[Senate Hearing 117-]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
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WEDNESDAY, MAY 19, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m. in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Durbin, Reed, Shaheen, Merkley,
Schatz, Baldwin, Murphy, Manchin, Blunt, Shelby, Graham, Moran,
Capito, Kennedy, Hyde-Smith, Braun, and Rubio.
REVIEW OF THE FISCAL YEAR 2022 BUDGET BLUEPRINT FOR THE CENTERS FOR
DISEASE CONTROL AND PREVENTION
opening statement of senator patty murray
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 Budget request for the Centers for Disease
Control and Prevention. It is our first subcommittee hearing
this Congress, and our first hearing on the CDC's annual
funding request since 2014.
Senator Blunt and I look forward to continuing to work with
you and our colleagues on both sides of the aisle, to build on
the progress we have made previously, and help families in
Washington State, Missouri, and across the country.
And I intend to follow the example you set when it came to
chairing hearings, Senator Blunt, and making sure that every
member has an opportunity to ask a question.
Senator Blunt and I will each have an opening statement.
And then I will introduce our witnesses, Director Walensky, and
Principal Deputy Director Schuchat. And after the witness'
testimony, Senators will each have 5 minutes for a round of
questions.
Before we begin, I do want to walk through the COVID-19
safety protocols in place. We are all very grateful to our
clerks, and everyone who has worked hard to get this set up and
help everyone stay safe and healthy.
Given the new guidance from the Centers for Disease Control
and Prevention and the Office of the Attending Physician, I
will be working with Senator Blunt, committee members and
staff, going forward, to follow the new guidance.
For today, we will be conducting this hearing following
similar COVID protocols to what we have used in the past.
Committee members are seated at least 6 feet apart. Some
Senators are participating by video conference, and while we
are unable to have the hearing fully open to the public, or
media for in-person attendance, live video is available on our
committee website.
And if you are in need of accommodations, including closed
captioning, you can reach out to the committee or the office of
Congressional Accessibility Services.
I always say a budget is a reflection of your values and
your priorities. And I think Americans can breathe a sigh of
relief knowing this budget shows they have a President who
values science and public health. COVID-19 has offered a stark
reminder of why we must make and maintain robust investments in
public health.
Experts at CDC (Centers for Disease Control and Prevention)
have been on the frontlines of this crisis from day one, and
every day since. We have seen first-hand how critical it is CDC
be equipped to effectively collect and analyze data in real
time, communicate science-based public health guidance, help
communities across the country get tests, and vaccines, and
clear, reliable information to people, and address inequities
that undermine the health of people of color, people with
disabilities, rural communities, and others.
That is why I have pushed for more funding for public
health throughout this crisis. The tens of billions of dollars
we have provided through six COVID bills so far, are supporting
invaluable public health work at every level so we can finally
end this pandemic.
It has helped update and modernize data systems needed to
track infections, variants, tests, vaccines, and inequities
among demographic groups. It has helped fight misinformation
and promote simple protective measures that have saved
countless lives, like wearing masks and social distancing.
It has helped expand our testing efforts, get vaccines into
arms, and build partnerships with trusted voices in hard-to-
reach communities. And I was pleased to hear the Biden
administration announced last week, it was investing over $7
billion from the American Rescue Plan, through CDC, to create
tens of thousands of jobs in public health at the State and
local level to fight COVID-19, and to help transition some of
those workers to permanent careers as public health
professionals.
With new cases and deaths both down over 80 percent from
their winter peaks, nearly three in five Americans vaccinated
with their first dose, and over a third of Americans fully
vaccinated, we can see the light at the end of the tunnel. But
even as we get closer to ending this crisis, we know we are not
there yet, and we cannot afford to come up short. That is why
after years of underinvestment in CDC and attempted cuts to CDC
by President Trump, this budget request is such a breath of
fresh air.
President Biden's request of $8.7 billion would increase
CDC's budget authority by nearly a quarter. I have been pushing
for more public health funding for years now. And I am excited
to say this would be the largest budget authority increase for
CDC in nearly two decades. These investments will help us
finish strong when it comes to this pandemic, prepare for the
next one, and make progress on other public health challenges.
Investments in CDC, as well as requested increases for the
Substance Abuse and Mental Health Services Administration will
help address the record number of drug overdose deaths, and the
spike in mental health issues, we have seen as a result of this
pandemic. COVID-19 has also put a painful spotlight on how
racism, sexism, ableism and bigotry hurt so many people in this
country.
CDC's recent announcement of a 2-year plan to invest more
than $2 billion to work on COVID-19-related health disparities
was an important step towards addressing this reality, and the
administration's request to dramatically increase the social
determinants of health program, Congress established at CDC
last year from 3 million to 153 million will help make sure our
response to health inequities is truly comprehensive, because
there are so many challenges we need to tackle head-on.
For example, Black, American Indian, and Alaska Native
women are two to three times more likely to die from pregnancy-
related causes than White women. And our overall maternal
mortality rate is the worst in a developed country, so I am
glad the administration budget request includes $200 million to
reduce maternal mortality nationwide, and address disparities,
an increase of 140 million.
It also invests in other public health threats that have
gone too long with too little attention. It doubles funding for
gun violence prevention research, and establishes a new 100
million community-based violence intervention program between
CDC and the Department of Justice. And it increases funding for
CDC's climate and health program by $100 million dollars.
Of course, the challenges we face are bigger than any one
budget. Before this pandemic hit, only half of Americans were
served by a comprehensive public health system. Our public
health workforce has lost 56,000 people, and State health
officials estimated a quarter of their workforce was eligible
to retire.
So we have a lot of work ahead, not just to end this
pandemic, but to build and maintain a public health system
capable of addressing other pressing public health challenges
and, of course, preparing for future ones.
That is why earlier this year I reintroduced the Public
Health Infrastructure Saves Lives Act, which would finally end
the dangerous cycle of crisis and complacency in public health
funding by providing dedicated annual investments in public
health.
Director Walensky, Principal Deputy Director Schuchat, I
look forward to hearing from both of you about how investments
like this, and like those put forward in the administration's
budget request, can help families and States across the
country. And I look forward to working with my colleagues to
make the investments we need a reality.
Finally, Dr. Schuchat, I understand you are leaving CDC
this summer after 30 years with the agency. And I know I speak
for absolutely everyone on this committee, when I say I am
grateful, grateful that we have had your expertise and
leadership, helping to see our Nation through so many public
health challenges. Thank you for your service, from all of us.
And with that, I will turn it over to Senator Blunt for his
remarks.
statement of senator roy blunt
Senator Blunt. Well, thank you, Chair Murray. This is your
first hearing as the Labor, Health and Human Services chair. I
certainly look forward to working with you in this role. We
have had a lot of success working together in the past 6 years
on this subcommittee, and I am sure we can continue with that
this year.
I also want to share your welcome to the CDC director and
the principal deputy director.
Dr. Schuchat, thanks for your service to our country, and
your incredible time at CDC. As I mentioned to you earlier as
we were visiting, I am sure there is not a single person who
knows as much about CDC as you do. And there may never be a
person who knows as much as you do after a 33-year career
there, and that long list of things that we have worked
together on in the last several years, but a list that goes
beyond that.
So Dr. Walensky, Dr. Schuchat, this is really an important
opportunity for us to hear about the CDC's budget proposal, and
understand more about CDC's priorities for this year. I don't
think there has been a year that CDC got more attention than it
got in the last year. And so the profile of CDC, the
understanding of the importance of CDC I think, is at a high
point.
I want to recognize the tireless efforts of the CDC staff,
working across the country during the pandemic. It has been a
challenging year for all Americans, but particularly for those
in public health.
Dr. Walensky, I look forward to hearing your testimony
today on the administration's fiscal year 2022 Budget.
Unfortunately, your comments will be limited somewhat by the
fact that we are really waiting for more information about that
budget. But from what we do know from the limited details
released last month, there are several areas of alignment where
we can work together.
For example, addressing the needs of the hard-hit public
health infrastructure, responding to the opioid crisis, which
has been exacerbated during the pandemic, along with other
mental health and behavioral health challenges, and continuing
the Ending the HIV Epidemic Initiative are important to both of
us.
These are critical areas that may need even more attention
as we emerge from the pandemic and gain an understanding of the
full impact, of the health impact, and the behavioral health
impact that the pandemic has had.
It also appears that Global Health Security and
Preparedness programs will continue as a priority for this
administration, as it has been for this subcommittee over the
past 6 years. During that time the subcommittee invested
heavily in these programs, increasing funding across the
department of HHS (Department of Health and Human Services) by
46 percent. Unfortunately, the so-called ``skinny budget'' also
includes what I believe are excessive areas of increases in
areas that are extremely partisan. I hope we can set those
issues aside and invest in areas of common ground that benefit
all Americans.
As this subcommittee thinks about the priorities for fiscal
year 2022, I hope we can spend time learning from the lessons
of the pandemic.
In 2020, Congress passed five bipartisan COVID relief
bills, total more than $16 billion for CDC. During the
infectious disease pandemic, that funding was critical for
State and local public health preparedness and response. I
think we would all agree that our focus on local public health
in this country is not what it was just a few decades ago, and
we can do better. Certainly those agencies and State
governments, generally, have been critical in the vaccine
distribution and planning.
Now, the other point to make is that $16 billion is a lot
of funding to absorb. To put it in perspective that is about
double your annual budget, or more than $50 million per day for
the CDC's response efforts last year.
Pretty hard to spend all of that as effectively as this
committee would like, but I think we understood that when we
were sending money to CDC to try to respond to a pandemic that
was unlike anything we had dealt with before.
We also really need to incorporate the lessons learned from
the pandemic, moving forward. It is important we highlight what
went right, when communities stepped up, when neighbors helped
neighbors, when innovators came forward to provide novel
solutions to some of the problems that plagued the pandemic.
Senator Durbin, and I, and seven of our colleagues went out
Monday to NIH (National Institutes of Health), and we saw what
happened there with testing and other things that, clearly, I
think as we look down the road, those are going to be great
advantages for us. In Missouri we saw a lot of those unique
things happen.
For example, the pandemic brought out innovation with
Washington University in St. Louis--Dr. Walensky, where you got
one of your degrees--developing their own COVID test, when
there was a nationwide shortage of testing, there was a test
that was developed at the Washington University campus to be
used on that campus.
Other resilience came through, other resourcefulness came
through. Throughout Missouri, independent and rural pharmacists
would drive 200 miles, some of them, to be sure they had the
vaccine that would be available at their location the very next
day, literally, going the extra mile, and the University of
Missouri developed a cutting-edge technology to track COVID
variants through wastewater epidemiology.
So I am proud of Missourians. I am proud of Americans
across the country, as we reached out to deal with this. We are
clearly not out of the woods yet. We need to continue to
understand and learn from the mistakes we made to figure out
where we fell short or missed the mark.
Also to understand, frankly, that there were lots of things
we know now that we did not know then. And looking back at
decisions where you don't have the same information, or
anything like it that we did now is a challenge. We need to
figure out what we learned from that, how we could have found
out more, earlier. I expect the budget to do just that. I want
to work with Senator Murray and others on this committee to do
that.
But under your leadership Dr. Walensky, I hope the agency
will make the difficult decisions necessary to make great
strides toward the enormous opportunity that I think public
health has at this moment, for the rest of this century. So
thank you for being with us today.
Chair, again, let me say, I look forward to your leadership
and the things that we can do together, and I really appreciate
where we are now compared to where we were 6 years ago. And I
think our partnership was an important part of that.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. This is your first hearing as the Labor/
HHS Chair and I look forward to working with you in this role. We have
had a lot of success the past six years working together on this
Subcommittee and I'm sure it will continue this year. I also want to
share your welcome to the CDC Director and the Principal Deputy
Director.
Dr. Walensky and Dr. Schuchat, this is an important opportunity for
us to hear about the CDC's budget proposal and understand more about
the CDC's priorities for this year. I also want to recognize the
tireless efforts of the CDC staff working across the country during the
pandemic. This has been a challenging year for all Americans, but
especially those who work in public health.
Dr. Walensky, I look forward to hearing your testimony today on the
Administration's fiscal year 2022 budget. Unfortunately, I think your
comments will be limited because we are still waiting for the
Administration to release their budget. What we do know, from the
limited details released last month, is that there are several areas of
alignment where we can work together. For example, addressing the needs
of the hard hit public health infrastructure; responding to the opioid
crisis, which has been exacerbated during the pandemic; and continuing
the Ending the HIV Epidemic initiative, are important to both of us.
These are critical areas that may need even greater attention as we
emerge from the pandemic and gain a better understanding of its full
impact on our nation's public health.
It also appears that global health security and preparedness
programs will continue as a priority for this Administration, as it was
for the Labor/HHS Subcommittee over the past six years. During that
time, this Subcommittee invested heavily in these programs, increasing
funding across the Department of Health and Human Services by 46
percent.
Unfortunately, the so-called ``skinny'' budget also includes
excessive increases in areas that are extremely partisan. I hope we can
set those issues aside and invest in areas of common ground that
benefit all Americans.
As this Subcommittee thinks about priorities for fiscal year 2022,
I hope we will spend time learning from the lessons of the pandemic. In
2020, Congress passed five bipartisan COVID relief bills, totaling more
than $16 billion for the CDC. During a global infectious disease
pandemic, that funding was critical for state and local public health
preparedness and response; for public health data modernization; and
for COVID-19 vaccine distribution.
However, $16 billion is a lot of funding for the CDC to absorb. To
put it in perspective, that is about double your annual budget or more
than $50 million per day for the CDC's response efforts last year. Our
Subcommittee has a responsibility to provide oversight and ensure
accountability of that funding for the taxpayers.
We also must incorporate the lessons learned during the pandemic
moving forward. But as important, we should highlight what went right.
When communities stepped up. When neighbors helped neighbors. And when
innovators came forward to provide novel solutions to some of the
problems that plagued the pandemic.
And in Missouri, we saw a lot of that.
For example, the pandemic brought out innovation, with Washington
University in St. Louis developing their own COVID-19 diagnostic test
when there was a nationwide testing shortage.
It brought out resilience and resourcefulness. Throughout Missouri,
independent and rural pharmacists will drive 200 miles a day to provide
vaccines to vulnerable and underserved populations. They are literally
going the extra mile to ensure communities and rural areas across our
state have access to the vaccine.
And it brought out ingenuity. The University of Missouri is
developing cutting-edge technology to track COVID variants through
wastewater epidemiology.
I am proud of how Missourians, and Americans across the country,
stepped up to respond during this crisis.
But, we are not out of the woods yet. We need to continue to
understand and learn from the mistakes we made. Figure out where we
fell short or missed the mark. And I would expect the CDC's fiscal year
2022 budget to do just that. This is the time to think about a long-
term strategy and not continue to jump from one disease outbreak to the
next.
The CDC is facing unprecedented challenges, but the agency is also
presented with an enormous opportunity to bring public health into the
21st Century. Under your leadership, Dr. Walensky, I hope the agency
will make the difficult decisions necessary to make great strides to
that end. Thank you for being with us today and I look forward to your
testimony.
Thank you.
Senator Murray. Thank you, Senator Blunt. And yes, I do
look forward to working with you on this as we always have. So
I appreciate it.
I want to welcome both of our witnesses again. Thank you
for being here.
Dr. Rochelle Walensky is the director of the Centers for
Disease Control and Prevention, and the administrator of the
Agency for Toxic Substances and Disease Registry.
Dr. Anne Schuchat is the principal deputy director of CDC,
and has twice served as acting director of the agency. Welcome
to you both.
Dr. Walensky, we will begin with you for your opening
remarks.
STATEMENT OF DR. ROCHELLE WALENSKY, DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION
Dr. Walensky. Chairman Murray, Ranking Member Blunt, and
everyone on the committee, I am grateful for the committee's
support of the CDC.
I am here today, as you noted, with Dr. Anne Schuchat,
CDC's principal deputy director. I have enormous gratitude for
Dr. Schuchat's leadership and contributions over three decades,
as well as during this very challenging period during our--for
our country, and for her rock-solid support of me in my
transition into this role.
Anne embodies selfless public service, the pinnacle of
scientific and intellectual standards, and has given her heart
to our agency and the public health community. I will be
forever grateful that our paths crossed even for such a short
period of time.
The COVID-19 pandemic threw the United States and the world
into a health, economic, and humanitarian crisis. As the crisis
unfolded, it put a spotlight on the fragility of our public
health infrastructure. It illuminated great disparities in
health outcomes by race and ethnicity; reminding us that--thus
far--we have failed to address the systemic racism that results
in poorer health for people of color in the United States.
I am committed to working with you, the administration, and
our public health partners to ensure that every lesson from
this horrible crisis is used to build a better, stronger,
healthier America.
I also commit to using our public health expertise and
experience in partnership with the global community to move the
world into a safer, healthier future. CDC's fiscal year 2022
Discretionary Budget Request of $8.7 billion is an increase of
$1.6 billion over fiscal year 2021--the largest increase CDC
has received in nearly 20 years.
The increase is focused on four critical areas: building
public health infrastructure, reducing health disparities,
using public health approaches to reduce violence, and
defeating diseases and epidemics.
These increases build on the investments made in the COVID-
19 supplementals, and are an important first step in addressing
deficits in the public health infrastructure. COVID-19 not only
exposed the vulnerabilities within the United States public
health infrastructure, but also how underlying chronic
conditions and lack of access to healthcare, put too many
Americans at great risk.
Across the globe we see billions of people without access
to vaccines and medical care, which means that SARS-CoV-2, its
variants, and other infectious disease threats will continue to
threaten us all. Experts had warned for years that a pandemic
of this scale was coming, and we must expect additional
diseases to emerge.
We need to ask ourselves, are we ready? We must have a
strong infrastructure that can identify and detect outbreaks at
their source and can take quick action before diseases take
hold.
Over the last 12 years, the United States has faced four
significant emerging infectious disease threats: the H1N1
influenza pandemic, Ebola, Zika, and COVID-19; we also
confronted a drug overdose epidemic with nearly 500,000 people
dying from an opioid-related overdose between 1999 and 2019.
This increase continued into 2020 and appeared to accelerate
during the COVID-19 pandemic.
These experiences show that public health emergencies are
here to stay. Each of those threats demanded a rapid and unique
response, but none resulted in a sustained public health
improvement. Long-term investments in flexible infrastructure
will save lives and avert economic losses caused by public
health emergencies and chronic public health problems.
The fiscal year 2022 request makes initial investments to
continue public health data modernization, build the public
health workforce, enhance global health security, and
strengthen our immunization infrastructure.
In addition, we are requesting funds to help states and
communities be climate-ready and prepare to confront new health
risks, such as those associated with vector-borne diseases. The
fiscal year 2022 Budget Request also makes specific investments
in programs that work to improve health equity, such as
maternal mortality review committees. With these new outlined
resources in this request, CDC will also significantly expand
efforts to address the social determinants of health.
Proposed increases will address public health problems that
have been exacerbated by this pandemic, such as opioids,
violence, HIV, and sexually-transmitted diseases.
We, at CDC, are grateful for your support and look forward
to working together to build a sustainable and resilient public
health system that can respond effectively to emerging threats,
and meet the public health needs of every American. We will
work tirelessly to ensure the health of this Nation and the
world.
Thank you. Dr. Schuchat and I look forward to your
questions.
[The statement follows:]
Prepared Statement of Rochelle P. Walensky, M.D., M.P.H. and
Anne Schuchat, M.D.
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Committee, it is an honor to appear before you today to discuss
how investments in the Centers for Disease Control and Prevention (CDC)
are protecting American's health, now and in the future. I am grateful
for this opportunity to address this committee, as well as for your
long-standing and consistent leadership on issues of critical
importance to the health of Americans, and the world.
It is my privilege to represent CDC at this hearing. CDC is
America's health protection agency. For 75 years, CDC has been trusted
to carry out its mission to protect America's safety, health, and
security. Even during the unprecedented circumstances of the past year,
CDC's scientific expertise, determination, selflessness, and innovation
has helped the agency continue to advance its mission. We work 24/7 to
prevent illness, save lives, and protect America from threats to our
health, safety, and security. Addressing infectious diseases and
pandemics, like COVID-19, is central to our mission. CDC's expertise
lies in our ability to study emerging pathogens like SARS-CoV-2, to
understand how they are transmitted, and to translate that knowledge
into timely action to protect the public's health. CDC identifies and
mitigates other causes of morbidity and mortality beyond infectious
diseases, such as environmental and workplace hazards and intentional
and unintentiona l injuries (such as those from falls, violence, or
overdose). CDC promotes healthy behaviors, such as exercise and
nutrition, to prevent chronic diseases such as diabetes and heart
disease, and to prevent outcomes such as stroke. We promote healthy
communities by increasing access to nutritious food and safe walking
and green space.
By deploying experts on the ground to support our state, Tribal,
local, territorial and global partners, we translate science into
implementing guidance that protects individua ls, communities, and
populations. In our work with other Federal agencies we ensure the safe
and appropriate use of medical countermeasures, including vaccines, and
collaborate with the academic and private sector to further our
understanding of new diseases and problems that affect health.
The COVID-19 pandemic threw the United States and the world into a
health, economic, and humanitarian crisis. As the crisis unfolded, it
put a spotlight on pre-existing weaknesses and gaps that threaten the
health of Americans. It brought into stark light the great disparities
in health outcomes by race and ethnicity. We must acknowledge the long-
standing and too often unstated impact that racism has on public
health. The pandemic has also highlighted our frail public health
infrastructure, and the way that frailty impacted our ability to
respond at thenecessary scale and speed.
Experts had warned for years that a pandemic of this scale was
coming. Today, we know to expect additional novel and currently rare
diseases to emerge and gain footing as a result of our changing
climate, closer interaction with animals, and globalization. Over the
last 12 years, the United States has faced four significant emerging
infectious disease threats--the H1N1 influenza pandemic, Ebola, Zika,
and COVID-19. These experiences show that public health emergencies
and, specifically, infectious disease threats, are here to stay. While
urgency demanded rapid and unique responses to each of these threats,
none resulted in the sustained improvements needed in our nation's
public health infrastructure. This lack of robust public health
infrastructure continues to present significant challenges in our
ongoing fight against COVID-19. In fact, emergencies have resulted in
the rapid build-up of infrastructure needed to address the emergency,
then dissolution of that infrastructure, often leaving no sustainable
infrastructure in place to address the next threat. This lack of robust
public health infrastructure continues to present significant
challenges in our ongoing fight to tackle COVID-19.
World-wide, billions of people do not and will not have immediate
access to COVID-19 vaccines. Cases will continue to increase, and
variant COVID-19 strains are likely to emerge, persist, and cause
outbreaks. As this becomes more common, our public health system at
home and abroad must be ready with highly sophisticated detection and
sequencing, combined with a rapid response at the source. The
unprecedented investments provided to CDC through COVID-19 supplemental
appropriations have helped our efforts to control COVID-19, and will
also go a long way toward addressing deficits in the core components of
the public health infrastructure that has long been ignored. Our
ability to respond to the next public health crisis will depend on
whether we invest in a public health system that is highly functional
on a day-to-day basis and pivots to meet new threats, rather than
continue our partial defense, which ramps up in response to an urgent
and often short-term event.
A resilient public health system can be realized with careful
planning that builds on the gains made with COVID-19 emergency
supplementals and incorporates lessons learned as a result of this
crisis, including reliable, flexible funding. The FY 2022 Discretionary
Budget Request for CDC and ATSDR includes a total funding request of
$8.7 billion, an increase of $1.6 billion over FY 2021 Enacted. This is
the largest increase in budget authority for CDC in nearly two decades
and defends Americans' health in four ways: 1) building public health
infrastructure, 2) reducing health disparities, 3) using public health
approaches to reduce violence, and 4) defeating other diseases and
epidemics.
First, building the public health infrastructure. CDC's FY 2022
request prioritizes foundational funding to rebuild the public health
infrastructure needed to safeguard the Nation's health and economic
security. Drawing on lessons learned, as well as the latest information
and technologies, CDC will begin to address long-standing
vulnerabilities in the U.S. public health network by training a larger
cadre of experts who can deploy and support public health efforts, and
building capacity to detect and respond to emerging global biologica l
threats.
Public health action is driven by data. Earlier improvements in our
systems for collecting information after other public health
emergencies, including Ebola and EVALI, facilitated exchange of health
information, linking local, state, and federal public health systems
with healthcare systems and the public. With investments in public
health data modernization in the FYs 2020 and 2021 appropriations and
the COVID-19 supplementals, CDC increased the scale and speed of these
systems during the COVID-19 response to protect people who are at risk
for severe illness (such as older Americans), those with chronic
medical conditions, and those from racial and ethnic minorities. These
advancements must be applied across the public health system and at all
levels of government. The funds requested in FY 2022 will be used to
continue building a modern disease surveillance system at CDC, which
will catalyze a multi-sectoral, comprehensive, and cohesive approach to
documenting evidence, using state-of-the-art technology and analytical
tools. CDC will continue working diligently to ensure its research and
data are of the highest quality and are disseminated nationally to
inform decision-making throughout the public health system, while
supporting advances in data systems at all levels.
The COVID-19 pandemic made clear the role that CDC labs and public
health labs across the nation play in conducting critical surveillance
and responding to outbreaks and emerging threats. CDC and state
laboratories were required to flex and surge during peak periods of
illness, far beyond routine clinical testing. In FY 2019, CDC was only
able to meet 50% of state and local health departments' stated needs
for epidemiology and laboratory capacity funding, with personnel
support being the biggest unfunded need, followed by equipment and
supplies.
The FY 2022 request will foster innovation, collaboration with the
clinical system, and a commitment to quality. Improving technologies at
the state and local levels would enable public health labs to quickly
utilize and scale up essential laboratory analyses. In a post-COVID-19
world, investments to maintain and improve laboratories will help
prevent the failures we experienced while trying to address COVID-19.
The U.S. needs a workforce of qualified public health professionals
who will prepare for, respond to, and prevent public health crises.
Physicians working for states often earn less than$150,000 per year.
This is after having taken on medical school debt of $200,000 on
average. The FY 2022 request includes an increase to build a diverse
and culturally competent workforce who can rapidly develop innovative
approaches in surveillance and detection, risk communications,
laboratory science, data systems, and disease containment. With this
funding, CDC will support critical training programs for public health
professionals that develop strategic and systems thinking, data
science, communication, and policy evaluation. Existing cooperative
agreement mechanisms will be leveraged to support public health jobs
that meet current needs and attract new personnel to work in
underserved and rural areas.
Addressing gaps in capacity across levels of government to detect
and respond to outbreaks while maintaining and surging in other problem
areas requires investments to be disease-agnostic and flexible. With FY
2022 funding, CDC will provide support to health departments to meet
national quality standards, conduct performance improvement activities,
increase communication and collaboration across the public health
system, and reshape health departments to meet changing conditions and
needs. Funding will help health departments strengthen their abilities
to effectively respond to a range of public health threats, such as
COVID-19, and build capacities that do not currently exist.
COVID-19 is a sobering reminder that a disease threat anywhere is a
disease threat everywhere. Or as stated by WHO: no one is safe unless
everyone is safe. We cannot adequately protect American lives and the
U.S. economy without addressing global disease threats wherever they
may arise. CDC's strategic investments in global health security are
critical to U.S. health security by building sustainable global
capacity to prevent, detect, and respond to emerging infectious disease
threats. CDC works in more than 60 countries on more than 150 projects
and is a key implementing agency for the U.S. Government's leadership
role in the Global Health Security Agenda. With additional resources
requested in FY 2022, CDC will build on existing partnerships with
Ministries of Health, public health agencies, infectious disease
research institutions, and international organizations to strengthen
global laboratory capacity for early disease detection, enhance disease
surveillance for accurate data to drive decision making, and foster
effective regional and global coordination.
Next, I'd like to talk about reducing health disparities. The
disparities seen over the past year among communities of color were not
a result of COVID-19. In fact, the pandemic illuminated inequities that
have existed for generations and revealed a known, unaddressed, and
serious public health threat: racism. The well-being of our entire
nation will be compromised as long as we fail to address this.
Racism is not just discrimination against one group based on the
color of their skin or their race or ethnicity, but the structural
barriers that impact racial and ethnic groups differently to influence
where a person lives, where they work, where their children play, and
where they worship and gather in community. The social determinants of
health (SDOH)--such as high-quality education, stable and fulfilling
employment opportunities, safe and affordable housing, access to
healthful foods, commercial tobacco-free policies, and safe green
spaces for physical activity--are critical drivers of health inequities
in this country. CDC is building the evidence-base for collaborative
approaches to SDOH through community accelerator planning and expanding
a network of community health workers to develop a sustainable
infrastructure to improve health equity. CDC's FY 2022 budget request
includes an increase of $150 million to use a social determinants of
health approach to improve health equity and health disparities in
racial and ethnic minority communities and other disproportionately
affected communities around the country.
This budget directly responds to health disparities recorded in our
public health data. For example, about 700 women die each year in the
U.S. as a result of pregnancy or delivery complications, and American
Indian, Alaska Native, and Black women are two to three times more
likely to die than White women. Data show that about 2/3 of these
deaths may be preventable. Children from lower-income and racial and
ethnic minority households experience a disparate, increased risk for
lead exposure.
Achieving health equity is central to addressing the HIV epidemic.
The U.S. government spends $20 billion per year in direct health
expenditures for HIV care and treatment. An estimated 1.2 million
persons have HIV and approximately 15% are unaware they have it. With
recent advancements in antiretroviral therapy and biomedical
advancements in HIV prevention, such as pre-exposure prophylaxis
(PrEP), along with effective care and treatment, we have the tools to
end the HIV epidemic. An increased investment requested in FY 2022 for
the Ending the HIV Epidemic (EHE) initiative will enable CDC to advance
the four key strategies needed to end the epidemic in the 57 EHE focus
jurisdictions. In addition, CDC will address health equity in the
entire HIV prevention portfolio, test innovation in service delivery
models to increase access to prevention services, use syndemic
approaches to broaden reach to key populations and create efficiencies,
and strengthen engagement of grassroots community-based organizations
in implementing EHE initiative.
Third, the budget request also addresses the public health epidemic
of violence. We know too well how this epidemic permanently alters the
lives of its victims and their families and puts enormous strain on our
communities and local economies. Increases in CDC's FY 2022 budget
request will help address violence through public health approaches,
which include improving reporting systems that provide the data needed
to understand and address violent deaths and injuries in the United
States.
And fourth, we must defeat other diseases and epidemics. Just as
racism underlies a number of public health issues, climate issues
underlie a number of infectious diseases and have significant health
impacts. Climate changes are associated with changes in the
geographical range of mosquitos, ticks, and other disease vectors.
Climate-related events impact a wide range of health outcomes. Some of
the most significant climate-related events--such as heat waves,
floods, droughts, and extreme storms--affect everyone. These climate
events compromise our access to clean air, clean water, and a reliable
food supply. In addition, climate events can impact the presence of
allergens and vectors, like ticks and mosquitoes, and the subsequent
health outcomes that can result from these changes in exposures. We
know that a changing climate can intensify existing public health
threats, and that new health threats will emerge: unequally distributed
risks (age, economic resources, location), increased respiratory and
cardiovascular disease, injuries and premature deaths related to
extreme weather events, changing prevalence and geography of foodborne
and waterborne illnesses and other infectious diseases, and threats to
mental health as people feel less safe.
CDC works with states, cities, and tribes to apply the best climate
science available, predicting health impacts, and preparing public
health programs to protect their communities. To do this, CDC developed
the Building Resilience Against Climate Effects (BRACE) framework to
help communities prepare for the health effects of climate change by
anticipating climate impacts, assessing vulnerabilities, projecting
disease burden, assessing public health interventions, developing
adaptation plans, and evaluating the impact and quality of activities.
With the requested increase in FY 2022, we can further expand the
Climate and Health Program by providing a larger number of health
departments with technical assistance and funding and finding
innovative ways to protect health via climate adaptations. As with
every other public health threat, we will inform our effort by building
and examining systems that collect data on conditions related to
climate, including asthma and vector-borne diseases, and coordinate
programs and communication that improve health outcomes.
The opioid epidemic has shattered families, claimed lives, and
ravaged communities across the Nation--and the COVID-19 pandemic has
only deepened this crisis. Addressing the current overdose epidemic
remains a priority for CDC. The Administration's strategy brings
together surveillance, prevention, treatment, recovery, law
enforcement, interdiction, and source-country efforts to address the
continuum of challenges facing this country due to drug use. CDC's role
is to prevent drug-related harms and overdose deaths.
The additional funding requested in FY 2022 to address the opioid
epidemic will enable CDC to provide more funding to all States,
Territories, and select cities/counties. CDC will prioritize support to
collect and report real-time, robust overdose mortality data and to
move from data to action, building upon the work of the Overdose Data
to Action (OD2A) program. To do so, CDC will partner with funded
jurisdictions to implement surveillance strategies that include
contextual information alongside data, as well as increase surveillance
capabilities for polysubstance use and emerging substance threats such
as stimulants. The additional resources requested will enable CDC to
support investments in prevention efforts for people put at highest
risk, for example, supporting risk reduction and access to medications
for opioid use disorder for people transitioning from alternate
residence (jail/prison, treatment facility, homeless shelter). CDC will
also address infectious disease consequences, such as viral hepatitis,
of the opioid epidemic.
I look forward to working together to address both the immediate
challenges ahead in our fight against COVID-19, as well as the
weaknesses in the public health infrastructure that left our country
vulnerable to this pandemic. We at CDC are grateful for your support.
We will continue to work tirelessly to ensure the health of this nation
and the world. Together, we can build a sustainable and resilient
public health system that can respond effectively to emerging threats
and also to ongoing public health needs of every American.
Senator Murray. Thank you very much. And we will now begin
a round of 5-minute questions of our witnesses. And I do ask my
colleagues to keep track of the clock, and if you can stay
within those 5 minutes.
Dr. Walensky, COVID has really exposed the importance of
having a robust and well-funded public system before a crisis
strikes; which is why I said it is so important that we make
sustained investments in public health infrastructure and
workforce a priority, including in CDC.
Over the last year Congress provided more than $8 billion
to support public health data modernization and expand the
public health workforce through six COVID supplemental bills.
What more needs to be done to sustain our public health
infrastructure and our workforce, so we don't lose gains when
the funding runs out?
Dr. Walensky. Thank you so much, Senator, for that
question.
INFRASTRUCTURE AFTER EMERGENCY
You have highlighted that we have had challenges with our
public health workforce, indeed. We have 56,000--we are down
56,000 jobs just in the last decade. We need to train and
upskill that workforce, in addition to bolster that workforce
over the years ahead. We need to keep them trained because the
science continues to evolve, we need training in
bioinformatics, in genomic epidemiology, and all of that needs
to live in our State and localities so that they are well
informed and trained over time, not just in creating a
workforce, but in keeping them skilled.
We need to do data modernization, as you noted, an initial
investment in data modernization. When I spoke early on in my
tenure to State and local health officials, I was hearing about
faxes of test results for COVID, and then manual data entry of
those results, and that those results were not received with
racial and ethnic data in them. So we had no way of tracking
how we were doing with racial and ethnic diversity across this
pandemic.
And then we need to build our public health labs. We don't
have--did not have the capacity to do genomic sequencing in all
of these labs, we have had to scale that up. And there is many
more, and in the infrastructure in the machinery, in the
technology that we need to put and deploy, not just at CDC, so
we are ready at CDC for this, but also in our public health and
localities.
Senator Murray. So I am curious; if we had had all that in
place before this pandemic, how would have things been
different?
Dr. Walensky. I think they would have been extraordinarily
different. We would have had contact tracers on the ground
ready to go. We would have been able to identify cases quickly.
We would have been able to see single, single outbreaks than in
clusters that we might have been able to pin down to contact
trace and not have outbreaks expand. I think we would not have
seen the diverse--the racial discrepancy and what happened with
this pandemic that----
Senator Murray. Because we would have known prior and made
more of a focus?
Dr. Walensky. Exactly. We would have been able to find it.
I think the testing, the inability of our public health systems
to be able to conduct these tests in massive scale up, did not
allow us to find the disease where it was, certainly, we had
not done genomic sequencing until January, we did not know
anything about the variants that were circulating here. There
are numerable ways that this could have gone better if we had
had a more robust public health infrastructure across all of
those domains.
Senator Murray. Thank you. That is a lot to think about. We
should all remember. We have now seen a lot of encouraging
progress against COVID over the last several months, and as
more people get vaccinated, and case counts, and
hospitalization, deaths are falling.
PANDEMIC TRAJECTORY
Dr. Walensky, speak to us about where we are in this fight.
How the funds Congress has provided have helped? And what we
need to focus on next to bring this crisis to an end?
Dr. Walensky. Today, I am cautiously optimistic. We have,
in the last several weeks, seen a stark downward trend in
cases. The last 2 days we have had case rates that have been
less than 20,000 per day. Our case rates now are around 30,000
per day, on average, for the last seven days; death rates, we
have been seeing at around 500 a day, still too high, but the
lowest we have seen since this pandemic began.
We have over 86 percent of Americans over the age of 65 who
have received their first dose of vaccine. And just yesterday--
today we have now 60 percent of Americans over the age of 18
having received their first dose of vaccine. I think that we
have had extraordinary progress, and we have needed the
resources to get here.
Senator Murray. So what do we need to focus on next?
Dr. Walensky. Certainly, a sustainable public health
infrastructure that is not necessarily just tied to one
disease, to one outbreak, to one disaster. We need longitudinal
money so that we are able to have sustainable infrastructure
that is up to date with the times. We need to focus on our
racial and ethnic minority groups.
They were previously under-vaccinated. We have made a huge
amount of strides just in the last 2 weeks in getting those
groups vaccinated. But we need to--and we need to get into the
communities. We need to have a public health infrastructure
that looks like the communities that they serve, and that
serves those communities a lot.
Senator Murray. Should we be worried about the variants?
Dr. Walensky. I think we would be remiss to say that we are
out of the woods. This pandemic, this virus has sent us too
many curve balls to say that we--too early to declare victory.
Certainly, with the virus circulating in other parts of the
world that is in high degree that it gives the opportunity for
more variants to emerge, so I still am--it is among the things
that keeps me up at night. But right now the variants that we
see here and we are doing a lot of sequencing now, demonstrate
that our current vaccines are working.
Senator Murray. Okay. Thank you very much.
Senator Blunt.
Senator Blunt. Thank you, Chair.
CHANGES TO MASK GUIDANCE AND REOPENING
Let's talk about the guidance that came out last week on
masks for people who have been fully vaccinated. There seems to
be some concern about how that would be applied. I listened
this morning to the CEO (Chief Executive Officer) at Target,
who was on CNBC, and he said that--they had followed all the
CDC guidance up till now, which meant until last week people in
their stores had a mask on, this week people in their stores
don't have a mask on unless they want to have a mask on.
In the Capitol, the attending physician, who has been the
person we look to, put out guidance last week that said: on the
Capitol grounds you would not need to wear a mask if you were
vaccinated, but the Speaker decided that she was going to keep
the mask mandate in place for the House until everyone was
vaccinated.
What are you seeing there? And what kind of further
direction have you been able to give? I know just yesterday the
President had his mask on part of the time, largely based, it
seemed to me, on what other people around him were comfortable
with. But give us some more thoughts on that.
Dr. Walensky. Thank you, Senator, for that question. I
think the first thing that we should do is celebrate where we
are in this pandemic, that we can even be having this
conversation, that cases are now down to 19,000 a day, reported
this morning. As those cases are coming down, people are
longing to understand what this means next.
How do we open up again? How do we take our masks off? With
those cases coming down, and now the fact that every American
who wants a vaccine has access to one, if you have not texted,
text your zipcode to GETVAX (438829), you can find vaccine
wherever you are in the country. Five pharmacies will show up
so you can get the vaccine.
So we now have cases coming down and access to vaccines for
everyone who wants one. Just in the last 2 weeks, we had
scientific data emerge in three important areas, (1) that the
vaccines are working in the public the way they worked in the
clinical trials. That doesn't always happen, but it happened
here. And we had one of the largest studies published on Friday
in the MMWR (Morbidity and Mortality Weekly Report).
(2) That the vaccines are working against the variants we
have here circulating in the United States. There have been
data, neutralizing data that demonstrates against B.1.1.7,
against B.1.351. These vaccines are working.
And (3), something that was not studied in the clinical
trials is, can you--if you were to get infection with SARS-CoV-
2 and were vaccinated, could you give it to somebody else? Were
you silently able to spread it? Those data were not covered in
the clinical trials, but now data have emerged again, that have
demonstrated, even if you were to get infected during post-
vaccination, that you cannot give it to anyone else.
Senator Blunt. Yes.
Dr. Walensky. So that scientific data was enough for us to
move forward. People had said we moved too slowly, people have
said we have moved too fast, we moved at the speed that the
science gave us.
Senator Blunt. Well, I think that is right. I do think on
the last topic if we--not evaluating, whether we could have
made that decision quicker. But I do think that decision that
you don't have to wear a mask once you have been fully
vaccinated, will encourage people to get vaccinated. I think
the fact that that is out there is good. I hope we got it out
there as quick as you were comfortable having it out there.
RACIAL DISPARITIES
On your comments about racial health disparities which, of
course, I am not for racial health disparities, and more than
happy to look at that; what about the other obvious health
disparities, like how low income, health disparities regardless
of race, or rural health disparities? Are we just going to
focus on racial health disparities, and leave those others
behind? Or why were those the disparities you specifically
mentioned in your comments?
Dr. Walensky. We have seen a lot of data on racial health
disparities in this pandemic. But, Senator, you are absolutely
right. Twenty percent of Americans live in rural areas. As we
talk about social determinants of health, this is not just
racial--on racial lines, this is urban and rural.
We just, yesterday, had an MMWR come out that demonstrated
that rural Americans were getting vaccinated around 39 percent,
while non-rural counties were at 46 percent. So we are intent,
and our values are going to be, to have public health reach all
areas, all Americans.
Senator Blunt. I am glad to hear that. My last question
here before I run out of time would be on drug overdose deaths.
You know, we saw this committee work really hard on this topic
for about four straight years, and we felt we were making some
real progress. And I think we were, the numbers were going down
every year, but in 2020 we had the highest number to date of
drug overdose deaths. Just comment briefly on that before my
time is up here.
Dr. Walensky. It is tragic. Before being here, I was an
infectious disease doc on the wards at Mass General, and while
we were talking about deaths, the people on the wards were also
talking about chronic infections, endocarditis, epidural
abscesses, leaving young people paralyzed.
So we were making some progress, and this pandemic hindered
that progress. And we, again, need to address this issue.
Senator Blunt. Thank you.
Senator Murray. Thank you.
Senator Durbin.
Senator Durbin. Thank you, Madam Chairman.
And Dr. Schuchat, let me join the chorus. Thank you for 33
years of remarkable service. I have a question for you in a
minute, but I wanted to start with a little different approach.
LESSONS LEARNED
And let me say that I think this pandemic has not broken
us, but it has taught us where our system is broken, and there
are many areas we need to look at seriously. If you take a look
at the public health scorecard and try to find an objective
measure, the one that I return to frequently is the fact that
the United States has less than 5 percent--has less than 5
percent of the world's population, yet 20 percent of the COVID-
19 infections and deaths. And that tells us we can improve
dramatically.
Where did we shine in this effort? Certainly vaccines, the
quick response as we learned again this week, and the visit to
the NIH, was because we were prepared, and we had the science
ready, and we had good fortune in identifying the culprit, and
in devising an effective strategy to go after it with vaccines.
I would also add that the Warp Speed program appears to
have dedicated and invested funds in a dramatic way at a time
when it was very important. And I think that accelerated the
availability of the mass vaccines, and I give the Biden
administration credit for administering them, and distributing.
So those are the positive sides.
But one of the messages learned, that I learned out at NIH,
was now let's get honest about this. We not only have to bring
this pandemic to an end, we have to prepare for the next
pandemic, which may be 5 years away or 15 years away. We don't
know. But history tells us there will be another one. And the
question is: will we be ready for it?
The CDC is going to play a critical role in this. And the
first question I have to ask is to Dr. Schuchat. After 33 years
of observing this agency and its role in the American scene
when it comes to public health, there is a fear that it has
been politicized in the last 4 years, or maybe even before.
That now public health issues are so political, with the
division on whether to get a vaccine, or a vaccination or not,
seems to break out on party lines and political lines. We have
reached a new stage.
What is your thinking? And having observed and worked with
the CDC all these years, about this politicization--if that is
the word--of public health?
Dr. Schuchat. Thank you so much for your comments and your
question. The viruses don't vote, and the pandemic has really
told us that everyone is vulnerable, everyone in America, and
everyone around the world. And CDC is a science-based agency,
and we lead from science. We are data-driven, and we work
together with State and local partners who reflect the values
of their communities. So I think that focusing on the science
and the service mission of the agency is what we need to do.
Senator Durbin. Have you noticed any change, recent change
in terms of the political image of CDC, which tries to be
apolitical?
Dr. Schuchat. You know, this pandemic has been so difficult
for--you know, for the Nation, I think for all of us in public
health, and certainly for our colleagues around the world. The
messaging has really been difficult, you know, very conflicting
messages that left Americans confused.
And so I think we are committed to clear, honest
communication of what we know, and what we don't know, and what
we recommend people do. So I do think the messaging environment
during this pandemic has been really tough.
Senator Durbin. I would agree with that.
GUN VIOLENCE
Dr. Walensky, I am worried about gun violence. I believe it
is a public health issue because I represent the State of
Illinois and the City of Chicago. And we have the equivalent of
a mass shooting every weekend in Chicago. It is a disaster in
terms of its impact on the lives of many people, and the life
of the city.
You have a proposal to make a-hundred-million-dollar
investment through the CDC, in community-based violence
intervention, working with neighborhood organizations and
hospitals to deliver services. I recommend to you a program,
which we started in Chicago called the HEAL Initiative. I will
send you some information on it. But I would like for you to
say a few words about what you anticipate that $100 million is
going to be used for.
Dr. Walensky. Thank you, Senator. Our intent here is to
look for areas in high-violence cities, where we can accumulate
data, we can get accurate information, where we have actionable
interventions to prevent all areas of violence, community
violence, domestic violence, suicide, to increase public health
using those resources in areas that have been highly impacted.
We want actionable interventions for prevention.
Senator Durbin. Thank you.
CHILD MENTAL HEALTH
Madam Chair, I would just say in closing, you are in a
unique position being on the Authorizing and Appropriating
Committee, but one element I hope we don't overlook, and I know
you feel sensitive to this as I do, is the need in schools to
have access to counselors, mental health counselors, and maybe
traditional school nurses, so that any public health effort,
which should focus first on our children, has the wherewithal
to do that effectively. I find that we have allowed that to
lapse in many areas of my State.
Senator Murray. Thank you, Senator Durbin.
Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Chairwoman Murray, and
Ranking Member Blunt for having this hearing. And I certainly
appreciate the speakers that are here today.
And Dr. Walensky, I appreciate being able to visit with you
last week to discuss your work as director at the CDC. I
thought we had a very good conversation, I certainly admire the
work that you have done.
And Dr. Schuchat, I certainly admire the work that you have
done over the past many years.
RURAL HEALTH DISPARITIES
I will be brief with my questions, but one thing that I am
really concerned about is rural healthcare. I had the
opportunity this past Saturday morning to visit with David
Ready. He is a pharmacist in a town in Mississippi, Monticello,
Mississippi; that has less than 1,500 people, and the concerns
that he has about them being able to get their medicines. The
reimbursements they get, because they are so small, they don't
buy in bulk.
So those are things that I am sure that we will be having
other conversations about. But the COVID-19 pandemic has
highlighted numerous aspects, obviously, of our healthcare
system that need improvements. One of them that we all
recognize is the disparities of Americans living in rural
health areas.
Addressing health infrastructure in rural areas is a
serious concern, and as I said, one of my top priorities, and
while the CDC has undertaken efforts to address that, there is
no entity within the CDC tasked specifically with this work.
And that is concerning to me.
I believe establishing a new Office of Rural Health within
the Center of Disease Control would be an important way to
support rural communities through the end of this pandemic, and
to prepare for any other future public health crises that we
could be faced with.
And, you know, I just envision this office to be empowered
to look across CDC programs, to ensure the work of the agency
is properly addressing the health needs of the 57 million
Americans who live in rural communities.
Director Walensky, how strongly do you support establishing
an official Office of Rural Health within the CDC? And how can
we work together to get this done, if you see that the way that
I see this?
Dr. Walensky. Thank you, Senator. As you noted, we have 20
percent of Americans, 57 million Americans living in rural
areas. Part of the deep need for investment in a public health
infrastructure is to develop a workforce that looks like the
community, that is from these communities, that knows how to
access and reach these communities, which is exactly one of the
challenges that has that has occurred during this pandemic. And
one of the reasons we had a differential distribution of
vaccines between rural and non-rural communities.
We also know that there are other issues, outside of COVID,
where we have learned from COVID, such as telehealth. We had a
previous MMWR that demonstrated, ironically, that telehealth
was not reaching rural communities. And that is, in fact, one
of the areas that we should be using telehealth. So why was it
not reaching their rural communities? CDC is investigating this
just by virtue of the fact that they have had several MMWRs in
the last 2 weeks examining these issues.
So as part of the public health infrastructure and the
disease agnostic infrastructure that works on labs, that works
on workforce that works on data; we are invested in urban
communities as well as rural communities.
FUNDING FLEXIBILITY
Senator Hyde-Smith. And I think a lot of that is broadband
issues as well, that we have to get addressed. But I understand
the CDC has a highly categorical manner for providing funding
to State health departments, with most funding tightly tied to
specific diseases, or specific purposes. And I am concerned
that restricting CDC money to specified activities prevents
States from being able to address issues that vary from State
to State, because all of them are different, and it makes it
difficult to respond efficiently to emerging challenges like
COVID-19.
And I have always been big on flexibility because the
States really know where their needs are, and I believe greater
flexibility on funding might allow States to better target
resources. So I just wanted to mention that to you, of the need
for flexibility there, that we sure saw that our hands were
tied in some cases during COVID. So I just wanted to address
that with you.
Dr. Walensky. I would just echo your thoughts and say, yes.
That one of the things that has been challenging for us at CDC
is the line items that have to go to X or Y, when in fact what
we need is the infrastructure, the disease agnostic
infrastructure, so that when we see community--this community
needs this, but they may both need to establish a lab, but one
needs broadband and the other needs a genomic sequencer that
we--it is flexible enough to be able to make sure that each of
the communities can scale up for what they need. Absolutely.
Senator Hyde-Smith. Thank you. That is very encouraging.
Thank you.
Dr. Walensky. Thank you.
Senator Murray. Senator Reed.
Senator Reed. Well, thank you, Madam Chairwoman; and thank
you Director for your extraordinary work.
317 IMMUNIZATION PROGRAM
I have been now working and trying to bolster the Section
317 Immunization Program for many years. And as we recognize
this year, because of the pandemic, there has been significant
increases in vaccination funding going out, and building an
infrastructure. But I don't want to take our eyes off the long-
term need for Section 317 programs to sustain improvements that
have been made in terms of routine immunization, which must be
given.
And so will the CDC be requesting an increase in funding
for the 317 Program this year, Madam Director?
Dr. Walensky. I am going to let Dr. Anne Schuchat take that
question.
Dr. Schuchat. I want to thank you for your long-time
support for the immunization needs of the Nation, and the
incredible progress we have been able to make, particularly
among children. COVID, the pandemic, has really highlighted
that we are not where we needed to be with adults. And that was
part of the slow start that we had in terms of getting--you
know, having the scale up of vaccination.
So there is a lot more work to do to catch up for the
vaccines that were not given during the pandemic, in children,
and to strengthen our infrastructure for adults going forward.
And so that work is part of the priorities for the agency.
Senator Reed. Thank you very much.
SUICIDE PREVENTION
Dr. Walensky, this is not the first time I think this
thought has been bridged, but the suicide epidemic has been
startling across the country related to the pandemic, and
perhaps related to other factors, and CDC has released some
startling statistics recently about suicide. And I know that
the CDC has launched some new suicide prevention efforts over
the last couple of years, and let me you to continue to do
that. But I understand only a handful of grant applications
were able to be funded. And one of those that were not funded
was from my State, but we were not alone. And what are you
intending to do with respect to the overall suicide epidemic
and also the more robust funding for prevention?
Dr. Walensky. Thank you, Senator. This is such a
challenging area it was--we had scale-up of mental health
challenges before the pandemic, right? So these were issues
that we really needed to tackle before the pandemic. And we saw
during the pandemic that these have only gotten worse, among
our youth, among our middle aged, we have seen challenges even
since the pandemic began.
So part of our resources that we are requesting are to
scale up these efforts. Again, we need surveillance data. We
need to understand how much this is a challenge. How many
people are presenting to the emergency room. We need toolkits
to deliver to States, to physicians, organizations, so that
they can--they are empowered as to how to prevent it. And then
we need actionable implementation that we can do for prevention
in areas of mental health.
LEAD POISONING PREVENTION
Senator Reed. Thank you. One final topic is lead exposure,
which I have been working on through my responsibilities on the
Banking Committee, and also the Appropriations Subcommittee on
Housing and Urban Development, over the last year rates of
screening for lead poisoning have decreased, obviously, as you
know, movement and these types of activities have been
curtailed. And then I think the statistics, although it would
probably be very dubious coming out of the last year because of
all these other factors, but it is a continuing problem.
And right now the CDC's Lead Poisoning Prevention Program
is at a high mark of $39 million. But we know more funding is
needed, and we also know that this initiative
disproportionately impacts lower-income communities because of
the housing circumstances, generally.
And I would hope that the President's CDC budget will
prioritize this work, keep increasing funding and focus. I
would note, he is going after the lead pipes, which I applaud.
But in many respects, particularly in older communities like
mine, the issue is not lead pipes, it is housing and lead
paint, and it is a whole series of issues.
Dr. Walensky. Thank you. I think this raises a very similar
point, as was previously raised by Senator Hyde-Smith, that
each community needs individual things to improve the health of
their community, which is why the public infrastructure
flexibility, the funding to be able to get the resources that
you need in individual communities.
One will be--you know, we need resources for broadband, but
one will be, we need resources for lead. And as you note we,
again, had an MMWR that demonstrated exactly what you said.
Screening for lead this past year has gone down. We know we
have missed lead toxicity that we really need to make up for.
Senator Reed. Thank you very much.
Thank you, Madam Chairwoman.
Senator Murray. Thank you.
Senator Moran.
Senator Kennedy.
Senator Kennedy. Thank you. Madam Chair.
Madam Director, thank you for being here today; I know how
busy you are. I have been in my office listening to some of the
testimony of both of you. And I am a little uncertain about
some of the answers, which is probably a shortcoming on my
part.
MASK GUIDANCE
Madam Director, could you, in one minute, summarize for me
what the recommendations are today from your agency about
wearing masks?
Dr. Walensky. Absolutely. First of all, can I just say,
thank you for your YouTube video, for promoting vaccines, which
I just adored.
Senator Kennedy. Did you like my singing?
Dr. Walensky. Yes, I did. Thank you very much for doing
that.
Senator Kennedy. You are under oath, now, madam.
[Laughter.]
Dr. Walensky. Yes, I did--even so, I did.
Senator Kennedy. Thank you for that.
Dr. Walensky. Last Thursday, we released guidance that
demonstrated for an individual who is able--who is fully
vaccinated and not immunocompromised, that they are able to
safely unmask with the exceptions--certain exceptions, of
course, in travel corridors, healthcare settings, that if you
are an individual you can safely unmask if you are fully
vaccinated.
Senator Kennedy. Inside and outside?
Dr. Walensky. Inside and outside.
Senator Kennedy. Okay. What role do the State regulations
play with respect to that?
Dr. Walensky. We are working now to update all areas of
guidance, but here is what is really, I think, important to
understand. We are not a homogeneous United States. We have
counties that have less than 20 percent vaccinated.
Senator Kennedy. Yes, ma'am. But I don't want to get too
off, off the question here. If I walk over to the House of
Representatives, do I have to wear a mask?
Dr. Walensky. Those are locally-driven policies, but we
felt that it was important for the science to--for us to convey
the science of what is safe for individuals.
Senator Kennedy. Well, I am trying to understand the CDC
recommendations, and I appreciate it. Based on the CDC
recommendations, if I walk over to the House, are you
recommending I wear a mask?
Dr. Walensky. If you are--if you are by yourself walking
over to the House and you are fully vaccinated?
Senator Kennedy. No, ma'am. Once I am over there. I am
vaccinated. Once I am over there and I am talking to some of my
colleagues?
Dr. Walensky. We have really encouraged that the policies
of mask-wearing be locally driven. And the reason for that is
because every community, every county, has different rates of
disease and different rates of vaccination. And that is really
what----
Senator Kennedy. What is different about the House? Do you
know?
Dr. Walensky. I don't actively--I don't know the rate of
vaccination around the Capitol, nor the rate of disease around
the Capitol off the top of my head.
Senator Kennedy. Okay. What about airplanes?
Dr. Walensky. What is the policy on airplanes? Currently,
the policy on airplanes is to wear a mask.
Senator Kennedy. Okay. And why is it different on an
airplane as opposed to a restaurant?
Dr. Walensky. So the CDC provides guidance for what is safe
to do. The Federal policy is obviously an interagency policy
that we need to look at across different agencies. What I will
say though, is that there is very little choice when you board
an airplane as to----
Senator Kennedy. Right.
Dr. Walensky [continuing]. Who is going to be sitting next
to you, who is around you. And also, airplanes may be a place
where we have more variants, because of the travel from
international places.
VIRUS ORIGINS
Senator Kennedy. Okay; last question. What, in your
opinion, was the origin of the virus?
Dr. Walensky. This has been studied by the WHO----
Senator Kennedy. Ma'am, I am asking your opinion.
Dr. Walensky. I don't believe I have seen enough data,
individual data, for me to be able to comment on that.
Senator Kennedy. What are the possibilities?
Dr. Walensky. Certainly, the possibility is that most
coronaviruses that we know of are of origin from--that have
infected the population, SARS-CoV-1, MERS, generally come from
an animal origin, and----
Senator Kennedy. Are there any other possibilities?
Dr. Walensky. Certainly, a lab-based origin is one
possibility.
Senator Kennedy. Okay. Is the United States funding gain-
of-function research?
Dr. Walensky. Not to my knowledge.
Senator Kennedy. Okay. Can you give an answer to that for
me, and let us know, let the committee know?
Dr. Walensky. Dr. Fauci would be the one who knows best,
and he testified last week----
Senator Kennedy. Dr. Fauci seems confused. I am asking--
with all due respect--I am asking you to get us that
information. Where throughout the world, including, but not
limited to the United States of America, are we doing research
on these viruses to make them contagious in order to study
them? That is what I mean by gain-of-function.
Dr. Walensky. I understand. I understand. We certainly can
have our staff look into this. I don't know that we have access
to labs across the world, just the ones that are funded here in
the U.S.
Senator Kennedy. Yes. But you are the Head of the CDC. I
bet if you--I bet that you get your phone calls returned.
Dr. Walensky. Okay.
Senator Kennedy. Would you get us that information?
Dr. Walensky. I would be happy to give you the information
to the best of my ability.
Senator Kennedy. Okay. And I am going to do long--a
complete album of my singing. I will send you--I will send you
a courtesy----
Dr. Walensky. Would you sign that, please?
Senator Kennedy. Sure. Thank you. Thank you, both, for
being here.
Thank you, Madam Chair.
Senator Murray. Senator Baldwin.
Senator Baldwin. Thank you. Madam Chair.
MASKS IN WORKPLACES
I want to pursue a similar line of questioning that we just
heard from Senator Kennedy, with regard to masking guidance.
And when I reflect from the period of time when the pandemic
was first identified, the Department of Labor and the agency
charged with occupational safety and health, did not issue any
sort of emergency temporary standard with regard to workplaces
relating to this pandemic.
And, frankly, while there has been much work done on that
in this new administration, we don't have one yet, and so I am
just delighted by the progress we are seeing. Generally, I see
that light at the end of the tunnel, getting brighter, and
brighter, and brighter, and certainly the CDC's updated mask
guidance for those who are vaccinated is a reflection of that
progress.
But I am concerned about the impact of this guidance on
workers, and particularly those who work in crowded conditions,
such as meat-packing facilities, where we have seen horrendous
outbreaks in the past year.
So, Dr. Walensky, I am wondering when we can expect perhaps
more detailed guidance for workplaces, such as meat-packing
plants, and other crowded facilities where there is going to be
a mix of vaccinated and unvaccinated workers? And how that is
going to interact with the very recent CDC guidance on mask use
for those who are vaccinated? What should workplaces be doing
right now?
Dr. Walensky. Thank you so much, Senator Baldwin. The meat-
packing situation was really, really difficult, so many, people
affected and lives lost. And a real challenge for the Nation to
react to that.
Updating guidance for workplaces, including the higher-risk
ones is a high priority for us that we are actively working on.
As you know, the initial individual guidance came out last
week, but updating guidance for particular settings is
critical. Our National Institute of Occupational Safety and
Health is working closely with OSHA around getting the best
science to the Department of Labor who has regulatory
authority, but we are at CDC, updating our guidance for the
particular settings in light of the newer science.
Senator Baldwin. I appreciate that.
PUBLIC HEALTH COMMUNICATION
I want to ask a question of you, Dr. Schuchat, about the
importance of communication in public health. Early in the
pandemic, again, we had to get out a lot of information on what
COVID-19 is, how it is spread, what precautions people can
take. And, likewise, now we are in the vaccination phase, and
we have to communicate about its safety, efficacy,
availability, et cetera.
Last year, I wrote the CDC requesting that they provide
information on the spread of COVID-19 in Hmong language. The
CDC later updated their material, which was extremely helpful
for Wisconsin's vibrant Hmong community. But we also need to
make sure that we are doing exactly the same to make
information on the COVID-19 vaccine accessible and available
for all communities.
So, Dr. Schuchat, how is the CDC using what it learned from
sharing information about the spread of COVID-19 to communicate
the importance of getting vaccinated, to those who have limited
English proficiency? And will the CDC be making information on
the COVID-19 vaccine, and how to get vaccinated available in
more languages?
Dr. Schuchat. Yes. Thank you so much for that set of
questions. I think that communication has never been more
important, nor more difficult than the past year, and reaching
people with limited English proficiency has been really
important.
We have a toolkit available in 34 languages, and our
vaccine information, including our V-safe, the little app that
helps people follow side effects after getting vaccinated, is
available in multiple languages. But it is not just what we
say, it is how we say it, and who says it; and so one of our
strategies is working through trusted messengers and partners
of the community, from the community, who work with groups day
in and day out, and so part of our strategy is funding of
jurisdictions for them to have community-based groups really
get that message out in ways that are accessible.
These are really important issues, as we know. You know,
back to the meat-packing outbreaks, we had people speaking
multiple languages in very close quarters at risk for spread,
but also not necessarily knowing who they could trust in what
they should do. So we clearly want to get the vaccine
information to them.
Another thing I would mention is the partnership that CDC
and the administration has had with HRSA (Health Resources and
Services Administration), around the federally-qualified health
programs, because they have--the federally-qualified health
centers have a real concentration of patients served with
limited English proficiency, in both mobile clinics for
vaccination, and through community clinicians--community
vaccination sites. They have been able to reach those groups.
Senator Baldwin. And Senator, if I am might add, just real
briefly. One of the things that would be really helpful for us,
is working with those industries to encourage employers to get
their employees vaccinated, that time off, paid time off, to
ensure that they--when they returned to work they are
vaccinated.
Senator Murray. Thank you, Senator.
Senator Braun.
Senator Braun. Thank you, Madam Chair.
MASK GUIDANCE FOR VACCINATED INDIVIDUALS
Dr. Walensky, I am glad that the recent ruling was made
that if you are vaccinated, you don't need to wear a mask. I
think it was getting very confusing for not only getting more
people vaccinated because they were saying, well, why should I
get vaccinated if I still have to wear a mask? So thank you for
that.
But I do have a question. I know that on March 29, the
President was criticizing some governors about removing mask
mandates. And of course that now has changed. And I think the
reason is what I have just said. But what about, since the
science now, and the guidance is clear, what about local mayors
and governors that are not following the science, when that has
kind of been ballyhooed as the thing to do. I believed in that
from the get-go as well, especially when the tools were very
uncertain, distancing and all that stuff, made sense. And I
thought you were silly not to abide by it.
What about now? For the places that are--I think there is a
liberation feeling out there, and thank goodness for the Warp
Speed, and getting the vaccines in the arms. Is this
unnecessary for governors and mayors across the country to
still keep a mask mandate in place?
Dr. Walensky. Thank you for that question, Senator. We
released guidance on Thursday that said for individuals, if you
are vaccinated, fully vaccinated, you can take off your mask
with several exceptions. One of the things I think that is
really key in this is to recognize that we are not a
homogeneous country.
That there are some areas that--some counties that still
have less than 20 percent of people vaccinated. There are some
counties that still have greater than a hundred cases per
hundred thousand in a seven-day period of time. And so I
actually think, as I look at the map, a very heterogeneous map
of how we are doing with cases, how we are doing with
vaccinations, the decisions about whether to take off a mask
mandate will have to be made at the local level, have to be
made at the community level.
There are still some communities who are suffering. We know
African-Americans lost 2.9 years of life compared to White
Americans losing 0.8 years of life. And they are probably the
communities that got access to vaccines last. We are working on
that. We have had extraordinary improvements in our access to--
in our racial and ethnic minorities having access to vaccines.
But I do think that these need to be made at the local and
community level for exactly that reason.
Senator Braun. Do you think it will be confusing though,
even for those places that have lagged in getting their
citizens vaccinated to see that there is not that incentive in
place, even in the places that have been slower to do it, that
would be an encouragement. If they see people without a mask
and they say, well, they are vaccinated. I want to get one.
Dr. Walensky. I think it would be really amazing if our new
guidance got more people vaccinated, and was an incentive for
more people to get vaccinated. But I don't make CDC guidance,
my whole agency does not make CDC guidance based on what it
will help people do. We have to do it based on the disease that
is out there, the access to vaccines, and based on the science
that has emerged.
I really am hopeful that that will help to incentivize
people to get vaccinated, but that was not the reason for our
guidance.
COVID IN INDIA
Senator Braun. Okay. Another subject, since we are kind of
at least ebbing into a situation, it looks like here in the
U.S., other countries, some places it is still running rampant
like India. When do we turn the focus? And I think we have been
lucky that vaccinations have come this quickly, but
therapeutics would seem to be that final defense for anyone
that did not have a vaccination available. And now for the few
cases that could still slip through the cracks to where it is
impacted with so much data, such a small portion of the
population, disproportionately, and horrifically, elderly
predisposed with other conditions.
COVID THERAPEUTICS
When do we start turning our attention to helping them once
they get it? Because we are going to still have cases,
depending on variants, how strong they are, to where the
emphasis goes to therapeutics, and not vaccinations, especially
for places where the vaccine is generally working, but you
still want to have tools to help those who get it?
Dr. Walensky. Absolutely. And I know--first of all, I think
we are--you know, we are working now, we have said, if anyone
is not safe, then no one is safe. We really do need to make
sure that we have resources to other places, if variants emerge
they will come to our shores. So we have to be able to do that.
I also know that NIH has invested in making sure that we
have therapeutics. One of the first things that we had when I
was rounding on the wards last May, was Remdesivir. And that
was the first sign of an antiviral.
We don't have anything really that we can give quickly over
the--you know, by prescription to outpatients. Right now we are
relying on monoclonal antibodies. They are hard, they are
clumsy, they take a lot of resources, and they are expensive.
And so I do believe that we need, in this next phase, after we
get the majority of Americans vaccinated, we do need to turn to
antivirals that are able to be easily administered in an
outpatient setting.
Senator Braun. And a final comment. I think that is going
to be important because we don't know how much variants will
become an issue. And at some point when we have generally
tamped it down, I think it is incumbent on us to put focus on
how to help those that end up getting it, especially that are
so predisposed with bad outcomes. Thank you.
Dr. Walensky. Thank you.
Senator Murray. Thank you.
Senator Manchin.
Senator Manchin. Okay. Thank you, Madam Chairwoman.
Appreciate it very much. And I want to thank all of you for
being here.
Dr. Schuchat, first of all, thank you for your service,
many, many years of service. And I appreciate very much, what
you have done. And my first question would go to you because
you probably have the historical knowledge of how we got to
where we are.
VULNERABLE PUBLIC HEALTH SYSTEM
Over the last decade, the United States has lost over
50,000 public health jobs. And during that time we have faced
the H1N1 flu outbreak, Ebola, Zika, and now COVID, within the
last 5 years alone, West Virginia has lost nearly 30 percent of
our public health workforce. One thing we know from this
pandemic is that we were not prepared. While we have been able
to hire temporary public health workers in the last year, as
these positions they were not permanent, and are at risk of
disappearing after the public emergency, health emergency is
over.
So can you speak to how we became so vulnerable and fell
behind the curve in our ability to respond to this pandemic,
and how can we keep it from not happening again? I know you
have all touched on it, but I just cannot believe we were
this--we were this unprepared.
Dr. Schuchat. Yes. I think the state of our preparedness
was a real tragedy. And part of that relates to the public
health infrastructure over and over, we invest in response to a
crisis, but in ways that haven't provided sustainable capacity
at that frontline where the problems happen, so----
Senator Manchin. But these decisions made higher up within,
whoever the administration may have been, whether they were
Republican or Democrat. Was it made at that level? Or was it
made at the Head of the CDC?
Dr. Schuchat. The biggest funding increases we have gotten
have been emergency funds from Congress that, you know, happily
supported response for H1N1, and Ebola, and Zika, and COVID.
But the dollars that were there day in and day out to provide
reliable jobs for the local public health workforce were not
there. And whether it was State budgets or Federal budgets
that, you know, you cited the statistics of the job loss.
Beyond that, the jobs were not the same anymore. You know,
we talked about the data. Our data systems have really not kept
up with the times. We have very fragmented data systems that
have not been modernized.
Senator Manchin. And my time--my time is limited, and I
want to ask Dr. Walensky this question.
But on this Dr. Schuchat, what type of time basis would you
say that we should be looking at for funding? I mean, to have
confidence in the funding, permanent funding, over what, a 5-
year, a 10-year period? So it is consistent you know what you
can do and be prepared?
Dr. Schuchat. You know, I think the approach that was taken
for NIH to strengthen their capacity for vital biomedical
research is what needs to happen for the vital public health
infrastructure in the country, where it is not a feast and
famine.
Senator Manchin. Sure.
Dr. Schuchat. But that local, State, and Federals can plan.
Senator Manchin. And now will be the time to do it. If we
are ever going to do it, we should do it now, since it is all
very fresh in what we have been able to endure.
OPIOIDS IN WEST VIRGINIA
Dr. Walensky, as you are aware, we are facing an epidemic
within the pandemic, West Virginia is ground zero for the drug
epidemic, with the highest rate of drug overdose deaths in the
country. To make matters worse, 2020 was the worst year yet
with over 90,000 deaths, and we saw at least 47 percent
increase in the State of West Virginia with overdose deaths. So
what resources is CDC providing to States to combat the
epidemic?
Dr. Walensky. Thank you, Senator, for that question.
Senator Manchin. And also, I would have made--and the
second part of that would be: in working on helping--what CDC
is--are working on helping increasing the testing for viral
hepatitis and HIV? We have had a tremendous--horrendous
situation with that.
Dr. Walensky. I can tell you, just before coming here, I
spoke to one of my infectious disease colleagues in West
Virginia, and she was telling me that they have opened neonatal
detox units, I understand, that it is unbelievable.
Senator Manchin. Unbelievable, unbelievable.
Dr. Walensky. It is unbelievable. And so we know that we
need to tackle this. We need to counter this. We need accurate
data. We need interventions that can--and we need resources to
be able to invest in Opioid Naloxone Programs that are reaching
the community. Community health workers that can do the
outreach to talk to people and intervene at the local level
where these are happening, we need toolkits, we need
information, and mental health support services to intervene.
AMERICAN MEDICAL MANUFACTURING
Senator Manchin. Right. My time is running out. I want to
ask you that one other thing that--we produce very little of
the things that we basically needed for medicine, penicillin,
do you think penicillin should be produced in America? Do you
think doxycycline should be produced, an antibiotic in America?
And if so, what should we do in order to do that? Or stockpile
strategically for our own protection?
Dr. Walensky. I think we need to have a public health
infrastructure and a pipeline that allows us to respond to
pandemics, and to epidemics, and to infectious threats.
Senator Manchin. Do we have any manufacturers that are
producing these in America?
Dr. Walensky. There are limited manufacturers producing
penicillin, that I can talk to. Because, in fact, we have had
penicillin shortages, penicillin has gotten extraordinarily
expensive. And in fact, some colleagues of mine have once said,
it should be cheaper than the pipe--than the tubing it runs
through. And in fact, it is not.
Senator Manchin. Should the CDC basically--I mean, your
recommendation would be for production. We should be producing
these in America. You know, we need to have something from a
professional, like yourself, to get back to producing things in
American, and not depending on supply chains.
Dr. Walensky. So one of the things I can just mention for
penicillin specifically, is it is particularly hard given the
allergies related to penicillin. It is actually, particularly
hard to do. There are limited plants that make penicillin. But
your point is well taken.
Senator Manchin. Thank you.
Thank you, Madam Chair.
Senator Murray. Thank you.
Senator Moran.
Senator Moran. Chairwoman, thank you. Thank you and Senator
Blunt for this hearing. And welcome to our two Doctors, thank
you for service.
COLLABORATION ON BIODEFENSE FACILITIES
I have four questions I am going to try to accomplish in 5
minutes. Let me first highlight something that is occurring in
my home State. Kansas will soon be the home to the National Bio
and Agro-Defense Facility. It is a $1.25 billion research
facility, nearing completion. Its mission is to--or the
facility is to protect U.S. livestock from foreign animal
diseases, including zoonotic diseases that can pose significant
threats to human health. NBAF (National Bio and Agro-Defense
Facility) will be the first bio containment facility in the
U.S. where there is a BSL4 laboratory, which zoonotic pathogens
for which there no treatments, currently, exist.
NBAF is operated by the U.S. Department of Agriculture with
cooperation from the Department of Homeland Security, right, so
truly going to be as a state-of-the-art facility, COVID-19,
which possibly is a zoonotic disease, has only highlighted the
importance for the U.S. to invest in this type of research.
Are you engaged with USDA (U.S. Department of Agriculture)
or Homeland Security on future research that could be conducted
at NBAF in regard to the zoonotic diseases? What kind of
research NBAF would be able to provide you with benefits in
your mission of protecting human life?
Dr. Schuchat. Let me just say that what we call One Health,
the idea of human and animal health, and the environment has
been a global issue for preparedness and response. We have seen
so many terrible diseases emerge from the animals, and we have
not been sufficiently ready for them.
Whether we are dealing with the genetic sequencing of
strains, and whether the animals' strains have adapted better
to humans, or research into containment interventions, it is
really important. And so our principle of collaboration between
Health and Human Services, and the Department of Agriculture,
and Department of Homeland Security is very important.
I can say that the CDC and USDA both have oversight over
select agents that, you know, are evaluated in those BSL4
facilities. And we work very closely with them to make sure
that animal health is protected, and that human health is
protected, and laboratories that are sending these pathogens do
so safely without risk to the surrounding community.
As to exactly where we are with collaboration, I think we
will have to get back to you, but it's a--congratulations on
the facility. And I think we will look forward to working
together.
Senator Moran. This is a post\1/1\1 development, and
designed to replace the Plum Island and the research done there
on a new advanced laboratory. I would welcome the opportunity
to connect you and the folks at either Agriculture or--and
those in Kansas as well.
INTERNATIONAL COLLABORATION
What, if anything, is steps that CDC, or perhaps broader,
the Federal Government should do to bring China into this world
of helping us combat diseases, the spread of viruses? Is there
any opportunity for us to get better information, in any way
that we can insist, encourage or demand that China behave
differently than what they did, after the arrival of this--the
evidence of this disease in China?
Dr. Walensky. I think that we are all a global community at
this point, and that when there is a threat anywhere, there is
a threat everywhere. And so when it comes to our health, when
it comes to science, it is helpful to have these connections we
have in office, our regional office in China, where we exchange
scientific information. So I think around the global community,
it is important that we--that we convey scientific inference.
Senator Moran. What is your evaluation of what cooperation
occurred between China and the United States in regard to
COVID-19? And has anything changed to increase or decrease that
cooperation now?
Dr. Walensky. The WHO (World Health Organisation) has done
a study--has numerous interactions to evaluate this. My
understanding is that there is another phase of that study
underway. And I think that that is really critically important,
because quite honestly, and in my review of that study, and
many have spent many hours reviewing this study--these studies,
there was not a lot of transparency in line-level data that is
able--that we are able to use to interpret.
Senator Moran. Dr. Walensky, there is probably a longer
answer than that. And maybe we can have that when you and I
have a chance to have a conversation.
A couple of things in the 30 seconds I have left. I would
highlight that you and I have had this conversation, Dr.
Frieden encouraged me in regard to the Global Health Security
Program, and I have tried to be an advocate for that program in
this appropriations subcommittee, with some success.
And I just would--I am interested now, you don't have to
answer this question in the lack of time that I have for you to
do so, but I would love an answer that tells me how I should
prioritize. You have said it, what happens elsewhere matters to
us, and absolutely the truth and we have known that for a long
time, but how do we prioritize now with the consequences of
this pandemic in the United States?
How do we prioritize the appropriations that will go to
programs that are outside the United States, that are
protecting us as well as citizens of the world, as compared to
things that need to be done domestically, which are
significant? So I would love to have a broader discussion about
where those priorities should lie.
LEARNING LESSONS FROM COVID
And finally, I would indicate, I am reading a book, which I
do regularly, The Premonition, and I don't know whether you
have read it, but I am two-thirds the way through. It is not
terribly derogatory, but not terribly complimentary of the CDC.
And I would welcome any suggestions you have of what the
takeaway should be for the CDC, or if it is a book that is
worthy of learning something from.
Dr. Walensky. Thank you, Senator. I would be happy to
engage in those conversations. I have not read The Premonition,
although I know of it, and I know many people who are in it.
And what I will say is, there are many lessons that we can
learn, some things that we have to do better at the CDC, and
some things that we have to do better as a country, and
investing in multiyear public health infrastructure.
I think among the comments in the book that I am familiar
with was one of the issues that I heard firsthand, you know,
labs receiving results by fax and, you know, people working in
data entry to do that. That is not a public health
infrastructure of the future. It is not a way to respond to a
pandemic.
And so I think the lessons to be learned from the book, are
yes, we have to understand where things could have gone better
at CDC, and we need multi-year infrastructure resources to make
sure that we have, you know, work force, and data, and labs up
to snuff to tackle whatever they need to tackle in the future.
Senator Moran. It seems well written to me, and by a
credible author. And I would encourage you to learn from it, as
I am trying to.
Madam Chairwoman, the last comment I would make is. One of
the things, my takeaway is the failure for CDC to authorize
testing early on in circumstances in which it appears to me,
testing should have been occurring.
Senator Murray. Thank you.
Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman. And thank you,
Dr. Walensky, and Dr. Schuchat, for your service to the
country, and for being here this morning.
OPIOIDS IN NEW HAMPSHIRE
Dr. Walensky, I very much appreciated our conversation
earlier this week. And one of the things we talked about is the
continuing challenge of the opioid epidemic that we are facing
in this country. New Hampshire, like West Virginia, has been
very hard hit. We are one of the 10 States in the country that
has been hardest hit by the epidemic.
And I was pleased that Congress provided some new
flexibility to deal with the epidemic last year, by including
meth and cocaine as part of the drugs that could be included in
programs to address opioid--the opioid epidemic. But can you
talk--one of the things we discussed was the challenge that I
have heard from providers in New Hampshire that we don't have a
response for those overdosing on meth in the same way that we
have Narcan for those who have overdosed on opioids.
Can you talk about what the CDC is doing to approach this
issue and what kind of help you might have available for States
like New Hampshire?
COMMUNITY HEALTH WORKERS
Dr. Walensky. Thank you, Senator. You know, I am thinking
back to, sort of, 6 months ago and what we needed to do when we
knew that one of our patients had relapsed, and how we get them
into care. And it was our community health workers that knew
where to find them. They knew where they were getting their
drugs, and they knew where to find them, and to say, somebody
cares for you, and brought them back.
And that, I think, is what we need in our public health
infrastructure. We need the community workers who live in the
community, who are from the community to make those
interventions, to find the people. And that is really among the
things that I think this public health infrastructure is going
to be able to do. Certainly, we don't have something like
Naloxone for meth overdose and that, you know, is unfortunate
right now, and we need to address that.
And then quite honestly, we have statistics of the
overdoses and the lethal overdoses. They are terrible. And yet
we also have statistics of, you know, all these
hospitalizations that are happening among young people that I
was taking care of just 6 months ago, 30-year-olds getting
their second valve replacement.
So this is something that we have to tackle, and it is not
just that we have to tackle it with Narcan in a given
community. We have to tackle it community by community, because
there are all different kinds of communities, and we need the
workers to be able to do so.
Senator Shaheen. Well, thank you. I hope that--and I know
this is not a CDC issue--but I hope that you will weigh in, if
you have the opportunity, with the administration on the
importance of the set-aside funding for States like New
Hampshire that have been hardest hit, because that has allowed
us to up a real statewide response to the epidemic.
PFAS CONTAMINATION
I want to go on to PFAS, which is an emerging contaminant
until we get the EPA (Environmental Protection Agency) to
designate it as something else. But it is one that we have seen
very directly in New Hampshire, and especially appreciate the
response from the Agency for Toxic Substances and Disease
Registry, which has been so helpful in undertaking a
comprehensive health study in New Hampshire, Portsmouth, and
Pease former Air Force base, have been one of the sites
designated.
But one of the things we have learned is that too many of
our members of the medical community don't have any idea about
PFAS. They don't know what it is. They don't know how to
respond to it. They don't know whether testing is appropriate
or not.
And I worked with Chairman Murray and Ranking Member Blunt
last year to fund a grant program to help educate our
physicians. And I am very interested in how that unfolds, and
the work that the CDC might be doing to help an ATSDR (Agency
for Toxic Substances and Disease Registry) to educate our
medical community.
So I don't know if either of you can speak to that on the
update on where that effort stands.
Dr. Schuchat. This has been such a complex and challenging
area, and I really appreciate the leadership that you have
shown, and the----
Senator Shaheen. Thank you.
Dr. Schuchat [continuing]. Support you have given, and also
the advocacy for us to learn what we need to learn so that
people who have been exposed, and the clinicians that they see
know what to do to get a result, and then not know what it
means and what you are supposed to do about it is challenging.
So we really are incredibly grateful for the resources that are
letting us begin to pave the way to get those answers.
I don't have specifics on the results of studies yet, but I
know it is a very high priority for ATSDR and the leadership
here.
Senator Shaheen. And do you know that, at one point in the
last year, there was a suggestion that there was a connection
between exposure to PFAS and severity of COVID-19. Do we have
any more information about that?
Dr. Schuchat. You know, I know that question came up and
that we were looking into it. I don't believe we have a final.
But we can get back to you if we do.
Senator Shaheen. That would be great. Thank you. If you
could just let me know, either way, what we know about that, I
would appreciate it. Thank you.
Thank you, Madam Chair.
Senator Murray. Senator Capito.
Senator Capito. Thank you, Madam Chair. And thank you for
our witnesses today. Both of, Dr. Walensky and Dr. Schuchat,
and I wish you the best in your--we won't call it retirement--
in your repurposing. How about that? Wherever you may land?
Let me ask specifically. Senator Shaheen and Senator
Manchin mentioned, obviously, the overdose rates in the State
of West Virginia, so I won't go back through that. But I am
concerned.
HIV IN WEST VIRGINIA
Dr. Walensky, I know you have a focus on ending the HIV
epidemic. I know this is in your academic career as well. You
mentioned it in the President's budget. West Virginia received
a grant in the Integrated Viral Health--or Hepatitis, excuse
me, Surveillance targeted funds to help us address certain
areas, hotspots, I guess you would call them. But we are not--
we are not in ending HIV epidemic focused jurisdiction, nor any
of our counties. And in your testimony, you state that
increased funding in the budget is for four key strategies in
the focus areas, but not to increase the amount of focus areas.
So my question is, I think we need to be a focus area
because we have some of the highest incidence. And how do you
expand that footprint? Or, how can you help me with that?
Dr. Walensky. Thank you, Senator. As I think you noted, my
20-year career prior to January 20 was in doing exactly that.
And I was really encouraged by ending the--the mission to end
the HIV epidemic, really through a diagnosis, prevention,
treatment and response. And, you know, when the initial tranche
of HIV and the HIV epidemic money went out, it was to areas
with the highest numbers, with truly a multi-year plan to
expand to other areas that we needed to really curb things in
the areas with the highest numbers.
Take some of the lessons that we learned and expand to some
of the other areas. And so I have a vision, and hope that we
will be able to do that in the--in the years ahead, and to
continue that expansion.
Senator Capito. Thank you. Thank you. So expansion into
areas such as ours, I think that would be welcome. I would make
note that in the initial disbursement of the vaccine, our State
of West Virginia did an incredible job working with our public
health infrastructure. But I think one of the lessons that we
learned, and that I hope this becomes part of a manual to
address future issues, is public health infrastructure cannot
do this by themselves, not to what we saw at the--the breadth
of what we saw.
So what happened? We had volunteers, we had county city
governments, and we had our National Guard. And so I would
encourage you while, I think, increasing our public health
infrastructure is absolutely essential. I think growing those
partnerships could be even more essential because there is a
roadmap there to success. And so I just put that on your radar
screen, as you are--as you are looking to expand.
MASK POLICY JURISDICTION
One thing I would like to ask, and Senator Blunt and I were
in the Oval Office when the announcement was made with the
President that we were going to lift the mask mandate. And I
cannot tell you how joyful we all were as we ripped our masks
off and had a great meeting after that.
But there is confusion still. And, you know, if we are
going to get more people vaccinated, which is the ultimate goal
all the way down through the age levels, we cannot have this
confusion, because it is just: should I get my child
vaccinated? You know, should I--how old can my child be to get
vaccinated?
Does my child need to wear a mask at school? Who is the
ultimate decider here? Is that the CDC? Is it the President? Is
the governor? Is it the NIH? I mean, there is just too much
coming at young families in particular, I think, to be able to
feel, number one; that their child is safe, and they are doing
the right thing for them to go to school. But also to get rid
of that, I would say not anti-vaxxer, but vaccine hesitation. I
think that is a large part of the people that are left as yet
to be vaccinated. So how would you respond to that question?
Dr. Walensky. Thank you. The guidance that we put out on
Thursday was individual guidance for people who are fully
vaccinated can take off their masks.
Senator Capito. Right. Right.
COVID-19 VACCINES FOR CHILDREN AND ADOLESCENTS
Dr. Walensky. I have--or I was pleased actually the day
before that the FDA (Food and Drug Administration) had
authorized and the CDC had recommended vaccination with Pfizer
vaccine for individuals as young as 12 years old, that is now
recommended. And my 16-year-old has been vaccinated, and we
have a lot of community workers out there encouraging
vaccination of youth.
And, in fact, over 600,000 people between the ages of 12
and 15 have been vaccinated just in this last week. In terms of
guidance, the CDC provides science-based, evidence-based
guidance to anybody who is the consumer of said guidance,
whether it be industries, jurisdictions, importantly the
country is not uniform. And so I think you really do need to
interpret our guidance in the context of what is happening in
your community. And that is really important in the context of
a transmissible agent.
Why is that important? Because the virus is going to be an
opportunist, if you have a county that has low vaccination
rates and high rates of disease, that county may interpret our
guidance differently than a county that has high vaccination
rates, and low incidence of disease.
So we really do have to do this at the local level because,
in fact, the virus will--where there is less vaccination, the
virus will emerge.
Senator Capito. So what do you say to the under-12
population, elementary school? The parents of those children
who have low vaccination rates, which is probably close to
nothing, they have low incident of infection and, you know, all
the studies that show the younger generation is not as affected
as older and even more senior. What do you--what do you tell
them? Listen to your governor? Listen to your school Board?
Dr. Walensky. So what we would say is, vaccines are coming
for youth. We are hopeful to have, they are doing dose de-
escalation studies now down to 9 years old, soon thereafter
down to six, soon thereafter down to three, and then down to 6
months. So we are working towards getting a vaccine that will
be available for all people.
Senator Capito. So when would that be?
Dr. Walensky. Well, some of it depends on how much disease
is out there in the community. So we cannot exactly predict,
but we are hoping to have more available in late fall, and by
the end of the year but through dose de-escalation studies.
And then of course, I think that the guidance that we have
had for schools has actually demonstrated that even in the
absence of vaccinations schools can be a very safe place, given
the guidance that we have. We have recommended that schools not
change anything for this school year, because it will be hard
for our youth to get fully vaccinated before the end of this
school year. We will be updating that soon. And then given that
guidance it will be--there will be policies at the local and
jurisdictional levels.
Senator Capito. Well, I still think it--I mean, I know you
probably would agree that it is a bit confusing to folks all
around the country who have children in school. I would just--
just be as clear, and concise, and definitive, when this
science comes forward and more vaccinations come forward,
because I think it really is--it is really difficult, I think,
for parents to decide how to do the right thing. Thank you.
Senator Murray. Thank you. That ends our first round of
questions. And I will start a second round for any Senators who
wish to ask additional questions.
RACIAL AND ETHNIC DISPARITIES
And Dr. Walensky, I will begin with you. You know, the
pandemics deadly impact on communities of color show we do have
a long way to go to address systemic racism and health
inequities. Black and Latino populations are receiving
vaccinations at disproportionally low rates, even as some of
our recent polls suggest both groups are more likely than White
people to say they want to get vaccinated.
And according to the CDC website data on race and ethnicity
is available for just over half of vaccinated people. How is
CDC working to improve vaccination access and collect more data
on these demographic issues that we need to see in front of us?
Dr. Walensky. Thank you very much for that question,
because we are working hard. We have placed our community
vaccination centers, or mass vaccination centers in areas that
have high Social Vulnerability Index, they are doing an
extraordinarily good job in getting our minority communities.
Our Federal Retail Pharmacy Program sites were selected
initially, in collaboration with the State, to see how we could
get vaccine to the most vulnerable communities, to Black and
Brown communities. And just this last 2 weeks, Federal Retail
Pharmacy Programs, 47 percent of vaccines that they delivered
were to minority communities.
And then our federally-qualified healthcare centers, in
collaboration with HRSA, we have been delivering to people who
are migrant workers, to people in rural communities, and people
who have less access. One of the things we have been able to do
to improve our race and ethnicity data, and this has been
challenging because some people are electing not to report it,
is to use HIPAA (Health Insurance Portability and
Accountability Act)-compliant electronic case reporting, so
that we can use cases--or this is on the case level, not the
vaccine level, but looking at cases and then match it medical
records via Cerner, via Epic, to be able to get case-level
data.
We are working really hard with the counties to get both
racial and ethnic minority data at the case and disease level,
but then also the vaccination level. And this is, again, one of
the areas where data has--you know, our data infrastructure has
not been robust enough to deliver this to us in real time.
Senator Murray. Are you seeing any political ideology plan
to this decision to get vaccinated?
VACCINE HESITANCY
Dr. Walensky. This is a personal choice. I think once we
start saying: this group wants vaccine, this group doesn't,
then we start telling the wrong message. When I was taking care
of patients with HIV, and I was told--the new patient I had to
deliver a new diagnosis. They always said to me, you deliver
the diagnosis and then you pause, and you see what means to
them, right?
Could it mean that they are worried about their baby, they
are going to lose their job, they think they are going to die,
they can't afford their meds? I think vaccines hesitancy is
exactly this.
What is it about the vaccine that is making you hesitant?
Is it that you are scared? Do you have to take the day off of
work to get it? Is it that you saw a friend get it and they had
a reaction? Is it that, wow, how did the science come so fast?
And so this is not about politics, this is about
understanding where individuals are, meeting them where they
are, and understanding what it is that is making them--making
them hesitant.
Senator Murray. Okay. Thank you.
VACCINES IN PREGNANCY
Dr. Schuchat, recent research on the impact COVID-19
infection has on pregnant women is really alarming. One study
last month showed pregnant women with COVID-19 are 22 times
more likely to die compared to women who are not pregnant who
contract the virus. What is the latest vaccine guidance for
pregnant women?
Dr. Schuchat. Yes. Thanks so much for that issue. COVID
complicates pregnancy, so women who are pregnant and get COVID
have worse experiences with the infection, than do non-pregnant
women. More time in the intensive care unit, more risk of
severe outcomes, including those rare deaths. COVID also
complicates pregnancy by increasing the risk of prematurity,
and leading to other types of complications.
While, as you know, clinical trials rarely enroll pregnant
women, we are fortunate that there has been intense effort to
get data about women who do get vaccinated while pregnant, to
understand what happens, so that other women can learn from
that.
Based on what we know right now, we recommend that women be
offered vaccines during pregnancy, that they are eligible to
get them, and that they make a choice about it; that choice
might be based on how they value that risk or that unknown. But
we do have reassuring data right now about vaccines given,
particularly in the third trimester that have been followed and
reported. We are continuing to follow and working closely with
FDA on that. And so we will be expecting this summer to have
even more data, particularly about vaccines given earlier in
pregnancy.
Senator Murray. Is there any research about pregnant or
lactating women who are vaccinated--who are vaccinated,
transferring antibodies to their infants?
Dr. Schuchat. We have emerging data that the antibody is
transferred. And so we hope it will be like the influenza,
where, getting vaccinated during pregnancy against influenza is
really important because newborns and young children are very
high risk for influenza complications. So, good news so far,
and continuing to follow that.
Senator Murray. Thank you.
Senator Blunt.
Senator Blunt. Thank you, Chair.
VACCINE BOOSTERS
The issue of a booster vaccine obviously is out there, so
far most of the people that have said they think we are going
to need it are from the companies that are making the vaccine.
Dr. Fauci, former CDC Director Tom Frieden, others have said
there is growing evidence that there will be enduring
protection with the vaccine we have.
Now, I have been a big supporter of the Warp Speed effort
to invest early in vaccines that were not approved yet, which I
think made a big difference in availability. I do question the
BARDA (Biomedical Advanced Research and Development Authority)
decision to purchase 400 million doses of Moderna and Pfizer as
a booster dose.
Were you asked about whether that was the right decision to
make or not? And if you weren't, should CDC be involved in a
$7.9 billion decision about a booster before we know whether we
need one or not?
Dr. Walensky. Thank you, Senator. I think the first thing
to recognize, and this has been miscommunicated, so I think it
is very important, in the media, is that if you have received
two doses of your Pfizer and Moderna vaccine, you are right now
protected.
Senator Blunt. Right.
Dr. Walensky. What we are looking at is whether we will
need boosters over time. And I think that this is really--given
how hard we were hit by this pandemic, I think it is really
important to understand where we will be with that. Data
suggest from SARS, not SARS-CoV-2, but from SARS, that is
similar to coronavirus, that people have waning immunity over
time.
And if you looked at what happened in the SARS outbreak
several years ago, you saw that people were eligible for
reinfection. So there is biologic plausibility that there would
be waning immunity after you were infected. And we just don't
know when that will be.
One of the concerns has been that if we first vaccinated
our very most vulnerable, our people in nursing homes, that
they may not have had as robust a response, and that they might
be the first to--they would be a first who would need a booster
anyway, because they were vaccinated first. But in fact that
they may not have had a robust response is in----
Senator Blunt. If we spend $7.9 billion, which I guess we
did decide to do on May the 2nd, do we think those vaccines
last for some time?
Dr. Walensky. I am not under the impression those are being
made right now. I think part of the issue is what do they need
to look like? Are we going to boost with the exact same mRNA
structure as we do now? Or might we want to boost with a
variant structure? And I think those are all conversations that
are happening.
Senator Blunt. Yes. Well, I think that is a pretty big
spending decision to make based on the information we have. But
we can talk about that more, later. If we do go forward with
booster vaccines, are you all working to see if in an adult
immunization program, we would try to combine more things with
that booster? A flu shot, or whatever other shot that an adult
might need at this point?
Dr. Walensky. I think it is pretty clear that we have had
an immunization program for adults that was not prepared for
what we needed in this, in this structure.
Senator Blunt. Right.
Dr. Walensky. And yes, I think it would be advantageous.
Currently, we don't have data as to whether you can co-
administer vaccines, those data we are looking for. And in
fact, the ACIP (Advisory Committee on Immunization Practices)
just opined on this last week, because we are so behind on
childhood immunizations, 11 million behind on childhood
immunizations. So those are all the data that we are looking
for, because I think it would be really great to be able to
leverage what we are doing for COVID for influenza as well, and
vice versa.
DATA MODERNIZATION
Senator Blunt. Exactly. And I hope you will keep us posted
on that as that happens. On data, that was actually where I was
going next. You know, the data, we obviously had a data
shortage, a shortage and some confusion about what data to
input, which was not as helpful as it might have been.
Now, the committee, in what was then a fairly controversial
decision, even among our colleagues, we decided, before COVID,
to invest $50 million in base funding over the last 2 years for
data. When COVID occurred, you know, and the numbers we were
suddenly looking at and dealing with, we did another $500
million.
Dr. Schuchat, tell me where you think we are on better data
preparation in the future? Or being better ready in the future
to have data, and the tracking that comes with data? Where are
we, and where would you think--that had CDC in the next fiscal
year, for instance?
Dr. Schuchat. This is essential. The $50 million base
appropriations were vital, but you saw how behind we were. This
is critical. We are so far behind, even with the increased
resources. This is a long-term need; we are better, but we are
not where we need to be. We have made huge progress this past
year with electronic lab reporting of enormous numbers in terms
of how many people were being tested, and getting us daily
data. But the data were not necessarily complete, and as you
heard the race/ethnicity data often missing.
We have a need to move to the cloud for many of our
systems. We have a need to become--have a workforce that can
handle the data at the local level, at the State level, that
can use these sophisticated tools and not just react, but
predict. So we still have a long way to go, but COVID, we have
made a lot of progress on. We need to make that progress across
the spectrum of public health issues.
Senator Blunt. Well data, and tracking, and other things I
think are an important part of the future of health. And we
want to be helpful. And I would hope that the $550 million,
collectively, in the last couple of years has made a
substantial difference in where we are headed.
Thank you, Chair.
Senator Murray. Senator Blunt. Thank you.
I have one additional question for you. The CDC faced
unexpected difficulties, as we all remember during those
opening phases of the pandemic, especially around testing, and
delays in establishing a large-scale testing, likely allowed
the virus to spread undetected, as we know, one of the several
factors that really hampered our efforts to contain that
outbreak.
EARLIEST COVID LESSONS
Dr. Walensky, I just wanted to ask you today, what lessons
has CDC learned from the experience in those first few weeks?
Dr. Walensky. There has been a lot of research going into
what we could have done better during that period of time. My
responsibility is to own that and to make sure that we are
better. Among the challenges were quality--assurance quality
control programs that were not in place the way they should
have been. And in fact, among the things that we are doing is
to ensure that all labs, research and diagnostic labs are fully
accredited.
So we are learning those lessons. Those were hard lessons
to learn. I do also think that we need to recognize that among
CDC's responsibilities is that when we have a new infectious
pathogen, we are responsible for creating the diagnostics for
that pathogen. Once we have done so, we need interagency
collaboration with ASPER, with FDA to make--with the private
sector to ensure that we can bring it to scale.
We are now at 1.1--we did one million tests yesterday, we
are testing one to two million a day. That scale up has to be
interagency. And so, yes, we have a lot of lessons that we can
learn from what occurred, and we are learning them and taking
resources that have been provided to us so that we can, not
just take a line--a line item and improve X-lab, but we can
improve all of the labs and through this accreditation process,
for example, but then also to be able to scale at the national
level.
Senator Murray. Okay. Thank you. Thank you very much. That
will end our hearing today.
But I do want to thank both Director Walensky, and
Principal Deputy Director Schuchat for joining us.
Thank you to all of our colleagues on the committee who
participated as well.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due one week after the
President's budget is delivered at 5:00 p.m. The hearing record
will also remain open until then for members who wish to submit
additional material for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Dr. Rochelle Walensky
Questions Submitted by Senator Patty Murray
Question. Researchers in the United States continue to discover new
variants of the coronavirus that are spreading throughout the country.
Congress provided $1.75 billion in the American Rescue Plan for CDC to
increase genomic sequencing of SARS-CoV2 to identify emerging variants.
President Biden's fiscal year 2022 budget proposal includes $8.7
billion for the CDC, a $1.6 billion increase from fiscal year 2021's
budget.
How will the CDC's budget be used to help state and local public
health offices expand their surveillance capabilities to keep pace with
new and emerging variants?
Answer. In May 2021, CDC awarded $240 million in American Rescue
Plan (ARP) funds to state and local health jurisdictions to build
sequencing and analytic capacity for all pathogens of interest,
including SARS-CoV-2. CDC plans to fund these state and local labs for
additional years, with ARP funds, to continue and to build on these
activities, including funding support for equipment, supplies, and
staffing. These activities build on expertise gained through the
Advanced Molecular Detection (AMD) program. In addition, CDC is
currently soliciting proposals for construction and renovation costs
necessary to modernize the sequencing units of the nation's public
health labs, which will also be funded through ARP funds. All of these
labs are currently sequencing bacterial foodborne pathogens, and at
last count, more than 60 labs were sequencing SARS-CoV-2. A subset of
these labs are sequencing other pathogens, such as antimicrobial-
resistant bacteria and fungi, influenza virus, and the agents of
tuberculosis and Legionnaire's disease. The number of labs sequencing
these pathogens, as well as the number of pathogens they are
sequencing, is expected to increase with the availability of these
funds. CDC is also providing technical assistance, as well as support
in planning and administration.
Question. How long will it take to revitalize all state and local
jurisdictions so they are equally equipped to help stop the spread of
COVID-19 and other future disease outbreaks?
Answer. All state public health laboratories, and an increasing
number of county/local public health laboratories, have the potential
to perform next-generation sequencing. At the beginning of the
pandemic, the main limiting factors were (1) limited staffing; (2) the
large number of competing priorities in responding to the pandemic; (3)
a lack of bioinformatics capacity; and (4) limited experience and
knowledge among epidemiologic staff in how to use genomic data as part
of the response. With the long-term investments to strengthen public
health infrastructure as proposed in the fiscal year 2022 Budget,
including public health laboratories, we will be in a better position
to respond and control future outbreaks. With experience from COVID-19,
these organizations are already in a better position to apply genomic
epidemiology during the next public health emergency. But over the next
three to 5 years, with both the investments above as well as
investments in the sequencing Centers of Excellence (also supported by
the ARP funds) and large increases in training, state and local
jurisdictions will be in a much better position to apply genomics to
intervene at the start of a public health emergency.
Question. Thus far, the available COVID-19 vaccines protect against
most of the variants currently circulating. A group of biostatisticians
at Fred Hutchinson Cancer Research Center, based in Seattle, WA, are
studying breakthrough infections of COVID-19 following full vaccination
to determine which variants are able to evade the body's immune
response. By understanding the correlation between needed level of
protection and infection prevention, they hope to simplify the process
of booster shots or vaccines against new variants.
What other research or studies would the CDC conduct to make sure
the United States can quickly and proactively protect people from new,
and potentially more dangerous, variants?
Answer. CDC has monitored for variant viruses since the beginning
of the pandemic and continues to monitor for variants nationwide, in
support of ongoing efforts by the SARS-CoV-2 Interagency Group. We use
genomic information in combination with hospitalization and other case
and outcomes data to identify the spread of, and potential consequences
of, variants of concern.
CDC leads the National SARS-CoV-2 Strain Surveillance (NS3)
program, which identifies new and emerging SARS-CoV-2 variants to
determine implications for COVID-19 diagnostics, treatments, and
vaccines authorized for use in the United States. Genomic sequencing
allows scientists to identify SARS-CoV-2 and monitor how it changes
over time into new variants, understand how these changes affect the
characteristics of the virus, and use this information to better
understand how it might impact health. A notable strength of NS3 is the
regular collection of specimens from across the United States to
support variant characterization efforts, which provides important data
to inform public health decision-making.
Since January 2021, CDC has significantly increased domestic
genomic surveillance platforms to monitor circulating viruses. NS3 was
scaled up to process 750 specimens per week from public health
laboratories across the U.S. CDC also is contracting with large
commercial diagnostic laboratories to sequence samples. CDC has
commitments from these laboratories to sequence more than 20,000
samples per week, pending the availability of SARS-CoV-2 positive
specimens, with the capacity to scale up in response to the nation's
needs.
Since 2014, CDC's Advanced Molecular Detection Program has been
integrating next-generation sequencing and bioinformatics capabilities
into the U.S. public health system. Many state and local health
departments have been applying these resources as part of their
response to COVID-19. Public health departments support local
investigations, conduct studies, and make genomic data available to
public databases. To further support these efforts, on December 18,
2020, CDC released $15 million from COVID supplemental funds through
the Epidemiology and Laboratory Capacity Program.
In May 2021, CDC made available $240 million in American Rescue
Plan funds to state and local health jurisdictions through the
Epidemiology and Laboratory Capacity for Prevention and Control of
Emerging Infectious Diseases (ELC) cooperative agreement. These funds
are to be used over 3 years to build sequencing and analytic capacity
for all pathogens of interest, including SARS-CoV-2. In addition, CDC
plans to fund these state and local labs for at least an additional 3
years, with ARP funds, to continue and to build on these activities,
including funding support for equipment, supplies, and staffing. These
activities build on expertise gained by the Advanced Molecular
Detection (AMD) program since 2014 in the application of pathogen
genomics to public health.
Furthermore, we have issued 29 awards, totaling approximately $37
million, as part of the SARS-CoV-2 Sequencing for Public Health
Emergency Response, Epidemiology, and Surveillance (SPHERES)
Initiative. These awards are intended to fill knowledge gaps and
promote innovation in the U.S. response to the COVID-19 pandemic and
will help integrate next-generation genomic sequencing technologies
with bioinformatics and epidemiology expertise across the US public
health system.
As CDC and our public health partners sequence more SARS-CoV-2
genomes, we will continually improve our understanding of which
variants are circulating in the US, how quickly variants emerge, and
which variants are of most concern to public health, and thus the most
important to characterize and track.
Question. Is the CDC continuing to monitor other public health
concerns such as influenza?
Answer. Yes, CDC has continued to maintain and strengthen its
surveillance systems during the COVID-19 pandemic. For example, in
preparation for the 2021-2022 influenza season, CDC made several
enhancements to influenza surveillance systems, which improve detection
of influenza circulation and illness, to differentiate influenza from
COVID-19, and support COVID-19 surveillance. Data enhancements include
adding more than 1,000 emergency departments to the U.S. Outpatient
Influenza-like Illness Surveillance Network (ILINet), adding new data
sources from the National Long Term Care Facility Surveillance system
that reports data from approximately 15,400 facilities weekly, and
integrating HHS Protect hospital data from approximately 6,000
hospitals. Differentiation between influenza and COVID-19 is supported
by the CDC-developed multiplex assay for use by CDC-supported public
health laboratories, which simultaneously tests for type A and B
seasonal influenza viruses and SARS-CoV-2. These and other updates have
further strengthened the U.S. influenza surveillance system.
Question. I am alarmed by increasing antimicrobial resistance, and
the fact that high levels of antibiotic use during the COVID-19
pandemic have likely driven the development of new resistance threats
that have not yet been identified. The 2020-2025 National Action Plan
for Combating Antibiotic Resistant Bacteria calls for expanded efforts
that will only be possible with significant new Federal resources.
Addressing AMR is central to preparedness, as resistant secondary
infections complicate public health emergencies.
How does the President's Budget Proposal support the CDC Antibiotic
Resistance Solutions Initiative in fiscal year 2022 to expand efforts
to preserve the effectiveness of antibiotics, reduce inappropriate
antibiotic use, increase surveillance and ensure that we are prepared
to address this public health threat, as outlined in the 2020-2025
National Action Plan for Combating Antibiotic Resistant Bacteria?
Answer. The fiscal year 2022 President's Budget has $172 million
for the Antibiotic Resistance Solution Initiative, consistent with the
fiscal year 2021 appropriation. CDC is working to effectively leverage
resources and invest in key prevention strategies, such as early
detection and containment, infection prevention, and ensuring the
appropriate use of antibiotics. The availability of safe, effective,
and quality-assured antibiotics underlies much of modern medicine, and
the emergence and spread of AR threatens to undo this progress at
enormous human and economic cost.
COVID-19 has potentially created a perfect storm for antibiotic
resistance (AR) infections in healthcare settings, with longer lengths
of stay, crowding, severely ill patients, antibiotics frequently
prescribed upon admission, and infection control challenges like PPE
shortages. CDC supports a robust domestic infrastructure through its AR
Solutions Initiative to respond to emerging threats wherever they occur
across healthcare, the community, and the environment while building
key capacity to address AR internationally. CDC continues to use a One
Health approach to tackle AR and to gain a better understanding of AR
transmission, interactions, and impact between humans, animals, and the
environment.
CDC has also proposed ambitious plans to strengthen international
public health infrastructure as outlined in the 2020-2025 National
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). Over
the next 5 years of the plan, it proposes that CDC would establish two
networks--the Global Action in Healthcare Network and Global
Antimicrobial Resistance Laboratory & Response Network, which would
expand CDC's surveillance efforts globally.
Working together, these new global networks would enhance detection
and response to infectious disease threats internationally, and
implement prevention and containment strategies at local, national, and
regional levels. CDC also has proposed plans to expand surveillance of
AR threats in the environment, domestically and globally. These
activities would help to better understand resistance in the
environment, the connections between resistance in healthcare,
agriculture, and environmental settings, and its impact on human
health. CDC is piloting investments in these activities in fiscal year
2021.
Question. The COVID-19 pandemic laid bare the gaps resulting from
decades-long erosion of support for the public health workforce, which
did not have the people or resources needed to surge to meet the
demands of the emergency response. Strategic investments in a diverse,
robust, well-trained public health workforce at the community level are
critical to ensure that we are able to tackle local public health
challenges and be prepared for the next infectious disease outbreak.
President Biden's fiscal year 2022 budget proposal includes a request
for $106 million, a $50 million increase above fiscal year 2021, to
develop the next generation of essential public health workers.
How does CDC envision this proposed investment in fellowship and
training programs will translate in rebuilding the public health
workforce of epidemiologists, contact tracers, lab scientists,
community health workers, data analysts, behavioral scientists, and
communicators?
Answer. The COVID-19 response shone a stark light on deficiencies
in the nation's investment in its public health workforce, which did
not have the people or resources to surge to meet the demands of a
pandemic emergency response. Strategic investments in a diverse, well-
trained public health workforce are needed. CDC's fellowships and
training programs continue to supply a competent and sustainable
workforce capable of surging in response to imminent public health
threats.
CDC hosts approximately 300 fellows across seven fellowship
programs each year in 45 U.S. states and five territories. In fiscal
year 2021, all 137 EIS officers and Laboratory Leadership Services
(LLS) fellows contributed to the COVID-19 response, leading COVID-19
responses in their assigned states and publishing key findings in the
MMWR leading to actionable recommendations around mitigating the spread
of disease. CDC designs its fellowships and curricula to meet the
evolving needs of the public health workforce. A survey of human
resources directors identified the highest priority workforce needs as
epidemiologists, laboratory scientists, and public health informatics
specialists. CDC's fellowships are a pathway for training the next
generation of public health leaders.
Actions taken now to invest in developing the next generation of
essential public health workers will better position our communities
and the nation to respond to the current pandemic and to build back a
better workforce to safeguard Americans' health. With the fiscal year
2022 request of $106,000,000 for Public Health Workforce, CDC will
rebuild the workforce of epidemiologists, contact tracers, lab
scientists, community health workers, data analysts, behavioral
scientists, and communicators who can help protect America's health.
While health departments are the frontlines of emergency response,
Federal investment in workforce development is essential to a
coordinated national health workforce strategy. In fiscal year 2022 CDC
will:
--Expand the pathway of critical public health workers through
fellowship programs; assisting state, tribal, and local health
departments to conduct barrier assessments and implement best
practices for recruitment, hiring, and retention, and
publishing training materials for state, tribal, and local use
and STEM resources highlighting pathways to careers in public
health.
--Modernize workforce development information technology systems.
--Increase participants in CDC fellowship programs and place them in
areas of critical need.
CDC will invest in understanding barriers and facilitating
solutions around matching graduates in critical discipline areas with
positions serving local, tribal, and state communities. Developing
robust pathways to attract graduates to public health is essential to
future health security of the United States.
CDC will expand fellowship opportunities, from the Public Health
Associate Program to Epidemic Intelligence Officers. CDC will enhance
recruitment efforts and pave pathways for careers in public health at
the Federal, state, tribal, and local levels. Increasing the cohort of
EIS officers will provide critical applied learning and pathways for
the next generation of public health leaders. CDC will increase the
number of fellows in the field that provide essential assistance and
expertise to CDC and state, local, territorial, and tribal health
departments.
CDC will also strengthen the laboratory workforce to support
clinical and public health laboratory practice. Of the 800,000
laboratory professionals who work across 295,000 CLIA-certified
laboratories, less than 10 percent of the nation's clinical laboratory
professionals currently access CDC training and workforce development
resources. CDC will:
--Expand the reach of CDC's training and workforce development
resources beyond the public health laboratory community into
the broad clinical laboratory community, including those who
perform point-of-care testing, building critical bridges
between healthcare and public health.
--Continue data-driven development, promotion, and dissemination of
laboratory capacity- building initiatives and resources that
enhance the laboratory community's ability to combat emerging
threats, learn evolving practices, and stay current with the
newest standards and technologies
--Formalize partnerships to expand its reach and accessibility of its
training products and resources to the laboratory community
through its learning course syndication system.
--Expand development of its virtual reality training portfolio to
meet the evolving needs of laboratory professionals.
Question. How will state and local health departments benefit from
an expansion of these training programs?
Answer. With investment in CDC's fellowship and training programs,
CDC will rebuild the workforce of epidemiologists, contact tracers, lab
scientists, community health workers, data analysts, behavioral
scientists, and communicators who can help protect America's health.
These investments are essential to build a competent and empowered
public health workforce prepared to respond to future public health
emergencies. CDC will work with state, tribal, local, and territorial
health departments to rebuild the workforce and support these partners
to assist in hiring and recruitment; identify and address barriers to
hiring at the state and local levels; address workforce gaps; and build
capacity to respond to current and future public health threats. These
funds will support recruitment and training of public health leaders
through Epidemic Intelligence Services (EIS), Laboratory Leadership
Service fellowship programs, and Public Health Associate Program
(PHAP). They will complement other initiatives including:
--Public Health AmeriCorps, a new public health workforce program in
partnership with AmeriCorp, supported by investment from the
American Rescue Plan, will deploy a nationwide cohort of
workers, who will receive applied learning training and a
stipend in non-Federal term positions.
--Modernization of the public health workforce in which CDC will work
with public health leaders across Federal, state, local, and
territorial jurisdictions to create a new grant program to
provide under-resourced health departments with the support
they need to hire staff and build a public health workforce for
the future.
______
Questions Submitted by Senator Jeanne Shaheen
Question. Given that diabetes is one of the co-morbid conditions
that puts patients with COVID-19 at highest risk, I was pleased to see
CDC guidance that recommended prioritization of both Type 1 and Type 2
diabetes patients for vaccination. With 34 million Americans currently
living with diabetes, the economic cost of the condition now exceeds
$300 billion per year. Now more than ever, we need to do more to help
prevent Type 2 diabetes where possible and help people with diabetes
improve their management of the condition, so that we can see improved
outcomes.
How is CDC approaching the rapid growth in diabetes prevalence in
this country and what can we do in Congress to help?
Answer. CDC established the National Diabetes Prevention Program
(National DPP) to address the growing epidemic of type 2 diabetes. The
National DPP lifestyle change program is led by trained coaches who
facilitate participants' strategies for eating a healthy diet,
increasing physical activity, and developing coping skills. The
Diabetes Prevention Program clinical trial showed that participants who
engage in these lifestyle changes through a structured program can lose
five to 7 percent of their body weight and reduce development of type 2
diabetes by as much as 58 percent (71 percent for those 60 years of age
and older).
CDC supports state health departments and other stakeholder
organizations in expanding access to the National DPP for populations
at greatest risk for type 2 diabetes. Achieving insurance coverage is a
critical step for increasing access to this highly effective program.
Based on recipient reported data from September 30, 2018 to June 30,
2019, state health departments and other partners have secured health
insurance coverage for the National DPP for more than 1 million public
employees and their dependents in 24 states. In addition, the National
DPP lifestyle change program is currently a covered benefit for more
than 2.2 million private sector employees and their dependents across
21 states, a 61 percent increase from 2018. More than 1.4 million
Medicaid beneficiaries have the National DPP lifestyle change program
as a covered benefit, which includes participation from 30 states.
In March 2016, the Centers for Medicare & Medicaid Services (CMS)
certified the expansion of the National DPP into the Medicare program.
This was the first preventive service model from the CMS Innovation
Center to become eligible for expansion into the Medicare program--a
landmark for public health. The future of the MDPP as a covered service
will be determined by the outcome of the CMS Innovation Center's
expanded model evaluation. However, based on findings from the original
DPP research trial, subsequent translation studies demonstrating the
program's effectiveness in non-clinical settings, and the 15-year
results of the DPP Outcomes Study, this intervention has been studied
extensively and already has substantial evidence supporting its
effectiveness across settings and populations.
Question. Can you provide an update on CDC's investments in the
Division of Diabetes Translation (DDT) and the National Diabetes
Prevention Program (NDPP)? How is CDC measuring success for those
programs?
Answer. More than 550,000 people at high risk for developing type 2
diabetes have participated in the National DPP lifestyle change program
across the U.S. Evaluated participants have lost an average of 5.5
percent of their body weight. To date, there are almost 1,900 CDC-
recognized organizations offering the program in-person, virtual and
through distance learning. CDC aims to enroll 1 million participants
into the National DPP lifestyle change program by 2025.
Since the onset of the COVID-19 pandemic, a majority of the CDC-
recognized organizations are offering virtual (telehealth) options for
the National DPP lifestyle change program, an especially critical
feature to ensure participant safety. A 2017 study (Vadheim, L.M, et
al., 2017) found that participants who received the National DPP
lifestyle change program through telehealth videoconferencing (distance
learning) had similar rates of participation and achieved similar
weight loss as participants who attended the program in-person.
Through implementation of the National DPP, CDC aims to reduce the
number of adults newly diagnosed with type 2 diabetes. The national
rate of diabetes incidence (6.4 new cases per 1,000 adults in 2018) has
successfully moved below the Healthy People 2020 target (7.2 new cases
per 1,000 adults). The continued growth of the diabetes burden in terms
of absolute prevalence, lifetime risk, years spent with diabetes, and
the incidence rate remaining considerably higher than it was in the
1990s, are all contributing factors indicating a need for continued
prevention efforts like the National DPP.
Question. The COVID-19 pandemic has exacerbated challenges in our
response to the substance use disorder epidemic. As you know, the 2020
state-level CDC data on opioid overdose deaths will also dictate the
distribution of Federal opioid response dollars through the State
Opioid Response (SOR) grant program administered by the Substance Abuse
and Mental Health Services Administration (SAMHSA).
When does CDC expect to publish state-level data for 2020 on drug
poisoning deaths per capita? When CDC does publish the data, please
keep my office informed.
Answer. The National Center for Health Statistics provides
provisional drug overdose death data by state: Products--Vital
Statistics Rapid Release--Provisional Drug Overdose Data (cdc.gov).
Provisional data currently provides information on drug overdose deaths
occurring through October 2020. Final drug overdose death data for 2020
will be available in late 2021.
Question. Often there are discrepancies in state rankings on opioid
overdose deaths per capita compared to overall drug poisoning deaths
per capita. For instance, in examining CDC's WONDER data on 2018 opioid
overdose deaths per capita, as reported by the National Institute on
Drug Abuse (NIDA), compared to CDC's publication of 2018 overall drug
poisoning deaths per capita, New Hampshire ranks third in opioid
overdose deaths per capita and sixth in overall drug poisoning deaths
per capita. Will CDC publish data on opioid specific overdose deaths
per capita by state for 2020, as a supplement to its publication of
overall state-by-state drug poisoning deaths per capita in 2020?
Answer. Yes. In addition to drug overdose death data (including
deaths attributed to opioids) CDC provides analyses on final drug
overdose death data, including deaths related to prescription opioids,
heroin, synthetics opioids, and psychostimulants. CDC will update the
data once final 2020 overdose data are available.
CDC currently funds 47 states and the District of Columbia to
improve the timeliness and comprehensiveness of unintentional/
undetermined drug overdose mortality data. The State Unintentional Drug
Overdose Reporting System (SUDORS) captures detailed information on
toxicology, death scene investigations, route of administration, and
other risk factors that may be associated with a fatal overdose from
funded recipients. CDC continues to release analyses of data received
through this program. For example, CDC published a report describing
decedent demographic characteristics and circumstances surrounding
overdose deaths during January--June 2019 among 25 jurisdictions
participating in SUDORS, and it highlights the involvement of opioids
and stimulants, separately and in combination.
Question. I was pleased to see that the administration's budget
proposal calls for a continued commitment to efforts to defeat HIV in
this country. At the same time, we are also seeing significant
increases in the spread of sexually-transmitted diseases, including a
heartbreaking 40 percent increase in congenital syphilis passed from
mother to child during pregnancy in recent years. I have been concerned
that we have underfunded state and local STD prevention efforts for a
long time, which may impede our abilities to stop the spread of STDs.
Can you discuss how CDC is addressing growing rates of STD
infections, and congenital syphilis infections in particular?
Answer. CDC provides national leadership, research, policy
assessment, and scientific information about STDs to the medical
community and the public. CDC coordinates and publishes national STI
Treatment Guidelines and Recommendations, which translates research
into practice and serves as the gold standard for STI care in the
United States. Further, CDC supports health departments in all 50
states, Washington, D.C., and select cities and territories to conduct
core and essential STD prevention work through our flagship STD
prevention program, totaling $95.5million in 2020. CDC also has seventy
field staff embedded in state and local STD programs around the
country, who provide technical assistance and capacity building in
disease investigation to support communities and public health
partners, including investigating STDs in the community through field
testing, public health detailing, outbreak response, and contact
tracing.
COVID-19 mitigation necessitated innovative approaches to
delivering STD care that may prove to be valuable investments into the
infrastructure for STD care in the U.S. for years to come, including
(but not limited to):
--STD express clinics, which provide walk-in testing & treatment
without a full clinical exam
--Partnerships with pharmacies & retail health clinics, which can
provide new access points for STD services (e.g., on-site
testing and treatment)
--Telehealth/telemedicine, which can close gaps in testing and
treatment, ensure access to healthcare providers, support self-
testing or patient-collected specimens, and is especially
critical in rural areas
These strategies and more are outlined in HHS's first ever STI
Federal Action Plan, which provides a roadmap to develop, enhance, and
expand prevention and care programs at the national, state, tribal and
local levels over the next 5 years to reverse the course of the STD
epidemic.
Further, through its flagship STD prevention program, CDC supports
state and local public health departments to prioritize and strengthen
their efforts to eliminate congenital syphilis by matching syphilis
surveillance data with birth and mortality data and strengthening
congenital syphilis morbidity and mortality case review boards. On July
13, CDC funded four state STD programs, working in cooperation with the
state epidemiologist, to ensure that the implementation of congenital
syphilis projects prioritize sustainable system level or policy level
interventions in alignment with local epidemiology.
Finally, CDC is working diligently to support the Disease
Intervention Specialists (DIS) Workforce with funding from the American
Rescue Plan. For many years, DIS have provided invaluable support to
prevent and control STDs, tuberculosis, HIV, and other infectious
diseases. More recently, DIS were called to support the COVID-19
response, conducting case investigation and contact tracing in a
variety of community settings. CDC is making a $1.13 billion investment
over a five-year period to continue supporting the COVID-19 response
and other infectious disease prevention and response, by:
1. Expanding and enhancing frontline public health staff
2. Conducting DIS workforce training and skills building
3. Building organizational capacity for outbreak response
4. Evaluating and improving recruitment, training, and outbreak
response efforts
In addition to helping to contain and prevent COVID-19, we expect
that this cadre of culturally competent and experienced DIS will be
able to address STDs, such as congenital syphilis, as well as other
infectious diseases.
Question. In 2016, the New Hampshire Department of Health & Human
Services requested that the CDC's Agency for Toxic Substances and
Disease Registry (ATSDR) conduct health consultations for the public
water systems and private wells in the Merrimack-area of southern New
Hampshire after the discovery of per- and polyfluoroalkyl substances
(PFAS) contamination in drinking water. It is my understanding that
these health consultations remain ongoing, and I am concerned that
residents are still waiting and wondering about their exposure risks.
Can you provide an update on the status of these health
consultations and when you expect they will be concluded and released?
Answer. ATSDR continues to work on the private well and public
water health consultations. ATSDR received comments on the private well
health consultation from the state environmental department through our
data validation review process and is working to address those
comments. After the comments are addressed the document is reviewed
through CDC's clearance process, it will be released for public
comment.
In addition, ATSDR is currently completing a draft of the public
water health consultation and preparing for internal review and
clearance.
Question. The last thing firefighters should have to worry about is
the safety of the equipment they wear while in the line of duty. Yet
many active and retired firefighters are deeply concerned about
exposure to harmful PFAS chemicals from their protective gear. I was
proud to include my bipartisan Guaranteeing Equipment Safety for
Firefighters Act provisions in the fiscal year 2021 National Defense
Authorization Act (NDAA), which as you know, includes collaborative
efforts at the National Institute of Standards and Technology (NIST)
and National Institute for Occupational Safety & Health (NIOSH) to
study of the personal protective equipment worn by firefighters. I have
also worked through the Appropriations process to kick start this
research at NIST.
Can you discuss the CDC's current collaboration with NIST as they
work to identify a firefighter's relative risk of exposure to PFAS
released from their protective gear? How will NIST's study inform the
CDC's work--within both ATSDR and NIOSH--to better understand the
health effects of PFAS exposure?
Answer. CDC's collaborates with NIST, sharing information,
presentations, and collaborating on research activities such as
characterizing PFAS in turnout gear textiles. In 2021, NIST and NIOSH
provide overviews of PFAS activities and identified three topics for
further discussion, analytical and collection methodologies, selection
of and access to turnout gear textiles, and PFAS toxicity testing.
Meetings on these topics were conducted with smaller groups to help
facilitate targeted discussions.
NIST's research into PFAS in firefighter turnout gear is
anticipated to provide valuable information on potential exposures for
firefighters by identifying PFAS present in textiles and the conditions
contributing to the release of PFAS from said material. The analytical
methods included in NIST's study comprise a larger panel of PFAS than
is currently used in many studies of human exposure. Results from this
expanded panel will help guide future PFAS analyses of serum collected
from this occupationally exposed population as well as inform future in
vivo and in vitro studies of toxicity. When paired with studies of
dermal absorption and exposure assessments of firehouse air or dust,
NIST's research will also provide insight into the contribution of PFAS
from gear to a firefighter's total exposure, providing a more complete
understanding of the relevant pathways and routes of exposure in this
population.
NIOSH's National Personal Protective Technology Laboratory (NPPTL)
has been collaborating with NIST to determine which PFAS compounds are
on firefighter turnout gear and if they are released through
laundering. NPPTL collaborated with NIST, providing 20 different
textile swatches laundered using current fire service protocols. These
samples will undergo additional aging and stressing techniques to
measure PFAS release from textiles by NIST researchers.
NPPTL's comprehensive laundry study to identify and quantify the
individual PFAS compounds on firefighter textiles and to measure their
release through a series of washings, supplements the ongoing NIST work
. Additional NPPTL research studies the ability of PFAS compounds to
migrate through the 3-layered garment to be in direct contact with a
wearer's skin.
The NIST-NIOSH research collaboration will provide valuable
information regarding possible PFAS exposures related to firefighter
PPE and will yield time and monetary cost savings to both institutes.
Question. The Firefighter Cancer Registry Act, which was passed by
Congress and signed by the President in 2018, directed the CDC to
establish and maintain a voluntary National Firefighter Registry to
better understand the link between on-the-job exposure to toxic
substances and cancer in firefighters. The National Firefighter
Registry will be used to track and analyze cancer trends and risk
factors among firefighters. I have heard from firefighters in my state
interested in volunteering to participate. It is my understanding that
at this time, however, enrollment for the National Firefighter Registry
is not yet open.
Can you provide an update on the work being done to establish the
registry and a timeline of when it will be open for enrollment? When
the registry is opened for enrollment, will you work with my office to
provide information to active and retired firefighters about how to
participate if they so choose?
Answer. The National Firefighter Registry (NFR) has made
substantial progress in developing a rigorous scientific protocol,
enrollment questionnaire, and consent form. These documents have been
posted publicly at www.cdc.gov/niosh/bsc/nfrs. The enrollment
questionnaire has been submitted to OMB for review under the Paperwork
Reduction Act. The NFR program has also drafted an Assurance of
Confidentiality (AoC), which provides additional protection for
identifying information.
The NFR program has also made progress on the online NFR
Registration System. However, any public-facing data collection portal
must meet numerous Federal data security regulations and requirements--
some of which are relatively new and costly. NIOSH is working closely
with our IT and security specialists to ensure that the NFR
Registration System is compliant with these requirements. This has
extended the original timeline for the launching of the NFR. NIOSH also
recognizes that the registration system not only needs to be highly
secure, but also needs to be relatively easy for firefighters to
complete in order to maximize voluntary participation across the United
States.
The NFR team has been working closely with key scientific and fire
service stakeholders to determine the optimal design of the NFR
Registration System and what data must be collected. Launching of the
NFR Registration System is one step in many that will be needed over
the next several years to ensure the success of the program and meet
the requirements under the Firefighter Cancer Registry Act of 2018.
Once the NFR opens for registration, NIOSH will work with numerous
fire service organizations and other stakeholder groups to encourage
firefighters throughout the country, including career and volunteer,
active and retired, and firefighters with and without cancer, to enroll
in the NFR. The NFR team has developed a robust communications plan and
strong connections to fire service organizations such as the
International Association of Fire Fighters (IAFF) and National
Volunteer Fire Council (NVFC), which are the two largest organizations
representing career and volunteer firefighters, respectively. We
welcome opportunities to work with congressional offices to reach
firefighters within your state or district.
Question. Can you discuss how you expect this epidemiological
information and analysis will help public safety officials,
researchers, scientists and medical professionals find better ways to
protect those in the fire service?
Answer. The enrollment questionnaire will serve as the primary data
collection instrument when firefighters initially register collecting
information about work history (including large or unusual responses),
implementation of control measures, family history of cancer, and
healthy behaviors. The questionnaire will also ask for identifying
information, such as name and date of birth, which can be used to make
linkages to state cancer registries. Collecting identifying information
will allow NIOSH to periodically link to existing cancer diagnosis
databases to detect new cases of cancer long-term that may not have
been reported.
Additional follow up questionnaires will allow for analysis of
specific workplace factors as well as topics of special interest to the
public safety community. The NFR program also plans to work with fire
departments to capture fire and incident information to build an
exposure profile for the NFR participants. Over time and with broad
participation, all this data can be used to better understand the
amount and types of cancer among firefighters; the prevalence of cancer
risk factors and healthy behaviors among firefighters; and the
relationship between firefighter cancer and workplace characteristics,
exposures, and practices. We will explore cancer risk among
understudied firefighter groups including women, minorities,
volunteers, and firefighters in sub-specialty assignments like wildland
firefighters or fire-cause investigators. We will also evaluate how the
adoption of certain control measures, like routine laundering of
turnout gear, affects cancer risk. These analyses will help scientists
at CDC/NIOSH identify the most important factors associated with
firefighters' risk of specific types of cancer, including rare forms of
cancer. Results can then be used by public safety officials to
implement new evidence-based policies or procedures to reduce
firefighters' cancer risk. Medical professionals will also have more
knowledge about the types of cancer that are most elevated among the
different groups of firefighters, which could assist them in providing
advanced screening and healthcare for firefighters.
______
Questions Submitted by Senator Joe Manchin, III
Question. The Food and Drug Administration reports that nearly 40
percent of finished drugs and roughly 80 percent of active
pharmaceutical ingredients are manufactured abroad. During the COVID-19
pandemic we saw factories shut down in order to prevent spread of the
virus, drug supply chains disrupted, and drug shortages increase. As a
result American's access to essential medicines was put into jeopardy.
To avoid future shortages of essential medicines, domestic
manufacturing is key to shoring up our supply chain.
How important is a strong domestic supply chain for essential
medicines?
Answer. Ensuring a safe and consistent public health supply chain
for medical materials, ingredients, and supplies is critical for any
national response to public health emergencies.
Question. How can we ensure we don't experience future drug
shortages when global supply chains are disrupted?
Answer:
--Investments in securing the industrial base and domestic supply
chain require dedicated and persistent management and
engagement.
--Throughout the COVID-19 response, ASPR has leveraged the
authorities delegated to the Secretary under the Defense
Production Act (DPA) to issue 62 priority ratings for United
States Government (USG) contracts for health resources, eight
priority ratings for USG contracts for industrial expansion,
three priority ratings for non-USG contracts to support the
production of resins for both diagnostics and infusion pumps,
and the manufacture of closed suction catheters for treatment
of patients with COVID-19--all to ensure private sector
partners making life-saving products are able to acquire the
raw materials, components, and products requisite to deliver
for the response.
--Also under the DPA, ASPR is strengthening the industrial base to
secure and develop domestic capacity, retool and expand
industry machinery, scale production facilities, train
workforces, and ultimately infuse the supply chain and
marketplace with products the US needs to contain further
pandemic waves. ASPR continues to invest in critical funding in
expanding domestic manufacturing including investments of: $250
million in manufacturing PPE; $268 million in manufacturing of
testing consumables; $14.8M in vaccine raw material
manufacturing; $160 million in fill finish capacity; $65
million in vaccine vial manufacturing; $168 million in
manufacturing capacity for at home and point of care tests;
and, $53.8M in testing raw materials. Each of these domestic
manufacturing initiatives meets current, as well as future
COVID-19 needs, and seeks to create or sustain high-value
domestic jobs.
Question. Last week, the CDC announced $7.4 billion from the
American Rescue Plan to support the public health workforce and the
response to the COVID pandemic. This funding included $2 billion for
state health departments. This will go a long way to shoring up our
public health workforce as you outlined, in particular the requirement
for at least 40 percent of the funding to support local hiring through
local health departments or community-based organizations. West
Virginia led the country in vaccination rates in large part due to our
local health departments and health centers across the state
establishing Local Leadership Planning teams to roll out vaccination
plans in all 55 counties. These teams are multisector,
multidisciplinary local health leaders. They know their communities,
and have stepped up to respond to this virus.
In addition to this funding, what is CDC doing to support local
initiatives like West Virginia's Local Leadership Planning teams?
Answer. Partnerships and trusted community members have been
critical to reaching communities disproportionately affected by the
pandemic. Community health workers (CHW) are frontline public health
workers who have a trusted relationship with the community and are able
to facilitate access to a variety of services and resources for
community members. Scaling up and sustaining a nationwide program of
CHWs who support populations hit hardest by COVID-19 is critical. In
addition to the $7.4 billion to support the public health workforce
awarded from the American Rescue Plan, CDC also plans to provide $300
million to jurisdictions for CHW services to support COVID-19
prevention and control. CDC plans to provide an additional $32 million
for training, technical assistance, and evaluation. CDC expects to
award funds to approximately 75 organizations through the ``Community
Health Workers for COVID Response and Resilient Communities.'' Notices
of awards will be issued in the summer, with the amount each
jurisdiction receives determined by population size, poverty rates, and
COVID-19 statistics.
CDC also provided funding with specific guidance to focus on
reaching disproportionately affected communities, including:
--$3 billion to strengthen vaccine confidence (awarded early April
2021): Funding focuses on reaching 64 communities hit hardest
by the pandemic, including those in rural areas, to ensure
greater equity and access to vaccine and expand COVID-19
vaccine programs. To ensure health equity and expanded access
to vaccines, 75 percent of funding must focus on specific
programs and initiatives intended to increase vaccine access,
acceptance, and uptake among racial and ethnic minority
communities, and 60 percent must go to support local health
departments, community-based organizations, and community
health centers.
--$3 billion in cooperative agreements to support broad-based
distribution, access, and vaccine coverage (awarded Jan. 2021):
A minimum of 10 percent to jurisdictions must be allocated for
high-risk and underserved populations, including rural
communities.
--75 percent of the total funding must focus on specific programs
and initiatives intended to increase vaccine access,
acceptance, and uptake among racial and ethnic minority
communities; and,
--60 percent must go to support local health departments,
community-based organizations, and community health
centers.
--$2.25 billion in grant funding to states and localities
(anticipated to be awarded June 2021) to address COVID-19 in
high-risk and underserved communities, including rural
communities and communities with large populations of racial
and ethnic minorities. Recipients are strongly encouraged to
collaborate with and provide funding and resources to reach
organizations such as community-based and civic organizations,
faith-based organizations, non-governmental organizations, and
state offices of rural health or their equivalent such as state
rural health associations.
Question. How can we maintain local efforts like these to ensure
they continue to operate after the public health emergency?
Answer. CDC must build on initial investments and lessons learned
from COVID-19 with sustained, flexible investments in the nation's
public health infrastructure as proposed in the fiscal year 2022
Budget. This work must include public health workforce development, as
well as public health data modernization and epidemiology and
laboratory capacities, so that we can address the broader public health
consequences of the pandemic such as opioids, injuries, violence,
immunization, and chronic disease control. It will also help us prepare
for the future, because there are and will be more public health
threats.
Question. Just last week the CDC updated its guidelines in regards
to people who have been fully vaccinated. One guideline has caused
confusion in my state, specifically in regards to reporting and the
quarantining of people who have been vaccinated with a known exposure
to COVID. Currently, the guidelines require a fully vaccinated person
to quarantine for 10 days only if they develop symptoms. However, there
does not appear to be a clear reporting requirement for persons who
have been exposed and develop minor symptoms. Nor is there flexibility
for a fully vaccinated person to quarantine for a shorter period of
time if their symptoms disappear. Tracking these breakthrough cases is
important to ensure we know if and when a booster may be needed to
ensure protection for our population, and tracking potentially
problematic COVID variants.
How does the CDC plan to effectively monitor breakthrough cases?
Answer. The goal of national surveillance for COVID-19 vaccine
breakthrough infections is to identify unusual patterns, such as trends
in age or sex, the vaccines involved, underlying health conditions, or
which of the SARS-CoV-2 variants made people sick. To date, CDC's
monitoring of breakthrough cases shows there are no unusual patterns in
cases that have been detected in the data CDC has received. Despite the
high level of vaccine efficacy, it is expected that a small percentage
of fully vaccinated persons will develop symptomatic or asymptomatic
infections (i.e. breakthrough infections) with SARS-CoV-2, the virus
that causes COVID-19.
Vaccine breakthrough surveillance focuses on those cases resulting
in hospitalization or death. CDC coordinates with state and local
health departments to investigate vaccine breakthrough cases and
identify patterns or trends. Health departments report breakthrough
cases to CDC on a voluntary basis. However, it is important to note
that tracking and publicly reporting vaccine breakthrough via national
surveillance is just one way CDC measures vaccine effectiveness. CDC is
leading multiple vaccine effectiveness studies, some of which include
information on vaccine breakthrough infections, to ensure COVID-19
vaccines are working as expected. Through these studies in various
populations, locations, and settings, CDC can obtain more
representative, scientifically valid, and complete information about
these types of infections.
CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track
and analyze breakthrough infections. This population-based surveillance
system includes data on laboratory-confirmed COVID-19- associated
hospitalizations in 99 counties in 14 states, representing
approximately 10 percent of the U.S. population. COVID-NET cases are
hospitalizations occurring in residents of a designated COVID-NET
catchment area who are admitted within 14 days of a positive SARS-CoV-2
test. COVID-NET personnel collect COVID-19 vaccination status (doses,
dates administered and product) from state Immunization information
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also
include information on clinical outcome. Some sites have expanded
collection of vaccination status to non-sampled cases, which were
included for analysis if all cases in a single month had vaccination
status available.
Question. Is the CDC considering reducing the required isolation
period for fully vaccinated persons after their symptoms disappear?
Answer. CDC data indicates that vaccinated people are less likely
to contract COVID-19 and are much safer from having serious outcomes if
they do contract it. If they become infected, they can spread the virus
to others. Moreover, if the infection is caused by the Delta variant,
based on what we know at this time, they can likely spread it as easily
as unvaccinated people who are infected, at least initially. As
infection progresses, vaccinated persons with COVID-19, including
COVID-19 caused by the Delta variant, appear to be infectious for a
shorter period of time than infected unvaccinated people.
CDC is reviewing all the emerging evidence and will continue to
monitor the data on duration of infectiousness for breakthrough cases.
Throughout the pandemic, CDC has updated guidance to reflect the latest
available information about COVID-19 and would consider changing
recommendations for isolation periods for vaccinated people who have
breakthrough infections if the accumulating science indicates such a
change were both safe and reasonable.
Question. As you are aware we are facing an epidemic within a
pandemic. West Virginia is ground zero for the drug epidemic, with the
highest rate of drug overdose deaths in the country. To make matters
worse, 2020 was the worst year for drug overdoses, with over 90,000
deaths. West Virginia saw at least a 47 percent increase in overdose
deaths last year. The drug epidemic has led to a sharp increase in
opioid-related infectious diseases, including HIV and viral hepatitis.
This has stretched the resources of our public health departments and
health providers even further.
What resources is the CDC providing to states to combat this
epidemic?
Answer. CDC is providing resources to states through Overdose Data
to Action (OD2A), a cooperative agreement that began in September 2019.
It combines strategies from previous surveillance and prevention
funding agreements to address the complex and changing nature of the
drug overdose epidemic. Through OD2A, 47 states, Washington D.C., 16
localities, and two territories are receiving almost $300 million in
funding.
CDC is also addressing the infectious disease consequences of the
opioid epidemic. Nearly $13 million of combined fiscal year 2019 and
fiscal year 2020 funding was awarded through the Infectious Disease and
the Opioid Epidemic initiative to state and local health departments
and national organizations to address the infectious disease
consequences of drug use.
In light of the COVID-19 pandemic, CDC has worked to provide
flexibilities to the 66 grantees by extending the funding for an
additional year and providing additional guidance and assistance as
needed. We have also engaged grantees to identify innovative ways to
respond during the pandemic. We are also using COVID-19 funding to:
--Understand how substance use patterns and attitudes among youth
have changed due to COVID-19 and disseminate tailored public
health messaging and interventions to help address increased
substance use during this period of time and prevent
detrimental long-term consequences.
--Identify innovative harm reduction practices to assess the extent
to which these strategies can be sustained and scaled. CDC
plans to summarize these strategies and disseminate them to
state, local, and Federal partners.
In addition, CDC is Combating Opioid Overdose Through Community-
level Intervention Initiatives (COOCLI). CDC, through its Opioid
Response Strategy partnership, provided funding to the Office of
National Drug Control Policy to create public health/public safety
interventions at the local level. COOCLI sub-awards funded pilot
programs to implement innovative, evidence- based, community-level
interventions.
Question. Is the CDC working on helping increase testing for viral
hepatitis and HIV as well as linking patients to care?
How can CDC help improve testing and surveillance of opioid-related
infectious diseases with our current substance use treatment programs
and recovery facilities?
Answer. Our nation has seen steady increases in infectious
diseases--including viral hepatitis and HIV--among people who use drugs
since the start of the opioid crisis over a decade ago. Making testing
for viral hepatitis and HIV accessible, convenient, and routine is
critical, especially in populations disproportionately affected by
these diseases, including people who inject drugs (PWID). CDC developed
programs to increase infectious disease testing among PWID and
continues to invest in these programs through state and local health
departments and through community-based organizations. Specifically,
CDC is focusing investments on scaling up HIV self-testing--like the
Take Me Home self-testing program that provides free HIV self-tests--
making HIV screening a regular part of healthcare, and delivering viral
hepatitis and HIV testing in non- traditional settings, such as
correctional facilities and syringe services programs (SSPs).
As viral hepatitis, HIV, and substance use disorders continue to
impact communities throughout the United States, CDC is not only
increasing support for testing, but also diagnosis, linkage to care,
and treatment. CDC is also improving implementation of and access to
high-quality SSPs across the country, where legal, through
dissemination of best practices and providing technical assistance.
CDC's core Integrated HIV Surveillance and Prevention for Health
Departments program (PS18-1802) supports the implementation of
comprehensive SSPs as part of a key community-level HIV prevention
strategy. In addition, CDC's National HIV Behavioral Surveillance
system collects important data among persons at high risk for HIV
infection, including persons who inject drugs. These programs work to
ensure the provision of high-quality, comprehensive harm reduction
services, which include testing for infectious diseases, linking
patients to opioid use disorder treatment, and providing infectious
disease care for clients of syringe services programs.
In addition to testing and treatment for infectious diseases, CDC
works to increase linkage to substance use disorder treatment within
SSPs and during healthcare encounters for PWID.
Question. The COVID-19 pandemic has revealed public health data
infrastructure shortcomings within both our Federal and state
institutions. West Virginia's response to the COVID-19 pandemic,
however, shows our ability to adapt in times of crisis. In addition to
the strong leadership of our National Guard, our local health
information exchange stepped up to track important health data, such as
hospitalization and vaccination rates, demographic data, and much more.
Most importantly, our health information exchange helped us build out
systems so that West Virginia health providers were able to fully
utilize the CDC's Vaccine Administration Management System (VAMS). As
outlined in President Biden's national strategy, we need improved
systems for public health data exchange and surveillance. This will
allow us to better track outbreaks, testing, vaccination rates and much
more.
How will you ensure Federal investments into public health data
will support data sharing between public health and healthcare
delivery, such as the West Virginia's health information exchange?
Answer. The success of CDC's Data Modernization Initiative (DMI) is
critical for our nation's response to COVID-19 and beyond. Improving
data sharing between public health and healthcare delivery is key to
realizing the full potential of public health data modernization.
Monitoring and evaluation are how we make sure we are delivering on the
promise of data to protect America's health. The need for modernization
never stops. Within DMI, we are monitoring progress on a growing suite
of modernization projects. These investments touch nearly every part of
the public health data ecosystem.
All of CDC's data modernization investments are guided by a Roadmap
of Activities and Expected Outcomes that guides all current and future
investments in data modernization. This strategic roadmap lays out our
priorities and keeps our end goals in front of us. It ensures work
going on through any given stream ties into and benefits the others--
and that we are moving toward the same definition of success. The
roadmap is the basis for our DMI monitoring and evaluation framework.
Robust monitoring and evaluation will maximize our impact on public
health. This is where we track our progress consistently and
scientifically to see what our investments have produced. We can also
see which solutions are working well and which may need additional
support to reach their goals.
Electronic case reporting (eCR) has demonstrated success in
improving data sharing between public health and healthcare. eCR is the
automated, real-time exchange of case report information between
electronic health records (EHRs) and public health agencies for review
and action. It moves data quickly, securely, and seamlessly from EHRs
in healthcare facilities to state or local health departments. All 50
states, D.C., and 11 large local jurisdictions are now capable of
receiving COVID-19 electronic case reports, up from only a handful of
jurisdictions in late 2019. As of May 15, more than 8.1 million COVID-
19 reports have been sent to 61 public health agencies and more than
7,900 healthcare facilities in all 50 states can send COVID-19
electronic case reports. There are currently 236 facilities in West
Virginia actively using eCR, including West Virginia University.
CDC is actively working to expand the number of healthcare
organizations implementing eCR and support public health agencies to
fully use the case reports within their data ecosystem. This includes
collaboration with healthcare systems, EHR vendors, and with the Office
of the National Coordinator for Health Information Technology (ONC) to
improve exchange of health information.
Question. Will you work with state partners like WVU Health
Sciences to continue to improve data analytics?
Answer. Support and engagement with partners to improve data and
analytics is an important component of the CDC Data Modernization
Initiative (DMI). Data modernization requires an ongoing commitment and
partnership across the public health sector--and especially with our
state, tribal, local, and territorial partners. CDC will continue to
support and engage with partners to improve data collection,
interoperability and data analytics. CDC is working closely with public
health partners to provide technical assistance focused on:
--Developing interoperable data systems to reduce the burden on
healthcare systems, facilities and laboratories that report
critical data to jurisdictions
--Increasing the overall efficiency of public health data systems at
the state level
CDC also supports public health partners like the Association of
Public Health Laboratories (APHL) and the Council of State and
Territorial Epidemiologists (CSTE). These partners are providing
technical assistance to jurisdictions focused on improving data
sharing, accelerating use of shared decision support services, data
science upskilling of the public health workforce, and developing and
increasing use of standards to improve quality and timeliness of
reported data.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Walensky, several of the COVID-19 vaccine developers
have indicated we may need a vaccine booster. To that end, BARDA
notified an intent to purchase 400 million doses of COVID-19 vaccine
from Moderna and Pfizer for $7.9 billion on May 2nd as booster shots.
Was that the right decision? Because many public health experts
indicate, including former CDC Director Tom Frieden, that there is
growing evidence that a first round of global vaccinations may offer
enduring protection. What is your opinion here? What I think could be
very dangerous is if vaccine companies, rather than public health
experts, are setting the public's expectations around COVID-19
boosters.
Answer. CDC will update its recommendations on re-vaccination or
additional doses of COVID-19 vaccines when additional information is
available. CDC is closely collaborating with Federal partners and the
global science and public health community to determine next steps on
COVID-19 vaccine boosters. Currently, there is not enough data to
support recommending boosters.
Question. Adult immunization programs are not typically done well
in the U.S.
Should we face the prospect of COVID-19 boosters next year, what is
CDC doing now to plan for that possibility?
Answer. CDC will update its recommendations on re-vaccination or
additional doses of COVID-19 vaccines when additional information is
available. CDC is closely collaborating with Federal partners and the
global science and public health community to determine next steps on
COVID-19 vaccine boosters. CDC works continuously with our state and
local immunization programs to strengthen their capacity to deliver
vaccines, monitor their safety and effectiveness and address identified
gaps.
The fiscal year 2022 budget request includes nearly a $100 million
increase to expand existing efforts to enhance the adult immunization
infrastructure to increase routine vaccination rates, detect and
respond to outbreaks of VPDs, and address vaccine hesitancy. Adult
immunization program funding will build on recent investments in the
COVID-19 vaccine program to support essential activities aimed at
strengthening the safety net for uninsured adults, addressing
disparities in adult vaccine coverage, and supporting vaccine efforts
across the lifespan.
Question. Will you try to team other adult vaccinations with the
COVID vaccination?
Answer. COVID-19 vaccines were previously recommended to be
administered alone, with a minimum interval of 14 days before or after
administration of any other vaccines. This was out of an abundance of
caution and not due to any known safety or immunogenicity concerns.
However, substantial data have now been collected regarding the safety
of COVID-19 vaccine currently authorized by FDA for use under Emergency
Use Authorization. Although data are not available for COVID-19
vaccines administered simultaneously with other vaccines, extensive
experience with non-COVID-19 vaccines has demonstrated that
immunogenicity and adverse event profiles are generally similar when
vaccines are administered simultaneously as when they are administered
alone.
COVID-19 vaccines and other vaccines may now be administered
without regard to timing. This includes simultaneous administration of
COVID-19 vaccine and other vaccines on the same day, as well as
coadministration within 14 days. When deciding whether to co-administer
vaccine(s) with COVID-19 vaccine, vaccination providers should consider
whether the patient is behind or at risk of becoming behind on
recommended vaccines, their risk of vaccine-preventable disease (e.g.,
during an outbreak or occupational exposures), and the reactogenicity
profile of the vaccines.
Question. There are reports, many of which the CDC has published,
highlighting the toll this pandemic has had on our nation's public
health. And there's an increasing number of reports that the overall
health of Americans has suffered as a result of the pandemic. It is
increasingly evident that in the coming months, as we emerge from under
the shadow of this pandemic, existing and emerging public health
challenges will have to be addressed.
How are you planning to address these challenges and how does the
fiscal year 2022 budget reflect those needs?
Answer. CDC is committed to upgrading the public health system so
the nation is ready for whatever may come next by building on
investments and lessons learned during the pandemic. Key priorities
include modernizing our public health data systems, supporting a
diverse and skilled public health workforce, enhancing laboratory
capacity, and promoting global health security. We now know that long-
term and flexible funding--as proposed in the fiscal year 2022 budget--
will be required to sustain improvements and address broader
consequences of the pandemic and historical underinvestment in areas
like health equity, opioid use and misuse, injuries and violence,
immunization planning, and hypertension control.
Question. What are the areas where this budget request may fall
short--perhaps because we're only just beginning to understand the vast
impact of the pandemic in areas such as chronic conditions, delayed
care and immunizations, or reemerging infectious diseases, such as STDs
and hepatitis?
Answer. The nation's public health system has not recovered from
the economic downturn in 2008, which resulted in significant reductions
in public health staffing at the state and local level. Similarly, CDC
has become increasingly reliant on infusions of supplemental funds to
address specific health crises. Building back a robust public health
infrastructure will take sustained investments over time to address
both foundational needs like data, lab capacity and workforce as well
as strategic investments to address health equity and social
determinants of health. The fiscal year 2022 President's budget
includes request for increased funding needed to address some of the
consequences of the pandemic including mental health, opioids, and
prevention of chronic and infectious diseases.
Question. Conversely, our nation has made great strides these last
several months against the COVID pandemic and we've gained a greater
understanding as to what is needed for a robust public health system--
from the public health laboratories to health statisticians and
academic researchers to private enterprise--advancements have been made
across the board.
How does the fiscal year 2022 budget request account for the
lessons learned over the last year to improve our public health
infrastructure?
Answer. The ability to respond to a public health emergency
requires a strong day-to-day public health system, supported by
infrastructure that is not highly segmented by disease, condition, or
activity. In addition to the COVID-19 pandemic, over the past 24
months, CDC has also responded to diverse public health threats from E-
cigarette or Vaping Product Use-Associated Lung Injuries (EVALI),
Ebola, complex multi-state food-borne disease outbreaks, wildfires, and
hurricanes. Responding to the unique characteristics of each of these
public health emergencies has required deep scientific expertise to
deploy a specialized approach and called for a robust public health
system with world-class infrastructure nationwide to stop disease at
its source. Unfortunately, this recent history has revealed the effects
of inadequate public health infrastructure. Ongoing health disparities
made us as a nation more vulnerable to pandemics and large-scale public
health emergencies, as well as burdening large segments of our
population with chronic public health concerns. Additional investment
in both domestic and global public health infrastructure is needed as
requested in the fiscal year 2022 Budget.
With investments requested in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the nation's
health and economic security.
Question. The budget includes $400 million for Public Health
Infrastructure Capacity.
How does this request account for the flexibility needed to scale
certain functions or respond in the future to a wholly different public
health threat?
Answer. CDC will expand its ability to leverage public health
infrastructure to address emerging and longstanding issues by providing
direct funding for capacity-building resources, guidance, and
collaboration to states, localities, and territories. These resources
will be disease-agnostic investments in core public health
infrastructure and capacity to expand programs and systems that address
long-standing public health issues and support public health response.
Question. How, specifically, will this $400 million be divided
between the different activities outlined in the budget?
Answer. This investment must be flexible, stable, and keep pace
with inflation and technological advancements in order for states,
localities, and territories to address their most urgent needs, such
as: a diverse, data-savvy workforce with secure funding that attracts
the best talent to public health; robust technological infrastructure
that is nimble and scalable; innovations and collaborations with
multiple sectors; and programs that address disparities during and
after the COVID-19 pandemic.
Question. Unfortunately, there is no question that the pandemic has
been challenging for many people--our nation has faced an unprecedented
mental health crisis and a rise in overdoses. CDC's provisional data
shows a 28 percent increase in overdose deaths in the 12-month period
ending in October 2020. More than 88,000 lives were lost to an overdose
during that period, the highest number of fatal overdoses ever recorded
in the U.S. in a single year, three-quarters of which were opioid-
related. Throughout my time on this Subcommittee, I made it a priority
to combat the opioid crisis and I'm concerned we have suffered a
significant setback. We need to better understand the impact that the
pandemic has had on overdoses and substance abuse.
What can you say about these trends in fatal overdoses and what are
some of the immediate needs to combat them?
Answer. Provisional 2020 data reveal that over 93,000 people died
of an overdose in 2020, a nearly 30 percent increase over 2019. The
recent increase in drug overdose mortality began in 2019 and continued
into 2020, prior to the declaration of the COVID-19 National Emergency
in the United States in March.
There are many factors that can be driving the increase in overdose
deaths including:
--The changing illicit drug marketplace and the wider availability of
illicitly manufactured fentanyl and fentanyl analogs,
--Co-use of illicitly manufactured fentanyl with other drugs such as
cocaine and methamphetamine, and
--Mixing of illicitly manufactured fentanyl into the drug supplies of
methamphetamine and cocaine
CDC's Overdose Data to Action (OD2A) funds health departments in 47
states, the District of Columbia, two territories, and 16 cities and
counties to obtain high-quality, comprehensive, and timely data on
fatal and nonfatal drug overdoses to inform prevention and response
efforts. To help curb this epidemic, Overdose Data to Action strategies
focus on enhancing linkage to and retention in substance use disorder
treatment, improving prescription drug monitoring programs,
implementing post-overdose protocols in emergency departments,
including naloxone provision to patients who use opioids or other
illicit drugs, and strengthening public health and public safety
partnerships, enabling data sharing to help inform comprehensive
interventions.
The President's Budget for fiscal year 2022 includes a requested
increase of $237.8 million for opioid overdose prevention and
surveillance. Immediate needs to combat the acceleration in overdoses
include:
--Expanding the provision and use of naloxone and overdose prevention
education;
--Expanding access to and provision of treatment for substance use
disorders;
--Intervening early with individuals at the highest risk for
overdose; improving detection of overdose outbreaks due to
fentanyl, novel psychoactive substances (e.g., fentanyl
analogs), or other drugs to facilitate an effective response;
--Continued partnerships with public safety to monitor trends in the
illicit drug supply, including educating the public that drug
products might be adulterated with fentanyl or fentanyl analogs
unbeknownst to users.
A comprehensive and coordinated approach from clinicians, public
health, public safety, community organizations, and the public must
incorporate innovative and established prevention and response
strategies, including those focused on polysubstance use.
Question. The Labor/HHS bill provides funding for opioid-related
programs at the CDC, and a particular area of focus addresses
infectious diseases associated with the opioid epidemic. Those
resources help strengthen our understanding of the full scope of the
burden of infectious diseases associated with substance use disorders.
As a result of the pandemic, many public health departments' staff that
would normally work on surveillance and prevention of infectious
diseases, such as hepatitis, have been detailed to work on the COVID
response.
What do we know about the impact of the pandemic on surveillance
and prevention of infectious diseases associated with the opioid
crisis?
Answer. The COVID-19 pandemic has deepened the opioid crisis and is
having a profound impact on the fight against infectious diseases
associated with this epidemic. We don't yet know the full impact but we
are concerned that the major disruptions in access to prevention
services and deferral of healthcare services during the pandemic may
result in more infections and lead to severe health consequences in the
long run. Deferral of healthcare services ultimately delays diagnosis
and treatment, leaving people living with Hepatitis C and/or HIV
unaware of their status and vulnerable to disease progression while
also increasing the risk of spreading the viruses. Available data from
CDC's funded programs also indicates that 50 percent of syringe
services programs (SSPs) have reduced operations and 25 percent have
closed further impacting opportunities for hepatitis testing and
linkage to care. The closures of these SSPs severely limited access to
vital hepatitis C virus and HIV prevention services, including
referrals to treatment services as well.
In October 2020, CDC released a health advisory about the
possibility of new injection-related HIV infections and outbreaks and
noted how prevention efforts could be hindered because of the COVID-19
pandemic. Many HIV and viral hepatitis program staff were reassigned to
support the COVID-19 response which further hindered prevention
efforts. In the context of the pandemic, ongoing delivery of core
public health services to address the injection drug use crisis and the
infectious diseases associated with this epidemic, like hepatitis C and
HIV are essential. CDC is committed to helping states build capacity to
combat both epidemics and will continue to provide guidance as we
address new and evolving challenges.
Question. In response to the COVID pandemic, states have received
billions of dollars in aid, with the intent of giving them maximum
flexibility to respond to their unique needs and challenges. Congress
passed five bipartisan emergency supplemental funding bills last year,
four of which included funding specifically for CDC activities totaling
$16.25 billion for the agency. The vast majority of the funding,
roughly 75 percent, is to support state and local public health
preparedness and response, laboratory capacity, and surveillance. It is
my understanding there is a sizable portion of unobligated funds
remaining from the bipartisan emergency supplemental bills. And now
there is even more funding provided as part of the American Rescue Plan
reconciliation bill for the same purpose. While it is important to know
how fast CDC is getting this funding into the hands of the frontline
responders on the state level, it is just as important to know if
they're spending the money.
What are the spend rates that CDC is seeing at the state level?
Answer. States have multiple funding sources, including
disbursements from the treasury, that are used for public health
purposes. The amounts and purposes vary greatly by state and it is not
possible to generalize about spend rates. Recipient cash drawdowns are
a lagging indicator of recipient performance because the recipient
draws down cash to reimburse at the time of, or after, they pay their
bills. In addition, as recipients have their own project plans and cash
management processes, cash drawn totals provide a high-level picture
for that recipient and are generally not comparable across a cohort of
recipients in the same program.
Question. What accountability do the States have to tell you how
they have used the funds?
Answer. Recipients regularly report on their use of funds and the
outcomes they achieved per the terms of the funding agreement by which
they are awarded the funds.
Question. Given the unprecedented volume of funding going out from
the CDC as a result of the partisan reconciliation bill--can you
explain CDC's decisionmaking infrastructure, process, and planning
mechanisms for deploying unprecedented sums of money in such a short
period of time? How does CDC plan for states and the public health
infrastructure to sustain these advancements when the supplemental and
mandatory funding runs out?
Answer. CDC is allocating funding to states based on the provisions
included in the statute. CDC uses funding mechanisms available to fit
the purpose outlined in the statute, and where needed, has developed
new ones.
The ability to respond to a public health emergency requires a
strong day-to-day public health system, supported by infrastructure
that is not highly segmented by disease, condition, or activity. In
addition to the COVID-19 pandemic, over the past 24 months, CDC has
also responded to diverse public health threats from E-cigarette or
Vaping Product Use-Associated Lung Injuries (EVALI), Ebola, complex
multi-state food-borne disease outbreaks, wildfires, and hurricanes.
Responding to the unique characteristics of each of these public health
emergencies has required deep scientific expertise to deploy a
specialized approach and called for a robust public health system with
world-class infrastructure nationwide to stop disease at its source.
Unfortunately, this recent history has revealed the effects of
inadequate public health infrastructure. Ongoing health disparities
made us as a nation more vulnerable to pandemics and large-scale public
health emergencies, as well as burdening large segments of our
population with chronic public health concerns. Additional investment
in both domestic and global public health infrastructure is needed as
proposed in the fiscal year 2022 Budget.
With investments requested in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the nation's
health and economic security.
Question. The Administration has placed an emphasis on addressing
health equity, especially as it relates to the pandemic response
efforts.
What trends are you seeing in rural communities right now with
regard to the pandemic?
Answer. Data continue to show the disproportionate impact of COVID-
19 on population groups, including people living in rural or frontier
areas. CDC's publication examining disparities in COVID-19 vaccination
coverage found COVID-19 vaccination was lower in rural counties (38.9
percent) than in urban counties (45.7 percent). These data are
available on the county tracker, which provides an integrated, county-
level view of key data for monitoring the COVID-19 pandemic in the
United States. It allows for the exploration of standardized data
across the country. The footnotes describe each data source and the
methods used for calculating the metrics. For the most complete and up-
to-date data for any particular county or state, visit the relevant
health department website.
Question. How does the CDC's health equity work account for the
needs of rural communities?
Answer. Rural areas face unique challenges both during the COVID-19
pandemic and when confronting ongoing public health challenges. The CDC
COVID-19 Response Health Equity Strategy, developed under the
leadership of the Chief Health Equity Officer Unit, affords a robust
platform from which CDC and its partners are pursuing deeper
engagements of diverse communities, stronger infrastructures to better
support data-driven action, and culturally responsive approaches
optimized for serving diverse, differentially impacted populations in
different areas, including rural and frontier populations. CDC has
provided historic funding to address health disparities, including
support for rural areas, as follows:
--$3.0 billion to strengthen vaccine confidence (awarded early April
2021): Funding will focus on reaching communities hit hardest
by the pandemic, including those in rural areas.
--$3.0 billion to ensure broad-based distribution, access and vaccine
coverage (awarded Jan. 2021): A minimum of 10 percent to
jurisdictions must be allocated for high- risk and underserved
populations, including rural communities.
--$2.25 billion to states and localities to address COVID-19 in
medically underserved communities including rural communities
and communities with large populations of racial and ethnic
minorities
Additionally, the Federal Retail Pharmacy Program continues to be
an important component in our commitment to address the
disproportionate and severe impact of COVID-19 on communities of color
and other underserved populations, including rural populations. From
February 10 to May 19, 2021, 46,811,020 vaccine doses had been
administered and reported by retail pharmacies across programs in the
U.S. A total of 21 retail pharmacy partners are participating in the
program, with more than 41,000 locations online and administering doses
nationwide.
CDC has numerous initiatives working to reduce disparities in rural
populations. A few examples include:
--Community Health Workers for Covid Response and Resilient
Communities (CCR) supports the training and deployment of
community health workers (CHWs) to response efforts and by
building and strengthening community resilience to fight COVID-
19 through addressing existing health disparities. Priority
populations are those with increased prevalence of COVID-19 and
are disproportionately impacted by long-standing health
disparities. Recipients to be announced at the end of August
2021.
--Racial and Ethnic Approaches to Community Health (REACH) program
works to reduce racial and ethnic health disparities, including
those found in rural communities. Interventions focus on proper
nutrition, physical activity, tobacco use and exposure, and
chronic disease prevention, risk reduction, and management.
--The Healthy Tribes Program funds tribal communities across the
country to strengthen connections to culture to promote healthy
lifestyles and reduce risk factors for chronic diseases. These
programs together support community-developed strategies that
work in rural settings to address the unique challenges that
contribute to health disparities for these communities.
--Scaling the National Diabetes Prevention Program in Underserved
Areas funds 10 national organizations to expand the reach of
the National Diabetes Prevention Program lifestyle change
program to underserved areas and populations, including hard-
to-reach rural regions of the US with fewer resources to
address health disparities. Priority populations include
Hispanic/Latino, African American, American Indian/Alaska
Native, and Asian American persons; Pacific Islanders; and
noninstitutionalized people with visual impairments or physical
disabilities.
Question. Dr. Walensky, as more Americans are vaccinated, there are
certainly going to be more ``breakthrough'' cases--individuals who test
positive for COVID-19 even after being fully vaccinated. This is to be
expected since no vaccine is 100 percent effective. What concerns me is
that while we're seeing breakthrough cases, for example the New York
Yankees reported a staggering number of breakthrough cases in the
spring, the CDC announced it will no longer track all breakthrough
cases.
Are we letting down our guard--should all COVID-19 cases continue
to be counted?
Answer. Despite the high level of vaccine efficacy, a small
percentage of fully vaccinated persons will develop symptomatic or
asymptomatic infections (i.e. breakthrough infections) with SARS-CoV-2,
the virus that causes COVID-19. The goal of national surveillance for
COVID-19 vaccine breakthrough infections is to identify unusual
patterns, such as trends in age or sex, the vaccines involved,
underlying health conditions, or which of the SARS-CoV-2 variants made
these people sick. To date, no unusual patterns in cases have been
detected in the data CDC has received.
Question. Can you explain why the change was made and exactly what
CDC is now tracking with regard to breakthrough cases?
Answer. State and local health departments report COVID-19 vaccine
breakthrough cases to CDC voluntarily. The number of COVID-19 vaccine
breakthrough infections reported to CDC likely are an undercount of all
SARS-CoV-2 infections among fully vaccinated persons. Reports may not
be complete and because not all infected persons get tested, not all
breakthrough cases will be identified. This is particularly true in
instances of asymptomatic or mild illness. The shift to focus on
hospitalized or fatal cases will help maximize the quality of the data
collected on cases of greatest clinical and public health importance,
while representative, scientifically valid data on vaccine
effectiveness comes from studies CDC is leading across the country.
Reporting vaccine breakthrough cases through national surveillance
is only one of the ways CDC measures COVID-19 vaccine effectiveness.
CDC continues to lead studies in multiple U.S. sites to evaluate
vaccine effectiveness and to collect information on COVID-19 vaccine
breakthrough infections from these sites regardless of clinical status.
For example, CDC is working with Emerging Infection Program (EIP) sites
in nine states to compare SARS-CoV-2 sequence data from vaccinated and
unvaccinated cases, regardless of clinical severity. CDC also is
working on more than 30 ongoing studies to assess vaccine
effectiveness, some of which include information on vaccine
breakthrough infections in patients with asymptomatic and milder
illness. Through these studies in various populations, locations, and
settings, CDC can obtain more representative, scientifically valid, and
complete information about these types of infections.
CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track
and analyze breakthrough infections. This population-based surveillance
system includes data on laboratory-confirmed COVID-19-associated
hospitalizations in 99 counties in 14 states, representing
approximately 10 percent of the U.S. population. COVID-NET cases are
hospitalizations occurring in residents of a designated COVID-NET
catchment area who are admitted within 14 days of a positive SARS-CoV-2
test. COVID-NET personnel collect COVID-19 vaccination status (doses,
dates administered and product) from state Immunization information
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also
include information on clinical outcome. Some sites have expanded
collection of vaccination status to non-sampled cases, which were
included for analysis if all cases in a single month had vaccination
status available.
This strategic, deliberative approach will yield better information
on vaccine effectiveness and provide critical insight on cases of
greatest concern.
Question. Related, there is increasing concern about the public
health impact of long-term symptoms weeks or months after an individual
has had COVID-19.
What monitoring or tracking is the CDC undertaking with regard to
COVID ``long-haulers''?
Answer. CDC is spearheading rapid and multi-year studies to further
investigate post-COVID conditions (PCC), also known as ``long COVID''
or ``long-haul COVID.'' These studies will help us better understand
post-COVID conditions and how to treat patients with these longer-term
effects. For example, ongoing studies will follow patients for up to 3
years and provide information on the percent of persons who develop
post-COVID conditions, assess risk factors for development of post-
COVID conditions, and evaluate different virus strains and antibody
responses.
Question. How many long-haulers would you estimate are living with
post-COVID related symptoms?
Answer. At this time, we do not have a precise way to measure and
capture the prevalence of persons living with post-COVID-19 related
symptoms, but we know there are many people who are suffering from
this.
Currently, CDC and its Federal partners have proposed a new PCC
ICD-10 code and are looking at all considerations on how this may
impact the final version of this new code. The new ICD-code could
potentially be used for a range of conditions, including subsequent
chronic respiratory failure to help track and monitor people living
with PCC. CDC's National Center for Health Statistics (NCHS) presented
a proposal for public input to implement the code U09.9, post-COVID-19
condition, based on a proposed international classification of
diseases, tenth revision (ICD-10) code from the World Health
Organization (WHO) last year. This proposal is expected to move forward
after public input and may be implemented in October 2021 (as part of
the regular ICD-10 code process/timelines) to allow clinical data
systems and health insurers to adapt and fully implement it. We hope
this will provide us with a better estimate of those who may be living
with PCC.
Question. How does CDC plan to continue to monitor and track the
long-term impacts of COVID?
Answer. CDC is using multiple de-identified electronic health
record (EHR) databases to examine persistence of symptoms and incidence
of post-COVID conditions. CDC has also partnered with health systems to
perform in-depth medical record reviews, which can provide insight into
the patterns of health effects that patients are experiencing.
Question. Dr. Walensky, CDC has received a lot of criticism
throughout the pandemic. A lot of it is justified. And most of it
transcends political leadership at the agency. There are a lot of
lessons to be learned from what we did right and what we did wrong. As
I said in my opening statement, we did a lot right--so much so, in
fact, that we have three FDA authorized vaccines that are getting into
Americans' arms as we speak. But we also must recognize the missteps
when they happen as well. That is how we learn and how we become better
for the next public health emergency. Unfortunately, much of the
criticism about our pandemic response, that continues to this day,
revolves around the CDC. As Chair Murray and Senator Burr work on a
pandemic reform bill in the health authorizing Committee, I think it
would be a benefit to this Subcommittee to hear from you on these
issues as well. Can you please respond to the comments below:
Answer. First, CDC is risk adverse. I think that we have seen that
in several cases, from mask mandates for campers to discouraging travel
for the fully vaccinated.
Question. Second, CDC guidelines are impractical. The agency simply
doesn't issue guidelines that are clear and straightforward enough to
be useful. What I continually heard is that Federal guidance needs to
be practical for implementers on the ground or the American people to
follow it.
Answer. Since the early days of the pandemic, scientists at CDC
have been using evidence from systematic reviews and expert judgement
to develop guidance that informs various populations on how to slow the
spread of COVID-19 and protect their health and their communities. The
process and information communicated can be complex and evolves as our
understanding of the virus increases. CDC's group of multidisciplinary
stakeholders assesses the benefits and risks informed by data from the
field and issues evidence-based guidelines. State and local health
departments then decide how the research and guidance is implemented.
Question. Third, CDC has an entrenched bureaucracy that is
unwilling or unable to think big or implement on a large scale. The
perfect, and befuddling, example is why CDC didn't engage with private
sector partners like Abbott or Roche to commercialize their assay.
Testing was one of the early failures. Was this the reason why?
Further, at the outset, lab testing followed the flu model.
Asymptomatic spread requires significant testing, but this was low-
balled and kept in-house which could only produce about 100,000 tests
when what needed to happen was to engage the private sector labs to get
1-2 million higher volume throughput.
Answer. CDC aids and equips state and public health laboratories in
diagnostic testing for novel pathogens. When a new virus emerges or a
public health need for a new diagnostic tool arises, CDC may develop a
new diagnostic tool and, in partnership with state and local public
health partners and non-governmental organizations, strategize
distribution. This process is intended to fulfill needs within the
public health scope of outbreaks or new technologies. It is not
currently intended to replace or fulfill testing that may need to be
developed or distributed by commercial vendors to meet broader health
sector needs.
Furthermore, the EUA process for diagnostic (IVD) test development
and analysis/validation follows a predetermined framework at CDC, as
does deployment of the test after FDA authorization.
Question. Lastly, the Center structure at CDC is stove piped and
hampered the response. As a result, response efforts were locked into
the flu center, which treated COVID-19 like the flu--which spreads
symptomatically. Is this the reason we missed asymptotic spread?
Because we didn't have the right experts in charge or a CDC-wide body
responsible?
Answer. On January 7, 2020, the Director of the National Center for
Immunization and Respiratory Diseases (NCIRD) issued the directive
authorizing a Center Level Response, Novel Coronavirus (nCoV) 2019
Response, for the pneumonia outbreak in Wuhan, China in consultation
with the CDC Director. This Directive was effective January 6, 2020. As
the situation evolved, CDC escalated its response from the Center and
activated its Emergency Operations Center facilitating a CDC-wide
response on January 20, 2020.
When reports of asymptomatic spread first emerged, CDC's guidance
addressed the current circumstances. CDC proactively and aggressively
investigated evidence from the field, and updated its guidance
accordingly based on the best available data.
Question. Dr. Walensky, the Influenza Hospitalization Surveillance
Network (FluSurv-Net) is a population-based surveillance system that
collects laboratory confirmed influenza associated hospitalizations
from 14 states. The coverage area for FluSurv-Net is roughly 29 million
people, or 9 percent of the U.S. population. There is no site in
Missouri and the Midwest is not represented at all, except for Iowa.
How can the CDC accurately track an influenza outbreak without
real-time data from 36 states?
Answer. CDC's influenza surveillance systems are a collaborative
effort between CDC and its many partners in state, local, and
territorial health departments, public health and clinical
laboratories, vital statistics offices, healthcare providers, clinics,
and emergency departments. The system consists of complementary
components that capture virologic surveillance, outpatient illness
surveillance, hospitalization surveillance, and mortality surveillance.
This comprehensive surveillance infrastructure is used to identify when
and where influenza activity is occurring, determine which influenza
viruses are circulating, detect changes in influenza viruses, and
measure the impact influenza is having on outpatient illness,
hospitalizations, and deaths. Surveillance is performed continuously
throughout the year and data are presented in FluView, a weekly
influenza surveillance report, and FluView Interactive, an online
application which allows for more in-depth exploration of influenza
surveillance data, which are updated weekly.
Additionally, the HHS Protect Hospital Data reporting system
provides daily information on the number of patients hospitalized with
influenza-related and COVID-related illnesses from over 6,000 hospitals
in all 50 states and U.S. territories. This system provides situational
awareness of severe respiratory illness and local hospitalization
trends for influenza and COVID-19 on a daily basis that is beneficial
for monitoring severe illness during an outbreak.
Question. And how did the lack of real-time data stymy the response
to COVID-19?
Answer. COVID-19 highlighted the importance of real-time data
needed to get ahead and stay ahead of the disease. CDC must build on
initial investments and lessons learned from COVID-19 by investing in
the nation's public health infrastructure. The ability to respond to a
public health emergency requires a strong day-to-day public health
system, including efficient data sharing, and supported by
infrastructure that is not highly segmented by disease, condition, or
activity. With investment in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
Question. Reports are already speculating that the next flu season
may be bad after a year of hardly any flu cases.
How concerned should we be that many Americans are left without an
immunity to flu--especially children--who may be more susceptible than
any other recent year?
Answer. A flu vaccine is the best way to protect children from flu.
CDC recommends that everyone 6 months and older should get a flu
vaccine every season. Annual vaccination is important to protect both
yourself and to provide protection for those who are more vulnerable to
serious flu illness, including children, older adults, and people with
certain chronic health conditions.
The flu can be dangerous for children. During the 2019--2020
season, nearly 200 flu deaths in children were reported to CDC in the
United States, which was the highest reported number of pediatric
influenza deaths on record. About 80 percent of those children were not
vaccinated. Last year, childhood influenza vaccination coverage is
estimated to have dropped 4.1 percentage points from 62 percent during
2019-2020 to 58 percent.
CDC is working diligently to support the vaccination of as many
Americans as possible during the upcoming influenza season. Vaccine
manufacturers have projected that they will supply 188 to 200 million
doses of influenza vaccine for the 2021-2022 season. CDC will continue
to emphasize the importance of influenza vaccination through targeted
communication outreach. CDC will build off its 2020-2021 communication
campaign, which was estimated to have been seen more than 5 billion
times. This year's media campaign will include population-wide outreach
and will have a special emphasis on targeting disproportionately
affected audiences, including people ages 40-64 with chronic medical
conditions, African American and Hispanic persons, essential workers,
pregnant women, and parents.
______
Questions Submitted by Senator Richard C. Shelby
Question. The Alabama Department of Public Health saw a delay in
the reporting of vaccine distributions upon the initial allocation of
vaccine allotments to states. Ultimately, there was not a delay in the
distribution of the vaccine, but in the reporting of administered
vaccines. In the last 15 months, Congress has appropriated $1.1 billion
to the CDC for the purpose of public health data modernization and
addressing public health data reporting issues that were experienced in
Alabama. In 2019, CDC stakeholders requested $1 billion over a ten-year
period to tackle public health data modernization, which CDC has
indicated is needed and Congress has far surpassed to this point. $500
million was appropriated through both the CARES Act and the American
Rescue Plan Act of 2021, and $50 million was appropriated for both
fiscal years 2020 and 2021 annual appropriations for the funding of
public health data modernization through the CDC.
Could you give a detailed description of how that $1.1 billion has
been used to date, who that funding has gone to (e.g., through
contracts, cooperative agreements, and grants), and for how much?
Please also provide a detailed plan for the remaining funds.
Answer:
ANNUAL APPROPRIATIONS
Table 1. Budget Plan for Annual Appropriations \1,2\
------------------------------------------------------------------------
Fiscal Year
Major Activity -------------------------------
2020 2021
------------------------------------------------------------------------
Partnering with State and Local Public $32.5M $32.5M
Health, Partners, and Health Care
Systems................................
Accelerating Public Health Data for $15.5M $15.5M
Action.................................
Sustaining Innovation................... $2 million $2 million
Total............................... $50 million $50 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
activities.
\2\ Amounts per activity are based on current information and may
require adjustment.
Data Modernization Base Funding
Congress recognized the need to modernize CDC's data systems and
provided funding in fiscal year 2020 dedicated specifically to data
modernization. DMI base funding is focused on strengthening and
sustaining the core foundational surveillance systems that state, local
and territorial jurisdictions use every day. These systems benefit all
of public health and serve as ``early warning signals'' for our biggest
threats--systems that handle emergency room visits, case reporting,
notifiable diseases, lab results, and death data. Investments to date
have laid the groundwork and spurred real progress, but much work
remains to be done.
In fiscal year 2020, CDC focused on solutions for the timely,
secure, and accurate flow of health data from electronic health
records, laboratories, and other primary data sources to state and
local jurisdictions and the multi-directional data flows between these
jurisdictions and CDC. The focus of these efforts has been on the
following:
--Expanded use of eCR and connectivity to Electronic Health Records
(EHR)
--Increasing the number of emergency departments and use of syndromic
and disease surveillance data through the NSSP
--Enhancing automated electronic laboratory reporting (ELR) and
implementation of Electronic Test Orders and Results (ETOR) at
clinical and public health laboratories
--Implementing improvements to birth and death reporting in NVSS
--Modernization of disease reporting through NNDSS and of states'
National Electronic Disease Surveillance System (NEDSS) Base
System (NBS)
CDC has continued to reimagine what its core surveillance systems
could deliver in fiscal year 2021. CDC works closely with public health
partners to reduce their reporting burden and make sure everyone has
the capacity to connect with each other. The pandemic drove huge leaps
in electronic case reporting (eCR), with thousands of healthcare
facilities now exchanging automated, real-time health information. All
50 states, D.C., and 11 large local jurisdictions are now capable of
receiving COVID-19 electronic case reports, up from only a handful of
jurisdictions in late 2019. The National Vital Statistics System (NVSS)
expanded its modernization community and began delivering provisional
COVID-19 death data and new data on excess deaths. Currently, 67
percent of deaths are reported electronically in less than 10 days, up
from 7 percent in 2010. CDC has dramatically improved the quality of
laboratory report data received by public health through nationwide use
of standardized messaging with Electronic Laboratory Reporting (ELR),
with 56 jurisdictions reporting lab data directly to CDC, up from zero
in 2019. Data from 70 percent of all U.S. emergency departments is
reported to CDC through the National Syndromic Surveillance Program
(NSSP), with 75 percent of emergency department data received in less
than 24 hours of a visit. As a result, more early warning signals from
systems that track emergency department visits and notifiable diseases
were and are being captured.
In fiscal year 2020, approximately $22.5 million was distributed
through a cooperative agreement to 58 awardees, including states,
cities, and territories, with an average award of $391,417. These funds
supported specific strategies, activities, and outcomes to improve
health information systems infrastructure, workforce development, and
public health laboratories. States have used these funds to conduct
needs assessments, strengthen technical and informatics skills,
streamline changes to surveillance systems, and identify a lead person
in each jurisdiction to support data modernization.
CDC is continuing to improve core public health data systems,
enhance data science and informatics workforce capabilities across the
public health systems, improve interoperability and innovation through
adoption of new standards and approaches for public health reporting
such as Fast Healthcare Interoperability Resources (FHIR) standards,
and support ongoing data modernization at CDC and with its partners.
Our focus in fiscal year 2021 has been on providing technical
assistance to state and local jurisdictions to leverage progress made
at the Federal, state, and local levels on electronic case reporting
(eCR) and Electronic Test Orders and Results (ETOR), as well as other
core systems and processes for data exchange. Technical assistance is
being provided by CDC and through a cooperative agreement with public
health partners like the Association of Public Health Laboratories
(APHL) and the Council of State and Territorial Epidemiologists (CSTE).
These partners are providing technical assistance to jurisdictions
focused on improving data sharing, accelerating use of shared decision
support services, data science upskilling of the public health
workforce, and developing and increasing use of standards to improve
quality and timeliness of reported data. Focus on continuing to improve
core public health data systems, enhance data science and informatics
workforce capabilities across the public health systems, improve
interoperability and innovation through adoption of new standards and
approaches for public health reporting (such as FHIR standards) and
support of ongoing data modernization at CDC and with its partners
CDC also provided funding through a cooperative agreement to three
tribal health entities to focus on three activity areas: augmenting
workforce development and capacity, identifying and deploying specific
enhancements in public health data and health information systems, and
employing shared services to improve data quality, exchange, and
management. CDC has provided funding to tribal entities in fiscal year
2021 to focus on the improving access to data, modernizing
infrastructure for data collection and analysis, and expanding
workforce data skills.
To keep CDC at the forefront of innovative, data-driven public
health solutions, we are strengthening skills for a state-of-the-art
data science workforce by supporting workforce development to assure
capable data scientists and informatics-skilled staff are available to
state, territorial, local, tribal, and Federal public health agencies.
In fiscal year 2020, CDC completed a pilot cohort of team training
through the Data Science Upskilling (DSU), which included 79 unique
learners on 18 teams. DSU is a new model of team training using
experiential learning tailored to agency priorities. Teams include both
CDC staff and fellows from the Public Health Informatics Fellowship
Program utilizing curated online courses and in-depth, boot-camp-style
training on topics like machine learning. Team projects align with
agency DMI priorities, CDC's winnable battles, or COVID-19 response.
CDC also funded the Council of State and Territorial Epidemiologists
(CSTE) to implement a similar program, Data Science Team Training
(DSTT).
DSTT was designed as a replica to CDC's Data Science Upskilling
program, with modifications to better meet state, tribal, local, and
territorial, needs. Training activities began in January 2021 with 20
teams and 86 learners. There is representation from a mix of state,
local, tribal, and territorial health departments.
cares act funds
Together with base funding, the Coronavirus Aid, Relief, and
Economic Security (CARES) Act extended and accelerated CDC's data
modernization goals for the nation. CARES funding focuses on
infrastructure, innovations, and connecting systems and data sources.
Rather than discrete, one-off projects or a narrow focus on individual
capacities, we have looked at the entire surveillance and data
ecosystem and identified the areas most in need of investment and
modernization. While COVID-19 is the priority, the end goal of DMI is
to create lasting, adaptable solutions that will make public health
more responsive and resilient in the future.
CARES funding is being invested across three major areas:
--Data Sharing across the Public Health Ecosystem
--Modernizing critical tracking capabilities and core surveillance
systems
--Extending data lakes and services that support electronic
laboratory reporting and immunization information
--Expanding the type, variety, and quality of data available to CDC
programs and STLT
--Automating the flow of data from electronic health records and
other sources
--CDC Systems and Service Enhancements for Ongoing Data Modernization
--Expanding enterprise cloud services to bring in and use large
datasets from partners in new ways
--Expanding CDC's enterprise data hub, orchestration, warehouse,
lake, analytics, and visualization capacity
--Building a state-of-the-art data science workforce
--Ensuring open and accessible data while protecting privacy and
security
--New Standards and Approaches for Public Health Reporting
--Implementing new standards and approaches, such as FHIR across the
public health ecosystem
--Assessing policy/legal barriers to sharing data, including STLT
data
Our work focused on data sharing across the public health ecosystem
includes modernizing critical tracking capabilities and surveillance
systems, such as the National Healthcare Safety Network (NHSN), Public
Health Environmental Tracking Network, the National Electronic Injury
Surveillance System-All Injuries Program (NEISS-AIP), and the National
Vital Statistics System (NVSS). We are also rapidly expanding
electronic case reporting (eCR) from healthcare to public health. We
have rapidly extended data lakes and services that support electronic
laboratory reporting and immunization information, including the
creation of a new immunization data lake that is now actively receiving
and making available 3.1M administration records per day. Funding has
also supported the creation of the Pan Respiratory Surveillance
Initiative, informing our knowledge of molecular surveillance, viral
evolution, and helping track trends in emerging variants.
Enhancements to CDC systems and service enhancements for ongoing
data modernization include deploying cloud-based technology to bring in
and use large data sets from partners in new ways, while also providing
highly scalable data analytic and visualization capabilities. This is
already strengthening our data sharing capabilities. For example, we
modernized data sharing with Homeland Security to ingest daily
international passenger arrival contact tracing information, parse it,
and provide it overnight to states through a secure, cloud-based file
transport system for STLTs to ingest into their individual tracking
systems. In the past year, the percentage of usable data has improved
to over 95 percent and time to transmit to STLTs has decreased from
days to overnight. Ongoing work to expand CDC's enterprise data hub,
orchestration, warehouse, lake, analytics, and visualization capacity
makes us better able to support modernization project needs across the
agency. We have streamlined identity proofing and access management,
use of enterprise code repositories, and enterprise security and code
complexity scanning. The CDC Data Hub actively continues to ensure that
analytics, including machine learning and artificial intelligence, are
enabled in cloud-based data pipelines. At the same time, we have
Initiated training opportunities to build a state-of-the-art data
science workforce, including CDC's Data Academy, which has delivered
more than 1000 hours of free training.
Our modernization efforts include developing new standards and
approaches for public health reporting. We are preparing CDC and our
STLT and healthcare partners to implement technologies and standards
that make systems interoperable and help these systems ``speak the same
language.'' Federal policies and advancements in technologies are
opening doors to make new connections for exchanging public health
data, and a major focus is on implementing Fast Healthcare
Interoperability Resources, or ``FHIR,'' across the public health
ecosystem. FHIR application programming interfaces (APIs) can help
public health to access detailed and timely data from EHRs while
lowering burden on and delivering greater value to data providers. We
are also working closely with jurisdictions and research partners to
innovate toward FHIR-based interoperability at every level. This will
give us more complete data and surveillance capabilities nationwide.
Our goal is to take what works and scale nationwide, through pragmatism
and collaboration to realize significant benefits to the way we use and
share data across all of public health.
Table 2. Budget Plan for CARES Act Appropriations \1,2\
------------------------------------------------------------------------
Funding Levels
Thematic Area for Fiscal Year
2020-2021
------------------------------------------------------------------------
Data Sharing Across the Public Health Ecosystem....... $140.55M
CDC Systems and Service Enhancements and Ongoing Data $120.62M
Modernization........................................
New Standards and Approaches for Public Health $13.83M
Reporting............................................
Additional fiscal year 2020 funding for Emergency $41.44M
Operations Center public health surveillance
activities...........................................
Future fiscal year 2022-2023 funding.................. $183.56M
TOTAL............................................. $500 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
activities.
\2\ Amounts per activity are based on current information and may
require adjustment.
american rescue plan funds
CDC appreciates further appropriations in data modernization
awarded through The American Rescue Plan Act. Where possible CDC is
evaluating recent investments made in national data infrastructure and
working with states to understand the gaps that still exist and
barriers to modernizing to further drive the best practices for
efficient and effective data modernization across the public health
ecosystem. Planning is currently underway to apply ARP data
modernization resources to drive a flexible, responsive, and modern,
response- ready data infrastructure.
______
Questions Submitted by Senator Jerry Moran
Question. In February, the CDC issued an order requiring face masks
on conveyances and at transportation hubs. Last week, you updated your
guidance for fully vaccinated individuals, saying they can stop wearing
masks indoors and outdoors. However, the CDC has not taken any steps to
update the February transportation order.
When can we expect such an update?
Answer. While those who are fully vaccinated may resume many
activities without wearing a mask, the travel environment presents a
unique set of circumstances based on the number and close interaction
of travelers (both vaccinated and unvaccinated). Traveling on public
transportation increases a person's risk of getting and spreading
COVID-19 by bringing people in close contact with others, often for
prolonged periods. Staying 6 feet away from others is often difficult
on public transportation conveyances. People may not be able to
distance themselves by the recommended minimum of 6 feet from other
people seated nearby or from those standing in or passing through the
aisles on airplanes or buses, for example.
Correct and consistent use of masks on public transportation
conveyances and at transportation hubs protects travelers and workers,
enables safe and responsible travel during the pandemic, and helps to
reduce the spread of coronavirus disease 2019 (COVID-19).
CDC will update the Order and other recommendations as more people
get vaccinated, as rates of COVID-19 change, and as additional
scientific evidence becomes available.
Question. Given the different risk levels of COVID transportation
across the transportation network, for instance traveling on public
transportation verses operating a freight locomotive, can we expect
different guidance?
Answer. CDC will continue to evaluate the requirements of its Order
and determine whether other changes are warranted by examining
characteristics like the transportation environment as well as indoor
and outdoor locations. CDC will update the Order and other
recommendations as more people get vaccinated, as rates of COVID-19
change, and as additional scientific evidence becomes available.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. There are two FDA-approved buprenorphine products for the
treatment of moderate to severe chronic pain. Both buprenorphine-based
products have been classified by the U.S. Drug Enforcement
Administration (DEA) as Schedule III meaning they have less abuse and
addiction potential compared to Schedule II drugs like oxycodone,
fentanyl, and oxymorphone. Furthermore, buprenorphine provides an
important safety advantage as it is the only opioid with a demonstrated
ceiling effect on respiratory depression, which is what typically leads
to death in an opioid overdose. In addition, there are several
buprenorphine-based products approved to treat opioid addiction. This
means that one of the same drug compounds that help millions of
Americans curb their addiction to illicit and prescription opioids can
also be used effectively to treat chronic pain with a lower chance of
addiction, abuse and overdose. However, it's my understanding that the
CDC's Guideline for Prescribing Opioids for Chronic Pain, which was
published in 2016, doesn't include any language about the benefits of
Schedule III buprenorphine products, even though they have less
potential for addiction and abuse, for the treatment of chronic pain.
Instead, the Guideline recommends starting opioid therapy with
immediate release Schedule II opioids, which have been shown to have
higher rates of addiction, abuse and overdose.
Do you know why the Guideline doesn't differentiate between
Schedule II and Schedule III opioids and recommend the use of Schedule
III opioids given their enhanced safety profile and lower risk of
abuse, addiction and overdose?
Answer. The evidence reviews informing the 2016 Guideline found
evidence of increased risks from extended-release/long acting (ER/LA)
full agonist opioids but did not identify other differences in safety
or effectiveness by type of opioid, including by schedule. Therefore,
there was no evidence on which to base recommendations to use different
types of opioids (except recommendations on ER/LA vs. short-acting
opioids).
Question. Can you provide an update on the process and timing of
the CDC's efforts to update the Guideline? Do you expect the updated
Guideline to consider DEA scheduling and recommend prescribers begin
opioid therapy with Schedule III drugs, when clinically appropriate,
before advancing to a Schedule II Drug?
Answer. CDC funded the Agency for Healthcare Research & Quality
(AHRQ) to conduct systematic reviews of the scientific evidence that
has been published since the Guideline's release in March 2016. These
reviews are the following:
--Noninvasive Nonpharmacological Treatment for Chronic Pain (An
Update)
--Nonopioid Pharmacologic Treatments for Chronic Pain
--Opioid Treatments for Chronic Pain
--Treatments for Acute Pain: A Systematic Review
--Acute Treatments for Episodic Migraine
Based on AHRQ's completed reviews, CDC has determined that an
update to the Guideline and an expansion of the Guideline to certain
acute conditions is warranted.
On December 4, 2019, the Board of Scientific Counselors of the
National Center for Injury Prevention and Control (BSC/NCIPC)
established the Opioid Workgroup (OWG). The OWG will report to the BSC/
NCIPC, a Federal advisory committee. The primary purpose of the OWG is
to review the updated draft Guideline for opioid prescribing (as
prepared by CDC) and to develop a report that will provide the
workgroup's findings and observations about the draft GL to the BSC/
NCIPC.
The OWG began reviewing a draft Guideline for opioid prescribing
(as prepared by CDC) in March 2021. The OWG met for a total of 11 times
since October 2020 and developed a report of findings and observations
about the draft Guideline update (prepared by CDC). The OWG presented
its findings at the July 2021 BSC/NCIPC meeting. The BSC/NCIPC will
then review the OWG's report and provide recommendations for CDC to
consider as part of the Guideline update process.
It is anticipated that a revised Guideline will be posted in the
Federal Register for a 60-day public comment in late 2021, which will
provide a critical opportunity for diverse input from the public.
Release of a final updated Guideline is anticipated to occur in
late 2022.
On opioid therapy--there are very limited clinical trial data
comparing safety and efficacy of partial agonist buprenorphine with
full agonist/schedule II opioids for chronic pain. In order to ensure
that the updated guideline would be informed by available clinical
evidence on types of opioids, CDC asked AHRQ to specifically address,
in its evidence review on opioids for chronic pain to inform CDC's
guideline update, the following questions on effectiveness and safety
of opioids by type of opioid:
``Key Question 1. Effectiveness and Comparative Effectiveness . . .
. b. How does effectiveness vary depending on . . . (4) the
type of opioids used (e.g., pure opioid agonists, partial
opioid agonists such as buprenorphine or drugs with mixed
opioid and nonopioid mechanisms of action such as tramadol or
tapentadol)?''
``Key Question 2. Harms and Adverse Events . . . . b. How do harms
vary depending on . . . (5) the mechanism of action of opioids
used (e.g., are there differences between pure opioid agonists
and partial opioid agonists such as buprenorphine or drugs with
opioid and nonopioid mechanisms of action such as tramadol and
tapentadol) . . . ?''
The AHRQ evidence review published in 2020 found very limited
evidence on comparative safety or effectiveness of opioids for chronic
pain by type of opioid. Please see the report for additional detail,
which can be found at https://effectivehealthcare.ahrq.gov/sites/
default/files/pdf/opioids-chronic-pain.pdf.
CDC is considering all findings from the AHRQ evidence reviews in
developing updated recommendations.
SUBCOMMITTEE RECESS
Senator Murray. The committee we will next meet in Dirksen
562, Wednesday, May 26 at 10 a.m., for a hearing on the Biden
Administration's Budget Request for the National Institutes of
Health.
Thank you very much.
[Whereupon, at 11:50 a.m., Wednesday, May 19, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
May 26.]