[Senate Hearing 116-]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2021
----------
WEDNESDAY, SEPTEMBER 16, 2020
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:12 a.m. in room SD-G50, Dirksen
Senate Office Building, Hon. Roy Blunt, (chairman) presiding.
Present: Senators Blunt, Alexander, Graham, Moran, Capito,
Kennedy, Hyde-Smith, Lankford, Murray, Durbin, Reed, Shaheen,
Merkley, Schatz, Baldwin, Murphy, and Manchin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Coronavirus Response:
A Review of Efforts to Date and Next Steps
opening statement of senator roy blunt
Senator Blunt. The Appropriations Subcommittee on Labor,
Health and Human Services, Education, and Related Agencies will
come to order.
I want to thank our witnesses for appearing before the
subcommittee today to provide an update on where we are on the
areas that they are so involved in on COVID-19.
As we continue to be challenged by this pandemic, in the
country, we know that 195,961 Americans have died as part of
the pandemic and 6.6 million have tested positive during the
process of testing in the pandemic. This has rapidly swept
across the globe, and even countries who thought their cases
were contained are facing new outbreaks and dealing with those
new and unanticipated outbreaks.
This is a new disease in many ways, and even after 9
months, we still know relatively little about this disease or
coronaviruses generally. This has hindered our public health
response. In many ways, this has been like trying to build a
plane while we were flying the plane, and that is a
challenging, challenging thing to deal with.
That is not to fully exonerate certainly the way the
administration has dealt with it or the way it has been funded,
and I am sure that justified criticisms can and will be
leveled.
But history allows us to look over past events and to put
current ones into perspective. If we wanted to look back just 6
years to 2014, for instance, when West Africa faced the largest
Ebola outbreak the world had ever seen, and unlike COVID-19, we
knew a lot about Ebola at the time. The disease has been around
since the mid-1970s. It was a disease that scientifically we
knew a lot more about in 2014 than we do about COVID-19 even
today.
And frankly, we just did not handle it very well. We made
significant mistakes, and we have seen those mistakes occur in
other disease areas. Members of Congress used words when they
talked about the CDC (Centers for Disease Control and
Prevention) response like ``cryptic'' and ``misleading'' and
thought that the information provided was not enough. We even
had an Ebola case that was found in a Dallas hospital, and the
CDC Director blamed the hospital. At the same time, one of the
nurses in the hospital was allowed to board a commercial flight
with CDC's consent.
So we seem to keep having to learn these lessons over and
over again that we have to be better prepared. Public health is
hard, and it seems to be hard for us to keep our eye on what
might happen in the future once we get beyond that moment. We
should have learned and, more importantly, implemented more
than we did from Ebola or from H1N1, both of which created real
response problems, but real lessons if we had tried to learn
them. Hopefully, we will do a better job learning the lessons
we need to learn right now.
Neither this administration nor the last one, frankly,
prioritized research like this committee has, and we know that
in our committee we have worked hard in the last 6 years and in
the last five budgets in a bipartisan manner to increase the
funding in the annual appropriations bills for the NIH
(National Institutes of Health) by nearly 40 percent, for CDC
by 21 percent, and for preparedness by 44 percent. But those
numbers all have to be coming together before we begin to use
them the way that our witnesses today or this committee would
like to see them used.
We have proven in our committee that medical research,
public health, preparedness are all priorities, and because we
have done so, we are more ready than we were at the last time
or hopefully more ready in the future for the next pandemic.
Right now, 238 FDA (Food and Drug Administration) emergency use
authorizations for diagnostic tests and antigen tests are on
the market, and every day we get closer to an affordable,
reliable rapid test where you can get an answer in a way that
allows us to really fight the pandemic rather than have another
data point.
In a few years, when someone gives a history lesson about
COVID-19 response, there will be criticism. It will go back
about 20 years, and it will be significant.
But I know there are things we all agree on. We need to
have more investment in testing, more resources for our vaccine
candidates to finish their trials, manufacture the vaccine and
for CDC to distribute through a vetted, well thought out plan.
I hope we learn more about--and I am going to insist that we
learn more about--all of those things today.
I had hoped we might be able to include child care in our
hearing today. We were not able to do that because of time, but
clearly if you are going to get back to school, back to work,
and back to better health, child care has to be part of that
and something this committee has to stay focused on.
So, again, I welcome our witnesses.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Good morning. I want to thank our witnesses for appearing before
the Subcommittee today to provide an update on COVID-19.
This continues to be an incredibly challenging time for our
country. COVID-19 has killed 195,961 Americans and 6.6 million have
tested positive. It has rapidly swept across the globe and even
countries that thought their cases were contained are facing new
outbreaks.
COVID-19 is a new disease and even after 9 months, relatively
little is known about it, or even coronaviruses generally. This has
hindered our public health response. Trying to find the answers has
been like building the plane while flying it.
That comment is not to exonerate this Administration's handling of
the response. Can justified criticisms be leveled? Yes.
But history allows us to look at past events to put current ones
into perspective. For this history lesson, we only need to remember
back 6 years to 2014 when West Africa faced the largest Ebola outbreak
the world had ever seen.
Unlike COVID-19, Ebola is a disease that has been around since the
mid-1970s. It is a disease that, scientifically, we knew a lot more
about in 2014 than we do COVID-19 in 2020.
But even the kindest recollections of our public health response to
Ebola would call it flawed. As the threat of an Ebola patient flying to
the U.S. was a growing reality, the Obama Administration refused to
consider closing borders.
When CDC began implementing infection control guidelines, critics
said they were too complicated and too hard to follow. Healthcare
worker unions stated that their members had inadequate training and
protective equipment. Public health experts said the CDC Director
should be more upfront about the unknowns and uncertainties of the
disease.
Members of Congress used words like ``cryptic'' and ``misleading''
to describe the information that was provided to them by the
Administration.
And when a case finally was found in the U.S. at a Dallas hospital,
the CDC Director blamed the hospital for a ``breach in protocol'' that
led to the infection of two nurses.
Yet, when one of those nurses wanted to board a commercial flight
while running a fever, she was allowed to with the CDC's consent.
This lesson is to illustrate a simple reality: public health is
hard. And it is especially difficult for a disease we are still
learning about as we fight it in pandemic form. Those in charge of the
response are never going to get everything right and it will always be
easier for talking heads or other experts to criticize those making the
tough decisions.
But we should have learned, and more importantly implemented, more
than we did from Ebola and H1N1. For example, the top two lessons
learned from the Ebola outbreak in West Africa according to the World
Health Organization were: (1) research at the heart of the response;
and (2) test results turned around quickly.
Neither this Administration nor the last prioritized medical
research. Would we have had a better response if there were more money
during the early 2000s for medical research? We'll never know. But I do
know that NIH turned its attention from other coronaviruses like MERS
or SARS when funding became tight.
And like Ebola, we all know the importance of rapid testing for
coronavirus. It can make or break a response. We need to ask ourselves
why CDC wasn't more prepared.
As someone who has chaired the LHHS Subcommittee for nearly 6
years, I have tried to refocus our efforts on medical research and
preparedness. Over the past 5 years, in a bipartisan manner, the
Subcommittee has been able to increase funding in the annual
appropriations bills for the National Institutes of Health by nearly 40
percent. CDC funding has increased 21 percent. And preparedness funding
is up 44 percent.
I believe the Appropriations Committee's job is to ensure funding
is prioritized to the most important activities. If everything is a
priority, then nothing is a priority. In the past 5 years, I think we
have proven that medical research, public health, and preparedness are
the priorities, and have done so in a bipartisan manner.
And because we had done so, we were more ready for an unknown
pandemic. This is illustrated by how quickly medical research pushed
several vaccine candidates into late-stage development only 6 months
after we discovered the disease in this country.
There are now 238 FDA emergency use authorizations for diagnostic
and antigen tests on the market, and every day we get closer to an
affordable, reliable, rapid test that can be deployed anywhere to be
taken at any time.
In a few years, when someone gives a history lesson about the
COVID-19 response there will be criticism. And it will be significant.
But I know there are things both sides agree to. This includes a
further investment in testing--so it can be as widespread as possible--
more resources for our vaccine candidates to finish their trials,
manufacture the vaccine, and for CDC to distribute it through a vetted,
well thought through plan.
We also know that parents are struggling to return to work without
many schools or child care facilities open. Child care programs
operated on razor thin margins prior to the pandemic. Now, with
additional costs and decreased enrollments, and social distancing, many
child care programs are being stretched beyond their breaking point.
More investment is needed to help child care providers safely stay open
or re-open, and to provide safe, high-quality child care so their
parents can return to work.
I know if we focus on COVID-19 related funding, we can reach an
agreement with the other side.
I want to once again thank the witnesses for appearing today. I
look forward to your testimonies and appreciate your thoughtful
dialogue with us. Thank you.
Senator Blunt. And Senator Murray is joining us from her
office, I believe. Senator Murray, we are ready for your
opening comments.
STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman,
and thank you to all of our witnesses who are joining us today.
You know, as our country approaches a tragic milestone in
this pandemic, 200,000 dead, I want to recognize that our
rising national death count represents countless personal
losses. Families have lost parents, grandparents, and children.
Communities have lost educators, healthcare providers, and
other frontline workers, and people have not only lost loved
ones, but many have lost a small solace of being able to visit
and comfort those they care about in their final moments. My
heart goes out to everyone who is struggling with the hardship
caused by this virus whether they are suffering with the loss
of life or livelihood.
You all deserve leaders who take this crisis seriously, who
take action to support and protect you, your family, and your
community, who arm you with the facts you need to stay safe.
Unfortunately, we have yet to see that leadership from the
President. Like many Americans, I was deeply angered last week
to hear President Trump admitting that even though he
understood COVID-19 was more deadly than even your strenuous
flu--that is a quote--he was intentionally playing down this
crisis. But I was not surprised. These recordings were not a
revelation. The reality has been painfully obvious for months.
Early on, President Trump not only claimed this virus was
contained, controlled, going away, he claimed it was a
Democratic hoax. His Vice President wrote an op-ed arguing that
there would be no second wave just before we saw a
heartbreaking and record-breaking increase in new cases and
deaths across our country.
When it came to testing, President Trump did not just say
he took no responsibility at all, he said he liked the numbers
where they were. He said he wanted to slow down testing, and he
blamed testing for the rising case numbers.
When it came to wearing masks, he not only said that masks
caused problems too, he also shared a tweet saying masks
represent a culture of silence, slavery, and social death, and
a video falsely claiming people do not need to wear masks and
there is no cure.
He made false claims on treatments as well, continuing to
promote hydroxychloroquine and has suggested we look at bleach
as an option.
And he is still--still--downplaying this virus. He is still
saying it will just go away. He is saying we are, quote,
rounding the final turn. Dr. Fauci has made it clear that is
not true and pointed out that we have plateaued at around
40,000 cases a day, that daily deaths are still regularly
around 1,000, and experts have warned that we still need to
prepare for a fall wave that will coincide with the flu season.
But President Trump has not been listening to the public health
experts. He has been fighting them, suggesting FDA is part of a
deep state conspiracy, and CDC is overstating the death counts.
But not only is he spreading inaccuracies and outright lies
at a time when truth is a matter of life and death and trust--
trust--in our public health agencies is paramount, his
administration has been recklessly interfering with the work of
these agencies for political benefit to promote unproven
treatments, alter CDC guidance on reopening and testing and
more. Just over the last week, we have learned that President
Trump put pressure on NIH and FDA to authorize convalescent
plasma as a treatment and that political appointees at HHS
(Department of Health and Human Services) have worked
unsuccessfully to dictate talking points for Dr. Fauci and has
succeeded in demanding oversight of and changes to CDC's
flagship scientific publication, the Morbidity and Mortality
Weekly Report. That publication is a cornerstone of public
health work across the world. It is dangerous and unprecedented
that political appointees are editing, censoring, and
ultimately undermining a report that is intended to give
families, public health professionals, researchers, and
healthcare providers what they need: the truth.
The Trump administration's political meddling shows a
dangerous disregard for truth, facts, science, and most
importantly, people's lives. Data and science are key tools in
our fight against any health crisis, and the damage being done
to public trust in those tools by this administration threatens
to undermine our ability to respond to this pandemic, public
trust in an eventual vaccine, and public health efforts for
years to come.
The Trump administration needs to leave the science to the
scientists immediately.
The leaders of our public health agencies need to provide a
full account of what political pressure has been applied and
what steps they are taking to make sure it does not influence
their work or the work of the agencies they lead.
Congress needs to act now to demand the transparency we
need to hold this administration accountable. Democrats will be
laying out steps soon for how we can do that, and I hope every
Republican who has said they believe we need to follow the
science will prove it by working with us on this because you
cannot be for science if you are not against political
interference.
I also hope Republicans will come to the table to work with
us in earnest on a larger COVID-19 package that our communities
so desperately need. Unfortunately, they have not taken this
seriously so far, and when Democrats put forward the HEROES Act
back in May, Republicans said there was no rush, they would
wait to see if more was needed. When Republicans finally did
put forward a proposal months later, it was woefully inadequate
to address the crisis at hand. And while Democrats have moved
to find common ground and even offered to negotiate towards a
lower top line number, Republicans refused that offer and
instead put forward a bill last week that moved us even further
away from common ground. This is not serious negotiating, and
the ideas that have been put forward are not serious solutions.
But the crisis we face remains deadly serious.
We cannot afford to waste any more time. We need to
stabilize the child care sector and make sure schools can
educate students safely whether remotely or in person. We need
to make significant investments in public health, particularly
regarding testing and contact tracing, and distributing and
administering a safe, effective, and trusted vaccine.
And we need to demand the type of comprehensive national
plan for those efforts that has been long overdue. The
distribution plan that CDC finally put out just today is a long
overdue step forward, but there is still more to do. I am still
reviewing this, and I will have more to say. But it is clear
this is still not the kind of comprehensive, end-to-end
national plan I have called for and that we desperately need.
We are still missing important details on research and review
like what standards FDA would use to authorize a vaccine for
emergency use development, like how we make sure disparities
are addressed in clinical trials, and manufacturing, like how
we address supply chain issues and avoid bottlenecks. And we
still need more details on addressing disparities.
We also need to protect the safety and civil rights of
those going to work and provide relief to those who have lost
their jobs.
We need to support families who are struggling to make rent
and afford healthcare and get nutritional meals.
And we need to address the severe disparities we are seeing
and how much harder this crisis is hitting black and Latino and
Tribal communities.
We need to provide relief for our State, local, and Tribal
governments.
And last but, as we have seen recently, certainly not
least, we need to make sure once and for all that political
interference from President Trump does not further undermine
our response to this crisis.
Now, I am going to have several questions for our
witnesses, but I hope we are all able to get more than just
answers in the days ahead. I hope we are all able to finally
come together and take action before we lose any more time to
save lives and prevent costly mistakes.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Murray.
Again, let me welcome our guests today, our witnesses
today. Admiral Brett Giroir is the Assistant Secretary for
Health. Dr. Robert Kadlec is the Assistant Secretary for
Preparedness and Response, and Dr. Robert Redfield is the
Director of the Centers for Disease Control and Prevention. We
are pleased you are here. I would like to give you time to make
an opening statement. We have the statements you have
presented. You can summarize those if you want, but we are
eager to get to questions, but we are also eager to hear from
you. So, Admiral Giroir, why do you not go ahead and start with
your opening statement.
STATEMENT OF HON. ADMIRAL BRETT GIROIR, M.D., ASSISTANT
SECRETARY FOR HEALTH, DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Admiral Giroir. Chairman Blunt, Ranking Member Murray, and
distinguished members of the subcommittee, I am honored to
update you on our Nation's effort to combat COVID-19 with a
specific focus on testing.
Testing is an essential component of America's public
health response to the pandemic. Recommended practices like
wearing a mask, avoiding crowds, especially indoors, and
washing your hands, combined with smart testing, is the formula
to effectively slow the spread, flatten the curve, and save
lives.
By being evidence-based, providing county-specific weekly
guidance to governors, expanding supplies, and managing their
distribution, providing the right test to the right person at
the right time, and developing and allocating safe and
effective therapeutics, we are seeing promising results.
Specifically, since the post-Memorial Day peaks in
community spread, the number of new COVID-19 cases is down 48
percent. The number of people hospitalized with COVID-19 is
down 49 percent. The number of people in an intensive care unit
due to COVID is down 62 percent, and deaths associated with
COVID are down 33 percent.
But let me say emphatically that these gains could be
fleeting or even reversed if we do not continue to follow the
national plan and exercise personal responsibility, especially
wearing masks and avoiding crowds.
Now, specifically regarding testing, the Nation will
surpass 100 million viral tests completed this week. We have
purchased and shipped over 95 million swabs and 81 million
tubes of media to States, Tribes, and Federal partners.
Starting April 7, we have purchased and delivered to public
health laboratories and the Indian Health Service 2.3 million
Abbott ID NOW point-of-care molecular tests to support outbreak
control and rural testing. We have established Federal surge
testing in 19 different sites, helping to squelch emerging
outbreaks typically among asymptomatic young adults. These
sites are in addition to the over 2,700 federally supported or
federally enabled community-based testing sites at trusted
retailers focused in areas of moderate to high social
vulnerability and the literally thousands of HRSA (Health
Resources and Services Administration) federally qualified
health centers that offer testing to predominantly racial or
ethnic minority patients.
We are now at an inflection point in testing. This month we
anticipate the availability of approximately 3 million tests
per day, and at least half of these will be rapid point-of-
care. We will have available more point-of-care tests in
September than the total number of tests performed in August.
We have been building towards this inflection point, and I have
previously testified to its coming several times over the past
months.
As a result of regulatory flexibility, investments in
coordination with the public and private sectors, we have
implemented comprehensive, cutting-edge testing initiatives to
flatten the curve and save lives while supporting reopening of
America. Let me discuss just two of these.
Protecting the elderly has been, is, and will continue to
be a foremost priority for this administration. So on July 14,
we announced that every single eligible nursing home in America
would receive a point-of-care instrument and point-of-care
testing supplies. We have delivered on this promise. All 13,850
eligible nursing homes have now received a total of 13,985
instruments and over 4.9 million rapid point-of-care tests
ahead of schedule.
On August 27, after months of planning and only 1 day after
its FDA authorization, the administration announced a $760
million contract with Abbott for the delivery of 150 million
rapid BinaxNOW point-of-care tests. This test is easy to
perform, does not require an instrument, delivers test results
in 15 minutes or less, and costs 5 bucks. It can easily be
deployed to many settings across the country, and it comes with
a companion app that enables instantaneous reporting. We have
already deployed 50,000 of these tests in support of disaster
operations in California, Texas, and Louisiana and now another
15,000 to support wildfire operations in Oregon.
This week, we will ship our first 2 million tests to
further prevent spread of COVID in nursing homes, assisted
living, and in Tribes. In the coming weeks, we will begin
shipping millions of tests per week in support of our teachers
and students to open and keep open K through 12 schools and to
support vulnerable populations at HBCUs (Historically Black
Colleges and Universities).
Thank you for the opportunity to provide these remarks, and
I look forward to your questions.
Senator Blunt. Thank you, Admiral.
Dr. Kadlec.
STATEMENT OF DR. BOB KADLEC, M.D., ASSISTANT SECRETARY
FOR PREPAREDNESS AND RESPONSE, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. Kadlec. Thank you, Chairman Blunt, Ranking Member
Murray, and distinguished members of the committee. I am Dr.
Bob Kadlec, the Assistant Secretary for Preparedness and
Response.
As a medical doctor and former Senate staffer, retired
military officer, and having served in the White House, I have
spent my adult career working to serve and protect the American
people.
I appreciate the opportunity to testify before you to
highlight ASPR's (Assistant Secretary for Preparedness and
Response) response to the COVID-19 pandemic, our progress in
vaccine development and our efforts to confront and mitigate
this pandemic.
I want to thank this committee for providing both
supplemental resources for COVID response, as well as
supporting and sustaining the ASPR organization in the past.
Your investments have been critical to support our operations
and ensure we have tools available to respond to the COVID-19
pandemic.
Throughout 2020, ASPR has used these resources to protect
American lives. We have assisted in the repatriation of
Americans from China and Japan at the start of the pandemic.
ASPR has provided medical surge support in Louisiana, Texas,
and Mississippi after Hurricane Laura, and today we have teams
deployed to Louisiana and Mississippi prepared to assist in
response and recovery operations following Hurricane Sally. We
have deployed personnel and teams to California and Oregon to
support wildfire response, and the Secretary has just signed
the public health emergency for Oregon to assist in the search
and rescue of personnel--of individuals who have been affected
there.
We have deployed personnel to Beirut to assist the
government in Lebanon with hospital recovery following the
catastrophic explosion.
With that, we have supported these calls to action while
simultaneously responding to State, local, territorial, and
Tribal requests for assistance in the COVID response.
It is an honor to lead this organization. I am truly
humbled by the selflessness and dedication of the men and women
of ASPR. While we have seen a decline in new cases and deaths
and hospitalizations, we know it takes constant vigilance and
personal responsibility by every American to wear masks, wash
hands, and keep our social distance. But as everyone does their
part, ASPR continues to work hard to enhance our country's
preparedness and response capabilities. I am proud that ASPR
has been part of a driving force in this whole-of-America
effort.
Since early 2020, ASPR and BARDA (Biomedical Advanced
Research and Development Authority) began working to accelerate
vaccine development. This work was foundational to the
development of Operation Warp Speed, a whole-of-government
approach working with our private sector partners to produce
and deliver a safe and effective vaccine as fast as possible.
The supplemental appropriations provided by this committee
have been essential in permitting significant advancements
under Warp Speed. As a result, America is far better positioned
than before to keep Americans safe, protect vulnerable
communities and individuals, and defeat the COVID-19 virus. To
date, we have awarded $13.6 billion to support over 50 medical
countermeasure projects. Seven of these awards are vaccine
contracts. We are making significant progress in advancing
these vaccines through a clinical trial process. In fact, three
candidates are in phase 3 clinical trials, meaning that we are
closer than ever to a safe and effective vaccine available to
the public. Three others are in phase 1 and 2.
Safety is our top priority in the development of vaccines
and therapeutics, which is why science is driving the
development of all COVID-19 countermeasures to ensure they meet
FDA's gold standard of approval. In the meantime, we have
implemented an intensive, efficient process to promote vaccine
development and, in parallel, manufacturing. Supporting these
efforts simultaneously ensures we are positioned to distribute
and administer the vaccine quickly once approved.
ASPR also continues to support advancements in lifesaving
therapeutics. For example, ASPR has taken a data-driven
approach to oversee the fair and equitable distribution of
remdesivir. To date, we have distributed to States enough
remdesivir to treat almost 650,000 patients.
ASPR has also supported the mitigation efforts to slow
virus transmission. Since March, ASPR has produced and
distributed more than 500 million cloth facial coverings across
the country to protect vulnerable populations and essential
workers. This month, we are supporting the administration's
school facial coverings initiative by sending an additional 125
million cloth facial masks to States and territories for
distribution to low-income students in order to support the
safe reopening of America's schools.
As the Federal agency leading the emergency support
function 8, ASPR is capitalizing on existing relationships with
DoD (Department of Defense), VA (Department of Veterans
Affairs), and DHS (Department of Homeland Security) to
coordinate a more comprehensive medical nationwide response. We
have responded to requests from 32 States, three territories,
five Tribes with nearly 100 medical support missions with over
5,700 staff from ASPR's national disaster medical teams, the
Public Health Service, the VA, and DoD.
We have provided personal protective equipment that I know
will be subject to quite a few questions under the SNS
(Strategic National Stockpile) 2.0 initiative to expand the
depth and breadth of our stockpile, grow the U.S. industrial
base, and reduce our vulnerabilities to foreign suppliers. We
have used the Defense Production Act as well.
I thank you again for your support and the opportunity to
testify before you on ASPR's efforts during this pandemic, and
I am happy to answer any questions you may have at this time.
Senator Blunt. Thank you, Dr. Kadlec.
Dr. Redfield.
STATEMENT OF DR. ROBERT R. REDFIELD, M.D., DIRECTOR,
CENTERS FOR DISEASE CONTROL AND PREVENTION
Dr. Redfield. Good morning, Chairman Blunt and Ranking
Member Murray and members of the committee. Thank you for the
opportunity to be here today.
On behalf of CDC, thank you also for your continued support
of our public health professionals and the lifesaving work they
are committed to do 24/7.
Over 6,700 CDC staff have been engaged in the agency's
COVID-19 response, 1,200 of whom have been deployed to more
than 200 locations in the United States and abroad. And I know
you share with me the gratitude for their resilience,
dedication, and service to our Nation.
Throughout this global pandemic, CDC has brought its
scientific expertise to the front lines, conducting rapid
investigation of disease outbreaks that identified the highest
risk populations and settings. Understanding which populations
are at risk and how the virus is spreading in various settings
is critical to developing the guidance and protecting the
health of Americans.
Today and even after we have a vaccine, CDC encourages all
Americans to embrace the powerful tools that we have right now:
to wear a mask, particularly when they are in public; maintain
social distancing; routine, vigilant hand washing; be smart
about crowds; and stay home when you are sick.
And as we move into the fall, we are adding one of the most
significant scientific contributions to medicine to our
evidence-based mitigation strategies: flu vaccination. Flu
vaccine is safe and CDC encourages Americans to embrace flu
vaccine with confidence for themselves, their families, and
their communities. These simple actions combined could help
this Nation avert a very difficult fall, lessening the burden
on our healthcare system and saving lives.
CDC has awarded $140 million to 64 jurisdictions through
our existing immunization cooperative agreements to scale up
flu vaccination this season. This funding is supporting staff
and preparedness with the focus of ensuring that flu vaccine
coverages can reach the populations at most risk. This year,
CDC purchased an additional 9.3 million doses of adult
influenza vaccine, up from the usual annual 500,000-dose
purchase in prior years, as well as 18.5 million doses for
children.
And CDC has developed a new multiplex laboratory test that
can check for three viruses at the same time, influenza A and
B, plus SARS-CoV-2, in a single test from a single sample. This
test was granted an EUA (Emergency Use Authorization) by the
FDA and will save public health laboratories time and resources
and help better understand and identify co-infections with
influenza 1 and SARS-CoV-2. To date, CDC has distributed over
135 multiplex kits to more than 100 laboratories across the
country, with each kit having enough reagents to do
approximately 500 tests.
CDC is also working with 64 immunization grant recipients
to build readiness for timely and, most importantly, equitable
administration when a COVID-19 vaccine becomes available. CDC
is leveraging its expertise and immunization infrastructure to
support Operation Warp Speed and vaccine promotion,
distribution, administration, and monitoring. In coordination
with Operation Warp Speed, CDC is working closely with State
and local, territorial, Tribal health departments and community
organizations to prepare a detailed, yet flexible plan for
vaccine distribution to critical infrastructure workers and
people at risk, increased risk for serious outcomes.
At this time, CDC continues to support partners with its
ongoing community mitigation efforts, including case
identification, contact tracing, surveillance, and reporting,
as well as testing capacity.
To support these activities on behalf of HHS, CDC has
awarded $12 billion to these jurisdictions in 2020, thanks to
the support of Congress. Included in that amount was more than
$200 million to support the American Indian and Alaska Native
communities, which have had some of the most significant
effects from COVID-19.
Timely, accurate and, most importantly, actionable data are
essential if we are going to learn to impact COVID-19 on all
Americans, particularly the populations at greater risk such as
older Americans, those with chronic medical conditions, racial
and ethnic minority populations. CDC reports monthly to the
Congress the most recent data analysis on the impact in racial
and ethnic groups.
As I have emphasized in my prior hearings, now is the time
to commit to prioritize a sustained investment in the core
capabilities of public health, that is, data and data
analytics, laboratory resilience, workforce expansion, and
rapid response capabilities. Years of under-investment in
public health have led to a system that has been sorely tested
by the current pandemic. COVID-19 is the most significant
public health challenge to face our Nation in more than a
century. Now is the time to build not only the public health
core capability that our Nation needs, but that the people of
our Nation deserve. As we work together collectively to fight
COVID-19 to end the pandemic, CDC is committed to the mission
to protect all Americans from the disease threats to save lives
now and in the future.
Thank you for the opportunity, and I look forward to your
questions.
[The statement follows:]
Prepared Statement of Admiral Brett P. Giroir, M.D., Bob Kadlec, M.D.,
and Robert Redfield, M.D.
Chairman Blunt, Ranking Member Murray and distinguished members of
this subcommittee. It is an honor to appear before you today to discuss
the Department of Health and Human Services' ongoing response to the
COVID-19 pandemic. We are grateful for this opportunity to address how
each of our agencies and offices are harnessing innovation to prevent,
diagnose, and treat the novel coronavirus SARS-CoV-2.
COVID-19 is a new disease, caused by a novel (or new) coronavirus
that has not previously been seen in humans. This new disease,
officially named Coronavirus Disease 2019 (COVID-19), is caused by the
SARS-CoV-2 virus. There are many types of human coronaviruses including
some that commonly cause mild upper-respiratory tract illnesses.
Coronaviruses are a large family of viruses. Some cause illness in
people, and others, such as canine and feline coronaviruses, only
infect animals. Rarely, coronaviruses that infect animals have emerged
to infect people and can spread between people. This is suspected to
have occurred for the virus that causes COVID-19. Middle East
Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome
(SARS) are two other examples of coronaviruses that originated in
animals and then spread to people.
The Department of Health and Human Services (HHS) is working
closely with all of our government partners in this response. Congress
passed the Coronavirus Preparedness and Response Supplemental
Appropriations Act, 2020; the Families First Coronavirus Response Act;
the Coronavirus Aid, Relief, and Economic Security (CARES) Act; and the
Paycheck Protection Program and Health Care Enhancement Act. These laws
have provided additional resources, authorities, and flexibility.
Within HHS, the Centers for Disease Control and Prevention (CDC), the
Assistant Secretary for Health, and the Assistant Secretary for
Preparedness and Response along with additional components not
represented today, play critical roles in the response to this public
health emergency as discussed below.
centers for disease control and prevention
CDC is America's health protection agency, and works 24/7 to
prevent illness, save lives and protect America from health, safety and
security threats. CDC has a key role in preparedness and response in
the U.S. and abroad. Addressing infectious diseases like COVID-19 is
central to our mission and CDC has decades of leadership in infectious
disease response.
When there is an emerging pathogen like the SARS-COV2 virus, CDC
expertise lies in our ability to study the new pathogen to understand
how it is transmitted, and translate that knowledge into public health
action. Since first learning of the cluster of cases in Wuhan, CDC has
rapidly advanced the science around this new human pathogen, SARS-CoV-
2. CDC has both been on the forefront of understanding this new disease
and led the Nation's efforts to protect Americans from infection.
Currently, over 6,700 CDC employees have been engaged in the agency's
COVID-19 response, and over 1,200 of these staff have been deployed to
nearly 200 different locations in the U.S. and abroad. CDC staff have
conducted rapid investigations of outbreaks that identified highest-
risk priority populations and settings. Understanding specific
population-level vulnerabilities and how infections spread in various
types of settings has been instrumental in the development of guidance
that will help keep the American people healthy and allow critical
infrastructure services to be provided safely.
The Morbidity and Mortality Weekly Report (MMWR), sometimes called
the ``voice of CDC,'' has published more than 100 COVID-19 reports
since the beginning of the pandemic, providing cutting-edge scientific
articles that have been viewed by tens of millions of readers. These
reports have provided the public, scientists, healthcare workers, and
policymakers critical information about the virus, how it spreads, and
the communities it has impacted. MMWR reports yielded the earliest
descriptions of asymptomatic and pre-symptomatic transmission of the
virus and elucidated the substantial risk of transmission at large
gatherings, choir practices, and congregate living situations including
nursing homes, prisons and jails, homeless shelters, and camps for
children. They have described the disparate impact of COVID-19 in
racial and ethnic minorities and identified the elevated risk of severe
outcomes for older adults and people with underlying conditions.
Finally, MMWR reports have indicated what successful control of the
virus looks like, through careful mitigation efforts in everyday high-
risk settings such as hair salons and childcare centers. In short,
MMWR's rapid publication of the highest quality science has laid the
foundation of what we know about COVID-19 and illuminated the way
forward.
In addition to publishing our own scientific information, CDC
scientists are monitoring in real time the rapidly expanding scientific
literature and have reviewed over 100,000 scientific papers thus far.
This approach ensures that CDC responders are armed with the best
information available. This comprehensive understanding of the emerging
science base helps direct CDC's scientific agenda and informs CDC
guidance, and helps guide CDC's direct support of clinicians and the
public. CDC's Clinical Response Line has fielded over 32,000 individual
inquiries from frontline healthcare providers, and the agency's hotline
for public inquiries has responded to nearly 500,000 calls and e-mails.
CDC is drawing on its emergency response capacity and its
relationships with State, Tribal, local, and territorial (STLT),
global, and private sector partners; and is leveraging our workforce's
strengths in public health surveillance, prevention, and laboratory
capacity to carry out research and share new knowledge related to this
novel pathogen and its consequences. CDC provides guidance for
healthcare professionals, essential workers, businesses, schools, and
the public to encourage safer practices, improve health outcomes, and
save lives. CDC works with partners to develop decision tools to assist
STLT officials and other stakeholders with mitigation strategies.
Importantly, CDC is preparing the Nation's public health system and the
private sector to disseminate a vaccine when one is available. CDC is
leveraging investments in global health security and pandemic influenza
preparedness infrastructures in over 60 countries to mitigate the
effects of COVID-19 and stop the disease from spreading.
As of September 9, 2020, there have been 6,310,633 COVID-19 cases
reported and 189,147 deaths attributed to the virus in the U.S. The
latest data can be found on CDC's website: https://www.cdc.gov/covid-
data-tracker/index.html. The U.S. Government has taken unprecedented
action to address the public health threat posed by this new
coronavirus. CDC has substantial supplemental funding to help respond
to this pandemic at home and abroad. This funding supports a federally
guided, State managed, and locally implemented response to COVID-19 in
the United States.
With funds provided by the Coronavirus Preparedness and Response
Supplemental Appropriations Act and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, CDC is providing States with needed
resources needed to detect, respond, and prevent the spread of COVID-19
and to inform community mitigation strategies.
CDC's highest priority is to ensure that STLT public health
programs have the resources they need to address the COVID-19 pandemic.
These jurisdictions are best positioned to understand the unique
situation of each community, including the status of their public
health infrastructure and workforce and its needs for enhancement. CDC
is supporting STLT partners who are working to identify cases; conduct
contact tracing; implement containment measures and mitigate spread in
the community. CDC is working alongside these health departments to
improve surveillance and reporting and enhance testing capacity.
Together, STLT and CDC teams are responding to COVID-19 outbreaks in
high-risk settings and implementing best practices to control the
spread.
As a public health agency and the Nation's primary resource for
STLT health departments on managing disease outbreaks, CDC provides
guidance and support on the development and implementation of effective
containment and community mitigation strategies. The goal is for all
jurisdictions to have robust public health systems which include a
contact tracing infrastructure that meets their unique needs. As of
September 2020, CDC has posted over 30 contact tracing guidance
documents, including case investigation guidelines, checklists for
developing a case investigation and contact tracing plan, digital
contact tracing tools, and a Contact Tracing Communications Toolkit for
Health Departments. To support these activities, described in further
detail below, CDC has awarded $12.1 billion to these entities in fiscal
year 2020, including $10.25 billion in funds executed on behalf of HHS
to be used primarily to support each jurisdiction's testing goals (as
outlined in State testing plans).
Testing Strategy
Beginning in April, the White House, and Federal partners including
CDC, convened calls with all 50 States, Puerto Rico, and the District
of Columbia to identify testing capacities and needs. Through these
calls and other outreach efforts, CDC has worked with individual
jurisdictions to identify needs, develop plans, and offer technical
assistance to enhance testing capacity. CDC, under the leadership of
the Office of Assistant Secretary for Health and in collaboration with
the Association of Public Health Laboratories, reviewed individual
State testing plans with a focus on achieving increased monthly testing
targets. These discussions and plans for action emphasized the need to
serve vulnerable populations and include focused efforts for long-term
care facilities, federally qualified health centers, and Tribal
Nations, among others.
CDC is working with STLT health departments to support forward-
looking testing strategies that ensure that vulnerable or high-risk
populations, such as some racial and ethnic minorities, have adequate
access to testing. For example, CDC worked with the Health Resources
and Services Administration and health centers to survey health centers
and better understand the populations they are serving. Approximately
60 percent of responding FQHCs are in urban areas, where persons of
Hispanic or Latinx ethnicity were the largest proportion of individuals
testing positive. This information allows STLT health departments to
implement strategies to increase testing in FQHCs and provide them with
the tools and resources to diagnose, treat, and monitor COVID-19
illness in the populations they serve.
CDC has developed a new multiplex laboratory test that checks for
three viruses at the same time, two types of influenza viruses (A and
B) and SARS-CoV-2, the virus that causes COVID-19, using a single
sample collected from an individual. Testing for all three viruses will
allow public health laboratories to continue surveillance for influenza
while testing for COVID-19. This will save public health laboratories
both time and resources, including testing materials that are in short
supply. Another benefit of the new test is that laboratories will be
better able to find co-infections of influenza and SARS-COV-2. The FDA
issued an Emergency Use Authorization (EUA) for this combined
laboratory test on July 2, 2020 and CDC released these reagents for
distribution to States' public health laboratories on August 5, 2020.
As of August 17, 2020, 135 multiplex kits were shipped to more than 100
laboratories. Each of these kits provides approximately 500 tests.
Adjusting for the controls, these 135 kits provide approximately 67,000
tests. CDC has provided these kits to each State's or territory's main
public health laboratory, as well as any regional or local laboratories
that is approved to provide SARS-CoV-2 surge testing support.
Importantly, multiplex assay technical information is publicly
available on CDC's website so that commercial developers can use this
information in developing proprietary tests. CDC also granted assay
manufacturers right of reference to its EUA, allowing developers to use
the data CDC submitted to FDA to streamline their efforts when applying
for an EUA. CDC took these steps to catalyze the development and
validation of these assays by the commercial sector which is better
equipped to scale up testing capacity.
In March 2020, CDC and public health partners began seroprevalence
surveys of community transmission of SARS-CoV-2. Seroprevalence surveys
help identify infections that might be missed due to lack of symptoms
or testing not being performed. Serology studies can also help
determine risk factors associated with SARS-CoV-2 infection, including
transmission in healthcare settings and communities, and inform
guidance and mitigation strategies. For example, CDC has published the
results from one of the seroprevalence studies that used remnants of
samples collected during routine clinical care. This was done in
conjunction with two commercial companies and results suggested that
greater than 10 times more SARS-CoV-2 infections occurred than the
number of reported COVID-19 cases. Another study on healthcare
personnel who routinely cared for COVID-19 patients found that 6
percent had evidence of previous SARS-CoV-2 infection. This study
identified two factors potentially associated with SARS-CoV-2 infection
among HCP: personal protective equipment (PPE) shortages and not
wearing a mask while interacting with patients.
Data Collection, Analysis and Understanding of the Pandemic
Accurate data are critical as we continue to assess the burden
placed on the American healthcare system to inform reopening. CDC is
leveraging all available surveillance systems, including influenza and
viral respiratory disease systems, to monitor COVID-19 and protect
vulnerable communities. These data collected by CDC help target
critical COVID-19 interventions. In collaboration with STLT public
health partners, CDC is committed to making data available to the
public, while protecting individual privacy.
This crisis has highlighted the need to continue efforts to
modernize the public health data systems that CDC and States rely on
for accurate data. Public health data surveillance and analytical
infrastructure modernization efforts started in fiscal year 2020.
Timely and accurate data are essential as CDC and the Nation work to
understand the impact of COVID-19 on all Americans, particularly for
populations at greater risk for severe illness, such as older
Americans, those with chronic medical conditions, and some racial and
ethnic minorities. Modernization efforts include support for
surveillance and data workforce, a key asset of the public health
system. For example, CDC is working closely with our partners to help
STLT health departments implement the Sara Alert system. Sara Alert is
a standards-based, open source tool that increases interoperability
among laboratory and clinical systems and automates the process of
public health monitoring and reporting individuals exposed to or
infected with COVID-19. To date, eleven States and territories, along
with nine jurisdictions including one Tribal Nation, have adopted the
Sara Alert system. Twenty additional jurisdictions including two
territories are in progress of or considering joining. At the current
level of participation during an average 10-14 day timeframe,
approximately 80,000 individuals are either entering, being monitored
by or exiting the system .
CDC's population-based COVID-NET system monitors COVID-19
associated hospitalizations that have a confirmed positive test in
greater than 250 acute care hospitals in 99 counties in 14 States. Data
gathered provide weekly estimates for age-specific hospitalization
rates and describe characteristics of persons hospitalized with COVID-
19 illness as well as predictors of those with more severe outcomes.
CDC's existing National Healthcare Safety Network (NHSN) continues to
collect COVID-19 data from nursing homes and other long-term care
facilities. NHSN also continues to collect data from hospitals across
the U.S. to address healthcare-associated infections and fight against
antibiotic resistance.
The COVID-19 Case Report Form includes variables such as race and
ethnicity to enable identification of populations that may be at higher
risk for severe illness and risk factors. Though States are not
required to report demographic information in the Case Report Form,
they have improved the completeness of their reporting. In particular,
the percentage of reports that include race data has increased from 21
percent in April to 61 percent in mid-August, while the percentage of
reports that include ethnicity data increased from 18 percent to 50
percent during the same time period. While progress has been made, CDC
will continue to work with States and other health system partners to
improve completeness of the data.
Health Disparities
COVID-19 has disproportionately impacted many racial and ethnic
groups. CDC continuously looks to enhance our COVID-19 outreach and
mitigation efforts for communities identified as most at risk. For
example, CDC is supporting local activities in African American,
Hispanic/Latino, American Indian and Alaska Native, and Asian American,
Pacific Islander, and Native Hawaiian communities to deliver COVID-19
prevention messages and community mitigation strategies. CDC recently
released a COVID-19 Health Equity Strategy (www.cdc.gov/coronavirus/
2019-ncov/community/health-equity/cdc-strategy.html) that provides an
evidence-based, comprehensive and coordinated framework for reducing
COVID-19 disparities. The Strategy includes expanded plans for
collecting and reporting timely, complete, representative, and relevant
data on testing, incidence, vaccination, and severe outcomes among
populations at highest risk. Additionally, CDC is working with existing
program grantees, such as Racial and Ethnic Approaches to Community
Health (REACH), to enhance outreach to populations at increased risk of
complications from COVID-19. These broad-based community engagements
and strategies are working with the aim of ensuring equitable access to
testing, healthcare, and future COVID-19 vaccines.
American Indian and Alaska Native communities are some of the most
affected by COVID-19. As of August 2020, CDC has provided $206.4
million to tribal nations, consortia, and organizations for responding
to COVID-19 across tribal communities. This amount exceeds the minimum
of $165 million directed by Congress through the Coronavirus
Preparedness and Response Supplemental Appropriations Act and the CARES
Act. CDC is using a multifaceted approach, guided by data, to allocate
COVID-19 funding to tribal communities, enabling broad access to COVID-
19 resources through a variety of direct and indirect supports.
Children
We are learning more about how COVID-19 impacts children every day.
Although children are less likely than adults to develop severe illness
when infected with SARS-CoV-2, household studies and outbreak
investigations confirm that children can transmit the virus and often
have the same or higher viral loads in their nasopharynx compared with
adults. Though the mortality rate is low for children aged 18 years and
younger, COVID-19--associated hospitalization rates increased among
this age group during the summer months and are continuing to rise.
From March 1, 2020 to July 25, 2020, one in three hospitalized children
was admitted to an intensive care unit.
CDC is committed to providing schools, teachers, staff, parents,
and caregivers with information and guidance to help keep our children
as safe and healthy as possible as schools reopen. CDC has developed
enhanced guidance based on the most recent science, including
considerations for operating schools during COVID-19, considerations
for Institutions of Higher Education regarding the appropriate use of
testing, and a school decisionmaking tool for parents, guardians, and
caregivers. These resources provide students, school administrators,
and parents the information the y need to guide decisionmaking and how
to adapt to local conditions.
Community Mitigation and Workplace Safety
The American people, communities, public health professionals,
medical providers, businesses, and schools look to CDC for trusted
guidance on responding to COVID-19. CDC is building and using a
growing, data-driven evidence base to develop and disseminate guidance
for a range of audiences, including business, schools, and healthcare
professionals. These recommendations include actions that every
American should take, such as wearing a mask, following good personal
hygiene practices, staying at home when sick, and practicing social
distancing to lower the risk of disease spread. CDC recently released
Interim Guidance for Businesses and Employers Responding to COVID-19 to
help prevent the spread of COVID-19 in the workplace and protect
critical infrastructure workers. CDC guidance specifies that business
operation decisions should be based on both the level of disease
transmission in the community and their readiness to protect the safety
and health of their employees and customers. CDC guidance for
businesses is available here: http://www.cdc.gov/coronavirus/2019-ncov/
community/guidance-business-response.html.
Vaccine Planning
While surveillance, testing, contact tracing, and community
mitigation interventions are the best tools we have right now, looking
to the future, CDC continues to work to prepare our Nation's public and
private health systems to deliver a COVID-19 vaccine once it is
available. CDC is using its expertise in public health preparedness and
response, along with its immunization infrastructure, to support
Operation Warp Speed in vaccine promotion, distribution,
administration, and monitoring. CDC is working closely with the
Advisory Committee on Immunization Practices (ACIP), a group of medical
and public health experts who develop recommendations on the use of
vaccines to control disease in the United States. ACIP members have
expertise in areas such as vaccinology, immunology, internal medicine,
family medicine, virology, public health, infectious diseases, and/or
preventive medicine, and one member is a consumer representative who
provides perspectives on the social and community aspects of
vaccination. An August ACIP meeting focused on post-marketing vaccine
safety surveillance, epidemiology of individuals at increased risk of
COVID-19, and modelling allocation strategies of the initial COVID-19
vaccine supply. Any recommendations ACIP makes for who should get
COVID-19 vaccine and in what order will be grounded in guidance from
the country's foremost experts on immunization science.
CDC is working closely with state and local health departments and
community organizations to prepare a detailed yet flexible plan for
vaccine distribution that will be informed by a prioritization
framework recommended by ACIP.
These efforts include working with CDC's 64 immunization grant
recipients to help ensure that the U.S. immunization system can mount
an effective vaccine delivery program, including vaccine distribution
and tracking. State and local health departments have conducted
pandemic vaccination planning with immunization and preparedness
funding from CDC for over a decade. Updating these vaccination response
plans for implementation of a COVID-19 vaccine will build readiness for
timely administration when a vaccine becomes available. During August
2020, CDC completed in-person and virtual site visits to assess needs
as vaccine planning intensifies. Lessons learned during these site
visits will inform CDC's provision of technical assistance to all
jurisdictions to aid in the development of State-specific COVID-19
vaccination plans.
In addition, some State and local health department's utilized
supplemental resources to build infrastructure that would address
current COVID-19 response needs and incorporated planning for future
phases. One example is in Chicago, where the health department has
developed the Chi COVID Coach app to communicate directly with
Chicago's residents who may be COVID-19 positive. The forward-thinking
app, built by private sector companies, can be adapted throughout the
course of the pandemic. It now allows users to register to receive the
vaccine once it becomes available.
While it remains unclear how long the pandemic will last, COVID-19
activity will likely continue for some time. It is also unclear what
impact the ongoing COVID-19 pandemic will have on healthcare and public
health systems during the upcoming influenza season and beyond.
Circulation of COVID-19 and influenza virus at the same time could
place a tremendous burden on the healthcare system. Therefore, getting
a flu vaccine is especially important. It is important that Americans
have confidence in all vaccines. CDC will leverage its immunization
program to help maintain high coverage in routine childhood
immunizations, promote immunization for adult vaccine-preventable
diseases, and increase coverage for flu vaccinations, and prepare for a
potential COVID-19 vaccine.
CDC works with public health and clinical partners each year to
increase the number of people who get a flu vaccine and eliminate
barriers to vaccination. Ongoing COVID-19 activity may affect where and
how flu vaccines are given. On June 4, CDC awarded $140 million to 64
jurisdictions through CDC's existing immunization cooperative agreement
to launch a scale up for influenza season, given the increased risk of
COVID-19. Funds are supporting staffing and preparedness with a focus
on ensuring flu vaccine coverage for populations most at risk.
Conclusion
COVID-19 is the most significant public health challenge to face
our Nation in more than a century. CDC is providing the American public
with the information and assistance it needs to defeat COVID-19. As we
work together to fight COVID-19 and end this pandemic, CDC is committed
to its mission to protect all Americans from disease threats and to
save lives, now and in the future.
office of the assistant secretary for health
Diagnostics and Testing
Testing is an essential component of the public health response to
SARS-CoV-2 (the virus that causes COVID-19). It enables clinical
decisionmaking, informs resource allocation and disease prevalence
monitoring, and is necessary to minimize community and economic
disruption through targeted infection prevention and control measures.
The indications for viral testing depend on the stage of the pandemic
and the extent of community spread. In general, testing is indicated
for diagnosis of those who are symptomatic or asymptomatic, tracing of
those in contact with those who are infected, screening of specific
employees (for example nursing home staff), and surveillance testing of
those who are asymptomatic to achieve infection control and/or other
public health objectives.
Repeated testing of a majority of the U.S. population is not
feasible at this time, nor necessary to assure safe return to work,
school, and other activities. Rather, a targeted testing strategy that
rapidly diagnoses those who are ill, protects the vulnerable, and
identifies emerging outbreak areas--when combined with public health
mitigation measures like mask wearing, is proven to reduce the spread
and flatten the curve.
To date, the U.S. has accomplished over 95 million tests, at an
average current rate of between 700,000--800,000 tests per day, with
enough tests in the market to perform three to four times that amount.
Since early March, we have increased our daily testing by over 30,000
percent. In June, July, and August, States far surpassed their goals
for testing. Specifically, State goals for June were 12.9 million
tests, and nearly 16 million were actually performed. The goals for
July were 13.7 million tests; again, States far exceeded their goals by
conducting over 25 million tests. In August the Nation completed over
25.2 million tests, far exceeding the August goal of 21.1 million
tests. Over the next several months, the Nation's testing capacity will
continue to increase. We anticipate that supplies and reagents will be
sufficient to conduct approximately 90 million tests in September. If
pooling occurs even for a fraction of these tests, there is capacity to
perform much greater than 100 million tests per month today. Turnaround
time is improving and continuing to improve. Currently, 97 percent of
ACLA tests ordered in the previous week received results within 3 days,
and 99 percent received results within 5 days.
The role of the Federal Government is to set the overall testing
strategy and requirements, provide technical guidance, secure the
supply chain, scale scarce resources, enable innovation, and support
State plans to achieve the overall national objectives as well as any
specific State objectives. States, territories, and tribes are
responsible for formulating and implementing testing plans that meet
national objectives and additional goals for their State. The academic,
commercial, and private sectors will continue to develop and produce
technologies, supplies, and services to meet the needs of the States
and the Nation at large.
The national strategy for testing was formally outlined in the
Testing Blueprint: Opening Up America Again, and the Addendum to the
Testing Blueprint. The immediate objectives of the strategy are to:
--Identify newly emergent outbreaks
--Support public health isolation and contract tracing
--Diagnose COVID-19 rapidly in hospitalized patients
--Protect the vulnerable
--Support safe reopening of schools and businesses
--Enable state testing plans
The national strategy for testing was further enumerated in the
COVID-19 Strategic Testing Plan Report to Congress initially submitted
to Congress on May 24th. On August 22nd, HHS submitted the first update
to the Strategic Testing Plan. The report outlines how HHS increased
domestic testing capacity across the United States and provides
additional guidance and information about diagnostic technologies,
platforms and inventory that States, territories and tribes can utilize
to develop flexible, adaptable, and robust COVID-19 testing plans.
Identifying Newly Emergent Outbreaks
In addition to public health surveillance systems monitored by the
CDC, the Nation is currently maintaining sufficient baseline testing
for SARS-CoV-2 in order to detect early changes in percent positivity.
At present, a minimum target of testing 2 percent of a State's
population per month has been sufficient to detect early changes in
percent positivity, and thus enable State and local officials--with the
technical assistance of the Federal team--to implement mitigation steps
rapidly to curb the emerging outbreak.
In order to assure that states meet this 2 percent threshold to
detect any threat of emergence in that State, the Federal Government
will continue to:
--Assist states with the procurement of collection supplies to
achieve minimum of 2 percent population testing per month; and
if possible, provide more supplies if needed to meet the
approved state plan targets. To date, the Federal Government
has procured and delivered 95 million swabs and 77 million
tubes of media
--Assure sufficient supply of reagents to achieve testing goals in
the context of point of care utilization and use of commercial
referral labs;
--Prioritize states with outbreaks or potential outbreaks, if needed,
and;
--Continue to expand the availability and use of point of care tests.
Support Public Health Isolation and Contact Tracing
A key function of testing is to support identification of infected
individuals, many of whom may be asymptomatic, in communities
identified with outbreaks or emerging outbreaks. In response to
``hotspot areas'', the Federal Government has set up surge testing to
increase baseline testing 2X-5X for short periods of time. Surge
testing sites have been implemented in Miami, FL; Jacksonville, FL;
Edinburg, TX; Uma County, AZ; Pima County, AZ; Coconino, AZ; Phoenix,
AZ; Atlanta, GA; Birmingham, AL; Cochise County, AZ; Mohave County, AZ;
Yavapai County, AZ; Baton Rouge, LA; New Orleans, LA; Bakersfield, CA;
Houston, TX; Harris County, TX; Clark County, NV; and Honolulu, HI.
These 19 sites have conducted approximately 290,000 tests. Surge
testing is a supportive adjunctive activity; it cannot substitute for
disciplined adherence to mitigation measures including masking,
hygiene, avoidance of indoor crowded areas and crowds, and protection
of the vulnerable. These mitigation techniques, when combined with
selective surge testing--have proven highly effective to reverse recent
community outbreaks.
In order to support public health isolation and contact tracing,
and to reduce turnaround time, the Federal Government has:
--Provided massive surge testing to localities prioritized by the
White House Coronavirus Taskforce, and agreed to by State and
local officials;
--Augmented testing, both baseline and surge, for federally Qualified
Health Centers (FQHCs) and retail sites, both fully federally
sponsored and federally enabled;
--Supported local testing efforts with surge of collection supplies
and reagents;
--Worked collaboratively to validate and promote EUAs for pooling
across all laboratory platforms;
--Worked collaboratively to validate and promote EUAs for new
extraction methods to increase productivity;
--Invested in new testing technologies that improve sensitivity,
specificity, and/or turnaround time, including new point-of-
care tests, and;
--Providing point-of-care testing to all nursing homes in America.
Diagnose COVID-19 Rapidly in Hospitalized Patients
Because there are now treatments authorized for hospitalized
patients with COVID-19, including Remdesivir, convalescent plasma, and
steroids, it is critical to diagnose patients as soon as possible.
Currently, large commercial labs are prioritizing inpatient samples to
ensure diagnosis within 24-36 hours. Our best information also suggests
that the great majority of individual hospitals are able to meet this
timeframe for patients within their hospital systems.
Protect the Vulnerable
Older Americans, particularly those in nursing homes, are much more
likely to suffer serious consequences including death, from COVID-19.
In addition to older Americans, racial and ethnic minorities are also
disproportionately affected.
To ensure that specimens are collected without overburdening the
traditional healthcare system, and to ensure testing in the most
vulnerable communities, in mid-March, the Federal Government
established Community-Based Testing Sites (CBTS) in CDC-prioritized
locations across the country. The CBTS model was developed for States,
local public health agencies, healthcare systems, and commercial
partners as they work together to stop the spread of COVID- 19 in their
communities, focusing initially on healthcare facility workers and
first responders.
The CBTS federally supported, State managed, locally executed model
has been a profound success, testing approximately 400,000 individuals.
For the initial 41 sites, CBTS 1.0, the Federal Government provided a
Federal physician who ordered all of the COVID-19 tests, the Federal
contracts for shipping the specimens, laboratory processing, patient
notification, and logistics (to include supplies, personal protective
equipment, language translation services). The Federal Government also
utilized U.S. Public Health Service personnel to provide data
management, safety and quality control checks at each site.
Building on the initial success of the CBTS model, the Federal
Government next leveraged public-private partnerships with pharmacy and
retail companies (CVS, Health Mart, Kroger, Rite Aid, Walgreens, and
Walmart), also known as CBTS 2.0, to accelerate testing for more
Americans in more communities across the country. The public-private
partnership model operates on the federally supported, State managed
model.
As the transition of CBTS federally run sites to State-run sites
has been completed, the Federal Government has broadened its community
testing support to a more sustainable model--specifically by continued
support of retail and pharmacy partnerships in more than 800 locations
in all 50 States and the District of Columbia, which collectively have
conducted over 2 million tests to date. The Federal Government focused
on communities with high social vulnerability using the CDC's Social
Vulnerability Index (SVI) as one of the main factors to select site
locations. Approximately 65 percent are located in communities with
moderate to high social vulnerability. The SVI measures the resilience
of communities when confronted by external stressors along four main
themes: socioeconomic status, household composition and disability,
minority status, and housing type.
This pharmacy and retail partnership provides convenient access to
COVID-19 testing, but it is also a bridge for retailers to implement
new regulatory flexibilities and expanded reimbursement options HHS has
provided through private insurance, Medicare, and Medicaid. This
partnership also leverages the newly expanded authority given to
pharmacists to order and administer COVID-19 testing, this effort is
also known as CBTS 3.0. Now, CVS and Walmart have over 1900 sites
utilizing these new regulatory and reimbursement options with over 2
million tests performed.
Health Resources & Services Administration (HRSA) supported health
centers are community-based and patient-directed organizations that
deliver affordable, accessible, quality, and cost-effective primary
healthcare to medically underserved communities and vulnerable
populations across the United States. Nationwide, nearly 1,400 HRSA-
funded health center grantees operate approximately 13,000 sites,
providing primary and preventive care to more than 28 million patients
each year. Over 91 percent of health center patients are individuals or
families living at or below 200 percent of the Federal Poverty
Guidelines and nearly 63 percent are racial/ethnic minorities. Health
centers are uniquely situated in communities to serve those that are
most vulnerable and 97 percent of these centers offer COVID-19 testing.
As of September 4, 2020, health centers have administered 3,690,098
COVID-19 tests (including 215,231 antibody detection tests), with over
49 percent of tests provided to racial and/or ethnic minority patients.
Of these tests, 444,186 returned positive, with 59 percent of racial
and/or ethnic minority patients testing positive.
To prevent further spread and deaths in nursing homes, CDC and CMS
recommended that nursing homes perform baseline testing of all
residents and staff, followed by routine testing of staff to reduce
outbreaks, morbidity, and mortality. CMS requires a regimen of staff
testing based on the degree of community spread. To protect the
vulnerable and to assist States in meeting these recommendations and
requirements, on July 14, 2020, the Trump Administration announced that
HHS would embark on a one-time procurement of rapid point-of-care
testing instruments and tests to be distributed to nursing homes using
the Defense Production Act.
Through this aggressive action, nursing homes will be able to
augment their current capacity for coronavirus testing, bolstering
their response and helping to prevent the spread of SARS-CoV-2. This
will facilitate baseline testing among nursing home residents and
staff, and enable a pathway to conduct ongoing testing according to
public health guidelines.
I am pleased to announce that all 13,850 initially eligible nursing
homes have received one or more point of care instruments, and nearly 5
million tests. Following this initial distribution, we will facilitate
nursing homes being able to reorder supplies via their normal
commercial distribution channels.
Vulnerable populations in many underserved communities are
suffering disproportionate health impacts resulting from COVID-19,
including number of infections, hospitalizations, and deaths. As part
of the HHS response to this crisis, on June 23, the HHS Office of
Minority Health (OMH) announced the selection of the Morehouse School
of Medicine as the awardee for a new $40 million initiative to fight
COVID-19 in racial and ethnic minority, rural and socially vulnerable
communities.
Morehouse School of Medicine has entered into a cooperative
agreement with OMH to lead the initiative to coordinate a strategic
network of national, State, territorial, tribal and local organizations
to deliver COVID-19-related information to communities hardest hit by
the pandemic. The three-year initiative will include the development
and coordination of a strategic and structured network of national,
State, territorial, and local public and community based organizations
that will help mitigate the impact of COVID-19 on racial and ethnic
minorities as well as rural and socially vulnerable communities across
the Nation. The initiative also includes a national multi-media
outreach and education effort. One of the primary goals of these
information dissemination efforts is to provide additional education
and community-level information on resources to help fight the pandemic
to those who need it most.
Support Safe Reopening of Schools and Businesses
While we must be prudent to protect those most vulnerable, we must
also be mindful of the prolonged effects that school and business
closures have on millions of children and parents. The efforts of the
Federal Government to galvanize the testing infrastructure in the
United States, and the efforts to reduce turnaround times, have
provided communities with the resources they need to safely reopen
schools and businesses.
Enable State Plans
To enable States to achieve the testing goals developed in
coordination with the Federal Government, the Federal Government has
worked with manufacturers to gain insight into diagnostic instrument
install bases; procured and shipped collection supplies; and determined
reagent inventory. The Federal Government then provided all information
to States so they could better determine how to optimize their testing
strategy. The Federal Government also purchased and allocated POC
devices and over 2.3 million tests; developed, implemented, and
facilitated community-based testing sites across the country; and
provided significant guidance and technical assistance for State plans.
The increase in the numbers of tests performed since early March is a
direct reflection of these efforts.
States and territories have now submitted two iterations of their
testing plans. These plans were developed in collaboration with Federal
multidisciplinary experts through teleconferences and other meetings.
Plans were reviewed by a multidisciplinary Federal team that included
leadership from CDC, the Immediate Office of the Secretary, and the
Office of the Assistant Secretary for Health.
The first iteration of the jurisdictional testing plans for May and
June were released to the public on July 10, 2020, and are available
for viewing here. The Federal team provided feedback to each State, and
each State incorporated this feedback into detailed plans covering July
through December. The State plans for July-December have been reviewed
and scored and were released to the public on August 10, and are
available for viewing here.
To ensure states meet their testing goals, the Federal Government
procured FDA authorized swabs and transport media, and is distributing
these supplies to a single location in each State determined by the
Governor's office. Starting in May and through September 11, the
Federal Government has distributed over 95 million swabs and more than
77 million tubes of transport media.
Moving forward, jurisdictions should use the $10.25 billion
provided to States, territories, and localities by the Federal
Government to support the purchase of tests and related supplies,
personnel for contact tracing, and reporting infrastructure, etc., for
their jurisdictions, as needed to fulfill their approved testing plans.
Other Initiatives
In order to capture feedback and foster communication between
Federal officials and the private sector, HHS created the National
Testing Implementation Forum. The Forum brings together representatives
from key stakeholder groups to share information and provide input to
Federal leaders about SARS-CoV-2 testing. Members of the Forum provide
their perspectives on how HHS can best identify and address end-to-end
testing supply chain issues across commercial, public health, academic,
and other sectors and define optimal testing in various settings
(diagnostic, screening, surveillance, others). Members also provide
input to improve technical assistance across the Nation to target
testing among the vulnerable and underserved and create a sustainable
diagnostics ecosystem that is sustainable and fully capable for future
public health challenges. The first Forum meeting was held on July 30th
and the principle topic of discussion was testing supply chain. On
August 13th the second meeting was held and surveillance and reopening
strategies were discussed. The third forum, with the topic of engaging
minority and underserved communities, was held on September 3rd.
On August 27th, the Administration announced that a $760 million
contract was awarded to Abbott for the delivery of 150 million rapid
BinaxNOW COVID-19 point of care tests. This initiative will expand
strategic testing in the United States. The Abbott BinaxNOW COVID-19 Ag
Card, which recently received an EUA from the FDA, does not require
instrumentation and will deliver COVID-19 test results in 15 minutes or
less. This test uses nasal swabs and can be easily deployed in many
settings across the country.
United States Public Health Service Commissioned Corps
Since the early stages of the COVID-19 outbreak, the Corps has been
an indispensable asset leveraged to address the public health needs of
the Nation in response to this crisis. The Corps is one of the eight
uniformed services of the United States and the only uniformed service
committed to protecting, promoting, and advancing the health and safety
of the Nation. Corps officers serve throughout the Nation in
communities that are most in need by providing essential healthcare
services to underserved and vulnerable populations.
In January, the Corps deployed officers to provide expert outbreak
response in direct support of CDC. Deployment expanded rapidly from 53
officers on January 24, 2020 to 4,170 officers deployed as of September
8th, with many officers being deployed numerous times. Corps officers
provided critical assistance to community-based testing sites
throughout the Nation and their contributions to this effort are
immeasurable. In response to the escalating crisis, the Corps
established COVID-19 Clinical Strike Teams, which include officers from
the variety of disciplines needed on the frontlines. This kind of
ready-made unit allows the Corps to deploy a ``cavalry'' to support
healthcare systems under stress in States across the country. COVID-19
Clinical Strike Teams have deployed to a long-term care facility in
Kirkland, Washington, to the Javits Center in New York City, and to the
TCF Center in Detroit. At the end of March, the Navajo Nation requested
CDC assistance to provide care amidst a surge of COVID-19 cases. Since
that time, the Corps has deployed teams to support the response.
The United States Public Health Service Commissioned Corps stands
ready and willing to respond to the public health needs of our country
and to provide essential healthcare services.
assistant secretary for preparedness response
The Assistant Secretary for Preparedness and Response's (ASPR)
mission is to save lives and protect Americans from 21st century health
security threats. During previous public health emergencies, ASPR has
led, on behalf of HHS, Emergency Support Function #8: Public Health and
Medical Services, under the National Response Framework. This means
ASPR serves as the primary coordinator for public health information
and deployment of assets to support the domestic health components of a
response.
For the current COVID-19 domestic response, ASPR funding has been
used to accelerate development of medical countermeasures, enter into
contracts to resupply personal protective equipment and other critical
components deployed from the Strategic National Stockpile (SNS) to aid
in the treatment of persons with or suspected of having COVID-19,
provide grants to hospital associations and healthcare centers to aid
in the ongoing response, and provide support via the National Disaster
Medical System (NDMS) to augment care in communities significantly
impact by COVID-19.
It is important to note that while the COVID-19 response remains
the primary mission and duty at ASPR today, there are other existing
requirements the organization has supported throughout 2020. Throughout
2020, ASPR has assisted in the repatriation of Americans from China and
Japan at the start of the COVID-19 outbreak. We deployed personnel to
Lebanon in August to assist with response and recovery efforts
following the explosion in the Port of Beirut. ASPR provided temporary
medical surge support in Louisiana, Texas and Mississippi after
Hurricane Laura, and we still have National Disaster Medical System
(NDMS) teams deployed to Louisiana to assist with recovery efforts
following Tropical Storm Sally. In addition, ASPR deployed personnel to
California and Oregon to support search and rescue efforts for the
wildfires. We supported these calls for action and support while
simultaneously responding to domestic requests for assistance to aid in
the COVID-19 response. . ASPR is a unique and nimble organization and
has been able to respond to emerging needs throughout the COVID-19
response.
medical countermeasure development efforts
Since late January, the Biomedical Advanced Research and
Development Authority (BARDA) within ASPR has collaborated with
counterparts across the government to identify potential COVID-19
medical countermeasure candidates and accelerate their development.
BARDA has a track record of success in delivering effective
countermeasures in response to public health emergencies. Past
successes include the 2009 H1N1 influenza pandemic, Ebola outbreaks in
2014-2016 in West Africa and in 2018 in the Democratic Republic of the
Congo, as well as the Zika outbreak in 2015.
At the onset of the pandemic, BARDA reviewed investments, modified
contracts, and began working with Regeneron, Janssen, and Sanofi
Pasteur to initiate the development of vaccines and therapeutics for
COVID-19. All three have successfully developed both prophylactic and
therapeutic medical countermeasures for emerging infectious diseases in
the recent past.
To date, utilizing the supplemental funding provided by this
Committee, ASPR/BARDA is supporting over 50 medical countermeasure
projects for COVID-19 response. All of these contract awards are listed
on medicalcountermeasures.gov in detail and include: nine therapeutics,
29 diagnostics, and seven vaccine candidates. Six vaccine candidates
are operating under Operation Warp Speed (OWS). In support of securing
a safe and effective vaccine as quickly as possible to protect the
American people and return to normal operations, we are making
significant progress in advancing these vaccines. In fact, three--
AstraZeneca, Moderna, and Pfizer--are in Phase 3 meaning that we are
closer than ever before in having a safe and effective COVID-19 vaccine
available to the public. The remaining three--Novavax, Sanofi Pasteur/
GSK, and Janssen are in Phase 1/2.
It is important to note that we are strictly adhering to and
following all regulatory and safety requirements to support vaccine
development. We are not sacrificing the safety of the vaccine in order
to expedite its development. We are instead supporting two steps at the
same time: vaccine development and vaccine manufacturing. Supporting
these efforts simultaneously ensures we are positioned to produce and
manufacture the vaccine quickly and effectively. Specifically, we are
making investments in the necessary manufacturing capacity at Federal
risk, giving companies confidence that they can invest aggressively in
development and allowing faster manufacturing and potential
distribution of an eventual vaccine. Specifically, the recent awards to
Pfizer, Novavax, AstraZeneca, Moderna, and Sanofi Pasteur/GSK all
include product development and investments in large-scale
manufacturing capabilities in the contract award.
BARDA is also working with and reviewing the capabilities and
capacity of our Centers for Innovation in Advanced Development and
Manufacturing (CIADMs). The CIADMs are government-sponsored facilities
that were created as public-private partnerships to establish domestic
manufacturing capacity and response capabilities in order to ensure the
Nation has adequate surge capacity for rapid medical countermeasure
production to address pandemics or other biological threats. The two
HHS CIADMs are Emergent BioSolutions in Baltimore, MD, and Texas A&M
University System in College Station, TX. Currently, AstraZeneca and
Janssen have reserved space at the Emergent facility to manufacture
vaccines at scale. In addition, in June, BARDA reserved existing
vaccine manufacturing capacity as well as expanded manufacturing
capacity at the Texas A&M CIADMThrough OWS, manufacturing capacity at
the Department of Defense's (DoD) Advanced Development and
Manufacturing facility, Ology Bioservices Inc. could also be utilized
if necessary. I would be happy to keep the Committee updated on the
progress of utilizing CIADMs as we move forward in this space.
Lastly, ASPR/BARDA is supporting efforts to expand capacity for
fill-finish to ensure that, once we have an approved vaccine, we can
begin manufacturing without having to wait for ancillary products (e.g.
(vials, needles, and syringes). Contracts include: capacity expansion
for needles and syringes (contracts with Smiths Medical, Inc.,
Retractable Technologies, Inc., and Becton, Dickinson, and Company);
capacity expansion for glass tubing and vials/cartridges (Corning
Pharmaceutical Technologies); expansion of sterile injectable capacity
(Thermo Fisher Scientific); establishment of manufacturing systems for
durable, high-performance glass/plastic vials (Si02); and, general
capacity expansion and reservations for fill/finish (Grand River
Aseptic Manufacturing, Inc.).
resupply of the strategic national stockpile
ASPR, through the Strategic National Stockpile (SNS) maintains a
national repository of large quantities of medical countermeasures for
a variety of threats (chemical, biological, radiological, and nuclear
(CBRN) threats as well as general public health responses) stored in
strategic locations around the nation. While SNS assets can be deployed
for CBRN incidents, the SNS is also poised to provide assets to support
response operations to large-scale public health emergencies, such as
those caused by hurricanes, disease outbreaks, or other natural
disasters..
Specific to the current COVID-19 response, as of August 18, 2020,
and in coordination with interagency partners including the Department
of Defense and the Department of Homeland Security, the SNS has
provided more than 18.5 thousand tons of personal protective equipment
(PPE) and other medical material to support States to aid in medical
response as well as the Federal repatriation effort to bring American
citizens back from abroad. This deployment of PPE encompassed
approximately 90 percent of the total SNS PPE inventory available at
the beginning of the COVID-19 pandemic. In addition to PPE, the SNS
deployed ventilators and Federal Medical Stations (FMS) to support the
response.
To respond and prepare for COVID-19, as well as prepare for any new
and emerging public health threat, ASPR/SNS is working to implement SNS
2.0. This initiative has three main objectives:
--Ensure the SNS has the breadth and depth to meet any future
pandemic or public health emergency;
--Bolster the U.S. industrial base for critical pharmaceuticals and
medical supplies; and,
--Reduce America's vulnerabilities and reliance on foreign suppliers
and manufacturers.
Under the first initiative, current planning is underway to achieve
a capacity to meet 90 days of need by this fall, which will require a
combination of actions to increase the supply of PPE and other critical
items in the SNS, in the commercial supply chain, and at the point of
use (such as hospitals). Since the start of the pandemic, orders have
been placed for approximately 800 million N95 respirators and face
masks for delivery to the SNS. The SNS currently holds approximately 80
million N95 respirators and face masks within the overall stockpile.
The SNS is currently on track to have 10 times more masks on hand by
the fall of 2020 than were available prior to the start of the COVID-19
pandemic. Additionally, the SNS has received more than 125,000 new
ventilators from COVID-19-related contracts awarded in the spring. The
SNS currently has more than 130,000 ventilators on hand for deployment,
which is more than seven times the quantity held in pre-COVID-19
pandemic inventory. The SNS has also began procuring necessary testing
supplies, including test kits, swabs, and viral transport media, to
ensure that Americans have access to the most advanced and robust
COVID-19 tests in the world. The SNS inventory is projected to include
44 million swabs and 65.5 million viral transport media by the end of
2020.
To support a number of these contracts, HHS has leveraged and
utilized actions under the Defense Production Act (DPA). Title I of the
DPA allows the President, among other authorities, to require
businesses and corporations to prioritize and accept government
contracts for materials and services. HHS has exercised Title I DPA
authorities using the Health Resource Priority and Allocations System
(HRPAS) in order to prioritize contract action to compel a direct
response to the place of greatest need. A number of health resource
materials have been identified that are essential to respond to the
COVID-19 pandemic; however, these items, like PPE and ventilators, are
in high demand. A priority rating has at times proved necessary to
provide the requested quantities and qualities of these health
resources within a specified time period or delivery date. These rated
orders are filled first when there are both commercial demands and
government demands for the same product, or component(s) of a product.
Utilizing this authority has enhanced national preparedness and is
helping ensure there is product available if and when it is needed.
Under the second initiative, ASPR/SNS is working with DoD to expand
domestic manufacturing capacity. The partnership between DoD and HHS,
which allowed SNS to tap into DoD's contracting resources and
experience with industrial based expansion projects, was critical for
the success of the U.S. Government's efforts to expand domestic
production capacity of medical supplies during the COVID-19 pandemic.
Using CARES Act funding, the SNS has funded a number of projects
including:
--Melt blown fiber (MBF)--to date the SNS has expanded the domestic
manufacturing capacity to produce MBF, a critical component in
N95 and surgical mask production.
--Increased domestic production capacity for surgical masks--to date
the SNS has supported contracts to allow manufacturers to stand
up additional production lines and production centers to
produce surgical masks.
--Increased domestic production capacity for nitrile gloves--to date
the supported contracts to increase annual domestic production
capacity of nitrile gloves by 450 million starting July 2020,
to be completed by July 2021.
--Increased domestic production capacity for testing swabs--to date
the SNS has supported an increase domestic production capacity
for swabs
--Increased domestic production capacity for rapid point-of-care test
kits--to date the SNS has supported an increase in annual
domestic production capacity of COVID-19 test kits by 8 million
a month by February 2021.
Lastly, to support efforts under the third initiative, ASPR is
working in partnership with the HHS Food and Drug Administration (FDA)
to understand and identify, as early as possible, supply chain issues.
Much of our supplies and medical materiel come from international
partners. We must, and will, continually evaluate and understand these
dependencies to best inform acquisitions and planned procurements.
preparing the nation's healthcare system
ASPR's Hospital Preparedness Program (HPP) strengthens healthcare
sector readiness to provide coordinated, life-saving care in the face
of emergencies and disasters. As the only source of Federal funding for
healthcare system preparedness and response, HPP promotes a consistent
national focus to improve patient outcomes during emergencies and
disasters and enables rapid recovery.
HPP was established after the September 11, 2001, terrorist
attacks, with the goal of improving the capacity of local hospitals
across the country to deal with disasters and a large influx of
patients in an emergency. Prior to COVID-19, HPP's annual appropriation
supported: the annual cooperative agreement program to 62 State, local,
and territorial health department recipients to support healthcare
coalitions; the Regional Disaster Health Response System (RDHRS); the
National Emerging Special Pathogens Training and Education Center
(NETEC); and ten Regional Ebola and Other Special Pathogen Treatment
Centers (RESPTCs).
In response to COVID-19, HPP has awarded additional funds COVID-19
supplemental funding to support National Special Pathogen System
(NSPS), building upon many of HPP's core programs and activities. Funds
were distributed to support the traditional HPP recipients, the 10
RESPTC recipients, the NETEC, and a new funding mechanism to directly
support hospitals and other healthcare facilities through 53 hospital
associations. The NSPS supports a coordinated national approach to
preparing for public health and medical emergencies so that the U.S.
has a tiered, capable system that coordinates national expertise,
regional capabilities, and State and sub-State healthcare capacity
across the public and private sectors in order to drive an effective
and safe pandemic response. The NSPS will continue to deploy and
enhance capabilities to address continued surge events during the
current pandemic--as well as prepare to address potential future
special pathogens.
Additional supplemental funding was awarded by HPP to support
efforts to secure the Nation's blood supply through a partnership with
the American Red Cross. Through this effort, we will be better able to
maintain blood operations, enabling hospitals and other healthcare
entities to meet demand for blood and avoid shortages of this
lifesaving medical resource. Lastly, HPP is also supporting a
collaborative effort with DoD to establish a National Emergency Tele-
Critical Care Network (NETCCN) to support expanded telehealth
capabilities nationally. The NETCCN is comprised of a cloud-based, low-
resource, stand-alone health information management system for the
creation and coordination of flexible and extendable ``virtual critical
care wards.'' These wards bring high-quality critical care capability
to nearly every bedside, whether in a healthcare facility, or in an
alternate care site such as a field hospital, or in a gymnasium--
enabling critical care anywhere.
aspr's support for covid-19 response
While we await a vaccine, ASPR has supported other efforts to help
mitigate the transmission of the virus when and where possible.
Beginning in March 2020, ASPR initiated the production and distribution
of more than 500 million cloth face masks across the country. Many of
these face masks were provided to long term care and dialysis
facilities to help protect some of the most vulnerable in our
communities. And, more recently, we are sending 125 million cloth face
masks to States and territories for distribution to schools.
ASPR also works to enhance medical surge capacity by organizing,
training, equipping, and deploying Federal public health and medical
personnel, such as National Disaster Medical System (NDMS) teams, and
providing logistical support for Federal responses to public health
emergencies. NDMS was originally created during the Cold War to take
care of military casualties from overseas in U.S. civilian hospitals.
At the start of the COVID-19 outbreak in January and February,
2020, NDMS teams were deployed to strategic locations across the
country to care for U.S. citizens evacuated from Japan who may have
been exposed to SARS-CoV-2, effectively providing medical care and
limiting the potential spread of the disease. Overall, HHS deployed
over 600 Public Health Service Commission Corps Officers and NDMS
personnel to support this repatriation effort. In addition, HHS
provided cache equipment, (e.g., medical supplies and resources) to the
repatriation sites to aid in the medical needs and care of returning
Americans.
As the response shifted and cases increased domestically, NDMS
teams have been deployed, when requested by a State, to provide
augmented care. Specifically, NDMS has supported hospital augmentation
(such duties include: emergency room support, hospital decompression,
setting up medical overflow centers for patients, and mortuary
support). As of September 10, 2020, ASPR has supported approximately
3200 NDMS deployments of medical, mortuary, and veterinarian
specialists to various missions across the country to 18 different
States. With the aid of NDMS personnel and resources, communities have
been able to continue to provide care to those in need of medical
assistance and treatment. NDMS will continue to support such requests,
and we appreciate the funding this Committee has provided to date to
support these efforts.
conclusion
On behalf of all the witnesses, we thank you again for your
support. Whether supporting hurricanes, floods, influenza outbreaks,
and other infectious disease outbreaks such as Pandemic Influenza,
Ebola, Zika, or the current COVID-19 pandemic, we have utilized the
authorities and resources provided by Congress to best support the
Nation in responding to the threat and mitigating the lasting impact.
Your partnership and support enable our mission accomplishment. We
would be happy to answer any additional questions you may have.
Senator Blunt. Well, thank you, Dr. Redfield.
So we are going to have a series of 5-minute rounds of
questions. There are a dozen members either here or virtually
here ready to ask questions. There will be an 11:30 vote that
we will just kind of work around those votes that come at
11:30, and certainly, we would hope to have an opportunity for
a second round of questions if people have them after their
first round is gone.
TESTING
Let me start, Admiral Giroir, with you. On tests, I think
tests are essential to get back to school, back to work, and
for tests to really work, they have to be easily taken. There
needs to be a quick response, and they need to be affordable.
It seems to me that with the Shark Tank effort that members of
this committee, particularly Senator Alexander and I, were
involved in trying to encourage looking at ideas that are out
there, I think the Shark Tank has approved at least 16
different tests now. In your testimony, you mentioned that a
significant number of these tests were point-of-care response
tests.
What should we expect in October or this month? I have been
told in October, we could reach 100 million tests between the
Shark Tank and Abbott alone. Is that a number that you think is
close to right?
Admiral Giroir. Yes, sir. And thank you for the question,
and thank you for the support of the Shark Tank and all of the
NIH efforts. We have seen just a tremendous blending of
programs at DARPA (Defense Advanced Research Projects Agency),
at NIH, at CDC, at BARDA and my office with the Defense
Production Act, all coming together, and we do meet every week
to put these together in a very cogent, synergistic way.
Yes. In October--and again, these are conservative
estimates based on what we know has EUAs and what we know the
manufacturing will be. In October, we are looking at somewhere
in the neighborhood of 125 million to 135 million tests
available. That does not mean that 125 million to 135 million
tests will be done, but these will be easily and readily
available. And the majority of them--we really hit that
inflection point--will be point-of-care.
Senator Blunt. Good.
Admiral Giroir. Many of them will be the Binax that we
talked about. That will be made at approximately 48 million to
50 million per month, again a $5 test, 15-minute result, no
instrument. Very, very important. But we are starting to see
the point of tests coming from the RADx program, the Shark
Tank, really hitting the street. So the next generation
sequencing, the microfluidics platforms like Fluidigm and some
advance point-of-care are all starting to hit from Shark Tank.
Senator Blunt. And I think you said in your testimony that
sometime this month we will have passed the first 100 million
tests that people have taken. Is that right?
Admiral Giroir. Yes, sir. Today's total as of about 5
o'clock this morning was 99.3 million tests having been
performed in the U.S. Those are viral tests, not serological
tests.
Senator Blunt. And starting the first of the year,
sometime--this is from the outbreak of the COVID-19. Right?
Admiral Giroir. Right. I mean, when I took over on March
12, I think there were 15,000 or 20,000 tests done. It was a
very small number. So this has ramped in a historic way not
just in number. Numbers are important, but it is the ecosystem,
the point-of-care, the laboratory. These all have to fit
together in a----
Senator Blunt. I think I am right in assuming--but the
three of you would know this better than anybody--if you take a
test and you do not get a result for 3 days or 5 days or 7
days, you find out a data point and you find out for that
individual the problem they have, but you have generally done
nothing to tell them that they could be spreading this disease.
Is that correct?
Admiral Giroir. Clearly we want tests to be turned around
as rapidly as possible, and that is why point-of-care is so
important. The issue with most point-of-care tests is they are
not as, quote, good, sensitive, and specific as the very
important laboratory tests. Now everybody is making progress.
But you are right. We want rapid turnarounds. And because
we have more point-of-care tests and because we are doing more
in the nursing homes that way, for the major referral labs that
had such an issue with turnaround times, our average turnaround
time for Quest, Labcorp, et cetera, this month is 1.49 days. So
that has been improved dramatically because of expansion of
their capability but also the insertion of point-of-care tests.
Senator Blunt. But again, that is the average. That
averages out the point-of-care plus the tests that averages all
this down to 1.----
Admiral Giroir. No, sir. That is just the referral
laboratories, Quest, Labcorp----
Senator Blunt. Got it.
Admiral Giroir. The other half of testing is either point-
of-care at your local hospital, which is generally either 15
minutes or within 24 hours. So the turnaround time, at least
right now with all the investments coming together, is under
control.
Senator Blunt. I think our sense--many of the members on
this committee--certainly my sense of testing has been we want
a test that millions of people can take, maybe dozens of times
and get the information at the time they take the test. And it
sounds like to me that we are finally getting to where that is
a realistic likelihood. All right.
Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman.
POLITICAL INTERFERENCE
And let me just say again I am deeply troubled by reports
of rampant political interference in scientific decisionmaking
at the CDC. It is unprecedented and it is unacceptable. We
learned last week that despite knowing in January how serious
COVID-19 was, President Trump has been working to downplay this
crisis. And on Friday night, we learned that Trump political
operatives in HHS's Communications Office have been
manipulating CDC's flagship publication for months to align
with that messaging.
Dr. Redfield, did anyone at CDC advise the President to
downplay this crisis?
Dr. Redfield. No.
Senator Murray. Did you agree with the President's decision
to downplay it?
Dr. Redfield. I am not going to comment on that, but no one
advised the President to downplay this crisis.
Senator Murray. Well, understanding the dangers, why have
you not done more to push back on President Trump's political
interference and its efforts to downplay this?
Dr. Redfield. I want to make it really clear, Senator--and
I appreciate your question and the opportunity--about the
respect for the science at CDC and the independent integrity of
the MMWR (Morbidity and Mortality Weekly Report). At no time
has the scientific integrity of the MMWR been compromised, and
I can say that under my watch, it will not be compromised.
Senator Murray. Well, I understand the efforts to edit the
CDC publication started in response to a May report that
reviewed the spread of COVID-19 in the U.S. It was authored by
CDC highly respected career deputy, Dr. Schuchat. HHS political
officials perceived this report as reflecting negatively on the
President.
Dr. Redfield, yes or no. Did that May report, as drafted by
Dr. Schuchat, adhere to the agency's strict code of scientific
integrity?
Dr. Redfield. Yes.
Senator Murray. Well, the spokesperson for HHS claimed that
there is a resistance unit at CDC and voiced concerns about
ulterior deep state motives, and President Trump has bolstered
skepticism in the agency's death toll. Do you agree with me
that there is no truth to all those claims?
Dr. Redfield. Absolutely, Senator. And I want to make a
comment that not only is not true, it deeply saddened me when I
read those comments because, as I said in my statement, CDC is
made up of thousands of dedicated men and women highly
competent--it is the premier public health agency in the
world--dedicated 24/7 to use their skills to protect the
American public and the world from the health issues. And it
deeply saddened me that those false accusations were made by a
group of really unbelievably professional people that serve
this Nation.
Senator Murray. Well, I agree.
Let me ask you then, what can Congress do to make sure we
are hearing directly from public health officials without
political interference?
Dr. Redfield. Well, again, I am willing to commit that we
are going to continue to give Congress and the Nation the best
public health advice. We are not going to let political
influence try to modulate that.
As I mentioned, the MMWR--and it is another thing that has
saddened me to hear on our watch the concern that somehow--some
have that the integrity of this really important publication
was somehow compromised. And I just want to assure you and the
other Senators and the American public that the scientific
integrity of the MMWR has not been compromised. It will not be
compromised on my watch. And I will stand by the men and women
that are the scientific experts that are there to do their job,
to express what they know in a way that can be interpreted to
the American public.
Senator Murray. Well, I hear you, but I do think Congress
needs to make clear that there is no political interference
there. I will be pursuing that.
SCIENTIFIC INTEGRITY
Admiral Giroir, on the same issue, you are among HHS's top
health officials. What are you doing to protect scientific
integrity of the work done by the scientists and public health
experts at CDC, HRSA, and NIH from political interference?
Admiral Giroir. Part of my job as the senior scientific
advisor to the Secretary is to make sure that he gets the best
science and the best evidence base that is unfiltered. I do
that every single day. I work with Bob Redfield. I work with
Bob Kadlec. Francis Collins and I are on speed dials; Tom
Engels, very, very important with HRSA. So you have my
commitment, as you always have, Senator, that I will provide
the best advice to the decision-makers that will be based on
science and evidence, and that is the way we are going to
operate going forward.
Senator Murray. But can you right now reject the unfounded,
harmful conspiracy theory that career professional leadership
of CDC or any of our public health agencies have, quote, deep
state ulterior motives that compromise their ability to act in
the best interest of public health, as other Trump political
appointees have claimed? Can you reject that? Yes or no.
Admiral Giroir. I have not seen anything out of CDC, HRSA,
any of the agencies I work with that is anything but people
acting in the best interest of the American people. I have
certainly not seen anything that you described.
Senator Blunt. Thank you, Senator Murray.
Senator Alexander.
Senator Alexander. Thank you, Mr. Chairman. And thanks to
the witnesses for coming.
PREPARING FOR THE NEXT PANDEMIC
This committee has shown on many occasions a good capacity
to work in a bipartisan way. So I would like to say something
to my Democratic friends, as well as my Republican colleagues,
on a subject that I think we agree on, but the Congress has had
a hard time doing over the last 20 years, and that is preparing
for the next pandemic.
I have been re-reading Jared Diamond's book, ``Guns, Germs,
and Steel.'' And he wrote an article in the ``Wall Street
Journal'' a few months ago about the current infectious
disease. He said the most different thing about COVID-19 is not
that it is more infectious, but the jet plane is what is
different about this disease, that it can spread instantly from
Wuhan to San Francisco to Nashville to Boston, and that the
next pandemic could be next year.
So we had a hearing about preparing for the next pandemic,
and people like Bill Frist, who was majority leader 20 years
ago, said we keep trying to do things to prepare for the next
pandemic, but we go, in Dr. Tom Frieden's words, from panic to
neglect to panic. In other words, while we are in the middle of
a pandemic, it has got our attention, but as soon as it is
over, we do not do all the things that we should do.
So my hope is that with any action that we take this year,
we would include the three or four things that we should take
to make sure that we sustain funding, which is the hardest
thing to do. How do you fund for more than 1 year for onshore
manufacturing of vaccines, for example, or stockpiles that were
depleted between pandemics to making sure that FEMA (Federal
Emergency Management Agency) and Dr. Kadlec's organization are
aligned properly and operating together? Dr. Redfield has
talked about and Mike Leavitt to our committee, the former
Governor of Utah, that we have been underfunding public health
for 30 or 40 years. I think it is important we do it this year.
And so in the Republican bill that we offered last week, we
did have in there some authorization from our committee to fund
onshore manufacturing and continuous funding of stockpiles, so
they would be full. And I would just like for our committee to
give that the same kind of attention in the subcommittee that
we gave, for example, to funding for NIH because it will take
some sort of mandatory funding or advance appropriation as this
committee did under Senator Gregg a few years ago for
Bioshield. It is not a lot of money. I think what we suggested
was a half billion dollars a year for 10 years for onshore
manufacturing.
Why is that important? In 2012, we created three
manufacturing plants just for this purpose, but two of them, in
Governor Leavitt's words, went cold. They were not available
instantly to do what we needed done. And the third one had a
hard time finding anything to do between pandemics. So we need
some funding for it.
And then for the stockpile, stockpiles got depleted at the
Federal level, in hospitals, and States because of budget cuts.
And so we were not ready for what we needed to be ready for.
And then public health funding is a separate one. Bioshield
is another one.
So I think we are not talking about lots of money. What we
are talking about is different is sustained funding for a
period of years.
Now, Dr. Kadlec, I have taken most of my time, but would
you comment on that? And precisely in the ideal world, what
should we do now to prepare for the next pandemic, which Jared
Diamond says might be next year?
Dr. Kadlec. Well, thank you very much, Senator Alexander.
And I agree entirely with your proposition that we do need to
make investments over the long term, that we need to look at
this problem as a national security problem as it is a public
health problem.
We lose on a day----
Senator Alexander. Yes, but what are the specific things.
We have got about 30 seconds.
Dr. Kadlec. Sir, manufacturing, domestic manufacturing, for
biologics and vaccines. We also basically need to have a
capacity to basically manage those stockpiles effectively
through both commercial and State-level processes. And we need
to probably require hospitals and other healthcare institutions
to have some baseline level of preparedness and stockpile.
Senator Alexander. So we need to keep the stockpiles full.
Are we talking about a lot of money?
Dr. Kadlec. No, sir. I think in your bill you have
identified about $2 billion. I think that is where you start.
And then again, most of these items are common used anyway
daily in hospital use and healthcare use, and just maintaining
that stockpile over time. But it does require a business model
to support that.
Senator Alexander. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Alexander.
Senator Durbin.
Senator Durbin. Thanks, Mr. Chairman.
VACCINE TIMING
Dr. Kadlec, last night the President of the United States
said--and I quote--we are within weeks of getting a vaccine.
Could be 3 weeks, 4 weeks. True or false?
Dr. Kadlec. Sir, it is possible. And so with Operation Warp
Speed, we have basically worked to basically do simultaneously
the clinical trials as well as doing the manufacturing of
vaccines. So if and when, whether that is 2 weeks, 3 weeks, 2
months, or 4 months, once a clinical trial is complete and that
scientific data is reviewed by the FDA and approved, then we
have vaccine potentially available immediately to use. And that
is the strategy that has been adopted in Operation Warp Speed,
sir.
Senator Durbin. So I want to make sure this is on the
record.
Dr. Kadlec. Yes, sir.
Senator Durbin. You are saying 3 weeks to 4 weeks for a
vaccine?
Dr. Kadlec. Sir, that is manufactured. Yes, sir. Now, is it
approved by the FDA? That is a decision that they will have to
do based on the scientific data that they receive from the
clinical trials.
Senator Durbin. So what you are saying to me is they could
manufacture it, but before it is approved as being safe and
effective for distribution in America is going to be beyond 3
or 4 weeks.
Dr. Kadlec. Sir, it depends on the outcomes of those
clinical trials. And so I cannot predict that. They are ongoing
right now, some of them complete in October, and the FDA is the
one who will make the decision to determine safety and
efficacy, sir.
Senator Durbin. The President predicted it last night.
We have about 4.5 percent of the world's population in the
United States. We have more than 20 percent of the deaths from
COVID-19. Last night, the President said, we have 20 percent of
the cases in the world because of the fact that we do much more
testing. If we would not do testing, you would not have cases.
You would have very few cases.
So let me ask Admiral Giroir, would ending testing end the
spread of the COVID-19 disease?
Admiral Giroir. No, sir.
Senator Durbin. Could you explain the President's
explanation last night? Does it make any sense to you?
Admiral Giroir. I did not hear----
Senator Durbin. Oh, we have heard this over and over again.
Come on. He is repeating what he said over and over again.
Admiral Giroir. So let me just clarify that the number of
cases are going to be the number of cases. We do more testing
so we could detect more and more cases. That is a good thing.
We want to detect as many cases as we can so that they can be
appropriately isolated, do contact tracing, et cetera.
It is true that the more testing you do, the more cases you
will discover, but the cases are there no matter what.
EXPANDING TESTING
Senator Durbin. Now, you talked in your testimony here
about expanding testing. And I could not endorse that more
heartily. The President says just the opposite. If we would not
do testing, you would not have cases. I mean, do we not want to
create the mindset in America that regular testing to make sure
that we are not positive and not spreading this disease should
be routine until we come to grips with a therapy or vaccine to
deal with this?
Admiral Giroir. So I do want to state what I did state
earlier in multiple testimonies. I have never been asked, told,
hinted, suggested that we should decrease testing. In fact,
basically every time at the task force, we work to expand
testing to the degree possible, investing hundreds, billions of
dollars in that. So my job is to expand testing as much as
feasibly, even infeasibly, possible and get the right tests to
the right people at the right time. And that has been my
mission. No one has told me to alter that.
AFFORDABLE CARE ACT REPLACEMENT
Senator Durbin. In July of 2017, the United States Senate
considered the repealing of the Affordable Care Act on the
floor of the Senate. I will remember that morning, that night
forever. A few feet away from me the late Senator John McCain
cast a no vote, and the Affordable Care Act survived.
The President has said repeatedly that he has a replacement
plan for the Affordable Care Act. As head of the agencies
responsible for dealing with such a public health undertaking,
I would like to ask you, does a replacement plan exist that you
are aware of? Any of you? Yes or no. Admiral?
Admiral Giroir. I am not involved in the replacement plan.
I do not know what that is. I supply public health advice as
much as I can for whatever that plan would be----
Senator Durbin. Dr. Kadlec, are you aware of such a
replacement plan?
Dr. Kadlec. Sir, it is not in my portfolio, and sir,
honestly I have been so busy with the other things. I have no
awareness of that.
Senator Durbin. Dr. Redfield, are you aware of a
replacement plan?
Dr. Redfield. Again, it is really not in my main lane, but
I am not aware of one.
VACCINE SAFETY
Senator Durbin. Just a few weeks ago, the nine major
pharmaceutical companies had full-page ads saying they would
not bow to political pressure to rush vaccine production. Were
any of you consulted before they made the decision to buy that
ad across the United States?
Dr. Kadlec. Sir, not consulted, but aware of it. And it
conforms with I think the feelings and the commitments that the
leadership in Warp Speed and in my organization are committed
to as well.
Senator Durbin. Do you know why they did it?
Dr. Kadlec. Sir, I think to the point of being sure that
everyone is believing in the same way, which is a safe and
efficacious vaccine, has to be trusted.
Senator Durbin. Thank you.
Senator Blunt. Thank you, Senator Durbin.
Senator Capito.
While we are trying to figure out how we get Senator Capito
for her questions, Senator Kennedy why do you not go ahead with
yours and then we will go to Senator Reed after Senator Kennedy
and see if Senator Capito is ready. Senator Kennedy.
Senator Kennedy. Thank you, Mr. Chairman.
Thank you, gentlemen, for being here today.
You are all M.D.s, medical doctors. Is that correct?
Dr. Kadlec. Yes.
Admiral Giroir. Yes, sir.
Senator Kennedy. Would any of you do anything to violate
your Hippocratic oath?
Admiral Giroir. Never.
Dr. Kadlec. No, sir.
Senator Kennedy. Have any of you, as Senator Murray
alleged, recklessly interfered with the treatment or prevention
of COVID-19?
Admiral Giroir. No.
Dr. Kadlec. No, sir.
Dr. Redfield. No.
Senator Kennedy. Do you know of anyone who has in the Trump
administration?
Admiral Giroir. No.
Dr. Kadlec. No, sir.
Dr. Redfield. No.
Senator Kennedy. Okay.
Dr. Redfield, have you ever had polio?
Dr. Redfield. No, sir.
Senator Kennedy. Me neither. Thank you, science.
When the coronavirus was first discovered, we did not have
much science about it. Did we?
Dr. Redfield. No, sir.
Senator Kennedy. You could not go to like WebM.D. and look
it up. Could you?
Dr. Redfield. No, sir.
Senator Kennedy. We have learned a lot about it. Have we
not?
Dr. Redfield. Yes, sir.
COVID-19 SPREAD
Senator Kennedy. Would it be fair to say--and disagree with
me--if you do, I know you will--that the coronavirus is a lot
more contagious than we originally thought. Is that fair?
Dr. Redfield. Yes, sir.
Senator Kennedy. Now, I read on the CDC site--tell me if I
misinterpret this--that out of every 1,000 people who get
coronavirus, not out of every 1,000 people but out of every
1,000 people who get the virus, 6 are going to die. Is that
accurate?
Dr. Redfield. It depends on age group and risk factors,
sir. So if you were to look right now, individuals under the
age of 18, it is about .01 percent. 19 to, say, 69, it is more
like .3 percent. And if you are over the age of 70, it is about
5 percent now.
Senator Kennedy. But if you look at population as a whole,
it is about 6 out 1,000. Is that correct?
Dr. Redfield. I would have to get back to you. Overall, we
are probably looking at an overall mortality in the range of
somewhere between .4 and .6 percent----
Senator Kennedy. Right. That would be 6 out of 1,000. That
is on the high end. Obviously, the older you get, the more at
risk you are.
VACCINE TIMING
Tell me when you think we will have a vaccine, as best you
can, ready to administer to the public, Dr. Redfield.
Dr. Redfield. Well, I think as Dr. Kadlec said, I think
there will be vaccine that initially will be available sometime
between November and December but very limited supply and will
have to be prioritized. If you are asking me when is it going
to be generally available to the American public so we can
begin to take advantage of vaccine to get back to our regular
life, I think we are probably looking at late second quarter,
third quarter 2021.
Senator Kennedy. And so you think by the late second or
third quarter, we will have started to vaccinate people?
Dr. Redfield. I think the vaccination will begin in
November-December, and then we will pick, you know, and it will
be in a prioritized way, those first responders and those at
greatest risk for death. And then eventually that will expand.
You know, there is about--it is hard to believe, but there are
about 80 million people in our country that have significant
comorbidities that put themselves at risk.
Senator Kennedy. Right.
Dr. Redfield. They have to get vaccinated, and then the
general public.
OPERATION WARP SPEED
Senator Kennedy. But I am about to run out of time.
And what do you call this effort, this worldwide effort led
by the United States of America to develop a vaccine? What is
the term for it?
Dr. Redfield. Operation Warp Speed, sir.
Senator Kennedy. Have you ever seen anything like Operation
Warp Speed?
Dr. Redfield. It is unprecedented.
Senator Kennedy. How long does it usually take--this will
be my last question, Mr. Chairman--to develop a vaccine?
Dr. Redfield. I think the fastest prior was 2 years and
usually 4 to 6 years.
Senator Kennedy. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Kennedy.
Senator Reed.
Senator Reed. Thank you very much, Mr. Chairman, and thank
you, gentlemen, for your testimony.
FACE MASKS
I was particularly struck how emphatic you all were
insisting that the use of face masks is absolutely critical in
a social setting. You are all wearing face masks. I have mine.
I took it off so I could question. Yet, last evening, the
President once again disparaged the importance of wearing face
masks. He does not wear one usually. He has conducted rallies
in which many of the participants are not with face masks. He
does not have on a face mask.
So let me just ask all of you. Admiral, you are a uniformed
officer. Is the President providing appropriate leadership when
it comes to this critical issue, one of the most direct and
important things anyone can do to protect themselves and the
community from this disease?
Admiral Giroir. Well, as a uniformed officer, I am not
going to comment about the President, but I do want to
emphasize that wearing a mask is one of the most important
things that we can do to prevent spread particularly because
people who are asymptomatic--you could feel totally fine but
still be spreading the virus, which is why wearing a mask when
you cannot physically distance is absolutely critical. And I
think I probably speak for my other two colleagues, but you
will want them----
Senator Reed. I want them to. But I think you just directly
contradicted the President's behavior and the President's
comments even though you have done it politely.
Doctor.
Dr. Kadlec. Sir, we are supportive of the mask. That is why
we produced a half a billion of them and made them available to
the American public at large.
Senator Reed. But the answer is----
Dr. Kadlec. Yes.
Senator Reed. Is the President undercutting what you have
all said and you have repeated one of the most important steps
that Americans can take to defend themselves and the country
against this disease?
Dr. Kadlec. Sir, my view is that he is an individual who
can exercise his rights to do what he pleases, as we see other
Americans doing that. And so he is----
Senator Reed. But it is also the leader of the country
trying to cope with a disease, a pandemic that has killed over
100,000 people, and he is rejecting this emphatic advice that
you give repeatedly and you yourselves demonstrate.
Dr. Redfield, your comment.
Dr. Redfield. I am not going to comment directly about the
President, but I am going to comment as the CDC Director that
these face masks are the most important powerful public health
tool we have. And I will continue to appeal for all Americans,
all individuals in our country, to embrace these face
coverings. I have said if we did it for 6, 8, 10, 12 weeks, we
would bring this pandemic under control. We have clear
scientific evidence they work, and they are our best defense. I
might even go so far as to say that this face mask is more
guarantee to protect me against COVID than when I take a COVID
vaccine because the immunogenicity may be 70 percent, and if I
do not get an immune response, the vaccine is not going to
protect me. This face mask will. So I do want to keep asking
the American public to take the responsibility, particularly
the 18 to 25-year-olds where we are seeing the outbreak in
America continue to go like this because we have not got the
acceptance, the personal responsibility that we need for all
Americans to embrace this face mask.
Senator Reed. Once again, I think you have refuted the
President more eloquently than I have heard. You are the
expert. Leaders have to depend on expert advice. That is why
they have people like you there, and when they do not take your
advice, in fact when they disregard it--and it has been said so
emphatically here. It is not a question of any doubt at all in
your views, all of you.
STATE DISTRIBUTION PLANNING
Just a final quick question, and I only have a bit of time.
Dr. Redfield and Dr. Kadlec, quickly. Your vaccine plan has to
involve the States. Can you just very, very briefly, Dr.
Redfield--is there a conscious integration of the States in
terms of their public health services, and are there resources
available for the States in this plan because they will need
them?
Dr. Redfield. Yes, sir. It is critical. We have done micro-
planning already with five jurisdictions, North Dakota,
Minnesota, California, Florida, and Philadelphia. And this plan
will be going out today to all of the States. I will be talking
to the State public health leaders this week. We will be
working with them so that they can integrate this plan in their
own unique way for their own State, and there will be support
to help them begin to resource this plan.
Senator Reed. Thank you.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Reed.
Senator Capito.
Senator Capito. Thank you, Senator Blunt, and thank all of
you. I am pleased to be a part of this hearing today.
QUARANTINE GUIDELINES
And I will start off with Dr. Redfield. I am not sure if
you are aware, Dr. Redfield, but I am abiding now by the CDC
guidelines. I was made aware on Monday that I had been exposed
to somebody who tested positive for COVID. According to what
the physician told me, I had been in and around that individual
for at least 15 minutes within 48 to 72 hours of when he
exhibited symptoms. And out of an abundance of caution and I
think acceding to your guidelines, I went immediately to the
physician at the Capitol who advised me then that I must
quarantine for 14 days. I did subsequently take a test and
tested negative, which I am very obviously pleased about.
But I want to ask you are your guidelines on quarantining--
for those of who are quarantining following the rules, what
kind of success does that bring in terms of isolating and
containing the spread? And do you further recommend further
testing as people are coming out of their quarantine, and at
what points of the quarantine would they need to get retested,
if that is necessary?
Dr. Redfield. Well, first, I want to thank you for setting
the example and embracing these guidelines.
Although misinterpreted, some of the changes that we put in
our guideline, the whole purpose of those guidelines was to
engage the public health and medical community back into the
decisions when people get tested so, as was talked about
earlier, there was the appropriate public health action. So the
tests led to an action. It was not just a test.
And so I want to thank you for setting that example.
The reality is if you have had close contact, it could take
7 days, it could take 10 days, it could take 12 days before you
turn virus-positive. That is why we have our current
recommendations, based on the data we have, for isolation for
14 days. And as we get more data, that may change, but the
reality is that the data that we have today, we still support
the 14 days of isolation.
We do have very good data in our household studies where
households that have introduced COVID, where individuals
practice masks and hand washing and distancing, we have been
able to show there is limited transmission in those household
settings. And in households that did not, we have seen attack
rates of 20 percent, 30 percent, 40 percent, 50 percent within
the household.
So again, that is where the state of knowledge is right
now. There may come a time when we have better data that can
shorten it. But right now, even if we shortened it to 10 days--
and a number of people have asked to look at the data--we would
still send home probably 10 to 12 percent of people who would
later turn out virus-positive.
Senator Capito. Well, thank you for that.
RAPID TESTS
Admiral Giroir, Dr. Redfield brought up an issue that I
know is cascading across the country, and that is, as some of
our colleges and universities are opening, the incidence in
testing and the incidence of positives have gone way up because
of some behavioral issues and just the whole atmosphere at
times in a college and university setting.
So there is a great interest on tests to get the rapid
turnaround test. The Abbott test I know is of interest to the
universities.
I know you are beginning to deploy these to nursing homes
and highly challenged communities, which I applaud. But how do
you deal with a college and university setting in terms of
testing, and what do you recommend here? What do you see in the
future?
Admiral Giroir. So thank you for that question.
Universities generally have a very substantial capability
to do testing in their research laboratories, in their
veterinary diagnostic laboratories. Senator Durbin, the
University of Illinois is one of the real leaders in being out
front. So we have had multiple calls, seminars, technical
webinars to allow the universities to turn on their research
equipment. We have done the CLIA waivers. We have done all of
that to really use that to support testing.
Eventually we want to get to a point that rapid point-of-
care tests are available for everyone. But 50 million a month
does not go into 300 million people. So what we are advising
universities is to use those rich resources that have been
funded by the NIH that they have to use them. A nursing home
cannot do that. Many universities, using their veterinary
laboratories, which are very successful--and again, the
University of Illinois has done just really tremendous. We had
them on one of our leadership calls as an example telling the
rest of the country.
Senator Capito. Thank you very much.
OVERDOSE DEATHS DURING THE PANDEMIC
And just in closing--I know my time is up--I am concerned,
Dr. Redfield, as we talked about before. The rise in overdose
and overdose deaths during this pandemic is extremely alarming.
And I am very concerned, as we keep moving forward, what kind
of impacts this is going to have on the addiction community.
You and I have talked about it. We got to keep our eye on it.
Thank you so much.
Senator Blunt. Dr. Redfield.
Dr. Redfield. Yes. I could not agree with you more. I mean,
we have seen an increase of almost 18 percent now, in our
suspected overdose----
Senator Capito. A lot.
Dr. Redfield [continuing]. In admissions into hospitals.
Clearly the isolation that has been associated, also the
ability to get access to the proper pain control when a lot of
the medical services cut back. CDC recently did a survey--and
it actually shocked me--just a survey across our Nation, and
found that 31 percent of adults reported now significant
anxiety and depressive disorders. So this is a significant
comorbidity that has been negatively influenced by the COVID
response, and it is something that we have to continue to
double our efforts to try to prevent death from overdose.
Senator Blunt. Thank you, Dr. Redfield. Thank you, Senator
Capito.
Senator Shaheen.
Senator Shaheen. Thank you, Mr. Chairman, and thank you to
each of you for being here.
INFECTION CONTROL IN LONG-TERM CARE FACILITIES
Admiral Giroir, in your opening statement, you talked about
the importance of protecting the elderly, which I think all of
us would agree is critical. And yet, the elderly have been
impacted the most by this COVID-19. In New Hampshire, over 80
percent of our deaths from COVID-19 have been in long-term care
facilities.
That is why I am so concerned about the slow pace that HHS
has provided in giving support for infection control in these
facilities. The CARES Act provided up to $200 million for
nursing home infection control efforts, and to date, only $17
million of that has been spent.
On top of that, HHS has only spent about half of the $16
billion that Congress has provided for the acquisition of
personal protective equipment, which continues to be a need.
Nursing facilities and providers across the CARES system in New
Hampshire desperately need these supplies.
So, Admiral, the infection control funds are vital to
helping our nursing homes reduce the spread of diseases. You
have alluded to that. So when can we expect the remaining funds
to be distributed?
Admiral Giroir. I cannot answer that on that specific. I do
not know when they will be distributed.
What I can say is that I know even in the last couple of
months there have been $5 billion of extra funding to nursing
homes. $2.5 billion of that is to support testing, which is
really in our regime. And we do get--Admiral Polacek, the other
admiral on the team with an unpronounceable name--every day we
get about 99 percent of nursing homes reporting. So we know
exactly what their PPE (Personal Protective Equipment)
situation is.
But in terms of that specific fund, I am going to have to
have the team get back to you on that.
Senator Shaheen. I would appreciate that.
One of the challenges with that $5 billion that was just
distributed is that it can only be used for hiring only, not
retention, and the biggest challenge our nursing homes have in
New Hampshire is retention of employees. So is there going to
be any thought given to providing more flexibility for long-
term care facilities in how those funds can be used?
Admiral Giroir. And I am really sorry. I am going to have
to get Seema Verma and the Secretary to respond to that. That
is not within my realm of responsibilities.
Senator Shaheen. Well, I would urge you to do that because
if we are providing funds to long-term care facilities that
cannot be used, then it is not accomplishing the concern that
all of us share.
PUBLIC RELATIONS CAMPAIGN
I want to go on to another issue because there was a report
that just came out about HHS seeking bids for a $250 million
contract for a public relations campaign to defeat fear and
inspire hope regarding the pandemic. And while I think all of
us want to make sure that Americans know that there is going to
be a better time ahead for us, the timing of this contract
raises real concerns about the potential intersection with the
President's reelection campaign, and more importantly, Congress
did not direct HHS to conduct this campaign. So is the $250
million that is going to that coming from funding that should
be going out to our long-term care facilities, to our
hospitals, to our medical providers to actually respond to the
spread of COVID-19? And what is the purpose of this contract at
this time to do a public relations campaign? Would it not be
better to give information to the American public about what
all of you have said so eloquently this morning about what we
need to do to respond to this virus and what we need to do to
ensure that people have the health care they need if they
contract it? Admiral, can you answer that?
Admiral Giroir. And, ma'am, I really do apologize, but I do
not know anything about public affairs campaigns or where that
money comes from or what it is going to do. That is just not
something that I deal with. We all try to provide the best
information we can through whatever vehicles we can, but I just
do not know about public affairs contracts.
Senator Shaheen. So you were not aware that the Department
is going to be spending $250 million on that advertising
campaign?
Admiral Giroir. I mean, I am generally aware from what I
read in the news, but I am not involved in--I am really not
involved in that. All I know about public affairs is that we do
want to get all of us in front of the public to make sure,
number one, they get their flu vaccines this year because that
is really critically important.
Senator Shaheen. Thank you. I think that is very helpful.
Dr. Kadlec, were you aware of this expenditure?
Dr. Kadlec. No, ma'am.
Senator Shaheen. Mr. Chairman, I would hope that this
committee would ask some very tough questions about what is
going on here because that is a lot of money for a campaign
that we ought to be spending to address this pandemic.
And, Senator Alexander, I totally agree with you on doing
some work now to respond to the next pandemic, and I would
suggest that we also ought to restore the Global Health
Security and Biodefense Unit either at the National Security
Council or somewhere where it can provide an early warning for
what is ahead.
Thank you very much.
Senator Blunt. Thank you, Senator Shaheen.
Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Mr. Chairman.
And to the panel, I truly thank you for all you have done
and your tremendous tireless efforts of guiding this country
through COVID-19. You are to be commended, applauded, and I am
certainly one that appreciates you being here today and
answering the questions that we have and being willing to serve
in the capacity that you serve in.
RURAL HEALTH
I represent Mississippi. We are less than 3 million people.
And one of our largest challenges is rural healthcare and
getting these vaccines to rural areas such as those in
Mississippi. Of course, I am very concerned about the
universities and colleges and the protection that we need there
through that age population.
But I am just going to ask you, what are your agencies
working on to help address the challenges in unique rural
America's response to COVID-19? But mainly, how can this
subcommittee support you in that? How can we help you address
those issues there? And I would like to hear from all three of
you on that and getting the vaccines to rural America where it
needs to be where we have such a challenge.
Dr. Redfield. Thank you very much, Senator.
Very, very important, we have continued to try to develop
outreach in vaccine distribution particularly in the hard-to-
reach rural areas. This is part of the efforts that we have
accelerated with our flu program right now with the idea of how
to vaccinate with confidence by trying to protect communities,
empower families, and stop myths.
We have developed rural partnerships with the National
Rural Health Association, the National Association of Rural
Health Clinics, and the National Organization of State Rural
Health Offices with the goal to really work to improve the
acceptance of vaccination in general, flu being the important
one with confidence.
I do think the recent decision that the Secretary made in
expanding the ability of pharmacies to vaccinate down to age 3
to down to age 18 is going to be an important expansion of
being able to engage pharmacies throughout our Nation as
vaccine centers.
But we are continuing to work with those rural
organizations to see if there are other innovative solutions to
try to expand vaccination. I am hopeful that the pharmacy
expansion is going to have a significant impact.
Senator Hyde-Smith. Thank you very much.
Dr. Kadlec. Ma'am, with regard to rural healthcare, what
ASPR has been doing in the last years prior to the COVID event
was trying to expand what would be the regionalization of
disaster care, emergency care to really focus on areas where
you have critical access hospitals or underserved populations.
In the current COVID event, we have been working with the
Department of Defense to employ a system that they originally
started, which was called the National Emergency Telecritical
Care Network, or NETCCN, which is a means by which to do
telemedicine to again rural and critical access hospitals to
make them available the best information critical care
specialty support, as well as arranging for transportation and
referral of cases to a higher level of care. So we are actively
doing that right now. We have done it in many parts of the
country as a result of our work in COVID response. And we are
also trying to do that for ambulatory care telemedicine as
well. So by building out our regionalization approach, our hope
is to not only create the established referral patterns but
also establish telemedicine consulting support so that we can
support the rural parts of this country over.
Senator Hyde-Smith. Thank you.
Admiral Giroir. And I will add on again with the PREP Act
guidance that allowed pharmacists to do COVID vaccines--I
issued that last week to get in the pharmacy communities.
But I just want to be a little bit of a cheerleader for
federally qualified health centers. We now have 221 federally
qualified health center sites in Mississippi performing
testing. I think FQHCs are a real gem. They take care of 30
million people and very much of the underserved migrant farm
workers, homeless, and they do so at a savings, better outcomes
at less cost. So again, that is a major point for us in
Mississippi where we are reaching people both urban and rural.
And anything I could do something for HRSA and health centers,
that is going to be money well invested.
Senator Hyde-Smith. Thank you all for those answers, and I
truly appreciate that because it is one of my top priorities.
We had a young lady not long ago that died of an asthma attack
because the emergency room had been closed in her area. So I
certainly appreciate your work there.
Senator Alexander [presiding]. Thank you, Senator Hyde-
Smith.
Senator Merkley.
Senator Merkley. Thank you very much.
ASYMPTOMATIC TESTING
Director Redfield, I am concerned that the CDC has revised
guidelines that no longer recommend testing for asymptomatic
individuals who have been in close contact with a person with
COVID-19 infection for at least 15 minutes.
Just a few days ago in a media interview on September 10,
Admiral Giroir stated that all of us in the room have been
hearing from public health experts we need to test asymptomatic
individuals.
So explain this to me. Is the admiral right or wrong?
Dr. Redfield. Thank you very much, Senator, for the
opportunity to address your question.
I think, first and foremost, I want to say the CDC guidance
that came out was clearly misinterpreted, and within 24 hours,
I published a statement to try to make it clear what CDC was
recommending. We were never recommending not to test
asymptomatics, and we were never recommending obviously not to
do the public health contact tracing and trace them.
What was attempted was to replace the emphasis of testing
so that, as we talked about earlier, testing led to an action.
It drove public health objectives. So we placed the emphasis on
testing symptomatics, but then we placed the emphasis on
individuals with significant exposure--they are asymptomatic--
or vulnerable populations, nursing homes, long-term care
facilities, critical infrastructure workers, healthcare
workers, first responders--they are asymptomatic. And the last
group that we talked about was individuals who may be
asymptomatic and rather than just get tested, what we asked
them to do was consult, like we heard from the Senator from
West Virginia--consult with your medical and public health
officials and follow their direction because, as you saw with
the Senator, when she chose to get tested, even though the test
was negative, there was a critical public health action. That
was for her to stay home for 14 days.
So we are going to continue to try to make sure our
guidance is not interpreted incorrectly because as the admiral
said and as I have said, asymptomatic infection and pre-
symptomatic infection is a critical component of the
transmission cycle of this virus.
Senator Merkley. I am going to ask you to stop there
because I have got other questions, and I think you have
answered it. And even the example you have given shows the
positive impact of testing asymptomatic individuals because
they can get appropriate guidance on how to behave thereafter.
And we know that a tremendous amount of infections are
happening from people who are asymptomatic. And so I think that
is such an important point to keep driving home.
STATE VACCINE DISTRIBUTION
I wanted to also ask you. You had told governors to prepare
for the distribution of COVID-19 vaccine on November 1. It
escapes no one's perspective that you are deliberately laying
it out 2 days before the election. Who in the administration
asked you to choose that particular date?
Dr. Redfield. No one, sir.
Senator Merkley. You just thought on your own political
motivation to try to influence the election in this manner.
What happened to science driving decisions?
Dr. Redfield. There was no political interest in it
whatsoever. It was actually prepared by our subject-matter
experts because we wanted to get to the point of realizing that
vaccine may be available--we do not know when--and we wanted
the governors to be able to not have red tape interfere with
the distributor McKesson from setting up their distribution
sites.
I will argue that the thing that I was most concerned of
and my subject-matter experts were, who actually generated the
letter which I signed, was that the worst thing that could
happen is we had vaccine delivered and we are still not ready
to distribute.
But I can tell you there was absolutely no political
thinking about it. You could say in a retroactive--somebody
should have thought a little more political. But there was no
political intention whatsoever.
Senator Merkley. Okay. Well, I must say that I do not find
that persuasive. You are saying that there was not a single
contact from the administration after the President said I
would like to have a vaccine before November, before the
election. No one from the administration contacted your team at
any level to say can you please emphasize that message. There
were no emails, no meetings, no phone calls, not back room
chats connected with your choosing that particular date.
Dr. Redfield. Absolutely not. It was independently
developed by our subject-matter experts that were laying out
this document to start to plan for the jurisdictions that we
needed to get that letter out so McKesson could get the
licensing agreements that they needed to get their distribution
sites up. And they drafted the letter--the subject-matter
experts--that I signed.
Senator Merkley. Yes.
Senator Alexander. Thank you, Senator Merkley.
Senator Merkley [continuing]. So much misrepresentation by
the administration. I think Americans would find it hard to
believe that there were no conversations when the
administration is actively pushing every piece of the Federal
Government to engage in actions to promote their election. So
it undermines your credibility. You should have at least
thought about how it undermines your credibility because it is
so important to have the CDC be above politics.
Senator Alexander. Thank you, Senator Merkley.
Senator Lankford.
Senator Lankford. Thank you.
It has been interesting how much the dialogue today has
been about politics and about the election. I do appreciate the
work that you are doing regardless of party. I do not find
people getting COVID only if they are Republican, Democrat, or
independent voters and non-voters. So I appreciate the ongoing
work that you have done for a very long time to be able to work
us through this. Your days are very long, and your work is very
important. So we appreciate the work that you continue to be
able to do. And this hearing should not try to be some sort of
political trap for the President. It should be about the facts
and details. So I appreciate that.
Let me ask you a couple of quick questions on this. One I
want to dig into more.
FUNDING FOR VACCINE PRODUCTION AND DISTRIBUTION
The first one is there has been a lot of conversation about
the amount of resources that is needed for the vaccines
especially and for vaccine production and distribution. What do
you still need for vaccine production and distribution as far
as supplemental appropriations?
Dr. Kadlec. Senator, thanks for that question.
At this point, we have funded six vaccine candidates for
both advanced development and manufacture. I think at this
stage the $13.6 billion that have been appropriated or--pardon
me--committed for this purpose is adequate for that, for the
initial part of this. If you are talking about at the point in
time when one vaccine candidate may fail and we may have to
replace it with another candidate or expand production of
another, that could basically change our accounting and our
calculus for what we would need. But at this stage, we have
what we need, and we are poised, at least at this point I think
by the end of this month and into early October, to at least
have the funds that we need to basically provide for the first
several candidates.
Senator Lankford. Okay. That is good to know. There are
obviously six different candidates going through the vaccine
process right now, and because no one knows if any one of them
is going to be successful, so you got basically six hooks in
the water at this point.
I am going to drill down a little bit on the vaccine
candidates that are out there and also some of the treatments.
ETHICAL PRODUCTION OF VACCINES
Some of the pharmaceutical companies have chosen to do
ethical production, that is, they are not using tissue from
aborted children for the production of the treatment or of the
vaccines. Some of them have chosen to use aborted fetal tissue
in the production of the vaccines. How are you balancing out to
be able to make sure that there will be an ethical alternative
for individuals that do not want to take a vaccine that is also
produced using the tissue of an aborted child?
Dr. Kadlec. Sir, thank you for that question. I am going to
have to take that for the record and bring you back an answer
to get more details on those particular matters. I do not have
those immediately available, and I do not want to misspeak on
this issue.
Senator Lankford. That is fair enough.
Dr. Redfield, do you have comments or thoughts on that on
the production?
Dr. Redfield. Again, I would have to go back and see
specifically. I think my recollection is we are going to have a
number of candidates. It is not going to compromise one's
ethics related to the use of human tissue. But I will have to
get back to you too because I do not want to say something that
is incorrect.
Senator Lankford. No. I get that. And it is not just human
tissue in the production. I mean, there are some companies that
are using adult stem cells. There are some that are using
placentas from children after birth. Those are not
objectionable. I do not find anyone challenging that. So it is
not just the use of human tissue. It is specifically the use of
tissue that is from aborted children that becomes the
challenge. Moderna is using embryonic kidney cells from aborted
children. Johnson & Johnson is using aborted children embryonic
retinal tissue for its production of the vaccines. There are
others that are not choosing to use those tissues from
children. So I think there just needs to be as many options out
there as we can.
And again, I just wonder on the science side if we do not
have to use tissue from aborted children, why would we do that
when there are others that are choosing to be able to develop
vaccines that are not being used that way.
So I want to be able to follow up with you on that just be
able to see what options are out there and how we are handling
the funding and what direction that we are going to go. And
long term for vaccines, most of the vaccines that we have in
America now do not use embryonic tissue in it. There are still
some that still do, that that is the line that is still used.
And again, when we do not have to do that, why would we do that
and to have it as ethical as we possibly can.
So again, I appreciate the work. We will follow up in the
days ahead on this particular topic because I think it is very
important that as many people get vaccinated as possible. And I
do not want to have a reason for people to not go get a vaccine
because they are concerned about the origin of the vaccine. I
want as many people as possible to actually get a vaccine
because I think it is important. And it has been an odd
conversation to hear so much of people saying, well, I am
challenging whether we are going to get a vaccine because the
Trump administration may be rushing this, and so I do not want
to go get one. I think we have to have nothing that distracts
from the science and the details of this as we walk through it
as well.
So I appreciate your work.
Senator Alexander. Thank you, Senator Lankford.
Senator Schatz.
Senator Schatz. Thank you, Mr. Chairman. Thank you to the
panelists for being here.
TESTING
I will start with Admiral Giroir. You said in July that it
was not a question that we would be soon running a million
tests per day. We have gone from about 800,000 tests per day to
675,000 tests per day. What is happening?
Admiral Giroir. I want to be clear that we are talking
about capability to produce tests. And I think we need to
always draw the distinction between how many tests we have that
can be deployed and what the States are doing.
In August, for example, the States' combined goals were in
the low 20 millions of tests, which they exceeded to 25
million.
But what we are seeing at some parts of the country is
testing is going down. We are trying to change that. I know you
are from Hawaii. We have a surge site in Honolulu right now
that we can test up to 5,000 per day and moving----
Senator Schatz. Right. You are saying this is volitional? I
guess the question is, is this a supply chain problem, or are
you saying that States are individually deciding to do less
testing?
Admiral Giroir. This is not a supply chain problem. We had
double the availability of tests that were done in August, and
we will be over 90 million tests available in September. I
would presume that a higher proportion will be done because
they are going to be very easy to do. They are going to be
point-of-care Binax testing and that we are surging nursing
homes.
Senator Schatz. Can we just talk a little bit about the
Binax testing?
Admiral Giroir. Yes.
Senator Schatz. Because I guess where a lot of people are
coming from is that we hope you are right that this new test is
a game-changer. And we are pleased, and I think it will be very
helpful in the context of first responders and in nursing homes
and perhaps educational contexts as well. But it is a card, and
as you know, you cannot really process that many tests at once
this way. And so although it is really useful in certain
contexts, it is not going to get you to your 90 million tests
goal. I mean, in your testimony today--today--you say that we
should have 90 million tests completed by the end of September.
Admiral Giroir. I did not say that.
Senator Schatz. We are about halfway through September --
Admiral Giroir. I did not say that.
Senator Schatz [continuing]. And we are at 10 million
tests.
Admiral Giroir. I did not say that. I said we have----
Senator Schatz. In today's testimony?
Admiral Giroir. I said we will have the availability of 90
million tests in September. I never stated that we would do 90
million tests in September. We are certainly hoping that the
testing goes up.
And let me just say about Binax, it only takes a swab and
put it in and wait 15 minutes. I could probably go through this
room and swab everyone and do that within about 5 or 10
minutes. So it is a low throughput test, but you could do them
very rapidly and quickly. So I would expect that as many of
these that get put in the market, particularly used in nursing
homes, assisted livings, and to support K through 12, that they
would be used very rapidly.
Senator Schatz. Just because I have limited time.
Admiral Giroir. Yes.
AVAILABILITY OF TESTS
Senator Schatz. What is the difference between testing
availability and tests being completed? Because that seems like
a sort of a distinction that is lost on the ground. To know
that there are 90 million tests theoretically available but the
nursing homes, the schools, the first responders, the
firehouses--they do not have the tests available. So what does
it mean that it is theoretically available to do 90 million
tests and yet people cannot get their hands on a test?
Admiral Giroir. I do not think that is true. I think people
can get their hands on the test. Even with Federal sites, we
have 2,700 in retailers. We have surge sites. There is enormous
capability in the referral labs. So the testing is available
even when we do surge sites. Unless there is--you know, there
is not a public order that demands people to come in and get a
swab up their nose. This is voluntary, and sometimes the demand
is not there.
But let me just turn that around and say with the Binax,
that is one reason why we purchased them all for the Federal
Government, the first 150 million, to make sure they got to
sites that would use them and really could benefit them like
nursing homes, assisted living, Tribes, HBCUs, disaster
situations, and in just a couple of weeks, to support K through
12.
Senator Schatz. Admiral, I know you are working on this,
and I know you are trying to do this in good faith. But I just
want to convey to you that when the surge testing happened in
the State of Hawaii on the Island of Oahu over the last 2
weeks, it was only then that we were able to test our fire
fighters. It was only then that we were able to test our first
responders. It was only then that we were able to have the
tests available to do what it is that is theoretically possible
under other circumstances. And it was only because we saw a
precipitous spike in COVID cases. And so it is not true--it is
not true--that tests are available for first responders except
in certain----
Admiral Giroir. I respectfully disagree with you that if
the State of Hawaii--you have a turnaround time of 124 hours
with the ACLA labs. And I am happy to work with your State. But
there is no reason before the surge--you could have hired this
company to come do the surge for you. We did it, sent it down
there. And the demand was great. Hawaii has been unbelievable
to work with. We have been doing fully subscribed 5,000 tests a
day. But I am very happy to work with Hawaii. The Surgeon
General just went down. We are expanding on the big island. But
there is no reason that first responders could not have been
tested before the surge.
Senator Schatz. Well, I will just end with this, and I am
sure my time is almost up.
There continues to be a disconnect with how things are
represented in this committee, in the United States Congress,
and how things are felt on the ground. This was evident in
February when we met with HHS, and it continues to be the case
here. We hear lots of triumphant statements with lots of data,
but on the ground people still lack resources.
Thank you, Mr. Chairman.
Senator Blunt [presiding]. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman.
AVAILABILITY OF SUPPLIES
So the administration's failure to confront this deadly
pandemic has led to lost lives. There is still an urgent need
to provide more support to our communities. And I am
increasingly concerned that the funds appropriated thus far
have not been handled as well as they could. They have been
misused and mishandled.
Last month, I wrote to Vice President Pence about a health
system in my State that temporarily suspended COVID testing for
patients undergoing surgery because of supply shortages. I have
heard from assisted living facilities that they cannot get the
tests they have ordered and academic medical centers that are
not able to secure a reliable source of reagent. However,
Wisconsin did receive un-requested hydroxychloroquine before it
ever received a ventilator.
Congress provided more than $16 billion for the strategic
national stockpile for critical supplies of PPE. Less than $9
billion of that has been obligated for the stockpile.
Dr. Kadlec, what percentage of the funds appropriated for
the stockpile this year have helped States get the PPE and
testing supplies they need? As of this moment, what is that
percentage?
Dr. Kadlec. Ma'am, I am going to have to get back to you
with a percentage. But what we have done in terms of our
approach to basically managing the PPE part--and I will defer
to Admiral Giroir to talk about the testing piece--is that we
have basically made available everything that we had in our
stockpile by May. Beginning with March with the monies that
were available in the CARES Act and subsequent to CARES Act, we
have been basically funding, if you will, the purchase of
personal protective equipment to be distributed through
commercial distributors directly to hospitals. And only
beginning in June and July have we been filling, if you will,
replenishing our stockpile as part of a strategy to make
available 3 months of supply for the fall and winter, should
that be necessary.
We are, by virtue of teletracking, now getting information
from hospitals. Last week, about 95 percent of hospitals have
been reporting to us. And I am just looking at your State,
ma'am. We have identified that 16 percent of hospitals have one
shortage of PPE that may be--one type of PPE that may be 3 days
of supply or less.
Senator Baldwin. Right. I am aware of the Wisconsin
statistics, but I am also aware of the $16 billion that we
appropriated to address stockpile issues. So you may have
chosen a different strategy, but I think when we are 6 months
into this pandemic and we still cannot get the supplies we need
and you have identified the supplies that are in high demand,
that you should use the money we appropriated to obtain those
things.
Congress also provided $1 billion for the Department of
Defense for similar purposes. And the President delegated
authorities under the Defense Production Act to HHS to increase
production of personal protective equipment. The Department of
Defense has only used $300 million for PPE and said they would
use the rest to support the defense industrial base.
DOMESTIC MANUFACTURING CAPACITY
Dr. Kadlec, how much funding have you spent on increasing
domestic manufacturing capacity using all of the DPA (Defense
Production Act) authorities available to you so that we can
prepare for the remainder of this pandemic or future pandemics?
Dr. Kadlec. Yes, ma'am. So far we have awarded $638 million
for that purpose, which runs the gamut from addressing
shortages of diagnostics and ancillary supplies, N95
respirators, injection technology for the use for vaccine
administration, filter media for masks, as well as ventilators,
gloves, surgical masks, as well as the ventilator supply chain.
There are other things that are being considered at this point
in time to use the rest of those funds, but we are trying to be
very strategic.
Senator Baldwin. Dr. Kadlec, what is melt-blown?
Dr. Kadlec. Ma'am, that is the material, the fiber
material, that is used in the disposable surgical masks, N95
respirators, as well as ventilators----
Senator Baldwin. Okay. And have you used the DPA to either
increase production of melt-blown in the U.S.? I am not talking
about contracting. I am talking about using the DPA
authorities.
Dr. Kadlec. Yes, ma'am, we have.
Senator Baldwin. And have you used DPA authorities to shut
off the export of melt-blown when it is obviously so needed
here?
Dr. Kadlec. Ma'am, I am going to have to get back to you on
a firm answer on that, but my recollection is that we have. We
did limit the export of that material, but I have to just be
sure and return you a----
Senator Baldwin. Please do.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Baldwin.
Senator Graham.
Senator Graham. Thank you, Mr. Chairman.
Dr. Redfield, have you been part of the task force since
its beginning?
Dr. Redfield. Yes, sir.
COVID-19 TIMELINE
Senator Graham. Okay. So see if I have got the timeline
right. I believe President Trump was briefed by Mr. O'Brien on
January 28 you had a major problem coming out of China when it
comes to the coronavirus. He sets up the task force on January
29. Is that correct?
Dr. Redfield. That is my recollection, sir.
Senator Graham. On January 31, the President issues an
order called the China travel ban. Does that sound right?
Dr. Redfield. Yes, sir. 31 of January was when the request
was to inhibit travel to China.
Senator Graham. On February the 29, Dr. Fauci was asked by
a host of the ``Today Show'' this is Saturday morning. People
are waking up right now were real concerned about this. They
want to go to malls and movies, maybe the gym as well. Should
we be changing our habits, and if so, how? Dr. Fauci says,
February the 29, no, right now at this moment there is no need
to change anything that you are doing on a day-by-day basis.
Right now, the risk is still low, but this could change.
Is that the general view back on February 29? Did you agree
with that assessment?
Dr. Redfield. At that time, there was limited evidence of
community transmission in the United States.
Senator Graham. So in March, there was an order basically
issued declaring this a national emergency. Do you recall that?
March 11?
Dr. Redfield. Yes, sir. I think Secretary Azar called it a
public health emergency. I think it was January 27, and then
the President, the national emergency----
Senator Graham. On March the 13. March 11, we do a travel
ban from Europe. Is that about right?
Dr. Redfield. Yes, sir.
Senator Graham. Between January the 29 and March 13, did
the task force ever recommend shutting the country down?
Dr. Redfield. No, sir.
Senator Graham. When the task force recommended to the
President to declare this a national emergency and to basically
encourage shelter-in-place orders, did the President respond to
the recommendation of the task force?
Dr. Redfield. Yes, sir.
Senator Graham. Was there any time when the President
refused to do what the task force recommended about shutting
the economy down before he made that decision?
Dr. Redfield. Not in the decisions that I was involved in.
Senator Graham. Thank you.
VACCINE DISTRIBUTION
So vaccines. If we found a vaccine, let us say, next month
at the end of October, how long would it take for it to be
distributed throughout the country and to become effective?
Dr. Redfield. Well, I think that is the critical question
because currently we have used the supplemental resources to
get this distribution capacity up, about $600 million, but the
funds that we currently have are not sufficient for us to get
all 64 jurisdictions ready to be able to implement this plan
that we issued----
Senator Graham. Right. And I am sure you have made a
request of the committee for additional money, and I am sure we
will respond.
But what I want the American people to know if a vaccine
was developed tomorrow that was considered to be safe and
acceptable, how long would it be before it would have a real
effect in terms of controlling the virus.
Dr. Redfield. I think we have to assume that if we had a
vaccine, say, released today that it is going to take us
probably in the order of 9 months--6 to 9 months to get the
American public vaccinated.
Senator Graham. So I just want everybody to understand that
we are working--Operation Warp Speed--do you feel like that it
is going well?
Dr. Redfield. Yes, sir.
Senator Graham. So if we got a vaccine in the near future,
before it would really have a massive impact, it would take 6
to 9 months to get it distributed and for it to begin to take
effect, for lack of a better word. Is that accurate?
Dr. Redfield. In order to have enough of us immunized so we
have immunity, I think it is going to take us 6 to 9 months.
Senator Graham. So during that 6 to 9 month period, we will
continue to do sort of basically what we are doing now. Is that
correct?
Dr. Redfield. Yes, Senator. That is why it is so important
to embrace these mitigation steps that we talked about.
ECONOMIC SHUTDOWN
Senator Graham. So is it fair to say that at no time did
President Trump reject the recommendation by the task force
when it came to slowing down the economy or putting shelter-in-
place orders, that when it was recommended to him to take those
actions, he complied? Is that correct?
Dr. Redfield. Yes, sir.
Senator Graham. Is it fair to say that as late as February
the 29, Dr. Fauci, one of the experts of our time, was telling
people it is okay to go to the gym, it is okay to go out and
about because at that time, we thought the risk was relatively
low?
Dr. Redfield. I have to defer that. I didn't follow Dr.
Fauci's statements. But I would say in general we all felt----
Senator Graham. That is what he said on national
television. That is what he said that day on February the 29.
So this idea that President Trump did not respond I think is
ridiculous for the President to be shutting the whole economy
down when his leading expert is telling people you can go to
the gym, you can go to a movie, you go out and about. So let us
do not rewrite history here.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Graham.
VACCINE PRIORITY
Before we go to Senator Murphy, Dr. Redfield, let us be
sure we are clear here on the vaccine. You are not saying that
it would take 6 to 9 months before the vaccine would do any
good for anybody, but you are trying to come up with a priority
that the country and governors should look at of who is the
most at risk that would get that vaccine first. Is that right?
Dr. Redfield. Yes, sir.
Senator Blunt. And if the vaccine works with the efficacy
that we would hope for, most of the people that get the vaccine
are then protected from the virus for at least the near-term
future. Is that right?
Dr. Redfield. The FDA has set guidance that if it is 50
percent efficacious, which is similar to the flu vaccine, that
that would meet their threshold for approval. And I do want to
be clear that as soon as this vaccine gets approved by an EUA
or actually approved, we want to be in the position to
distribute that within 24 hours because you pointed out very
clearly this vaccine has the potential to save a lot of lives
in November and December. But we need to be able to get that
vaccine, once it is ready to--once it is approved, we need to
get it distributed as rapidly as we can.
Senator Blunt. Right. And in July, at the hearing we had in
July, I asked you specifically to focus on being able to report
back on a plan that hopefully we will get to later. I just do
not want to leave this moment with any thought that just
because everybody that wants to have the vaccine might not have
it before Memorial Day, that does not mean that many people who
do have it--and hopefully would be the most in need--would be
substantially better off than they are right now. Is that
right?
Dr. Redfield. Yes, Mr. Chairman. You are going to have an
enormous impact, we believe, on the mortality and the most
vulnerable and an enormous impact in protecting those at
greater risk of infection. And we should see that impact
relatively immediately.
Senator Blunt. Thank you, sir.
Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman.
Thank you for spending so much time with us today.
COVID-19 PUBLIC HEALTH CAMPAIGN
Just first a note on communication to and through Congress
and this committee. Senator Shaheen earlier asked about a $250
million contract that is being awarded by HHS to defeat despair
and promote hope, which sounds an awful lot like a political
reelection year-oriented message out of the administration. And
we have two deputy secretaries of HHS before us today, and
neither one of them can testify as to whether that contract was
awarded, why it was awarded, what the reasons for it were. It
is increasingly impossible for any of us to know who is charge.
We have got two people who are at the highest echelon of HHS
and cannot answer a question about a massive contract that has
been awarded.
And I think that is the same thing for the American public.
Dr. Birx was in charge. Then Vice President Pence was in
charge. It is really hard for there to be any accountability
around decisions when we cannot get these basic questions
answered.
TESTING
I want to come back to Senator Merkley's question regarding
the changed guidance, Dr. Redfield. So the President says he
wants less testing. He say that out loud. He is asked for
clarification. He doubles down and says I want less testing.
And then right around that time, you issue this guidance that
dramatically scales back recommendations for who gets tested.
And the ``New York Times'' reports that that is because, in
part, of instruction from the White House. You say today that
that report is in fact untrue.
But to many of us, it just belies reason that we would be
encouraging fewer people to get tested today given the massive
expansion of this virus. On the day that we passed the CARES
Act, there were 10,000 new cases reported in this country. On
average, we are seeing 34,000 new cases all across this country
today.
Your testimony was that you were not necessarily saying
folks who are asymptomatic should not get tested. You are
saying they should just see a doctor first. Is that correct?
That was your clarification today.
Dr. Redfield. No. What I was saying that when you get a
test, like any physician who does a test, it needs to be linked
to an action. And what we were trying to do is reemphasize that
testing is linked to an action, just like the Senator said. She
got tested. She was in quarantine. She got tested. She was
negative, but that still was linked to an action to stay in
quarantine for 14 days. What was happening was people were
getting tested, and there was no action. So we were trying to
bring action back into testing. We were not trying to limit.
And I will be very clear----
Senator Murphy. Let me just--before you do that, let me
just read you this. This is from a medical journal. This is
from the American Journal of Managed Care. Earlier in this
week, CDC changed its guidance saying even if you come into
contact with an infected individual, a test is not necessary if
there are no symptoms.
Dr. Redfield. That is not true what the guidance was
attempting to say. It is true that some people interpreted it
that way, and that is why I issued a very clear statement in 24
hours afterwards to say CDC is not trying to emphasize. I do
believe that more tests, as was said by Senator Durbin--more
tests actually can lead to less cases if testing is linked to
public health actions.
Senator Murphy. But you did recommend--you did say they do
not need a test.
Dr. Redfield. No. We said they may not necessarily need a
test.
Senator Murphy. What does that mean? Listen, you are
speaking to the American public when you tell them that they do
not necessarily need a test.
Dr. Redfield. You need to consult a doctor, a public health
person to make that decision----
Senator Murphy. What is the difference?
Dr. Redfield [continuing]. So the appropriate public health
action can be taken in conjunction----
Senator Murphy. Okay. When you tell them that it is not
automatic that they need a test, that they should see a doctor
first, it gets communicated to people that the urgency is much
lower.
Dr. Redfield. For all contexts, sir, we are recommending
all of them be tested. So it was a misinterpretation by some.
And again, we are going to continue to clarify because we are
not recommending less tests. I do believe more tests ultimately
are going to lead to less cases in this country because it is
going to allow public health action to happen, just like it did
for the Senator. And we can use those tools to stop this
pandemic.
WORLD HEALTH ORGANIZATION
Senator Murphy. I will ask this question for the record,
Mr. Chairman, to Admiral Giroir. There was a report earlier
this month that the United States is going to scale down its
engagement further with the WHO, including recalling detailees
from WHO headquarters, regional offices, and country offices,
and then reassigning these experts. I acknowledge I do not have
time to get the answer today, but I think it is incredibly
concerning that we might not have American personnel on the
front lines to sort of watch this virus and others through WHO
(World Health Organization) field offices. And so I would
appreciate an answer for the record regarding who is going to
replace those individuals inside countries of concern and how
we keep eyes on this virus and future viruses.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Murphy.
Senator Moran.
Senator Moran. Chairman, thank you.
VENTILATORS
Dr. Kadlec, let me start with you. I want to talk a moment
about ventilators.
HHS has entered into a number of ventilator contracts, most
of which were cancelled a week or so ago before they reached
their intended, I guess, conclusion. And is there an accounting
of how many ventilators--which is troublesome to me because the
signals even a week before that was fulfill your
responsibilities first to USAID (U.S. Agency for International
Development) and then come back and finish your contract to us
at HHS. And then a week later, the message is we do not want
any more ventilators. And it is interesting to me that the
contract requires HHS, the taxpayers, to pay for the startup
costs, the closing down costs, and all the equipment and
materials that have been purchased. So for a marginal amount of
money, the contract could be fulfilled.
Setting that aside, what is the accounting on how many
ventilators that are high acuity ventilators in the strategic
national stockpile? And is there a calculation by HHS as how
many need to be this higher acuity as compared to a more
standard ventilator with kind of one dial that you adjust?
Dr. Kadlec. Well, thank you, sir, for the question.
And, yes, sir, we have been looking at our ventilator
supply. Just to put this in context, when the COVID-19 event
occurred in January, we had 17,000 ventilators in our stockpile
with another 10,000 ordered. As a consequence of the modeling
and the concern that we may need much more ventilators by pre-
pandemic calculations for pandemic influenza, it was figured or
calculated that you needed about 170,000 ventilators. As the
course of this event, there was a concern that we may actually
need more than that number, and that is when we went into
agreements with seven companies across the country and a few
from outside the United States to basically produce over
200,000 ventilators.
As things progressed as we learned more about the disease
and, more importantly, how to clinically manage this disease
both from a respiratory setting, as well as an intensive care
setting, we identified we needed to change maybe our strategy
with the ventilators, maybe needing less but also different
kinds of machines. And so with your point, the higher acuity
kind of ventilators, which we have over 120,000 of at this
point, was to basically diversify that so that we could use
some that could be used for high flow nasal cannula which seem
to have better clinical outcomes.
So adjusting that number with modifications to some of the
orders that we made, we basically also identified that we could
meet our pandemic requirements of 170,000, make available to
other countries an additional 20,000 ventilators, that we
decided to then, if you will, cut back on the number of
ventilators that we needed to order and to have shipped.
Yes, there is a cost to that, but there is a significant
cost on the back end of this with the maintenance requirements
that you need to maintain these ventilators.
And so that is why we did it, sir. I am the responsible
party. And sir, I will be happy to get with you and your staff
to provide you any other details you need.
Senator Moran. Doctor, thank you.
PROVIDER RELIEF FUND
Let me quickly turn to Admiral Giroir. I think the position
the witnesses have taken this morning is that you are incapable
of telling us but would take back these issues for the record--
you are in capable of telling us about future spending from the
provider relief fund.
Let me just suggest to you that please take back for the
record that the ability to get information from HHS on any
spending from the provider relief fund has been minimal at
best. As a United States Senator who appropriates money, who
supported the CARES package, my ability to communicate with my
constituents as to how you are going to spend the money, what
the plan is has been next to nil. And I have not experienced
that during coronavirus with other departments, with other
agencies, but HHS has failed time and time again to respond to
congressional inquiry and provide us with information about how
taxpayer money is being spent, about how to help our
constituents prepare for what you might be doing or what you
are not going to do.
LONG-TERM CARE FACILITIES
Admiral, somewhat in that regard, the increasing costs
associated with complying with HHS rules and regulations by our
nursing homes, our skilled nursing facilities, our senior
living facilities is significant. And my question for HHS,
because I would understand that you will defer to somebody else
than who is here today to answer the question, is what can they
expect to help them pay for the tremendous increase in costs in
compliance with COVID regulations in policies that they are
attempting to comply with to protect the safety and wellbeing
of their residents but have little financial capability to
actually pay for?
Admiral Giroir. Thank you for that question.
Independent of whatever regulations there are nursing homes
have the responsibility and the ethical responsibility to do
the types of testing that we recommended. It is the only way
that you protect the elderly. Full stop.
Number 2, the reason why we distributed point-of-care tests
to the nursing homes is because they are about 20 percent of
the costs that they would incur as opposed to a laboratory
test. The Binax test that we are distributing to all of those
right now, 2 million this week, are at no cost to the nursing
homes, and they come with automated reporting.
And finally, again I do defer to Seema about sending money,
but I know $5 billion was sent to nursing homes, of which $2.5
billion was to support testing. That is the level of detail I
know, but I am happy to bring anything back from her or from
our Assistant Secretary for Finances to you, sir.
Senator Moran. Admiral, I am using you as a conduit for
purposes of expressing my concern and expressing my desire for
a lot more information.
Admiral Giroir. Yes, sir.
Senator Moran. I would point out that every time that I
have raised this issue--these issues with HHS, I talk about
senior living, nursing home, and skilled nursing facilities,
and every response, just as I think yours was, comes back to
what we are doing for nursing homes. And again, I cannot
determine if there is any plan to be helpful, which I think is
necessary, for example, to senior living.
Admiral Giroir. So I will bring that back, and we will take
it for the record. I do want to let you know that the moment we
had the Binax test, we are sending it to 5,000 assisted living
centers this week to support testing in an assisted living
environment, not a nursing home environment. There are still
6,000 of those or even more that do not have a CLIA waiver that
we need to work with, but we are going to work with them. You
know, as soon as we get the technology, it is out the door to
support our seniors.
Senator Moran. Admiral, you caused me just to change my
commentary slightly. So every time I raise this topic, now you
mentioned two of the three topics, and I still would raise for
you and for HHS senior living, which never seems to be a
component of any conversation that I have had with--what few
conversations I have been able to have with HHS.
Admiral Giroir. Yes, sir.
Senator Blunt. Thank you, Senator Moran.
Senator Moran. My time has expired.
Senator Blunt. Thank you.
I have got a couple of other questions and Senator Murray
has another question or two.
FUNDING FLEXIBILITY
On the point that Senator Moran raised, what is going to
happen at the Department is going to be an increasing
reluctance by this committee to appropriate money and give the
Department flexibility. You know, when we appropriate money for
the provider fund, we expect that money to go to the provider
fund, not to go to whatever other fund the Department think it
is better spent. So in fact, when we appropriated the second
$75 billion to the provider fund, we absolutely prohibited
spending that money any other way or some language close to
that. And that is all because of the Department's actions. The
appropriating committee appropriates, based on your request and
responds to that request, in ways we think it is appropriate,
and you cannot just decide to ignore that.
On the vaccine, Dr. Kadlec, we specifically did not
appropriate to Warp Speed. We appropriated money to the
partners, NIH and BARDA. My understanding is that at least $16
billion has come through those agencies for the vaccine up
until now. HHS has told us that to have 300 million copies of
vaccine available, they need another $20 billion that they do
not have in any specifically appropriated line. Do you agree
with that number?
Dr. Kadlec. Sir, based on the current situation, yes, sir,
that seems to be the number.
Senator Blunt. All right.
STATE VACCINATION PLANS
Dr. Redfield, the plans you expect to get back from the
States by November 1 on distribution of the vaccine--do you
think you will be ready shortly after that to announce your
final distribution plan for vaccine?
Dr. Redfield. Senator, it is going to be dependent on the
Advisory Committee of Immunization Practices, which will make
the final recommendation for prioritization. We will----
VACCINE PRIORITIZATION
Senator Blunt. I think I am asking another question. Maybe
I did not ask it well. Prioritization--I want to talk about
that too, but surely prioritization will not impact how you
send this out to the States. It might impact the number they
get, but in terms of the protection of the vaccine, the way it
is distributed, to be sure that you have a plan to get this in
response to all these State plans as soon as possible, is that
your intention?
Dr. Redfield. Yes, sir. Obviously, the issue that I tried
to mention earlier is that--and I have said this in our earlier
testimony. Some people--it does not seem like they see this.
Just as it was important----
Senator Blunt. It is important. It is a second issue, but
it is really important. And that was my next question.
Where are we on the prioritization? And that will be
recommended to the States or will that be a prioritization we
expect the States to comply with?
Dr. Redfield. Yes. It will be in a recommendation of the
advisory committee for how this vaccine, whichever ones are
approved, are recommended to be used.
Senator Blunt. And when will that be available?
Dr. Redfield. That will be available after the committee
gets to see the data on the particular vaccine.
But to answer your first question, because I think it was
really important and I want to get to it, this plan for
distribution is what we are now to get. And what I was trying
to say is I said before this committee it is as important that
we start that plan back in June as manufacturing. And right
now, we have leveraged about $600 million, but we do not have
the resources to support 64 jurisdictions to get this plan
operational. So to me it is an urgency, you know, that we get
that. We have done this in the past. We have experience in what
it is going to take for us to do distribution and monitoring
safety and get the vaccines. As I mentioned, we distribute 80
million doses of vaccine a year at CDC. We have an idea. But
this is going to take substantial resources, and like I
suggested in June, the time is now for us to be able to get
those resources out to the States, and we currently do not have
those resources.
VACCINE DISTRIBUTION FUNDING
Senator Blunt. The best I could tell, there were no
resources provided in the HEROES Act in the House. In both the
bill we voted on in the Senate and the bigger bill we proposed
in the Senate, we had roughly $6 billion for distribution. Is
that the right number, or is that close to the right number?
Dr. Redfield. Senator, in my professional opinion, I think
you have got that really nailed. Somewhere between $5.5 million
and $6 million is what I think it is going to take to
distribute this vaccine.
Senator Blunt. And you do not have that money right now.
Dr. Redfield. No, sir.
Senator Blunt. And you need it to distribute the vaccine.
Dr. Redfield. I think it is as urgent as getting these
manufacturing facilities up.
Senator Blunt. I think I said in July--and you agreed--that
if you have the vaccine and do not have either the plan or the
resources to distribute it, that is a huge failure on the part
of the Congress to provide the resources that we know are going
to be necessary. I hope it is a part of whatever package we put
together this very month to be sure you have the capacity to do
that.
Senator Murray.
Senator Blunt. She may have gone to vote.
Senator Murray. Mr. Chairman, can you see me?
Senator Blunt. There you are. I see you now.
Senator Murray. Well, thank you so much. I appreciate it,
and I am just getting back to my desk here so hold on one
second.
Thank you very much. I appreciate it.
PUBLIC HEALTH CAMPAIGN
Listen, I wanted to follow up on Senator Shaheen's question
regarding HHS' $250 million contract for public service
advertisements to, quote, defeat despair and inspire hope amid
the coronavirus pandemic.
Based on comments made by Michael Caputo, it looks like the
administration intends to use a quarter of a billion dollars on
a massive media campaign to mislead the public, to actually
downplay the pandemic, and that is really unacceptable.
Congress provided these funds to fight COVID-19, not to support
any kind of campaign or reelection campaign.
Dr. Redfield, let me just ask you, can you clarify if CDC
was tapped to provide that funding?
Dr. Redfield. Thank you, Senator.
CDC received the direction from HHS and OMB (Office of
Management and Budget) to transfer $300 million to HHS ASPA.
Senator Murray. What role has CDC played in the award
process and developing that media campaign?
Dr. Redfield. We have not played a role. We were just, as I
mentioned, instructed by HHS and OMB to transfer the funds to
HHS ASPA.
Senator Murray. Well, then what role is CDC going to play
in making sure the messages put out will include accurate
public health information based on science?
Dr. Redfield. Again, Senator, at this moment, we have not
been involved other than given the directive from HHS and OMB
to transfer the funds.
Senator Murray. So funds only. You are not going to help
them with information to make sure it is accurate?
Dr. Redfield. Well, again, I would assume that they would
want our instruction to do all of that, but we have not been
involved in this other than the extent that the funds were
transferred to HHS ASPA. I assume that they are going to come
back to the different subject-matter experts, but again, we
have not been involved in that.
Senator Murray. Okay.
Dr. Giroir, what role are you going to play in making sure
the media campaign will only be used to disseminate public
health information based on science?
Admiral Giroir. Thank you, Senator.
I have not been involved in any discussions. I have only
been asked peripherally, which I think is the same campaign, to
be subject to questions and to have a dialogue about public
health issues. But I have not been involved in the development
of the content, the same way that Dr. Redfield mentioned.
Senator Murray. Do you think it is your role, either of
you, to weigh in to make sure this is accurate?
Admiral Giroir. I certainly believe that the CDC Director
has an important role in messaging, and I am the senior public
health advisor to the Secretary. So we certainly would welcome
the opportunity to help support the correct messages to the
American people. I do not mean to speak for Bob.
Dr. Redfield. Again, I would echo that, you know, if given
the opportunity, the CDC would obviously want to put forth the
accurate messaging for the American public.
VACCINE DISTRIBUTION
Senator Murray. Well, finally, Dr. Redfield, public health
groups have really raised the alarm that billions of dollars
are needed for vaccine distribution and administration. CDC
should be leading that effort, and I wanted to know what
activities should be included in a distribution campaign and
how you plan to make sure you are involved.
Dr. Redfield. Thank you very much, Senator.
I think it is critical. CDC does have the lead within
Operation Warp Speed. Again, the playbook that we put out is in
its version 1. It is going to go through, I am sure, iterations
as the States get involved and help improve the plan. And so
CDC is in the lead of working with the State and territorials
to do this.
As I mentioned, since the last time--I think it was June--
when you asked me and we really did not have funds, and we have
been able to leverage about $600 million to start some of the
most critical activity. But as I mentioned to the chairman just
a minute--now is the time. It is now. I mean, the rubber is
hitting the road now to get these 64 jurisdictions up to speed.
This is going to be a very resource-intensive distribution. We
have never tried to distribute a vaccine that has a cold chain
requirement like this one does, minus 80 degrees potentially
for one of the vaccines. And so we are prepared. We did meet
with five of the jurisdictions, North Dakota, California,
Minnesota, Florida, and Philadelphia, to go down to micro-
planning. So we got a pretty good idea. But now we are getting
the plans for the rest of the 61 jurisdictions. And it really
is going to require resources. These jurisdictions are not
going to be able to put these plans in place without resources.
Admiral Giroir. Senator Murray----
Senator Murray. Mr. Chairman, let me emphasize that
response because as we just heard, one of these vaccines is
going to require very cold storage. I think you said minus 60
or minus 80 degrees. Distribution across this country is going
to be extremely challenging, and we need to make sure the
resources are there and that it is planned at a national--has a
national plan for distribution and that communities that do not
actually have often access to healthcare really get access to
this and the distribution and storage and all the things that
go along with this is going to be very complex, will require
resources, and it, again, requires a national plan.
Senator Blunt. Thank you, Senator Murray. I could not agree
more. It is all about priorities, and this should be one of our
top priorities at this moment.
Senator Moran for the last question.
Senator Moran. Mr. Chairman, thank you for that courtesy.
And I know the second vote has been called.
LABORATORY SCALE UP
So this question is for the admiral, and I think it should
be brief, at least if I would start asking it. Admiral, we were
alerted just recently about an HHS request for information that
was posted. I think it was posted last week. It was soliciting
interests from laboratories that could scale up with additional
equipment from Thermo Fisher Scientific. Thermo Fisher is
located in Kansas, and just recently they had an expansion to
create more test tubes to do the test results.
Could you tell me what the ultimate plans are, assuming
that you receive interest from these laboratories, and more
specifically, what is the budget for this strategy? How many
labs do you intend to support, and how much more testing will
be accomplished?
Admiral Giroir. So let me just say first it was an NIH
solicitation, and we received information from about 27
universities that had interest.
Let me just say a top line piece particularly now is that
there are certain types of assays like Hologic, like Roche,
like Cepheid that are relatively flat, but there is a huge
supply of other outstanding assays, of which Thermo Fisher has.
They have a huge industrial capability. They have instruments.
They have everything that goes with it, soup to nuts, a full
Happy Meal, however you want to say it. So we are trying to
encourage laboratories around the country, including
universities, to use these because Thermo Fisher can make tens
of millions of high quality laboratory-based assays.
We have supplied some of these to private laboratories like
Sonic and Aegis, and we are trying to make sure that the
universities use what they have, but also if they need help, we
are happy to fund this. This is a relatively small amount of
money to get them the capability to do assays. And Thermo
Fisher has been really good to work with about really knocking
down the prices, particularly for surveillance.
So it is really another way to try to get the message out.
We talk of thousands of universities. But Thermo is just one of
those assets that we have a lot of. It is an excellent test. It
is a great company. We want people to use it.
Senator Moran. And too early to tell whether there is a
response, whether your outreach is having any effect?
Admiral Giroir. Seriously, probably three times a week we
match a major laboratory up with Thermo Fisher, getting their
instruments together with their supplies. So it is absolutely
having effect. Again, we have a lot of capability. We just want
to make sure that people understand where the capabilities are,
and Thermo is one of them.
Senator Moran. Admiral, thank you for your work.
Senator Blunt. Thank you, Senator Moran.
I think I am going to turn to Senator Alexander for a final
question, but before I do that, we are going to go vote. And I
want to thank all of you for being here. The country is
depending on all three of you to lead in these critically
important issues. As Dr. Redfield and one way or another all of
you have said this--we are at a critical moment in testing and
vaccines and therapeutics and distribution and prioritization.
All these things need to come to as much of a conclusion as
they can so we can move forward.
I think you have all been great witnesses today. There were
questions that were asked that were outside of your area of
responsibility, and of course, the proper answer to that is
that is not what I am doing every day and that is totally fine.
We are grateful for your time. I know this is a critical time
for all of you, and I am grateful to you for having been here.
Senator Alexander will mention that the record will stay
open for a week for additional questions, but we hope you will
respond as quickly as possible to those questions. We are
intensely involved in being your partner in this effort, but we
need to know what we need to do so we can do it and do it in
the right way.
Senator Alexander.
Senator Alexander [presiding]. Thank you, Mr. Chairman. And
thanks to Senator Blunt for being aggressive on all these
issues and leading especially in the area of support for the
maximum number of tests.
I do have some wrap-up questions.
VACCINE DISTRIBUTION
Dr. Redfield, I heard the questions that Senator Merkley
asked you about whether there was some invidious scheme in
asking the States to get ready to receive the vaccine, and you
said no, that it had been recommended.
Am I remembering right that when we had a problem with a
virus called H1N1 that the administration and the companies had
a vaccine to distribute, but the States were not ready to
receive it and that was a big problem. Is that right?
Dr. Redfield. Yes, Senator.
Senator Alexander. When was that?
Dr. Redfield. 2009, 2010.
Senator Alexander. And what happened.
Dr. Redfield. Well, I was not there, but we are very
fortunate to have the gentleman that was part of that and had
the opportunity to learn from all of the experiences now
leading our distribution for this to ensure that we do not have
the same hiccups. That is why I was stressing how important it
is for us now to be able to operationalize this plan.
Senator Alexander. Yes, more than a hiccup. I mean, it
would be a tragedy if we had vaccines ready and available and
we could not distribute them because no one had asked the
States to be ready.
Now, I believe you said, Dr. Kadlec said--I believe you
said that vaccines could be ready as early as November-
December. Is that correct?
Dr. Kadlec. Yes, sir.
Senator Alexander. And they would be ready in much larger
volume most likely after the first of the year and then on into
the second and third quarter. Correct?
Dr. Kadlec. Yes, sir.
Senator Alexander. And how long does it take a State to get
ready to manage the distribution of these vaccines and make
sure they go properly to the right people with the right
equipment at the right time?
Dr. Kadlec. I will defer to Dr. Redfield.
Dr. Redfield. Senator, I think this is why I have said it
is urgent. I mean, when we say that the vaccine could be ready
in November, you know, that is really 6 weeks away.
Senator Alexander. Yes.
Dr. Redfield. So it is really urgent that we operationalize
as rapidly as possible.
Senator Alexander. What do you suppose this committee and
many others would say to you if you had a vaccine ready in
November and December and you had not asked the States to get
ready to receive it?
Dr. Redfield. You would probably be recommending that I get
replaced.
Senator Alexander. I think so. I think so. So I think this
criticism of you and the professionals at the CDC for asking
States to get ready to receive the vaccine, when we know full
well that it is likely to begin to be available in November and
December, is very misplaced. And I appreciated your comments
and the way you handled them.
COVID-19 TRANSMISSIBILITY
A dentist told me that there is no evidence, Dr. Redfield,
of transmissibility of COVID-19 in a dentist office. Is that
true?
Dr. Redfield. I would not necessarily have stated that. I
think the dentist is probably going to say there has been no
proven transmission in a dentist's office.
Senator Alexander. So I was a little surprised by that. The
dentist said that dentists have a history of handling
infections all the time, all the way back to HIV, and so they
are trained to do that and they know how to wear protective
equipment and they know how to adopt practices.
Do you any of you know whether it is true that in other
parts of the world and the United States, there have been
problems with going to the dentist because of transmissibility
of COVID?
Dr. Redfield. I would just come back to the statement I
tried to make earlier. These masks work, and one thing you will
know about when you go to a dentist, everyone is masked up. So
I can say that we have not had evidence--outbreaks that we have
linked back to dentists. I am not going to say it will never
happen. But just like we reported recently, two hair salon
people that were highly infected--they went and did their work
to do, I think, over 150 people, but they wore masks. And there
was no evidence of transmission. So I keep coming back to the
importance of wearing masks.
Senator Alexander. And I have one last question, and I
understand Senator Murray would like to make a closing
statement or question. So I will go to her when I finish.
ASYMPTOMATIC TESTING
I want to go back to the CDC guidance on asymptomatic
testing, which you acknowledged has created confusion. And I
wonder what else you might be able to do to eliminate that
confusion. And let me tell you why I think it is important.
My feeling all along has been that it was a good idea to
produce tens of millions of rapid tests so that anybody who
wanted a test could get one basically. Now, from a medical
point of view, there is no reason to do that. But that is not
the only concern we have in the United States right now. I
mean, we would like to go back to school. We would like to go
back to college. We would like to go back to child care. We
would like to go back to work. We would like to go out to eat.
And if by frequent testing or surveillance testing or any of a
whole number of strategies that test a lot of people who do not
have symptoms, we build confidence that your school is a safe
place, your college campus is a safe place, that your child
care center is a safe place, that your workplace is safe, that
your restaurant is safe. If we build confidence, we will have
better lives.
And so it seems to me, particularly since Admiral Giroir
has said that we are now heading toward a situation where we
may have 120 million, 150 million tests a month, we are going
to have plenty of tests. We are going to have capacity for
plenty of tests. And by frequent tests, I mean what if a school
wanted to test every student at the beginning of school or at
the beginning of a week for 2 or 3 weeks just to make sure that
there was not some spreading and wanted to create a regime
where you do random testing--surveillance testing is I think a
word for it--of the kind of testing--when you go through the
airport, for example, they pull you out of line every now and
then and check to see if you have got explosives on your hands.
That makes us feel better when we get on an airplane that we
are not going to blow up. And so people fly, 2 million a day,
without worrying too much about getting blown up by passengers
with explosives on their hands.
The University of Illinois, as one of you have mentioned,
is I think testing twice a week. I think the University of
Illinois must have 40,000-50,000 students and faculty members
and staff on that campus. I know the President of Brown said
she wanted to test everybody before they came back. I can
imagine in a workplace that somebody would worry about working
next to somebody who is infected and worry they might have--
just be afraid that they might have COVID, and would it not be
a good idea for the manager to say come in here and take a 15-
minute test and you do not have it today? That is all that
means. Or you could say to all your employees we give you tests
if you are symptomatic, but we also give random tests on a
regular basis throughout the plant so you can have more
confidence when you come back to work.
So it seems to me that it is a good thing for our country
to have more tests than we need, more rapid tests than we need
so that anyone who wants a test can get one if they feel it is
necessary.
Now, I think once they know that they can, they will not
want one. And I think that is one reason we are seeing a lower
demand in other parts of the country because people understand
the limited value of a diagnostic test. It just tells you on
that one day whether you have it.
But this is a little bit of a long question, but what I am
trying to get around to, is there some way that the CDC could
clear up whatever confusion has been caused and make it clear
that since we now have such a large supply of tests, that
different strategies for testing people without symptoms is a
perfectly good idea and does not take tests away from
healthcare professionals or people in nursing homes or assisted
living or people like that? That clearly would help I think, as
we move into October, November, and December, to encourage
people to use this growing number especially of rapid tests
that we have to build confidence that the school, the college,
the child care center, the workplace, and the restaurant are
safe places to go regularly check, and that would help us
restore our economy. What could you do about clearing up the
confusion?
Dr. Redfield. Yes. I appreciate the comment, Senator.
First--there are three areas here, but I will be very
brief.
First is we are working on a clarification document related
to the diagnostic and public health use of testing. And again,
we have never recommended against asymptomatic testing. You
will see in the clarification it is very clear that we make it
very clear that asymptomatic and pre-symptomatic transmission
is important. We make it very clear that if you have been
exposed to somebody, you need to be tested and contact traced.
So that is going to come out hopefully--you know, I have done
my clarification statement 24 hours after, but it did not solve
the problem. So we are going to come out with that hopefully
sometime in the next--I hope before the end of the week.
Secondly--and the Admiral may want to comment--we are
working on guidance because in addition diagnosis--public
health, as you pointed out there is screening. And screening
can be very powerful for maybe non-public health reasons, maybe
getting us back to life and screening in schools, K through 12,
screening in universities, screening in business. So you will
see that CDC will be coming out, in conjunction with the
Admiral--we will be coming out with some guidance around
screening.
Then there is the other word that you used, which we also
believe is really important, which is surveillance where you
can actually systematically begin to look at random individuals
to get an idea is this outbreak starting to pop into a new
community.
So all three of those are important. All three of those you
are going to see that we are developing follow-up guidance for.
It really was not possible to really have a lot of that
guidance when there was no test.
Senator Alexander. Right.
Dr. Redfield. But as you point out, Admiral Giroir has
really done a yeoman's job with the private sector and really
has gotten to the point now so that we have--we are going to
try to clarify the clinical public health use. We are going to
try to give guidance to screening particularly in K through 12s
and universities, but it is also going to have a role in
businesses and also in entertainment activity like sports. And
then there is the other side of how to set up systematic
surveillance so that we do not get blindsided by all of a
sudden finding that there was a huge, new outbreak that we just
did not have eyes on until it got too big.
But, Admiral, do you want to----
Senator Alexander. Admiral, do you want to add to that?
Admiral Giroir. I just agree 100 percent with everything
that has been said. We are going to continue to invest in a
number of different types of platforms, but clearly low-cost,
ultra-available, sensitive and specific tests like the
BinaxNOW--and there are going to be more like that coming
through. And again, we are going to increase that supply as
much as possible. There also are going to be some new point-of-
care tests that are actually very sophisticated and very
sensitive and specific that could be layered on top of the
Binax. And our goal is to provide as many tools as possible in
the right domain so we could implement this type of guidance.
Again, in March, it does not make sense to talk about
random screening of children going to school because you did
not have that available. Now that we have a very robust
ecosystem of testing, this is the exact right time, which is
why we purchased 150 million of those card-based tests while we
have point-of-care and distributing them first to protect the
vulnerable, but then within a couple weeks, they are going out
to States to support school reopening and other infrastructure
according to their priorities. We are at that point.
DISTRIBUTION OF TESTS
Senator Alexander. Now, how many will be going out to
States in a couple of weeks? Could you give me a rough idea?
Admiral Giroir. So when Binax--when Abbott gets to their
full production capability, about 12 million per week, which
will be within a few weeks, we anticipate, depending on how
things go with the nursing homes, et cetera, somewhere between
5 million to 8 million per week going to States that we could
provide them for those needs. Again, if the cases continue to
go down in nursing homes, we will need less and less tests to
protect the nursing homes. If it stays high----
Senator Alexander. So that is 5 million to 8 million a
week?
Admiral Giroir. Yes, sir.
Senator Alexander. Well, 5 million to 8 million a week--
Tennessee is usually about 2 percent of everything. So that
would mean a State like Tennessee would be getting a few
hundred thousand tests a week or several hundred thousand tests
a month at least that the State could distribute according to
its priorities. Is that the general idea after you have--with
that 5 million to 8 million?
Admiral Giroir. Yes, sir. There is some policy discussion.
We certainly want to support the States but we think it is a
priority, as I know you do, to open education, K through 12,
even pre-school and potentially universities. But I think
universities are in a different class because they have
resources. So we do want to emphasize very strongly the
protection of teachers and the reopening of K through 12 as a
significant priority.
Senator Alexander. Well, I certainly do too. But some
States are doing some things; some States are doing others. I
think it is a good idea to reserve some of--first, I
congratulate the administration on buying the full 3 months'
supply of that which is, as I understand it, about 50 million
tests a month starting in October, with several million this
month, and then assigning it to the priorities like nursing
homes, et cetera, and then giving a lot to States, which would
be--I mean, if the State of Tennessee got 200,000 tests a week
that it knew it could distribute during the rest of this school
semester, my guess is many of them would go to schools because
the ones who are most worried about that are not the kids, it
is the teachers and the parents and the grandparents when the
kids go home. So I think that is a tremendously reassuring
prospect that a State might receive that many rapid tests just
from that source.
And, Dr. Redfield--and we will conclude with this because I
think Senator Murray does not want to say anything now. But one
time, you and I had a discussion about a guidance that used
examples. I think we talked about colleges, and I think you did
that. And maybe one way to help clarify the use of tests for
asymptomatic individuals would be to list five, six, eight, ten
examples of schools, colleges, workplaces that are doing that
now. That makes sense whether--and I will let you decide what
those might be, and it would not be only those things. But I
think if you said these are all the kinds of ways that this
large number of tests that we have may be used effectively and
sensibly to build confidence in going back to school, work,
child care, and out to eat. That might be easier for people to
read and understand than the words in a guidance. So the use of
examples is a suggestion I would make.
Dr. Redfield. I appreciate your advice, sir.
Senator Alexander. Thanks to the three of you. As Senator
Blunt said, we are grateful to you for your long hours, for
your effective work, for your planning. And if the money that
this appropriations subcommittee has targeted for you is not
forthcoming in the way the Congress intended for it to be, we
expect you to let Senator Blunt, Senator Murray, and others of
us on the subcommittee know that.
ADDITIONAL COMMITTEE QUESTIONS
The record will stay open for 1 week.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Admiral Brett Giroir, M.D.
Questions Submitted by Senator Roy Blunt
vaccine distribution
Question. Which agency is lead for managing the vaccine
distribution plan?
Answer. Operation Warp Speed (OWS) is a joint effort that utilizes
a whole-of-America approach that leverages the expertise and experience
of the Department of Health and Human Services (HHS) and the Department
of Defense. As the vaccine manufacturing process continues, the focus
of OWS moves to supporting the Centers for Disease Control and
Prevention (CDC) in planning and execution of the distribution and
administration of any Food and Drug Administration (FDA) approved or
authorized COVID-19 vaccine.
CDC has successfully utilized both public and private
infrastructure to deliver vaccines in the past, and the current
planning efforts within the CDC jurisdictional framework builds upon
the existing CDC structure in the distribution of COVID-19 vaccines. As
the distribution of these crucial life-saving vaccines begins, CDC will
execute the distribution plan.
Question. What assumptions is HHS making about the quantity of
vaccine that will be distributed in November and December?
Answer. Biological science is an unpredictable art, and the process
of developing an FDA licensed or authorized vaccine can involve
unanticipated issues. The highest standards of science drive the
decisions being made regarding these vaccines; this process results in
an imprecise timeline for vaccine approval. Currently, there are four
vaccine candidates in Phase III clinical trials and two additional
candidates approaching this critical milestone. All six of these
vaccine candidates are in the process of being manufactured at-scale.
Based on the data from these clinical trials, a vaccine
manufacturer will submit to FDA either a request for an Emergency Use
Authorization (EUA) or a Biologics License Application (BLA). After
authorization or licensure of a candidate vaccine, demand will most
likely outweigh supply, necessitating allocation of the limited number
of initially available doses. A prioritization policy will be informed
by the National Academies of Sciences, Engineering, and Medicine
(NASEM), and a formal recommendation by the independent Advisory
Committee on Immunization Practices (ACIP) that has been adopted by the
CDC Director.
reagent supply
Question. We have seen, firsthand, during the COVID-19 pandemic
supply shortages affecting the ability to do wide scale testing. In
particular, I'm concerned with the upcoming flu season we may continue
to experience strain on the supply chain for raw materials. Can you
discuss the importance of these raw materials if we need to ramp up
testing and what we are doing to address another sharp spike in demand?
Answer. To enable States to achieve the testing goals developed in
coordination with the Federal Government, the Federal Government has
worked with manufacturers to gain insight into diagnostic instrument
install bases; procured and shipped collection supplies; and determined
reagent inventory. The Federal Government then provided all information
to States so they could better determine how to optimize their testing
strategy. States, including the District of Columbia, selected large
cities and territories have now submitted two iterations of their
testing plans. These plans were developed in collaboration with Federal
multidisciplinary experts through teleconferences and other meetings.
Plans were reviewed by a multidisciplinary Federal team that included
leadership from CDC, the Immediate Office of the Secretary, and the
Office of the Assistant Secretary for Health. To ensure that
jurisdictions meet their testing goals, the Federal Government procured
swabs and transport media, and is distributing these supplies to a
single location in each State determined by the Governor or Mayor's
office. Starting in May and through September 11, the Federal
Government has distributed over 95 million swabs and more than 77
million tubes of transport media. These supplies were provided to
jurisdictions over the course of each month to equip them with
sufficient materials to meet their specific testing goals.
To further secure and galvanize the testing supply chain in the
United Sates, the Federal Government used the Defense Production Act
(DPA). One example of leveraging the DPA to increase the production of
supplies was the investment in Puritan Medical Products. After in-
depth market research on testing availability and producibility, the
Federal Government applied DPA title III authorities to award a $75.5
million contract to Puritan Medical Products to increase foam specimen
collection swab manufacturing capacity by 20 million swabs per month.
An additional swab requirement was identified for both COVID-19 and
influenza specimen collection; a second expansion investment of $51.15
million CARES Act funds in Puritan (the only U.S. based manufacturer of
flock tip swabs) to produce an additional 45 million flock tip swabs
per month. HHS is leveraging all authorities, including DPA title III,
to acquire additional testing capability. HHS has exercised title I DPA
authorities using the Health Resource Priority and Allocations System
(HRPAS) in order to prioritize contract action to compel a direct
response to the place of greatest need. A number of health resource
materials have been identified that are essential to respond to the
COVID-19 pandemic; however, these items, like PPE and ventilators, are
in high demand. Utilizing this authority has enhanced national
preparedness and is helping ensure there is product available if and
when it is needed.
Because the Federal Government has equipped jurisdictions with the
materials they need to meet or exceed their State testing plans each
month, the United States has conducted over 125 million COVID-19 tests
and capacity continues to increase. Since early March, we have
increased our daily testing by over 30,000 percent. These efforts and
the increased availability of point of care testing will ensure the
Unites States will be equipped to conduct the amount of testing needed
during flu season and if there is a spike in cases.
The supply chain for raw components and consumables, the
manufacturing capacity to produce diagnostic tests, and, in many cases,
the instrument systems needed to perform the tests are to a great
extent common for both SARS-CoV-2 and Influenza testing. Because
existing manufacturing capacity is operating at maximum for SARS-CoV-2
response, influenza testing with a separate test would reduce available
COVID-19 testing capacity. Foreseeing this issue, ASPR/BARDA, CDC, and
industry began work in the summer to develop multiplexed tests that
test for both SARS-CoV-2 and influenza simultaneously in one testing
action. Though there are a small additional amount of reagents needed
for these multiplexed tests, the majority of the components that are in
short supply (e.g. swabs, plastic consumables, pipette tips, etc.) can
be used for both tests and no additional supply is needed. These
multiplexed tests can also be performed in the same amount of time as
one single test so no testing capacity negative impact either. Three
multiplex tests ASPR/BARDA has funded have received emergency use
authorization (EUA) so far, CDC has developed and received an EUA for a
multiplexed test for public health lab use, and industry has developed
and received EUAs for an additional three multiplexed tests so far in
preparation for influenza season. More multiplexed tests are in
development.
Question. Admiral Giroir and Dr. Redfield, we all hope and expect
that the U.S. will develop a safe and effective COVID-19 vaccine first.
When that happens, what is our strategy for deploying this vaccine
internationally and how is its coordination being implemented? What
discussions have you had with other countries or international
organizations about the plan to ensure that a vaccine is distributed to
more countries than those that can produce them or afford to buy them?
Answer. CDC is building on its longstanding global immunization
efforts focused on polio, measles, influenza, and other priorities, and
is planning to use CARES Act funding to provide technical assistance
and help ensure select low- and middle-income countries are ready and
able to deploy and evaluate COVID-19 vaccines when they become
available. Through CDC country offices around the world, and through
headquarters-based subject matter experts, CDC is beginning to engage
international organizations and select low- and middle-income partner
countries to support these efforts.
The COVID-19 pandemic has demonstrated once again that infectious
diseases do not respect borders and threaten local, regional, and
global economies. Recognizing the critical role that medical
countermeasures play in controlling and ending a public health
emergency, especially in a pandemic, the U.S. Government remains
committed to working closely with partners overseas to mitigate the
impact of this devastating pandemic.
Question. Admiral Giroir, even though the Chinese have not yet
developed a safe and effective coronavirus vaccine, they have already
started a so-called charm offensive to provide access to a Chinese
vaccine to pro-Chinese nations as well as using it to repair damaged
diplomatic ties with other nations. What steps are we taking to counter
China's aggressive COVID-diplomacy? And how is the Department working
with USAID and the State Department on the international response?
Answer. HHS is working with other countries in the Indo-Pacific and
around the world to communicate U.S. values and to highlight successful
COVID-19 responses among friendly nations. Most significantly, in
August, Secretary Azar became the highest ranking Cabinet Secretary to
travel to Taiwan since the U.S. established diplomatic relations with
the People's Republic of China in 1979. His trip emphasized U.S.
support for Taiwan's role as a leader in COVID-19 response, as
evidenced by their transparent and highly effective evidence based
COVID-19 response and Taiwan's ability to access a COVID-19 vaccine
when a safe and effective vaccine becomes available. HHS also has been
working through regional bodies in Asia to support other like-minded
country responses and to counter Chinese narratives that falsely assert
their leadership in the global response to COVID-19. Misinformation and
disinformation have been serious problems throughout the pandemic,
especially regarding the development of COVID-19 vaccine candidates.
The urgent need exists to address and manage COVID-19 misinformation
and disinformation, and to continuously dispel myths and re-assert
facts with evidence.
provider relief fund
Question. Admiral Giroir, by my count, HHS has yet to announce how
$52 billion of the Provider Relief Fund will be allocated. Hospitals
need funding now. Can you outline how and when you think the remaining
resources will be distributed to providers?
I am concerned that HHS is holding back the Provider Relief funding
because you may be planning to transfer it to another account. Should I
be concerned?
Answer. From the very start of this pandemic, HHS has led a whole-
of-government, whole-of-America approach to defeating the virus. A
critical part of that work includes ensuring that our healthcare system
remains strong and financially viable during this unprecedented time.
HHS is distributing $175 billion to hospitals and healthcare providers
on the front lines of the COVID-19 response via the Provider Relief
Fund (www.hhs.gov/providerrelief).
HHS acted quickly to distribute the Phase 1 General Distribution
payments on a rolling basis beginning on April 10, 2020. These payments
were made to providers who billed Medicare on a fee-for-service basis
(Parts A or B) in Calendar Year 2019. For example, as of September 14,
2020, HHS has made 16,472 payments totaling more than $2.1 billion to
healthcare providers in Pennsylvania.
In June, HHS began making General Distribution payments to Medicaid
and Children's Health Insurance Program providers, dentists, and
assisted living facilities. HHS further expanded this Phase 2 General
Distribution to Medicare providers that have not received a full
payment, including Medicare Part A providers who experienced a change
of ownership in 2019 or 2020 that was approved by the Centers for
Medicare & Medicaid Services as of August 10, 2020. Phase 2 payments
are made on a rolling basis to providers based on approximately 2
percent of a provider's annual revenue from patient care. As of
September 14, 2020, HRSA has distributed more than $104 million to
2,191 providers in Pennsylvania as part of this distribution.
On October 1, HHS announced $20 billion for another General
Distribution allocation of the Provider Relief Fund. For this Phase 3
funding, applicants that have not yet received payments of 2 percent of
patient revenue will receive a payment that, when combined with prior
payments (if any), equals 2 percent of patient revenue. Phase 3
payments will also consider changes in patient care revenues and
increased expenses incurred related to the coronavirus. Providers will
have from October 5, 2020 through November 6, 2020 to apply for Phase 3
General Distribution funding.
Question. Beyond the General Distributions, HHS made several
Targeted Distributions to facilities and geographic areas that have
been particularly susceptible to lost revenue or increased healthcare
expenses as a result of the pandemic. Admiral Giroir, Congress
appropriated $175 billion for the Provider Relief Fund to make sure our
healthcare providers keep their doors open as coronavirus continues to
change how frequently patients go to their doctors. I want to
acknowledge the challenges the Department has faced in executing these
funds and the effort made to get funds to those who need it. At the
same time, I hear from many different providers, particularly
behavioral health providers, that they continue to have challenges
accessing funds. What more can HHS do to make sure all providers are
being treated equally and that providers that focus on mental health
services are not overlooked?
Answer. In the Phase 3 General Distribution, an expanded group of
behavioral health and other providers will be eligible for relief
payments. While behavioral health providers who participate in
Medicare, Medicaid, and Children's Health Insurance Program (CHIP) have
had the opportunity to apply for prior General Distribution payments,
others have not. Working with the Substance Abuse and Mental Health
Services Administration (SAMHSA), HRSA developed a list of the nation's
behavioral health providers now eligible for funding, which includes,
for example, addiction counseling centers, mental health counselors,
and psychiatrists.
Phase 3 will take into account documentation of the financial
impact of COVID-19 by assessing a provider's change in operating
revenues and expenses. The Phase 3 payment methodology also ensures
providers have received 2 percent of annual revenue from patient care.
Question. I applaud the Department's release of a comprehensive
Rural Action Plan earlier this month. It is important to note the
significant challenges rural communities face with regard to the
healthcare infrastructure and that nearly 1 in 5 Americans live in a
rural community. COVID-19 is only exacerbating the challenges facing
rural healthcare providers. Can you speak to the targeted distribution
of provider relief funds to rural communities and any ongoing gaps in
funding to rural healthcare providers? HHS has targeted $11 billion to
rural healthcare providers that is less than 10 percent of the Provider
Relief Fund. Can we anticipate another tranche of funding to rural
communities specifically and when would this occur?
Answer. HHS identified 4,460 organizations that were eligible for
the Rural Targeted Distribution. These organizations operate 11,640
healthcare delivery sites including 2,374 rural hospitals and critical
access hospitals, 383 hospitals in small metro areas or with Medicare
special payment designations, 4,655 Rural Health Clinics, and 4,228
Community Health Center sites in rural areas.
Rural providers were also eligible for other General and Targeted
Distributions. As of November 17, 2020, providers located in rural and
frontier areas received approximately $21 billion across all Provider
Relief Fund distributions.
At this point, HHS does not anticipate an additional Targeted
Distribution for rural communities. Providers in rural areas are
eligible to apply for Phase 3 General Distribution payments.
testing
Question. The Paycheck Protection Program and Health Care
Enhancement Act included over $8 billion to give flexibility to the
Administration to address future testing needs. How much of that
funding remains unspent? What is the plan and timing for allocation of
those resources? Why is HHS not spending this funding when we know that
testing is still in short supply across the country?
Answer. The testing infrastructure in the United States has been
galvanized and has reached unprecedented levels. The U.S. has conducted
over 125 million tests, at an average current rate of about 1 million
tests per day, with enough tests in the market to perform three to four
times that amount. Since early March, we have increased our daily
testing by over 30,000 percent. Turnaround time in providing test
results continues to improve. Currently, in the cases of 97 percent of
tests that were performed by American Clinical Laboratory Association
laboratories and that were ordered in the previous week, the
individuals received results within 3 days, and 99 percent received
results within 5 days. In June, July, and August, States far surpassed
their goals for testing. Specifically, State goals for June were 12.9
million tests, and nearly 16 million were actually performed. The goals
for July were 13.7 million tests; again, States far exceeded their
goals by conducting over 25 million tests. In August the nation
completed over 25.2 million tests, far exceeding the August goal of
21.1 million tests. The United States continues to conduct testing at a
large scale and as more point of care tests are developed and become
available, the testing capacity will continue to increase HHS continues
to leverage funds to support, grow, and drive the testing
infrastructure in the United States.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Admiral Giroir, I want to commend you for your efforts in
supporting the manufacturing of vaccine candidates to ensure a
sufficient supply upon approval. I believe a safe and effective vaccine
is the pathway for America's return to normal daily life. But there are
still people that are vulnerable to the virus who become infected and
could greatly benefit from a treatment. I think vaccines and
therapeutics can both be a priority. I understand that there are some
therapeutic candidates currently undergoing stage III clinical trials
that have shown promising results. Why is OWS not funding the
manufacturing of promising therapeutic candidates to prepare for the
winter season?
Answer. BARDA, in conjunction with OWS, has a strong ongoing effort
to support development of many therapeutic candidates. OWS and BARDA
are supporting platform clinical trials under the Accelerating COVID-19
Therapeutic Interventions and Vaccines (ACTIV) public private
partnership, which was announced in April 2020 by the National
Institutes of Health (NIH), and is being coordinated by the Foundation
for NIH. The five platform trials (ACTIV 1 through 5) allow for testing
multiple therapeutics in the same trial. This is the most efficient use
of funding and clinical resources, which have been stretched thin
throughout the pandemic response.
Individual funding awards to companies for research and development
have focused on candidate therapeutics with the highest likelihood of
success, such as the monoclonal antibody therapeutics that are being
developed using platform technologies that were established for other
pathogens like influenza and Ebola.
Additionally, the antibody testing and collection of convalescent
plasma has been a pillar of the OWS therapeutic response. While we are
still investing in randomized, controlled clinical trials to study the
safety and effectiveness of this investigational product, which was
issued an EUA, we are encouraged by the early results from the expanded
access protocol. The therapeutic portfolio will continue to evolve in
the coming weeks as results from clinical trials become available.
Lastly, OWS provided PPE and COVID-19 test capabilities critical to
the clinical teams executing therapeutics trials and staffed a
logistics support element dedicated solely to the advancement of the
therapeutics effort's clinical trial needs. That team is posturing to
deliver trial-site expansion capabilities to prospective test locations
to advance and accelerate their programs' subject enrollment.
______
Questions Submitted by Senator Patty Murray
unspent testing funds
Question. Admiral Giroir, 5 months ago Congress appropriated $25
billion to expand COVID-19 testing capacity through the Paycheck
Protection Program and Health Care Enhancement Act. To date, the
Department has yet to spend approximately $12 billion of this funding.
HHS' spend plans submitted to this committee outline comprehensive
testing-related activities focused on procurement and distribution, POC
diagnostics, serological testing, community based testing, and building
future capacity all from a large $8.3 billion flexible pot of funding
that was provided to the Department.
How much of the $8.3 billion in ``other activities'' funding
provided to HHS under the Public Health and Social Services Emergency
Fund through the Paycheck Protection Program and Health Care
Enhancement Act have been obligated?
Why, as States across the country grapple with trying to get this
virus under control, has HHS not spent more of these resources to build
up our testing capacity?
To date, none of the $1 billion provided for testing for the
uninsured has been obligated. Please explain why these funds continue
to languish in Federal coffers.
Answer. The testing infrastructure in the United States has been
galvanized and has reached unprecedented levels. The U.S. has conducted
over 125 million tests, at an average current rate of about 1 million
tests per day, with enough tests in the market to perform three to four
times that amount. Since early March, we have increased our daily
testing by over 30,000 percent. Turnaround time in providing test
results continues to improve. Currently, in the cases of 97 percent of
tests that were performed by American Clinical Laboratory Association
laboratories and that were ordered in the previous week, the
individuals received results within 3 days, and 99 percent received
results within 5 days. In June, July, and August, States far surpassed
their goals for testing. Specifically, State goals for June were 12.9
million tests, and nearly 16 million were actually performed. The goals
for July were 13.7 million tests; again, States far exceeded their
goals by conducting over 25 million tests. In August the nation
completed over 25.2 million tests, far exceeding the August goal of
21.1 million tests. The United States continues to conduct testing at a
large scale and as more point of care tests are developed and become
available, the testing capacity will continue to increase.
One example of leveraging funds to increase the amount of tests
available is the HHS procurement and distribution of point of care
tests. On August 27th, the Administration announced that a $760million
contract was awarded to Abbott for the delivery of 150 million rapid
BinaxNOW COVID-19 Ag Card point-of-care tests. This initiative will
expand strategic testing in the United States. The Abbott BinaxNOW
COVID-19 Ag Card, which recently received an EUA from the FDA, does not
require instrumentation and generally delivers COVID-19 test results in
15 minutes or less. This test uses nasal swabs and can be easily
deployed in many settings across the country.
______
Questions Submitted by Senator Jeanne Shaheen
expediting allocation of covid-19 testing funding
Question. Continued expansion of testing capacity and improved
contact tracing will be critically important to our effort to mitigate
the spread of COVID-19 this fall. That's why I'm concerned with the
slow pace at which HHS is distributing the $25 billion that Congress
provided in COVID-19 testing funding. It's been almost 5 months, and to
date, HHS has only allocated about half of the money.
Dr. Giroir, when will HHS distribute the rest of the testing
dollars?
Answer. As new technologies and opportunities arise, HHS will
allocate funds based on the needs of the United States and based on the
current data on the pandemic and the options available. The testing
infrastructure in the United States has been galvanized and has reached
unprecedented levels. The U.S. has conducted over 125 million tests, at
an average current rate of about 1 million tests per day, with enough
tests in the market to perform three to four times that amount. Since
early March, we have increased our daily testing by over 30,000
percent.
______
Questions Submitted by Senator Brian Schatz
Question. Why have daily testing numbers declined between the
summer and September?
Answer. As of October 13, 2020 the 7 day average for COVID-19 tests
has exceeded 1 million tests, and continues to grow. Since early March,
we have increased our daily testing by over 30,000 percent Daily
testing numbers continue to increase and the turnaround times are
continuing to improve as well. The United States has conducted over 125
million COVID-19 and with the investments made by the Federal
Government, the success in galvanizing the testing infrastructure in
the United States, and the introduction of new technologies, testing
numbers will continue to increase.
Question. At the hearing, Admiral Giroir stated that supply chain
issues have not played a role in declines in the number of new tests,
yet this is not consistent with the experience of labs in Hawaii, which
recently faced significant supply chain shortages of pipette tips and
test kits that meant they could not maximize their testing capacity. In
addition, a recent survey found that 67 percent of labs surveyed
reported issues getting test kits and reagents and that shortages had
recently become worse.\1\ Why did Admiral Giroir state that there are
no supply chain issues?
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\1\ https://www.wsj.com/articles/covid-19-testing-is-hampered-by-
shortages-of-critical-ingredient-11600772400.
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Answer. To enable States to achieve the testing goals developed in
coordination with the Federal government, the Federal government has
worked with manufacturers to gain insight into diagnostic instrument
install bases; procured and shipped collection supplies; and determined
reagent inventory. The Federal Government then provided all information
to States so they could better determine how to optimize their testing
strategy. States and territories have now submitted two iterations of
their testing plans. These plans were developed in collaboration with
Federal multidisciplinary experts through teleconferences and other
meetings. Plans were reviewed by a multidisciplinary Federal team that
included leadership from CDC, the Immediate Office of the Secretary,
and the Office of the Assistant Secretary for Health. To ensure States
meet their testing goals, the Federal Government procured swabs and
transport media, and is distributing these supplies to a single
location in each State determined by the Governor's office. Starting in
May and through September 11, the Federal Government has distributed
over 95 million swabs and more than 77 million tubes of transport
media. These supplies are provided to States throughout the month to
equip them with sufficient materials to meet their specific testing
goals.
To further secure and galvanize the testing supply chain in the
United Sates, the Federal Government has utilized the Defense
Production Act. One example of leveraging the DPA to increase the
production of supplies was the investment in Puritan Medical Products.
After in-depth market research on testing availability and
producibility, the Federal Government applied DPA title III authorities
to award a $75.5 million contract to Puritan Medical Products to
increase foam specimen collection swab manufacturing capacity by 20
million swabs per month. An additional swab requirement was identified
for both COVID- 19 and flu specimen collection; a second expansion
investment of $51.15 million CARES Act funds in Puritan (the only U.S.
based manufacturer of flock tip swabs) to produce an additional 45
million flock tip swabs per month. HHS is leveraging all authorities,
including DPA title III, to acquire additional testing capability. HHS
has exercised title I DPA authorities using the Health Resource
Priority and Allocations System (HRPAS) in order to prioritize contract
action to compel a direct response to the place of greatest need. A
number of health resource materials have been identified that are
essential to respond to the COVID-19 pandemic; however, these items,
like PPE and ventilators, are in high demand. Utilizing this authority
has enhanced national preparedness and is helping ensure there is
product available if and when it is needed.
Because the Federal Government has equipped States with the
materials they need to meet or exceed their State testing plans each
month, the United States has conducted over 125 million COVID-19 tests
and capacity continues to increase. Since early March, we have
increased our daily testing by over 30,000 percent. Turnaround time in
providing test results continues to improve. Currently, in the cases of
97 percent of tests that were performed by American Clinical Laboratory
Association laboratories and that were ordered in the previous week,
the individuals received results within 3 days, and 99 percent received
results within 5 days. These efforts and the increased availability of
point of care testing will ensure the Unites States will be equipped to
conduct the amount of testing needed during flu season and if there is
a spike in cases.
Question. Has the administration taken every step possible to ramp
up manufacturing of tests, including utilizing the Defense Production
Act to the fullest extent? Has the DPA been used to increase
manufacturing of pipette tips?
Answer. One example of leveraging the DPA to increase the
production of supplies was the investment in Puritan Medical Products.
After in-depth market research on testing availability and
producibility, the Federal Government applied DPA title III authorities
to award a $75.5 million contract to Puritan Medical Products to
increase foam specimen collection swab manufacturing capacity by 20
million swabs per month. An additional swab requirement was identified
for both COVID-19 and flu specimen collection; a second expansion
investment of $51.15 million CARES Act funds in Puritan (the ONLY U.S.
based manufacturer of flock tip swabs) to produce an additional 45
million flock tip swabs per month. HHS is leveraging all authorities,
including DPA title III, to acquire additional testing capability. HHS
has exercised title I DPA authorities using the Health Resource
Priority and Allocations System (HRPAS) in order to prioritize contract
action to compel a direct response to the place of greatest need. A
number of health resource materials have been identified that are
essential to respond to the COVID-19 pandemic; however, these items,
like PPE and ventilators, are in high demand. Utilizing this authority
has enhanced national preparedness and is helping ensure there is
product available if and when it is needed.
Information in regards to the use of the DPA as it relates to
testing and related materials can be found in the numerous National
Testing Strategy Reports to Congress that have been submitted.
Question. Why has HHS failed to obligate almost half of the $25
billion in funding that Congress appropriated for testing? When does
HHS plan to spend those funds?
Answer. The testing infrastructure in the United States has been
galvanized and has reached unprecedented levels. The U.S. has conducted
over 125 million tests, at an average current rate of about 1 million
tests per day, with enough tests in the market to perform three to four
times that amount. Since early March, we have increased our daily
testing by over 30,000 percent. Turnaround time in providing test
results continues to improve. Currently, in the cases of 97 percent of
tests that were performed by American Clinical Laboratory Association
laboratories and that were ordered in the previous week, the
individuals received results within 3 days, and 99 percent received
results within 5 days. In June, July, and August, States far surpassed
their goals for testing. Specifically, State goals for June were 12.9
million tests, and nearly 16 million were actually performed. The goals
for July were 13.7 million tests; again, States far exceeded their
goals by conducting over 25 million tests. In August the nation
completed over 25.2 million tests, far exceeding the August goal of
21.1 million tests. The United States continues to conduct testing at a
large scale and as more point of care tests are developed and become
available, the testing capacity will continue to increase.
One example of leveraging funds to increase the amount of tests
available is the HHS procurement and distribution of point of care
tests. On August 27th, the Administration announced that a $760 million
contract was awarded to Abbott for the delivery of 150 million rapid
BinaxNOW COVID-19 Ag Card point-of-care tests. This initiative will
expand strategic testing in the United States. The Abbott BinaxNOW
COVID-19 Ag Card, which recently received an EUA from the FDA, does not
require instrumentation and generally delivers COVID-19 test results in
15 minutes or less. This test uses nasal swabs and can be easily
deployed in many settings across the country.
To further secure and galvanize the testing supply chain in the
United Sates, the Federal Government has utilized the Defense
Production Act. One example of leveraging the DPA to increase the
production of supplies was the investment in Puritan Medical Products.
After in-depth market research on testing availability and
producibility, the Federal Government applied DPA Title III authorities
to award a $75.5 million contract to Puritan Medical Products to
increase foam specimen collection swab manufacturing capacity by 20
million swabs per month. An additional swab requirement was identified
for both COVID- 19 and flu specimen collection; a second expansion
investment of $51.15 million CARES Act funds in Puritan (the only U.S.
based manufacturer of flock tip swabs) to produce an additional 45
million flock tip swabs per month. HHS is leveraging all authorities,
including DPA title III, to acquire additional testing capability.
HHS is utilizing funds based on available technologies, data and
the needs across the country. We will continue to ensure that the
testing infrastructure throughout the country is supported and grows.
Question. Why hasn't HHS developed a national testing plan, which
States and public health experts have pleaded for?
Answer. HHS and the Federal Government have released numerous
documents enumerating and laying out the national testing plan. The
administration released the Opening Up America Again Guidelines:
Testing Overview on April 27, 2020 and on that same day the Opening
America Again Guidelines: Testing Blueprint was released. These
documents outline the test strategy early on in the pandemic and
several documents have followed that provided further detail. On June
15, 2020 the Addendum to the Testing Blueprint was released which
provided more details to the national testing strategy. Furthermore,
HHS submitted on May 24, 2020 the COVID-19 Strategic Testing Plan
Report to Congress, this 84 page document clearly lays out and provides
information about the national testing plan. On August 22, 2020 the
first update to the COVID-19 Strategic Testing Plan Report to Congress
was submitted. This first update to the report was 142 pages of
information about the national testing plan. On November 20, 2020 the
second update to the COVID-19 Strategic Testing Plan Report to Congress
was submitted. This second update was 22 pages of additional
information in regards to the national testing plan. All of these
documents have been made widely available to Congress, States, and the
American people.
The CDC has also released many testing related guidance documents
and technical assistance that further provide States and public health
experts with information on how to implement testing in a variety of
settings.
Question. How is it effective for States, cities, schools, and
other institutions to compete against each other and individually
manage testing resources?
Answer. To ensure States meet their testing goals, the Federal
Government procured swabs and transport media, and is distributing
these supplies to a single location in each State determined by the
Governor's office. Starting in May and through September 11, the
Federal Government has distributed over 95 million swabs and more than
77 million tubes of transport media. These supplies are provided to
States throughout the month to equip them with sufficient materials to
meet their specific testing goals and many States have continued to
exceed their testing goals each month. Equipping States with the
materials they need to meet or exceed their testing goals has reduced
competition for supplies and for the governors of each State to
determine how best to meet the needs of their State. Also, as stated
before, there are currently more tests in the market place to test
three to four times the amount typically tested each day.
On August 27, 2020, the Administration announced that a $760
million contract was awarded to Abbott for the delivery of 150 million
rapid BinaxNOW COVID-19 Ag Card point-of-care tests. HHS will
distribute approximately 100 million tests to States and territories
through the end of December 2020, distributed by proportion of their
population. Governors will determine the best use of tests for their
States; suggested deployment includes use cases for which a low-cost,
rapid, easily administered test is uniquely able to fill State needs,
such as opening of K-through-12 schools through testing of teachers,
staff, and students, protecting first responders, supporting critical
infrastructure, enhancing higher education programs, and other
priorities the governors deem fit. Overall, we have distributed over 58
million BinaxNOW tests to date.
Question. What is HHS' exact role in the allocation and
distribution of diagnostic tests and testing supplies from private
companies to labs across the country?
Does HHS instruct diagnostic and medical supply companies how to
allocate test kits and testing instruments? How are these decisions
made?
What improvements should HHS make in its testing distribution
process?
Answer. HHS has exercised title I DPA authorities using the Health
Resource Priority and Allocations System (HRPAS) in order to prioritize
contract action to compel a direct response to the place of greatest
need. A number of health resource materials have been identified that
are essential to respond to the COVID-19 pandemic; however, these
items, like PPE and ventilators, are in high demand. Utilizing this
authority has enhanced national preparedness and is helping ensure
there is product available if and when it is needed. Allocation and
prioritization, when used, are based off of data and where these
supplies are needed the most and decisions are made by the Coronavirus
Taskforce. Testing distribution is guided by the national testing
strategy and implemented by States based off of their testing plans
that have been reviewed by experts at HHS and CDC.
Question. At the beginning of the pandemic, did State public health
departments have adequate staff capacity, resources, and infrastructure
to respond to a crisis of this magnitude?
Answer. The COVID-19 pandemic put a spotlight on the needs and
disparities in public health infrastructure and highlighted the
importance of public health core capabilities across the country and
throughout the world. These core capabilities form the backbone of
CDC's capacity to protect America's health. A strong public health
system includes robust data and analytics, laboratory capacity, a top-
tier workforce, rapid response capabilities and a broad global
footprint to stop disease at its source. The Administration worked
closely with Congress to ensure that State and local public health
departments had necessary resources to respond to COVID-19.
Question. To what extent has the lack of investment in public
health increased spending, delays, and ultimately the loss of life as
health departments struggled to hire staff and upgrade technology
during the pandemic?
Answer. The COVID-19 pandemic put a spotlight on the needs and
disparities in public health infrastructure across the country and
throughout the world. The Administration worked closely with Congress
to ensure that State and local public health departments had necessary
resources to respond to COVID-19.
Question. Public health experts have proposed that key health
defense line items at CDC, BARDA, and NIH should not be subject to
annual budget caps in order to sufficiently invest in the country's
health security. Does HHS agree that this proposal would be beneficial,
and would it help us prepare for the next pandemic?
Answer. The structure of the President's Budget and current
Congressional appropriations does not contemplate excluding health line
items in HHS from annual budget caps.
______
Questions Submitted by Senator Joe Manchin, III
drug epidemic
Question. A majority of adults believe the pandemic is taking a
toll on their mental health and one in three adults report symptoms of
anxiety (up from one in twelve last summer). Reports of drug overdoses
are on the rise as well, triggered by the factors that are contributing
to mental health issues, with recent reports estimating that 75,000
Americans are at risk of drug overdose and suicide due to this
pandemic. Social isolation, increased anxiety, and economic and social
pressure have created what experts are calling a ``perfect storm'' for
suicide and substance misuse. West Virginia has been ravaged by the
drug epidemic and we already have some of the highest suicide rates in
the country. Now we are facing these two public health crises at the
same time as we combat the ongoing COVID-19 pandemic. What can we do to
help ensure patients suffering from substance use disorder get the
resources they need?
Answer. During the COVID-19 pandemic, normal resources that
individuals may use to manage treatment or distraction from harmful
substance using behaviors may no longer be available or have changed in
important ways (e.g., no face-to-face contact). Lockdowns, shelter-in-
place orders, and social distancing have forced treatment facilities,
social services, and support groups to shut down, reduce hours, or move
online-leaving people who use drugs and those in recovery to face
greater risks with less support. As CDC continues to work with states,
territories, and localities to provide technical assistance to identify
mitigation strategies. For example, one State is now using social media
and other virtual communications to message the importance of naloxone.
Harm reduction organizations, including syringe service programs
(SSPs) and facilities that provide medications for opioid use disorder
(MOUD), have had to adapt in the wake of this pandemic and change their
practices in order to continue to serve their clients. In response, CDC
is working to identify and support innovative and emerging practices.
Strategies will be summarized in technical assistance tools for
dissemination to partners.
CDC is also working to curb and lower substance use patterns and
attitudes among youth whose use has risen during COVID-19 CDC is
working with States engaged in Overdose Data to Action (OD2A), a 3-year
cooperative agreement that began in September 2019 and focuses on the
drug overdose epidemic, to respond to the realities of how their work
is changing in this environment. This includes assessing overdose data
and to understand trends in light of COVID-19, as well as working with
our 66 funded jurisdictions to provide flexibilities where needed and
technical assistance to inform public health action during the
pandemic.
CDC Foundation has collaborated on a new initiative, called How
Right Now, that addresses people's feelings of grief, loneliness,
stress, and worry during the pandemic. This initiative is managed by
NORC at the University of Chicago, with support from the CDC
Foundation. CDC is providing technical assistance. The initiative
offers information and resources (in English and Spanish) to help
people cope and be resilient during this time, including a
comprehensive suite of culturally appropriate materials from a variety
of national partners.
The current pandemic is unprecedented and it is likely to impact
the health, safety, and well-being of individuals and communities for
many years to come. The effects of emotional isolation, insecurity,
economic hardship, school closures, furlough, unemployment, and reduced
access to resources will translate into an array of emotional reactions
(such as distress or psychiatric conditions), unhealthy behaviors (such
as excessive substance use), and noncompliance with public health
directives (such as home confinement and vaccination) among people
directly and indirectly impacted by COVID-19. Extensive research in
disaster mental health has established that emotional distress is
ubiquitous in affected populations and that such times are associated
with increased rates of substance abuse and treatment relapse.\2\
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\2\ Brooks SK, Webster RK, Smith LE, et al. The psychological
impact of quarantine and how to reduce it: rapid review of the
evidence. Lancet 2020;395:912-920.
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Some groups may be more vulnerable than others to the psychosocial
effects of a pandemic. In particular, people who contract the disease,
those at heightened risk for it (including the elderly, people with
compromised immune function, and those living or receiving care in
group settings), and people with preexisting medical, psychiatric, or
substance use problems are at increased risk for adverse psychosocial
outcomes. Beyond this, mass home-confinement directives (including
stay-at-home orders, quarantine, and isolation) raise concern about how
people will react individually and collectively. A recent review of
psychological sequelae in samples of quarantined people and of
healthcare providers revealed numerous emotional outcomes, including
stress, depression, irritability, insomnia, fear, confusion, anger,
frustration, boredom, and stigma associated with quarantine, some of
which persisted after the quarantine was lifted.\2\ Specific stressors
include greater duration of confinement, having inadequate supplies,
difficulty securing medical care and medications, and resulting
financial losses.\2,\\3\ Such conditions are also known to potentiate
substance abuse or to be a risk factor for relapse.\4\ Moreover, social
distancing measures can limit access to meetings of peer-support groups
or other sources of social connection that are important to those in
recovery from substance use disorders.
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\3\ DiGiovanni C, Conley J, Chiu D, Zaborski J. Factors influencing
compliance with quarantine in Toronto during the 2003 SARS outbreak.
Biosecur Bioterror 2004;2:265-272.
\4\ Volkow ND. Collision of the COVID-19 and Addiction Epidemics.
Ann Intern Med. 2020;173(1):61-62.
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In recognition of these potential impacts, the Substance Abuse and
Mental Health Services Administration (SAMHSA) has not only provided
$425,000,000 in emergency grants and funding to the States and tribes
since the start of the pandemic, but it has also supported rules that
allow the provision and monitoring of evidence-based treatments through
telemedicine and remote platforms. SAMHSA has also issued new
regulations at 42 C.F.R. part 2 around the management of patients so
that treatment and services will not be substantially limited by
illness or quarantine measures.
In the current environment most psychosocial services, which are
increasingly delivered in primary care settings, are being offered by
means of telemedicine. In the context of COVID-19, psychosocial
assessment and monitoring should include queries about COVID-19-related
stressors (such as exposures to infected sources, infected family
members, loss of loved ones, and physical distancing), secondary
adversities (economic loss, for example), psychosocial effects (such as
depression, anxiety, psychosomatic preoccupations, insomnia, increased
substance use, and domestic violence), and indicators of vulnerability
(such as preexisting physical or psychological conditions). Some
patients will need referral for formal mental health evaluation and
care, while others may benefit from supportive interventions designed
to promote wellness and enhance coping (such as psychoeducation or
cognitive behavioral techniques). In light of the widening economic
crisis and numerous uncertainties surrounding this pandemic, suicidal
ideation may emerge and necessitate immediate consultation with a
mental health professional or referral for possible emergency
psychiatric hospitalization. State programs can support these
activities while also ensuring timely access to substance abuse and
mental health services.
Many of the experiences of patients, family members, and the public
can be compassionately normalized by providing information about usual
reactions to this kind of stress and by pointing out that people can
and do manage even in the midst of dire circumstances. Healthcare
providers can offer suggestions for stress management and coping (such
as structuring activities and maintaining routines), link patients to
social and mental health services, and counsel patients to seek
professional mental health assistance when needed. Such interventions
should be supported by consistent messaging across the public and
private sector while also providing reassurance.
Given that most COVID-19 cases will be identified and treated in
healthcare settings by workers with little mental health training, it
is imperative that assessment and intervention for psychosocial and
substance abuse concerns be administered in those settings. Ideally,
the integration of mental health considerations into COVID-19 care will
be addressed at the organizational level through State and local
planning; mechanisms for identifying, referring, and treating severe
psychosocial consequences; and ensuring the capacity for consulting
with specialists.\5\ To this end, education and training regarding
psychosocial issues should be provided to health system leaders, first
responders, and healthcare professionals. The mental health and
emergency management communities should work together to identify,
develop, and disseminate evidence-based resources related to disaster
mental health, mental health and substance abuse triage and referral,
the needs of special populations, and bereavement care. Risk-
communication efforts should anticipate the complexities of emerging
issues such as prevention directives, vaccine availability and
acceptability, and they should address a range of psychosocial and
substance abuse concerns. Mental health professionals can help craft
messages to be delivered by trusted leaders.\4\
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\5\ Pfefferbaum B, Schonfeld D, Flynn BW, et al. The H1N1 crisis: a
case study of the integration of mental and behavioral health in public
health crises. Disaster Med Public Health Prep 2012;6:67-71.
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The COVID-19 pandemic imparts both current and long-term
implications for individual and collective health, as well as emotional
and social functioning. Rates of substance abuse should not be looked
at in isolation, since they are linked to psychologic wellbeing,
community health and access to resources. In this way, the already
stretched health system has an important role in monitoring
psychosocial needs and delivering support to their patients, healthcare
providers, and the public. Such activities should be integrated into
general pandemic healthcare and delivered in a variety of settings and
through different platforms. An integrated approach between government
officials and health system leaders can facilitate this while also
creating the foundation for longer-term coordinated care platforms.
Question. What financial resources is HHS providing to our
behavioral health and recovery services to continue treating patients
during this time?
Answer. In one example, CDC provided $12 million to tribal-health-
serving consortia organizations to build public health capacity in the
COVID-19 response in preventing injuries and violence, focusing on
suicide, adverse childhood experiences, and intimate partner violence.
In addition, CDC is funding two projects to prevent substance use
during this COVID-19 pandemic, Novel Harm Reduction and Treatment
Strategies to Support Individual with Opioid Use Disorder and Youth
Substance Use and Messaging Development during COVID-19.
The Substance Abuse and Mental Health Services Administration
(SAMHSA) is a grant-making agency within the U.S. Department of Health
and Human Services (HHS) that leads public health efforts to advance
the behavioral health of the nation.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act
provided $425 million in funding to SAMHSA to address the mental health
and substance use disorder effects of COVID-19.
To date, SAMHSA has awarded $424,244,671 in Emergency Grants to
Address Mental and Substance Use Disorders during COVID-19 to the
following:
--Certified Community Behavioral Health Clinics (CCBHC COVID)
Expansion Grants totaling $249,657,910 to provide a
comprehensive range of mental health and substance use disorder
services to vulnerable individuals;
--Tribal Behavioral Health (TBH COVID) supplements totaling
$14,999,908 to meet the increased mental and substance use
disorders of tribes during the COVID-19 pandemic;
--Suicide Prevention Lifeline Crisis Center Follow-Up (CCF-COVID)
Expansion Grants totaling $2,978,828;
--Suicide Lifeline/Disaster Distress Helpline (SPH COVID) supplement
totaling $12,077,216 to support the Lifeline's use of text
messaging and expand access to the Lifeline's suicide
prevention services;
--COVID-19 Emergency Response for Suicide Prevention (ERSP) Grants
totaling $40 million to support States and communities during
the COVID-19 pandemic in advancing efforts to prevent suicide,
suicide attempts and domestic violence.
rural health
Question. In West Virginia, we have had 3 hospitals shut down this
year alone. Many more rural hospitals and health centers are operating
on shoestring budgets. Congress provided $175 billion to the Provider
Relief Fund to directly support health providers responding to the
pandemic. So far, only $11 billion has been allocated directly to rural
health providers. With 20 percent of Americans living in rural America,
their access to care is in jeopardy if their hospitals shut down. That
is why I have asked HHS to allocate at least 20 percent of the Provider
Relief Fund to rural providers. The Save Our Rural Providers Act is a
bipartisan, bicameral legislation targeting these funds to rural
providers who serve high rates or Medicaid and vulnerable patients. Are
there plans to direct more resources to our struggling rural providers?
Answer. Rural hospitals, many of whom were operating on thin
margins prior to COVID-19, have also been particularly devastated by
this pandemic. As healthy patients delay care and cancel elective
services, rural hospitals are struggling to keep their doors open.
Acknowledging these unique barriers, HHS distributed $11 billion
through two Rural Targeted Distributions.
Organizations that received these targeted distributions operate
11,640 healthcare delivery sites including 2,374 rural hospitals and
critical access hospitals, 383 hospitals in small metro areas or with
Medicare special payment designations, 4,655 Rural Health Clinics, and
4,228 Community Health Center sites in rural areas.
In addition to targeted rural distributions, rural providers are
also eligible for other General and Targeted Distributions. As of
November 17, 2020, providers located in rural and frontier areas
received approximately $21 billion across all Provider Relief Fund
distributions.
At this point, HHS does not anticipate an additional Targeted
Distribution for rural communities. Providers in rural areas may be
eligible to apply for Phase 3 General Distribution payments.
Question. What other actions is HHS taking to support rural health
providers in West Virginia and across America to prevent more hospitals
from shutting down?
Answer. As of October 5, 2020, West Virginia providers received and
attested to 2,615 Provider Relief Fund payments totaling
$622,122,647.10. Payments to rural providers account for 24 percent of
all attested payments in West Virginia. This includes 78 payments to
organizations operating 294 healthcare delivery sites under the Rural
Targeted Distribution totaling $152,080,433.20, as well as 13 payments
to hospitals under the Safety Net Hospital Targeted Distribution
totaling $192,273,920.32.
In May, HRSA made $225 million available to over 4,500 RHCs across
the country to support COVID-19 testing efforts and expand access to
testing in rural communities. In addition, under HRSA's Health Center
Program, 84 HRSA-funded health centers in West Virginia received COVID-
19 supplemental funding grants totaling $33,712,162.
In addition to grants and payments, HRSA also has three programs
that provide support to hospitals in West Virginia or other parts of
the country.
The Vulnerable Rural Hospital Assistance Program (VRHAP) provides
targeted assistance to at-risk rural hospitals struggling to maintain
healthcare services. VRHAP works with hospitals and their communities
to understand community health needs and resources, ensure hospitals
and communities can keep needed healthcare local, and address economic
challenges. Solutions may include assessing key healthcare services to
provide, identifying cost efficiencies, exploring other mechanisms to
meet community healthcare needs. This $800,000 per year award supports
one awardee to provide consultative support to five hospitals in depth
and 25 hospitals virtually in groups. A hospital in West Virginia is
part of the five selected for comprehensive support for the current
program year (Sept 2020-August 2021).
The Rural Healthcare Provider Transition Project is new in Fiscal
Year (FY) 2020. This project provides technical assistance to assist
eligible small rural hospitals and RHCs in strengthening key elements
of value-based care: quality, efficiency, patient experience, and
patient safety. Technical assistance will be designed to give hospitals
and RHCs a clear understanding of value-based care and the strategies
they can implement to be effective participants in a healthcare system
focused on value. This program will target hospitals and RHCs that are
not yet at the level to participate in value-based programs. HRSA
awarded $800,000 in 2020, with technical assistance to begin later this
year.
The Federal Office of Rural Health Policy in partnership with the
Delta Regional Authority administers the Delta Region Community Health
Systems Development Program. The program provides technical assistance
through comprehensive onsite consultations to eligible healthcare
facilities located in the 252 counties and parishes across eight States
served by the Delta Regional Authority. The program supports capacity
building for healthcare facilities around quality improvement,
financial and operational improvement, telehealth, community care
coordination, workforce, emergency medical services, and population
health.
covid testing
Question. National testing reports have consistently fallen far
below even the lowest estimated targets, and supply limitations and
lengthy test turnaround times continue to be an obstacle for frontline
providers and patients. HHS funding for expanded testing capacity has
helped to alleviate existing shortages but capacity remains
insufficient for a long- term, strategic response. Beyond the immediate
challenges, a successful national testing strategy must consider
medium- and long-term planning for capacity, including for supply
stockpiles, public health workforce and infrastructure, health system
preparedness, and more. How are CDC and ASPR supporting State and local
health departments to ensure they have adequate capacity for widespread
COVID-19 testing and what additional resources are required to increase
testing for all populations?
Answer. The majority of COVID funds CDC awarded to date--over $12
billion--has gone directly to States, tribes, territories, and
localities to support a wide range of COVID-19 response activities
including testing, reporting data, contact tracing, personnel, and
health department readiness and coordination. These funds also help
health departments respond to current COVID-19 outbreaks and prepare
for future outbreaks, including supporting accelerated laboratory
testing, data collection, and real- time reporting to CDC for
identification and tracking of COVID-19 cases in the community, as well
as supporting implementation of COVID-19 community intervention plans.
CDC also works with State, tribal, local, and territorial health
departments to provide guidance, detect and investigate cases,
implement mitigation measures, identify needs for surge staff, develop
new resources and tools, support epidemiologic investigations and data
analysis efforts, and more.
local health department funding
Question. Congress has appropriated billions of dollars for COVID
response to State and local health departments. So far, funding has
gone out to States and territories that are either battling outbreaks
of the virus or at risk for an outbreak. However, since many
communities are dependent on States to pass through Federal dollars,
there are vast inconsistencies across the country with Federal funds
making it to local health departments to support this response. For
example, in my home State of West Virginia, 50 percent of our local
health departments only have 90 days of cash on hand, and 13 percent
have only 30 days of cash hand. What can CDC do to ensure in the future
that local health departments have the resources they need to protect
the public from COVID-19?
Answer. The majority of COVID funds CDC awarded to date--over $12
billion--went directly to States, tribes, territories, and localities
to support a wide range of COVID response activities including testing,
reporting data, contact tracing, personnel, and health department
readiness and coordination. CDC has, and will continue to, encourage
States to support their local health departments with these
supplemental funds.
______
Questions Submitted to Bob Kadlec, M.D.
Questions Submitted by Senator Roy Blunt
chinese vaccine and international strategy
Question. Dr. Kadlec, the U.S. has invested in several strong
contenders in the race to get a vaccine. However, of the eight vaccines
in Phase III trials, half are Chinese. That makes it entirely possible
that a Chinese vaccine could be the first to succeed. What happens if
China gets the vaccine first?
Answer. The U.S. Government is focused on developing a safe and
effective vaccine as quickly as possible. It is not a competition.
Through Operation Warp Speed (OWS), the U.S. Government has invested in
multiple COVID-19 candidate vaccines using different platform
technologies, so that we have the best chance of securing at least one
safe and effective COVID-19 vaccine for the American people. Of the
four Chinese-developed vaccine candidates currently in Phase 3 trials,
three are developed using an inactivated SARS-CoV-2 platform, which
some researchers feel has a higher potential of significant safety
concerns, including antibody- dependent enhancement of disease. For
this reason, OWS has deliberately chosen not to invest in vaccine
candidates that are developed using this platform, including
inactivated vaccine candidates from companies outside China. Under OWS,
we also continue to increase our domestic manufacturing capacities for
COVID-19 vaccines, to maintain availability of a reliable vaccine
supply for the American people.
We are aware that several of the Chinese-developed vaccine
candidates have been used outside of clinical trials to vaccinate
individuals in China and the United Arab Emirates under their
respective emergency use programs. Russia approved a vaccine candidate
before large-scale phase 3 safety trials of the vaccine had been
completed, with several countries planning to acquire the vaccine.
Making such vaccines available to the public prior to completion of
clinical trials is a risky approach when data on safety and
effectiveness are still pending that could set back confidence in
vaccines everywhere and damage the global fight against COVID-19.
vaccine development
Question. Dr. Kadlec, both the HEALS Act and the targeted
supplemental that received a majority of votes in the Senate last week
provides an additional $20 billion to BARDA to continue investing in
vaccine manufacturing and purchasing. HHS has reached agreement to
purchase roughly 100 million doses of various vaccine candidates.
Knowing that HHS is nearly out of funding specifically appropriated for
vaccine manufacturing and purchase, are you concerned that HHS does not
have the resources from such accounts to purchase vaccine in the event
that only one or two candidates are successful?
When do you need additional funding to avoid delays in either
vaccine, therapeutic, or diagnostic development, manufacturing, or
purchase?
Answer. To accelerate the development and subsequent production of
a vaccine for COVID-19, in mid-May, President Trump announced Operation
Warp Speed (OWS), which aims to deliver up to 300 million doses of a
safe and effective vaccine for COVID-19 in early 2021. OWS is a
partnership among components of the Department of Health and Human
Services (HHS), including the Centers for Disease Control and
Prevention (CDC), the National Institutes of Health (NIH), and the
Biomedical Advanced Research and Development Authority (BARDA), and the
Department of Defense (DoD), with the aim of a unified government
approach to respond to the pandemic. OWS engages with private sector
partners and other Federal agencies, including the Department of
Agriculture, the Department of Energy, and the Department of Veterans
Affairs.
BARDA supported early research and development for five of these
candidates prior to OWS and has continued and expanded these
partnerships to include large-scale prototype manufacturing. Unlike the
typical sequential vaccine development pathway, which can take up to 10
years, the U.S. Government is asking its industry partners to develop
and manufacture their vaccine candidates in parallel to rapidly
accelerate this process into less than 1 year. Rapid acceleration of
manufacturing while clinical trials to test the safety and efficacy of
candidate vaccines are still underway is a financially high risk
proposition. To mitigate this risk for our partners, multi- billion
dollar investments were required to secure the necessary manufacturing
capacity for drug substance and fill-finish capacity for final drug
products as well as to secure the supply chain needed to produce
hundreds of millions of vaccine doses. The U.S. Government has
contracted with its partners for 100 million doses of the Moderna,
Janssen, Pfizer, Novavax and Sanofi/GSK vaccines and 300 million doses
of the AstraZeneca vaccine at the Government's financial risk. Once the
safety, efficacy, and large-scale manufacturability of one or more of
the candidates are confirmed, the Government may procure additional
vaccine doses to ensure enough doses are available for every American
who wishes to be vaccinated.
Specific to manufacturing efforts, OWS continues to analyze and
engage domestic pharmaceutical manufacturing and fill/finish capacity
across the vaccines landscape. OWS is also identifying suppliers of
secondary items for administration of any authorized or licensed
vaccines, and providers of pharmaceutical distribution to ensure
sufficient capacity exists once products have been granted FDA EUA or
licensure/approval. HHS is procuring secondary items (syringes, needles
and other ancillary supplies) and investing in the expansion of
domestic manufacturing capacity while countermeasures are still in
clinical development to maximize domestic supply chains and ensure that
the American people are poised to receive safe and effective vaccine(s)
as soon as possible.
HHS has accelerated the availability of diagnostics for the COVID-
19 response. ASPR/BARDA is funding established and newly emerging
diagnostics test manufacturers to develop COVID-19 diagnostic tests,
which has resulted in more than 45 million tests being available to
test Americans. ASPR/BARDA, with the assistance of DoD, is working to
expand domestic manufacturing capacity with many of these diagnostics
developers to further increase the rate that tests are available. One
company that ASPR/BARDA funded to develop a SARS-CoV-2 test was just
awarded a DoD/OASH contract to increase manufacturing capacity to over
100,000 tests per day for use in non-traditional testing sites.
therapeutic development
Question. Dr. Kadlec, the Committee has provided $6.5 billion to
BARDA for the development and manufacturing of vaccines, therapeutics,
and diagnostics. As I said in our last hearing on COVID-19 and during
this hearing, our priority should be vaccine development,
manufacturing, and distribution. However, we should not put all our
eggs in one basket. Until every American who wants a vaccine receives
one, we need to have readily available treatments for those who are
sick. But it appears that the vast majority of the money we provided to
BARDA has gone to vaccines. What is the plan for therapeutics
development? Why is there not more focus on this area? Is it because
you're lacking resources or because it is lacking priority?
Answer. BARDA, in conjunction with OWS, has a strong ongoing effort
to support development of many therapeutic candidates. OWS and BARDA
are supporting platform clinical trials under the Accelerating COVID-19
Therapeutic Interventions and Vaccines (ACTIV) public private
partnership, which was announced in April 2020 by the National
Institutes of Health (NIH), and is being coordinated by the Foundation
for NIH. The five platform trials (ACTIV 1 through 5) allow for testing
multiple therapeutics in the same trial. This is the most efficient use
of funding and clinical resources, which have been stretched thin
throughout the pandemic response.
Individual funding awards to companies for research and development
have focused on candidate therapeutics with the highest likelihood of
success, such as the monoclonal antibody therapeutics that are being
developed using platform technologies that were established for other
pathogens like influenza and Ebola.
Additionally, the testing and collection of convalescent plasma has
been a pillar of the OWS therapeutic response. While we are still
investing in randomized, controlled clinical trials, we are encouraged
by the early results from the expanded access protocol. The therapeutic
portfolio will continue to evolve in the coming weeks as results from
clinical trials become available.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Kadlec, we are in the middle of the worst pandemic in
a century. You predicted this, but you thought it was going to be the
flu just as so many in public health did. Can you speak for a minute or
two on your thoughts on our current state of pandemic flu preparedness
and whether you think we have the medical countermeasures, public
health infrastructure, and perhaps most importantly sustainable
resources our nation needs to help prevent what is likely an inevitable
influenza pandemic that could happen 5 years from now, or 5 months from
now.
Answer. ASPR's priorities include helping to meet the requirements
of Executive Order (EO) 13887, Modernizing Influenza Vaccines in the
United States to Promote National Security and Public Health, signed by
President Trump on September 19, 2019. Influenza is a very serious
threat to human health and poses a significant national security risk,
it leads to hundreds of thousands of hospitalizations, placing a
significant strain on our healthcare system. Mitigating the impact of
both seasonal and pandemic influenza is critical to saving lives and
reducing economic and healthcare burdens. To mitigate such risks, EO
13887 requires accelerated vaccine development of faster, more scalable
platforms to expand domestic manufacturing. Consistent with the EO,
ASPR promotes the modernization of facilities and infrastructure in
ways that expand the domestic manufacturing capacity for non-egg based
vaccines and adjuvants. ASPR is dedicated to advancing the development
of broad-acting antivirals, transition to near-patient or in- home
diagnostics, and addressing gaps in capabilities.
The National Influenza Vaccine Task Force-established by the EO
13887 and co-chaired by Secretaries of Defense and Health and Human
Services-published the National Influenza Vaccine Modernization
Strategy 2020-2030. This ten-year strategy prioritizes U.S. Government
efforts toward (1) strengthening domestic advanced manufacturing of
influenza medical countermeasures, (2) promoting innovative
technologies to detect, prevent, and respond to influenza, and (3)
increasing influenza vaccine access and coverage across all
populations. The Task Force-with representation from the Departments of
Health and Human Services, Agriculture, Defense, Homeland Security,
Justice, State, and Veterans Affairs, and the National Security
Council-is responsible for implementation of the strategy through an
iterative process. The Task Force has identified short-, mid-, and
long-term activities necessary to accomplish the above priorities, and
will consult with State, local, tribal, and territorial government
officials as well as industry leaders as appropriate to coordinate
actions. Progress will be reported to the White House on an annual
basis.
ASPR's investments in pandemic influenza preparedness to date have
made our nation significantly prepared for an outbreak. These include:
--Built dual-purpose infrastructure and capabilities that were
utilized to support the COVID-19 response;
--Developed a standard process to rapidly develop vaccine banks for
different production platforms. As a result, multiple vaccine
seed stocks are readily available for rapid vaccine production
as the need arises, including against H5N1, H5N6, and H7N9;
--Developed and purchased H5N1, H5N6, and H7N9 influenza bulk vaccine
antigen (the component of vaccine that stimulates the human
immune system) for the National Pre-Pandemic Influenza Vaccine
Stockpile (NPIVS);
--With FDA licensure, developed new seasonal and pandemic influenza
vaccines using modern cell- and recombinant-based production
technologies to expedite and expand domestic production
capacity;
--Supported improved assessment of the relative effectiveness of
newly licensed influenza vaccines produced in cell cultures or
recombinant platforms as compared to traditional egg- based
vaccines; Advanced the development of sensitive diagnostic
tests to detect influenza viruses that can be used in near-
patient settings, and high-throughput diagnostics capable of
detecting influenza strains at hospital-based, reference, and
public health laboratories;
--Developed, tested, and stockpiled new antigen-sparing adjuvants
that are required for vaccines to stimulate sufficient immunity
and decrease the amount of antigen needed in each vaccine dose
for the vaccine to be effective;
--Expanded the surge capacity of domestic vaccine manufacturing,
while increasing its flexibility to help manufacture pandemic
influenza vaccines as quickly as possible;
--Supported development of new technologies that will help influenza
vaccines become available faster than currently possible in
response to a pandemic or other public health emergency;
--Conducted clinical trials for stockpiled and newly manufactured
adjuvanted H5N1 and H7N9 vaccines in response to an emerging
pandemic;
--Supported development of broad-spectrum monoclonal antibodies,
host-targeted therapeutic drug candidates, and small molecule
antivirals with novel mechanisms of action--when compared to
currently licensed influenza antiviral drugs these candidates
have shown activity against drug-resistant influenza viruses
and are currently under evaluation in phase two and phase three
clinical trials;
--To significantly increase the supply of respirators available
during an influenza pandemic, supported the development of
technology and processes that promote rapid production of N95
respirators;
--Supported the development through FDA authorization of next-
generation portable ventilators needed for a surge in
hospitalized patients of all ages during a pandemic;
--Supported development of re-usable elastomeric respirator masks;
--Responded to the 2017 H7N9 influenza threat, with production,
stockpiling and clinical trial testing of vaccine antigen for
H7N9 influenza vaccine from the 2016-2017 Yangtze River Delta
virus lineage candidate vaccine virus provided by CDC. ASPR
worked with partners to improve preparedness at the local,
State, and international levels, including:
--Improved technical knowledge and capacity for manufacturing in
developing countries in order to increase global pandemic
influenza vaccine capacity;
--Conducted surveillance, research, and international collaboration
on policies, plans, and training;
--Provided risk communication to improve public understanding of
the actions that individuals, businesses, and organizations
can take to protect the public from emerging infectious
diseases, including those with pandemic potential;
--Supported development, through FDA authorization, of point-of-
care clinical diagnostics;
--Increased stockpiling of vaccines, next-generation ventilators,
and medical supplies, including adjuvants and antiviral
drugs, and,
--Through capacity expansion and support of adjuvant production,
enabled development of additional seasonal influenza
vaccine products.
All of these investments have led and contributed to innovative
technologic advancements for pandemic influenza MCMs including, inter
alia, cell-based and recombinant vaccine technology, vaccine adjuvants,
advanced development and manufacturing, and vaccine surge capacity.
The rapid vaccine development response to COVID-19 has, further,
revealed the value of new manufacturing technologies. We may be nearing
the dawn of a new era in response capability if the ``genetic
vaccines'' whose development is being supported by Operation Warp Speed
prove to be safe and effective, because these production approaches can
be applied to pandemic influenza.
______
Questions Submitted by Senator Patty Murray
antivirals for influenza
Question. Dr. Kadlec, as devastating as the coronavirus pandemic
has been to date, the situation could get even worse this fall and
winter, when the nation is expected to face a ``twindemic'' of COVID-19
and the annual influenza season. If the nation could--to the extent
possible--mitigate the impact of flu, that would greatly improve our
ability to address COVID-19's second wave. Flu vaccinations are, of
course, a critical component of that strategy, and I commend ASPR for
allocating additional funding to procure vaccines. You have stated many
times that we also need significantly more antivirals, especially for
high- risk populations, to treat influenza.
How much funding does ASPR need to procure a sufficient number of
antivirals for this flu season?
Does ASPR currently have the necessary funding on hand--either in
emergency or regular annual funds--and at the President's fiscal year
2021 request level?
Answer. ASPR/BARDA supports efforts to address the threat of a
pandemic influenza. While these efforts generally augment the annual
influenza response, ASPR/BARDA does not procure or support the
development of antivirals for the common flu. Rather, ASPR/BARDA is
supporting innovative manufacturing capabilities to rapidly manufacture
and produce vaccine for an influenza event, as well as novel
technologies to enhance such production (such as cell-based
technologies).
The commercial market for influenza antivirals can support the
needs of a typical influenza season. If we have a pandemic level event,
there are millions of influenza antiviral treatment courses in the
Strategic National Stockpile (SNS). SNS resources can be activated if
the commercial market cannot keep up with demand.
The SNS lacks diversity in its influenza antiviral stockpile A
diverse antiviral stockpile will allow the U.S. Government to respond
if the pandemic virus is resistant to any one mechanism of action.
ASPR/SNS seeks to maximize the value of the SNS appropriation in
collaboration with the Food and Drug Administration (FDA) through the
Shelf Life Extension Program (SLEP). In December 2019, prior to the
COVID-19 pandemic, the FDA reviewed pertinent data and agreed to extend
the shelf life for some influenza antivirals for use during emergency
responses. This action represents a significant cost avoidance in
fiscal year 2020 and beyond, as large volumes of SNS held antivirals
approaching final expiration in 2019 and 2020 will remain viable for
additional years without replacement. In addition, pending availability
of funding in fiscal year 2021, SNS plans to expand its holdings of
antivirals to respond to pandemic influenza.
rapid diagnostics
Question. Dr. Kadlec, the availability of point-of-care and over-
the-counter tests would allow people to be screened for COVID-19 easily
and quickly by yielding results in minutes instead of days. In short,
if these kinds of tests were reliable and widely available, they would
be game-changing for our testing capacity. BARDA currently has 29
diagnostics in its COVID-19 countermeasure portfolio and some of them
offer rapid point of care options that require no equipment,
processing, or refrigeration, and can be deployed in homes or the
workplace to deliver lab quality results in minutes.
How much of the $16 billion that has been spent by BARDA for
developing medical countermeasures against COVID-19 has gone toward
diagnostics?
Answer. ASPR has obligated approximately $370 million on
diagnostics to date.
Question. How much of the $16 billion has gone toward therapeutics
and vaccines?
Answer. ASPR has obligated approximately $15.7 billion on vaccines
and therapeutics to date.
Question. Could rapid antigen tests obviate some of the supply
chain issues that have emerged with processing molecular PCR tests?
Answer. Rapid antigen tests (RATs) would obviate some supply chain
issues that are being experienced with molecular tests, such as
shortages of pipette tips, but shortages of other supplies (like swabs
and viral transport medium) are also applicable to RATs.
Question. How does HHS plan to address any new or unique supply
chain issues that emerge with rapid antigen tests?
Answer. ASPR is working with the Joint Acquisition Task Force to
reduce supply chain issues for diagnostics tests. This includes
investments in manufacturing capacity for swabs, viral transport media,
and pipette tips.
Question. How does the cost of running the traditional molecular
PCR test for coronavirus compare to one of these rapid antigen tests?
What is the estimated cost per test for each of them?
ows spend plan
Please provide a detailed obligations table and spend plan of
obligated and anticipated uses of any appropriated supplemental funds
made available for Operation Warp Speed by HHS, including estimated
personnel and administrative costs and contract obligations that exceed
$5,000,000. Please include any inter-agency transfers or IAAs of funds,
and a breakdown of medical countermeasure activities by therapeutics
and vaccines.
Answer. Please see attached PDF labeled, ``QFR OWS--Contracts Over
$5 million.'' Note, the response was drafted as of the date of the
hearing (i.e. September 16, 2020).
______
Question Submitted by Senator Jeanne Shaheen
Question. Dr. Kadlec, has anyone from the White House or HHS asked
the companies or researchers participating in Operation Warp Speed to
seek FDA review of the company's vaccine candidate by a certain date or
time on the calendar?
Answer. No. We are adhering to and following all required
regulatory and safety requirements required for vaccine development. We
are not sacrificing the safety of the vaccine in order to expedite its
development.
______
Questions Submitted by Senator Brian Schatz
Question. What are the key steps in setting up the vaccine
distribution network, and what is the status of each step?
Answer. OWS, through the CDC, is establishing a central
distribution network through the McKesson Corporation, our primary
distributor under contract. The key steps in establishing the network
are bringing into operation the McKesson facilities that will
distribute COVID vaccines and supporting ancillary supply kits. Select
facilities will be ready to conduct operations in November 2020, and
all will be operational no later than early in 2021. Additionally,
States and Territories are in the process of identifying the locations
to which vaccines will be distributed and from which they will be
administered. The initial versions of these plans were completed and
submitted to the CDC from all jurisdictions in mid-October 2020.
Question. Do we currently have sufficient amounts of all of the
equipment and materials needed for vaccine administration--such as
syringes, glass vials, and refrigerators? How will those materials be
distributed to States?
Answer. Supporting and securing an adequate supply of ancillary
products is a collaborative, interagency effort.
Specific to securing needles and syringes, to date, BARDA has
awarded four large task orders for such products. Going forward, BARDA
will support additional solicitations, in coordination with the
Strategic National Stockpile (SNS), to maximize the availability of
needles and syringes toward the end of 2020. BARDA and the DoD Joint
Program Executive Office for Chemical, Biological, Radiological, and
Nuclear Defense (JPEO-CBRND) CBRND, on behalf of HHS, have awarded
three agreements to increase needle and syringe capacity in the United
States for the future, some of which will be available in time to
support the COVID-19 vaccination in early 2021. Lastly, BARDA and JPEO-
CBRND, on behalf of HHS, have awarded agreements with two domestic
manufacturers of vials to increase production capacity of vials to
support multiple vaccine candidates.
To specifically support domestic manufacturing efforts for active
pharmaceutical ingredients and other essential medicines, May 19, 2020,
BARDA announced a $354 million four-year contract with Phlow
Corporation and its partners-including CivicaRx, Virginia Commonwealth
University's Medicines for All Institute, and AMPAC Fine Chemicals. The
partnership with Phlow allows flexibility in selecting and prioritizing
active pharmaceutical ingredients and finished drugs for manufacturing
to allow for rapid response to situations such as the current COVID-19
public health emergency. Phlow's criteria for prioritizing APIs and
finished drugs for early manufacturing are based on data on essential
medicines shortages that have been exacerbated by COVID-19-associated
increases in hospitalized patients.
Projected administration sites include pharmacies, public and
private clinics, hospitals, and doctor's offices, the vast majority of
which have refrigerated storage capacity. Jurisdiction planning that is
currently ongoing will further refine potential administration sites to
identify those that are planned for use for both refrigerated and
frozen vaccines. All jurisdictions have submitted vaccine distribution
plans or playbooks to CDC. Executive summaries have been published
here: COVID-19 Vaccination Program Operational Guidance (cdc.gov). OWS
and CDC continue to provide technical assistance to all jurisdictions
to ensure initial readiness for vaccine allocations. There is no
identified need, or current plan, to acquire and distribute
refrigerators to jurisdictions.
______
Questions Submitted to Robert R. Redfield, M.D.
Questions Submitted by Senator Roy Blunt
Question. How much has CDC obligated in supplemental resources for
this effort? Please provide by specific activity. How much does CDC
have available to spend for this purpose?
Answer. As of October 1, 2020, more than $500 million has been
invested in the COVID-19 vaccination effort to support distribution,
vaccine safety and effectiveness, and investment in tracking systems.
On June 4, 2020, CDC awarded $140 million to 64 jurisdictions through
CDC's existing immunization cooperative agreement to enable State
including the District of Columbia, tribal, local, and territorial
health departments to enhance their immunization programs, including
launching an initial scale-up for influenza season, given the increased
risk of COVID-19. On September 23, 2020, CDC also awarded $200 million
to 64 jurisdictions through the existing Immunizations and Vaccines for
Children cooperative agreements. These funds, along with the previous
support CDC has provided, will help jurisdictions plan for and
implement COVID-19 vaccination services. In addition, CDC invested $180
million in a centralized depot for distribution of 200 million
refrigerated vaccine doses and $21 million in vaccine safety
surveillance ramp up.
Question. What deadline has CDC established for the Federal
Government to be ready to roll out all of the requirements necessary
for successful vaccine distribution and administration?
Answer. Based on early data from OWS that vaccine could be
available in November, CDC had asked that all jurisdictions be prepared
to distribute initial doses of vaccine to prioritized populations by
November 1, 2020.
Question. Dr. Redfield, on April 28th, President Trump issued an
Executive order under section 101(b) of the Defense Production Act to
``take all appropriate action under that section to ensure that meat
and poultry processors continue operations consistent with the guidance
for their operations jointly issued by the CDC and OSHA.'' How will CDC
take into account industries like meat and poultry processors
specifically, but any industry deemed critical generally, into their
vaccination distribution plan?
Answer. CDC is planning for the many logistical considerations
involved in implementation of COVID-19 vaccination. After FDA
authorization or approval of a COVID-19 vaccine, ACIP will review and
provide its recommendations to the CDC Director for adoption. Within
this recommendation, ACIP may prioritize certain groups of the
population, such as essential workers (including those working in the
food industry), while COVID-19 vaccines are limited. The National
Institute for Occupational Safety and Health at CDC will assist with
dissemination of information to all Americans, including essential
industries and workers via well-established partnerships, and with
development of customized communications materials. CDC also plans to
help with development of workplace-specific guidance and will conduct
surveillance to track vaccine uptake in various occupational groups.
Question. Some poll results show that anywhere between 25-35
percent of Americans have no interest in getting a vaccine which could
be a major setback to protect Americans from this virus. Specifically,
what steps has the CDC taken to engage community groups, physicians,
and the general public about the importance of being vaccinated?
Answer. Understanding public confidence in any and all vaccines is
necessary for promoting high vaccine uptake, and CDC is adapting its
strategic framework, Vaccinate with Confidence, to strengthen public
trust in COVID-19 vaccines. The framework emphasizes three key
priorities: reinforcing communication to the public about the vaccine's
rollout and its safety and benefits, empowering healthcare providers to
communicate effectively with patients about the vaccine and engaging
with individuals and communities. Because COVID-19 affects so many
aspects of society, CDC is engaging with a wide breadth of community
groups, local partners and stakeholders, and trusted messengers to
conduct communications about the vaccine development process and roll
out, promote vaccine uptake with a focus on priority populations, and
increase confidence in the vaccine. Building confidence is inherent to
all our work, and CDC will continue to build upon the investments of
our immunization program as we prepare both the nation's public health
system and the private sector to disseminate a safe and effective
COVID-19 vaccine.
As COVID-19 vaccine developments continue, CDC is working with OWS
to ensure community groups, healthcare providers, and the general
public receive the most up to date guidance and data on available
prevention measures that can help reduce COVID-19 infection and spread.
Adapting from approaches used with past coronavirus-related threats,
CDC will work with its public health partners to deliver resources on
COVID-19 vaccine that assist physicians with proper vaccine
administration and enhances public confidence in COVID-19 vaccine
uptake.
Question. What are CDC goals for getting Americans vaccinated in
2021? Given that less than half of Americans took a seasonal flu
vaccine last year, what percentage of the population is CDC targeting
to have received the vaccine by this time next year?
Answer. While influenza vaccination is always important, getting
vaccinated this season is more important than ever, especially for
people who are at higher risk of exposure or serious complications from
influenza and COVID-19. Co-circulation of the viruses that cause COVID-
19 and influenza could place a tremendous burden on the healthcare
system and result in many illnesses, hospitalizations, and deaths. In
addition to prolonging the influenza vaccine season into spring 2021,
CDC is working across various fronts to increase influenza vaccination
coverage. CDC's goal is that 70 percent of adults ages 18 years and
older are vaccinated annually against seasonal influenza.
Vaccine manufacturers are maximizing the available number of doses
for all age groups to accommodate increased demand. CDC is projecting
this will increase available doses to 194-198 million this season,
about 12 percent more than last year. CDC has also purchased an
additional two million pediatric and 9.3 million adult doses of
influenza vaccine to enhance coverage in under-served and under-
vaccinated communities. This includes optimizing the use of federally
procured vaccine through promotion of influenza vaccination within the
Vaccines for Children program and expanding partnerships to increase
vaccine utilization by community health centers. A critical component
of the effort is to ensure that parents who are newly unemployed are
informed about the Vaccines for Children safety net program that
provides access for uninsured or underinsured children.
seasonal influenza
Question. Dr. Redfield, what efforts are currently underway at CDC
to improve seasonal influenza vaccination?
Answer. While flu vaccination is always important, getting
vaccinated this season is more important than ever, especially for
people who are at higher risk of exposure to or serious complications
from flu and COVID-19. Co-circulation of COVID-19 and flu could place a
tremendous burden on the healthcare system and result in many
illnesses, hospitalizations, and deaths. In addition to vaccine
manufacturers maximizing the available number of doses for all age
groups and CDC purchasing additional doses of influenza vaccine, CDC is
working across various fronts to increase influenza vaccination
coverage.
Regarding the focus on high-risk patient categories and other
critical populations (e.g., healthcare workers), CDC collaborated with
CMS to develop an additional module in CDC's National Healthcare Safety
Network (NHSN) for long-term care facilities' (LTCF) resident and
healthcare practitioner influenza vaccination reporting data. The
module adapts the current NHSN module used by acute care facilities for
healthcare practitioner influenza vaccination reporting. Currently, all
CMS-certified nursing homes ( 15,400) already use the existing NHSN
LTCF component for other required weekly COVID-19 reporting. CDC also
updated and augmented the LTCF Flu Vaccination Toolkit for posting on
the web and dissemination to partners.
CDC is leveraging a number of new and existing partnerships to
promote influenza vaccination among communities of color. For example,
CDC is working with the Million Hearts Campaign to address
sociodemographic disparities in influenza vaccines among adults with
Atherosclerotic Cardiovascular Disease. CDC is also collaborating with
partners to explore strategies to reduce racial and ethnic disparities
in adult immunization. Additionally, this year's flu communication
campaign will be enhanced through a partnership with the American
Medical Association and the Ad Council and include messaging tailored
to African American and Hispanic audiences as these groups have lower
rates of flu vaccination, but higher risk for COVID-19 complications.
While CDC is updating guidance and providing messaging toolkits to
partners, engaging local communities and leveraging trusted messengers
at the ground level will be critical to expanding coverage.
Question. The HEALS bill included $500 million to bolster CDC's
efforts to increase seasonal influenza vaccination rates. How would CDC
us those resources for seasonal influenza and why are they needed
sooner rather than later?
Answer. If additional funds were appropriated, CDC would allocate
them consistent with the purpose outlined in relevant appropriations
language. In this case, additional funds would support CDC's work to
increase seasonal influenza vaccination coverage.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Redfield, Do you anticipate additional support for
State governments to support and implement COVID-19 vaccine mass
administration once effective and safe vaccines are available in large
numbers?
Answer. Yes.
Question. Dr. Redfield, I have been hearing from a lot of my
constituents that they have concerned with coronavirus vaccines being
developed using aborted cell lines. From what I understand, there are
several candidates moving along the process some using ethical sources
and others using aborted cell lines. I know the need for getting a
vaccine to market as quickly as possible but the pro-life community
does very much care about if the vaccine is ethically sourced. Are
Federal funds being used to develop coronavirus vaccines that use
aborted fetal cell lines?
If so what are those specific trials and what is their status?
Answer. President Trump announced Operation Warp Speed (OWS) to
accelerate the development and subsequent production of a vaccine for
COVID-19. OWS aims to deliver up to 300 million doses of a safe and
effective vaccine for COVID-19 in early 2021, as part of a broader
strategy to accelerate the development, manufacturing, and distribution
of COVID-19 vaccines, therapeutics, and diagnostics (collectively known
as countermeasures). This unprecedented action by the Administration
means we are closer than ever before to having a vaccine for COVID-19
in the coming months.
Because there are no guarantees of successful development of any
particular vaccine, and vaccines may impact populations differently, it
is only prudent to pursue a number of vaccine candidates.
With this in mind, we would like to emphasize that, as an
Administration, we are proud to have the highest commitment to
protecting the life of the unborn through our policies across the
departments. HHS and the Trump Administration have taken multiple steps
to protect life, and one clear action relevant to this discussion is
the policy we announced last year with regard to the use of fetal
tissue in research. NIH-employed scientists may no longer use fetal
tissue from elective abortions in their research. Research grants made
by NIH to outside institutions and scientists follow a statutory policy
requiring an ethics advisory board comprised of individuals who are not
Federal employees to review new grant applications or current research
projects in the competitive renewal process that propose to use fetal
tissue and recommend whether, in light of the ethical considerations,
NIH should fund the research.
Among the COVID-19 vaccine candidates being developed by the seven
companies which are receiving Federal support (both through OWS and
BARDA), five companies do not use any cell lines developed from human
fetal tissue from elective abortions. These candidates are vaccines
being developed by Moderna, Pfizer, Novavax, Sanofi, and Merck.\6\ Two
of the companies receiving Federal dollars use established fetal cell
lines in their vaccine candidates. Those vaccine candidates are from
Jansen/Johnson & Johnson and AstraZeneca.
---------------------------------------------------------------------------
\6\ The Merck vaccine has received support only through BARDA.
---------------------------------------------------------------------------
The Department's support for the development of COVID-19 vaccines
is consistent with the Administration's policy on the use of human
fetal tissue from elective abortions in research. The policy
specifically excluded ``already-established (as of June 5, 2019) human
fetal cell lines (e.g. induced pluripotent cell lines from human fetal
tissue, immortalized cell lines, differentiated cell lines).'' Both
AstraZeneca and Jansen/Johnson & Johnson use such ``already-
established'' human fetal cell lines.
Scientific evidence will determine the FDA's approval of any
vaccine, but with five of the seven vaccine companies not using fetal
cell lines in the development of their vaccine candidates, we are
hopeful we will see an option for individuals who do not wish to take a
vaccine that has been developed with human fetal tissue from elective
abortions. Part of the OWS strategy has been to plan for approval of
more than one vaccine, knowing that different vaccines may work better
in specific populations.
Question. Dr. Redfield, as we look at this seasons flu campaign,
CDC is taking special efforts increase vaccination rates among higher
risk populations for Covid-19 and/or flu-related complications. As I
understand it the CDC recently purchased as many as 9 million flu
vaccine doses to target these at-risk populations. Can you speak for a
minute or so on how CDC plans to ensure the unprecedented number of
influenza doses, over 190M manufactured and under distribution will be
administered? What efforts are planned to drive an extended season
campaign?
Answer. CDC has a strong vaccine delivery infrastructure connecting
public health departments, healthcare providers, community groups,
pharmacists/chain drug stores, and others that can be used to
efficiently reach the population. During an emergency, this proven
system can be scaled up and expedited to manage and distribute many
more doses of vaccine than in a typical year.
CDC is enhancing communications efforts to target special
audiences, including older Americans, people of any age with underlying
health conditions, workers in long-term care facilities, and other
essential workers. Targeted communication and education efforts will be
implemented for African American and Hispanic/Latino communities as
these groups have lower rates of flu vaccination, but higher risk for
COVID-19 complications. CDC is testing flu vaccine messages to learn
what impacts the pandemic may have on the intent to vaccinate,
including fears about getting vaccinated in a safe environment, and CDC
will continue to work with our public health and clinical partners to
eliminate barriers to vaccination. CDC has expanded outreach to
populations at high risk of severe COVID-19 by working with new and
existing partners, including leveraging existing partnerships with the
National Association of Community Health Centers (NACHC) and State and
local immunization programs to distribute 9.3 million supplemental
influenza vaccine doses to those seeking care at community health
centers.
Congress's recent investments through the Coronavirus Aid, Relief,
and Economic Security Act (CARES Act) have allowed CDC to provide its
immunization awardees $140 million in supplemental funding to support
and enhance their immunization programs.
In addition, CDC has been working with influenza vaccine
manufacturers to maximize influenza vaccine supply; CDC is projecting
this will increase available doses to 194-198 million this season,
about 12 percent more than last year. CDC is also increasing the length
of the vaccination season through the duration of flu season, into
spring 2021. CDC also purchased an additional 2 million pediatric doses
and 9.3 million adult doses to enhance influenza vaccine coverage in
under-vaccinated communities. This includes optimizing the use of
federally procured vaccine through promotion of influenza vaccination
within the Vaccines for Children (VFC) program and expanding
partnerships to increase vaccine utilization by community health
centers.
CDC is providing increased support and resources for immunization
programs and partners, including disseminating guidance for safe
immunization services, encouraging vaccination where it is most
convenient to maximize vaccine uptake, and developing and disseminating
guidance for planning vaccination clinics held at satellite, temporary,
or off-site locations.
Question. What is the outreach plan to these communities to reach
your stated goal of 65 percent total flu vaccination this year which is
so important?
Answer. CDC will be working with the National Association for
Community Health Centers to implement evidence-based strategies to
increase adult vaccination coverage among underserved priority
populations. CDC will engage in individual expert consultation to
develop strategies for addressing racial and ethnic disparities in
adult immunization by soliciting simultaneous individual expert
opinions from 15 national leaders in health disparities, health equity,
and social determinants of health.
CDC is also working with Vaccines for Children program providers to
ensure they are prepared for a potential increased number of eligible
children due to the economic impact of the pandemic. Children and
adults with private insurance should be able to access the flu vaccine
at no cost if they are seen at in-network providers.
CDC is also enhancing its efforts in promoting influenza
vaccination in high-risk populations. CDC collaborated with CMS to
develop an additional module in CDC's National Healthcare Safety
Network (NHSN) for long-term care facilities' (LTCF) resident and
healthcare practitioner influenza vaccination reporting data. The
module adapts the current NHSN module used by acute care facilities for
healthcare practitioner influenza vaccination reporting. Currently, all
CMS- certified nursing homes ( 15,400) already use the existing NHSN
LTCF Component for other required weekly COVID-19 reporting. CDC also
updated and augmented the LTCF Flu Vaccination Toolkit for posting on
the web and dissemination to partners.
With respect to communities of color, CDC is leveraging a number of
new and existing partnerships to promote influenza vaccination. For
example, CDC is working with the Million Hearts Campaign to address
sociodemographic disparities in influenza vaccines among adults with
Atherosclerotic Cardiovascular Disease. CDC is collaborating with
partners to speak with Health Equity Directors to explore strategies to
reduce racial and ethnic disparities in adult immunization.
Additionally, this year's flu communication campaign will be enhanced
through a partnership with the American Medical Association and the Ad
Council and include messaging tailored to African American and Hispanic
audiences as these groups have lower rates of flu vaccination, but
higher risk for COVID-19 complications. While CDC is updating guidance
and providing messaging toolkits to partners, engaging within local
communities and leveraging trusted messengers at the ground level will
be critical to expanding coverage.
Question. Additionally, how do you plan to monitor influenza
vaccine doses administered assure we are on track in real time, and do
you need additional resources for to collect data from each State
Immunization Information Systems (IIS) program to collect State and
national aggregate numbers of doses administered?
Answer. Data sharing through vaccine tracking is a critical
component of CDC's COVID-19 vaccination initiative. CDC is actively
working to improve the data infrastructure needed to better track
vaccines, vaccination, and related information. For example, the
Immunization Gateway is a data exchange hub that routes messages
between State immunization registries and multi-State providers and
allows consumers to access their immunization record. The support of
the COVID-19 vaccine response requires significant enhancement of the
Gateway's infrastructure and rapid onboarding of State immunization
registries and multi-State providers. Enhancements and data exchange
are critical for a multi-dose candidate to ensure proper administration
of the second dose.
Question. Dr. Redfield, the flu and Covid-19 look very similar and
most public health experts believe that Covid-19 and influenza will
circulate widely this upcoming fall and winter. What are your views on
how medical professionals can further distinguish flu diagnoses from
Covid-19 diagnoses?
Answer. Because some of the symptoms of flu and COVID-19 are
similar, it may be hard to tell the difference between them based on
symptoms alone, and testing may be needed to help confirm a diagnosis.
CDC has developed a new diagnostic laboratory test (multiplex PCR
assay) to assist with efforts to determine if an individual is infected
with SARS-CoV-2, the virus that causes COVID-19. The diagnostic test
can identify three viruses: Influenza A, Influenza B, and SARS-CoV-2.
Although flu and COVID-19 share many characteristics, there are some
key differences between the two. While more is learned every day, there
is still a lot that is unknown about COVID-19 and the virus that causes
it. This table compares COVID-19 and flu, given the best available
information to date.
Question. What will CDC's guidance be on things like antivirals for
instance--will someone with influenza and COVID like symptoms be
advised to get an antiviral by default?
Answer. CDC developed guidance for clinicians during times when
influenza viruses and SARS-CoV-2 are in co-circulation. The guidance
includes information on testing to help distinguish between influenza
virus infection and SARS-CoV-2 infection and provides information about
initiating empiric antiviral treatment for influenza in priority
groups. People who fall into priority groups include hospitalized
patients with respiratory illness; outpatients with severe,
complicated, or progressive respiratory illness; and outpatients at
higher risk for influenza complications who present with any acute
respiratory illness symptoms (with or without fever).
Question. Do we have enough antivirals to achieve that?
Answer. CDC is in regular contact with influenza antiviral
manufacturers regarding supply and other issues. There are currently no
major market shortages of antiviral drugs for treatment of influenza
being reported. CDC provides information on antiviral drug supply on
our website and will update as needed with respect to influenza
antiviral supply this season.
______
Questions Submitted by Senator Patty Murray
guidance to child care centers
Question. Child care providers are confused by conflicting public
health guidance that CDC has provided to date and are waiting for
concrete actions and practices they can take to keep children and staff
safe. While a CDC study of reopened childcare centers in Rhode Island
showed that resuming operation at a time of low community spread can
successfully limit new coronavirus cases, providers still need clear
guidance on how to translate health and safety precautions that have
become widely accepted for adults to young children. Dr. Redfield, I
sent you a letter with dozens of other lawmakers on this topic last
month.
It's now mid-September, 7 months into the pandemic. Why haven't you
already issued comprehensive guidance for child care centers?
When is the CDC going to issue this guidance?
Answer. CDC has developed guidance to assist childcare centers:
(www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/
guidance-for-childcare.html). In part, this guidance includes
considerations to help childcare programs promote behaviors that reduce
the spread of COVID-19 and maintain healthy environments, as well as
monitor and prepare for absenteeism among staff. CDC will update this
and other resources as new evidence becomes available.
In addition, CDC collaborated with the Administration for Children
and Families (ACF) within HHS on the development and periodic updating
of the CDC guidance for childcare providers. ACF has also shared the
CDC Foundation's webinar, Adapting, Evolving, and Thriving: Tools to
Evolve Your COVID-19 Child Care Strategy (https://
childcareta.acf.hhs.gov/covid-19-resources), to their partners and
grantees. This webinar provides strategies for childcare providers to
make evidence-based, actionable decisions, grounded in the CDC
guidance, to keep staff and children safer in childcare programs
regardless of provider type.
CDC recognizes that there is no one-size-fits-all national solution
for childcare providers during this time. Differences exist among types
of childcare providers, and local contexts vary in terms of the levels
of transmission of COVID-19 and community mitigation strategies that
may already be in place. Many other factors, such as socioeconomic
status, the availability of personal protective equipment and supplies
and childcare staffing capacity, including the health status and age of
individual providers, also shape decisions about how to safely reopen
and continue the operation of childcare programs.
As childcare providers think about how and when to open or have
questions about operating during this time, we encourage them to
consult State and local health officials and their local childcare
licensing agency for data on community transmission, as well as support
for implementing mitigation strategies and other guidance to promote
the health and safety of children, staff, and their community.
As more data becomes available and our scientific understanding of
COVID-19 evolves, CDC is committed to sharing additional evidence-
informed guidance to childcare program administrators, staff, and
families to help keep them as safe and healthy as possible.
______
Questions Submitted by Senator Jeanne Shaheen
ensuring vaccine review and distribution is free of political pressure
Question. Dr. Redfield, last month, you told governors to prepare
for distribution of a COVID-19 vaccine by November 1st. Yet, Dr. Moncef
Slaoui, the chief advisor for Operation Warp Speed, said that this
timeline is ``extremely unlikely'' and public health experts make it
clear that despite President Trump's predictions, a vaccine may not be
available on election day.
Dr. Redfield, what is CDC doing right now to build trust with the
American people and ensure that science and public health--not
politics--is dictating decisionmaking for distributing and
administering a vaccine?
Answer. CDC continues to fulfill its mission as a data-driven,
science-based agency. Our scientists are working 24/7 to respond to the
current COVID-19 pandemic, and we are proud of the long history of
scientific integrity in our guidance and our publications.
CDC will receive recommendations regarding any potentially licensed
or authorized COVID-19 vaccine from both the Advisory Committee on
Immunization Practices (ACIP) and the National Academies of Science,
Engineering, and Medicine (NASEM).
As outlined in our Vaccination Program Interim Playbook, published
on September 16, 2020, we have prepared a vaccination program
communication designed to build trust and confidence in the process,
and to guide jurisdictions including State, local, and tribal partners
to share useful, actionable information with their constituents:
--We recognize the importance of messaging through partners and
trusted sources,
--We emphasize key crisis communication principles: be first, be
right, be credible, express empathy, and show respect,
--We describe the different phases of communication that will be
required through the vaccine rollout process, and
--We encourage development of culturally relevant and sensitive
messages.
recent changes in ppe assistance from fema
Question. Dr. Redfield, I am deeply concerned with the
administration's decision to stop FEMA reimbursements for purchases of
PPE and other medical equipment for what it considers to be non-
emergency work. Manchester, NH alone expects approximately $11 million
in COVID-19 related expenditures over fiscal years 2020 and 2021, some
of which the City expected FEMA to reimburse. This decision is
particularly reckless as communities attempt to reopen schools safely.
Dr. Redfield, do you agree with the administration's decision to
stop reimbursement for purchases of PPE that go towards protecting our
schools and other critical institutions?
Answer. Employers are responsible for providing a safe and healthy
workforce. Some school staff need PPE to perform their jobs safely,
such as janitorial and maintenance staff. In light of potential PPE
shortages, school administrators should consider modifying staff and
student interaction and use engineering and administrative controls as
primary prevention and control measures that reduce the need for PPE.
When engineering and administrative controls cannot be implemented
or are not fully protective, employers are required by OSHA standards
(29 CFR part 1910, Subpart I) to:
--Determine what PPE is needed for their specific job duties
--Select and provide appropriate PPE to staff at no cost, if required
--Train their staff on hazard identification and correct use
(including putting on and removing) of PPE.
relationship between substance use disorders and covid-19 risks
Question. This week, the National Institutes of Health released a
study showing that people with a history of substance use disorder were
more susceptible to COVID-19 infection. People with substance use
disorders made up 10.3 percent of the study's participants, but
accounted for 15.6 percent of COVID-19 infected individuals in the
study.
Dr. Redfield, what is the CDC doing to support State efforts to
mitigate the spread of COVID-19 among people with behavioral health and
substance misuse issues?
Answer. CDC shares your concern about the intersection of drug
misuse and the COVID-19 pandemic. CDC is monitoring data closely. CDC
is working with States, territories, and localities to provide
technical assistance to identify mitigation strategies. For example,
one State is now using social media and other virtual communications to
message the importance of naloxone CDC is also supporting work to track
youth substance use during COVID-19 to intervene and prevent long-term
issues.
Harm reduction organizations, including syringe service programs
(SSPs) and facilities that provide medications for opioid use disorder
(MOUD), have had to adapt in the wake of this pandemic and change their
practices to continue serving their clients. In response, CDC is
working to identify and support innovative and emerging practices; up
to 15 organizations will be funded. Strategies will be summarized in
technical assistance tools for dissemination to partners.
CDC is also working to curb and lower substance use patterns and
attitudes among youth whose use has risen during COVID-19.
CDC is working with States engaged in Overdose Data to Action
(OD2A), a 3-year cooperative agreement that began in September 2019 and
focuses on the drug overdose epidemic, to respond to the realities of
how their work is changing in this environment. This includes assessing
overdose data to understand trends in light of COVID-19, as well as
working with our 66 funded jurisdictions to provide flexibilities where
needed and technical assistance to inform public health action during
the pandemic.
addressing connection between covid-19 and pfas exposure
Question. Dr. Redfield, last time you were here before the
Subcommittee, I asked you about a statement from your agency indicating
that ``exposure to high levels of PFAS may impact the immune system''
and ``more research is needed to understand how PFAS exposure may
affect illness from COVID-19.'' At that time, you said the CDC and the
Agency for Toxic Substances and Disease Registry (ATSDR) were examining
those connections.
Dr. Redfield, will CDC and ATSDR help facilitate COVID-19
serological testing for participants in the Pease PFAS Study and the
nationwide Multi-Site PFAS Study? Getting serological testing would
help determine whether these individuals with known PFAS exposures are
more likely to have contracted COVID-19.
Answer. CDC and ATSDR are not currently planning any serological
testing for COVID-19 in the Pease Study. The agency is focused on
getting back in the field to conduct the PFAS study using the
appropriate safety measures to keep staff and community members safe at
the Pease Study office by following CDC COVID-19 guidance. At this
time, there would be significant challenges to including serological
testing for participants in the study, including amending the Office of
Management and Budget (OMB) and Institutional Review Board (IRB)
protocol which would further delay implementing the study in the field.
We continue to explore the possibility of including cohorts, such as
those captured in the Pease Study and the multi-site study, in a future
study on PFAS and SARS-CoV-2 exposure.
______
Questions Submitted by Senator Brian Schatz
Question. A recent poll found that public confidence in the CDC has
dropped significantly since April. What actions has Dr. Redfield taken
to increase public confidence in the CDC?
Answer. CDC is providing the American public with the information
and assistance it needs to address COVID-19 head on and continues to
issue guidance and recommendations based on the best available science
and data. As we work together to fight COVID-19 and end this pandemic,
CDC is committed to its mission to protect all Americans from disease
threats and to save lives.
Question. Given President Trump's statements contradicting Dr.
Redfield's statements on masks and vaccines at the hearing, does Dr.
Redfield maintain his statements?
Answer. Dr. Redfield fully believes in the importance of vaccines
and the importance of a COVID-19 vaccine. A COVID-19 vaccine is one
tool to helping Americans get back to normal everyday life. The best
defense we currently have against this virus are the important
mitigation efforts of wearing a mask, washing your hands, practicing
social distancing and avoiding large gatherings.
Question. Was the White House, in any way, involved in the CDC's
removal of guidance from its website on how COVID-19 spreads?
Answer. The airborne transmission information posted in late
September to the CDC website was posted in error. The guidance had not
yet completed appropriate technical review by CDC. Thus, CDC reverted
to the guidance that had been technically reviewed. We are reviewing
our protocols to prevent this from happening again. Appropriate
technical review has now occurred on this topic, and CDC posted updated
information to the website October 5: https://www.cdc.gov/coronavirus/
2019-ncov/prevent-getting-sick/how-covid-spreads.html.
Question. Does the CDC believe that the main way that COVID-19
spreads is through airborne transmission of droplets and aerosols?
Answer. COVID-19 is thought to spread mainly through close contact
from person to person, including between people who are physically near
each other (within about 6 feet). People who are infected but do not
show symptoms can spread the virus to others. Infections occur mainly
through exposure to respiratory droplets when a person is in close
contact with someone who has COVID-19. When people with COVID-19 cough,
sneeze, sing, talk, or breathe, they produce respiratory droplets. As
droplets travel further from the person with COVID-19, the
concentration of these droplets decreases. These droplets can range in
size from larger droplets, which fall out of the air due to gravity, to
smaller droplets which spread apart in the air. Small droplets can also
form particles when they dry very quickly in the airstream.
Some infections can be spread by exposure to virus in small
droplets and particles that can linger in the air for minutes to hours.
This kind of spread is referred to as airborne transmission. These
viruses may be able to infect people who are further than 6 feet away
from the person who is infected or after that person has left the
space. There is evidence that under certain conditions, people with
COVID-19 seem to have infected others who were more than 6 feet away.
These transmissions occurred within enclosed spaces that had inadequate
ventilation. Sometimes the infected person was breathing heavily, for
example while singing or exercising. Under these circumstances,
scientists believe that the amount of infectious smaller droplets and
particles produced by the people with COVID-19 became concentrated
enough to spread the virus to other people. However, available data
indicate that it is much more common for the virus to spread through
close contact with a person who has COVID-19 than through airborne
transmission.
Question. There have been major cuts to the public health workforce
and State and local health departments are overwhelmed in responding to
the pandemic. How is the CDC supporting State and local health
departments in carrying out a vast vaccination program?
Answer. CDC has worked for decades with its State and local
partners to ensure public health systems are prepared with plans,
trained personnel, strategic relationships and partnerships, data
systems, and other resources needed for sustaining a successful routine
immunization infrastructure. This will help ensure that effective
distribution can occur once a safe and effective COVID-19 vaccine is
available. CDC is working closely with our government partners in
response to this pandemic, including with our sister agencies at HHS.
CDC has provided its immunization awardees $140 million in supplemental
funding to support and enhance their immunization programs. This
supplemental funding will be used to support awardee and local health
department staffing, communications campaigns, pandemic preparedness,
and mass vaccination. In addition to other COVID-19 vaccine response
work, awardee activities will include a specific focus on significantly
enhancing influenza coverage and enrolling and working with additional
vaccinators (e.g., pharmacists).
SUBCOMMITTEE RECESS
Senator Alexander. The subcommittee stands adjourned.
[Whereupon, at 12:56 p.m., Wednesday, September 16, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
MATERIAL SUBMITTED SUBSEQUENT TO THE HEARING
[Clerk's Note.--The following outside witness testimony was
received subsequent to the hearing for inclusion in the
record.]
Prepared Statement of the Alzheimer's Association and
Alzheimer's Impact Movement
The Alzheimer's Association and Alzheimer's Impact Movement (AIM)
appreciate the opportunity to submit this statement for the record for
the Senate Committee on Appropriations, Subcommittee on Labor, Health
and Human Services, Education, and Related Agencies hearing entitled
``Review of Coronavirus Response Efforts.'' The Association and AIM
thank the Subcommittee for its continued leadership on issues important
to the millions of people living with Alzheimer's and other dementia
and their caregivers. This statement provides an overview of urgent
policies that are needed now to protect this vulnerable population
during the COVID-19 pandemic and beyond, including actions for the
long-term care community, robust fiscal year 2021 funding for
Alzheimer's activities at the CDC and NIH, and efforts to expand
capacity for health outcomes through Project ECHO.
Founded in 1980, the Alzheimer's Association is the world's leading
voluntary health organization in Alzheimer's care, support, and
research. Our mission is to eliminate Alzheimer's and other dementia
through the advancement of research to provide and enhance care and
support for all affected, and to reduce the risk of dementia through
the promotion of brain health. AIM is the Association's sister
organization, working in strategic partnership to make Alzheimer's a
national priority. Together, the Alzheimer's Association and AIM
advocate for policies to fight Alzheimer's disease, including increased
investment in research, improved care and support, and development of
approaches to reduce the risk of developing dementia.
covid-19 impact on long-term care
Nursing homes and assisted living communities are on the frontlines
of the COVID-19 crisis, where 48 percent of nursing home residents are
living with dementia, and 42 percent of residents in residential care
facilities have Alzheimer's or another dementia. Residents with
dementia are particularly susceptible to COVID-19 due to their typical
age, their significantly increased likelihood of coexisting chronic
conditions, and the community nature of long-term care settings. Across
the country these facilities, their staff, and their residents are
experiencing a crisis due to a lack of transparency, an inability to
access the necessary testing, inaccurate reporting, and more. According
to some reports, nearly 70,000 residents and employees of nursing homes
and long-term care facilities have died, representing more than 40
percent of the total death toll in the United States.
The Alzheimer's Association released policy recommendations,
Improving the State and Federal Response to COVID-19 in Long-Term Care
Settings, to address both the immediate and long-term issues impacting
these settings during the COVID-19 pandemic. These recommendations
focus on four main areas: enhancing rapid, point-of-care testing in
long-term care community settings; implementing timely reporting;
developing protocols to respond to a rise in cases; and ensuring all
facilities have necessary support, like personal protective equipment
(PPE) and televisitation services.
It is absolutely imperative that each nursing home and residential
care community have the onsite testing capability to verify that all
residents, staff, and visitors are free of COVID-19 infection, whether
or not they are symptomatic. We appreciate the Administration's recent
purchase of 150 million rapid tests, a portion of which we expect will
be directed to long-term care settings. We also appreciate the recent
announcement by the Centers for Medicare and Medicaid Services (CMS)
that certain nursing home workers should receive testing as frequently
as twice a week. However these actions still fall woefully short of
what is urgently needed to protect the vulnerable Americans living in
long-term care communities. We continue to advocate for the ``White
House Standard'' of daily rapid-response testing for all new
individuals who come onsite, and retesting for returning individuals
who enter the facility, in accordance with local guidance. We also
support the immediate and accurate reporting of long-term care COVID-19
cases. These reports should be updated upon remission, death, transfer,
or other appropriate status update. With all appropriate privacy
safeguards for individuals, this reported data should be freely and
immediately accessible to everyone, down to the facility level. Any
reported cases should trigger careful, ongoing monitoring and, if
conditions warrant, ``strike teams'' should be deployed to provide
needed support until the outbreak is appropriately contained and
eliminated. It is also essential that all nursing homes and residential
living communities have full, timely access to all needed PPE, testing
equipment, training, and external support to keep them COVID-19-free.
Importantly, this includes requiring these settings to address social
isolation and ensure people with Alzheimer's and other dementia are
able to communicate with their family and friends.
fiscal year 2021 alzheimer's appropriations at cdc and nih
Now more than ever it is apparent how crucial it is to have an
established infrastructure in place to respond to public health
threats. Public health plays an important role in promoting cognitive
function and reducing the risk of cognitive decline. Investing in a
nationwide Alzheimer's public health response will help create
population-level improvements, achieve a higher quality of life for
those living with the disease and their caregivers, and reduce
associated costs. The Alzheimer's Association and AIM thank the
Subcommittee for it's leadership in providing the Centers for Disease
Control and Prevention (CDC) $10 million in fiscal year 2020 to
implement the first year of the BOLD Infrastructure for Alzheimer's Act
(Public Law 115-406). This funding enabled CDC to recently award three
Public Health Centers of Excellence, one focused on Dementia Risk
Reduction, one on Dementia Caregiving and one on Early Detection of
Dementia. CDC also awarded BOLD funding to 16 public health departments
at the State, local and Tribal level. While this funding is an
important step forward, CDC must receive the full $20 million
authorized for fiscal year 2021 to ensure the meaningful impact that
Congress intended.
Furthermore, as the current pandemic has shown, continued
investment in medical research is absolutely critical to understanding
and responding to diseases. We thank the Subcommittee for it's
leadership in providing a $350 million increase in Alzheimer's research
funding at the National Institutes of Health (NIH) in fiscal year 2020.
However, if America is going to succeed in the fight against
Alzheimer's, Congress must continue to provide the resources scientists
need to do their work. Therefore we urge the Subcommittee to fund the
research targets outlined in the Alzheimer's Professional Judgment
Budget by supporting an additional $354 million for NIH Alzheimer's
funding in fiscal year 2021.
expanding capacity for health outcomes (project echo)
Finally, we ask the Subcommittee to support provisions to expand
the use of technology-enabled collaborative learning and capacity-
building models. These education models, often referred to as Project
ECHO, can improve the capacity of providers, especially those in rural
and underserved areas, on how to best meet the needs of people living
with Alzheimer's. During the COVID-19 pandemic, Project ECHO is helping
primary care physicians in real-time understand how to use validated
assessment tools appropriate for virtual use to make early and accurate
diagnoses, educate families about the diagnosis and home management
strategies, and help caregivers understand the behavioral changes
associated with Alzheimer's, which can be heightened during isolation.
Project ECHO is also helping long-term care providers understand in
real-time how to train temporary staff that may not be familiar with
how to best care for people with Alzheimer's, implement important
health strategies such as hand-washing and social distancing for people
with Alzheimer's, and effectively communicate with residents to help
them understand the COVID-19 pandemic. In fact, the Alzheimer's
Association developed a special topic Project ECHO dementia series to
help assisted living communities during COVID-19 based on our
guidelines, Emergency Preparedness: Caring for persons living with
dementia in a long-term or community-based care setting.
conclusion
The Alzheimer's Association and AIM appreciate the steadfast
support of the Subcommittee and its priority setting activities,
especially during this time. However, our Nation must do more to
support the millions of Americans living with Alzheimer's and other
dementia, and their caregivers. We urge the Subcommittee and other
members of Congress to work in a bipartisan way to advance policies
that will help protect this vulnerable population during the COVID-19
pandemic and beyond, including actions for the long-term care
community, robust fiscal year 2021 funding for Alzheimer's activities
at the CDC and NIH, and efforts to expand capacity for health outcomes
through Project ECHO.
______
Prepared Statement of the North American Meat Institute
Chairman Blunt, Ranking Member Murray, and Members of the
Committee:
Thank you for holding the hearing, ``Review of Coronavirus Response
Efforts.'' The North American Meat Institute (Meat Institute)
appreciates your leadership as the Nation has responded to the novel
coronavirus, COVID-19.
The Meat Institute is the Nation's oldest and largest trade
association representing packers and processors of beef, pork, lamb,
veal, turkey, and processed meat products, and Meat Institute member
companies account for more than 95 percent of United States output of
these products. The Meat Institute provides regulatory, scientific,
legislative, public relations, and educational services to the meat and
poultry packing and processing industry.
On March 18, 2020, the Department of Homeland Security identified
food manufacturing as a critical infrastructure sector, which included
meat and poultry workers.\1\ Those employees have been on the front
lines, working in plants and ensuring Americans have access to safe,
nutritious, and affordable food. Despite a range of challenges
fulfilling unprecedented demand during the pandemic, the industry has
proven to be resilient and the supply chain remains intact.
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\1\ Cybersecurity & Infrastructure Security Agency. https://
www.cisa.gov/identifying-critical-infrastructure-during-covid-19.
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Developing an effective vaccine to COVID-19 is priority 1;
developing an effective plan for its distribution is priority 1A. The
many workers in the food sector, including those who work in meat and
poultry processing plants, should be a top priority for receiving a
vaccine. Specifically, meat and poultry workers and USDA inspectors
should be given the highest priority for vaccinations in the Tier 2
population.
The National Academies of Sciences, Engineering, and Medicine
(NASEM) got it right when NASEM asserted that workers in the population
group that includes meat and poultry workers ``need to be provided the
vaccine, and special efforts must be made to reach these workers in
ways that encourage them to be vaccinated.'' \2\
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\2\ National Academies of Sciences, Engineering, and Medicine,
Discussion Draft of the Preliminary Framework for Equitable Allocation
of COVID-19 Vaccine, p. 67.
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Thank you again for leadership during the pandemic and holding the
hearing to review the coronavirus response. The Meat Institute hopes
this statement is helpful as the Subcommittee considers COVID-19
vaccine distribution.
______
Prepared Statement of Patient ID Now Coalition
On behalf of the Patient ID Now coalition, thank you for the
opportunity to provide written testimony regarding the U.S. Senate's
Appropriations Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies (Labor-HHS) hearing, ``Review of
Coronavirus Response Efforts.''
Patient ID Now is a coalition of healthcare organizations that
represents a wide range of healthcare stakeholders committed to
advancing through legislation and regulations the development and
implementation of a national strategy to address patient identification
and matching.
The response to the COVID-19 pandemic has highlighted the need to
address patient misidentification throughout the health system.
Accurate identification of patients is one of the most difficult
operational issues during a public health emergency, including the
gathering of patient demographic information (e.g.--address, phone,
email, etc.) and ensuring such information remains attached to the
correct patient. Field hospitals and temporary testing sites in parks,
convention centers, and parking lots have exacerbated these challenges.
Without the ability to accurately identify and match patients to
their health information, this critical information becomes lost and
safe, effective and timely diagnosis and is jeopardized. For example,
there are reports of instances where patient specimens are collected
for COVID-19 testing in temporary sites and then sent off-site to a
public health lab for testing. Once the results were returned, there
have been difficulties matching the results to the correct patient
given the inconsistent and scant amount of demographic information
included with the sample. This has resulted not only in a backlog of
COVID-19 results unable to be sent to patients, but even results being
sent to the wrong patient, increasing the privacy and safety risks to
the entire community. Without test results being returned to the
correct patients, contact tracing and individuals' own ability to
quarantine effectively is hindered.
Correctly matching patients to their information is not just vital
for the initial COVID-19 diagnosis. Ensuring the correct patient
medical history is accurately matched to the patient is also critical
for future patient care, claims billing, patients' long-term access to
their complete health record, and for tracking the long-term health
effects of COVID-19, which the medical community does not currently
know.
Furthermore, the nationwide response in the coming months to the
COVID-19 pandemic hinges on accurate information. For example, once a
vaccine is created, any large-scale immunization programs will depend
on accurate patient information to identify who has had the disease,
who has been vaccinated, and what their outcomes are. Multiple dose
vaccines will rely even more heavily on patient records being complete
to ensure the correct timing and dosage for patients to be fully
protected. As public health systems increasingly rely on patient data
pulled from electronic health records (EHRs), we must make sure that
the patient information within these EHRs is accurate in order to have
the best public health response to these emergencies.
The COVID-19 pandemic has also laid bare healthcare disparities in
underserved communities and populations. As the coronavirus has
disproportionately affected these communities, so has patient
misidentification, increasingly putting these patients' health at
higher risk. According to OCHIN, a national, non-for-profit, health IT
service provider for a national network of more than 500 healthcare
delivery sites across the country--
--Black patients make up 13 percent of their patient population but
21 percent of duplicate records;
--Hispanic/Latino patients make up 21 percent of the population that
OCHIN's members serve, yet they make up 35 percent of
duplicates;
--The homeless population makes up 4.3 percent of OCHIN patients, but
12 percent of its duplicates (almost three times the expected
rate); and
--Migrant patients make up 2.1 percent of the OCHIN patient
population but 3.6 percent of its duplicates.
Failure to accurately identify and match patients to their health
information raises serious quality of care and patient safety concerns,
which must be a top priority during a pandemic. Difficulties in
correctly matching patients to their health information across health
information technology systems limits health information exchange,
which can result in medical errors, delayed or lost diagnoses,
duplicative testing, and wrong patient orders. The problem of patient
misidentification is so dire that one of the Nation's leading patient
safety organizations, the ECRI Institute, named patient
misidentification among the top ten threats to patient safety.\1\
Patient matching issues can cause everything from delayed or
unnecessary care, to adverse drug events, to even death.\2\
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\1\ Top 10 Patient Safety Concerns for Healthcare Organizations,
Available at: https://www.ecri.org/EmailResources/PSRQ/Top10/
2017_PSTop10_ExecutiveBrief.pdf.
\2\ http://www.healthcarebusinesstech.com/patient-identification-
errors/.
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The problem of patient misidentification extends to hospitals and
providers that are already overburdened during this health crisis.
Approximately 33 percent of all denied hospital claims are associated
with inaccurate patient identification, costing the average hospital
$1.5 million each year, and the healthcare system more than $6
billion.\3\ Patient misidentification costs the average clinician
almost half an hour in wasted time per shift at a time when many
providers are already stretched thin.\4\
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\3\ https://www.securitymagazine.com/articles/88999-inaccurate-
patient-ids-cost-hospitals-15m-a-year.
\4\ https://www.imprivata.com/company/press/positive-patient-
identification-can-dramatically-improve-patient-care-and-
hospital%E2%80%99s.
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Finally, patient privacy must continue to be a priority during a
pandemic. Without a national strategy addressing patient identification
and matching, the healthcare ecosystem faces an ``inverse'' privacy
problem, whereby individuals must repeatedly disclose individually
identifiable information to each healthcare provider they see to
accurately match the patients to their medical record. Furthermore,
each payer still maintains separate proprietary identifiers for
patients, increasing the number of identifiers in use. Even more
worrying for patient privacy is risk of overlays--i.e.--the merging of
multiple patients' data into one medical record, causing patients to
have access to other patients' health information, which could result
in an unauthorized disclosure under HIPAA.
The issues around patient identification arise due to a narrow
interpretation of a two-decade old appropriations restriction included
in Section 510 of the Labor-HHS appropriations bill that prohibits the
U.S. Department of Health and Human Services from spending Federal
dollars to promulgate or adopt a unique health identifier for
individuals. This archaic ban has had a detrimental impact across the
healthcare system to patients, providers, and public health. Striking
Section 510 from the Labor-HHS appropriations bill will provide the
U.S. Department of Health and Human Services the ability to evaluate a
full range of patient matching solutions and enable it to work with the
private sector to identify a nationwide strategy that is cost-
effective, scalable, secure and one that protects patient privacy.
Accurate patient identification and matching must be a top priority
during public health emergencies to protect patient safety, patient
privacy, and strengthen the public health response. While Section 510
remains in the Labor-HHS appropriations bill, the ability to address
these issues will continue to be stifled.
We appreciate the opportunity to provide comments on the issue of
patient identity and matching as it relates to the national coronavirus
response. We look forward to working with you and acting as a resource
on patient identification. Should you or your staff have any additional
questions or comments, please contact Kate McFadyen, Director,
Government Affairs, AHIMA, at [email protected].
______
Prepared Statement of the Premier Healthcare Alliance
The Premier healthcare alliance appreciates the opportunity to
submit a statement for the record on the Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and Related
Agencies hearing titled ``Hearing to review Coronavirus Response
Efforts'' scheduled for September 16, 2020. We applaud the leadership
of Chairman Blunt, Ranking Member Murray and members of the
Subcommittee for holding this hearing to examine the Nation's response
to the COVID-19 pandemic.
The Premier healthcare alliance is a leading healthcare improvement
company, uniting an alliance of more than 4,100 U.S. hospitals and
health systems and approximately 200,000 other providers and
organizations to transform healthcare. With integrated data and
analytics, collaboratives, supply chain solutions, and consulting and
other services, Premier enables better care and outcomes at a lower
cost. Premier plays a critical role in the rapidly evolving healthcare
industry, collaborating with members to co-develop long-term
innovations that reinvent and improve the way care is delivered to
patients nationwide.
COVID-19 has exposed one of healthcare's fundamental weaknesses:
the fragmented and siloed nature of care delivery and the lack of
centralized coordination when it comes to managing and preventing
disease spread. The public health system continues to rely on flawed
data and obsolete technology that consistently fails to accurately
identify and track current cases, monitor disease progression, or
predict future surges. Not only do these blind spots create
opportunities for the disease to spread, they also undermine the
ability to safely plan for economic recovery and re-opening of the
country.
America Needs to Modernize its Disease Surveillance Process Using the
Existing HIT Infrastructure
The COVID-19 public health emergency has heightened the awareness
of the need to modernize our public health surveillance capabilities.
America needs an automated, near real-time means to collect this
symptom and confirmed case information consistently and comprehensively
so that it can be shared between and among multiple stakeholders,
including Federal, State, local, and tribal public health agencies and
authorities. Existing health IT infrastructure and policies governing
interoperability, standards and electronic health records (EHRs) can be
leveraged to achieve effective and efficient public health systems
modernization. The modernized public health infrastructure should
include the following components.
--Collection and reporting of standardized and consistent data for
use by Federal, State, local and tribal health agencies and
authorities.
--Ensure that nationwide syndromic surveillance is achieved by
beginning with the collection of signs and symptoms data and
add confirmed cases as testing results become available.
--Provide clinical decision support (CDS) to help clinicians follow
the latest evidence-based guidelines at the point of care.
Inaccurate patient matching is widespread, disrupts the
coordination and quality of care during the COVID-19 pandemic, can
cause serious safety events and is costly to the healthcare system
One of the most significant challenges impeding the safe, secure
and efficient electronic exchange of health information is the lack of
a consistent, national approach to patient data matching. As our
Nation's healthcare providers innovate care to test, treat and prevent
the spread of COVID-19, patient identification and data matching errors
have become exponentially more problematic and dangerous.
These challenges stem from a narrow interpretation of archaic
language that has been included in Labor- HHS Appropriations bills
since fiscal year 1999. We urge the Senate to follow the House of
Representatives' lead and remove the language from the fiscal year 2021
Labor-HHS Appropriations bill that prohibits spending Federal dollars
to promulgate or adopt standards for a national unique patient
identifier (UPI) to help improve the Nation's pandemic response and
overall public safety. This effort is widely backed by a broad array of
healthcare leaders who are united in their commitment to improve safety
processes for our Nation's healthcare providers and the patients they
serve.
While the issue has received little attention, accurately matching
patients to their records is an ongoing challenge for providers and
patient mismatching happens at an alarming rate. The Government
Accountability Office found that inaccurate, incomplete or
inconsistently formatted demographic information in patients' records
can pose challenges to accurate matching. When records for different
patients are mistakenly matched, or records for the same patient are
not matched, it can adversely affect the patient's care. A Pew
Charitable Trusts study found that patient matching rates can fall as
low as 80 percent, leaving as many as one in five patients not matched
to the correct record when receiving care from different providers.
The problem is so serious in fact, that the ECRI Institute, a
widely respected national safety patient organization, ranked patient
misidentification as one of the top ten patient safety concerns for
healthcare organizations. Not only is the lack of unique patient
identifiers putting patients in danger and compromising their privacy ,
misidentification costs the average healthcare facility $17.4 million
per year in denied claims and potential lost revenue. The adoption of
electronic health records and the exchange of electronic health
information to better coordinate care and encourage value-based payment
arrangements is also suffering due to the lack of a national strategy
for patient matching and identification.
COVID-19 Elevates the Urgency to Remove the Ban that Threatens the
Lives of Americans
As patients' information is exchanged among various types of
providers--including hospitals, primary care physicians, specialty
physicians, pharmacies, and laboratories--it's imperative that the
healthcare information belonging to the same patient is correctly
matched. This has never been so critical than during the current public
health emergency. With patients getting tested for COVID-19 in
different settings such as drive-through and other makeshift testing
sites and being treated in field hospitals, ensuring that healthcare
records follow the right patient has become extremely problematic.
Providers treating COVID-19 patients in hospitals or other
facilities urgently need current and accurate information about
patients' laboratory or other diagnostic test results, their medication
history and any comorbidities or diagnosed medical conditions to inform
their treatment decisions. Public health experts must similarly rely on
accurate and timely information on patients to conduct contact tracing
and track outbreaks to stem the spread of the disease. Once a vaccine
is developed, records must be accurately matched to the correct patient
in order to identify who has been infected, who has been vaccinated,
and what are the clinical outcomes.
Implementing unique patient identifiers will also help the Nation
address the disparate impact of COVID-19 that the Administration has
identified during the pandemic. According to OCHIN, the Black,
Hispanic/Latino, homeless and migrant population make up a
disproportionate share of those who experienced duplication of
healthcare records.
Premier urges Congress to remove the ban in the appropriation
process to finally address the impediment to patient matching and
identification which is putting patients at risk, increasing costs to
the healthcare system, perpetuating inefficiencies in care delivery and
coordination, and undermining efforts to achieve nationwide
interoperability.
conclusion
In closing, the Premier healthcare alliance appreciates the
opportunity to submit a statement for the record on the Senate
Appropriations Subcommittee on Labor, Health and Human Services,
Education and Related Agencies hearing on the response to the
coronavirus. Premier is available as a resource and looks forward to
working with Congress as it considers policy options to continue to
address this very important issue.
If you have any questions regarding our comments or need more
information, please contact Duanne Pearson at
[email protected].