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



 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2018

                              ----------                              


                       TUESDAY, DECEMBER 5, 2017

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:06 a.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
    Present: Senators Blunt, Alexander, Moran, Capito, 
Lankford, Murray, Durbin, Shaheen, Merkley, Murphy, Manchin, 
and Leahy.

               Addressing the Opioid Crisis in America: 
                   Prevention, Treatment and Recovery


                 opening statement of senator roy blunt


    Senator Blunt. The Appropriations Subcommittee on Labor, 
Health and Human Services, Education, and Related Agencies will 
come to order.
    Good morning to everybody. We're glad you're here. We want 
to particularly thank our witnesses for coming today to give us 
a chance to talk about this critical issue that confronts our 
country. The opioid epidemic crisis is the worst drug epidemic 
that our Nation has ever faced. Current death rates of all drug 
overdoses rival those at the peak of the AIDS crisis in the 
1990s. And opioid-specific overdoses now surpass car accidents 
as the number one accidental death cause in the country.
    Over the last 3 years, Senator Murray and I have been the 
chair and the ranking member of this subcommittee. We've 
written bills that repeatedly increased the opioid funding, an 
increase of about $760 million, which is a 1,300 percent 
increase from where we were just 3 years ago. Obviously, more 
money needs to follow that, but this committee particularly 
needs your help and the help of others, the help of these 
witnesses, in determining how that money can best be spent, how 
it can best work its way into the system, and then some other 
group will have to help us figure out where to find the money 
that we need, know we need to find, for this issue.
    We've confronted the epidemic head-on. I'm glad to see that 
the President is also focused on this problem. In October, 
President Trump declared a public health emergency. And in 
November, his Commission on Opioids related released its final 
report recommending a number of specific areas where we could 
focus.
    Included in the panel today, we have my friend from our 
service in the House of Representatives together, Patrick 
Kennedy, who is a member of the President's Commission. The 
Commission's recommendations include many of the programs we 
have funded the last several years as well as some really new 
ideas that I think our subcommittee wants to closely consider 
as we finalize the spending bill for the fiscal year that we're 
already in but haven't yet come to final conclusion as to how 
that money needs to be spent. We need to look at what programs 
are effective at where we should focus future funding and what 
new proposals we should consider as part of an omnibus spending 
bill for this year.
    In particular, as I hear from people in my State of 
Missouri, the experts of the field, including the panelists 
here today, I think that this subcommittee needs to consider 
three key proposals moving forward.
    One is what is the best option for treating an opioid use 
disorder. I believe this means recognizing that behavioral 
health issues should be treated like all other health issues, 
that mood and anxiety disorders double the risk of addiction. 
If you are going to effectively address opioid addiction, we 
need to ensure that those suffering can access effective 
treatment, and that needs to include mental health services.
    Secondly, we need to stem the number of individuals who 
become addicted in the first place. We need to do all we can to 
ensure that the people that we work for, the people of our 
States and of the country, understand the real and obvious risk 
of taking opioids and taking them in a way that can lead to 
addiction.
    Finally, simply reducing opioid prescriptions doesn't 
address the core problem with the crisis: effective pain 
management. So we need to be focusing on new pain management 
strategies and research strategies that help get us there.
    There is clearly no one silver bullet to solve this crisis, 
and so we have a panel today that really brings a broad base of 
the kinds of things that we need to be thinking about, the 
kinds of areas that we need to be addressing, and then to help 
us work through a realistic implementation strategy. You know, 
a 1,300 percent increase is a pretty big increase over 3 years, 
but, admittedly, we started at a pretty small number. And so 
we're going to be listening carefully to what advice you have 
for us. And we'll have questions for you.
    I'm glad to have the President pro tem emeritus of the 
Senate and the ranking member of the Appropriations Committee 
with us.
    Senator Leahy, if you would like to make some comments, 
that would be certainly appropriate.
    [The statement follows:]
                Prepared Statement of Senator Roy Blunt
    Good morning. Thank you to our witnesses for being here today to 
talk about a critical issue confronting our Nation--the opioid 
epidemic.
    The opioid crisis has been called the worst drug epidemic our 
Nation has ever faced. Current death rates for all drug overdoses rival 
those at the peak of the AIDS crisis in the 1990s and opioid-specific 
overdoses now surpass car accidents as the number one accidental death 
in the country.
    Over the last 3 years that Senator Murray and I have been the Chair 
and Ranking Member of the Labor/HHS Subcommittee, we have written bills 
that have increased opioid funding by $760 million, or over 1,300 
percent.
    This is an issue the Appropriations Committee has confronted head-
on and I appreciate that we have a president focused on this problem. 
In October, President Trump declared a Public Health Emergency, and in 
November his commission on opioids released its final report 
recommending a number of specific areas where we should focus response 
efforts.
    These recommendations include many of the programs we have funded 
the last several years as well as novel ideas that I think our 
Subcommittee should closely consider as we finalize a funding bill for 
fiscal year 2018. As we move forward, I am interested to hear our 
witnesses' perspectives on what programs are effective, where we should 
focus future funding, and what new proposals we should consider as part 
of an Omnibus.
    In particular, as I continue to hear from constituents back home, 
leaders on this issue in Missouri, and experts in the addiction field--
including all the panelists from HHS here with us today--I think this 
Subcommittee needs to consider three key proposals moving forward.
    First, we need to understand the best options for treating an 
opioid use disorder. I believe this means recognizing that behavioral 
health issues should be treated like any other physical health ailment. 
Mood and anxiety disorders double the risk of addiction. If we are 
going to effectively address opioid addiction, we need to ensure that 
those suffering can access effective treatment--and that should include 
mental health services.
    Second, we need to stem the number of individuals who become 
addicted in the first place. This involves improving surveillance to 
better understand where the problems are and where they are most 
severe. It includes educating physicians about the possible risks of 
prescribing opioids while also ensuring that we do not penalize 
physicians who act responsibly. Also, and perhaps most importantly, we 
need to ensure the public understands the risks of taking opioids. Many 
individuals do not realize how easy it is to become addicted and we 
need to increase our public awareness education efforts.
    Finally, simply reducing opioid prescriptions does not address the 
core problem of the crisis--effective pain management. We need to focus 
on developing new pain treatments as adequate alternatives to opioids. 
If patients with acute or chronic pain do not have reasonable access to 
non-addictive pain medications or alternative treatments, it will be 
difficult to get this crisis under control.
    Unfortunately, there is no silver bullet to solve this crisis. We 
need a comprehensive plan to address all of these issues if we're going 
to get the opioid epidemic under control. I look forward to hearing the 
witnesses' testimony today and remain committed to working with my 
colleagues to continue to address this significant public health 
crisis.
    Thank you.

                 STATEMENT OF SENATOR PATRICK J. LEAHY

    Senator Leahy. Well, thank you, Mr. Chairman. And I'm glad 
to see Dr. Collins, and my good friend Congressman Kennedy, and 
Dr. McCance-Katz here, and I guess we--Dr. Houry, I'm sorry.
    You know, we have--just think about it, what we have here. 
Last year drug overdoses claimed the lives of 64,000 people in 
this country, 64,000. That's 10 percent of the population of my 
own State of Vermont. The latest figure in the shocking rise in 
overdose deaths is driven by the opioid epidemic, but it's in 
every corner of our country, it plagues every community. 
There's no member on this committee who hasn't seen or heard 
about it in their own State. It's a public health crisis.
    We should start to treat it like one. The Kennedy Forum 
talked about how the amount of money we threw into Ebola, which 
barely touched this country. Well, look at what is touching 
this country, and we need to allocate every necessary resource. 
We made tremendous strides in Vermont by leveraging Medicaid 
dollars to a hub-and-spoke model, to confront opioid addiction 
as a healthcare crisis, not as an incarceration problem, as a 
system that provides patients with medication-assisted 
treatment, connects patients with a variety of resources, from 
housing to peer support to counseling, not just once or twice, 
but throughout their recovery and beyond. In Vermont, this 
model is proving effective, but we have to continue to invest 
in it.
    It's alarming and disappointing that from the start of the 
administration, the President has not made the necessary 
investments to tackle the opioid epidemic. If you look at the 
President's budget request, it seeks to eliminate programs like 
the Anti-Heroin Task Force grants that are proven to be 
effective. In fact, in his budget, President Trump called for 
reducing funding for the opioid epidemic by $104 million.
    Now, Mr. Chairman, you spoke of the President's declaration 
in October. I was encouraged by the declaration, but then we 
find it's only talk. There's no action, there's no new funding, 
behind the President's words to address this crisis. Talk is 
cheap; money is effective. And even worse, in the middle of the 
night Saturday, the Republican-controlled Senate voted to slash 
Medicaid by $1 trillion to pay for tax cuts for the wealthy. 
Well, Medicaid is a critical lifeline to provide care for 
victims of opioid abuse; it's the main funding source, for 
example, behind Vermont's hub-and-spoke model, a model that 
actually works.
    So we can't pretend to be seriously addressing this issue 
by good speeches. I mean, who's in favor of the opioid 
epidemic? Nobody. It's easy to say you're against it, but if 
you kick the legs, the money, out from recovery systems, that's 
what counts.
    Now, in the Senate Appropriations Committee, though, we're 
trying to meet our commitment to address this public health 
crisis. The fiscal year 2018 appropriations bills, if we can 
get to them, they provide more than $1.6 billion in funding. I 
mean, we're coming together as members of this committee in a 
bipartisan way to get the money. I've been calling since March 
for a bipartisan deal that would raise the spending caps for 
both defense and non-defense spending, to allow us to increase 
these investments, because we need to be doing more. It's now 
December. We need the deal.
    Again, I'll close with this, 64,000 people lost their lives 
to opioid addiction last year, but think of the tens of 
thousands of more people who were affected by that: parents, 
spouses, friends, family, and communities. And I fear those 
numbers are going to rise this year and beyond if we don't 
fight it. We have to do this. It's a matter of the integrity of 
our country.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator.
    We're pleased to have our panel with us today: Dr. Francis 
Collins, the Director of the National Institutes of Health; 
former Congressman Patrick Kennedy, a former Member of the 
House, as I said, that we served together in the House, from 
Rhode Island, a member of the President's Commission on 
Combating Drug Addiction and the Opioid Crisis; Dr. Elinore 
McCance-Katz, the Assistant Secretary for Mental Health and 
Substance Use at the Substance Abuse and Mental Health Services 
Administration; and Dr. Debra Houry, the Director for the 
National Center for Injury Prevention and Control at the 
Centers for Disease Control and Prevention.
    We have your statements for the record, but we would like 
for you to take up to 5 minutes, starting with Dr. Collins and 
coming right down the list, summarizing or dealing with that 5 
minutes however you want. And we are again grateful that all 
four of you are here with us today.
STATEMENT OF DR. FRANCIS S. COLLINS, M.D., PH.D., 
            DIRECTOR, NATIONAL INSTITUTES OF HEALTH, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Dr. Collins. Well, thank you, Chairman Blunt and 
distinguished members of this committee. Your opening 
statements have already painted a vivid picture of the vast 
scope of the opioid epidemic.
    I'd like to take just a moment to put a personal face on 
this crisis that's devastated the lives of so many Americans. 
I'll tell you about an American named Tammy from a small 
community in Southern Oregon. Tammy is 47. She's one of the 
more than 25 million Americans living with chronic pain. Her 
doctor prescribed opioid medications to manage the pain caused 
by her lupus and rheumatoid arthritis. But eventually Tammy's 
reliance on opioid medications grew to where she was taking 
over 15 Vicodin pills per day plus fentanyl patches, feeling 
literally out of control and afraid that any morning she might 
not wake up. She eventually sought help from a friend whose 
husband worked in a local community-based addiction treatment 
center called ADAPT. As fate would have it, ADAPT was part of 
an early NIH-funded research study to determine the 
effectiveness of medication-assisted treatment, which we'll 
talk about a lot today.
    Tammy received counseling along with a medication that 
combined buprenorphine and naloxone to treat her addiction. 
These medications not only allowed her to stop using opioids, 
they also successfully managed her pain. Tammy says that 
buprenorphine literally saved her life. Eventually, she was 
able to taper off and she's been opioid-free for the past 8 
years. She's back at work successfully managing her lupus and 
arthritis with exercise and anti-inflammatory medications.
    Now, I don't want to give the impression that Tammy's story 
is easy or even typical. People who have experienced the brain 
disease of opioid addiction--and it is a brain disease--have 
different stories and may need different interventions. But 
Tammy's story does show how research can provide a broader 
array of treatments for opioid use disorders, and that 
treatments for addiction can sometimes even address the very 
pain conditions that brought opioids into the picture in the 
first place.
    As you may know, there are three currently approved 
medications for opioid use disorder: methadone, buprenorphine, 
and naltrexone. But relapse rates are still way too high, and 
more options are needed to end this epidemic. For example, 
Tammy is unable to take nonsteroidal pain medications, and 
she's understandably terrified of taking opioids again. We need 
to develop new and better options for treating pain. We need to 
understand which individuals succeed on which medicine, in what 
doses, over what time period, combined with what kind of 
psychosocial support. In other words, we need precision 
medicine for chronic pain management.
    NIH (National Institutes of Health) has a successful record 
of partnering with industry to develop new treatments and 
interventions. For example, just last week the FDA (Food and 
Drug Administration) approved for the treatment of opioid use 
disorder a once-monthly injection of buprenorphine. This 
formulation was developed in partnership within industry and by 
NIH, and patients can now take one injection per month instead 
of a daily medication, which is a great encouragement to 
maintaining sobriety.
    As another example, many communities have invested in 
naloxone injection kits to enable their first responders to 
reverse opioid overdoses. But unfortunately not everyone is 
comfortable administering the injectable form of naloxone. So 
in partnership with industry, we have developed a naloxone 
nasal spray, you can see this, that can be far more easily 
administered, and now it's the most widely used antidote by 
first responders for overdose, saving many lives.
    And we're not stopping. NIH, the FDA, and our partners at 
PhRMA (Pharmaceutical Research and Manufacturers of America) 
have been working over several months with more than 30 
companies to build a powerful research partnership. We'll be 
gathering again for two intense days next week to nail down a 
detailed plan to expand medication options, to treat addiction, 
to reverse overdose in the face of even more deadly opioids, 
like fentanyl or carfentanil, and most important for the long 
term, to develop potent, non-addictive medications for pain. We 
must find better ways to help the 25 million Americans like 
Tammy who suffer from pain on a daily basis.
    Our partnership will build on basic science insights that 
are opening new avenues for development of non-addictive drugs. 
For example, we once thought the brain's pain relief and reward 
systems were inextricably intertwined. ``Reward'' sounds like a 
good thing, but in this situation, it's definitely not. It's 
part of the opioid effect that leads to irresistible craving 
and ultimate addiction. But we've recently learned that when 
drug molecules bind to an opioid receptor, the pain and reward 
pathways can be separated. So new technology is now being 
applied to design drugs that inhibit the pain without 
activating the reward system.
    Other promising targets for non-addictive pain meds have 
been identified through studies of non-opioid receptor systems. 
One promising drug target, a sodium channel, has been 
identified by studying rare individuals who were born with 
complete insensitivity to pain.
    Another target, called CGRP (calcitonin gene-related 
peptide), just last week led to exciting research results for 
the treatment of migraine. And building on our evolving 
understanding of inflammation's role in chronic pain, our 
partnership with industry will seek to determine whether agents 
that reduce inflammation can also provide potent pain relief.
    That's not all. The partnership will work to develop 
biomarkers that can distinguish different types of pain and 
predict likely responses to intervention. It will strive to 
develop objective measures of pain that can be used to compare 
experimental therapies with greater precision and build a new 
clinical trial network.
    There's a great deal to be done. For this effort to 
succeed, we need all hands on deck: my colleagues here, 
academic researchers, private sector partners, and last, but 
certainly not least, we need you, Members of Congress. Your 
support is essential to bring this terrible epidemic to an end.
    So thank you for holding this hearing today. And I'm happy 
to respond to your questions.
    [The statement follows:]
          Prepared Statement of Francis Collins, M.D., Ph.D., 
    Elinore McCance-Katz, M.D., Ph.D., and Debra Houry, M.D., M.P.H.
    Good morning Chairman Blunt, Ranking Member Murray and Members of 
the Subcommittee. Thank you for the opportunity to discuss the opioid 
crisis in the United States and the Federal response. From the start of 
his Administration, President Trump has made addressing the opioid 
epidemic a top priority, and at the Department of Health and Human 
Services (HHS) we share the President's commitment to bringing an end 
to this crisis, which is exacting a toll on individuals, families, and 
communities across the country. The Department has made the crisis a 
top clinical priority and is committed to using our full expertise and 
resources to combat the epidemic.
    Over the past 15 years, communities across our Nation have been 
devastated by increasing prescription and illicit opioid abuse, 
addiction, and overdose. According the Substance Abuse and Mental 
Health Services Administration (SAMHSA)'s 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. Over the 
past decade, the U.S. 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. Preliminary data for 2016 
indicate at least 64,000 drug overdose deaths, the highest number ever 
recorded in the U.S. There are also downstream consequences to the 
opioid epidemic, as research shows a strong association between opioid 
misuse and child maltreatment. Too many of our citizens are being 
robbed of their God-given potential in the prime of their life.
    The opioid epidemic in the U.S. is fundamentally tied to two 
primary issues. The first issue was the significant rise in opioid 
analgesic prescriptions that began in the mid-to-late 1990s. Not only 
did the volume of opioids prescribed increase, but 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 longer durations. The second issue is a lack of health system and 
healthcare provider capacity to identify and engage individuals, and 
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 U.S. 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. In response to the President's directive, 
HHS is supporting more rigorous research to better understand how 
existing programs or policies might be contributing to or mitigating 
the opioid epidemic. In addition, we need to better understand how the 
epidemic affects other services and programs, including those promoting 
employment, self-sufficiency and child well-being.
    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 
        drugs 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, as evidenced by the nearly $900 million 
in funding allocated by HHS to address the opioid crisis in communities 
all across the country. President Trump's declaration of a nationwide 
public health emergency regarding the opioid crisis on October 26, 
2017, is yet another action that underscores the commitment by the 
Administration and HHS to a comprehensive strategy. Further, we 
appreciate the work of the President's Commission on Combating Drug 
Addiction and the Opioid Crisis; the Administration is reviewing the 
recommendations.
    While this statement does not represent an exhaustive list of HHS 
activities underway, SAMHSA, CDC, and NIH bring unique expertise and 
capabilities that enable HHS to take a comprehensive, complementary, 
and flexible approach to the opioid crisis.
Substance Abuse and Mental Health Services Administration (SAMHSA)
    As HHS's lead agency for behavioral health, SAMHSA's core mission 
is to reduce the impact of substance abuse and mental illness on 
America's communities. SAMHSA supports a portfolio of activities that 
address all five prongs of HHS's Opioid Strategy.
            Improving Access to Prevention, Treatment, and Recovery 
                    Support Services
    SAMHSA administers the Opioid State Targeted Response (STR) grants, 
a 2-year program authorized by the 21st Century Cures Act (Public Law 
114-255). By providing $485 million to States and U.S. territories in 
fiscal year 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.
    The President's Budget requests $500 million for this program in 
fiscal year 2018, the full level authorized by Congress. SAMHSA is 
supporting a new approach to technical assistance around this program 
to ensure the provision of the most effective and evidence-based 
programs. This approach capitalizes on localized expertise of 
physicians and other professionals around the opioid epidemic. These 
practitioners will be used in each State/territory to provide guidance 
on the STR implementation in the jurisdiction.
    The Substance Abuse Prevention and Treatment Block Grant (SABG), 
first authorized in 1992, is a vital source of funding for States that 
accounts for approximately 32 percent of total State substance abuse 
agency funding. For many people seeking to recover from opioid 
addiction, this public funding represents the only support for 
treatment. In addition, the block grant's flexible structure enables 
States to use the funds to address pressing challenges within their 
communities, such as the opioid crisis.
    SAMHSA also has several initiatives aimed specifically at advancing 
the utilization of MAT for opioid use disorder, which is proven 
effective but is highly underutilized. SAMHSA's Medication Assisted 
Treatment for Prescription Drug and Opioid Addiction (MAT-PDOA) program 
expands MAT access by providing grants to States with the highest rates 
of treatment admissions for opioid addiction. Twenty-two States are 
currently funded by MAT-PDOA, and in September 2017, SAMHSA awarded $35 
million dollars over 3 years in additional MAT-PDOA grants to six 
States.
    SAMHSA also provides critical funding for MAT for specific high-
risk and vulnerable populations, such as those involved with the 
criminal justice system and pregnant and postpartum women. SAMHSA's 
criminal justice grantees can use up to 20 percent of their grant 
awards for the purchase of medications approved by the Food and Drug 
Administration (FDA) for treatment of opioid and alcohol addiction. 
Since 2013, SAMHSA has seen a steady increase in the number of drug 
courts integrating MAT into their programs with 57 percent of active 
programs currently integrating MAT.
    Under SAMHSA's Pregnant and Postpartum Women's (PPW) program, 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, which has been shown to improve 
birth outcomes. In September SAMHSA awarded $9.8 million over 3 years 
for new State Pilot PPW grants authorized by the Comprehensive 
Addiction and Recovery Act (CARA, Public Law 114-198) and $49 million 
over 5 years in new PPW service grants to support the recovery of 
pregnant and postpartum women struggling with substance abuse, 
including opioid addiction.
    A well-documented challenge to improving access to opioid use 
disorder treatment is a lack of providers who can provide MAT. SAMHSA 
supports a number of training initiatives to increase the number of 
qualified healthcare providers who can provide treatment for opioid 
addiction. In the last 4 years, more than 62,000 medical professionals 
have participated in online or in-person trainings on MAT for opioid 
addiction through SAMHSA's Provider's Clinical Support System (PCSS)-
MAT. This program is a national training and clinical mentoring project 
that provides mentoring of newly trained physicians by experienced 
specialists, maintains a library of evidence-based practice materials, 
and offers at no cost to the trainee the required DATA 2000 waiver 
training to enable providers to prescribe buprenorphine for opioid 
addiction treatment.
    SAMHSA regulates opioid treatment programs (OTPs), which dispense 
methadone and may also dispense and prescribe buprenorphine and 
administer extended-release naltrexone. In coordination with the Drug 
Enforcement Administration (DEA) and States, territories, and the 
District of Columbia, SAMHSA reviews new and renewal applications for 
OTPs through an accreditation process that ensures programs have sound 
risk management practices in place and are using evidence-based 
treatments. SAMHSA also oversees physicians, nurse practitioners (NPs), 
and physician assistants' (PAs) ability to prescribe buprenorphine in 
office-based outpatient treatment settings. Last year, SAMHSA published 
a final rule which allows certain qualified physicians who have 
obtained a waiver to prescribe buprenorphine for up to 100 patients for 
at least a year, to now acquire a waiver to treat up to 275 patients. 
The regulation provides that these licensed physicians can become 
eligible for the patient limit of 275 either by being board certified 
in Addiction Medicine or Addiction Psychiatry or by practicing in a 
qualified practice setting.
    These physicians are required to complete a SAMHSA reporting form 
each year to ensure that physicians prescribing at the new, higher 
level are in compliance with safe and appropriate prescribing 
practices. As of October 28th, 3,677 physicians have obtained a waiver 
to treat up to 275 patients. Most recently, SAMHSA began processing 
waivers to allow NPs and PAs to prescribe buprenorphine in accordance 
with the requirements of CARA. As of October 28th, 3,231 NPs and 839 
PAs have received a waiver.
    SAMHSA also promotes recovery through targeted grants, such as last 
month's award of $4.6 million over 3 years in Building Communities of 
Recovery program grants, created by CARA. The purpose of this program 
is to mobilize resources within and outside of the recovery community 
to increase the availability and quality of long-term recovery supports 
for individuals in or seeking recovery from addiction. These grants are 
intended to support the development, enhancement, expansion, and 
delivery of recovery support services as well as promotion of and 
education about recovery. Programs will be principally governed by 
people in recovery from substance abuse and addiction who reflect the 
community served.
    In partnership with the HHS Administration for Children and 
Families, SAMHSA co-sponsors the National Center on Substance Abuse and 
Child Welfare (NCSACW). NCSACW is 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. In particular, 
NCSACW provides States with support related to opioid use disorders and 
MAT during pregnancy, as well as practices related to substance-exposed 
infants.
            Targeting Overdose-Reversing Drugs
    SAMHSA has been a leader in efforts to reduce overdose deaths by 
increasing, through funding and technical assistance, the availability 
and use of naloxone to reverse overdose.
    SAMHSA's ``Opioid Overdose Prevention Toolkit,'' first released in 
2013, is one of SAMHSA's most downloaded resources. The Toolkit 
provides information on risks for opioid overdose, recognition of 
overdose, and how to provide emergency care in an overdose situation. 
The Toolkit is intended for community members, first responders, 
prescribers, people who have recovered from an opioid overdose and 
family members, as well as communities and local governments.
    SAMHSA provides a number of funding streams that can be used to 
expand access to naloxone. States are able to use Opioid STR funds to 
purchase and distribute naloxone, and some States are also using a 
portion of their 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.
    In September 2017, SAMHSA awarded funding for grants authorized by 
CARA, including almost $46 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.
            Strengthening Public Health Data and Reporting
    SAMHSA's National Survey on Drug Use and Health (NSDUH) provides 
key national and State level data on a variety of substance use and 
mental health topics, including opioid misuse. NSDUH is a vital part of 
the surveillance effort related to opioids, and the data from NSDUH has 
been used to track historical and emerging trends in opioid misuse, 
including geographic and demographic variability.
    SAMHSA also works collaboratively with other agencies to better 
understand the epidemic through sharing of data and assessing the 
implications of that data and develops publications based on NSDUH and 
other national surveys and data. Examples of recent SAMHSA publications 
include: Trends in the Use of Methadone, Buprenorphine, and Extended-
release Naltrexone at Substance Abuse Treatment Facilities; Trends in 
Average Days' Supply of Opioid Medications in Medicaid and Commercial 
Insurance; and Opioid Prescribing Trends for Adolescents and Young 
Adults with Commercial Insurance and Medicaid.
            Supporting Cutting-Edge Research
    SAMHSA is building on existing partnerships with the NIH to improve 
the research to practice pipeline and is committed to promoting 
evidence-based practices and service delivery models. The newly formed 
Office of the Chief Medical Officer and the National Mental Health and 
Substance Use Policy Laboratory, which were authorized through the 21st 
Century Cures Act to promote evidence-based practices and service 
delivery models, will be pivotal to these efforts. Additionally, the 
National Mental Health and Substance Use Policy Laboratory will assist 
in addressing the opioid crisis through its evaluation of models that 
would benefit from further development and through expanding, 
replicating, or scaling evidence-based practices across wider areas as 
we seek to increase access to and delivery of the best treatment 
services for opioid use disorders across America.
Centers for Disease Control and Prevention (CDC)
    As the Nation's public health and prevention agency, CDC's 
expertise and leadership is essential in reversing the opioid epidemic. 
It was CDC that first identified the increase in opioid overdose deaths 
in 2004, and since then the agency has applied its scientific expertise 
to track the epidemic and develop evidence-based prevention strategies. 
Through various programs and initiatives, CDC supports all five parts 
of the Secretary's Opioid Strategy:
            Strengthening Public Health Data and Reporting
    Timely, high-quality data help both public health officials and law 
enforcement understand the extent of the problem and how it is 
evolving, develop interventions, focus resources where they are needed 
most, and evaluate the success of prevention and response efforts. 
Understanding that data is crucial, CDC is helping States build 
capacity to monitor the scope of the epidemic and better focus their 
prevention activities through several programs and activities.
    CDC's Overdose Prevention in States (OPIS) provides resources and 
scientific support to 45 States and Washington, D.C. through three 
programs. The first two programs, Prescription Drug Overdose: 
Prevention for States (PfS) and Data-Driven Prevention Initiative 
(DDPI), provide States with the resources, tools and technical 
expertise to execute and evaluate prevention strategies to improve safe 
prescribing practices and prevent prescription drug misuse, abuse, and 
overdose. States use their funding to advance prevention in four key 
areas: 1) Enhancing Prescription Drug Monitoring Programs (PDMP) and 
leveraging them as public health tools; 2) Improving health system and 
insurer practices for safer opioid prescribing; 3) Evaluating policies 
that may have an impact on the opioid epidemic (e.g.. naloxone 
distribution and Good Samaritan laws); and 4) Quickly responding to 
emerging and critical needs.
    CDC's Enhanced State Opioid Overdose Surveillance (ESOOS) program, 
the third program under OPIS, funds 32 States and Washington, D.C. 
Started in 2016, ESOOS strives to improve the timeliness of reporting 
both fatal and non-fatal opioid overdoses and associated risk factors 
in order to inform public health responses within and across States. 
What is particularly unique and innovative about this program is the 
use of emergency department and emergency medical services (EMS) data 
to track and analyze morbidity data. ESOOS uses this data to establish 
an early warning system to detect sharp increases (e.g. potential 
outbreaks) or decreases (e.g. successful intervention efforts) in non-
fatal overdoses.
    CDC has made progress in improving the timeliness of data reporting 
and is now releasing quarterly and, as of August 2017, monthly 
provisional counts of overall drug and opioid overdose deaths in the 
Vital Statistics Rapid Release (VSRR) series. CDC also relies on its 
existing infrastructure to monitor rates of new cases of HIV and viral 
hepatitis in many States. CDC is working with coroners and medical 
examiners to improve both comprehensive toxicology efforts that help 
with the detection of fentanyl analogs and the capacity for mortality 
surveillance by identifying ways to help strengthen case management 
systems to report data more easily and quickly. While CDC has made 
progress, improvements are needed to build infrastructure (medical 
examiners, coroners, toxicological testing, additional electronic 
reporting, etc.). A stronger disease detection system will identify 
potential problems sooner.
    CDC is also tracking opioid use among pregnant and reproductive-
aged women and its impact on the mother and newborn as a part of the 
Treating for Two: Safer Medication Use in Pregnancy initiative. Pilot 
programs are underway to obtain State-level estimates of NAS to better 
understand hospital readmissions and long-term adverse outcomes among 
infants identified with NAS.
    In addition to providing funding and technical assistance, CDC 
conducts epidemiological investigations (Epi-Aids) in States, providing 
on the ground assistance during a public health crisis. Between 2012 
and 2015, Massachusetts experienced a surge of opioid-related deaths, 
from 698 to 1,747, with over 74 percent of these deaths involving 
fentanyl. The Massachusetts Department of Public Health (MDPH) called 
on CDC to help investigate the extent to which illicitly-manufactured 
fentanyl (IMF) contributed to the surge in opioid-related overdose 
deaths. CDC worked closely with the MDPH, SAMHSA, and DEA to determine 
whether IMF mixed with or sold as heroin was the primary cause of the 
surge of deaths and found that 82 percent of fentanyl-related overdose 
deaths were suspected to have involved IMF.
    To stop the surge, CDC recommended that the MDPH train physicians, 
treatment providers, and law enforcement on overdose prevention, screen 
at-risk people for heroin or fentanyl use, and expand access to 
naloxone. CDC also recommended outreach to those who experienced an 
opioid overdose, had a history of substance abuse, or were accessing 
health programs for active users to link them to treatment and educate 
them on the dangers of fentanyl.
    Often, CDC's work in States leads to further, national initiatives. 
The 2015 response to an HIV and Hepatitis C (HCV) outbreak in Scott 
County, Indiana, led to a CDC analysis which identified over 220 U.S. 
communities that could be especially vulnerable to HIV and HCV 
outbreaks among persons who inject opioid drugs. One of those States, 
Tennessee, used CDC's assessment to do further analysis of the State's 
vulnerabilities. As a result, Tennessee is working to direct its HIV 
and viral hepatitis resources where they are most needed.
    In addition to working with States, a partnership across sectors is 
necessary. CDC has been working on initiatives with law enforcement 
agencies, like the DEA, to strengthen public health and law enforcement 
collaboration on the Federal level.
    In addition, the Heroin Response Strategy (HRS), funded by the 
Office of National Drug Control Policy and deployed in eight High 
Intensity Drug Trafficking Areas (HIDTAs), covering 20 States, links 
public health and public safety at the State level. CDC works with the 
HIDTA directors to sharpen strategic directions, ensure proper 
coordination and training, support the 20 public health analysts 
embedded in the program, and improve performance measurement. There is 
currently a shortage of evidence to guide public health-law enforcement 
integrated community response, thus as part of the HRS, CDC is 
launching eight pilot projects across the 20-State initiative to build 
scientific evidence about what works.
            Advancing the Practice of Pain Management
    Another of CDC's key focus areas is supplying healthcare providers 
with the tools and resources necessary to advance the practice of pain 
management. In March 2016, CDC released the Guideline for Prescribing 
Opioids for Chronic Pain, which was developed to help primary care 
doctors provide safer, more effective care for patients with chronic 
pain outside of active cancer, palliative, and end-of-life care. The 
Guideline provides 12 voluntary recommendations for prescribing opioids 
for patients 18 and older, in primary care settings, based on the most 
current scientific evidence. This helps patients and physicians better 
understand and assess risks and benefits of opioid therapy and 
determine the optimal method for each patient to manage their pain.
    CDC has created a number of resources for healthcare providers to 
make the Guideline easy to understand and access. Earlier this year, 
CDC launched the first in a series of interactive, online trainings 
which provide sample scenarios, feedback, and resources for each 
recommendation. CDC is also capitalizing on technology to help 
disseminate the Guideline through the development of an Opioid 
Guideline Application (mobile app) which contains all of the Guideline 
recommendations, a morphine milligram equivalent (MME) calculator, and 
an interactive interviewing feature to help providers prescribe with 
confidence. Other materials developed for providers, pharmacists, and 
patients include graphics, fact sheets, posters, and podcasts, all 
available on CDC's website.
    CDC is also committed to educating consumers about the risks of 
opioids and the importance of discussing safer, more effective pain 
management options with their healthcare providers. In September 2017, 
CDC released the Rx Awareness communications campaign to increase 
awareness about the risks of prescription opioids and deter 
inappropriate use. The campaign features real-life accounts of 
individuals living in recovery, and those who have lost someone to an 
overdose. CDC is running digital, radio, and out-of-home campaign ads 
for 14 weeks in select States (KY, MA, NM, and OH) with broader release 
anticipated in 22 additional OPIS funded States.
            Improving Access to Prevention, Treatment, and Recovery 
                    Support Services
    CDC brings scientific expertise and leverages existing 
relationships with health systems to link patients who need MAT to the 
appropriate care. As part of the OPIS effort, several States funded 
under the PfS program are supporting health system approaches to link 
patients to treatment and recovery services. For example, States are 
building systems that facilitate better linkages to treatment, 
emergency room peer patient navigators, and data dashboards to identify 
hot spots for treatment needs.
    Additionally, CDC is conducting an epidemiologic study to assess 
what type of MAT (methadone maintenance; buprenorphine; naltrexone) or 
counseling and other non-medication interventions is most effective, 
and which contextual, provider, and individual factors influence 
implementation, prevent relapse, and improve patient wellbeing over a 
2-year period. This study can help identify who may benefit from which 
type of treatment to ensure individuals receive the treatment best 
suited to their needs.
            Targeting Overdose-Reversing Drugs
    CDC is currently working with SAMHSA to evaluate its Grants to 
Prevent Prescription Drug/Opioid Overdose-Related Deaths program with 
the goals of describing and understanding the scope and impact of 
naloxone education and distribution efforts in high-need communities 
and to identify barriers and potential solutions to increase program 
effectiveness. Additionally, States funded under OPIS are evaluating 
practices to improve the distribution and use of overdose reversing 
drugs and Good Samaritan laws (policies that protect the victim and the 
bystander from drug possession charges). States utilize CDC data to 
identify communities experiencing a significant increase in opioid 
overdose deaths, which helps to inform both the targeted distribution 
of naloxone and the training of community members, EMS, and law 
enforcement on naloxone administration.
            Supporting Cutting-Edge Research
    To better understand the epidemic, identify risk and protective 
factors, and determine effective interventions, CDC also funds 
innovative research to prevent misuse and abuse. One CDC funded project 
at the Carolinas Medical Center in Charlotte, North Carolina, is 
working to assess and compare changes in prescribing behaviors when 
providers are presented with electronic alerts on potential misuse or 
abuse of opioids. This research will inform efforts to improve clinical 
decisionmaking. In addition, CDC funds academic research centers to 
conduct translational research in order to better understand how to get 
information into the hands of practitioners. For example, the Johns 
Hopkins Injury Control Research Center (ICRC) is working to reduce 
injured patients' risk for opioid misuse through mobile health 
technology while the West Virginia University (WVU) ICRC was 
instrumental in the development and implementation of a pilot take-home 
program for naloxone in rural communities. There were at least 25 
overdose reversals in the first 9 months of the program in 16 counties. 
As part of a rapid response project using CDC funds, the WVU ICRC 
distributed 8,250 naloxone kits to first response agencies and take-
home naloxone programs throughout the State in the first half of 2017.
National Institutes of Health (NIH)
    NIH is the lead HHS agency providing support for cutting-edge 
research on pain and opioid misuse, addiction, and overdose. Drug 
addiction is a complex neurological condition, driven by many 
biological, environmental, social, and developmental factors. Continued 
research will be key to understanding the crisis and informing future 
efforts. Pain is an equally complex condition. To this end, NIH 
supports a range of activities to advance research on pain and 
addiction.
            Supporting Cutting-Edge Research
    Because the most effective way to end opioid misuse and addiction 
is to prevent it from beginning, NIH is supporting innovative research 
to better understand what makes an individual vulnerable to opioid 
misuse. For example, the Adolescent Brain Cognitive Development (ABCD) 
study, the largest long-term study of brain development and child 
health in the U.S., will help build an evidence base to draw on for a 
future of precision medicine approaches to prevent opioid addiction.
    As the President announced in his speech on October 26, NIH has 
taken the first steps of a public-private partnership with the goal of 
bringing scientific solutions to the opioid crisis. NIH is exploring 
ways to promote (1) new, innovative medications and technologies to 
treat opioid addiction and improve overdose prevention and reversal 
interventions, and (2) safe, effective, non-addictive strategies to 
manage pain. In April 2017, NIH Director Francis S. Collins, M.D., 
Ph.D., met with research and development leaders from the world's 
leading biopharmaceutical companies to discuss new ways for government 
and industry to work together to address the opioid crisis. NIH 
continued meetings throughout the summer. As part of these ongoing 
discussions, NIH participated in a recent meeting with pharmaceutical 
company CEOs convened by Governor Chris Christie, Chair of the 
President's Commission on Combating Drug Addiction and the Opioid 
Crisis, in Trenton, New Jersey, on September 18th. Some advances NIH is 
working to promote may occur rapidly, such as improved formulations of 
existing medications, longer-acting overdose-reversal drugs, and 
repurposing of treatments approved for other conditions. Others may 
take longer, such as novel overdose-reversal medications and 
identifying biomarkers to measure pain in patients. Our goal for these 
activities is to cut in half the time needed to develop new, safe and 
effective therapeutics to help end the opioid crisis.
    NIH will continue to build upon breakthroughs in the treatment of 
opioid addiction and the reversal of opioid overdose and find ways to 
advance the development of new products. For example, buprenorphine, 
one of the three FDA-approved options for MAT treatment, was developed 
through a partnership between NIH and industry. The intramural program 
of the National Institute on Drug Abuse (NIDA) conducted the early 
clinical studies on buprenorphine and then later partnered with 
industry to develop user- friendly and abuse deterrent formulations. In 
addition, a NIH public-private partnership helped to develop the only 
FDA-approved intranasal naloxone product to reverse opioid overdose, an 
invaluable tool to those on the front lines combating the opioid 
crisis. In 2013, NIDA funded a biopharmaceutical company to conduct 
clinical studies to evaluate the pharmacokinetic properties--how much 
and how rapidly the naloxone is absorbed--of an intranasal formulation. 
In 2015, the intranasal naloxone was approved by the FDA. With 
knowledge gained from neuroscience advances, NIH researchers now seek 
ways to turn the tide in the opioid crisis through a wider range of 
formulations of existing and new medications, as well as innovative 
strategies to treat opioid use disorder and prevent and reverse 
overdose.
    NIH is also working toward preventing the most serious health 
consequences for infants born with NAS. Currently, NIH research aims to 
determine more precise dosing of buprenorphine in pregnant women, and 
to reduce the time to develop new treatments. NIH is also launching a 
new effort on opioid use in pregnancy, to study the effects of 
medically supervised opioid withdrawal on mother and newborn, and 
better understand the genetic or epigenetic factors associated with 
opioid use on neonatal outcomes. NIH will also develop and pilot a 
common study protocol to generate evidence for best practices in 
treating newborns with NAS, through a partnership between the NIH 
Neonatal Research Network and the new IDeA States Pediatric Clinical 
Trials Network.
    NIH researchers are also working to build an understanding of how 
to effectively integrate prevention and treatment services within 
healthcare and community systems. For example, NIH is studying 
strategies to improve the implementation of MAT for people with opioid 
use disorder in the criminal justice system. This research aims to 
optimize implementation of evidence-based screening, assessment, and 
treatment services by juvenile justice agencies and improve 
coordination with community healthcare providers in a way that promotes 
long-term recovery from opioid addiction in real-world settings.
            Advance the Practice of Pain Management
    Our mission to end the opioid crisis will not be successful until 
we can provide patients with better options for the treatment of pain, 
which touches 25 million Americans every day. NIH funds a broad range 
of research on pain, from basic research into the molecular, genetic, 
and bio-behavioral basis of chronic pain to large-scale clinical 
studies of potential treatments. NIH funded basic research has 
identified a myriad of potential targets for future non-addictive 
therapies. Pathological pain and addiction are classic disorders of 
brain circuits, and the neurotechnologies emanating from the US BRAIN 
Initiative enable scientists to explore these circuits to advance both 
diagnostics and therapeutics. Research efforts to understand and 
alleviate pain depend on better objective measures of the pain 
experience for patients. To address this, NIH also supports development 
of resources to advance the research agenda. One example is the 
Patient-Reported Outcomes Measurement Information System (PROMIS). 
PROMIS provides a rigorously tested patient-reported outcome 
measurement tool to measure pain, fatigue, physical functioning, and 
emotional well-being.
    NIH works with Federal partners across government to carry out 
cutting-edge research on pain. Through the Interagency Pain Research 
Coordinating Committee, NIH developed the Federal Pain Research 
Strategy, a long-term strategic plan to coordinate and advance the 
Federal research agenda on pain. The Strategy's research priorities 
include prevention of acute and chronic pain, management of acute pain, 
transition from acute to chronic pain, and understanding the 
disparities that influence pain and pain management. Ongoing projects 
that already are advancing the goals laid out in the Strategy include 
the NIH-DoD-VA Pain Management Collaboratory program, which recently 
announced $81 million in research funding to implement cost-effective 
large-scale clinical research in military and veteran healthcare 
delivery organizations, focusing on non-pharmacologic approaches to 
pain management and other comorbid conditions.
    Beyond research activities, 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, 
which highlights the need for evidence based treatments. NIH is 
actively working with other Departments and Agencies and external 
stakeholders to implement the Strategy. In addition, NIH is supporting 
Centers of Excellence for Pain Education that act as hubs for the 
development, evaluation, and distribution of pain management curriculum 
resources for medical, dental, nursing, pharmacy and other schools to 
enhance education about pain and pain care.
    In addition to the efforts described above, HHS continues to engage 
with a broad range of stakeholders--State and local governments, 
addiction specialists, medical, nursing, dental, and pharmacy 
providers, community and faith-based organizations, private-sector 
partners, community organizations, and law enforcement partners--to 
share best practices, build collaborations, and identify barriers that 
could prevent success. We are committed to this fight and will continue 
to advance a multi-pronged strategy, never forgetting that behind all 
the statistics are individuals, families, and communities who are being 
torn apart each day. Our guiding vision must be to improve the lives of 
all Americans who have been touched by this crisis. That will be the 
true measure of our success.
    Lastly, HHS, through the President's fiscal year 2018 budget, has 
requested more than $800 million to continue to support the 
Department's critical opioid investments. We look forward to continuing 
to work with Congress to identify solutions and to secure the funding 
needed to turn the tide against the opioid crisis.
    Thank you again for inviting SAMHSA, CDC, and NIH to testify today. 
We look forward to answering your questions.

    Senator Blunt. Thank you, Dr. Collins.
    Congressman Kennedy.
STATEMENT OF PATRICK J. KENNEDY, FORMER CONGRESSMAN, 
            PRESIDENT'S COMMISSION ON COMBATTING DRUG 
            ADDICTION AND THE OPIOID CRISIS
    Mr. Kennedy. Thank you. Thank you very much, Chairman 
Blunt.
    Voice. Your mic. Thank you.
    Mr. Kennedy. I should know better, after all the years 
serving with you guys.
    I appreciate the opportunity. It's a great honor to appear 
before all of you, and especially in this United States Senate, 
which was my dad's second home, especially to talk about this 
subject, which I have lived experience about. I've suffered 
from an opioid use disorder, and I've also been, along with all 
of you, in the policy-making branch.
    And I can tell you that this is an issue whose only 
solution is a comprehensive approach, and by that I mean, you 
know, this is not just a couple of agency budgets that are 
going to be increased here and there. This is something that 
has to be done across all agencies that may not even understand 
how and what impact they have in helping to provide the kind of 
comprehensive care that's going to make it possible for people 
in this country who are trying to achieve sobriety and live in 
recovery to be able to do that effectively.
    In other words, if the Housing budget is not really where 
it needs to be, then people are going to be shifted over to CMS 
(Centers for Medicare & Medicaid Services) in terms of the 
costs that are going to be borne by more inpatient care than 
would be otherwise necessary if you properly funded HUD 
(Department of Housing and Urban Development). And, you know, 
if we're not doing more on education to screen kids early who 
have these, you know, early signs of having a mental illness or 
addiction, then you're never going to be able to catch the 
illness at a time when you can properly manage it most 
effectively with the least amount of dollars.
    You know, so it is--and we have to address obviously the 
interdiction and the fact that we have fentanyl coming across 
our borders. And China knows what it's doing, they're looking 
the other way on this issue. We just need to go after this as 
an emergency, not as a HHS (Department of Health and Human 
Services) public health emergency. God bless the President for 
calling for a public health emergency, but that's just 
rearranging chairs on the Titanic, because what we really need 
to do is have an overarching emergency here, all aspects of 
government need to be called in.
    The State Department needs to be working overtime to go 
after those fentanyl manufacturers in China and in Mexico.
    We have to have a comprehensive approach to the Postal 
Service. We think those wholesalers are getting into trouble 
with pushing these pills; they have nothing over the U.S. 
Postal Service and what they're not doing to interdict this 
fentanyl.
    And so my point is that this thing is so comprehensive, we 
need all hands on deck. In the Interim Report of the 
President's Commission, we call for a Stafford Act declaration 
in addition to a public health emergency declaration. Why? 
Because to, Chairman Leahy, your point, we knew that just 
lifting--the fighting amongst these dollars and the current 
caps is not going to be sufficient to take on the 
extraordinary, extraordinary burden that this is going to be on 
our country and already is.
    We need to do something extraordinary, and it ain't going 
to be, as I said, just, you know, borrowing from Peter to pay 
Paul, which is essentially having been where you sit on the 
House side on the Appropriations Committee, that's what you 
often end up doing, is taking a little bit from over there to 
put a little bit over there, not understanding the bigger 
picture.
    So I would say and recommend to this committee that they 
urge the President to declare a Stafford Act emergency and 
allow us to get a fraction of the dollars that we're spending 
currently towards other natural disasters. It will be a way of 
us getting those additional dollars that won't come from the 
ordinary appropriations process, which you know ties your 
hands, Mr. Chairman, in the total number of dollars that you 
can put towards these very challenging issues. So that would be 
my biggest message.
    And I concur with Chairman Leahy when he said that Medicaid 
is the source of treatment for people with mental illness and 
addiction in this country, period. And I'm not making this as a 
partisan statement, this is a practical statement. It is the 
largest provider of treatment for people with substance use 
disorders and mental illnesses in this country. So cutting 
Medicaid in the face of this disaster, you know, is hard to 
even begin to put words into trying to explain, but I would 
just say that would be the first no-no in my book of what we 
should not do. Instead, what we should be doing is getting the 
Stafford Act emergency and getting the necessary funds into all 
the programs that you're going to hear described today at this 
hearing.
    Thanks.
    [The Surgeon General's Report on Mental Health and 
Addiction follows:]

    Dr. David Satcher, Surgeon General's Report on Mental Health: 
https://profiles.nlm.nih.gov/ps/access/NNBBHS.pdf.
    Dr. Vivek Murthy, Surgeon General's Report on Addiction: https://
addiction.surgeongeneral.gov/surgeon-generals-report.pdf.

    [The statement follows:]
      Prepared Statement of Former Congressman Patrick J. Kennedy
    Thank you for inviting me to testify about the concurrent opioid 
and suicide crises facing our Nation.
    Before I testify, I have to speak to the most important issue that 
could greatly affect the crises: the tax vote. It has everything to do 
with this topic, and there is no sense in my testifying if you have 
already given away all of the tax money we need to address the crises. 
Thousands of people are dying every month, and the wave of misery 
impacting countless American families only seems to be gaining steam. 
How do we help all of those who are suffering and restore our shattered 
families and communities? Should the top priority be cutting taxes for 
transnational corporations and wealthy inheritors? Should we do this 
knowing that the next step is gutting Federal aid to the poor and 
elderly? I can assure you, there is definitely one thing we CANNOT do, 
or history will judge this Congress very harshly. WE CANNOT CUT FUNDING 
TO MEDICAID. That is not a political statement, it is a practical one. 
Medicaid is the single largest payer of mental healthcare in the 
country. Medicaid beneficiaries with mental illness and substance use 
disorder, particularly those enrolled in expanded Medicaid, often have 
other comorbid illnesses such as hepatitis C or HIV that must be 
treated. I understand there is not an unlimited pot of money for the 
Federal Government to dip into, but now is not the time to cut the 
greatest funding source for mental health and addiction treatment. 
Doing so would be unconscionable and frankly, immoral.
    In 2016, suicides claimed more than 44,000 lives. Combine that with 
the 64,000 lives lost to drug overdoses in 2016 and the total is over 
100,000 American lives lost. And God only knows how many other lives 
were torn apart or shattered due to the trauma brought upon by these 
tragedies.
    Do the math: nearly 300 people die EVERY SINGLE DAY due to brain 
illnesses. What are we doing for this crisis? Not nearly enough. 
Talking and reporting about this crisis is not enough. Hiring expensive 
agencies to create national advertising campaigns is not enough. We 
need real, substantial, emergent dollars--NOW!
    Preliminary data compiled by the Office of National Drug Control 
Policy (ONDCP) and the National Institute on Drug Abuse (NIDA) for 2017 
shows the death toll is rising. What are we waiting for?
    This epidemic is crushing our society by inciting financial ruin 
for those who attempt to get treatment due to our broken healthcare 
system, ripping families apart, leaving children without parents, and 
leaving our most vulnerable to fend for themselves. The number of 
infants born dependent on opioids has more than tripled in the last 15 
years, and is only getting worse. The number of children in foster 
care, because of parental substance use, has doubled since 1999 and is 
rapidly increasing. Social workers often have to stay with young 
children in hotel rooms because they cannot locate a foster family. 
Caseloads are completely unmanageable, and already underfunded budgets 
are entirely insufficient, which escalates the burden placed on the 
system.
    The situation continues to grow dire, and yet our country seems to 
be in denial that we are dealing with the worst public health 
catastrophe of the 21st Century!
    If 300 people died each day from Ebola, starting in the beginning 
of 2016, I would not be standing in front of Senate Appropriations 
Committee members almost 2 years later--in December of 2017--testifying 
that we need to appropriate more money to solve the problem. Congress 
would have appropriated billions of dollars to address the issue right 
away!
    In September, Congress passed a disaster relief bill totaling more 
than $15 billion to address the effects of Hurricanes Harvey and Irma. 
In October, Congress passed another bill, amounting to over $36 
billion, in response to Hurricane Maria and the wildfires on the West 
Coast. Those tragedies claimed several hundred lives and caused the 
destruction of infrastructure and personal property. Congress was right 
to appropriate funds toward rebuilding.
    But since Hurricane Harvey made landfall in Texas on August 25th, 
more than 30,000 people have likely died from drug overdoses and 
suicides. And again, the death toll keeps rising!
    So, several hundred people die or suffer property damage and 
Congress delivers $50 billion, no problem. Thousands upon thousands of 
people die, with no end in sight, and Congress holds a hearing in front 
of Senate Appropriations subcommittees. If that does not prove we are 
in denial as a Nation, I don't know what would. If that does not prove 
there is something else at play here, namely discrimination against 
those with mental health and substance use disorders, again, I don't 
know what would.
    I am planting my flag in the ground right here and right now, 
demanding Congress allocate no less than $25 billion in supplemental 
appropriations to address these crises. If Congress can spend over $50 
billion to address natural disasters, it can absolutely spend just half 
that to address an escalating national disaster killing more than 
100,000 Americans just this year!
    Thankfully, we have a blueprint from the recent past that can guide 
us in addressing such a national disaster: our Nation's response to the 
HIV/AIDS crisis just two decades ago. In the mid 90s, over 50,000 
people were dying each year from that epidemic. In less than 10 years 
we DOUBLED total Federal spending on HIV/AIDS from $12 billion to $24 
billion, and the death toll plummeted to less than 10,000 per year. The 
history lesson is clear: when confronted with a similar public health 
calamity just 20 years ago, we understood that the only appropriate 
response was to get serious and allocate significant Federal dollars to 
address the issue. There is no reason why we shouldn't address this 
challenge in the same manner.
    Recently, the President announced that he directed the Department 
of Health and Human Services (HHS) to declare a Public Health Emergency 
(PHE). While that partially actualized the recommendations of the 
interim report of the President's Commission on Combating Drug 
Addiction and the Opioid Crisis, it was only a first step to what is 
really needed. The interim report also asked the President to declare a 
national emergency under the Stafford Act.
    He could still declare that emergency, and all members of Congress 
have a responsibility to demand such an action. The PHE declaration 
allows for greater coordination and the relaxation of certain 
regulatory roadblocks, but it does not come with any funding. There is 
only $57,000 in the PHE fund, whereas a declaration under the Stafford 
Act would unlock billions of dollars from the Disaster Relief Fund. 
Declaring a PHE alone without a Stafford Act declaration amounts to 
nothing more than rearranging the deck chairs on the Titanic.
    The necessary outline for action is simple: interdiction, 
prevention, treatment, recovery, and parity enforcement. Each of these 
efforts has a series of programs associated with them. While I've asked 
for $25 billion annually, there is another way to unlock money--in 
addition to the Stanford act--and that is parity enforcement. It is a 
scathing indictment on the insurance industry that they are not 
following the very law YOU passed--the noncompliance is costing 
American families thousands of lives, and costing our country billions 
of dollars a year in added services. These are services that commercial 
health plans should be covering, but instead are passing the tab along 
to the Federal Government. The actual Federal investment to bring 
insurers into compliance and pay their fair share is very small, 
relatively speaking.
    This is an immediate step the Appropriations Committee can take--
one that hardly costs anything at all, but would have a huge impact in 
making sure people who have employer-sponsored commercial health 
insurance actually receive the addiction and mental health treatment 
they deserve. The Subcommittee on Labor, Health, and Human Services, 
Education, and Related Agencies must appropriate $17 million annually 
to the Department of Labor (DOL) so that it may adequately enforce the 
Mental Health Parity and Addiction Equity Act. That is $15 million for 
the Employee Benefits Security Administration for more direct 
enforcement activity, and $2 million to the Solicitor's Office for 
litigation.
    Parity has been the law for nearly a decade, yet we are still a 
long way from fulfilling its fundamental promise that insurance 
coverage for illnesses of the brain is no more restrictive than 
insurance coverage for illnesses of the body. Insurers still routinely 
deny coverage of lifesaving and life-restoring mental health and 
addiction treatment in ways that violate the law. DOL has enforcement 
authority over the majority of commercial insurance plans in America, 
yet it does not have the resources necessary to adequately enforce the 
law and investigate illegal health plan negligence.
    Because of its lack of capacity, DOL is unable to perform the 
systematic and targeted audits that are critical to enforcing 
compliance. Parity has broad bipartisan support and everyone, including 
the insurance industry, knows that we still have not achieved it. 
Enforcing the Parity Law will save the Federal Government money. What 
happens now is that private insurance plans deny coverage for people in 
need of costly mental health and addiction treatment, and push them 
into the public system. This often happens after much delay, when 
people are in a late stage of illness. This diversion to the public 
system shifts costs to Medicaid, Medicare, the Substance Abuse 
Prevention and Treatment Block Grant, and the Mental Health Block 
Grant. Just last week a report commissioned by the actuarial firm, 
Milliman, found that people with commercial insurance plans were far 
more likely to access treatment out-of- network for mental healthcare 
than they were for other medical care, which results in higher out-of-
pocket spending for those affected by brain illnesses. This is yet 
another powerful indicator of the insurance industry's negligence.
    We know what we have to do: appropriate money commensurate with the 
severity of this epidemic and follow the recommendations made of the 
President's Commission on Combating Drug Addiction and the Opioid 
Crisis, former Surgeon General Dr. David Satcher, and former Surgeon 
General Dr. Vivek Murthy.
    Each day that passes is another day that we are turning our backs 
on American families in need. They are calling out for help and it is 
past time to listen. If this disaster hasn't yet touched your family, 
be warned. It is only a matter of time. You have the power to save 
lives. I urge you to use it.

    Senator Blunt. Thank you, Mr. Kennedy.
    Dr. McCance-Katz.
STATEMENT OF DR. ELINORE MCCANCE-KATZ, M.D., PH.D., 
            ASSISTANT SECRETARY FOR MENTAL HEALTH AND 
            SUBSTANCE USE, SUBSTANCE ABUSE AND MENTAL 
            HEALTH SERVICES ADMINISTRATION, DEPARTMENT 
            OF HEALTH AND HUMAN SERVICES
    Dr. McCance-Katz. Chairman Blunt, Ranking Member Murray, 
and members of the subcommittee, thank you for inviting me to 
testify at this important hearing. I'm honored to testify today 
along with my colleagues from the Department of Health and 
Human Services, and Congressman Kennedy, on ``Addressing the 
Opioid Crisis in America: Prevention, Treatment & Recovery.''
    Over the past 15 years, communities across our country have 
been devastated by increasing prescription and illicit opioid 
abuse, addiction, and overdose. In 2016, according to SAMHSA's 
(Substance Abuse and Mental Health Services Administration) 
National Survey on Drug Use and Health, 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. Most alarming are the continued 
increases in overdose deaths, especially the rapid increase in 
deaths involving illicitly made fentanyl and other highly 
potent synthetic opioids contaminating the heroin supply since 
2013.
    The Trump administration is committed to bringing 
everything the government has to bear on this health crisis. To 
date, the Department of Health and Human Services has taken 
significant steps to advance the goals of our opioid strategy 
as evidenced by the funding of $900 million allocated by HHS to 
address the opioid crisis in communities all across the 
country.
    The declaration of a nationwide public health emergency 
regarding the opioid crisis on October 26, 2017, is yet another 
tool that underscores the commitment by HHS to a comprehensive 
strategy. Further, we appreciate the work of the President's 
Commission on Combating Drug Addiction and the Opioid Crisis, 
and the Department is reviewing its recommendations.
    HHS is implementing five specific strategies that are 
guiding our response. The comprehensive evidence-based opioid 
strategy aims to improve access to treatment and recovery 
services to prevent the health, social, and economic 
consequences associated with opioid addiction and to enable 
individuals to achieve long-term recovery; to promote the use 
of overdose-reversing drugs to save lives; to 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; to 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 to 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.
    HHS appreciates Congress's dedication to this issue, as 
evidenced by passage of the 21st Century Cures Act and the 
Comprehensive Addiction and Recovery Act, also known as CARA.
    In my role as Assistant Secretary for Mental Health and 
Substance Use at HHS, I lead the Substance Abuse and Mental 
Health Services Administration. I appreciate the opportunity to 
share with you a portion of SAMHSA's portfolio of activities in 
alignment with HHS's five strategies, and how SAMHSA is 
implementing CARA in the 21st Century Cures Act.
    SAMHSA is administering the Opioid State Targeted Response 
Grants program created by the 21st Century Cures Act by 
providing $485 billion to States in fiscal year 2017. This 
program is increasing access to treatment, reducing unmet 
treatment need, and reducing opioid overdose-related deaths 
through the provision of prevention, treatment, and recovery 
services.
    SAMHSA is working to ensure that programs are as clinically 
sound, evidence-based, and efficient as they can be.
    One of the ways we are assisting States and territories 
will be through a new technical assistance program that brings 
teams of experts together to assist directly in jurisdictions 
needing help in implementation of evidence-based approaches to 
the treatment of opioid addiction. SAMHSA has several 
initiatives aimed at advancing the utilization of medication-
assisted treatment for opioid use disorder. For example, in the 
past 4 years, more than 62,000 medical professionals have 
participated in online or in-person SAMHSA-funded trainings on 
the use of medication-assisted treatment for opioid addiction.
    SAMHSA regulates opioid treatment programs and provides 
waivers to providers who prescribe buprenorphine for the 
treatment of opioid use disorders from office-based settings. 
Last year, SAMHSA published a final rule allowing qualified 
physicians to obtain a waiver to treat up to 275 patients.
    SAMHSA also has implemented the CARA provision that allows 
nurse practitioners and physician assistants to prescribe 
buprenorphine. SAMHSA has been actively implementing new 
initiatives to address the opioid crisis, made possible by 
CARA. In September, SAMHSA awarded $4.6 million over 3 years in 
the Building Communities of Recovery grant program created by 
CARA. And last month, SAMHSA also awarded $9.8 million in 
grants over 3 years for the new outpatient State Pilot Programs 
for Pregnant and Postpartum Women authorized by the CARA act, 
and $49 million over 5 years in new Residential Pregnant and 
Postpartum Women Service grants.
    SAMHSA has been a leader in efforts to reduce overdose 
deaths by increasing the availability and use of naloxone, the 
opioid antagonist antidote. SAMHSA is currently providing 
grants to prevent opioid overdose-related deaths, which are 
being used to train first responders as well as to purchase and 
distribute naloxone.
    In September, SAMHSA awarded additional grants authorized 
by CARA, including almost $46 million over 5 years to grants 
used in 22 States to provide naloxone and related resources to 
first responders and treatment providers.
    Finally, SAMHSA's National Survey on Drug Use and Health 
provides key national and State-level data and is a vital part 
of the surveillance effort related to opioids.
    Thank you again for the opportunity to share with you our 
work to combat the opioid epidemic. And I look forward to 
answering your questions.
    Senator Blunt. Thank you.
    Dr. Houry.
STATEMENT OF DR. DEBRA HOURY, M.D., M.P.H., DIRECTOR, 
            NATIONAL CENTER FOR INJURY PREVENTION AND 
            CONTROL, CENTERS FOR DISEASE CONTROL AND 
            PREVENTION, DEPARTMENT OF HEALTH AND HUMAN 
            SERVICES
    Dr. Houry. Good morning, Chairman Blunt, Ranking Member 
Murray, and members of the committee. I am Dr. Deb Houry, the 
Director of the National Center for Injury Prevention and 
Control at the CDC (Centers for Disease Control and 
Prevention).
    As an emergency physician, I was honored to join CDC 3 
years ago to save even more lives in this role.
    CDC has vast experience serving as the common defense of 
our country against health threats, and I appreciate the 
opportunity to be here today to speak about the issues 
surrounding the opioid crisis.
    CDC focuses on preventing people from becoming addicted in 
the first place. We have the unique role of leading prevention 
by addressing opioid prescribing, tracking trends, and driving 
prevention activities in States and communities.
    America's opioid overdose epidemic affects people from 
every community and is one of the few public health problems 
that is getting worse instead of better.
    Drug overdoses have dramatically increased, nearly tripling 
over the last 2 decades. But today's overdose deaths are just 
the tip of the iceberg. For every one person who dies of an 
opioid overdose, over 60 more are addicted to prescription 
opioids, almost 400 misuse them, and nearly 3,000 have taken 
one.
    CDC has been on the front lines since the beginning. Over a 
decade ago, after hearing alarming news from medical examiners 
about increases in overdose deaths, and after an outbreak 
investigation in North Carolina, CDC scientists made the 
connection to prescription opioids. CDC received our first 
appropriated funding for the public health response to opioids 
in 2015. With that funding, we established the foundation for 
State-based prevention programs so that States have the 
resources for targeted interventions.
    We also are funding an opioid surveillance program, 
collecting timely data on both fatal and non-fatal overdoses so 
we can pinpoint resources and responses where needed most. We 
appreciate the expanded funding provided in fiscal year 2017. 
Thank you. We now fund 45 States and Washington, D.C., to 
implement strategies to prevent opioid overdoses.
    States are improving prescription drug monitoring programs, 
or PDMPs, by integrating into electronic health records and 
sending reports to providers to protect patients at risk for 
overdose. For example, in West Virginia, PDMP data is now being 
used and distributing reports of high-risk patient prescribing 
to providers and expanding outreach to high-burden communities. 
We've seen the rate of patients with multiple provider episodes 
decline by 62 percent. This is just one example of the great 
work being done in the States. These kind of improvements can 
literally save lives.
    CDC also leads the public health data collection that we 
all rely on to understand the crisis. We have improved 
reporting of overdose deaths from a lag of 2 years to 7 months.
    As part of CDC's funding to States, we've implemented a 
program to get more reliable and timely data from emergency 
rooms, medical examiners, and coroners. This program tracks 
fatal and non-fatal opioid overdoses in near real time to 
better understand the changing epidemic so we can respond.
    States also call on CDC to provide on-the-ground assistance 
when they experience an opioid-related crisis. We helped Rhode 
Island identify that a surge in opioid deaths was caused by 
fentanyl. And we assisted Indiana to identify and contain an 
HIV and hepatitis outbreak related to injections of 
prescription opioids. CDC developed recommendations for States 
to help avoid or respond to similar situations.
    We have been working diligently to disseminate our 
guideline for prescribing opioids for chronic pain, which we 
released last year. We have provided tailored tools and 
resources to make the guideline easy for clinicians to use, 
develop trainings for providers, and we have partnered with 
multiple organizations to implement the guideline.
    We are also focusing on patients and families. CDC's Rx 
Awareness Communications campaign features real life accounts 
of individuals living in recovery and those who have lost 
someone to an overdose. The campaign is currently running in 
four high-burden States, and 22 additional States will be 
implementing the campaign with CDC's funding.
    CDC's unique activities and expertise are key in reversing 
the opioid epidemic. 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.
    Thank you. And I'm happy to answer any questions that you 
might have.
    Senator Blunt. Thank you, Dr. Houry.
    I'm glad that Senator Murray is here today. She and Senator 
Alexander both have another, the Authorizing Committee hearing 
going on, on nominations.
    And so we're glad, Senator, you're here, and I think we'll 
let Senator Murray do two things: one, your opening statement 
would be welcomed, and then we'll let you start the 5-minute 
round of questions after your opening statement.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Mr. Chairman, thank you so much for your 
accommodation. I really appreciate it. And I really appreciate 
you calling a hearing on this urgent issue.
    Welcome, all of our distinguished panel.
    Congressman Kennedy, great to have you here. I appreciate 
your testimony as well as hearing from all of you, especially 
from the Department of Health and Human Services, about what 
additional actions we need to take to stem this epidemic.
    I do want to note I am once again disappointed that the 
Director of the Centers for Disease Control, Brenda Fitzgerald, 
was unable today to join us to give her perspective. But since 
this is an Appropriations Committee, I'll be pressing our 
witnesses to talk specifically about funding needs.
    Every day from every corner of our country, we hear more 
about the devastation being caused by the opioid crisis, from 
doctors who are treating babies born addicted to opioids, to 
parents who have lost children to an overdose, to veterans in 
chronic pain who are struggling with addiction, and the list 
goes on.
    In my home State of Washington, nearly 10,000 people have 
died of an opioid overdose since 2000. That is 10,000 lives 
that were cut short with countless more families and friends 
who are left suffering and picking up the pieces. And I know 
these heartbreaking numbers are reflective of what is going on 
in States across our country.
    Because this epidemic doesn't discriminate, it can reach 
anyone and anywhere. So the opioid epidemic is a public health 
crisis as well as an emergency. And I personally am 
disappointed the administration has not taken decisive action 
to address it. What's needed to make a real difference in the 
lives of countless patients and families in my State and across 
the country struggling from addiction are real immediate 
resources to fight this battle on the ground. And despite the 
work of the Commission and its recommendations, the Commission 
failed to identify any additional funding to battle this 
epidemic.
    Make no mistake, this epidemic is an emergency. Every day, 
175 Americans die from opioid overdose; yet, the administration 
has been shockingly silent when it comes to identifying the 
resources to address this public health crisis of addiction 
here at home. And just to underscore how inadequate this 
administration's response to this has been, last month the 
White House's own Council of Economic Advisors released a 
report estimating the economic cost of the opioid crisis to be 
at over $500 billion just for 2015. That is six times larger 
than the most recently estimated economic cost of this opioid 
epidemic. And this cost is growing more each and every day, and 
it won't be addressed by stunts like the President committing 
to donating his third quarter salary to HHS.
    It's long past time for this administration to get serious 
about this crisis. Now, given the current budget caps, this 
subcommittee simply has not been able to provide the level of 
funding needed to make real progress in preventing and treating 
opioid addiction. Funding in the LHHS appropriations bills has 
remained basically level, but the epidemic has not remained 
level, it has escalated. Overdose rates continue to soar. The 
epidemic is now being driven by synthetic drugs like fentanyl 
that are up to 50 to 100 times more powerful than morphine. And 
the most recent data suggests that more people are skipping 
prescription pain killers' altogether, going straight to heroin 
as their first opioid.
    Given the scope of this crisis, emergency supplemental 
funding is desperately needed that will give our States and the 
communities evidence-based tools to turn this epidemic around. 
The current situation is unacceptable, and we need more than 
tough talk from President Trump to address this. Congress and 
patients and families need this administration to be an equal 
partner in fighting this epidemic, and unfortunately, we have 
not seen that yet.
    So, Mr. Chairman, I appreciate that. I do just have a few 
questions I want to ask before I have to return to my other 
hearing. And again, I appreciate the accommodation.
    Dr. Houry, I wanted to talk with you. I'm very concerned 
with this administration's lack of seriousness and response to 
this crisis. And I must say I am worried about the potential 
impact that it has on the work you all do at CDC.
    For one, I have to say, I am, as I said, troubled to learn 
that CDS's new Director, and your boss, Brenda Fitzgerald, 
could be left unable to engage on issues related to the opioid 
epidemic due to her potential conflicts of interest. More than 
ever, we need CDC to be at the forefront leading to combat this 
epidemic, and it has to start at the top.

                            ILLEGAL OPIOIDS

    Now, I want to ask more about CDC's current prevention 
strategies and what you're doing. Up until now, CDC's 
prevention efforts have focused on reducing the prescribing of 
legal opioids and improving prescription drug monitoring 
programs. Those efforts are undoubtedly worthwhile, but I 
understand that illicit drugs, like fentanyl and heroin, are 
increasingly driving the drug overdose. So I wanted to ask you, 
how are CDC's overdose prevention activities changing to 
reflect those trends?
    Dr. Houry. Absolutely. Thank you for that question. Some of 
the Epi-Aids we've done on the outbreak investigations have 
shown that still prescription opioids are driving a lot of the 
illicit--like in Rhode Island, a third of the fentanyl overdose 
deaths still had a recent prescription opioid. So we think it's 
important to still focus on prescription opioids, but also 
focus on illegal opioids.
    So what we're doing to address illegal opioids is we've 
recently invested $2 million in the heroin response strategy so 
we can work directly with communities with public safety. Some 
of the things we're doing are looking at people after an 
overdose. How do we link them to treatment? People that have 
experienced adverse childhood experiences, how do we prevent 
them from having that next overdose? We also did a personnel 
swap with the DEA (Drug Enforcement Administration) and are 
doing data exchanges with them so we can look at illegal drug 
seizures so that we can inform public health responses in those 
communities.
    We have done many outbreak investigations. Fentanyl--I'm 
sorry, in Rhode Island, Florida, Ohio, among them, to really 
look at in each State, are there specific counties or is it due 
to incarceration? What is driving those increases so that we 
can provide really targeted response for the States?
    We have also had three health advisory notices that we've 
released in the past few years around fentanyl and these 
illicit overdoses. And we also, within our Prevention for 
States program, built in a rapid response so that each State 
has the ability to address each unique challenge that they have 
really on a flexible basis because we know that this epidemic 
evolves, so we wanted to give them the tools that they need to 
address it.

                        OPIOID/MEDICAID FUNDING

    Senator Murray. Okay, I appreciate that.
    And Congressman Kennedy, you've publicly stated that the 
Federal Government needs to make at least $10 billion available 
per year for a decade. Do you still believe that number is 
accurate?
    Mr. Kennedy. I think that's at a minimum. Honestly, when we 
were fighting the AIDS epidemic, which was claiming 53,000 
lives, this is claiming 64,000 lives, we were spending the 
equivalent of $24 billion with today's dollars. So we're doing 
a rain dance thinking how great it is that we spent $500 
million a year in, you know, the 21st Century Cures, and we 
think that's great.
    Senator Murray. Okay. Can I----
    Mr. Kennedy. In New Jersey, over and above Medicaid, we're 
spending----

                         EMERGENCY DECLARATION

    Senator Murray. Can I just have a second? I wanted to ask 
you, did the Commission ever consider including funding? And if 
so, why was it not addressed in the final report?
    Mr. Kennedy. So I think that the--the interim report 
thankfully did call for Stafford Act so that we could get the 
President to declare an emergency that would be commensurate to 
the $500 billion price tag so that we could get in the area of 
$20, $25 billion, what we spent on HIV, for this crisis per 
year. Okay? That's the only way to do this. We can't, as you 
mentioned, do this within the current restrictions in the 
appropriations process. The only way for us to do this is an 
emergency supplemental, as you said, and it has to be 
comprehensive.
    We have the experts. Honest to God, I've had the honor of 
being with many of them on many panels. We know how to do this. 
Let's--it's all political will, Senator. That's the only thing 
that's missing. If we can appropriate upward to $60 billion for 
the fires and hurricanes, and since Harvey hit landfall, where 
over 35,000 Americans lost, since Harvey.
    Senator Murray. Okay.
    Mr. Kennedy. And I'm just saying it is a matter--
proportion. This--it's inexplicable why we aren't spending in 
the order of $20 billion. I said 100 because that's what it 
would take to expand Medicaid expense to the States that don't 
have it.
    Senator Murray. All right. Thank you very much, I really 
appreciate it.
    Senator Blunt. Thank you, Senator.

                       OPIOID RESEARCH PRIORITIES

    Dr. Collins, what kind of research efforts do you envision 
we need? And what problems do you think are most likely 
benefited by research? And we may come--let's do those first. 
We may come back in a second round about what that would cost. 
But talk about what's needed, where the partners may be, and 
where do you see the greatest promise of those dollars 
producing a quick result?
    Dr. Collins. Mr. Chairman, I appreciate the question 
because that's something many of us are spending a lot of time 
working with partners to try to identify what the needs are and 
how we can meet them. I would put them in two categories. There 
is the shorter term need where we need to have better options 
for medication-assisted treatment, and we need to have the 
evidence to show what actually works and results in long-term 
outcomes that get people free of addiction and are not 
associated with relapse.
    We need better treatments for overdose. What we have now 
with Narcan, and I showed you the example of the nasal form of 
this, which we had a lot to do with working with the company, 
that works really well for people who have had overdoses of 
heroin. We are concerned that for fentanyl and carfentanil, 
that are even more potent, that the Narcan may wear off and 
then the respiratory arrest recurs. And so we need longer 
acting, more effective overdose treatments.
    So those are short-term needs and ones that we believe 
working with an associate group of companies--and we have 33 
companies we're now working with on a partnership for which 
we've had a total of already seven meetings and another major 
one next week to work out the real details of what would look 
like an action plan, and we're quite far along with that.
    The second area is somewhat longer term, but, if anything, 
more important, and that is to develop effective, but non-
addictive, potent pain medicines. We don't want to----
    Senator Blunt. Let me ask a question about the Narcan.
    Dr. Collins. Yes.

                    COST OF NASAL TREATMENT NALOXONE

    Senator Blunt. How does the nasal treatment that has been 
developed, how does that compare costwise to the previous 
intravenous treatment of that?
    Dr. Collins. It's substantially cheaper. So this particular 
version, a dose pack of two of these, is about $70, whereas the 
injectable form is about $4,500. And if you look at use by 
first responders, the nasal version has now greatly outstripped 
the injectable form in terms of what first responders now have 
access to in part because it's cheaper, but mostly because it's 
easier to administer, it doesn't require any special treatment, 
just a blast in the nose.
    Senator Blunt. And anybody can answer this that knows the 
answer, who provides that to the first responder? That's 
locally provided by the----
    Dr. Collins. Right.
    Senator Blunt. So that's provided locally.
    Dr. Collins. Indeed. And the local municipality has to find 
a way to pay for it.
    Senator Blunt. I want to come back later to the whole 
partnership and how that might be financially--but, I'm going 
to run out of time here.

                     SUBSTANCE USE DISORDER STIGMA

    Congressman Kennedy, stigma is something you and I both 
talked about for a long time, looking at behavioral health 
differently than other health. How do you see that relating to 
people's reluctance here to ask for help when they realize 
they've got a problem but still are bound by that stigma of 
going out and asking for help?
    Mr. Kennedy. Thank you, Mr. Chairman. Obviously, attitudes 
are a huge, huge barrier. But the barriers that insurance 
companies place before people when trying to access treatment 
reinforce stigma because it makes people feel like that they 
really shouldn't be getting this care because it's really not 
real medical care. And that's why this Milliman Report, which 
I've made available to all the members of the committee, just 
came out, showed a scathing report on insurance non-compliance 
with the Federal Mental Health Parity and Addiction Equity Act, 
which you all supported, was a bipartisan bill. Frankly, 
without its proper enforcement, which you, as a committee, can 
actually help through an additional appropriation of $17 
billion, 15 for the Department of Labor, 2 for the Solicitor 
Generals, in order to oversee enforcement of the Federal Mental 
Health Parity law, you can actually leverage a lot more 
resources to this crisis that should be coming out of these 
insurance companies, who, by the way, when they neglect to 
cover people with these illnesses, only forces those folks onto 
the Federal payroll, so to speak, through criminal justice 
systems, through Medicaid, Medicare, and the like.

                    MENTAL HEALTH PARITY ENFORCEMENT

    So, Mr. Chairman, I made a recommendation to the committee 
that you give Secretary Acosta--and by the way, I've personally 
met with Secretary Acosta--he wants to be aggressive with the 
insurance companies. Seventy percent of all health plans, ERISA 
plans, come under his jurisdiction in the building like three 
blocks away from here. So I hope--there are some things this 
committee can do and appropriating those dollars for greater 
oversight of the parity through Department of Labor would be 
one of those.
    Senator Blunt. Thank you.
    We want to hold this first round to 5 minutes, but there 
will be time for a second, and more than that if necessary.
    Senator Leahy.
    Senator Leahy. Thank you, Mr. Chairman.

                                MEDICAID

    You know, Congressman Kennedy, you stressed the role that 
Medicaid plays in combating this, and you and I have discussed 
this at other times, and we saw how the vote to slash Medicaid 
by a trillion dollars to pay for the high-end tax cuts this 
past weekend. I obviously did not vote for that. We are using 
this hub-and-spoke method in Vermont, which has worked very 
well. We wish we didn't have to have any method, but we're 
doing that, but we've been able to do it through Medicaid. How 
will the cuts to Medicaid impact health in the opioid crisis?
    Mr. Kennedy. So first let me say the solution, the default 
mode, in cutting Medicaid is to replace it with block grants. 
Block grants set up a separate and unequal system of care and 
basically mean that your luck of the draw is what State you 
come from in terms of whether you get access to treatment or 
not. If this is truly a national issue, not just a State issue, 
then we should approach it on a national basis, and the best 
way to do that is to continue to provide Medicaid.
    These are not illnesses that are one-off. When someone 
suffers from an addiction, they also have other comorbidities, 
as they are called. And in order to treat these illnesses, it 
has to be done on a continuous basis because these are chronic 
illnesses. You don't just solve the illness with one, you know, 
dose.
    You know, the way to solve this crisis is to get people in 
a course of treatment that actually reduces their utilization 
in the medical system. The irony here is that you could save 
total spending on healthcare by being more aggressive in how 
you manage those very scarce public dollars in Medicaid because 
these alternative payment models that are coming out of CMS, 
thanks to the ACA (Affordable Care Act), are going to really 
transform our ability to actually provide healthcare, not sick 
care.
    We've always talked that talk, but we're actually going 
backwards, Senator, as you know. And the hub-and-spoke model, 
by the way, is a fantastic model and the direction we do need 
to be going towards.
    Senator Leahy. Thank you.
    In fact, let me follow up a little bit with Dr. Collins. 
And we've been here before in discussing some of these things. 
We're trying to learn the best ways to treat individuals with 
opioid dependence, but the best way, of course, is if you could 
prevent the addiction in the first place. NIH has worked to 
study and develop addiction disorder treatment options that 
have used--excuse me if I mispronounce this--buprenorphine. Is 
that close?

                            PAIN MANAGEMENT

    Dr. Collins. Yes. Buprenorphine, you got it right.
    Senator Leahy. Thank you--and naloxone and so on. What 
steps are part of the Federal pain research strategy to find 
other ways to prevent chronic pain or because some people have 
injuries or whatever reason they have that chronic pain? How do 
we prevent it in the first place without using opioids?
    Dr. Collins. Let me quickly suggest two things that we 
could put a lot of effort into with good outcomes, but they're 
not easy. One is to really understand this transition from 
acute to chronic pain. Everybody who has lived on this planet 
knows there's going to be a time, unless you're born with 
congenital insensitivity to pain, where something is going to 
happen that's going to cause pain, and for many people, that 
will be an acute pain that needs some intervention, a kidney 
stone, a broken bone.
    Opioids actually work really well in that situation for a 
very short exposure. But a certain proportion of people, 
especially if they're given a prescription that goes on for 
many days, will transition into addiction, and for a certain 
portion of people, that acute pain becomes chronic pain. We 
need to understand what's happening in the neuroscience aspect 
of this to appreciate what that transition is like in order to 
keep it from happening. Because most people who are now 
addicted to opioids started out with prescriptions, and we need 
to figure out how we prevent that.
    But more than that, we need to have a better set of options 
to treat pain that are not based on opioids because we 
understand the risks now better than ever. And this is the 
other part of what we're trying to do working with industry, is 
to develop a pipeline for speeding up the process of the 
development of potent but non-addictive pain medicines that 
could be used safely for those 25 million people who already 
suffer from daily chronic pain without putting them at risk. 
I'm optimistic. We can shorten the time for that approval 
working with our colleagues at FDA by a factor of two over what 
would happen if we do nothing.
    Senator Blunt. Thank you, Senator.
    Senator Leahy. Thank you, Mr. Chairman.
    Senator Blunt. Senator Shaheen.
    Senator Shaheen. Thank you, Mr. Chairman.
    And thank you to all of our panelists for being here. I 
especially appreciate the work that The Kennedy Forum has done, 
Mr. Kennedy. And you showed this earlier. This is actually the 
kind of report that I do not like the State of New Hampshire 
being on the front of because what it points out is that we 
have actually the second highest rate of overdose deaths in the 
country. We have the highest rate of fentanyl deaths in the 
country. This year alone we had 12 people who have died from 
carfentanil. And the cost to the State of New Hampshire--we 
talk about the costs nationally--the costs just in New 
Hampshire in 2014, which is the year we have data for, was 
$2.36 billion. So this is a national epidemic.
    I certainly supported the Commission's work. I wish, as you 
pointed out, that the President had declared a national 
emergency here because, in fact, that's what he promised in New 
Hampshire when he was campaigning there. And I am very 
concerned about the impact of treatment, as you all have talked 
about, and how we make sure that the people who need treatment 
get treatment.

                          ACCESS TO TREATMENT

    In New Hampshire, what has made the biggest difference in 
treatment has been the expansion of Medicaid. That was the 
result of the Affordable Care Act.
    And Dr. McCance-Katz, I would point you to the report that 
came out from the Department of Health and Human Services 
earlier this year in January that talks about the strategies to 
deal with the opioid epidemic. The third one they point out is 
expansion of access to in the provision of medication-assisted 
treatment with methadone, buprenorphine, or naltrexone. And it 
points out that the success of these strategies really rests on 
a base of health insurance coverage, which means that our 
Nation's best shot--and I'm quoting here--at reversing the 
opioid epidemic and providing needed care for opioid use 
disorders, substance use disorders, and mental illness depends 
on the continued success of the Affordable Care Act.
    So I wonder if--I would ask you, Mr. Kennedy, if you would 
talk about what happens in greater detail if we lose the 
ability to provide care under the Affordable Care Act. One of 
the things, as you're aware, happened as the result of passing 
the tax bill, is that we eliminated the individual mandate, 
which reports show from the CBO (Congressional Budget Office) 
will throw about 13 million people off of their healthcare.
    So what should we look for that's going to happen with 
respect to the opioid epidemic if this repeal of an undermining 
of healthcare continues in terms of treatment for people?

                    MENTAL HEALTH PARITY ENFORCEMENT

    Mr. Kennedy. Well, thank you, Senator. I'm sorry that your 
State has such high rankings in so many areas, and also in the 
non-adherence to the parity law by your State's insurance 
companies.
    And I would commend you, Mr. Chairman, maybe to have those 
insurance companies come and talk to you all as to, how do they 
explain why they're denying this care at such record rates 
instead of the fact that it is a national crisis?
    So, you know, it's hard to paint a picture of how much 
worse it could get because it's pretty awful out there right 
now. I mean, the number of children in foster care has 
quadrupled in the last couple of years. You know, social 
workers are forced to sit with these children in hotel rooms 
because there aren't available foster families.
    I mean, this is a dire, dire situation that is unbecoming 
of this great Nation that we would allow our fellow Americans 
to live and die like this. And yet we find the political will, 
as you said, to pay for a tax cut, which is not for 
individuals, this is to corporations, transnational 
corporations, who are not American citizens, who are getting 
the benefit of all the money we need in order to address this 
crisis through a tax cut from 35 to 20 percent.
    Honestly, the politics of it I just can't explain, I just 
cannot explain. I can just say anybody who is out there and 
seeing this shudders every time they're out there. And then we 
all have to kind of put our suits back on and try to get back 
into life because it's too devastating to imagine that this 
could get any worse.
    Senator Shaheen. Well, as you point out, I have friends who 
have had to adopt their grandchildren because they had their 
daughter and her husband were affected. He had died from an 
overdose. And one of the things he said to me which really 
resonated is he said, ``I hope I can live to be 80 so I can get 
the youngest one through high school.'' We should not be having 
that happen in the United States of America.
    Mr. Kennedy. No. No.
    Senator Shaheen. Thank you.
    Mr. Kennedy. Thank you.
    Senator Blunt. Senator Merkley and then Senator Capito.
    Senator Merkley. Well, thank you very much, Mr. Chairman.
    I appreciate your all's testimony. I think about how the 
number of deaths are now way over the number of deaths from car 
accidents, which we always thought of as such a menace.
    Director Collins, one of the things that I found 
interesting was information handed out that said that States 
with medical cannabis have a 25 percent lower mean annual 
opioid overdose mortality rate as compared to States without 
it.

                           CANNABIS RESEARCH

    Now, NIH has not really been able to look, I think, into 
the medical effects of cannabis. But has there been a 
correlation that has raised researchers' interest? You 
mentioned the issue of seeking alternative pain strategies. And 
is this an area that bears investigation?
    Dr. Collins. Well, you cite a study that we also noticed 
and are wondering exactly what conclusion to draw from it, 
namely, that States that do have medical marijuana have a 
statistically lower incidence of opioid overdose deaths. So 
there's a correlation there for epidemiologists. The question 
always is, Is a correlation a causation? Is there a connection 
there? And we don't know, but it's a very intriguing finding.
    But to go beyond that, in our efforts to try to identify 
alternatives that would be effective for treating pain, 
certainly the receptor pathway in the brain, the cannabinoid 
receptor, is one of those that is getting intense scrutiny 
because we do understand that the neuroscience connections 
there to the pain mechanism are significant. So among the 
various strategies that we expect to explore in greater 
intensity in this public-private partnership for identifying 
alternatives to opioids would be cannabinoids of various types 
that might produce pain relief without producing the 
unfortunate other side effects that people are concerned about 
with smoking marijuana. But, yes, we are very interested in 
pursuing this space, and the National Institute of Drug Abuse 
has a lot of experience in that chemistry.
    Senator Merkley. Great. And you're not currently hindered 
in that by any particular legislation, you have a free pathway 
to follow the science where you would like to go?
    Dr. Collins. Well, I appreciate the question because one 
problem for us is the way in which Schedule I has been applied 
to marijuana, which means that doing research in that and in 
other Schedule I drugs can be extremely onerous for 
researchers. The approvals take as along as a year to happen. 
One of the asks, I guess if we had one, in terms of a policy 
change, would be to provide special exemptions to allow more 
research to be done on Schedule I drugs.
    Senator Merkley. Thank you. I think that's worth certainly 
the Congress looking at given that it's a dramatic difference, 
25 percent between the two States. As you note, it may not be 
causation, but it certainly bears investigation.
    Dr. Collins. Agreed.
    Senator Merkley. Dr. McCance-Katz, I hope I'm not abusing 
your name too much there. Am I close?
    Dr. McCance-Katz. That's quite good.

                        FISCAL YEAR 2018 BUDGET

    Senator Merkley. Okay, great. As we go into the next budget 
cycle, are we going to see the President's team recommend large 
amounts of funding to further this effort? It's been widely 
noted time and time again that a lot of the programs were cut 
in the President's budget the first time around, but the second 
time around, will we see a different outcome?
    Dr. McCance-Katz. That budget is not decided upon, so I 
can't comment on it. I don't actually know what it's going to 
look like. I think you'll see it, I believe, in February. What 
I can say is that we are putting a lot of effort into many 
different types of approaches to addressing the opioid 
epidemic, and we are trying to very wisely use all of the 
resources that Congress has made available to us and that the 
President has supported us in very diligently carrying out.

                              STAFFORD ACT

    Senator Merkley. Well, we're probably going to keep sending 
resources whether you ask for them or not, but I think it would 
be great to see the President's team help lead this. Why not 
the Stafford Act emergency? Is that worth looking into for a 
second look to see if that's worth declaring?
    Dr. McCance-Katz. My understanding of the Stafford Act is 
that it's usually reserved for geographic types of disasters, 
which this opioid epidemic is not. The folks in the 
administration took quite a long time to look at this and 
decided that the public health emergency was the best route to 
go, and that is the course that we've taken.
    Senator Merkley. Well, I just want to encourage continuing 
to take a look at that because I think a number of folks have 
noted it's a more powerful way to approach this. And right now 
the size of this challenge means we need the most powerful 
instruments.
    My time is running out, so I just want to close by noting I 
want to encourage a lot of work on the prescription end of 
this. My daughter went to the dentist, and for a wisdom tooth 
extraction, came home with a bottle of pills, and I gave her 
the dad lecture about how dangerous these things were. And she 
rolled her eyes and said, ``Oh, Dad, like now you're a 
doctor.'' And, ``No, no, daughter, no, I'm not a doctor, but 
these pills have an addictive property.'' And she said, ``Well, 
why wouldn't I have been told about that at the dentist?''

                          PRESCRIBER EDUCATION

    And that's a great question. Why should opioids ever be 
disbursed without intense, intense education? Isn't that 
something we can make happen as part of the medical protocols 
in this country?
    And also the number of pills that were given. There is a 
feedback look in terms of, ``Was the pain managed 
appropriately?'' that incentivizes prescribers to give far more 
than is needed, and isn't that something that we can tackle? So 
on the very front end of this addiction, we are educating 
people to prevent that, limiting the number of pills so people 
have to go back and get more pills. I don't know, I'll leave it 
up to the chairman if there is time to comment on that, but I 
wanted to get that point in.
    Thanks.
    Senator Blunt. Thank you, Senator.
    Senator Capito followed by Senator Manchin.
    Senator Capito. Thank you, Mr. Chairman. And I want to 
thank all of you.
    And Congressman Kennedy, it's good to see you again. Yes.
    I want to start with it's no accident that New Hampshire or 
West Virginia, we're here, as smaller States, really keyed in 
on what these issues are. The Senator from New Hampshire 
mentioned they were the second highest State for opioid 
overdose deaths. Unfortunately, Senator Manchin and I, our 
State is number one, in West Virginia. In the year 2015, we had 
638 deaths, and we expect that to rise over the next several 
years.

                       21ST CENTURY CURES FUNDING

    So, Dr. McCance-Katz, a few weeks ago, we introduced a 
bipartisan piece of legislation with Senator Shaheen, Senator 
Manchin, and Senator Hassan, from the smaller States, when 
we're talking about targeting resources. The State of West 
Virginia, under 21st Century Cures, the first $485 million that 
went out, the State of West Virginia, $6 million. And what did 
you tell me the State of----
    Senator Shaheen. Six.
    Senator Capito. Six.
    Senator Shaheen. Over 2 years.
    Senator Capito. Over 2 years for New Hampshire. So we have 
decided that this is not going to help us solve this problem. 
And what we're trying to look at is encouraging SAMHSA to look 
at mortality rates, lack of access to treatment and services, 
when doing the State Targeted Response to the Opioid Crisis 
Grants. In other words, let's weight these grants to where the 
greatest needs are. Everybody, yes, can get something, but not 
population size. I was actually looking at the top six States: 
West Virginia, New Hampshire, Ohio, Rhode Island, 
Massachusetts, Kentucky, Maine, and Connecticut. These are 
smaller population, relatively smaller population States that 
have the deepest problems at this moment.

                      SAMSA STATE FUNDING FORMULA

    So do you understand what we're trying to get here? And 
what would your reaction be to--and we've talked to Secretary--
or to Seema Verma about this, and it seems to be an 
understanding concept. Do you have a reaction to that?
    Dr. McCance-Katz. Well, what I would say, Senator, is that 
when we were considering the funding formula for the second 
year of the STR (State Targeted Response) money, in order to 
make any change at all, Federal regulations would require that 
every State submit a new application. That we thought would be 
possibly very disruptive. We were getting a lot of feedback 
from the States that there was reluctance to move forward with 
the plans that they had formulated because they weren't sure of 
what the funding would be. And so the decision was made to 
stick with the funding formula that was decided, that had been 
decided on, for the first year, and to look for additional 
resources for those States hardest hit, of course, West 
Virginia and New Hampshire being two of those States.
    What we have done at SAMHSA has been to review whether we 
could find some additional resources to bring to bear on the 
problem, particularly for the hardest hit States. And you may 
know that we released a funding announcement a few weeks ago 
that is targeted to the 10 States that have the highest rates 
of opioid overdose deaths and the highest change rate of opioid 
overdose deaths. So we found resources to do that.
    We also have been able to put together a new funding 
announcement for a new way of providing technical assistance to 
States. We were able to put $12 million into that. That will be 
technical assistance and training that is going to be 
individualized to States and their communities that need to 
provide resources to treat opioid use disorder in terms of 
prevention, treatment, and recovery.
    So we are trying as best we can to bring more resources to 
those States hardest hit.
    Senator Capito. Well, I think you can look for us to be 
very aggressive on working to be more encouraging to you either 
regulatorily or through the legislation to make sure that we--
because if we don't stop this epidemic in West Virginia and New 
Hampshire, then the numbers are going to go up proportionally 
in all of these States.
    This is--so we have an opportunity here. $6 million sounds 
like a lot in some circles, but when you try to do treatment 
and recovery and prevention and NAS (neonatal abstinence 
syndrome) babies and everything else, the comprehensive 
solution, it's just not even--it's barely hitting the bucket.

                       PRESCRIPTION DRUG TRACKING

    The last question, I'm sorry to go a little bit further 
here, in the little town of West Virginia, Kermit, 9 million 
prescriptions were sent in 2 years in a town of 392 people; 
overall, in the State of West Virginia, between 2007 and 2012, 
423 million opioid pain killers in the State of West Virginia. 
We have 1.8 million people.
    Dr. Houry, you talked a lot about tracking prescription 
drugs. How did this happen? Did you all, all of a sudden wake 
up to this and decide that this was something you need to track 
and improve? Where were these numbers 5, 10 years ago that we 
weren't recognizing this problem?
    Dr. Houry. So for prescriptions, we've actually been able 
to get this on IMS (Information Management Services) database, 
so it's not a CDC database. So we've been tracking this for the 
past few years, and we reported on this, this summer in one of 
our Vital Signs showing that there's a difference between 
counties by sixfold sometimes.
    And so one of the things we're doing, including in States 
like West Virginia, is we're looking for where there is high 
prescribing rates and making sure that local health departments 
go out to those communities to be able to provide education to 
providers who might be overprescribing.
    Another thing we're doing is with States like in Tennessee, 
now providers are learning, what is their prescribing rate in 
relation to others within their own specialty to see if they 
are overprescribing to really help educate and bring the 
prescribers into this.
    Senator Capito. I mean, I think, you know, these stats have 
gotten better, but the fact that they were where they are is 
just astounding I think to all of us.
    Thank you.
    Senator Blunt. Thank you, Senator.
    Senator Manchin, and then followed by Senator Murphy.

           DISPROPORTIONATE PRESCRIPTION OPIOID DISTRIBUTION

    Senator Manchin. Let me just say, first of all, thank you 
all for being here, but this is truly a bipartisan problem. So 
this is not a Democrat/Republican problem that we have here, 
and it's a killer. It's been a silent killer for far too long.
    I would ask all of you, if you all--the figures that 
Senator Capito gave out in my little State, and you're talking 
about 780 million hydrocodone and oxycodone painkillers between 
2007 and 2012. Now, mind you, we only have 1,800,000 people; 
that's all we have in our State. 780 million hydrocodone and 
oxycodone. That's 433 pain pills for every man, woman, and 
child, 433, and you're saying a flag was never raised, and now 
all of a sudden you're looking at them?
    Do you all believe that this has been basically from the 
pharmaceuticals to the distributors to the PBMs (pharmacy 
benefit managers)? Has this been a business model or a health 
healing model? What's your all's take on that? Is this a 
business model? Do you agree it's a business model?
    Dr. Houry. So what I would say is, you know, for the 
illegal aspects of it, I know that DEA and Justice have been 
looking at this, and there has been----
    Senator Manchin. We know. I'm going to get to that, too. 
We've got problems there. So you don't want to jump into that 
one.
    [Laughter.]
    Senator Manchin. Trust me, you better to stay away from 
that one. But do you believe this is a business model, that 
many pills?
    Dr. Houry. You know, when I went to medical school, I was--
--
    Senator Manchin. Just a yes or no would help me right now 
because I'm almost out----
    Dr. Houry. I would say doctors are really on the front 
lines. I still see----
    Senator Manchin. Doctors don't have any idea. My brother is 
a doctor, and only had 1 week out of 8 or 10 years of 
schooling, 1 week about how he prescribes.
    Dr. Houry. Exactly. So----
    Senator Manchin. So he believes everybody that comes 
through the door that tells him this will do this, a miracle 
drug.
    Dr. Houry. Well, and that's what we're really trying to 
focus on, is making sure that people are using the electronic 
medical records.
    Senator Manchin. So is it yes or no on as far as a business 
model?
    Dr. Houry. I think there is still work to be done.
    Senator Manchin. You'd rather not say.
    How about you, ma'am?
    Dr. McCance-Katz. I think the business model is to relieve 
pain, and there was an entire--an entire piece of our history 
where false information----
    Senator Manchin. No, there's not a person up here, Democrat 
or Republican, that doesn't want to help people that are in 
severe pain, end-of-life pain, chronic illnesses, cancer. We're 
all fighting for that. But when you--and just take my State, 
and you can multiply it by 50 States, 780 million pills. Now is 
that a business model or is that trying to cure the people of 
West Virginia of a health problem? It's a yes-or-no.
    Dr. McCance-Katz. I think that the legal actions can speak 
for themselves.
    Senator Manchin. You're not going to answer that. Okay.
    Congressman Kennedy.
    Mr. Kennedy. I'll give you an easy yes.
    Senator Manchin. Yes.
    Voice. Turn on your mic, Congressman.
    Senator Manchin. Turn your mic on, Congressman.
    Mr. Kennedy. I'll give you an easy yes. There's just no way 
to explain that.
    Senator Manchin. Okay.
    Mr. Kennedy. No way to----

                          OPIOID DISTRIBUTION

    Senator Manchin. No way at all, is there?
    Mr. Kennedy. No way to explain----
    Senator Manchin. We can try to massage it all you want, but 
you can't massage----
    Mr. Kennedy. No, no. I mean, the bottom line is--I mean, if 
you've read Dreamland----
    Senator Manchin. Yes.
    Mr. Kennedy [continuing]. As I'm sure you have, you know 
all the factors that conspired to develop this perfect storm, 
and frankly, there are guilty hands all around.
    Senator Manchin. Yes.
    Mr. Kennedy. I will say that there is a problem now with 
the AMA (American Medical Association) and the other physicians 
who refuse to write for medication-assisted treatment because 
now they're all spooked by anything having to do with, quote/
unquote, ``PhRMA.'' And then there are people dying out there 
because we're not providing evidence-based treatment, which is 
opiate replacement therapy.
    So, Senator, we have--there is a specter here we have to 
get out and talk about. And I'm glad you're raising it. This is 
a bad part of our American history. We better understand it, to 
know where we're going.
    Senator Manchin. Oh, this is a scourge that we have.
    Dr. Collins, how do you feel?
    Dr. Collins. I'm not knowledgeable enough to know if 
``business model'' is the right term, but it certain seems 
market forces were involved.
    Senator Manchin. Okay. The only thing I'm saying, the 
reason I kind of caution you about going DEA, we know we have a 
problem there, and it's been played out in the news media, as 
you know, and they're pretty accurate what's happened. We've 
got to correct that as quickly as we can.
    And so we've had--you know, we've got a couple bills, and 
Senator Capito and I are working on these bills, Jessie's Law 
and all, and I think, Congressman, you might have a little 
knowledge on this.

                              JESSIE'S LAW

    But Jessie's Law is this. We had a young lady, Jessie 
Grubb, and we both know the parents, and they're both from our 
home area. And the little girl overdosed at 30 years of age, 
but she had been having problems all along, and she was getting 
herself clean. Went in for a minor operation, and then 
basically she said, ``Please,'' she was so proud of being 
clean. Her parents were with her. But basically her condition 
was not marked efficiently on her records because of HIPAA 
(Health Insurance Portability and Accountability Act) and 
everything else. We're just trying to correct that, and we're 
having a hard time.
    Mr. Kennedy. God bless you for doing that. That's 
absolutely essential. This is medical care. No more separate 
and unequal treatment. No more separate and unequal medical 
records and secrecy. We're our own worst enemy in the addiction 
recovery community because we go to anonymous meetings because 
we're all anonymous, in the basements, we all want this secret. 
Those days should be over. This is a biological disorder, it is 
part of the medical system, the medical system has to treat 
this as the illness it is, and we, as those who are in 
recovery, need to be supporting it as----
    Senator Manchin. Well, we're down to the point now if you 
go to the hospital and now we took the parents and guardians 
out of it, just the patient themself, if they say, ``Listen, 
I'm recovering, I'm proud of it, and I need you to make sure 
everyone knows about my condition,'' so if you're--penicillin, 
if you're allergic, we mark it and stamp it.
    Mr. Kennedy. I do that myself. I said, ``I'm addicted--,'' 
``I'm allergic to opioids and penicillin,'' which is the truth, 
and I guarantee you even after my medical procedure, they still 
gave me a prescription for Percocet.
    Senator Manchin. Absolutely.
    Mr. Kennedy. So we're still in really tough----
    Senator Manchin. Okay.
    Mr. Kennedy. But 42 CFR (Code of Federal Regulations) does 
need to be fixed. I would encourage the Senate to work on it.
    Senator Blunt. Thank you, Senator. We'll have time for----
    Senator Manchin. I've got--please, I've got just----
    Senator Blunt. We'll have time for a second round.
    Senator Manchin. No, no, I'm just----
    Senator Blunt. Everybody else limited their time to 5 
minutes.
    Senator Manchin. Well, I'm----
    Senator Blunt. Senator Murphy.

                         PARITY LAW ENFORCEMENT

    Senator Murphy. Thank you very much, Mr. Chairman.
    Congressman Kennedy, this is a scathing indictment of 
insurance practices across this country. You've got data here 
that says that behavioral care and addiction care is four to 
six times more likely to be provided out of network than for 
other medical or surgical care. You've got 24 States where the 
reimbursement disparity between addiction and mental healthcare 
is 30 to 70 percent higher than for medical and surgical care. 
Is there any way to explain this other than companies being in 
gross violation of the parity law? Parity is not just about the 
statement of benefits, right? Parity is also about how you are 
administering the benefits.
    Mr. Kennedy. And I'm happy to say, Senator, it's really 
encouraging to know that Secretary Acosta, who is Department of 
Labor, oversees ERISA (Employee Retirement Income Security Act) 
plans, who could do so much to help change this current 
disregard by insurance plans of their obligations under the 
Federal parity law, he's looking for more resources to do it.
    I was just with him last week in his office, and he asked 
for those resources. He said, ``I cannot do these letters,'' 
which is basically his staff being able to flag these insurers 
for where they're disregarding the parity law, ``the way I can 
in others because I don't have the resources to do it.'' In 
addition to that, he asked for actually enforcement authority, 
if you can imagine the Secretary of Labor, to sue insurance 
companies. I'm not kidding you.
    This is coming out of the Republican administration. It was 
part of our strong recommendations in the President's report 
that he get those authorities because, frankly, if you don't 
enforce parity, the taxpayer ends up picking up the pieces in 
the criminal justice system, as I said, in the Medicaid system.
    Senator Murphy. These are not small violations, these are 
giant gaping violations of the parity law, and there is no way 
to explain these differences in reimbursement rates, these 
differences in network quality, other than the discriminatory 
treatment of these patients.
    So let me talk to you, Dr. McCance-Katz, about the powers 
that you have been granted. So in the 21st Century Cures Act, 
on a bipartisan basis, we gave the Department of Labor and the 
Department of Health and Human Services new authority on the 
issue of non-quantitative treatment limitations. These are ways 
in which insurance companies use reimbursement rates, use 
network registration, use prior authorizations, to shut down 
addiction and mental healthcare.
    So, Dr. McCance-Katz, you were given the ability to issue 
guidance to insurance companies to give them more clarity on 
when they are violating parity and not violating parity on this 
issue of non-quantitative treatment limitations, you were given 
the authority to issue a report listing all of the results of 
closed investigations and the results with respect to parity 
violations, and you were given new audit authority to go and 
audit insurance companies where there were five or more 
reported complaints of parity violations. Have you used any of 
those three authorities? Have you issued the guidance? Have you 
issued the report on investigations? Have you conducted any 
audits?
    Dr. McCance-Katz. What I can tell you that I know is that 
we have put in place a portal where people can make complaints 
where the Department of Labor does investigate, as does CMS, 
depending on what type of company was the potential violator. 
And we also--SAMHSA has done Parity Policy Academies times two 
with the States, and we are working on guidance to individuals 
about their rights as well as making a toolkit available to 
insurance regulators within States so that they can enforce 
parity rules.

                    MENTAL HEALTH PARITY ENFORCEMENT

    Senator Murphy. You and I have talked about this a number 
of times. I've talked to the Secretary of Labor. I've talked to 
our new nominee to HHS. Everyone tells me that they are serious 
about taking on this issue of mental health and addiction 
parity. Everybody tells me that they want to use the new 
authorities that Republicans and Democrats agreed were 
necessary in the 21st Century Cures Act.
    For the record, HHS and Labor have not issued that 
guidance, they have not issued a report on investigations, and 
they have not conducted any audits of insurance companies. 
Insurance companies are clearly in violation of the parity law. 
That's what this report says.
    I'm glad that you've opened up this portal because I'm sure 
you will get more than five complaints on an individual 
insurance company, but I would beg you and I would beg the 
Department of Labor, use the authority you have to make sure 
that people suffering from addiction and mental illness are 
treated the same as people who have cancer diagnosis and 
orthopedic diagnoses. You can do it, and you have the authority 
under existing law.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator.
    Senator Murphy. Thanks.
    Senator Blunt. Senator Durbin.

                          OPIOID DISTRIBUTION

    Senator Durbin. Thanks, Mr. Chairman.
    Thanks to the panel. And it's good to see my friends Dr. 
Collins and Congressman Kennedy with us again.
    I can't imagine how much money we spend in America to try 
to find the sources of heroin and cocaine. We literally scour 
the Earth to try to figure out how these drugs are produced and 
how they get into this country. It's unimaginable how much 
money is being spent by so many different agencies, from the 
Department of Defense, Department of Justice, and you name it. 
And then we spend an even greater sum of money trying to figure 
out how, once arrived in this country, these drugs get into the 
hands of drug dealers and ultimately to the drug users.
    Think of all the money we spend on law enforcement to try 
to get to that basic question and answer it, and yet here we 
are talking about something, an opioid crisis, a narcotic 
crisis, an addiction crisis, and we already know the answers to 
those questions.
    Where are these opioid pills coming from? From PhRMA, 
that's where. They produce 14 billion opioid pills a year in 
the United States of America, enough for every adult in America 
to have a 1 month prescription. So we know the source of this 
narcotic.
    How does it get in the hands of unsuspecting innocent 
people? Well, we sure know that, too. It turns out to be a 
distribution network from PhRMA that ends up on a prescription 
pad by a doctor or a dentist or a nurse practitioner, and 
that's how they get into the hands of people in unexplainable 
quantities.
    It just strikes me that we talk a lot, as we should, about 
what to do after the addiction instead of really going to the 
root source of this addiction. It is PhRMA and their business 
model to produce way more opioid pills than can conceivably be 
allowed in America. And what does Congress do about it? 
Nothing.
    What do we do about the distribution network? Well, 
frankly, we go backwards: instead of holding accountability, we 
find exceptions to accountability. I witnessed a ``60 Minutes'' 
special just a few months ago about what was going on here in 
Congress, some of us unsuspectingly were approving changes, 
which I'm afraid made it easier for the distribution.

                           OPIOID PRESCRIBING

    And I want to get to this issue of the doctors, Dr. Collins 
and others on the panel. I don't understand how a doctor could 
ignore this little publication from CDC. This publication was 
sent to virtually every doctor in America saying, what is the 
appropriate prescribing regime to follow when it comes to 
opioids.
    If you were a doctor practicing in Springfield, Illinois, 
and ignored this, and your patient got addicted and died, and 
you were brought into court and asked about the community 
standard of care that led you to your prescription that led him 
to his death, how do you get around this? How do you avoid this 
standard? That to me is troubling. And I would like those who 
wish, maybe Dr. Collins, to address this.
    But the last point I want to make to this, while Congress 
talks about this once in a while in a hearing, thank goodness 
others are doing something about it, at least in the area that 
I just described. A man by the name of Michael Moore, ring a 
bell? Former Mississippi attorney general. He decided to raise 
hell with the tobacco companies. Guess what happened. All of 
the State attorneys general came together and changed the way 
we sell tobacco in America.
    Now he's on to opioids, and he should be. He's going to 
create a legal force that we cannot match with a political 
force, and thank goodness he does, unless somebody decides to 
put in requirements for mandatory arbitration and eliminate 
class actions. He'll get this job done while we're still 
debating it here in Congress.
    Dr. Collins, are doctors paying attention to this?
    Dr. Collins. Well, clearly not sufficiently so when you 
hear about the stories, and we heard one a few minutes ago 
about too many pills after wisdom teeth being extracted.
    Back in the 1990s, there was this emphasis of pain as the 
fifth thing that you should pay attention to as far as a vital 
sign, and many physicians who were trained at that point got 
the idea that actually it was safe to give things like 
OxyContin, the longer duration pain meds, without the risk of 
addiction, which turned out to be absolutely wrong. And old 
habits, I'm afraid, seem to be slow to come around. I do 
believe most doctors really do want to help patients and don't 
want to hurt them, but the turnaround time in this educational 
process is way too long.
    We fund centers of excellence on pain education, there are 
12 of those across the country, aimed at doctors, at nurses, at 
nurse practitioners, at physicians assistants, but we really 
have to ramp that effort up to be sure that no physician or 
anybody who is writing these prescriptions could miss the point 
that giving a bottle of 30 pills to somebody who had a sprained 
ankle is the wrong thing to do.
    I'd like to hear, though, from CDC because Dr. Houry is 
actually an ER doc----
    Senator Murphy. Is it not true, incidentally, that if you 
were prescribed an opioid regime for 7 days, the likelihood 
that you will still be taking opioids in a year is 9 percent?
    Dr. Collins. That's what I've heard.

                          PRESCRIBER EDUCATION

    Dr. Houry. And I would just add that, you know, at CDC 
we're doing many things. One is starting, I think just like 
what Dr. Collins said, early on, so now with more than 60 
medical schools who are focused on physician training, also 
with nurses, more than 200 nurses, we also know that for docs 
like myself, who had that training, not focused on addiction 
when I was in medical school, we need continuing ed for the 
docs out in practice now. So we have several modules online, 
free continuing ed, case-based, really interactive. And then 
while I'm in the ER, I'm not going to read a 60-page guideline. 
So I've got a mobile app on my phone that really helps me 
navigate the guidelines. So we're hard at work on this.
    Senator Blunt. Thank you, Senator.
    Senator Alexander.

             NIH PUBLIC-PRIVATE PARTNERSHIP--PAIN RESEARCH

    Senator Alexander. Thanks, Mr. Chairman.
    Dr. Collins, let's talk about people who are hurting. I 
believe I've heard you say there are about 100 million 
Americans in some pain, and about 25 million in chronic pain. 
Is that right?
    Dr. Collins. That's right.
    Senator Alexander. So they're really hurting. They need 
some help.
    Dr. Collins. Daily pain, 25 million people.
    Senator Alexander. Yes. And we, in our opioid testimony 
with the Authorizing Committee recently, Dr. Paul, who had 
broken ribs, and Senator Isakson, who had back surgery, talked 
about how they took Advil and Tylenol because they steered away 
from opioids. But you testified before this subcommittee that 
of the biomedical miracles that you expected to see in the next 
decade, that a non-addictive pain medicine would be one of 
them.
    Now, it seems to me the most commonsense solution to this 
problem is that you have an alternative, if you're in real 
pain, to something that's addictive. So I want to ask you about 
how we're doing on that. You have a public-private partnership, 
I've heard----
    Dr. Collins. Yes.
    Senator Alexander [continuing]. Involving a lot of private 
companies. You've testified before our committees that you 
would like to have more flexible funding, other transaction 
authority. And you also know that working together, we passed 
the Cures Act, the most important bill in the last Congress, 
Senator McConnell said, not just to give you funding for such 
priorities as non-addictive pain medicine, but to speed 
whatever you discover through the FDA so they can actually get 
in the doctor's office.
    So could you use the remaining time to talk about non-
addictive pain medicine in that way?
    Dr. Collins. I really appreciate the opportunity to do so. 
This is an area of intense personal priority, and for many 
people around me, the same----
    Senator Alexander. And specifically, whether you need money 
for research when we're appropriating money for treatment at 
the same time.
    Dr. Collins. So the answer to that will also be yes. The 
goal right now, and you've articulated very well, is to come up 
with an effective potent pain medicine, particularly for people 
with chronic pain, that is not addictive. The scientific 
opportunities here have never been more exciting than right now 
because we're learning a lot about the neuroscience of pain.
    An example, these individuals who are born with complete 
insensitivity to pain turn out to be missing a particular 
sodium channel that is one of the ways in which the pain 
sensation gets transmitted. That's pretty interesting because 
they're otherwise fine. If we could come up with a drug that 
blocked that same channel, a totally different mechanism than 
what we do with opioids, it ought to be both very effective and 
non-addictive, and there are at least four or five companies 
that we are working with to try to accelerate the process of 
getting those over the finish line into FDA approval. And FDA 
is a strong partner in all of this, as you suggested, and the 
Cures bill has helped them and us in that regard.
    There are now 33 companies that we are working with in this 
space of developing a partnership. We will have an intense 2-
day meeting next week to really put the finishing touches on 
what is going to be a work plan and try to make this happen at 
twice the speed that it would if we didn't have this focus. And 
yes, resources are going to be necessary.

                        OPIOID RESEARCH FUNDING

    You asked me on October 5th, ``What is this going to 
mean?'' We currently spend $116 million a year on opioid 
research at NIH. That needs to be multiplied by at least a 
factor of four or five if we're going to be really all hands on 
deck for this effort.
    Now, I do think, Senator, that companies who are intensely 
interested in this may actually be willing to put up some of 
the funds for this in the way that we would like to see for a 
partnership that's a true partnership where everybody has skin 
in the game, but there's no question that the main force----
    Senator Alexander. Well, you've estimated how much you 
think we should put up. How much should they put up?
    Dr. Collins. You know, of the part of this that is clearly 
fitting in the mold of a partnership, it's probably something 
in the neighborhood of a couple hundred million dollars. If 
companies were able to come up with half that, that would be 
really helpful, but there's a lot of other things, like 
vaccines, that our companies are not yet involved in that we 
just will have to do ourselves.

                    TIMELINE FOR NEW PAIN TREATMENTS

    Senator Alexander. Is there a real--what's the timeline for 
this? And take into account what the FDA is able to do through 
its accelerated procedures. How soon could we have a non-
addictive pain medicine that actually had strength for these 25 
million people who are in chronic pain?
    Dr. Collins. Well, just last week, as a first hint of this, 
a new treatment for migraine, which is a source of pain for 21 
million people, a monoclonal antibody against something called 
CGRP, two research studies showing that this appears to be very 
effective and non-addictive. So there's a sort of leading edge.
    The other targets that are out there will come along in 
different ways, but I do think it's not unrealistic with a big 
push that we could have alternatives in the next few years, 
maybe 5 years, that would make for chronic pain sufferers, 
opioids no longer the thing you want to go to because there is 
something much better. And I should say there are even drugs 
that are already available that could potentially, in 
combination, turn out to be more effective for pain than we 
have realized, and we need to look at that as well.

                      OTHER TRANSACTION AUTHORITY

    Senator Alexander. In 10 seconds, what do you mean by you 
want more other transactional authority?
    Dr. Collins. In order to move quickly in a program of this 
urgency, other transaction authority allows us to do things in 
a few weeks that might take a year, and we are flexible in 
terms of which grantees we can bring into it, how we can decide 
who to support and who to basically pull the plug on if they're 
not performing. It allows us to function in the way that DARPA 
(Defense Advanced Research Projects Agency) does to move 
forward on a program with the maximum speed.
    Senator Alexander. Thanks, Mr. Chairman.
    Senator Blunt. Senator Moran.

               FDA'S ROLE IN PUBLIC-PRIVATE PARTNERSHIPS

    Senator Moran. Chairman, thank you. Thank you for having 
this hearing. Let me start by asking about the FDA, the Food 
and Drug Administration. They're not represented here. This 
subcommittee doesn't have jurisdiction over the FDA. The 
Agriculture Appropriations Subcommittee does, that Senator 
Blunt and I are on. Is there something that we ought to be 
exploring with the FDA based upon the folks in this room's 
suggestions?
    Dr. Collins.
    Dr. Collins. So I'm working closely with FDA. And I've got 
to say, Scott Gottlieb has been a wonderful partner in this 
space, really looking in very creative ways at how FDA can, in 
fact, speed up the process of review of such things as new non-
addictive pain medicines and recognize that when you're talking 
about something that's going to be a substitute for opioids, 
that having a side effect profile doesn't have to be completely 
missing any side effects in order to consider that as a useful 
alternative. That had been a bit of a problem in the past. And 
yes, they are very willing, and he has stated so publicly, to 
use such things as breakthrough pathway authority in order to 
speed up the process of review.
    Senator Moran. Dr. Collins talks about how the FDA can be 
helpful in finding a solution, an alternative, in the future. 
Is there something the FDA is not doing today in prevention and 
education?

                RISK EVALUATION AND MITIGATION STRATEGY

    Dr. Houry. So they've been very helpful to work with. I 
think when you look at the REMS (Risk Evaluation and Mitigation 
Strategy) education, they have incorporated a lot of the CDC 
guideline into it. And I think as they look at continuing to 
increase their education, we're very willing to partner with 
them on this.

                 CONSUMER/PRESCRIBER EDUCATION EFFORTS

    Senator Moran. Dr. Houry, while we're on that topic, you 
indicated, in response to Senator Durbin's card and education, 
the changing nature of the profession, the different standards. 
Tell me what I could do as a member of the United States 
Senate, who is interested in all Americans, but especially in 
Kansans, how could I partner with CDC or someone else to get 
more information to more patients and to more providers?
    Dr. Houry. So one of the things that we have just launched 
literally the end of September was our Rx Awareness 
communications campaign because we want patients and consumers 
to be part of the discussion with their physicians. This has 
testimonials about people that have experienced either 
addiction themselves or a loss. Being able to promote that more 
in your community will allow those consumers to know more about 
the dangers of opioids.

                          PHARMACIST EDUCATION

    Senator Moran. What role can I play in getting that 
information to my constituents, to my citizens? And tell me 
what needs to happen with the local pharmacist, what he or she 
is doing. What role do they play in prevention?
    Dr. Houry. So with regard to the campaign, all of our 
funded States--and Kansas is one of them--has access to a 
toolkit so they can really modify it and use it to really have 
that local flavor and to also pick the hardest hit communities. 
Additional resources for Kansas and all States that have an 
interest in using it, obviously, it's helpful so they can 
continue the reach of this message.

                 PRESCRIPTION DRUG MONITORING PROGRAMS

    With regard to pharmacists, they are very instrumental in 
this. And we've got great successes like in Ohio where Kroeger, 
their pharmacy is integrated with a prescription drug 
monitoring program, saw a 500 percent increase in pharmacists 
checking that prescription drug monitoring program.
    So in your State, I would say, you know, 21 hospitals are 
already integrated with their prescription drug monitoring 
program. We need to look at what pharmacies are also integrated 
into the PDMP so they have the information easily accessible.
    Senator Moran. I look forward to working with you to make 
sure that--and our State officials, to make certain that that's 
expanded and effective.
    Dr. Houry. Absolutely.
    Senator Moran. Thank you.

                             VA PRESCRIBING

    And Dr. McCance-Katz and others, I chair the subcommittee 
that's responsible for the Department of Veterans Affairs and 
its funding. I think we clearly have a problem with opioid 
prescriptions across the spectrum, but the VA (Department of 
Veterans Affairs) is not immune from this either. In fact, our 
subcommittee had a hearing several weeks ago on this topic, the 
opioid crisis impact on veterans. There was a recent Newsweek 
article that indicated, ``For over a decade, the VA recklessly 
overprescribed opiates and psychiatric medications.''
    My question is, Is there information from the VA? What role 
do you, at the Department of Health and Human Services, CDC, 
the NIH, what's the relationship between the VA and your 
efforts? Anything special or are they just there?

     INTERDEPARTMENTAL COLLABORATION ON ALTERNATIVE PAIN TREATMENT

    Dr. Collins. Very quickly, I can say we do have a 
collaboration just announced a couple months ago between NIH, 
VA, and the Department of Defense, $81 million, to look into 
alternative pain treatments that are not based on drugs at all, 
but other kinds of interventions, such as cognitive behavioral 
therapy, such as acupuncture, and that is an area that also 
needs to be pushed really hard right now.
    Dr. McCance-Katz. And SAMHSA has an interagency agreement 
with the VA and the Department of Defense. We assist them 
around issues related to substance use disorders, specifically 
opioid addiction and use of medication-assisted treatment. And 
we work with them very closely on suicide. There are very high 
rates of suicide in veterans. One of the concerns we have is 
that veterans often experience pain, addiction, and difficulty 
going forward with getting the medications that they have been 
prescribed and have developed problems with that can contribute 
to the development of very severe psychiatric disorders. Those 
are very complex people and have a lot of healthcare needs that 
we work with VA and DOD (Department of Defense).
    Senator Moran. Do you have any sense that you're making a 
difference, that that--you talked about the agreement and these 
efforts. Is the VA different today than it was a year ago?
    Dr. McCance-Katz. I think the VA has come out with some 
very good guidelines in terms of how to provide care to 
veterans. I think they have made improvements. Is there more 
improvement to be made? Absolutely, and we continue to work 
with them. We also have worked with them to develop their 
suicide hotline that's linked to our national suicide hotline 
program, and we think that that's helping veterans as well.
    Senator Blunt. Thank you, Senator.
    Mr. Kennedy. If I could just finish answering the question, 
Senator. As you know, most veterans never ever go to the VA. 
They are Guard and reservists who go back to their employee-
sponsored health plans. Now, that's not in your jurisdiction, 
but it might be something that in a future hearing you might 
take up because this recent report where it shows that health 
insurers are routinely limiting access to care for the 
signature wounds of war that you just heard of by our veterans, 
just because they work at any number of companies in America, 
their health plan doesn't allow them access to get treatment 
for the illnesses they suffered while serving our country.
    It should be the interest of this committee for our 
patriots that we enforce a Federal law that, by the way, was 
sponsored, widely supported by both Republicans and Democrats, 
that insist that payers cover these illnesses like they would 
any other set of illnesses. And when we failed to enforce that, 
veterans are disproportionately affected. Again, I say that. 
That's not in your purview in the fact that the VA is there, 
but these are a bunch of veterans who are just outside the VA 
in their employee-sponsored healthcare and not getting what 
they need.
    Senator Moran. Representative Kennedy, thank you, and it's 
nice to see you again.
    Mr. Kennedy. Thank you.
    Senator Blunt. And we'll assume that you started your 
second round of questions early.
    [Laughter.]
    Senator Blunt. Senator Shaheen.
    Senator Moran. I think I'll leave then, Mr. Chairman.
    [Laughter.]
    Senator Shaheen. Thank you, Mr. Chairman.
    Dr. Collins, I very much appreciate the work that you've 
been doing to try and work with private industry with 
pharmaceutical companies to encourage them to help as we look 
at how we develop new medications and address the opioid 
epidemic. Can you talk about what more you think Congress can 
do in this respect as you're looking at the role that private 
companies can play?

                      OTHER TRANSACTION AUTHORITY

    Dr. Collins. Well, already mentioned was the opportunity 
for us to have greater flexibility and moving quickly on these 
research needs. And so this other transaction authority, which 
Senator Alexander asked about, would be very helpful. We have 
that authority in some other things that we do. Our Common 
Fund, which is sort of our venture capital space, the All of Us 
program, which is enrolling a million Americans over the course 
of the next few years, and it turns out to be incredibly useful 
for moving swiftly and flexibly guided by very astute program 
managers, and that would be very useful to have in this space 
as well, but it requires approval from you all.

                          SCHEDULE I RESEARCH

    I did mention also the opportunity to get a special 
exception to Schedule I drugs for research purposes because 
that's getting in the way of being able to look, for instance, 
at some of these synthetic opioids, fentanyl, and others that 
are even more wild and crazy out there that we can't really 
study because they're characterized as Schedule I and it takes 
too long to be able to get the approvals. And so we may be 
missing out on learning more about this next generation of 
synthetics that we should really get more information about.
    And of course, particularly from this Congress, we 
appreciate the strong support you have given to NIH just in 
terms of our ability to do the research. I can promise you we 
are prioritizing this area of research to the maximum level 
possible with the funds that come forward from this 
appropriations process every year. But from what you've heard, 
clearly, if we're serious about putting the accelerator all the 
way down, we're going to need to do something pretty 
exceptional here, or we are going to be slower than we should 
be.
    Senator Shaheen. Well, I appreciate that, and certainly 
look forward to working on some of those changes that would 
give you that flexibility.

                             NALOXONE COSTS

    You talked about the development of a more effective drug 
that will do what naloxone, Narcan, is doing. One of the issues 
we've had in New Hampshire has been the dramatic increases in 
the cost of Narcan that makes it more expensive for communities 
to give out to law enforcement and firefighters. Have you see 
those increases and is there anything--I mean, my assumption is 
it's a market response, and it's not really an increase in cost 
to the pharmaceutical companies so that they need to raise the 
prices.
    Dr. Collins. Certainly there has been a dramatic increase 
in the cost of the injectable form of Narcan, but I'm happy to 
say the nasal installation, again something that we had a lot 
to do with working with the company to develop, has remained 
reasonably affordable. As I said earlier, you can get two of 
these that are ready for use for $70 bucks, and so that is much 
more within the realm of affordability from what people would 
like to see. And we're proud that we had a chance to make that 
contribution, both in terms of the fact that this is more, easy 
to administer and that there's a competition there that's 
managed, I think, to keep the prices more reasonable.
    Senator Shaheen. I certainly agree with that, and I applaud 
the work that NIH has done. I would point out that in 
communities where they're responding to literally dozens of 
overdose calls in a day, and many times they have to give 
patients two and three doses of Narcan, that $70 is still 
pretty expensive. And we need to encourage the pharmaceutical 
companies to take responsibility for the situation that they 
have helped create, and I certainly hope that they will do that 
and thinking about how they can come to the table to help us 
develop new ways of treating overdose--substance use disorders 
and overdoses.
    Dr. Collins. Yes.

                          STR FUNDING FORMULA

    Senator Shaheen. I want to go back, Dr. Elinore McCance-
Katz, to the comments that Senator Capito made. I applaud and 
echo those. I think we would like to see SAMHSA relook at the 
formula. I was very disappointed during the Obama 
administration when SAMHSA issued that formula. I continue to 
be disappointed that you have reiterated it for this year as 
well, for 2018.
    And I just want to make sure I understand. I know that we 
all appreciate SAMHSA is trying to get additional funds to help 
those States that are most at risk, but you talked about the 
effort to do that. Now, New Hampshire was one of 10 States 
eligible for an additional funding from SAMHSA, but it's $1 
million for those 10 States. It's over 3 years. That's, you 
know, just over $300,000, and it's only going to go to three 
States. So that is just a drop in the ocean, not even in the 
bucket, in terms of the challenges that we face.
    So I would urge you at SAMHSA--and you know, I think all of 
us in Congress are happy to work with you on this. This is a 
bipartisan issue. We want to try and address the issue in the 
best way we can. But I would urge you to go back and look at 
what can be done that will be more effective than a pittance of 
help for those States that most need it.
    Dr. McCance-Katz. We certainly are looking at that and 
doing everything we can to try to bring resources to those 
States that have the greatest--the greatest need, and we'll 
continue to do that.
    Senator Shaheen. Thank you.
    Senator Blunt. Thank you, Senator Shaheen. Thank you for 
all your work on this issue as well.

                          NARCAN AVAILABILITY

    Senator Shaheen, in her comments, Dr. Collins, and in your 
response to her, in the nasal-injected Narcan that you 
mentioned that NIH had a lot to do with, does that reflect both 
availability of competitors to that product? Or what can we do 
when there is a significant NIH involvement to share that 
research in ways that inject more competition earlier into the 
delivery process?
    Dr. Collins. So that's a complicated dynamic, and I 
appreciate your phrasing it the way you did. We are very much 
in the place of trying to make everything that we do as public 
as quickly as possible. Certainly working in that particular 
instance, the real innovation was the mechanics of the injector 
and making sure that we got the dose in the right place and 
then being able to show with appropriate data that this reached 
systemic levels that were going to be effective in reversing an 
overdose.
    That was a fair amount of work to do, but again, as a 
partnership with a company that knew something about 
formulation and injections of this sort was the way that it was 
possible. And it did end up creating a competition with the 
existing injectable form. We will continue to do everything we 
can to encourage those kinds of competitive things to come 
forward. We need a better antidote that has a longer potency 
than what we currently have----
    Senator Blunt. Is that nasal product coming from one 
company now?
    Dr. Collins. Yes, it is.

                              DATA SHARING

    Senator Blunt. And if you're dealing with 33 companies or 
some portion of 33 companies, how would you envision that 
research going in a way that more than one company becomes the 
beneficiary of that research that I think we're also and you're 
envisioning that those companies also put some money on the 
table in addition to their brain power and effort?
    Dr. Collins. So let's talk about the development of a new 
effective, non-addictive pain medicine. So we know that there 
are these projects going on in companies that are looking at 
things like that sodium channel that I mentioned. In fact, 
there are probably four or five companies doing that.
    What we need to do in the partnership is to identify the 
part of that that is essentially precompetitive and then agree 
to share the data. I'm not sure 10 years ago companies would 
have been interested in that. They are now because we've seen 
that work for diabetes and Alzheimer's disease and Parkinson's 
disease and rheumatoid arthritis in a different set of 
partnerships we've built with industry.
    So as part of this, there will be more data-sharing. There 
will be, therefore, an acceleration of everybody's efforts to 
get their drug actually to FDA for approval. You will want to 
see them compete with each other and you will also want to see 
out of the end of this the successful approval of more than one 
drug in a particular category so that the competitive aspects 
will drive the price down. That's our goal, to stimulate all 
that to happen.
    Senator Blunt. Well, I'd like you to work with us in the 
report language or whatever else, whatever mechanism we need to 
use so that it's clear that we're encouraging that kind of 
effort. That if there's a matching fund or another fund that we 
anticipate would be augmented by the companies themselves, that 
you have the clarity you need from the Congress, if we can give 
you any clarity, that this money is available in a partnership 
kind of environment. But we also want the result to be 
available, as much as possible, in a broader context than one 
company somehow being able to pick that up and--so we'll 
continue to work together on that.
    Dr. Collins. I'd like to do that.
    Senator Blunt. Also, Dr. McCance-Katz, how long have you 
been in this job?
    Dr. McCance-Katz. A little less than 4 months.
    Senator Blunt. A little less than 4 months. So any 
suggestion that you've had this authority a long time and 
haven't used it would be not accurate. But we hope you do use 
the authority you have and be expansive in your sense of what 
the Congress has said clearly they'd like to see here.

             CERTIFIED COMMUNITY BEHAVIORAL HEALTH CENTERS

    Mr. Kennedy mentioned earlier that his belief, which I 
share, that treating behavioral health like all other health 
will actually save money. And there are some large county 
studies that indicate that's the case, but you know, and we've 
talked about this before, we've got this eight-State pilot 
program going on right now. It's 6 months into the 2 years.
    And I think the way that you collect information on that 
with an eye toward either proving or disproving the Kennedy-
Blunt theory here that if you look at the behavioral health 
population, which is substantial, NIH says one out of four 
adult Americans has a behavioral health issue--that's 
diagnosable and almost always treatable. So one out of four is 
a pretty big group, and that one out of four has collectively 
lots of other health problems as well.
    And I think if we--if the record produces what I think it 
will, every State that's not a participant should look--be able 
to look at that and say we're going to save money if we do what 
everybody agrees is the right thing to do, treat behavioral 
health like all other health, but we're going to save money. 
We're going to do both the right thing and save money doing the 
right thing. And this gives you an opportunity that nobody has 
had before to look beyond one or two counties, which, in 
several cases, have proven that this is what will happen. But 
let's see what happens in the context of eight States.
    There's another bill that Senator Stabenow and I introduced 
to let you look at the other eleven States that went through 
the full process of applying to be one of the eight. Twenty-
four said they would like to try it. Nineteen went through the 
full process. And we've got a bill, if we can move it forward, 
that would encourage you to look at the other eleven States, 
and if they meet the criteria, let's move this further faster 
so that we've got a bigger group, kind of down to Dr. Collins' 
million person context of looking at healthcare generally, but 
getting that information available. And I'm specifically asking 
that you focus on getting it available in how it impacts other 
healthcare costs. Would you--will you do that?
    Dr. McCance-Katz. Oh, yes. And we have an evaluation that 
is already articulated for that program and being done right 
now. We hope to have some information that perhaps I can share 
with you by mid-2018. So absolutely. And we also have the model 
of FQHCs (federally Qualified Health Centers), which integrate 
different types of physical healthcare and increasingly 
behavioral healthcare as well----
    Senator Blunt. Right, right.
    Dr. McCance-Katz [continuing]. Which have been shown to be 
effective.
    Senator Blunt. And I think in all eight States, certainly 
in Missouri, the FQHCs are an important component of that 
delivery system. And I think we have 15 agencies with 200 
different locations that are 6 months into this context of 
behavioral health being treated like all other health.
    Dr. McCance-Katz. Yes.
    Senator Blunt. Senator Moran.
    Senator Moran. Chairman, thank you.

                       MEDICAL MARIJUANA RESEARCH

    Dr. Collins, at our VA hearing, the topic was raised by 
some of my colleagues about the efficacy of medical marijuana. 
There's a number of veterans organizations now that are 
supportive of introducing medical marijuana to the arena. 
What's the state of the research?
    Dr. Collins. The National Institute of Drug Abuse has a 
significant research portfolio in that space. One of the 
challenges, of course, is figuring out, what are you referring 
to in terms of medical marijuana? Are we talking about smoked 
marijuana? Are we talking about a purified cannabinoid, which 
is easier, therefore, to be able to evaluate because there 
otherwise can be such variation in the actual dose that 
somebody is receiving. I think most of this still remains 
pretty unclear in terms of what the actual benefits are and for 
which conditions, although there are certainly encouraging 
signs that this may well turn out to be rigorously and 
evidentially supported in many cases.
    We talked earlier about whether there was a circumstance 
where studying the pathway that marijuana acts on, the 
cannabinoid system, might also give us insights into pain 
research because there are clearly some indications that 
benefit could be achieved there if you could find, in this 
case, a different substitute for opioids, namely, a 
cannabinoid. And we're actively pursuing that as part of this 
public-private partnership with industry that I mentioned 
earlier.
    But I think at the moment it's mostly not clear exactly 
what the evidence would ultimately get us to, and we need to 
find that out as soon as possible. And again, we have a lot of 
investments in that space, and I can share more of those with 
you in detail if that would be helpful.
    Senator Moran. It sounds like you may have already answered 
that question in a previous part of this hearing, and I 
apologize for----
    Dr. Collins. I wouldn't say I answered it. I took a stab at 
it.
    Senator Moran. Thank you for taking a stab at it again. 
Thank you for answering it again.
    Mr. Chairman, thank you.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Blunt. Thank you, Senator Moran. And thanks to the 
panelists for being here. It's been very helpful for us today. 
There is follow-up with all of you as we try to work our way 
through this. The record will stay open for one week for any 
additional questions, or if the panelists have any additional 
comments that they would like to make for the record, it will 
be open for one week for that purpose.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
                Questions Submitted by Senator Roy Blunt
                             opioid funding
    Question. Since fiscal year 2015, the LHHS Subcommittee has 
increased opioid funding by over 1,300 percent. Much of that increase 
has been provided to SAMHSA for treatment and prevention programs. How 
are these resources helping states and communities address the crisis?
    Answer (SAMHSA). The Cures Act funding is helping states fill in 
the gaps in their state systems to address the opioid crisis. States 
are targeting high need areas to distribute naloxone, identify and 
engage people in treatment, and provide evidence-based treatment and 
recovery services. For example, in Missouri, the state is using funds 
to ensure that healthcare providers are capable of treating opioid use 
disorder, provide naloxone and pay for recovery support services that 
help to engage and retain people in treatment.
    States report that the resources have been an essential component 
of addressing unmet treatment need. We have received many reports of 
lives saved and people accessing treatment. Initial data indicate that 
in the early months of implementation, nearly 37,000 people have 
received treatment.
    Additionally, SAMHSA is also administering funding used to support 
states through its Medication-Assisted Treatment for Prescription Drug 
and Opioid Addiction (MAT PDOA) program, which aims to address the 
opioid crisis through the state's designation of high need areas on 
which to focus. States and communities are also supported through 
efforts such as the First Responder Training, Strategic Prevention 
Framework for Prescription Drugs, and the Grants to Prevent 
Prescription Drug and Opioid Overdose-Related Deaths.
    Question. Which SAMHSA programs do you think are most effective and 
are there any areas that may have funding gaps?
    Answer (SAMHSA). Critical elements of all substance abuse 
prevention and treatment programs include assessment, capacity 
building, planning, implementation, and evaluation to ensure the 
deliberate collection, analysis, interpretation, and application of 
lessons learned from substance use and related consequences data. These 
data-driven processes direct efforts in identifying problems and 
setting priorities to determine the selection of strategies that 
address issues affecting the health and well-being of the community and 
target audiences.
    SAMHSA continues to strengthen prevention activities in addressing 
the opioid crisis; many grants are assisting states and communities by 
training first responders and other key individuals on life-saving drug 
reversal medications; purchasing of life-saving drug reversal 
medications (naloxone); use of prescription drug monitoring program 
information for prevention activities; training of prescribers; and 
strengthening community-based activities.
    We know that the healthcare system does an inadequate job of 
identifying people who have a substance use disorder, so greater focus 
on screening high-risk patients is crucial. Over the course of a drug-
using career, most people will seek treatment at multiple points in 
time. However, they may be unable to access that treatment because of 
financial barriers, lack of availability in a specific geographic area, 
or a facility's hours of operation, among other barriers. When they do 
receive treatment, most patients do not remain in treatment long enough 
for it to be effective.
    The Substance Abuse Prevention and Treatment (SAPT) Block Grant, 
Comprehensive Addiction and Recovery Act (CARA), and 21st Century Cures 
Act funding can be used to address these issues. Funds can be utilized 
to ensure there are services in underserved areas, to incentivize 
providers to improve access to and retention in care, and to provide 
essential services like recovery coaching and recovery housing that are 
not typically funded by the healthcare system. SAMHSA is aggressively 
engaging the opioid crisis utilizing a variety of targeted opioid 
prevention and treatment programs. Specific activities include:
    Strategic Prevention Framework Partnerships for Success (SPF-PFS)--
provides grants to states to prevent underage drinking and prescription 
drug abuse. In 2015, over 300 communities increased the use of 
evidence-based opioid prevention programs demonstrating the importance 
of this grant.
    Strategic Prevention Framework for Prescription Drugs (SPF Rx)--
beginning in 2016 in a partnership with the Centers for Disease Control 
and Prevention (CDC) to address the non-medical use of prescription 
drugs as well as opioid overdoses. This grant raises awareness about 
the dangers of sharing medications and works with the pharmacy and 
medical communities on the risks of opioid overprescribing.
    Grants to Prevent Prescription Drug/Opioid Overdose-Related 
Deaths--helps states identify communities of high need and provides 
education, training, and resources necessary to tailor the use of 
naloxone to meet their specific needs. The grant funds can be used for 
purchasing overdose-reversing drugs, equipping first responders with 
them, providing training on their use, and developing other overdose-
related death prevention strategies, and providing materials to 
assemble and disseminate opioid overdose kits. This program is 
currently being evaluated.
    Medication Assisted Treatment for Prescription Drug and Opioid 
Addiction (MAT-PDOA)--expands/enhances access to medication-assisted 
treatment (MAT) services for persons with an opioid use disorder 
seeking or receiving treatment. MAT-PDOA has provided treatment for 
3,153 individuals in 2017, 76 percent of whom were abstinent from 
opioids at six-month follow up.
    Opioid STR (State Targeted Response)--addresses the opioid crisis 
by increasing access to treatment, reducing unmet treatment needs, and 
reducing opioid overdose-related deaths through the provision of 
prevention, treatment, and recovery activities for opioid use disorder. 
During the first 6 months of the Opioid STR program, nearly 37,000 new 
patients began substance use disorder treatment. It is too soon to 
assess outcomes, but states are changing their service delivery systems 
to ensure immediate access to care. Additionally, states distributed 
37,478 naloxone kits and trained 13,531 individuals to help combat the 
opioid crisis.
       opioid abuse prevention through surveillance and education
    Question. CDC recently reported that 60 percent of all opioid 
overdose deaths in Missouri contained fentanyl. How can the CDC improve 
data collection and help identify and perhaps predict areas that will 
see spikes in opioid overdose deaths?
    Answer (CDC). With increased funding in fiscal year 2017, CDC now 
funds the Enhanced State Opioid Overdose Surveillance (ESOOS) program 
in 32 states and Washington DC, including Missouri. In 2016, CDC only 
funded 12 states to implement the program.
    Program strategies include: (1) Improving the timeliness of 
reporting of nonfatal opioid overdoses using Emergency Department (ED) 
and Emergency Medical Services (EMS) data; (2) Improving the timeliness 
of reporting of fatal opioid overdoses and associated risk factors so 
that these data can be used to inform public health response tactics 
within and across states; and (3) Disseminating findings to 
stakeholders to support prevention efforts.
    ESOOS collects data on fatal opioid overdoses through the State 
Unintentional Drug Overdose Reporting System (SUDORS), which uniquely 
captures detailed information on toxicology, death scene 
investigations, and other risk factors that may be associated with a 
fatal overdose. For instance, SUDORS data have identified and tracked 
large increases in fentanyl analog deaths driven by carfentanyl within 
one state's borders. Early findings from these data reinforce the need 
and urgency for more timely and comprehensive toxicology testing.
    ESOOS also utilizes syndromic surveillance, which serves as an 
early alert for health events. Emergency departments send this 
information as electronic messages to public health agencies which 
provides a comprehensive picture of non-fatal opioid overdoses. The use 
of this data can act as an early warning system to detect sharp 
increases or decreases in overdoses. In addition, this data inform 
where more resources, such as naloxone or treatment capacity, are 
needed.
    With the increase in funds appropriated to CDC in fiscal year 2017, 
CDC was able to expand the ESOOS program and to provide supplemental 
funds to all ESOOS-funded states, with the expectation that a minimum 
of 60 percent of the supplemental funds was to support comprehensive 
toxicology testing for opioid-involved deaths through medical examiner 
and coroners offices. This directly addresses one of the needs 
identified through SUDORS, as mentioned above.
    Question. I understand that CDC has recently initiated a national 
awareness campaign to increase awareness and knowledge among Americans 
about the risks of prescription opioids. What additional steps can be 
taken to improve awareness and education with both patients and their 
doctors?
    Answer (CDC). In September 2017, CDC released the Rx Awareness 
communications campaign. For 14 weeks, CDC ran digital, radio, and out-
of-home campaign ads in select states (OH, KY, MA, and NM). In just 2 
months, the video campaign had 3.7 million views. With increased 
funding appropriated in 2017, a total of 22 states will now be able to 
amplify the reach of the Rx Awareness campaign.
    In addition, CDC released its Guideline for Prescribing Opioids for 
Chronic Pain in March 2016. Following its release, CDC focused efforts 
on a Guideline implementation strategy, which includes tactics related 
to communication and dissemination, clinical training, insurer/pharmacy 
benefit manager strategies, and health system strategies. CDC has been 
engaging medical schools, professional societies, insurers, health 
systems, and various other entities to incorporate the guideline in 
their work.
    In addition to our efforts with medical schools, CDC-funded state 
health departments also are involved with a wide breadth of work 
related to provider outreach and education. One particular strategy to 
align opioid prescribing practices with Guideline recommendations is to 
implement academic detailing, a practice where unbiased and evidence-
based information is presented to medical providers to affect behavior 
change. The in-person and one-on-one academic detailing session is 
based on principles of social marketing and the health behavior model.
    The distinction between academic detailing and provider education 
and outreach is best characterized by the emphasis on behavior change 
found within academic detailing. Across all of our funded states, each 
state has different programmatic goals and resources for planning and 
implementing provider outreach and education. Currently, about a third 
of the states funded through our Prevention for States program are 
engaging in work that use the principles of academic detailing as a 
model to drive behavior change among providers.
    One example of a state implementing academic detailing is New 
Mexico. NMDOH executed a contract with the University of New Mexico 
(UNM) to provide academic detailing to prescribers around the state. 
UNM developed multiple notifications to providers, licensing boards, 
and associations about the detailing project. DOH referred community 
health groups to UNM for information on the drug detailing project as a 
kick-off to the training effort. UNM finalized the training toolkit for 
the project.
    In addition, CDC has created an interactive training series and a 
webinar series for healthcare providers that offer the ability to earn 
continuing education credits. The interactive, web-based training 
features self-paced learning, case-based content, knowledge checks, and 
integrated resources to help healthcare providers gain a deeper 
understanding of the Guideline. The webinar series provides information 
about applying the CDC Guideline in a primary care practice setting 
from CDC and University of Washington experts. The CDC website offers 
archived webinars which include slides, real case examples, and 
question-and-answer sessions.
                 prescription drug monitoring programs
    Question. Dr. Houry, earlier this year, Missouri committed to 
establishing a Prescription Drug Monitoring Program. This is a positive 
step towards managing prescription drugs in my state. How have these 
monitoring programs curbed opioid abuse?
    Answer (CDC). Prescription Drug Monitoring Programs (PDMPs) are a 
key tool to address the opioid epidemic and prevent misuse, abuse, and 
overdose. PDMPs can be utilized as a public health resource, a clinical 
decisionmaking tool, and an early warning system. Public Health 
Practitioners use PDMP data to inform strategic prevention programming 
and resource allocation.
    PDMPs can tell us where prescribing is problematic, where we need 
to focus prescriber education efforts, and where overdoses may be more 
likely to occur so that we can ensure availability of naloxone and use 
health systems to connect people to treatment and care.
    PDMPs provide essential information to clinicians at the point of 
care as they are making critical treatment decisions for their 
patients. An inherent value of PDMPs is that the data can inform 
providers about their own prescribing behavior and help to put it 
within the context of their peers throughout the state. CDC is 
assisting states in leveraging PDMPs as clinical decision support 
tools, to improve prescribing at the point of care.
    PDMPs can also act as part of an early warning system to detect 
increases in prescribing in certain communities. Analyzing de-
identified PDMP data by geographic area, whether that be county, zip 
code, or other indicators can show trends in the medical and non-
medical use of prescription drugs.
    Question. What are the key components that you see in State PDMPs 
that make them particularly successful?
    Answer (CDC). State PDMPs are particularly successful when states 
ensure universal use, real-time reporting, active management, and ease 
of use and access.
    Universal Use.--States have implemented policies that require 
providers to check a state PDMP prior to prescribing certain controlled 
substances and in certain circumstances.
    Real-Time Reporting.--Timely data can maximize the utility of the 
prescription history data and increase provider and dispenser use of 
the PDMP.
    Actively Managed.--As a public health tool, PDMPs can be used by 
state health departments to aggregate data and target resources and 
interventions. PDMPs can also be used to send proactive reports to 
providers to protect patients at the highest risk and identify 
inappropriate prescribing trends.
    Easy to Use and Access.--States have taken steps to make PDMPs 
easier to access, including integrating them into electronic health 
record systems, permitting physicians to delegate PDMP access to other 
allied health professionals in their office (e.g., physicians 
assistants and nurse practitioners), and streamlining the process for 
providers to register with the PDMP.
    As an example, Kansas is enhancing public health access and 
application of PDMP data by establishing a data use agreement with the 
Kansas Board of Pharmacy to receive PDMP data on a quarterly basis, 
disseminating technical guidance on the use of PDMP data for public 
health surveillance, and enhancing its technological infrastructure to 
allow for more timely and better analysis of PDMP data. Finally, Kansas 
is developing a report with surveillance data to send to key partners 
such as the Kansas Board of Pharmacy and the Kansas Board of Healing 
Arts. In addition, as of October 27, 2017, Kansas' PDMP is integrated 
with 21 hospitals, 32 pharmacies and one clinic with six prescribers.
                           relapse prevention
    Question. One of the challenges I hear about is that people are 
completing a detox or rehabilitation stay and then are released without 
getting any relapse prevention medications. What does the data say 
about the benefits of providing relapse prevention medications before a 
person is discharged?
    Answer (SAMHSA). The data show that people who have received detox 
treatment have very high rates of relapse in the year following the 
treatment (80 percent and higher) if they have not received MAT and 
ongoing follow-up counseling.
    Question (SAMHSA). What can SAMHSA do to improve our understanding 
of these potential benefits?
    Answer. States and providers are required to provide evidence-based 
treatment with SAMHSA funds. SAMHSA is working to ensure that patients 
and families have access to information about what treatments are 
effective. As part of this effort, SAMHSA is developing a one-pager on 
how to find treatment. Once finalized, it will be used with other media 
to provide information to patients, families, and providers regarding 
the benefits of medication-assisted treatment.
                                 ______
                                 
            Questions Submitted by Senator Richard C. Shelby
                    reduction of perscription opioid
    Question. Dr. Collins, some have indicated that a reduction of 
prescription opioid use among clinically stable patients may have 
adverse effects on the pain, suffering and possible suicide rates. Do 
you think that there is sufficient information available to guide 
policy on this question, and is research ongoing to gain a deeper 
understanding of this issue? Additionally, what role do you believe 
translational science can play in helping address this issue?
    Answer (NIH). The CDC reported in 2017 \1\ that opioid prescribing 
rates dropped between 2010 and 2015. The CDC Guideline for Prescribing 
Opioids for Chronic Pain was released in March 2016. It set 
recommendations for limits on opioid prescribing for chronic non-cancer 
pain. Data on further reductions in prescribing rates since its release 
are not yet available.
---------------------------------------------------------------------------
    \1\ Https://www.cdc.gov/mmwr/volumes/66/wr/mm6626a4.htm.
---------------------------------------------------------------------------
    There are frequent anecdotal reports and some patient surveys that 
indicate reductions in opioid prescribing have had adverse effects on 
people with chronic pain. As highlighted at a recent NIH symposium,\2\ 
reduced access to opioids for people with sickle cell disease is a 
notable example of adverse effects on patients with severe pain. 
Published data on these effects are sparse, and more research clearly 
is needed.
---------------------------------------------------------------------------
    \2\ Https://www.nhlbi.nih.gov/news/2017/opioid-crisis-adds-pain-
sickle-cell-patients.
---------------------------------------------------------------------------
    It is known however, that suicidal ideation and attempts are 
increased significantly in people with chronic pain. An NIH supported 
review \3\ notes that risk of successful suicide is doubled in chronic 
pain patients relative to non-pain controls. Pain-specific risk factors 
included location of pain, high pain intensity, long pain duration, and 
presence of co-occurring insomnia. Analysis of data \4\ from the 
National Comorbidity Survey Replication (n=5,692) discovered that the 
presence of any pain condition was significantly associated with 
lifetime and 12-month suicidal ideation, plan, and attempt and that 
pain was an independent risk factor for suicidal ideation and attempt.
---------------------------------------------------------------------------
    \3\ Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3125689/.
    \4\ Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2614911/.
---------------------------------------------------------------------------
    We understand that CDC initiated a study on suicide rates among 
people with certain chronic pain conditions, and their data are 
expected to be released in early 2018. These data will shed more light 
on the issue and may provide a baseline for potential prescribing 
policy effects on pain related suicide rates.
                     non-addictive pain medications
    Question. Dr. Collins, I am curious of NIH's involvement in 
developing non-addictive pain medications and new treatments for 
addiction and overdose. Can you please elaborate on NIH's work to 
develop non-addictive alternatives to opioids? Are public/private 
partnerships playing a large role?
    Answer (NIH). There is an urgent need to expand the number of 
treatment options for individuals experiencing pain, misusing opioids, 
and those with opioid use disorders. To identify research priorities to 
help address this problem, NIH convened innovative experts from 
government, industry, and academia for a series of three cutting-edge 
science meetings this summer. These meetings are informing the launch 
of a new public-private collaborative research initiative on pain and 
opioid addiction.
    The initial plan for this initiative was recently described by Dr. 
Collins and Dr. Volkow in the New England Journal of Medicine and 
includes three major areas for advancement: (1) safe, more effective, 
and non-addictive strategies for chronic pain management to prevent 
misuse of and addiction to prescription opioids; (2) new and innovative 
opioid addiction treatments to reduce drug use and support recovery; 
and (3) overdose reversal interventions to reduce mortality and promote 
access to treatment.\5\
---------------------------------------------------------------------------
    \5\ Volkow, N. D. and F. S. Collins (2017). ``The Role of Science 
in Addressing the Opioid Crisis.'' New England Journal of Medicine.
---------------------------------------------------------------------------
    Plans are underway to develop a draft strategy that will include 
major goals of the initiative, action steps, key partners, 
deliverables, timeline, and resources (in-kind and financial costs) to 
fully carry out the proposed action steps. The Foundation for the 
National Institutes of Health will solicit input on the final draft 
from participants including Federal partners as well as other relevant 
stakeholders. Upon final approval of the plan, it will be posted on the 
NIH website at: https://www.nih.gov/opioid-crisis.
                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
                       opioid agonist treatments
    Question. NIDA recently issued a Request for Proposals to 
investigators to evaluate the effects of opioid agonist treatments 
(methadone and buprenorphine) on the developing fetus and newborn 
babies. Are there plans to study the effects of opioid antagonist 
treatment on developing fetuses, as well?
    Answer (NIH). Research on the most effective treatments for opioid 
use disorder (OUD) in pregnant women to minimize risk to the developing 
fetus is a high priority at NIH. The recent NIH RFA on Opioid Use 
Disorder during Pregnancy \6\ is focused on clinical research; agonist 
treatment is specifically mentioned because it is the current standard 
of care for OUD during pregnancy. Research on the effects of opioid 
antagonist (naltrexone) treatment during pregnancy is ongoing, but far 
less is known about its safety.
---------------------------------------------------------------------------
    \6\ Https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-18-
036.html.
---------------------------------------------------------------------------
    A recent retrospective clinical study of a naltrexone implant in 
pregnant women conducted in Australia didn't show significantly 
different risks compared to cohorts treated with methadone or 
buprenorphine; however, it was not a controlled study and should be 
interpreted cautiously.\7\ Preclinical studies in this area have shown 
negative outcomes (see below), and a lack of preclinical safety data is 
a large reason that a controlled clinical trial of naltrexone treatment 
for OUD in pregnant women has not been carried out.
---------------------------------------------------------------------------
    \7\ Kelty, E. and G. Hulse (2017). ``A Retrospective Cohort Study 
of Birth Outcomes in Neonates Exposed to Naltrexone in Utero: A 
Comparison with Methadone-, Buprenorphine- and Non-opioid-Exposed 
Neonates.'' Drugs 77(11): 1211-1219.
---------------------------------------------------------------------------
    Currently, the main concerns are that: (1) little is known about 
the fetal effects of opioid detoxification (which is required to start 
naltrexone treatment), including the potential of precipitating fetal 
opioid withdrawal; (2) the neurobehavioral effects of naltrexone on the 
fetus remain unknown; and (3) the limited preclinical data are 
available to identify potential risks of naltrexone treatment during 
pregnancy.
    In one study of sustained-release naltrexone in pregnant rats, the 
pups exposed to naltrexone had significant adverse developmental 
effects that also appeared into adulthood, including enhanced morphine 
self-administration, leading to the hypothesis that naltrexone may 
negatively impact brain circuitry and signaling.\8\ Another study 
demonstrated that naltrexone-exposed pups may have altered DNA 
synthesis regulatory control.\9\ In studies of larger doses of prenatal 
naltrexone than would be used in a medical setting, some studies have 
shown no difference in congenital malformation, pregnancy course or 
maternal health, while others have shown an early fetal loss, increased 
prenatal growth, and altered pain perception and adult behaviors.\10\ 
It will be important to carry out more preclinical studies to determine 
the feasibility of a clinical evaluation of naltrexone for OUD in 
pregnancy. In the meantime, information gained from clinical studies of 
medically-supervised withdrawal in pregnant women, as also described in 
the recent RFA, will be useful in assessing the potential of future 
clinical trials of naltrexone treatment.
---------------------------------------------------------------------------
    \8\ Farid, W. O., et al. (2012). ``Maternally administered 
sustained-release naltrexone in rats affects offspring neurochemistry 
and behaviour in adulthood.'' PLoS ONE 7(12): e52812.
    \9\ McLaughlin, P. J. (2002). ``Exposure to the opioid antagonist 
naltrexone throughout gestation alters postnatal heart development.'' 
Biol Neonate 82(3): 207-216.
    \10\ Ross, E. J., et al. (2015). ``Developmental consequences of 
fetal exposure to drugs: what we know and what we still must learn.'' 
Neuropsychopharmacology: Official Publication of the American College 
of Neuropsychopharmacology 40(1): 61-87.
---------------------------------------------------------------------------
    Question. The current opioid addiction treatment system is 
incredibly siloed with some centers, for example, only offering 
methadone to every single patient they admit. The idea of 
individualizing care based on the needs of the patient is something 
that has been embraced by the rest of medicine a long time ago. Do you 
have any thoughts about how we can move these treatment centers out of 
this antiquated, one-size-fits-all mentality?
    Answer (SAMHSA). Some states have addressed the need for 
individualized care through their licensing regulations, making it 
easier to have, or in some cases, requiring providers to have multiple 
levels of care, and by changing reimbursement so that it is easier for 
providers to offer a variety of services and medications.
    Bundled rates that include both medications and clinical services 
together and don't take into account the differential costs of 
medications, for example, could affect the treatment options offered by 
opioid treatment programs. SAMHSA has also taken steps to ensure that 
all FDA-approved medications for the treatment of opioid use disorder 
are known and utilized throughout communities. SAMHSA is in the process 
of releasing a new Treatment Improvement Protocol (TIP), which will 
provide clinicians the most-to-date information on all three FDA-
approved medications for opioid use disorder.
                                 ______
                                 
               Questions Submitted by Senator Marco Rubio
                             opioid vaccine
    Question. At the beginning of this year, this committee learned of 
a possible opioid vaccine being developed by the National Institutes of 
Health. Could you please update us on the progress of this possibility, 
and if/when it may become widely available?
    Answer (NIH). Vaccine formulations specific to opioids include two 
heroin vaccines, a heroin-HIV combination vaccine, an oxycodone 
vaccine, and a fentanyl vaccine that is currently being adapted to 
respond to other synthetic opioids. Initial preclinical findings 
published in 2016 demonstrated that the fentanyl vaccine conferred 
significant protection from lethal doses of fentanyl.\11\ Clinical 
testing remains to be carried out; however, and 7-10 years is the 
estimated timeframe before this vaccine may be made available.
---------------------------------------------------------------------------
    \11\ Bremer, P. T., et al. (2016). ``Combatting Synthetic Designer 
Opioids: A Conjugate Vaccine Ablates Lethal Doses of Fentanyl Class 
Drugs.'' Anew CChem into Ed Engle 55(11): 3772-3775.
---------------------------------------------------------------------------
    NIDA-supported work on the development of a heroin vaccine has 
progressed to testing in non-human primates, following up on promising 
findings in other animal models. Findings published in 2017 
demonstrated that the vaccine was effective in rhesus monkeys, 
generating a significant and sustained antibody response and causing 
marked attenuation of a measure of heroin reward. Human trials are 
required before the vaccine can be made available, and will likely 
require significant time and investment.
                             heroin vaccine
    Question. There has also been recent reporting on a vaccine 
specific to heroin. Do you foresee these studies as something we can 
expand upon to treat other types of opioids?
    Answer (NIH). NIDA-supported work on the development of a heroin 
vaccine has progressed to testing in non-human primates, following up 
on promising findings in other animal models. Findings published in 
2017 demonstrated that the vaccine was effective in rhesus monkeys, 
generating a significant and sustained antibody response and causing 
marked attenuation of a measure of heroin reward.\12\ Human trials are 
required before the vaccine can be made available, and will likely 
require significant time and investment.
---------------------------------------------------------------------------
    \12\ Bremer, P. T., et al. (2017). ``Development of a Clinically 
Viable Heroin Vaccine.'' Journal of the American Chemical Society 
139(25): 8601-8611.
---------------------------------------------------------------------------
                              chronic pain
    Question. The BRAIN initiative, through the NIH, holds tremendous 
hope to a number of neurological conditions, including how individual 
experience pain. Could you please update us on the NIH's research to 
better understand and treat chronic pain? How do you foresee the BRAIN 
initiative impacting our current understanding, and treatment, of pain?
    Answer (NIH). NIH funds a broad research portfolio on chronic pain, 
ranging from basic research into the molecular, genetic, and bio-
behavioral basis of chronic pain to large-scale clinical studies of 
potential treatments. Many institutes, centers and offices across the 
NIH fund pain research. In 2016, NIH invested $483 million dollars on 
pain research. As the lead institute for pain, the National Institute 
of Neurological Disorders and Stroke (NINDS) has a designated pain 
policy office to coordinate pain research efforts across NIH through 
the NIH Pain Consortium and across Federal agencies through the 
Interagency Pain Research Coordinating Committee (IPRCC).
    The NIH Pain Consortium is a trans-NIH group representing 25 NIH 
institutes, centers and offices that support pain research. The mission 
of the NIH Pain Consortium is to enhance pain research through 
collaborative research initiatives, pain-related workshops and 
symposia. Pain research funding opportunities initiated by the NIH Pain 
Consortium Institutes and Centers have led to multidisciplinary pain 
studies that seek to understand pain mechanisms, the experience of pain 
and associated treatment challenges.
    One area of NIH supported research is development of safer 
medications to relieve pain. Several investigations are underway to 
identify analgesic compounds that target receptors and ion channels 
known to be integral to pain pathways in the nervous system. For 
example, people with gene mutations that switch off function in nerve 
ion channels were found to be unable to sense pain, others with 
mutations in the same channel but that switch on function, were found 
to suffer from devastating chronic pain conditions. These ion channels 
are now targets for pharmaceutical development. Cannabinoids also have 
potential as analgesics in that they change information processing in 
pain circuits.
    Funding solicitations were released for research to support that 
potential. In addition, NIH-supported studies are investigating anti-
inflammatory compounds for their potential to inhibit the transition 
from acute to chronic pain and treat chronic pain conditions such as 
neuropathic pain and osteoarthritis. NIH supported much of the basic 
science research that led to the understanding of the role of 
calcitonin gene-related peptide (CGRP) in migraine and nerve growth 
factor. Currently, anti-CGRP antibodies and anti-nerve growth factor 
antibodies are in Phase 3 clinical trials to treat migraine and 
osteoarthritis pain, respectively.
    The IPRCC and NINDS Office of Pain Policy developed a long-term 
strategic plan to enhance Federal pain research. The Federal Pain 
Research Strategy (FPRS) includes important research priorities 
spanning from basic to clinical research across the continuum of acute 
to chronic pain, including disparities in pain care. These 
recommendations are being considered as research priorities by NIH and 
other Federal agencies.
    A major hurdle to therapy development and pain management is lack 
of an objective measure of pain. Current studies use a person's 
assessment of their pain on a 1-10 scale. An objective biomarker, or 
measure of pain, would be a significant milestone in the development of 
new therapies as well as in pain management. NIH funds promising 
avenues of research focused on developing such a biomarker.
    Complementary and integrative health approaches address the 
biopsychosocial nature of pain and its treatment. NIH supported 
research in this area includes clinical studies on cognitive behavioral 
therapy (CBT), exercise, yoga, acupuncture, massage, fitness, and 
mindfulness practices. For example, NIH supported clinical trials 
showed that mindfulness-based stress reduction with CBT and yoga 
improved function and reduced low back pain. The NIH Health Care 
Systems Research Collaboratory supports large-scale, pragmatic clinical 
trials focused on the management of patients with multiple chronic 
conditions, including pain. One study is evaluating multidisciplinary 
approaches to pain management in the primary care setting in patients 
who are currently on long-term opioids. This largescale trial aims to 
develop integrated pain care approaches to reduce pain and opioid use 
in a large healthcare system.
    The NIH BRAIN Initiative is a major effort to develop tools to (1) 
map neural circuits, (2) monitor their activity to characterize circuit 
disorders, and (3) modulate circuit activity for health benefit. This 
initiative is being leveraged through a funding solicitation notice 
that calls specifically for pain research under the BRAIN Initiative. 
Pain is a perception that is hard-wired in neural circuits in the 
brain, spinal cord, and peripheral nerves.
    Chronic pain alters the normal pain circuits and is therefore, a 
prototypical disorder of the neural pain circuitry. The advanced neuro-
technologies from the BRAIN Initiative will enable much more powerful 
approaches to diagnose, classify and treat pain through increased 
knowledge of the normal and altered circuits and discovery of means to 
modify circuit changes associated with chronic pain. In addition, the 
All of Us Research Program offers a unique opportunity to collect data 
on pain and pain treatment strategies on a population level.
    In recognition of the urgency to address the opioid epidemic and 
the related chronic pain crisis, the NIH is working to launch a public-
private initiative beginning with a series of workshops in June and 
July 2017. The first workshop focused on development of medications for 
opioid use disorder and overdose prevention and reversal. The second 
workshop focused on development of safe, effective, and non-addictive 
pain treatments. The third workshop focused on understanding the 
neurobiological mechanisms of pain with the goal of developing novel 
pain treatments. A set of action items to move the research agenda 
forward were released and are being developed as research strategies.
    Question. Your testimony highlights CDC's collaboration with states 
to address the opioid crisis, including helping to link patients with 
treatment and recovery services. South Florida has become a popular 
`destination' area of substance abuse treatments. Unfortunately, this 
has also created a market for bad actors that have opened treatment 
facilities that ultimately do not help patients but instead take 
advantage of these vulnerable patients and their families. This problem 
has been further fueled by Obamacare's requirements for all insurers to 
cover substance abuse treatment, creating a lucrative source of income 
for these less than reputable facilities. In fact, Florida officials 
have been pleading with families in other states to stop sending family 
members to Florida for treatment. These bad actors ultimately harm 
patients and non-Floridians have contributed to the majority of 
overdose cases. This influx of people from other people seeking 
treatment in Florida also reduces the local treatment options available 
to Floridians. Does the CDC keep track of facilities that patients 
should avoid? If so, what metrics are being used to identify which 
facilities would fall under this category?
    Answer (CDC). Neither CDC nor SAMHSA collects this type of 
information on substance abuse treatment centers. The work that CDC 
funds through its state programs is around specific components to 
incorporate public health strategies to reverse the opioid overdose 
epidemic. The first program, through which Florida is funded, is 
focused on improving morbidity and mortality data on opioid overdoses. 
The additional two programs focus on prevention and response activities 
that align with the following strategies: maximizing and enhancing the 
use of prescription drug monitoring programs, implementing insurer or 
health systems interventions, evaluating policies, and implementing 
rapid response activities. In regards to access to treatment, CDC does 
provide information on treatment resources for individuals with 
substance use disorder who are at risk for further overdose. For 
example, CDC's Prevention for States and Data-Driven Prevention 
Initiative grantees have developed projects to create linkages to care 
for individuals who have experienced an overdose. In addition to work 
being done within funded states, CDC is also leading an evaluation of 
medication-assisted treatment (MAT) to improve the evidence base with 
the intent of scaling up MAT to achieve population-level impact.
    Question. Does the CDC or HHS advise states to coordinate with 
health insurers licensed in their particular state about which 
treatment facilities should undergo heightened scrutiny? Or perhaps 
trends that that the CDC is finding that may help detect ill reputable 
treatment facilities?
    Answer (CDC). The extent to which CDC engages with health insurers 
is in regards to public health strategies that hold efficacies to 
prevent overdoses, such as increasing access to evidence-based 
treatment of opioid use disorder. Specifics around treatment fall 
outside of CDC's scope and expertise. However, CMS develops Conditions 
of Participation (CoPs) and Conditions for Coverage (CfCs) that 
healthcare organizations must meet in order to begin and continue 
participating in the Medicare and Medicaid programs. These health and 
safety standards are the foundation for improving quality and 
protecting the health and safety of beneficiaries.
    Question. Is this something that the CDC is capable of doing?
    Answer (CDC). Currently, this falls outside of CDC's scope and 
expertise.
    Question. Your testimony highlighted a new pilot program that will 
cover 20 states with the goal of increasing collaboration between 
public health and law enforcement officials. Could you provide further 
details about this pilot program and its potential impacts on local 
communities' joint public health-law enforcement response?
    Answer (CDC). CDC's collaboration with public safety is within the 
implementation of the Heroin Response Strategy. CDC is currently 
collaborating with the Drug Enforcement Agency (DEA) in 28 High-
Intensity Drug Trafficking Areas (HIDTAs) to target local response 
efforts to address and prevent drug overdose. The 28 HIDTAs include 
approximately 18 percent of all counties in the U.S. HIDTA-designated 
counties are located in 49 states, as well as Puerto Rico, the U.S. 
Virgin Islands, and Washington, D.C.
    With support from the Office of the National Drug Control Policy, 
the Heroin Response Strategy is an initiative designed to enhance 
public health (led by CDC) and public safety (led by DEA) 
collaboration, and to strengthen and improve efforts to reduce drug 
overdose deaths across HIDTAs.
    CDC is managing the Public Health and Public Safety Network. Public 
health analysts (PHAs) in each of the HRS states work collaboratively 
across sectors and agencies within each state to gather, analyze, and 
distribute drug-related public health data; develop and support data-
driven policy and programming initiatives; facilitate interagency 
collaboration; and advance efforts in surveillance, treatment and 
prevention initiatives within their state. They bring a public health 
perspective to law enforcement efforts, and enhance public health 
efforts with law enforcement intelligence and relevant data.
    One of the initiatives conducted through the HRS is the Good 
Samaritan Project that assesses law enforcement knowledge of and 
perspective about Good Samaritan laws (laws that offer legal protection 
to people who give reasonable assistance to those who are, or who they 
believe to be, injured, ill, in peril, or otherwise incapacitated) 
within their state, which is one of the strategies implemented as means 
to prevent drug overdose fatalities.
    Recently, CDC has invested resources to support the piloting of 13 
community-level initiatives to further HRS efforts. Communities will be 
funded at $150,000 to support implementation of innovative strategies 
within a targeted geographic area with the aim of building the evidence 
base for response activities that other communities can employ. 
Projects may address topics such as post-overdose strategies to link 
people to care using patient navigators and recovery coaches; justice-
involved populations and access to medication-assisted treatment; pre-
arrest diversion; buprenorphine induction in the emergency department; 
neo-natal abstinence syndrome; and adverse child experiences.
    Question. Which states are going to be part of this pilot program? 
If successful, could these programs be implementing in other states?
    Answer (CDC). Projects have been awarded in West Virginia, Ohio, 
Massachusetts, Delaware, Arizona, Connecticut, Philadelphia, Rhode 
Island, and Texas.
    In 2018, 10 demonstration sites will be launched across the 10 
HIDTA regions to pilot and evaluate interventions, which will build 
scientific evidence about what works at the community level. Pilot 
projects help support the implementation of evidence-based 
interventions and CDC will evaluate them with the goal of growing the 
evidence base about the most effective public health in communities 
across the U.S.
                      21st century cures act/cara
    Question. This Subcommittee recommended $816 million in 
discretionary funding in fiscal year 2018 to aggressively fight the 
opioid crisis. This is a 440 percent funding increase over the past 2 
years. This is in addition to the steps the Congress took through a 
number of reforms in 21st Century Cures Act and the Comprehensive 
Addiction and Recovery Act (CARA), which were enacted about a year ago. 
Have we begun to see the full effects of the funding increases, 21st 
Century Cures or CARA?
    Answer (SAMHSA). While we have not yet begun to see the full 
effects of the funding increases made available through the 21st 
Century Cures, or CARA, we have already seen some remarkable goals, 
efforts, and outcomes. A few state examples include:
    Rhode Island is in the process of purchasing 1,333 naloxone kits to 
be distributed by outreach workers and to individuals being released 
from prison over a 12 month period; and working with 12 identified 
communities to receive training and technical assistance to increase 
understanding of evidence-based or evidence-informed practices in 
opioid overdose prevention. This past year, Rhode Island has seen a 9 
percent decline in drug overdose death rates, which mirror data from 
Massachusetts, where the data shows a 10 percent decline in deaths from 
opioid overdoses.
    New York grants are helping deliver the Strengthening Families 
Program (SFP) to homeless families; delivering evidence-based programs 
to youth in foster care; and delivering a targeted media campaign to 
residents ages 18-30, with a focus on tribal territories and Latino 
communities. In addition, the state has 16 upstate counties (including 
tribal territories) of focus for OUD treatment services, which include 
seven (7) Centers of Treatment Innovation (COTI) sites where selected 
certified providers are expanding treatment services for MAT.
    Oklahoma is in the process of training the primary care workforce 
in indicated non-opioid alternatives to pain management and improving 
insurance coverage for alternative therapies; and partnering with 
medical licensure boards and associations to provide continuing medical 
education courses to Oklahoma prescribers, as well as with a network of 
17 community-based organizations it currently supports.
    Utah, universal prevention is addressed through two of the 
statewide campaigns, ``Use Only as Directed,'' and ``Stop the 
Epidemic.'' Moreover, Utah Naloxone was established in 2016 and is 
committed to increasing access to naloxone to prevent the opioid 
overdose deaths in the State of Utah. This group consists of 
prescribers, pharmacists, public health workers, recovery advocates, 
and people who have lost family members and friends to the opioid 
epidemic. They educate individuals on the use of naloxone, provide 
information to prescribers and pharmacists, advocate for distribution 
of naloxone kits throughout the community, and provide information for 
referrals to treatment and recovery.
    West Virginia has served over 500 patients prior to December 2, 
2017, mostly from Morgantown. The state is one of many states 
initiating a Hub-and-Spoke model to increase access to addiction 
treatment Subject Matter Experts (SMEs) and qualified physicians for 
case management and initial assessments. Clients can be assessed in a 
centralized Hub for initiation on MAT and then transferred to a more 
remote Spoke for on-going care and continued medication. In January, 
West Virginia's Hub-and-Spoke model will begin providing increased 
access to care in rural areas. West Virginia will also begin a ``Moms 
and Babies'' program in January focused on improving outcomes for 
newborns.
    Washington State has set up their hub-and-spoke model of service 
delivery and has provided treatment to 512 individuals between July 1 
and November 30, 2017.
    South Carolina has expanded treatment to an additional 3535 people, 
116 of whom are pregnant women who are receiving specialty care to 
improve outcomes for their newborns.
    Missouri has contracted with eight treatment providers and 800 
uninsured or underinsured individuals are now officially enrolled in 
evidence-based OUD treatment.
    Question. Are there ways in which Congress can improve the 
effectiveness of these program?
    Answer (SAMHSA). In 2016, CDC data indicate that opioids were 
involved in approximately 42,000 deaths. The opioid crisis must be 
addressed in a systematic and comprehensive way. As such, with 
Congress's important reforms in the 21st Century Cures Act and CARA, 
SAMHSA awarded approximately $500 million to combat the opioid crisis 
and works with states and communities to develop, implement, and 
evaluate activities. Prevention, treatment, and recovery are addressed 
in these grants. To date, 36,852 persons have received opioid use 
disorder (OUD) treatment services as a result of the funding provided 
by the 21st Century Cures Act.
    Highlights of how some of the states are effectively utilizing the 
21st Century Cures resources include:
  --Assisting states with the highest rates of treatment admissions for 
        opioid addiction in expanding and enhancing access to 
        medication-assisted treatment (MAT);
  --Expanding residential treatment and outpatient services to pregnant 
        and Post-Partum Women with substance use disorder (SUD), and 
        their families;
  --Expanding the number of treatment providers serving youth with SUD 
        and/or co-occurring substance use and mental disorders;
  --Expanding the number of criminal justice grants to organizations to 
        provide treatment to individuals involved in the criminal 
        justice system, including veterans and tribal communities;
  --Training first responders and other key individuals on life-saving 
        overdose reversal medications;
  --Purchasing of life-saving, overdose reversal medications 
        (naloxone);
  --Use of Prescription Drug Monitoring Program (PDMP) information for 
        prevention activities;
  --Training prescribers on opioid prescribing and recognizing and 
        treating substance use disorders;
  --Community-based education and awareness activities; and
  --Mobilizing resources within and outside of the recovery community 
        to increase the prevalence and quality of long-term recovery 
        support.
    Question. There appears to be unified consensus that data reporting 
of opioids prescribed is important in fighting this crisis. Currently, 
what percent of physicians are opioid prescriptions to a Federal or 
state database?
    Answer (SAMHSA). Although there is currently no national database 
to track opioid prescriptions, to date, 49 states, the District of 
Columbia and one U.S. territory (Guam) have operational Prescription 
Drug Monitoring Programs (PDMPs) to which pharmacists and other 
practitioners may report opioids prescribed or dispensed. PDMPs are 
state-managed databases and, therefore vary regarding how they collect, 
monitor, and analyze electronically transmitted prescription data, 
including opioids.
    Question. Do some states have a higher percentage of physicians 
that report this information than others?
    Answer (SAMHSA). SAMHSA does not collect state data regarding how 
many physicians utilize their state's PDMP.
    Question. What is being done to encourage the remaining physicians 
to report this information?
    Answer (SAMHSA). The increased use of PDMPs is essential in 
protecting public health by decreasing unnecessary and/or inappropriate 
opioid prescribing or doctor shopping. HHS has provided resources to 
states to enable electronic health records in hospital emergency 
departments, primary care facilities, and retail store pharmacy 
dispensing systems to link electronically to PDMPs as well as to more 
effectively and efficiently link PDMP data across state lines and 
increase the use of electronic health records with PDMPs.
    Question. Your testimony mentioned recent actions to allow 
physicians using medication-assisted treatment to increase the cap on 
the number of patients treated from 100 patients to up to 275 patients. 
As of this past October, about 4,000 physicians and physician-
assistants have received this waiver. Are you aware if all of these 
waivers is for the maximum number of 275 patients, or do the patient 
caps vary?
    Answer (SAMHSA). The 4,000 figure used in the October testimony 
related to the total number of physicians who have received waivers to 
authorize them to serve a maximum of 275 patients. Physicians 
Assistants (PAs) and Nurse Practitioners (NPs) may apply for waiver to 
treat 30 patients in the first year and then can apply to increase the 
cap to 100 patients in the second year.
    The 275 limit is not available to PAs and NPs. SAMHSA continues to 
receive applications for waivers at all levels, and as of December 23, 
2017, a total of 3,946 NPs and 1,023 PAs have received the 30-patient 
waiver. SAMHSA expects to begin processing waiver applications from NPs 
and PAs to increase to the 100 patient limit within the next few 
months. In addition to the 4,000 physicians who have received waivers 
at the 275 limit, as of December 23, 2017, 9,021 physicians have 
waivers to treat 100 patients, and another 27,066 have waivers at the 
30 patient limit.
    Question. Have these increased waivers had an impact on patients' 
quality of care or patient outcomes?
    Answer (SAMHSA). Increasing the patient limit for physicians to 275 
and adding PAs and NPs to the list of eligible waivered providers has 
expanded potential access to treatment significantly. Physicians who 
have received the 275 patient limit waiver are required to report 
annually to SAMHSA regarding the number of patients actually served and 
how many of those patients received appropriate behavioral health 
services in addition to their medication.
    The receipt of such services is an important aspect of medication-
assisted treatment and essential to ensuring quality treatment outcomes 
and sustainable recovery. These annual reports are currently being 
reviewed and analyzed by SAMHSA. SAMHSA will be able to share that 
information once the analysis is complete.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
             emergency funding to stop the opioid epidemic
    Question. My Republican colleagues have passed a massive tax bill, 
which will cost over $1 trillion to provide tax breaks to the very 
wealthy, yet we have provided nowhere near enough funding to deal with 
the opioid crisis. Congressman Kennedy outlined in his written 
testimony that Congress should provide $25 billion in emergency funding 
for the opioid epidemic, similar to how we fund disasters and other 
emergencies. How much money do you think is needed overall to address 
the opioid crisis, in particular for ensuring access to treatment? Do 
you agree that we need immediate, emergency funding?
    Answer. 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 Department is investing in a five-part strategy 
which includes: (1) Improving access to treatment and recovery 
services, including medication-assisted treatment (MAT); (2) Targeting 
availability and distribution of overdose-reversing drugs, (3) 
strengthening our understanding of the epidemic through better public 
health data and reporting, (4) supporting cutting edge research on pain 
and addiction, and (5) advancing better practices for pain management.
                     medication-assisted treatment
    Question. Funding for medication-assisted treatment is critical for 
improving access to treatment, but tackling this crisis also requires 
better approaches to getting effective treatment to those who need it. 
One innovation happening in Rhode Island is that hospitals and 
community organizations are intervening immediately when someone comes 
in to the ER having overdosed, to try to get those people into 
treatment. While we have seen success with this approach, we need to do 
more. How can we intervene and get someone into treatment before an 
overdose? And if they do overdose, how can we help put them on the path 
towards treatment and recovery?
    Answer (SAMHSA). Reducing the risk for fatal overdose rests on a 
combination of prevention, treatment, recovery support services, and 
risk-reduction initiatives, and it is critical that we strive to 
implement these initiatives as quickly and efficiently as possible to 
get people into treatment before an overdose.
    We must inform healthcare providers, first responders, family 
members and the general public to embrace prevention and early 
intervention. Prescribers should consider prescribing naloxone to high-
risk populations such as those prescribed high doses of opioids, those 
with a history of a non-fatal opioid overdose, those receiving opioids 
and benzodiazepines concomitantly, and those recently released from a 
controlled environment such as prison or inpatient treatment.
    The state of New York uses Harm Reduction and Recovery Safety Plans 
to reduce opioid and illicit drug overdose. For example, The Institute 
for Family Health, which has community health centers throughout New 
York City and in the Mid-Hudson region, has designed and begun to use 
personalized Harm Reduction and Early Recovery Safety Plans, which take 
into account the different ways in which a person might be at risk of 
an opioid overdose. These plans list overdose prevention tips, recovery 
resources and information about dispensing and the use of naloxone. The 
new safety plans are being used in all 26 health centers in New York, 
which are federally qualified health centers that are focused on 
serving underinsured patients.
    SAMHSA is also awarding the Opioid State Targeted Response 
Technical Assistance grant that will serve as the central coordinating 
point to identify local physicians, other clinicians, and other 
providers, for example, advance practice nurses, physician assistants, 
peers and other healthcare professionals with expertise in treatment 
and in recovery services for opioid use disorders (OUDs). Based on a 
state, territory, or tribal nation's assessed need, these providers 
will serve as the primary providers of federally supported TA for the 
program's successful implementation. The goal of this TA is to ensure 
the provision of evidence-based prevention, treatment, and recovery 
support programs/services across the Opioid STR program.
    (NIH). A multipronged research approach is tackling the issue of 
expanding access to effective treatment for opioid use disorder (OUD) 
to prevent overdose. This includes:
    Community-specific solutions: The National Institute on Drug Abuse 
(NIDA), in partnership with SAMHSA and CDC, is collaborating with the 
Appalachian Regional Council (ARC) to fund research specific to 
addressing the opioid crisis and reducing adverse outcomes of injection 
opioid use in rural communities. These studies should yield evidence of 
the effectiveness of community response models and best practices in 
responding to opioid injection epidemics that can be implemented by 
public health systems in similar rural communities in the U.S.\13\
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    \13\ Https://www.drugabuse.gov/news-events/news-releases/2017/08/
grants-awarded-to-address-opioid-crisis-in-rural-regions.
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    NIDA is also funding projects to test approaches for expanding 
access to medication-assisted treatment (MAT) for OUD in the context of 
states' plans for use of funds authorized under the 21st Century Cures 
Act that was disseminated under SAMHSA's State Targeted Response to the 
Opioid Crisis Grants.\14\
---------------------------------------------------------------------------
    \14\ Https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-18-
005.html.
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    NIDA funds the National Drug Early Warning System (NDEWS), which 
carried out the New Hampshire hot-spot study to characterize the 
outbreak of fentanyl overdoses in that state and develop a community-
specific understanding of drug use, response, and gaps in treatment 
access.\15\
---------------------------------------------------------------------------
    \15\ Https://ndews.umd.edu/resources/understanding-increase-opioid-
overdoses-ndews-new-hampshire-hotspot-study-results.
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    Improved medication formulations and access: Newly developed weekly 
and monthly buprenorphine formulations may help address some issues of 
treatment access and adherence.\16\ Research is ongoing to assess the 
expansion of access to MAT through interim medication provision, 
syringe exchange programs, and pharmacies. NIH is working on a public-
private partnership with over 30 pharmaceutical companies to accelerate 
the development of new medications for the treatment of OUD and 
prevention and reversal of opioid overdose.\17\
---------------------------------------------------------------------------
    \16\ Https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm587312.htm, https://www.braeburnpharmaceuticals.com/braeburn-
announces-fda-advisory-committee-recommends-approval-of-cam2038-
buprenorphine-depot-for-the-treatment-of-opioid-use-disorder/.
    \17\ Https://www.nih.gov/research-training/medical-research-
initiatives/opioid-crisis/public-
private-partnership.
---------------------------------------------------------------------------
    NIDA also supports research into the integration of mobile health 
and web-based patient support tools into treatment services to reduce 
risk behaviors and improve treatment access, retention and long-term 
outcomes.
    Linkage to treatment after overdose: As you mentioned, initial 
studies have supported the utility of buprenorphine initiation in the 
emergency department following opioid overdose.\18\ Four sites within 
NIDA's Clinical Trials Network are currently conducting effectiveness-
implementation research for addressing OUD in the emergency department. 
NIDA also supports research to coordinate such emergency department-
initiated treatment with primary care. Research is also underway to 
assess a novel law-enforcement delivered intervention to link people 
receiving naloxone for opioid overdose reversal with treatment for OUD.
---------------------------------------------------------------------------
    \18\ D'Onofrio, G., et al. (2015). ``Emergency department-initiated 
buprenorphine/naloxone treatment for opioid dependence: a randomized 
clinical trial.'' JAMA 313(16): 1636-1644.
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                                 ______
                                 
              Questions Submitted by Senator Jeff Merkley
                           marijuana research
    Question. A well-known study published in the journal JAMA Internal 
Medicine in 2014 found a 25 percent decrease in opioid overdose deaths 
in states with legal medical marijuana . A more recent study, published 
in Health Affairs in 2016, found that among those enrolled in Medicare 
part D plans ``the use of prescription drugs for which marijuana could 
serve as a clinical alternative fell significantly, once a medical 
marijuana law was implemented,'' based on data from 2010 to 2013 . 
These studies raise questions about the potential benefit of legalizing 
marijuana on reducing opioid use and abuse. Yet many have observed that 
the current regulatory environment hinders further research into the 
medical applicability of marijuana, namely its Schedule 1 designation. 
Is NIH currently engaged in any research into the medicinal 
applications of marijuana? Or the association between medical marijuana 
and reductions in opioid use? If not, what are the barriers to pursuing 
this research?
    Answer (NIH). While there is a growing body of research suggesting 
the potential therapeutic value of cannabinoids (which are the 
chemicals in the marijuana plant) for pain, epilepsy, and other health 
conditions, promising early findings do not always translate to 
effective treatments,\19\ and in general, adequate and well-controlled 
trials are lacking. Patients across the country are using marijuana 
strains and extracts that have not undergone rigorous clinical trials, 
are not regulated for consistency or quality.
---------------------------------------------------------------------------
    \19\ Gloss, D. and B. Vickrey (2014). Cannabinoids for epilepsy. 
Cochrane Database of Systematic Reviews. C. The Cochrane. Chichester, 
UK, John Wiley & Sons, Ltd.
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    NIH shares the Committee's concerns in this area and believes that 
more research is needed on both the harms associated with marijuana use 
and the therapeutic potential of marijuana and its constituent 
compounds. NIH welcomes investigator-initiated research proposals for 
pre-clinical and clinical research evaluating marijuana and its 
constituent cannabinoids for treating disease. In addition, to 
facilitate more research on the therapeutic potential of cannabinoids, 
NIH has released funding opportunity announcements (FOAs) on:
  --Fast-Track Development of Medications to Treat Cannabis Use 
        Disorders \20\
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    \20\ Https://grants.nih.gov/grants/guide/pa-files/PAR-15-267.html.
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  --Effects of Cannabis Use and Cannabinoids on the Developing Brain 
        \21\
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    \21\ Https://grants.nih.gov/grants/guide/pa-files/PA-14-162.html.
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  --Developing the Therapeutic Potential of the Endocannabinoid System 
        for Pain Treatment \22\
---------------------------------------------------------------------------
    \22\ Https://grants.nih.gov/grants/guide/pa-files/pa-15-188.html.
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  --Blueprint Neurotherapeutics Network Small Molecule Drug Discovery 
        and Development for Disorders of the Nervous System \23\
---------------------------------------------------------------------------
    \23\ Https://grants.nih.gov/grants/guide/pa-files/PAR-17-205.html.
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  --Clinical Evaluation of Adjuncts to Opioid Therapies for the 
        Treatment of Chronic Pain \24\
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    \24\ Https://grants.nih.gov/grants/guide/pa-files/PAR-14-225.html.
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    Despite efforts to stimulate research on marijuana, the progress of 
therapeutics development and clinical trials has been slow, in part due 
to the increased time, costs, and administrative efforts associated 
with the regulatory framework for conducting research on these and 
other Schedule I compounds. Specifically:
    Single Source of Marijuana for Research Purposes.--Currently, there 
is one registration for marijuana cultivation in the US--the University 
of Mississippi, which, through a contract with the National Institute 
on Drug Abuse (NIDA), supports the cultivation and distribution of 
research-grade marijuana for the country. While the NIDA supply of 
marijuana has diversified to include different strains of interest to 
researchers, it is not possible to provide access to the diversity of 
strains and products currently available through state dispensaries.
    Making marijuana for research available from other sources, 
potentially could both speed the pace of research and afford individual 
developers and researchers more options in formulating marijuana-
derived investigational products for eventual marketing.\25\
---------------------------------------------------------------------------
    \25\ Https://www.dea.gov/divisions/hq/2016/hq081116.shtml.
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    Widespread perceptions of the difficulty of doing research on 
Schedule I drugs: The perception throughout the scientific community of 
barriers to Schedule I research can dis-incentivize scientists from 
engaging in this type of research. Most biomedical research in the 
country is conducted by graduate students and postdoctoral fellows, who 
are under significant pressure to complete their research projects in a 
few years. Many avoid research areas where barriers may pose 
significant or unpredictable delays in the initiation of their 
research.
    Discrepancies between Federal and state laws: NIH is unable to fund 
researchers to analyze marijuana products available in state 
dispensaries, since obtaining these samples would violate Federal law. 
Understanding the characteristics of the marijuana that is being 
dispensed, including the potency (i.e., amount of Delta(9)-
tetrahydrocannabinol (THC), the psychoactive component of marijuana) 
and concentration of other chemical components (e.g., cannabidiol), is 
important for studying the impact of medical and recreational marijuana 
on individual and public health. In addition, there are open questions 
about the legality of state-funded research using marijuana from state 
dispensaries. Universities and researchers are concerned about the 
potential impact of this type of research on their ability to obtain 
Drug Enforcement Administration (DEA) licenses or Federal funding, even 
if they are not using Federal funds.
    Path From the Use of NIDA-Supplied Marijuana to Market.--The 
University of Mississippi, under the contract with NIDA, currently 
produces a limited supply of marijuana extracts for researchers to use 
in drug development. Drug developers would need to transition from 
using NIDA-supplied marijuana products to other sources before Food and 
Drug Administration (FDA) approval and market entry. It may be 
challenging for a pharmaceutical company to demonstrate equivalency 
between the marijuana used in the clinical trials and the drug product 
that will be marketed. While FDA has provided guidance on how this 
should occur,\26\ the process requires additional time and resources of 
the developer.
---------------------------------------------------------------------------
    \26\ Https://www.fda.gov/OHRMS/DOCKETS/98fr/2000d-1392-gdl0002.pdf.
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    NIH is committed to working with Congress and our Federal partners 
to facilitate more research on both the harms, and therapeutic 
potential, of marijuana and cannabinoids, and to reduce barriers to 
research. NIH will continue working closely with the Office of National 
Drug Control Policy (ONDCP), DEA, and FDA to explore ways to streamline 
these processes to facilitate research.
                     medication-assisted treatment
    Question. A report by the Pew Charitable Trusts concluded last year 
that medication-assisted treatment (MAT) is the most effective way to 
deal with opioid use disorder . In Oregon, opioid use disorder is most 
acute in our rural areas, but despite this high need, there is 
significantly low access to MAT providers in these regions. Many Oregon 
providers attribute this to the waiver requirement from the Drug 
Enforcement Agency. As part of HHS' 5-Point plan to improve access to 
treatment, how will you work with the DEA to improve access to 
Medication Assisted Treatment in rural communities?
    Answer (SAMHSA). The Comprehensive Addiction and Recovery Act 
directed that in addition to physicians, Nurse Practitioners (NP) and 
Physician Assistants (PA) be authorized to receive waivers under the 
Controlled Substances Act to prescribe FDA-approved drugs such as 
buprenorphine for the treatment of opioid use disorder. SAMHSA 
implemented the provisions of CARA for NPs and PAs within 6 months of 
passage of the law, and also increased the limit on the number of 
patients that physicians can treat with buprenorphine. Qualified 
physicians may, as of the summer of 2016, treat up to 275 patients. 
Approximately 4,000 physicians have been DATA 2000 Act waived to 
provide care to this maximum number of patients.
    Question. CDC has reported that cases of acute HCV infection 
increased more than 2.9-fold from 2010 through 2015, largely due to the 
opioid epidemic. This past summer, Dr. Richard Wolitski, the Director 
of HHS's Office of HIV/AIDS and Infectious Disease Policy, wrote that 
``the current situation threatens to become a perfect storm, with the 
opioid, HIV, and viral hepatitis epidemics intersecting in dangerous 
ways.'' That terrible storm came to a head in 2015, with the outbreak 
of HIV and HCV in Scott County, Indiana. Given the interconnectedness 
of these issues, are there opportunities that you see here to integrate 
CDC's responses to these crises? Are there ways for CDC's Prevention 
and Injury center to collaborate with and support the CDC Division of 
Viral Hepatitis, if it is not doing so already?
    Answer (CDC). The opioid crisis has led not only to large increases 
in overdose deaths, but also tens of thousands of cases of viral 
hepatitis and HIV. CDC formed the Opioid Response Coordinating Unit to 
coordinate activities across the agency related to the opioid crisis 
and to ensure the relevant work of all CDC Centers are aligned under 
one set of goals, strategies, and actions.
    CDC works collaboratively to ensure that infectious disease 
prevention remains a pillar of the overall response. As part of this 
initiative, the National Center for Injury Prevention and Control 
(NCIPC) and the National Center for HIV/AIDS, Viral Hepatitis, STD, and 
TB Prevention (NCHHSTP) collaborate on activities related to prevention 
of both opioid overdoses and infectious disease consequences of the 
opioid crisis, and have established two cross-center groups to focus on 
these issues.
    One group is focused on ensuring people with the substance use 
disorder are tested for viral hepatitis and HIV and linked to treatment 
for these infections as well as substance use treatment. We will work 
to compile evidence-based recommendations and best practices in this 
arena to support state and local health officials as they plan and 
implement community programs.
    The other group is specifically addressing community interventions 
for people who use drugs. A comprehensive, multi-sectoral approach is 
needed to prevent infectious diseases attributed to opioid use disorder 
which includes collaboration at the community level between public 
health, law enforcement, healthcare, education, and faith-based 
stakeholders, coordination across multiple levels of the US healthcare 
system, and implementation of tailored community-based prevention 
services. Healthcare and non-healthcare settings with high prevalence 
of substance use including primary care settings, emergency 
departments, HIV and sexually transmitted disease clinics can screen 
for substance use disorder.
    Substance use treatment programs can screen for viral hepatitis and 
HIV. CDC's work with non-traditional partners like law enforcement and 
non-public health-oriented government agencies prevents overdoses and 
outbreaks of infectious disease. For example, CDC is collaborating with 
the Drug Enforcement Administration on the High-Intensity Drug 
Trafficking Areas (HIDTA) program, with the National Association of 
County and City Health Officials (NACCHO) on building capacity for 
rurally-located syringe services programs, and with HHS Region 5 on 
partnering with states to address local need for tailored prevention 
programs.
                                 ______
                                 
               Questions Submitted by Senator Joe Manchin
             emergency funding to stop the opioid epidemic
    Question. A recent report from the Council of Economic Advisers 
finds that the cost of the opioid epidemic in this country in 2015 was 
$504 billion dollars. That's 6 times more than the previous estimate 
because this was the first report to truly take into account the cost 
of the lives lost.
    According to this report, the 33,000 lives lost in 2015 cost our 
economy $431.7 billion dollars and that non-fatal costs--including 
healthcare costs, criminal justice costs, and lost productivity due to 
addiction and incarceration--were $72.3 billion in 2015.
    That is why I have strongly urged my colleagues to provide 
emergency funding to stop this epidemic.
    The President declared a public health emergency and we know that 
this is costing our economy hundreds of billions of dollars so it is 
foolish if we don't invest money now in prevention, treatment--and 
every effort to stop this epidemic. It will cost us a lot more in the 
future if we don't.
    I strongly believe that we need emergency funding. I hope that my 
colleagues on both sides of the aisle--on this important committee--
will join with me in supporting and pushing for emergency funding.
    And I ask each of our panelists today to give us a sense of the 
resources that you will need to truly bring an end to this crisis. What 
would you be able to accomplish if you had more funding from Congress 
that you cannot fully do now? What resources--financial or otherwise--
do you wish you had, but don't?
    Answer. 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 Department is supporting a five-part strategy which 
includes: (1) Improving access to treatment and recovery services, 
including medication-assisted treatment (MAT); (2) Targeting 
availability and distribution of overdose-reversing drugs, (3) 
strengthening our understanding of the epidemic through better public 
health data and reporting, (4) supporting cutting edge research on pain 
and addiction, and (5) advancing better practices for pain management.

                          SUBCOMMITTEE RECESS

    Senator Blunt. And the hearing is adjourned.
    [Whereupon, at 12:01 p.m., Tuesday, December 5, the 
subcommittee was recessed, to reconvene subject to the call of 
the chair.]