[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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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.
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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\
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\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\
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\12\ Four States currently focus health home benefits on improving
treatment for opioid use disorders: VT, MD, RI, and ME.
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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\
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\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.
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\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\
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\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.
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\17\ http://qioprogram.org/about/why-cms-has-qios.
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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\
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\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
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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.
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\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
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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.
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\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
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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\
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\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.
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\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
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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.
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\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
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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.
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\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
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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\
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\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
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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.
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\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
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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.
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\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
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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
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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\
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\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\
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\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\
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\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:
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\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\
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\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\
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\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\
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\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.
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\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\
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\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\
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\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
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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\
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\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\
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\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
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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.
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\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\
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\80\ https://www.medicaid.gov/state-resource-center/downloads/mac-
learning-collaboratives/justice-involved-populations.pdf.
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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.
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\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
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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\
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\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
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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.
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\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.
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\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.
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\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
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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\
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\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
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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.
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\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
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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\
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\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\
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\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.
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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\
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\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\
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\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\
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\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.
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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\
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\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\
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\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/.
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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.
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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
[all]