[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
EXAMINING HHS'S PUBLIC HEALTH PREPAREDNESS FOR AND RESPONSE TO THE 2017
HURRICANE SEASON
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 24, 2017
__________
Serial No. 115-67
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
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COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee GENE GREEN, Texas
STEVE SCALISE, Louisiana DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
ADAM KINZINGER, Illinois PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida PAUL TONKO, New York
BILL JOHNSON, Ohio YVETTE D. CLARKE, New York
BILLY LONG, Missouri DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana KURT SCHRADER, Oregon
BILL FLORES, Texas JOSEPH P. KENNEDY, III,
SUSAN W. BROOKS, Indiana Massachusetts
MARKWAYNE MULLIN, Oklahoma TONY CARDENAS, California
RICHARD HUDSON, North Carolina RAUL RUIZ, California
CHRIS COLLINS, New York SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
Subcommittee on Oversight and Investigations
VACANCY
Chairman
H. MORGAN GRIFFITH, Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
JOE BARTON, Texas JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana PAUL TONKO, New York
CHRIS COLLINS, New York YVETTE D. CLARKE, New York
TIM WALBERG, Michigan RAUL RUIZ, California
MIMI WALTERS, California SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania FRANK PALLONE, Jr., New Jersey (ex
EARL L. ``BUDDY'' CARTER, Georgia officio)
GREG WALDEN, Oregon (ex officio)
C O N T E N T S
----------
Page
Hon. H. Morgan Griffith, a Representative in Congress from the
Commonwealth of Virginia, opening statement.................... 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the state
of Colorado, opening statement................................. 4
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 6
Prepared statement........................................... 7
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 8
Prepared statement........................................... 9
Witnesses
Robert P. Kadlec, M.D., Assistant Secretary for Preparedness and
Response, U.S. Department of Health and Human Services......... 12
Prepared statement........................................... 15
Answers to submitted questions............................... 101
Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug
Administration................................................. 24
Prepared statement........................................... 26
Answers to submitted questions............................... 130
Kimberly Brandt, Principal Deputy Administrator for Operations,
Centers for Medicare and Medicaid Services..................... 40
Prepared statement........................................... 42
Answers to submitted questions............................... 138
Stephen C. Redd, M.D., RADM, Director of the Office of Public
Health Preparedness and Response, Centers for Disease Control
and Prevention................................................. 50
Prepared statement........................................... 52
Answers to submitted questions............................... 146
Submitted Material
Article entitled, ```Like Going Back in Time': Puerto Ricans Put
Survival Skills to Use,'' New York Times, October 24, 2017,
submitted by Ms. DeGette....................................... 95
EXAMINING HHS'S PUBLIC HEALTH PREPAREDNESS FOR AND RESPONSE TO THE 2017
HURRICANE SEASON
----------
TUESDAY, OCTOBER 24, 2017
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:02 a.m., in
room 2123, Rayburn House Office Building, Hon. Morgan Griffith
(vice chairman of the subcommittee) presiding.
Present: Representatives Griffith, Brooks, Collins, Barton,
Walberg, Walters, Costello, Carter, Walden (ex officio),
DeGette, Schakowsky, Castor, Tonko, Clarke, Ruiz, Peters, and
Pallone (ex officio).
Also Present: Representatives Olson, Bilirakis, Duncan,
Green, Gonzalez-Colon, and Wasserman-Schultz,
Staff Present: Jennifer Barblan, Chief Counsel, O&I; Ray
Baum, Staff Director; Karen Christian, General Counsel; Kelly
Collins, Staff Assistant; Zachary Dareshori, Staff Assistant;
Lamar Echols, Counsel, O&I; Adam Fromm, Director of Outreach
and Coalitions; Ali Fulling, Legislative Clerk, O&I, DCCP;
Theresa Gambo, Human Resources/Office Administrator; Alex
Miller, Video Production Aide and Press Assistant; Christopher
Santini, Counsel, O&I; Jennifer Sherman, Press Secretary;
Natalie Turner, Counsel, O&I; Hamlin Wade, Special Advisor,
External Affairs; Everett Winnick, Director of Information
Technology; Christina Calce, Minority Counsel; Jeff Carroll,
Minority Staff Director; Tiffany Guarascio, Minority Deputy
Staff Director and Chief Health Advisor; Chris Knauer, Minority
Oversight Staff Director; Miles Lichtman, Minority Policy
Analyst; Jon Monger, Minority Counsel; and C.J. Young, Minority
Press Secretary.
OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE
IN CONGRESS FROM THE COMMONWEALTH OF VIRGINIA
Mr. Griffith. I can go ahead and get started. I thank
everybody. I appreciate it.
We are here today to examine the Department of Health and
Human Services' public health preparedness for and response to
the 2017 hurricane season. In the last 2 months, Texas,
Florida, Puerto Rico, and the U.S. Virgin Islands have been
devastated by hurricanes.
I first want to express our heartfelt sorrow for the
millions of Americans impacted by these devastating storms and
say that all members of this committee, on both sides of the
aisle, stand with those affected by these hurricanes. I would
also like to thank Dr. Burgess and Dr. Ruiz, both members of
this subcommittee, who each recently visited Puerto Rico to
assess the impact these hurricanes have had and continue to
have on our fellow Americans.
This committee has been conducting oversight of the Federal
response to the recent hurricanes since shortly after Harvey
made landfall in Texas. Unfortunately, I expect that our work
here will continue for years to come. The committee's
jurisdiction involves not just the public health issues we will
be discussing today but also rebuilding the electrical grid,
addressing environmental cleanup, and restoring
telecommunications, to name only a few.
The people of Puerto Rico and the U.S. Virgin Islands
continue to face a long road to recovery and many are living
without power and running water.
I believe we are going to be joined today by Representative
Jenniffer Gonzalez-Colon from Puerto Rico, someone who knows
all too well about the difficult challenges her home is facing.
Thank you for being here at this important hearing.
From coordinating the overall Federal healthcare response
to ensuring that individuals have the medical treatment they
need to protecting the blood and pharmaceutical supply to
granting emergency waivers and everything in between, HHS has
been working with tirelessly to provide medical care and
services to individuals affected by the storms. The
overwhelming majority of healthcare facilities in the impacted
areas went above and beyond to protect and treat those in
harm's way, yet media reports indicate that some healthcare
providers failed in their duty to protect their patients. There
was a tragic situation at a nursing home in Florida where 14
residents died after the facility lost its air-conditioning,
and this, despite a hospital across the street that never lost
power or cooling.
The response in Puerto Rico and the U.S. Virgin Islands has
involved numerous Federal agencies working together with each
other and state and local officials. For example, before
Hurricane Maria made landfall in Puerto Rico and every day
since, HHS, the Department of Defense, the Department of
Veterans Affairs, and the Federal Emergency Management Agency,
or FEMA, have been coordinating with local emergency response
officials to provide medical care and help reestablish the
island's healthcare infrastructure. HHS has worked with Puerto
Rico's Department of Health to prioritize resources needed for
dialysis facilitates and has coordinated with FEMA to help
ensure critical supplies are delivered where they are needed.
Similar efforts are ongoing in the U.S. Virgin Islands as well.
But many questions remain. Has the interagency response
been effective from the perspective of HHS? Are the Federal
policies causing delays in response efforts? Are we utilizing
our resources in the most efficient and effective ways to help
our fellow Americans in Puerto Rico and the U.S. Virgin Islands
in particular?
Finally, it is critical that we understand the public
health challenges ahead. Mold formation is likely in nearly all
the affected regions. As we have seen after Hurricane Harvey,
there is an increased risk for the spread of infectious disease
due to contaminated water. Media reports indicate that, 1 month
after Hurricane Maria, over 1 million Americans are still
without clean, safe drinking water. Rebuilding Puerto Rico and
the U.S. Virgin Islands will take years. The healthcare systems
are in dire condition, and most of the operational facilities
need some degree of assistance. To make matters worse, the
electrical grid has been devastated, which has significantly
hampered recovery efforts. We still don't even know the full
extent of the damage, let alone when our fellow citizens will
have electricity and running water restored. We are trying to
make sure we are doing everything possible to address the
short- and long-term needs of those living in the areas
impacted by Hurricanes Harvey, Irma, and Maria, especially in
the face of the public health threats that have resulted and
will continue to result from these storms.
I would like to thank the witnesses for testifying here
today, and I look forward to hearing your testimony.
And with that, I will now yield 5 minutes for an opening
statement to Ms. DeGette, the ranking member from Colorado.
[The prepared statement of Mr. Griffith follows:]
Prepared statement for Hon. H. Morgan Griffith
We are here today to examine the Department of Health and
Human Services' public health preparedness for and response to
the 2017 hurricane season.
In the last 2 months, Texas, Florida, Puerto Rico, and the
U.S. Virgin Islands have been devastated by hurricanes. I first
want to express our heartfelt sorrow for the millions of
Americans impacted by these devastating storms and say that all
Members of this Committee on both sides of the aisle stand with
those affected by the hurricanes.
I would also like to thank Dr. Burgess and Dr. Ruiz, both
members of this subcommittee, who each recently visited Puerto
Rico to assess the impact these hurricanes have had, and
continue to have, on our fellow Americans.
This Committee has been conducting oversight of the federal
response to the recent hurricanes since shortly after Harvey
made landfall in Texas. Unfortunately, I expect that our work
here will continue for years to come. The Committee's
jurisdiction involves not just the public health issues we will
be discussing today, but also rebuilding the electrical grid,
addressing environmental cleanup, and restoring
telecommunications, to name only a few.
The people of Puerto Rico and the U.S. Virgin Islands
continue to face a long road to recovery and many are living
without power and running water. We are joined today by
Representative Jenniffer Gonzalez-Colon from Puerto Rico--
someone who knows all too well about the difficult challenges
her home is facing. Thank you for being here for this important
hearing.
From coordinating the overall federal health care response,
to ensuring that individuals have the medical treatment they
need, to protecting the blood and pharmaceutical supply, to
granting emergency waivers, and everything in between, HHS has
been working tirelessly to provide medical care and services to
individuals affected by the storms.
The overwhelming majority of health care facilities in the
impacted areas went above and beyond to protect and treat those
in harm's way. Yet, media reports indicate that some health
care providers failed in their duty to protect their patients.
There was a tragic situation at a nursing home in Florida where
fourteen residents died after the facility lost its air
conditioning--and this despite a hospital across the street
that never lost power or cooling.
The response in Puerto Rico and the U.S. Virgin Islands has
involved numerous federal agencies, working together with each
other and state and local officials. For example, before
Hurricane Maria made landfall in Puerto Rico and every day
since, HHS, the Department of Defense, the Department of
Veterans Affairs, and the Federal Emergency Management Agency,
or FEMA, have been coordinating with local emergency response
officials to provide medical care and help re-establish the
island's health care infrastructure. HHS has worked with Puerto
Rico's Department of Health to prioritize resources needed for
dialysis facilities and has coordinated with FEMA to help
ensure critical supplies are delivered where they are needed.
Similar efforts are ongoing in the U.S. Virgin Islands, too.
But many questions remain. Has the inter-agency response
been effective, from the perspective of HHS? Are federal
policies causing delays in response efforts? Are we utilizing
our resources in the most efficient and effective ways to help
our fellow Americans in Puerto Rico and the U.S. Virgin Islands
in particular?
Finally, it is critical that we understand the public
health challenges ahead. Mold formation is likely in nearly all
the affected regions. As we have seen after Hurricane Harvey,
there is an increased risk for the spread of infectious disease
due to contaminated water. Media reports indicate that one
month after Hurricane Maria, over one million Americans are
still without clean, safe drinking water.
Rebuilding Puerto Rico and the U.S. Virgin Islands will
take years. The health care systems are in dire condition and
most of the operational facilities need some degree of
assistance. To make matters worse, the electrical grid has been
devastated which has significantly hampered recovery efforts.
We still don't even know the full extent of the damage, let
alone when our fellow citizens will have electricity and
running water restored. We are trying to make sure we are doing
everything possible to address the short- and long-term needs
of those living in the areas impacted by Hurricanes Harvey,
Irma, and Maria, especially in the face of the public health
threats that have resulted--and will continue to result--from
these storms.
I would like to thank the witnesses for testifying here
today and I look forward to hearing your testimony.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you, so much, Mr. Chairman.
This 2017 hurricane season has been one of the most
damaging on record. Hurricane Harvey broke the record for the
greatest amount of rain recorded from a single tropical storm
or hurricane in the United States and inundated Houston and
south Texas with more than 51 inches of rain. Hurricane Irma
became the strongest Atlantic hurricane on record before it hit
the Virgin Islands and Florida. And while these storms have
been devastating, Hurricane Maria's impact on Puerto Rico and
the U.S. Virgin Islands has been nothing less than
catastrophic.
Mr. Chairman, as you said, the scope of potential health
risks that are caused by this ongoing crisis, it is still
coming into focus, but it is clearly considerable. Over a month
after Maria hit, the infrastructure in Puerto Rico and the
Virgin Islands remains decimated. Nearly 80 percent of Puerto
Rico still doesn't have power, and HHS reported that a
substantial number of Puerto Rico's hospitals are either
nonoperational or require diesel to run generators in order
just to keep functioning.
Over a third of Puerto Rican residents lack reliable access
to potable water. Contaminated water is also spreading
contagious diseases. And while I certainly appreciate the
effort by volunteers, including physicians and nurses
volunteering their time with the HHS DMAT teams, I am concerned
that poor management of the hurricane response at a Federal
level may be hindering response efforts. The Federal
Government, I believe, probably does not have a complete
picture of what healthcare challenges exist because, frankly,
most of the island of Puerto Rico lacks adequate communication.
I think that this committee needs to hold further hearings
to address the status of all these vital services that you, Mr.
Chairman, talked about. And I even think, as time goes on, we
should have field hearings on Puerto Rico, in particular, but
also the Virgin Islands, as much of the recovery effort, as you
so accurately describe, involves the jurisdiction of this
committee. I can't stress enough how important it is for us to
send our staff down there to investigate this and how important
it is for members to go and investigate this.
I was part of a group of members that went after Hurricane
Katrina to New Orleans to observe the recovery efforts. What we
found through years of oversight on this subcommittee was this
Washington's understanding regarding the situation on the
ground was very different than we were able to observe
firsthand when we went into the basement of Charity Hospital
and we saw what happened to those records. When we had our
field hearings--Congresswoman Blackburn was there and a bunch
of the rest of us--and we saw what had happened to small
business people down there in New Orleans, you just cannot
substitute for that. And as we begin to think about our public
response as Members of Congress, we need to see what we are
doing on the ground.
Mr. Chairman, last week, President Trump said the
administration deserves a 10 for its response to the
devastation of Hurricane Maria. Given the fact that most
residents lack power, nearly a million Americans lack access to
safe and reliable drinking water, and endless reports of near
subsistence living for many, I find that statement to be
breathtaking. I hope that our witnesses today are better
prepared than that to talk about what is really happening on
the ground and what we can do to address this unfolding crisis.
I hope it will be the beginning of an ongoing and concerted
effort to understand what is going on, and I would now like to
yield the balance of my time to Representative Castor, who
wants to talk, appropriately, about the health challenges
facing her State of Florida.
Ms. Castor. Well, I thank Ranking Member DeGette for
yielding the time. This simply was a catastrophic hurricane
season. And we have so many challenges ahead. I want to thank
our witnesses who are here today. I want to thank all of my
colleagues for holding this hearing. Hopefully this is just the
first of many because this is going to be a very long recovery
period.
And after 75 lives lost in Texas, 75 lives lost in
Florida--including 14 related to a nursing home, that were
completely avoidable--we need to discuss that. We know that we
have about 50 deaths in Puerto Rico so far, with the threat of
bacterial infections growing. I am very concerned about Puerto
Rico and the whole interplay between the folks that live there
and the U.S. Virgin Islands and their migration and what that
means for the health needs of everyone. And on the island, the
drinking water issue is simply critical. So I look forward to
your expert testimony today and the committee's work in the
days ahead. Thank you.
Ms. DeGette. I yield back.
Mr. Griffith. The gentlelady yields back.
I now recognize the chairman of the full committee, Mr.
Walden of Oregon.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. I thank the vice chairman for holding this
hearing. I, too, want to express my deepest sympathy for those
who have been impacted by these horrible storms, particularly
our fellow citizens in Puerto Rico and the U.S. Virgin Islands.
This committee stands ready to assist in whatever way we can.
We will continue to be diligent in our oversight of the work
that the agencies are doing and the needs of the people there.
I am very pleased that Dr. Burgess, who chairs our Health
subcommittee, has already been to Puerto Rico, visited some of
the hospitals, looked at the healthcare issues. We know we have
much more work to do, and we hope to hear from all of you today
about what is out there ahead, where we have made progress,
where there are still problems that we need to uncover and get
better solutions to.
Today, we are examining the Department of Health and Human
Services' continuing efforts to protect the public health in
Texas, Florida, Puerto Rico, and the U.S. Virgin Islands in the
aftermath of Hurricanes Harvey, Irma, and Maria. This is the
first in a series of hearings on the preparedness for and
responses to Hurricanes Harvey, Irma, and Maria. And, in the
coming weeks, we will also hold hearings before the Energy and
Environment subcommittees on these matters. And as the vice
chairman stated, this committee will be conducting oversight of
the rebuilding of Puerto Rico and the U.S. Virgin Islands for
years to come.
The public health risk typically associated with natural
disasters are varied and include heightened incidences of
infectious diseases, diminished access to medical care, and
long-term mental health trauma, just to name a few of the
concerns we all need to be aware of. These risks can be
particularly dangerous, especially for vulnerable populations,
such as infants, dialysis patients, individuals who may be
immunosuppressed, and, of course, the elderly.
Tragically, we saw this in the aftermath of Hurricane Irma
where 14 elderly residents, as we have heard before, of the
Rehabilitation Center at Hollywood Hills in Florida lost their
lives as a result of heat-induced death issues after the
facility's air-conditioning system failed during the storm.
Last week, this committee sent a bipartisan letter to the
nursing home's owner requesting information on the facility's
emergency preparedness plan, inspection history, and the steps
it took to protect residents after its air-conditioning system
stopped working.
We will hear today that, while the three major hurricanes
to impact the United States in 2017 were distinct events that
presented and continue to present their own unique challenges,
many of the protocols that are necessary to conduct an
effective public health response are immutable. For example,
Federal agencies responding to disasters must be able to
communicate effectively with each other and with local, state,
and territorial officials to identify any areas of need,
ensuring that individuals have adequate access to basic
necessities, such as food, water and medical supplies, critical
in any public health protection effort. And as we head into a
recovery phase, it is important we also carefully monitor
patients as they transition from hospitals or under medical
supervision back to their homes or other long-term living
arrangements.
News reports indicate more than 60 percent of Puerto Ricans
are now homeless as a result of the devastating hurricanes. We
need to make sure, when patients are discharged from the
hospitals, that they have safe places to go and don't end up on
the streets and then back into the hospital.
However, following Hurricane Maria, various media reports
have called into question whether the Federal Government is
adequately meeting its obligation to protect the health and
welfare of American citizens in Puerto Rico and the Virgin
Islands. On this matter, I am eager to gain the perspective of
our witnesses who have been on the ground in the areas that
have been affected by the most recent hurricanes. Making sure
that Americans in need get the assistance they require cannot
and should not be a partisan matter. If certain agencies aren't
pulling their weight, we want to know. If there are Federal
laws or policies that are impeding the recovery efforts, we
want to know as well.
In addition, we also want to hear about any best practices
that can be gleaned from the ongoing recovery efforts and can
be utilized in response to any future natural disasters. So,
again, thanks to you and your teams for being on the ground
trying to do the best you can in these horrible circumstances,
but we really need to know the facts, what is working, what is
not, where there have been shortfalls, what are the lessons
learned, and where do you need additional help to help our
citizens.
So, with that, Mr. Vice Chair, I yield back the balance of
my time and look forward to the testimony of our witnesses.
Before I do that, I would also like to welcome our newest
member to the committee. Mr. Duncan was just approved by the
House Conference this morning, Steering Committee last night,
replacing Dr. Murphy.
And Jeff, we are delighted to have you on board the
committee. Thanks for being here today.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Thank you, Mr. Vice Chairman, for holding this important
hearing. I too want to express my deepest sympathy for those
impacted by these storms, particularly our fellow citizens in
Puerto Rico and the U.S. Virgin Islands. This committee stands
ready to assist in whatever way we can.
Today we are examining the Department of Health and Human
Services' continuing efforts to protect the public health in
Texas, Florida, Puerto Rico, and the U.S. Virgin Islands in the
aftermath of Hurricanes Harvey, Irma, and Maria.
This is the first in a series of hearings on the
preparedness for and response to Hurricanes Harvey, Irma, and
Maria. In the coming weeks, we will also hold hearings before
the Energy and Environment subcommittees. And, as the Vice
Chairman stated, this committee will be conducting oversight of
the rebuilding of Puerto Rico and the U.S. Virgin Islands for
years to come.
The public health risks typically associated with natural
disasters are varied and include heightened incidences of
infectious diseases, diminished access to medical care, and
long-term mental health trauma, just to name a few concerns.
These risks can be particularly dangerous for vulnerable
populations such as infants, dialysis patients, individuals who
may be immunosuppressed, and the elderly.
Tragically we saw this in the aftermath of Hurricane Irma
where 14 elderly residents of the Rehabilitation Center at
Hollywood Hills in Florida lost their lives as a result of
heat-induced health issues after the facility's air
conditioning system failed during the storm. Last week, the
committee sent a bipartisan letter to the nursing home's owner
requesting information on the facility's emergency preparedness
plan, inspection history, and the steps it took to protect
residents after its air conditioning system stopped working.
We will hear today that while the three major Hurricanes to
impact the United States in 2017--Harvey, Irma, and Maria--were
distinct events that presented, and continue to present, their
own unique challenges, many of the protocols that are necessary
to conduct an effective public health response are immutable.
For example, federal agencies responding to disasters must
communicate effectively with each other and with local, state,
and territorial officials to identify any areas of need.
Ensuring that individuals have adequate access to basic
necessities such as food, water, and medical supplies is
critical in any public health protection effort.
As we head into a recovery phase, it is important that we
also carefully monitor patients as they transition from
hospitals or under medical supervision back to their homes or
other long-term living arrangements. News reports indicate over
60 percent of Puerto Ricans are now homeless as a result of the
devastating hurricanes. We need to make sure when patients are
discharged from the hospitals they have safe places to go and
don't end up back at the hospital.
However, following Hurricane Maria, various media reports
have called into question whether the federal government is
adequately meeting its obligation to protect the health and
welfare of American citizens in Puerto Rico and the Virgin
Islands. On this matter, I am eager to gain the perspective of
our witnesses who have been on the ground in the areas that
have been affected by the most recent hurricanes.
Making sure that Americans in need get the assistance they
require, cannot and should not be a partisan matter. If certain
agencies are not pulling their weight, we want to know; if
there are federal laws or policies that are impeding the
recovery efforts, we want to know that as well. In addition, we
also want to hear about any best practices that can be gleaned
from the ongoing recovery efforts that can be utilized in the
response to any future natural disasters.
Mr. Griffith. Thank you, Mr. Chairman.
Mr. Walden. I yield back.
Mr. Griffith. Thank you, Mr. Chairman.
I now recognize the ranking member of the full committee,
Mr. Pallone of New Jersey.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman, and thank you for
holding this hearing on this critical issue. And I hope that
this hearing is the first of many hurricane-related hearings,
as Congress needs to hear further from HHS and other agencies
regarding the ongoing response and recovery efforts in all of
the affected areas.
I would also like to take a moment to recognize the
Federal, state, and local responders who are working hard to
address the many public health issues which exist as response
and recovery continues in all of the areas that were impacted
by these three major hurricanes.
I know firsthand of the tragic devastation caused by such
immense natural disasters. In 2012, my district was hit hard by
Hurricane Sandy. I have never seen worse storm damage in our
area in my lifetime. For many, the storm was a worst-case
scenario: lost lives, homes flooded, and businesses lost. The
fifth anniversary is coming up this weekend, and we still have
a lot of people that are not back in their homes or their
businesses.
Our Nation is now experiencing historic levels of
destruction and loss in Puerto Rico and the Virgin Islands, as
well as in Florida, Texas, and along the Gulf Coast, in the
wake of Hurricanes Maria, Irma, and Harvey. And while no two
natural disasters are alike, the areas affected by these
massive hurricanes have unique needs and challenges. While
Congress continues to address the response in Florida and
Texas, we must also work to ensure that Puerto Rico and the
U.S. Virgin Islands receive the full and immediate support of
the Federal Government as they recover. I recognize there are a
number of ongoing challenges facing the residents of south
Florida and the Gulf Coast, but much of the hearing today will
likely to need to address the situation in Puerto Rico and the
U.S. Virgin Islands. The reports coming from these areas
indicate that hundreds of thousands of Americans continue to
struggle to meet day-to-day needs, and I am particularly
concerned that there are still reports that residents do not
have access to food or medicine. As many as a million Americans
lack access to reliable sources of clean water. Accounts from
the areas affected by these storms paint a dire situation that
completely contradict the often rosy stories that come from the
President and the White House.
Hurricanes Irma and Maria caused widespread flooding and
destruction in Puerto Rico and the U.S. Virgin Islands,
including critical damage to electrical grids,
telecommunications systems, drinking water systems, and
transportation infrastructure. Virtually all residents of
Puerto Rico and the U.S. Virgin Islands have been impacted, and
these infrastructure failures create acute public health
issues. We have seen and heard reports of death, dehydration,
and desperation as residents of Puerto Rico and the U.S. Virgin
Islands continue to struggle in the post-apocalyptic landscape
where fundamental health needs remain unaddressed even a month
after Hurricane Maria and almost 2 months after Hurricane Irma.
The lists of serious needs and challenges is long. Many
hospitals still do not have reliable power. Many communities in
Puerto Rico still lack safe drinking water, and people have
resorted to drinking from questionable water sources. Where
water service has been he restored, residents are still unsure
if the water is safe. In a recent EPA briefing to the
committee, we learned that crews going into communities to test
for water quality were arriving only to find that people still
lacked adequate food and drinking water.
So Congress must provide ongoing support in the aftermath
of these hurricanes to restore and rebuild, and I hope our
witnesses today will help us understand what needs to be
improved in the response and recovery efforts so that Congress
can more effectively provide assistance and understand the
impacts on public health, not just today but in the months and
years to come.
I also wanted to say something about the fact that many
Puerto Ricans are actually coming from the island to our
states, in particularly in New Jersey, in my district. And, my
mayors and my elected officials locally are saying: You know,
is there any kind of help for us? Because a lot of these people
come here, and they don't have a lot of money. They need
support as well. So that is also something we need to look
into.
I would like to yield the remainder of my time to Mr.
Green.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Mr. Chairman, thank you for holding this hearing on this
critical issue. I hope that this hearing is the first of many
hurricane related hearings, as Congress needs to hear further
from HHS and other agencies regarding the ongoing response and
recovery efforts in all of the affected areas.
I also would like to take a moment to recognize the
federal, state, and local responders who are working hard to
address the many public health issues which exist as response
and recovery continues in all of the areas that were impacted
by these three major hurricanes.
I know firsthand of the tragic devastation caused by such
immense natural disasters. In 2012, my district was hit hard by
Hurricane Sandy. I had never seen worse storm damage in our
area in my lifetime. For many, the storm was a worst case
scenario: lives lost, homes flooded, and businesses lost.
Our nation is now experiencing historic levels of
destruction and loss in Puerto Rico and the U.S. Virgin
Islands, as well as in Florida, Texas and all along the Gulf
Coast in the wake of Hurricanes Maria, Irma, and Harvey.
No two natural disasters are alike, and the areas affected
by these massive hurricanes have unique needs and challenges.
While Congress continues to address the response in Florida and
Texas, we must also work to ensure that Puerto Rico and the
U.S. Virgin Islands receive the full and immediate support of
the federal government as they recover.
While I recognize that there are a number of ongoing
challenges facing the residents of South Florida and the Gulf
Coast, much of the hearing today will likely need to address
the situation in Puerto Rico and the U.S. Virgin Islands. The
reports coming from these areas indicate that hundreds of
thousands of Americans continue to struggle to meet day-to-day
needs.
I am particularly concerned that there are still reports
that residents do not have access to food or medicine and as
many as a million Americans lack access to reliable sources of
clean water.
Accounts from the areas affected by these storms paint a
dire situation that completely contradict the often rosy
stories that come from the White House. Hurricanes Irma and
Maria caused widespread flooding and destruction in Puerto Rico
and the U.S. Virgin Islands, including critical damage to
electrical grids, telecommunications systems, drinking water
systems, and transportation infrastructure.
Virtually all residents of Puerto Rico and the U.S. Virgin
Islands have been impacted, and these infrastructure failures
create acute public health issues. We have seen and heard
reports of death, dehydration, and desperation as residents of
Puerto Rico and the U.S. Virgin islands continue to struggle in
a post-apocalyptic landscape where fundamental health needs
remain unaddressed even a month after Hurricane Maria and
almost two months after Hurricane Irma.
The list of serious needs and challenges is long. Many
hospitals still do not have reliable power. Many communities in
Puerto Rico still lack safe drinking water, and people have
resorted to drinking from questionable water sources. Where
water service has been restored, residents are still unsure if
the water is safe. In a recent EPA briefing to the Committee,
we learned that crews going into communities to test for water
quality were arriving only to find that people still lacked
adequate food and drinking water.
Congress must provide ongoing support in the aftermath of
these hurricanes to restore and rebuild. I hope that our
witnesses today will help us understand what needs to be
improved in the response and recovery efforts, so that Congress
can more effectively provide assistance and understand the
impacts on public health, not just today but in the months and
years to come.
Thank you, I yield back.
Mr. Green. Thank you, Mr. Chairman.
I thank my colleague for yielding to me today.
Our district in Houston, in Harris County, Texas, was
heavily impacted by Hurricane Harvey. We actually had at least
eight deaths in our district alone in a very urban area of
Houston. But I thank the heroism and the tireless work of our
first responders, public health professionals, community
members, for helping fellow Texans and Houstonians during their
time of need. I would also like to thank my colleagues for
supporting our two supplementals so far, and there will be much
more for, not just Texas, but Louisiana, Florida, Puerto Rico,
the Virgin Islands, and a number of other disasters.
The State of Texas and CMS need to work together to make
sure we are taking advantage of every opportunity to help
people in need, especially when it comes to Medicaid. I hope
CMS will act expeditiously to get the necessary resources to
our local hospital in Texas to help uninsured disaster victims.
We shifted to recovery in Houston and the Texas Gulf Coast and
are responding to public health concerns related to Harvey,
including the spread of mold in flooded homes, businesses, and
the spread of disease-carrying mosquitoes.
We must also be fully responsive to the environmental
impact of Harvey, including community members' possible
exposure to toxic chemicals and wastewater. I look forward to
hearing from our witnesses and working with our Federal public
health agencies to fully address these pressing concerns. And
in our office in Houston, we do a lot of casework on typically
Social Security, Medicare, veterans, you name it. But now every
staff member has casework with FEMA because it goes through the
process. But we are working through it, again, with our Federal
agencies helping us to make sure we can get people back to
where they were before the storm.
And thank my colleague, again, for yielding.
I yield back my time.
Mr. Pallone. And I yield back, as well, Mr. Chairman.
Mr. Griffith. I thank the gentleman.
I ask unanimous consent that the members' written opening
statements be made a part of the record.
Without objection, they will be entered into the record.
Additionally, I ask unanimous consent that Energy and
Commerce members not on the Subcommittee on Oversight and
Investigations be permitted to participate in today's hearing.
Without objection, so ordered.
Further, just so everybody knows what we are doing, Mr.
Duncan has joined the committee and the subcommittee. And we
are glad to have him on our subcommittee. However, until a
formal motion is made on the floor at approximately 12:30, the
Parliamentarians tell us that we have to treat him as a member
of the Energy and Commerce Committee but not yet on the
Subcommittee on Oversight and Investigations. So he will be
treated like all other members in that circumstance, which
means he will go last. As the newest member of the committee,
he would go last anyway, but we are just rubbing it in. No, but
I did want to let everybody else know what the status was so,
when they hear a motion later today on the floor, they will
understand that that is what the Parliamentarians have told us
that we need to do.
But welcome to the committee and the subcommittee.
Mr. Walden. Mr. Vice Chairman?
Mr. Griffith. Mr. Chairman.
Mr. Walden. I assume he knows, too, his other
responsibilities for all the committee members: getting us each
coffee----
Mr. Griffith. We have heard tell of these stories.
Mr. Walden [continuing]. Like Mr. Scalise----
Mr. Griffith. That is correct.
Yes. Thank you. We will make sure he is aware of those
duties, Mr. Chairman.
Finally, we welcome non-Energy and Commerce Committee
members who are with us today or who may show up at a later
time. Pursuant to House rules, Members not on the committee are
able to attend our hearings--and we are glad to have them--but
are not permitted to ask questions.
I would like now to introduce our panel of witnesses for
today's hearing.
First, we have the Honorable Robert Kadlec, the Assistant
Secretary for Preparedness and Response at the Department of
Health and Human Services. Welcome. Next is the Honorable Scott
Gottlieb, who serves as Commissioner of the U.S. Food and Drug
Administration. Welcome. Then we have Ms. Kimberly Brandt, who
is the Principal Deputy Administrator for Operations at the
Centers for Medicare and Medicaid Services. Welcome. We are
glad you are here. And finally, we have Rear Admiral Stephen
Redd, who is the Director of the Office of Public Health
Preparedness and Response at the Centers for Disease Control
and Prevention.
Thank you all for being here today and providing testimony.
We are looking forward to the opportunity to examine the
preparedness for and responses to the recent hurricanes.
Now, as a part of what we do in this committee, we are
holding an investigative hearing. And when doing so, it has
been the practice of this subcommittee to take testimony under
oath. Do any of you have objection to testifying under oath?
Seeing none, the chair then advises you that, under the rules
of the House and the rules of the committee, you are entitled
to be accompanied by counsel. Do any of you desire to be
accompanied by counsel during your testimony today?
Seeing none, I will move forward.
In that case, if you would please rise and raise your right
hand, I will swear you all in.
[Witnesses sworn.]
Mr. Griffith. Hearing affirmative answers from all, I
appreciate it. Thank you very much. You are now under oath and
subject to the penalties set forth in title 18, section 1001,
of the United States Code.
You may now give a 5-minute summary of your written
statement.
And, obviously, we will begin with the Honorable Mr.
Kadlec.
TESTIMONY OF ROBERT P. KADLEC, M.D., ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES; SCOTT GOTTLIEB, M.D., COMMISSIONER, U.S. FOOD AND
DRUG ADMINISTRATION; KIMBERLY BRANDT, PRINCIPAL DEPUTY
ADMINISTRATOR FOR OPERATIONS, CENTERS FOR MEDICARE AND MEDICAID
SERVICES; AND STEPHEN C. REDD, M.D., RADM, DIRECTOR OF THE
OFFICE OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR
DISEASE CONTROL AND PREVENTION
TESTIMONY OF ROBERT P. KADLEC, M.D.
Dr. Kadlec. Good morning, Mr. Vice Chairman, Ranking Member
DeGette, and members of the subcommittee. It is a privilege to
appear before you to discuss our Nation's medical and public
health response to a series of unprecedented and nearly
simultaneous Category 4 and Category 5 hurricanes that hit the
U.S. mainland and its territories so far this season.
HHS--and when I include that, it is the ASPR--the CMS, FDA,
and CDC, as well as our interagency partners of FEMA, DHS, VA,
and DoD, have pushed the boundaries in unprecedented ways to
save lives and support the communities and people impacted by
these major hurricanes. I recognize that, in some regions in
Puerto Rico and the Virgin Islands, people are still facing
dire conditions. I recently saw that for myself and the
devastation firsthand and can assure you that HHS continues our
response at 110 percent and will continue to work as hard as we
can until conditions improve.
Since this is my first time testifying before this
committee as the ASPR, I will begin with a brief description of
my view on the role of this position. After it was created
almost 11 years ago in response to Hurricane Katrina by the
Pandemic and All-Hazards Preparedness Act, its objective was to
create unity of command by consolidating all HHS public health
and medical preparedness and response functions under one
person, the ASPR. I had the privilege of serving as a staff
director of the subcommittee that drafted this legislation.
ASPR's mission is simply to save lives and protect America from
health security threats. On behalf of HHS, ASPR leads the
public health and medical response to disasters and public
health emergencies in accordance with the National Response
Framework Emergency Support Function No. 8.
Today, the threats facing our country are increasingly
diverse and more lethal. Therefore, my main objective is to
improve national readiness and response capabilities from 21st
century threats. I aim to do that through four key priority
areas and efforts: first, provide strong leadership; second,
create a national disaster healthcare system; third, sustain
robust and reliable public health security capabilities; and,
finally, advance innovative medical countermeasure development.
Hurricanes Harvey, Irma, Maria, and, lastly, Nate's near
simultaneity and severity created unique challenges. Especially
in Puerto Rico, no place, no person, no life was untouched.
During my trip there, I was overwhelmed by the resilience of
its citizens who are making do in extraordinarily difficult
situations. Of the three major hurricanes to date, our strategy
has been threefold: first, save lives; second, stabilize the
healthcare system; third, restore healthcare services.
In Puerto Rico, we're still responding. In other areas,
recovery is underway. Here are just some of the many actions
taken by ESFA partners:
In order to save lives, ASPR activated the National
Disaster Medical System, or NDMS, and deployed more than 2,500
personnel from 21 states and hundreds of other Federal
employees, including U.S. Public Health Service Commissioned
Corps personnel, to communities impacted by these storms. In
fact, in each of these storms, we deployed teams even before
the hurricanes made landfall so they were ready to respond
immediately. We cared for more than 15,000 patients in the
affected states and territories and more than 10,700 in Puerto
Rico alone. HHS has also sent 439 tons of medical equipment and
supplies to the affected areas. HHS declared public health
emergencies for impacted states and territories before landfall
with each storm.
ASPR and CMS proactively utilized the emPOWER tool to
identify Medicare/Medicaid beneficiaries in each impacted area
who rely on life-maintaining and assistive medical equipment as
well as people who rely on dialysis and home health services.
We evacuated more than 200 dialysis patients from the U.S.
Virgin Islands. In Florida and St. Thomas, for the first time
in its history, NDMS personnel joined urban search and rescue
teams to locate and evacuate dialysis patients.
HHS activated the Emergency Prescription Assistance Program
in Puerto Rico, which provides free medications to disaster
victims who cannot afford to pay.
HHS deployed mental health teams and activated behavioral
health hotlines, in partnership with SAMHSA, to aid people
coping with the psychological effects of these storms.
I'd like to show you a map. You can see it on your screens
and you have paper copies in front of you. This illustrates the
comprehensive approach to providing healthcare and DoD
services--pardon me, medical services we implemented together,
with our interagency partners at the VA and DoD, as well as the
Puerto Rico Health Department.
My overview of activities we took on behalf of Americans in
distress is just a fraction of what we actually did. I have not
and could not speak to all the work that HHS disaster medical
assistance teams and Public Health Service Commissioned Corps
personnel did. They are true American heroes who left their
families, their medical and clinical practices to render aid,
often in arduous circumstances.
We're committed to the long period of recovery ahead. We
also reflect on this experience by conducting a comprehensive
after-action review to identify ways to improve our capacity to
respond to future public health emergencies, be they naturally
occurring or manmade.
I thank you again for this opportunity to address these
issues, and I'm happy to answer any questions that you may
have.
[The prepared statement of Dr. Kadlec follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. Thank you. Thank very much.
Now 5 minutes for an opening statement for the Honorable--
--
TESTIMONY OF SCOTT GOTTLIEB, M.D.
Dr. Gottlieb. Thank you, Chairman Griffith, Ranking Member
DeGette, members of the subcommittee. I appreciate the
invitation to discuss the FDA's response to Hurricanes Harvey,
Irma, and Maria. My remarks today are going to be focused on
the impact of Maria on Puerto Rico because of the unique role
the FDA has in the island's recovery and because of the
enormous magnitude of the devastation that Maria caused to our
fellow citizens.
First and foremost, our commitment is to the people of
Puerto Rico as they begin the long recovery from the
overwhelming devastation. But FDA also has a broader mission in
Puerto Rico: A substantial portion of the island's economic
base is comprised of facilities that manufacture medical
products. This includes many critical medical products. There
are currently more than 50 medical device manufacturing plants
in Puerto Rico. Collectively, they produce more than 1,000
different kinds of devices. To date, we are especially focused
on about 50 types of medical devices manufactured by about 10
firms in Puerto Rico. These devices are critically important to
patient care because they may be life-sustaining or life-
supporting or the island may be the only manufacturing site for
these devices.
At the same time, we're focused on about 30 different
medically important drugs and about 10 biological devices or
biologics that are solely or primarily manufactured on the
island. Fourteen of these products are sole-source, meaning
they're manufactured only in Puerto Rico.
To avert shortages of critical medical products, we have
been working closely with our partners at FEMA, DHS, and, of
course, HHS to troubleshoot challenges related to getting fuel
for generators and raw ingredients for manufacturing processes,
as well as the logistics to move finished products off the
island. Our interventions have evolved as the nature of the
risk has changed, and our response progresses. Early on, we
helped individual firms secure landing rights for planes to
ferry off finished products that were, in some cases, at risk
of being destroyed by flooding warehouses. As days went on, we
started to get more actively involved in helping facilities
secure diesel fuel for generators. In the last week, we have
been actively engaged in helping a few facilities that
manufacture products critical to the blood supply secure small
quantities of medical-grade gases that they use in their
manufacturing processes. As the recovery efforts proceed, a lot
of these challenges are being solved through better logistics
and no longer require our active intervention.
That's the good news. We have processes in place now that
are helping guarantee supply of diesel fuel, raw manufacturing
ingredients, and medical gases, and other critical components.
But there will be other challenges that arise as this crisis
evolves.
The one that concerns us the most is long-term power. Many
generators weren't meant to function for months on end.
Moreover, a lot of the facilities can't return to full
production on generator power alone. Most are producing at
anywhere from 20 to 70 percent of their normal capacity based
on our informal survey. They won't be able to resume full
production until they get back on the power grid. And if they
don't return to the grid by the end of this year, we're
concerned that we could face multiple potential shortages
unless we can also help these facilities temporarily ship more
of their manufacturing off the island.
But with my remarks, I'd like to give you a perspective on
the human factor that we're seeing every day where we see the
island's residents taking often heroic steps to keep supplies
and critical products flowing and where the firms that
manufacture these items are taking their own extraordinary
steps as good corporate citizens to support these efforts. If
we're going to avert major product shortages, it's going to be
as a consequence of these efforts. I want to take a moment to
take note of these activities and to support them.
First and foremost, I want to take note of the Americans
who reside in Puerto Rico. The medical product industry
directly employs about 90,000 Puerto Ricans. And if we do avert
critical shortages, it will be primarily because of our fellow
citizens who returned to their post at this critical time, even
as their own families were displaced and their lives
devastated. We owe them all an enormous debt of gratitude.
I also want to use this chance to take measure of the good
corporate citizenship that FDA has been witness to. Even as we
watched some companies take extraordinary efforts to maintain
their production, they took equivalent steps to support their
employees and the families of their workers, using their
facilities as a way to deliver direct assistance to those
harmed by Maria. Many of these manufacturing facilities are
serving as disaster relief stations across the island. They are
helping distribute FEMA aid to the outlying towns. Companies
are distributing gasoline to their employees and general relief
items like water, food, and batteries. Facilities have been
using their cafeterias to feed employees and their families.
One multinational drug company told us that they shipped
thousands of generators to the island for distribution to their
employees as part of hundreds of tons of relief aid and
emergency supplies that they shipped by air and sea. We know of
companies that have created financial programs to help
employees rebuild their homes and resume their lives. Some of
these programs include cash grants or matched donations they
accept from employees across the globe as a way to help Puerto
Rico employees rebuild their homes.
I want to take a moment to recognize these efforts. These
kinds of commitments are going to be a key part of helping
Puerto Rico fully recover. We all need to do our part.
Most of all, I want to recognize the resilience of the
people of Puerto Rico and the fidelity to our public health
mission. The FDA has a long history of operating on the island.
It has been an integral part of our work. We owe the island's
residents our steadfast and long-term commitment to a full
recovery. Thanks a lot.
[The prepared statement of Dr. Gottlieb follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. Thank you. I thank you for your testimony.
And now I recognize Ms. Brandt for a 5-minute opening
statement.
TESTIMONY OF KIMBERLY BRANDT
Ms. Brandt. Thank you. Chairman Griffith, Ranking Member
DeGette, and members of the subcommittee, thank you for the
opportunity to discuss efforts by the Centers for Medicare and
Medicaid Services, or CMS, to respond to the recent hurricanes.
CMS plays an integral role in emergency response during
these natural disasters. I have almost 20 years of experience
working on Medicare and Medicaid issues. And even with that
perspective, I was surprised at the depth and breadth of CMS'
involvement in the hurricane response efforts.
This is a role our agency takes very seriously, as
evidenced by, even while I am here today, CMS Administrator
Verma is in Puerto Rico assessing our on-the-ground efforts and
gaining valuable insights from patients, providers, and local
officials. Many people think of CMS, firstly, as a pair,
reimbursing for the care delivered to our over 100 million
Medicare/Medicaid and CHIP beneficiaries, and, secondly, as a
regulator, overseeing and enforcing standards for the care
delivered by millions of providers and suppliers. While CMS
does not directly provide care to our beneficiaries, we do have
a direct impact on the care they receive. And the last several
weeks have allowed CMS to demonstrate the important role we can
play in emergency preparedness and response efforts.
One of CMS' most valuable emergency response tools is our
ability to waive or modify certain program requirements, which
CMS can do after the President declares a major disaster and
the HHS Secretary declares a public health emergency. CMS is
using the full breadth of this authority to ensure our
beneficiaries have access to the care they need by providing
flexibility to Medicare and Medicaid providers so they can
deliver high-quality care to those who need it, when they need
it, and where they need it. For example, we use waivers to
allow Medicare providers to move patients between facilities
and administer care in alternative locations and to expedite
Medicaid enrollment for out-of-state providers. Already, we
have approved nearly 100 waivers in total across the impacted
disaster areas.
Last month, I joined Administrator Verma on a visit to
Houston, Texas, where we are able to speak to several of those
impacted, including beneficiaries and providers who
demonstrated how important these flexibilities were to them
following an emergency. We want beneficiaries and providers to
be able to focus on their immediate needs to provide urgent
care without worrying about reimbursement policies, and we
heard firsthand during our visit what a difference those
flexibilities make.
That is why CMS is taking an active listening approach and
meeting and talking with stakeholders in all of the impacted
areas on an ongoing basis to make sure we understand their
needs and are able to meet them.
One of the Administrator's top priorities has been to
provide access to necessary care for one of our most vulnerable
beneficiary groups, dialysis patients, during these challenging
circumstances. One of the ways we have done this is using our
authority to temporarily designate dialysis facilities licensed
in locations impacted by the hurricanes--but that are not yet
certified--to serve as a special-purpose renal dialysis
facilities so they can provide care for Medicare beneficiaries.
In fact, we were able to designate one of these facilities in
Florida before the storm hit to ensure that patients were
dialyzed in anticipation of the storm.
In Puerto Rico and the U.S. Virgin Islands, CMS has been
working closely with ASPR, the Kidney Community Emergency
Response Program, and the End Stage Renal Disease Networks to
monitor conditions before, during, and after the storms to
predict and assess the impact to these extremely fragile
patients. Here are two examples of our combined efforts: Under
the direction of one of our CMS Commissioned Corps members, we
are working with these partners to daily track the operational
status of dialysis facilities in Puerto Rico and their status
with respect to fuel, water, and other supplies, as well as
developing delivery schedules for those supplies necessary for
the facilities to treat the nearly 6,000 dialysis patients on
the island.
CMS also partnered with several of our Federal and local
partners to arrange support for approximately 120 dialysis
patients evacuated from the U.S. Virgin Islands to Atlanta when
conditions were no longer safe in the Virgin Islands. This
included working with staff on the ground in Atlanta from day
one to greet and medically assess each patient as they arrived.
Unfortunately, these recent events will not be the last
public health emergencies our Nation faces. Making sure
providers and suppliers are prepared for future disasters,
whether it is a hurricane, wildfire, or disease pandemic, is
essential to ensuring patient safety. That is why CMS requires
all Medicare and Medicaid facilities to comply with basic
health and safety requirements, including emergency
preparedness standards, which we updated last fall. The updates
include a more comprehensive approach to emergency planning and
requiring facilities to more thoroughly address location-
specific hazards. In addition, we required facilities to meet
additional emergency training standards for staff and implement
a communication system to contact patients, physicians, and
other necessary persons to ensure continuation of patient care
functions.
While much has been done, there's still much to be done,
particularly in Puerto Rico, where over 50 percent of the
population is covered through a CMS program. Together, we must
continue to think creatively about all the ways we can help
ensure our beneficiaries have access to needed care, supplies,
and prescriptions, even in the midst of emergencies and natural
disasters. We appreciate the subcommittee's interest in these
efforts and look forward to working with you throughout the
recovery process.
[The prepared statement of Ms. Brandt follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. Thank you very much for your testimony.
I now recognize Rear Admiral Redd for 5 minutes for an
opening statement.
TESTIMONY OF STEPHEN C. REDD, M.D., RADM
Dr. Redd. Good morning, Vice Chairman Griffith, Ranking
Member DeGette, and distinguished members of the subcommittee.
I am Rear Admiral Stephen Redd, Director of the Centers for
Disease Control and Prevention's Office of Public Health
Preparedness and Response. I appreciate the opportunity to be
here today to discuss CDC's efforts and activities in response
to the 2017 hurricanes.
To address the impacts of these hurricanes, CDC has
provided public health support to the coordinated Federal,
State, local, territorial and Tribal responses. The focus of
CDC's efforts have been in epidemiology and health
surveillance, laboratory support, environmental and
occupational health, and health communications.
On August 30, 2017, CDC activated its emergency operation
center to coordinate our response to Hurricane Harvey, and
subsequently, we've expanded that activation to include
Hurricanes Irma and Maria. Since the end of August, CDC has had
approximately 500 staff members supporting the response.
Additionally, we have deployed over 70 staff to the affected
areas to provide on-the-ground support, including 34 to Puerto
Rico and 12 to the U.S. Virgin Islands. To address immediate
health concerns, CDC deployed Federal medical stations to serve
as temporary, non-acute, medical care facilities. Each Federal
medical station can accommodate up to 250 patients and includes
a cache of medical supplies and equipment. HHS deploys medical
teams to staff these facilities, and CDC has deployed six of
these to Puerto Rico, four to Texas, and two to Florida.
CDC has used syndromic surveillance to monitor health-
related data that may signal disease outbreak. Our National
Syndromic Surveillance Program has collaborated with ASPR's
disaster medical assistance teams to collect data on patient
encounters and works closely with the American Red Cross to
monitor data on shelter populations so that health officials
can respond quickly when that's called for.
Surveillance during this response has indicated elevations
in carbon monoxide poisoning. And this has led to increased
messaging to prevent this condition and guidance on the safe
operation of generators.
Identifying and controlling public health--diseases of
public health importance in Puerto Rico and the U.S. Virgin
Islands are a priority. The Puerto Rico Department of Health
sustained significant damage during Hurricane Maria, including
damage to their laboratories. These laboratories are not able
to conduct any public health tests. They're not able to confirm
diagnoses of infectious or environmental diseases. CDC is
working with the Puerto Rico Department of Health and FEMA to
get these laboratories back in operation. And, in the meantime,
we have arranged for packaging and shipment of clinical
specimens of suspected priority infectious diseases, such as
tuberculosis, leptospirosis, rabies, influenza, salmonella, to
the U.S. mainland for testing. In fact, the first shipment of
diagnostic specimens for leptospirosis recently arrived in
Atlanta.
Let me touch briefly on a few other components of our
response. We've provided technical assistance to the affected
areas to address health issues, such as food safety, water
issues, including sewage. We've provided guidance on injury
prevention from debris and drowning. We've helped with shelter
assessments. We've provided guidance regarding the safety of
responders, and we have developed and disseminated key public
health messages to individuals in the affected areas.
CDC recognizes that the full recovery from the recent
hurricanes will take time, particularly in Puerto Rico and the
Virgin Islands, where the damage has been extensive. But we're
here to continue to provide that support.
Thank you, again, for the opportunity to appear before you
to discuss our response and recovery efforts, and I'd be glad
to answer any questions you might have.
[The prepared statement of Dr. Redd follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. Thank you all very much for your testimony.
And I will now begin questioning by recognizing the
chairman of the full committee, Chairman Walden, for 5 minutes
for questions.
Mr. Walden. Thank you, Vice Chairman.
And I thank all of you for your testimony and the work that
the people that you represent are doing in these terrible
tragedies.
And we all know there's more to be done, and it's hard, in
the aftermath, to get it right. And we sure appreciate what
you're doing.
On behalf of the at-large Resident Commissioner from Puerto
Rico, Jenniffer, thank you for joining us today. I know you're
not able to ask questions as part of our committee rules, but I
can on your behalf. So I appreciate your submitting some of
these because I think they're really important to get on the
record.
So, Dr. Kadlec, I'm going to start with you. Puerto Rico
remains in the response mode of saving lives and stabilizing
healthcare services. What major milestones must be completed to
progress from the response phase to the recovery phase? If you
can just be fairly brief on that because I've got a couple
other----
Dr. Kadlec. Yes, sir, I think it has been highlighted by
members of your committee. The power situation on the island
does represent a significant limitation. Right now, we have
about 60 percent of the 67 hospitals that are on the power grid
and have reliable power. But there are 36 percent, total of 24,
that still do not. And that's an important benchmark in terms
of our ability. The other----
Mr. Walden. What do you think the timeline is to get them
the power they need?
Dr. Kadlec. Sir, I really wouldn't be in a position to
answer that. I think the U.S. Army Corps of Engineers is trying
to move as aggressively as possible to do that. They have
prioritized hospitals, health clinics, and dialysis centers on
the top of the list to, basically, re-electrify with the grid.
So I think the intent is to get them up as quickly as
physically and humanly possible.
The other part of the sustainment is also knowing about the
operational status of those hospitals, because some of them
have physical damage, to ensure that they can basically resume
full functionality. It is, again, working closely with FEMA and
with the Army Corps of Engineers. We performed assessments of
those hospitals to identify which ones need physical repair.
And then there are also issues that relate to supply-chain
restoration, things like oxygen, which I think is a matter of
topical interest here.
Mr. Walden. All right. Thank you.
Rear Admiral, thank you for being here and, again, for the
work you're doing.
How is the CDC Dengue Branch in Puerto Rico being utilized
during this recovery effort? And then I have one more for you.
Dr. Redd. Yes. The Dengue Branch was affected just like
every other location in Puerto Rico. As of October 10th, the
laboratory is back in operation. It's functioning at a low
level under generator power right now. So I think it's more in
the affected than in the response zone of the efforts at this
point.
Mr. Walden. When do you think it might be up to full
operation?
Dr. Redd. I think some of the issues that Dr. Kadlec raised
would be germane to the full activation and operation of the
Dengue Branch lab as well.
Mr. Walden. All right. Particularly concerning is the
damage to Puerto Rico Department of Health public health labs.
To date, the labs are not able to conduct any public health
testing, including the ability to confirm diagnoses of
infectious and environmental diseases. What will it take to get
them up and running? And, in their absence, what is happening
to do this kind of lab work?
Dr. Redd. Yes, sir. So restoring power is the first step.
There is work with the Army Corps to identify the generator
capacity needed to bring the laboratories back to power. There
will be a second level of effort to determine what equipment
can be salvaged and what equipment can't be salvaged. So we
don't know the results of that assessment until the power is
back. So it is going to be some time.
Mr. Walden. You don't know a timeline on power?
Dr. Redd. I think, for generators, we're talking weeks at
the most.
Mr. Walden. That they'll be running on generators or before
they get them----
Dr. Redd. Generators. Yes. And maybe less than that. So I
can't say about the back on the grid. But there should be power
to the labs within a relatively short period of time.
In the meantime, we are working with the Department of
Health in Puerto Rico to ship specimens to Atlanta for testing.
And that's where the first shipment of leptospirosis cases has
been shipped.
Mr. Walden. And are you comfortable with that kind of
arrangement to do the lab testing? Is that quick enough? Is it
adequate enough?
Dr. Redd. It's certainly not optimal. I think it's the best
that we can do at this point in time. I think that what we
really need is to be where those tests can be done in Puerto
Rico and having the lab back up to full speed.
Mr. Walden. But if it's going to be weeks before that can
happen, is there a temporary sort of lab that could be flown in
there?
Dr. Redd. We've had quite a bit of discussion on that. I
think that, in general, the feeling is that getting specimens
to Atlanta for testing is going to be, since it's not going to
be a very, very prolonged period of time, that this is a
temporizing measure. It's not optimal, but it's the best that
we can do under the circumstances.
Mr. Walden. It works? You feel it works?
Dr. Redd. Yes, sir.
Mr. Walden. All right. My time has expired.
Mr. Vice Chair, thank you for this hearing.
Again, thank you for your testimony.
Mr. Griffith. Thank you, very much, Mr. Chairman.
I now recognize the ranking member of the subcommittee, Ms.
DeGette of Colorado, for 5 minutes.
Ms. DeGette. Thank you, so much, Mr. Vice Chairman.
I just want to remind the panel: You all know very well
it's now been over a month since Maria hit both the U.S. Virgin
Islands and Puerto Rico. And, even now, there was just an
article in The New York Times today which is entitled ``'Like
Going Back in Time': Puerto Ricans Put Survival Skills to
Use.'' And it's a very powerful article that talks about how
people still don't have power. People are still eating canned
foods. Elderly people are afraid to go outside because of
gangs. And what it talks about is the way everybody is helping
themselves is the neighbors are bonding together. And there's a
fellow, the director of a local nonprofit, said most of the
aid--the neighborhood, which appears to be in San Juan, not in
the remote mountains, had received was from private citizens
and celebrities. Quote: ``The government hasn't arrived here.''
As I mentioned in my opening remarks, having been on this
subcommittee when we investigated Katrina, it's wonderful to
reflect back on what we've done. But it's more important to
think about, A, how quickly we can do more. And, B, what we can
do to improve our efforts in the future. And I just want to
remind,, everybody, listening to a lot of this testimony, you'd
think that everything was just swell. And I hope none of you
intended to intimate that. And I know we're going to have a lot
of questions about that.
But, Commissioner Gottlieb, I kind of wanted to hone in
with you about your testimony because, as you said, there are a
lot of drugs and devices that are produced in Puerto Rico.
There's 13 of them that are--drugs--that are only produced in
Puerto Rico. Is that correct?
Dr. Gottlieb. There's more than 13. There's probably
somewhere in the nature of 40 sole-source drugs but only 14
that we think are critical insofar as they are medically
important and we couldn't find a therapeutic alternative. So
we're focused on about 14 products.
Ms. DeGette. About 14. And most of the plants where those
drugs are being manufactured are relying on generators. Is that
right?
Dr. Gottlieb. That's right. I believe almost all, if not
all, of the plants are on generator power.
Ms. DeGette. On generator. Now, I think you testified that
this is not a long-term solution. Is that right?
Dr. Gottlieb. That's right, Congresswoman. There are some
facilities that have substantial generators and probably could
operate for a sustained period of time.
Ms. DeGette. What do you mean by ``a sustained period of
time''?
Dr. Gottlieb. Some of them are very hardened. So I don't
want to say that there aren't facilities there that couldn't
operate, perhaps indefinitely, on generators. But that's the
exception. Most of those facilities will not be able to operate
for a sustained period of time.
And if we get into the first quarter of next year and these
facilities aren't back on the grid, we're going to have some
concerns. And so we're trying to think now how we can work with
our partners at HHS and the Army Corps of Engineers to
prioritize a handful of the facilities that are critical.
Ms. DeGette. And the reason you're going to have concerns
is sort of twofold. Number one, the generators don't produce
the kind of energy that they need to produce these products,
right?
Dr. Gottlieb. That's right.
Ms. DeGette. And, number two, even if you can use it, it's
going to be a reduced supply.
Dr. Gottlieb. That's right. I know of one firm that's
producing at 100 percent output right now, but they've dialed
back certain portions of the facility. In most cases, these
facilities can't operate at 100 percent production on their
generators----
Ms. DeGette. Right.
Dr. Gottlieb [continuing]. And they certainly can't operate
100 percent of their facilities on the generators.
And the other point is that the generators themselves are
going to start to break down. These weren't meant to operate--
--
Ms. DeGette. That's right. They are not meant to operate.
Dr. Gottlieb. That's right.
Ms. DeGette [continuing]. These plants.
Now, let me just ask you quickly. On Friday, you released a
statement that said the FDA is monitoring about 50 types of
medical devices manufactured in Puerto Rico that are critically
important to patient care, including everything from insulin
pumps to pacemakers. Is this the same kind of problem that
we're seeing with the drug manufacturers?
Dr. Gottlieb. Same challenge. So these are 50 devices that
we're monitoring, manufactured by 10 different firms. And it's
a similar challenge. In some cases, the device manufacturing is
more energy dependent and the facilities themselves need a more
reliable flow from the grid. So, even as these facilities get
put back on the grid, if the grid itself is unreliable, they
might prefer to stay on their generator power for a longer
period of time. And many of them also are going to want dual
feeds off the grid. So it could be a while before some of these
facilities could get the kind of connection to the grid that
they need.
Ms. DeGette. Mr. Chairman, let me just say, if anybody has
any concern this is impacting all American families, my
daughter, who is a Type 1 diabetic, just got a letter from
Medtronic last week saying her new insulin pump was not going
to arrive because of the problems we're having in Puerto Rico.
So this is impacting every American, not just the Americans in
the U.S. Virgin Islands and Puerto Rico. Thank you.
And I'd like to ask unanimous consent to put that New York
Times article into the record.
Mr. Griffith. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Griffith. I now recognize the vice chairman of the full
committee, Mr. Barton of Texas, for 5 minutes for questions.
Mr. Barton. Thank you, Mr. Chairman.
I want to extend my personal welcome to our newest member,
Mr. Duncan. He's an outstanding member of the Republican
baseball team that I manage, like Mr. Costello. And I'm sure
he'll do just as good, if not a better, job on the committee.
So we're glad to have you, Jeff, and look forward to a bright
future with you.
Mr. Chairman, I appreciate this hearing. I know the primary
focus is Puerto Rico and the Virgin Islands, but we had a
hurricane in Texas too. We're a little bit more developed as a
state, so our ability to endure it was possibly somewhat
stronger. Having said that, there's still issues in Texas.
My first question, I think, will be to Mr. Redd. In a
normal year, there's a lot of mosquitoes in the Houston area.
But, given the amount of water that was sustained and we still
haven't had a freeze, so we still have that issue, what
cooperation, if any, have you and your agency had on helping to
minimize that problem in the Houston area specifically but the
Gulf Coast generally?
Dr. Redd. Yes. We operate as part of the combined Federal
response here. We've worked with DoD through the FEMA managed
response system to provide advice on what kind of mosquito
control efforts would be most appropriate. And we've worked
with that system. We don't do spraying ourselves, but we
provide that expertise on mosquitoes.
Mr. Barton. As far as you know, there's not an issue of not
enough insecticide?
Dr. Redd. That's correct. This is a problem that happens
after virtually every hurricane which has a rain element to it.
The types of mosquitoes that follow a hurricane typically
aren't the ones that transmit disease. And there's pretty much
a standard approach to that with CDC providing technical
advice, DoD providing the equipment and actually doing the
spraying in consultation with the local mosquito control
districts.
Mr. Barton. Similar question. I guess this would be to Dr.
Kadlec.
Is that correct?
Dr. Kadlec. Yes, sir.
Mr. Barton. Lots of Medicare patients in the Texas Gulf
Coast area, and many of them have had to go to hospitals for
treatment. Under current regulations, does CMS have the
authority to reimburse these hospitals for the emergency
treatment of Medicare patients?
Dr. Kadlec. Sir, since we have a representative from CMS,
I'll ask Ms. Brandt to maybe respond to that.
Mr. Barton. Well, that's my fault. I should have directed
it to her to start with.
Ms. Brandt. No problem, sir. Thank you.
We are currently working with state officials to work with
them on the uncompensated care issues and to develop a plan so
that we can make sure to appropriately reimburse those
providers.
Mr. Barton. Is there anything the State of Texas needs to
supply CMS to get that put together fairly quickly?
Ms. Brandt. Currently we are working with the State
officials to do what's called a multistate 1115 waiver to allow
them to request Federal matching dollars for an uncompensated
care pool, and that would be for those people who have been
displaced or who needed to receive care within the disaster
area. So we are working with the state and hope to complete
that in the foreseeable future.
Mr. Barton. Well, I'm the co-chairman of the Texas
Congressional Delegation Harvey Task Force. My Democrat co-
chairman is Henry Cuellar. If there's anything the delegation
needs to do to assist in that, if you'd let his office or my
office know, we'll make sure that you get whatever information
that you want.
Ms. Brandt. We will certainly do so, and we will keep you
apprised of that, sir.
Mr. Barton. Thank you.
And with that, Mr. Chairman, I yield back.
Mr. Griffith. The gentleman yields back. Appreciate that.
I now recognize the chairman of the full committee, Mr.
Pallone of New Jersey, for 5 minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman.
At a recent press event with the Governor of Puerto Rico,
President Trump said that he would give his administration a 10
on its response efforts in Puerto Rico. But I have to be honest
with you, from what I hear from my mayors and council people
and people that are coming into my district from Puerto Rico, I
would give at best a 2 on a scale of 1 to 10.
And my concern is, as I expressed a little bit in my
opening statement, that this isn't only an issue of what's
happening on the island, but also the people that are coming to
the United States that have needs. And I don't think they would
be coming here if they were able to stay in Puerto Rico.
Just as an example, I'm looking at the Home News, which is
my daily in New Brunswick, which is one of my towns in my
district, and it says that when the Puerto Rican Governor
visited with President Donald Trump on Thursday to ask for aid,
he said that without immediate help from the United States to
rebuild the island there would be a mass exodus to the mainland
of the United States.
And then we have a professor at Rutgers, which is in my
district, who said that the number of Puerto Ricans who will
move to the Garden State due to the storm will likely spike
once people determine they can't stay on the island longer if
power and access to running water, food, and Medicare do not
improve.
Now, I obviously would like people to come here if they
can't get basic necessities on the island. But, I mean, this
is--you know, the fact that the President would call this a 10
is absurd, in my opinion.
So let me start with Dr. Kadlec. Recent reports still
indicate that nearly 80 percent of the Americans on the island
are without electricity. One mayor reported that his city's
ambulances had responded to at least four calls where a patient
who had lost power for oxygen tanks or ventilators had died.
Other reports have stated that hospitals have had to take in
patients from medical centers where generators have failed.
I'll tell you, when we had Sandy, I think our power was out
for 2 weeks and it was impossible. I can't imagine going for
months without power.
So, Dr. Kadlec, a lack of reliable electricity has created
serious risks to the health of American citizens in Puerto
Rico. Would you agree with that?
Dr. Kadlec. Sir, it's decremented the whole society there.
So the answer is, yes, it is a risk to people.
Mr. Pallone. All right. Well, I appreciate your honest
response.
Last Friday, CNN reported that a million Americans on the
island or about 35 percent of all residents still lack access
to running water. And I understand that without adequate
drinking water or safe running water to provide basic hygiene,
affected populations run the risk of serious gastrointestinal
and related diseases. Again, in Sandy, I think I only went a
couple days without a shower and I couldn't deal with it.
So let me ask, I guess, Dr. Redd, would you agree that if
nearly a million Americans lack access to reliable clean water
that this poses a major health concern?
Dr. Redd. Yes, sir.
Mr. Pallone. All right. Thank you.
This morning an article in The New York Times described the
situation in Puerto Rico like going back in time. And WIRED
Magazine previously reported that the breakdown in electricity
and telecommunications systems had pushed Puerto Rico ``back a
century or so.''
Just yesterday, the FCC reported that nearly 70 percent of
the island's cellphone towers are still out of service. Again,
lack of communication, lack of cell towers, you can't even
address emergencies if you can't communicate.
So let me go back to Dr. Kadlec. Would you agree that a
functioning communications system is also an essential
component to reaching and communicating with Puerto Ricans to
ensure that healthcare needs are met?
Dr. Kadlec. Sir, it is. And we've done a lot to basically
ensure that we have positive communications with those
hospitals on the island, either by radio, cell communication,
or landline.
So we've really worked hard to maintain--we actually
deployed National Guardsmen with satellite phones initially
when there was no cell service on the island to ensure that we
could keep positive contact.
And to your point about the generators, sir, I think that's
a fair one. But, quite frankly, sir, we've created a whole
system to basically address that.
And, in fact, when I was there the first week after the
storm, Humacao, one of the hospitals where one of our DMAT
teams was located, co-located, lost generator power. And they
had several patients in the intensive care unit, actually a
couple having surgery at the time, and we were able to transfer
those patients safely without loss of life not only to our
shelters where our DMAT teams were, but transport them through
ambulances, Medevac helicopters.
Mr. Pallone. Well, I appreciate that.
Dr. Kadlec. The point is, so that we've gone to
extraordinary steps to basically help----
Mr. Pallone. All right. Well, I appreciate it.
Let me just issue one thing as my time runs out. The
President said it's a 10. I gave it a 2. Would you give me a
number between 1 and 10?
Dr. Kadlec. I'm not in the business to give you marks, but
I can tell you we're working 110 percent even today to help
those people, help our fellow Americans on that island.
Mr. Pallone. I appreciate that.
Thank you, Mr. Chairman.
Mr. Griffith. Thank you so much.
I now recognize the gentlelady of Indiana, Mrs. Brooks, for
5 minutes for questions.
Mrs. Brooks. Thank you, Mr. Chairman.
And thank you to all of our panel members for being here.
Dr. Kadlec, I want to talk a little bit more about the
National Disaster Medical System that you've described. And I
know you've only been on the job for a few months now. In fact,
how many months have you been on the job?
Dr. Kadlec. Sixty days.
Mrs. Brooks. Sixty days. Tough first 60 days.
Dr. Kadlec. It has been a baptism.
Mrs. Brooks. And obviously you were very familiar with the
organization prior to becoming in charge of ASPR. Are there
reforms to the National Disaster Medical System that you're
already considering, or are there challenges you've already
faced, whether it's on the deployment, whether it is on the
number of resources you have or the authorities you have? And
if so, what are they?
Dr. Kadlec. Ma'am, all the above. I think one of the things
that this event demonstrated, because of the extraordinary
nature, and to Representative DeGette's point, to go down there
and actually see the devastation is pretty extraordinary. I've
made five combat tours in Iraq, and I never saw anything like
what I saw in Puerto Rico, number one.
Number two is, that would kind of simulate what we'd
probably expect if we had a nuclear detonation without the fire
or the radiation. So the physical destruction to that island,
as I said, affected everyone, and the psychological and
physiological effects are pretty extraordinary.
To that point, we were stretched in terms of our DMAT
capabilities or NDMS capabilities to deploy. I give a lot of
credit to those DMAT physicians, nurses, paramedics,
pharmacists from your states who basically deployed down there
on numerous occasions. We had people from Colorado who were at
Harvey, Irma, and now Maria.
And so the answer is, is that we probably need to do some
creative thinking how to do that. We worked very well with the
VA in Puerto Rico. We need to probably work better with DoD on
that.
But I think there are a lot of things we need to do to
remove dependencies that require us to basically do ``Mother,
May I'''s for transportation. We probably need a larger supply
capability. And we need to move things faster and better.
That said, we deployed before landfall, we had 150 people
from our DMAT teams in San Juan riding out that storm. So we
have extraordinary people doing extraordinary things. They're
from your jurisdictions. They're American heroes. And we
probably don't give them enough credit, and we certainly don't
give them enough resources.
Mrs. Brooks. And, Dr. Kadlec, with respect to the
authorities of ASPR, has it been clear as to who is actually in
charge of the response efforts, or do there need to be
additional operational capabilities provided to ASPR?
Dr. Kadlec. Ma'am, I think that's something that we're
going to do an after-action and look at that. I'd like to say
we were able to do pretty well. I think we can do better. But
I'd like to hold an answer on that to work with your staff to
identify those things. Again, to remove those dependencies, the
``Mother, May I'''s for ambulances, for air transportation, for
a variety of things, are things that we need to resolve.
Mrs. Brooks. Thank you.
Ms. Brandt--and, again, I have some questions also provided
by Representative Gonzalez--apparently, prior to the hurricane,
retention of medical personnel has been a challenge to Puerto
Rico. And so prior to Hurricane Maria, according to my
colleague, almost a physician a day would leave the island,
would not be practicing there, and it affected a number of
specialists left in the territory. How is that impacting the
short-term and long-term recovery efforts?
And I actually received communication from a constituent of
mine whose cousin was a specialist overseas at the time that it
hit, and she had difficulties getting back on to the island to
help her people.
And so what is CMS doing relative to the physician
retention issue?
Ms. Brandt. Thank you for the question, and that is
something that CMS is very concerned about and very aware of.
In terms of the retention issue, we've been working with
the Department of Health on the island and seeing what
flexibilities we can do administratively to be able to lift any
requirements that would make it easier for people to stay on
the island or to work with them, to see what other types of
programs that we have that would provide incentives for
physicians and other medical personnel on the island. But
ultimately that is a decision by the government of the island.
In terms of allowing people to come in to assist with the
efforts on the island, especially in wake of what has happened,
we have waived many different regulations and other authorities
that we have that would have limited out-of-state--or out-of-
territory in this particular instance--providers to be able to
come in and provide care, and have been working with the
Department of Health on the island to see what else we can do
to ensure that they have as much access to as many personnel as
we can get them.
Mrs. Brooks. Thank you for that flexibility.
My time is up. I yield back.
Mr. Griffith. I thank the gentlelady.
I now recognize the gentlelady of Florida, Ms. Castor, 5
minutes for questions.
Ms. Castor. Thank you, Mr. Chairman.
Over a month later, folks in Florida and all across the
country are still reeling from the avoidable deaths in the
nursing facilities in Florida. There are now criminal cases.
There are civil cases. We're trying to figure out why in the
heck Florida's governor has deleted voicemails that came
directly from the center to his cellphone.
But there's an important backstory here. In 2005, after
Hurricane Katrina and the 215 deaths in nursing homes there,
CMS and everyone determined, well, many skilled nursing centers
are not prepared. So you went into rural development then to
try to ensure that there is going to be an alternative power
source available. I understand that it will be November when a
CMS rule relating to alternative power sources for skilled
nursing centers will come into being, will become effective.
Why has it taken so long? And are you confident that it
will do what we need to do?
And I want to recognize my colleague, Congresswoman
Wasserman Schultz from south Florida, and thank Congresswoman
Wilson and the Florida delegation that has been pressing this
issue as well.
Ms. Brandt. Well, first of all, let me just state that from
CMS's perspective, we share everyone's concern about the
tragedy that happened at Hollywood Hills. That's an event that
should not have occurred. And from a CMS perspective, our first
and ultimate priority is ensuring that we have patient safety
and patient protection at every one of the facilities that
accepts Medicare and Medicaid beneficiaries.
With respect to the rule itself, to clarify, the rule went
into effect last year. We will begin serving against it in this
November. So the rule actually went into effect last year, it's
just that the actual surveys against it will go into effect
starting next month.
However, it is something that we think does go a long way
toward addressing a lot of the concerns that have been raised
by Hollywood Hills. But in light of the event there, we want to
continue to look at it to see if we could do more.
But some of the things it does that were pointed out as
part of the problem at Hollywood Hills are ensuring that there
is an emergency preparedness plan at every facility, ensuring
that every facility has adequate backup supplies, such as
generators and others, to be able to provide that there's a
temperature between 71 to 81 degrees within the facility and
that it doesn't go beyond that.
We also are working to make sure that the appropriate staff
are trained so they know what to do in the case of an
emergency. Based on the reports that I've read of the incident
at Hollywood Hills, several of the failings that led to the
unfortunate set of circumstances were that the personnel did
not respond to the emergency preparedness plan. The personnel
were not adequately trained on the plan, and they weren't able
to take steps accordingly. And those are things that we are
going to be working with to ensure that, as I said, we survey
people going forward, starting in November, that that's
happening.
Ms. Castor. Thank you. And I encourage you to do that on an
expeditious basis because that timeframe is not acceptable.
And, Ms. Brandt, health services provided under Medicaid
play a critical role in how quickly families are able to
recover from natural disasters. Following Katrina, the Bush
administration took a number of actions to ease barriers to
health insurance coverage through Medicaid. For example, CMS
allowed for a temporary expansion of Medicaid eligibility in
affected areas, a moratorium on eligibility redetermination,
self-attestation of all Medicaid eligibility factors, and
various waivers. And Congress in the Deficit Reduction Act
acted to ensure that states were fully reimbursed at 100
percent FMAP.
Does CMS intend to take similar actions in response to
Harvey, Irma, and Maria? What exactly, and what, if any,
difference will there be between Puerto Rico and the U.S.
Virgin Islands and the states and the mainland?
Ms. Brandt. So multiple parts to the question.
So with respect to the self-attestation in the eligibility
requirements, we have already put in place all of those same
flexibilities that were in place for Katrina to allow it, so
that people have the flexibilities to self-attest, if they
don't have their appropriate documentation, if it was lost in
the floods or the winds or any of the other natural disasters.
So that is already taking place.
With respect to the uncompensated care pools that you
mentioned, that is something that we're working with the Office
of Management and Budget to work with Congress on because that
is something that only Congress can address from a funding
perspective.
And then, with respect to how the states are treated
differently than the territories with respect to that, we've
basically been holding them all to having the same amount of
waivers and the same amount of flexibilities across the board.
But one of the things that we are watching is, as has been
mentioned, the number of people leaving Puerto Rico and going
to the states and making sure that we're working with the
states that they're going to, to make sure those states are
compensated for the care that they're providing to those
evacuees.
Ms. Castor. Good. I'll look forward to working with you
more on it.
And thank you to the panel.
Mr. Griffith. Thank you very much.
I now recognize the gentleman from Michigan, Mr. Walberg, 5
minutes.
Mr. Walberg. Thank you, Mr. Chairman.
Thanks to the panel for being here.
I have a few questions as well that Congressman Jennifer
Gonzalez-Colon has asked to address, and they're important,
because I think they address some concerns now, but even for
future consideration.
The first, would it be beneficial to postpone the Medicare
Advantage enrollment period to January of 2018--I ask this of
Ms. Brandt--given that 80 percent of the population is without
electricity and telecommunications remains largely down
throughout the island? What would be your answer to that?
Ms. Brandt. We have been working to establish a special
enrollment period for the citizens of Puerto Rico so that they
have flexibility because we recognize that many of them may
have trouble meeting the current enrollment period.
Mr. Walberg. OK. So that is viable with that?
Ms. Brandt. Yes.
Mr. Walberg. OK. How are you ensuring that Puerto Rico has
the medicine it needs?
Ms. Brandt. On that one, I would defer to Dr. Kadlec
because that's more of a supply chain issue. We simply pay for
the prescriptions.
Mr. Walberg. OK.
Mr. Kadlec.
Dr. Kadlec. So there have been several approaches to
basically address medicines on the island. Probably the most
important thing we did with the principal medical supplier on
the island was provide them fuel to maintain their generator so
they could keep refrigerated products and basically maintain
their supply chain as well as making sure their trucks had gas
to deliver it.
We've also been monitoring the availability or the
functionality of pharmacies. There are over 700 pharmacies on
the island; 92 percent, 93 percent of them are open at the
present time.
We have worked with mainland distributors of temperature-
sensitive items to ensure that they can basically push in
there. Insulin is a very big one that we've worked with people
as well as with the major transporters of materials in to make
sure that those issues are--materials are prioritized.
I'd also turn to Dr. Gottlieb because his agency has been
very influential as well as working with mainland suppliers to
bring in products. But we've been working at a variety of
different ways.
Our DMAT teams have caches that they take and provide
pharmaceutical resupply to not only hospitals, to patients they
see anywhere. We've done tailgate medicine where we've actually
gone into areas that are rural, remote, and have been cut off.
Done so by helicopter and altering vehicles to ensure that we
can deliver medicines to people who need them.
So we've gone through a variety of different lengths, some
very straightforward and some pretty exotic to do so, but we've
tried to meet whatever need is out there.
Mr. Walberg. OK.
Commissioner Gottlieb, could you respond to that as well,
especially in context with the power problems and how we're
keeping up with the pharmaceuticals?
Dr. Gottlieb. The point that I'd add to the comments is
just that there's a number of facilities that manufacture
largely and predominantly for the island of Puerto Rico on
Puerto Rico and we've prioritized those facilities.
So in terms of how we've thought about our mission, we have
prioritized manufacturers who supply critical products to the
people of Puerto Rico. So there are some local manufacturers
that, for example, provide sterilization services to the
hospitals that fall within FDA's regulatory scope. And so early
on we worked to prioritize getting those back online.
Mr. Walberg. Mr. Gottlieb, one more question. It's been
reported that medical oxygen production and access continues to
be a challenge in Puerto Rico. Could you please update the
committee both on the actions the FDA is taking to ensure that
all patients and facilities that require oxygen are able to
receive it as well, as the agency's actions to guard against a
potential shortage of medical oxygen?
Dr. Gottlieb. Yes, we've worked with our partners at HHS.
I'm going to defer to them on this because they've played a
more active role directly with these facilities.
Dr. Kadlec. Sir, there are two principal suppliers of
oxygen on the island. Both of them are back operational on the
grid right now. There was a smaller supplier and then a very
large supplier of oxygen, and they both suffered loss of
electricity in the immediate aftermath of the storm.
Again, barging in oxygen cylinders, it's not something you
can fly in necessarily. But oxygen is not the only gas that's
needed. CO2, nitrogen, argon, are all medical gases
that are needed by manufacturers as well as the clinics out
there.
So we basically have been trying to move what we could. The
USS Comfort, which is floating around the island on the western
side, can produce oxygen. And so we were actually filling
cylinders of oxygen using the Comfort's capabilities to
basically provide that, as well as bring in liquid oxygen
generators so that we could actually provide temporary filling.
So right now I think we're on the right side of the oxygen
problem. Both facilities are operational. And I think the
supply should be sufficient as we go over time as the capacity
and particularly the larger manufacturer comes full steam.
Dr. Gottlieb. Just to build on that, I'll tell you there's
a number of medical product manufacturers who use oxygen and
nitrogen in their manufacturing processes. They've been able to
secure the supply they need. In a few instances, historically,
we had to prioritize getting some of those supplies onto the
island or from the island.
But in most cases they're sourcing that outside the island.
That seems to be stable right now. We've moved past what I
think is the critical phase of trying to work through this.
Most of the facilities that need access to medical gases for
their manufacturing processes are getting them now.
Mr. Walberg. Thank you. I yield back.
Mr. Griffith. I thank the gentleman.
I now recognize the gentleman from California, Dr. Ruiz,
for 5 minutes.
Mr. Ruiz. Thank you, Mr. Chairman, for holding this
hearing.
By way of background, I'm a board certified emergency
physician. I was trained by the Harvard Humanitarian Initiative
on humanitarian disaster aid, including the International
Committee of the Red Cross.
And I was one of the first responders after the earthquake
in Haiti and the medical director for the largest internally
displaced camp in all of Port-au-Prince after that earthquake
and worked hand in hand with the 82nd Airborne.
I have seen firsthand the challenges that arise in the
middle of a humanitarian crisis and the importance of having
clarity and a plan and have clarity in coordinating among
agencies, local government officials, and NGOs in the field.
So while I am grateful that we are having a hearing on this
issue with HHS, we need a fuller, more accurate view of what is
happening in Puerto Rico with all stakeholders from all levels
of government and all the different agencies, including
clinical workers and NGOs and people that are actually on the
field.
Two weeks ago, I flew down to Puerto Rico to see the
conditions for myself and do a needs assessment based on my
training and my experience. I'm here to report to you what I
saw and give you some helpful recommendations.
One, the people of Puerto Rico are very hardworking, humble
people with respect for themselves and their dignity, and
they're doing everything possible to help one another, to get
the job done, to take care of one another.
Number two, the people who work in your agencies are giving
110 percent. I have to give kudos to the DMAT teams that I
spoke with firsthand. California 11 from Orange County and
Sacramento did fabulous jobs. The HHS liaison was there doing
an amazing job.
I went further into the community and did not stay in San
Juan and listen just to leaders. I listened to pediatricians on
the ground, shelter coordinators, patients that were on the
ground. And what I can tell you, these are the problems.
One, there's a lack of clarity of leadership. I'm talking
to high-level officials from all the different agencies, and
I'm not going to mention names, but the folks in the Puerto
Rican Government are saying that FEMA is running the show.
People at FEMA are saying that we're taking orders from the
Puerto Rican Government. I talked to people from HHS, and
they're saying, we don't communicate very much with the needs
with the DoD. And so there's a lack of clarity with who's
actually running the show in Puerto Rico.
Two, there's a lack of coordination. You're not going to
get the full picture, folks, if you stay in San Juan. You're
not going to get the full picture if your leadership and people
making decisions are based in San Juan in a convention center
with air conditioning and food and drinks and everything.
You've got to get your butts out of San Juan into the remotest
areas in Puerto Rico to talk to people and see firsthand.
So the problem is that there's a lack of priorities and
clarity in the metrics that you're using and what you're
telling the American people what your efforts are.
What does it mean when you say that bottles and food were
delivered to all municipalities for PR purposes so that people
get a sense that you're doing your job, when, in fact, what you
should be talking about is capacity for food supply chains,
capacity for electrical grid repairs, capacity to deal with the
need?
All of you have mentioned numbers and the numerators and
the number of clinics and the number of people on the ground.
But what you haven't mentioned is a denominator, the actual
need. So of your hospital capacity, what is the capacity to the
overall need that the people on the ground actually need?
So this is my one recommendation. And I strongly agree that
you will be able to better handle the situation on the ground
with a lot more sense of urgency and realtime flexibility.
Yes, keep your command center in San Juan, but create
command posts on the ground with representatives from the HHS,
the Army Corps of Engineers, the DoD, Department of Housing,
Department of Homeland Security with FEMA, the representatives
from the local grid, Federal and state counterpart, including
NGOs and local mayors, so they can have daily briefing and
problem solving as they arise on the ground.
Let me give you an example. I went to one clinic. They had
a generator fixed by FEMA. The local clinic didn't know that
that generator that FEMA installed went down. They were without
power for 2 days turning patients away. They didn't have a
number to call the Army Corps of Engineers to determine whether
they were on the queue.
I went to a temporary shelter at a local school in one of
the communities. They were going to close their doors on
October 23 when school starts. The mothers tell me their
children needed bottled water. There is a Department of Defense
Army guy saying, ``Doc, we have a caseload of bottles, can we
get authority to move them down?'' Hell, yes.
So having command posts on the ground in every municipality
where NGOs, local mayors, and everybody can hold each other
accountable to address needs and realtime actions and cut the
``Mother, May I'''s, like you suggest, Dr. Kadlec, and just get
the food and get the transportation, get the medicines that
people need in realtime, addressing problems realtime, is what
the people of Puerto Rico need, and there's a lack of sense of
urgency when we talk about these issues.
Your folks on the ground are doing an incredible job, but
the urgency to meet the needs of 3.4 million people, water,
food supply chain, electrical grids, those are your top three
priorities to prevent unnecessary loss of life of Americans on
the island.
I feel very passionate about this because I took care of a
woman who in front of me in a shelter had a seizure. I
protected her airway. I tried to get her to emergency care.
There was no oxygen. There was no medicine at this temporary
shelter. We need to do a better job on the ground coordinating
with different agencies so that we can save more lives and do
what all your mandates are about to do.
So I thank the people on the ground. They're incredible,
incredible workers.
Mr. Griffith. And we appreciate your passion.
Mr. Ruiz. And I look forward to working with you more to
make sure that we have command posts out in the field.
Mr. Griffith. And we appreciate your passion and agree that
we probably ought to get down there and get out and see things,
and appreciate you and Dr. Burgess having both visited down
there, and look forward to your input as the committee works
further on these issues.
I now turn to Mr. Costello of Pennsylvania for 5 minutes
for questions.
Mr. Costello. Thank you, Mr. Chairman.
Dr. Kadlec, in your written testimony you mentioned that
Puerto Rico faced public health and public health
infrastructure challenges prior to Hurricane Maria's arrival,
which exacerbated the hurricane's effects. Could you describe
what some of these challenges were and how they adversely
impacted the public health response efforts?
Dr. Kadlec. Well, sir, I mean, I'd just make a quick
comment. Remember that Puerto Rico sustained two hurricanes,
not one. So the first, Hurricane Irma, took a wallop, again, on
the northern side of the island where a lot of their public
health infrastructure is, laboratories. I'll have to defer to
Admiral Redd to talk more about some of the particulars there.
But remember that there were two events on Puerto Rico, not
one, and that was the challenge right there from the get-go.
Admiral Redd.
Dr. Redd. Thanks.
I think that the nature of the event really is what
stressed the system so much that it was so destructive. I think
also some of the things that have been talked about earlier,
about the migration of physicians and the overall waning of the
number of providers, is really a risk factor for damage to the
public health system.
Mr. Costello. So are you saying that the infrastructure was
sufficient and that even if the infrastructure was more
improved than the condition that it was in, it wouldn't have
mattered because the storm was so devastating?
Dr. Redd. Well, I think whatever amount of destruction you
sustain, it is changed from what you had before. So a stronger
system before an event would mean you'd have a stronger system
afterward. It wasn't 100 percent destruction. But the----
Mr. Costello. I guess what I think I'm trying to drive at--
I didn't mean to cut you off--was what kind of infrastructure
improvements are necessary to make moving forward so that maybe
a storm of lesser destructive magnitude, but still nevertheless
damaging, there be a better response--there would be the
ability to have a better response because better infrastructure
was in place?
Dr. Redd. Sure. Well, I think that some of the instances of
damage, for example, if the laboratory had been constructed in
such a way that it wouldn't have sustained as severe damage, if
there had been a generator capability there that could have
been stood up more quickly than what's going on now, those are
the kinds of things that would have been able to bring the
system back online more quickly.
Mr. Costello. Could I ask you to supplement your answer in
writing with any additional type of infrastructure elements?
Dr. Redd. Sure. Happy to do so.
Mr. Costello. Thank you.
Dr. Kadlec, can you elaborate on how some of the lessons
learned from previous natural disasters, such as Hurricane
Katrina, improved HHS' response to the recent series of storms?
And see, I just said series of storms, so it was more than one.
Dr. Kadlec. Thank you, sir.
I think one of the things from Katrina was basically unity
of effort. To capitalize on Dr. Ruiz's comments earlier, one of
the things that created the ASPR was the idea of a fragmented
medical response.
And so while I can't dispute the issues of field command
posts, I can just say certainly and with great authority that
throughout our efforts we were trying to work very closely not
only with the Department of Health in Puerto Rico, which kind
of sets the requirements for what they need that we try to
service and satisfy, but working across not only the Department
of Health and Human Services, as we show here our solidarity
with CDC, FDA, and CMS, and other entities within HHS, but
across the Federal Government with VA and DoD.
So the uniqueness of that is displayed in Puerto Rico that
wasn't displayed in Katrina where you had Veterans Affairs
clinics and hospitals basically providing for not only veterans
and their families, which is not typical, but also the general
population, and doing so with combined DMAT assistance with our
National Disaster Medical Service teams.
So that just gives you a flavor of that. I think the other
part of it is, is the lessons learned, that we saw it in Texas
and we saw it in Florida that there are hospital preparedness
grants, these grants that basically help hospitals prepare.
First it was initially for hospitals, then it was coalitions of
hospitals, that basically were able to demonstrate
communications and capabilities within those coalitions that
made them more sufficient and resilient to these effects.
I'll give you an example, one in particular, which is
pretty extraordinary, which is in Houston with Ben Taub
Hospital, which, if you recall back several years ago, there
were very bad floods, I think 2008 in Houston, that basically
flooded out a lot of the hospital infrastructure in downtown
Houston.
Well, they took hospital preparedness grants that you
authorized and appropriated against and basically ensured that
they could not only withstand flooding, as they did, they
developed water-tight doors to basically prevent that, but also
a whole set of procedures and communications, that they could
continue operations despite hurricanes, despite floods.
And that was not only the case in Houston, but in Beaumont,
Texas, where some of those same grants basically made sure that
the hospital personnel had waders so they could go recover
patients from the Cajun Navy that went out there to recover
patients.
So there are a lot of great lessons learned in this. One
thing is about the capacity of Americans to not only help, but
to volunteer, as we are witnessing in Puerto Rico right now.
But the idea is that we're going to do a little bit more of a
formal one to take advantage of these terrible events to see
what we can do better.
Mr. Costello. Thank you. And such a thorough response that
you actually answered the question that I didn't get to ask as
part of the answer to that question.
Could I just ask you to supplement in writing any
additional lessons learned, not an admission that you didn't do
anything right, but sort of consistent with Congressman Ruiz's
comments relative to what moving forward can be done in order
to improve the next time a tragedy like this might occur so
that we're better prepared. Because that's what we all want to
do, be better.
Dr. Kadlec. Sir, be happy to.
Mr. Griffith. I thank the gentleman.
And I now will recognize Ms. Schakowsky of Illinois for 5
minutes for questions.
Ms. Schakowsky. Thank you very much.
Fourteen people died at the rehabilitation center in
Hollywood Hills in Florida when it lost power and overheated
from September 11 to September 13.
Ms. Brandt, as seniors went into distress, workers
struggled to provide 911 with basic information, including the
address. It was also reported that the same facility had
previously laid off hundreds of workers, including nurses.
The nursing home stated that it employs ``full-time and
part-time employees,'' but did not state if a nurse was present
when those patients went into cardiac arrest.
You could give me yes or no to these simple questions--did
CMS find that there was a nurse onsite at this nursing facility
from the 11th of September to the 13th?
Ms. Brandt. We have a full report on that, Madam
Congresswoman, which I'd be glad to get you. I don't know the
specifics of if there was specifically a nurse. I can't answer
that.
Ms. Schakowsky. Is a nurse required to be present in a
nursing home?
Ms. Brandt. We have conditions of participation which
require clinical staff to be present.
Ms. Schakowsky. And are the requirements for nursing home
disaster preparedness plans, is that a requirement?
Ms. Brandt. That is a requirement, yes.
Ms. Schakowsky. And were they followed?
Ms. Brandt. According to the report that we got from our
state facilities, they were not followed in this instance, and
that is why the facility has been terminated from accepting
Medicare and Medicaid patients.
Ms. Schakowsky. So that's the consequence?
Ms. Brandt. That is the consequence.
Ms. Schakowsky. OK.
I wanted to talk to Dr. Kadlec about the hospitals. A week
after Hurricane Maria, HHS told the committee staff that most
hospitals were damaged, faced major challenges in getting food,
water. We've talked about that. And then, of course, more than
a month after Hurricane Maria, Slate reported that surgery is
being done by cellphone flashlight. There's pictures that show
that, so, I guess, it's pretty well documented.
And so what I wanted to know is do hospitals connected to
the electric grid have access to the full regular power, or is
it only being provided intermittently?
Dr. Kadlec. Ma'am, it depends where those hospitals are.
There have been some issues with reliability. I would have to
turn you over to the U.S. Army Corps of Engineers to talk about
what specific areas----
Ms. Schakowsky. OK. So when you say all hospitals now are
corrected to the grid, that doesn't mean that----
Dr. Kadlec. No, ma'am. There's only 60 percent of the
hospitals that are connected to the grid currently as of today.
Ms. Schakowsky. And the others, are they operating on----
Dr. Kadlec. They're operating on generators. And we're
basically working with FEMA to actually have what we call N-
plus-one, where they have two backup generators--they have a
generator, a principal generator and a backup, so that if they
need to switch, if the generator fails, they can go immediately
to the next one. And, again, the plan is, is to basically have
a 911 FEMA generator repair team to come out and fix the
primary generator.
Ms. Schakowsky. But as a consequence of all this, you would
say that there is not 24/7 power at what percent of the
hospitals?
Dr. Kadlec. Well, 60 percent right now are on the grid,
which would have regular power, and even then sometimes there's
some reliability issues as it relates to transmission wires and
distribution, that I have very little understanding of because
I did very badly in electrical engineering. But I think the
point is, is that there are hospitals out there that are on the
grid and even those hospitals have generator backups.
Ms. Schakowsky. OK. I wanted to turn for a minute to the
Virgin Islands, Dr. Kadlec. I understand that Hurricane Maria
tore the roofs off of the two largest hospitals in St. Croix
and St. Thomas. So what is HHS doing to ensure that Americans
in the Virgin Islands are receiving the healthcare that they
need?
Dr. Kadlec. Ma'am, immediately after the storms passed,
both Irma and Maria had effects on both St. Thomas and St.
Croix, where the hospitals are located. And then with the
passing of those storms, the initial storm Irma, we basically
just set up a DMAT team with its temporary shelter there. And
that was replaced with a more capable Army support clearing
medical station, which is a 40-bed mini-hospital that's there.
And now we're in the midst of basically deploying a western
shelter assembly so that would allow the physicians and nurses
and healthcare practitioners on the Virgin Islands to go back
to work and take care of their patients while the hospitals are
being assessed by the Army Corps of Engineers to either be
repaired or replaced. I think in the case of St. Thomas it's
going to need to be replaced.
So we've provided immediate care, we're providing the
intermediate support, and then we're basically transitioning to
a capability that would allow the healthcare workers on the
Virgin Islands to go back to work, and then with that give time
to basically repair or replace those hospitals.
Ms. Schakowsky. Thank you. I yield back.
Mr. Griffith. I thank the gentlelady.
I now recognize Mr. Collins of New York for 5 minutes for
questions.
Mr. Collins. Thank you, Mr. Chairman.
Thank you, all the witnesses, for coming.
So, Dr. Kadlec, while we're operating the hospitals under
generator power and the like, as people are being transitioned
out of the hospitals, in many cases, in fact probably in most
cases, the residents don't have power at home and they don't
have running water.
Could you perhaps explain what's going on relative to these
patients leaving? And how are you and others now dealing with
the fact that they're moving into an environment without power,
and in many cases without running water?
Dr. Kadlec. Sir, just to highlight a comment made earlier
by Admiral Redd, there are six Federal medical stations that
have been deployed to Puerto Rico. At the present time two are
operational, two 250-bed facilities that are being staffed by
VA workers as well as volunteers.
In one case, from the Greater New York Hospital
Association, a great example of a combined effort between our
Federal and volunteer partners that are basically providing
those kind of transition places for people who need additional
medical support or care, don't need to be in the hospital but
can't get home, go home for whatever reason. So we've set up
those and have more in position as required to do so.
Mr. Collins. Well, that's reassuring that you're basically
assessing patients one by one to make sure that when they're
released they're getting the care they need.
Dr. Kadlec. Yes, sir.
Mr. Collins. Another question, again back to the individual
situations, is the report that the pharmacies are asking for
cash payments because of a lack of ability to connect into
insurance companies and the like. Yet, in many cases, the folks
needing prescriptions filled don't have that cash.
So whether the question should go to you or Dr. Gottlieb,
how are we handling what at least has been reported?
Dr. Kadlec. So in Puerto Rico there's a program called the
Emergency Pharmacy Assistance Program, which provides free
medications to individuals who can't pay for it. So that's been
invoked so that people who don't have cash, would need
medicines, can get it. That's one way.
The other way is if they were to go to one of our DMAT
facilities that are colocated in seven of the regions in Puerto
Rico. They can get medicines from there as well. We'd provide
prescriptions or medications as required.
Mr. Collins. That's reassuring as well.
Now, in some cases someone that's been on prescriptions,
I'm assuming there's some difficulty even in a pharmacy
contacting the physician's office. I know if I go to fill one
and it's expired, they say, ``OK, we'll contact the physician.
We'll get back to you.'' But, again, because of the lack of
infrastructure, how is that being handled?
Dr. Kadlec. Well, not only medicine but prescriptions are
being basically filled out for people who seek them out. They
have to basically present themselves either to one of our DMAT
teams or military facilities or VA facilities and they will get
a prescription, if not the medication itself.
Mr. Collins. Again, I appreciate this is--you're basically
taking what I would call a one-by-one-by-one approach, every
situation is somewhat different, but I'm getting comfortable
that you're taking care of people as best we can, given the
limited infrastructure and in some cases doing things in an
unusual way.
Dr. Kadlec. Yes, sir.
Mr. Collins. So, Dr. Gottlieb, Representative Gonzalez has
asked me to ask you, on the FDA issue related to food and
agriculture, what would be your overall assessment? And are
there cases where the FDA is granting waivers and things of
that sort, understanding it's not business as usual at all?
Dr. Gottlieb. Thanks for the question, Congressman.
We would typically grant waivers, for example, if crops
that were damaged in a hurricane, if the producer was looking
to divert crops intended for human consumption into animal
feed. And we do process those waivers.
In terms of what we're doing right now, we've already
conducted, I believe, 20 not inspections, but site visits to
various agricultural facilities and food production facilities
to help them get back online.
We've done this in the last week or so, even as our own
employees down there have been devastated by the hurricane. We
have about 100 employees on the island. We've conducted a total
of, I believe, about 36 right now inspections of various
medical product facilities and food production facilities to
help them get back into production.
Mr. Collins. Well, I want to thank you.
And, Mr. Chairman, I'll yield back, but I guess I need to
say, I'm really happy to hear of the response that we have in
Puerto Rico given the fact that the island was devastated. It
is an island nation. And while it's always easy to criticize
response, what I'm hearing is a lot of actions have been taken
one by one to make sure people are getting the services they
need. We can't snap our fingers and rebuild an electric grid
overnight, but everything I'm hearing is.
And I would disagree with the member that was going to give
them a 2 on a scale of 1 to 10. I also don't like to give
grades, but I think that's a bit harsh, considering the
devastation that the island withstood and the fact we've never
seen anything like this before.
So, again, I want to thank all four witnesses for coming
here today. And I certainly am leaving today feeling much more
comfortable about what's being done to take care of the tragedy
that did occur on Puerto Rico.
I yield back.
Mr. Griffith. I thank the gentleman.
I now recognize the gentleman from California, Mr. Peters,
for 5 minutes for questions.
Mr. Peters. Thank you, Mr. Chairman.
When you get down at the end like this, a lot of questions
have been asked already. So I wanted to ask you an open-ended
kind of question from a perspective of prevention.
So I think a lot about what we might do with respect to
preparing communities to deal with earthquakes or fires or
floods. But from a health perspective, I haven't really given
that much thought. Do you have any thoughts about what you
would have liked to have seen the Federal Government do or
Puerto Rico do before this that would have mitigated the need
to respond to the extent that we had? Anybody?
Dr. Kadlec. So I would just comment that in all the three
hurricanes, the major ones, Harvey, Irma, and Maria, that we
were very aggressive in deploying our assets--people,
capabilities, logistics--as far forward as we could safely in
the case of Puerto Rico, actually putting people in harm's way
to be there when things happened.
You can never anticipate how things will unfold. And
particularly Florida, if you recall, the turn of Irma that went
from the east coast to the west coast, thankfully, and then
that kind of deceleration of the storm just before it hit
Tampa. That's a little bit of good luck. You can't always count
on that.
But I think one of the things that comes out of this is the
importance for community resilience, individual resilience.
Those are things that somehow, again, are not necessarily the
domain of HHS, but I think FEMA and Department of Homeland
Security often use October as preparedness month and ask people
to see if they have a plan, if they have supplies, if they have
the necessary things at home.
I think these events highlight that element, that
individual preparedness. No matter how good we may be, it's
always going to be a circumstance that we may not be able to
get to you immediately and you're going to have to provide for
yourself and your family in the immediate term.
Mr. Peters. From your perspective, though, so as the health
agencies, including CDC, do you feel like you have input into
what is the content of the outreach that's happening around
October to tell people how to be ready, from your perspective?
Dr. Kadlec. I'll have to defer to Admiral Redd to talk
about CDC, but we do participate in these kind of interagency
conversations. But, again, if you just wonder what kind of
messaging you need, I think as we look to the threats of the
21st century and my role in preparedness and response, the
circumstances that we found ourselves in after 9/11 are clearly
different today. The circumstances that we find ourselves in
when this position, my position was created in 2006 are
different today than they were then. And so I think the thing
is, is part of it is keeping up with the rapidly changing
threat environment.
Mr. Peters. That is the premise of my question. My question
is, are we keeping up with it? Is there something we need to be
doing? Is there something reflecting back on?
Dr. Kadlec. I'm going to take advantage of an opportunity
to point out that the Pandemic and All Hazards Preparedness Act
will be reauthorized hopefully in the spring of 2018, and I
believe there should be things that reflect that changed threat
environment.
I think Mrs. Brooks mentioned the issue about the structure
of the National Disaster Medical System. I've called for the
idea of a national disaster healthcare system that would be
basically built potentially on what has been proposed with the
national trauma system to basically ensure that we have the
capabilities the country needs to face whatever the threats may
be in the future, whether they're natural or manmade.
Mr. Peters. Right. Thank you.
Let me turn to the admiral real quickly.
Dr. Redd. Yes. The answer to your question, I think, is
different depending on the horizon. I think that certainly
since 9/11 there have been remarkable improvements in our
ability to respond in a coordinated, cohesive way.
One comment that I'd make is that these three different
hurricanes were actually very different events, that in Texas
was really a flooding event with not very much wind damage in
the most populated areas. In Puerto Rico it was primarily a
destructive wind event.
And so I think the lesson from that is that really being
adaptable is a critical capability. And I think that we are
continuing to get better at being adaptable to the
circumstances that we're confronting.
Mr. Peters. Great. I want to thank the witnesses and yield
my remaining time to Dr. Ruiz.
Mr. Ruiz. Quick, because I just have a few seconds, but the
idea of peripheral field command posts, would that be helpful
to better coordinate on-the-ground realtime with all the
stakeholders, Dr. Kadlec?
Dr. Kadlec. Sir, it is, and we have that communications
capabilities with our DMAT teams.
Mr. Ruiz. So it can happen?
Dr. Kadlec. It can happen. As it is, you defined a joint--
--
Mr. Ruiz. So, Dr. Redd, would that be a solution that would
be worthy of pursuing?
Dr. Redd. Yes, it would. And I think, just in a narrower
way, from a surveillance standpoint, having hubs that could
report in would be something that would be helpful to
understand what the facts on the ground are.
Mr. Ruiz. So I'm going to highly suggest that we start
doing that as well.
And another metric to count is unnecessary deaths,
epidemiology. It's one thing to be killed by a falling branch
or drowning from the river. The other thing is to die from not
having medications that they could have had if it wasn't for
the hurricane.
So there's a lot of unidentified bodies and there's a lot
of deaths occurring. We need a better way to count how many are
due primarily and secondarily from the hurricane.
Thank you.
Mr. Griffith. Thank you for yielding back.
I now recognize the gentleman from Texas, Mr. Olson, for 5
minutes for questions.
Mr. Olson. I thank the chair and welcome the chair as our
new chairman of this subcommittee. I thank you for allowing me
to participate in this hearing even though I'm not a member of
the subcommittee. I'm here to talk about three aspects of
Hurricane Harvey, I'll call them the three M's: mental health,
mold, and mosquitoes.
I moved to the Texas Gulf Coast in the summer of 1972. If
you were there at that time and since then you hear of the
legends of Hurricane Galveston in 1900. The worst natural
disaster in our country's history, over 6,000 lives lost,
probably 8,000 to 10,000 if you count them all. I was there for
Hurricane Alicia in 2001, Ike in 2008.
Harvey did more damage than those hurricanes combined. It
hit us twice. It hit us once, got stopped, then came and hit us
again.
We faced many health challenges. The San Jacinto Waste Pits
with Dioxin were breached, leaked out in the San Jacinto River.
There were chemical spills, raw sewage spills, floating walls
of fire ants, toxic smoke fires that got out of control. Flesh-
eating bacteria took two lives, one in Galveston and one in
Kingwood. A first responder in my district was infected but
beat it with heavy, heavy antibiotics.
Mental health became a big issue. I saw this firsthand. I
was at a school there, elementary school hit by the tornado
that hit Sienna Plantation called Scanlan Oaks. Talked to
parents, school kids come to class. One young man came, very
proud.
``The tornado hit my home. Knocked out my window as I was
sleeping.''
Mom came back, and I said, ``Man, he's doing great.''
And she said, ``No, he's not.''
He's greater at school. It's a great story. I beat the
hurricane, the tornado. But since that hit his house, he can't
sleep in his own bed. He crawls in with Mom and Dad just for
security and safety b+ecause he fears for his life after what
happened with Hurricane Harvey. And that's just one example of
how our kids are traumatized by these events.
And also the adults. We went through days and days of
tornado warning, flood warning, the whole night for 3 nights,
probably slept 4 hours over 3 days. Four days after Harvey
cleared there was a little flash flood. Those alarms went off.
People all around said, ``I kind of freaked out hearing those
alarms again.''
So my question is, what resources--probably you, Admiral
Redd, and maybe you, Mr. Gottlieb--what resources are you
providing our communities to address the mental health issues
that they face because of Hurricane Harvey? What can be done
for these people?
Dr. Gottlieb. Well, I'll defer to my colleagues on the
panel.
In my role as FDA Commissioner with respect to what we've
been focused on coming out of Hurricane Harvey in addition to
there being some medical product facilities in the region, the
predominant issue has been related to crop destruction and
issues related to requests for waivers, for diversion of crops
into animal feed.
And going forward, we will probably have to take some steps
to help with remediation of certain fields that might have been
expose to heavy metals from the flooding. But we're primarily
focused on issues related to the crops that were damaged in the
aftermath of the hurricane.
Mr. Olson. Thank you.
Admiral Redd, do you have any comments on that, sir?
Dr. Redd. On the mental health question in particular, I
think that there are maybe three points. Well, four points.
One is that these events are devastating and they have
effects on everyone. Most of those effects are relatively
short-term for most people. And I think for people, when those
effects are not short-term, we need to be able to make sure
that there is availability of services.
The second point is really understanding the magnitude of
that group of people that need long-term help.
Let me think if I could remember my third point. I think
that's it for me, is the two points.
Dr. Kadlec. Sir, I'll add to his point, though, really
quick, which is just simply that we've used the Public Health
Commissioned Corps. They have behavioral health teams that
basically are going out. They've been most recently deployed in
the Virgin Islands.
But also SAMHSA has provided a hotline to call for people
who have had it. They've had 11,000 calls. And basically you
can speak to a counselor on the phone to ask about their
emotional issues and find some assistance and solace in that
way.
So there are some capabilities out there, and we've been
working with--and, again, it's dependent on the local
authorities to basically initiate these things. But we
certainly stand ready to assist when it is appropriate.
Mr. Olson. Thank you, sir.
Come on, Admiral Redd, you are ready for your third point.
Dr. Redd. Well, actually, there may be a couple more.
But let me talk about mold. We're working closely with the
Department of Health. When there's a flooding event, structures
that are flooded will become moldy.
We're actually doing three different things in mold. One is
training of responders. The other is working on communication
materials. And the third thing is working with the Department
of Health to investigate the potential for an increase in
infections due to invasive mold.
Mr. Olson. I thank the witnesses and my chairman.
Also remind me about our region, there's one thing that
unites us: Beat L.A.
I yield back.
Mr. Griffith. I thank the gentleman.
And I now recognize the gentlelady from New York, Ms.
Clarke, for 5 minutes for questions.
Ms. Clarke. Thank you so much, Mr. Chairman.
I'd also just like to remind everyone that we're talking
about territories that are in tropical climate and that these
are tri-island territories. I hear people talk about Puerto
Rico as though it's a monolith. There's also Vieques and
there's Culebra. There's also three islands with respect to the
U.S. Virgin Islands, and that is St. John, St. Thomas, and St.
Croix.
So I don't want us to see this as a monolith because each
of these islands have their own identity, their own
inhabitants, and I'm not hearing enough of a deep enough dive
into what is happening with the inhabitants of all of these
territories. Because it's not one singular event. It's an event
that hit three separate geographic territories.
I'm putting that out there because I'm going to want to
hear more about what has happened in terms of response to those
territories. We're not hearing at all about how the people of
St. John are receiving healthcare, the people of Vieques are
receiving healthcare. We're not hearing that information, and
that is just as important.
I'd like to start my question about the evacuation process.
What assistance was provided to prepare and implement an
adequate and efficient evacuation plan for those whose health
are compromised? And was there coordination assistance provided
to the local health departments in the wake of the hurricanes
to track evacuees who were sent to other islands and/or the
mainland?
Dr. Kadlec. Ma'am, I can probably address that. In
deference to your question, I would also just highlight our map
that we provided which identifies where HHS has basically been
providing augmentation support to St. John, as well as St.
Croix and Virgin Islands. And also we had a presence on Vieques
as well.
But to your point about evacuation, again, for the
complexity of this event--and, again, Irma struck St. Thomas
first, and for which we were doing some unprecedented things.
Using CMS' emPOWER database, we actually were able to send
in our DMAT teams with urban search and rescue and identify
dialysis patients on the island, which we recovered 120 of them
and then evacuated them to relative safety in Puerto Rico until
Maria hit, at which point in time we evacuated them literally
the day of landfall of Maria, evacuated those patients to
Miami, to a medical shelter there, where we could ensure that
they were being cared for.
In the cases of other patients who were evacuated from the
Virgin Islands, they were evacuated through Atlanta, and,
again, receiving care through there, through the local
resources.
And so throughout, the intent here is not only did we
evacuate those dialysis patients, but sent them with a
nonmedical attendant, a family member, so they would have
someone to assist them along the way.
At the present time, there's only been a handful of
evacuations off the island to the mainland. There were two
pediatric patients, intensive care patients, that were
evacuated from San Juan to Miami soon after landfall.
But what we've tried to do is basically maintain the health
infrastructure on Puerto Rico, because we're hopeful that those
people get better, and they need to be closer to family and
support units there.
So the way we addressed the problem in Puerto Rico is we
created these seven regional hubs of hospitals that we
augmented with our disaster medical assistance teams.
We took the benefit of a level one trauma center in Centro
Medico in San Juan, where we made it one, if you will, the
eastern hub, a receiving hospital for high acuity or intensive
care patients, and then used the USS Comfort as the other hub,
the western hub, a mobile hub that we could basically run from
basically from the top of Arecibo down to Ponce to collect
patients, depending on their acuity, as required, and then have
been able to use DoD assets, both ground ambulances and Medevac
Dustoff helicopters, to provide response on the island, and
then using Naval medical assets and rotary-wing and fixed-wing
assets to fly them.
Ms. Clarke. If there is a document that you have that just
sort of outlines all of that, that would be great.
Dr. Kadlec. Yes, ma'am.
Ms. Clarke. If you can provide it to the committee.
Dr. Kadlec. I can make that available to you.
Ms. Clarke. I also wanted to talk about the public health
challenges of these island territories. The islands will need
the assistance of the Federal Government in the weeks, months,
and years to come. What is the agency's position of the
Medicaid cap as it relates to the Virgin Islands with its
already-limited resources? And do you support a full Federal
contribution as the Federal Government did for Katrina?
Dr. Kadlec. Ma'am, I'll defer to Ms. Brandt.
Ms. Brandt. Thank you for that question.
That is certainly something that we are looking at, and we
are exploring whether or not we would have the flexibility to
do that. But the Federal match is set by Congress. It's
statutory.
Ms. Clarke. Yes. I'm asking about your recommendation.
Right now you have these islands, island territories, where in
one case, the U.S. Virgin Islands, their major employment is
through tourism, right? No one's working. So are we requiring
that government come up with a match or are we going to suspend
it and do a full Federal contribution as we did for Katrina on
the mainland?
Ms. Brandt. Excuse me for not answering directly. We are
pursuing that. We are working with the Office of Management and
Budget to pursue that with congressional approval.
Ms. Clarke. Wonderful. Thank you.
I yield back, Mr. Chairman.
Mr. Griffith. I thank the gentlelady.
I now recognize the gentleman from Georgia, Mr. Carter, for
5 minutes.
Mr. Carter. Thank you, Mr. Chairman.
And thank all of you for being here today. I appreciate
your presence.
I'm going to assume this goes to CMS, and that's Ms.
Brandt.
Can you help me here? I know the situation that exists with
the nursing home situation in Florida. Are you going to now
require nursing homes to have generators? Is that going to be a
requirement? And can you very briefly tell me how that's going
to work?
Ms. Brandt. Sure. We actually have an emergency
preparedness rule which was finalized last year that is going
to be surveyed again starting next month. So that's when the
state surveyors go out. It requires generators, it requires
emergency preparedness plans, and it requires training on a
continual basis.
Mr. Carter. Will there be any kind of reimbursements for
nursing homes? I've spent much of my professional career as a
nursing home consultant, and I can tell you, they are pushed
for trying to stay solvent as it is. Is there going to be any
kind of help for them or is this just another government
mandate?
Ms. Brandt. That is certainly something that we are looking
at, but I can't speak specifically to that at this time.
Mr. Carter. OK. Thank you.
Mr. Kadlec, there was an article in The Wall Street Journal
the other day about the USN Comfort, the Naval ship, that was a
medical ship, and how it was off the coast of Puerto Rico but
it wasn't being utilized. And I just wanted to get your input
on how we could do a better job in the future of making sure--
from what I understand, it's a 250-bed hospital on the water,
but only 150 beds were being utilized at one time?
Dr. Kadlec. Yes, sir.
Mr. Carter. What can we do to make that better? It's
costing us $180,000 a day just to have it there. And those
people desperately off of Puerto Rico need help.
Dr. Kadlec. Yes, sir. And, again, to allude to Ms. Clarke's
question before, part of our plan was basically to use the
Comfort as a capability to deal with high acuity patients,
intensive care patients, particularly in circumstances where
hospitals on generators would fail, where we would need to
urgently transfer critically ill patients somewhere. And so we
were basically using the 50-bed ICU on the boat, sir.
Mr. Carter. And we understand and appreciate that. But it
seems like we could have made better use of it. And have we
learned anything? Is there anything we can do differently to
make it more accessible in the future?
Dr. Kadlec. And so we are in the midst of actually looking
how we can utilize it more, as more of a stationary platform,
probably berth in one of the ports in Puerto Rico.
Mr. Carter. Exactly. Make it more accessible.
Dr. Kadlec. That has been an ongoing conversation with the
Department of Health in Puerto Rico to assess how we can use
that more to their needs.
Mr. Carter. OK. Thank you.
Dr. Gottlieb, it's my understanding that the FDA can
declare on a shortage list medications that are not available
and that they can be compounded. Is that true, they can be
compounded by pharmacies if they're put on the FDA shortage
list?
Dr. Gottlieb. We don't typically look at the opportunity to
compound as an alternative or solution for shortages. Our drug
shortage staff would typically try to work to help get the
approved product back in supply and might look to help source
the same products from overseas manufacturing facilities that
might be inspected by FDA.
It is the case that in certain situations you might see
practitioners go to approved compounding facilities, facilities
that are compounding within the confines of the statute, to
source certain products.
Mr. Carter. OK. So you're actually increasing access to
alternative medications? Is that what you're trying to do?
Dr. Kadlec. Thanks to some of the new authorities that
Congress gave us with respect to our drug shortage staff and
our ability to identify shortages further out from the actual
occurrence of a shortage, we've been taking steps to try to
mitigate the shortages that have occurred, but also situations
where we see the potential for products to tip into shortage.
So we're looking out typically 1 to 2 months for what we
think could potentially happen if production doesn't resume and
taking steps to, for example, move temporarily certain
manufacturing out of facilities that might be damaged or not up
to full production to facilities in other markets that could
help supply the U.S. market.
Mr. Carter. Right. OK. I would ask you, as you continue on
your process for the memorandum of understanding dealing with
compounded medications, that you would take into consideration
natural disasters and that there would be exceptions put in
there where compounding pharmacies could be utilized so that
they could get those medications to those patients in the case
of natural disasters such as this.
Dr. Gottlieb. And we would be happy to work with the
Congressman as well. It might be something more appropriately
addressed in the statute. I certainly look forward to working
with you on that.
Mr. Carter. And I will be glad to work on that if it needs
to be addressed in the statute.
One final question. I will just ask you, Dr. Gottlieb. Is
the CDC supporting vaccinations to prevent Leptospirosis?
Dr. Gottlieb. Well, I would defer to my CDC colleague.
Mr. Carter. OK. Excuse me. I'm sorry.
Dr. Redd. There's no vaccine for Leptospirosis.
Mr. Carter. There is no vaccine for that right now?
Dr. Redd. No.
Mr. Carter. What about treatment for it?
Dr. Redd. It's very treatable. It works better the earlier
the disease is identified. So earlier treatment is more
effective.
Mr. Carter. Is that being supplied to Puerto Rico now?
Dr. Redd. It is. The antibiotics that are used for
treatment, they're not----
Mr. Carter. Pretty common?
Dr. Redd. Yes, they are. They're not anything special.
Mr. Carter. OK.
Dr. Redd. Penicillin and tetracycline.
Mr. Carter. OK. Great. Well, tetracycline is not available
as much as it ought to be.
Dr. Redd. Depends on which variety.
Mr. Carter. As Dr. Gottlieb will attest, unless you're
getting it for fish tanks. I'm serious. Nevertheless, it is a
problem.
But thank you very much. And thank all of you again.
And I yield back.
Mr. Griffith. I now recognize the gentleman from New York,
Mr. Tonko, for 5 minutes for questions.
Mr. Tonko. Thank you, Mr. Chair.
As ranker on the Subcommittee of Environment that reports
to the standing Committee of Energy and Commerce, I have made
clean drinking water a major effort to focus that I'm very
appreciative the committee is responding to. We have recently
reported a bill from the subcommittee and then standing
committee. So, therefore, I want to address that concern, clean
drinking water.
There are many reports about a lack of safe drinking water
in Puerto Rico. Unfortunately, neither FEMA nor the EPA is
before us today. So, Dr. Redd, I'm hoping that you might be
able to share some insights into the water situation in Puerto
Rico and the Virgin Islands.
Recent news reports have stated that roughly one-third of
Puerto Rico has no reliable access to potable water at home.
Because of this, we have heard reports of people drinking and
bathing in rivers and streams in Puerto Rico.
Last Tuesday, Puerto Rico's state epidemiologist, Carmen
Deseda, announced that there have been some 74 cases of
Leptospirosis reported on the island so far this month. Puerto
Rico usually sees only 60 cases of this disease, as I'm
informed, in a given year. Some reports have connected this
outbreak to public use of contaminated water sources.
So I ask, can you tell us about this whole concern about
Leptospirosis, and what are its symptoms?
Dr. Redd. Certainly. Leptospirosis is a bacterial
infection. It's acquired, as you described, by drinking or
being exposed to water that's contaminated with those bacteria.
They infect many species of animals. And animal urine is the
vehicle for transmission of the disease. So situations where
there's a shortage of potable water or exposure to floodwaters
that are contaminated with the bacteria are the settings for
exposure.
We are working closely with the Department of Health in
Puerto Rico to determine whether those suspected cases actually
are cases. We have specimens in the laboratory at CDC right now
doing those tests. We are aware of one confirmed case that was
diagnosed in a patient at the VA. So how large this outbreak
actually is--if it's an outbreak--is something that really
remains to be determined.
The best way to control the outbreak is to prevent exposure
to contaminated water, and that really is an issue that you've
started with, with wider availability of potable water and then
early treatment for people that have symptoms of fever,
weakness, exposure to those things. And then, in the later
stages, more characteristic is jaundice, yellowing of the skin,
because of liver damage.
For the question about the extent of the water supply
system, I might refer to Dr. Kadlec on what the situation is,
proportion of people that have access to potable water.
Dr. Kadlec. So I can give you just basically down that
we've been following: 25 out of the 115 public drinking water
facilities are out of service. So, again, that's an intense
issue of concern. And, again, prioritization in terms of
reelectrification.
But significantly, too, is 10 out of the 51 wastewater
treatment facilities are out of service. So that gives you a
rough estimate of what the situation for water is. But that's
being followed by the U.S. Army Corps of Engineers.
Mr. Tonko. Then back to the disease itself, like, is it
normally treatable?
Dr. Redd. It is treatable. It does have a significant
mortality rate for severe cases, 5 to 15 percent fatality. So
it's a serious disease that we need to take steps to try to
prevent and when it's recognized treat promptly.
Mr. Tonko. And how critical is it that patients be treated
in a matter of days or hours after----
Dr. Redd. Well, like many bacterial infections, the sooner
treatment can be started, the more effective it is. So early
recognition is very important. And some of that has to do with
access to medical care.
Mr. Tonko. Yes. And are there any other diseases or hazards
associated with drinking and bathing in rivers and streams,
particularly after these heavy rains and floodings that we saw
in Puerto Rico? Are there other health concerns?
Dr. Redd. There are. There are. So the conditions that can
cause gastrointestinal illness are going to be more common in
floodwater, wastewater that has sewage in it. There are also
skin infections that could be more common when people become
exposed to that. So really it's a variety of diseases, as well
as something that's been alluded to earlier, the inability to
wash your hands, do things that will have many other beneficial
effects.
Mr. Tonko. Thank you very much. I yield back.
Mr. Griffith. I thank the gentleman.
And I appreciate everybody bearing with me. I am going to
reserve to go at the end.
I now recognize Mr. Bilirakis from Florida for 5 minutes
for questions.
Mr. Bilirakis. Thank you, Mr. Chairman. Thank you for
allowing me to sit in on the subcommittee.
Secretary Kadlec, does the Hospital Preparedness Program
currently allow states to use grant funds to help defray costs
associated with procurement and maintenance of generators for
assisted living facilities and skilled nursing facilities to
support the development and sustainment of regional healthcare
coalitions?
Dr. Kadlec. Sir, the way the grants are structured, it is
principally for healthcare facilities and for coalitions
thereof. So as part of a plan of a coalition, that could be
considered as part of it, but we don't dictate that as being
part of it. We are looking to identify how these hospitals and
hospital systems can become more resilient.
But, in fairness to your question, sir, if I may get back
to you on that, I can give you a more fulsome followup on that.
Mr. Bilirakis. Yes. Please, that's very important, to see
whether it's permissible.
Dr. Kadlec. Yes, sir.
Mr. Bilirakis. Because, again, in our area, there are small
nursing facilities, but also ALFs, that do not have generators.
And that's a priority, and that's what I'm concerned with.
Dr. Kadlec. Sir, I'll get back to you on that.
Mr. Bilirakis. Maybe they have 10 patients or less, and
we've got to make sure they have the generators, the backup.
And, Ms. Brandt, last Friday the committee sent a
bipartisan letter to the owner of the rehabilitation center at
the Hollywood Hills in Florida raising concerns, again, about
the nursing home in Florida where 14 residents eventually died
after the facility lost air conditioning in the wake of
Hurricane Irma.
There was apparently a fully functional hospital across the
street. Unbelievable. And according to the Florida Agency for
Healthcare Administration, the facility administrator and
medical professionals didn't know to call 911 in an emergency.
I can't understand this. What's wrong with these people?
How could a nursing home be so unprepared for a medical
emergency that 14 residents lost their life, especially when
there's a hospital across the street? Can you answer that
question, please----
Ms. Brandt. Well, thank you for the question, sir.
Mr. Bilirakis. Attempt to.
Ms. Brandt. And, as you're aware. Hollywood Hills has been
terminated from participation in the Medicare and Medicaid
program.
We make patient safety our number one priority for the
residents of all of our Medicare and Medicaid facilities, and
this was a complete management failure at Hollywood Hills,
which is why they were terminated. They did not meet our
conditions of participation for keeping the temperature at a
reasonable level. They did not provide adequate care to the
patients. As you mentioned, there was a hospital right across
the street which they could have availed them.
So they had several levels of what we call immediate
jeopardy for patients, which is why they were terminated.
Mr. Bilirakis. OK. Who is ultimately responsible for their
safety?
Ms. Brandt. In terms of the patient safety, the facility
has the responsibility and the management of the facility has
the responsibility to ensure that they are meeting emergency
preparedness requirements, that they are providing adequate
care to the patients. And we survey and hold the facilities
accountable to those requirements.
Mr. Bilirakis. OK. That's very important, the
accountability, obviously, the supervision, is so important.
What can CMS do to ensure a tragedy like this never happens
again?
Ms. Brandt. Well, one of the things that we have done, as I
mentioned in my opening statement and in the written testimony,
is that we have instituted an emergency preparedness role which
requires that facilities have an emergency preparedness plan,
that they train on that plan and make sure all employees are
aware of it, and that they have adequate backup in place to
allow--you mentioned the discussion of generators and other
things--to ensure that they have adequate power supplies and
other things to ensure that patient care can be provided, and
that they have a plan for where the patients can go if it
cannot be provided.
Mr. Bilirakis. Well, what about Puerto Rico now? I
understand that there are nursing homes operating without air
conditioning and people are very unsafe. Who's responsible for
this? Who's supervising this? Is it CMS? HHS? And, obviously,
it's unacceptable. Can you respond to that?
Ms. Brandt. Well, so, in situations like in Puerto Rico,
where you have an almost unheard of position, where you have no
water, you have no power, you have really no ability to provide
it, we work with all of our partners.
Dr. Kadlec and the ASPR team, as well as the FEMA teams and
everyone on the ground works with not only Federal and state,
but also the territory officials in Puerto Rico to pull
together to get patients to a safe place.
If they don't have the ability to provide that care, then
we work together to get them transported to a safer place, such
as the evacuees that Dr. Kadlec was talking about earlier from
the Virgin Islands.
Mr. Bilirakis. Thank you very much. I appreciate it.
And I'll yield back, Mr. Chairman.
Mr. Griffith. I thank the gentleman for yielding back.
I now recognize Mr. Green, the gentleman from Texas, for 5
minutes.
Mr. Green. Thank you, Mr. Chairman.
And coming from the Houston area, again, a very urban area,
I heard today that we had our second death from a flesh-eating
bacteria in Galveston County. That's to the south of us, where
I'm at. But, also, to the north we had a 77-year-old lady in
the Kingwood area, up in Congressman Poe's district, pass away.
We have some great medical facilities. And that gentleman was
actually at UTMB because it's infectious disease.
Has that been prevalent in Puerto Rico or the Virgin
Islands? Because I know we have a lot of standing water or at
least we did have. And I'd like to ask if CDC----
Dr. Redd. I'm not aware of cases that have occurred in the
other hurricane-affected areas.
The condition that you're describing is pretty infrequent
in the U.S., about 600 to 700 cases per year over the last 4 or
5 years of that disease occur. So it's not common. But the
exposure to floodwaters is a risk factor for that condition.
Mr. Green. OK. Thank you.
Hurricane Harvey created so many serious environmental and
public health issues, including evidence of compromised
Superfund sites, and toxic spills, chemical fires, and high
levels of air pollution. EPA confirmed that in the aftermath of
Hurricane Harvey--we have a location called the San Jacinto
Waste Pits in Harris County that's now in Congressman Babin's
district--but welcome to the redistricting in Texas. It was in
my district. It was in Ted Poe's district. So we changed those,
but our constituents still contact all three of us.
The analysis found that it was concentrations of 2,000
times higher than the level in which the EPA required a
cleanup. And the EPA administrator was there literally 2 weeks
ago to visit that site, and the decision has been made to
permanently clean up that facility there in east Harris County.
So I was glad of that.
Dr. Redd, what are the types of risks associated with
substances such as this? It's a dioxin facility. It was dumped
there in the '60s by a paper mill. We have responsible parties.
But in both the State of Texas, Harris County and city of
Baytown that's there, put signs up in both English, Spanish,
and Vietnamese not to eat the crabs or the fish--but when I go
out there, you can't find anybody that doesn't have a fishing
pole--because the signs say, if you're an expectant mother or a
small child, you shouldn't digest these crabs, but a lot of
people still do.
What are the types of risks that are associated with that
other than problems with eating it?
Dr. Redd. I'd like to respond to that question in a
followup. I don't want to say anything that's incorrect here,
and I think especially with the levels that we're seeing in
that setting.
Mr. Green. OK. Like I said, the decision has been made to
clean it up. But my concern is a lot of my constituents who go
out there and fish and crab, and I keep explaining to them, you
need to pay attention to those signs.
According to the Houston Health Department, there are
millions of contaminants in floodwaters covering most of the
city. Arsenic, lead, heavy metals in floodwater sediment also
were repeatedly found.
Dr. Redd, following Hurricane Harvey, what role did the CDC
play in warning affected communities of possible water-borne
risk and other public health risk.
Dr. Redd. So, in general, in that part of the response, we
were working in support of EPA. The kinds of things that we
would do would be to try to make the kinds of warnings that you
described, make sure people know those things. So, really,
public health communications because of the flooding.
Mr. Green. OK. Additionally, not just from industry, but
about 50 drinking water systems were shut down following
Hurricane Harvey and more than 160 systems issued boil water
advisories. This is an issue also we're seeing in Puerto Rico,
which is still issuing boil water notices. However, given the
lack of power, some people are not able to boil the water.
Dr. Redd, given that boiling water may not be an available
option, what are some of the hazards of drinking potentially
contaminated drinking water without boiling it? And how does
the CDC communicate these hazards?
Now, we may be over it, I hope, at least in southeast
Texas, but, again, in the Virgin Islands and Puerto Rico.
Dr. Redd. So the hazards that one would be exposed to
drinking water that could be contaminated with sewage would be
the things we've talked about before, gastrointestinal
illnesses, the inability to do hand hygiene that prevents a lot
of other diseases. And if there's Superfund site contamination,
exposure to some of the materials in those waters.
Just to bring back one other point, that's one of the
reasons that having the public health laboratory in Puerto Rico
online again is so important so that that testing can be done,
and when water is safe to drink, it will be easier to confirm
when that testing is available.
Mr. Green. Thank you, Mr. Chairman. I know I'm out of time.
But, you know, every year the upper Texas coast--I mean, every
7 or 8 years we get a hurricane or a tropical storm. So, you
know, hopefully it will be that long a time.
But are we learning any lessons from Hurricane Harvey, both
in southeast Texas, Louisiana, that could be applied in Puerto
Rico or the Virgin Islands now? Or, hopefully, we are learning
to be better prepared, particularly for our water system,
because when they shut down, that's really a human need that we
have to have.
And, Dr. Kadlec, you had mentioned that.
Thank you, Mr. Chairman, for letting me run over time.
Mr. Griffith. I appreciate that, and thank you.
That being said, I now recognize myself for 5 minutes, and
this will be the end. So you're almost done.
Dr. Gottlieb, black mold. All of the areas we've talked
about, everybody knows there's going to be some black mold
issues. But here's one of the issues that I'm not sure most
Americans know. What are the symptoms? Because, obviously, if
you see it, you're going to do something about it, or try to do
something. But oftentimes it's a hidden concern.
So what should people be on the lookout for? You want to
take it.
Dr. Gottlieb. I'd probably defer to CDC, if that's----
Mr. Griffith. All right. That's fine.
Dr. Redd. You're absolutely correct, Chairman, that
flooding leads to mold contamination.
There are two different hazards from exposure to mold. One
is the worsening of allergic conditions. And that can be quite
serious in the case of somebody that has asthma that's
sensitive to mold. The other is, particularly for people who
have weakened immune systems, infection from mold, that also
can be very serious.
Mr. Griffith. But how are they going to know? I recognize
the seriousness. What are they going to be seeing?
Dr. Redd. Well, I think when building materials have been
damaged, if mold can grow on it, it will. And so really it's a
question of remediation. In other words, for porous surfaces,
removing those surfaces and rebuilding. And for surfaces that
aren't porous, cleaning them. That's the guidance in those
areas, is what CDC has been providing, working with the Texas
Department of Health.
Mr. Griffith. All right. I guess I'm concerned that if you
don't see it, you don't know it's there. I know that you're
going to start having some rasping, particularly if you have
asthma. But what if you don't? Or what if you don't know about
that? Isn't that one of the first ways you tell, is you start
having some chest congestion?
Dr. Redd. Well, I think for areas that have floodwaters,
you can tell where that floodwater has been.
Mr. Griffith. OK. So you just do remediation. All right.
Dr. Kadlec, it's been a month. We have any hospitals in
Puerto Rico that are not accepting patients?
Dr. Kadlec. Sir, there are about three that were closed. So
there are some that have been----
Mr. Griffith. That aren't open.
Dr. Kadlec [continuing]. Physically damaged to the point
where they could not----
Mr. Griffith. OK. And the ones that are open, are any of
them refusing to accept patients?
Dr. Kadlec. Sir, on a daily basis, I don't know what their
census are, but it could be the circumstance where they defer/
divert patients. So I can't give you an affirmative answer.
Mr. Griffith. We've talked about dialysis before. Any other
specialized treatments that are currently unavailable at
various hospitals?
Dr. Kadlec. Well, sir, dialysis is available through 46 of
the 48 clinics on the island. Depending on the hospital, there
may be some services that are not available. So I can't give
you an affirmative, if I can take that for----
Mr. Griffith. Let me ask you this. Because I read a report
somewhere that even though dialysis was available, they were
cutting short the treatment time period from what it normally
would be. Is that still the case?
Dr. Kadlec. Sir, it is, and we're looking to actually work
that problem out in terms of lowering the stress on some of
those clinics where they see fewer patients or defer patients
to places that have more functionality.
Mr. Griffith. All right. And that brings up the United
States Navy Ship Comfort.
Dr. Kadlec. Yes, sir.
Mr. Griffith. It's sitting out there, hadn't had a whole
lot of patients. And this is a question my colleague gave to us
earlier--what is the approval process or the admission process
to get on or to be approved for the Comfort?
Dr. Kadlec. Yes, sir. The plan is very simple, is that the
island was not cut in half, but based on the swath of the
hurricane that came through, westward side, eastward side, on
the east side referrals of any high acute patients, intensive
care patients, that need to be made from hospitals that are on
the east side of the island would go to Centro Medico, which is
their level one trauma center, and that would be done through
ground or rotary-wing transportation.
The determination of whether those patients would be moved
to Centro Medico, same as to the Comfort, would be based on
decisions by the clinicians at Centro Medico that would review
and talk to the doctors at the local hospitals to say: What is
this patient suffering from? What kind of care do they need?
What kind of service do they need?
Mr. Griffith. And I appreciate that.
Dr. Kadlec. So based on that, then they would be
transferred to eastward----
Mr. Griffith. One of my concerns, I recognize some might
argue that it's good that you haven't sent more to the Comfort,
I think we have got an asset down there we're not using.
Dr. Gottlieb, biggest long-term concern that you have, both
for Puerto Rico and otherwise? What's your biggest concern that
FDA may be having?
Dr. Gottlieb. Well, our biggest long-term concern right now
from a public health standpoint is that we may face product
shortages of critical medical products heading into the first
quarter. We are going to do everything we can to head them off.
My biggest long-term concern for the island of Puerto Rico
is that if we don't do our job and help these facilities stand
back up in a timely fashion we could start to see some of the
production move out of the island, and I think that would put a
strain on the Puerto Rican economy. And so part of our
solidarity to the people of Puerto Rico is to make sure we
maintain that production down there. It's an important part of
the island.
Mr. Griffith. And I appreciate that.
I see that my time is up. I yield back.
Ms. DeGette. Just following up on that. Also, it would take
away good jobs from the island if those facilities start to
close down. Is that right?
Dr. Gottlieb. That's right. About 90,000 people are
directly employed by the industry. These are very high-paying
manufacturing jobs relative to other manufacturing jobs on the
island. It's an important part. Depending on the estimates,
it's anywhere between 20 to 30 percent of the GDP of Puerto
Rico, a very important part of the island.
Mr. Griffith. In conclusion, I want to thank all of the
witnesses and the members who participated in today's hearing.
I remind members that they have 10 business days in which to
submit questions for the record. I ask that the witnesses all
agree to respond promptly to the questions that they may
receive after the hearing from members.
I have to tell you, I learned a lot. This was a good
hearing. Thank you all for participating. You all contributed
greatly, and I think I have a better understanding.
I do look forward--and maybe you all can suggest where we
should go--but I do look forward at some point to the committee
and the subcommittee perhaps visiting the islands to see what
we've got and, perhaps, as well, the other areas that have been
affected by the recent hurricanes.
With that being said, the committee is adjourned.
[Whereupon, at 12:38 p.m., the subcommittee was adjourned.]
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