-media/breaking-millions-in-payments-among-findings-of-
mccaskill-opioid-investigation-into-ties-between-manufacturers-and-
third-party-advocacy-groups-.

    Greater transparency is needed to understand how manufacturers and 
distributors may be continuing to influence advocates, physicians, and 
other stakeholders in ways that undercut Federal efforts to curb 
---------------------------------------------------------------------------
prescription opioid misuse.

    Please explain whether the administration is examining ongoing 
financial arrangements among opioid manufacturers, distributors, pain 
advocates, and/or physicians.

    What steps is HHS taking to ensure that these financial 
relationships are subject to greater transparency and scrutiny going 
forward?

    Answer. We share your interest in building greater transparency to 
ensure that there are no financial conflicts of interest among the 
opioid manufacturers and distributors and those in the medical and 
patient advocacy community who are working closely with the Federal 
Government to address the public health crisis resulting from the 
opioid epidemic.

    In terms of the membership on the IPRCC, as relayed in our response 
to your inquiry in 2016, the policies and appointments to and terms for 
service for non-
Federal members of the IPRCC are mandated by the Affordable Care Act 
(Pub. L. 111-148) and agency policy for Federal advisory committees. 
The members are not representatives of their organizations, employers, 
or institutions and provide advice based on their own points of view. 
HHS will continue to ensure that all members of advisory groups follow 
agency policies and disclosure requirements.

    With respect to the administration's activities related to 
examining ongoing financial arrangements among the opioid 
manufacturers, distributors, pain advocates, and/or physicians, I can 
share the work of the HHS Office of the Inspector General (OIG). Since 
March of 2017, OIG has excluded six individuals and entities and 
participated in eight civil settlements under the False Claims Act 
related to opioids. These cases have involved allegations of fraud in 
sober homes and excessive prescribing of opioids, and have resulted in 
$52,748,965 recovered and 133 years of exclusion.

    The OIG excluded Dr. Xiulu Ruan and Dr. John Couch for 50 years as 
a result of their convictions for running a massive pill mill in 
Mobile, AL. Of particular importance in the trial were two brand name 
instant-release fentanyl drugs--Subsys and Abstral. Both Subsys and 
Abstral are only FDA-indicated for breakthrough cancer pain in opioid-
tolerant adult patients. However, evidence showed that Dr. Ruan and Dr. 
Couch almost exclusively prescribed these drugs off-label for neck, 
back, and joint pain. Dr. Ruan and Dr. Couch received illegal kickbacks 
from Insys Therapeutics, the manufacturer of Subsys, in exchange for 
the defendants prescribing massive quantities of this drug.

    We do not have any Corporate Integrity Agreements (CIAs) with 
opioid manufacturers (or more specifically, any such CIAs that are 
directed at or resulting from opioid-related conduct specifically) to 
report.

    The following links below provide some additional info on oversight 
and investigation cases related to financial relationships between 
opioid manufacturers and physicians:

         https://www.reuters.com/article/us-insys-opioids/doctor-tied-
        to-insys-opioid-kickback-probe-gets-prison-term-idUSKCN1GA2WE.

         https://www.reuters.com/article/us-insys-opioids/ex-insys-
        employee-in-u-s-opioid-case-sentenced-to-home-confinement-
        idUSKBN1HU2U1.

         https://www.justice.gov/usao-ri/pr/doctor-sentenced-
        healthcare-fraud-accepting-kickbacks-prescribe-highly-
        addictive-version.

    Regarding HHS efforts to create transparency, we refer you to the 
Open Payments data at the CMS website (https://www.cms.gov/
openpayments/). The law requires CMS to collect and display information 
reported by applicable manufacturers and group purchasing organizations 
(GPOs) about the payments and other transfers of value these 
organizations have made to physicians and teaching hospitals. 
Researchers and others have used the data to study a variety of related 
issues, including opioids. The Open Payments data does not gather 
information on payments to patient advocacy groups or other supply 
chain participants, such as distributors.

    Question. What steps is HHS taking to protect consumers from 
misleading research or marketing practices that may suppress or distort 
accurate information about prescription opioids?

    Answer. The Office of Prescription Drug Promotion (OPDP) within 
FDA's Center for Drug Evaluation and Research (CDER) is responsible for 
ensuring prescription drug information is truthful, balanced, and 
accurately communicated. FDA issued warning letters in January to 11 
online entities for selling illegal opioid cessation products using 
deceptive claims. In June, FDA issued warning letters to 53 websites 
for marketing unapproved opioid medications. In April, the FDA 
Commissioner asked certain social media companies (e.g., Facebook, 
Twitter) to help stop illegal opioid sales on their platforms.

    In addition, FDA's Bad Ad program is an outreach program designed 
to educate health-care providers about the role they can play in 
helping the agency make sure that prescription drug advertising and 
promotion is truthful and not misleading.

    The Bad Ad Program is administered by the agency's Office of 
Prescription Drug Promotion (OPDP) in the CDR. The program's goal is to 
help raise awareness among health-care providers about misleading 
prescription drug promotion and provide them with an easy way to report 
this activity to the agency by emailing [email protected] or calling 855-
RX-BADAD.

    The President's Initiative to stop Opioid Abuse and Reduce Drug 
Supply and Demand includes aggressively deploying appropriate criminal 
and civil actions to hold opioid manufacturers accountable for any 
unlawful practices. As part of this effort HHS is participating in 
investigations of unlawful marketing (such as https://www.justice.gov/
opa/pr/united-states-intervenes-false-claims-act-lawsuits-accusing-
insys-therapeutics-paying and https://www.justice.gov/opa/pr/founder-
and-owner-pharmaceutical-company-insys-arrested-and-charged-
racketeering).
                        rollback of access rule
    Question. The Medicaid statute requires State Medicaid provider 
payments to be ``sufficient to enlist enough providers so that care and 
services are available under the plan at least to the extent that such 
care and services are available to the general population in the 
geographic area.'' \23\ In January 2016, the previous administration 
released final regulations to help implement this longstanding 
statutory protection.\24\
---------------------------------------------------------------------------
    \23\ 42 U.S.C. Sec. 1396a(a)(30)(A).
    \24\ ``Medicaid Program; Methods for Assuring Access to Covered 
Medicaid Services,'' 80 Federal Register 67575 (January 4, 2016), 
https://www.federalregister.gov/documents/2015/11/02/2015-27697/
medicaid-program-methods-for-assuring-access-to-covered-medicaid-
services.

    However, in March 2018, the Trump administration announced two 
proposed amendments to the equal access rule that would exempt 
additional States from oversight and undermine the ability of CMS and 
others to understand how provider payment cuts will impact access to 
care.\25\ First, the Trump administration proposed exempting States 
from AMRP requirements if States had 85 percent or more of their 
Medicaid enrollees in managed care organizations (MCOs). As a result, 
these States would not be required to assess impacts for access to care 
even if these States propose cuts in fee-for-service payment rates. 
Second, the administration proposed exempting States from key 
requirements if cuts to fee-for-service providers did not exceed 4 
percent in a single fiscal year or 6 percent over 2 consecutive years. 
These States would no longer be required to obtain beneficiary and 
provider input on the impact of proposed cuts, use AMRPs to assess a 
proposed cut's effects, or monitor access to care for 3 years after a 
rate cut's implementation.
---------------------------------------------------------------------------
    \25\ ``Medicaid Program; Methods for Assuring Access to Covered 
Medicaid Services-Exemptions for States With High Managed Care 
Penetration Rates and Rate Reduction Threshold,'' 83 Federal Register 
12696 (March 23, 2018), https://www.federalregister.gov/documents/2018/
03/23/2018-05898/medicaid-program-methods-for-assuring-access-to-
covered-medicaid-services-exemptions-for-states-with.

    As the country grapples with the opioid epidemic, protecting access 
to Medicaid is essential to ensuring that beneficiaries are able to 
receive the mental health and substance use disorder (SUD) services 
---------------------------------------------------------------------------
they need to overcome addiction.

    Why is the administration proposing to eliminate information on 
access to SUD and mental health services in States with high managed 
care enrollment?

    The administration's proposal would allow more States to cut 
payments to mental health and SUD providers without holding States 
accountable for compromising access to care. Why would CMS permit these 
cuts without protecting access to essential services for individuals 
struggling with opioid use disorder?

    Answer. States have raised concerns over undue administrative 
burden associated with meeting the requirements of the final rule, 
Medicaid Program; Methods for Assuring Access to Covered Medicaid 
Services (published in November 2015). Specifically, States with few 
Medicaid members enrolled in their fee-for-service program or when 
members are only temporarily enrolled, and States making small 
reductions to fee-for-service payment rates, have urged CMS to consider 
whether analyzing data and monitoring access in that program is a 
beneficial use of State resources. To respond to these concerns, a 
notice of proposed rulemaking (NPRM) issued by CMS last March that 
includes a proposal exempting States with an overall Medicaid managed 
care penetration rate of 85 percent or greater (currently, 17 States) 
from most access monitoring requirements.

    These proposed regulatory changes do not change the underlying 
statutory responsibilities for States to ensure that Medicaid 
recipients have appropriate access to services. States proposing 
payment reductions that meet the exceptions described in the NPRM would 
need to provide alternative information to support compliance with the 
Social Security Act. In addition, States would still be required to 
inform providers of changes to Medicaid payment rates through the 
public notice process.

    The NPRM is designed to support CMS efforts to move away from 
micromanaging State programs and instead focus on measuring program 
outcomes and holding States accountable for achieving results. 
Addressing the opioid epidemic, including making sure Medicaid 
enrollees have adequate access to treatment for opioid use disorder, is 
a top priority to this administration and we will continue to work with 
our Federal and State partners, beneficiary and patient advocate 
groups, plans, providers, and other interested stakeholders to combat 
this crisis.
         medicaid cuts and state efforts to combat the epidemic
    Question. As the largest single payer of substance use disorder 
(SUD) services in the Nation, Medicaid plays an essential role in the 
national fight against the opioid epidemic. Medicaid pays for roughly 
one quarter of all prescriptions for buprenorphine in the U.S. and 
covers 4 of every 10 people battling opioid dependence. In States 
bearing the brunt of the crisis--including Kentucky, Ohio, and West 
Virginia--Medicaid pays for roughly half of all Medication Assisted 
Treatment (MAT), thanks in large part to the Medicaid expansion. In 
fact, nearly one of three people who gained coverage under the 
expansion had a SUD, mental health condition, or both.

    States have also leveraged Medicaid expansion dollars to provide 
innovative and comprehensive SUD programs to individuals struggling 
with addiction. For example, when Ohio adopted the Medicaid expansion 
in 2014, the State extended coverage to an estimated 500,000 
individuals with mental health or SUD needs and added more than $1 
billion to the State's behavioral health system capacity, allowing the 
State to undertake an initiative to modernize mental health benefits, 
expand services for those with high-intensity needs, and integrate 
behavioral and physical health services.\26\ In Kentucky, Medicaid 
expansion significantly helped reduce the unmet need for SUD services, 
as reported by a study in 2016.\27\ From 2014 to mid-2016, Kentucky saw 
a 740 percent increase in the use of treatment services for SUD among 
expansion beneficiaries. Many other States have also been able to 
employ the Medicaid expansion to help tackle the opioid epidemic.
---------------------------------------------------------------------------
    \26\ Ohio Governor's Office of Health Transformation, ``Rebuild 
Community Behavioral Health System Capacity'' (January 30, 2017), 
http://healthtransformation.ohio.gov/Portals/0/18-19
%2005%20Rebuild%20Community%20Behavioral%20Health%20System%20Capacity%20
v2.pdf?
ver=2017-02-16-171817-497.
    \27\ Foundation for a Healthy Kentucky, ``Substance Use Treatment 
Services Covered by Medicaid Expansion Jumped 740 Percent Over 2.5 
Years'' (December 28, 2016), https://www.healthy-ky.org/newsroom/news-
releases/article/60/substance-use-treatment-services-covered-by-
medicaid-expansion-jumped-740-percent-over-2.5-years.

    Despite the expansion's clear role in supporting State efforts in 
this space, the President's budget for fiscal year 2019 proposed 
eliminating the Medicaid expansion and capping the traditional Medicaid 
program, the sum of which would gut an estimated $1.4 trillion from 
Medicaid over the next 10 years. These severe cuts would likely cripple 
State efforts to expand access to comprehensive mental health services, 
particularly in expansion States that have used increased Federal 
---------------------------------------------------------------------------
funding to transform their behavioral health systems.

    How does CMS expect to help States combat the opioid epidemic if 
States are forced to restrict eligibility, reduce payments for mental 
health providers, and roll back mental health and SUD benefits in the 
face of trillion-dollar cuts to Medicaid? Please explain whether and 
how CMS would provide different resources or supports to expansion 
versus non-expansion States.

    Answer. Our Medicaid program is an important tool in providing 
health care to many Americans but we must put it on a stable long-term 
sustainable footing for it to be there for this and future generations. 
That is the challenge that we have as we seek to empower the States 
with the right incentives to deliver quality service. The FY 2019 
budget provides additional flexibilities to States, puts Medicaid on a 
path to fiscal stability by restructuring Medicaid financing, and 
refocuses on the populations Medicaid was intended to serve--the 
elderly, people with disabilities, children, and pregnant women. Annual 
Federal Medicaid spending will grow from $421 billion in FY19 to $702 
billion in FY28 over the budget window. The Medicaid expansion does get 
rescinded, but is replaced along with the individual subsidy program 
with a $1.2 trillion grant program through the Graham-Cassidy 
legislation.

    Opioid misuse, abuse, and overdose impose immense costs on the 
Nation, contributing to two-thirds of deaths by drug overdose. Deaths 
by drug overdose are the leading cause of injury death in the United 
States. The FY 2019 President's budget recognizes the devastation 
caused by the opioid crisis in communities across America and fulfills 
the President's promise to mobilize resources across the Federal 
Government to address the epidemic. The budget provides a historic 
level of new resources across HHS to combat the opioid epidemic and 
serious mental illness--$10 billion--to build upon the work started 
under the 21st Century Cures Act.

    The budget's targeted investments advance the Department's five-
part strategy, which involves:

          Improving access to prevention, treatment, and recovery 
        services, including medication assisted therapies;

          Targeting availability and distribution of overdose-
        reversing drugs;

          Strengthening our understanding of the epidemic through 
        better public health data and reporting;

          Supporting cutting edge research on pain and addiction; and

          Advancing better practices for pain management.

    Question. During your testimony before the committee, in response 
to a question regarding these cuts to Medicaid, you stated that the 
Department of Health and Human Services has approved grants for States 
to combat this epidemic. Does CMS expect these grants to fully 
compensate for the $1.4 trillion in Federal dollars that would be 
gutted from Medicaid programs under the administration's proposed 
budget?

    Answer. CMS is committed to working with all States to provide 
flexibility, so that they can provide the right treatment to the right 
people in the right setting. The recently approved demonstration 
projects that focus on substance use disorder are examples of such 
flexibility so States can tailor their response to the opioid crisis to 
the needs of their State.
             section 1115 waivers and care in imd settings
    Question. In July 2015, CMS released guidance outlining 
opportunities for States to use section 1115 waivers to cover 
additional substance use disorder (SUD) services through Medicaid. In 
addition to describing other flexibilities, this guidance outlined how 
States could use section 1115 waivers to cover SUD care in residential 
settings called Institutions for Mental Diseases (IMDs), which are 
hospitals, nursing facilities, or other institutions with more than 16 
beds that are primarily focused on the provision of mental health care. 
Under current law, without a section 1115 waiver, Medicaid does not pay 
for services provided to beneficiaries between the ages of 21 and 65 in 
IMD settings. In November 2017, the administration released its own 
letter to State Medicaid Directors revising and reinforcing the 
previous administration's guidance. According to the Kaiser Family 
Foundation, as of April 2018, 10 States have waivers approved to 
provide care for individuals suffering from SUD in residential settings 
like IMDs. An additional 12 States have waivers pending.

    Please highlight how States are using these waivers and other 
flexibilities in Medicaid to provide expanded SUD and mental health 
services to individuals with opioid use disorder in IMDs.

    Answer. Addressing the opioid epidemic is a top priority of this 
administration, and CMS is committed to providing States with the tools 
and flexibility they need to best address the issues in their States. 
The substance use demonstration projects are a critical part of these 
efforts. Under the leadership provided by this administration, CMS has 
approved SUD demonstration projects for five States as of April 2018 
that take advantage of the IMD flexibility announced in November of 
2017--Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    Under these SUD 1115 demonstration projects, States develop a 5-
year demonstration allowing them to receive Federal financial 
participation for services to treat addiction to opioids or other 
substances for Medicaid beneficiaries residing in IMDs, including those 
aged 21 to 64 for whom Medicaid otherwise would not pay for services 
while the beneficiary is residing in an IMD, as these States work to 
improve access to treatment in outpatient settings as well. In 
addition, we are working with States that operate these demonstrations 
to establish strong quality of care standards, particularly for 
residential treatment settings.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones approved by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these projects; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis.

    Addendum: Since the time of this hearing, CMS has approved a 
demonstration project for a sixth State, Illinois.

    Question. This epidemic grows more urgent and deadly every day that 
passes. How is CMS ensuring that these waivers are reviewed and 
approved as soon as possible so that States can use the full extent of 
Medicaid's flexibility and Federal resources to address this crisis?

    Answer. CMS is working hard to facilitate the development of 
substance use demonstrations and encourage States to apply for a 
demonstration project, as discussed in the November 2017 State Medicaid 
Director Letter. To further support this initiative, throughout 2018, 
the Medicaid Innovation Accelerator Program (IAP) will be available to 
States that would benefit from strategic design support related to 
improving their treatment delivery systems. The IAP provides States 
with access to national learning opportunities and technical expert 
resources, including strategic design support to States planning 
targeted addiction treatment delivery system reforms and developing 
1115 proposals. In addition, CMS is available to provide technical 
assistance to States on how to meet Federal transparency requirements 
as well as to preview States' draft 1115 proposals and public notice 
documentation to help ensure States successfully meet Federal 
requirements. CMS is committed to helping States implement these 
important flexibilities, and we are in regular communication to help 
interested States through the demonstration application process. We 
look forward to reviewing the results of the State demonstration 
projects that we have already approved and applying lessons learned to 
further reduce barriers and assist States with their efforts to combat 
the opioid crisis.
                   part d and opioid overprescribing
    Question. To monitor opioid overutilization among Medicare Part D 
beneficiaries, CMS requires plan sponsors to implement drug utilization 
review systems for beneficiaries determined to be most at risk of 
opioid misuse, as defined by CMS criteria. However, in October 2017, 
the Governmental Accountability Office (GAO) released a report stating 
that Medicare needed to expand its oversight efforts to effectively 
reduce OUDs, overdoses, inappropriate prescribing, and drug 
diversion.\28\ For example, GAO found that CMS's criteria for at-risk 
beneficiaries misses individuals vulnerable to opioid misuse. Further, 
GAO reported that CMS lacks the information necessary to adequately 
determine which providers overprescribe opioids because CMS tracks 
providers who generally prescribe drugs at high risk for abuse (rather 
than opioids specifically). Moreover, CMS does not require plan 
sponsors to report actions taken against providers, making it difficult 
for CMS to understand which plan sponsors are actively taking steps to 
reduce overprescribing.
---------------------------------------------------------------------------
    \28\ GAO, ``Prescription Opioids: Medicare Needs to Expand 
Oversight Efforts to Reduce the Risk of Harm'' (October 2017), https://
www.gao.gov/assets/690/687629.pdf.

    Does CMS plan to address the gaps identified by GAO and pursue the 
three recommendations outlined by the report? If so, please explain the 
steps CMS is taking to improve Part D monitoring of opioid 
---------------------------------------------------------------------------
overprescribing and misuse.

    Answer. CMS greatly appreciates the work of the GAO, particularly 
with how we can strengthen our systems and programs to assist in the 
fight against the opioid epidemic.

    CMS uses the Overutilization Monitoring System (OMS) to help CMS 
ensure that sponsors have established reasonable and appropriate drug 
utilization management programs to assist in preventing overutilization 
of certain prescribed medications, including opioid pain medications. 
CMS has continued to refine and improve the criteria used in OMS. OMS 
identifies and reports on beneficiaries with a high risk of misusing 
opioids and plan sponsors can then use these reports generated by OMS 
to conduct case management and beneficiary-specific edits. Starting 
this year, beneficiaries are now identified as at-risk and reported to 
plans if, in the most recent 6 months, their daily dose of opioids 
exceeds 90 morphine milligram equivalent (MME); and if they have 
received opioids from more than three prescribers and more than three 
pharmacies, or from more than five prescribers, regardless of the 
number of opioid dispensing pharmacies.\29\
---------------------------------------------------------------------------
    \29\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2018.pdf.

    In the 2019 Final Call Letter,\30\ CMS finalized additional 
enhancements to the OMS including revised metrics to track high opioid 
overuse and to provide additional information to sponsors about high 
risk beneficiaries who take opioids and ``potentiator'' drugs, such as 
benzodiazepines (which when taken with an opioid increase the risk of 
an adverse event). To help identify and prevent opioid users from 
taking duplicate or key ``potentiator'' drugs, in 2019 we also expect 
sponsors to implement additional safety edits to alert the pharmacist 
about duplicative opioid therapy and concurrent use of opioids and 
benzodiazepines.
---------------------------------------------------------------------------
    \30\ https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf.

    CMS utilizes the National Benefit Integrity Medicare Drug Integrity 
Contractor (NBI MEDIC) to conduct data analysis that is shared with 
plan sponsors to help them identify outlier prescribers or pharmacies. 
For example, plans receive Quarterly Outlier Prescriber Schedule II 
Controlled Substances Reports, which provide a peer comparison of 
prescribers of Schedule II controlled substances. This report now 
provides a separate analysis of just opioids. Plans also receive 
quarterly pharmacy risk assessment reports, which contain a list of 
pharmacies identified by CMS as high risk and provide plan sponsors 
with information to initiate new investigations, conduct audits, and 
potentially terminate pharmacies from their network, if appropriate. 
CMS has also sent letters to prescribers that include educational 
information and comparative billing data to, and held webinars \31\ 
for, prescribers whose opioid prescribing patterns were different as 
compared with their peers on both a specialty and/or national level.
---------------------------------------------------------------------------
    \31\ https://www.cbrinfo.net/cbr201801-webinar.

    Additionally, plan sponsors report potential fraud to the NBI 
MEDIC. The NBI MEDIC uses the PLATO system, which is a voluntary, web-
based system that allows CMS, the NBI MEDIC, and plan sponsors to more 
easily share information and help combat potential fraud, waste, and 
abuse in the Medicare Advantage and Medicare Part D programs. CMS's 
---------------------------------------------------------------------------
Federal law enforcement partners can also access PLATO data.

    CMS looks forward to continuing to work with the GAO to strengthen 
and improve our programs.
                       quality in medicare part d
    Question. In 2016, one in three beneficiaries enrolled in Medicare 
Part D received at least one opioid prescription.\32\ To discourage the 
overprescribing and abuse of prescription opioids through this program, 
CMS could explore basing payments to Part D plans on a plan's 
performance in appropriately preventing opioid misuse. In other words, 
CMS could adjust Part D payments according to the quality of care 
delivered to beneficiaries. To achieve this, CMS could employ already 
established and endorsed opioid-related quality measures, including: 
(1) the prevalence of high opioid utilization in combination with 
multiple prescribers or pharmacies and (2) the prevalence of 
beneficiaries taking an opioid and benzodiazepine prescription at the 
same time.
---------------------------------------------------------------------------
    \32\ ``Data Brief: Opioids in Medicare Part D: Concerns About 
Extreme Use and Questionable Prescribing,'' Office of Inspector 
General, Department of Health and Human Services, July 2017, https://
oig.hhs.gov/oei/reports/oei-02-17-00250.pdf.

    Has CMS taken steps to incentivize Part D plans to target opioid 
---------------------------------------------------------------------------
misuse through quality-adjusted payments?

    If so, please discuss the steps CMS has taken, and how CMS plans to 
continue implementing such a policy.

    If not, please explain the barriers to rewarding Part D plans for 
preventing opioid misuse.

    Answer. CMS is taking a number of steps to reduce overprescribing 
in order to help prevent the development of new opioid use disorders 
that originate from opioid prescriptions while balancing the need for 
continued access to prescription opioids for certain medical conditions 
and pain management. Due to the structure of the Medicare Part D 
program, Medicare Advantage Organizations (MAOs) and Medicare Part D 
sponsors have a primary role in detecting and preventing potential 
misuse of opioids. CMS is always interested in pursuing new ways to 
incentivize our plan partners to provide high-quality care.

    On April 2, 2018, the Centers for Medicare and Medicaid Services 
(CMS) issued a final rule \33\ that updates Medicare Advantage (MA) and 
the prescription drug benefit program (Part D) by promoting innovation 
and empowering MA and Part D sponsors with new tools to improve quality 
of care and provide more plan choices for MA and Part D enrollees. For 
example, in the final rule, we incentivize Part D plans to expand 
Medication Therapy Management (MTM) services to additional 
beneficiaries. Under current law, Part D plans are required to 
calculate a medical loss ratio (MLR), expressed as a percentage that 
generally represents the percentage of revenue used for patient care 
rather than for such other items as administrative expenses or profit. 
If a plan fails to meet minimum MLR requirements, they are subject to 
financial and other penalties. Our rule will allow Part D plans to 
include MTM services as patient care as opposed to administrative 
expenses. We hope that, by removing any restrictions or uncertainty 
about whether compliant MTM programs will qualify for inclusion in the 
MLR numerator as QIA, the finalized changes will encourage Part D 
sponsors to strengthen their MTM programs by implementing innovative 
strategies for this potentially vulnerable population. We believe that 
beneficiaries with higher rates of medication adherence have better 
health outcomes, and that medication adherence can also produce medical 
spending offsets, which could lead to government and taxpayer savings 
in the trust fund as well as beneficiary savings in the form of reduced 
premiums.
---------------------------------------------------------------------------
    \33\  https://www.federalregister.gov/documents/2018/04/16/2018-
07179/medicare-program-contract-year-2019-policy-and-technical-changes-
to-the-medicare-advantage-medicare.

    CMS encourages Part D plans to offer MTM services to beneficiaries 
who meet the plan's criteria for retrospective identification of opioid 
overutilization, but do not otherwise qualify for MTM. These 
beneficiaries may benefit from MTM services including targeted 
---------------------------------------------------------------------------
medication reviews and interventions with their prescribers.

    CMS will continue to work with our plan partners, along with 
beneficiary and advocacy groups, States, clinicians, and other 
stakeholders to address this devastating epidemic.
                    seniors and opioid use disorder
    Question. In 2016, 14.4 million of the 43.6 million beneficiaries 
enrolled in Medicare Part D received at least one opioid 
prescription.\34\ Despite the widespread use of these medications in 
the Medicare program, opioid use disorder (OUD) in seniors often goes 
overlooked. As a result, many seniors experience falls, confusion or 
other secondary complications due to opioid misuse that can lead to 
injury or hospitalization. The data bear this out: between 1993 and 
2012, hospitalizations among seniors related to opioid overuse 
quintupled.\35\
---------------------------------------------------------------------------
    \34\ Data Brief: ``Opioids in Medicare Part D: Concerns About 
Extreme Use and Questionable Prescribing,'' Office of Inspector 
General, Department of Health and Human Services, July 2017, https://
oig.hhs.gov/oei/reports/oei-02-17-00250.pdf.
    \35\ Pamela Owens et al., ``Hospital Inpatient Utilization Related 
to Opioid Overuse Among Adults, 1993-2012'' (August 2014), https://
www.hcup-us.ahrq.gov/reports/statbriefs/sb177-Hospitalizations-for-
Opioid-Overuse.jsp.

    What educational initiatives are being supported by CMS to help 
front line health care providers effectively use risk assessment tools 
---------------------------------------------------------------------------
specific to seniors?

    Answer. CMS's primary role with respect to Medicare is to serve as 
a payer, and we do not establish prescription guidelines or recommend 
specific treatments. However, we have published several educational 
materials for providers and prescribers that we also make available 
online to raise awareness on the non-medical use or abuse of opioids by 
patients. Information in these materials includes signs of opioid 
diversion and symptoms of abuse and clinical practices to minimize the 
non-medical use of medication.

    In addition, CMS provides outreach regarding best practices and 
technical assistance through the Transforming Clinical Practice 
Initiative's (TCPI's) Practice Transformation Networks.\36\ TCPI is 
designed to use peer-based learning networks for information sharing, 
outreach, and dissemination of evidence-based practices to educate 
prescribers on safe and appropriate methods of pain treatment. For 
example, the TCPI Medication Management and Opioid Initiative is 
mobilizing the existing network of more than 100,000 clinicians into 
action to address the opioid crisis, generating collaborations with 
other CMS quality improvement projects, showcasing successful 
strategies in engaging providers and patients on proper opioid 
utilization and spreading the successful strategies throughout all CMS 
communities.
---------------------------------------------------------------------------
    \36\ https://innovation.cms.gov/initiatives/Transforming-Clinical-
Practices/.

    The CMS Quality Innovation Network Quality Improvement Organization 
(QIN-QIO) program, consisting of 14 quality contractors, also works to 
improve health-care quality and safety for Medicare beneficiaries. The 
QIN-QIO program has established a methodology using CMS claims data to 
identify adverse events, hospital admissions, readmissions, emergency 
visits, and observation stays for high-risk Medicare beneficiaries who 
have taken an opioid medication in the outpatient setting. QIN-QIOs 
collaborate with providers and other community coalitions, using their 
reports to support local and national efforts to address the opioid 
---------------------------------------------------------------------------
epidemic and increase surveillance of adverse events.

    Question. What steps is CMS taking to support and improve 
procedures to screen seniors for opioid misuse at the point of care 
after seniors are prescribed an opioid pain reliever?

    Answer. In addition to the work of the QIN-QIO program, CMS 
continues to make enhancements in our work with and oversight of plan 
sponsors to help prevent the misuse of opioids. Safety edits alert a 
pharmacist of possible overutilization at the point of sale. In real-
time they can flag for a pharmacist that they should conduct additional 
review and/or consultation with the plan sponsor or prescriber to 
ensure that a prescription is appropriate. In 2018, all plan sponsors 
are utilizing these safety edits. Beginning in 2019, we expect all 
sponsors to implement a new opioid care coordination safety-edit. This 
new edit would create an alert for pharmacists when a beneficiary's 
total daily opioid usage reaches high levels. When this occurs, plan 
sponsors are expected to direct pharmacists to consult with the 
prescriber to confirm their intent. This new policy aims to strike a 
balance between addressing opioid overuse without a negative impact on 
the patient-doctor relationship, preserving access to medically 
necessary drug regimens, and reducing the potential for unintended 
consequences.
                  behavioral health integration codes
    Question. In its December 2015 Policy Options Document, the Senate 
Finance Committee's Chronic Care Working Group discussed the need to 
improve the integration of care for Medicare beneficiaries managing 
both chronic disease and behavioral health conditions, such as 
substance use disorder. In July 2016, in the Physician Fee Schedule 
proposed rule, CMS acted on this recommendation by proposing the 
creation of four new payment codes for behavioral health integration 
(BHI) services, which are services that integrate behavioral health 
care into the primary care setting, to compensate primary care 
providers for team-based behavioral health care. These BHI codes were 
finalized in November 2016 and went into effect on January 1, 2017.

    Please provide an update on the utilization of these new behavioral 
health integration (BHI) codes over the past year.

    Answer. CMS began making separate payment for behavioral health 
integration services beginning in 2017. In 2017, approximately 10,200 
of these services were utilized by Medicare fee-for-service 
beneficiaries. (A beneficiary may have received multiple behavioral 
health integration services.) Medicare payments totaled roughly 
$450,000 for these services in 2017. These data were drawn from 
Medicare Part B non-institutional claims, which are the Medicare claims 
submitted by physicians, practitioners, and other suppliers for Part B 
services/items. These data may not be complete for 2017 because claims 
can be submitted to Medicare up to 1 year after the date of service and 
because of lags in claims processing.

    Question. Has CMS identified any barriers related to the 
implementation or utilization of the BHI codes? If so, please describe 
those barriers and how CMS is addressing them.

    Answer. CMS began making separate payment for behavioral health 
integration services beginning in 2017. Since that time, the agency has 
issued a fact sheet and a frequently asked questions document on these 
services to help physicians and practitioners learn about and bill for 
them. We will continue to work to ensure that beneficiaries have access 
to these important services.

    Question. The Medicare program should continue to promote the 
integration of behavioral health services into primary care to support 
access to treatment for beneficiaries suffering from substance use 
disorders. Has CMS considered any further steps to improve access to 
BHI services for Medicare beneficiaries? If so, please describe those 
steps.

    Answer. CMS supports access to behavioral health integration 
services for Medicare beneficiaries. Care management and the 
integration of behavioral health care with primary care have crucial 
roles in the care of beneficiaries with mental or behavioral health 
conditions. Since CMS began paying for these services in 2017, the 
agency has issued a fact sheet and a frequently asked questions 
document on these services to help physicians and practitioners learn 
about and bill for them. CMS will continue to work to ensure that 
beneficiaries have access to these important services.
  medicare demonstration proposal for substance use disorder treatment
    Question. The President's budget for fiscal year 2019 proposed 
requiring CMS to conduct a demonstration to test the effectiveness of 
covering comprehensive substance use disorder treatments under 
Medicare. As described in the budget in Brief for the Department of 
Health and Human Services, this demonstration would specifically test 
the use of a bundled payment for methadone treatment or similar 
Medication Assisted Treatment for the treatment of opioid use disorder. 
Additionally, the demonstration would recognize opioid treatment 
programs and substance abuse treatment facilities as independent 
provider types. The administration noted that this demonstration could 
be expanded nationwide if it successfully reduced opioid-related 
deaths, hospitalizations, and emergency room utilization over time.

    Please describe in detail the proposed structure of this 
demonstration, including how CMS and/or the Center for Medicare and 
Medicaid Innovation (CMMI) would design this bundled payment.

    Answer. Under the proposal, CMS would conduct a demonstration to 
test the effectiveness of covering comprehensive substance abuse 
treatment in Medicare. Medicare would provide bundled reimbursement on 
a per-week per-patient basis to health-care providers for methadone 
treatment or similar medication-assisted therapy and would recognize 
opioid treatment programs and substance abuse treatment facilities as 
independent health-care provider types. Outpatient counseling would be 
billed separately as clinically necessary. Payment for methadone 
treatment or other similar medication-assisted therapy would be site-
neutral. The model would be allowed to target beneficiaries determined 
to be at-risk, as defined by the Overutilization Monitoring System, to 
voluntarily receive comprehensive substance abuse treatment, including 
medication assisted treatment and substance use disorder counseling.

    Question. Has CMS and/or CMMI taken any steps to move forward with 
this proposed demonstration? If so, please describe any action taken by 
CMS and/or CMMI with respect to this proposed model to date.

    Answer. This is a priority of the administration, and we are 
committed to implementing it appropriately. With this in mind, CMS 
continues to examine options for this demonstration given statutory 
limitations and other considerations.
                  family first prevention services act
    Question. As you know, the Family First Prevention Services Act 
(FFPSA) allows States to receive a Federal match for evidence-based 
substance use and mental health treatment services, among other things. 
Given these services are often provided through State mental health, 
public health, or home visiting networks, effective implementation of 
FFPSA will require more than just a traditional ``child welfare'' 
response. Accordingly, it is critical that HHS engage multiple agencies 
as it develops guidance and aids States in implementation.

    Please describe the process that HHS and ACF in particular are 
utilizing to ensure coordination between the relevant agencies (e.g., 
ACF, CMS, SAMHSA, HRSA, etc.) in the development of the clearinghouse 
of eligible evidence-based programs and practice criteria under the 
Family First Prevention Services Act.

    How are programs that have been funded under various HHS grants 
(e.g., RPGs, PPWs, home visiting) being consulted to provide input into 
this list of evidence-based programs?

    After the development of the original list, what will HHS's process 
be in updating the list of eligible interventions and how often does 
HHS plan to update the list of eligible services to ensure States are 
able to avail themselves to the most up-to-date research and best 
practices?

    When does HHS plan to issue guidance to States on how to draw down 
funding for these evidence-based services?

    Will the guidance be issued to State authorities on home visiting, 
substance use disorder treatment, mental health, and other relevant 
State agencies in addition to State child welfare agencies?

    Answer. To respond to all of your questions, I believe it's helpful 
to give an overview of the plan for implementation. As you know, the 
statute requires the Secretary to develop criteria that interventions 
must meet in order to receive funding under the title IV-E prevention 
services program. Over the course of the next few months, ACF will 
consult broadly across HHS and the field in the development of those 
criteria. Once the criteria are established, ACF will take an equally 
broad approach for identifying interventions that meet the criteria, 
including interventions related to opioid use disorder. The vendor that 
operates the clearinghouse will assess interventions for inclusion in 
the clearinghouse and elevation within the levels of evidence on an 
ongoing basis. ACF will issue instructions to States and tribes on what 
must be included in plans submitted to operate a title IV-E prevention 
services program in conjunction with publication of the criteria for 
allowable interventions. The Department would be happy to provide you 
and your staff with updates on our progress.

    Question. As you know, starting October 1, 2018, States are 
eligible to receive Federal matching funds for maintenance payments on 
behalf of children in foster care who are placed with a parent in a 
residential family treatment facility.

    What activities are underway to inform substance use treatment 
agencies of the availability of title IV-E foster care maintenance 
funds for candidates for foster care effective October 1, 2018?

    When does HHS plan to issue guidance to States on this provision?

    Will the guidance be issued to both child welfare agencies and the 
State authorities on substance use disorder treatment?

    Answer. ACF's implementation plan includes the provision of 
training and technical assistance to States as we roll out guidance 
over the summer of 2018. For example, SAMHSA and ACF jointly fund the 
National Center on Substance Abuse and Child Welfare, which is 
available to assist States with developing collaborative practices to 
expand access to family-centered treatment services on a system-wide 
basis.

                                 ______
                                 
              Questions Submitted by Hon. Debbie Stabenow
                      school-based health centers
    Question. In addition to recognizing the need to help and treat 
those afflicted by addiction, I also want to make sure we are also 
meeting the needs of the so-called ``secondary victims'' of addiction, 
or the children of those struggling.

    Senator Grassley and I co-chair the Senate Foster Care Caucus, and 
as many news reports have documented, tens of thousands of children are 
entering into foster care due to the opioid epidemic.

    And we are seeing opioid addiction happening at a much younger age: 
last year, a study presented at the American Academy of Pediatrics 
conference found that an average of 135 children each day were testing 
positive for opioid addiction or dependency in emergency departments.

    I want to know what the administration is doing to break down the 
barriers to make sure children and adolescents receive the mental 
health services they may need to address the trauma from an adverse 
experience.

    For example, I am working on improving reimbursement for school 
health services and school based health centers and on building the 
school nurse workforce. Many schools and local communities would like 
to provide cost-effective, accessible services on campus, but there are 
many challenges to do so.

    Can you tell me how the administration is working with schools and 
school-based health centers as well as health plans to ensure that 
students can receive mental health services and counseling while at 
school?

    Answer. On March 12, 2018, President Trump established a Federal 
Commission on School Safety to address school safety and the culture of 
school violence. The Commission will also address mental health issues. 
U.S. Secretary Betsy DeVos was appointed to chair the commission by 
President Trump, and it is comprised with department heads who agencies 
have jurisdiction over key school safety issues, including Attorney 
General Jeff Sessions, Secretary of Health and Human Services Alex Azar 
and Secretary of Homeland Security Kirstjen Nielsen.

    HHS has hosted an in-person meeting, a site visit, and is 
contributing to the development of the final report in support of the 
Commission's work. Specifically, HHS hosted the third of five 
Commission meetings on July 11, 2018, the title of which was ``Curating 
a Healthier and Safer Approach: Issues of Mental Health and Counseling 
for Our Young.'' The HHS Assistant Secretary for Mental Health and 
Substance Abuse Elinore McCance-Katz developed the agenda for this 
meeting. Panel 1 focused on Integrating Behavioral Health Services into 
Schools.

    In addition, HHS facilitated the Commission's second site visit to 
Adams County, WI to learn about and observe a model statewide 
initiative used to guide districts in transforming school climate and 
culture to meet the behavioral health needs of students.

    HHS also supports several activities to ensure that children of all 
ages have access to evidence-based early mental health treatment and 
interventions. For example, to help ensure that our youth get the best 
start possible early on in life, SAMHSA supports the Center of 
Excellence for Infant and Early Childhood Mental Health Consultation 
(IECMHC) and the Project LAUNCH (Linking Actions for Unmet Needs in 
Children's Health) grant program. Both of these resources serve to not 
only support the healthy social and emotional development of young 
children, but also to support, educate, and strengthen personnel and 
systems, including early childcare and preschool.

    SAMHSA also supports activities that are focused on addressing the 
needs of school-aged youth and adolescents, including Project AWARE 
(Advancing Wellness and Resilience in Education), Safe Schools/Healthy 
Students, Mental Awareness Training, and the Garrett Lee Smith Campus 
Suicide Prevention grant programs.

    Project AWARE grants provide funding to build and expand capacity 
at the State and local levels to improve student mental health, 
increase awareness of mental health issues among school-aged youth, 
provide training for school personnel and other adults who interact 
with school-aged youth to detect and respond to mental health issues in 
children and young adults, and connect children, youth, and families 
who may have behavioral health issues with appropriate services.

    These efforts help to develop a comprehensive, coordinated, and 
integrated program for advancing wellness and resilience in educational 
settings for school-aged youth that leads to better student mental 
health and lower rates of addiction. To date, outcomes of this program 
include over 50,000 teachers, student support personnel, parents, and 
others trained in mental health awareness; over 117,000 youth connected 
to services and additional resources; and an increase in early and 
accurate identification of student mental health needs. Since 2014, 
SAMHSA has provided funding of up to $1.95 million per year for up to 5 
years to 20 States and subsequent to the date of the hearing has 
awarded 24 new grants in FY 2018.

    The Safe Schools/Healthy Students program has provided services to 
more than 13 million youth and has offered resources to 365 communities 
in 49 States across the Nation. A 5-year study found that the 
initiative decreased school violence and substance use, and it 
significantly increased the number of students who received school-
based mental health services and community-based services.

    Mental Health First Aid Training is also provided to train and 
educate school personnel and other adults to recognize the signs and 
symptoms of mental health issues; know how to appropriately respond; 
and be able to refer the child, youth, or young adult to the 
appropriate services and supports. In April 2018, SAMHSA issued a 
Funding Opportunity Announcement for up to 126 new Mental Health 
Awareness Training grants at up to $125,000 per year for up to 3 years.

    In addition to support for programs focused on children, youth, and 
adolescents, SAMHSA also provides support for programs that focus on 
college-age students, through programs such as the Garrett Lee Smith 
(GLS) Campus Suicide Prevention Grant Program. The purpose of the GLS 
Campus Suicide Prevention Program is to develop a comprehensive, 
collaborative, well-coordinated and evidence-based approach to enhance 
services for college students, including improving prevention, 
identification and treatment of those at risk for suicide, depression, 
serious mental illness, and/or substance use disorders. The program 
enables colleges and universities to build essential capacity and 
infrastructure to expand mental health and substance use disorder 
services and supports to all students. In fiscal year 2018, SAMHSA 
awarded 20 new GLS Campus grants at up to $102,000 per year for up to 3 
years.

    Furthermore, the Health Resources and Services Administration 
(HRSA) funds nearly 1,400 health centers operating more than 11,000 
service delivery sites, 1,900 of which are located in schools. In 2017, 
more than 800,000 students and their families relied on school-based 
health center sites to meet their needs for a full range of age-
appropriate health-care services, including primary medical care, 
mental health care, substance use disorder counseling, health education 
and promotion, and case management.

    Question. What can the administration do to reduce barriers for 
schools and school-based health centers to bill and be reimbursed for 
mental health services?

    Answer. School-based services play an important role in assuring 
that Medicaid-eligible adolescents and children receive needed health 
care. States have been innovative in their financing strategies for 
school-based mental health care, including the use of Medicaid, and in 
2015, the Federal share of Medicaid funding for school-based services 
was more than $2 billion, with States matching nearly $1.8 billion. 
Examples of State innovation include efforts by Louisiana, which 
authorized the use of Advanced Practice Registered Nurses with 
specialized experience in psychiatric services to deliver Medicaid-
funded mental health and substance use disorder services Medicaid-
eligible students with Individualized Education Plans (IEPs), and 
Arkansas, which developed administrative procedures to finance school-
based mental health programs. Additionally, 46 States offer 
reimbursement for some school-based services through Medicaid. However, 
some States may not be fully aware of the scope of Medicaid services 
and activities available within school settings that may be reimbursed 
under the Medicaid program. In an effort to assist States in leveraging 
current Federal statutory and regulatory authorities for school-based 
services, CMS issued a State Medicaid Director Letter, #14-006, 
entitled, ``Medicaid Payment for Services Provided without Charge (Free 
Care): https://www.medicaid.gov/federal-policy-guidance/downloads/smd-
medicaid-payment-for-services-provided-without-charge-free-care.pdf. 
Medicaid reimburses for Medicaid-coverable services that are provided 
by Medicaid qualified practitioners to Medicaid-eligible and enrolled 
children who are determined to need the services. CMS also issued the 
EPSDT Guide for States: Coverage in the Medicaid Benefit for Children 
and Adolescents,\37\ which discussed screening and rehabilitation 
services that could be delivered in school-based settings under Early 
and Periodic Screening Detection and Treatment provisions of Medicaid.
---------------------------------------------------------------------------
    \37\ https://www.medicaid.gov/medicaid/benefits/downloads/
epsdt_coverage_guide.pdf.

    Question. And would the administration be willing to work with me 
on my legislation, Hallways to Health, to improve school-health 
---------------------------------------------------------------------------
services?

    Answer. HHS is happy to work with members of Congress and their 
staff, including providing TA on pending or proposed legislation.

                                 ______
                                 
               Questions Submitted by Hon. Maria Cantwell
    Question. I introduced S. 2440 with Senator Harris to increase 
current law penalties for the negligent distribution and marketing of 
prescription opioids. I appreciate your commitment to review this 
legislation and provide feedback to my office. In our exchange at the 
committee's hearing, you also indicated that the Centers for Medicare 
and Medicaid Services (CMS) is working on controls to prevent improper 
prescribing, billing, and dispensing of prescription opioids covered by 
Medicare and Medicaid. Please elaborate on your answer by describing: 
(a) CMS's current authorities and work related to tracking and 
preventing prescription opioid diversion in Medicare Parts A, B, 
Medicare Advantage, Part D, and State Medicaid and CHIP programs, 
including coordination with insurers and States; (b) how CMS is 
specifically working to strengthen such controls across its programs, 
as you indicated during the hearing; and (c) to what extent CMS faces 
limitations or barriers that inhibit your ability to track and prevent 
such diversion.

    Answer. CMS is committed to preventing inappropriate prescribing 
and diversion of opioids across our programs. With regards to the 
Medicare program, CMS utilizes the NBI MEDIC to identify and 
investigate potential fraud, waste, and abuse in Medicare Part C and 
Part D, and to refer cases to law enforcement agencies when necessary. 
In particular, the NBI MEDIC identifies prescribers of drug 
combinations known to increase the effects of opioids, those with 
prescribing behavior that indicates they may be operating a pill mill, 
and those who prescribe Transmucosal Immediate-Release Fentanyl 
products to non-cancer patients. CMS shares this information with plans 
to assist in their investigation of fraud, waste, and abuse.

    The NBI MEDIC also conducts data analysis and other work to support 
ongoing law enforcement activities. Examples include impact 
calculations, medical review of claims and medical records, and 
prescription drug invoice reconciliation reviews. As a result of its 
work, the NBI MEDIC makes recommendations for administrative action to 
both CMS and the OIG, including revocations of Medicare billing 
privileges and exclusions from Federally funded health-care programs, 
respectively.

    Additionally, plan sponsors report potential fraud to the NBI 
MEDIC. The NBI MEDIC uses the PLATO system, which is a voluntary, web-
based system that allows CMS, the NBI MEDIC, and plan sponsors to more 
easily share information and help combat potential fraud, waste, and 
abuse in the Medicare Advantage and Medicare Part D programs. CMS's 
Federal law enforcement partners can also access PLATO data.

    To strengthen and improve our controls and oversight, CMS has 
directed the NBI MEDIC to increase its focus on proactive data analysis 
in Part D, including producing, at a minimum, quarterly reports to plan 
sponsors on specific data projects, such as high risk pharmacy 
assessments. These assessments contain a list of pharmacies identified 
by CMS as high risk and provide plan sponsors with information to 
initiate new investigations, conduct audits, and potentially terminate 
pharmacies from their network, if appropriate. In addition to the 
Quarterly Pharmacy Risk Assessment, the NBI MEDIC produces a Quarterly 
Outlier Prescriber Schedule II Controlled Substances Report, which 
provides a peer comparison of Schedule II controlled substances.

    With regard to Medicaid, States design, implement, and administer 
their own programs under general guidelines established by the Federal 
Government. To reduce opioid misuse without restricting access to 
legitimate services, Medicaid programs can utilize medical management 
techniques such as step therapy, prior authorization, and quantity 
limits. As of FY 2016, 37 States have edits in place to limit the 
quantity of short-acting opioids that will be covered for a beneficiary 
and 39 States have similar edits in place to limit the quantity of 
long-acting opioids. Additionally, to increase oversight of certain 
prescription opioids, States have the option of amending their 
Preferred Drug Lists and Non-Preferred Drug Lists to require prior 
authorization for certain opioids.

    States are required to report on their providers' prescribing 
patterns, including prescription opioids, as part of the Medicaid Drug 
Utilization Review (DUR) program. This is a two-phase process that is 
conducted by the State Medicaid agencies. During the first phase, 
(prospective DUR), the State agency's electronic monitoring system 
screens prescription drug claims to identify problems such as 
therapeutic duplication, contraindications, incorrect dosage, and 
clinical misuse or abuse. The second phase (retrospective DUR) involves 
ongoing and periodic examination of claims to identify patterns of 
fraud, abuse, gross overuse, or medically unnecessary care.

    The President's FY 2019 budget includes a proposal that would 
establish minimum standards for Medicaid Drug Utilization Review 
programs. Currently, CMS does not set minimum requirements for these 
programs, and there is substantial variation in how States approach 
this issue. Establishing minimum standards would not only help increase 
oversight of opioid prescriptions and dispensing in Medicaid, but would 
save the program an estimated $245 million over 10 years.

    Question. During our exchange at the committee's hearing, you 
indicated that CMS does not work directly with the Drug Enforcement 
Administration (DEA) to prevent the diversion of prescription opioids 
covered by CMS programs. Is there a reason CMS does not work directly 
with the DEA in this area?

    Would such direct collaboration between CMS and DEA (and other 
appropriate agencies within the Departments of Justice and Health and 
Human Services) allow the Federal Government to more effectively deter 
the diversion of prescription opioids?

    Answer. CMS works closely with the HHS Office of Inspector General 
(HHS OIG) and other Federal partners in law enforcement, including the 
Department of Justice. HHS OIG and DOJ are important Federal partners 
in the Healthcare Fraud Prevention Partnership (HFPP), which is a 
voluntary, public-private partnership consisting of the Federal 
Government, State agencies, law enforcement, private health insurance 
plans, and health-care anti-fraud associations. Established in July 
2012 by the Secretary of HHS and the U.S. Attorney General, the HFPP 
provides visibility into the larger universe of health-care claims and 
claimants beyond those encountered by any single partner. The ultimate 
goal of the HFPP is to exchange facts and information to identify 
trends and patterns that will uncover potential fraud, waste, and abuse 
that may not otherwise be identified. The HFPP provides a unique 
opportunity for payers to combat the opioid crisis by identifying and 
sharing strategies to prevent prescription opioid misuse and opioid use 
disorder. By sharing information among payers, the HFPP aims to 
identify and intervene on behalf of patients at risk of opioid-related 
harm, as well as to target fraud, waste, and abuse in opioid 
prescribing.

    To address potentially abusive prescribing practices, the 
President's FY 2019 budget proposes to allow the Secretary to work with 
the Drug Enforcement Administration (DEA) to revoke a provider's DEA 
Certificate of Registration after CMS revokes a provider's Medicare 
enrollment based on a pattern of abusive prescribing via a newly 
established mandatory reporting requirement. Under this proposal, CMS 
will be required to report all revocation actions to DEA that are based 
totally or in part on abusive prescribing of controlled substances and 
the DEA would be able to use this data to establish revocation of a 
provider's certification of registration.

    CMS is always eager for opportunities to strengthen our 
partnerships and work together to address the opioid epidemic.

    Question. During your testimony, you outlined CMS's overutilization 
monitoring systems and fraud investigation unit. I understand that CMS 
employs these tools to track beneficiaries who receive high amounts of 
prescription opioids and access prescribing data for pharmacies and 
prescribers who are outliers. However, watching suspicious prescribing 
or utilization patterns is different than acting to stop them when 
their activities constitute fraud or violate Federal rules. What tools 
does CMS currently have to stop, or penalize, fraudulent opioid 
prescribing within CMS programs?

    Answer. CMS has a variety of tools to stop potentially problematic 
prescribing. Plan sponsors utilize safety edits, which alert a 
pharmacist of possible overutilization at the point of sale. In real-
time they can flag for a pharmacist that they should conduct additional 
review and/or consultation with the plan sponsor or prescriber to 
ensure that a prescription is appropriate. In 2018, all plan sponsors 
are utilizing these safety edits. Beginning in 2019, we expect all 
sponsors to implement a new opioid care coordination safety-edit. This 
new edit would create an alert for pharmacists when a beneficiary's 
daily opioid usage reaches high levels. When this occurs, plan sponsors 
are expected to direct pharmacists to consult with the prescriber to 
confirm their intent. This new policy aims to strike a balance between 
addressing opioid overuse without a negative impact on the patient-
doctor relationship, preserving access to medically necessary drug 
regimens, and reducing the potential for unintended consequences.

    To help protect beneficiaries from potentially problematic 
prescribers, CMS is also compiling a ``Preclusion List'' of 
prescribers, individuals, and entities that fall within either of the 
following categories: (a) are currently revoked from Medicare, are 
under an active reenrollment bar, and CMS determines that the 
underlying conduct that led to the revocation is detrimental to the 
best interests of the Medicare program; or (b) have engaged in behavior 
for which CMS could have revoked the prescriber, individual, or entity 
to the extent applicable if they had been enrolled in Medicare, and CMS 
determines that the underlying conduct that would have led to the 
revocation is detrimental to the best interests of the Medicare 
program. Under this option, CMS will make the Preclusion List available 
to Part D prescription drug plans and Medicare Advantage plans. Plans 
would be required to deny payment for claims submitted by, or 
associated with prescriptions written by prescribers and providers on 
the list. Additionally, the NBI MEDIC can refer suspected fraud to the 
HHS OIG for investigation.

    Addendum: In April 2018, CMS finalized a rule \38\ adopting the 
Preclusion list and prohibiting Medicare Advantage plans and Part D 
prescription drug plans from paying prescribers, individuals, and 
entities on that list. In addition, under the final rule, CMS will make 
the Preclusion List available to Medicare Advantage plans and Part D 
prescription drug plans.
---------------------------------------------------------------------------
    \38\  https://www.federalregister.gov/documents/2018/04/16/2018-
07179/medicare-program-contract-year-2019-policy-and-technical-changes-
to-the-medicare-advantage-medicare.

                                 ______
                                 
                Questions Submitted by Hon. Bill Nelson
    Question. About one in three people on Medicare across the United 
States received at least one opioid prescription in 2016. A 2017 HHS 
Inspector General report found that approximately 500,000 Medicare 
recipients received a high amount of opioids and around 400 prescribers 
were identified as having questionable opioid prescribing patterns.

    Almost 90,000 people on Medicare are at serious risk of misuse or 
overdose. In one example, the report pointed to a Florida physician who 
repeatedly ordered three opioids for one person in a single day. In 
total, this physician prescribed opioids to 125 beneficiaries who 
received extreme amounts.

    What else does CMS plan to do to inform seniors on Medicare about 
safe opioid use and non-opioid alternatives? Do you currently make 
Medicare patients aware of opioid prescribing practices?

    Answer. Evidence-based practice is an integral part of all of CMS's 
priority areas, but expanding the evidence base of effective and 
alternative treatments for acute and chronic pain is especially vital. 
The opioid crisis cannot be tackled by CMS alone, and that is why we 
are collaborating with research-focused HHS agencies, such as the NIH, 
to identify services that need more evidence to support coverage by 
Medicare and other health plans.

    CMS has partnered with the CDC to develop the Opioid Safety 
Commitment poster campaign,\39\ which promotes the most effective pain 
management treatments and strategies. This campaign emphasizes patient 
engagement, clinician counseling regarding opioid alternative pain 
management strategies, and discussion with patients of the risks and 
benefits of opioids when opioids are prescribed.
---------------------------------------------------------------------------
    \39\ https://www.cdc.gov/drugoverdose/prescribing/posters.html.

    Question. Senator Heller and I introduced a bill to update the 
``Medicare and You'' handbook to include information about opioid use, 
pain management, and alternative pain management treatments. This 
handbook is mailed to all Medicare households each year, and is 
sometimes the starting point to learn about various benefits, plans, 
rights, and protections. Yet, it doesn't include anything about 
opioids. Do I have your commitment that your agency will work with my 
---------------------------------------------------------------------------
staff on this bill?

    Answer. The ``Medicare and You'' handbook is only one of many ways 
that CMS communicates with beneficiaries. CMS is working with the 
Centers for Disease Control and Prevention and other Federal partners 
to make information about opioids and pain management available to our 
beneficiaries through a variety of channels. While CMS can make changes 
to the Handbook contents without legislation, we are happy to provide 
any technical assistance that you and your staff may require.

    Question. There are some exciting things happening with research 
and development of opioid-alternative drugs that mitigate high-
intensity pain. These drugs include injections administered at the site 
of a surgery by health-care professionals, keeping them out of the 
hands of the patient. Another such drug works as a long-acting 
anesthetic to control pain and inflammation after a surgery.

    Could these products help alleviate opioid addiction and diversion?

    Answer. CMS is exploring a variety of options to help alleviate 
opioid addiction and diversion. Regarding injectable pain medications, 
Medicare Part B covers drugs and biologicals furnished ``incident to'' 
a physician's service. These drugs furnished under the ``incident to'' 
provision are typically injectable drugs that are bought by the 
physician, administered in the physician's office, and billed by the 
physician to Medicare. In the Calendar Year 2013 Medicare Physician Fee 
Schedule final rule, CMS clarified a Part B payment policy that drugs 
used by a physician to refill an implanted item of durable medical 
equipment would be considered under the ``incident to'' benefit. Based 
on this policy, physicians, but not pharmacies, must purchase the drugs 
used to refill intrathecal pumps and bill for them under Medicare Part 
B. However, these drugs may be payable to the pharmacy under Part D if 
the ingredients that are being compounded independently meet the 
definition of a Part D drug.

    Supporting cutting-edge research that advances our understanding of 
pain, overdose, and addiction and leads to the development of new 
treatments is a key part of the comprehensive, five-point HHS Opioid 
Strategy. There are many opportunities for development of opioid 
alternatives for acute pain. Plans to facilitate research to develop 
potential non-addictive treatments for acute and/or chronic pain are 
underway through the NIH Helping to End Addiction Long-term (HEAL) 
Initiative (https://www.nih.gov/research-training/medical-research-
initiatives/heal-initiative). As a part of the HEAL Initiative, a 
program will be established to identify potential candidates for pain 
medication through rapid screening of a large volumes of molecules for 
pain-relevant biological activity, bringing more options into the drug 
pipeline. NIH is working to develop a platform for pain biomarker 
discovery and validation to inform early stage clinical studies of 
potential drug effectiveness and safety. In addition, NIH will 
facilitate the sharing of data on past and future drug development 
across industry and academia, to focus more research on bringing new 
pain medications to patients.

    To accelerate testing of novel non-addictive pain medications and 
devices in humans, NIH is establishing a Clinical Trial Network to 
optimize analgesic trial design, target appropriate patient populations 
for trials, and engage research expertise at existing clinical sites. A 
related initiative is to pursue through the Network, development and 
validation of biomarkers of pharmacodynamic response, to show if tested 
drugs are working at pain circuits. These efforts provide a valuable 
set of basic and clinical research resources to accelerate safe, non-
addictive drug development.

    Injection of anesthetic agents, i.e., nerve blocks, to a surgical 
site are sometimes administered with analgesics or general anesthesia 
to reduce opioid dosing during surgery. They provide temporary 
analgesia, and some evidence suggests that their use reduces the 
severity of post-operative pain, although may not improve other pain 
related measures (https://www.ncbi.nlm.nih.gov/pubmed/25501884).

    NIH is exploring many avenues to accelerate development of non-
addictive medications that may reduce or ultimately eliminate the need 
for opioids for acute, severe pain management such as during or 
following surgical procedures or injuries. One program that is underway 
at NIH is a large-scale clinical study to understand the mechanisms 
that lead some people to develop chronic pain after an acute pain event 
such as surgery or musculoskeletal trauma. Patients who are about to 
undergo surgery or have a bone fracture will be followed for 6 months 
from the injury. Many different bio-psychosocial characteristics, such 
as gene variants, inflammation markers, and mental health will be 
collected and correlated with risk for chronic pain. This information 
will provide mechanistic targets for novel drugs for acute pain 
treatment. It also will help us to develop precision medicine treatment 
guidelines that should reduce opioid use for those who don't need it--
those who are not likely to develop persistent pain.

    Current NIH programs for discovery of new formulations and 
combinations of existing medicines, as well as for finding existing 
molecules developed for treatment of other disorders that will provide 
safe and effective pain relief are being leveraged for rapid expansion. 
NIH supports an initiative, the Blueprint Neurotherapeutics Program for 
small molecule drug discovery and development. It funds studies that 
aim to develop non-addictive kappa opioid receptor antagonists for 
migraine and a safe, non-opioid analgesic that can be taken orally to 
reduce diabetic nerve pain.

    Question. I introduced the Protecting Newborns from Opioids Act 
with Senator Rubio, to improve the quality of care provided to newborn 
babies suffering from opioid withdrawal. The bill would provide Federal 
funding to States to ramp up the tracking, analysis, and research on 
babies born with neonatal abstinence syndrome.

    In addition to enhanced surveillance and research, what can we do 
to protect our newborns from this terrible syndrome?

    Answer. Addressing neonatal abstinence syndrome is a priority for 
HHS, and we appreciate your interest in this critical health 
consequence of opioid use by pregnant women. As you are aware, in 
November 2015, Congress passed the Protecting our Infants Act (POIA) of 
2015 to address the needs of pregnant women and their newborns. As a 
result of this Act and a subsequent Government Accountability Office 
(GAO) report, HHS developed the POIA strategy to inform planning and 
policy across the Department. The recommendations in this report range 
from aspirational to practical and include preventing prenatal opioid 
exposure, providing evidence-based treatment for both mother and 
infant, increasing the accessibility of family-friendly services for 
pregnant and parenting women with opioid use disorder, supporting 
continuing education for health-care providers, and determining optimal 
family and development support services for children who have 
experienced prenatal opioid exposure. The recommendations are critical 
to addressing the needs of infants and their mothers who are caught in 
the midst of this unprecedented opioid use crisis, and HHS is actively 
working across agencies to implement these recommendations.

    SAMHSA developed ``Clinical Guidance for Treating Pregnant and 
Parenting Women with Opioid Use Disorder and Their Infants. (The 
Guidance can be accessed here: https://store.samhsa.gov/product/
Clinical-Guidance-for-Treating-Pregnant-and-Parenting-Women-With-
Opioid-Use-Disorder-and-Their-Infants/SMA18-5054). This Guidance 
outlines optimal management of pregnant and parenting women with an 
opioid use disorder and their infants based on the recommendations of 
experts. This Guidance also provides information for healthcare 
professionals to determine the most clinically appropriate action for a 
particular circumstance. HHS, through SAMHSA, is supporting a number of 
grant programs aimed at pregnant and parenting women with substance use 
and opioid use disorder. These include grants for residential treatment 
centers that provide comprehensive services to women with substance use 
disorders and their families, and three new State Pilot Grants for 
Pregnant and Post-Partum women, the goal of which is to expand 
outpatient services for this population.

    In addition to implementing what we know about the prevention of 
and treatment for NAS, continuing to support biomedical research to 
further our understanding of this syndrome is equally critical. The 
National Institutes of Health (NIH) announced in 2017 a new study 
called the Advancing Clinical Trials in Neonatal Opioid Withdrawal 
Syndrome (ACT NOW), which will evaluate treatment options and improve 
clinical care of infants with NAS/NOWS. The study is a collaboration 
between the Eunice Kennedy National Institute of Child Health and Human 
Development (NICHD) Neonatal Research Network (which has 30 years of 
experience in conducting clinical trials with newborns) and the new 
IDeA States Pediatric Clinical Trials Network (within the NIH Office of 
the Director's Environmental Influences on Child Health Outcomes (ECHO) 
program), with sites located in rural and medically underserved 
communities. This joint research effort will use the reach of both 
networks to assess the prevalence of NAS, understand current approaches 
to managing NOWS cases (including non-pharmacological approaches), and 
develop protocols for conducting large scale studies across the country 
to inform clinical care for affected infants. As part of the recently-
launched NIH Helping to End Addiction Long-term (HEAL) Initiative 
(https://www.nih.gov/research-training/medical-research-initiatives/
heal-initiative), NIH will use the results of this study to conduct 
clinical trials aimed at determining best practices for clinical care 
of infants with NOWS, including assessment of currently used 
medications and of drug-free treatment approaches.''

    Question. The opioid epidemic is now a national public health 
emergency. Medicaid is the single largest payer substance use services 
across the country, giving millions access to life-saving treatments. 
In fact, adults on Medicaid are more than twice as likely as those with 
private insurance to get treatment for a substance use disorder.

    In 2015, Medicaid covered a quarter of people in our Nation with 
opioid use disorders. This program covers a broad range of important 
services to treat opioid abuse, including counseling, peer support 
services, medication-assisted treatment, intensive outpatient 
treatment, and in some circumstances, inpatient and residential care.

    The President's budget for fiscal year 2019 proposes to cut 
Medicaid and our Nation's health-care system by hundreds of billions of 
dollars by reviving repeal legislation that came before this committee 
last year to block grant or cap Medicaid.

    This legislation, along with the other Medicaid proposals in the 
President's budget would result in more than $1 trillion in cuts to 
Medicaid, undoubtedly shifting cost to States. States would ultimately 
have to cut Medicaid benefits, drop people from the program, and cut 
payments to providers.

    The administration said its top priority is fighting the opioid 
epidemic. How does slashing Medicaid and kicking people with opioid use 
disorders off their insurance fight the opioid epidemic?

    Answer. Our Medicaid program is an important tool in providing 
health care to many Americans, but we must put it on a stable long-term 
sustainable footing for it to be there for this and future generations. 
That is the challenge that we have as we seek to empower the States 
with the right incentives to deliver quality service. The FY 2019 
budget provides additional flexibilities to States, puts Medicaid on a 
path to fiscal stability by restructuring Medicaid financing, and 
refocuses on the populations Medicaid was intended to serve--the 
elderly, people with disabilities, children, and pregnant women. The 
traditional Medicaid program will grow under our budget from about $400 
billion over 10 years. The Medicaid expansion does get rescinded, but 
is replaced along with the individual subsidy program with a $1.2 
trillion grant program through the Graham-Cassidy legislation.

    Opioid misuse, abuse, and overdose impose immense costs on the 
Nation, contributing to two-thirds of deaths by drug overdose. Deaths 
by drug overdose are the leading cause of injury death in the United 
States. The FY 2019 President's budget recognizes the devastation 
caused by the opioid crisis in communities across America and fulfills 
the President's promise to mobilize resources across the Federal 
Government to address the epidemic. The budget provides a historic 
level of new resources across HHS to combat the opioid epidemic and 
serious mental illness--$10 billion--to build upon the work started 
under the 21st Century Cures Act.

    The budget's targeted investments advance the Department's five-
part strategy, which involves:

          Improving access to prevention, treatment, and recovery 
        services, including medication-assisted therapies;

          Targeting availability and distribution of overdose-
        reversing drugs;

          Strengthening our understanding of the epidemic through 
        better public health data and reporting;

          Supporting cutting edge research on pain and addiction; and

          Advancing better practices for pain management.

                                 ______
                                 
              Questions Submitted by Hon. Robert Menendez
    Question. Last month, Secretary Azar said, ``there is no such thing 
as medical marijuana.'' Yet, a recent study published in JAMA Internal 
Medicine and led by researchers at the Perelman School of Medicine at 
the University of Pennsylvania, examined the rate of deaths caused by 
opioid overdoses between 1999 and 2010. Results reveal that on average, 
the 13 States allowing the use of medical marijuana had a 24.8-percent 
lower annual opioid overdose mortality rate after the laws were enacted 
than States without the laws, indicating that the alternative treatment 
may be safer for patients suffering from chronic pain related to cancer 
and other conditions. Another study, also published in JAMA Internal 
Medicine and led by researchers at the University of Kentucky College 
of Public Health found that laws that permit both medical marijuana and 
recreational marijuana for adults ``have the potential to reduce opioid 
prescribing for Medicaid enrollees, a segment of population with 
disproportionately high risk for chronic pain, opioid use disorder and 
opioid overdose.''

    Will HHS continue to ignore scientifically proven medical marijuana 
as a treatment alternative to opioids?

    Answer. HHS believes that more research is needed on both the harms 
associated with marijuana use and the therapeutic potential of 
marijuana and its constituent compounds. To this end, NIH welcomes 
investigator-initiated research proposals for pre-clinical and clinical 
research evaluating marijuana and its constituent cannabinoids for 
treating disease. The current research portfolio includes some studies 
utilizing the whole marijuana plant, however most studies focus on 
individual cannabinoid compounds or other strategies to manipulate the 
function of the endogenous cannabinoid system. The marijuana plant 
itself is not considered an ideal medication candidate because: (1) it 
is an unpurified plant containing numerous chemicals that have not been 
fully characterized; (2) the variability of active components makes it 
difficult to reproduce a consistent dose; (3) it is often consumed by 
smoking, potentially contributing to adverse effects on lung health; 
and (4) its cognitive- and motor-impairing effects may limit its 
utility.

    In order to facilitate more research on the therapeutic potential 
of cannabinoids, NIH has released funding opportunity announcements 
(FOAs) on:

          Developing the Therapeutic Potential of the Endocannabinoid 
        System for Pain Treatment.\40\, \41\
---------------------------------------------------------------------------
    \40\ https://grants.nih.gov/grants/guide/pa-files/pa-15-188.html.
    \41\ https://grants.nih.gov/grants/guide/pa-files/PAR-14-225.html.

          Clinical Evaluation of Adjuncts to Opioid Therapies for the 
        Treatment of Chronic Pain.\42\
---------------------------------------------------------------------------
    \42\ https://grants.nih.gov/grants/guide/pa-files/PAR-14-225.html.

          Blueprint Neurotherapeutics Network Small Molecule Drug 
        Discovery and Development for Disorders of the Nervous 
        System.\43\
---------------------------------------------------------------------------
    \43\ https://grants.nih.gov/grants/guide/pa-files/PAR-17-205.html.

          Effects of Cannabis Use and Cannabinoids on the Developing 
        Brain.\44\
---------------------------------------------------------------------------
    \44\ https://grants.nih.gov/grants/guide/pa-files/PA-14-162.html.

    In addition, FDA has issued the guidance for industry, Botanical 
Drug Development, for companies developing new therapies that are 
plant-derived, such as from the cannabis plant. FDA's recent approval 
of a product containing a purified form of cannabidiol to treat 
seizures associated with two rare, severe forms of epilepsy in patients 
2 years of age and older demonstrates that advancing sound scientific 
research to investigate ingredients derived from marijuana can lead to 
important therapies. FDA will continue to support the development of 
potential medical treatments using marijuana and its components through 
---------------------------------------------------------------------------
the appropriate scientific channels and the drug approval process.

    Question. Is there a circumstance under which HHS would commit to 
further study of the risks and rewards to the use of medical marijuana 
in pain management?

    Answer. HHS is committed to working with Congress and our Federal 
partners to facilitate more research on marijuana and cannabinoids, and 
to reduce barriers to research. For example, NIH supports a broad 
portfolio of research on cannabinoids and the endocannabinoid system 
(ECS). In FY 2016, NIH supported 292 projects totaling over $115 
million \45\ on cannabinoid research including 53 projects ($28 
million) on research evaluating the therapeutic potential of 
cannabinoids.\46\ Research on the therapeutic potential of cannabinoids 
included 26 studies related to pain. These studies include:
---------------------------------------------------------------------------
    \45\ https://report.nih.gov/
categorical_spending_project_listing.aspx?FY=2016&ARRA
=N&DCat=Cannabinoid%20Research.
    \46\ https://report.nih.gov/
categorical_spending_project_listing.aspx?FY=2016&ARRA
=N&DCat=Therapeutic%20Cannabinoid%20Research.

          A randomized controlled trial of dronabinol (a synthetic 
        form of THC) and vaporized cannabis for neuropathic low back 
        pain.\47\
---------------------------------------------------------------------------
    \47\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=8964406.

          An observational study of the effects of edible cannabis and 
        its constituent cannabinoids on pain, inflammation, and 
        cognition.\48\
---------------------------------------------------------------------------
    \48\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9361825.

          Research on the use of cannabinoid receptor type 2 (CB2) 
        agonists for treating breast cancer induced bone pain.\49\
---------------------------------------------------------------------------
    \49\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9329913.

          Cannabinoid based therapeutics for pain in sickle cell 
        disease.\50\
---------------------------------------------------------------------------
    \50\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9301005.

          Studies exploring the therapeutic potential of compounds 
        that modulate the ECS such as diacylglycerol kinase, fatty acid 
        amide hydrolase (FAAH), fatty acid binding proteins (FABPs), 
        and G-protein receptor 55.\51\
---------------------------------------------------------------------------
    \51\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9205939, 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9328534, 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9222649, 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9040444, 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=8878443, and 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9247769.

          Research on the use of cannabinoid compounds as adjunct 
        therapies with opioids or non-steroidal anti-inflammatories 
        (NSAIDs) to improve pain control and reduce adverse events.\52\
---------------------------------------------------------------------------
    \52\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9329184, 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9324176, and
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9557937.

          Studies of the therapeutic effects of cannabis and 
        cannabinoids on HIV-
        related pain.\53\
---------------------------------------------------------------------------
    \53\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9271603.

          Studies of the efficacy of peripherally restricted 
        cannabinoids for cancer and chemotherapy-induced pain.\54\
---------------------------------------------------------------------------
    \54\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9056010.

---------------------------------------------------------------------------
          Basic research on:

            The mechanisms through which cannabinoids and 
        the ECS modulate pain;\55\
---------------------------------------------------------------------------
    \55\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9309675, and 
https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=8918260.

            The role of cannabinoids in modulating 
        hyperalgesia;\56\
---------------------------------------------------------------------------
    \56\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9107004.

            The role of CB2 receptors in peripheral 
        neuropathy;\57\ and
---------------------------------------------------------------------------
    \57\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9279120.

            The role of the ECS in the efficacy of spinal 
        manipulation therapy for neuropathic pain.\58\
---------------------------------------------------------------------------
    \58\ https://projectreporter.nih.gov/
project_info_description.cfm?icde=0&aid=9377578.

    FDA will continue to support the development of potential medical 
treatments using marijuana and its components, including for the 
treatment of pain, through the appropriate scientific channels and the 
---------------------------------------------------------------------------
drug approval process.

    Question. Speaking in February 2018, Attorney General Jeff Sessions 
stated that ``The DEA said that a huge percentage of the heroin 
addiction starts with prescriptions. That may be an exaggerated number; 
they had it as high as 80 percent. . . . We think a lot of this is 
starting with marijuana and other drugs too.'' Research indicates 
however, that there is no causal link between marijuana and harder drug 
use.

    Do you agree with the statements made by the Attorney General?

    Answer. Prescription opioids and heroin belong to the same drug 
class, act on the same receptors in the brain, produce similar effects, 
and alleviate opioid withdrawal symptoms. The available data clearly 
demonstrate the intertwined nature of prescription opioid misuse and 
heroin use.

    Analysis of nationally representative data collected in 2011 showed 
that 80 percent of people who started using heroin that year had 
previously misused prescription opioids,\59\ a finding that aligned 
with other reports that prescription opioids were the most common 
opioids of initiation.\60\ More recent data, however, suggest that 
heroin may have become more common as an opioid of first abuse, at 
least among people entering treatment. Based on data regarding people 
who have opioid use disorder upon entering treatment, Cicero et al., 
found that approximately one-third reported heroin as the first opioid 
they used regularly to get high.\61\
---------------------------------------------------------------------------
    \59\ Muhuri, P.K., Gfroerer, J.C., Davies, C., ``Associations of 
nonmedical pain reliever use and initiation of heroin use in the United 
States,'' CBHSQ Data Review, 2013.
    \60\ Compton, W.M., Jones, C.M., Baldwin, G.T., ``Relationship 
Between Nonmedical Prescription-Opioid Use and Heroin Use,'' N. Engl. 
J. Med. 2016 January 14;374(2):154-63. doi: 10.1056/NEJMra1508490. 
Review. PubMed PMID: 26760086.
    \61\ Cicero, T.J., Ellis, M.S., Kasper, Z.A., increased use of 
heroin as an initiating opioid of abuse. Addict. Behav. 2017 November 
74:63-66. doi: 10.1016/j.addbeh.2017.05.030. Epub 2017 May 23. PubMed 
PMID: 28582659.

    It is important to note that many people who use drugs use multiple 
substances, and many people who initiate drug use will do so with 
substances that are easiest to obtain, such as nicotine, alcohol, and 
marijuana. However, the majority of people who use nicotine, alcohol, 
and/or marijuana do not go on to use more potent illicit substances. 
There is evidence of an association between marijuana use and opioid 
---------------------------------------------------------------------------
misuse, including:

          A recent nationally representative study found that adults 
        who reported marijuana use in 2001-2002 were nearly 6 times as 
        likely to have initiated prescription opioid misuse and nearly 
        8 times as likely to have a prescription opioid use disorder by 
        2001-2005 compared to adults who did not report marijuana use 
        in 2001-2002.\62\
---------------------------------------------------------------------------
    \62\ Olfson, M., Wall, M.W., Liu, S.M., Blanco, C., ``Cannabis use 
and risk of prescription opioid use disorder in the United States,'' 
Am. J. Psychiatry, 2018;175(1):47-53.

          An analysis by SAMHSA researchers among youth aged 12 to 17 
        years old found that youth who had ever used marijuana had 
        elevated risk for prescription opioid misuse and use of other 
        illicit drugs compared with youth who had never used marijuana, 
        even after accounting for tobacco and alcohol use.\63\
---------------------------------------------------------------------------
    \63\ Jones, C.M., McCance-Katz, E.F., Unpublished analysis of the 
2015-2016 National Survey on Drug Use and Health data.

          A 2015 study by HHS researchers found that nearly 1 in 4 
        people who used heroin in the past year had a marijuana 
        (cannabis) use disorder and that people with marijuana use 
        disorder were nearly three times as likely to have a heroin use 
        disorder, compared to people without a marijuana use 
        disorder.\64\
---------------------------------------------------------------------------
    \64\ Jones C.M., Logan J., Gladden R.M., Bohm M.K., ``Vital Signs: 
Demographic and substance use trends among heroin users--United States, 
2002-2013,'' MMWR Morb. Mortal. Wkly. Rep. 2015;64(26):719-725.

    These findings are consistent with a large volume of literature 
demonstrating that marijuana use, especially early and frequent use, is 
associated with use of other illicit substances,\65\, \66\ 
though more research is needed to determine the degree to which cross-
sensitization, shared underlying risk factors, and social environment 
underlie this association.
---------------------------------------------------------------------------
    \65\ Volkow, N.D., Baler, R.D., Compton, W.M., Weiss, S.R.B., 
``Adverse health effects of marijuana use: State of the science,'' N. 
Eng. J. Med., 2014;370:2219-2227.
    \66\ Silins, E., Horwood, L.J., Patton, G.C., Fergusson, D.M., 
Olsson, C.A., Hutchinson, D.M., Spry, E., Toumbourou, J.W., Degenhardt, 
L., Swift, W., Coffey, C., Tait, R.J., Letcher, P., Copeland, J., 
Mattick, R.P., ``Young adult sequelae of adolescent cannabis use: An 
integrative analysis,'' Lancet Psychiatry, 2014;1:286-2.

    Question. During the hearing, we spoke about leveraging Medicaid 
data to inform policy on the opioid epidemic. What additional Federal 
supports would aid CMS and States in using the data of the States and 
territories to inform policy and programs? Are there statutory 
limitations or changes that require congressional action to advance the 
---------------------------------------------------------------------------
use of data?

    Answer. CMS understands the importance of having complete, accurate 
data. The Transformed Medicaid Statistical Information System (T-MSIS) 
is a critical data and systems component of CMS's efforts to gather 
information from State Medicaid programs. CMS has made significant 
progress with its Federal T-MSIS information technology (IT) platform, 
and CMS is continuing to work with States on T-MSIS data quality and 
technical compliance as a priority for 2018. CMS continues to focus on 
improving the quality and completeness of the State submissions, 
technical compliance and building the agency's Medicaid and CHIP data 
analytic capacity. We look forward to making data more widely available 
as quality improves.

    Question. As mentioned in the hearing, the Family First Preventions 
Services Act is of critical importance to many programs. What is the 
timeline for guidance to be issued so programs can access funds for 
their programs? What is the proposed timeline for continuous updates to 
the list of eligible programs for the clearinghouse of evidence-based 
programs?

    Answer. To respond to your questions, I believe it's helpful to 
give an overview of the plan for implementation. As you know, the 
statute requires the Secretary to develop criteria that interventions 
must meet in order to receive funding under the title IV-E prevention 
services program. Over the course of the next few months, we intend to 
consult broadly across HHS and the field in the development of those 
criteria. Once the criteria are established, ACF will take an equally 
broad approach for identifying interventions that meet the criteria. 
The vendor that operates the clearinghouse will assess interventions 
for inclusion in the clearinghouse and elevation within the levels of 
evidence on an ongoing basis. ACF will issue instructions to States and 
tribes on what must be included in plans submitted to operate a title 
IV-E prevention services program in conjunction with publication of the 
criteria for allowable interventions.

    Question. Prescription Drug Monitoring Programs continue to evolve. 
What would the benefits be of establishing a new, national PDMP that 
integrates developing prescribing technology as well as data from law 
enforcement to better track abuses and pressure points in and allow 
cross-agency collaboration to further stem the flow of opioids into our 
communities?

    Answer. PDMPs are State-run databases that collect patient-specific 
prescription information at the point of dispensing. The use of PDMPs 
among all providers is a promising State-level intervention to improve 
opioid prescribing, inform clinical practice, and protect patients at 
heightened risk of opioid misuse, abuse, and overdose. Clinicians can 
use PDMPs to help inform their prescribing decisions by checking to see 
if a patient already has an opioid prescription, has prescriptions from 
multiple providers, or has both opioids and benzodiazepine 
prescriptions--all risk factors for an overdose.

    PDMPs also can provide public health authorities with timely 
information about prescribing and patient behaviors that contribute to 
the epidemic. In addition, States can use PDMP data to determine ``hot 
spots'' or geographic areas within a State with disproportionately 
higher rates of opioid prescribing and dispensing and therefore target 
interventions.

    CDC's primary goal pertaining to PDMPs is to maximize their utility 
as both a public health surveillance and clinical decision support 
tool. CDC is working to actualize such outcomes through State-based 
programs as well as within the context of health systems.

    The establishment and operation of PDMPs vary given that each PDMP 
is subject to existing policies and management of their own respective 
State. While PDMPs may operate differently, there are system components 
that CDC promotes to improve PDMP functionality as a public health 
tool. Those include:

          Universal use among providers and/or their delegates (for 
        example, nurse practitioners or physician assistants) within a 
        State;

          More timely or real-time data contained within a PDMP;

          Actively managing the PDMP in part by sending proactive 
        reports to providers to inform prescribing; and

          Ensuring that PDMPs are easy to use and accessible by 
        providers.

    In addition to those strategies that enhance the functionality of a 
PDMP as a public health surveillance and clinical decision support 
tool, there are additional strategies that can assist States in scaling 
up the widespread use of PDMP data. States can implement strategies to 
improve integration of PDMP data within a State (intrastate) and 
interstate interoperability.

    Intrastate interoperability refers to the ability of a State to 
share PDMP data with other technologies utilized within the State 
including electronic health records (EHRs), pharmacy dispensing 
software (PDS) systems, and Health Information Technology (Health IT) 
infrastructure. Integrating PDMP data into Health IT systems (e.g., 
EHRs, PDS systems) allows providers to access PDMP data and reports as 
seamlessly as possible in their clinical workflow. Through such 
integration, the PDMP report is automatically accessed when an EHR/
Health Information Exchange (HIE) patient record is opened. In 
addition, the ONC Interoperability Standards Advisory includes updated 
National Council for Prescription Drug Programs Standards for 
exchanging controlled substance prescription history from State PDMPs 
so that prescription history may be integrated into Health IT systems. 
Health IT developers and implementers can use these standards to 
provide prescribers a more complete picture of their patients' 
prescription history. Efforts such as these can lead to improved 
patient care by ensuring clinicians easier access to data, such as 
consolidated prescription history (including, daily opioid dosage).

    In addition to integrating PDMP data within Health IT systems, 
intrastate interoperability strategies also include linking PDMP data 
to other data systems within the same State. Examples include linking 
PDMP data to the following data sources:

          Pharmacy Benefit Managers.

          Medical Examiners/Coroners.

          Medicaid.

          Worker's compensation.

          VA.

          Indian Health Service providers.

    Leveraging PDMP data with other data sources within the same State 
can provide a more comprehensive picture of prescribing behavior, care 
and treatment services, and/or resultant fatalities following an 
overdose. Doing so improves a State's understanding of risk factors 
associated with opioid misuse, opioid use disorders and overdose and 
allows for targeting of strategies to reverse the epidemic.

    Interstate interoperability refers to the ability of a State to 
share PDMP data across State lines. Interstate interoperability 
involves accessing a shared national platform/resource that supports 
and creates more sustainable and higher-functioning State PDMPs by 
virtue of their ability to share data across State boundaries.

    A national means to connect PDMP data from one State to another is 
essential. Two national platforms (RxCheck from the U.S. Department of 
Justice's Bureau of Justice Assistance and PMP Interconnect from the 
National Association of Boards of Pharmacy, which was developed by 
Appriss Inc.) facilitate bilateral exchange of data across States. 
Currently 46 States and Washington, DC are exchanging data with other 
States via one or both of these existing data hubs. Given that CDC's 
opioid overdose prevention programs emphasize strategies that maximize 
the utility of PDMPs to support a sustained infrastructure that 
promotes mindful stewardship of Federal resources, CDC has been 
collaborating with Federal partners on how best to improve State access 
to tools and other resources to advance interoperability at the 
national level. CDC has been collaborating with Federal partners, 
including DOH's Bureau of Justice Assistance and the Office of the 
National Coordinator for Health IT to improve State access to tools and 
other resources to advance interoperability at the national level, 
which has been identified as a White House Priority discussed in the 
President Trump's Initiative to Stop Opioid Abuse.\67\
---------------------------------------------------------------------------
    \67\ https://www.whitehouse.gov/briefings-statements/president-
donald-j-trumps-initiative-stop-opioid-abuse-reduce-drug-supply-
demand/.

                                 ______
                                 
              Questions Submitted by Hon. Thomas R. Carper
    Question. According to the CDC, 11 percent of American adults 
suffer from chronic, daily pain and 20 percent of patients who go to 
the doctor with pain-related concerns receive an opioids prescription. 
In 2012, health-care providers wrote more than 250 million 
prescriptions for opioids, enough for every adult to have a bottle of 
pills, even though opioids are not the first line of treatment for 
chronic pain.

    What are HHS and CMS doing to ensure that Medicare and Medicaid 
enrollees have better access to evidence-based non-opioid treatments 
for pain, such as physical therapy, counseling, non-addictive 
medications, and FDA-approved medical technologies?

    Answer. The opioid crisis cannot be tackled by CMS alone, and that 
is why we are collaborating with other HHS agencies, such as the FDA, 
CDC, and NIH, to identify services that need more evidence to support 
coverage by Medicare and other health plans.

    Both medicinal and non-medicinal therapeutic alternatives to 
opioid-based pain medications exist; although Medicare coverage and 
payment varies. In general, Medicare covers items and services that are 
``reasonable and necessary.'' This includes several non-pharmacologic 
therapies and other non-opioid pharmaceuticals. CMS uses the national 
and local coverage determination process to evaluate new or promising 
items and services with respect to Medicare Parts A and B, through 
well-delineated processes set forth in statute. Those items and 
services for which evidence demonstrates improvement in health outcomes 
in the Medicare population are more likely to be coverable, while those 
items and services for which such evidence is insufficient or lacking 
warrant further research.

    CMS has partnered with the CDC to develop the Opioid Safety 
Commitment poster campaign,\68\ which promotes the most effective pain 
management treatments and strategies. This campaign emphasizes patient 
engagement, clinician counseling regarding opioid alternative pain 
management strategies, and discussion with patients of the risks and 
benefits of opioids when opioids are prescribed.
---------------------------------------------------------------------------
    \68\ https://www.cdc.gov/drugoverdose/prescribing/posters.html.

    CMS has a number of initiatives underway to increase the use of 
recommended evidence-based practices for pain management. In addition 
to the work of the Quality Innovation Network Quality Improvement 
Organization program, described above, CMS provides outreach regarding 
best practices and technical assistance through the Transforming 
Clinical Practice Initiative's (TCPI's) Practice Transformation 
Networks.\69\ TCPI is designed to use peer-based learning networks for 
information sharing, outreach, and dissemination of evidence-based 
practices to educate prescribers on safe and appropriate methods of 
pain treatment. For example, the TCPI Medication Management and Opioid 
Initiative is mobilizing the existing network of more than 100,000 
clinicians into action to address the opioid crisis, generating 
collaborations with other CMS quality improvement projects, showcasing 
successful strategies in engaging providers and patients on proper 
opioid utilization and spreading the successful strategies throughout 
all CMS communities.
---------------------------------------------------------------------------
    \69\ https://innovation.cms.gov/initiatives/Transforming-Clinical-
Practices/.

    CMS also promotes free educational materials for health-care 
professionals on CMS programs, policies, and initiatives through the 
Medicare Learning Network (MLN).\70\ The ``CDC Guidelines for 
Prescribing Opioids for Chronic Pain'' is featured in the January 12, 
2017 \71\ MLN Connects newsletter.
---------------------------------------------------------------------------
    \70\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLNGen
Info/Index.html.
    \71\ https://www.cms.gov/Outreach-and-Education/Outreach/
FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2017-01-12-
eNews.html?DLPage=7&DLEntries=10&DLSort=0&DL
SortDir=descending#_Toc471878721.

    Question. Patients in Medicaid and their providers often wrestle 
with prior authorization requirements for medication assisted 
treatments for opioid abuse, increasing the odds that these patients 
---------------------------------------------------------------------------
will relapse and return to their use of opioids.

    Would increasing use of electronic prior authorization in Medicaid, 
Medicare, and private health insurance plans help improve access to 
medication-assisted treatment?

    What do you need from Congress to increase the use of electronic 
prior authorization for medication-assisted treatment?

    Answer. CMS is always interested in finding ways that will improve 
our programs and reduce physician and patient burden. Electronic prior 
authorization is one of many tools currently available to Medicare Part 
D and/or Medicare Advantage plans as they continue to work with CMS in 
identifying ways to further address the opioid epidemic. While 
interoperability is important among the tools used by plans and 
providers to combat the opioid epidemic, we are cognizant of the 
potential for administrative burden and expense for providers any time 
we introduce new requirements.

    CMS is committed to working with plans and making sure they have 
the flexibility they need in order to best serve beneficiaries.

    Question. As Governor of Delaware, I convened a special council to 
advise me on how to strengthen families in our State. We knew that 
stronger families led to better academic results for children and 
stronger communities and economies. As we confront the opioid epidemic, 
I urge you to focus not just on treatment but also on the root causes 
for this crisis. Our child and family experts tell us that individuals 
with mental health conditions and adverse childhood experiences are at 
greater risk for abusing drugs.

    What are HHS and CMS doing to ensure at-risk children and families 
have adequate access to early mental health treatments and 
interventions that could reduce drug abuse and addiction?

    Answer. The Early and Periodic Screening, Diagnostic and Treatment 
(EPSDT) benefit \72\ provides comprehensive and preventive health-care 
services for children under age 21 who are enrolled in Medicaid. EPSDT 
is key to ensuring that children and adolescents receive appropriate 
preventive, dental, mental health, and developmental, and specialty 
services.
---------------------------------------------------------------------------
    \72\ Additional resource at https://www.medicaid.gov/medicaid/
benefits/downloads/epsdt_
coverage_guide.pdf.

    Periodic developmental and behavioral health screenings are 
required for all children enrolled in Medicaid, through the EPSDT 
benefit, and they are also covered for children enrolled in the 
Children's Health Insurance Program (CHIP). In addition to the required 
periodic screenings, Medicaid-eligible children are entitled to inter-
periodic screenings in order to identify a suspected illness or 
condition not present or discovered during the periodic exam. A change 
in living circumstance, presentation of acute behavioral needs, and 
entry into the foster care system are all events that may elicit the 
need for an inter-periodic screening. Federal matching funds are 
available for States that provide additional reimbursement to providers 
who perform developmental and behavioral screenings during a well-child 
---------------------------------------------------------------------------
visit.

    The Department of Health and Human Services supports several 
activities to ensure that at-risk children of all ages and their 
families are identified as early as possible, and have adequate access 
to evidence-based early mental health treatments and interventions. 
SAMHSA's Project LAUNCH (Linking Actions of Unmet Needs in Children's 
Health) provides funding to States to implement strategies specific to 
addressing the needs of children from birth through age 8. This program 
aims to: increase access to mental health screening; assessment, and 
referral to appropriate services for young children and families: 
expand use of culturally relevant, evidence-based prevention and 
wellness promotion practices in a range of child-
serving settings; increase integration of behavioral health into 
primary care settings; improve coordination and collaboration across 
disciplines at the local, State, territorial, tribal, and Federal 
level; and increase workforce knowledge of children's social and 
emotional development and skills to respond to behavioral health 
challenges of young children and families. These strategies have been 
shown to help prevent future substance use and addiction. SAMHSA is 
currently funding 55 grants to States, tribes, and territories and will 
fund a cohort of grants specifically to serve tribal populations this 
fiscal year.

    The Infant and Early Childhood Mental Health Grant Program is a new 
fiscal year 2018 effort to provide funding of up to $500,000 per year 
for up to 5 years to organizations to address gaps in the continuum of 
services for youth from birth through age 12 who are at risk for, show 
early signs of, or have been diagnosed with mental illness. The purpose 
of this program is to improve outcomes for these children by 
developing, maintaining, or enhancing infant and early childhood mental 
health promotion, intervention, and treatment services. SAMHSA 
anticipates making nine awards this fiscal year.

    SAMHSA also supports grant programs that are focused on addressing 
the needs of school-aged youth. Project AWARE (Advancing Wellness and 
Resilience in Education) State grants provide funding to State 
Education Agencies (SEAs) to partner with State Behavioral Health 
Authorities (SBHAs) to build and expand the capacity to improve student 
mental health. The program aims to increase awareness of mental health 
issues among school-aged youth, provide training for school personnel 
and other adults who interact with school-aged youth to detect and 
respond to mental health issues in children and young adults, and 
connect children, youth, and families who may have behavioral health 
issues with appropriate services. These efforts will help develop a 
comprehensive, coordinated, and integrated program for advancing 
wellness and resilience in educational settings for school-aged youth 
that leads to better student mental health and lower rates of 
addiction. Current grantees are implementing or enhancing comprehensive 
school mental health systems, improving early identification and 
referral systems, increasing access to qualified behavioral health 
providers, improving school climates, and implementing prevention 
programming to reduce youth violence, including bullying, among other 
activities. Since 2014, SAMHSA has provided funding of up to $1.95 
million per year for up to 5 years to 20 States. Subsequent to the date 
of the hearing, SAMHSA awarded 24 grants for a second cohort, funding 
$1.8 million per grant for up to 5 years.

    To further train providers and others who interact with children to 
identify mental health issues and connect children and families to 
services, SAMHSA funds the Center of Excellence for Infant and 
Childhood Mental Health Consultation (IECMHC) in partnership with HHS's 
Health Resources and Services Administration and Administration for 
Children and Families. This Center of Excellence provides supports to 
States, tribes, and communities to implement quality training. SAMHSA 
also currently funds 70 grants to community organizations to implement 
mental health awareness training and establish referral mechanisms 
through the Project AWARE Community grants. These are 3-year grants 
funded at up to $125,000 per year. SAMHSA is currently accepting 
applications to support up to an additional 126 grants through the 
Mental Health Awareness Training grant program, which expands current 
activities by adding a priority focus area of military veterans and 
families, and by adding a requirement of crisis de-escalation training.

    Finally, SAMHSA supports the Children's Mental Health Initiative, 
which is designed to support States and communities in developing 
evidence-based systems of care approaches for children and families 
with serious emotional disturbances that lead to improved outcomes in 
such areas as school retention, juvenile justice involvement, and rates 
of addiction. On April 10, 2018, SAMHSA issued the Community Programs 
for Outreach and Intervention with Youth and Young Adults at Clinical 
High Risk for Psychosis funding opportunity announcement. This grant 
program will identify youth and young adults (up to 25 years old) at 
clinical high risk for psychosis and provide evidence-based 
interventions to prevent the onset of psychosis or lessen the severity 
of the psychotic disorder.

    Additionally, the SAMHSA's Community Mental Health Services Block 
Grant (MHBG) and Substance Abuse Prevention and Treatment Block Grant 
(SABG) include set-aside provisions applicable to all grantees (States, 
territories and the tribal grantee). For example, since 2016, grantees 
have been required to use 10 percent of their MHBG funds to assist 
individuals experiencing first episode psychosis (FEP). With this 
funding and SAMHSA's support, the number of specialty programs 
providing evidence-based care for FEP has increased from just a few 
programs in 17 States to over 250 programs in 49 States. As psychosis 
often begins when an individual is in their late teens to mid-twenties, 
these programs primarily focus on adolescents and young adults. Through 
the SABG grantees were required to establish a base of expenditures for 
special treatment services for pregnant women and women with dependent 
children. Grantees must ensure that programs that receive funds set-
aside for pregnant women and women with dependent children provide or 
arrange for:

          Primary medical care, including prenatal care;

          Primary pediatric care for the woman's children, including 
        immunizations;

          Gender-specific substance abuse treatment; and

          Other therapeutic interventions for women addressing issues 
        such as relationships, sexual and physical abuse, and 
        parenting.

    Grantees must require all SABG-funded programs to give pregnant 
women preference in admissions to treatment.

    Question. How can we make better use of telehealth in Medicaid and 
CHIP to improve access to mental health treatment, especially for at-
risk kids?

    Answer. CMS believes that telehealth can be an important tool in 
our efforts to fight this epidemic. Expanding the use of telehealth is 
a priority of CMS Administrator Verma. To promote the use of 
telehealth, CMS is seeking to reduce some of the barriers to telehealth 
such as reimbursement and cross-state licensure issues, particularly 
for rural areas and we are committed to working with States to ensure 
that they have the flexibility to provide the right care in the right 
setting.

                                 ______
                                 
            Questions Submitted by Hon. Benjamin L. Cardin, 
                Hon. Bill Cassidy, and Hon. Bill Nelson
                         stabilization centers
    Question. I am following up on the conversation we had regarding 
stabilization centers, which provide an alternative to the emergency 
room, and can also act as diversion from incarceration. Admiral Giroir 
and Deputy Administrator Brandt, you both expressed a willingness to 
work with me in finding solutions to encourage the appropriate 
placement of those who are suffering from substance use disorder, so 
that they can get referred to the appropriate care.

    Can you provide me with a list of suggestions on ways we can 
leverage existing resources available at the Federal level to increase 
the creation of and to provide more access to stabilization centers?

    Answer. One way to leverage existing resources at the Federal level 
is to clearly define the stabilization center model as an evidence 
based practice-utilizing Medication-Assisted Treatment (MAT). This 
emphasis can be through communications to the field that stabilization 
centers, utilized appropriately, enhance the continuity of care in the 
outpatient setting increasing the potential for positive recovery 
outcomes. In particular, SAMHSA communicates that its preference is to 
fund such models with stronger evidence of effectiveness as opposed to 
those that facilitate repetitious revolving door detoxification only 
service episodes.

    In addition, emergency departments and first responders can be the 
critical link between the crisis and the connection to care to a 
stabilization center or similar program when an individual experiences 
an overdose and/or a substance use disorder (SUD) related crisis. This 
presents an opportunity to leverage the crisis and connect the 
individual to a system of care that will address their comprehensive 
SUD and related health-care needs. For example, in spring 2019, the 
Baltimore City Health Department will open the State's first 
Stabilization Center, a place for individuals who are under the 
influence of drugs and/or alcohol to receive short-term medical and 
targeted interventions. Through emergency medical system transport, the 
Center will divert patients who meet specific criteria from emergency 
departments and provide stronger links to community-based behavioral 
health care. Services provided will include medical screening and 
monitoring, connections to behavioral health and social services, and 
buprenorphine induction to treat opioid addiction. Part of the funding 
for this program is from the SAMHSA's Opioid State Targeted Response 
(STR) grant program authorized by the 21st Centuries Cures Act.

    Question. Alternatively, are there new approaches that we can take 
through legislative action that would encourage expanding the creation 
of these centers?

    Answer. Through our funding, training, and technical assistance, 
the Department is supporting State, local, tribal, and territorial 
efforts to expand capacity for treatment and recovery support services 
that match the clinical needs of the individual with the appropriate 
level of care. With the additional resources provided by Congress in 
the FY 2018 Omnibus, HHS is significantly expanding its resources to 
communities to advance this work. A number of service delivery models 
that provide the full spectrum of care such as the Hub and Spoke model, 
the nurse care manager model, and the Centers of Excellence model are 
being supported by HHS funding.

    Question. Admiral Giroir, in your testimony you also expressed 
support for community based programs, as well as discussed the 
flexibility that States possess in utilizing State Targeted Response 
(STR) grants in order to test programs.

    Would you support and encourage States to use their current STR 
grant funding to invest in stabilization centers?

    Answer. Crisis Stabilization Centers are typically used as 
alternatives to patient admission to inpatient hospitalization, 
emergency department care, or detention centers for individuals with 
significant mental health or substance use disorders, including those 
who are intoxicated or present a danger to self or others. Persons with 
opioid use disorders typically can benefit from this level of care with 
rapid medical assessment, referral, and induction into a program of 
medication-assisted treatment with psychosocial services and community 
recovery supports. This meets the criteria for services supported by 
the Opioid STR Grant Program. SAMHSA does not recommend medically 
managed withdrawal (``detox'') from opioids in the absence of 
transition to medication assisted treatment (MAT) for people with an 
opioid use disorder, as the evidence indicates poor outcomes for these 
individuals who are withdrawing from opioids without MAT. In fact, 
through SAMHSA's Opioid STR program, States and territories are using 
funding to implement a broad range of evidence-based interventions that 
span prevention, treatment, and recovery support services. SAMHSA is 
encouraging States to implement innovative service delivery models that 
can provide the full complement of treatment and recovery support 
services matched to the clinical needs of individuals with opioid use 
disorder. A number of service delivery models are being pursued with 
STR funds including Centers of Excellence, Hub and Spoke, Project ECHO, 
and emergency department initiated buprenorphine.

    Question. Would you support Congress increasing the funding for STR 
grants with the intent of funding stabilization centers?

    Answer. The President's fiscal year 2019 budget includes $10 
billion in new resources across HHS to combat the opioid epidemic and 
address serious mental illness. In FY 2019, an initial allocation 
provides $1.2 billion in SAMHSA for a variety of new and expanded 
efforts to fight the opioid crisis. Of that amount, $1 billion is 
included to expand State Targeted Response Grants. As noted above, 
States are currently using Opioid STR funding for stabilization 
centers. However, persons with opioid use disorders typically can 
benefit from a lower level of care with rapid medical assessment, 
referral, and induction into a program of medication-assisted 
treatment.
                            naloxone pricing
    Question. I have heard from first responders and local health 
departments across Maryland that the rising cost of naloxone is pricing 
them out of saving lives--despite the fact that naloxone is a generic 
drug that costs pennies in other countries. For example, the Baltimore 
City Health Department spent $118,236 for 3,340 doses in fiscal 2016. 
That was up from $33,540 for 1,540 doses in fiscal 2014--an increase of 
almost 63 percent per dose. As you know, the Federal Government has the 
statutory authority to purchase naloxone at a price that it determines.

    Will HHS support the use of this authority to get naloxone into the 
hands of those who desperately need it?

    Answer. Targeting the availability and distribution of overdose 
reversing drugs like naloxone is a key part of the comprehensive, five-
point HHS Opioid Strategy. We recognize the critical role naloxone 
plays in supporting communities' response to the opioid epidemic, 
especially with the increasing supply of highly potent synthetic 
opioids like illicitly made fentanyl and carfentanil. To support these 
efforts, HHS has prioritized making funding available to States for the 
direct purchase of and training on over-dose reversing drugs. 
Specifically, States can use a portion of the $485 million in funding 
through SAMHSA's STR grants for the purchase and training on 
appropriate use of overdose reversing drugs. SAMHSA also has other 
naloxone-specific programs including the CARA First Responders program 
and a State-based naloxone program that provide funding to purchase and 
train individuals on the use of naloxone. In addition, HHS has provided 
guidance to States informing them that they can utilize their Substance 
Abuse Prevention and Treatment Block Grant funds to support overdose 
prevention education and training and to support the purchase and 
distribution of naloxone. Finally, HHS is working to ensure that there 
is adequate competition for naloxone, which would lead to lower 
pricing. FDA has indicated the agency is identifying ways to encourage 
over-the-counter naloxone applications. Additionally, Commissioner 
Gottlieb is already working on ways to increase generic competition, 
which can help drive down drug costs.

                                 ______
                                 
            Question Submitted by Hon. Benjamin L. Cardin, 
             Hon. Thomas R. Carper, and Hon. Sherrod Brown
    Question. As you know, Medicaid plays a central role in the 
Nation's efforts to address the opioid epidemic. While all State 
Medicaid programs cover at least one Food and Drug Administration 
(FDA)-approved form of MAT, not all States cover all current FDA-
approved forms of MAT (methadone, buprenorphine (Suboxone), and 
naltrexone (Vivatrol)). In the fiscal year 2019 budget, the Department 
of Health and Human Services (HHS), expressed support to require that 
State Medicaid programs cover all FDA-approved MAT for opioid use 
disorder, including associated counseling and other costs.

    What is CMS doing to provide States with information and technical 
assistance on best practices for covering MAT in their Medicaid 
programs?

    What is CMS doing to encourage States to update their policies to 
cover all three FDA-approved forms of MAT as well as associated 
counseling and behavioral supports?

    Answer. Medication-Assisted Therapy (MAT) is a valuable 
intervention that has been proven to be the most effective treatment 
for OUD, particularly because it sustains long-term recovery and has 
been shown to reduce opioid-related morbidity and mortality.\73\
---------------------------------------------------------------------------
    \73\ https://www.ncbi.nlm.nih.gov/pubmed/24500948.

    While Medicaid programs vary greatly by State, all 50 States 
currently offer some form of MAT. CMS has issued guidance on best 
practices in Medicaid for covering MAT in a joint informational 
bulletin with the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the CDC, and the National Institute on Drug 
Abuse.\74\ CMS also released an informational bulletin with SAMHSA on 
coverage of treatment services for youth with SUD.\75\
---------------------------------------------------------------------------
    \74\ https://www.medicaid.gov/Federal-Policy-Guidance/downloads/
CIB-07-11-2014.pdf.
    \75\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-01-26-2015.pdf.

    The President's FY 2019 budget includes a proposal that would 
require State Medicaid programs to cover all FDA-approved MAT for 
opioid use disorder, including associated counseling and other costs. 
These up-front investments in expanded MAT treatment are expected to 
reduce total Medicaid expenditures over time as more individuals 
recover from opioid use disorder; this provision would result in an 
---------------------------------------------------------------------------
estimated $865 million is savings over 10 years.

    Under the demonstration authority granted by section 1115 of the 
Social Security Act, CMS can also waive certain Federal requirements 
and pay Federal matching funds certain expenditures that otherwise 
would not be matchable so that States can test new or existing ways to 
deliver and pay for health-care services in Medicaid.

    We are encouraging States to apply for CMS approval of a 5-year 
demonstration allowing them to receive Federal financial participation 
for services to treat addiction to opioids or other substances for 
Medicaid beneficiaries residing in IMDs, including those aged 21 to 64 
for whom Medicaid otherwise would not pay for services while the 
beneficiary is residing in an IMD, as these States work to improve 
access to treatment in outpatient settings as well. In addition, we are 
working with States that operate these demonstrations to establish 
strong quality of care standards, particularly for residential 
treatment settings.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones established by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these programs; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis. To date, we have approved these SUD demonstration projects for 
five States--Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    Addendum: Since the time of this hearing, CMS has approved a 
demonstration project for a sixth State: Illinois.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                     medication-assisted treatment
    Question. As you know, Medicaid plays a central role in the 
Nation's efforts to address the opioid epidemic. While all State 
Medicaid programs cover at least one Food and Drug Administration 
(FDA)-approved form of MAT, not all States cover all current FDA-
approved forms of MAT (methadone, buprenorphine (Suboxone), and 
naltrexone (Vivatrol)).

    In the Fiscal Year 2019 budget, the Department of Health and Human 
Services (HHS), expressed support to require that State Medicaid 
programs cover all FDA-approved MAT for opioid use disorder, including 
associated counseling and other costs.

    What is CMS doing to provide States with information and technical 
assistance on best practices for covering MAT in their Medicaid 
programs?

    What is CMS doing to and encourage States to update their policies 
to cover all three FDA-approved forms of MAT as well as associated 
counseling and behavioral supports?

    Answer. Medication-Assisted Therapy (MAT) is a valuable 
intervention that has been proven to be the most effective treatment 
for OUD, particularly because it sustains long-term recovery and has 
been shown to reduce opioid-related morbidity and mortality.\76\
---------------------------------------------------------------------------
    \76\ https://www.ncbi.nlm.nih.gov/pubmed/24500948.

    While Medicaid programs vary greatly by State, all 50 States 
currently offer some form of MAT. CMS has issued guidance on best 
practices in Medicaid for covering MAT in a joint informational 
bulletin with the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the CDC, and the National Institute on Drug 
Abuse.\77\ CMS also released an informational bulletin with SAMHSA on 
coverage of treatment services for youth with SUD.\78\
---------------------------------------------------------------------------
    \77\ https://www.medicaid.gov/Federal-Policy-Guidance/downloads/
CIB-07-11-2014.pdf.
    \78\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-01-26-2015.pdf.

    The President's FY 2019 budget includes a proposal that would 
require State Medicaid programs to cover all FDA-approved MAT for 
opioid use disorder, including associated counseling and other costs. 
These up-front investments in expanded MAT treatment are expected to 
reduce total Medicaid expenditures over time as more individuals 
recover from opioid use disorder; this provision would result in an 
---------------------------------------------------------------------------
estimated $865 million is savings over 10 years.

    Under the demonstration authority granted by section 1115 of the 
Social Security Act, CMS can also waive certain Federal requirements 
and pay Federal matching funds for expenditures that otherwise would 
not be matchable so that States can test new or existing ways to 
deliver and pay for health-care services in Medicaid.

    We are encouraging States to apply for CMS approval of a 5-year 
demonstration allowing them to receive Federal financial participation 
for services to treat addiction to opioids or other substances for 
Medicaid beneficiaries residing in IMDs, including those aged 21 to 64 
for whom Medicaid otherwise would not pay for services while the 
beneficiary is residing in an IMD, as these States work to improve 
access to treatment in outpatient settings as well. In addition, we are 
working with States that operate these demonstrations to establish 
strong quality of care standards, particularly for residential 
treatment settings.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones established by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these programs; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis. To date, we have approved these SUD demonstration projects for 
five States--Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    Addendum: Since the time of this hearing, CMS has approved a 
demonstration project for a sixth State: Illinois.

                            quality measures
    Question. Together, Medicaid and the Children's Health Insurance 
Program (CHIP) provide vital health-care coverage for nearly 80 million 
low-income Americans, including pregnant women and children, 
individuals with mental and physical disabilities, and the elderly. 
However, despite the fact that so many Americans receive their health-
care services through these two programs, nobody truly understands the 
quality of care provided to all enrollees.

    Data collection is essential to ensure quality care. The only way 
to reduce costs, address health-care disparities, or improve quality of 
care is by gathering and understanding such data. Over the past decade, 
Congress has prioritized the importance of data collection to measure, 
compare, and improve the quality of health care for all Americans. 
Although there is some understanding of the quality of care provided to 
enrollees in Medicaid health plans, it is time that the same standard 
applies to all Medicaid enrollees across all delivery systems--fee-for-
service, managed-care, and primary-care case management--throughout the 
country.

    Congress took action just a few weeks ago to require States to 
submit Medicaid and CHIP pediatric quality measures to HHS. 
Unfortunately, reporting on adult quality measures remains entirely 
voluntary.

    The 2018 Core Set of Adult Health Care Quality measures for 
Medicaid includes 10 behavioral health measures. How many States 
consistently report quality data across these measures?

    What other measures does CMS have in development to measure quality 
in behavioral health, specifically substance use disorder that may be 
added to the adult core set in the future?

    Answer. As the single largest payer for mental health services in 
the United States, Medicaid plays an important role in providing 
behavioral health care to adults, and monitoring the effectiveness of 
that care. CMS annually releases information on State progress in 
reporting the Adult Core Set measures that are reported by at least 25 
States and which met internal standards of data quality. Our 2017 
measures release includes data from FFY 2016.

    For FFY 2016, 41 States voluntarily provided data for the Adult 
Core Set. Since the release of the Core Set in 2012, the number of 
States voluntarily reporting at least one measure has increased 
steadily from 30 States in FFY13, 34 States for FFY14, and 39 States 
for FFY15. Additionally, the median number of measures reported by 
States is 17 for FFY16, up from 16 measures for FFY15. In addition, 21 
States reported more measures for FFY16 than for FFY15, including two 
States reporting for the first time.

    CMS recognizes the importance of State's abilities to measure the 
quality of care for Medicaid beneficiaries with substance use disorders 
(SUD). Of the 33 measures on the 2018 Adult Core Set, four of them 
specifically focus on SUD. CMS has added to the number of SUD related 
measures on the Adult Core Set annually for the last 3 years.

          Initiation and Engagement of Alcohol and Other Drug 
        Dependence Treatment (NQF #0004)--on the initial Adult Core 
        Set.

          Use of Opioids at High Dosage in Persons Without Cancer (NQF 
        #2940)--added in 2016.

          Follow-up After Discharge from Emergency Department for 
        Mental Health or Alcohol or Other Drug Dependence (NQF #2605)--
        added in 2017.

          Concurrent Use of Opioids and Benzodiazepines (PQA)--added 
        in 2018.

    medicaid suspension vs. termination for incarcerated populations
    Question. The Medicaid Inmate Exclusion prohibits Medicaid from 
paying for health-care services for ``inmates of a public 
institution,'' meaning Medicaid will not pay for health-care services 
provided to otherwise eligible individuals during incarceration. In 
order to ensure compliance with this provision--which has been in place 
since the creation of Medicaid more than 50 years ago--States can 
either suspend or terminate an individual's Medicaid coverage upon 
entry into a correctional facility. As of last year, 31 States suspend 
Medicaid enrollment for either a portion or the entire duration of an 
inmate's incarceration, and 19 States terminate Medicaid enrollment for 
inmates.

    Terminating Medicaid enrollment during incarceration presents a 
continuity of care issue, particularly for individuals suffering opioid 
use disorders. Re-enrolling can take months, becoming a barrier for 
individuals who need to access mental health care or medication-
assisted treatment. Not only can lapsing coverage contribute to 
recidivism, but it could be a life or death situation, given that 
inmates are 129 times more likely to die from a drug overdose within 
the first 2 weeks of release compared to the general population.

    Does CMS need additional statutory authority to require States to 
suspend, rather than terminate, Medicaid coverage for incarcerated 
individuals?

    What is CMS doing to continue to encourage States to suspend, 
rather than terminate, Medicaid coverage for incarcerated individuals?

    How is CMS engaging with States where there are structural or 
administrative barriers that make suspending Medicaid enrollment more 
difficult than terminating Medicaid for an inmate and re-enrolling upon 
community reentry?

    In light of the opioid crisis, does CMS possess statistical or 
anecdotal on the public health impact of suspending Medicaid for 
inmates?

    How does CMS intend to study or evaluate the difference in both 
access to care and health outcomes in States that suspend Medicaid 
coverage for inmates compared to those that terminate coverage?

    Answer. Facilitating enrollment in Medicaid and supporting access 
to services following incarceration has the potential to make a 
significant difference in the health of this population and in eligible 
individuals' ability to obtain health services that can promote their 
well-being.

    States have the authority to determine Medicaid coverage 
transitions for incarcerated individuals. CMS welcomes the opportunity 
to work closely with States to identify ways to improve access to 
needed health care for individuals returning to the community following 
incarceration. Increased Federal support is available to assist States 
with upgrading Medicaid eligibility and enrollment technologies.

    We addressed frequently asked questions regarding eligibility and 
coverage issues for individuals reentering their communities after 
incarceration in an April 2016 State Health Official letter (SHO #16-
007),\79\ including how States can facilitate access to Medicaid for 
eligible individuals before and after time in a correctional 
institution.
---------------------------------------------------------------------------
    \79\ https://www.medicaid.gov/federal-policy-guidance/downloads/
sho16007.pdf.

    CMS also began facilitating a Learning Collaborative in February 
2016 that reviewed Medicaid eligibility rules and enrollment strategies 
for justice-involved populations. CMS hosted another Learning 
Collaborative discussion on this issue in August 2017.\80\
---------------------------------------------------------------------------
    \80\ https://www.medicaid.gov/state-resource-center/downloads/mac-
learning-collaboratives/justice-involved-populations.pdf.
---------------------------------------------------------------------------
                             imd exclusion
    Question. Only 12 percent of Americans who need substance abuse 
treatment actually receive it. We need to expand access to care. One 
way to do this would be to allow adult Medicaid beneficiaries to get 
help at residential facilities with more than 16 beds. Because of an 
arcane law--the ``IMD Exclusion''--this is currently prohibited. Public 
health experts and a large bipartisan group of Senators and Governors 
want to fix this outdated policy, and the President's own Opioid 
Commission supports it. While States can receive waivers from the 16-
bed limit, we need a comprehensive, long-term national solution. I am 
an original sponsor of the Medicaid CARE Act, the leading bipartisan 
bill in Congress to provide relief from this arbitrary limit.

    How would fixing the IMD Exclusion expand patient access to opioid 
addiction treatment?

    Answer. Current law prohibits Medicaid from making payments for 
services rendered to Medicaid beneficiaries ages 21 to 64 who are 
residing in an IMD. Last November, we announced an opportunity for 
States to apply for section 1115 demonstration projects through a 
streamlined process for States interested in increasing access to 
treatment for OUDs and other SUDs by permitting services to be covered 
in an institution for mental diseases (IMD) as part of a State's 
comprehensive OUD/SUD strategy. Previously, States seeking to cover 
services otherwise subject to the exclusion of coverage for 
beneficiaries residing in an IMD had been required to meet rigid CMS 
standards concerning operational details for implementation before 
Medicaid demonstration approvals would be granted.

    We are encouraging States to apply for CMS approval of a 5-year 
demonstration allowing them to receive Federal financial participation 
for services to treat addiction to opioids or other substances for 
Medicaid beneficiaries residing in IMDs, including those aged 21 to 64 
for whom Medicaid otherwise would not pay for services while the 
beneficiary is residing in an IMD, as these States work to improve 
access to treatment in outpatient settings as well. In addition, we are 
working with States that operate these demonstrations to establish 
strong quality of care standards, particularly for residential 
treatment settings. The new policy will allow States to begin to 
provide better treatment options more quickly while improving the 
continuum of care over time.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones established by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these programs; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis. To date, we have approved these SUD demonstration projects for 
five States--Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    Addendum: Since the time of this hearing, CMS has approved a 
demonstration project for a sixth State: Illinois.
   president's commission on combating drug addiction and the opioid 
                                 crisis
    Question. Nearly 6 months ago, the President's Commission on 
Combating Drug Addiction and the Opioid Crisis submitted a report on 
the crisis, which included a long list of recommendations. Many of 
these recommendations were specific to CMS and other entities under the 
purview of both Adm. Giroir and Ms. Brandt.

    Please provide an update on your respective agency's and program's 
status in implementing the recommendations included in the Commission's 
report.

    Recognizing that some of the recommendations would require 
congressional action, of the other recommendations included in the 
report, does CMS plan on implementing any of the proposals which do not 
require additional statutory authority?

    Answer. CMS is always looking to improve our programs, and the 
opioid epidemic is a top priority for this administration. HHS has a 
five-part strategy to address the epidemic, which involves: improving 
access to prevention, treatment, and recovery services, including 
medication-assisted therapies; targeting availability and distribution 
of overdose-reversing drugs; strengthening our understanding of the 
epidemic through better public health data and reporting; supporting 
cutting edge research on pain and addiction; and advancing better 
practices for pain management.

    As a payer, CMS plays an important part in this plan by working to 
make sure providers are providing the right services to the right 
patients at the right time. Beneficiaries are our top priority across 
all of our programs, and we work hard to protect their safety and put 
them in the driver's seat of their care. CMS is keenly focused on three 
areas--preventing and reducing opioid use disorders by promoting CDC 
guidelines for opioid prescriptions and encouraging non-opioid pain 
treatments; increasing access to evidence-based treatment for opioid 
use disorder; and leveraging data to target prevention and treatment 
efforts and to support fraud, waste, and abuse detection efforts. Our 
efforts align with many of the recommendations outlined in the 
President's commission, as well as with input from various 
stakeholders.

    CMS is actively engaged in addressing the opioid epidemic and is 
committed to implementing effective tools across our programs. CMS will 
continue to work with beneficiary and advocacy groups, health plans, 
States, our Federal and State partners, and other interested 
stakeholders to address this devastating epidemic. This epidemic is 
devastating families and communities, and CMS is committed to using all 
the tools at its disposal to take meaningful action to stem this tide.

    The HHS Opioid Strategy is well aligned with the Commission's 
recommendations and much work is underway that is consistent with the 
vision of the Commission. Following are some examples.

Prevention Through a Public Awareness Campaign--On June 7th, the White 
House launched the first phase of its anti-opioid media campaign, a 
part of the administration's efforts to address the opioid crisis. The 
first ads target young adults, warning them of the dangers of opioid 
addiction, and it includes four television and digital ads featuring 
true stories of young people who have struggled with addiction. The 
goal of the campaign is to show the dangers of misusing opioids and how 
quickly one can become addicted. The effort is a partnership among the 
White House and the Ad Council, the organization behind many of the 
government's public service announcements, including the Truth 
Initiative, a national anti-tobacco campaign. The campaign is funded 
largely from donations, including free media time from NBC Universal, 
Turner Broadcasting, Facebook, YouTube, Google and the Ad Council. 
ONDCP is providing $380,000 to the campaign.
Improving Access to Prevention, Treatment, and Support Services
          SAMHSA's State Targeted Response to the Opioid Crisis (STR) 
        Grant Program--On April 18th, SAMHSA released the second year 
        of funding to States and territories totaling $485 million. 
        States can use the funds to focus on areas of greatest need, 
        including increasing access to treatment, supporting prevention 
        and recovery services, and paying for naloxone. HHS has been 
        criticized for the formula on the grounds that it does not 
        target funding to the hardest hit States. SAMHSA issued a 
        supplemental STR grant FOA targeted to the hardest hit States 
        and in March 2018, SAMHSA awarded grants totaling $1 million to 
        New Hampshire, Massachusetts, and West Virginia. The 2018 
        omnibus provides for an additional $1 billion for a new State 
        Opioid Response Grant. Subsequent to the date of the hearing, 
        SAMHSA released funding opportunity announcements (FOAs) that 
        include the required 15 percent set aside for hardest hit 
        States and $50 million for tribes.

          Programs Targeting Medication-Assisted Treatment (MAT)--
        SAMHSA has several initiatives aimed at advancing the 
        utilization of MAT, which is proven effective but is highly 
        underutilized. The Medication Assisted Treatment for 
        Prescription Drug and Opioid Addiction (MAT-PDOA) program aims 
        to increase the number of people receiving MAT for their opioid 
        use disorders, leading to a decrease in illicit opioid use and 
        prescription opioid misuse. In May 2018, SAMHSA announced a new 
        Funding Opportunity Announcement for States, political 
        subdivisions within States, and public and private nonprofit 
        organizations in States with the highest rates of primary 
        treatment admissions for heroin and opioids per capita.

          Pregnant and Postpartum Women (PPW)--The PPW Program expands 
        the availability of comprehensive, substance use disorder 
        treatment, prevention, and recovery support services for PPW, 
        their minor children, and other family members. Under this CARA 
        program, grantees are encouraged to ensure access to MAT for 
        opioid addiction, which has been shown to improve outcomes. In 
        FY 2018, SAMHSA will fund three new 3-year PPW Pilot grants, 
        totaling $3.2 million annually and three continuing PPW Pilot 
        grants also at $3.2 million annually. Additionally, in FY 2018, 
        SAMHSA will fund 18 new 5-year residential PPW grants, totaling 
        $9.5 million annually and 19 continuing PPW 5-year residential 
        grants, totaling $10.7 million annually.

          Offender Reentry Program (ORP)--The purpose of this program 
        is to expand substance use disorder treatment and related 
        recovery and reentry services to sentenced adult offenders/ex-
        offenders who are returning to their families and communities 
        from incarceration in State and local facilities, including 
        prisons, jails, or detention centers. Grant recipients 
        receiving new grants in FY 2018 may use up to 35 percent of 
        their annual grant award to pay for FDA-approved medications 
        for the treatment of substance use disorders (e.g., methadone, 
        buprenorphine products including buprenorphine/naloxone 
        combination formulations and buprenorphine mono-product 
        formulations, naltrexone products including extended-release 
        and oral formulations, disulfiram, and acamprosate calcium) 
        when the client has no other source of funds to do so. In FY 
        2018, SAMHSA will fund 21 new 5-year Offender Reentry Program 
        grants, totaling $8.8 million annually.

          Adult Treatment Drug Courts, Adult Tribal Healing to 
        Wellness Courts, and Family Treatment Drug Courts--The purpose 
        of SAMHSA's treatment drug courts is to expand and/or enhance 
        substance use disorder treatment services in existing adult and 
        family ``problem solving'' courts that use the treatment drug 
        court model to provide substance use disorder (SUD) treatment 
        to persons in drug courts who are identified with SUD. Grant 
        recipients receiving new grants in FY 2018 may use up to 35 
        percent of the annual grant award to pay for Food and Drug 
        Administration (FDA)-approved medications (e.g., methadone, 
        buprenorphine, naltrexone, disulfiram, acamprosate calcium,) 
        when the client has no other source of funds to do so. Grantees 
        must affirm that the treatment drug court(s) will not deny 
        access to the program to any eligible client for his/her use of 
        FDA-approved medications for SUD. In FY 2018, SAMHSA will fund 
        70 new 5-year Adult Treatment Drug Court grants and three Adult 
        Healing to Wellness Court grants, totaling $32.1 million 
        annually. In FY 2018, SAMHSA will also fund 13 new 5-year 
        Family Treatment Drug Court grants, totaling $5.1 million 
        annually.
Improving Access to Overdose Treatment and the Availability of 
        Overdose-Reversing Drugs
          Improving Access to Overdose Treatment--This SAMHSA program, 
        authorized by CARA, provides funds to Federally Qualified 
        Health Centers (FQHC), Opioid Treatment Programs, or 
        practitioners who have a waiver to prescribe buprenorphine to 
        expand access to FDA-approved drugs or devices for emergency 
        treatment of known or suspected opioid overdose. A new Funding 
        Opportunity Announcement was released in April 2018 and 
        grantees will partner with other prescribers at the community 
        level to develop best practices for prescribing and co-
        prescribing FDA-approved overdose reversal drugs. After 
        developing best practices, the recipients will train other 
        prescribers in key community sectors as well as individuals who 
        support persons at high risk for overdose.

          Increasing Availability of Naloxone--SAMHSA has a number of 
        funding streams to expand access to naloxone: States may use 
        their STR funds to purchase and distribute access to naloxone; 
        the Substance Use Block Grants can be used for opioid overdose 
        prevention activities; and SAMHSA has provided $11 million per 
        year in grants to Prevent Prescription Drug/Opioid Overdose 
        Related Deaths. These funds are being used to train first 
        responders on emergency medical care to be rendered in an 
        overdose situation and how to administer naloxone as well as to 
        how to purchase and distribute naloxone.
Research and Development
          NIH Opioid Research to End the Opioid Crisis--In April 2018, 
        NIH launched the Helping to End Addiction Long-term (HEAL) 
        Initiative to speed scientific solutions to stem the national 
        opioid public health crisis. The HEAL Initiative will bolster 
        research across NIH to:

            Prevent addiction through enhanced pain 
        management--NIH will work with partners from the 
        biopharmaceutical industry to develop a data sharing 
        collaborative, new biomarkers for pain, and clinical trials 
        network for testing new pain therapies.

            Improve treatments for opioid misuse and 
        addiction--NIH will support research that can prevent and treat 
        opioid misuse and addiction, and that will help people with 
        OUDs achieve and maintain a meaningful and sustained recovery.

    Moving forward, HHS will work with leadership across the 
Department, our sister agencies, and the White House to continue 
implementing a robust public health response to the opioid crisis and 
determine how best to incorporate the Commission's recommendations into 
our work.
 screening for substance use disorders (sud) in the medicare population
    Question. SAMHSA has estimated that more than 1 million adults 65 
or older have a substance use disorder. This number is only going to 
grow as more and more baby boomers age into Medicare. It is important 
that we do not ignore the Medicare population when it comes to this 
epidemic.

    Ms. Brandt, I would like to thank you and your colleagues at CMS 
for your work on the Medicare Part D patient review and restriction 
program that Senator Toomey, Senator Portman, and I worked to get in to 
CARA. Now that the program is being implemented, I look forward to 
continuing to work with CMS to ensure that beneficiaries who are 
identified through this program have the right to auto-
escalate their appeals.

    Unfortunately, we do not do a great job when it comes to screening 
older Americans for substance use disorders. We don't screen often 
enough, and screening can be difficult: chronic conditions and other 
health-care issues like dementia can complicate a screening for 
potential substance use disorder.

    As I understand it, right now individuals are screened for a 
variety of physical health conditions and also screened for depression 
during their Welcome to Medicare visit and annual Medicare wellness 
visits, but these visits do not currently include a screening for 
substance use disorder and referral to treatment, correct?

    Answer. A critical part of tackling this epidemic is making sure 
that beneficiaries grappling with opioid use disorder have access to 
the most effective treatment options. Improving the way opioids are 
prescribed through clinical practice guidelines can ensure patients 
have access to safer, more effective chronic pain treatment while 
reducing the risk of opioid use disorder and that is why the CDC issued 
the CDC Guideline for Prescribing Opioids for Chronic Pain.\81\ We hope 
that physicians are communicating with their patients about medications 
and medical conditions. In addition to the CDC guidelines, through its 
networks of health quality experts and clinicians, CMS advocates the 
sharing of best practices for opioid use disorder screening and 
treatment.
---------------------------------------------------------------------------
    \81\ https://www.cdc.gov/drugoverdose/prescribing/guideline.html.

    I am working with a few of my colleagues here on the Finance 
Committee on legislation to make sure that Medicare does a better job 
of screening older Americans for potential substance use disorders, 
both at the time they enter Medicare, and throughout their time in the 
---------------------------------------------------------------------------
program.

    Question. Would CMS be willing to give us some technical assistance 
on the best way to make sure seniors receive these important screenings 
as we develop our legislation?

    Answer. CMS is happy to work with members of Congress and their 
staff, including providing technical assistance on potential 
legislation. CMS is always looking for ways to improve beneficiary 
services across our programs, including making sure they have access to 
appropriate screenings.
 emerging technologies and new, non-addictive therapies and treatments
    Question. As part of the recent Bipartisan Budget Act, Congress 
provided new funds to both the NIH and FDA to incentivize investment in 
potential new non-
addictive treatments and technologies to manage pain and addiction, as 
well as new ways to treat addiction. From new, non-addictive pain 
medications to new technologies in the emerging field of prescription 
digital therapeutics, there are many innovative products in the 
pipeline that could help prevent and treat addiction.

    In order to ensure these new therapies and technologies get to 
patients as quickly as possible post-approval, it is critical CMS be 
ready to evaluate these innovative products and establish coverage 
policies as quickly as possible.

    Does CMS have all the tools necessary to provide coverage for novel 
treatment options, such as alternative or interventional therapies for 
pain treatment, new technologies, and new addiction treatments, in an 
expedited manner as these products come on to the market?

    Answer. A critical part of tackling this epidemic is making sure 
that beneficiaries grappling with opioid use disorder have access to 
the most effective treatment options. Through its networks of health 
quality experts and clinicians, CMS advocates the sharing of best 
practices for opioid use screening and treatment.

    Both medicinal and non-medicinal therapeutic alternatives to 
opioid-based pain medications exist; although Medicare coverage and 
payment varies. In general, Medicare covers items and services that are 
``reasonable and necessary.'' This includes several non-pharmacologic 
therapies and other non-opioid pharmaceuticals. CMS uses the national 
and local coverage determination process to evaluate new or promising 
items and services with respect to Medicare Parts A and B, through 
well-delineated processes set forth in statute. Those items and 
services for which evidence demonstrates improvement in health outcomes 
in the Medicare population are more likely to be coverable, while those 
items and services for which such evidence is insufficient or lacking 
warrant further research. Therefore, CMS is playing an important role 
in expanding access to evidence-supported treatments and services while 
also specifying the subpopulations of patients who can benefit 
meaningfully from their use. CMS collaborates with research-focused HHS 
agencies, such as the National Institutes of Health (NIH) and the 
Agency for Healthcare Research and Quality (AHRQ), who can concentrate 
research resources on these need areas.

    Question. What plans does CMS have in place to ensure the agency is 
able to act quickly to cover and reimburse for these new technologies 
and treatments to ensure patient access?

    Answer. Since 2010, the FDA-CMS Parallel Review program has been a 
collaborative effort intended to reduce the time between FDA marketing 
authorization and a CMS national coverage determination. This pathway 
is distinct because manufacturers can engage CMS before FDA approval. 
By the manufacturer engaging FDA and CMS together while under FDA 
review, a stronger evidentiary base could be developed in a more 
efficient manner accelerating patient access to innovative medical 
devices. This program is intended to ensure prompt and efficient 
patient access to safe and effective and appropriate medical devices 
for the Medicare population.

    Question. What is the current policy around updating the Health 
Care Common Procedure Coding System (HCPCS) and the National Coverage 
Determination (NCD) and coverage with evidence development (CED) 
standards to ensure new therapies, both pharmacological and non-
pharmacological? Should the standard practice for updating HCPCS and 
NCDs need to be updated in light of this epidemic and emerging 
technologies and treatments?

    Answer. There are two levels of HCPCS codes. Level I of the HCPCS 
is comprised of Common Procedural Terminology (CPT) codes, which are 
maintained by the American Medical Association. The American Medical 
Association makes decisions regarding any updates to the CPT codes.

    Level II of the HCPCS is used primarily to identify products, 
supplies, and services not included in the CPT codes. CMS maintains the 
Level II HCPCS codes, except for the dental codes in the code set, 
which are maintained and thus updated by the American Dental 
Association. CMS makes annual updates to the Level II HCPCS code set 
that may originate internally from CMS or from external requests made 
by the public. The public has an ongoing opportunity to submit requests 
to add codes, modify the language used to describe existing codes, or 
discontinue existing codes. The annual updates allow for the Level II 
HCPCS code set to be revised for new pharmacological and non-
pharmacological therapies, if the criteria for a code set revision are 
met.

    In addition, CMS may alter the Level II HCPCS code set in between 
the scheduled annual updates by establishing temporary codes. If 
established, temporary codes are used to address within a short time 
frame the national program operational needs of a particular insurance 
sector that are not addressed by an already existing code. As needed by 
Medicare or other insurers, temporary codes may allow for the Level II 
HCPCS code set to reflect new therapies for pain management and 
addiction treatment prior to an annual update, based on national 
program operating needs.

    In terms of coverage of new therapies, Medicare coverage is limited 
to items and services that are reasonable and necessary for the 
diagnosis or treatment of an illness or injury (and within the scope of 
a Medicare benefit category). National coverage determinations (NCDs) 
are made through an evidence-based process, with opportunities for 
public participation. In some cases, CMS' own research is supplemented 
by an outside technology assessment and/or consultation with the 
Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). 
In the absence of a national coverage policy, an item or service may be 
covered at the discretion of the Medicare contractors based on a local 
coverage determination (LCD).

    Coverage with Evidence Development (CED) is a paradigm whereby 
Medicare covers items and services on the condition that they are 
furnished in the context of approved clinical studies or with the 
collection of additional clinical data. In making coverage decisions 
involving CED, CMS decides after a formal review of the medical 
literature to cover an item or service only in the context of an 
approved clinical study or when additional clinical data are collected 
to assess the appropriateness of an item or service for use with a 
particular beneficiary.
                                  cmmi
    Question. What demonstration projects is CMMI currently doing that 
could help provide alternative models of payment/models of care for 
individuals struggling with substance abuse disorder or mental health 
issues and the affiliated provider community?

    What projects does CMMI anticipate initiating that could be 
relevant in light of the addiction epidemic?

    Answer. The CMS Center for Medicare and Medicaid Innovation 
(Innovation Center) maintains a growing portfolio supporting the design 
and testing of innovative payment and service delivery models. Last 
fall, we announced that we are setting a new direction for the 
Innovation Center and will carefully assess how models developed 
consistent with this new direction can complement what we are learning 
from the existing models. As part of setting this new direction, CMS 
sought public input and suggestions on innovative payment and service 
delivery models focused on behavioral health, including models focused 
on areas such as opioids and substance use disorder.\82\
---------------------------------------------------------------------------
    \82\ https://innovation.cms.gov/Files/x/newdirection-rfi.pdf.

    CMS received over 1,000 responses to the RFI from a wide variety of 
individuals and organizations located across the country, including 
medical societies and associations, health systems, physician groups, 
and private businesses. The RFI was a critical step in the model design 
process to ensure stakeholder input was available to help shape new 
models. Over the coming year, CMS will use the feedback as it works to 
develop new models, focusing on the eight focus areas outlined in the 
---------------------------------------------------------------------------
RFI.

    The President's FY 2019 budget includes a proposal for CMS to 
conduct a demonstration to test the effectiveness of covering 
comprehensive substance abuse treatment in Medicare. Through this 
proposal, Medicare would provide bundled reimbursement on a per-week-
per-patient basis to health-care providers for methadone treatment or 
similar MAT and would recognize opioid treatment programs and substance 
abuse treatment facilities as independent health-care provider types; 
outpatient counseling would be billed separately as clinically 
necessary. The model would be allowed to target beneficiaries 
determined to be at-risk, as defined by the Overutilization Monitoring 
System, to voluntarily receive comprehensive substance abuse treatment, 
including MAT and SUD counseling.
            twelve-month continuous eligibility in medicaid
    Question. According to the Institute for Medicaid Innovation, 
``while current policymaking efforts are focused on addressing the 
opioid epidemic in the United States through prevention and treatment, 
additional efforts are needed to slow the rate of opioid misuse and 
overdose deaths in pregnant and postpartum women enrolled in the 
Medicaid program. Additionally, issues regarding churn in this 
population need to be addressed. Churn is defined as fluctuations in 
sources of eligibility (between Medicaid and private insurance) as 
individuals experience income-related changes. Churn leads to 
disruptions in care, making it difficult for Medicaid managed care 
plans to provide care coordination and case management when they are 
unable to retain Medicaid enrollees for extended periods of time. This 
problem is especially true for Medicaid-eligible pregnant women 
misusing opioids who become eligible as a result of two different 
eligibility pathways: pregnancy (i.e., single episode of care) and 
income.''

    States currently have the option to provide children with 12 months 
of continuous coverage through Medicaid/CHIP, even if the child's 
family experiences a change in income during the year that would 
otherwise make the child ineligible. This type of policy helps ensure 
maintenance of coverage for kids, which results in better health 
outcomes and continuity of care at a modest cost.

    CMS should consider providing States with similar flexibility for 
adults in Medicaid, particularly those struggling with SUD who may 
churn in and out of Medicaid coverage at a rate higher than the average 
Medicaid population, disrupting their potential for recovery. This is 
especially important for post-partum women.

    Does CMS acknowledge the challenges that churn creates when it 
comes to providing sustained, uninterrupted treatment for chronic 
conditions, including opioid use disorder? What are the unintended 
consequences for individuals receiving treatment who churn in and out 
of Medicaid coverage?

    What policies currently exist to provide States with the 
flexibility to offer continuous coverage to adults, particularly those 
struggling with substance use disorder or mental health diagnoses, in 
Medicaid?

    Answer. CMS is committed to making sure the right patient is 
getting the right treatment in the right setting. In 2017, CMS issued 
guidance describing additional flexibilities to help States improve 
access to and improve the quality of substance use disorder treatment 
through Medicaid section 1115 demonstrations. States need the 
flexibility to operate their Medicaid programs in the way that best 
meets their needs. CMS wants to work with States to help them share 
best practices and offer better guidance, and we are interested in 
exploring important market issues such as churn within the Medicaid 
program.
                         reevaluating e&m codes
    Question. As you both know, the primary care workforce plays a 
critical role in addressing the opioid epidemic by offering a full 
range of services from initial screening for substance use disorder to 
helping coordinate or provide addiction treatment services.

    Unfortunately, primary care providers are facing a growing 
workforce shortage, due in part to problematic clinician reimbursement 
evaluation and management 
(E/M) codes, which do not accurately value or describe cognitive (non-
procedural) services.

    Does CMS currently collect data on E/M code utilization? How often 
is this data analyzed to reevaluate reimbursement and update the code 
set?

    Answer. CMS previously has acknowledged the limitations of the 
current E/M code set. The agency expects to continue to work on the 
structure and valuation of the E/M code set with stakeholders in future 
years, although it is immediately focused on revision of the current E/
M documentation guidelines in order to reduce unnecessary 
administrative burden. In addition, the Physician and Other Supplier 
Public Use File (Physician and Other Supplier PUF) provides information 
on services and procedures provided to Medicare beneficiaries by 
physicians and other health-care professionals. The Physician and Other 
Supplier PUF contains information on utilization, payment (allowed 
amount and Medicare payment), and submitted charges organized by 
National Provider Identifier (NPI), Health Care Common Procedure Coding 
System (HCPCS) code, and place of service. This PUF is based on 
information from CMS administrative claims data for Medicare 
beneficiaries enrolled in the fee-for-service program.

    CMS is currently undergoing a study to redefine and revalue codes 
associated with global surgical packages.

    Question. Does CMS have plans to reevaluate all E/M codes to ensure 
the physician fee schedule maintains adequate incentives and value for 
screening for substance use disorder in the primary care setting, and 
offering integrated primary and behavioral health care?

    Answer. CMS previously has acknowledged the general limitations of 
the current E/M code set. The agency expects to continue to work on the 
structure and valuation of the E/M code set with stakeholders in future 
years, although it is immediately focused on revision of the current E/
M documentation guidelines in order to reduce unnecessary 
administrative burden.
          family first prevention services act implementation
State Engagement
    Question. As you are aware, Family First Prevention Services Act 
(FFPSA) implementation will be a large systemic change for many States, 
particularly States that have utilized IV-E waivers. There is 
understandable anxiety and numerous questions regarding the transition 
to FFPSA.

    Ohio is a IV-E waiver State, and the State has had notable success 
utilizing 
evidence-based programs and promising prevention practices aimed at 
mitigating the trauma experienced by children and reducing the number 
of placement days in care. HHS itself has acknowledged that Ohio's 
targeted use of flexible funds for family preservation efforts has 
promoted improved outcomes. I want to be sure that HHS knows of the 
success Ohio has in administering prevention programs, and I feel that 
it is imperative that, in transitioning to FFPSA, HHS strive to help 
States--like Ohio--build upon successful prevention programs already 
operated in those States.

    HHS is in the process of developing guidance on practice criteria 
for prevention programs under FFPSA and will issue that guidance to 
States by October 1st of this year. As HHS develops the guidance, I 
think it is important for HHS to engage with States that have been 
providing prevention services--particularly States like Ohio, that have 
had success with such programs.

    How will HHS engage with States in developing guidance on practice 
criteria for prevention programs?

    Will HHS hold any meetings with Ohio officials to discuss 
prevention programs that are provided in the State?

    Answer. As the Secretary develops criteria that interventions must 
meet in order to receive funding under the title IV-E prevention 
services program, HHS will be opening the conversation up for public 
comment to allow for States and others to submit feedback. Once the 
criteria are established, we intend to take an equally broad approach 
for identifying interventions that meet the criteria. The vendor that 
operates the clearinghouse will assess interventions for inclusion in 
the clearinghouse and elevation within the levels of evidence on an 
ongoing basis. We intend to issue instructions to States and tribes on 
what must be included in plans submitted to operate a title IV-E 
prevention services program in conjunction with publication of the 
criteria for allowable interventions.
State Flexibility
    Question. States have varying factors to consider in addressing 
child welfare, including the specific needs of the community, available 
resources, State laws and regulations, etc. Therefore, it is important 
that States have some flexibility to be able to tailor prevention 
programs to the specific and sometimes unique conditions present in 
communities.

    Will HHS guidance include flexibility to allow for prevention 
programs to be tailored to meet local needs?

    Answer. As you know, the statute requires the Secretary to develop 
criteria that interventions must meet in order to receive funding under 
the title IV-E prevention services program. Over the course of the next 
few months, ACF will consult broadly across HHS and the field in the 
development of those criteria. Once the criteria are established, ACF 
will take an equally broad approach for identifying interventions that 
meet the criteria, including interventions related to opioid use 
disorder.
Transition
    Question. As you know, the IV-E waivers expire at the end of FY 
2019 and recent projections seem to show that CBO does not view the 
waivers as cost neutral to the Federal Government. Therefore, their 
expiration will result in a loss of child welfare funds to Ohio and 
other States (and presumably, should Congress consider an extension, 
such an extension would be very costly to the Federal Government).

    As Congress considers the FY 2019 and FY 2020 appropriations bills, 
are there steps that can be taken to ensure States like Ohio have 
adequate resources to adjust to the new system under Family First so 
that States do not face the cliff effect of an immediate loss in 
funding?

    Answer. In the President's budget proposal, ACF proposed to create 
a funding option for title IV-E agencies to utilize the title IV-E 
foster care maintenance payments program more flexibly, including 
payments for associated administration, but excluding costs for 
training and systems. Title IV-E agencies could use the flexible 
funding option for any of the purposes or services under titles IV-B 
and IV-E. Providing States and tribes the ability to utilize title IV-E 
funds for specified time-
limited prevention services for a certain population through Family 
First, along with the flexible funding option proposed in the 
President's budget should provide States and tribes with the 
flexibility needed to better target Federal funds towards successful 
prevention and other services to the children and families they serve, 
while reducing the need for States to spend their funds complying with 
overly prescriptive IV-E plan requirements. This could help address 
State concerns about potential loss of Federal funding.

                                 ______
                                 
               Questions Submitted by Hon. Mark R. Warner
    Question. Access to timely and comprehensive substance use disorder 
treatment is critical in combating opioid use disorder. Unfortunately, 
access to qualified medical professionals can often be limited and 
difficult to access in areas that need it most. Recently, my colleagues 
and I worked on legislation to expand the use of telehealth, especially 
in Medicare, in our CHRONIC Care Act. I believe there is merit to 
expanding the use of telehealth to combat opioid use disorder as well.

    If Congress were to give the Centers for Medicare and Medicaid 
Services (CMS) more authority to waive existing geographic and 
originating site restrictions--specifically for substance use 
disorders--could that help reduce wait times and increase access to 
treatment for individuals with substance use disorders?

    Answer. CMS believes that telehealth can be an important tool in 
our efforts to fight this epidemic. Expanding the use of telehealth is 
a priority of CMS Administrator Verma and CMS has been looking at ways 
to expand the use of telehealth, particularly for rural areas. CMS 
looks forward to working with Congress to identify ways we can further 
expand access to telehealth services within Medicare.

    Question. Does the Centers for Medicare and Medicaid Services (CMS) 
have existing plans to implement telehealth demonstration programs that 
could expand access to substance use disorder treatment?

    Answer. CMS believes that telehealth can be an important tool in 
our efforts to fight this epidemic. Expanding the use of telehealth is 
a priority of CMS Administrator Verma and CMS has been looking at ways 
to expand the use of telehealth, particularly for rural areas. CMS is 
actively exploring potential models focused on opioids and substance 
use disorder.

    Question. What other policy changes might Congress consider to 
increase access to substance use disorder treatment via telehealth?

    Answer. Currently, telehealth services may be furnished to a 
Medicare beneficiary at an originating site meeting statutory 
requirements by a physician or other practitioner authorized by statute 
at a distant site. CMS is expanding the services that can be provided 
as Medicare telehealth services and reducing the administrative burden 
for health-care providers to bill for these services. Improving access 
to telehealth services reflects CMS's work to modernize Medicare 
payments to promote 
patient-centered innovations.

    This administration is committed to expanding opportunities within 
telehealth, and CMS looks forward to working with Congress to identify 
ways we can further expand access to telehealth services within 
Medicare.

    Question. Recently, the United States Surgeon General recommended 
that individuals taking a high dose of opioids know how to use naloxone 
and keep it within reach. I am aware that CMS is already trying to 
increase the availability of naloxone by requiring it be on Medicare 
Part D formularies and by working with State Medicaid programs to 
ensure they improve access.

    Virginia has been a national leader in naloxone access. In March 
2017, the Virginia Board of Medicine implemented rules that now require 
co-prescribing of naloxone for certain patients prescribed a high-dose 
opioid or where other factors may place them at a higher risk for 
overdose. The Department of Veterans Affairs has taken similar action.

    These policy changes have increased the availability of naloxone, 
and initial data indicates it may actually be decreasing opioid 
utilization and significantly reducing opioid-related emergency room 
visits.

    Has CMS conducted an evaluation of policies similar to the 
Department of Veterans Affairs or Virginia's that would require a co-
prescription of an opioid overdose reversal drug when a patient 
receives a high-dose or high-risk opioid prescription?

    If not, would CMS consider evaluating these policies and whether 
expanding them more broadly could save lives and help reduce opioid use 
disorder?

    Answer. CMS is promoting improved access to the opioid overdose 
reversal drug naloxone. For example, we require that naloxone appear on 
all Medicare Part D formularies. In addition, Medicaid programs in a 
number of States include forms of naloxone on their Medicaid Preferred 
Drug Lists. CMS has also issued guidance to States on improving access 
to naloxone. States can offer training in overdose prevention and 
response for providers and members of the community, including family 
members and friends of opioid users.

    CMS is always looking for ways to improve our programs, including 
increasing access to naloxone for beneficiaries at risk of an opioid 
overdose. We look forward to working with stakeholders to share best 
practices and gain valuable insight into ways we can further address 
the opioid epidemic.

    Question. On April 1, 2017, Virginia implemented the Addiction and 
Recovery Treatment Services (ARTS) program, and the initial results 
have demonstrated success. The Commonwealth has been able to increase 
treatment options for individuals with substance use disorder and 
potentially bring down the long term costs associated with the opioid 
epidemic. The program did this by implementing several new rules and 
regulations including: enhancing reimbursement for rates for substance 
use disorder treatment providers and using clinically recommended 
criteria to increase provider qualifications and payment for evidence-
based treatments.

    A Virginia Commonwealth University report on the first 9 months of 
the program found a substantial increase in the number of providers and 
facilities providing addiction treatment, a 64 percent increase in 
treatment rates for Medicaid enrollees with a substance use disorder 
and a 31 percent decrease in costly emergency room visits related to 
opioid use disorders.

    I do believe it makes sense to pay treatment providers more when we 
have evidence their work can save lives and save money down the road. 
We have to make long-term investments in this problem.

    How is CMS working to take successful models like the Virginia ARTS 
program and either scaling them up into national programs or 
encouraging them as models other States should replicate?

    Answer. Under the demonstration authority granted by section 1115 
of the Social Security Act, CMS can waive certain Federal requirements 
and pay Federal matching funds for certain expenditures that otherwise 
would not be matchable so that States can test new or existing ways to 
deliver and pay for health-care services in Medicaid. Virginia's ARTS 
program is operating under such an 1115 demonstration project. CMS is 
committed to sharing best practices and encourages other States to look 
into whether a demonstration project would meet the needs of their 
residents.

    We are encouraging States to apply for CMS approval of a 5-year 
demonstration allowing them to receive Federal financial participation 
for services to treat addiction to opioids or other substances for 
Medicaid beneficiaries residing in IMDs, including those aged 21 to 64 
for whom Medicaid otherwise would not pay for services while the 
beneficiary is residing in an IMD, as these States work to improve 
access to treatment in outpatient settings as well. In addition, we are 
working with States that operate these demonstrations to establish 
strong quality of care standards, particularly for residential 
treatment settings.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones established by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these programs; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis. To date, we have approved these SUD demonstration projects for 
five States: Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    To further support this initiative, throughout 2018, the Medicaid 
Innovation Accelerator Program (IAP) will be available to States that 
would benefit from strategic design support related to improving their 
treatment delivery systems. The IAP provides States with access to 
national learning opportunities and technical expert resources, 
including strategic design support to States planning targeted 
addiction treatment delivery system reforms and developing 1115 
proposals. In addition, CMS is available to provide technical 
assistance to States on how to meet Federal transparency requirements 
as well as to preview States' draft 1115 proposals and public notice 
documentation to help ensure States successfully meet Federal 
requirements.

    Addendum: Since the time of this hearing, CMS has approved an 
additional demonstration project for a sixth State: Illinois.

    Question. How can we better align CMS reimbursement rates to 
increase the number of substance use disorder treatment providers?

    Answer. A critical part of tackling this epidemic is making sure 
that beneficiaries grappling with substance use disorder have access to 
the most effective treatment options. As a payer, CMS plays an 
important part in this plan by working to make sure providers are 
providing the right services to the right patients at the right time. 
CMS recently made changes to the Medicare Physician Fee Schedule that 
help support the fight against the opioid epidemic, such as 
establishing separate coding and payment for the insertion and removal 
of buprenorphine implants, a key drug used in medication-assisted 
treatment for opioid addiction, and improving payment for office-based 
behavioral health services. CMS continues to evaluate reimbursement to 
support opioid use disorder treatment efforts.

    Question. Naloxone is critical in combating the opioid epidemic, 
and I believe we need to do everything we can to make sure this product 
is available at an affordable cost.

    As I understand it, there are some manufacturers that--given the 
scope of this epidemic--are willing to and have been donating their 
products at no-cost to non-profits, first responders and others that 
are on the front lines.

    Has CMS been working directly with manufacturers to facilitate the 
affordable availability of naloxone to communities in need? If so, how?

    Has CMS worked specifically with manufacturers that have been 
willing to donate their products for free? If not, would CMS be willing 
to consider such a voluntary partnership?

    Answer. CMS is promoting improved access to the opioid overdose 
reversal drug naloxone. For example, we require that naloxone appear on 
all Medicare Part D formularies. In addition, Medicaid programs in a 
number of States include forms of naloxone on their Medicaid Preferred 
Drug Lists. CMS has also issued guidance to States on improving access 
to naloxone. States can offer training in overdose prevention and 
response for providers and members of the community, including family 
members and friends of opioid users.

    CMS is always looking for ways to improve our programs, including 
increasing access to naloxone for beneficiaries at risk of an opioid 
overdose. The President's FY 2019 budget includes several proposals 
aimed at lowering the price of prescriptions, including a proposal that 
would establish a new Medicaid demonstration authority to allow up to 
five States more flexibility in negotiating prices with manufacturers.

    Question. Existing Federal rules can often serve as a barrier to 
treatment providers looking to better serve their patients and can be 
dangerous to a patient in cases where, for example, a physician 
prescribes an opioid to an individual with an unknown existing 
substance use disorder. If that physician had prior access to the 
patient's substance use and behavioral health records they may not have 
prescribed an opioid.

    This stands in contrast to other integrated approaches to health 
care that are governed under the Health Insurance Portability and 
Accountability Act (HIPAA) and can often lead to medical providers 
needing to get multiple consent forms from a patient in order to access 
and appropriately share their substance use records.

    How can we fix this and allow medical professionals to 
appropriately share a patients substance use records without 
jeopardizing patient privacy?

    Answer. Part 2, the Federal regulation governing confidentiality of 
substance use disorder patient information, and its governing statute, 
42 U.S.C. 290dd-2 permit sharing of a patient's substance use disorder 
patient records during a bona fide medical emergency when prior patient 
consent cannot be obtained, such as a known or suspected drug overdose. 
A Part 2 program also may disclose information needed by medical 
providers to respond to that emergency (42 CFR Sec. 2.51--Medical 
emergencies). Moreover, many general medical facilities such as 
hospital emergency rooms treating overdoses most likely would not meet 
the definition of a Part 2 program and therefore would not be barred 
from sharing information with family members or other medical providers 
during an emergency, assuming such action would not conflict with other 
applicable confidentiality laws.

    More broadly, SAMHSA encourages Part 2 programs and patients to 
discuss how a patient wants their information to be shared and the 
benefits patients may obtain from integrated care which, in turn, is 
facilitated by patients consenting to sharing their health-care 
information with their treating providers (see 42 CFR 2.33). SAMHSA 
revised Part 2 in January 2018 to permit additional information sharing 
by lawful holders, including Medicare and Medicaid entities, with 
contractors, subcontractors, and legal representatives for payment and 
health-care operations purposes consistent with HIPAA (42 CFR 2.33). 
SAMHSA's 2017 final rule also permits patients to consent in writing to 
the use of a general designation to share their Part 2 information with 
all of their past, current, and/or future treating providers (42 CFR 
2.31).

    SAMHSA continues to work to provide guidance to Part 2 programs and 
lawful holders on application of these provisions. Further, patients 
may share information with non-part 2 providers about their substance 
use history. This information, as recorded in the record of the non-
part 2 provider, is not protected by 42 CFR part 2, but it is protected 
by HIPAA and is a means by which treating providers can be aware of the 
patient's history and vulnerabilities related to substances with abuse 
liability such as opioids or other prescribed medications. This only 
requires that clinicians ask the appropriate questions and record the 
patient's answers. SAMHSA will be working to educate providers and 
clinicians about appropriate interpretation of statutes related to 
privacy through guidance to the public and funding of a national 
technical assistance center on this topic.

    Question. Should Congress consider revising HIPAA before giving 
medical professionals greater access to share a patients substance use 
records?

    Answer. At HHS, we take the confidentiality of patient records 
seriously. It is critical that we aim to protect the rights of 
individuals with substance use disorders--the rights to privacy, but 
also the rights to high quality care in a way no different than for 
others without substance use disorders seeking treatment. While patient 
privacy is a critical concern, equally important is the need for 
individuals with substance use disorders to get the safest and most 
effective treatment possible when they experience medical illnesses. 
This requires that health-care providers be able to share information 
and for care to be provided in a coordinated and integrated manner. HHS 
supports Congress's further consideration of the benefits of aligning 
part 2 and its governing statute with HIPAA.

    Question. I've heard from providers in Virginia that when it comes 
to reimbursement policies--more often than not--it's in the financial 
interest of patients and physicians to simply use an opioid as their 
course of treatment for pain management. This commonly occurs even when 
another non-opioid alternative might be readily available and 
clinically appropriate.

    How can we do a better job of reviewing and realigning CMS 
reimbursement rates in a way that provides patients equally affordable 
opportunities to access non-opioid pain management treatments?

    Answer. The opioid crisis cannot be tackled by CMS alone, and that 
is why we are collaborating with other HHS agencies, such as the FDA, 
CDC, and NIH, to identify services that need more evidence to support 
coverage by Medicare and other health plans.

    Both medicinal and non-medicinal therapeutic alternatives to 
opioid-based pain medications exist; although Medicare coverage and 
payment varies. In general, Medicare covers items and services that are 
``reasonable and necessary.'' This includes several non-pharmacologic 
therapies and other non-opioid pharmaceuticals. CMS uses the national 
and local coverage determination process to evaluate new or promising 
items and services with respect to Medicare Parts A and B, through 
well-delineated processes set forth in statute. Those items and 
services for which evidence demonstrates improvement in health outcomes 
in the Medicare population are more likely to be coverable, while those 
items and services for which such evidence is insufficient or lacking 
warrant further research.

    CMS has partnered with the CDC to develop the Opioid Safety 
Commitment poster campaign,\83\ which promotes the most effective pain 
management treatments and strategies. This campaign emphasizes patient 
engagement, clinician counseling regarding opioid alternative pain 
management strategies, and discussion with patients of the risks and 
benefits of opioids when opioids are prescribed.
---------------------------------------------------------------------------
    \83\ https://www.cdc.gov/drugoverdose/prescribing/posters.html.

    CMS has a number of initiatives underway to increase the use of 
recommended evidence-based practices for pain management. In addition 
to the work of the Quality Innovation Network Quality Improvement 
Organization program, described above, CMS provides outreach regarding 
best practices and technical assistance through the Transforming 
Clinical Practice Initiative's (TCPI's) Practice Transformation 
Networks.\84\ TCPI is designed to use peer-based learning networks for 
information sharing, outreach, and dissemination of evidence-based 
practices to educate prescribers on safe and appropriate methods of 
pain treatment. For example, the TCPI Medication Management and Opioid 
Initiative is mobilizing the existing network of more than 100,000 
clinicians into action to address the opioid crisis, generating 
collaborations with other CMS quality improvement projects, showcasing 
successful strategies in engaging providers and patients on proper 
opioid utilization and spreading the successful strategies throughout 
all CMS communities.
---------------------------------------------------------------------------
    \84\ https://innovation.cms.gov/initiatives/Transforming-Clinical-
Practices/.

    CMS also promotes free educational materials for health-care 
professionals on CMS programs, policies, and initiatives through the 
Medicare Learning Network (MLN).\85\ The ``CDC Guidelines for 
Prescribing Opioids for Chronic Pain'' is featured in the January 12, 
2017 \86\ MLN Connects newsletter.
---------------------------------------------------------------------------
    \85\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-
Network-MLN/MLNGen
Info/Index.html.
    \86\ https://www.cms.gov/Outreach-and-Education/Outreach/
FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2017-01-12-
eNews.html?DLPage=7&DLEntries=10&DLSort=0&DL
SortDir=descending#_Toc471878721.

    Question. Would CMS consider opportunities to test new pilots at 
---------------------------------------------------------------------------
the Center's for Medicare and Medicaid Innovation Institute (CMMI)?

    Answer. The CMS Center for Medicare and Medicaid Innovation 
(Innovation Center) maintains a growing portfolio supporting the design 
and testing of innovative payment and service delivery models. Last 
fall, we announced that we are setting a new direction for the 
Innovation Center and will carefully assess how models developed 
consistent with this new direction can complement what we are learning 
from the existing models. As part of setting this new direction, CMS 
sought public input and suggestions on innovative payment and service 
delivery models focused on behavioral health, including models focused 
on areas such as opioids and substance use disorder.\87\
---------------------------------------------------------------------------
    \87\ https://innovation.cms.gov/Files/x/newdirection-rfi.pdf.

    CMS received over 1,000 responses to the RFI from a wide variety of 
individuals and organizations located across the country, including 
medical societies and associations, health systems, physician groups, 
and private businesses. The RFI was a critical step in the model design 
process to ensure stakeholder input was available to help shape new 
models. Over the coming year CMS will use the feedback as it works to 
develop new models, focusing on the eight focus areas outlined in the 
---------------------------------------------------------------------------
RFI.

    The President's FY 2019 budget includes a proposal for CMS to 
conduct a demonstration to test the effectiveness of covering 
comprehensive substance abuse treatment in Medicare. Through this 
proposal, Medicare would provide bundled reimbursement on a per-week-
per-patient basis to health-care providers for methadone treatment or 
similar MAT and would recognize opioid treatment programs and substance 
abuse treatment facilities as independent health-care provider types; 
outpatient counseling would be billed separately as clinically 
necessary. The model would be allowed to target beneficiaries 
determined to be at-risk, as defined by the Overutilization Monitoring 
System, to voluntarily receive comprehensive substance abuse treatment, 
including MAT and SUD counseling.

    Question. Medication-Assisted Treatment (MAT) is a clinically 
recommended treatment course for individuals suffering from opioid use 
disorder and has proven effective in saving lives and ensuring 
individuals undergoing treatment for substance use disorder 
successfully complete their treatment.

    There are significant barriers in place that make it difficult for 
many individuals to access MAT--including availability of prescribing 
physicians, burden on physicians to obtain additional training and 
more.

    These barriers are even more prevalent among the young adult and 
adolescent populations where pediatricians haven't traditionally 
administered MAT.

    What is the existing strategy for ensuring Medication Assisted 
Treatment is available to young adults and adolescents that are 
struggling with opioid use disorder?

    Answer. Medication-Assisted Therapy (MAT) is a valuable 
intervention that has been proven to be the most effective treatment 
for OUD, particularly because it sustains long-term recovery and has 
been shown to reduce opioid-related morbidity and mortality.\88\ To 
increase access to MAT, CMS requires that Medicare Part D formularies 
include covered Medicare Part D drugs used for MAT and mandates 
Medicare Part C coverage of the behavioral health element of MAT 
services. In addition, CMS issued guidance on best practices in 
Medicaid for covering MAT in a joint informational bulletin with the 
Substance Abuse and Mental Health Services Administration (SAMHSA), the 
CDC, and the National Institute on Drug Abuse.\89\ CMS also released an 
informational bulletin with SAMHSA on coverage of treatment services 
for youth with SUD.\90\
---------------------------------------------------------------------------
    \88\ https://www.ncbi.nlm.nih.gov/pubmed/24500948.
    \89\ https://www.medicaid.gov/Federal-Policy-Guidance/downloads/
CIB-07-11-2014.pdf.
    \90\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-01-26-2015.pdf.

    While Medicaid programs vary greatly by State, all 50 States 
currently offer some form of MAT. In addition, the President's FY 2019 
budget includes a proposal that would require State Medicaid programs 
to cover all FDA-approved MAT for OUD, including associated counseling 
and other costs. These up-front investments in expanded MAT treatment 
are expected to reduce total Medicaid expenditures over time as more 
individuals recover from OUD; this provision would result in an 
---------------------------------------------------------------------------
estimated $865 million is savings over 10 years.

    Under an additional proposal in the President's FY 2019 budget, CMS 
would conduct a demonstration to test the effectiveness of covering 
comprehensive substance abuse treatment in Medicare. This demonstration 
could be expanded nation-wide if successful in key metrics, such as 
reducing opioid-related deaths among beneficiaries, reducing 
hospitalization for opioid poisoning, and reducing emergency room 
utilization for opioid-related issues. Through this proposal, Medicare 
would provide bundled reimbursement on a per-week-per-patient basis to 
health-care providers for methadone treatment or similar MAT and would 
recognize opioid treatment programs and substance abuse treatment 
facilities as independent health-care provider types; outpatient 
counseling would be billed separately as clinically necessary. The 
model would be allowed to target beneficiaries determined to be at-
risk, as defined by the Overutilization Monitoring System, to 
voluntarily receive comprehensive substance abuse treatment, including 
MAT and SUD counseling.

    There are three approved medications for the treatment of OUD in 
adults. Buprenorphine is approved for use starting at age 16, while 
methadone can be used within certified opioid treatment programs in 
anyone under age 18, providing that there have been two prior 
unsuccessful treatments without using any OUD medication in a 12-month 
period and that there is parental informed consent. Injectable 
naltrexone is approved for OUD for people age 18 and up.

    In addition to the ability to use SAMHSA funds from the State 
Targeted Response, State Opioid Response, and Tribal Opioid Response 
grant programs for adolescents and youth in clinical need of MAT, there 
are other programs relevant to this age group. SAMHSA is funding the 
provision of MAT for adolescents and young adults with OUD in fiscal 
year 2018 funding opportunity announcement, TI-18-010, Enhancement and 
Expansion of Treatment and Recovery Services for Adolescents, 
Transitional Aged Youth, and their Families. The purpose of this grant 
program is to enhance and expand comprehensive treatment, early 
intervention, and recovery support services for adolescents (ages 12-
18), transitional aged youth (ages 16-25), and their families/primary 
caregivers with substance use disorders (SUD) and/or co-occurring 
substance use and mental disorders.

    SAMHSA anticipates making 27 new awards to public and non-profit 
entities at up to $541,350 per award annually for 5 years. Grant 
recipients can provide medication as part of their SUD, specifically 
alcohol use disorder (AUD) and OUD, as part of a comprehensive 
treatment approach. Up to 10 percent of annual grant funds may be used 
to pay for Food and Drug Administration (FDA)-approved medications for 
the treatment of SUDs and/or co-occurring disorders.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. The Ensuring Patient Access and Effective Drug 
Enforcement Act of 2016 (Pub. L. 114-145) required the Secretary of 
Health and Human Services to report to Congress on a number of issues, 
including issues with diversion of controlled substances, how 
collaboration between law enforcement agencies and the pharmaceutical 
industry can prevent diversion and abuse of controlled substances, and 
steps to improve reporting requirements regarding opioid prescriptions. 
Under the law, HHS was required to produce this report no later than 
April 19, 2017, over 1 year ago. This report is particularly critical 
as Congress reevaluates Pub. L. 114-145 and considers changes to make 
the law more effective.

    What is the status of this report?

    When can Congress expect the report?

    Why is the report over 1 year late?

    Answer. The HHS Behavioral Health Coordinating Council Subcommittee 
on Opioids and Controlled Substances is currently working to finalize 
the Report required under the Ensuring Patient Access and Effective 
Drug Enforcement Act of 2016. The Subcommittee has been working with 
interagency partners such as the Drug Enforcement Administration and 
the HHS Office of the Inspector General to compile the report. The last 
phase of the development of the Report is engaging with medical and 
pharmacy providers and patients, as required in the Act. HHS staff will 
incorporate the feedback provided by these stakeholders into the 
Report. The Report will then undergo final review by HHS before being 
transmitted to the committees of jurisdiction as required in the Act.

    Question. As we discussed at the Opioid Listening Session with 
Senior Counselor Conway and other administration officials, I am 
interested in an update on the implementation of each provision of the 
Comprehensive Addiction and Recovery Act of 2016 (Pub. L. 114-198). 
Please provide an update on which provisions have been fully 
implemented, and the status of any remaining items that have not yet 
been fully implemented.

    Answer. The Comprehensive Addiction and Recovery Act (CARA) of 2016 
provided HHS with a variety of new authorities to continue the 
Department's implementation of a robust public health response to the 
opioid crisis. As you are aware, in April 2017, HHS outlined its five-
point strategy, which provides the overarching strategy and framework 
to leverage the expertise and resources of the HHS agencies in a 
strategic and coordinated effort. The Opioid Strategy is well-aligned 
with the provisions in CARA, and, to date, HHS has taken significant 
steps to implement programs that are responsive to the intent of the 
law. Following are HHS-related provisions that have been implemented 
within each title.

Title 1 Prevention and Education--

          Task Force on Pain Management: On August 25, 2017, HHS 
        established the Pain Management Best Practices Inter-Agency 
        Task Force on Pain Management (``The Task Force''). The first 
        meeting of the Task Force was held on May 31, 2018.

          Public Awareness Campaign: On June 7th, the White House 
        launched the first phase of its anti-opioid media campaign, a 
        part of the administration's efforts to address the opioid 
        crisis. The first ads target young adults, warning them of the 
        dangers of opioid addiction, and it includes four television 
        and digital ads featuring true stories of young people who have 
        struggled with addiction. The goal of the campaign is to show 
        the dangers of misusing opioids and how quickly one can become 
        addicted. The effort is a partnership among the White House and 
        the Ad Council, the organization behind many of the 
        government's public service announcements, including the Truth 
        Initiative, a national anti-tobacco campaign. The campaign is 
        funded largely from donations, including free media time from 
        NBC Universal, Turner Broadcasting, Facebook, YouTube, Google 
        and the Ad Council. ONDCP is providing $380,000 to the 
        campaign. In addition, CDC launched its RxAwareness campaign on 
        September 25, 2018. RxAwareness has had a total of 141-million 
        digital impressions and 5.9 million digital interactions since 
        the campaign went live. All campaign digital assets performed 
        at or above government benchmark for interaction rate, which 
        has remained at or above government benchmark for interaction 
        rate, which has remained steady.

          Community-Based Coalition Enhancement Grants: SAMHSA 
        released a funding opportunity announcement (FOA) for awards in 
        FY 2018.

          FDA Opioid Action Plan: FDA has consulted with advisory 
        committees on new opioids, including on pediatric issues. In 
        addition, FDA announced its intention to expand its Risk 
        Evaluation and Mitigation Strategies (REMS) to incorporate all 
        opioid analgesics that are intended for use in outpatient 
        settings, including immediate-release formulations. And, FDA 
        revised the associated Blueprint \91\ for how providers should 
        be educated about pain management in general, and prescribing 
        opioid analgesics specifically.
---------------------------------------------------------------------------
    \91\ https://www.regulations.gov/contentStreamer?documentID=FDA-
2017-D-2497-0683&attach
mentNumber=1&contentType=pdf.

          Improving Access to Opioid Treatment: In FY 2017, SAMHSA 
        awarded one multi-year grant in the amount of $1 million for 5 
---------------------------------------------------------------------------
        years.

          NIH Opioid Research With Respect to Pain: NIH launched HEAL, 
        Helping to End Addiction Long-term, to provide scientific 
        solutions to the national opioid crisis and offer new hope for 
        individuals, families, and communities affected by this 
        devastating crisis. NIH has put ``all hands on deck'' to 
        identify a set of research priorities reflecting urgent unmet 
        needs, areas of promising scientific opportunity, and concrete 
        strategies capable of providing rapid and durable solutions to 
        the opioid crisis.

          Opioid Overdose Reversal Medication Access: SAMHSA provides 
        a number of funding streams that can be used to expand access 
        to naloxone. States are able to use State Targeted Response 
        (STR) Opioid Crisis Grants to purchase and distribute naloxone, 
        and some States are also using a portion of their Substance 
        Abuse Prevention and Treatment Block Grants (SABG) funds for 
        opioid overdose prevention activities. SAMHSA is currently 
        providing $11 million per year in Grants to Prevent 
        Prescription Drug/Opioid Overdose Related Deaths to 12 States. 
        These grants are also being used to train first responders on 
        emergency medical care to be rendered in an overdose situation 
        and how to administer naloxone as well as how to purchase and 
        distribute naloxone.

Title II--Law Enforcement and Treatment

          First Responder Training: In September 2017, SAMHSA awarded 
        funding for grants authorized by CARA, including almost $45 
        million over 5 years to grantees in 22 States to provide 
        resources to first responders and treatment providers who work 
        directly with the populations at highest risk for opioid 
        overdose.

Title III--Treatment and Recovery

          Evidence-Based Prescription Opioid and Heroin Treatment and 
        Interventions: SAMHSA has several initiatives aimed 
        specifically at advancing the utilization of medication 
        assisted treatment (MAT), which is proven effective but is 
        highly underutilized. SAMHSA's Medication Assisted Treatment 
        for Prescription Drug and Opioid Addiction (MAT-PDOA) program 
        expands MAT access by providing grants to States with the 
        highest rates of treatment admissions for opioid addiction. 
        Twenty-eight States are currently funded by MAT-PDOA, and in 
        September 2017, SAMHSA awarded $35 million dollars over 3 years 
        in additional MAT-PDOA grants to six States.

          Building Communities of Recovery: In March 2018, SAMHSA 
        awarded $4.6 million over 3 to 8 years in Building Communities 
        of Recovery (BCOR) program grants. An additional 13 awards are 
        expected to be made in September 2018 for an additional $11.7 
        million over 3 years.

          Medication-Assisted Treatment for Recovery From Addiction: 
        Prior to the passage of CARA, HHS already had the ability to 
        change the maximum patient limit and finalized a rule to allow 
        physicians to prescribe buprenorphine for up to 275 patients if 
        they met the requirements of the regulation. Subsequent to the 
        hearing date, As of July 21, 2018, there are 4,272 physicians 
        that have a waiver to treat up to 275 patients. In addition, 
        the passage of CARA, extended the privilege of prescribing 
        buprenorphine to qualifying nurse practitioners (NPs) and 
        physician assistants (PAs) until October 1, 2021. CARA requires 
        that NPs and PAs complete 24 hours of training to be eligible 
        for a prescribing waiver. NPs and PAs who have completed the 
        required training and obtained the DATA-waiver are allowed to 
        treat up to 30 patients during the first year. After 1 year, 
        they can apply to increase their patient limit to 100. As of 
        July 21, 2018, 6,465 NPs (5,825 at the 30-patient limit and 640 
        at the 100 patient limit) and 1,735 PAs (1,513 at the 30-
        patient limit and 222 at the 100 patient limit) have received 
        waivers.

Title IV--NA to HHS

Title V--Addiction and Treatment Services for Women, Families, and 
Veterans

          Improving Treatment for Pregnant and Postpartum Women: Under 
        SAMHSA's Pregnant and Postpartum Women's Program (PPW), which 
        serves women with opioid or other substance use disorders who 
        are pregnant and/or newly parenting, grantees are encouraged to 
        ensure access to MAT for opioid addiction. In FY 2018, SAMHSA 
        will fund 18 new 5-year residential PPW grants totaling $9.5 
        million annually and 19 continuing PPW 5-year residential 
        grants totaling $10.7 million annually. Additionally, SAMHSA 
        will fund three new 3-year PPW Pilot grants totaling $3.2 
        million annually. The PPW Pilot Program was created under the 
        Comprehensive Addiction and Recovery Act (CARA) of 2016 with 
        the first three grants funded in FY 2017 totaling $3.2 million 
        annually. PPW Pilot grants are awarded to State substance abuse 
        agencies to increase outpatient treatment and recovery support 
        services for substance use disorder, including opioid use 
        disorder, across the continuum of care and promote new 
        approaches and models of service delivery. In FY 2017, SAMHSA 
        began a 3-year PPW cross site evaluation to examine the 
        effectiveness of the PPW Pilot Program. The evaluation results 
        will be used broadly to improve the collective understanding 
        about effective components of the continuum of care for 
        pregnant and postpartum women with a primary diagnosis of a 
        substance use disorder, including whether the PPW Pilot Program 
        is an effective approach to increase access to the use of 
        medication-
        assisted treatment.

          Infant Plan of Safe Care: Since the passage of CARA, the 
        Children's Bureau in the Administration for Children and 
        Families (ACF) has taken a number of steps to inform States of 
        steps they must take to comply with the updated Child Abuse 
        Prevention Treatment Act (CAPTA) requirements and to share best 
        practices to guide their implementation of the updated 
        requirement. Steps included an Informational Memorandum (IM) 
        (ACF-CB-IM-16-05) to inform States of amendments to CAPTA; a 
        Program Instruction (PI) (ACYF-CB-PI-17-02) to provide guidance 
        to States on implementing new CAPTA provisions added by CARA 
        relating to infants affected by substance abuse; and another 
        Program Instruction (ACYF-CB-PI-17-05). The SAMHSA-ACF funded 
        National Center on Substance Abuse and Child Welfare (NCSACW) 
        is providing technical assistance to States on development and 
        implementation of the Plans of Safe Care.

Title VI--Incentivizing State Comprehensive Initiatives to Address 
Prescription Opioid Abuse

          State Demonstration Grants for Comprehensive Abuse Response: 
        This provision required HHS to award grants to States to 
        establish and implement a comprehensive State and local 
        response including education, PDMP, treatment and overdose 
        death prevention. This provision is similar to the Opioid State 
        Targeted Response grant program authorized by the 21st Century 
        Cures Act and Congress appropriated funding for that program at 
        $500 million in both FY 2017 and FY 2018. States can use the 
        funds to focus on areas of greatest need, including increasing 
        access to treatment, supporting prevention and recovery 
        services, and paying for naloxone. SAMHSA issued a supplemental 
        STR grant FOA targeted to the hardest hit States and in March 
        2018, SAMHSA awarded grants totaling $1 million to New 
        Hampshire, Massachusetts, and West Virginia. The 2018 omnibus 
        provides for an additional $1 billion for a new State Opioid 
        Response Grant. Subsequent to the hearing date, SAMHSA released 
        funding opportunity announcements (FOA) that include the 
        required 15 percent set aside for hardest hit States and $50 
        million for tribes.

Title VII--Miscellaneous

          Grant Accountability and Evaluations: This provision 
        requires DOJ and HHS to enter into an agreement with the 
        National Academy of Sciences--or another non-governmental 
        entity with expertise in conducting and evaluating research 
        pertaining to opioid use and drawing conclusions about overall 
        opioid use and misuse on the basis of that research--to 
        identify outcomes to be achieved, the metrics by which the 
        performance will be evaluated, and the evaluation of the 
        Comprehensive Opioid Abuse Grant Program. HHS is working 
        actively to meet the intent of the law with respect to working 
        with the National Academy of Sciences.

          Programs to Prevent Prescription Drug Abuse Under Medicare 
        Parts C and D: In response to the requirements under section 
        704 of CARA. CMS issued a report to Congress (July 2017) on 
        ways to improve the appeals process for Medicare prescription 
        drug coverage under Part D, including an analysis comparing 
        appeals processes under parts C and D. In developing such 
        report, the Secretary was required to solicit feedback on the 
        current appeals process from stakeholders, such as 
        beneficiaries, consumer advocates, plan sponsors, pharmacy 
        benefit managers (PBMs), pharmacists, providers, independent 
        review entity (IRE) evaluators, and pharmaceutical 
        manufacturers. CMS held a special Open Door Forum (ODF) 
        telephone conference on December 20, 2016, to solicit 
        stakeholder feedback on how to make the Part D coverage 
        determination, appeal, and grievance processes more 
        understandable and accessible for Medicare beneficiaries. CMS 
        also collected feedback from stakeholders via email until 
        December 29, 2016. CMS also held a stakeholder listening 
        session on November 14, 2016, to solicit input regarding CMS's 
        implementation of section 704 of CARA.

    HHS will continue to work with Congress on any CARA provisions that 
have not been implemented due to the lack of an appropriation for the 
specific authorization.

    Question. This year, Senator Portman and I introduced the CARA 2.0 
Act (S. 2456), which would build on the successes of CARA (Pub. L. 114-
198).

    Does the administration support CARA 2.0?

    Answer. While the administration has not taken a position on this 
bill, the Department looks forward to working with congressional 
members on ways to address the opioid crisis and is always available to 
provide technical assistance, as requested, on pending legislation.

    Question. What is the administration's position on increasing 
funding for the Building Communities of Recovery Program (section 6)?

    Answer. The administration supports the Building Communities of 
Recovery (BCOR) program and increased funding for these activities. The 
purpose of this program is to mobilize resources within and outside of 
the recovery community to increase the prevalence and quality of long-
term recovery support from substance abuse and addiction. The grants 
support the development, enhancement, expansion, and delivery of 
recovery support services as well as promotion of and education about 
recovery. The BCOR program also supports all pathways to recovery, 
including abstinence attained with FDA-approved medications. Through 
participation in BCOR, participants benefit from peer-to-peer services 
and much needed recovery supports such as assistance with housing, 
education, employment, parenting, life skills and other supports and 
services. In addition to the eight BCOR grants funded in FY17, 13 
additional BCOR grants will be funded in FY18.

    Question. What is the administration's position on the bill's 
proposed policy changes related to prescription drug monitoring 
programs (section 13)?

    Answer. The use of PDMPs among all providers is a promising State-
level intervention to improve opioid prescribing, inform clinical 
practice, and protect patients at heightened risk of opioid misuse, 
abuse, and overdose. PDMP data can also provide public health 
authorities with timely information about prescribing and patient 
behaviors that contribute to the epidemic. For example, States can use 
PDMP data to determine ``hot spots'' or geographic areas within a State 
with disproportionately higher rates of opioid prescribing and 
dispensing and therefore target interventions. While PDMPs vary in 
operation across States, there are system components that can improve 
PDMP functionality as a public health tool. Those include: universal 
use among providers and/or their delegates (for example, nurse 
practitioners or physician assistants) within a State; more timely or 
real-time data contained within a PDMP; actively managing the PDMP in 
part by sending proactive reports to providers to inform prescribing; 
and ensuring that PDMPs are easy to use and accessible by providers.

    The Department is supportive of the use of PDMPs in this manner, as 
both a public health surveillance and a clinical decision support tool.

    From a public health standpoint, data sharing with law enforcement 
is helpful when done at the aggregate level and with the aim of helping 
law enforcement partners allocate resources accordingly. For instance, 
PDMP data can inform where prescribing (and overdose) rates are highest 
within a given State and therefore in most need of enhanced public 
health and public safety efforts to reduce risk of overdose.

    When PDMP data are shared with licensing boards, best practices 
indicate that the underlying purpose in doing so should be to engage in 
increasing awareness, educating, and providing additional trainings to 
prescribers to share with them the most updated science and data on 
prescribing, as opposed to for punitive purposes. It often is the case 
that prescribers may not realize that they are prescribing opioids for 
pain management at rates disproportionately higher than their peers. 
Therefore, making providers aware of this reality, through provider 
outreach, academic detailing, or unsolicited reporting through the 
PDMP, is often the precipitating event that encourages them to align 
their prescribing with clinical best practices.

    Question. As you know, the $6 billion for opioid response 
activities appropriated in the bipartisan budget agreement will flow 
through multiple departments and multiple agencies within those 
departments. Who is the best point of contact in the administration to 
help State and local agencies and other organizations understand and 
take advantage of new grant funding opportunities arising from the 
bipartisan budget agreement?

    Answer. State and local agencies and other organizations that want 
information on current and new grant funding opportunities related to 
the opioid crisis may contact the HHS Office of the Assistant Secretary 
for Legislation (ASL) at 202-690-7627. ASL staff will connect the State 
or local agency or organization with the appropriate HHS agency, 
depending on their interest. Here are a links to several agency 
websites where grant information is posted and updated regularly.

          Substance Abuse and Mental Health Services Administration 
        (SAMHSA): https://www.samhsa.gov/grants.

          National Institutes of Health (NIH): https://www.nih.gov/
        grants-funding.

          NIH National Institute on Drug Abuse: https://
        www.drugabuse.gov/drugs-abuse/opioids.

          Food and Drug Administration (FDA): https://www.fda.gov/
        newsevents/newsroom/pressannouncements/ucm609188.htm.

          Centers for Disease Control and Prevention (CDC): https://
        www.cdc.gov/funding/resources/index.html.

          Health Resources and Services Administration: https://
        www.hrsa.gov/grants/index.html.

          Grants.gov is a central source for information on over 1,000 
        grant programs and provides access to information on awards: 
        https://www.grants.gov/.

    Question. The 21st Century Cures Act included $1 billion for States 
to combat the opioid crisis, but the formula used to allocate that 
funding accounted for the number of opioid overdose deaths, rather than 
the rate, disadvantaging small States like Rhode Island. Would the 
Department consider using the local intensity of the opioid crisis as a 
criterion for competitive grant proposals, to ensure funds are directed 
at States that are hit the hardest by this epidemic?

    Answer. As you know, Congress has incorporated a 15 percent set-
aside for those States who have been hardest hit by the crisis as 
evidenced by mortality data. And subsequent to the hearing on June 14, 
2018, SAMHSA issued a funding opportunity announcement announcing it is 
accepting applications for FY 2018 State Opioid Response Grants. This 
program also includes a 15 percent set-aside for the 10 States with the 
highest mortality rate related to drug overdose deaths.

    Question. In March, I sent the attached letter to Chairman Hatch 
and Ranking Member Wyden describing policies I am interested in as the 
Finance Committee explores opportunities to improve the Federal 
response to the opioid crisis. Please summarize CMS's efforts in the 
following areas, and opportunities CMS has identified that may require 
legislative action.

    Authorizing the CMS Innovation Center to test new care delivery and 
payment models for behavioral health that include incentive payments to 
behavioral health providers for adopting electronic health record 
technology, as outlined in the Improve Access to Behavioral Health 
Information Technology Act (S. 1732).

    Answer. The CMS Center for Medicare and Medicaid Innovation 
(Innovation Center) maintains a growing portfolio supporting the design 
and testing of innovative payment and service delivery models. Last 
fall, we announced that we are setting a new direction for the 
Innovation Center and will carefully assess how models developed 
consistent with this new direction can complement what we are learning 
from the existing models. As part of setting this new direction, CMS 
sought public input and suggestions on innovative payment and service 
delivery models focused on behavioral health, including models focused 
on areas such as opioids and substance use disorder.\92\
---------------------------------------------------------------------------
    \92\ https://innovation.cms.gov/Files/x/newdirection-rfi.pdf.

    CMS received over 1,000 responses to the RFI from a wide variety of 
individuals and organizations located across the country, including 
medical societies and associations, health systems, physician groups, 
and private businesses. The RFI was a critical step in the model design 
process to ensure stakeholder input was available to help shape new 
models. Over the coming year CMS will use the feedback as it works to 
develop new models, focusing on the eight focus areas outlined in the 
---------------------------------------------------------------------------
RFI.

    In addition, as part of the government-wide MyHealthEData 
initiative, led by the White House Office of American Innovation, CMS 
intends to overhaul its Electronic Health Record (EHR) Incentive 
Programs, since renamed the Promoting Interoperability Programs, to 
refocus the programs on interoperability and to reduce the time and 
cost required of providers to comply with the programs' requirements. 
CMS will continue to collaborate with the Office of the National 
Coordinator for Health Information Technology (ONC) to improve the 
clinician experience with their EHRs. The MyHealthEData initiative will 
work to make clear that patients deserve to not only electronically 
receive a copy of their entire health record, but also be able to share 
their data with whomever they want, making the patient the center of 
the health-care system. Patients can use their information to actively 
seek out providers and services that meet their unique health-care 
needs, have a better understanding of their overall health, prevent 
disease, and make more informed decisions about their care.

    Question. Improving Medicare and Medicaid coverage for medication-
assisted treatment, including coverage for methadone under Medicare and 
requiring coverage of all FDA-approved forms of medication-assisted 
treatment under Medicaid.

    Answer. Medication-Assisted Therapy (MAT) is a valuable 
intervention that has been proven to be the most effective treatment 
for OUD, particularly because it sustains long-term recovery and has 
been shown to reduce opioid-related morbidity and mortality.\93\ To 
increase access to MAT, CMS requires that Medicare Part D formularies 
include covered Medicare Part D drugs used for MAT and mandates 
Medicare Part C coverage of the behavioral health element of MAT 
services. In addition, CMS issued guidance on best practices in 
Medicaid for covering MAT in a joint informational bulletin with the 
Substance Abuse and Mental Health Services Administration (SAMHSA), the 
CDC, and the National Institute on Drug Abuse.\94\ CMS also released an 
informational bulletin with SAMHSA on coverage of treatment services 
for youth with SUD.\95\
---------------------------------------------------------------------------
    \93\ https://www.ncbi.nlm.nih.gov/pubmed/24500948.
    \94\ https://www.medicaid.gov/Federal-Policy-Guidance/downloads/
CIB-07-11-2014.pdf.
    \95\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib-01-26-2015.pdf.

    While Medicaid programs vary greatly by State, all 50 States 
currently offer some form of MAT. In addition, the President's FY 2019 
budget includes a proposal that would require State Medicaid programs 
to cover all FDA-approved MAT for OUD, including associated counseling 
and other costs. These up-front investments in expanded MAT treatment 
are expected to reduce total Medicaid expenditures over time as more 
individuals recover from OUD; this provision would result in an 
---------------------------------------------------------------------------
estimated $865 million is savings over 10 years.

    Under an additional proposal in the President's FY 2019 budget, CMS 
would conduct a demonstration to test the effectiveness of covering 
comprehensive substance abuse treatment in Medicare. Through this 
proposal, Medicare would provide bundled reimbursement on a per-week-
per-patient basis to health-care providers for methadone treatment or 
similar MAT and would recognize opioid treatment programs and substance 
abuse treatment facilities as independent health-care provider types; 
outpatient counseling would be billed separately as clinically 
necessary. The model would be allowed to target beneficiaries 
determined to be at-risk, as defined by the Overutilization Monitoring 
System, to voluntarily receive comprehensive substance abuse treatment, 
including MAT and SUD counseling.

    Question. Ensuring continuity of care for individuals with 
substance use disorders, including incarcerated individuals.

    Answer. CMS is committed to making sure patients get the right 
care, in the right setting. We are also committed to working with 
States to find innovative and efficient ways to provide care to those 
eligible for Medicaid coverage. States need the flexibility to operate 
their Medicaid programs in the way that best meets their needs. CMS 
wants to work with States to help them share best practices and offer 
better guidance around these issues, and look forward to continuing to 
work with you and the committee on possible solutions.

    Question. Supporting certified peer recovery coaches under 
Medicare, including through alternative payment models.

    Answer. CMS is committed to making sure that all Medicare 
beneficiaries receive the right care in the right setting, and 
understand that peer recovery coaches can be an important part of the 
care team. Certified peer recovery coaches are not enrolled as Medicare 
providers. The Center for Medicare and Medicaid Innovation (Innovation 
Center) maintains an expanding portfolio supporting the development and 
testing of innovative health-care payment and service delivery models 
that can include different types of providers, for example, the Health 
Care Innovation Awards tested funding for community health workers, 
another provider not typically enrolled in Medicare. In addition, CMS 
recently sought public input and suggestions on innovative payment 
system models that will help promote effective substance abuse 
treatment programs, including models focused on opioids and substance 
use disorder.\96\
---------------------------------------------------------------------------
    \96\ https://innovation.cms.gov/Files/x/newdirection-rfi.pdf.

    Question. Loosening restrictions on Medicaid reimbursement for 
---------------------------------------------------------------------------
residential substance use treatment facilities.

    Answer. Under the demonstration authority granted by section 1115 
of the Social Security Act, CMS can waive certain Federal requirements 
and pay Federal matching funds certain expenditures that otherwise 
would not be matchable so that States can test new or existing ways to 
deliver and pay for health-care services in Medicaid. Last November, we 
announced that we were using this authority to provide for a 
streamlined process for States interested in designing demonstration 
projects that increase access to treatment for OUDs and other SUDs by 
permitting services to be covered in an institution for mental diseases 
(IMD) as part of a State's comprehensive OUD/SUD strategy. Current law 
prohibits Medicaid from making payments to IMDs for services rendered 
to Medicaid beneficiaries ages 21 to 64. Previously, States seeking to 
cover services otherwise subject to the exclusion of coverage for IMD 
patients had been required to meet rigid CMS standards concerning 
operational details for implementation before Medicaid demonstration 
approvals could be granted. The new policy will allow States to begin 
to provide better treatment options more quickly while improving the 
continuum of care over time.

    We are encouraging States to apply for CMS approval of a 5-year 
demonstration allowing them to receive Federal financial participation 
for services to treat addiction to opioids or other substances for 
Medicaid beneficiaries residing in IMDs, including those aged 21 to 64 
for whom Medicaid otherwise would not pay for services while the 
beneficiary is residing in an IMD, as these States work to improve 
access to treatment in outpatient settings as well. In addition, we are 
working with States that operate these demonstrations to establish 
strong quality of care standards, particularly for residential 
treatment settings.

    This initiative offers a more flexible, streamlined approach to 
accelerate States' ability to respond to the national opioid crisis 
while enhancing States' monitoring and reporting of the impact of any 
changes implemented through these demonstrations. In addition to being 
budget neutral, demonstrations must include a rigorous evaluation based 
on goals and milestones established by CMS. States must also make 
available on Medicaid.gov information on the progress and outcomes of 
these demonstrations and evaluations so that other States can learn 
from these programs; this cycle of evaluation and reporting will be 
critical to informing our evolving response to the national opioid 
crisis. To date, we have approved these SUD demonstration projects for 
five States: Louisiana, New Jersey, Utah, Indiana, and Kentucky.

    To further support this initiative, throughout 2018, the Medicaid 
Innovation Accelerator Program (IAP) will be available to States that 
would benefit from strategic design support related to improving their 
treatment delivery systems. The IAP provides States with access to 
national learning opportunities and technical expert resources, 
including strategic design support to States planning targeted 
addiction treatment delivery system reforms and developing 1115 
proposals. In addition, CMS is available to provide technical 
assistance to States on how to meet Federal transparency requirements 
as well as to preview States' draft 1115 proposals and public notice 
documentation to help ensure States successfully meet Federal 
requirements.

    Addendum: Since the time of this hearing, CMS has approved a 
demonstration project for a sixth State: Illinois.

                                 ______
                                 
              Prepared Statement of Hon. Orrin G. Hatch, 
                        a U.S. Senator From Utah
WASHINGTON--Senate Finance Committee Chairman Orrin Hatch (R-Utah) 
today delivered the following opening statement at the Senate Finance 
Committee hearing to address opioid and substance-abuse disorders in 
Medicare, Medicaid, and human services programs.

    I'd like to welcome everyone to today's hearing on tackling opioid 
and substance use disorders in Medicare, Medicaid, and human services 
programs.

    I feel compelled to start with news that we all wish was untrue: 
more than 60,000 Americans died from a drug overdose in 2016. The 
majority of these overdoses involved prescription opioids or illicit 
opioids like heroin or fentanyl. These numbers are more than mere 
statistics. They represent our constituents, our friends, and our loved 
ones.

    My home State of Utah continues to be hard hit. An alarming number 
of Utahans have undergone hospital stays and emergency room visits due 
to opioid overdoses. In 2016 alone, over 450 Utahans died from an 
opioid overdose.

    Americans across the country recognize the challenges posed by the 
epidemic and are fighting against it. President Trump and Secretary of 
Health and Human Services Alex Azar have made tackling the opioid 
epidemic a top priority, and I look forward to working with them to 
advance policy solutions.

    Congress continues to support States and communities in their 
efforts, and has a record of working in a bipartisan manner to identify 
solutions that can have a meaningful impact for struggling individuals 
and families. I was proud to work with Ranking Member Wyden and other 
members of this committee to lead an effort that makes significant 
strides to address the opioid epidemic: the Family First Prevention 
Services Act, enacted in February.

    This bill will provide States with access to funds to help families 
with substance abuse disorders and allow more children to stay safely 
with their families instead of being placed in foster care.

    I'm also pleased that Congress wisely opted to build on the 
foundation of the Family First Prevention Services Act in the March 
omnibus law by providing States with additional funds to ramp up these 
services immediately. This will allow States to develop more evidence-
based services that will make a real difference in the lives of 
families affected by substance use disorders.

    The Federal Government cannot solve this crisis alone, but my hope 
is that we can work together to ensure that our Federal programs, such 
as Medicare, Medicaid, and human services programs are innovative and 
responsive to the needs of Americans with chronic pain or opioid use 
disorders.

    Ranking Member Wyden and I have successfully partnered to make 
numerous recent improvements in health care. We worked together to 
realize a 10-year extension of the Children's Health Insurance Program. 
We pushed through a package of policies, known as the CHRONIC Care Act, 
that improve Medicare for beneficiaries with chronic conditions.

    I'd be remiss if I didn't point out that none of these 
accomplishments would have been possible without the bipartisan 
engagement of members on this committee.

    Identifying policies to evaluate and improve the Federal response 
to the opioid epidemic will be no different, and the success of these 
efforts will depend upon bipartisan, committee-wide support.

    Today, members will have an opportunity to speak with two of the 
administration's leading experts on opioid-related policies about how 
Medicare, Medicaid, and human services programs can adapt and be 
improved to address the crisis, and what this administration and 
Congress can do to save lives together.

    It is my hope that members take advantage of this hearing and the 
expertise of our two witnesses to drill down into policies that are 
likely to garner bipartisan support to help this committee advance its 
long record of working together collaboratively. Anything less would be 
a missed opportunity to help individuals, families, and communities 
across the Nation.

    In fact, through outreach to stakeholders and soliciting input from 
each member of the committee, we've already identified areas of 
potential bipartisan support. These include the need to evaluate access 
to and utilization of non-opioid treatment options for managing pain; 
enhancing data-sharing to promote appropriate health-care interventions 
and strengthen program integrity; and ensuring evidence-based care is 
available for patients to identify and treat opioid use disorders.

    In closing, my view is that the committee must do all it can to 
prevent and relieve opioid-related suffering by implementing effective 
policies in Medicare, Medicaid, and human services programs. We have a 
unique opportunity to do so in the near term.

    We'll hear the ranking member's thoughts on this momentarily, but I 
do hope that he agrees on the need to work toward bipartisan solutions 
that would add to the committee's long list of bipartisan health-care 
accomplishments.

    The witnesses will get a proper introduction shortly, but I would 
like to briefly say a few words before I have to attend a Judiciary 
Committee markup.

    First, I'd like to welcome Dr. Brett P. Giroir. His recent 
appointment as Secretary Azar's point-person on opioid policy speaks 
highly of his capabilities. I am grateful that the Finance Committee 
will be the first congressional committee to hear from him in this 
capacity.

    I am also delighted to have CMS's Kim Brandt appear before the 
committee today.

    Ms. Brandt likely needs no introduction to my fellow committee 
members, as she served as a senior member of my staff for 6 years 
before assuming the role of Principal Deputy Administrator for 
Operations at CMS last year.

    I would like to quickly say that, while I certainly gave my 
blessing to Ms. Brandt before she moved on to a CMS leadership role, it 
was difficult for me to see Kim go.

    I ask that you all indulge a point of personal privilege to allow 
me to explain why. I no longer get those uplifting visits from her 
puppy, Sherlock.

    And those incredible cookies and other goodies she frequently 
provided to members and staff are now much harder to come by.

    But I am glad to know that Kim is helping to steer the ship at CMS. 
Truly, it could not be in better hands. As we all know, Kim served me 
and the other members of this committee--on both sides of the aisle--
with great distinction. And I'm glad to have her here today.

                                 ______
                                 
                    Submitted by Hon. Dean Heller, 
                       a U.S. Senator From Nevada
April 19, 2018

The Honorable Michael Bennet        The Honorable Dean Heller
U.S. Senate                         U.S. Senate
261 Russell Senate Office Building  324 Hart Senate Office Building
Washington, DC 20510                Washington, DC 20510

Dear Senators,

We write to thank you for your leadership on the Every Prescription 
Conveyed Securely Act and urge your colleagues in Congress to support 
this vital legislation. The opioid crisis is devastating families and 
communities from coast to coast. In 2016, more than 42,000 people died 
as a result of the crisis, more than any year on record according to 
the Centers for Disease Control and Prevention (CDC).\1\
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention, ``Drug Overdose 
Death Data, 2016 Deaths,'' available at: https://www.cdc.gov/
drugoverdose/index.html.

A number of approaches have been summoned to attack this epidemic, but 
we believe that the use of already-existing electronic prescribing of 
controlled substances (EPCS) technology is going underutilized. EPCS 
reduces opportunities for diversion, as the DEA-approved electronic 
prescribing process provides more protection from diversion than the 
current system of paper and oral prescriptions. EPCS prescriptions 
cannot be altered, cannot be copied, and are electronically trackable. 
Furthermore, the federal DEA rules for EPCS establish strict security 
measures, such as two-factor authentication, that reduce the likelihood 
of fraudulent prescribing. Additionally, electronic prescribing offers 
new dimensions of safety and security for controlled substance 
---------------------------------------------------------------------------
prescriptions.

Over the past few years, the private sector has dramatically improved 
its use of 
e-prescribing. Data from self-reported drug abusers suggest that 
between 3 percent and 9 percent of diverted opioid prescriptions are 
tied to forged prescriptions.\2\ While in 2013, 1 billion prescriptions 
were e-prescribed, in 2016, 1.6 billion prescriptions were e-
prescribed. Yet, despite this vast growth, EPCS is lagging behind 
broader 
e-prescribing trends. According to health information network 
Surescripts, while approximately 90 percent of non-controlled substance 
prescriptions are e-prescribed, only 15 percent of prescriptions for 
controlled substances were submitted electronically in 2017.\3\
---------------------------------------------------------------------------
    \2\ Rosenblum, Andrew, et al., ``Prescription opioid abuse among 
enrollees into methadone maintenance treatment,'' Drug and Alcohol 
Dependence 90.1 (2007): 64-71; and Inciardi, James A., et al., ``The 
`black box' of prescription drug diversion,'' Journal of Addictive 
Diseases 28.4 (2009): 332-347.
    \3\ Surescripts, Data Brief, January 2018.

The Every Prescription Conveyed Securely Act promotes the use of EPCS 
to help address the opioid crisis by requiring that controlled 
substances for Medicare beneficiaries are prescribed electronically. 
This connection will encourage wider adoption of EPCS and help curtail 
---------------------------------------------------------------------------
``doctor shopping.''

FDA Commissioner, Scott Gottlieb, has indicated that a national e-
prescribing system would allow his agency to think more strategically 
about controlled substances and their REMS program. EPCS could be used 
to strengthen the tools at the disposal of prescribers and pharmacists 
and even present a solution to a problem recognized by the 
Commissioner, interoperability across state lines.\4\
---------------------------------------------------------------------------
    \4\ Michael Mezher, ``Gottlieb: FDA Looking Beyond Opioids in 
Overdose Epidemic,'' Regulatory Affairs Professionals Society, 
Regulatory Focus TM, February 2018, available at: https://
www.raps.org/news-and-articles/news-articles/2018/2/gottlieb-fda-
looking-beyond-opioids-in-overdose-e.

Seven states (New York, Maine, Virginia, Connecticut, North Carolina, 
Rhode Island, and Arizona) have already passed legislation to mandate 
EPCS. These states now have a significantly more secure process in 
place or in the works. The system provides security and convenience 
from start to finish: from the doctors' electronic prescription-writing 
---------------------------------------------------------------------------
process to the pharmacy dispensing medications to the patient.

A national bill such as the one you have proposed would make available 
the promise of EPCS to the entire country and mark a significant step 
forward in the fight against the opioid crisis. Your bill would help 
fill a critical gap in the current prescription drug distribution 
chain.

The time to act on this common-sense policy is now. EPCS is a bi-
partisan solution that the President's Commission on Combating Drug 
Addiction and the Opioid Epidemic endorsed as a part of its November 
2017 recommendations. In the same 2017 report the Commission states 
that each day 175 deaths are attributed to the opioid epidemic. We can 
no longer afford to delay the advancement of policies, such as 
electronic prescribing, that will help curb diversion and abuse rates 
and inform appropriate interventions.\5\
---------------------------------------------------------------------------
    \5\ The President's Commission on Combating Drug Addiction and the 
Opioid Crisis, ``Recommendations on Drug Addiction and the Opioid 
Crisis,'' November 1, 2017.

Thank you for your critical leadership with the Every Prescription 
Conveyed Securely Act. We encourage your colleagues to cosponsor the 
---------------------------------------------------------------------------
bill and ensure its speedy passage in both chambers of Congress.

Sincerely,

Albertsons Companies
America's Health Insurance Plans
AmerisourceBergen
Association for Accessible Medicines
College of Healthcare Information Management Executives
CVS Health
Express Scripts
Healthcare Information and Management Systems Society
Health IT Now
Imprivata
Magellan Health
National Coalition on Health Care
National Consumers League
National Association of Chain Drug Stores
National Community Pharmacists Association
Prime Therapeutics
Pharmaceutical Care Management Association
Rite Aid
Surescripts
Walgreens

cc:
The Honorable Elizabeth Warren
The Honorable Patrick Toomey

                             Freedom Caucus

Mark Meadows of North Carolina      Justin Amash of Michigan
Joe Barton of Texas                 Andy Biggs of Arizona
Rod Blum of Iowa                    Dave Brat of Virginia
Jim Bridenstine of Oklahoma         Mo Brooks of Alabama
Ken Buck of Colorado                Ted Budd of North Carolina
Warren Davidson of Ohio             Ron DeSantis of Florida
Scott DesJarlais of Tennessee       Jeff Duncan of South Carolina
Matt Gaetz of Florida               Tom Garrett Jr. of Virginia
Louie Gohmert of Texas              Paul Gosar of Arizona
Morgan Griffith of Virginia         Andy Harris of Maryland
Jody Hice of Georgia                Jim Jordan of Ohio
Raul Labrador of Idaho              Alex Mooney of West Virginia
Gary Palmer of Alabama              Steve Pearce of New Mexico
Scott Perry of Pennsylvania         Bill Posey of Florida
Mark Sanford of South Carolina      David Schweikert of Arizona
Randy Weber of Texas                Ted Yoho of Florida

                                 ______
                                 
                  Submitted by Hon. Claire McCaskill, 
                      a U.S. Senator From Missouri

                          United States Senate

Homeland Security and Governmental Affairs Committee, Ranking Member's 
                                 Office

                         minority staff report

                          Fueling an Epidemic

Insys Therapeutics and the Systemic Manipulation of Prior Authorization

The opioid epidemic has exacted a staggering human and financial cost 
in the United States over the past 20 years. Approximately 183,000 
Americans died from prescription opioid overdoses between 1999 and 
2015, with more than 15,000 Americans dying in 2015 alone.\1\ According 
to the Centers for Disease Control and Prevention (CDC), in 2015 
``[t]he age-adjusted rate of drug overdose deaths in the United States 
in 2015 . . . was more than 2.5 times the rate in 1999.'' \2\ 
Provisional 2016 statistics from the CDC also show that ``[d]rug deaths 
involving fentanyl more than doubled from 2015 to 2016,'' and ``deaths 
involving synthetic opioids, mostly fentanyls, have risen to more than 
20,000 from 3,000 in just 3 years.'' \3\ In Missouri, the rate of 
prescription opioid-related inpatient hospitalizations and emergency 
room visits more than doubled from 187 per 100,000 to 424 per 100,000 
between 2005 and 2014.\4\ Similarly, Medicare Part D spending on 
commonly abused opioids increased 165 percent between 2006 and 2015, 
and one out of three Part D recipients received at least one 
prescription opioid in 2016 at a cost of $4.1 billion.\5\
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention, ``Prescription 
Opioid Overdose Data'' (August 1, 2017) (www.cdc.gov/drugoverdose/data/
overdose.html).
    \2\ Centers for Disease Control and Prevention, ``Drug Overdose 
Deaths in the United States, 1999-2015'' (February 24, 2017) 
(www.cdc.gov/nchs/products/databriefs/db273.htm).
    \3\ ``The First Count of Fentanyl Deaths in 2016: Up 540 Percent in 
Three Years,'' New York Times (September 2, 2017) (www.nytimes.com/
interactive/2017/09/02/upshot/fentanyldrug-overdose-deaths.html).
    \4\ Hospital Industry Data Institute, ``Alarming Trends in Hospital 
Utilization for Opioid Overuse in Missouri'' (October 2015) 
(www.mhanet.com/mhaimages/HIDIHealthStats/ Opioids_
HealthStats_1015.pdf).
    \5\ Department of Health and Human Services Office of Inspector 
General, ``High Part D Spending on Opioids and Substantial Growth in 
Compounded Drugs Raise Concerns'' (OEI-02-16-00290) (June 21, 2016); 
Department of Health and Human Services Office of Inspector General, 
``Opioids in Medicare Part D: Concerns About Extreme Use and 
Questionable Prescribing'' (OEI-02-17-00250) (July 13, 2017).

In response to this crisis, Senator McCaskill issued wide-ranging 
requests for documents related to opioid sales and marketing efforts to 
five major opioid manufacturers.\6\ These requests focused on internal 
estimates concerning the risk of opioid addiction, compliance audits 
and reports concerning sales and marketing policies, marketing and 
business plans, materials related to manufacturer payments to 
physicians and manufacturer-created physician presentations, funding of 
educational materials targeted to opioid-prescribing physicians, and 
funding for major pain advocacy groups and other groups. In response, 
the minority staff has received thousands of pages of internal company 
documents, including extensive materials from Insys Therapeutics.
---------------------------------------------------------------------------
    \6\ Letter from Senator Claire McCaskill to Santosh Vetticaden, 
Interim Chief Executive Officer of Therapeutics, Inc. (March 28, 2017).

Drawing on these documents and other materials, this report provides 
new information regarding the significant efforts Insys has undertaken 
to reduce barriers to the prescription of Subsys, its powerful fentanyl 
product. These efforts include actions to mislead pharmacy benefit 
managers (PBMs) about the role of Insys in the prior authorization 
process and the presence of breakthrough cancer pain in potential 
Subsys patients. An internal Insys document suggests Insys apparently 
lacked even basic measures to prevent its employees from manipulating 
the prior authorization process and received clear notice of these 
deficiencies. In the case of Subsys patient Sarah Fuller, an audio 
recording reveals that an Insys employee repeatedly misled 
representatives of Envision Pharmaceutical Services to obtain approval 
for her prescription. The result, in the case of Ms. Fuller, was death 
---------------------------------------------------------------------------
due to allegedly improper and excessive Subsys use.

BACKGROUND ON Insys THERAPEUTICS AND Subsys

Insys Therapeutics was co-founded in 2002 by Dr. John Kapoor, a serial 
pharmaceutical industry entrepreneur ``known for applying aggressive 
marketing tactics and sharp price increases on older drugs.'' \7\ In 
2012, Insys received U.S. Food and Drug Administration (FDA) approval 
for Subsys, a fentanyl sublingual spray product designed to treat 
breakthrough cancer pain, and the drug proved incredibly successful 
financially.\8\ Insys had ``the best-performing initial public offering 
in 2013,'' and, over the next 2 years, revenues tripled and profits 
rose 45 percent.\9\ The value of company stock increased 296 percent 
between 2013 and 2016.\10\
---------------------------------------------------------------------------
    \7\ ``Fentanyl Billionaire Comes Under Fire as Death Toll Mounts 
From Prescription Opioids,'' Wall Street Journal (November 22, 2016) 
(www.wsj.com/articles/fentanylbillionaire-comes-under-fire-as-death-
toll-mounts-from-prescription-opioids-1479830968).
    \8\ Id.
    \9\ Id.
    \10\ ``An Opioid Spray Showered Billionaire John Kapoor in Riches. 
Now He's Feeling the Pain,'' Forbes (October 4, 2016) (www.forbes.com/
sites/matthewherper/2016/10/04/death-kickbacks-and-a-billionaire-the-
story-of-a-dangerous-opioid/).

To prevent the overprescription and abuse of powerful and expensive 
drugs like Subsys, insurers--often using PBMs--employ a process known 
as prior authorization. As noted in a Permanent Subcommittee on 
Investigations report Senator McCaskill and Senator Rob Portman issued 
on October 4, 2016, the prior authorization process ``requires 
additional approval from an insurer or its pharmacy benefit manager 
before dispensing. . . . Prior authorization policies can also impose 
`step therapy,' which requires beneficiaries to first use less 
expensive medications before moving on to a more expensive approach.'' 
\11\
---------------------------------------------------------------------------
    \11\ Senate Permanent Subcommittee on Investigations, ``Combatting 
the Opioid Epidemic: A Review of Anti-Abuse Efforts in Medicare and 
Private Health Insurance Systems'' (October 4, 2016); see also 
Department of Health and Human Services, Centers for Medicare and 
Medicaid Services, ``How Medicare Prescription Drug Plans and Medicare 
Advantage Plans With Prescription Drug Coverage (MA-PDs) Use 
Pharmacies, Formularies, and Common Coverage Rules'' (October 2015).

With regard to Insys specifically, recent court filings explain that 
insurers have ``required that a prior authorization be obtained before 
a claim [can] be submitted for a Subsys prescription.'' \12\ This 
process includes ``confirmation that the patient had an active cancer 
diagnosis, was being treated by an opioid (and, thus, was opioid 
tolerant), and was being prescribed Subsys to treat breakthrough pain 
that the other opioid could not eliminate. If any one of those factors 
was not present, the prior authorization would be denied . . . meaning 
no reimbursement would be due.'' \13\
---------------------------------------------------------------------------
    \12\ Complaint (July 12, 2017), Blue Cross of California, Inc., et 
al. v. Insys Therapeutics, Inc., D. Ariz. (No. 2:17 CV 02286).
    \13\ Id.

These screening processes reportedly raised significant obstacles to 
Subsys prescriptions shortly after Insys introduced the drug. According 
to a criminal indictment filed against former Insys CEO Michael Babich 
and five other Insys executives, an internal company analysis in 
November 2012 revealed that insurers and PBMs approved reimbursements 
for Subsys in only approximately 30 percent of cases.\14\
---------------------------------------------------------------------------
    \14\ Indictment (December 6, 2016), United States v. Babich, et 
al., D. Mass. (No. 1:16 CR 10343).

In response to these challenges, Insys allegedly created a prior 
authorization unit, known at one point as the Insys Reimbursement 
Center (IRC), to intervene with PBMs and secure reimbursements between 
January 2013 and October 2016.\15\ Led by an Insys employee named 
Elizabeth Gurrieri, IRC employees reportedly received significant 
financial incentives and management pressure--including quotas and 
group and individual bonuses--to boost the rate of Subsys 
authorizations.\16\ According to Patty Nixon, a former Insys employee, 
Ms. Gurrieri personally pressured IRC employees to improve the rate of 
prescription approvals, noting that ``Dr. Kapoor's not happy; we have 
to get these approvals up.'' \17\
---------------------------------------------------------------------------
    \15\ See Complaint (July 12, 2017), Blue Cross of California, Inc., 
et al. v. Insys Therapeutics, Inc., D. Ariz. (No. 2:17 CV 02286).
    \16\ ``Murder Incorporated: Insys Therapeutics, Part I,'' Southern 
Investigative Reporting Foundation (December 3, 2015) (sirf-online.org/
2015/12/03/murder-incorporatedthe-insys-therapeutics-story/); see also 
Indictment (December 6, 2016), United States v. Babich, et al., D. 
Mass. (No. 1:16 CR 10343).
    \17\ ``Fentanyl Billionaire Comes Under Fire as Death Toll Mounts 
From Prescription Opioids,'' Wall Street Journal (November 22, 2016).

IRC employees allegedly met this demand through a number of techniques. 
Employees, for example, reportedly falsified medical histories for 
prospective Subsys patients, ``fraudulently assert[ing] that a patient 
had a cancer diagnosis regardless of the patient's history and 
regardless of whether the prescriber had prescribed Subsys for a 
different diagnosis.'' \18\ In response to increased scrutiny from PBMs 
and the U.S. Department of Health and Human Services, Insys allegedly 
developed a canned response to questions concerning whether a potential 
Subsys patient suffered from breakthrough cancer pain. In this 
response, Insys employees stated that ``[t]he physician is aware that 
the medication is intended for the management of breakthrough pain in 
cancer patients [and] [t]he physician is treating the patient for their 
pain (or breakthrough pain, whichever is applicable).'' \19\ According 
to an affidavit filed in support of criminal charges against Ms. 
Gurrieri, the script ``deliberately omitted the word `cancer' in order 
to mislead agents of insurers and PBMs.'' \20\
---------------------------------------------------------------------------
    \18\ Complaint (July 12, 2017), Blue Cross of California, Inc., et 
al. v. Insys Therapeutics, Inc., D. Ariz. (No. 2:17 CV 02286).
    \19\ Indictment (December 6, 2016), United States v. Babich, et 
al., D. Mass. (No. 1:16 CR 10343).
    \20\ Affidavit of Special Agent Paul S. Baumrind, Federal Bureau of 
Investigation, in Support of a Criminal Complaint and Arrest Warrant 
(October 12, 2016), United States v. Gurrieri, D. Mass. (No. 1:17 CR 
10083); see also Complaint (July 12, 2017), Blue Cross of California, 
Inc., et al. v. Insys Therapeutics, Inc., D. Ariz. (No. 2:17 CV 02286).

The IRC also allegedly misled PBMs and insurers about the unit's role 
in facilitating approvals for Subsys.\21\ To prevent PBMs from tracing 
calls back to Insys, for example, the IRC obscured its outgoing phone 
number on caller ID.\22\ When PBMs required a phone number for a return 
call, Insys employees reportedly provided a 1-800 number manned by 
another Insys representative--instead of contact information for the 
prescribing physician.\23\ Insys executives also allegedly told IRC 
employees to claim they were calling ``from'' a physician's office; 
later, ``employees were instructed to tell agents of insurers and 
pharmacy benefit managers that they were calling `on behalf' of a 
specific doctor, and were `with' a specific doctor's office.'' \24\
---------------------------------------------------------------------------
    \21\ Indictment (December 6, 2016), United States v. Babich, et 
al., D. Mass. (No. 1:16 CR 10343).
    \22\ ``Murder Incorporated: Insys Therapeutics, Part I,'' Southern 
Investigative Reporting Foundation (December 3, 2015); see also 
Indictment (December 6, 2016), United States v. Babich, et al., D. 
Mass. (No. 1:16 CR 10343).
    \23\ ``Murder Incorporated: Insys Therapeutics, Part I,'' Southern 
Investigative Reporting Foundation (December 3, 2015).
    \24\ Indictment (December 6, 2016), United States v. Babich, et 
al., D. Mass. (No. 1:16 CR 10343).

According to a class action lawsuit, Insys management ``was aware that 
only about 10 percent of prescriptions approved through the Prior 
Authorization Department were for cancer patients,'' and an Oregon 
Department of Justice investigation found that 78 percent of 
preauthorization forms submitted by Insys on behalf of Oregon patients 
were for off-label uses.\25\ In just one example, an Anthem review of 
Subsys claims ``revealed that 54 percent of members with Subsys 
prescriptions that had been reimbursed by Anthem did not actually have 
an underlying cancer diagnosis,'' and ``[f]or an additional 6 percent 
of members with reimbursed Subsys prescriptions, it was unclear 
whether Subsys was properly prescribed.'' \26\ Anthem estimates that 
it ``paid over $19 million in reimbursements for Subsys prescriptions 
that were not covered by Anthem's plans.'' \27\
---------------------------------------------------------------------------
    \25\ ``The Pain Killer: A Drug Company Putting Profits Above 
Patients,'' CNBC (November 4, 2015) (www.cnbc.com/2015/11/04/the-
deadly-drug-appeal-of-insys-pharmaceuticals.html).
    \26\ Complaint (July 12, 2017), Blue Cross of California, Inc., et 
al. v. Insys Therapeutics, Inc., D. Ariz. (No. 2:17 CV 02286).
    \27\ Id.
---------------------------------------------------------------------------

 INSYS KNEW ABOUT PROBLEMATIC PRIOR AUTHORIZATION PRACTICES AND FAILED 
                       TO TAKE CORRECTIVE ACTION

Internal Insys documents suggest the company knew--more than a year 
before the events involving Sarah Fuller, described below--that the IRC 
lacked formal policies or monitoring procedures to ensure proper 
communication between Insys employees and health-care professionals. 
Insys, in other words, lacked even basic measures to prevent its 
employees from manipulating the prior authorization process and 
received clear notice of these deficiencies.

In an internal presentation dated 2012 and entitled, ``2013 Subsys 
Brand Plan,'' Insys identified one of six ``key strategic imperatives'' 
as ``Mitigate Prior Authorization barriers.'' \28\ On a later slide, 
the company identified several tasks associated with this effort, 
including ``Build internal [prior authorization] assistance 
infrastructure,'' ``Establish an internal 1-800 reimbursement 
assistance hotline,'' and ``Educate field force on [prior 
authorization] process and facilitation.'' \29\
---------------------------------------------------------------------------
    \28\ Insys Therapeutics, Inc., ``2013 Subsys Brand Plan, 2012 
Assessment'' (2012) (INSYS_HSGAC_00007472) (selected slides attached as 
Exhibit A).
    \29\ Id. at INSYS_HSGAC_00007473.

Additional materials produced by Insys to the minority staff suggest, 
however, that Insys did not match these efforts with sufficient 
compliance processes to prevent fraud and was internally aware of the 
danger of problematic practices. Specifically, on February 18, 2014, 
Compliance Implementation Services (CIS)--a health-care consultant--
issued a draft report to Insys titled, ``Insys Call Note, Email, and 
IRC Verbatim Data Audit Report.'' \30\ The introduction to the report 
explained that ``CIS was approached by Insys's legal representative . . 
. on behalf of the Board of Directors for Insys to request that CIS 
support in review of certain communications with Health Care 
Professionals (HCPs) and Insys employees, and report how they were 
being documented.'' \31\ Insys had expressed concerns ``with respect to 
communications with HCPs by Insys employees being professional in 
nature and in alignment with Insys approved topics regarding off or on-
label promotion of an Insys product, and general adherence to Insys 
documentation requirements.'' \32\ An additional concern ``stemmed from 
the lack of monitoring of commercial activities where these types of 
interactions could occur.'' \33\
---------------------------------------------------------------------------
    \30\ Compliance Implementation Services, ``Insys Call Note, Email 
and IRC Verbatim Data Audit Report'' (February 18, 2014) 
(INSYS_HSGAC_00007763) (attached as Exhibit B).
    \31\ Id. at INSYS_HSGAC_00007765.
    \32\ Id.
    \33\ Id.

Given these issues, Insys requested that CIS review--in part--``the 
general communications from the Insys Reimbursement Center (IRC) to 
HCPs, their office staff or representatives, as well as health 
insurance carriers . . . to ensure they were appropriate in nature with 
respect to specific uses of Subsys, Insys's commercially marketed 
product.'' \34\
---------------------------------------------------------------------------
    \34\ Id.

According to the findings CIS issued, Insys lacked formal policies 
governing the actions of its prior authorization unit. For example, 
``[n]o formal and approved policy on appropriate communications between 
IRC employees and HCPs, their staff, [health care insurers (HCIs)], or 
patients exists . . . that governs the support function of obtaining a 
prior authorization for the use of Subsys.'' \35\ In addition, the 
report noted that ``there were also gaps in formally approved 
foundational policies, procedures, and [standard operating procedures] 
with respect to required processes specifically within the IRC.'' \36\ 
In fact, ``[t]he majority of managerial directives, changes to 
controlled documents or templates, as well as updates or revisions to 
processes were not formally approved, documented, and disseminated for 
use, and were sent informally via email blast.'' \37\ Although four 
informal standard operating procedures existed with regard to IRC 
functions, these documents ``lacked a formal review and approval'' and 
failed to ``outline appropriately the actions performed within the 
IRC.'' \38\
---------------------------------------------------------------------------
    \35\ Id. at INSYS_HSGAC_00007770.
    \36\ Id. at INSYS_HSGAC_00007768.
    \37\ Id. at INSYS_HSGAC_00007771.
    \38\ Id. at INSYS_HSGAC_00007770.

The report also explains that Insys lacked procedures for auditing 
interactions between IRC employees and outside entities. According to 
CIS, ``no formal, documented, or detailed processes by which IRC 
representatives' calls via telephone were audited for proper 
communication with HCPs or HCIs in any fashion [existed] other than 
random physical review of a call in a very informal and sporadic 
manner.'' \39\ More broadly, the report notes that ``no formal and 
documented auditing and monitoring or quality control policy, process, 
or function exists between IRC employee communications and HCPs, HCP 
staff, HCIs, or patients.'' \40\
---------------------------------------------------------------------------
    \39\ Id. at INSYS_HSGAC_00007769.
    \40\ Id. at INSYS_HSGAC_00007771.

At the end of the report, CIS provided a number of recommendations 
concerning IRC activities. First, CIS suggested that IRC management 
``formally draft and obtain proper review and approval of an IRC 
specific policy detailing the appropriate communications that should 
occur while performing the IRC associate job functions and interacting 
with HCPs.'' \41\ Similarly, IRC management was urged to formally draft 
IRC-specific standard operating procedures ``specific to each job 
function within the IRC,'' accompanied by ``adequate training and 
understanding of these processes.'' \42\ To ensure compliance with IRC 
standards, Insys was also directed to create an electronic system to 
allow management ``to monitor both live and anonymously IRC employee 
communications both incoming and outgoing.'' \43\ Finally, CIS 
recommended that Insys institute a formal process for revising and 
updating ``IRC documentation used for patient and HCP data.'' \44\
---------------------------------------------------------------------------
    \41\ Id. at INSYS_HSGAC_00007770.
    \42\ Id. at INSYS_HSGAC_00007771.
    \43\ Id.
    \44\ Id.

The CIS report concluded by noting, in part, that a review of 10 
conversations between IRC employees and health-care providers, office 
staff, and insurance carriers revealed ``that all IRC staff was 
professional in communication, and in no instance was inaccurate or 
off-label usage of Subsys communicated.'' \45\ Yet within a year of 
this conclusion, according to the recording transcribed below, an Insys 
IRC employee appears to have misled a PBM representative regarding the 
IRC employee's affiliation and the diagnosis applicable to Sarah 
Fuller. The alleged result, in that case, was death due to 
inappropriate and excessive Subsys prescriptions.
---------------------------------------------------------------------------
    \45\ Id. at INSYS_HSGAC_00007772.

---------------------------------------------------------------------------
INSYS REPRESENTATIVE SOUGHT AUTHORIZATION FOR PATIENT SARAH FULLER

As part of its investigation, the minority staff received an audio 
recording of conversations between an Insys employee and PBM 
representatives related to a Subsys prescription for Sarah Fuller, who 
later died from an alleged fentanyl overdose. This recording suggests 
the IRC employee in question repeatedly misled Envision Pharmaceutical 
Services to obtain approval for Subsys treatment for Ms. Fuller.

The recording reveals that the Insys employee identified herself as 
being ``with'' the office of Ms. Fuller's doctor; in the second 
conversation, the employee confirms she is ``calling from the doctor's 
office.'' The Insys employee also states that Subsys is ``intended for 
the management of breakthrough cancer pain'' without explicitly 
claiming that Ms. Fuller suffers from this type of pain. She then 
states that Ms. Fuller suffers from breakthrough pain--pointedly 
dropping ``cancer'' from the description. Later, when asked whether the 
Subsys prescription will treat ``breakthrough cancer pain or not,'' the 
Insys employee sidesteps the question by merely stating there is ``no 
code for breakthrough cancer pain.'' She then reaffirms that the 
prescription is ``for breakthrough pain, yeah.''

    Background About Sarah Fuller
        According to a March 23, 2017, complaint filed in the Superior 
        Court of Middlesex County, NJ, Sarah A. Fuller died from a 
        Subsys overdose on March 25, 2016.\46\ In 2014, Ms. Fuller 
        allegedly sought treatment under the care of Dr. Vivienne 
        Matalon of Cherry Hill to manage the medications she took for 
        various health conditions, including fibromyalgia and back 
        pain.\47\ During this initial consultation, Ms. Fuller's 
        parents indicated she had previously overcome an addiction to 
        narcotic pain medication; despite this information, Dr. Matalon 
        prescribed OxyContin and Percocet to Ms. Fuller over the next 
        few months.\48\ In January 2015, Dr. Matalon, Ms. Fuller, and 
        her father allegedly met with an Insys representative to 
        discuss Subsys as a remedy for Ms. Fuller's neck and back 
        pain.\49\ According to the complaint, ``[n]either the Insys 
        sales representative nor Dr. Matalon informed Sarah or her 
        father that Subsys was fentanyl and that it was only approved 
        and indicated for patients that were experiencing breakthrough 
        cancer pain from malignant cancer.'' \50\
---------------------------------------------------------------------------
    \46\ Complaint (March 23, 2017), Fuller v. Matalon, et al., 
Middlesex Cty. Sup. Ct. (No. L1859-17).
    \47\ Id.
    \48\ Id.
    \49\ Id.
    \50\ Id.

        Over the next several months, Ms. Fuller received increasing 
        amounts of Subsys on a monthly basis until she was admitted, on 
        October 28, 2015, to a local hospital suffering from ``hyper-
        sedation with hypoxia secondary to narcotics and sedatives.'' 
        \51\ Despite instructions to discontinue Subsys--included in 
        medical records provided to Dr. Matalon--Ms. Fuller received 
        additional Subsys prescriptions, along with prescriptions for 
        Percocet, OxyContin, and Alprazolam, over the next 5 
        months.\52\ On March 25, 2016, Ms. Fuller died ``due to an 
        adverse reaction to prescription medications.'' \53\ During the 
        14-month period in which Ms. Fuller received Subsys treatment, 
        Medicare paid as much as $24,000 per month for the 
        prescriptions.\54\
---------------------------------------------------------------------------
    \51\ Id.
    \52\ Id.
    \53\ Id.
    \54\ Id.

        According to the Centers for Medicare and Medicaid Services 
        (CMS) Open Payments database, Dr. Matalon received almost $600 
        in payments from Insys in 2015.\55\ Although this amount pales 
        in comparison to other payments physicians have received from 
        the company, a clear link exists between even minimal 
        manufacturer payments and physician prescribing practices. A 
        2016 study published in JAMA Internal Medicine, for example, 
        found ``a significant association between [a physician] 
        attending a single meal promoting a specific drug, with a mean 
        value of less than $20, and the prescribing of the promoted 
        drug over therapeutic alternatives.'' \56\ In addition, 
        ``additional meals and costlier meals [were] associated with 
        greater increases in prescribing of the promoted drug.'' \57\ 
        ProPublica has similarly found that ``doctors who received 
        industry payments were two to three times as likely to 
        prescribe brand-name drugs at exceptionally high rates as 
        others in their specialty.'' \58\
---------------------------------------------------------------------------
    \55\ Open Payments Data, Centers for Medicare and Medicaid 
Services, Physician Profile for Vivienne I. Matalon (https://
openpaymentsdata.cms.gov/physician/153888/payment-information) 
(accessed July 18, 2017).
    \56\ Colette DeJong, et al., ``Pharmaceutical Industry-Sponsored 
Meals and Physician Prescribing Patterns for Medicare Beneficiaries,'' 
JAMA Internal Medicine (June 20, 2016).
    \57\ Id.
    \58\ ``Now There's Proof: Docs Who Get Company Cash Tend to 
Prescribe More Brand-Name Meds,'' ProPublica (March 17, 2016) 
(www.propublica.org/article/doctors-who-take-company-cash-tend-to-
prescribe-more-brand-name-drugs).

---------------------------------------------------------------------------
Insys Representative Misleads PBM to Obtain Prior Authorization

        The minority staff has obtained an audio recording of a 
        conversation between an Insys employee and the PBM Envision, 
        which provided prior authorization services in connection with 
        the Subsys prescription for Ms. Fuller. During this January 
        2015 conversation, an IRC employee discussed prior 
        authorization for Subsys with a representative from Convey 
        Health Solutions, a call center support vendor for Envision 
        Pharmaceutical Services, as well as a member of the clinical 
        department of EnvisionRx Plus.

        In the first portion of this recording, the Insys employee 
        begins her conversation with a PBM representative by 
        misleadingly identifying herself as ``with the doctor's 
        office.'' At no point does the employee identify herself as 
        working for Insys or explain she is calling from an Insys 
        office. After being transferred to the Envision clinical 
        department for further questioning, the Insys employee confirms 
        she is calling ``from'' a doctor's office and claims the prior 
        authorization request is ``urgent.''

                Insys Representative: Hi, my name is [XXXX], and I'm 
                with the doctor's office. I never heard an option for 
                me to choose to . . . I need to see if a certain 
                medication requires authorization.

                Representative from Convey Health Solutions: Okay, can 
                I . . . for security purposes, can I have your NPI 
                number?

                I: It's [XXXX].

                R: You say [XXXXX]?

                I: Yes.

                R: Okay, and which doctor is that?

                I: It's Dr. Matalon.

                R: Okay, and for security purposes can you verify the 
                member ID number?

                I: Yes, it's . . . well, you know what, I have . . . I 
                only have their Medicare ID number.

                R: Okay, you can go ahead with that number.

                I: It's [XXXX].

                [. . .]

                            *      *      *

                R: Hi [XXXX], thank you so much for holding. Yeah, I'm 
                going to have to connect you to our clinical department 
                so that they can go ahead and try to do that override 
                for you.

                [. . .]

                            *      *      *

                Envision Clinical Department Representative: Clinical 
                Department, this is [XXXX]. How can I help you?

                I: Hi [XXXX], you guys must be very busy people.

                E: We are, and I apologize for the long wait, but how 
                can I help you now?

                I: I need to know if a certain medication requires 
                authorization, and if it does, can I do it over the 
                phone. It's urgent.

                E: Oh, okay. You're calling from the doctor's office 
                then, correct?

                I: Yeah, Dr. Matalon's office.

                [. . .]

As the conversation with the Envision clinical department 
representative proceeds, the Insys employee correctly notes that Subsys 
is ``intended for the management of breakthrough cancer pain,'' but 
then states only that Dr. Matalon is treating Ms. Fuller for 
``breakthrough pain.'' When questioned as to whether Ms. Fuller does, 
in fact, suffer from breakthrough cancer pain, the Insys employee 
avoids responding directly and instead explains ``there's no code for 
breakthrough cancer pain.'' She then states again that the Subsys 
prescription is ``for breakthrough pain, yeah,'' and the Envision 
representative discontinues this line of questioning. Toward the end of 
the call, the Insys employee states that Ms. Fuller is anticipated to 
remain on Subsys indefinitely.

                E: Okay, and what is the diagnosis for the patient?

                I: Let me look through here [inaudible] . . . 
                medication is intended for the management of 
                breakthrough cancer pain. The doctor is treating the 
                patient for breakthrough pain, with a diagnosis code of 
                338.29--

                [. . .]

                E: Thank you. Is it also for the breakthrough cancer 
                pain or not?

                I: Well, there's no code for breakthrough cancer pain.

                E: Yeah, and that's fine. I typed out the description; 
                I just want to make sure that I heard you correctly.

                I: It's for breakthrough pain, yeah.

                E: Good. Okay.

                [. . .]

                E: And what is the anticipated duration of therapy?

                I: Well, there's no end date. I mean, we just try to 
                give her a year and go from there.

                E: Okay. And is this a brand or a generic? This is 
                single-source, no generic, so the brand is required. . 
                . . What other medications in the same therapeutic 
                class have been tried?

                I: Okay, they've tried morphine, morphine sulfate. . . 
                . Let me know if you need me to spell something or go 
                slow, okay?

                E: You're doing fine at the pace you're at right now. 
                Morphine sulfate, okay.

                I: Oxycodone, OxyContin, and I think that's all I can 
                tell from the notes.

                E: Okay, were those ineffective?

                I: Yeah, let me see what the note says. It says it had 
                an inadequate analgesic effect. Patient is opioid-
                tolerant.

                E: Thank you. And are there any alternatives that are 
                contraindicated, that are not appropriate for the 
                patient? You know, aside from not being effective.

                I: That's all that I have.

                E: Okay. And this is a spray. Okay.

                I: Yeah, it's 200 micrograms, 120 units, for 30 days.

                E: And it doesn't look like it's going to have a 
                problem with the quantity limitation. So is there any 
                other clinical information you'd like to provide at 
                this time?

                I: No, just that patient will remain on a long-acting 
                opioid and patient is opioid-tolerant. Other than that, 
                I think we've covered everything.

                [. . .]

RESPONSE FROM INSYS 

The minority staff requested that Insys officials address whether the 
company implemented the recommendations in the CIS report or took any 
other action to address deficiencies in prior authorization policies. 
In response, Insys President and CEO Saeed Motahari provided a letter 
explaining that the company had ``completely transformed its employee 
base over the last several years,'' including in ``key management 
positions,'' and has ``actively taken the appropriate steps to place 
ethical standards of conduct and patient interests at the heart of 
[its] business decisions.'' \59\ Specifically, Mr. Motahari noted that 
Insys had ``invested significant resources in establishing an effective 
compliance program with protocols designed to ensure compliant and 
ethical behavior''; the company also engaged an independent ``gap 
assessment into [its] compliance protocols.'' \60\ In closing, Mr. 
Motahari pledged ``to play a positive and productive role in helping 
our Nation overcome the opioid epidemic.'' \61\
---------------------------------------------------------------------------
    \59\ Letter from Saeed Motahari, Insys President and CEO, to 
Senator Claire McCaskill (September 1, 2017) (attached as Exhibit C).
    \60\ Id.
    \61\ Id.

As part of its ongoing investigation, the minority staff will continue 
to evaluate whether these efforts have resulted in a true 
---------------------------------------------------------------------------
transformation of the Insys corporate culture.

CONCLUSION

According to public reporting, lawsuits from Subsys patients, and 
criminal indictments, Insys Therapeutics has repeatedly employed 
aggressive and likely illegal techniques to boost prescriptions for its 
fentanyl product Subsys. An audio recording and other materials the 
minority staff have reviewed suggest these efforts have included 
actions to undermine critical safeguards in the prior authorization 
process--with Insys officials aware, at the very least, of the serious 
danger of these acts occurring. The high stakes of opioid 
overprescription--including patient death--demand close attention to 
these practices by law enforcement officials, policymakers, and the 
PBMs charged with approving or rejecting fentanyl treatment.

The PBM Express Scripts excluded Subsys from its list of covered drugs 
in 2015, and UnitedHealth Group, which owns the PBM OptumRx, did the 
same in 2016.\62\ In December 2016, Federal prosecutors indicted Mr. 
Babich and five other former Insys executives on racketeering charges, 
alleging that these individuals ``approved and fostered'' fraudulent 
prior authorization practices.\63\ In June 2017, Ms. Gurrieri, the 
former head of the IRC, pled guilty ``to having conspired to defraud 
insurers.'' \64\
---------------------------------------------------------------------------
    \62\ ``The Pain Killer: A Drug Company Putting Profits Above 
Patients,'' CNBC (November 4, 2015).
    \63\ Indictment (December 6, 2016), United States v. Babich, et 
al., D. Mass. (No. 1:16 CR 10343).
    \64\ ``Ex-Insys Employee Pleads Guilty in U.S. Opioid Drug Probe,'' 
Reuters (June 19, 2017) (www.reuters.com/article/us-insys-court-
idUSKBN19A2MB).

On July 17, 2017, shortly after the filing of a complaint by Anthem 
insurance plans, Insys released a statement explaining that the company 
has ``taken, and will continue to take, appropriate steps to learn from 
the past and to ensure that appropriate protocols and policies are in 
place at our Company.'' \65\ As part of its ongoing investigation, the 
minority staff will continue to evaluate whether these efforts have 
resulted in a true transformation of the Insys corporate culture.
---------------------------------------------------------------------------
    \65\ Insys Therapeutics, Inc.: Insys Therapeutics, Inc. Releases 
Statement on Payor Interactions (July 17, 2017) (www.globenewswire.com/
news-release/2017/07/17/1047299/ 0/en/Insys -Therapeutics-Inc-Releases-
Statement-on-Payor-Interactions.html).
---------------------------------------------------------------------------

                               EXHIBIT A

                         2013 Subsys Brand Plan

                            2012 Assessment

             For Planning Purposes Only: Not for Promotion

[GRAPHIC] [TIFF OMITTED] T1918.001


                      KSI 1: Prior Authorizations

_______________________________________________________________________

      Mitigate prior authorization barrier

        -  Build internal PA assistance infrastructure
        -  Track all PAs via a comprehensive database
        -  Establish an internal 1-800 reimbursement assistance hotline
        -  Educate field force on PA process and facilitation
        -  Partner with PA specialists in key provider offices via best 
        practice ad boards and educational programming
        -  Partner with private pharmacies to orchestrate PA logistics
        -  Continue to provide Super Voucher during PA navigation

                               EXHIBIT B

       Insys Call Note, Email, and IRC Verbatim Data Audit Report

                              Presented to

                                 Insys

                           therapeutics, inc.

                           February 18, 2014

                                   By

                   Compliance Implementation Services

                             Ellis Preserve

                   3809 West Chester Pike, Suite 100

                        Newtown Square, PA 19073

Introduction

In mid-2013, CIS was approached by Insys's legal representative (at 
that time Leslie Zacks) on behalf of the Board of Directors for Insys 
to request that CIS support in the review of certain communications 
with Health Care Professionals (HCPs) and Insys employees, and report 
how they were being documented. It was communicated at that time to CIS 
that there was concern with respect to communications with HCPs by 
Insys employees being professional in nature and in alignment with 
Insys approved topics regarding off or on-label promotion of an Insys 
product, and general adherence to Insys documentation requirements of 
these types of communications. It was also communicated to CIS that 
while there were no documented examples of this type of interaction to 
date, the concern stemmed from the lack of monitoring of commercial 
activities where these types of interactions could occur. This was to 
more specifically include a review of email communications that had 
occurred (if any) with HCPs by Insys employees and the documentation 
process and quality of the call notes recorded after in office meetings 
with HCPs by Insys employees had occurred. All of this was to be 
reviewed against existing Insys policy and procedure that governed the 
above discussed activities (if any), interviews with senior leadership 
to understand more fully any directive given with respect to 
communications with HPCs, and verifying compliance to them.

It was further requested that a review of the general communications 
from the Insys Reimbursement Center (IRC) to HCPs, their office staff 
or representatives, as well as health insurance carriers occur to 
ensure they were appropriate in nature with respect to specific uses of 
Subsys, Insys's commercially marketed product. All requests ultimately 
came together to provide a thorough review of internal Insys email 
communications with the top twenty (20) Subsys prescribing physicians, 
the call notes that were recorded post an Insys employee visit with 
these specific twenty (20) HCPs, as well as an onsite review of IRB 
operations that included interviews, live monitoring, and a review of 
existing policies and procedures (if any) governing the actions of 
those working within the IRC.

CIS is pleased to present the following observations and 
recommendations found within this report.

Project Objective and Scope

Objective:

The objective of this audit was to evaluate and assess the existence, 
adequacy, and comprehensiveness of Insys's existing policy and 
procedural documentation to determine whether adequate controls were in 
place to effectively ensure compliance and adherence to said documents, 
Insys guidance and industry best practices related to all forms of 
communication from Insys employees to HCPs.

Specifically, the objective of this audit was to review sales 
representative call notes and other communications ad documentation to 
ensure oversight of day-to-day promotional activities and to ensure 
prospective compliance with the Insys policies, procedures, and 
communicated controls (if any). Further, the objective of this review 
was to ensure that the IRC's communications were in alignment with 
Insys and IRC specific policies, procedures, and communicated controls 
(if any) regarding interactions with HCPs, as well as on label with 
respect to product indication.
HCP and IRC Scope:

The project sponsors both Leslie Zacks and Desiree Hollandsworth at the 
request of the Insys Board of Directors and in conjunction with the CIS 
team, narrowed the scope of the engagement to specifically target all 
communications, interactions, and documentation with the top twenty 
(20) prescribing HCPs for Insys's commercially marketed product, 
Subsys. Further, the scope of data and document review of the IRC 
interactions with HCPs was to be narrowed to a random sampling of live 
phone calls, interviews with employees and management, and review of 
existing policy, procedure, and SOPs (if any) governing the actions of 
the IRC and its employees.

Documentation, Interview, and Live Monitoring Scope:

CIS reviewed the following policies and procedures that Insys provided 
related to their internal requirements governing interactions with 
HCPs, the documentation of HCP visits within the Insys Sales Force 360 
platform (call note repository), and the IRC. CIS also collected 
functional data for the audit which is listed below. Finally, CIS 
scheduled interviews with the below listed Insys employees to obtain a 
better understanding of processes and requirements as they related to 
HCP communication and documentation both in the field and the IRC. It 
should be noted that during the onsite IRC visit there were employees 
on vacation and or out of the office, so multiple calls were monitored 
for the same employee. CIS would like to note that the recording and 
transcripts of the live monitoring session was not possible to obtain, 
as currently Insys does not have the ability to do so with its current 
phone system.


------------------------------------------------------------------------
       Document Type                            Title
------------------------------------------------------------------------
Governance                   Insys Code of Business Conduct
------------------------------------------------------------------------
Governance                   Compliance Program and Certification of
                              Compliance
------------------------------------------------------------------------
Governance                   Insys Employee Handbook
------------------------------------------------------------------------
SOP #4                       Insurance Reimbursement Center
                              Communication Process
------------------------------------------------------------------------
SOP #3                       Insys Reimbursement Center Line
------------------------------------------------------------------------
SOP #2                       Insys Reimbursement Center
------------------------------------------------------------------------
SOP #1                       30 Units Free and Super-Vouchers
------------------------------------------------------------------------
PPT-Training                 Overview of IRC Impact
------------------------------------------------------------------------
Document                     IRC At-A-Glance
------------------------------------------------------------------------
PPT-Training                 Prescription Process Flow Chart
------------------------------------------------------------------------
PPT-Training                 PA Workshop (New Hire Training and
                              Refresher Training)
------------------------------------------------------------------------
PPT-Training                 IRC Sales Force Training
------------------------------------------------------------------------
Internal Document            New Opt-In Form
------------------------------------------------------------------------
Internal Document            IRC Flow Chart--Appeal Process
------------------------------------------------------------------------
Internal Document            IRC Flow Chart--PA Process
------------------------------------------------------------------------
Corporate Email              Multiple Internal IRC Emails with
                              directives from management on numerous
                              topics
------------------------------------------------------------------------
PPT-Training                 Revised Core Speaker Deck
------------------------------------------------------------------------
PPT-Training                 Supplemental Speaker Deck Slides
------------------------------------------------------------------------
PPT-Training                 New Sales Force Training Curriculum
------------------------------------------------------------------------
HCP Data                     Top Twenty (20) HCP Prescriber data excel
                              files (2)
------------------------------------------------------------------------
Call Notes Data              All call notes associated with the top
                              twenty (20) HCP Prescibers for 2013
------------------------------------------------------------------------
Corporate Email Data         Email communications associated with the
                              top twenty (20) HCP Prescibers--2013
------------------------------------------------------------------------



------------------------------------------------------------------------
      Insys Employee Interview                       Date
------------------------------------------------------------------------
Desiree Hollandsworth--Marketing/    October 27, 2013, November 15,
 Communication                        2013, December 19, 2013
------------------------------------------------------------------------
Leslie Zacks--Legal                  October 27, 2013
------------------------------------------------------------------------
Maury Rice--IT                       December 19, 2013
------------------------------------------------------------------------
Mike Gurry--Managed Markets (IRC)    December 18, 2013
------------------------------------------------------------------------
Liz Gurrieri--Managed Markets (IRC)  December 18, 2013
------------------------------------------------------------------------
Darin Fila--Sales Training           December 19, 2013
------------------------------------------------------------------------


------------------------------------------------------------------------
  Insys IRC Employee--Live Monitor                   Date
------------------------------------------------------------------------
Allyson Fulton                       December 18, 2013
------------------------------------------------------------------------
Sam Renzetti                         December 18, 2013
------------------------------------------------------------------------
Traci Giles                          December 18, 2013
------------------------------------------------------------------------
Allyson Fulton                       December 18, 2013
------------------------------------------------------------------------
Patricia Ray Nixon                   December 19, 2013
------------------------------------------------------------------------
Patricia Ray Nixon                   December 19, 2013
------------------------------------------------------------------------
Sam Renzetti                         December 19, 2013
------------------------------------------------------------------------
Traci Giles                          December 19, 2013
------------------------------------------------------------------------
Allison Fulton                       December 19, 2013
------------------------------------------------------------------------
Traci Giles                          December 19, 2013
------------------------------------------------------------------------

Project Methodology

The audit focused on evaluating any existing written documentation that 
governs appropriate communication with HCPs as an Insys employee and 
whether or not there are adequate controls in place that effectively 
ensure compliance and adherence with said documentation, Insys 
guidance, and industry best practices related to HCP communication and 
interactions.

The methodology outlined below was used for the Call Notes, Email, and 
IRC Verbatim Audit Report:

FIELD WORK AND GENERAL OBSERVATIONS

      Document Collection, Review, and Interviews

        CIS collected and reviewed various documents provided by Insys 
        as well as carried out interviews with key stakeholders to 
        better understand specific processes in place with respect to 
        HCP interactions and communication. These documents and 
        interviews are listed in the Documentation and Interview scope 
        section above and include, but are not limited to:

                  I. Policies and Procedures

                     Insys has various policies and procedures in place 
                that provide certain instruction for compliance and 
                governance related to appropriate interactions and 
                communications with HPCs. The documentation listed 
                above was reviewed and covered both organization wide 
                requirements as well as business unit specific; 
                specifically those governing the IRC and its employees.

                 II. Call Notes Repository (Salesforce 360), Corporate 
                email account platform

                      Insys provided CIS with one (1) year worth of 
                call notes associated with the top twenty (20) Subsys 
                prescribing HCPs to assess whether the calls were 
                recorded in a manner consistent with Insys communicated 
                guidance, policies, and procedures. Insys also provided 
                CIS with one (1) year worth of corporate email data 
                associated in some way to the top twenty (20) HCP 
                prescribers of Subsys listed by Insys, to review and 
                ensure appropriate communication with HCPs via email 
                per Insys communicated guidance, policy, and 
                procedures.

                III. IRC Specific Work Instructions and Governance 
                Documentation

                     Insys provided CIS with all existing documentation 
                that governs the work processes, templates, SOPs, and 
                expectations on how to appropriately engage HPCs or 
                their staff, Health Care Insurers, and other third 
                party entities that may be part of a conversation 
                regarding IRC support and proper documentation of those 
                engagements with the ultimate goal of supporting 
                patients in obtaining a Prior Authorization (PA) for an 
                Insys marketed product.

                IV.  IRC Interviews, Live Monitoring, and Walkthroughs 
                of current requirements

                     CIS met with Mike Gurry, Vice President Managed 
                Markets, and Liz Gurrieri Manager Managed Markets, on 
                December 18, 2013 to review the IRC support process and 
                gain a more in depth understanding of the specific 
                roles and responsibilities of the IRC staff, as well as 
                the general procedures which occur daily with respect 
                to HCP and Health Care Insurer (HCI) interactions and 
                how specific support to gain a PA is obtained. CIS also 
                was present for the live monitoring of ten (10) calls 
                made by IRC representatives, both incoming and outgoing 
                in support of obtaining a PA for patients. After each 
                call, CIS asked the IRC representative to walk them 
                through the process flow of the particular type of 
                call, and the expected documentation to be on file with 
                it. Further, the CIS monitor spoke with Liz regarding 
                the current auditing and monitoring of IRC associate 
                calls, and what processes were in place to ensure 
                adherence to Insys and IRC communicated guidance, 
                policy, and procedures regarding HCP interaction and 
                communication. It was apparent to the CIS monitor 
                during the live telephone interactions that the IRC 
                staff was adequately trained with respect to HCP, HCI, 
                and IRC employee communication standards. All employees 
                conducted themselves in a professional manner and no 
                deviance from Insys or IRC controls was observed.

      Identified Existing Key Document Controls
        CIS identified that some key controls related to the 
        appropriate communication and interaction with HCPs were in 
        place through the documentation review process. Additionally, 
        CIS determined that some of the submitted IRC communications, 
        procedures, and governance documentation supported in the 
        training and adherence of IRC personnel to Insys and IRC 
        communicated guidance and industry best practices related to 
        the specific HCP and HCI interactions that occur. CIS also 
        noted upon review of the call notes provided for the audit, 
        that all HCP interactions were filled out completely using the 
        required drop down descriptions, and incomplete or partial 
        entries were not found.

      Identified the Lack of Formal and Approved Governance 
Documentation, Policy, Procedures, and SOPs
        CIS identified that while documentation with respect to 
        communication and interactions with HCPs existed, there were 
        also gaps in formally approved foundational policies, 
        procedures, and SOPs with respect to required processes 
        specifically within the IRC. CIS also identified the lack of a 
        formal policy with respect to email communication from a sales 
        representative to an HCP and the appropriate and approved 
        methods by which they are to occur.

      Identified the Absence of an Auditing and Monitoring Function 
Within Multiple Business Units as Well as Through Interviews With Key 
Insys Stake Holders
        During the interviews held with Insys employees, it was 
        apparent that no quality assurance processes were in place to 
        monitor or audit the actions of sales representatives with 
        respect to a timely call note record creation of an HCP visit 
        within the SalesForce 360 platform. Further, there were no 
        plans communicated to CIS with respect to implementing an 
        auditing and monitoring function to ensure adherence to 
        communications with this action. Further, through interviews it 
        was apparent that no specific email monitoring process was in 
        place and documented with respect to corporate email 
        communication and HCPs in general, and specifically those that 
        may occur from a field sales representative to an HCP. Finally, 
        through interviews with the IRC management, there was no 
        formal, documented, or detailed process by which IRC 
        representatives' calls via telephone were audited for proper 
        communication with HCPs or HCIs in any fashion other than 
        random physical review of a call in a very informal and 
        sporadic manner.

Specific Observations and Recommendations

Based on the audit procedures performed that related to the Verbatim 
Data Audit Process, CIS is providing the following specific 
observations and recommendations identified as a result of the review 
and audit performed.

All observations and recommendations are based on compliance coverage 
for adherence to Insys communicated guidance, policies, and SOPs, as 
well as benchmarking against industry best practices.

Observation #1: Upon reviewing the training curriculum with respect to 
sales representatives entering in call notes post an HCP visit, as well 
as any associated written requirements, interviews with Insys Marketing 
Communication and Sales Training employees, the following observations 
were made:

      Observation 1-1: While sales representatives are required to 
record a call note for each visit made to an HCP, governance 
documentation and training generally lack specificity on the time frame 
a representative has to input the call note by.
      Recommendation 1-1: The requirement to input a call note for an 
HCP visit within an Insys approved time frame should be pronounced 
during trainings, and specifically called out within procedural 
guidance for inputting HCP call notes. It is recommended that a 
``Documentation of HCP Communication'' SOP be created, approved, and 
disseminated.

      Observation 1-2: No formal auditing and monitoring process 
currently exists to ensure that sales representatives are inputting 
call notes within a specified time frame post and HCP visit.
      Recommendation 1-2: CIS recommends that a job description and 
requirement be added to District Managers and above to periodically 
review the call note input date within the Salesforce 360 platform to 
ensure that they are in alignment with Insys requirements for call note 
creation post an HCP visit. These audits to be retained for performance 
review issues, further training when deemed necessary, and in some 
cases disciplinary action.

Observation #2: Upon initiating the corporate email review and 
assessing how to query any communication from Insys employees with the 
top twenty (20) HPC prescribers of Subsys, it became apparent that due 
to the extremely high volume of email search hits that came back under 
keyword queries, (all of which consisted of internal emails discussing 
HCP engagements or mention of the HCP's name) a random sampling of each 
of the twenty (20) top HCP Subsys prescribers would serve as a more 
realistic sample. The randomly sampled emails were reviewed for 
adherence to Insys communication and interactions with HCPs 
documentation, as well as specific Insys communicated guidance with 
respect to email communication and HCPs. Many multiple thousands of 
emails were produced over a year's time frame, which presented a 
challenge for the IT department when searching and categorizing them. 
For the size and scope of this particular review, CIS chose to randomly 
sample one hundred (100) emails from each of the top twenty (20) HCP 
Subsys prescribers to ensure all communication was in alignment with 
Insys policy, procedure, and appropriate in nature.

Out of the two thousand (2,000) randomly selected emails (100 for each 
of the top twenty (20) HCP prescribers of Subsys); no direct email was 
found between a sales or field representative and an HCP. Any direct 
email communication with the HCP was engaged by a member of the 
Marketing, Executive, or Senior Management team and found appropriate 
in nature. CIS would like to note that the majority of reviewed emails 
consisted of internal Insys discussions with respect to that particular 
HCP and all appropriate in nature.

Recommendation: Although no inappropriate communication or violation of 
Insys policy around HCP communication was found, CIS does recommend 
that a corporate compliance auditing and monitoring function be created 
and implemented to ensure periodic reviews of HCP email communication 
as on ongoing monitoring activity. This will ensure a much more up to 
date picture of communications between HCPs and Insys employees in 
general, and also serve to satisfy the Office of Inspector General's 
specified element of an effective compliance program, by having this 
function ongoing. CIS also recommends that while sections of the Insys 
Employee Handbook and Code of Ethics do discuss appropriate 
interactions with HCPs, a separate and distinct ``Interactions With 
Health Care Professionals'' policy should be drafted and disseminated 
company wide.

      Observation 2-1: During the interview process CIS learned that 
Insys field sales representatives are prohibited from emailing HCPs, 
and communication was to be restricted to in-person, telephone, or text 
messaging only. There was no policy found to support this requirement.
      Recommendation 2-1: A separate and distinct policy should be 
created that outlines the approved methods of communication with HCPs 
as they relate to Insys employees, and specifically the sales 
representatives to ensure accountability and establish a baseline 
standard of communication that can be measured.

      Observation 2-2: No formal auditing and monitoring process 
currently exists to ensure that email communications between HCPs and 
Insys employees are both appropriate and professional in nature, as 
well as being initiated and sent solely by an authorized Insys 
employee.
      Recommendation 2-2: CIS recommends that Insys incorporate an 
auditing and monitoring function, as well as system controls within the 
corporate email server that can notify appropriate levels of management 
when a key word on HCP name is scanned. This will serve as a monitoring 
tool for compliance to communication standards as they relate to HCP 
interactions.

Observation #3: CIS observed that there was a specific lack of formal 
and approved policies, procedures, and SOPs that govern the actions of 
the IRC. Upon review of submitted IRC documentation and interviews held 
with IRC representatives, the following observations were made:

      Observation 3-1: No formal and approved policy on appropriate 
communications between IRC employees and HCPs, their staff, HCIs, or 
patients exists (or wasn't supplied to CIS for review) that governs the 
support function of obtaining a prior authorization for the use of 
Subsys.
      Recommendation 3-1: Insys IRC management to formally draft and 
obtain proper review and approval of an IRC specific policy detailing 
the appropriate communications that should occur while performing the 
IRC associate job functions and interacting with HCPs.

      Observation 3-2: CIS observed that four (4) informal SOPs 
existed (see document scope section) but lacked a formal review and 
approval, as well as specificity with respect to the referenced topic. 
CIS noted that the documents were most likely white papers or narrative 
flow charts of processes, but no formal and approved SOPs exist (or 
weren't supplied to CIS for review) that outline appropriately the 
actions performed within the IRC.
      Recommendation 3-2: Insys IRC management to formally draft and 
obtain proper review and approval of IRC specific SOPs that in a 
detailed and action specific manner will govern all processes engaged 
within the IRC. Insys IRC management should ensure these SOPs are 
specific to each job function within the IRC and that once formally 
reviewed and approved, adequate training and understanding of these 
processes exists.

      Observation 3-3: While a quality control function does exist 
with respect to IRC documentation regarding the Opt-in program and 
patient file information, no formal and documented auditing and 
monitoring or quality control policy, process, or function exists 
between IRC employee communications and HCPs, HCP staff, HCIs, or 
patients.
      Recommendation 3-3: Insys IRC management to formally draft and 
obtain proper review and approval of an IRC Auditing and Monitoring 
specific policy and SOP. Further a specific schedule to monitor both 
live and anonymously IRC employee communications both incoming and 
outgoing and at any given time should be created and adhered to. This 
function will serve to ensure adherence to IRC communication standards 
and serve as supporting documentation for training, annual reviews, and 
if necessary disciplinary action. It is recommended that the Insys IRC 
implement an electronic system that will allow management to listen to 
calls in real time to ensure total anonymity.

Observation #4: Upon review of submitted IRC documentation (CIS 
requested all governance documentation in general that could be 
reviewed), CIS noted the following:

      Observation 4-1: The majority of managerial directives, changes 
to controlled documents or templates, as well as updates or revisions 
to processes were not formally approved, documented, and disseminated 
for use, and were sent informally via email blast, and in some reviewed 
document submissions, updates or changes to existing templates and 
documents were copy and pasted into the body of emails and disseminated 
for immediate use.
      Recommendation 4-1: Insys IRC management formally implement a 
change control process by which standardized documents, templates, and 
IRC documentation used for patient and HCP data may be revised or 
updated in a formal, approved method that is in alignment with existing 
Insys change control and documentation creation and revision policies 
and guidelines. This is industry best practice and will allow for 
periodic review of file audits to ensure the most up to date templates 
are in use.

Conclusion

This audit report supports an ongoing acknowledgement by Insys of the 
need to conduct continual monitoring activities to ensure Policies, 
Standard Operating Procedures, and industry best practices exist and 
are adhered to within the organization and throughout various business 
units. Insys recognizes its responsibility in monitoring company 
activities and as such requested this specific audit as a means to 
assist in its ongoing monitoring of communication and interactions 
between HCPs, HCIs, and other affiliated entities and Insys employees 
from both the corporate side, as well as the commercial or field force 
side of the business.

Throughout the review of Insys wide email communications with specific 
HCPs and the documentation of interactions with specific HCPs via call 
note creation and entry by sales representatives, CIS concluded that 
while there lacks specific policies as well as auditing and monitoring 
procedures, (see recommendations section) very few adverse observations 
were noted, and no major violation of Insys communicated guidance or 
governance documentation existed. The following points were also noted:

      There is sound compliance to documenting appropriately 
interactions with an HCP via a call note within the SalesForce 360 
platform. There were no instances of non-compliance or incomplete 
entries found upon review, and the Insys sales force should be 
commended for their dedication to this requirement.

      Out of 2,000 reviewed emails that all referenced a specific 
subset of high Subsys prescribing HCPs, there were no instances of 
inappropriate communication or discussion found as they related to off-
label promotion of a product or use, and no violation of Insys policy 
with respect to email communication with HCPs and specific job titles 
namely sales representatives.

      Upon monitoring ten (10) IRC associate conversations with HCPs, 
their office staff, and insurance carriers with respect to the 
authorization and use of Subsys, CIS noted that all IRC staff was 
professional in communication, and in no instance was inaccurate or 
off-label usage of Subsys communicated.

Despite changes in original scope of this engagement, and specific 
review requests such as not being able to record IRC employee 
conversations while on the phone anonymously due to the lack of 
technology, and the unexpected volume of emails referencing a specific 
subset of high Subsys prescribing HCPs, the Call Notes, Email, and IRC 
Verbatim Data Audit was completed and found to be exemplary in the 
minimal amount of specific findings and recommendations noted. In 
conclusion, CIS recommends that all types of communication, 
interaction, and documentation between HCPs and Insys employees be 
associated with a governing policy and SOP, to ensure compliance to 
clear and concise Insys communicated guidance and standards. CIS also 
recommends that an auditing and monitoring function across the reviewed 
areas be implemented immediately to ensure a constant and ongoing 
review of interactions and communications between HCPs and Insys 
employees, and that they are in compliance with formally drafted and 
approved governance documentation.

                               EXHIBIT C

                           September 1, 2017

The Honorable Claire McCaskill
U.S. Senate
Committee on Homeland Security and Governmental Affairs
Washington, DC 20510

Re: Insys Therapeutics, Inc.

Dear Senator McCaskill:

As you and your staff continue to review certain aspects of the 
commercial practices of Insys Therapeutics, Inc. (``Insys''), I would 
like to assure you that I stand with you and share the desire to 
address the serious national challenge related to the misuse and abuse 
of opioids that has led to addiction and unnecessary deaths and has 
caused so much pain to families and communities around the country.

Four months ago, I joined Insys after undergoing my own due diligence 
process and coming to the understanding that this company has great 
potential to assist patients in unmet medical needs. Like you and your 
staff, I was concerned about certain mistakes and unacceptable actions 
of former Insys employees that have been disclosed and discussed in 
public forums over the past several years. These mistakes and actions 
are not indicative of the people that are currently employed at Insys 
and I share your belief that the ``vast majority of the employees, 
executives, sales representatives, scientists, and doctors involved 
with this industry are good people and responsible actors'' including 
our employees. In this regard, Insys has completely transformed its 
employee base over the last several years. Notably, over 90 percent of 
the 250 field-based sales staff employed prior to 2014 are no longer 
with the organization. Even in the limited time since I joined the 
company, we have hired over 50 new employees and replaced key 
management positions including the following leaders:

      President and Chief Executive Officer
      Chief Financial Officer
      Vice President of Sales
      Regional Director of Sales
      Vice President of Marketing and Managed Care
      Senior Director of Commercial Operations
      Vice President of Medical Affairs
      Senior Director, Clinical Development Medical Affairs (a pain 
and addiction specialist)

Over the past several years, Insys has actively taken the appropriate 
steps to place ethical standards of conduct and patient interests at 
the heart of our business decisions. Our compliance program has been 
under significant scrutiny for several years from both governmental 
authorities but also as a result of internal reviews conducted with the 
assistance of external experts and counsel. During this period, we have 
invested significant resources in establishing an effective compliance 
program with protocols designed to ensure compliant and ethical 
behavior. We recently completed a successful gap assessment into our 
compliance protocols and processes by an independent, global consulting 
firm. This assessment was voluntarily conducted with oversight from our 
Compliance Committee of the Board of Directors. We passionately believe 
that the company has taken necessary steps to ensure that we will not 
repeat the mistakes of the past.

Notwithstanding these transformative changes, as the Chief Executive 
Officer of Insys and a member of its board of directors, I believe that 
it is imperative that we take responsibility for the actions of our 
former employees. This belief is strongly shared by our board of 
directors. Insys continues to strive to do that where the facts and 
circumstances dictate that we do so.

I write to you today on behalf of over 400 employees, across three 
facilities including a research and development laboratory and a fully 
functional manufacturing facility who have worked tirelessly to develop 
and manufacture our two FDA-approved products approved for the 
conditions of breakthrough pain in cancer patients, nausea and vomiting 
associated with chemotherapy and weight loss in AIDS patients. These 
products fulfill a significant unmet need for patients requiring 
supportive or palliative care as they fight their battle with cancer or 
AIDS. These employees, many of whom have advanced and doctorate level 
degrees in the technical and health sciences are working diligently 
every day to develop new medicines and therapies to treat severe 
catastrophic diseases such as intractable pediatric epilepsy, rare 
genetic diseases such as Prader-Willi Syndrome, life-threatening 
anaphylaxis reactions, opioid overdose, opioid addiction and 
dependence, agitation in Alzheimer's Disease and anorexia in cancer 
patients. It is worth noting that since 2012, Insys has invested over 
$170 million in research and development to advance our pipeline and 
make a positive impact in the lives of patients and caregivers.

Like so many stakeholders in health care and government, we hear the 
call to action to address the Nation's opioid crisis. The opioid 
epidemic is a highly complex and multi-faceted issue requiring a 
solutions based approach. We stand ready to help address this public 
health crisis collaboratively through educational initiatives and drug 
monitoring programs centered around patients, caregivers, health-care 
providers and the overall community. We feel strongly that to develop a 
solution we must first understand and correct the drivers of the 
problem.

Subsys is one of six pharmaceutical products in a class called 
Transmucosal Immediate Release Fentanyl (TIRF). A doctor is not 
permitted to prescribe, a pharmacy is not permitted to dispense, and a 
patient is not permitted to receive any TIRF product, including 
Subsys, unless each of them is enrolled in the Food and Drug 
Administration (``FDA'') mandatory TIRF Risk Evaluation and Mitigation 
Strategy (``REMS'') program. The TIRF-REMS program strives to limit the 
risk of abuse and misuse by restricting prescriptions to appropriate 
patients, preventing inappropriate conversions between medicines and 
educating patients, pharmacists, and prescribers about potential for 
abuse, addiction, and overdose of TIRFs, as well as the label for these 
products.

In 2016, there were 215 million opioid prescriptions written in the 
United States. Subsys accounted for approximately 34,000 (less than 
0.02 percent) of these prescriptions nationally. These 2016 
prescription numbers for Subsys place Insys below the top 50 
manufacturers of opioids in the United States. When considering 
fentanyl's role in the current opioid crisis, it is important to note 
that in the National Heroin Threat Assessment Summary issued in June 
2016, the Drug Enforcement Administration concluded that 
``pharmaceutical fentanyl is diverted for abuse in the United States at 
small levels'' and recent overdose deaths from fentanyl are ``largely 
due to clandestinely-produced fentanyl, not diverted pharmaceutical 
fentanyl.''

From a personal perspective, we all have been touched or been affected 
by cancer-as a patient, caregiver, friend, family member, or loved one. 
An aspect of cancer that can be easily overlooked and greatly 
underappreciated is the excruciating pain that often accompanies the 
disease as it progresses and is associated with surgical, radiation, 
and chemotherapy treatment. For some patients, the breakthrough cancer 
pain or cancer related pain can be debilitating and devastating. We 
would be willing to share with you some of the experiences of patients 
who have benefited from Subsys. Their experiences illustrate the 
importance of addressing and treating breakthrough cancer pain 
appropriately.

I sincerely welcome an opportunity to engage in a meaningful dialogue 
and partner with key stakeholders such as yourself, other Senators and 
professional consortiums to play a positive and productive role in 
helping our Nation overcome the opioid epidemic.

Respectfully,

Saeed Motahari
President and Chief Executive Officer
Insys Therapeutics, Inc.

                                 ______
                                 

                          United States Senate

Homeland Security and Governmental Affairs Committee, Ranking Member's 
                                 Office

                         minority staff report

                          Fueling an Epidemic

                               Report Two

     Exposing the Financial Ties Between Opioid Manufacturers and 
                      Third Party Advocacy Groups

EXECUTIVE SUMMARY

This report provides the first comprehensive snapshot of the financial 
connections between opioid manufacturers and advocacy groups and 
professional societies operating in the area of opioids policy. Drawing 
on disclosures from Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., 
Mylan N.V., Depomed, Inc., and Insys Therapeutics, Inc., in response to 
requests from Ranking Member McCaskill, the sections below describe 
nearly $9 million in payments from these manufacturers to 14 outside 
groups working on chronic pain and other opioid-related issues between 
2012 and 2017. In addition, physicians affiliated with these groups 
accepted more than $1.6 million in payments from the five manufacturers 
between 2013 and the present. In total, the five manufacturers have 
made more than $10 million in payments to these groups and affiliated 
individuals since January 2012.

Payments from Purdue totaling $4,153,554.33 account for roughly half of 
the nearly $9 million in funding to groups, and the company provided 
donations to the most diverse array of groups--a significant majority 
of the organizations profiled below. Primarily due to large payments to 
the National Pain Foundation and the U.S. Pain Foundation, Insys had 
the second-highest contribution total from 2012 to 2017, with 
$3,146,265 in payments. Depomed contributed the third-highest total--
$1,071,116.95--during this period, and Janssen contributed $465,152.85. 
At the other end of the spectrum, Mylan reported only $20,250 in 
payments during the same period.

Initiatives from the groups in this report often echoed and amplified 
messages favorable to increased opioid use--and ultimately, the 
financial interests of opioid manufacturers. These groups have issued 
guidelines and policies minimizing the risk of opioid addiction and 
promoting opioids for chronic pain, lobbied to change laws directed at 
curbing opioid use, and argued against accountability for physicians 
and industry executives responsible for overprescription and 
misbranding. Notably, a majority of these groups also strongly 
criticized 2016 guidelines from the Centers for Disease Control and 
Prevention (CDC) that recommended limits on opioid prescriptions for 
chronic pain--the first national standards for prescription opioids and 
a key Federal response to the ongoing epidemic.

The fact that these same manufacturers provided millions of dollars to 
the groups described below suggests, at the very least, a direct link 
between corporate donations and the advancement of opioids-friendly 
messaging. By aligning medical culture with industry goals in this way, 
many of the groups described in this report may have played a 
significant role in creating the necessary conditions for the U.S. 
opioids epidemic.

INTRODUCTION AND METHODOLOGY

More than 42,000 Americans died from opioid overdoses in 2016, with 
deaths from natural and semisynthetic opioid painkillers like 
hydrocodone and oxycodone rising roughly 14 percent compared to 
2015.\1\ In Missouri, around 60 percent of the more than 1,300 drug 
overdose deaths in 2016 involved opioids,\2\ and the epidemic cost the 
State $12.6 billion the same year, according to the Missouri Hospital 
Association.\3\ Alarmingly, fatal overdoses from fentanyl and other 
synthetic opioids more than doubled in the United States between 2015 
and 2016--``more than an exponential increase,'' according to the chief 
of the mortality statistics branch at the National Center for Health 
Statistics.\4\ This surge in overdose deaths resulted in the first 2-
year drop in average U.S. life expectancy since the early 1960s.\5\
---------------------------------------------------------------------------
    \1\ Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Center for Health Statistics, NCHS 
Data Brief No. 294, ``Drug Overdose Deaths in the United States, 1999-
2016'' (December 21, 2017) (www.cdc.gov/nchs/products/databriefs/
db294.htm); ``CDC Releases Grim New Opioid Overdose Figures: `We're 
Talking About More Than an Exponential Increase,' '' Washington Post 
(December 21, 2017) (www.
washingtonpost.com/news/ wonk/wp/2017/12/21/cdc-releases-grim-new-
opioid-overdose-figures-were-talking-about-more-than-an-exponential-
increase/?utm_term=.79af03095271).
    \2\ ``Opioid Crisis Drives Declines in U.S., Missouri Life 
Expectancy,'' Columbia Missourian (January 10, 2018) 
(www.columbiamissourian.com/news/local/opioid-crisis-drives-declines-
in-u-s-missouri-life-expectancy/article_cd71e66e-f488-11e7-ac3f-
d77b751b7c73.html); see also Department of Health and Human Services, 
Centers for Disease Control and Prevention, ``Drug Overdose Mortality 
by State'' (January 10, 2018) (www.cdc.gov/nchs/pressroom/sosmap/ 
drug_poisoning_mortality/drug_poisoning.htm).
    \3\ ``Opioid Crisis Cost Missouri $12.6 Billion in 2016, Report 
Says,'' St. Louis Business Journal (January 17, 2018).
    \4\ ``CDC Releases Grim New Opioid Overdose Figures: `We're Talking 
About More Than an Exponential Increase,' '' Washington Post (December 
21, 2017).
    \5\ ``Opioid Crisis Trims U.S. Life Expectancy, Boosts Hepatitis C: 
CDC,'' Reuters (December 21, 2017) (www.reuters.com/article/ususa-
healthcare-cdc/opioid-crisis-trims-u-s-life-expectancy-boosts-
hepatitis-c-cdc-idUSKBN1EF1TF).

The necessary conditions for this crisis may have arisen, in part, due 
to the financial relationships between opioid manufacturers and patient 
advocacy groups and medical professional societies--the precise terms 
of which parties to these transactions rarely disclose. Patient 
advocacy organizations and professional societies play a significant 
role in shaping health policy debates, setting national guidelines for 
patient treatment, raising disease awareness, and educating the public. 
Even small organizations--with ``their large numbers and credibility 
with policymakers and the public''--have ``extensive influence in 
specific disease areas.'' \6\ Larger organizations with extensive 
funding and outreach capabilities ``likely have a substantial effect on 
policies relevant to their industry sponsors.'' \7\
---------------------------------------------------------------------------
    \6\ Susannah L. Rose et al., ``Patient Advocacy Organizations, 
Industry Funding, and Conflicts of Interest,'' JAMA Internal Medicine 
(March 2017).
    \7\ Id.

Nearly all health advocacy groups accept funding from the 
pharmaceutical industry. According to a recent study from PharmedOut--a 
Georgetown University Medical Center project focused on pharmaceutical 
marketing practices--only ``a handful of 7,865 health advocacy groups 
in the United States are completely independent of pharmaceutical 
industry money.'' \8\ As a result, ``[t]he voices of independent groups 
that truly represent patients and consumers are drowned out by the 
thousands of groups that take money from industry and push industry 
viewpoints.'' \9\
---------------------------------------------------------------------------
    \8\ ``Very Few Patient Groups Don't Take Pharma Money,'' Bloomberg 
BNA (October 20, 2017) (www.bna.com/few-patient-groups-b73014471175/).
    \9\ PharmedOut, Pharma-Free Advocacy Groups (www.pharmedout.org/
pharma-free-groups.
html) (accessed December 7, 2017).

Moreover, neither pharmaceutical manufacturers nor advocacy groups 
fully or routinely disclose the extent of their financial 
relationships. In a special report published in The New England Journal 
of Medicine in March 2017, for example, researchers found that out of 
104 organizations, ``at least 83 percent received financial support 
from drug, device, and biotechnologies companies, and at least 39 
percent have a current or former industry executive on the governing 
board.'' \10\ Full disclosure of these payments was limited, with only 
57 percent of organizations disclosing amounts of donations; even then, 
this disclosure ``was typically done with the use of broad ranges 
rather than exact figures.'' \11\ Moreover, only 12 percent of the 
organizations researchers examined ``have published policies in place 
for managing institutional conflicts of interest.'' \12\
---------------------------------------------------------------------------
    \10\ Matthew S. McCoy et al., ``Conflicts of Interest for Patient-
Advocacy Organizations,'' New England Journal of Medicine (March 2, 
2017).
    \11\ Id.
    \12\ Id.

A January 2017 article in JAMA Internal Medicine similarly examined 
relationships between patient advocacy organizations and the 
pharmaceutical industry. According to the study, more than 67 percent 
of 245 examined organizations received industry funding within the last 
fiscal year, with almost 12 percent receiving more than half of their 
funding from industry sources.\13\ Only 65 percent of organizations 
that provided information on their funding from for-profit sources 
``provided a detailed breakdown'' of this funding, and a similar 
percentage (63.9 percent) of 274 responsive organizations ``reported 
having a written organizational conflict of interest policy.'' \14\
---------------------------------------------------------------------------
    \13\ Susannah L. Rose et al., ``Patient Advocacy Organizations, 
Industry Funding, and Conflicts of Interest,'' JAMA Internal Medicine 
(March 2017).
    \14\ Id.

These financial relationships--and the lack of transparency surrounding 
them--have raised concerns regarding the information and initiatives 
patient advocacy organizations promote. In the JAMA study discussed 
above, 8 percent of respondents in the study ``reported [that] pressure 
to conform their organizations' positions to the interests of industry 
funders is of concern.'' \15\ Without additional disclosure, according 
to David Mitchell of Patients for Affordable Drugs, ``policy makers or 
patients are unable to make informed judgments about the motives of the 
information being given, and the credibility of the information.'' \16\
---------------------------------------------------------------------------
    \15\ Id.
    \16\ ``More Than 80 Percent of Patient Groups Accept Drug Industry 
Funds, Study Shows,'' New York Times (March 1, 2017) (www.nytimes.com/
2017/03/01/health/patient-groups-drug-industry-money.html).

On March 28, 2017, Ranking Member McCaskill issued wide-ranging 
requests for documents related to opioid sales and marketing efforts to 
five major opioid manufacturers: Purdue Pharma L.P., Janssen 
Pharmaceuticals, Inc., Mylan N.V., Depomed, Inc., and Insys 
Therapeutics, Inc.\17\ As the requests explain, these companies 
manufactured the top five opioid products as measured by worldwide 2015 
sales.\18\ Among other items, the requests required manufacturers to 
produce records of payments to certain advocacy groups and professional 
societies since 2012, including the date, amount, and purpose of each 
payment.\19\ (Many of the groups at issue appeared in a previous 
congressional request from 2012 and feature prominently in nationwide 
litigation against the opioids manufacturing industry.\20\) In 
response, manufacturers produced information on payments flowing to 
many--but not all--of the groups listed in the March 2017 requests. To 
verify this information, Ranking Member McCaskill issued additional 
requests directly to 15 of the organizations at issue on October 5, 
2017.\21\
---------------------------------------------------------------------------
    \17\ See, e.g., Letter from Senator Claire McCaskill to Santosh 
Vetticaden, Interim Chief Executive Officer of Insys Therapeutics, Inc. 
(March 28, 2017).
    \18\ Id.
    \19\ Id.
    \20\ See, e.g., Letter from Senator Baucus and Senator Grassley to 
Catherine Underwood, Executive Director, American Pain Society (May 8, 
2012); Third Amended Complaint (October 25, 2016), City of Chicago v. 
Purdue Pharma L.P., et al., N.D. III. (No. 1:14 CV 04361).
    \21\ See, e.g., Letter from Senator Claire McCaskill to Steven P. 
Stanos, President, American Academy of Pain Medicine (October 5, 2017).

The information produced to the committee demonstrates that many 
patient advocacy organizations and professional societies focusing on 
opioids policy have promoted messages and policies favorable to opioid 
use while receiving millions of dollars in payments from opioid 
manufacturers. Through criticism of government prescribing guidelines, 
minimization of opioid addiction risk, and other efforts, ostensibly 
neutral advocacy organizations have often supported industry interests 
---------------------------------------------------------------------------
at the expense of their own constituencies.

PAYMENTS BY OPIOID MANUFACTURERS TO PATIENT ADVOCACY 
ORGANIZATIONS AND PROFESSIONAL SOCIETIES

Between January 2012 and March 2017, the five opioid manufacturers 
featured in this report contributed nearly $9 million to leading 
patient advocacy organizations and professional societies operating in 
the opioids policy area. For some groups, contributions from these 
manufacturers--alone--constituted significant portions of their total 
annual contributions and grants.

In addition, the five manufacturers specifically at issue in this 
report also made substantial payments to individual group executives, 
staff members, board members, and advisory board members. Physicians 
affiliated with these groups accepted more than $1.6 million in 
payments from the five manufacturers between 2013 and the present. 
These same individuals received payments totaling over $10 million from 
all opioid manufacturers during this time period.

        Opioid Manufacturers Contributed Millions to Patient Advocacy 
        Organizations and Professional Societies

        Purdue, Janssen, Mylan, Depomed, and Insys provided at least 
        $8,856,339.13 in funding to 14 outside groups working on 
        chronic pain and other opioid-
        related issues between January 2012 and March 2017. Detailed 
        information on these payments, including payment totals for 
        each manufacturer and group and the contributions applicable to 
        each relationship, appears below in Figure 1.


                         FIGURE 1: Manufacturer Payments to Selected Groups, 2012-2017
----------------------------------------------------------------------------------------------------------------
                    Purdue \22\     Janssen \23\       Depomed          Insys           Mylan          Total
----------------------------------------------------------------------------------------------------------------
Academy of          $1,091,024.86     $128,000.00      $43,491.95    $3,050.00 \24\        $0.00   $1,265,566.81
 Integrative
 Pain
 Management
----------------------------------------------------------------------------------------------------------------
American              $725,584.95      $83,975.00     $332,100.00        $57,750.00        $0.00   $1,199,409.95
 Academy of
 Pain Medicine
----------------------------------------------------------------------------------------------------------------
AAPM Foundation             $0.00           $0.00     $304,605.00             $0.00        $0.00     $304,605.00
----------------------------------------------------------------------------------------------------------------
ACS Cancer       $168,500.00 \25\           $0.00           $0.00             $0.00        $0.00     $168,500.00
 Action Network
----------------------------------------------------------------------------------------------------------------
American              $312,470.00      $50,000.00      $54,670.00             $0.00        $0.00     $417,140.00
 Chronic Pain
 Association
----------------------------------------------------------------------------------------------------------------
American          $11,785.00 \26\           $0.00           $0.00             $0.00        $0.00      $11,785.00
 Geriatrics
 Society
----------------------------------------------------------------------------------------------------------------
American Pain          $25,000.00           $0.00           $0.00             $0.00        $0.00      $25,000.00
 Foundation
----------------------------------------------------------------------------------------------------------------
American Pain         $542,259.52      $88,500.00     $288,750.00        $22,965.00   $20,250.00     $962,724.52
 Society
----------------------------------------------------------------------------------------------------------------
American               $30,000.00           $0.00           $0.00             $0.00        $0.00      $30,000.00
 Society of
 Pain Educators
----------------------------------------------------------------------------------------------------------------
American              $242,535.00  $55,177.85 \27  $25,500.00 \28             $0.00        $0.00     $323,212.85
 Society of                                     \               \
 Pain
 Management
 Nursing
----------------------------------------------------------------------------------------------------------------
The Center for        $145,095.00      $18,000.00           $0.00             $0.00        $0.00     $163,095.00
 Practical
 Bioethics
----------------------------------------------------------------------------------------------------------------
The National                $0.00           $0.00           $0.00       $562,500.00        $0.00     $562,500.00
 Pain
 Foundation \29
 \
----------------------------------------------------------------------------------------------------------------
U.S. Pain             $359,300.00      $41,500.00      $22,000.00  $2,500,000.00 \3        $0.00  $2,922,800.00
 Foundation                                                                      0\
----------------------------------------------------------------------------------------------------------------
Washington            $500,000.00           $0.00           $0.00             $0.00        $0.00     $500,000.00
 Legal
 Foundation
----------------------------------------------------------------------------------------------------------------
                    $4,153,554.33     $465,152.85   $1,071,116.95     $3,146,265.00   $20,250.00   $8,856,339.13
----------------------------------------------------------------------------------------------------------------
\22\ Purdue also reported $91,449 in payments to entities with incomplete names like ``American Academy of
  Pain'' and ``American Society of.'' Production from Purdue Pharma to the Senate Homeland Security and
  Governmental Affairs Committee (November 13, 2017).
\23\ Payments from Janssen include payments from Johnson & Johnson Health Care Systems, Inc. Letter from Daniel
  F. Donovan, Counsel for Janssen, to Senator Claire McCaskill (November 10, 2017).
\24\ Insys was unable to account for $12,500 in payments to the Academy of Integrative Pain Management for
  expenses related to the organization's 2014 and 2015 annual meetings. Brian D. Smith, Counsel for Insys
  Therapeutics, briefing with Senate Committee on Homeland Security and Governmental Affairs minority staff
  (November 28, 2017).
\25\ Payments from Purdue to the American Cancer Society Cancer Action Network include payments to the American
  Cancer Society that could potentially have applied to the Cancer Action Network. Production from Purdue Pharma
  to the Senate Homeland Security and Governmental Affairs Committee (November 13, 2017).
\26\ The American Geriatrics Society reported that Purdue also provided $40,000 in ``corporate roundtable dues''
  to its AGS Health in Aging Foundation, a 501(c)(3) organization affiliated with the group, between 2012 and
  2015. Letter from Nancy E. Lundebjerg, chief executive officer, American Geriatrics Society, to Senator Claire
  McCaskill (October 11, 2017).
\27\ Payments from Janssen to the American Society of Pain Management Nursing include two payments to Rockpointe
  Corporation for an educational grant with signatories including the American Society of Pain Management
  Nursing. Production from Johnson & Johnson to the Senate Homeland Security and Governmental Affairs Committee
  (November 10, 2017).
\28\ This total includes $4,500 in reported payments from Depomed to the ``American Society of Pain Management
  Nurses.'' Production from Depomed to the Senate Homeland Security and Governmental Affairs Committee (April
  25, 2017).
\29\ The National Pain Foundation changed its name to the Global Pain Initiative in mid-2017. Email from Dr.
  Daniel Bennett, chairman, board of directors, Global Pain Initiative, to Committee on Homeland Security and
  Governmental Affairs minority staff (January 10, 2018). According to Dr. Bennett, the Global Pain Initiative
  board decided in the fourth quarter of 2016 not to accept contributions from pharmaceutical or device
  manufacturers. This decision ``permits an academic `hands off' approach, which is crucial to [the Global Pain
  Initiative's] public credibility and mission.'' Id.
\30\ An additional payment from Insys to the U.S. Pain Foundation of $250,000--on April 7, 2017--fell outside
  the scope of the March 28, 2017, requests and is not included in this total.


As shown in Figure 2, payments from Purdue account for roughly half of 
this funding, and the company provided donations to the most diverse 
array of groups--a significant majority of the organizations profiled 
below. Primarily due to large payments to the National Pain Foundation 
and the U.S. Pain Foundation, Insys had the second-highest contribution 
total from 2012 to 2017. At the other end of the spectrum, Mylan 
reported only $20,250 in payments during the same period; in 
correspondence with the committee, the company has claimed a ``very 
limited role in the opioid-containing products marketplace.'' \31\
---------------------------------------------------------------------------
    \31\ Letter from Jonathan C. Su, Counsel for Mylan, to Senator 
Claire McCaskill (September 15, 2017).

[GRAPHIC] [TIFF OMITTED] T1918.002


As shown in Figure 3 below, trends based on yearly payment totals 
varied between manufacturers from 2012 to 2017. Payments from Purdue, 
for example, fell dramatically in 2016 after remaining in the $800,000-
$1,000,000 range between 2012 and 2015. Conversely, payments from Insys 
to advocacy groups rose significantly between 2012--when the company 
received U.S. Food and Drug Administration approval for its fentanyl 
drug Subsys--and 2017. As Ranking Member McCaskill noted in a recent 
report entitled, ``Fueling an Epidemic: Insys Therapeutics and the 
Systemic Manipulation of Prior Authorization,'' Insys revenues tripled 
and profits rose 45 percent between 2013 and 2015, and the value of 
company stock increased 296 percent between 2013 and 2016.\32\
---------------------------------------------------------------------------
    \32\ ``Fentanyl Billionaire Comes Under Fire as Death Toll Mounts 
From Prescription Opioids,'' Wall Street Journal (November 22, 2016) 
(www.wsj.com/articles/fentanyl-billionaire-comes-under-fire-as-death-
toll-mounts-from-prescription-opioids-1479830968); ``An Opioid Spray 
Showered Billionaire John Kapoor in Riches. Now He's Feeling the 
Pain,'' Forbes (October 4, 2016) (www.forbes.com/sites/matthewherper/
2016/10/04/death-kickbacks-and-a-billionaire-the-story-of-adangerous-
opioid/).

Payments from Janssen to the groups listed above dropped sharply to $0 
in 2015 from $126,000 in 2014 (and $99,250 and $239,902.85 in 2013 and 
2012, respectively) and remained at $0 for 2016 and 2017. In April 
2015, Janssen sold U.S. licensing rights for its major Nucynta opioid 
product line to Depomed for $1.05 billion.\33\ For its part, Depomed 
more than tripled payments to the advocacy groups featured in this 
report in 2015 relative to 2014, and the payments total for 2016--
$318,257.47--remained steady compared to the 2015 total.
---------------------------------------------------------------------------
    \33\ Janssen Pharmaceuticals, Inc.: ``Janssen Pharmaceuticals, Inc. 
Completes Divestiture of U.S. License Rights to Nucynta (tapentadol), 
Nucynta ER (tapentadol) extended-release tablets and Nucynta 
(tapentadol) Oral Solution to Depomed, Inc.'' (April 2, 2015); 
``DepoMed to Buy U.S. Rights to Nucynta From J&J Unit,'' Wall Street 
Journal (January 16, 2015) (www.wsj.com/articles/depomed-to-buy-u-s-
rights-to-nucynta-from-j-j-unit-1421357503).

Mylan made a single $15,000 payment to the American Pain Society in 
March 2015--its first payment to the groups in this report--before 
making significantly smaller payments to the same group in 2016 and 
2017. Also in March 2015, Mylan announced the launch of intermediate 
dosage strengths for its fentanyl transdermal system.\34\ In connection 
with this launch, according to the company, Mylan ``engaged in 
marketing efforts to educate doctors about the availability of the 
intermediate strengths.'' \35\
---------------------------------------------------------------------------
    \34\ Mylan N.V.: ``Mylan Launches First and Only Available 
Intermediate Dosage Strengths of Fentanyl Transdermal System 37.5, 62.5 
and 87.5 mcg/hr'' (March 11, 2015).
    \35\ Letter from Jonathan C. Su, Counsel for Mylan, to Senator 
Claire McCaskill (September 15, 2017).
---------------------------------------------------------------------------

Purpose of Manufacturer Contributions

Based on the descriptions manufacturers submitted in connection with 
each specific reported payment, the minority staff designated broad 
payment categories. Payments directed to special projects and 
restricted grants comprise the largest category of contributions, 
totaling $2,617,899 and constituting roughly 30 percent of total 
contributions between 2012 and 2017. For these types of restricted 
grants, donors specify a use for their contribution beyond the broad 
parameters resulting from the nature of the non-profit entity at issue, 
the environment in which it operates, or the purposes specified in its 
organizing documents.\37\
---------------------------------------------------------------------------
    \37\ Financial Accounting Standards Board, ``Not-for-Profit 
Entities'' (Topic 958) (August 2016) (https://asc.fasb.org/imageRoot/
56/92564756.pdf).

Following closely behind the total for special projects and restricted 
grants is the amount manufacturers contributed in the form of non-
education grants, which totaled $2,269,765 and constituted roughly 26 
percent of all contributions. According to a publicly available 
overview from Purdue, non-education grants provide support for health-
care related organizations or initiatives focused on patient and public 
education, scientific research, and other programs.\38\
---------------------------------------------------------------------------
    \38\ Purdue Pharma L.P., ``Grants and Giving Frequently Asked 
Questions'' (July 11, 2014).

Payments for advertising and sponsorship related to group events and 
dues occupy the next tier of categories, with $1,564,215.86 and 
$1,253,988 in payments and roughly 18 percent and 14 percent of the 
total contributions, respectively. Finally, national grants and 
education grants occupy the third tier of categories, with similar 
payments totals of $413,154 and $413,128, respectively, and percentages 
of roughly 5 percent. According to Purdue, an education grant 
``[p]rovides for health-care professional continuing education (CE) 
activities designed to foster improved understanding of scientific, 
clinical, and other health-care issues that help to improve patient 
care.'' \39\ See Figure 4.
---------------------------------------------------------------------------
    \39\ Id.


                                                FIGURE 3: Manufacturer Yearly Payment Totals, 2012-2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              2012             2013            2014            2015            2016            2017            Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purdue                                       $824,227.86     $973,328.00     $812,451.95     $935,344.00     $558,067.52      $50,135.00   $4,153,554.33
--------------------------------------------------------------------------------------------------------------------------------------------------------
Janssen                                 $239,902.85 \36\      $99,250.00     $126,000.00                                                     $465,152.85
--------------------------------------------------------------------------------------------------------------------------------------------------------
Depomed                                       $73,080.00     $135,300.00     $113,600.00     $350,000.00     $318,257.47      $80,879.48   $1,071,116.95
--------------------------------------------------------------------------------------------------------------------------------------------------------
Insys                                         $14,040.00      $68,000.00      $34,200.00     $530,025.00                   $2,500,000.00   $3,146,265.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mylan                                                                                         $15,000.00       $2,500.00       $2,750.00      $20,250.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total                                  $1,151,250.71   $1,275,878.00   $1,086,251.95   $1,830,369.00     $878,824.99   $2,633,764.48   $8,856,339.13
--------------------------------------------------------------------------------------------------------------------------------------------------------
\36\ Although Janssen representatives confirmed the company made a $60,000 payment to the American Pain Society and $75,975 in payments to the American
  Academy of Pain Medicine via a third party during the 2012-2017 time period, it could not provide the exact day and month associated with these
  payments. See Daniel F. Donovan, counsel for Janssen, briefing with Senate Committee on Homeland Security and Governmental Affairs minority staff
  (January 17, 2018). According to information the minority staff received from Janssen, the American Pain Society, and the American Academy of Pain
  Medicine, all these payments occurred in 2012. See email from Daniel F. Donovan, counsel for Janssen, to Committee on Homeland Security and
  Governmental Affairs minority staff (January 31, 2018); production from the American Pain Society to the Senate Homeland Security and Governmental
  Affairs Committee (October 9, 2017); production from the American Academy of Pain Medicine (October 16, 2017). Janssen representatives later reported
  an additional $8,500 payment to the American Pain Society and an additional $500 payment to the American Academy of Pain Medicine--both via a third
  party in 2012. Email from Daniel F. Donovan, counsel for Janssen, to Committee on Homeland Security and Governmental Affairs minority staff (January
  31, 2018).


  [GRAPHIC] [TIFF OMITTED] T1918.003
  

Payments by Organization

The U.S. Pain Foundation received the largest amount of payments during 
the 2012-2017 period--almost $3 million--which includes $2,500,000 in 
payments from Insys . The Academy of Integrative Pain Management, 
formerly the American Academy of Pain Management, received 
$1,265,566.81 in donations--the second-highest total--followed closely 
by the American Academy of Pain Medicine with $1,199,409.95 in 
payments. (The American Academy of Pain Medicine Foundation also 
received $304,605 in payments from Depomed during the same period.)

      FIGURE 5: Group Rankings by Manufacturer Payments, 2012-2017
------------------------------------------------------------------------
 
------------------------------------------------------------------------
U.S. Pain Foundation                                       $2,922,800.00
------------------------------------------------------------------------
Academy of Integrative Pain Management                     $1,265,566.81
------------------------------------------------------------------------
American Academy of Pain Medicine                          $1,199,409.95
------------------------------------------------------------------------
American Pain Society                                        $962,724.52
------------------------------------------------------------------------
The National Pain Foundation                                 $562,500.00
------------------------------------------------------------------------
Washington Legal Foundation                                  $500,000.00
------------------------------------------------------------------------
American Chronic Pain Association                            $417,140.00
------------------------------------------------------------------------
American Society of Pain Management Nursing                  $323,212.85
------------------------------------------------------------------------
AAPM Foundation                                              $304,605.00
------------------------------------------------------------------------
ACS Cancer Action Network                                    $168,500.00
------------------------------------------------------------------------
The Center for Practical Bioethics                           $163,095.00
------------------------------------------------------------------------
American Society of Pain Educators                            $30,000.00
------------------------------------------------------------------------
American Pain Foundation                                      $25,000.00
------------------------------------------------------------------------
American Geriatrics Society                                   $11,785.00
------------------------------------------------------------------------

Contributions by Selected Manufacturers as a Percentage of Overall 
Contributions

Based on comparisons between manufacturer contributions to groups and 
group reporting on contributions and grants in IRS filings between 2013 
and 2015, the percentage of total contributions attributable to the 
five manufacturers discussed in this report vary significantly. Insys 
contributions to the National Pain Foundation in 2015, for example, 
actually exceeded total contributions the group reported on its Form 
990 by $154,800. In a less extreme example, the American Society of 
Pain Management Nursing received approximately 76 percent of its 
funding from Depomed, Janssen, and Purdue in 2013, although this 
percentage declined for 2014 and 2015. For other groups, the 
percentages of contributions attributable to the five manufacturers 
remained consistent during 2013-2015. The Academy of Integrative Pain 
Management and the American Academy of Pain Medicine, for example, 
received between 13 percent and 20 percent of their contributions from 
at least one of the five manufacturers during this 3-year period. At 
the other end of the spectrum, the American Cancer Society Cancer 
Action Network received less than 1 percent of its contributions from 
Purdue between 2013 and 2015.


  FIGURE 6: Comparison of Contributions From Selected Manufacturers and
             Total Contributions and Grants, 2013-2015 \40\
------------------------------------------------------------------------
                           Contributions                    Percent of
    2013 Information       From Selected   Contributions     Selected
                           Manufacturers    and Grants     Contributions
------------------------------------------------------------------------
Academy of Integrative          $319,929      $1,624,115          19.70%
 Pain Management
------------------------------------------------------------------------
American Academy of Pain        $201,944      $1,071,992          18.84%
 Medicine
------------------------------------------------------------------------
AAPM Foundation                  $50,000        $381,738          13.10%
------------------------------------------------------------------------
ACS Cancer Action                $28,500     $35,409,632           0.08%
 Network
------------------------------------------------------------------------
American Chronic Pain           $100,970        $564,004          17.90%
 Association
------------------------------------------------------------------------
American Geriatrics                   $0      $2,709,179           0.00%
 Society
------------------------------------------------------------------------
American Pain Foundation     Unavailable     Unavailable     Unavailable
------------------------------------------------------------------------
American Pain Society           $161,585      $1,271,537          12.71%
------------------------------------------------------------------------
American Society of Pain          $5,000     Unavailable     Unavailable
 Educators
------------------------------------------------------------------------
American Society of Pain         $97,950        $129,167          75.83%
 Management Nursing
------------------------------------------------------------------------
The Center for Practical        $101,000      $1,276,473           7.91%
 Bioethics
------------------------------------------------------------------------
The National Pain                $50,000         $50,100          99.80%
 Foundation
------------------------------------------------------------------------
U.S. Pain Foundation             $84,000        $467,040          17.99%
------------------------------------------------------------------------
Washington Legal                 $75,000      $4,113,151          1.82%
 Foundation
------------------------------------------------------------------------
\40\ Data on contributions and grants are taken from line 8 of Form 990
  for each group. The American Pain Foundation ended its operations in
  2012.



  FIGURE 6: Comparison of Contributions From Selected Manufacturers and
                Total Contributions and Grants, 2013-2015
------------------------------------------------------------------------
                           Contributions                    Percent of
    2014 Information       From Selected   Contributions     Selected
                           Manufacturers    and Grants     Contributions
------------------------------------------------------------------------
Academy of Integrative          $269,980      $1,929,818          13.99%
 Pain Management
------------------------------------------------------------------------
American Academy of Pain        $255,087      $1,346,712          18.94%
 Medicine
------------------------------------------------------------------------
AAPM Foundation                       $0        $533,776           0.00%
------------------------------------------------------------------------
ACS Cancer Action                $40,000     $35,288,961           0.11%
 Network
------------------------------------------------------------------------
American Chronic Pain            $85,000        $558,510          15.22%
 Association
------------------------------------------------------------------------
American Geriatrics                   $0      $3,197,135           0.00%
 Society
------------------------------------------------------------------------
American Pain Foundation     Unavailable     Unavailable     Unavailable
------------------------------------------------------------------------
American Pain Society           $161,190        $949,867          16.97%
------------------------------------------------------------------------
American Society of Pain          $5,000     Unavailable     Unavailable
 Educators
------------------------------------------------------------------------
American Society of Pain         $68,100        $229,732          29.64%
 Management Nursing
------------------------------------------------------------------------
The Center for Practical         $30,095      $1,232,768           2.44%
 Bioethics
------------------------------------------------------------------------
The National Pain                     $0          $3,100           0.00%
 Foundation
------------------------------------------------------------------------
U.S. Pain Foundation            $121,800        $791,657          15.39%
------------------------------------------------------------------------
Washington Legal                 $50,000      $4,213,431           1.19%
 Foundation
------------------------------------------------------------------------



  FIGURE 6: Comparison of Contributions From Selected Manufacturers and
                Total Contributions and Grants, 2013-2015
------------------------------------------------------------------------
                           Contributions                    Percent of
    2015 Information       From Selected   Contributions     Selected
                           Manufacturers    and Grants     Contributions
------------------------------------------------------------------------
Academy of Integrative          $275,098      $1,465,067          18.78%
 Pain Management
------------------------------------------------------------------------
American Academy of Pain        $239,941      $1,482,707          16.18%
 Medicine
------------------------------------------------------------------------
AAPM Foundation                 $100,000        $451,835          22.13%
------------------------------------------------------------------------
ACS Cancer Action               $100,000     $37,925,236           0.26%
 Network
------------------------------------------------------------------------
American Chronic Pain            $30,000        $382,671           7.84%
 Association
------------------------------------------------------------------------
American Geriatrics                   $0      $4,041,760           0.00%
 Society
------------------------------------------------------------------------
American Pain Foundation     Unavailable     Unavailable     Unavailable
------------------------------------------------------------------------
American Pain Society           $266,020        $660,894          40.25%
------------------------------------------------------------------------
American Society of Pain         $10,000     Unavailable     Unavailable
 Educators
------------------------------------------------------------------------
American Society of Pain         $63,810        $171,256          37.26%
 Management Nursing
------------------------------------------------------------------------
The Center for Practical          $3,500        $857,788           0.41%
 Bioethics
------------------------------------------------------------------------
The National Pain               $512,500        $357,700         143.28%
 Foundation
------------------------------------------------------------------------
U.S. Pain Foundation            $129,500     Unavailable     Unavailable
------------------------------------------------------------------------
Washington Legal                $100,000      $4,583,620           2.18%
 Foundation
------------------------------------------------------------------------


Manufacturers Also Provided Payments to Group-Affiliated Individuals

The five manufacturers specifically at issue in this report also made 
substantial payments to individual group executives, staff members, 
board members, and advisory board members. Figure 7 below lists totals 
for these payments between August 2013 and the present, as well as the 
sum of these payments and the amounts manufacturers contributed to the 
groups directly. In terms of total contributions, the U.S. Pain 
Foundation ranks first among the groups despite minimal payments to 
affiliated individuals, and the National Pain Foundation assumes the 
second-place ranking due to payments to individual physicians of over 
$800,000. Notably, the nearly $300,000 in payments to individuals 
affiliated with the American Society of Pain Educators significantly 
outweighs the relatively minor amount the group received from Purdue 
directly. In contrast, manufacturer payments to groups like the Academy 
of Integrative Pain Management, the American Academy of Pain Medicine, 
the American Pain Society, and the American Chronic Pain Association 
far exceeded payments to physicians affiliated with these 
organizations.


 FIGURE 7: Purdue, Janssen, Insys, Depomed, and Mylan Payments to Groups
           and Group-Affiliated Individuals, 2012-Present \41\
------------------------------------------------------------------------
                                          Payments to
                          Payments to       Group-
                             Group        Affiliated          Total
                                          Individuals
------------------------------------------------------------------------
U.S. Pain Foundation     $2,922,800.00         $126.20     $2,922,926.20
------------------------------------------------------------------------
The National Pain          $562,500.00     $839,848.84     $1,402,348.84
 Foundation
------------------------------------------------------------------------
Academy of Integrative   $1,265,566.81      $30,223.42     $1,295,790.23
 Pain Management
------------------------------------------------------------------------
American Academy of      $1,199,409.95      $16,462.42     $1,215,872.37
 Pain Medicine
------------------------------------------------------------------------
American Pain Society      $962,724.52      $95,474.56     $1,058,199.08
------------------------------------------------------------------------
AAPM Foundation            $304,605.00     $314,175.58       $618,780.58
------------------------------------------------------------------------
Washington Legal           $500,000.00             N/A       $500,000.00
 Foundation
------------------------------------------------------------------------
American Chronic Pain      $417,140.00      $31,265.87       $448,405.87
 Association
------------------------------------------------------------------------
American Society of        $323,212.85             N/A       $323,212.85
 Pain Management
 Nursing
------------------------------------------------------------------------
American Society of         $30,000.00     $280,765.92       $310,765.92
 Pain Educators
------------------------------------------------------------------------
The Center for             $163,095.00       $7,116.86       $170,211.86
 Practical Bioethics
------------------------------------------------------------------------
ACS Cancer Action          $168,500.00             N/A       $168,500.00
 Network
------------------------------------------------------------------------
American Pain               $25,000.00             N/A        $25,000.00
 Foundation
------------------------------------------------------------------------
American Geriatrics         $11,785.00         $194.13        $11,979.13
 Society
------------------------------------------------------------------------
    Total                $8,856,339.13   $1,615,653.80    $10,471,992.93
------------------------------------------------------------------------
\41\ These totals consist of payments in the Open Payments database from
  the five opioid manufacturers at issue to physician board members,
  advisory board members, advisory council members, staff members, and
  officers and executives of the advocacy groups listed. The totals only
  include payments from manufacturers to physicians since August 2013,
  when the first reporting period for the CMS Open Payments database
  began. See Centers for Medicare and Medicaid Services, ``How Open
  Payments Works'' (September 2, 2015), (www.cms.gov/OpenPayments/About/
  How-Open-Payments-Works.html). The listed payments from manufacturers
  to the groups occurred between January 2012 and March 2017.


As shown in Figure 8 below, individuals affiliated with these groups 
have significant financial ties not only with the five companies at 
issue in this report, but also with all other opioid manufacturers. 
According to CMS Open Payments data, for example, the current President 
of the American Academy of Pain Medicine, Dr. Steven Stanos, received 
over $90,000 in payments from opioid manufacturers between 2013 and 
2016.\42\ Additional searches of Open Payments data also show that 
multiple American Academy of Pain Medicine Corporate Relations Council 
members made payments directly to at least one American Academy of Pain 
Medicine board member between 2013 and 2016.\43\ In total, between 2013 
and 2016, American Academy of Pain Medicine board members received more 
than $200,000 in payments from opioid manufacturers.\44\ In addition, 
Dr. Charles Argoff, current president of the American Academy of Pain 
Medicine Foundation, received over $600,000 in payments from opioid 
manufacturers between 2013 and 2016.\45\
---------------------------------------------------------------------------
    \42\ Centers for Medicare and Medicaid Services, Steven Stanos, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/138667/
summary) (accessed December 22, 2017). See also American Academy of 
Pain Medicine, AAPM Fact Sheet (www.painmed.org/files/aapm-fact-
sheet.pdf) (accessed December 22, 2017).
    \43\ Centers for Medicare and Medicaid Services, Steven Stanos, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/138667/
summary) (accessed December 22, 2017); Centers for Medicare and 
Medicaid Services, Jianguo Cheng, Open Payments Data (http://
openpaymentsdata.cms.gov/physician/163794/summary) (accessed December 
22, 2017); Centers for Medicare and Medicaid Services, Ajay Wasan, Open 
Payments Data (https://openpaymentsdata.cms.gov/physician/1272772/
summary) (accessed December 22, 2017); Centers for Medicare and 
Medicaid Services, Daniel B. Carr, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/202832/summary) (accessed December 
22, 2017); Centers for Medicare and Medicaid Services, Robert Hurley, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/299398/
summary) (accessed December 22, 2017); Centers for Medicare and 
Medicaid Services, Robert Wailes, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/233305/summary) (accessed December 
22, 2017); Centers for Medicare and Medicaid Services, Chester Church 
Buckenmaier III, Open Payments Data (https://openpaymentsdata.cms.gov/
physician/1035447/summary) (accessed December 22, 2017). See also 
American Academy of Pain Medicine, AAPM Fact Sheet (www.painmed.org/
files/aapm-fact-sheet.pdf) (accessed December 22, 2017).
    \44\ Id.
    \45\ Centers for Medicare and Medicaid Services, Charles Argoff, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/93628/
summary) (accessed December 22, 2017). See also American Academy of 
Pain Medicine Foundation, AAPM Foundation Leadership (https://
aapmfoundation.org/leadership) (accessed December 22, 2017).

Similarly, Open Payments data indicates that between 2013 and 2016, ten 
members of the American Chronic Pain Association Advisory Board 
received more than $140,000 from opioid manufacturers, including Endo, 
Purdue, Mallinckrodt, Pfizer, Teva, and Depomed.\46\ In another 
prominent example, National Pain Foundation chairman and founder Dr. 
Daniel Bennett \47\ received over $170,000 from Insys Therapeutics, 
manufacturer of the powerful fentanyl drug Subsys, between 2013 and 
2016.\48\ Members of the National Pain Foundation Board of Directors, 
which include Dr. Bennett, received more than $950,000 from opioid 
manufacturers, including more than $250,000 from Insys Therapeutics, 
during the same period.\49\ In addition, at least half of the members 
of the National Pain Foundation Clinical and Scientific Advisory 
Council \50\ have received general payments--totaling more than 
$7,900,000--from opioid manufacturers between 2013 and 2016.\51\ 
Manufacturer payments to all individuals affiliated with the National 
Pain Foundation total more than $8,000,000 since 2013--by far the 
largest total for the groups profiled in this report.
---------------------------------------------------------------------------
    \46\ Centers for Medicare and Medicaid Services, Daniel B. Carr, 
Open Payments Data, (https://openpaymentsdata.cms.gov/physician/202832/
summary) (accessed December 22, 2017); Centers for Medicare and 
Medicaid Services, Edward C. Covington, Open Payments Data, (https://
openpaymentsdata.cms.gov/physician/1008604/summary) (accessed December 
22, 2017); Centers for Medicare and Medicaid Services, Steven Feinberg, 
Open Payments Data, (https://openpaymentsdata.cms.gov/physician/308924/
payment-information) (accessed December 22, 2017); Centers for Medicare 
and Medicaid Services, Gary W. Jay, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/1134064/payment-information) 
(accessed December 22, 2017); Centers for Medicare and Medicaid 
Services, John D. Loeser, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/555855/payment-information) 
(accessed December 22, 2017); Centers for Medicare and Medicaid 
Services, Sean Mackey, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/406055/summary) (accessed December 
22, 2017); Centers for Medicare and Medicaid Services, Srinivasa Raja, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/72208/
payment-information) (accessed December 22, 2017); Centers for Medicare 
and Medicaid Services, Steven Stanos, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/138667/summary) (accessed December 
22, 2017); Centers for Medicare and Medicaid Services, Knox Todd, Open 
Payments Data (https://openpaymentsdata.cms.gov/physician/1052955/
payment-information) (accessed December 22, 2017); Centers for Medicare 
and Medicaid Services, Debra Weiner, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/591428/payment-information) 
(accessed December 22, 2017). See also American Chronic Pain 
Association, Advisory Board (https://theacpa.org/Advisory-Board) 
(accessed December 22, 2017).
    \47\ Global Pain Initiative, board of directors 
(www.globalpaininitiative.org/board-of-directors/) (accessed January 2, 
2018).
    \48\ Centers for Medicare and Medicaid Services, Daniel S. Bennett, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/329225/
summary) (accessed January 2, 2018). See also Global Pain Initiative, 
board of directors (https://globalpaininitiative.org/board-of-
directors/) (accessed January 2, 2018).
    \49\ Centers for Medicare and Medicaid Services, Daniel S. Bennett, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/329225/
summary) (accessed January 2, 2018); Centers for Medicare and Medicaid 
Services, Dmitry M. Arbuck, Open Payments Data (http://
openpaymentsdata.cms.gov/physician/213597/summary) (accessed January 2, 
2018); Centers for Medicare and Medicaid Services, Joseph V. 
Pergolizzi, Jr., Open Payments Data (https://openpaymentsdata.cms.gov/
physician/223423/summary) (accessed January 2, 2018). See also Global 
Pain Initiative, board of directors (https://globalpaininitiative.org/
board-of-directors/) (accessed January 2, 2018).
    \50\ Global Pain Initiative, Clinical and Scientific Advisory 
Council (www.
globalpaininitiative.org/clinical-scientific-council/) (accessed 
October 3, 2017).
    \51\ Centers for Medicare and Medicaid Services, Kenny Chantasi, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/64321/
summary) (accessed January 2, 2018); Centers for Medicare and Medicaid 
Services, Leonard A. Farber, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/300520/summary) (accessed January 2, 
2018); Centers for Medicare and Medicaid Services, Perry G. Fine, Open 
Payments Data (https://openpaymentsdata.cms.gov/physician/672854/
summary) (accessed January 2, 2018); Centers for Medicare and Medicaid 
Services, Joseph Pergolizzi, Jr., Open Payments Data (https://
openpaymentsdata.cms.gov/physician/223423/summary) (accessed January 2, 
2018); Centers for Medicare and Medicaid Services, Steven M. Simon, 
Open Payments Data (https://openpaymentsdata.cms.gov/physician/386520/
summary) (accessed January 2, 2018); Centers for Medicare and Medicaid 
Services, Lisa Jo Stearns, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/41530/summary) (accessed January 2, 
2018); Centers for Medicare and Medicaid Services, Andrea Trescot, Open 
Payments Data (https://openpaymentsdata.cms.gov/physician/231857/
summary) (accessed January 2, 2018); Centers for Medicare and Medicaid 
Services, Lynn R. Webster, Open Payments Data (https://
openpaymentsdata.cms.gov/physician/1136720/summary) (accessed January 
2, 2018). See also Global Pain Initiative, Clinical and Scientific 
Advisory Council (https://globalpaininitiative.org/clinical-scientific-
council/) (accessed January 2, 2018).


  FIGURE 8: Payments From All Opioid Manufacturers to Group-Affiliated
                     Individuals, P2013-Present \52\
------------------------------------------------------------------------
                                                         Manufacturer
                                                          Payments to
                                                          Affiliated
                                                          Individuals
------------------------------------------------------------------------
The National Pain Foundation                               $8,307,243.47
------------------------------------------------------------------------
AAPM Foundation                                              $798,051.22
------------------------------------------------------------------------
American Society of Pain Educators                           $749,564.78
------------------------------------------------------------------------
American Academy of Pain Medicine                            $204,631.53
------------------------------------------------------------------------
American Pain Society                                        $187,699.34
------------------------------------------------------------------------
ACS Cancer Action Network                                    $154,578.09
------------------------------------------------------------------------
American Chronic Pain Association                            $145,861.30
------------------------------------------------------------------------
Academy of Integrative Pain Management                        $82,596.98
------------------------------------------------------------------------
The Center for Practical Bioethics                            $16,945.88
------------------------------------------------------------------------
American Geriatrics Society                                    $7,548.35
------------------------------------------------------------------------
U.S. Pain Foundation                                             $138.91
------------------------------------------------------------------------
American Pain Foundation                                             N/A
------------------------------------------------------------------------
American Society of Pain Management Nursing                          N/A
------------------------------------------------------------------------
Washington Legal Foundation                                          N/A
------------------------------------------------------------------------
    Total                                                $10,654,859.85
------------------------------------------------------------------------
\52\ As with the previous figure, these totals only include payments to
  group-affiliated physicians since August 2013.


GROUPS FAIL TO ADEQUATELY DISCLOSE MANUFACTURER CONTRIBUTIONS

Due to their classification under the U.S. tax code, the groups 
profiled in this report have no obligation to disclose their donors 
publicly; as a result, each group maintains different levels of 
transparency regarding its financial connections to the pharmaceutical 
industry. Specifically, as either 501(c)(3), 501(c)(4), or 501(c)(6) 
public charities, the groups discussed below have no obligation to 
publicly disclose the list of donors they provide to the Internal 
Revenue Service with their annual Form 990 filing.\53\ Instead, these 
organizations have the ability to selectively disclose donors, 
donations, and other support--or no information at all. Importantly, no 
organization profiled in this report provides an online list linking 
donors, their specific donations, and the projects or events benefiting 
from each donation for each of the years between 2012 and 2017.
---------------------------------------------------------------------------
    \53\ See 26 U.S.C. Sec. 6104(d)(3)(A).

The minority staff reviewed disclosure policies available online for 
each of the groups listed in the March 28, 2017, requests. Several 
groups--the American Society of Pain Educators, the National Pain 
Foundation, and the Academy of Integrative Pain Management--provided no 
information concerning their policies for disclosing donors and 
donations. Other groups stated explicitly that they do not disclose any 
information concerning donor relationships. The Washington Legal 
Foundation, for example, states in its 2016 Annual Report: ``All 
contributions to WLF are strictly confidential. WLF does not disclose, 
publish, or trade the names of its donors.'' \54\
---------------------------------------------------------------------------
    \54\ Washington Legal Foundation, ``2016 Annual Report (2016)'' 
(www.wlf.org/pdf/ WLF2016AnnualReport.pdf).

Other groups simply list donors, ``corporate members,'' or ``corporate 
partners'' without indicating specific donation amounts or even the 
range of donations for each category of contributor. The website for 
the American Geriatrics Society, for example, states that ``AGS 
corporate arrangements will be disclosed regularly as part of the 
organization's financial reporting to the Board of Directors,'' but for 
the public, the organization simply lists three ``corporate partners'' 
without details of the amounts donated or any related arrangements.\55\ 
The U.S. Pain Foundation similarly lists ``Platinum,'' ``Gold,'' and 
``Basic'' corporate members--including opioid manufacturers like 
Pfizer, Teva, Depomed, Endo, Purdue, and Mallinckrodt--without 
indicating the level of donations required for each classification.\56\ 
The American Chronic Pain Association lists many of the same 
corporations as ``Partners and Contributors'' at the ``Champion,'' 
``Ambassador,'' ``Educator,'' and ``Builder'' levels without specifying 
the applicable ranges of contributions.\57\ Both the American Cancer 
Society Cancer Action Network and the Center for Practical Bioethics 
also list corporate or individual donors without including donation 
amounts.\58\ Finally, the American Academy of Pain Medicine website 
lists donors between January 1, 2017, and October 31, 2017, and 
describes the list as including ``matching gifts from companies,'' but 
no companies appear on the list.\59\
---------------------------------------------------------------------------
    \55\ American Geriatrics Society Health in Aging Foundation, 
``Guidelines for Corporate Relationships'' 
(www.healthinagingfoundation.org/support-us/become-a-corporate-partner/
guidelines-for-corporate-relationships/) (accessed October 18, 2017); 
American Geriatrics Society Health in Aging Foundation, ``Meet Our 
Partners'' (www.healthinagingfoundation.org/support-us/become-a-
corporate-partner/meet-our-partners/) (accessed January 2, 2018).
    \56\ U.S. Pain Foundation, ``Transparency'' 
(www.uspainfoundation.org/transparency/) (accessed October 18, 2017).
    \57\ American Chronic Pain Association, ``Partners and 
Contributors'' (www.theacpa.org/Partners-Contributors) (accessed 
October 18, 2017).
    \58\ American Cancer Society Cancer Action Network, ``Our 
Partners'' (www.cancer.org/our-partners.html) (accessed October 18, 
2017); Center for Practical Bioethics, ``Community Supporters'' 
(www.practicalbioethics.org/support-our-mission/community-
supporters.html) (accessed October 18, 2017). The website for the 
Center for Practical Bioethics also provides a link to the 
organization's annual audits and Form 990 filings, which list total 
amounts of contributions and grants per year. See ``Ways to Help,'' 
Center for Practical Bioethics (www.practicalbioethics.org/support-our-
mission/ways-to-help.html) (accessed February 13, 2018).
    \59\ American Academy of Pain Medicine Foundation, AAPM Foundation 
Donors (www.
aapmfoundation.org/donors) (accessed Oct. 18, 2017).

A handful of groups disclose both their donors and list the ranges of 
donations applicable to each category of contributor. The American Pain 
Society, for example, specifies that ``Corporate Council'' contributors 
donated at least $25,000, ``Executive'' donors provided at least 
$15,000, and ``Associate'' contributors donated at least $7,500.\60\ 
Opioid manufacturers, including Pfizer, Teva, Depomed, Purdue, and 
Mallinckrodt, appear at all three donor levels.\61\ The website of the 
American Society of Pain Management Nursing similarly specifies that 
all listed corporations contributed more than $5,000.\62\
---------------------------------------------------------------------------
    \60\ American Pain Society, ``Corporate Council Members'' 
(www.americanpainsociety.org/get-involved/corporate-council/overview) 
(accessed Oct. 18, 2017).
    \61\ Id.
    \62\ American Society for Pain Management Nursing, ``Corporate 
Membership'' (www.
aspmn.org/Pages/corporatemembership.aspx) (accessed October 18, 2017); 
American Society for Pain Management Nursing, ``ASPMN Corporate 
Membership Categories'' (www.aspmn.org/Documents/Membership/
Corporate%20membership%20information_17.pdf) (accessed January 2, 
2018).

---------------------------------------------------------------------------
GROUP ACTIVITIES CONTRIBUTING TO OPIOID OVERPRESCRIPTION AND OVERUSE

Many of the groups discussed in this report have amplified or issued 
messages that reinforce industry efforts to promote opioid prescription 
and use, including guidelines and policies minimizing the risk of 
addiction and promoting opioids for chronic pain. Several groups have 
also lobbied to change laws directed at curbing opioid use, strongly 
criticized landmark CDC guidelines on opioid prescribing, and 
challenged legal efforts to hold physicians and industry executives 
responsible for overprescription and misbranding.

        Minimizing the Risk of Addiction
        Many of the groups have issued guidelines to physicians and 
        other health practitioners that minimize the risk of opioid 
        addiction or emphasize the long-term use of opioids to treat 
        chronic pain. According to a complaint from the city of 
        Chicago, for example, the American Academy of Pain Medicine and 
        the American Pain Society issued a consensus statement in 1997 
        ``which endorsed opioids to treat chronic pain and claimed that 
        the risk that patients would become addicted to opioids was 
        low.'' \63\ Dr. J. David Haddox, then a paid speaker for Purdue 
        and now the Vice President of Health Policy at the company, co-
        authored the statement.\64\ The American Academy of Pain 
        Medicine and the American Pain Society also allegedly issued 
        guidelines in 2009 that ``promote[d] opioids as `safe and 
        effective' for treating chronic pain, despite acknowledging 
        limited evidence, and conclude[d] that the risk of addiction is 
        manageable for patients regardless of past abuse histories.'' 
        \65\
---------------------------------------------------------------------------
    \63\ Third Amended Complaint (October 25, 2016), City of Chicago v. 
Purdue Pharma L.P., et al., N.D. III. (No. 1:14 CV 04361).
    \64\ Id.
    \65\ Id.

        Similarly, the American Geriatrics Society released guidelines 
        in 2009 for the management of persistent pain in older 
        patients.\66\ While acetaminophen remained the preferred option 
        for the treatment of chronic pain patients, the American 
        Geriatrics Society recommended opioids--as opposed to aspirin 
        or ibuprofen--for those unable to gain relief from Tylenol and 
        similar products.\67\ According to the city of Chicago 
        complaint, the guidelines included these recommendations: ``All 
        patients with moderate to severe pain . . . should be 
        considered for opioid therapy (low quality of evidence, strong 
        recommendation),'' and ``the risks [of addiction] are 
        exceedingly low in older patients with no current or past 
        history of substance abuse.'' \68\ The American Geriatrics 
        Society also partnered with the American Academy of Pain 
        Medicine and Janssen to create the 2009 patient education guide 
        entitled, ``Finding Relief: Pain Management for Older Adults,'' 
        which stated that ``[m]any studies show that opioids are rarely 
        addictive when used properly for the management of chronic 
        pain.'' \69\
---------------------------------------------------------------------------
    \66\ ``Chronic Pain Guidelines Suggest Opioids,'' New York Times 
(May 12, 2009) (http://query.nytimes.com/gst/
fullpage.html?res=9806E0D71E3AF931A25756C0A96F9C8B63).
    \67\ Id.; see also ``Pharmacological Management of Persistent Pain 
in Older Persons: American Geriatrics Society Panel on the 
Pharmacological Management of Persistent Pain in Older Persons,'' 
Journal of the American Geriatrics Society (August 2009).
    \68\ Third Amended Complaint (October 25, 2016), City of Chicago v. 
Purdue Pharma L.P., et al., N.D. III. (No. 1:14 CV 04361).
    \69\ Id.

---------------------------------------------------------------------------
        Lobbying to Defeat Measures to Restrict Overprescription

        Advocacy groups have engaged in extensive lobbying efforts to 
        either defeat legislation restricting opioid prescribing or 
        promote laws encouraging opioid treatment for pain. In 2014, 
        for example, the Academy of Integrative Pain Management and the 
        American Cancer Society Cancer Action Network led an effort to 
        protect a 2001 Tennessee law that made it difficult to 
        discipline doctors for overprescribing opioids and prohibited 
        them from refusing to prescribe opioids unless they referred 
        the patient to another ``opioid-friendly'' doctor.\70\
---------------------------------------------------------------------------
    \70\ ``Politics of Pain: Drugmakers Fought State Opioid Limits Amid 
Crisis,'' The Center for Public Integrity (December 15, 2016) 
(www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-
fought-state-opioid-limits-amid-crisis).

        According to a joint investigation by the Associated Press and 
        the Center for Public Integrity, the Academy of Integrative 
        Pain Management and the American Cancer Society Cancer Action 
        Network have contacted legislators and other officials about 
        opioid measures in at least 18 States.\71\ More broadly, the 
        American Cancer Society Cancer Action Network reportedly 
        maintains ``about 200 lobbyists around the country opposed to 
        opioid restrictions even in some cases where they specifically 
        exempted cancer patients.'' \72\ In an example of the general 
        legislative reach of these groups, the U.S. Pain Foundation has 
        ``participated in more than 30 State and national advocacy 
        coalitions, alliances, and task forces . . . [and is] actively 
        engaged in 70 legislative bills in 20 States with the support 
        of 250 advocates engaged in outreach to policymakers.'' \73\
---------------------------------------------------------------------------
    \71\ Id.
    \72\ ``Industry Uses 50-State Strategy to Weaken Drug Laws,'' The 
Journal (September 22, 2016) (https://the-journal.com/articles/1047-
industry-uses-50-state-strategy-to-weaken-drug-laws).
    \73\ U.S. Pain Foundation, Annual Report (www.uspainfoundation.org/
about-us/annual-report/) (accessed October 3, 2017).

---------------------------------------------------------------------------
        Efforts to Criticize or Undermine CDC Guidelines

        On March 15, 2016, the CDC issued guidelines providing 
        prescribing recommendations for ``primary care clinicians who 
        are prescribing opioids for chronic pain outside of active 
        cancer treatment, palliative care, and end-of-life care.'' \74\ 
        In introducing these guidelines--``the first national standards 
        for prescription painkillers,'' \75\ as The New York Times 
        reported--the CDC noted that opioid prescriptions per capita 
        had increased 7.3 percent from 2007 to 2012, ``more than 
        165,000 persons died from overdose related to opioid pain 
        medication in the United States'' from 1999 to 2014, and ``the 
        death rate associated with opioid pain medication'' had 
        increased ``markedly'' in the previous decade.\76\ The 
        guidelines explained that non-opioid therapies are preferred 
        for chronic pain and recommended that physicians prescribe 
        immediate-release opioids at the lowest effective dosage and 
        evaluate the benefits and harms of continued opioid use within 
        1 to 4 weeks of starting opioid therapy.\77\ The guidelines 
        also noted that for opioid therapy for acute pain, ``[t]hree 
        days or less will often be sufficient; more than 7 days will 
        rarely be needed.'' \78\
---------------------------------------------------------------------------
    \74\ Department of Health and Human Services, Centers for Disease 
Control and Prevention, ``CDC Guideline for Prescribing Opioids for 
Chronic Pain--United States, 2016'' (March 15, 2016) (www.cdc.gov/mmwr/
volumes/65/rr/pdfs/rr6501e1er.pdf). See also Deborah Dowell et al., 
``CDC Guideline for Prescribing Opioids for Chronic Pain--United 
States, 2016,'' JAMA Internal Medicine (April 19, 2016).
    \75\ ``CDC Painkiller Guidelines Aim to Reduce Addiction Risk,'' 
New York Times (March 15, 2016) (www.nytimes.com/2016/03/16/health/cdc-
opioid-guidelines.html).
    \76\ Department of Health and Human Services, Centers for Disease 
Control and Prevention, ``CDC Guideline for Prescribing Opioids for 
Chronic Pain--United States, 2016'' (March 15, 2016) (www.cdc.gov/mmwr/
volumes/65/rr/pdfs/rr6501e1er.pdf).
    \77\ Id.
    \78\ Id.

        These guidelines represented an important step--and perhaps the 
        first major step from the Federal Government--toward limiting 
        opioid prescriptions for chronic pain in the face of an 
        unprecedented public health crisis. A majority of the groups 
        described in this report, however, strongly criticized the 
        content of the guidelines, the process by which the CDC drafted 
        them, or the experts who assisted during their development. In 
        fact, The New York Times reported that the release of the CDC 
        guidelines ended ``months of arguments with pain doctors and 
        drug industry groups, which had bitterly opposed the 
        recommendations on the grounds that they would create unfair 
        hurdles for patients.'' \79\ As Dr. Andrew Kolodny, executive 
        director of Physicians for Responsible Opioid Prescribing, has 
        explained, ``[t]he opioid lobby has very actively blocked 
        interventions that might result in more cautious prescribing or 
        reduced prescribing. They've very clearly defended their 
        financial stake in the status quo.'' \80\
---------------------------------------------------------------------------
    \79\ ``CDC Painkiller Guidelines Aim to Reduce Addiction Risk,'' 
New York Times (March 15, 2016) (www.nytimes.com/2016/03/16/health/cdc-
opioid-guidelines.html).
    \80\ ``Opioid Epidemic: Ex-DEA Official Says Congress Is Protecting 
Drug Makers,'' Guardian (October 31, 2016) (www.theguardian.com/us-
news/2016/oct/31/opioid-epidemic-dea-official-congress-big-pharma).

        In 2016, for example, the immediate past president of the 
        American Academy of Pain Medicine, Daniel Carr, criticized the 
        prescribing guidelines, stating ``that the CDC guideline makes 
        disproportionately strong recommendations based upon a narrowly 
        selected portion of the available clinical evidence.'' \81\ 
        Similarly, several advocacy groups criticized draft guidelines 
        in 2015, arguing that the ``CDC slides presented on Wednesday 
        were not transparent relative to process and failed to disclose 
        the names, affiliations, and conflicts of interest of the 
        individuals who participated in the construction of these 
        guidelines.'' \82\ Dr. Richard Payne, a physician affiliated 
        with the Center for Practical Bioethics, made a similar 
        argument, criticizing the CDC guidelines as the product of 
        ``conflicts of interests in terms of biases [and] intellectual 
        conflicts''--while himself maintaining ``financial links to 
        numerous drug companies.'' \83\ The Washington Legal Foundation 
        also strongly criticized the guidelines on procedural grounds, 
        claiming CDC had developed its guidelines in an ``overly 
        secretive manner'' and in violation of the Federal Advisory 
        Committee Act, which called ``into question the viability of 
        the entire enterprise.'' \84\ The Washington Legal Foundation 
        claimed, moreover, that ``[s]tate governments and the medical 
        community are unlikely to accept any guidelines tainted by 
        charges that they were prepared in secret without meaningful 
        stakeholder input.'' \85\ When the CDC published its final 
        opioid prescribing guidelines, Richard A. Samp, Washington 
        Legal Foundation general counsel, reportedly believed the 
        guidelines ``were inherently biased, crafted by people who 
        already had strong views about what opioid policy should look 
        like.'' \86\
---------------------------------------------------------------------------
    \81\ Practical Pain Management, ``Responses and Criticisms Over New 
CDC Opioid Prescribing Guidelines'' (www.practicalpainmanagement.com/
resources/news-and-research/responses-criticisms-over-new-cdc-
opioidprescribing-guidelines) (accessed September 28, 2017).
    \82\ ``Chronic Pain Groups Blast CDC for Opioid Guidelines,'' Pain 
News Network (September 22, 2015) (www.painnewsnetwork.org/stories/
2015/9/22/chronic-pain-groups-blast-cdc-for-opioid-guidelines).
    \83\ ``Pro-Painkiller Echo Chamber Shaped Policy Amid Drug 
Epidemic,'' The Center for Public Integrity (September 19, 2016) 
(www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-
shaped-policy-amid-drug-epidemic).
    \84\ Washington Legal Foundation, ``Re: Guideline for Prescribing 
Opioids for Chronic Pain'' (November 17, 2015) (www.wlf.org/upload/
litigation/misc/CDCComments-Opioids.pdf). In addition to its work 
related to the pharmaceutical industry, the Washington Legal Foundation 
has also recently challenged the validity of Consumer Financial 
Protection Bureau enforcement actions, raised objections to certain 
Department of Labor disclosure requirements, and sought to enjoin the 
enforcement of a local ordinance requiring health warnings in 
advertisements for sugary drinks, among other initiatives. See 
Washington Legal Foundation, ``2016 Annual Report (2016)'' 
(www.wlf.org/pdf/WLF2016AnnualReport.pdf). WLF previously maintained a 
relationship with the Philip Morris tobacco company during regulatory 
disputes with the Food and Drug Administration throughout the 1990s. 
See, e.g., Letter from Steven C. Parrish, senior vice president, 
corporate affairs, Philip Morris, to Daniel J. Popeo, chairman and 
general counsel, Washington Legal Foundation (March 21, 1996) 
(www.industrydocumentslibrary.ucsf.edu/tobacco/docs/#id=zhfw0096); 
Philip Morris, ``REM Monthly Report'' (April 1994) (www.industry
documentslibrary.ucsf.edu/tobacco/docs/#id=fphm0071); memorandum from 
BSMG Worldwide to Philip Morris, ``Communications Plan--Supersized'' 
(February 25, 1999) (www.industry
documentslibrary.ucsf.edu/tobacco/docs/#id=xmyd0068).
    \85\ Washington Legal Foundation, ``Re: Guideline for Prescribing 
Opioids for Chronic Pain'' (November 17, 2015) (www.wlf.org/upload/
litigation/misc/CDCComments-Opioids.pdf).
    \86\ ``The CDC Just Told American Doctors to Rethink Pain Treatment 
and Opioid Addiction,'' Vice (March 17, 2016) (https://news.vice.com/
article/the-cdc-just-told-american-doctors-to-rethink-pain-treatment-
and-opioid-addiction).

        The fact that these groups registered their opposition while 
        receiving funding from the opioids industry raises the 
        appearance--at the very least--of a direct link between 
        corporate donations and the advancement of opioids-friendly 
        messaging. Relatedly, in a March 2017 article published in JAMA 
        Internal Medicine, researchers from Johns Hopkins University 
        and Brandeis University examined industry payments to over 150 
        organizations that had submitted comments on the draft CDC 
        guidelines.\87\ After coding guideline comments by 
        supportiveness and reviewing financial disclosures, including 
        annual reports, tax returns, and self-reported information, 
        researchers found ``opposition to the guidelines was 
        significantly more common among organizations with funding from 
        opioid manufacturers than those without funding from the life 
        sciences industry.'' \88\ Accordingly, a ``major concern is 
        that opposition to regulatory, payment, or clinical policies to 
        reduce opioid use may originate from groups that stand to lose 
        financially if opioids sales decline.'' \89\ In an extended 
        version of their findings, the researchers are more explicit: 
        ``[O]pposition to more conservative opioid use may, at least in 
        part, be financially motivated.'' \90\
---------------------------------------------------------------------------
    \87\ Dora H. Lin et al., ``Financial Conflicts of Interest and the 
Centers for Disease Control and Prevention's 2016 Guideline for 
Prescribing Opioids for Chronic Pain,'' JAMA Internal Medicine (March 
2017).
    \88\ Id. (emphasis added).
    \89\ Id.
    \90\ Dora H. Lin et al., ``Potential Financial Conflicts of 
Interest and Federal Opioid Guidelines: A Cross-Sectional Study 
(2017)'' (manuscript provided to minority staff).

---------------------------------------------------------------------------
        Efforts to Limit Accountability

        Certain advocacy groups and professional societies have also 
        organized legal efforts to challenge government actions to 
        punish physicians engaging in opioid overprescription and 
        executives responsible for fraudulent marketing of opioid 
        products. In 2005, for example, the National Pain Foundation 
        submitted to the U.S. Court of Appeals for the Fourth Circuit 
        an amicus brief in support of Dr. William Hurwitz,\91\ a doctor 
        convicted ``of 16 counts of drug trafficking, [for] 
        prescrib[ing] massive quantities of medicine to patients in 
        chronic pain.'' \92\ Prosecutors asserted that Dr. Hurwitz 
        ``prescribed excessive amounts of Oxycodone and other dangerous 
        narcotics--in one instance more than 1,600 pills a day--to 
        addicts and others, some of whom then sold the medication on a 
        lucrative black market.'' \93\ In defense of Dr. Hurwitz, the 
        National Pain Foundation suggested that ``[t]he conviction [in 
        the trial court] broke ground by holding that a doctor acting 
        in the good faith belief that he was serving the best medical 
        interest of his patient could be found to be a drug dealer.'' 
        \94\ Similarly, the Washington Legal Foundation filed an amicus 
        brief challenging the exclusion of three former Purdue 
        executives from participation in Federal health-care programs 
        for 12 years for their admitted failure to prevent the 
        fraudulent marketing of OxyContin.\95\ In a brief filed with 
        the U.S. Court of Appeals for the District of Columbia Circuit, 
        the Washington Legal Foundation argued-- unsuccessfully--that 
        the exclusion raised serious constitutional due process 
        concerns.\96\
---------------------------------------------------------------------------
    \91\ Brief for Amici, The American Pain Foundation, ``The National 
Pain Foundation and The National Foundation for the Treatment of Pain 
in Support of Appellant and Reversal of the Conviction'' (September 8, 
2005), United States v. William Eliot Hurwitz, 4th Cir. (No. 05-4474).
    \92\ ``Pain Doctor is Guilty of Drug Trafficking,'' Washington Post 
(April 28, 2007) (www.
washingtonpost.com/wp-dyn/content/article/2007/04/27/
AR2007042702204.html).
    \93\ Id.
    \94\ Brief for Amici, The American Pain Foundation, ``The National 
Pain Foundation and The National Foundation for the Treatment of Pain 
in Support of Appellant and Reversal of the Conviction'' (September 8 
2005), United States v. William Eliot Hurwitz, 4th Cir. (No. 05-4474).
    \95\ Brief of Washington Legal Foundation as Amicus Curiae in 
Support of Appellants Urging Reversal (June 29, 2011), Friedman v. 
Sebelius, D.C. Cir. (No. 11-5028); Friedman v. Sebelius, 686 F.3d 813 
(D.C. Cir. July 27, 2012)
    \96\ Brief of Washington Legal Foundation as Amicus Curiae in 
Support of Appellants Urging Reversal (June 29, 2011), Friedman v. 
Sebelius, D.C. Cir. (No. 11-5028).

FULL EXTENT OF INDUSTRY INFLUENCE ON GROUPS IS UNKNOWN 
This report does not capture the full extent of the financial ties 
between opioid manufacturers and patient advocacy groups and 
professional societies. According to the Associated Press and the 
Center for Public Integrity, for example, opioid manufacturers ``spent 
more than $880 million nationwide on lobbying and campaign 
contributions from 2006 through 2015--more than 200 times what those 
advocating for stricter [opioid] policies spent.'' \97\
---------------------------------------------------------------------------
    \97\ ``Politics of Pain: Drugmakers Fought State Opioid Limits Amid 
Crisis,'' The Center for Public Integrity (December 15, 2016) 
(www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-
fought-state-opioid-limits-amid-crisis).

Moreover, payments between 2012 and 2017 may not fully reflect 
historical funding activities by manufacturers, given that several of 
the most prominent advocates in this space historically--the American 
Pain Foundation, for example--no longer operate. The fact that opioid 
prescribing, as measured in morphine milligram equivalents (MME) per 
capita, peaked between 2010 and 2012 before declining from 2012 to 2015 
may also suggest more robust financing of advocacy groups in the pre-
2012 period.\98\
---------------------------------------------------------------------------
    \98\ See Dr. Gery P. Guy Jr. et al., ``Vital Signs: Changes in 
Opioid Prescribing in the United States, 2006-2015,'' CDC Morbidity and 
Mortality Weekly Report (July 7, 2017) (www.cdc.gov/mmwr/volumes/66/wr/
mm6626a4.htm).

In addition, the data contained in this report may not even capture the 
full extent of payments between the covered manufacturers and patient 
advocacy groups and professional societies. This report is based on 
information provided voluntarily to the committee at the request of the 
ranking member--information which certain manufacturers changed 
following further inquiries from the minority staff. A timeline of 
interactions between the committee, manufacturers, and advocacy groups 
---------------------------------------------------------------------------
appears below as Figure 9.

As mentioned above, Ranking Member McCaskill sent requests for payments 
information to Purdue, Janssen, Insys , Depomed, and Mylan on March 28, 
2017.\99\ On April 25, 2017, Depomed provided an initial response, 
closely followed a response from Purdue on May 11, 2017, and a response 
from Janssen on June 12, 2017.\100\ Following extensive discussions 
with minority staff, Mylan provided payments information on October 5, 
2017.\101\
---------------------------------------------------------------------------
    \99\ See, e.g., letter from Senator Claire McCaskill to Santosh 
Vetticaden, interim chief executive officer of Insys Therapeutics, Inc. 
(March 28, 2017).
    \100\ Production from Depomed to the Senate Homeland Security and 
Governmental Affairs Committee (April 25, 2017); production from Purdue 
Pharma to the Senate Homeland Security and Governmental Affairs 
Committee (May 11, 2017); production from Johnson & Johnson to the 
Senate Homeland Security and Governmental Affairs Committee (June 12, 
2017).
    \101\ Production from Mylan to the Senate Homeland Security and 
Governmental Affairs Committee (October 5, 2017).

On October 5, 2017, Ranking Member McCaskill sent requests for payment 
information directly to 15 advocacy groups and professional 
societies.\102\ Following these letters, several manufacturers 
volunteered additional or revised data. After further due diligence, 
for example, Janssen reported an additional $7,500 payment to the 
American Academy of Pain Medicine and an additional $128,000 in 
cumulative payments to the Academy of Integrative Pain Management.\103\ 
Purdue also provided updated information showing an additional $70,552 
in payments to the American Academy of Pain Medicine, $415,574 in 
payments to the American Pain Society, and $17,755 in payments to the 
American Society of Pain Management Nursing.\104\ For the first time, 
Purdue also reported $1,091,025 in payments to the Academy of 
Integrative Pain Management--the company had not searched for payments 
to the American Academy of Pain Management, the previous name of the 
organization--and $168,500 in payments to the American Cancer Society 
Cancer Action Network.\105\ Purdue additionally reported over $91,000 
in payments associated with incomplete entity names in company 
records.\106\
---------------------------------------------------------------------------
    \102\ See, e.g., letter from Senator Claire McCaskill to Steven P. 
Stanos, president, American Academy of Pain Medicine (October 5, 2017).
    \103\ See Production from Johnson & Johnson to the Senate Homeland 
Security and Governmental Affairs Committee (June 12, 2017); production 
from Johnson & Johnson to the Senate Homeland Security and Governmental 
Affairs Committee (November 10, 2017).
    \104\ See production from Purdue Pharma to the Senate Homeland 
Security and Governmental Affairs Committee (May 11, 2017); production 
from Purdue Pharma to the Senate Homeland Security and Governmental 
Affairs Committee (November 13, 2017).
    \105\ Id. As stated above, the total for the American Cancer 
Society Cancer Action Network also included payments from Purdue to the 
American Cancer Society that could potentially apply to the Cancer 
Action Network.
    \106\ Production from Purdue Pharma to the Senate Homeland Security 
and Governmental Affairs Committee (November 13, 2017).

A comparison of payments information from the five manufacturers and 
the information advocacy groups provided directly to the committee 
revealed several discrepancies. Most significantly, Insys Therapeutics 
initially failed to report $2,500,000 in responsive payments to the 
U.S. Pain Foundation for the ``Gain Against Pain'' patient assistance 
program.\107\ The company also did not report $12,500 in payments the 
Academy of Integrative Pain Management reported receiving in 2014 and 
2015 and could not confirm or deny these payments after further due 
diligence.\108\ (Insys did, however, report an additional $3,050 in 
payments to the Academy of Integrative Pain Management during 
2012.\109\) Purdue also failed to report $40,000 in corporate 
roundtable dues to the American Geriatrics Society Health in Aging 
Foundation; according to the American Geriatrics Society, this 
foundation received all payments Purdue directed to the organization 
between 2012 and 2017.\110\
---------------------------------------------------------------------------
    \107\ See letter from Paul Gileno, U.S. Pain Foundation, to Senator 
Claire McCaskill (October 5, 2017); letter from Brian D. Smith, counsel 
for Insys Therapeutics, to Senator Claire McCaskill (November 10, 
2017). As stated above, one payment between Insys and the U.S. Pain 
Foundation related to this program--a $250,000 payment on April 7, 
2017--fell outside of the scope of the March 28, 2017 requests, and is 
not included in this total. See email from Brian D. Smith, counsel for 
Insys Therapeutics, to Senate Committee on Homeland Security and 
Governmental Affairs minority staff (December 1, 2017).
    \108\ See production from the Academy of Integrative Pain 
Management to the Senate Homeland Security and Governmental Affairs 
Committee (October 31, 2017); Brian D. Smith, counsel for Insys 
Therapeutics, briefing with Senate Committee on Homeland Security and 
Governmental Affairs minority staff (November 28, 2017).
    \109\ Email from Brian D. Smith, counsel for Insys Therapeutics, to 
Committee on Homeland Security and Governmental Affairs minority staff 
(December 1, 2017).
    \110\ Letter from Nancy E. Lundebjerg, American Geriatrics Society, 
to Senator Claire McCaskill (October 11, 2017). According to counsel 
for Purdue, the company could verify three out of four payments to the 
American Geriatrics Society Health in Aging Foundation. Reginald J. 
Brown, Counsel for Purdue Pharma, briefing with Senate Committee on 
Homeland Security and Governmental Affairs minority staff (November 29, 
2017).

[GRAPHIC] [TIFF OMITTED] T1918.004


In addition, Depomed later reported five additional responsive 
payments--totaling $17,600 to the American Chronic Pain Association and 
$28,174.95 to the Academy of Integrative Pain Management--after 
receiving further correspondence from minority staff.\111\ According to 
Depomed, these payments ``were for advertising or promotional 
purposes,'' and the company initially considered them outside the scope 
of the March 28, 2017, requests.\112\ Finally, in response to 
information from minority staff, Janssen representatives also reported 
the company had made an additional $68,500 in payments to the American 
Pain Society and an additional $76,475 in payments to the American 
Academy of Pain Medicine via a third party during the 2012-2017 time 
period.\113\
---------------------------------------------------------------------------
    \111\ Email from Catherine A. Byrd to Committee on Homeland 
Security and Governmental Affairs minority staff (December 1, 2017); 
letter from J. Evans Rice, counsel for Depomed, to Senator Claire 
McCaskill (December 5, 2017).
    \112\ Id.
    \113\ Daniel F. Donovan, counsel for Janssen, briefing with Senate 
Committee on Homeland Security and Governmental Affairs minority staff 
(December 11, 2017); Daniel F. Donovan, counsel for Janssen, briefing 
with Senate Committee on Homeland Security and Governmental Affairs 
minority staff (January 17, 2018); email from Daniel F. Donovan, 
counsel for Janssen, to Committee on Homeland Security and Governmental 
Affairs minority staff (January 31, 2018).
---------------------------------------------------------------------------

CONCLUSION

The privacy the advocacy groups discussed above have guarded for their 
donors has come at a high price for the public debate on chronic pain 
and opioid use in the United States. As a 2011 study in the American 
Journal of Public Health noted, a tension exists between the status of 
advocacy organizations as ``among the most influential and trusted 
stakeholders in U.S. health policy,'' and the reality that their 
``positions closely correspond to the marketing aims of pharmaceutical 
and device companies.'' \114\ The findings in this report indicate that 
this tension exists in the area of opioids policy--that organizations 
receiving substantial funding from manufacturers have, in fact, 
amplified and reinforced messages favoring increased opioid use. By 
aligning medical culture with industry goals in this way, many of the 
groups described above may have played a significant role in creating 
the necessary conditions for the U.S. opioids epidemic.
---------------------------------------------------------------------------
    \114\ Sheila M. Rothman et al., ``Health Advocacy Organizations and 
the Pharmaceutical Industry: An Analysis of Disclosure Practices,'' 
American Journal of Public Health (April 2011).

                                 ______
                                 
                 Prepared Statement of Hon. Ron Wyden, 
                       a U.S. Senator From Oregon
    Thank you, Chairman Hatch, for convening this vitally important 
hearing, which gives the committee an opportunity to examine the opioid 
issue while it works on bipartisan legislation under the chairman's 
leadership. I'm going to have some comments on that process in a 
moment, but here's where I want to begin my remarks.

    It is long past time to get the opioid executives before this 
committee, have them raise their right hands, and hold them accountable 
for their role in creating a public health calamity that is killing 
tens of thousands of Americans each year.

    Some years ago, I participated in a House hearing where a panel of 
tobacco executives said under oath that their products were not 
addictive. And in my view, there's a clear parallel you can draw to 
this issue today.

    Back then it was tobacco companies that concealed the dangers of 
their products and denied they were addictive. Now it's the opioid 
companies, including those that manufacture the drugs and those that 
distribute the drugs, that have misled the country about the dangers of 
their products. The opioid executives, however, have avoided the 
spotlight that Congress put on the executives of the big tobacco 
companies.

    That has got to change, colleagues. The executives need to be 
brought before this committee and held accountable. Flooding American 
communities with these drugs is big business, and so-called ``safer'' 
opioid pills keep the cash registers ringing. Congress would be 
derelict in its responsibilities if it pretends there is no profit 
motive or corporate scheming behind this addiction crisis.

    In 2015, more than 52,000 Americans died of a drug overdose. In 
2016, it increased to 64,000. In 2017, it was 71,000. There's a tragic 
and well-documented pattern of opioid addiction escalating into abuse 
of heroin and fentanyl. Now an even stronger narcotic called 
carfentanil is spreading. Carfentanil is supposed to be used as a 
sedative for elephants. It's so potent and dangerous, first responders 
are advised to wear hazmat suits when they're around it. That's the 
horrifying level of danger plaguing our communities as a result of this 
epidemic.

    Those of us looking for answers also have to deal with the 
paradoxical reality that cutting down the supply of opioids too sharply 
could drive even more people to heroin and other drugs, leading to even 
more overdose deaths. There is no easy way out of this crisis. With 
that said, I believe Congress has an opportunity to take bipartisan 
action. For example, there must be a way to address what I call the 
``prescription pendulum.'' Doctors used to be criticized for 
prescribing too conservatively. Now they're criticized fairly for 
prescribing too much. There's got to be a safer middle ground.

    I remember a case from my days as the head of the Oregon Gray 
Panthers. A gentleman called me and said his 92 year old father was in 
pain and couldn't get a prescription. Ninety-two years old, and his 
doctor said ``No no no, the risk of addiction is way too high.'' 
Compare that with the fact that today, one in three Medicare patients 
has a prescription for opioids.

    I've also heard powerful, agonizing stories from parents in Oregon 
who've lost children to this epidemic. At a roundtable, I met Kerry 
Strickland, who lost her son Jordan to an overdose. Jordan was a star 
athlete in the tiny Columbia River town of Knappa. When he suffered an 
injury, he was prescribed opioids. He started using heroin, and for 
years he struggled in the battle between addiction and recovery. I went 
to school on a basketball scholarship myself. It's heartbreaking to 
hear these stories, which are far too common. I've heard them in every 
corner of my home State, in communities of all stripes.

    Here on this committee, under Chairman Hatch's leadership, there is 
bipartisan interest in finding new legislative proposals to help make a 
difference. And the chronic care legislation that just became law shows 
that this committee can work together on the big health policy 
challenges. So the chairman and I are working with every member to 
identify meaningful policies that can achieve broad, bipartisan 
support. Colleagues on both sides have done a lot of work on this 
issue. On our side, Senator Brown has been tireless. And I particularly 
want to mention how fortunate the committee is to have the senior 
Senator from Missouri on our roster. Nobody has outworked Senator 
McCaskill when it comes to investigating how this crisis came to be and 
how to hold accountable those who are responsible.

    Particularly important to this committee is the vital role Medicaid 
plays in treatment. Four out of 10 working-age Americans suffering from 
opioid addiction rely on Medicaid. It's the largest source of funding 
for treatment in the country, so in my view, Medicaid is going to be a 
key part of any solution.

    The landmark reforms to our child welfare system that this 
committee led on a bipartisan basis, the Family First Act, are also 
going to help curb this epidemic. Family First is all about keeping 
families together whenever possible. So under the law, if a parent is 
swept up in opioid addiction, a grandparent or another close relative 
can step in to care for youngsters while mom or dad gets the treatment 
they need. It would provide support for both the parent's treatment and 
services for the relatives. The end result you hope for is a family 
that's able to stay together safely. It's going to take hard work 
between HHS and the States to prepare for this major reform, but the 
chairman and I are determined to see this law implemented as intended.

    Finally, a warm welcome to our witnesses, one of whom, Kim Brandt, 
is a Finance Committee veteran. It's great to have Kim back to work on 
this vital subject.

    Thank you, Chairman Hatch. I look forward to continuing our work on 
this critical issue.

                                 ______
                                 

                          United States Senate

                          committee on finance

                       Washington, DC 20510-6200

                            February 5, 2016

The Honorable Sylvia Mathews Burwell
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Burwell:

Prescription opioid addiction is a serious condition, and its increased 
prevalence in recent years is cause for alarm. Since 2000, the rate of 
deaths from opioid-related overdoses has increased by 200% and in 2014 
alone, 61% of all overdose deaths were opioid-related.\1\ A recent 
examination of Medicare Part D prescribers found that total opioid 
prescriptions are dominated by general practitioners in the primary 
care setting.\2\ While the study found that opioid prescriptions are 
concentrated in select specialty services such as pain, and anesthesia, 
data from Medicare Part D suggests opioid prescribing in the program is 
a ``widespread practice relatively indifferent to individual 
physicians, specialty or region.'' \3\
---------------------------------------------------------------------------
    \1\ CDC, ``Increases in Drug and Opioid Overdose Deaths--United 
States, 2000-2014,'' https://www.cdc.gov/mmwr/preview/mmwrhtml/
mm6450a3.htm.
    \2\ Jonathan H. Chen, et al., ``Distribution of Opioids by 
Different Types of Medicare Providers,'' JAMA Intern. Med. 2015, 
available at https://jamanetwork.com/journals/jamainternalmedicine/
fullarticle/2474400.
    \3\ Id.

Consequently, I was alarmed to read of efforts by the members of the 
Interagency Pain Research Coordinating Committee (IPRCC) to weaken 
efforts underway at the Centers for Disease Control and Prevention 
(CDC) to develop guidance on opioid prescribing practices.\4\ A 
preliminary review by my staff of the IPRCC has raised a number of 
concerns including what appear to be personal and institutional 
conflicts of interest of non-Federal IPRCC members related to opioid 
manufacturers. The Associated Press also has reported on some of these 
apparent conflicts.\5\ I am writing today to seek clarification on the 
procedures and conflict of interest requirements that govern operation 
of, and membership on, the IPRCC.
---------------------------------------------------------------------------
    \4\ Politico, ``HHS split on CDC opioid prescription guidelines,'' 
by Brett Norman, December 3, 2015, https://www.politicopro.com/staff/
brett-norman.
    \5\ Associated Press. ``Federal pain panel rife with links to 
pharma companies,'' by Matthew Perrone, January 27, 2016, https://
apnews.com/6e22f8ffcded4b2e9ba278bcc00f4f53.

As you know, the Secretary of Health and Human Services was required by 
law to establish the IPRCC.\6\ In addition to members appointed by the 
Secretary from Federal agencies that conduct pain care research and 
treatment, the Secretary is required to appoint six non-Federal members 
who are scientists, physicians, or other health professionals.\7\ The 
Secretary is also required to appoint six members who are 
representatives of leading research, advocacy and services 
organizations for individuals with pain-related conditions.\8\ The 
statute makes no provision that representatives of the pharmaceutical 
industry are included on the panel. The statute also does not specify 
terms of service of board members, but it is my understanding that 
members are appointed to specific terms. At the December 3, 2015 
meeting of the IPRCC at which the CDC opioid guidance was discussed, 
several members whose terms had expired were allowed to continue to 
serve on the Committee and to participate in the meeting.\9\
---------------------------------------------------------------------------
    \6\ Sec. 409J. Pub. L. 111-148.
    \7\ Sec. 409J(b)(2)(B)(i).
    \8\ Sec. 409J(b)(2)(B)(ii).
    \9\ According to the committee roster provided by the Department, 
three of the six public members of the committee had terms that expired 
on July 31, 2015--Myra J. Christopher, Center for Practical Bioethics; 
Tina M. Tockarshewsky, The Neuropathy Association; and Christin L. 
Veasley, Chronic Pain Research Alliance. All attended the December 3, 
2015 meeting, http://iprcc.nih.gov/meetings/12-3-
2015_IPRCC_Meeting.htm.

Several non-Federal IPRCC members, their organizations, or both, appear 
to be recipients of funding from major pharmaceutical companies that 
manufacture opioids or related products at levels that raise concerns 
regarding the potential for conflicts of interest. These financial and 
professional relationships raise serious concerns about the objectivity 
of the panel's members that deserve additional review. In addition, 
three non-Federal IPRCC public members appear to have strong 
---------------------------------------------------------------------------
connections to opioid-related drug manufacturers.

One public member who attended the December 3rd meeting--Ms. Myra 
Christopher--is financially supported through an endowed chair at the 
organization that employs her--the Center for Practical Bioethics. 
According to publicly available records, the $1.5 million endowment for 
that chair came from Purdue Pharma, the manufacturer of the opioid 
Oxycontin--and was established while she was the chief executive of the 
organization.\10\ Funding for the endowment was provided by Purdue 
Pharma in three $500,000 allocations in 2008, 2009, and 2011 
respectively.\11\ She has remained on the staff of that 
organization.\12\
---------------------------------------------------------------------------
    \10\ McBride, Lock, and Associates, ``Report of Examination of the 
Center for Practical Bioethics, Inc., Kansas City, MO for the Year 
Ended December 31, 2008,'' April 13, 2008, http://gkccf.guidestar.org/
nonprofit.aspx?orgid=1193.
    \11\ McBride, Lock, and Associates, ``Report on Examination of the 
Center for Practical Bioethics, Inc., Kansas City, MO as of and for the 
Year Ended December 31, 2010,'' July 21, 2011, http://
gkccf.guidestar.org/nonprofit.aspx?orgid=1193.
    \12\ Based on tax records and the organization's annual reports, it 
appears that Ms. Christopher did not step down as president and CEO of 
the Center until mid-2011. The Greater Kansas City Community Foundation 
makes publicly available the records for the organization at http://
gkccf.guidestar.org/nonprofit.aspx?orgid=1193 (accessed January 28, 
2016).

In addition to the endowment supporting Ms. Christopher's employment, 
Purdue Pharma provides substantial funding to the organization that 
employs Ms. Christopher. For instance, in 2013, publicly available 
records indicate Purdue Pharma contributed $100,000 to the Center, 
making the company its second largest contributor that year.\13\ As 
noted above, Ms. Christopher's term of service had expired, but she 
continued to participate in the Committee's December 3rd deliberations.
---------------------------------------------------------------------------
    \13\ Ibid.

One of the IPRCC's other non-Federal members--Dr. Richard Payne--is 
also employed by the Center for Practical Bioethics.\14\ I am concerned 
that this single organization with significant ties to a major opioid 
manufacturer had two paid staff sitting as committee members at the 
same time.
---------------------------------------------------------------------------
    \14\ According to Center's website, Dr. Payne is listed as Center 
staff. https://www.
practicalbioethics.org/about-us/staff. The Center's Form 990 for 2013 
and 2014 each list Dr. Payne under Part VII, ``Officers, Directors, 
Trustees, Key Employees, and Highly Compensated Staff,'' with annual 
compensation exceeding $111,000, http://gkccf.guidestar.org/
nonprofit.aspx?orgid=1193.

I also note that Dr. Payne appears to have additional ties to Purdue 
Pharma. In 2013, Dr. Payne reportedly received $2,000 in travel and 
lodging from the company to attend a meeting for which he received an 
additional $4,700 for ``services other than consulting, including 
serving as faculty or as a speaker'' from a Purdue affiliate--Purdue 
Transdermal Technologies L.P.\15\ Dr. Payne was selected to be one of 
two coordinators of the IPRCC efforts to critique the proposed CDC 
guidelines according to the minutes of the December 3, 2015 
meeting.\16\
---------------------------------------------------------------------------
    \15\ Centers for Medicare and Medicaid Services Open Payments, 
https://openpaymentsdata.cms.gov/physician/1094555. Open Payments also 
includes a report for 2014 showing that Dr. Payne received an honoria 
of $1,500 from Teva Pharmaceuticals USA, Inc., another manufacturer of 
opioid prescription drugs, along with travel and lodging associated 
with the event, http://www.uspainfoundation.org/.
    \16\ Interagency Pain Research Coordinating Committee, December 3, 
2015 meeting minutes, http://iprcc.nih.gov/meetings/12-3-
15_Meeting_Minutes.htm (accessed January 28, 2016).

Another public member of the IPRCC--Cindy Steinberg--is the National 
Policy Director of the U.S. Pain Foundation. This organization appears 
to receive substantial funding from opioid manufacturers. According to 
publicly available documents posted on the Foundation's website, a 
majority of the organization's funding in 2012 came from major 
pharmaceutical manufacturers.\17\ That year the organization received 
more than $180,000 from pharmaceutical manufacturers including Pfizer 
($50,000), Purdue Pharma ($30,000), Teva ($43,000), Endo ($30,000), 
Johnson & Johnson ($7,500), and the trade group PHRMA ($20,000).\18\ 
The organization's most recent IRS filing for 2014 shows that the 
organization continues to receive large contributions from the 
pharmaceutical industry, including $104,800 from Purdue Pharma.\19\
---------------------------------------------------------------------------
    \17\ U.S. Pain Foundation, Form 990 for tax year 2012, at http://
uspainfoundation.org/Docs/2012-990-taxes-signed-complete.pdf (accessed 
January 28, 2016).
    \18\ Ibid.
    \19\ U.S. Pain Foundation, Form 990 for tax year 2014, at http://
www.uspainfoundation.org/wp-content/uploads/2015/12/2014-taxes.pdf 
(accessed January 28, 2016).

A third public member--Penney Cowan--heads the American Chronic Pain 
Association. The organization reports receiving corporate support from 
11 companies that manufactured opioid-based drugs--AbbVie, Collegium 
Pharmaceutical, Depomed, Egalet, Janssen, Mallinckrodt, Pfizer, Purdue, 
Shionogi, Teva, and Zogenix.\20\ Its ``corporate champion,'' which 
appears to be its highest corporate contributor, is AstraZeneca. The 
company produces and markets a drug to relieve opioid-induced side-
effects--Movantik.\21\ Furthermore, the organization's advisory board 
includes J. David Haddox, Purdue Pharma's vice president for health 
policy.\22\ The advisory board also includes Dr. Judith Paice, one of 
the IPRCC scientific members. Dr. Paice is the second coordinator of 
the IPRCC critique of the CDC guidelines.
---------------------------------------------------------------------------
    \20\ American Chronic Pain Foundation, ``Partners and 
Contributors,'' at https://theacpa.org/Partners-Contributors (accessed 
January 28, 2016). Zogenix sold its pain franchise in May 2015.
    \21\ AstraZeneca, ``MovantikTM (naloxegol) tablets for 
the treatment of opioid-induced constipation in adult patients with 
chronic non-cancer pain launched in the U.S.,'' March 31, 2015, http://
www.astrazeneca-us.com/media/press-releases/Article/20150330-movantik-
launched-in-the-us.
    \22\ The advisory panel also includes three doctors who received 
$1,000 or more from opioid-related pharmaceutical companies according 
to Open Payments data for 2014. One of those doctors, Steven Stanos, 
received over $40,000 in consulting fees and other reimbursements from 
three companies--Mallinckrodt, Pfizer, Inc., and Zogenix, Inc. in 2013 
and 2014. Centers for Medicare and Medicaid Services Open Payments, 
https://openpaymentsdata.cms.gov/physician/138667.

I am requesting that you provide the following information within 
---------------------------------------------------------------------------
twenty-one (21) days from the date of this letter:

    (1)  The Department's policies on appointments to and terms of 
service for non-Federal members of the IPRCC.

    (2)  The personal and organizational conflict of interest policies 
and disclosure requirements for non-Federal members of the IPRCC.

    (3)  Confirmation that employees and representatives of the Center 
for Practical Bioethics and the U.S. Pain Foundation who serve on the 
IPRCC, as well as all other members of the IPRCC, fully disclosed the 
financial and institutional support they and their organizations 
receive from Purdue Pharma and other pharmaceutical manufacturers.

    (4)  A description of the process by which the IPRCC comments 
concerning the CDC guidelines were drafted and approved by the 
Committee.

Thank you for assistance in this matter. If you or your staff have 
questions concerning this request please contact David Berick, Chief 
Investigator for the Democratic staff of the Finance Committee, at 202-
224-4515.

Sincerely,

Ron Wyden
Ranking Member
U.S. Senate
Committee on Finance

                                 ______
                                 

                          United States Senate

                          committee on finance

                       Washington, DC 20510-6200

                             June 23, 2016

The Honorable Sylvia Mathews Burwell
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Burwell:

On April 8, 2016, I received a response from Dr. Francis Collins to my 
February 5, 2016 letter regarding apparent conflicts of interest 
associated with the Interagency Pain Research Coordinating Committee 
(IPRCC).

After reviewing Dr. Collin's response, I am even more concerned that 
the Department of Health and Human Services does not adequately 
consider financial and organizational conflicts of interest when 
creating and managing advisory committees. For example, an opioid 
manufacturer directly funded an endowment for one of the committee's 
participants, and despite this relationship, that individual 
participated on the panel--including deliberations regarding the CDC's 
opioid prescription guidelines. In my view, this is indicative of a 
flawed conflicts of interest policy.

Dr. Collins also asserts that these conflicts of interest are absent 
given that committee members are not representatives of their 
organizations when they serve on the committee. This assertion 
conflicts with the requirements of the authorizing statute which 
establishes that 6 of the 12 non-Federal members ``. . . shall be 
members of the general public, who are representatives of leading 
research, advocacy, and service organizations . . . '' (emphasis 
added).\1\
---------------------------------------------------------------------------
    \1\ 42 U.S.C. 284q.

Dr. Collins's assertion that committee members are not representatives 
of the organizations is further undercut by the committee's website,\2\ 
minutes,\3\ and members' statements at meetings. For example, Dr. 
Richard Payne, one of the two panel members who lead the panel's 
discussion of the proposed CDC opioid prescribing guidelines, 
identified himself as being ``from Duke and the Center for Practical 
Bioethics in Kansas City'' during that discussion.\4\ I would note that 
although the meeting roster and minutes identify Dr. Payne as being 
affiliated with Duke, they do not identify his affiliation with the 
Center.\5\
---------------------------------------------------------------------------
    \2\ National Institutes of Health, December 3, 2015 IPRCC meeting 
roster, December 3, 2015, https://iprcc.nih.gov/meetings/2015/12-3-
2015_IPRCC_Meeting_Roster.htm, accessed on June 16, 2016.
    \3\ National Institutes of Health, meeting minutes, Interagency 
Pain Research Coordinating Committee, December 3, 2015, https://
iprcc.nih.gov/meetings/12-3-2015_Meeting_Minutes.htm, accessed on June 
16, 2016.
    \4\ National Institutes of Health, Interagency Pain Research 
Coordinating Committee--December 2015, 6:05:58 (comments at 4:58:15), 
December 3, 2015, https://videocast.nih.gov/
summary.asp?Live=17523&bhcp=1, accessed on June 16, 2016.
    \5\ Supra, notes 2 and 3.

In regards to the concerns I raised about two employees of a single 
organization filling 2 of the 12 statutorily designated, non-Federal 
positions failing to provide balance--like Payne, Ms. Myra Christopher 
also is employed by the Center for Practical Bioethics--Dr. Collins 
reiterated his argument that members do not represent their own 
organizations. Dr. Collins also insisted that HHS has taken great care 
to ensure that committee ``. . . membership is balanced in terms of the 
points of view and the functions performed . . .'' when this appears 
---------------------------------------------------------------------------
not to have been the case.

Dr. Collins's acceptance of these conflicts is of serious concern, 
particularly considering that Dr. Payne, in his capacity as a panel 
member moderating the discussion on the CDC prescribing guidelines, 
appeared intent on holding CDC to a much higher conflict of interest 
standard than NIH has appeared to have done with its own IPRCC panel 
members.

During the December meeting, Dr. Payne questioned both the methodology 
the CDC took in developing its opioid prescribing recommendations, and 
the objectivity of CDC's reviewers:

        So I guess just one more question and follow-up from me. So if 
        there is strong recommendations (sic) with weak evidence, that 
        suggests that you are heavily dependent on kind of the 
        expertise of the reviewers, which then leads to the question of 
        who are the reviewers, and what were the processes by which the 
        reviewers were selected--who they were, how transparent was the 
        process by which they were working, etc. . . . Were there any 
        conflict of interest (sic)--beyond just financial conflict of 
        interest--but conflicts of interests in terms of, possible--you 
        know--perceptions, biases, intellectual kinds of conflicts of 
        interest or confluence, conflicts of interest that need to be 
        disclosed as part of the guideline dissemination process? . . . 
        It just seems to me that if there is weak evidence, then you 
        are--having been involved with guideline processes myself in 
        the old [Agency Healthcare Research and Quality] days--it does 
        really suggest you are very dependent on the expert reviewers 
        and then the question is, you know, do you have a really kind 
        of--for want of a better term--balanced perspective in terms of 
        who is reviewing what.\6\
---------------------------------------------------------------------------
    \6\ National Institutes of Health, Interagency Pain Research 
Coordinating Committee--December 2015, 6:05:58 (comments at 5:01:16), 
December 3, 2015, https://videocast.nih.gov/
summary.asp?Live=17523&bhcp=1, accessed on June 16, 2016.

Given these continuing concerns, please provide responses to the 
---------------------------------------------------------------------------
questions and information requests below:

    1.  According to the letter of April 8, 2016, candidates for the 
public and scientific panels ``are reviewed for eligibility through 
criteria for leadership, expertise, and contributions to pain cure and 
relevant research by NIH staff and Institute and Center Directors with 
pain care research expertise.''

         a.  Please provide the standards for each of the above-listed 
        criteria, and any such guidance that is used by staff to 
        evaluate candidates in the selection process.
         b.  Please provide an analysis of each individual committee 
        member, and how each scientific and public member of the IPRCC 
        met these criteria as of December 2015.
         c.  Please provide any documents, including but not limited 
        to: emails, memos, notes, or any additional written or 
        electronic materials that discuss the appointment of past or 
        present members to the IPRCC and their qualifications met the 
        required standards.

    2.  The statute establishing the committee requires that six non-
Federal members ``shall be appointed from among scientists, physicians, 
and other health professionals, and that the remaining six shall be 
appointed from members of the public, who are representatives of 
leading research, advocacy, and service organizations for individuals 
with pain-related conditions.''

         a.  Please provide the standards and any relevant guidance 
        utilized to evaluate and select the scientific appointees, in 
        addition to the members of the public serving on the committee.
         b.  Please provide a member-by-member analysis of how each 
        scientific and public member of the IPRCC met this criteria, as 
        of December 3, 2015.
         c.  Please provide any documents, including, but not limited 
        to: emails, memos, or any additional written or electronic 
        materials that discuss the appointment of former or current 
        members on the IPRCC, and the ways in which their 
        qualifications met the required standards.

    3.  According to the letter received on April 8, 2016, ``the 
nomination slate is drafted at the National Institute of Neurological 
Disorders and Stroke (NINDS), forwarded to the NIH Director for 
concurrence then approved by the Secretary.'' Please provide all 
nomination slates that were drafted by the NINDS, and occurrences or 
alterations made by the NIH Director and the Secretary since the 
creation of the Panel.

    4.  According to the April 8, 2016 letter, ``under some 
circumstances, [committee member's] terms may be extended 
administratively for a specific period.''

         a.  Please detail all policies and guiding materials that were 
        utilized in setting standards and terms for extension.
         b.  Please provide a list of all IPRCC members, past or 
        present, whose terms have been extended.
         c.  For each such person, provide the documentation and 
        material proof that these guiding policies were used in the 
        approval of each member's term extension.

    5.  According to the April 8, 2016 letter, ``the conflict of 
interest policies and disclosure requirements for non-Federal members 
of the IPRCC follow agency policies for members of Federal advisory 
committees.''

         a.  Please provide all such policies and disclosure 
        requirements.
         b.  Do agency policies differ from the Department's policy? If 
        so, please explain how they differ.
         c.  Please provide a list of all advisory committees within 
        NIH to which these ``agency policies'' apply regarding 
        conflicts of interest.

    6.  According to the April 8, 2016 letter, ``before serving as a 
member of the IPRCC, each non-Federal member is appointed as a Special 
Government Employee, and is required to file a detailed financial 
disclosure form (OGE 450), which is updated bi-annually during their 
term of service.'' The letter also notes that each member disclosed 
``the research support or earned income they receive from 
pharmaceutical manufacturers and other biomedical entities.''

         a.  Please provide completed copies of these forms for each 
        non-Federal member since the inception of the IPRCC.
         b.  Please provide a detailed, written itemization of the 
        research support or earned income received by each IPRCC member 
        from pharmaceutical manufacturers and other biomedical 
        entities, and associated documentation disclosing this support 
        or income.

    7.  According to the April 8, 2016 letter, IPRCC members are 
``advised, in writing, of applicable standards of conduct, including 
conflict of interest statutes, and must affirm with signature that they 
received and read the information.''

         a.  Please provide copies of the above-referenced materials 
        that were provided to members.
         b.  Please provide the signed forms for each non-Federal 
        member of the IPRCC since its inception.

    8.  According to the April 8, 2016 letter, IPRCC members ``agree to 
recuse, consistent with applicable law, from discussions that might 
specifically involve a particular company or product.''

         a.  Please provide a list of all instances in which IPRCC 
        members recused themselves from committee discussions, the 
        dates, and the topics of the discussion.
         b.  Please provide a list of all instances when the IPRCC 
        discussed prescription opioids, including but not limited to 
        those manufactured by or being developed by Purdue Pharma, 
        Pfizer, Inc., Teva Pharmaceuticals, Teva, Endo, Johnson & 
        Johnson, AbbVie, Collegium Pharmaceutical, Depomed, Eglat, 
        Janssen, Mallinckrodt, Shionogi, or Zogenix.
         c.  Please provide a list of all instances when the IPRCC 
        received written or oral communications or presentations 
        related to its work from representatives of any of the 
        companies listed in question (b), other manufacturers of 
        prescription opioids, or any group or organization that 
        represents or is funded by manufacturers of prescription 
        opioids.

The public expects governmental advisory committees to be impartial 
authorities when it comes to research and guidance on policy. When 
conflicts of interest are not sufficiently transparent or accounted for 
that impartiality can too easily be called into question. Given the 
public health epidemic rooted in prescription opioid addiction, current 
policy governing these powerful drugs merits particularly close 
scrutiny and at this time appears to be inadequate.

Please provide your responses to this request by June 30, 2016. If you 
or your staff have questions concerning this matter, please contact 
David Berick or Peter Gartrell of the Democratic staff at (202) 224-
4515.

Sincerely,

Ron Wyden
Ranking Member

                                 ______
                                 

                          United States Senate

                          committee on finance

                       Washington, DC 20510-6200

                              July 1, 2016

Dr. Victor J. Dzau, M.D.
President
National Academy of Medicine
500 5th Street, NW
Washington, DC 20001

Dear Dr. Dzau:

I am writing to you in regards to the provisional committee member 
appointments to the Pain Management and Regulatory Strategies to 
Address Prescription Opioid Abuse committee (``opioid committee'') that 
the National Academy of Medicine (``NAM'') announced for public comment 
on June 14, 2016.\1\ I am concerned that the Academy's review and the 
corresponding announcement failed to fully disclose or address 
important information related to potential conflicts of interest and 
bias.
---------------------------------------------------------------------------
    \1\ The National Academies of Science, Engineering, and Medicine, 
``Committee Membership Information, Pain Management, and Regulatory 
Strategies to Address Prescription Opioid Abuse,'' IOM-HSP-16-05, 
https://www.nationalacademies.org/cp/CommitteeView.aspx?key=49792, 
accessed on July 1, 2016.

Specifically, these omissions concern provisional committee members, 
Dr. Gregory Terman and Dr. Mary Lynn McPherson. In both cases, my 
concerns relate to leadership positions that they hold or have held in 
professional societies with substantial ties to the pharmaceutical 
industry, and, specifically, opioid manufacturers. These relationships 
suggest conflicts and biases that should have been made public when the 
provisional committee announcement was made last month, and require 
---------------------------------------------------------------------------
further examination by the Academy.

The proposed work on which the NAM is about to embark is of great 
importance to my constituents in Oregon, where prescription opioid 
abuse is a major public health problem, as well as the jurisdictional 
interests of the Senate Committee on Finance. Opioid addiction and 
treatment have a great impact on agencies in this Committee's 
jurisdiction, such as Medicaid and Medicare. By 2020, public and 
private spending on the treatment of substance abuse disorder(s) are 
anticipated to reach $42.1 billion, compared with $24.3 billion in 
2009.\2\ Medicare and Medicaid are expected to account for a third of 
this spending.\3\
---------------------------------------------------------------------------
    \2\ Substance Abuse and Mental Health Administration, Projections 
of National Expenditures for Treatment of Mental and Substance Use 
Disorders, 2010-2020, SMA-14-4883, 2014, https://store.samhsa.gov/
system/files/sma14-4883.pdf, 30-31.
    \3\ Ibid.
---------------------------------------------------------------------------

                             Gregory Terman

The NAM announcement failed to disclose that Dr. Terman was president 
of the American Pain Society (``APS'') from 2014-2016; that he has been 
on the board of directors since 1998, or that he has been a member of 
the society for more than 30 years.\4\ In his role as a board member, 
Terman has represented APS, an advocacy group that has substantial 
financial ties to opioid manufacturers, before the Food and Drug 
Administration (``FDA'').\5\ Terman also acknowledged to the FDA in 
2014 that APS receives money from opioid manufacturers:
---------------------------------------------------------------------------
    \4\ American Pain Society, ``University of Washington 
Anesthesiologist Gregory W. Terman, M.D., Ph.D. Becomes President of 
the American Pain Society,'' June 23, 2014, http://
americanpainsociety.org/about-us/press-room/gregory-terman-aps-
president, accessed July 1, 2016.
    \5\ Food and Drug Administration, ``Risk Evaluation and Mitigation 
Strategies for Certain Opioids'' (transcript), May 27, 2009, p. 88, 
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/
UCM211814.pdf, accessed July 1, 2016.

        The American Pain Society and that society has taken money from 
        companies making long acting opiates in the past. Although I 
        have never received money personally from such companies in 
        other work for the FDA I have had to declare money given to the 
        organization as well.\6\
---------------------------------------------------------------------------
    \6\ Food and Drug Administration, Postmarketing Requirements for 
the Class-Wide Extended-Release/Long-Acting Opioid Analgesics, 
Participant Disclosure Form, May 19-20, 2014, http://www.fda.gov/
downloads/Drugs/NewsEvents/UCM392235.pdf, accessed July 1, 2016.

A closer review shows that the organization has received hundreds of 
thousands of dollars from opioid manufacturers, and, in return, 
provides industry sponsors significant access to the organization's 
---------------------------------------------------------------------------
leadership.

The APS maintains a ``corporate council'' that is made up of 
pharmaceutical manufacturers who contribute to the APS.\7\ The 
council's page currently show eight members of the council--
AstraZeneca, Depomed, Endo, Mallinckrodt, Purdue, Pernix, Pfizer, 
Teva--that donated at least $132,500 to APS, based on financial 
contribution levels required to be classified as a member of the 
``Corporate Circle'' ($25,000), ``Executive Level'' ($15,000), and 
``Associate'' ($7,500).\8\ Please refer to Attachment 1 for more 
details about the benefits APS offers its corporate council members.
---------------------------------------------------------------------------
    \7\ American Pain Society, ``Corporate Council Members,'' http://
americanpainsociety.org/get-involved/corporate-council/members, 
accessed July 1, 2016.
    \8\ American Pain Society, ``Corporate Council,'' http://
americanpainsociety.org/get-involved/corporate-council/overview, 
accessed July 1, 2016.

In addition, the APS lists commercial supporters on its website, which 
shows that in 2013 six pharmaceutical manufacturers contributed 
$225,000 to various APS programs.\9\ The contributors were Eli Lilly, 
Millenium, Purdue, Pfizer, Teva, and Zogenix.\10\ The contributions 
fund programs including grants, meeting sponsorship, awards, and 
sponsorship of the organization's electronic newsletter.\11\
---------------------------------------------------------------------------
    \9\ American Pain Society, ``APS Transparency of Commercial Support 
for 2013,'' http://americanpainsociety.org/uploads/get-involved/
transparency-of-support-2013.pdf, accessed July 1, 2016.
    \10\ Ibid.
    \11\ American Pain Society, ``Commercial Support,'' http://
americanpainsocietv.org/get-involved/commercial-support/overview, 
accessed July 1, 2016.

One of the roles of the APS board is to review and approve position 
statements. Several of the position statements are associated with 
Federal actions related to opioids, including actions by the FDA.\12\ 
One such statement opposed more stringent labeling guidelines for the 
use of opioid painkillers, partly due to the organization's assertion 
that there were insufficient data to justify changes.\13\ Terman was 
among the co-signers of this statement, which was sent to FDA. More 
recently, the American Pain Society submitted comments to the CDC on 
its opioid guidance. Major points in the letter included:
---------------------------------------------------------------------------
    \12\ American Pain Society, ``Position Statements,'' http://
americanpainsociety.org/about-us/position-statements/overview, accessed 
July 1, 2016.
    \13\ Roger Filligim, et al., letter to Margaret A. Hamburg, August 
8, 2012, http://americanpainsociety.org/uploads/about/position-
statements/fda-opioids-letter.pdf, accessed July 1, 2016.

      Discouraging specific dosage limits;
      Criticizing the guidelines for being reliant on insufficient 
data;
      Encouraging exclusion of any reference to cancer pain;
      Raising concerns about qualifications of reviewers were confined 
to experts in toxicology and epidemiology; and
      Criticizing the exclusion of guidelines for pediatric pain 
care.\14\
---------------------------------------------------------------------------
    \14\ American Pain Society to Deborah Dowell, January 13, 2016, 
http://www.regulations.gov/#!documentDetail;D=CDC-2015-0112-3700, 
accessed July 1, 2016.

The APS also is a member of the Pain Care Coalition, a policy advocacy 
coalition that includes the American Academy of Pain Medicine, and the 
American Society of Anesthesiologists. It bills itself as ``a national 
coalition for responsible pain care.'' Public records show that the 
coalition spent more than $121,000 for lobbying activities in 2015, a 
year during which Terman was president of APS, including pain care 
legislation, NIH appropriations, and meetings with the U.S. House of 
Representatives, the Department of Health and Human Services, and the 
Department of Justice.\15\
---------------------------------------------------------------------------
    \15\ Powers, Pyles, Sutter, and Verville, P.C., Lobbying Report to 
Clerk of the House of Representatives and Secretary of the Senate, 
first quarter 2015 (April 20, 2015), http://soprweb.senate.gov/
index.cfm?event=getFilingDetails&filingID=00983e5d-4368-4b6f-9004-
d10f6ce
76b1f&filingTypeID=51, accessed July 1, 2016; Powers, Pyles, Sutter, 
and Verville, P.C., Lobbying Report to Clerk of the House of 
Representatives and Secretary of the Senate, second quarter 2015 (July 
15, 2015), http://soprweb.senate.gov/
index.cfm?event=getFilingDetails&filingID
=87f41d5e-16bc-4480-aa16-9a4b625e8e79&filingTypeID=60, accessed July 1, 
2016; Powers, Pyles, Sutter, and Verville, P.C., Lobbying Report to 
Clerk of the House of Representatives and Secretary of the Senate, 
third quarter 2015 (October 14, 2015), http://soprweb.senate.gov/
index.cfm?event=getFilingDetails&filingID=60bceb42-2073-454d-b6bb-
c628e4ac74bb&filingType
ID=69, accessed July 1, 2016; Powers, Pyles, Sutter, and Verville, 
P.C., Lobbying Report to Clerk of the House of Representatives and 
Secretary of the Senate, fourth quarter 2015 (January 15, 2016), http:/
/soprweb.senate.gov/index.cfm?event=getFilingDetails&filingID=9579f732-
eb68-4af4-b3e1-2ea0f83b4cac&filingTypeID=78, accessed July 1, 2016.

In addition to his ties to APS, the NAM failed to note that Terman is a 
temporary voting member of the FDA's science board.\16\ This position 
presents another potential organizational conflict of interest since 
FDA has commissioned the Academies to conduct this study as part of the 
FDA's reexamination of its approach to balancing the risks of opioid 
prescription use.\17\
---------------------------------------------------------------------------
    \16\ Food and Drug Administration, Science Board to the Food and 
Drug Administration, committee roster, March 1, 2016, http://
www.fda.gov/downloads/advisorycommittees/committees
meetingmaterials/scienceboardtothefoodanddrugadministration/
ucm488096.pdf, accessed July 1, 2016.
    \17\ Robert M. Califf, et al., ``A Proactive Response to 
Prescription Opioid Abuse,'' New England Journal of Medicine, 374 
(April 14, 2016), http://www.nejm.org/doi/full/10.1056/NEJMsr
1601307.
---------------------------------------------------------------------------

                          Mary Lynn McPherson

Another provisional appointee at issue is Mary Lynn McPherson, who 
appears to have had significant ties to the pharmaceutical industry 
dating back at least 2 decades. Her extensive ties to opioid 
manufacturers and related businesses raise significant concerns about 
potential conflicts of interest and bias, and deserve further 
examination.

McPherson's curriculum vitae show she has received grants and 
residencies worth at least $300,000 that were sponsored--or paid 
directly--by opioid manufacturers.\18\ Between 1997 and 2004, she 
listed three residencies funded by Purdue Pharma and three more funded 
by Purdue Frederick that totaled $253,500.\19\ In 2010, she received a 
$50,000 unrestricted educational grant from King Pharmaceuticals.\20\
---------------------------------------------------------------------------
    \18\ Mary Lynn McPherson, curriculum vitae, March 2, 2015, http://
mlmcpherson.weebly.com/biographycv.html, accessed July 1, 2016.
    \19\ Ibid.
    \20\ Ibid.

McPherson's association with opioid manufacturers is ongoing, as 
demonstrated by her authorship of a continuing education presentation 
that was supported by Purdue Pharma.\21\ This presentation was 
published in 2014 and is current through 2017. Another current 
continuing education activity she authored promotes the idea of 
``pseudoaddiction,'' which has increasingly been viewed as a 
dangerous--and false--justification to overprescribe prescription 
opioids.\22\ Of this concept, former FDA Commissioner David A. Kessler 
recently wrote:
---------------------------------------------------------------------------
    \21\ Mary Lynn McPherson, ``Prescription Opioids for Chronic Pain--
Minimizing the Risks, Maximizing the Benefit,'' 0798-0000-14-174-LOI-
P&T, December 3, 2014, http://www.
freece.com/Files/Classroom/ProgramSlides/cb9bb72c-252e-43c4-b220-
354da5819ef4/PO_ho_cp.
pdf, accessed July 1, 2016.
    \22\ Mary Lynn McPherson, ``The Pain Stops Here: Part 5--Opioid 
Therapy,'' 0798-0000-14-100-HOI-P&T, May 11, 2015, http://
www.freece.com/Files/Classroom/ProgramSlides/56ae
4493-b051-496c-a547-0047e05bcbb6/slidedocument_0798000014100H01PT.pdf, 
accessed July 1, 2016.

        Equally dangerous was the notion that there was virtually no 
        dose ceiling. The mantra was: ``Prescribe until patients 
        achieve pain relief.'' And then there was the flawed concept of 
        pseudoaddiction: If the patient comes in and is showing signs 
        of drug seeking, that doesn't mean the patient is actually 
        addicted to opioids; it more likely means that he or she just 
        needs more opioids to control pain. So the first response 
        should be to prescribe more.\23\
---------------------------------------------------------------------------
    \23\ David A. Kessler, ``The Opioid Epidemic We Failed to Forsee,'' 
The New York Times, May 6, 2016, http://www.nytimes.com/2016/05/07/
opinion/the-opioid-epidemic-we-failed-to-foresee.
html?_r=O, accessed July 1, 2016.

None of the ongoing financial ties with opioid manufacturers discussed 
above were noted by the NAM in its biography about McPherson. I believe 
these omissions were a significant oversight.

          McPherson and the American Society of Pain Educators

McPherson's biography on the NAM website did disclose her role as 
president of the American Society of Pain Educators (``ASPE''). What 
the NAM does not disclose, and what I have detailed below, is that:

      ASPE is sponsored in part by opioid manufacturers;
      APSE's board of directors and advisory board include individuals 
closely associated with, and in some cases, employed as consultants by, 
opioid manufacturers; and
      ASPE does not appear to be an independent organization. Rather 
it was founded and is managed by Aventine HealthSciences, a 
communications firm that organizes continuing education events and 
conferences related to pain treatment and related services.

The APSE webpage lists two corporate members--AbbVie and Purdue Pharma 
L.P.--both of which are manufacturers of opioids. It is unclear how 
much these companies contributed to the organization because ASPE does 
not make available its tax forms on its website. The charitable 
information database Guidestar also does not appear to have tax records 
for the organization on file.

In addition to being president of ASPE, the organization's website 
lists McPherson as chair of a seven-person board of directors.\24\ My 
staff found that at least three of the six other APSE board members 
have significant financial ties to the pharmaceutical industry. In 
addition to the financial ties to opioid manufacturers on the board of 
directors, two of the six members of the organization's advisory board 
\25\ have significant financial ties to the pharmaceutical industry, 
and opioid manufacturers, specifically.
---------------------------------------------------------------------------
    \24\ American Society of Pain Educators, ``Board of Directors,'' 
http://www.paineducators.org/home/board-of-directors/, accessed on July 
1, 2016.
    \25\ American Society of Pain Educators, ``Advisory Board,'' http:/
/www.paineducators.org/home/advisorv-board/, accessed on July 1, 2016.
---------------------------------------------------------------------------

                           ASPE and Aventine

It also is not clear whether ASPE is an independent entity. ASPE was 
incorporated in 2004 by three employees of Aventine HealthSciences, a 
medical communications firm.\26\ The ASPE board's current secretary is 
a managing partner of Aventine.\27\ Aventine continues to manage the 
daily operation of ASPE, and ASPE board members, including Dr. 
McPherson, participate in Aventine business activities such as PAINWeek 
and PAINWeek Journal. If there are direct management and financial ties 
between ASPE and Aventine, then those relationships would be relevant 
to McPherson's leadership role at ASPE and should be disclosed and 
reviewed for bias and potential conflicts of interest.
---------------------------------------------------------------------------
    \26\ Attachment 2.
    \27\ American Society of Pain Educators, ``Debra Weiner,'' http://
www.paineducators.org/home/board-of-directors/weiner/, accessed July 1, 
2016.

Aventine describes itself as a ``highly niched medical communications 
agency focused on pain and neuroscience . . . [that] has become an 
information resource to all pain management stakeholders: 
pharmaceutical companies, payers, health-care providers, and 
patients.'' \28\ Since 2007, the company also has managed PAINWeek, 
which began as an annual conference in Las Vegas. Aventine has patented 
PAINWeek, describing it as providing ``educational services, namely, 
conducting workshops, seminars and special events in the nature of 
exhibitions to promote awareness on pain issues.'' \29\ The company 
appears to receive a great deal of sponsorship money from the 
pharmaceutical industry, including several opioid manufacturers, for 
its PAINWeek franchise.
---------------------------------------------------------------------------
    \28\ Linkedln, Aventine Health Sciences, https://www.linkedin.com/
company/aventine-healthsciences, accessed July 1, 2016.
    \29\ U.S. Patent and Trademark Office, PAINWeek (Registration No. 
4659545), December 23, 2014 (via Trademark Electronic Search System), 
http://tmsearch.uspto.gov/bin/gate.exe?f=
tess&state=4806:t8vqvh.1.1.

Aventine's overlapping roles running ASPE and PAINWeek are significant 
concerns given Dr. McPherson's leadership position at ASPE. The two 
franchises also appear to be very closely related both in terms of 
personnel and frequent cross-promotion of activities. McPherson and 
several members of the ASPE board are listed as presenters for PAINWeek 
and have video presentations on the organization's website and social 
media channels \30\ In addition, McPherson and four other members of 
ASPE's boards are on the editorial board of PAINWeek Journal.\31\ 
McPherson's curriculum vitae also show that she received a $65,000 
unrestricted education grant from Aventine in 2011.\32\
---------------------------------------------------------------------------
    \30\ PAINWeek, ``Brainfood,'' http://www.painweek.org/brainfood/, 
accessed July 1, 2016; YouTube, ``Informed Deprescribing: The 
Medication Regimen in Advanced Illness,'' June 22, 2016, https://
www.voutubc.com/watch?v=093E0cEcVaVI, accessed July 1, 2016.
    \31\ PAINWeek Journal, http://www.painweek.org/painweek-journal/, 
accessed July 1, 2016.
    \32\ Mary Lynn McPherson, curriculum vitae, March 2, 2015, http://
mlmcpherson.weebly.com/biographycv.html, accessed July 1, 2016.

PAINWeek receives financial support from numerous pharmaceutical 
manufacturers and opioid makers. The 2015 national conference included 
sponsored programs ``presented by AstraZeneca, Cara Therapeutics, 
Depomed, Indivior, Iroko, kaleo, Pernix, Purdue Pharma, Salix, and Teva 
Pharmaceuticals.'' \33\ The company's website also includes numerous 
banner advertisements from opioids manufacturers, and a video-and-slide 
presentation sponsored by Zogenix, the manufacturer of Zohydro.\34\ The 
PAINWeek franchise has expanded to include regional conferences held in 
11 different states, which also include multiple sponsored programs and 
presentations, as well as ``PAINWeek at Sea,'' an ocean cruise offering 
CME classes.\35\
---------------------------------------------------------------------------
    \33\ PAINWeek, ``PAINWeek 2015: A Huge Success!'', September 14, 
2015, http://www.
painweek.org/news_posts/painweek-2015-a-huge-success/, accessed July 1, 
2016.
    \34\ PAINWeek, ``Extended-Release Opioids for Pain Management: A 
Roundtable Discussion,'' http://www.painweek.org/pernix14/, accessed 
July 1, 2016.
    \35\ PAINWeek, Agenda for Nashville regional conference, http://
conference.painweek.org/painweekend/locationsanddates/nashville-tn, 
accessed July 1, 2016; PAINWeek, ``Conferences,'' http://
www.painweek.org/conferences/, accessed July 1, 2016.

In 2015, Aventine sold the rights to PAINWeek to a media firm, Tarsus 
Group plc, in a deal worth as much as $50 million, depending on 
deferred payments linked to performance.\36\ A press release at the 
time of the sale stated that PAINWeek provided ``Tarsus with increased 
exposure to a key area of the preventative medicine market.'' \37\ The 
release noted that Aventine would continue to manage PAINWeek through 
at least 2018.\38\
---------------------------------------------------------------------------
    \36\ Tarus Group plc, ``Corporate Activity and Trading Update,'' 
May 22, 2015, http://www.londonstockexchange.com/exchange/news/market-
news/market-news-detai1/TRS/123620
35.html, accessed July 1, 2016.
    \37\ Ibid.
    \38\ Ibid.
---------------------------------------------------------------------------

              The Academy's Disclosures and Due Diligence

The potential sources of bias and conflicts of interests for Terman and 
McPherson described in this letter should have been publicly disclosed, 
since they meet or exceed the NAM test of ``relevant information 
bearing on the committee's composition and balance . . . concerning 
potential sources of bias and conflict of interest pertaining to his or 
her service on the committee.'' \39\
---------------------------------------------------------------------------
    \39\ The National Academies of Science, Engineering, and Medicine, 
``Committee Membership Information, Pain Management and Regulatory 
Strategies to Address Prescription Opioid Abuse,'' IOM-HSP-16-05, 
https://www.nationalacademies.org/cp/CommitteeView.aspx?key=
49792, accessed on July 1, 2016.

If NAM was aware of these relationships and did not publicize them, the 
omissions may undermine the public's confidence that the organization 
has done everything it can to ensure that the committee can ``address 
its charge objectively.'' If NAM was unaware of these relationships or 
made the committee selections knowing that the relationships existed, 
the Academy should consider restarting the provisional appointment 
process, including a de novo review of committee members' experience 
---------------------------------------------------------------------------
and potential biases and conflicts of interest.

The National Academy's history of vetting potential committee members 
to study issues related to pain and opioid use leaves much to be 
desired. I have recently raised conflict of interest concerns with 
Health and Human Services Secretary Sylvia Burwell regarding Myra 
Christopher who was a member of the committee that produced the 2011 
Institute of Medicine report ``Relieving Pain in America: A Blueprint 
for Transforming Prevention, Care, Education, and Research.'' \40\ At 
the time, Christopher had a significant financial relationship with the 
opioid manufacturer Purdue Pharma through its funding of Christopher's 
employer--the Center for Practical Bioethics, and an endowed chair.\41\
---------------------------------------------------------------------------
    \40\ Senator Ron Wyden to the Honorable Sylvia Mathews Burwell, 
February 5, 2016, http://www.finance.senate.gov/imo/media/doc/
Wyden%20Letter%20to%20HHS_Opioid%20Conflicts
.pdf: accessed July 1, 2016.
    \41\ Ibid.

My staff has been unable to thoroughly examine all of the members given 
the limited time available to review the provisional committee members. 
Still, the omissions that have been identified are extremely troubling, 
and strongly suggest that the Academy should undertake a more thorough 
review not only of Drs. Terman and McPherson, but other provisional 
---------------------------------------------------------------------------
members of the committee.

Please include this letter in the permanent record for consideration 
before committee membership is finalized. Thank you for your 
consideration of this important issue.

Sincerely,

Ron Wyden
Ranking Member

Enclosures: American Pain Society Corporate Council website
            American Society for Pain Educators certificate of 
incorporation

                                 ______
                                 

                              Attachment 1

                         American Pain Society

Corporate Council

Connect Directly with Pain Professionals

The APS Corporate Council provides industry partners with a direct 
connection to APS members, a multidisciplinary community of more than 
2,500 leaders in the study and treatment of pain. Companies whose 
products and services support the pain profession can meet with APS 
leaders annually at a 1-day Corporate Council Roundtable to engage in 
ongoing dialogue on hot topics and future trends in the field. In 
addition, council members can network at the annual scientific 
meeting's President's Recognition Reception, a private reception with 
APS board members, committee chairs, and other leaders where award 
recipients are recognized.

Why Join?

      Reach more than 2,500 leaders in the study and treatment of 
pain.
      Meet with the leaders in pain to exchange ideas and knowledge.
      Join APS to enhance patient outcomes.

Membership Levels

APS has tailored membership tiers to offer you various levels of 
involvement based on your company's objectives and financial resources. 
Corporate Council dues are set on a 12-month cycle. Click here to see a 
list of current Corporate Council members.

Corporate Circle ($25,000)

An exclusive, high-level corporate partnership is available to a 
limited group of industry supporters, offering benefits that will 
reinforce your company's industry leadership position, offer key 
networking opportunities, and fulfill multiple marketing objectives.

Executive ($15,000)

A mid-level partnership that offers enhanced benefits designed to 
maximize your impact on the leaders in the study and treatment of pain. 
This level will provide additional opportunities for visibility, 
research, and communication.

Associate ($7,500)

An entry-level corporate partnership that offers a variety of benefits 
designed to fit the needs of your company and reach leaders in the 
study and treatment of pain.

Benefits

Corporate Council Roundtable

Meet with APS leaders to exchange ideas and knowledge. This 1-day 
meeting is designed to facilitate an ongoing dialogue between industry 
and APS leaders. This is a unique opportunity for open discussion on 
hot topics and future trends in the field of pain and is a way for both 
the association and industry to capitalize on each other's strengths to 
advance the specialty of pain and enhance patient care. The purpose of 
the roundtable is to:

      Inform the Corporate Council about the APS strategic plan and 
achievements;
      Provide socioeconomic updates;
      Review practice development initiatives; and
      Offer industry feedback and guidance to the society.

President's Recognition Reception

You will be invited to network with APS board members, committee 
chairs, and leaders at a private reception during the APS Annual 
Scientific Meeting. The reception recognizes the many award recipients, 
including the Clinical Centers of Excellence in Pain Management Award.

APS Communications

Receive all APS communications and stay informed. You will receive The 
Journal of Pain, APS's official, frequently cited, indexed journal. The 
journal provides a forum for scholarly presentations and commentaries 
on issues and controversies. Each issue presents reports of original 
clinical and scientific research. APS E-News delivers relevant monthly 
information such as the latest pain news, information on advocacy 
related to pain, and clinical trials.

Clinical Practice Guidelines

Receive access to clinical practice guidelines that are created by 
interdisciplinary panels with expertise in methods used to critique and 
synthesize published research and other sources.

Contact

Joseph Maginot
Professional Relations and Development
847-375-4873

                                 ______
                                 

                              Attachment 2
[GRAPHIC] [TIFF OMITTED] T1918.005


[GRAPHIC] [TIFF OMITTED] T1918.006


[GRAPHIC] [TIFF OMITTED] T1918.007


[GRAPHIC] [TIFF OMITTED] T1918.008


                                 ______
                                 

                          United States Senate

                          committee on finance

                       Washington, DC 20510-6200

                              May 5, 2017

The Honorable Thomas E. Price
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Price:

I write to you with concern about the proposed composition of a Food 
and Drug Administration (FDA) workshop scheduled for May 9th and 10th 
in Silver Spring, MD, that will examine how medical providers use and 
prescribe opioids to treat pain. A preliminary list of organizations 
scheduled to participate in the workshop, ``Training Health Care 
Providers on Pain Management and Safe Use of Opioid Analgesics--
Exploring the Path Forward,'' includes many groups with deep financial 
ties to opioid manufacturers.\1\
---------------------------------------------------------------------------
    \1\ The preliminary list of participants included 26 non-Federal 
participants: American Medical Association, American Academy of 
Physician Assistants, American Association of Nurse Practitioners, 
American Academy of Integrative Pain Management, American Society of 
Addiction Medicine, American Pharmacist Association, American Dental 
Association, American Osteopathic Association, American Pain Society, 
Federation of State Medical Boards, National Governors Association, 
Project Lazarus, New Mexico, Medical Board of California, Permanente 
Medical group Northern California, Moffitt Cancer Center, Veterans 
Health Administration, Department of Defense, Duke University, Indian 
Health Service, Pain Action Alliance to Implement a National Strategy, 
PatientsLikeMe, American Chronic Pain Association, National 
Fibromyalgia and Chronic Pain Foundation, Consumers Union, and Facing 
Addiction.

Given these financial relationships between manufacturers and the 
participating pain groups, I request that you delay the workshop until 
the Department of Health and Human Services (HHS) can conduct a full 
conflict-of-interest review of all proposed participants. Such a review 
will ensure that the workshop provides a genuine balance of views. 
Following this review, HHS should consider including additional groups 
or organizations that have both (a) worked on opioid prescriber 
practices, and (b) can certify they have not received funds from--and 
are not currently partnering with--opioid manufacturers. These steps 
would improve the balance of the workshop, and diminish the influence 
of companies that have a financial stake in loosening opioid prescriber 
---------------------------------------------------------------------------
guidelines.

As you noted in recent remarks at the National Rx Drug Abuse and Heroin 
Summit, the prescribing practices of medical providers treating pain 
has contributed to the opioid overdose crisis the Nation now faces.\2\ 
The Centers for Disease Control and Prevention (CDC) found that ``sales 
of prescription opioids in the U.S. nearly quadrupled from 1999 to 
2014, but there has not been an overall change in the amount of pain 
Americans report. During this time period, prescription opioid overdose 
deaths increased similarly.'' \3\ As you pointed out during the summit, 
this rapid rise of opioid prescriptions has had devastating 
consequences for millions of Americans.\4\
---------------------------------------------------------------------------
    \2\ Department of Health and Humans Services, ``Secretary Price 
Announces HHS Strategy for Fighting Opioid Crisis,'' April 19, 2017, 
https://www.hhs.gov/about/leadership/secretary/speeches/2017-speeches/
secretary-price-announces-hhs-strategy-for-fighting-opioid-crisis/
index.
html.
    \3\ Centers for Disease Control and Prevention, ``Opioid Overdose: 
Prescribing Data,'' https://www.cdc.gov/drugoverdose/data/
prescribing.html, accessed May 5, 2017.
    \4\ Supra, note 2.

In addition to the human toll of opioid use disorder, overdoses and 
death, the rise in associated health costs has had a major impact on 
programs within the jurisdiction of the Senate Committee on Finance. By 
2020, public and private spending on substance abuse disorder treatment 
is expected to reach $42.1 billion, compared to $24.3 billion in 
2009.\5\ Medicare and Medicaid costs are expected to account for a 
third of this spending.\6\ The Affordable Care Act (ACA) has been an 
important link to care for people seeking treatment for substance use 
disorder. Leading health economists estimate that repealing the ACA 
would result in coverage losses for ``about 2.8 million Americans with 
a substance use disorder, of whom about 222,000 have an opioid 
disorder.'' \7\ The spike in opioid use has also led to higher 
transmission rates of blood borne diseases such as HIV and hepatitis, 
adding to the costs of the epidemic.\8\
---------------------------------------------------------------------------
    \5\ Substance Abuse and Mental Health Administration, ``Projections 
of National Expenditures for Treatment of Mental and Substance Use 
Disorders, 2010-2020,'' SMA-14-4883, 2014, https://store.samhsa.gov/
system/files/sma14-4883.pdf, 30-31.
    \6\ Ibid.
    \7\ Richard G. Frank and Sherry Glied, ``Keep Obamacare to keep 
progress on treating opioid disorders and mental illnesses,'' The Hill, 
January 11, 2017, http://thehill.com/blogs/pundits-blog/healthcare/
313672-keep-obamacare-to-keep-progress-on-treating-opioid-disorders.
    \8\ Philip J. Peters, et al., ``HIV Infection Linked to Injection 
Use of Oxymorphone in Indiana, 2014-2015,'' New England Journal of 
Medicine, 375:229-239, July 21, 2016, http://www.nejm.org/doi/full/
10.1056/NEJMoa1515195#t=abstract.

The FDA workshop has the potential to build on the work the CDC has 
performed in recent years, which resulted in national guidelines that 
medical providers can follow when prescribing opioids. Specifically, 
---------------------------------------------------------------------------
the FDA workshop is set to discuss:

      The role of health-care provider training in improving pain 
management and ensuring the safe use of opioids.
      How best to provide appropriate training in pain management and 
safe opioid use to health-care providers who prescribe or are directly 
involved in the management or support of patients with pain.
      Issues and challenges associated with possible changes to 
Federal efforts to educate health-care providers on pain management and 
the safe use of opioids.\9\
---------------------------------------------------------------------------
    \9\ ``Training Health Care Providers on Pain Management and Safe 
Use of Opioid Analgesics--Exploring the Path Forward,'' Public 
Workshop, 82 Fed. Reg. 18300 (April 18, 2017), https://
www.federalregister.gov/documents/2017/04/18/2017-07821/training-
health-care-providers-011
-pain-management-and-safe-use-of-opioid-analgesics-exploring-the.

Unfortunately, the apparent financial relationships between opioid 
manufacturers and pain advocacy groups participating in the workshop 
raise serious conflict-of-
interest concerns that could undercut efforts to curb over-prescribing. 
I have continued to investigate the role of opioid manufacturers 
spending millions of dollars to fund pain groups through arrangements 
like pay-to-play corporate councils that grant companies access to 
executives and membership of the organizations. The pain groups, which 
also receive money from the companies through advertising, grants and 
other forms of sponsorship, have worked, oftentimes in concert with 
other industry-funded groups, to steer State and Federal policy toward 
favoring opioids as a treatment for pain. For example, four of the six 
groups detailed in this letter co-signed a letter in 2015 criticizing 
the CDC's draft of guidelines on opioid prescribing practices.\10\
---------------------------------------------------------------------------
    \10\ Pat Anson, ``Chronic Pain Groups Blast CDC Opioid 
Guidelines,'' Pain News Network, September 22, 2015, https://
www.painnewsnetwork.org/stories/2015/9/22/chronic-pain-groups-blast-
cdc-for-opioid-guidelines.

Additional information regarding the financial ties between opioid 
manufacturers and organizations participating in the workshop include 
---------------------------------------------------------------------------
the following:

      American Academy of Integrative Pain Management: Until recently, 
this group was known as the American Academy of Pain Management.\11\ 
The name change appears to be little more than cosmetic. The content of 
the group's website remains largely unchanged, and the group is still 
heavily funded by opioid manufacturers, with a corporate council 
consisting of AstraZeneca, Endo, Janssen, Mallinckrodt, Medtronic, 
Pernix, Pfizer, Purdue and Teva.\12\ Regarding the corporate council, 
the academy states that it ``greatly values its relationships with the 
commercial sponsors who make the products that enable members to 
provide the best pain care possible. To that end, AIPM considers 
commercial sponsors to be an integral part of the pain care team.'' 
\13\ In return for membership dues, corporate council members receive 
access to leadership and data the organization collects.\14\ Similarly, 
the State policy arm of the organization, the State Pain Policy 
Advocacy Network, is sponsored by Endo, Janssen, Medtronic, Pfizer, 
Purdue, and Teva; the only non-opioid sponsors are the American Cancer 
Society and Livestrong.\15\ Moreover, the Associated Press and Center 
for Public Integrity reported last year that the organization 
``receives 15 percent of its funding from pharmaceutical companies . . 
. [and] its state advocacy project is 100 percent funded by drug 
makers.''\16\ Under the previous name, the organization led a letter to 
the Centers for Disease Control and Prevention criticizing the draft 
opioid prescribing guidelines.\17\
---------------------------------------------------------------------------
    \11\ American Academy of Integrative Pain Management, ``Leading 
Pain Organization Changes Name, Brings Alternative Solutions to Complex 
Pain Challenges,'' June 17, 2016, http://blog.aapainmanage.org/leading-
pain-organization-changes-name-brings-alternative-solutions-complex-
pain-challenges/, accessed May 5, 2017.
    \12\ American Academy of Integrated Pain Management, ``Corporate 
Council,'' http://www.aapainmanage.org/about/corporate-council/, 
accessed May 5, 2017.
    \13\ American Academy of Integrated Pain Management, ``AIPM 
Announces New Corporate Council Program,'' October 4, 2016, http://
www.aapainmanage.org/announcement/academy-announces-new-corporate-
council-program/, accessed May 5, 2017.
    \14\ Ibid.
    \15\ http://sppan.aapainmanage.org/supporters.
    \16\ Liz Essley Whyte, Geoff Mulvihill, and Ben Wieder, ``Politics 
of pain: Drug makers fought State opioid limits amid crisis,'' 
Associated Press and Center for Public Integrity, September 18, 2016, 
https://www.publicintegrity.org/2016/09/18/20200/politics-pain-
drugmakers-fought-state
-opioid-limits-amid-crisis.
    \17\ Supra, note 10.

      American Chronic Pain Association: I previously raised concerns 
about this organization's participation in HHS's Interagency Pain 
Research Coordinating Committee (IPRCC) because of its ties to 
industry.\18\ The association reports receiving corporate support from 
11 companies that manufactured opioid-based drugs--AbbVie, Collegium 
Pharmaceutical, Depomed, Egalet, Janssen, Mallinckrodt, Pfizer, Purdue, 
Shionogi, Teva, and Zogenix.\19\ Its ``corporate champion,'' which 
appears to be its highest corporate contributor, is AstraZeneca,\20\ 
which produces and markets a drug to relieve opioid-induced side 
effects--Movantik.\21\ Furthermore, the organization's advisory board 
includes J. David Haddox, Purdue Pharma's Vice President for Health 
Policy.\22\ However, the organization's connections to Purdue are not 
limited to Haddox; every page of the website states that ``Development 
of this new ACPA website was made possible through an unrestricted 
educational grant from Medtronic Foundation and Purdue Pharma.'' The 
association also has promoted Purdue-funded initiatives such as a 
Spanish language website \23\ and a guide for pain patients.\24\ The 
association's advisory board includes four doctors who have received 
thousands of dollars from opioid manufacturers including Endo, Purdue, 
Mallinckrodt, Pfizer, Teva, Depomed and Zogenix, according to Open 
Payments data.\25\ One of the doctors received $75,000 in payments over 
3 years.\26\ Another advisory board member, Dr. Judith Paice, served as 
the second coordinator of the IPRCC critique of the CDC guidelines.\27\
---------------------------------------------------------------------------
    \18\ Senator Ron Wyden to Health and Human Services Secretary 
Sylvia Mathews Burwell, February 5, 2016, https://
www.finance.senate.gov/imo/media/doc/Wyden%20Letter%20to%20HHS
_Opioid%20Conflicts.pdf.
    \19\ American Chronic Pain Association, ``Partners and 
Contributors,'' https://theacpa.org/Partners-Contributors, accessed May 
5, 2017. Zogenix sold its pain franchise in May 2015.
    \20\ Ibid.
    \21\ AstraZeneca, ``MovantikTM (naloxegol) tablets for 
the treatment of opioid-induced constipation in adult patients with 
chronic non-cancer pain launched in the U.S.,'' March 31, 2015, http://
www.astrazeneca-us.com/media/press-releases/Article/20150330-movantik-
launched-in-the-us.
    \22\ American Chronic Pain Association, ``Advisory Board,'' https:/
/theacpa.org/Advisory-Board, accessed May 5, 2017.
    \23\ American Chronic Pain Association, ``PAIN Exhibit Launches 
Website in Spanish,'' October 28, 2013, https://theacpa.org/news/PAIN-
Exhibit-Launches-Website-in-Spanish, accessed May 5, 2017.
    \24\ American Chronic Pain Association, ``About Partners: Helping 
you do more to build pain awareness,'' https://theacpa.org/About-
Partners, accessed May 5, 2017.
    \25\ American Chronic Pain Association, https://theacpa.org/
Advisory-Board.
    \26\ Centers for Medicare and Medicaid Services, Steven P. Stanos 
(Open Payments), https://openpaymentsdata.cms.gov/physician/138667/
payment-information, accessed May 5, 2017.
    \27\ Supra, note 18.

      American Pain Society (APS): This organization has for years 
reported receiving money from opioid manufacturers, prompting an 
investigation by the Senate Finance Committee in 2012.\28\ APS in 2013 
reported that six pharmaceutical manufacturers contributed $225,000 to 
various APS programs,\29\ including grants, meeting sponsorship, 
awards, and sponsorship of the organization's electronic 
newsletter.\30\ Contributors to APS include Teva, Purdue, Pharma, Eli 
Lilly, Millenium and Zogenix.\31\ The organization currently maintains 
a ``corporate council'' consisting of 11 pharmaceutical companies, most 
of which manufacturer opioids or opioid-related products.\32\ These 
companies appear to have paid APS at least $180,000, based on the 
minimum financial requirements advertised on the organization's 
website; in return for dues, companies are granted access to the 
organization's leadership and members.\33\ As recently as April 2017, 
the organization presented its electronic newsletter as being funded by 
Purdue Phanna.\34\ This is apparently a long-standing relationship; in 
2013, for example, APS indicated that Purdue contributed $45,000 
annually to sponsor the newsletter.\35\ Furthermore, two of the four 
doctors on the organization's board of directors \36\ have received 
substantial payments from opioid manufacturers, according to Open 
Payments data.\37\ The organization's immediate past president, Gregory 
Terman, was dismissed from a National Academy of Medicine panel 
studying opioid addiction, following conflict-of-interest concerns I 
raised to the academy.\38\
---------------------------------------------------------------------------
    \28\ Senators Max Baucus and Charles Grassley to Catherine 
Underwood, May 8, 2012, https://www.finance.senate.gov/imo/media/doc/
05092012%20Baucus%20Grassley%20Opioid%20Investi
gation%20Letter%20to%20American%20Pain%20Society.pdf, accessed May 5, 
2017.
    \29\ American Pain Society, ``APS Transparency of Commercial 
Support for 2013,'' http://americanpainsociety.org/uploads/get-
involved/transparency-of-support-2013.pdf, accessed May 5, 2017.
    \30\ American Pain Society, Commercial Support, http://
americanpainsociety.org/get-involved/commercial-support/overview, 
accessed May 5, 2017.
    \31\ Ibid.
    \32\ American Pain Society, ``Corporate Council Members,'' http://
americanpainsociety.org/get-involved/corporate-council/members, 
accessed May 5, 2017.
    \33\ Supra, note 30.
    \34\ American Pain Society, E-News, April 2017, http://
americanpainsociety.org/education/e-news/2017/april/society, accessed 
May 5, 2017.
    \35\ Supra, note 29.
    \36\ American Pain Society, ``Board of Directors,'' http://
americanpainsociety.org/about-us/who-s-who-in-aps/board-of-directors, 
accessed May 5, 2017.
    \37\ Centers for Medicare and Medicaid Services, Mark Wallace, 
(Open Payments), https://openpaymentsdata.cms.gov/physician/64875/
payment-information, accessed May 5, 2017; Centers for Medicare and 
Medicaid Services, Edward Michna, (Open Payments), https://
openpaymentsdata.cms.gov/physician/247077/summary, accessed May 5, 
2017.
    \38\ Matthew Perrone, ``Painkiller panel drops experts linked to 
pharma industry,'' Associated Press, July 6, 2016, http://
www.seattletimes.com/business/painkiller-panel-drops-experts-linked-to-
pharma-industry/.

      National Fibromyalgia and Chronic Pain Foundation: This 
organization appears to receive funding from Purdue Pharma, and is 
closely associated with other organizations and people who have long-
standing financial ties to opioid manufacturers. Purdue funded one of 
foundation's trademarked initiatives, ``Leaders Against Pain,'' in 
2012.\39\ The organization's founder, Jan Chambers, also is a member of 
industry-funded groups noted elsewhere in this letter. Chambers is an 
advisory council member for Pain Action Alliance to Implement a 
National Strategy \40\ (see more information below) and the State Pain 
Policy Advocacy Network which, as noted above, is reportedly fully 
funded by drug makers.\41\ The Foundation also lists a number of 
``affiliated organizations'' that have established connections to 
opioid manufacturers.\42\ Written products Chambers has produced also 
raise conflict-of-interest concerns, both because of their content and 
co-authors. For example, Chambers was co-author of a paper, featured in 
an American Academy of Pain Management publication, which criticized 
the Drug Enforcement Administration's decision to classify hydrocodone 
as a Schedule III narcotic.\43\ The paper was co-authored by AAPM's 
president, Bob Twillman; a Utah physician, Lynn Webster, who reported 
receiving $160,000 from drug makers between 2013 and 2015;\44\ and 
three employees of Millennium Health. In the same year the paper was 
published, Millenium Health paid ``$256 million to resolve alleged 
violations of the False Claims Act for billing Medicare, Medicaid and 
other federal health care programs for medically unnecessary urine, 
drug and genetic testing and for providing free items to physicians who 
agreed to refer expensive laboratory testing business to Millennium.'' 
\45\ The Foundation also signed on to the American Academy of Pain 
Management letter challenging the CDC guidelines noted above.\46\
---------------------------------------------------------------------------
    \39\ National Fibromyalgia and Chronic Pain Association, ``National 
Fibromyalgia and Chronic Pain Association Hosting Leaders Against 
PainTM National Training Event for New and Veteran Support 
Group Leaders and Patient Advocates in DC,'' PRWeb, September 25, 2012, 
http://www.prweb.com/releases/nfmcpa/09_24_2012/prweb9923245.htm, 
accessed May 5, 2012.
    \40\ PAINS Project, ``Advisory Committee,'' http://
painsproject.org/who-we-are/advisory-committee/, accessed May 5, 2017.
    \41\ State Pain Policy Advocacy Network, ``SPPAN Leadership,'' 
http://sppan.aapainmanage.
org/leadership, accessed May 5, 2017.
    \42\ National Fibromyalgia and Chronic Pain Association, 
``Affiliate and Education Organizations,'' http://www.fmcpaware.org/
affiliate-organizations.html, accessed May 5, 2017.
    \43\ Jan Chambers, et al., ``An Online Survey of Patients' 
Experiences Since the Rescheduling of Hydrocodone: The First 100 
Days,'' Pain Medicine, September 16, v. 17 no. 9, https://
academic.oup.com/painmedicine/article/17/9/1686/2399259/An-Online-
Survey-of-Patients-Experiences-Since-the.
    \44\ Centers for Medicare and Medicaid Services, Lynn Webster (Open 
Payments), https://openpaymentsdata.cms.gov/physician/1136720/summary, 
accessed May 5, 2017.
    \45\ Department of Justice, ``Millennium Health Agrees to Pay $256 
Million to Resolve Allegations of Unnecessary Drug and Genetic Testing 
and Illegal Remuneration to Physicians,'' October 19, 2015, https://
www.justice.gov/opa/pr/millennium-health-agrees-pay-256-million-
resolve-allegations-unnecessary-drug-and-genetic, accessed May 5, 2017.
    \46\ Supra, note 10.

      Pain Action Alliance to Implement a National Strategy: Also 
known by its acronym, PAINS, this group is run by the Center for 
Practical Bioethics, which has received substantial donations from 
opioid manufacturers. The Center was one of several groups investigated 
by the Committee on Finance in 2012 for its links to industry and its 
role in promoting the use of prescription opioids.\47\ The financial 
relationship between the Center and opioids manufacturers is ongoing. 
In 2013, publicly available records indicate Purdue Pharma contributed 
$100,000 to the Center, making the company the second largest 
contributor to the group that year.\48\ When Finance Committee staff 
reviewed the Center's website in August 2015, it listed several 
corporate supporters, including opioid manufacturers, among its donors 
between January 2014 and March 31, 2015: Janssen Pharmaceuticals, 
Mallinckrodt Pharmaceuticals, Medtronic, Inc., Purdue, Teva 
Pharmaceuticals, and Zogenix. The website has since been updated to 
show 2016 sponsors, which still shows Purdue among them.\49\ Moreover, 
the leadership of PAINS, Myra Christopher and Richard Payne, have 
longtime financial relationships with opioid manufacturers. During 
Christopher's time as CEO of the Center, Purdue Pharma established a 
$1.5 million endowment for that chair \50\ through three $500,000 
allocations in 2008, 2009, and 2011 respectively.\51\ Dr. Payne, 
meanwhile, continues to receive money from opioid manufacturers. In 
2013, Dr. Payne reportedly received $2,000 in travel and lodging from 
Purdue to attend a meeting for which he received an additional $4,700 
for ``services other than consulting, including serving as faculty or 
as a speaker'' from a Purdue affiliate--Purdue Transdermal Technologies 
L.P.\52\ Dr. Payne also received $7,538 from Teva in 2015.\53\ 
Moreover, PAINS also signed onto the American Academy of Pain 
Management letter to CDC noted above.\54\
---------------------------------------------------------------------------
    \47\ Senators Max Baucus and Charles Grassley to John G. Carney, 
https://www.
finance.senate.gov/imo/media/doc/
05092012%20Baucus%20Grassley%20Opioid%20Investi
gation%20Letter%20to%20Center%20for%20Practical%20Bioethics1.pdf.
    \48\ The Greater Kansas City Community Foundation makes publically 
available the records for the organization at http://
gkccf.guidestar.org/nonprofit.aspx?orgId=1193, accessed May 5, 2017.
    \49\ Center for Practical Bioethics, ``Our 2016 Community 
Supporters,'' https://practicalbio
ethics.org/support-our-mission/community-
supporters?highlight=WyJwdXJkdWUiXQ, accessed May 5, 2017.
    \50\ McBride, Lock, and Associates, ``Report of Examination of the 
Center for Practical Bioethics, Inc., Kansas City, Missouri for the 
Year Ended December 31, 2008,'' April 13, 2008, http://
gkccf.guidestar.org/nonprofit.aspx?orgId=1193.
    \51\ McBride, Lock, and Associates, ``Report on Examination of the 
Center for Practical Bioethics, Inc., Kansas City, Missouri as of and 
for the Year Ended December 31, 2010,'' July 21, 2011, http://
gkccf.guidestar.org/nonprofit.aspx?orgId=1193.
    \52\ Centers for Medicare and Medicaid Services, Richard Pain (Open 
Payments), https://openpaymentsdata.cms.gov/physician/1094555, accessed 
May 5, 2017.
    \53\ Ibid.
    \54\ Supra, note 10.

      Project Lazarus: In a 2015 presentation to the FDA, this 
organization's founder, Frederick Brason, disclosed financial 
relationships with Ameritox, Indivior, Kaleo, Purdue, and Zogenix.\55\ 
The organization's website also shows it is partnering with KemPharm, 
which is developing several opioid-based drugs;\56\ the Academy of 
Integrative Pain Management, noted above; and the American Academy of 
Pain Medicine.\57\ Last month, Purdue Pharma touted its funding of the 
organization in a press release on its website.\58\ The organization 
also has partnered with other industry-funded groups in signing the 
American Academy of Pain Management letter to CDC cited above. In 
addition to the industry relationships of Project Lazarus and its 
founder, a 2016 Washington Examiner article questioned the 
effectiveness of the organization's work, noting that after a temporary 
decline, opioid overdose rates in the county where the organization 
works, have been on the rise.\59\ The amount of money the organization 
has received from industry is difficult to gauge. Project Lazarus was 
an independent nonprofit until 2011, when the director transferred all 
of its assets to a religious organization that he controlled, 
Coastlands Ministries.\60\ Publically available tax records for 
Coastlands Ministries show that it received a $500,000 grant in 2012, 
but the donor is undisclosed.\61\ The group also signed onto the 
American Academy of Pain Management letter to CDC noted above.
---------------------------------------------------------------------------
    \55\ Fred Wells Brason, ``Exploring Naloxone Uptake and Use Public 
Meeting,'' July 1-2, 2015, https://www.fda.gov/downloads/Drugs/
NewsEvents/UCM454759.pdf, accessed May 5, 2015.
    \56\ KemPharm, Inc., ``Product Portfolio: Pain,'' http://
www.kempharm.com/pages/pipeline/pain.php, accessed May 5, 2017.
    \57\ Project Lazarus website, https://www.projectlazarus.org/, 
accessed May 5, 2017.
    \58\ Purdue Pharma, L.P., ``Purdue Pharma, Project Lazarus, and 
Safe Kids NC Partner to Improve Public Health Outcomes in North 
Carolina through the North Carolina Disposal Initiative,'' April 5, 
2017, http://www.purduepharma.com/news-media/2017/04/purdue-pharma-
project-lazarus-and-safe-kids-nc-partner-to-improve-public-health-
outcomes-in-north-carolina-through-the-north-carolina-disposal-
initiative/, accessed May 5, 2017.
    \59\ Paige Winfield Cunningham, ``Model program to fight drug abuse 
falls flat,'' Washington Examiner, April 3, 2016, http://
www.washingtonexaminer.com/model-program-to-fight-drug-abuse-falls-
flat/article/2587359.
    \60\ Project Lazarus, Form 990-EZ for the year ending 2011, http://
990s.foundationcenter.org/990_pdf_archive/270/270602284/
270602284_201112_990EZ.pdf, accessed May 5, 2017.
    \61\ Coastlands Ministries, Form 990 for the year ending 2015, 
http://990s.foundation
center.org/990_pdf_archive/562/562087110/562087110_201512_990.pdf, 
accessed May 5, 2017.

The long-standing and ongoing financial relationships between opioid 
manufacturers and participants in the upcoming FDA workshop warrant 
your intervention to investigate and minimize potential conflicts of 
interest when addressing a matter literally of life and death. I 
appreciate your attention to this important issue and your 
---------------------------------------------------------------------------
consideration of my requests.

            Sincerely,

            Ron Wyden
            Ranking Member

                                 ______
                                 

                             Communications

                              ----------                              


         Alliance for the Treatment of Intractable Pain (ATIP)

                           3591 Nestling Lane

                          Fort Mill, SC 29708

                             (803) 566-8011

From: Richard A Lawhern, Ph.D.
Co-Founder and Corresponding Secretary

To: U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

April 16, 2018

Subject: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Services Programs''

This letter submits a statement for the record in April 19, 2018 public 
hearings of the Senate, subject as above. I write as a co-founder of 
the Alliance for the Treatment of Intractable Pain. We are an 
organization of over 250 medical professionals, health-care writers, 
knowledgeable pain patients and caregivers. We have previously 
addressed other government forums, among them the FDA Opioid Policy 
Steering Committee (January 30, 2018), and State regulatory agencies in 
Washington, Ohio, and Illinois.

This statement offers a White Paper on Prescription Opioids and Chronic 
Pain, attached. This Paper is available online at https://atipusa.org/
2018/04/02/atip-white-paper-on-prescription-opioids-and-chronic-pain/ 
and was downloaded over 5,000 times in the first week of its 
availability. It has been shared with hundreds of House and Senate 
Staff engaged in health-care policy. It is extensively referenced from 
both medical literature and current media.

We advocate that immediate legislation is necessary, if the intended 
charter of these hearings is to bear fruit. The Senate must join the 
House in directing the U.S. Centers for Disease Control and Prevention 
to withdraw and rewrite the March 2016 Guidelines on prescription of 
opioid analgesics to adults with non-cancer chronic pain. CDC officials 
have acknowledged that overdose death statistics due to prescription 
drugs have been inflated by almost 100% for years. In their present 
form, the Guidelines are actively dangerous due to weak science and 
anti-opioid bias which violates research standards of the CDC itself. 
Guidelines omit pertinent science on opioid metabolism, leading to 
``one size fits all'' regulations which are destroying pain management 
and patient quality of life for millions of citizens.

Thank you for your attention. Please call on us if we may contribute 
further. We can send medical experts to follow-up hearings or provide 
staff support during the coming weeks before passage of legislation.

Richard A. Lawhern, Ph.D.

                                 ______
                                 

       The Alliance for the Treatment of Intractable Pain (ATIP)

                Available online at https://atipusa.org

A White Paper

                 Prescription Opioids and Chronic Pain

Richard A. Lawhern, Ph.D.

1. Main Points

1.1. There Are Over 116 Million Chronic Pain Patients in the U.S. 
(Institute of Medicine)

Chronic pain is defined as pain lasting longer than 90 days or 
otherwise exceeding medically expected recovery times. Once diagnosed, 
many chronic pain patients will have debilitating severe pain for the 
rest of their lives. For many, pain is resistant (refractory) to a wide 
range of therapies.

For millions of people, management of severe pain has for years 
included prescription opioid medications as a key element. Opioid 
medications frequently make a life-or-death difference in quality of 
life. However, at present, patients with severe pain are being made 
scapegoats for a perceived--and largely false--``epidemic'' of opioid 
addiction and overdose deaths, which have been misattributed to 
prescription analgesics.\1\, \2\, \3\, 
\4\
---------------------------------------------------------------------------
    \1\ Mark Edmund Rose, ``Are Prescription Opioids Driving the Opioid 
Crisis? Assumptions vs. Facts,'' Pain Medicine, December 17, 2017, 
https://doi.org/10.1093/pm/pnx048.
    \2\ Carl L. Hart, Ph.D., ``People Are Dying of Ignorance, Not 
Because of Opioids,'' Scientific American, November 1, 2017, https://
www.scientificamerican.com/article/people-are-dying-because-of-
ignorance-not-because-of-opioids/.
    \3\ Stefan J. Kertesz and Adam J. Gordon, ``Strict limits on opioid 
prescribing risk the `inhumane treatment' of pain patients.'' Stat. 
News, February 24, 2017 (see reader comments), https://
www.statnews.com/2017/02/24/opioids-Prescribing-limits-pain-patients/.
    \4\ Jacob Sullum, ``Opioid Commission Mistakenly Blames Pain 
Treatment for Drug Deaths,'' Reason Magazine, November 2, 2017.

There are presently no reliable replacements for opioids.\5\ Due to 
under funding of research on treatments for pain, there are no 
significant prospects for new treatments in the foreseeable future.
---------------------------------------------------------------------------
    \5\ Agency for Healthcare Research and Quality, ``Noninvasive, 
Nonpharmacological Treatment for Chronic Pain: A Systematic Review,'' 
Draft circulated, December 2017, pp vii, 270.

---------------------------------------------------------------------------
1.2. March 2016 CDC Chronic Pain Guidelines

In March 2016, the Centers for Disease Control released updated 
guidelines for prescription of opioids in adult, non-cancer chronic 
pain. Outcomes of these guidelines have been horrific for millions of 
patients. The CDC guidelines \6\ recommended that general practitioners 
should perform an analysis of risks and benefits before prescribing 
more than 90 Morphine Milligram Equivalent Daily Dose (MMEDD). Although 
originally phrased as voluntary, the Guidelines became a statutory 
requirement on the Department of Veterans Affairs, 3 months before CDC 
published its final guideline. Non-VA Hospitals and doctors across 
America quickly interpreted the Guidelines on safety review as a 
mandatory maximum dose standard.\7\, \8\
---------------------------------------------------------------------------
    \6\ Dowell D., Haegerich T.M., and Chou R., ``CDC Guideline for 
Prescribing Opioids for Chronic Pain--United States, 2016,'' JAMA, 
2016;65, doi:10.1001/jama.2016.1464, https://jamanetwork.com/journals/
jama/fullarticle/2503508.
    \7\ Jacob Sullum, ``America's War on Pain Pills is Killing Addicts 
and Leaving Patients in Agony,'' Reason Magazine, April 2018 edition.
    \8\ Jeffrey A. Singer, M.D., ``Let's Stop the Hysterical Rhetoric 
About the Opioid Crisis,'' Cato Institute--Commentary, August 31, 2017, 
https://www.cato.org/publications/commentary/lets-stop-hysterical-
rhetoric-about-opioid-crisis.

Fearing sanctions by the U.S. Drug Enforcement Agency or State 
authorities if they prescribe opioids to people who need them, doctors 
are leaving pain management practice in droves.\9\ Availability of pain 
management specialists is dropping in most areas of the U.S. and 
Canada. Pharmacies are limiting inventories of opioid medications, and 
challenging doctors' prescriptions on grounds of corporate policy. 
Patients with legitimate prescriptions are being turned away.\10\
---------------------------------------------------------------------------
    \9\ Matthew Adams, ``Dr. Steven Ziegler interview with George 
Knapp,'' February 22, 2018, https://www.youtube.com/
watch?v=Ci_snaj4mkE&feature=youtu.be.
    \10\ Pauline Bartolony, ``The Other Opioid Crisis: Hospitals Are 
Running Short of Powerful Painkillers,'' Los Angeles Times, March 16, 
2017, http://www.latimes.com/business/la-fi-opioid-painkiller-
hospitals-20180316-story.html#nws=mcnewsletter.

The U.S. Centers for Medicare and Medicaid estimate that approximately 
1.6 million older citizens are presently maintained on opioid doses at 
levels above 90 MMED.\11\ U.S. CDC has estimated that over 19 million 
prescriptions were written in 2016 for ``high dose'' (over 90 MMED) 
opioids for all purposes--acute, chronic, or palliative care 
treatment.\12\ However, among doctors who remain in pain management 
practice, many are discharging high-dose patients or coercing them to 
quickly taper down to levels below 90 MMED--levels that are ineffective 
in hundreds of thousands of patients. Many high-dose patients are being 
discharged without management for withdrawal symptoms.\13\
---------------------------------------------------------------------------
    \11\ U.S. Health and Human Services Centers for Medicare and 
Medicaid, ``Advance Notice of Methodological Changes for Calendar Year 
(CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part 
D Payment Policies, and 2019 Draft Call Letter,'' https://www.
regulations.gov/docket?D=CMS-2017-0163.
    \12\ U.S. Centers for Disease Control and Prevention, ``Annual 
Surveillance Report of Drug-
Related Risks and Outcomes, United States 2017,'' Table 1B, August 21, 
2017, https://www.cdc.gov/drugoverdose/pdf/pubs/2017-cdc-drug-
surveillance-report.pdf.
    \13\ Bob Tedeschi, ``A `civil war' over painkillers rips apart the 
medical community--and leaves patients in fear,'' Stat. News, January 
17, 2017, https://www.statnews.com/2017/01/17/chronic-pain-management-
opioids/.

Effects of CDC Guidelines are compounded by restrictive legislation in 
several U.S. States, which are imposing limits on dose levels, the 
number of days a prescription may extend , and/or the number of 
renewals allowed. Tens of thousands of patients are being driven into 
outright agony, with significant suicide risk.\14\, \15\ 
Among patients treated by the Veterans Administration, hundreds of 
suicides have been confirmed.\16\
---------------------------------------------------------------------------
    \14\ Geralyn Datz, ``Chronic Pain--A Suicide Story,'' National Pain 
Report, February 26, 2018, http://nationalpainreport.com/chronic-pain-
a-suicide-story-8835614.html.
    \15\ Thomas Kline, M.D., Ph.D., ``Pain Related Suicides,'' February 
2018, Medium Corporation, https://medium.com/@ThomasKlineMD/suicides-
associated-with-non-consented-opioid-pain-medication-reductions-
356b4ef7e02a.
    \16\ Art Levine, ``How the VA Fueled the Opioid Crisis and Is 
Killing Thousands of Veterans,'' Newsweek, October 27, 2017, http://
www.newsweek.com/2017/10/20/va-fueled-opioid-crisis-killing-veterans-
681552.html.

---------------------------------------------------------------------------
1.3. Weak Evidence for CDC Guidelines

Medical evidence underlying the CDC Guidelines is extremely weak, 
absent or biased.

The Core Experts writing group that authored the CDC Guidelines 
included no practicing Board Certified Pain Management specialists who 
had experience managing patients in community settings. Psychiatrists 
in addiction management dominated the group. There was no 
representation by the CDC's own medical ethics group.

The majority of the published studies that the CDC used as evidence in 
the writing of the Guidelines were evaluated as ``Type 4''--``Subject 
to significant limitations and uncertainties.'' \17\ Significant 
studies, which contradicted assumptions of the writers group, were 
omitted.\18\ Four studies quoted by CDC to justify risk thresholds for 
opioid daily dose were mutually contradictory and inconsistent.\19\ 
Methodology for comparing different opioids (Morphine Milligram 
Equivalent Daily Dose) is founded upon opinion and pseudoscience.\20\
---------------------------------------------------------------------------
    \17\ Stephen A. Martin, M.D., EdM; Ruth A. Potee, M.D., DABAM; and 
Andrew Lazris, M.D., ``Neat, Plausible, and Generally Wrong: A Response 
to the CDC Recommendations for Chronic Opioid Use,'' Medium 
Corporation, September 7, 2016, https://medium.com/@stmartin/neat-
plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-
for-chronic-opioid-use-5c9d9d319f71.
    \18\ Noble M., Treadwell J.R., Tregear S.J., Coates V.H., Wiffen 
P.J., Akafomo C., Schoelles K.M., and Chou R., ``Opioids for Long Term 
Treatment of Non-Cancer Pain,'' Journal of Pain and Symptom Management, 
Vol. 35, No. 2, February 2008, updated December 2010, http://
onlinelibrary.wiley.com/doi/10.1002/14651858.CD006605.pub2/
abstract;jsessionid=7ADC6E2B6
8764AD8E13574321C769E2B.f04t04.
    \19\ Richard A. Lawhern, ``Tracking Down the `Research' Behind the 
CDC's Opioid Prescribing Guidelines,'' National Pain Report, August 10, 
2016, http://nationalpainreport.com/tracking-down-the-research-behind-
the-cdcs-opioid-prescribing-guidelines-8831122.html.
    \20\ Michael E. Schatman, Ph.D.; and Jeffrey Fudin, PharmD, ``The 
Myth of Morphine Milligram Equivalent Daily Dose,'' Medscape, March 18, 
2018, https://www.medscape.com/viewarticle/863477.

The four studies used by the Guidelines writers do show an increased 
risk of apparent overdose death associated with high dosing. However, 
the absolute annual risk of dying with doses greater than 100 MMED was 
estimated at 0.21 to 0.25%/year. In a related study by one of these 
authors, the annual risk of overdose death with a MMED of greater than 
400 was 0.5%.\21\
---------------------------------------------------------------------------
    \21\ Gomes T., et al., ``Trends in opioid mortality among 
socioeconomically disadvantaged patients,'' Open Med., 2011;5:E13-E22.

Even if we accept the questionable methodology of some of these studies 
without challenge, it still seems reasonable to compare their estimated 
risks of death to outcomes of other drug therapy. Consider, for 
instance, medical conditions like atrial fibrillation, for which 
thousands of patients are treated every year. Atrial fibrillation is 
very common in older patients, as is deep venous thrombosis and 
---------------------------------------------------------------------------
associated pulmonary embolism.

A risk of prescription opioid overdose of 0.25%/year is comparable to 
the risk of fatal hemorrhage with the best anticoagulants available for 
preventing stroke due to atrial fibrillation. The estimated risk of 
death from so-called ``very high dose'' opioids (0.5%/year) is 
comparable to the risk of fatal hemorrhage with Warfarin for stroke 
prevention (0.38-0.5%/year). So why do we focus on the supposed 
``risk'' of opioid overdose attending the treatment of severe chronic 
pain? This is a ``risk'' that many patients in agony would consider 
trivial. It is comparable to risks of other drug therapies.

Because of very high dropout rates among pain patients treated with 
placebos, there are few published randomized double-blind trials of the 
long-term effectiveness of opioids in chronic pain. However, the CDC 
writers misinterpreted the rarity of trials to assert that opioids are 
ineffective.\22\, \23\ The writers violated research 
standards of the CDC itself by failing to disclose that criteria for 
including trials of opioids were different and more stringent than 
those applied to non-opioid analgesics and behavioural therapies.\24\
---------------------------------------------------------------------------
    \22\ Op. cit., Martin et al.
    \23\ Brooke Keefer, ``A Former Federal Peer Reviewer's Analysis of 
the Draft CDC Guidelines,'' National Pain Report, December 30, 2015, 
http://nationalpainreport.com/a-former-federal-peer-reviewers-analysis-
of-the-draft-cdc-guidelines-8828910.html.
    \24\ Baraa O. Tayeb, Ana E. Barreiro, Ylsabyth S. Bradshaw, Kenneth 
K.H. Chui, and Daniel B. Carr, ``Durations of Opioid, Nonopioid Drug, 
and Behavioral Clinical Trials for Chronic Pain: Adequate or 
Inadequate?'', Pain Medicine, Volume 17, Issue 11, November 1, 2016, 
Pages 2,036-2,046, https://academic.oup.com/painmedicine/article/17/11/
2036/2447887.

Although medical professionals often label patient reports 
``anecdotal,'' many thousands report they have been stable on opioid 
medications for years and received substantial benefits in reduced 
pain, improved mobility, and better quality of life. Many of these 
patients are being discharged or coerced to taper down medications to 
less than therapeutic levels.\25\
---------------------------------------------------------------------------
    \25\ Op. cit., Tedeschi.

The term ``opioid induced hyperalgesia'' is sometimes seen in medical 
literature as a justification for claiming that opioid analgesics 
really aren't effective. The claim is that due to some mechanism of the 
nervous system, opioids cause the body to become more sensitive to pain 
after a short period of exposure. However, no medical consensus exists 
on what this mechanism might be, or any criteria for confirming this 
unproven diagnosis. A search of the medical literature reveals no 
reports of patients whose pain improved with reduction in opioid 
---------------------------------------------------------------------------
dosage.

A label is not a diagnosis.

1.4. The Confounding Problem of Individual Metabolism

The CDC writers group also ignored well-established medical literature, 
which examines variations between individuals in their ability to 
metabolize (break down) opioid pain relievers.\26\, \27\ Six 
key liver enzymes are involved in metabolism for 90% of all 
medications. Due to genetic polymorphism, the expression of these 
enzymes can vary significantly between individuals. The result is that 
millions of patients are poor metabolizers of opioids, passing very low 
amounts of active breakdown products across the blood-brain barrier. 
Others are ``hyper-active'' metabolizers, in whom opioids pass through 
the body so rapidly that pain is reduced for only minutes rather than 
hours.
---------------------------------------------------------------------------
    \26\ Tom Lynch and Amy Price, ``The Effect of Cytochrome P450 
Metabolism on Drug Response, Interactions, and Adverse Events,'' 
American Family Physician, August 1, 2007, https://www.aafp.org/afp/
2007/0801/p391.html.
    \27\ Howard S. Smith, M.D., ``Opioid Metabolism,'' Mayo Clinic 
Proceedings, 2009 July, 84(7): 613-624, https://www.ncbi.nlm.nih.gov/
pmc/articles/PMC2704133/.

Both of these populations can potentially benefit from opioid therapy--
but not below the 90 MMED dose limits recommended in the CDC 
Guidelines. Some pain management specialists identify the range of 
``minimum therapeutic dose'' for opioids as 20 to 1,000 MMED.\28\ There 
are published case reports of ``hyper-dose'' patients who do well on 
dose levels over 2,000 MMED, with no unacceptable side effects or 
observed symptoms of addiction.\29\
---------------------------------------------------------------------------
    \28\ Stephen Nadeau, M.D. [a specialist in pain management with 
over 100 published peer-
reviewed papers in medical literature]. Personal correspondence with 
the author.
    \29\ Forest Tennant, M.D., DrPH, ``Ultra High Dose Opioid Therapy--
Uncommon and Declining, but Still Needed,'' Practical Pain Management, 
May 2013, https://www.practicalpainmanage
ment.com/treatments/pharmacological/opioids/ultra-high-dose-opioid-
therapy-uncommon-declining-still-needed.

The CDC Guidelines have had such horrific results that some of the 
writers in the Core Expert's group and outside reviewers of the 
document have disavowed it.\30\ Additional medical professionals have 
directly opposed proposed changes in Medicare and Medicaid rules 
intended to implement CDC Guidelines as a mandatory standard of 
practice.\31\
---------------------------------------------------------------------------
    \30\ Stefan Kertsz, et al., ``An Opioid Metric Based on Dose Alone? 
80 Professionals Respond to NCQA,'' Medium, March 22, 2017, https://
medium.com/@StefanKertesz/an-opioid-quality-metric-based-on-dose-alone-
80-professionals-respond-to-ncqa-6f9fbaa2338.
    \31\ Lev Facher, ``Proposed Federal Limits to Opioid Prescriptions 
Draw Opposition From Physicians and Patients,'' Stat. News, March 6, 
2018, https://www.statnews.com/2018/03/06/cms-rule-limits-opioid-
prescriptions/.

---------------------------------------------------------------------------
2. Mythologies of Chronic Pain and Addiction

It is becoming clear that major implicit but mostly unstated 
assumptions of the CDC Guideline writers were inappropriate or outright 
fallacious.\32\ Among these assumptions is the claim that all opioid 
prescriptions should be regarded as immediate addiction risks for all 
patients exposed to them. We now know this assumption to be false.
---------------------------------------------------------------------------
    \32\ Op. cit., Rose.

---------------------------------------------------------------------------
2.1. Media Narrative

We've all heard media stories about young people who quickly became 
addicted after minimal exposure to medically managed opioids descending 
into a spiral of drug seeking, life failure, and eventual overdose 
death. Such stories are tragedies for the families that actually 
experience them.

Families grieve. They demand that government ``do something.'' Their 
stories are very influential in our public conversation about substance 
abuse and overdose deaths. It is small wonder that government policy 
has focused centrally on reducing the availability of medical opioids.

2.2. Focus on Prescription Reduction

Is the present focus on reduction of medical supply appropriate? Almost 
certainly not! No matter how tragic these stories are, they are neither 
typical nor representative. As noted by Dr. Nora Volkow and Thomas A. 
McMillan, Ph.D. of the U.S. National Institutes of Drug Abuse.

``Unlike tolerance and physical dependence, addiction is not a 
predictable result of opioid prescribing. Addiction occurs in only a 
small percentage of persons who are exposed to opioids--even among 
those with pre-existing vulnerabilities. . . . Older medical texts and 
several versions of the Diagnostic and Statistical Manual of Mental 
Disorders (DSM) either overemphasized the role of tolerance and 
physical dependence in the definition of addiction or equated these 
processes (DSM-III and DSM-IV). However, more recent studies have shown 
that the molecular mechanisms underlying addiction are distinct from 
those responsible for tolerance and physical dependence, in that they 
evolve much more slowly, last much longer, and disrupt multiple brain 
processes'' (emphasis--ATIP).\33\
---------------------------------------------------------------------------
    \33\ Nora D. Volkow, M.D., and Thomas A. McLellan, Ph.D., ``Opioid 
Abuse in Chronic Pain--Misconceptions and Mitigation Strategies,'' NEMJ 
2016; 374:1253-1263, March 31, 2016, http://www.nejm.org/doi/full/
10.1056/NEJMra1507771.

Even the statistics of the CDC itself have proven to be faulty, over-
magnifying what has been called a ``prescription opioid crisis.'' CDC 
has acknowledged that it has reported as ``prescription opioid 
overdoses,'' deaths that were in fact due to illegally imported 
fentanyl and its analogs. They called their reported prescription 
opioid overdose rate ``significantly inflated'' \34\ over several 
years. For 2016, this ``inflation'' amounted to nearly doubling the 
number of deaths attributed to prescription medications.\35\
---------------------------------------------------------------------------
    \34\ Jeffrey A. Singer, M.D., ``CDC Researchers State Overdose 
Death Rates From Prescription Opioids Are Inaccurately High,'' Cato at 
Liberty, March 22, 2018, https://www.cato.org/blog/cdc-researchers-
state-overdose-death-rates-prescription-opioids-are-inaccurately-high.
    \35\ Josh Bloom, Ph.D., ``The CDC Quietly Admits it Screwed Up 
Counting Opioid Pills,'' American Council on Science and Health, March 
19, 2018, https://www.acsh.org/news/2018/03/19/cdc-quietly-admits-it-
screwed-dishonestly-counting-pills-12717.

---------------------------------------------------------------------------
2.3. Large-Scale Medical Studies

We also know from recently published, large-scale studies of surgical 
patients treated with opioids after discharge, that opioid abuse 
emerging from managed medical exposure is rare among patients who are 
profiled carefully before surgery. Millions of patients have such 
exposures every year.

A 2018 study reported in the British Medical Journal examined outcomes 
among more than 586,000 patients prescribed opioids for the first time 
after surgery.\36\ Less than 1% continued renewing their prescriptions 
longer than 13 weeks, 0.6% were later diagnosed with Opioid Abuse 
Disorder during follow-up periods averaging 2.6 years between 2008 and 
2016. Likelihood of diagnosis increased with the length of 
prescriptions, but rose only modestly as dose levels increased from 
under 20 to over 120 MMED.
---------------------------------------------------------------------------
    \36\ Gabriel A. Brat, Denis Agniel, Andrew Beam, Brian Yorkgitis, 
Mark Bicket, Mark Homer, Kathe P. Fox, Daniel B. Knecht, Cheryl N. 
McMahill-Walraven, Nathan Palmer, and Isaac Kohane, ``Postsurgical 
prescriptions for opioid naive patients and association with overdose 
and misuse: retrospective cohort study,'' BMJ 2018;360:j5790, http://
www.bmj.com/content/360/
bmj.j5790.long.

It is quite possible--even likely--that the diagnosis of Opioid Abuse 
Disorder in many of these patients was incorrect. The diagnosis is 
typically made by treating physicians without recourse to accepted 
definitions of the disorder such as the American Psychiatric 
Association Diagnostic and Statistical Manual, 5th edition. Many 
doctors who diagnose patients with abuse are general practitioners who 
lack sufficient training in addiction and have little experience 
evaluating the behaviours that actually define drug addiction. 
Likewise, some physicians confuse patient reports of emerging chronic 
---------------------------------------------------------------------------
pain--caused by failed surgery--for potential opioid abuse.

During the period of the study, doctors increasingly became concerned 
with being sanctioned by law enforcement authorities for their use of 
opioid doses high enough to reliably manage pain. Thus they may have 
diagnosed drug abuse to protect themselves--not their patients, who 
were often summarily discharged.

A 2016 study reported in the Journal of the American Medical Society 
\37\ tracked long-term opioid prescriptions in non-surgical patients, 
and compared prescription rates to 642,000 patients who received 1 of 
11 common types of surgery. Opioid prescriptions were defined as 
``chronic'' when 10 or more scripts were written in 1 year or a 
prescription was renewed continuously for more than 120 days.
---------------------------------------------------------------------------
    \37\ Eric C. Sun, Beth D. Darnall, Laurence C. Baker, and Sean 
Mackey, ``Incidence of and Risk Factors for Chronic Opioid Use Among 
Opioid-Naive Patients in the Postoperative Period,'' JAMA Internal 
Medicine 2016;176(9): 1286-1293, https://jamanetwork.com/journals/jama
internalmedicine/fullarticle/2532789.

In this study, the rate for chronic prescriptions of opioid analgesics 
among millions of non-surgical patients was estimated at 0.136%. 
(Parenthetically, this finding strongly suggests that ``doctor 
shopping'' is not a significant source of opioids abused by people with 
addiction.) For 4 of the 11 surgical procedures studied, the same rate 
of prescriptions occurred after surgery as before. For the seven 
remaining procedures, long-term opioid prescriptions rose by factors 
varying from 1.28 (0.174%) for caesarean delivery, up to 5.07 (0.69%) 
---------------------------------------------------------------------------
for total knee replacement.

The highest rate of post-surgical chronic prescriptions occurred for 
total knee replacement--a procedure known to cause lingering pain in 
many who undergo it. \38\,\39\ It is likely that many on-
going prescriptions after knee replacement reflected chronic post-
surgical pain, rather than issues of opioid misuse. Although not 
examined in the study, this outcome may also be true of other 
procedures where long-term prescribing was observed.
---------------------------------------------------------------------------
    \38\ G.M. Woolhead, J.L. Donovan, and P.A. Dieppe, ``Outcomes of 
Total Knee Replacement: A Qualitative Study,'' Rheumatology, Volume 44, 
Issue 8, August 1, 2005, pages 1032-1037, May 3, 2005, https://
academic.oup.com/rheumatology/article/44/8/1032/1772033.
    \39\ Michael J. Bade, Wendy H. Kohrt, and Jennifer E. Stevens-
Laplsey, ``Outcomes Before and After Total Knee Arthroplasty Compared 
to Healthy Adults,'' J. Orthop. Sports Phys. Ther. 2010 Sept.; 40(9): 
559-567, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3164265/.

These studies demonstrate beyond any reasonable contradiction that 
managed medical exposure does not by itself significantly raise risks 
of opioid abuse in surgical patients who are properly screened for 
previous opioid exposure. This outcome directly contradicts the false 
claim that addiction starts with just a few pain pills in any large 
number of people.

3. Addiction Risks

It may well be asked, what are the risks of opioid involvement or 
addiction among patients who have already experimented with drugs 
before they see a doctor? Volkow and McMillan offer us some insight on 
this question.\40\ The CDC does not publish definitive statistics on 
this issue. But well-established demographics can offer general 
guidance. In the great majority of cases, the typical beginning addict 
and the typical chronic pain patient are different people.
---------------------------------------------------------------------------
    \40\ Op. cit., Volkow and McMillan.

---------------------------------------------------------------------------
3.1. The Demographics of Addiction and Chronic Pain

We now know that the most common beginning opioid abuser is an 
adolescent or early-20's male who has a history of family trauma, 
prolonged unemployment, and often mental health issues. This population 
is generally medically under-served. It is unusual for young males in 
economically distressed regions of the U.S. to be seen by a doctor. 
When they are seen, it is unusual for them to be prescribed pain 
relievers for more than a few days. As noted by Volkow and McMillan, a 
few days are insufficient to cause drug dependency, much less 
addiction.

By contrast, the typical chronic pain patient (by a ratio of 60/40 or 
higher compared to men) is a woman in her 40s or older who has a 
history of traumatic injury, failed back surgery, neuropathic pain, 
fibromyalgia, or other disorders which generate prolonged severe 
pain.\41\ Among women whose lives are stable enough that they can see a 
doctor repeatedly, addiction to opioids is quite uncommon.
---------------------------------------------------------------------------
    \41\ American Academy of Pain Medicine ``AAPM Facts and Figures on 
Pain'' (current edition accessed November 11, 2017), http://
www.painmed.org/patientcenter/facts_on_pain.aspx.

Clearly, ``some'' patients of any age may become physically dependent 
on opioids for pain relief, or later display the obsessive drug seeking 
and self-destructive behaviors which define Opioid Use Disorder. But 
equally clearly, the overlap between addiction and chronic pain occurs 
in a relatively small minority. To deal with our public health crisis 
constructively, public policy must centrally address the majority of 
---------------------------------------------------------------------------
people with addiction, before plotting excursions to help the outliers.

3.2. More Misleading Statistics

A statistic often quoted in popular media is that over 70% of all 
people with addiction report that their first exposure to opioids was 
from prescription drugs. So how are these young men and women exposed 
to prescriptions? The answer is almost entirely through theft and 
diversion of unused medications left over after legitimate patients no 
longer need them. Seventy-five percent of people with addiction who 
begin this way never saw a doctor for pain.\42\ Few are able to sustain 
a developing addiction from home supplies. They soon begin purchasing 
street drugs--either illegal drugs like heroin (often laced with 
illicitly-manufactured fentanyl), or safer, but diverted, prescription 
drugs that cost much more.
---------------------------------------------------------------------------
    \42\ National Survey on Drug Use and Health, quoted by Maia 
Szalavitz in ``Opioid Addiction Is a Huge Problem, but Pain 
Prescriptions Are Not the Cause,'' Scientific American, May 10, 2016, 
https://blogs.scientificamerican.com/mind-guest-blog/opioid-addiction-
is-a-huge-problem-but-pain-prescriptions-are-not-the-cause/.

---------------------------------------------------------------------------
3.3. The Role of Self-Administered Poly-Pharmacy

It has also become clear in recent years that overdose deaths only 
rarely involve a single prescription opioid given by a doctor to a pain 
patient. When the Commonwealth of Massachusetts did an extensive 
analysis of 2 years of overdose-related fatalities, they discovered 
that in only 9% of 1,657 deaths did medical examiners detect an opioid 
in post-mortem examinations that could be tracked to the State 
Prescription Drug Monitoring Program.\43\
---------------------------------------------------------------------------
    \43\ Commonwealth of Massachusetts, ``An Assessment of Opioid-
Related Deaths in Massachusetts (2013-2014),'' September 2016, https://
www.mass.gov/files/documents/2016/09/tx/chapter-55-report.docx.

The best predictor for overdose related death was self-administered 
poly-pharmacy, not a medically managed prescription. It can be credibly 
argued that such poly-pharmacy seems a plausible consequence of under-
treatment of pain, rather than over-prescription. In 79% of 154 
Massachusetts deaths where a prescription opioid was detected, the 
prescribed dose was below the 90 MMED threshold of risk identified in 
the CDC Guidelines. Likewise, two-thirds of the prescriptions were more 
than 30 days out of date, suggesting that some of those who died may 
---------------------------------------------------------------------------
have been cut off from pain management.

4. The Myth of Opioid Alternatives

Another mythology that greatly distorts our public conversation about 
opioid pain relievers is the idea that safer alternative therapies for 
pain exist and would be used if only they were covered by medical 
insurance. This assumption was explicit in recommendations of the CDC 
Guidelines. However, this idea is unfortunately naive and largely 
unsupported by medical evidence.

4.1. AHRQ Review of Existing Data

In December 2017, the U.S. Agency for Healthcare Research Quality 
(AHRQ) circulated a draft ``Systematic Review'' of published trials 
data on non-pharmacological and non-invasive therapies for treatment of 
pain.\44\ The yearlong review identified 4,470 published trials for 
techniques including Rational Cognitive Therapy, mindfulness, 
psychological counseling, acupuncture, massage, yoga, spinal 
manipulation and low-level laser therapy, among others. Five common 
types of pain were addressed: chronic low back pain, chronic neck pain, 
fibromyalgia, tension headache, and osteoarthritis.
---------------------------------------------------------------------------
    \44\ Agency for Healthcare Research and Quality, ``Noninvasive, 
Nonpharmacological Treatment for Chronic Pain: A Systematic Review,'' 
circulated in draft, December 2017.

After a rigorous multi-level quality review by medical experts, only 
205 published trials were chosen for inclusion in the Systematic 
Review. The main reasons for study rejection were failure to follow 
patients for at least 30 days after trial, and failure to sufficiently 
document treatment protocols to establish repeatability of results. 
Among the surviving trials, AHRQ applied the assessment ``Medical 
---------------------------------------------------------------------------
Evidence Weak'' more than 100 times.

A further and potentially disqualifying weakness of the trials 
literature was that few investigators bothered to document the nature 
and protocols of ``usual treatment'' to which these non-invasive 
therapies were generally added or compared. In point of fact, ``usual 
therapy'' often comprises NSAIDs or opioid analgesics. But most trials 
reported in the literature do not establish the precise protocols that 
were followed under ``usual treatment.''

4.2. Alternative Therapies May Be no Better Than Placebo

The AHRQ systematic review made an effort to dress up a pig in ballet 
tights, by claiming that at least a few of the trials they examined 
demonstrated measurable improvement in outcomes. However a detailed 
probe of details of the report brings us to a different insight. The 
most supportable conclusion that we may draw from the AHRQ systematic 
review is that non-invasive, non-pharmacological therapies can help 
some patients, some of the time--when applied as adjuncts to treatment 
with analgesics. But the present state of knowledge does not permit us 
to establish whether such alternative therapies are in fact any more 
effective than placebo.

The one true test of alternative therapies would be to test their 
efficacy in reducing opioid dosage in patients with pain severe enough 
to warrant chronic opioid management. Such a study has never been done. 
Thus, non-pharmacological therapies do not offer realistic 
``replacements'' for analgesic treatment.

5. A Necessary Way Forward

Much public and government discussion of opioid addiction and overdose 
deaths is now focused on restriction of prescriptions to people in 
pain, and restriction of opioid supply overall. However, it is clear 
that this focus is miss-placed. The ``war'' on drugs has become a war 
on pain patients.\45\
---------------------------------------------------------------------------
    \45\ Cheryl K. Chumley, ``Opioid Regulation Not the Way to Fight 
ODs, Cure Addiction,'' The Washington Times, February 15, 2018, https:/
/www.washingtontimes.com/news/2018/feb/15/opioid-regulation-not-the-
way-to-fight-ods-cure-ad/.

[GRAPHIC] [TIFF OMITTED] T1918.009


Even the most basic attention to overdose and prescription statistics 
must reveal that attempts to mode rate the opioid ``epidemic'' by 
restricting supply have failed. According to the CDC, prescriptions are 
now at a 10-year low, but overdose-related deaths continue to 
escalate.\46\
---------------------------------------------------------------------------
    \46\ Short, Paul K., ``Opioid Prescriptions Move to a 10 Year 
Low,'' https://atipusa.org/2018/01/13/opioid-prescriptions-move-to-a-
10-year-low/.

---------------------------------------------------------------------------
5.1. Review of CDC Data

It is also becoming clear that further restrictions on medical opioid 
supply will do nothing to moderate the trends revealed in Figure 1. 
There is evidence that restrictions may indeed be contributing to 
increased deaths, by driving chronic pain patients into the streets for 
pain relief--or otherwise--into decline, disability, and suicide.\47\
---------------------------------------------------------------------------
    \47\ Op. cit., Jacob Sullum.

---------------------------------------------------------------------------
5.2. A Necessary First Step

A necessary first step in correcting the horrid outcomes of the 2016 
CDC Guidelines must be their formal withdrawal for a major re-write to 
correct multiple biases, errors and omissions. Board-Certified Pain 
Management physicians experienced in community-based, long-term 
treatment of chronic pain patients should lead such an effort.

This rewriting must be supported by a wide range of stakeholders, 
including providers from hospice, palliative care, cancer treatment, 
and patients or their advocates as voting members. Guideline 
development must be conducted using a publicly transparent process, 
supported by sufficient staff to process, analyze, and integrate 
external input.

5.3. Guideline Recommendations

Recommendations must be evidence-based, and guiding principles must 
include the following:

There is no one-size-fits-all patient or therapy. Medical 
professionals, responding to the needs of the patient, must tailor all 
pain treatment.

    1.  There can be no generalized single threshold of risk for Opioid 
Use Disorder versus opioid dose level or duration. There is no science 
to support such a threshold. Doctors must be able to trial their 
patients on different medications and dose regimes, perhaps combined 
with ancillary non-pharmaceutical therapies.

    2.  Medically managed exposure to opioid analgesics may create 
physical dependence without symptoms of addiction in patients treated 
long-term. Dependence, when it occurs, is an acceptable and 
physiologically expected outcome of effective pain treatment. 
Withdrawal symptoms can be managed with appropriately gradual tapering, 
if change or reduction of medication is medically indicated.

    3.  There is no medical evidence of benefit and ample evidence of 
needless harms in forced reductions of dose for patients who are 
medically stable and who benefit from existing dose regimes.

    4.  Risk of opioid abuse or protracted opioid prescription in 
properly screened, opioid-naive post-surgical patients is significantly 
less than 1%. Doctors need training to distinguish between patients in 
whom prolonged need for opioid prescription is an in dictator for 
development of chronic pain rather than an indicator of opioid misuse.

    5.  Patient screening for opioids should be oriented to identifying 
patients who have previous or present non-medical opioid exposure, in 
order to apply enhanced management protocols and make referral for drug 
abuse treatment where appropriate. The costs of urine testing are now 
outrageously high. False positives of urine testing are replete, and 
must be substantially reduced through better education and 
understanding of their results as they are often misused as grounds for 
patient dismissal.\48\
---------------------------------------------------------------------------
    \48\ Fudin Argoff C.E., Alford D.P., Fudin J., Adler J.A., Bair 
M.J., Dart R.C., Gandolfi R., McCarberg B.H., Stanos S.P., Gudin J.A., 
and Polomano R.C., ``Rational Urine Drug Monitoring in Patients 
Receiving Opioids for Chronic Pain: Consensus Recommendations.'' Pain 
Medicine, December 1, 2017.

    6.  A single deviation from an opioid management contract--however 
minor--is all too often viewed as adequate reason to discharge a 
chronic pain patient from care. However, best available medical 
evidence suggests that patients who ``doctor shop'' or ``pharmacy 
shop'' likely comprise less than 1% of all patients treated with opioid 
analgesics. Care must be taken to avoid patient stigmatization and 
false alarms in applying data from Prescription Drug Management 
Programs. Patient treatment contracts must recognize conditions and 
limitations of patient daily life before mandating arbitrary discharge 
---------------------------------------------------------------------------
or otherwise damaging the patient.

    7.  No physician who treats verifiable chronic pain should be 
subjected to disciplinary action or government sanction solely because 
of the gross volume of opioids that he or she prescribes. Without 
reference to the medical conditions and numbers of patients treated, 
volume of prescriptions is not a reliable indicator for drug diversion 
to opioid abusers or street markets.

A related step in avoiding further harms must be immediate direction 
from the U.S. Congress to the Department of Veterans Affairs, to cease 
enforcement of the present VHA no-opioids policy. It is now well 
established that such policy is causing significant numbers of patient 
suicides in Veteran and non-Veteran populations.

Finally, pending issuance of a new CDC prescription guideline, all US 
States must stand down from efforts to impose further limitations on 
opioid prescribing for acute, chronic, or terminal pain. Enforcement of 
existing State limitations on dose level or duration should be 
suspended. If and when re-considered, such limitations must be grounded 
on published medical evidence of benefit and qualified by exceptions 
for chronic, intractable, or terminal pain conditions.

                                 ______
                                 
       American College of Osteopathic Family Physicians (ACOFP)

                    330 East Algonquin Road, Suite 1

                      Arlington Heights, IL 60005

                    (P) 800-323-0794 or 847-952-5100

                            (F) 847-228-9755

                         https://www.acofp.org/

May 3, 2018

U.S. Senate
Committee on Finance
Dirksen Senate Office Building
Washington, DC 20510-6200

Re: April 19, 2018 hearing on ``Tackling Opioid and Substance Use 
Disorder in Medicare, Medicaid, and Human Services Programs''

The American College of Osteopathic Family Physicians (ACOFP) is the 
professional organization representing more than 20,000 practicing 
osteopathic family physicians, residents, and students throughout the 
United States who are deeply committed to advancing our nation's 
health-care system by improving health-care delivery and outcomes, and 
ensuring that patients receive high-quality care.

Thank you for the opportunity to share our statement for the record for 
the April 19, 2018 hearing entitled, ``Tackling Opioid and Substance 
Use Disorder in Medicare, Medicaid, and Human Services Programs.'' In 
addition to our statement below, we offer our continued support and 
commitment to work together on addressing the opioid epidemic. Should 
you need any additional information or if you have any questions, 
please feel free to contact Debbie Sarason, Manager, Practice 
Enhancement and Quality Reporting at (847) 952-5523 or 
[email protected].

Sincerely,

Duane G. Koehler, DO, FACOFP dist.
ACOFP President 2018-2019

                                 ______
                                 
The American College of Osteopathic Family Physicians (ACOFP) 
appreciates the opportunity to provide this statement to the Senate 
Committee on Finance (Committee) regarding ways the federal government 
can combat the opioid crisis.

Overall, as an organization our osteopathic family medicine physicians 
practice in a variety of settings, including solo, small, rural, Native 
American/Indian health care, group, and alternative payment model 
practices. Our members treat many individuals suffering from pain and 
those who suffer from opioid addiction. We recognize the importance of 
addressing the ongoing opioid crisis that faces the nation.

Primary care physicians (PCPs) are at the frontlines of care and often 
are the first to uncover the presentation of behavioral health 
symptoms, including opioid addiction. PCPs are also in the unique 
position of diagnosing, treating and prescribing opioids, when 
medically necessary and clinically indicated. For these reasons, we 
believe PCPs are in a vital position to provide input on improving safe 
opioid use and on how to limit abuse.

                     Addressing the Opioid Epidemic

ACOFP believes the opioid epidemic must be addressed through a 
multifaceted, collaborative approach. Specifically, we believe each 
stakeholder and industry component has a role to play in combatting the 
opioid crisis. We support and encourage efforts to address the 
following areas:

      Prescribing practices of bad actors who inappropriately 
prescribe or prescribe unnecessary amounts or dosages of opioids;
      Ensuring insurers cover and incentivize the use of non-opioid 
pain management therapies or less addictive opioid medications;
      Providing additional training and certification in medication-
assisted treatment (MAT) for substance use;
      Curbing ``doctor shopping'' through a prescription drug registry 
or ``lock-in'' program;
      Facilitating safe and efficient ways to dispose of unused/
remaining opioids;
      Supporting the development of new, non-addictive pain 
medications; and
      Curbing access to illicit opioids.

Based on our members' firsthand experience with the opioid crisis, we 
offer the following comments on these areas of concern.
            Prescribing Practices
ACOFP supports efforts to encourage responsible prescribing behavior, 
including curbing over-prescribing and monitoring to ensure ``bad 
actors'' are held responsible for clearly fraudulent prescribing 
practices. However, as solutions are being contemplated, we urge you to 
preserve patient access to pain management treatments, including 
medications that are consistent with best medical practices and 
clinical guidelines.

As family physicians, our primary concern is to ensure that clinically 
appropriate items and services are delivered efficiently to patients. 
This includes balancing pain management with the appropriate 
prescribing and use of opioids as well as the necessary follow-up to 
monitor for misuse or abuse. Clinically appropriate services, including 
non-opioid pain management, should be incentivized and reimbursed at an 
appropriate rate to ensure they are provided when needed.

Recently, there has been a heightened focus on prescribing practices as 
a potential contributor to the opioid epidemic. As you know, there are 
numerous factors related to the opioid epidemic. However, we believe 
that other factors including illegal opioids, such as heroin and 
fentanyl, currently play a more significant role than prescribing 
practices.\1\ A recent report from the Centers for Disease Control and 
Prevention (CDC) found that opioid related overdose deaths increased 
27.9 percent from 2015 to 2016 and that the increase ``primarily [was] 
driven by deaths involving synthetic opioids, for which the rate 
doubled from 2015 to 2016.'' \2\ Based on our experience, artificially 
limiting prescribing has had the unintended consequence of driving 
patients to illicit drug use.
---------------------------------------------------------------------------
    \1\ See, https://www.drugabuse.gov/related-topics/trends-
statistics/overdose-death-rates.
    \2\ See, https://www.cdc.gov/mmwr/volumes/67/wr/mm6712a1.htm.

Therefore, we strongly support an evaluation of the impact of laws that 
regulate length, quantity, and dosage of opioid prescriptions. We 
believe it will be critical to first study the effect of laws or 
regulations that limit prescribing practices and the impact they have 
on patient care. Such an assessment also will help to identify bad 
actors and the impact these policies have on patient quality outcomes.
            Insurance Coverage
Currently, insurance coverage remains a significant barrier to 
transitioning patients from less addictive medications to medications 
with less abuse potential. For example, some insurers only will cover 
the less expensive (and highly addictive) short-acting opioids, but 
will not cover long-acting hydrocodone with abuse deterrent or 
alternatives like a Butrans patch. We believe this is counter to 
efforts to combat the opioid crisis.

We also believe that reimbursement for non-opioid pain management 
therapies needs to be revisited and updated. There are opportunities to 
change routine practices so that we are no longer a ``prescribe-first'' 
health-care system and instead work towards addressing and treating 
root causes of pain through non-pharmacological interventions such as 
osteopathic manipulative treatment (OMT). OMT is hands-on care that can 
help to alleviate and prevent pain, thereby reducing the need for 
addictive medications.
            Medication-Assisted Treatment (MAT)
ACOFP is also committed to ensuring its members obtain training and 
certification in MAT for substance use disorders to bolster their 
osteopathic training and holistic treatment of patients. We recognize 
the distinct need for MAT and the benefits the certification provides 
in terms of recognizing potential problems and how to address them. We 
strongly support efforts to improve education, training, and 
certification opportunities.
            Curbing ``Doctor Shopping''
We strongly support efforts to share data to limit fraudulent access to 
prescription opioids. Efforts such as a lock-in program (as implemented 
by the Centers for Medicare and Medicaid Services (CMS) pursuant to the 
Comprehensive Addiction and Recovery Act of 2016) could be beneficial 
to ensure there is an ongoing relationship between the patient and 
physician. Lock-in programs enable physicians to monitor for signs of 
drug abuse and to intervene when medically necessary. Additional 
efforts, such as nationwide prescription drug monitoring programs 
(PDMPs) could help to limit fraudulent access to opioids. We appreciate 
and urge your continued focus in this area. We also offer our support 
in developing policies to leverage PDMPs.
            Disposing of Unused Opioids, Developing New Medications, 
                    and Fighting Illicit Opioids
While not specifically related to the practice of family medicine, we 
also have concerns with properly disposing of remaining opioids and the 
importance and need for the development of new medications that are 
non-addictive, have favorable safety profiles, and are cost effective. 
We believe that these efforts should be a significant part of the 
strategy to address the opioid epidemic.

In terms of illicit opioids, our members have found it especially 
troubling that efforts to limit opioid prescriptions are offset by 
patients accessing lethal and illegal alternatives. As noted above, 
limiting prescribing can drive patients to fentanyl and other illicit 
opioids, which are now the largest driver of opioid-related overdose 
deaths. We urge you to take steps to limit the availability of illegal 
opioids.

                               Conclusion

ACOFP urges the Committee to consider the on-the-ground experience of 
family medicine physicians and the stark reality we face in combatting 
the opioid epidemic. Our members work with our patients to provide 
clinically appropriate medications and services to ensure patients are 
not unnecessarily suffering from chronic pain. At the same time, we are 
committed to addressing over-prescribing, but reiterate that 
prescribing practices are neither the sole nor the most significant 
cause of the opioid epidemic. We strongly urge the Committee to focus 
additional efforts on: (1) covering and incentivizing the use of non-
opioid pain management therapies; (2) supporting training and 
certification in MAT; (3) curbing doctor shopping; (4) ensuring the 
safe and efficient disposal of unused opioids; (5) developing new, non-
addictive analgesics; and (6) curbing access to illegal drugs.

                                 ______
                                 
                   Letter Submitted by Kristi Becker
May 1, 2018

U.S. Senate
Committee on Finance
Dirksen Senate Office Building
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Service Programs''

My name is Kristi, and I am a chronic pain patient. I've been diagnosed 
with degenerative disk disease, spinal stenosis, facet joint disease 
and spondylolisthesis. These diseases affect my entire spine and cause 
me significant pain every single day for the past 15 years. I was 30 
when my pain started and was told I had the spine of a 60 year old.

I tried lidocaine patches, heating pad, ice packs, over the counter Icy 
Hot, Tiger Balm, Copper Fit, and all nonopioid options. My doctor 
prescribed Tramadol, Gabapentin, Naproxen, Flexeril, Tylenol, and 
Advil. All non-narcotic medications failed, nothing gave me any relief 
round the clock, I was always in pain.

I've tried physical therapy, aqua therapy, stretching, ultrasound 
therapy, chiropractic treatment, massage therapy, acupuncture, yoga, 
inversion table, TENS unit, biofeedback (cognitive behavioral health). 
I've received trigger point injections, steroid injections, SI 
injections, nerve ablation in multiple areas and levels of my spine. I 
had an implanted neurostimulator and an intrathecal pain pump implant.

These were not my first choice. I put off the neurostimulator for 5 
years; when that didn't work, it was removed. Then 5 years ago I 
received an intrathecal pain pump; implanted in my lower abdomen, which 
delivers a low dose of pain medicine to my spinal fluid. While the pain 
pump helps with some lower back and leg pain, I still have no relief in 
my neck and shoulders. I am in need of pain medicine around the clock.

The rest did not provide adequate relief. I have tried every therapy my 
Pain Management Clinic has offered/suggested. I have been a model 
patient, submitting to pill counts, random urine screens, avoiding 
alcohol, securing my medications, using one pharmacy, and keeping all 
of my appointments.

Opioid pain medications help by managing my pain and allow me to work 
full time, work in my garden, care for my pets, home and family. They 
allow me to have some semblance of a life. I can go for walks, go 
geocaching, travel long distances, ride my bicycle, and even kayak with 
my husband.

Everything I tried failed to heal/help or adequately control my pain. 
Opioids and pain management are my last resort; without them, I will 
suffer constant pain. I won't be able to spend quality time, doing the 
things I love or spend time with people I care about. I will likely 
lose my ability to work full time, which is very important to me; also 
I carry the family's health insurance.

It is unlikely that my condition will improve and the effects of time 
and aging will make things worse. I am part of the C-50/Coalition of 50 
State Pain Advocacy Group, a grass roots national organization, not 
funded by pharmaceutical companies. It is run by chronic pain patients 
advocating for a revision of the CDC Guidelines and a National Pain 
Policy Program.

Prescribing has markedly declined and the cause of the crisis is 
illicit fentanyl and heroin; anti-prescribing laws will not solve the 
problem. These laws will only further stigmatize patients, promote more 
fear among doctors and cause more suffering and death by cardiac/
physiological issues and suicide.

These guideline are glossing over the fact that there is ``a 
distinction between taking medicine to destroy function versus taking 
medicine to increase function.''

Addiction is a serious problem in the United States and needs to be 
addressed. However, these guidelines are not accounting for chronic 
pain patients who follow the rules and are productive members of 
society.

Thank you for your time and consideration.

Kristi Becker

                                 ______
                                 
         Letter Submitted by Robert C. Bransfield, M.D., DLFAPA
U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

April 23, 2018

Re: Association between the opioid crisis and the Lyme epidemic

Greetings:

As a psychiatrist, I have dealt with substance abuse problems on a 
daily basis for the past 45 years. Clearly there are many contributors 
to the opioid and substance abuse epidemic and only an approach that 
understands and addresses all of the facets of this problem will be 
effective. It is not just an opioid crisis, it is a substance abuse 
crisis. One of the greatest contributors this crisis is the inadequate 
treatment of psychiatric and general medical conditions.

I assume others have communicated to you sufficiently about this 
connection. I shall instead focus upon a different and often overlooked 
component to the substance abuse crisis. I shall give a representative 
case history describing something I have seen far too many times.

        A young patient acquires Lyme/tick-borne diseases and the 
        diagnosis is missed, dismissed and/or they are undertreated. 
        The symptoms progress over a period of years to include 
        psychiatric symptoms, chronic pain and other symptoms. 
        Eventually they are prescribed pain medications and/or other 
        controlled substances and/or they acquire these medications 
        through other means. Their use of pain medications (opioids) 
        and other controlled substances increases and becomes an 
        addiction. They may then turn to multiple physicians, multiple 
        pharmacies, illegitimate sources of drugs and/or turn to 
        illegal activity. They attempt to overcome their addiction, 
        have a period of sobriety, then have some triggering event, 
        relapse and take the dose of opioid they had previously used. 
        However, the period of sobriety altered their tolerance to the 
        drug and that same dose is now a lethal dose. They are 
        discovered deceased and everyone is surprised, puzzled, and 
        grief stricken.

The point I would like to make is that not only inadequately diagnosed 
and treated psychiatric and general medical conditions, but also 
inadequately diagnosed and inadequately treated Lyme/tick-borne 
diseases are components contributing to the substance abuse and opioid 
epidemic. Better attention to the Lyme epidemic contributing to the 
substance abuse epidemic can help protect health, improve economic 
stability, and save lives.

Sincerely,

Robert C. Bransfield, MD, DLFAPA

                                 ______
                                 
                        Center for Fiscal Equity

                    Statement of Michael G. Bindner

Chairman Hatch and Ranking Member Wyden, thank you for the opportunity 
to submit my comments on this topic. We will reprise our remarks from 
February of this year to the Ways and Means Health Subcommittee. That 
hearing discussed the ongoing opioid crisis, and the important role 
data, addiction prevention, and access to treatment play in addressing 
the crisis. The hearing also examined possible legislative solutions to 
combat opioid abuse. I submit these comments as past health research 
data manager, prevention community leader, and a current recovered 
abuser and Medicare patient. As it does apply to this issue, I will 
repeat our four-part tax reform plan, which is as follows:

      A Value-Added Tax (VAT) to fund domestic military spending and 
domestic discretionary spending with a rate between 10% and 13%, which 
makes sure very American pays something.
      Personal income surtaxes on joint and widowed filers with net 
annual incomes of $100,000 and single filers earning $50,000 per year 
to fund net interest payments, debt retirement and overseas and 
strategic military spending and other international spending, with 
graduated rates between 5% and 25% in either 5% or 10% increments. 
Heirs would also pay taxes on distributions from estates, but not the 
assets themselves, with distributions from sales to a qualified ESOP 
continuing to be exempt.
      Employee contributions to Old-Age and Survivors Insurance (OASI) 
with a lower income cap, which allows for lower payment levels to 
wealthier retirees without making bend points more progressive.
      A VAT-like Net Business Receipts Tax (NBRT), essentially a 
subtraction VAT with additional tax expenditures for family support , 
health care and the private delivery of governmental services, to fund 
entitlement spending and replace income tax filing for most people 
(including people who file without paying), the corporate income tax, 
business tax filing through individual income taxes and the employer 
contribution to OASI, all payroll taxes for hospital insurance, 
disability insurance, unemployment insurance and survivors under age 
60.

The Ongoing Opioid Crisis

This national pandemic has been gaining steam for a long time. What was 
once the province of rural America and a few Doctors Feelgood has moved 
everywhere. Before opioids, the recreational pill of choice was the 
quaalude, which was before my time. It is the only drug war battle that 
could be won because there were few suppliers. That is not the case 
with opioids, which have old patents, new patents and suicidal hybrids 
that take life on a massive scale. This epidemic affects everyone, from 
workers with jobs and insured to poor and disabled people on Medicaid, 
both employed and not and Medicare beneficiaries, both disabled workers 
and mentally disabled recovering addicts and elderly who never thought 
they would become addicts, Indeed, the mentally ill former addicts have 
a much better chance of escaping addiction again because they know when 
to throw the pills away or they simply refuse them--I have done both.

The Role of Data

Properly used, Medicare care providers can track pharmacy data in an 
Accountable Care Organization where everything is in house. If outside 
pharmacies are available, this becomes harder but not impossible using 
Pharmacy and Medicare databases. Paper prescriptions are, of course, 
easier to abuse and should be entered into any tracking system, even if 
the scrip is not filled automatically. A photocopier, scanner or 
electronic printer can do amazing things when multiplying pain pills 
for groups of people. Of course, pharmacy networks can be hacked and 
overseas pharmacies can be accessed by the Internet, where perfectly 
legal appearing abusive prescriptions can be had with a credit card. 
While stopping such trafficking is not the job of Medicare, it does 
impact the system when beneficiaries become addicted. Creating a cyber-
crime unit in HHS or a separate medical crimes unit in Homeland 
Security is called for here.

The Role of Addiction Prevention

The question of gateway drugs does come up. Alcohol and Opioids have 
similar uptake patterns according to research reported in the book 
Beyond the Influence. Of course, opioids are their own gateway if 
prescribed too long. In prior centuries, cannabis was used to detox 
both alcohol and opium addictions. While it is not recommended in most 
cases, the opioid crisis is not an excuse to resist the legalization of 
cannabis for either medical or recreational use and for some, is a 
better solution for chronic pain. It is time to admit defeat in the 
culture war on this subject and explore this alternative, even if those 
who are already addicts probably cannot or will not use it.

I spent years directing community addiction programs. They never kept 
me sober, prevented anyone from drinking and certainly did not prevent 
anyone who had an extended pain medication prescription from becoming 
an addict. They may be useful in helping people identify if they are at 
risk, but most children of alcoholics already know of the risks they 
have and drink anyway, becoming alcoholic if they are genetically 
destined to and not becoming alcoholic if not.

Addiction prevention is more helpful in medical offices, where proper 
screening may stop people who use alcohol from becoming cross-addicted 
to both alcohol and benzodiazepines by combining together. Likewise, 
educating doctors and changing pain management regimens from 30 days to 
30 hours would prevent addiction, as well as research on both natural 
and synthesized cannaboids.

Access to Treatment

Access to both initial and continuing treatment is vital to both 
addiction and mental health care, as addiction can often uncover pre-
existing psychiatric conditions that drug and alcohol use was covering 
up. Even for non-alcoholics, once addiction has been turned on by 
opioids, the patient can never drink safely again and even moderate or 
heavy drinking previously will have to end, along with any medicinal 
effect it had.

For initial treatment, the question is not just access for willing 
patients, but mandated treatment for the unwilling. The liberalization 
of commitment laws in the 1970s has likely gone too far. Our first clue 
was mental patients, especially veterans, living on the street. Even 
when forced into treatment, taking a sober breath in a few days, 
treatment plan or no, resulted in release and resumption of the 
previous lifestyle. This is not freedom or health. State laws or one 
overarching federal standard must make it easier for families, police, 
doctors, and social service agencies to begin mandatory treatment, with 
the outcome being assignment to medical care if required and housing 
beyond shelter space if not already possessed. While some will not need 
the latter, those who do, especially our nation's seniors, disabled and 
veterans, should not be sent back to the cold.

Ongoing treatment should be adequate. Medicaid will pay for a nurse 
practitioner to see a patient in a psychiatric rehabilitation program 
twice a month. Non-PRP patients are seen less often if their medication 
is stable. Affordable Care Act policies authorize fewer visits and 
Medicare provides for two visits a year, which is not enough even when 
stable. Talk therapy under Medicaid is weekly and includes any licensed 
professional. Medicare requires Social Workers and that requirement 
makes care less available. Stable patients may be seen once every few 
months, which is hardly effective for more than a brief check-in, 
especially if a patient is dual-diagnosed with addiction. The pool of 
allowable treatment professionals must be expanded so that nurse 
practitioners and licensed counselors can bill Medicare if more 
frequent visits are desired, with Doctors and Social Workers 
supervising treatment and proving occasional care, especially 
medication adjustments.

Early addiction after-care with an HMO (my experience) provided two 
sessions a week, going to one a week nearing discharge and self-paid 
sessions for the last few, which is a sign of recovery. If relapse is 
detected during this period, the addiction specialist should be 
empowered (and the patient funded) to go back into treatment, possibly 
in a more intense setting than originally. The therapist should be 
similarly empowered, even with patients with long-term sobriety. 
Needless to say, Medicare should pay for all of it.

Legislative Solutions

Several proposals were provided above regarding data security, Internet 
prescription abuse, cannabis legalization, expanding the pool of 
practitioners under Medicare and the power to initially hospitalize and 
re-hospitalize addicts and the mentally ill. Freedom requires a clear 
head but it does not require being a culture warrior. Any so-called 
Freedom Caucus member who uses that name should stop if they disagree 
with me and Drs. Ron and Rand Paul on the cannabis issue.

Our remaining comments will be in regard to our tax plan.

Medicare is a Hydra, taking money from the Hospital Insurance Tax, the 
high income dividend and capital gains surtax, patient premiums and 
copayments and the general fund. Some of the reforms required will be 
cash intensive. Hospital Treatment will come out of HI and ACA/HI and 
the general fund. Aftercare will come from Part B or C, with some 
monies coming from the general fund, including three of every four 
premium dollars.

It is always important to note that the whole purpose of social 
insurance, including Medicare, is to prevent the imposition of unearned 
costs and payment of unearned benefits for not only the beneficiaries, 
but also their families. Cuts which cause patients to pick up the slack 
favor richer patients, richer children and grandchildren, patients with 
larger families and families whose parents and grandparents are already 
deceased, given that the alternative is higher taxes on each working 
member. Such cuts would be an undue burden on poorer retirees without 
savings, poor families, small families with fewer children or with 
surviving parents, grandparents and (to add insult to injury) in-laws.

Recent history shows what happens when benefit levels are cut too 
drastically. Prior to the passage of Medicare Part D, provider cuts did 
take place in Medicare Advantage (as they have recently). Utilization 
went down until the act made providers whole and went a bit too far the 
other way by adding bonuses (which were reversed in the Affordable Care 
Act). There is a middle ground, and the subcommittee's job is to find 
it and our job to help.

In our plan, funding Medicare has nothing to do with the income tax, so 
bullet two above can be disregarded. Likewise, we would repeal the 
Medicare and Affordable Care Act dividend and capital gains surtaxes 
targeted only at upper income taxpayers. Because the benefits are 
general, the taxation should be as well.

Bullet three on employer contributions to Social Security is also not 
affected by our proposal, which already moves the Medicare Hospital 
Insurance Tax paid by employees to the Net Business Receipts Tax/
Subtraction VAT.

It could also be moved to bullet one, the Value-Added Tax taken on 
receipts (along with the Employer Contribution to Social Security), 
making that part of the tax border adjustable but at the cost of 
eliminating offsets that can be taken against the NBRT for providing 
direct insurance and care for employees and retirees, which would make 
the tax border non-adjustable (no zero rating). If the VAT is used, it 
would be considerably higher than the 13% proposed by either this 
Center or Michael Graetz. Just shifting taxes without accounting for 
ACA/HI inclusion would add 9.3% of income, making the VAT visible for 
22.3% of every transaction. The VAT will fund any enhanced Internet law 
enforcement efforts, however, unless housed in HHS. VAT funding would 
also mean all savings must come from government enforcement rather than 
employer/taxpayer efficiency, which would put cost payment and cost 
cutting in the same hands.

Again, the Net Business Receipts Tax, bullet four, proposes to combine 
all employer income taxes, payroll taxes, ACA taxes and the HI payroll 
tax. It will include offsets, including an enhanced child tax credit 
and the health insurance exclusion. It will fund all social insurance 
costs, including those with state revenue participation, including 
education and we expect states to fund their share of this tax with 
matching taxes and the same VAT base.

One of the options is a personal retirement account holding employer 
voting stock and an insurance fund of such companies (a third to 
insurance). We believe such employee-owned firms will take bolder cost 
cutting measures without losing compassion for their retiree/
shareholders who could even by-pass Medicare and be funded by an 
internal plan which must be at least as generous. Note that employee-
owned firms could also pay all Part Band D premiums. More information 
on this aspect is available in our previous comments to the committee.

The NBRT can provide an incentive for cost savings if we allow 
employers to offer services privately to both employees and retirees in 
exchange for a substantial tax benefit, either by providing insurance 
or hiring health-care workers directly and building their own 
facilities. Employers who fund catastrophic care or operate nursing 
care facilities would get an even higher benefit, with the proviso that 
any care so provided be superior to the care available through 
Medicaid. Making employers responsible for most costs and for all cost 
savings allows them to use some market power to get lower rates, but no 
so much that the free market is destroyed.

This proposal is probably the most promising way to arrest health-care 
costs from their current upward spiral--as employers who would be 
financially responsible for this care through taxes would have a real 
incentive to limit spending in a way that individual taxpayers simply 
do not have the means or incentive to exercise. While not all employers 
would participate, those who do would dramatically alter the market. In 
addition, a kind of beneficiary exchange could be established so that 
participating employers might trade credits for the funding of former 
employees who retired elsewhere, so that no one must pay unduly for the 
medical costs of workers who spent the majority of their careers in the 
service of other employers.

Let me also comment on Senator Sanders's proposal for Medicare for All. 
The reality is that Medicare is not as generous as younger people 
assume and that the Senator's proposal would eliminate those cost 
sharing features of Medicare, making it Medicaid for all (but with 
higher doctor reimbursements) and then replacing both Affordable Care 
Act and Health Insurance Exclusion supported policies with the 
expanding program. Of course, like Medicare and Medicaid, it will be 
impossible to do without using the Affordable Care Act's Accountable 
Care Organizations. In other words, health insurance companies are 
going nowhere nor will all cost control efforts be abandoned. We like 
our proposal better, which is more cooperative socialist than 
democratic socialist. In either case, however, something like the Net 
Business Receipts Tax/Subtraction VAT in bullet four will be necessary, 
especially if we are serious about fighting the opioid crisis.

A final word on drug testing. It should lead to treatment, not 
exclusion of benefits, especially medical benefits, but all other 
social benefits are as applicable, as no one should have to choose 
between getting treatment and feeding their children. You would think 
this would be obvious, but almost every other week some Tea Partier 
introduces legislation to test SNAP or TANF recipients. Their arguments 
are without merit.

Thank you for the opportunity to address the committee. We are, of 
course, available for direct testimony or to answer questions by 
members and staff.

                                 ______
                                 
                 Letter Submitted by Kathleen M. Clark

April 20, 2018

Member of the Idaho Pain Advocacy Group C-50

Dear Senators, I would like to introduce myself: I am a chronic pain 
sufferer. I was born without a left hip socket. This condition went 
undiagnosed until I was 8 years old! At the time, I was born in the 
small State of Rhode Island. My older sister and I went to the YMCA to 
learn how to swim. I remember vaguely, crying out in pain as I was 
trying to learn the swimming ``frog kick.'' This caused me intense pain 
and the lifeguard called my parents. Next, I heard the words: ``She 
doesn't have any hip socket.'' I spent my entire 3 month summer 
vacation in the hospital. First, for 6 weeks, I was in traction with 
weights and pulleys at the bottom of my bed. This was supposed to bring 
my femur bone (which was riding above my hip), down to at my hip level. 
Secondly, after that was accomplished, I had major surgery to have some 
semblance of a hip socket created. This was very painful post-op. In 
those days, parents weren't allowed to spend the night. My dad came 
every evening after work to see me and encourage me. Before going home, 
I had physical therapy. I walked on crutches for 1 year, and had a lift 
placed in my left shoe, as this was my shorter leg, and I limped quite 
pronounced. This is a hereditary condition, but yet my seven other 
siblings were lucky enough to not have this problem. All the surgeon 
recommended to my parents, make sure that she gets a hip x-ray every 
year. I do remember being around 14 years old and experiencing severe 
bone pain due to the fact that my left hip was growing. All I received: 
aspirin. This really did nothing for my pain.

Fast forward--I met my husband at age 21 and married. However, I still 
had bad pain spells. I also went into the field of nursing. First, I 
worked as an LVN, in Newport Beach, CA (I loved my hospital nursing 
job. This was the hospital where the famous western actor John Wayne 
died.) I always made certain that my patients were never in pain. It is 
like taking the Hippocratic Oath (which doctor's take); believe it or 
not, we nurses had to take a Nurses Oath. I did a lot of walking on my 
job. It was very physical work. Then I went back to school to become a 
Registered Nurse or RN. I was able to perform my job, until 
overwhelming pain took over my life. I had to quit my job. At age 25, I 
had an orthopedic surgeon who performed a primary total hip surgery. 
When he performed this surgery, he found that my left hip had 
dislocated, and I suffered from severe osteoarthritis. If I did not 
have this surgery then, my surgeon said that I would have been in a 
wheelchair. The next amazing accomplishment: I gave birth (regular) to 
one beautiful daughter and all with a total hip replacement.

The worse thing I had to endure: four more total hip revision 
surgeries. Not many orthopedic surgeons wish to do these revision type 
surgeries. But, because I had been so active the glue material gave out 
and mechanical failure happened due to the fact that medical doctors 
cannot predict how long these hip replacement surgeries will last. At 
present, my last hip revision surgery on my left hip was in 2002. It 
has now lasted 15 years (the longest lasting yet). I have my left hip 
x-rayed yearly. Since 2013, my husband retired and he wanted to move to 
Idaho Falls, ID. He loves to fly-fish and builds bamboo fly fishing 
rods. I am so proud of him! My daughter obtained her Psy D in 
psychology for marriage and family therapy; she is also working with 
stroke patients and our military veterans suffering from PTSD. She 
lives in Spokane, WA.

I want to address now what has happened to me since the age of 
approximately 38 years. I tried acupuncture for my pain, but it did not 
work due to the fact that I had a lot of scar tissue. I tried 
psychology and was placed on an anti-depressant medication called 
Elavil. After about a month on this drug, I gained approximately 40 
lbs. and it made me feel like a zombie. I tried the TENS unit without 
much success. All the TENS unit did was make my left hip and back 
nerves become extremely irritated. I tried psychology, biofeedback, 
imagery, all to no avail. All this time took about 10 years to try to 
relieve my constant nagging pain. My husband felt helpless, as I cried 
each night. So, when I made the decision to see a chronic pain doctor 
in southern California, I was so relieved that I started to cry!

Let me explain how my pain program worked to help me: first my medical 
doctor carefully did a hormone profile. He and I worked out a formula 
for the type of pain medication that worked for me, along with a muscle 
relaxant. We found out that I did well on 120 MMDs per day. Our program 
was zero tolerance policy. This meant that for 23 years, I had to visit 
my pain doctor each month. We could not go over the amount of pain 
medication which worked for us. (Remember, each individual is unique; 
what works for one person, may not work for another patient). My pain 
doctor gave us tools also which gave me a chance to use Icy Hot patches 
to my lower back and hip. I would take aspirin three times weekly. I 
would have my husband massage my leg when it went into awful spasms. I 
am a law-abiding citizen. We patients also had random drug urine 
testing, could use only one pharmacy, and never go ``doctor shopping.'' 
Anyone not abiding by these rules, they would be kicked out of the pain 
program. I have been successful on my pain medication and I always told 
my doctor, please include me in a study if it would be helpful.

So, here in Idaho Falls, the pain doctors are usually 
anesthesiologists/pain doctors. I was with one doctor who gave me my 
med dosage which worked for me until the CDC guidelines came into 
effect. When this happened, it put a strain on the doctor/patient 
relationship. All of a sudden (with no input from myself), I found out 
that my pain meds had to be reduced down to the 90 MMD rule. Each pain 
doctor here in Idaho as well as nationwide is in total fear of losing 
their medical licenses if they prescribe over the 90 MMD rules. I also 
keep reading articles which state that there are not enough studies 
done to determine if opioid medications work. If I were only included 
in that study (sigh)! The addiction rate for a pain patient on long 
term meds is about 1-3%. This is quite low. But due to the ODs 
happening, the word opioid has been given a broad definition. There are 
quite a few lay-people who do not even know how these pain meds work. 
Here is a short education. Think about a diabetic person, they may need 
to take insulin injections in order to lower their blood sugar and have 
a life. My pain medication is a lifesaver. My pain disability is a 
disease and should be considered as such.

We do not get ``high'' from our pain medications, what we get is much 
needed pain relief. This gives me the ability to get out of bed, be 
able to socialize, be able to travel, and to summarize it all: to give 
me a ``quality of life.'' Right now, this has been taken away from me 
and nobody even bothered to care. I want people to become educated to 
know that when taken correctly, pain medication is a life saver to us 
pain patients. I wish to let you know that Medicare/Medicaid is now 
under scrutiny and I voted against the CMS beginning to drop the pain 
dosage to the 90 MMDs each day. Why is the Federal Government 
interfering with my pain doctor relationship? I have heard of well-
deserved physicians having their offices raided by the DEA; this is 
absurd. The CDC even came out to say that they were in error in 
reporting the number of overdoses that had taken place in the last year 
or two. So, is it right to say something that is not true? There are 
numerous pain sufferers like myself who have been maintained on a 
dosage which works for them. What has happened to our great Nation? 
Since when has it become shameful to admit that we are experiencing 
pain? Another true fact: let's say you go in to the hospital to have an 
appendectomy. Yes, you experience pain, but it is short lived and goes 
away. Chronic pain lasts more than 90 days and is constant and 
unbearable. Please note that I want the Senate to understand the reason 
for we pain patients not wanting to have to be limited by this so 
called 90 MMD ruling. What needs to be done first? Please take away the 
fear of the pain doctor losing his medical license. What has been 
discovered? There is illicit fentanyl pouring in from places like China 
and Mexico, which is all sold on the dark web and delivered by the U.S. 
Postal Service. The DEA needs to concentrate their efforts in this 
area. It is true and sad, that a number of individuals have died from 
these bad drugs. However, I feel that each individual is responsible 
for their own actions. The Addictionists choose and continue to choose 
to take drugs to make them get ``high'' . . . nobody told me to put a 
needle in my arm to inject heroin.

To summarize: the general public, and the primary care physicians need 
to take pain management classes and reeducate themselves as to how 
these meds are vital to us pain patients to be able to have a life and 
not suffer. Imagine our poor veterans being cut off their pain 
medications. It is a travesty as to what is happening to our Nation. 
Nobody wants to take notice of us pain patients. I would love it if 
somebody would read my pain story. Let's get educated and realize that 
the pain meds are not what's causing evil in our society; it is 
imperative to have a quality of life. I am suffering along with 100 
million other pain patients. My pain condition warrants the fact that 
the medications at 120 MMDs have worked for me for almost 27 years and 
I am still here. The last thing I would like to add is, many of us pain 
patients have pain flares which occur out of the blue. For instance, I 
do not have hardly any bone left in my left hip joint, and I have a 
metal rod which goes to the knee hammered into my femur bone. I have 
screws, nails (just like in a hardware store). When the barometric 
pressure drops and it rains, my entire hip goes crazy in pain. When 
this happens, my little bone that is left expands and it feels like my 
hip and thigh will burst. Another huge problem is that my blood 
pressure is not stable with the decreased dosage of pain medication. I 
already take two blood pressure pills from my primary care physician. 
My blood pressure has been high, around 150/100. This in itself could 
cause me to have a stroke. I found out that I currently have a broken 
screw in the hip socket which I have never experienced before. In 
nursing school, I not only had to take 2 days of state boards to 
receive my RN license, but I had to be well versed in all pain 
medications. I sometimes feel that not all doctors are aware of how 
certain pain meds work, and there are definitely some meds that 
shouldn't interact. But we pain patients know this. I write down each 
time I take a pain pill, I lock up always all of these medications. It 
is just not true to make a statement that pain medication will lead to 
heroin addiction. That is so very wrong to advertise. It would be nice 
to have a commercial which shares our stories. Much works needs to be 
done to change the mindset over this much uninformed topic. I have had 
to walk with a cane since the year 2002. I just want my life back.

Respectfully submitted,

Mrs. Kathleen Clark, RN (retired)

P.S.--I am an active member of the Advocacy for Pain Patients in Idaho, 
C-50.

                      IMPORTANT ADDED INFORMATION

My birth defect should be considered a disease condition. I have a 
totally deformed left hip socket. Imagine if I had diabetes. I would be 
treated with the appropriate medication--such as insulin to regulate my 
blood sugar levels and keep me alive. The same holds true for my pain 
condition. My pain medication works when my pain doctor and I can 
figure out a formula which works for me (remember, each person is a 
unique individual). What may work for one patient, may not work for 
another patient.

Secondly, there is genetic opioid testing for us pain patients. It is 
an invaluable tool which shows how our bodies metabolize opioid 
medicines. This has been around since approximately 2010. Also, doing a 
hormonal profile each year will give the pain doctor valuable 
information as to how hormone levels can affect pain levels. If a 
hormone level is out of balance, the pain doctor can make adjustments 
to fix this.

I have had my adrenal glands tested periodically. This is one hormone 
that a good knowledgeable pain doctor knows how to treat. I have taken 
DHEA supplements 3 times a week, approximately every 2 months.

                                 ______
                                 
               Coalition of 50 State Pain Advocacy Groups
May 2, 2018

U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Services Programs,'' Thursday, April 19, 2018, 
Senate Finance Committee

The Senate Finance Committee has requested additional input from 
stakeholders and other interested parties for the record of the hearing 
``Tackling Opioid and Substance Use Disorders in Medicare, Medicaid, 
and Human Services Programs.'' As a nationwide advocacy group 
representing chronic intractable pain patients from all walks of life, 
we believe we bring a different perspective to the table. Below are our 
comments and suggestions to the Senate Committee on Finance.

As a starting point, two major points of clarification that must be 
made. One is that prescription opioids are not causing the current 
crisis. Illicit substances, such as heroin and fentanyl, are. In fact, 
opioid prescriptions have been falling dramatically and steadily since 
mid-2010. At the same time, the number of overdose deaths have been 
skyrocketing. The second point is that the vast majority of those 
currently addicted to illegal substances did not get their start with a 
legal physician's prescription for opioids. Study after study have 
found that the majority of these individuals begin by stealing from 
someone's legitimate supply, or purchasing pills on the street. 
Therefore, the tying of physician's hand will not stop this crisis. It 
needs to be stopped where it begins--on the streets. The major problem 
with overarching pain control guidelines, including the 2016 opioid 
guidelines by the CDC, is that the true intractable pain patients are 
swept up in the aftermath. Chronic intractable pain patients' dosages 
get reduced or removed, along with everyone else's, no matter the 
individual patient's situation. After the CDC Guidelines were revealed, 
many physicians stopped prescribing opioids altogether, and even more 
refused to prescribe above the suggested 90 MME, no matter the previous 
dosage of the patient. A lot of physicians stated that they feared 
retribution by governmental agencies if they continued to prescribe to 
chronic intractable pain patients as they had before the guidelines. 
These broad guidelines and other state regulation is now affecting 
those with cancer, those receiving and post-major surgery, and those in 
palliative and hospice care. Additionally, due to the DEA cutbacks in 
opioid products in their misguided attempted to stem to opioid crisis, 
hospitals are running low, or are completely lacking necessary pain 
medications for the sickest of patients. The madness must end.

In the case of chronic intractable pain patients, the major problem 
with this situation is that the logic behind removing or quickly 
reducing opioids for stable chronic intractable pain patients is 
untested and unproven. There have been no prospective clinical studies 
to show that discontinuing opioids for currently stable pain patients 
helps those patients or anyone else. While slowly weaning from some of 
their medications under a physician's supervision could theoretically 
be helpful to a minority of chronic pain patients, it seriously 
destabilizes the vast majority, and would likely promote the use of 
heroin or other illegal substances. Thus, the discontinuation of pain 
control medication for these patients, who rely on them in order to 
work, and be otherwise productive, contributes directly to the 
decompensation of the patient. A very ill chronic pain patient will no 
longer be able to work, or otherwise be productive, which will lead to 
more individuals on disability, Medicare, and Medicaid. Thus, an 
expensive, vicious downward cycle develops, as more formally stable 
patients have their pain control medications taken away, and they join 
the ranks of the disabled. Meanwhile, those on disability become 
sicker, and rely on the governmental safety nets more and more.

To significantly lessen the risk of OUD and SUDs within the greater 
Medicare and Medicaid populations, without harming those patients who 
rely on opioids to function in their daily lives, any and all 
regulation must be targeted. Specifically, instead of the broad 
regulations and guidelines of the past few years that paint every 
person with an opioid prescription with one stroke, we suggest 
targeting certain aspects, such as:

      Establishing a uniform physician education program;
      Updating the ICD-10 codes for chronic intractable pain;
      Establishing a national Prescription Monitoring Program (PMP);
      Requiring that all prescription opiates are tagged with a unique 
identification number; and
      Requiring and covering genetic testing for medication metabolism 
markers.

Taken together, these suggestions will give physicians the tools they 
need in order to diagnose true chronic intractable pain patients, and 
monitor those patients who are already receiving opioids. We envision a 
uniform physician education program in the form of mandatory CME 
classes that would inform physicians of the steps needed to diagnose 
and treat intractable pain patients. Physicians could learn a 
guidelines for approaching newly diagnosed intractable pain patients, 
such as prescribing neuropathic agents and anti-inflammatories before 
trying opioids, running genetic testing to see how each patient 
metabolizes medications, and ordering targeted physical therapy for 
musculoskeletal pain and dysfunction. These classes could also discuss 
the benefits and drawbacks of alternative therapies, including 
acupuncture, massage, aqua therapy, etc. Physicians would also be 
instructed on guidelines for diagnosing chronic intractable pain.

Hand-in-hand with physician education, the suggestion to update the 
ICD-10 codes would eliminate uncertainty about the diagnostic criteria 
for chronic intractable pain patients. Currently, the ICD-10 has 
approximately 100 different codes for pain. Code R52.1 purports to 
address chronic intractable pain; however, it is included under the 
heading of ``Pain, unspecified,'' and the description is intermixed 
with that of acute pain. Also, none of these codes properly addresses 
the biopsychosocial aspects of chronic intractable pain. A new code or 
updated code for chronic intractable pain would limit any confusion 
between chronic and acute pain for diagnostic purposes.

A federally mandated national PMP would help to eliminate any abuses of 
the system. Currently, most states have PMPs, while the rest have 
enacted legislation in order to establish them. However, a system to 
monitor patients nationally does not yet exist, although about 40 
states are voluntarily participating in PMP Interconnect, a secure 
communications exchange platform that facilitates the transmission of 
PMP data across state lines to authorized requestors. A federally 
mandated system would combat prescription medication abuse and 
diversion with neighboring states, and allow CMS to monitor Medicare 
and Medicaid beneficiaries.

We also suggest that CMS work with the FDA to require that all 
prescription opioids be tagged with a unique identifier. This unique 
identifier would be akin to a car's VIN number and would allow the 
tracing of all opioid-based prescription medications. The major cause 
of the influx of prescription medications to the street is diversion, 
most of it out the back doors of pharmacies and distributors. If every 
type of opioid medication had a unique identifier, governmental 
agencies would be able to track the patterns of diversion and shut them 
down. This suggestion would assist the federal government is stopping 
the diversion of prescription medications, which is a significant 
problem in the opioid crisis.

Finally, CMS should both require and cover genetic testing for 
medication metabolism marker. More than 75% of people have genetic 
variations that determine how their bodies process and use medications. 
Because of these genetic differences, two people can take the same dose 
of the same medication, but respond in very different ways. For 
example, a medication might work very well for one patient, not at all 
for another, and causes serious side effects for a third. Especially 
when dealing with opioids, genetic testing is helpful to discover how 
quickly a patient will metabolize the medication without trial-and-
error. This type of genetic testing, therefore, could assist physicians 
in determining the correct course of action for chronic intractable 
pain patients. Additionally, when a physician decides that opioids are 
necessary, this genetic testing will help physicians in determining 
what dosages are appropriate.

We hope that the above-referenced explanation of why broad legislation 
and regulations harms chronic intractable pain patients. We also hope 
that our suggestions on how to target specific legislation and 
regulations will assist you in your decision-making process. Thank you 
for your time and consideration.

Sincerely,

Valorie Hawk
Director and Founder

Amie Schaadt Knauer
Special Projects

Sherri Cantara Martin
Operations and Research

Rhonda Posey
Membership Coordinator

                                 ______
                                 
                     Letter Submitted by Carol Efaw

              Member, Washington Pain Advocacy Group, C-50

May 2, 2018

U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Services Programs,'' Thursday, April 19, 2018

Since the CDC and DEA have been involved in the illicit fentanyl and 
heroin opioid crisis, their efforts have resulted in fewer medical 
providers and fewer prescriptions for legal pain medications. Their 
efforts have not helped to reduce opioid deaths but rather deaths are 
on the increase. Because of the DEA mandating production cuts, even 
hospitals are now having trouble obtaining necessary pain medications 
for post-operative patients.

I am a member of the C-50/Coalition of 50 State Pain Advocacy Groups, a 
grass roots national organization, not funded by pharmaceutical 
companies and run by patients advocating for a revision of the CDC 
guidelines and a National Pain Policy program.

A carve out MUST BE CREATED--not merely allowed to be created--for 
intractable pain patients under a Palliative Care exemption from CDC 
guidelines, Medicare restrictions, and federal and state laws.

National Pain Policy could include: (1) mandated genetic testing for 
hyper-metabolizing (no patient metabolizes medications alike); (2) 
standardized pain contracts (reasonable UAs, pill counts, one 
pharmacy); (3) intractable pain diagnostic code re-defined so 
physicians are paid a higher fee for the extra time it takes to manage 
our complex cases; (4) the Palliative Care definition clarified to 
include all incurable, progressive conditions and exempt from CDC 
guidelines/Medicare restrictions, and patients' records protected for 
our lifetimes.

I am a pain patient and have been diagnosed with various inflammatory 
diseases including degenerative disk disease and scoliosis for over 40 
years. I have tried numerous non-opioid medications including 
ibuprofen, aspirin, Lyrica, Gabapentin, steroids, and others too 
numerous to list, before being prescribed opioids. I have received over 
a dozen spinal steroid injections, acupuncture, massage, chiropractic 
care, bio-feedback, spinal braces, TENS units, as well as numerous 
courses of physical therapy. None of these healed my conditions and 
none adequately controlled my pain. And the spinal injections actually 
worsened my pain. Opioid pain medications help by managing my pain and 
allow me to care for myself, my family, and my home as well as work 
part-time from home as an advocate helping others. I am never 
completely free from pain nor do I ever experience a ``high'' from my 
medications. I am not a drug seeker and I resent being treated like a 
criminal by all parties involved in this heroin and illegal fentanyl 
``opioid crisis.''

I have had cervical decompression/fusion surgery and was told last 
month I need the same surgery in my lumbar area. Because I already 
receive pain medications, my surgeon said she would not be giving me 
any additional pain relief after surgery. I cannot proceed with this 
surgery under these conditions without additional pain relief--
regardless of the future consequences.

In 2015, my mother was assigned to hospice care. She had taken pain 
medications for severe back pain for more than 20 years. The hospice 
doctor refused to renew her prescriptions saying, because she had 
dementia, she couldn't feel any pain. I know that to be untrue. I 
appealed on her behalf to no avail. She died a year later suffering an 
extremely painful death--literally--TORTURED TO DEATH.

If I did not have access to my medication, I would deteriorate rapidly 
and end up in bed most, if not all, of the time due to extreme, 
unrelenting pain and fatigue. I would not be able to work part-time. I 
would not be able to care for myself, my family, or my home. Already, I 
am depressed just worrying each day might be the day I lose my 
medications. My husband works full-time; he is not in great health so 
he would not be able to take care of me and we could not afford in-home 
care. If he had to stop working to care for me, we would lose our home 
and God knows what would happen to us.

In all the years I have taken pain medications, never once have I 
broken my pain contract. I have always been a compliant patient. 
Besides the ridicule, I have been subjected to pill counts, urine 
tests, etc. the entire time. My current pain specialist says I have 
been a model patient--one that she considers ``low-risk'' even though I 
am prescribed more than 90 MMEs/day. My condition will not likely 
improve and the effects of added pain will only result in more doctor 
visits and costs to the health-care system. Opioids and pain management 
are what keeps me functioning as a contributing member of my community 
and they are a low-cost, effective modality in dealing with my 
incurable issues.

Thank you for listening.

Carol Efaw

                                 ______
                                 
                    Letter Submitted by Sonya Huber

             Member, Connecticut Pain Advocacy Group, C-50

U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Services Programs,'' Thursday, April 19, 2018

Dear Senators,

Prescribing of opioids has declined. Instead, people are dying from 
cheap heroin and illegal fentanyl. I know this as an informed member of 
the C-50/ Coalition of 50 State Pain Advocacy Groups, a grassroots 
national organization, not funded by pharmaceutical companies and run 
by patients advocating for a revision of the CDC guidelines and a 
National Pain Policy program.

I know from personal experience that laws targeting the prescription of 
all kinds of painkillers have spooked doctors, leading to drastic 
decreases in medication for legitimate and painful life-long 
conditions, such as my own of rheumatoid arthritis, fibromyalgia, and 
Hashimoto's Thyroiditis. I have been living with these conditions for 9 
years. I use Cognitive Behavioral Therapy, I meditate daily, I ride an 
exercise bicycle, I use topical muscle relaxing creams, I use a Quell 
TENS unit, and a variety of supplements such as turmeric and fish oil. 
None of these even comes close to chipping away at the pain. One of the 
important things to know about pain is that it builds to an exhausting 
level, and occasionally without a relief from it, a person in pain is 
not able to sleep and to get the rest and physical repair necessary to 
continue. I took one Tramadol a day for sleep, and that has been 
discontinued by my doctor as the result of the opioid scare.

I was recently in the ER for a related pain condition, and surgery was 
recommended. I saw how high my blood pressure was spiking because of 
pain. I am afraid to have surgery for fear of what the pain treatment 
situation would be like afterward. The current environment in the 
medical community with regard to opioids means that there is a great 
deal of shaming if a patient confesses to any pain. Anyone who tells a 
doctor they are in pain is branded as a suspected drug seeker. This 
shame in addition to having multiple chronic conditions is unbearable.

I am a model patient. I use one pharmacy and coordinate my care with 
multiple doctors. I have always followed prescription instructions 
exactly--and in fact when given pain pills, I usually take less than 
prescribed. I take the minimum I need to function. In addition I have a 
med safe at home in which I keep all opioids and anything else that 
might be dangerous locked up, and I turn in my old medications to a 
drop-box at the fire station near my house. I am not able to drink any 
alcohol due to negative interaction with an injectable non-opioid 
chemotherapy drug I take weekly for my condition, which is at this 
point incurable.

I work full time as a college professor, I am a mother to a 14-year-old 
son, and I'm as active as I can be. Knowing there is no help today for 
chronic pain patients makes contemplating my future to be a crushing 
exercise. If you don't know what it is every day to get up in 
excruciating pain, you don't fully understand how punishing an overly 
aggressive and wrongly targeted law can be.

We as a nation need a carve out for intractable pain patients under a 
Palliative Care exemption from CDC guidelines, Medicare restrictions 
and federal law. We need a National Pain Policy, which could include: 
mandated genetic testing for hyper-metabolizing (no patient metabolizes 
medications alike), standardized pain contracts (reasonable UAs, pill 
counts, one pharmacy), intractable pain diagnostic code re-defined so 
physicians are paid a higher fee for the extra time it takes to manage 
our complex cases, the Palliative Care definition clarified to include 
all incurable, progressive conditions and exempt from CDC guidelines/
Medicare restrictions, and patients records protected for our 
lifetimes.

I worry every day about being disabled because of lack of access to 
effective pain treatment, and I worry about the depression and loss of 
functioning and career that might result. I urge you to take this huge 
segment of the population into consideration. Pain people are also 
voters, and we are human beings.

Sincerely,

Sonya Huber

                                 ______
                                 
                  Letter Submitted by Mark Ibsen, M.D.
U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Dear Senators:

My name is Dr. Mark Ibsen. Please know there is truly an epidemic in 
medicine: an epidemic of misinformation and disinformation. Someone has 
developed the idea that Percocet causes heroin overdose deaths. This is 
false.

The war on drugs and people has been a $2 trillion failure. Claiming 
that doctors have fueled an opiate epidemic is not proven. In fact 
opiate prescriptions have been decreasing since 2010 and yet overdoses 
have continued to skyrocket. Because of the scarcity of pain relief for 
pain patients, more people are turning to heroin. Therefore more 
complications from that drug, which is often contaminated by elicit 
Fentanyl from China, causes epidemics of death in various communities. 
In addition, street pills are now known to be mostly counterfeit. These 
counterfeit pills can look like an innocuous Percocet or hydrocodone 
tablets and contain deadly Fentanyl from China.

My promise is that you cannot arrest doctors expecting to change this 
dynamic. The consequence of restricting prescription opioids, and 
making it very difficult to obtain pain relief, is abandonment of the 
25 million Americans who have been stable on their palliative opiate 
programs. Many patients metabolize opiates rapidly, requiring higher 
doses then the arbitrary doses given in the CDC guidelines. These 
guidelines have been misinterpreted as ``rules,'' creating havoc for 
doctors and patients.

The key question to be asking is what is causing all these heroin 
overdose deaths? That would be heroin. Prince and Tom Petty both died 
of severe pain. They were treating their pain with counterfeit pills, 
resulting in death.

Please refer to the experience of the country Portugal, where opiates 
and other drugs were decriminalized, resulting in less crime, less 
rates of addiction, and less than 10 deaths a year in the entire 
country.

While there is a bandwagon of interested parties claiming that opiates 
prescribed by physicians are harmful, less than 1% of pain patients 
given an opiate develop an addiction. One way to sort this out is to 
collect better data. One way to get better data would be to put a 
marker on every pill that is manufactured legitimately. This will be 
like a fingerprint or a VIN number. I'm sure we have the technology to 
do this and we're already spending boatloads of money on this issue, 
but the data we are obtaining is inaccurate. Anyone who dies in America 
with any amount of opiate in their system is listed as an opiate 
overdose. This gets us data which is ``fake news.''

We could actually do the research and find out what is the cause of the 
deaths that have been reported. Often these are suicides. Yet doctors 
get arrested and sent to prison when their patients use their 
medications to kill themselves.

Suicides are increasing in the pain population and veterans who suffer 
from pain and PTSD. Trying to arrest our way out of this problem has 
been unsuccessful for over 50 years.

Please review the Institute of Medicine report on Pain in America from 
2011, which indicates that pain itself is present in 100 million 
Americans, causing a $650 billion impact on our economy. That's a lot 
of voters. That's also a lot of expense and drag on our economy. Please 
ignore bad data; only look at good data.

People are in agony, abandoned by their physicians who are too 
terrified to treat their pain.

Thank you,

Mark Ibsen, M.D.
Helena, MT

                                 ______
                                 

        American Council on Science and Health, October 12, 2017

        The Opioid Epidemic in 6 Charts Designed to Deceive You
                             By Josh Bloom

https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-
                           deceive-you-11935

I do not know Dr. Andrew Kolodny \1\ personally, and, aside from one 
brief phone call last year, I have had no contact with him. Therefore I 
cannot know his motivation for becoming a driving force behind ``opioid 
reform''--a concept which would border on hysterically funny if not for 
the tragedy that it is causing in this country.
---------------------------------------------------------------------------
    \1\ (https://www.phoenixhouse.org/news-and-views/news-and-events/
phoenix-house-appoints-dr-andrew-kolodny-as-chief-medical-officer/).

Dr. Kolodny, a psychiatrist, is the executive director of Physicians 
for Responsible Opioid Prescribing (PROP)--a group that played a 
significant role in creating the disastrous CDC Guideline for 
Prescribing Opioids for Chronic Pain (https://www.cdc.gov/mmwr/volumes/
65/rr/rr6501e1.htm) (2016). The CDC ended up incorporating much of 
PROP's recommendations, which were supposedly designed to help the U.S. 
mitigate the damage done by opioid (1) drugs, despite the fact that the 
``evidence'' contained in the recommendations had been carefully 
scrutinized and found unsupportable by FDA scientists (http://
paindr.com/wp-content/uploads/2013/09/
FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribing_
---------------------------------------------------------------------------
Partial_Petition_Approval_and_Denial.pdf).

Since I cannot read his mind, I have no way of knowing whether 
Kolodny's efforts are an honest, but misguided, attempt to help, or 
something else.

But I can read his writings, and based on ``The opioid epidemic in 6 
charts,'' recently published (https://theconversation.com/the-opioid-
epidemic-in-6-charts-81601) in The Conversation, honesty is not the 
word that first pops into my mind. Yes, Dr. Kolodny does present 6 
charts to explain his version of what I will now call ``The Fentanyl 
Crisis,'' (2) but even a quick read of his editorial reveals that it 
appears to be designed to confuse rather than clarify matters. Let's 
take a look.

Trick #1: Manipulative and misleading statistics.

``Drug overdose deaths, once rare, are now the leading cause of 
accidental death in the United States, surpassing peak annual deaths 
caused by motor vehicle accidents, guns and HIV infection.''

This sentence, the very first of the editorial, doesn't pass the sniff 
test. Why?

      The term ``drug overdose deaths'' (there are about 60,000 
annually) is now standard jargon used to characterize fatalities from 
all drugs of all sorts, anticoagulants, antidepressants, aspirin, 
cocaine, etc. But most people will read what Kolodny wrote and arrive 
at the conclusion that 60,000 people were killed by prescription pain 
medications. They were not. All opioids together (including heroin) 
killed 30,000 people. The number of deaths from prescription opioids--
the target of the current crusade--was about 17,000--half the number 
killed by accidental falls (https://www.cdc.gov/nchs/fastats/
accidental-injury.htm). Are we having an ``accidental fall epidemic?'' 
Why not? Accidental falls are killing twice as many people as 
prescription pain medicines.

      The figure 60,000 is, of course, inaccurate, but so is 17,000. 
This is because opioid overdose deaths are frequently the result of 
combination with other drugs, especially benzodiazepines, which 
potentiate the effect of the opioid action. In 2015 almost half (7,500) 
of the overdose deaths from opioids also involved benzodiazepines 
(Figure 1). When you include other drugs that are taken with opioids, 
especially alcohol and cocaine, it can reasonably be assumed that the 
number of deaths from opioid pills alone will be much lower, perhaps in 
the neighborhood of 5,000--10 times lower than the 60,000 that Kolodny 
implies, and roughly the same as bicycle and bicycle-related deaths 
(http://www.pedbikeinfo.org/data/factsheet_crash.cfm). This is what the 
hysteria is about?

[GRAPHIC] [TIFF OMITTED] T1918.010

    Figure 1. Opioid involvement in benzodiazepine death, and also 
              benzodiazepine involvement in opioid deaths.

      Comparing the number of drug overdose and motor vehicle deaths 
is pointless, arbitrary, and manipulative. What's more, these unrelated 
numbers can be interpreted in either of two ways. Annual deaths from 
auto accidents peaked in 1972--before seatbelt laws were in effect--and 
decreased by 41% as of 2011. What was responsible for the switch? Was 
it rising drug ODs? Decreasing auto accidents? Both? Does it matter? 
No, it doesn't. It's a stupid comparison.

      A comparison to deaths from HIV is similarly meaningless. HIV 
deaths have declined because of antiretroviral drugs.

This same sentence could be rewritten to be just as accurate, but send 
an entirely different, albeit, still pointless message:

``Life in the United States is now significantly safer. The number of 
annual deaths from automobile accidents, AIDS, and guns is now lower 
than that from drug overdoses, even when illegal street drugs, such as 
heroin, are included.''

Trick #2: Telling a half-truth.

``The effects of hydrocodone and oxycodone on the brain are 
indistinguishable from the effects produced by heroin.''

Yes, they are. But Kolodny omits a vital bit of information--potency. 
While the physiological effect of hydrocodone on the brain may be the 
same as heroin (the two drugs hit the same receptors), the functional 
difference between the two drugs is night and day. The magnitude of the 
effect is conveniently omitted from this ``equation.'' Heroin packs a 
much more powerful punch than hydrocodone, especially at doses that are 
used by addicts. People can become addicted to heroin (or even die) 
from a single injection. It is virtually impossible for one hydrocodone 
pill to kill or addict anyone. The two drugs don't even belong in the 
same sentence, even though they happen to belong to the same class of 
drugs.

Trick #3: The absence of evidence is not the evidence of absence.

``In cases [of long-term use], opioids are more likely to harm patients 
than help them because the risks of long-term use, such as addiction, 
outweigh potential benefit. Opioids have not been proven effective for 
daily, long-term use.''

      Trick #3 actually consists of a trick and maybe even a lie. 
Opioids may not have been proven to be effective for long-term use, but 
this is because such studies have not been done. This does not mean 
that opioids have been proven ineffective, even though the wording of 
this sentence implies this.

      The ``lie'' about addiction potential of opiates is perfectly 
obvious to anyone who has read the literature on addiction. The risk of 
addiction is very low for pain patients (less than 1% (https://
www.ncbi.nlm.nih.gov/pubmed/20091598)) who take pain medicine to 
control their pain. Overwhelmingly, addiction arises from recreational, 
not therapeutic use of these drugs.

Trick #4: Blame the drug companies.

``The increase in opioid prescription was fueled by a multifaceted 
campaign underwritten by pharmaceutical companies. Doctors heard from 
their professional societies, their hospitals and even from state 
medical boards that patients were suffering needlessly because of an 
overblown fear of addiction.''

      This tactic is appallingly unoriginal. There is no better way to 
shore up a weak argument than to introduce an ``enemy.'' And if there 
is one failsafe enemy, it is the pharmaceutical industry. There is 
little doubt that there was malfeasance taking place, especially 
involving companies that were pushing the idea that certain drugs were 
safer than they really were. Purdue, the maker of OxyContin, was fined 
$653 million for its former actions. Other companies are now being 
investigated. But this is now irrelevant. Assigning blame may score 
some points with the readers, and provide fodder for trial attorneys, 
but does absolutely nothing to keep a single OD victim alive. Whatever 
certain companies did two decades ago is partly responsible for 
starting today's fentanyl OD epidemic, but it has nothing whatsoever to 
do with keeping it going.

Trick #5: Twist the truth.

``Why did this happen? A common misconception is that so-called `drug 
abusers' suddenly switched from prescription opioids to heroin due to a 
federal government `crackdown' on painkillers. There is a kernel of 
truth in this narrative.''

Yes, there is, barely. But it is only a small part of the story. What 
Kolodny cites as a common misconception is probably a result of his 
twisting what I have written in previous articles (see: ``No, Vicodin 
Is Not the Real Killer in the Opioid Crisis'' (https://www.acsh.org/
news/2017/04/12/no-vicodin-not-real-killer-opioid-crisis-11123) and 
``Heads in the Sand--The Real Cause of Today's Opioid Deaths'' (https:/
/www.acsh.org/news/2017/08/16/heads-sand-%E2%80%94-real-cause-todays-
opioid-deaths-11681)). Except I never said this. The reasons for opioid 
abuse are multifactorial, but there is no question that epidemic began 
to escalate in 2010, not from any crackdown, but from an improvement in 
the formulation of abuse-
resistant OxyContin and the unintended consequences that followed. This 
is indisputable.

[GRAPHIC] [TIFF OMITTED] T1918.011

                               Figure 2.

From this point on, there was a ``shortage'' of pills, both because of 
market forces and government intervention. The difficulty in getting 
pills was clearly responsible for some/most of the switch to heroin. 
Koldony's statement itself was a ``kernel of truth.'' And a rather 
small kernel at that.

Now let's look at what is really going on. Figure 3 makes this crystal 
clear. Despite 7 years of increasing ``vigilance,'' the number of 
deaths caused by prescription pain medications remains unchanged, yet 
total opioid overdose deaths have increased dramatically. The reason is 
obvious. Virtually all of the additional overdose deaths since can be 
accounted for by increased use of heroin/fentanyl. Prescription pain 
medicines are much more difficult to get than 7 years ago, and the only 
result has been suffering by pain patients and no benefit. It could be 
no other way. Pills are not the primary driver of overdose deaths. They 
never were.

[GRAPHIC] [TIFF OMITTED] T1918.013

    Figure 3. The futility of limiting prescription pain medication.
   The result was more deaths from heroin/fentanyl and nothing else.

Trick #6: Ignore what doctors are saying.

``Here's another reason not to believe the narrative about a 
`crackdown' on painkillers leading to a sudden shift to heroin: There 
hasn't been a crackdown on prescription opioids.''

To say that there hasn't been a crackdown on opioid prescriptions is to 
ignore reality. Pharmacy chains are imposing bureaucratic barriers on 
filling prescriptions and denying prescription refills. The U.S. 
Association of Attorneys General is lobbying U.S. insurance (https://
ag.ny.gov/sites/default/files/final--naag--opioid--letter--to--
ahip.pdf) providers to revise their formularies to emphasize non-opioid 
medications in preference to opioids. The Veterans Administration has 
been directed by Congress to make the CDC prescription guidelines 
mandatory (http://www.
usmedicine.com/clinical-topics/addiction/cdc-guidelines-could-cause-
problems-for-va-patients-clinicians/) rather than voluntary. Hospitals 
and pain management practices all across America are discharging 
patients and forcibly tapering down the dose levels (http://
www.statnews.com/2017/01/17/chronic-pain-management-opioids/) of those 
they retain.

And Kolodny's statement also contradicts what every single physician I 
have spoken with has said (see: ``Pain in the Time of Opioid Denial: An 
Interview With Arie Hausknecht, M.D.'' (https://www.acsh.org/news/2017/
07/30/pain-time-opioid-denial-interview-aric-hausknecht-md-11628)). I'm 
not sure what Kolodny means by ``crackdown,'' but when doctors are 
receiving ``friendly'' warning letters from departments of health and 
law enforcement agencies, that's not merely a crackdown. It's 
Kristallnacht.

In closing, although I have questioned whether the intentions of 
Kolodny and his acolytes are well-meaning or not, it really doesn't 
matter to the 6 million people who are cut off from pain treatment in 
this country. The resulting ``opioid pain refugee crisis'' is a 
national disgrace. As is the undue influence granted to a handful of 
ideologues, well intended or not. As public policy goes, this may be as 
cruel as it gets.

Notes

(1) The term ``opioids'' is scientifically meaningless. Technically, 
``opioid'' means a drug that interacts with the same receptors as 
morphine etc., regardless of whether the drug is derived from a natural 
source, for example, poppy. Opiates are a subset of opioids; they are 
drugs that are found in plants (e.g., codeine) or semi-synthetic 
derivatives of them. Heroin, which does not occur naturally, is 
considered to be an opiate because it is made from morphine, which 
does. Fentanyl is considered to be an ``opioid'' because it is not an 
opium derivative. These classifications are a distinction without a 
difference. The term ``opiates'' is more than sufficient to describe 
drugs with morphine-like properties. The word ``opioid'' should be 
dropped from the English language.

(2) There is no such thing as an opioid crisis. It is a fabricated 
term. People who are now dying from overdoses are now (most of the 
time) dying from fentanyl and its chemical cousins. A far better and 
more accurate term is ``the fentanyl crisis.''

                                 ______
                                 
                   Letter Submitted by Cherri O'Keefe

May 2, 2018

U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Services Programs,'' Thursday, April 19, 2018

I am a 54-year-old wife, mother, grandmother, daughter and sister. I am 
also and have been for many years sadly a chronic pain patient. I have 
had 36 surgical procedures starting at the age of 16--four of my 
procedures have been to my brain due to a brain aneurysm. I suffer 
daily from severe osteoporosis, degenerative bone disease, 
osteoarthritis and numerous fractured disks in my back, seizure 
disorder and anxiety disorder. I have titanium in my brain, back and 
abdomen. The laws that have been changed allowing us to be treated with 
opioid medications have caused irreparable damage not just to us 
patients but to those who love us, care for us and pray for us. They 
now say it is an epidemic. For us patients who have worked so hard, 
have done everything asked of us, have subjected ourselves to at times 
feel like criminals by the way we are now treated, these laws are cruel 
and unusual punishment.

I sit and wonder how stupid the government must think we all are--most 
of us have worked jobs, paid taxes, raised children, been foster 
parents and law-abiding citizens. If we were just drug addicts, we 
would do what those with addictions do. We would just walk to any 
street corner and buy that crap--that is the real epidemic in this 
country--but we don't. We pay for insurance, we pay co-payments, we are 
subjected to signing contracts, UAs, pill counts, have one doctor, use 
one pharmacy and the list goes on. I have never met a chronic pain 
patient who enjoys their life. We need to take pain medicine on a daily 
basis so that we can just have a small amount of dignity, independence 
and the edge taken off the pain that never stops. We miss family 
functions, we miss our grandchildren's events--we miss our lives. We 
don't live, we just exist.

I have seen and dealt with cancer front and center. As a matter of 
fact, my first brain aneurysm was just 7 weeks after my mother died in 
my arms from breast cancer. I had taken care of her and we had made it 
5 years. We were supposed to be in Hawaii celebrating but instead we 
were in a hospital for 11 days as she slipped away. It is a horrible 
disease, but it is not the only disease that can cause so much pain 
that we need to be medicated properly. The answer now is for us to just 
smoke pot. What happened to being an American with the Constitution and 
our rights? Since the CDC implemented their guidelines, chronic pain 
patients are bed ridden again, they are back in their wheelchairs, 
they've lost the hope we so desperately held onto, and many have chosen 
suicide. I have lots of pictures of my children and my grandchildren 
and my husband, but you know what's missing? Me! That breaks my heart 
and theirs.

If monitored prescribing of opioid medications to chronic pain patients 
was this epidemic then how do you explain the rise in ODs--30% rise 
since the policies were changed? Who is standing up for us who cannot 
stand for ourselves? What if it were any of you who had to live like we 
do or watch someone you love crying as they toss and turn in bed 
because of the pain. I hope with everything in my being that the 
government really stops, puts themselves in our shoes for just one 
moment--which by the way, I would not wish on my worst enemy--and see 
what they are doing and how wrong it is?

We have done PT, TENS units, needles to try to block the pain, 
acupuncture, meditation. Please give us back our lives. Let us live, 
not just exist--even if it's just showing up for a brief period for our 
children, or our grandchildren's milestones and for us. That is our 
life and we accept it, but we continue daily to try to do better than 
we did the day before. We are trying to live not die!

Sincerely,

Cherri O'Keefe
Washington Pain Advocacy Group, C-50

                                 ______
                                 
                  Letter Submitted by Elizabeth Polson
April 20, 2018

U.S. Senate
Committee on Finance
Dirksen Senate Office Bldg.
Washington, DC 20510-6200

After watching the Senate full committee hearing on April 19th 
(``Tackling Opioid and Substance Use Disorders in Medicare, Medicaid, 
and Human Services Programs'') I felt the need to write and share my 
opinion on this topic. There are two types of patients in this issue: 
acute, temporary pain and chronic pain. The hearing and most of what I 
have heard in the news addressed the former. I am afflicted with the 
latter, chronic pain. I feel the patients suffering from chronic pain 
have not been heard and their needs are not being considered in the 
changes being made.

After a year of suffering with unexplained and widespread pain, and not 
knowing why, I was diagnosed with fibromyalgia in late 1996 at age 41. 
Unless a cure is found, I will live with this condition the remainder 
of my life. Fibromyalgia is a disorder characterized by widespread 
musculoskeletal pain accompanied by fatigue, sleep, memory, and mood 
issues. Researchers believe that fibromyalgia amplifies painful 
sensations by affecting the way your brain processes pain signals. Over 
the counter drugs like aspirin, ibuprofen, and acetaminophen do 
absolutely nothing to ease my pain.

The horrible pain and fatigue disrupted my daily life to a large degree 
and made working full time extremely difficult. My daughter had left 
for college and I was living alone and I found it almost impossible to 
complete daily chores, shop for groceries, etc. I was extremely lucky 
to have a supportive manager that allowed me to work from home for 2 
years, otherwise I would not have been able to work and support myself. 
My life consisted of work and very little else. I was in too much pain 
to enjoy anything. In late 1998 I was prescribed an opioid for the 
pain, Tramadol, 50 mg once a day. It was a miracle for me and allowed 
me to function much better. The pain was not erased but was improved 
enough to give me a better quality of life and allowed me to continue 
to work until my retirement 2 years ago.

Shortly after, I went through specialized testing with a fibromyalgia 
specialist physician at Seattle's Harborview Medical Center. They had 
me try acupuncture, massage and homeopathy. The homeopathy did help to 
a degree but the other methods had no effect. Years later I discussed 
the new medications for fibromyalgia with my physician and was told my 
current treatment of Tramadol was probably best--the new drugs had too 
many side effects.

I would like to stress that in 20 years I have only seen three doctors 
for this condition. One was the specialist and the other two my regular 
physicians. My starting dose in 1998 remains the dose I still use 
today. I have never increased it over the years, I am not physically 
addicted, and I use the medication responsibly and under the constant 
care of my physician. I could easily stop using it tomorrow, but 
unfortunately I would be in constant pain.

When the mandates to reduce over-prescribing of opioids were put in 
place the last several years I cooperated with my physician. I 
discussed a Controlled Substance Agreement and we both signed it. I 
also agreed to a drug screen during my visit (with no prior notice). 
Nothing but my Tramadol was found and that was within the range of my 
current dose.

I am now 63 years old, retired, and terrified that the government will 
decide that I should no longer have the treatment that has worked so 
well for me for 20 years. I can live a relatively normal life with some 
joy and peace and even travel--my lifelong retirement dream.

Please consider the plight of people like myself when mandating the 
changes currently in work. I completely understand the crisis our 
nation is facing and know things need to be done, but not at the 
expense of my needs. Please let the doctors decide what is best for 
their patients. If it is found later that they misused that trust, then 
take away their license to practice medicine, don't inflict more pain 
and suffering on me because of their errors.

Opioid manufacturers most certainly should be held accountable for 
their efforts to get physicians to over-prescribe, providing incentives 
to prescribe, etc. They are one large piece of the cause of our current 
epidemic and I am all for suing them. It is reprehensible what they 
have done.

The pendulum is swinging from the extreme of over-prescribing opioids 
to the other on this issue. In my lifetime I've seen this phenomenon 
occur many times and in the end it typically swings back to middle 
ground eventually, the best answer. Neither extreme ends up being a 
good choice. Please take my needs and the needs of so many others in 
similar situations into consideration.

Sincerely,

Elizabeth Polson

                                 ______
                                 
                    Letter Submitted by Amanda Smith
U.S. Senate
Committee on Finance
Dirksen Senate Office Building
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Service Programs,'' Thursday, April 19, 2018

To whom it may concern,

My name is Amanda Smith and I am the daughter of Kristi Becker. I am 25 
years old and cannot remember a time when my mother DID NOT experience 
back pain. Her medications would keep it under control so she could 
live a somewhat normal life. Over the past few years her pain has 
increased to where sitting for any length of time causes her back to 
stiffen and cramp up.

She has been told that the medications she needs to control her pain 
are not going to be covered by her insurance any longer and she will 
have to pay out of pocket. She is unable to pay for her medications 
without the help of her insurance; without these medications her pain 
would become so severe and she will not have any kind of quality of 
life.

These medications are required so that her pain is under control.

Her back pain has affected our relationship a lot. We couldn't do a lot 
as a mother and daughter can normally do. Now I barely speak to her and 
never see her because of her pain.

Please, I'm asking to not cut production of these medications or cut 
funding away from these people in pain. As a daughter I should not be 
able to hear my mother in pain.

My mother is a very strong woman but I can hear the pain in her voice 
and it pains me to hear her like that.

Sincerely,

Amanda Smith

                                 ______
                                 
                    Letter Submitted by Reese Tyrell

                Member, Texas Pain Advocacy Group, C-50

U.S. Senate
Committee on Finance
Dirksen Senate Office Building
Washington, DC 20510-6200

Re: ``Tackling Opioid and Substance Use Disorders in Medicare, 
Medicaid, and Human Services Programs''

I am writing to ask that chronic intractable pain conditions be 
exempted from CDC guidelines and Medicare/Medicaid policy on pain 
medication.

Background: I have an incurable autoimmune disease (IC/BPS) that causes 
lifelong, unrelenting cancer-level pain. Essentially, my body has its 
own tiny built-in torture device, punching holes in my flesh from the 
inside and dripping water on the razor wounds, 24/7.

For 20 years I have visited doctor after doctor, trying every known 
treatment from diet to meditation to electrical stimulation to pouring 
medicine into my own bladder through a catheter. I am a medical 
mystery, one of the 5% for whom no known treatments made any 
difference, including the alternative/experimental ones.

Science does not yet know how to remove my torture device. While 
research continues over the 40+ years I have left to live, treatment 
allowing me to work and contribute to society is my human right. That 
human right is being threatened.

My condition has been well controlled on pain medication for 20 years. 
Combined with other coping techniques, pain medication has allowed me 
to earn a doctorate, become an expert in my field, teach college, and 
raise a healthy, happy son with my loving husband.

Thanks to pain management, if you met me, the only difference you'd 
notice between me and a normal person is I pee once an hour. As a 
legitimate patient, I adhere to a narcotics contract and have never 
treated medication irresponsibly or taken more than prescribed. To keep 
my home and family safe, I do not publish medical information under my 
real name, but I do have 20 years of impeccable records in the state 
prescription database(s).

The medication I have thrived on for 20 years is suddenly not okay, 
because . . . why exactly? Because other people--people who are not 
me--fraudulently prescribed, abused, and overdosed on a similar 
substance?

I'm being told I have to cut back because the DEA and the state medical 
board are enforcing CDC guidelines. CDC guidelines do not say legacy 
patients have to cut back, they say ``lowest effective dose.''

There is a direct relationship between my medication and how long I can 
wait between bathroom visits. At or below the levels the CDC 
recommends, I have to pee every 10-15 minutes, around the clock. I know 
this for a fact.

That is not an ``effective'' dose. There are jobs that let you pee once 
an hour. There are no jobs that let you pee every 10 minutes. Not to 
mention, ever tried sleeping in 10-minute increments?

And . . . only legacy patients? If someone exactly like me was born in 
the 1990s instead of the 1970s, she just has to suffer? While the 
government has a responsibility to prevent diversion of drugs into the 
wrong hands, the government has no business telling doctors what 
dosages to prescribe. Threats of DEA action have spread far beyond the 
agency mandate, affecting patients who need medication to work, parent, 
and live our lives. Americans with lifelong, incurable painful 
disorders need two things from our legislators:

(1) Within Medicare/Medicaid policy, please carve out an exemption to 
opioid prescribing guidelines for patients with intractable chronic 
pain conditions (such as IC/BPS, among others). This exception should 
be similar to the current exception for cancer pain. Treating cancer 
and non-cancer pain differently amounts to federal discrimination 
against people with disabilities.

(2) Please clarify to the DEA, CDC, and state medical boards that 
nonconsensual dosage reduction is not required. Finally, please help us 
in the chronic pain community educate the public on how unwarranted 
federal regulation damages the practice of much-needed medicine.

Thank you for your time.

Reese Tyrell
Austin, TX

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