U.S. GOVERNMENT PUBLISHING OFFICE

27–737 WASHINGTON : 2018

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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

VACANCY 

Chairman 

H. MORGAN GRIFFITH, Virginia 

Vice Chairman 

JOE BARTON, Texas 

MICHAEL C. BURGESS, Texas 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(III) 

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 

(1) 

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, 

Gonza ́lez-Colo ́n, 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. 

2 

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 Gonza ́lez-Colo ́n 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 reVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
3 

gions. 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 Gonza ́lez-Colo ́n 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 isVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
4 

land’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, 

5 

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. 

6 

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. 

7 

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 preparedVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
8 

ness 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 

9 

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. 

10 

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 exVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
11 

peditiously 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 

12 

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 CatVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00016 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
13 

egory 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 deVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
14 

clared 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:] 

15 


27737.001

rr~ 

.. ~~ Written Testimony f House Committee on Energy and 

fa f: Commerce, Subcommittee on Oversight 

' and Investigations 

Hurricane Response 

Statement of 

Robert Kadlec, MD 

Assistant Secretary For Preparedness and Response 

U.S. Department of Health and Human Services 

For Release on Delivery 

Expected at 10:00 a.m. 

October 24, 2017 

1 
16 


27737.002

Mr. Chairman and Ranking Member DeGette, it is a privilege and an honor to appear before you 

and members of the Subcommittee to discuss our nation's medical and public health response to 

the unprecedented string of hurricanes that have hit the U.S. this season. [am Dr. Robert 

Kadlec, Assistant Secretary for Preparedness and Response or ASPR- at the U.S. Department 

of Health and Human Services (HHS). 

After being confirmed in August, I barely had enough time to introduce myself to the ASPR staff 

before Hurricane Harvey made landfall in Texas. The past few months have been very 

challenging, testing our capabilities and resources. I can proudly appear before you today and 

say that HHS, as well as our interagency partners, have pushed forward in equally unprecedented 

ways to save lives and support the communities and people impacted by three major hurricanes, 

while at the same time dealing with a fourth hurricane and standing ready to respond to potential 

requests from California for health (especially mental health) support with respect to the 

California wildfires and from Nevada health authorities with respect to the mass shooting in Los 

Vegas. I recognize that in some regions, especially Puerto Rico, people are still facing dire 

conditions and it feels like the government has not done enough. I saw the devastation first hand 

and want to reassure you all that HilS will continue working as hard and smart as we can until 

conditions improve. 

Since this is my first time testifying as the ASPR, please let me begin with a brief description of 

my background and my view on the role of ASPR. Then, I will describe what ASPR has done in 

leading the medical and public health responses, as well as supporting human services responses, 

to Hurricanes Harvey, Irma, and Maria. Lastly, I will share some initial lessons learned. 

2 
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27737.003

The Role and Vision of ASPR 

During my confinnation hearing, I told Senators that assuming the role of ASPR would be both 

exciting and daunting. It is exciting because I now lead an organization that I helped create in 

2006 when I was staff director of the Senate Subcommittee on Bioterrorism and Public Health 

Preparedness. It is daunting due to the immense responsibility of this position and the 

increasingly challenging threat landscape we face. 

When ASPR was originally established in the Pandemic and All-Hazards Preparedness Act 

(PAHPA) under the bipartisan leadership of Senator Richard Burr and the late Senator Ted 

Kennedy, the objective was to create "unity of command" by consolidating all public health and 

medical preparedness and response functions under the ASPR. This approach was modeled on 

the Goldwater-Nichols Act that created the Department of Defense (DoD) combatant commands 

and the impetus was the disorganized and fragmented response to Hurricane Katrina in 2005. 

Recognizing this, as I took over as the ASPR two months ago, one of my top priorities was to 

transform ASPR from a policy-centric organization to an operations-centric agency. 

ASPR's mission is to save lives. 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 and Emergency Support Function #8. HHS also supports other federal entities who 

lead Emergency Support Function 6, with respect to the human/social services. In addition, HHS 

leads Federal health and human services recovery support under the Health and Social Services 

Recovery Support Function. Today, the threats facing our country are increasingly diverse and 

3 
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more lethal. My main objective is to improve national readiness and response capabilities for 

21st century health security threats. I aim to do that through four key priority areas: 

• First, provide strong leadership, including clear policy direction, improved threat and 

situational awareness, and secure adequate resources. 

Second, seek the creation of a "national contingency healthcare system" by better 

leveraging and augmenting existing programs- such as the Hospital Preparedness 

Program (HPP) and the National Disaster Medical System (NOMS) to create a more 

coherent, comprehensive, and capable system integrated into daily care delivery. 

• Third, support the sustainment of robust and reliable public health security capabilities, 

including an improved ability to detect and diagnose infectious diseases and other threats, 

as well as the capability to rapidly dispense medical countermeasures in an emergency. 

• Fourth, advance an innovative medical countermeasures enterprise by capitalizing on 

advances in biotechnology and science to develop and maintain a robust stockpile of safe 

and efficacious vaccines, medicines, and supplies to respond to emerging disease 

outbreaks, pandemics, and chemical, biological, nuclear, and radiological incidents and 

attacks. 

Medical and Public Health Responses to Hurricanes Harvey, Irma and Maria 

The scale and scope of this year's hurricane season has been unprecedented. Hurricanes Harvey, 

Irma, Maria, and Nate's proximity and severity have created unique challenges. For example, 

while we were responding to Hurricane Harvey, teams had to be mobilized for Hurricane Irma, 

which devastated the U.S. Virgin Islands, and made landfall again in Florida. In the wake of 

4 
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Hurricane Irma, Hurricane Maria made landfall in the U.S. Virgin Islands and was extremely 

destructive to the Commonwealth of Puerto Rico. It took out large portions of Puerto Rico's 

fragile electrical grid, which impacted the entire island. Additionally, Puerto Rico faced public 

health and health system infrastructure challenges prior to the hurricane that exacerbated the 

hurricane's effects. Especially in Puerto Rico, no place, no person, no life was untouched by 

these hurricanes- the physical destruction was unfathomable. But during my trip there, I was 

overwhelmed by the resilience of the citizens who were making do in extraordinarily difficult 

situations. 

For the three hurricanes to date, ASPR activated the National Disaster Medical System (NOMS) 

and deployed more than 2,500 personnel and hundreds of other Federal employees to 

communities impacted by the storms. NOMS teams were deployed from 21 states outside the 

affected areas for all three hurricanes. In fact, HHS through ASPR deployed NOMS teams and 

U.S. Public Health Service Commissioned Corps (USPHS) teams before the hurricanes hit so 

they were ready to respond immediately. HHS sent tons of equipment and supplies to affected 

areas and declared public health emergencies in TX, FL, LA, AL, MS, SC, GA, USVI and PR, as 

well as for California with respect to the wildfires. This enabled the Centers for Medicare & 

Medicaid Services (CMS), in response to requests from State/territorial public health or health 

departments, to waive certain Medicare/Medicaid, CHIP and the Emergency Medical Treatment 

and Labor Act (EMTALA) requirements, in order to expedite patient care in affected areas. We 

cared for more than I 0,000 patients and evacuated patients to facilities that could provide the 

expert care needed. HHS requested activation of a FEMA national ambulance contract, which 

provided aeromedical and ground ambulances to move patients from harm's way to hospitals. 

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l-IHS activated the Emergency Prescription Assistance Program, which provides medications to 

disaster victims who cannot afford to pay. 

Under the National Response Framework, HI-IS is the coordinator and primary Federal agency 

responsible for Public Health and Medical Emergency Support Function #8 (ESF #8). ASPR 

leads this coordination on behalf of the Secretary. Our strategy in the hurricane response has 

been three fold: save lives, stabilize the hcalthcarc system, then restore services. In some areas, 

such as Puerto Rico, we are still in the response mode of saving lives and stabilizing healthcare 

services. 

HI-IS has 17 core medical and public health functions under ESF #8. One of those functions is to 

assess medical needs. ASPR worked closely with State, local, and territorial public health 

departments in each of the affected areas to determine their needs and to best integrate our 

support. I maintained contact with them throughout our response, and personally visited several 

of the affected States and territories. Our field personnel worked closely with the Federal 

Emergency Management Agency (FEMA), and were placed as liaison officers within State and 

territorial operations centers, in order to provide immediate support and services to local 

officials. In Puerto Rico, we assessed all 67 hospitals and continue to monitor nursing homes 

and skilled nursing facilities. And, the Health Resources and Services Administration (HRSA) 

has been supporting its community based grantees who operate primary care delivery sites in 

these areas by connecting them to local, state, and Federal resources. 

Another ESF #8 responsibility is public health surveillance. Working with the Centers for 

Disease Control and Prevention (CDC), we supported the monitoring of diseases within the 

shelters we staffed and responded to State requests for assistance with post-hurricane disease 

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surveillance. In Puerto Rico, we provided CDC environmental health officers and 

epidemiologists to support their public health response efforts. Additionally, CDC sent experts 

to Puerto Rico to assist with restoring and augmenting their public health laboratory capacity. 

Our HHS team has worked with Puerto Rico to provide testing for waterborne diseases such as 

leptospirosis, an infectious disease endemic to PR, though traditionally with low case numbers. 

Another ESF #8 responsibility is to provide healthcare services. HHS provided medical services 

in the form of emergency department decompression, hospital augmentation, Federal medical 

stations, and free-standing medical teams. Through the NDMS, ASPR engaged in the evacuation 

of patients, when necessary. We proactively evacuated more than 200 dialysis patients from 

USVI before Hurricanes Irma and Maria struck. Our partners from DoD and the Department of 

Veterans Affairs (VA) were key components of these moves. Once the hurricanes passed, teams 

provided on-site medical care through Federal medical stations (FMS) with 50 to 250 beds 

provided through the Strategic National Stockpile. In Puerto Rico, ASPR developed an 

innovative approach to providing medical care. Using a "hub and spoke" approach, we were 

able to cover all seven regions of PR and provide care and evacuation to each region. ASPR 

collaborated with the VA and DoD to increase the number of patients who could be seen. 

An important lesson learned from events such as Hurricanes Katrina and Sandy and during the 

20 I 0 Haiti earthquake was the impact that disasters have on persons who rely on durable medical 

equipment (DME), especially energy dependent DME. To rectify this problem, ASPR and CMS 

created the emPower tool. EmPower provides information to local public health officials about 

the number of Medicare beneficiaries in each impacted area who rely on 14 types of lifemaintaining and assistive equipment, ranging from oxygen concentrators to electric wheelchairs, 

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as well as data on the number of people who rely on dialysis, oxygen, and home health services. 

Citizens who use durable medical equipment tend to be at-risk populations with access and 

functional needs, including the chronically ill and aging populations- those who are the most 

vulnerable in their communities and most likely to need life-saving assistance in prolonged 

power outages. EmPower also provides real-time severe weather tracking information from the 

National Oceanic and Atmospheric Administration to help communities track and plan for 

emergencies. In Florida and St. Thomas (USVI), for the first time in its history, NDMS 

personnel joined DoD's Urban Search and Rescue (USAR) teams to locate dialysis patients 

whom authorities were unable to reach during the initial evacuation, using EmPower data. 

HHS's Food and Drug Administration (FDA) monitored pharmaceutical supplies impacted by 

the storms to help prevent hurricane-related devastation from causing drug shortages. ASPR also 

worked with FDA, Red Cross, and the American Association of Blood Banks to ensure the blood 

supply was sufficient in the impacted areas. HHS deployed mental health teams and activated 

behavioral health hotlines in partnership with the Substance Abuse and Mental Health Services 

Administration (SAMHSA) to aid people in coping with the effects of the storm and help those 

in impacted areas connect with local behavioral health professionals. HHS created and 

distributed information and education on carbon monoxide poisoning, worker safety, food safety, 

vector control, and other health related topics. Our partners at CDC provided expertise in 

controlling mosquitoes. CDC and FDA also provided technical expertise with potable water 

ranging from municipal systems to individual wells. Finally, HHS provided mortuary affairs 

teams that assisted with respectful re-interment of human remains uncovered by flooding of 

cemeteries. 

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ASPR coordinated these broad range of activities through daily ESF #8 Federal interagency calls 

across all departments and agencies that play a role in health and medical responses, including 

Federal Emergency Management Agency (FEMA), DoD combatant commands (e.g., 

NORTH COM, TRANSCOM, and SOUTH COM) and other DoD entities, VA, and all HHS 

operating divisions such as CDC and FDA. 

Conclusion 

ASPR is still actively in response mode with respect to the impact of Hurricane Maria in Puerto 

Rico. Now that much of the response effort is concluding, the recovery effort will continue for 

years. We will continue to partner with FEMA over the next several years during this long period 

of recovery. 

We have a team who has been tracking information throughout the response for an after action 

report. This report will be critical to future operations. We will be building on things we 

performed well, and fixing areas that need improvement. 

The Pandemic and All-Hazards Preparedness Act (PAHPA) was designed to improve our 

nation's public health and medical preparedness and response capabilities for emergencies, 

whether they are naturally occurring disasters, infectious disease outbreaks, or acts of terrorism. 

ASPR's forward leaning response during this challenging hurricane season was made possible 

thanks to PAHPA and its 2013 reauthorization. Indeed, our nation is better prepared thanks to 

this landmark legislation, which has brought cohesion and efficiency to the Federal public health 

and health response. PAHPA is due for reauthorization in 2018, and I look forward to working 

closely with you to move this important legislation forward. Together, we can continue to 

strengthen our nation's readiness and response capabilities for 21st century health security 

threats. I thank you again for this opportunity to address these issues and am happy to answer 

any questions. 

9 
24 

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 lifesupporting 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 perVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
25 

cent 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:] 

26 


27737.010

U.S. FOOD AOM!NISTRAT!ON 

TESTIMONY 

OF 

SCOTT GOTTLIEB, M.D. 

COMMISSIONER OF FOOD AND DRUGS 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

""EXAMINING HHS' S PUBLIC HEALTH PREPAREDNESS FORAND 

RESPONSE TO THE 2017 HURRICANE SEASON" 

OCTOBER 24, 2017 

RELEASE ONLY UPON DELIVERY 
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27737.011

Mr. Chairman, Ranking Member, and Members of the Subcommittee, I am Dr. Scott Gottlieb, 

Commissioner of Food and Drugs at the Food and Drug Administration (FDA or the Agency), 

which is part of the Department of Health and Human Services (HHS). Thank you for the 

opportunity to testify today on FDA's response to the hurricanes that have devastated parts of 

our country. 

First, I would like to extend my thoughts to all those who have been affected by these storms. I 

traveled to San Juan, Puerto Rico, shortly after Hurricane Maria devastated the island. The ruin 

left in the storm's path was overwhelming. I saw long lines for gasoline and banks, and very 

little commercial activity on the city's streets. Homes were completely destroyed. I met with 

about 50 members of FDA's staff in San Juan, and heard many stories of extreme hardship. 

People were worried about how they would safely tend to the basic needs of daily living in a city 

without electricity. By every measure, this was an epic event of historic destruction that will 

require our sustained commitment to our fellow citizens on the island, as well as to the public at 

large as we maintain our mission to protect and promote the public health. 

This hurricane season has left other regions devastated, as three major storms have made landfall 

on the United States. This combination of major catastrophic events is unmatched in recent 

history. FDA has longstanding experience responding to natural disasters and is dedicated to 

supporting the U.S. response in the interest of public health. In the 2017 hurricane season, 

beginning with Harvey, the Agency has played an integral role in the hurricane response efforts 

with a multifaceted approach, including providing on the ground support and making 

recommendations regarding food and medical products that may have been affected by the 
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storms. We pcrfonn extensive preliminary work in advance of storms to help prepare for the 

potential impacts. For example, we utilize storm protection data, Geographic Information 

Systems (GIS), and firm registration databases to prepare maps to identify FDA-regulated firms, 

including those that manufacture critical products that could be impacted by the storms. Where 

necessary, we may take contingency steps to help ensure a continuous supply of critical medical 

product manufacturing. 

But often the most significant role that FDA plays comes after the storm, as facilities come back 

on line and may need remediation, and farmers seck to put crops or farmland that were damaged 

back into commercial use. For example, since Hurricane Harvey devastated the rice fields around 

Houston, FDA has been working with local producers and states to help detennine which crops 

can be used commercially, including diversion into animal feed based on review of supportive 

scientific data. More infonnation on animal food can be found at: 

https:llwwwjda.govlanimalveterinary/resource.\foryoulucm575263.htm. The devastation brought 

by the 2017 storms goes beyond the manufacturing of medical products. The storms hit hard in 

areas where there are a significant number of farmers, including Texas, Florida, Georgia, 

Louisiana, Alabama, South Carolina, North Carolina, Puerto Rico, and the U.S. Virgin Islands. 

However, Puerto Rico was a singular tragedy that challenges FDA in unique ways that the 

Agency has not confronted in other storms. Puerto Rico is home to a substantial base of medical 

product manufacturing. This includes both pharmaceuticals and medical devices. At least 33 

percent of Puerto Rico's gross domestic product is from its phannaccutical sector. About 8 

percent of the medicines consumed by Americans (based on the dollar value of pharmaceuticals) 

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27737.013

are manufactured in Puerto Rico, with major categories including blood fraction products, 

cardiovascular drugs, and treatments for cancer and HIV. On the medical device side, there arc 

about 50 medical device manufacturing facilities on the island that supply products to 

Americans, with many sophisticated and medically-necessary products manufactured in Puerto 

Rico, including cardiovascular devices such as pacemakers and blood collection devices. 

As a consequence of the devastating impacts to the island, the people of Puerto Rico, and the 

facilities that manufacture these critical products, FDA has been working around the clock to 

help troubleshoot individual challenges associated with maintaining a continuous supply of the 

most critical medical products. To give you some data: when it comes to pharmaceutical 

products, there are hundreds of drugs manufactured on the island and many of these drugs made 

on the island are critical medicines. We are monitoring closely a list of about 40 products that are 

critical and either manufactured solely or primarily in Puerto Rico. Of those 40 products, 14 are 

sole-source products, meaning there are no alternative drug products available. The impact of 

Puerto Rican manufactured medical products to the public health of all Americans is significant, 

and we will continue to monitor all pharmaceutical manufacturers on the island to identify other 

opportunities where the Agency can assist, such as additional imports. 

In Puerto Rico, even while we work to restore manufacturing, our first priority continues to be 

our fellow citizens who live on the island. FDA and its Federal partners are coordinating with 

health care service companies located in Puerto Rico. We are working to provide Puerto Ricans 

access to medical products and helping medical product manufacturers that supply the island 

recover after the storms. W c have undertaken sweeping, Agency-wide actions to provide direct 

assistance to our staff and fellow citizens on the island. This includes efforts to help get food and 

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27737.014

medical products onto the island, and help hospitals get back to full operation. FDA is also 

working in partnership with the AABB Inter-organizational Task Force (ITF), to facilitate access 

to safe blood products for the people of Puerto Rico. 

Each natural disaster brings unique challenges. But the magnitude of these storms, and their 

historic impact, has required FDA to engage in ways we have not before, in order to minimize 

the etTects on consumers, healthcare delivery, and the U.S. medical supply, in addition to 

addressing the direct challenges faced by our fellow citizens. Below, I will address in more detail 

some of the steps we are taking in respect to these challenges, and the impact they have on the 

different products that we regulate. 

Medical Products 

Even before the storms hit, FDA reached out to pharmaceutical and medical device firms with 

facilities in the path of the storms to determine what products might be impacted. Approximately 

9,000 medical product firms in the path of the storms were identified for follow-up by FDA. 

Calls have been placed to approximately 5,000 firms to assess the impact of the storms; the 

Agency has reached 60 percent of those firms and more than 200 site visits are planned. In many 

cases, owing to downed communications, we have not been able to reach certain firms. But we 

have been in contact with all of the firms that manufacture medical products that we consider 

critical, where a falloff in production and an ensuing shortage could have public health 

implications. We believe we have a good understanding of the potential risks that we face, and 

are taking steps to mitigate them. 

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27737.015

I was grateful for the opportunity to accompany the Acting Secretary of Homeland Security 

Elaine Duke on her trip to Puerto Rico on October 6 to meet with FDA staff on the island and 

bring them supplies. We have I 00 people on staff in our San Juan headquarters. This footprint is 

a reflection of the significant medical manufacturing presence on the island. As I mentioned 

earlier, the devastation in Puerto Rico presents a broader challenge because it is home to a large 

medical product manufacturing base for both drugs and medical devices and supplies. Some of 

these facilities produce products that could be in shortage if production is sharply diminished or 

pushed offline. Approximately 80 percent of the drug products that are manufactured on the 

island arc consumed by U.S. citizens in Puerto Rico and across the 50 states. Puerto Rico plays a 

pivotal role in supporting the public health of all Americans. In total, there arc about 50 firms in 

Puerto Rico that manufacture drug products, and about 40 that manufacture devices. 

Shortages have traditionally been handled by individual centers within FDA, which have unique 

approaches to address potential shortages. Given the magnitude of this crisis, coupled with the 

unique logistical challenges in Puerto Rico, it was critical to coordinate these efforts across FDA, 

prioritize our efforts, and organize a larger response to this crisis. We expanded our response 

capacity through our emergency operations staff, leveraging their expertise and crosscutting 

perspective to address and prioritize based on the potential for medical product shortages and 

work toward solutions more effectively with Federal partners and industry. 

We organized a new team to work in direct response to the tragedy in Puerto Rico and increased 

the staff that is working directly on these efforts, as well as staff working part time to support 
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27737.016

this response. Understanding how important communications are, we have also created a new 

task force to make information available, especially to affected consumers, to keep people 

informed about our response and steps they can take to recover. In all, FDA has hundreds of staff 

working full or part time in response to these tragic storms. 

Some of the medical product facilities in Puerto Rico were hit harder than others. But even the 

facilities that sustained relatively minor damage are running on generator power. Many firms 

have requested assistance in securing fuel to keep their generators running. Many of these 

generators were not designed to run this long and are old. So it is unclear how long they can last. 

In select cases, we have tried to work with sponsors to secure additional, back-up generators. If 

the generators fail, and the facilities shut down, re-starting these plants is not always a seamless 

and fast process. The facility usually needs to be re-inspected. The impact of disruptions on 

continuous equipment like HVAC and refrigeration of the batches that arc in storage is also 

significant. 

You have probably heard most drug and device firms say that their facilities in Puerto Rico are 

back in operation. It is true that the manufacturing has been restarted, or was never interrupted at 

most of the major production facilities. Many facilities implemented emergency plans to prepare 

for the hurricane, mitigating the most severe damage. But these facts do not reveal the true scope 

of the challenge that we are facing when it comes to the continuation of medical product 

production in Puerto Rico. 

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27737.017

For most facilities, we understand that manufacturing is running at minimal levels, and certainly 

far from full production. W c have surveyed firms and can anecdotally relate that reports of 

manufacturing running below 50 percent are common, with many firms operating around 20 

percent capacity, and some even less. We have found no firm operating above 70 percent of their 

normal operation. The initial challenge was securing gasoline for employees so they can return to 

work. The highly skilled workforce has returned to their jobs in high numbers, even as their own 

lives were devastated by the storm, and even as they had to tend to their families. For those of us 

concerned about the potential for medical product shortages of critical products, we owe our 

fellow citizens of Puerto Rico a great debt of gratitude for helping to sustain production. 

Now, the major challenges that remain include fuel for generators and the availability of 

secondary supplies used in the manufacturing processes, such as medical gas that is used in 

various production steps. Power, in particular, remains a critical concern. Many of the generators 

were not meant to operate for long periods oftime. But, electrical power grid restoration is likely 

to take many months. For critical manufacturing facilities, we have helped selected firms 

troubleshoot the issues involved in securing and installing secondary generators that can operate 

more reliably or back up critical production processes. However, we remain very concerned 

about a handful of firms whose facilities are vulnerable and manufacture critical products. 

In rare cases, we address drug shortages through the careful and selective importation of 

alternative supplies from other approved manufacturing sites and reliable markets. We have had 

to do this for one manufacturer, so far, as a result of circumstances related to Hurricane Maria. 

This involves the importation of an alternative supply of an IV solution product and 

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27737.018

metronidazole manufactured by Baxter from multiple sites from around the world. Some of these 

products were on FDA's drug shortage list prior to Hurricane Maria, but, the existing shortages 

were exacerbated as a result of the reduction in manufacturing experienced in Baxter's Puerto 

Rico facility. 

When FDA contemplates the importation of an alternative product to address a drug shortage, 

the Agency often works with the approved manufacturer on securing supplies they produce for 

overseas markets that they are able to redirect to the U.S. Sometimes these products are 

manufactured in facilities already inspected by FDA. In the recent case ofthc Baxter IV fluids 

importations, for example, the company has supplies they can redirect from their Ireland and 

Australian sites to the U.S. Our goal is to meet all U.S. patients' needs with the temporary 

imports until the approved U.S. versions can cover U.S. market demand. To enable these 

imports, FDA conducts a complex process of review of the foreign facility and product to ensure 

that the imported products can be safely used interchangeably with the U.S. approved product, 

and that the production process for the substitute products is safe and reliable. 

To do this, we evaluate the overseas formulation, labeling, and other attributes, as well as the 

quality of the manufacturing sites to ensure that the substitute product poses no undue risks for 

U.S. patients. Any differences from the approved version are outlined in a letter shipped with the 

product and posted on FDA's website. If the U.S. approved firms do not have any ex-U.S. 

supplies that they are able to redirect to U.S. market, FDA will work with our regulatory 

counterparts in countries such as Canada, Australia, and the European Union on other potential 

sources. These are typically products that are approved for markets that have good inspectional 

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27737.019

histories. FDA's Drug Shortage staff has sanctioned the procurement of products in these ways 

on 37 different occasions in the past seven years to address shortages. It has been a valuable and 

successful tool. But it is resource intensive for FDA, and only works because we adopt this 

practice on relatively rare occasions. It is important to note that in most cases, overseas firms 

cannot fully meet U.S. needs. In other cases, it lakes overseas production sites significant time to 

ramp up manufacturing capacity to meet the extra U.S. market needs. In the case of Baxter, !he 

company has supplies from the overseas sites, where production will increase over time to meet 

the needs of the U.S. This is another way we address drug shortage situations. 

The ultimate goal is to get all facilities back online at full capacity, both as a public health 

priority and for Puerto Rico's economic recovery from the hurricane. I discussed this matter 

directly with the Governor of Puerto Rico and his staff. These sites directly employ close to 

90,000 residents of Puerto Rico, and represent more than 30 percent of the island's GDP. 

Pharmaceutical manufacturing alone accounts for about 16 percent of all the manufacturing jobs 

in Puerto Rico. These are highly skilled, higher-wage jobs. They arc an important clement of 

Puerto Rico's economic base and one of the island's signature industries. 

According to analysis prepared by FDA in conjunction with colleagues at the Council of 

Economic Advisors, pharmaceutical workers in Puerto Rico earn about 60 percent more than the 

average manufacturing wage in Puerto Rico. Many of these citizens are back at work. But 

hypothetically speaking, if pharmaceutical production were to shut down for six months, and 

employees lost their income related to these jobs, workers would stand to lose about $500 

million. This figure is meant only to give you a representation of the magnitude of the 

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27737.020

importance of these jobs to the island's residents. In order to help Puerto Rico secure its 

economic future, getting this manufacturing base back online is a critical step. W c need to do our 

part to help these firms maintain their commitment to operate in Puerto Rico. 

I can tell you the leadership of FDA is committed to all of these efforts. We stand with the 

people of Puerto Rico. I have been personally engaged in troubleshooting these issues, working 

directly with my colleagues at HHS and the Department of Homeland Security, as well as the 

Governor of Puerto Rico. 

l want to highlight some of the other challenges we have been addressing related to these tragic 

storms: 

Blood Supply 

Another critical area is ensuring access to safe blood in the face of so many storm-related 

injuries. Since the storms' onset, my colleagues have been working closely with the AABB ITF 

to help ensure that not only are needs being met, but that we maintain the same level of blood 

safety as we do when we arc not amidst three natural disasters. Thanks to the continued 

donations, blood banks have successfully met the needs across all impacted regions in the 

continental U.S. to date. We will continue to work with this important group to monitor the 

needs in Puerto Rico and the U.S. Virgin Islands. 

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27737.021

FDA Personnel 

In addition to helping the public to recover, we have a responsibility for the well-being of FDA 

employees in areas ravaged by the storm. FDA staff is fully accounted for across all areas of 

impact from hurricanes Harvey, Irma, and Maria. I visited with the FDA team stationed in San 

Juan, where we have about 100 full-time staff, who worked hard to prepare and secure our 

facilities ahead of the storm. And I deeply appreciate the work of all FDA staff preparing for and 

responding to these disasters, including over 400 FDA staff who have deployed or are ready to 

deploy as part of the U.S. Public Health Service Commissioned Corps, and those who put in 

countless hours in support of FDA's response on top of other mission-critical work at FDA. I am 

proud of their work and dedication to help our fellow Americans. I was also deeply moved by the 

more than 150 FDA civilian staff who responded to the Federal Emergency Management 

Agency's (FEMA) request for volunteers. My staff and I are fully committed in our support of 

the nation's efforts to recover and rebuild over the months that follow. 

Agriculture and the Food Supply 

FDA plays an integral role, working with states, in protecting the safety of the food supplyboth human and animal. We recognize that these hurricanes have presented unique challenges for 

farmers, and FDA is committed to working with farmers, as well as with our Federal and state 

partners, so that the food we serve our families is safe and that consumers have confidence in the 

products they consume. 

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27737.022

FDA has been providing support to farmers and food producers who have been impacted by 

these storms, and in particular, disseminating information about the proper handling of crops that 

have been exposed to floodwaters, and when these products can be safely diverted into animal 

feed uses. 

Both human and animal food must meet well-established safety requirements. We have recently 

updated our public documents on these matters in response to the flooding in Hurricane Harvey, 

to make sure that our well-established scientific principles are accessible to producers and 

purchasers. Some of the major concerns for crop safety arc heavy metals, chemical, bacterial, 

and mold contamination. Crops may be submerged in flood water, exposed to contaminants, or 

susceptible to mold, resulting in crop losses. In many cases, it is challenging to determine what 

contaminants may be in crops that were submerged by floodwaters. We arc working to address 

these issues. 

We have been in close consultation with farmers, consumer representatives, and state officials 

regarding concerns about how crops may be impacted. The direct discussions we are having with 

state officials and with farmers are aimed at providing our most up-to-date, science-based 

information on which crops can enter commerce without creating risks to consumers or animals. 

W c have experts in the affected regions who can help provide direct assistance and we are taking 

additional steps to support recovery efforts. We also understand that state Departments of 

Agriculture may have specific requirements regarding any attempt to clean, process, test, use, or 

sell crops for human or animal food. In many of these efforts, we have worked closely with our 

counterparts at other Federal agencies. 

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Our primary mission is the protection and promotion of the public health. We arc committed to 

making sure food is safe for consumers and animals. But, we recognize there are hard questions 

that must be quickly answered about crops affected by these storms, or else crops that might be 

safe because they were not exposed to contaminated floodwaters- could age past their point of 

use. We recognize the significant impact these storms have had on farming families. We arc 

working hard to provide them with timely guidance. My staff and I arc committed to doing our 

part to help farmers get back to work. 

This will be a long recovery. The devastation was significant. But we are in this for the long run. 

All of these storms present FDA with hard challenges. We have committed ourselves to provide 

relief to affected Americans. This has been our highest priority at FDA since these storms struck. 

I have been personally engaged, on a daily basis, in these efforts. The devastation in Puerto Rico 

-owing to its unique role as a base for the manufacture of many sophisticated, complex, and 

vital medical products- presents FDA with especially complex challenges. We are committed to 

the people of Puerto Rico, their recovery, and their efforts to maintain their jobs and their proud 

and vital manufacturing history. 

Thank you for inviting FDA to testify today. I would be happy to answer any questions you may 

have. 

13 
40 

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. 

41 

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:] 

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U. S. House Energy and Commerce Committee, 

Subcommittee on Oversight and Investigations 

Hurricane Response 

October 24,2017 

Chairman Griffith, Ranking Member DeGette, and members of the Subcommittee, thank you for 

the invitation and the opportunity to discuss efforts at the Centers for Medicare & Medicaid 

Services (CMS) to respond to and prepare for emergencies and natural disasters, including 

Hurricanes Harvey, Irma, Maria, and Nate. The Department of Health and Human Services 

(HHS) plays a significant role in emergency recovery and response efforts, and CMS is an 

important contributor in this work. In the weeks following these devastating storms, CMS has 

worked tirelessly to anticipate and respond to the needs of the millions of Medicare, Medicaid, 

and CHIP beneficiaries who have been impacted by these disastrous events. Our job is to make 

sure that the people served by our programs, in conjunction with the states and territories, 

continue to receive high quality healthcare even in the face of serious natural disasters. 

CMS Emergency Response Efforts 

Following a natural disaster, CMS works diligently across the agency to provide immediate relief 

to those impacted and to ensure those served by CMS programs have access to the life-saving 

treatments they need. Our approach to disaster preparedness and response has been informed by 

CMS's experience responding to Hurricane Katrina and the recent significant disasters. Each 

hurricane presented unique challenges-the flood water in Houston, the wind damage across 

Florida, and the combination of the two in Puerto Rico. The facts on the ground dictated a unique 

approach before, during, and after each storm, and our lessons learned helped us tailor our 

responses accordingly. For example, the devastation of Hurricane Harvey taught us valuable 

lessons that allowed us to respond even more quickly for Hurricanes Irma, Maria, and Nate. 

While we worked with states to assess need and grant waivers immediately following Hurricane 

Harvey, we worked with states and facilities to assess needs and prepare waivers while 

Hurricane Irma was still underway, and before the onset of Hurricanes Maria and Nate. In the 

weeks and months following these devastating storms, we continue to be proactive and monitor 

the needs of the local governments to make sure providers, suppliers, and hospitals and other 

healthcare facilities can continue to provide care. 
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Giving Beneficiaries, Providers, and Suppliers Flexibility to Meet Emergency Health Needs 

Federal statute allows, at the request of the Governor of an affected State, the President to 

declare a major disaster or emergency if an event is beyond the co:>mbined response capabilities 

of the State and affected local governments. Federal law also allows the Secretary of Health and 

Human Services (HHS) to declare that a Public Health Emergency exists in the affected State, 

and authorize waiver or modification of certain Medicare, Medicaid, CHIP, and EMTALA 

requirements under section 1135 of the Social Security Act. The HHS Secretary (or Acting 

Secretary) declared a Public Health Emergency and Section 1135 waiver determination in the 

areas impacted by Hurricanes Harvey (August 26), Irma (September 8), Maria (September 19), 

and Nate (October 8) almost immediately upon receiving information regarding the levels of 

devastation being caused by these storms. 

With a public health emergency and a Presidential declaration in effect, there are many things we 

can do to help. For example, the Section 1135 waiver determination enables CMS to waive or 

modify certain Medicare, Medicaid, CHIP, Stark Law, and EMTALA requirements, including 

certain deadlines, quality reporting requirements, conditions of participation, and certification 

requirements. Providers can now submit waiver requests to the state survey agency or the CMS 

regional office, 1 and they will be evaluated to ensure that they meet the requirements set out 

under the law. CMS made all approved waivers and hurricane related information, such as 

Frequently Asked Questions and Presidential declarations, available on our website.2 

In each of these emergency events, CMS is using the full breadth of our waiver authority to 

maintain access to care for Medicare and Medicaid beneficiaries by supporting the ability of 

providers, suppliers, hospitals, and other healthcare facilities that participate in those programs to 

provide timely care to as many people impacted by the storm as possible. For example, using our 

waiver authority, CMS: 

1 https://www.cms.gov/ About-CMS/ Agency-! nformation/Emergency/Downloads/Requesting-an-1135-WaiverUpdated-1l-16-2016.pdf 

' https :1/www .ems. gov/ About-CMSI Agency-! nformation!Emergency/H urricanes.html 

2 
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• Gave Medicare providers in locations impacted by the hurricanes the flexibility to move 

patients between facilities, administer care in alternative locations, and approve out-ofnetwork providers as needed to ensure continuity of care. 

• Expedited Medicaid enrollment for out-of-state providers. This means providers can be 

reimbursed for services provided to beneficiaries who have been evacuated from 

locations impacted by the hurricanes, and allows reimbursement to providers who go into 

impacted areas to provide relief. 

• Lifted the moratoria on non-emergency ambulance suppliers in Texas, to reduce potential 

access to care concerns. 

• Allowed impacted Critical Access Hospitals to exceed their limits on the number of beds 

(25) and the length of stay (96 hours). This means, for example, a Critical Access 

Hospital would be reimbursed for services provided to a beneficiary who needed care that 

was expected to require more than a 96-hour stay. 

• Allowed Medicare payments for replacement Part B prescriptions in circumstances where 

dispensed medication has been lost or otherwise rendered unusable by damage due to the 

emergency. 

• Required Medicare Part D plans to suspend some of their utilization controls, such as 

prohibiting prescriptions from being refilled too soon, for beneficiaries who evacuated 

their homes without their prescription medications. 

• Established a hotline to assist healthcare providers in Texas, Florida, Louisiana, Puerto 

Rico, and the U.S. Virgin Islands in receiving temporary Medicare billing privileges, 

making sure providers will be appropriately reimbursed for their critical services. 

• Coordinated with local emergency response and public health officials and organizations 

to provide beneficiary access to life-saving services by temporarily designating dialysis 

facilities licensed in locations impacted by the hurricanes, but not yet certified to provide 

care for Medicare beneficiaries, as Special Purpose Renal Dialysis Facilities so they 

could serve as Medicare dialysis facilities for a limited period of time. 

3 
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• Temporarily suspended certain requirements necessary for Medicare beneficiaries who 

lost or realized damage to their durable medical equipment, prosthetics, orthotics, and 

supplies as a result of a hurricane. This is helping make sure that beneficiaries can 

continue to access the needed medical equipment and supplies they rely on each day. 

• Expedited Texas's request to allow officials to adjust CHIP enrollment, redetermination 

policies and cost-sharing requirements for families living in, or evacuated from, areas 

impacted by Hurricane Harvey. For example, these provisions, retroactive to August 25, 

2017, will extend children's eligibility so they can receive healthcare services beyond 

their usual renewal period. 

• Established a Medicare Part C and D special enrollment period, allowing individuals 

affected by the hurricanes to enroll in, dis-enroll from, or switch, Medicare health or 

prescription drug plans. It is available at the start of the incident period and runs through 

the end of the calendar year. 

Waivers are a vital tool available for CMS to use in emergency response efforts, but there are 

also additional steps we can take. For example, CMS made sure that beneficiaries were not 

discharged to unsafe conditions and continued to receive quality medical care by monitoring 

discharge appeals and quality of care reviews that arose as a result of the hurricanes. To help 

clarify billing instructions, we have issued technical direction to the Medicare Administrative 

Contractors regarding the waivers and have reminded area Medicare Advantage plans of their 

responsibilities to relax certain requirements during a disaster or emergency. 

In response to requests or direction from the relevant state authorities, CMS clarified that issuers 

participating in the Federal Health Insurance Exchange have the flexibility to extend certain 

payment deadlines, including deadlines for binder payments to effectuate new policies and grace 

periods for existing enrollees. CMS also established a Federal Health Insurance Exchange 

special enrollment period, allowing certain individuals impacted by these hurricanes who 

experienced a qualifying life event to select a new 2017 Exchange plan or make changes to their 

existing plan at any time through December 3!, 2017. In addition, individuals who reside in, or 

move from, areas affected by a hurricane in 2017 will be eligible for a special enrollment period 

that extends the 2018 Annual Open Enrollment Period through December 31, 2017. 

4 
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27737.029

Coordinating Relief Efforts with Local, State, and Federal Partners 

The massive amount of destruction caused by the hurricanes requires extensive coordination 

between local, state, and federal public health officials. CMS teams, along with our 

state/territorial and federal partners, have been working around-the-clock to stay in constant 

communication with local officials to better understand the changing needs on the ground to help 

us get Americans the assistance they need to survive. For example, CMS: 

• Coordinated with Puerto Rico Department of Health to develop a process for 

credentialing nurses and technicians from the mainland to provide relief for dialysis 

facility staff. 

• Through the Kidney Community Emergency Response Program and the End State Renal 

Disease Networks, monitors before, during, and after the event to assess the impact to the 

End Stage Renal Disease Community. The Networks are CMS contractors responsible for 

working with individual dialysis facilities, the large dialysis organizations, and local 

officials to arrange for patients to have dialysis prior to a known event such as Hurricane 

Maria, increasing patients' capacity to wait for evacuation after the storm. Following the 

recent hurricanes, staff from the Networks, under the direction of CMS Project Officers, 

have been a critical part of the community effort to make sure patients in affected areas 

were able to access dialysis services. 

• Through the End Stage Renal Disease Network 3, developed and tracked daily the 

operational status of dialysis facilities in Puerto Rico and their status with respect to fuel, 

water, and other supplies, and developed delivery schedules for fuel and water supplies. 

• Worked with dialysis facilities, End Stage Renal Disease Networks, and the Kidney 

Community Emergency Response Program to assess the operational status of dialysis 

facilities, account for patients, and, with federal and state/territorial partners, to assure the 

delivery of necessary fuel for generators, water for dialysis treatments, and dialysis 

supplies. 

5 
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• Through the End Stage Renal Disease Networks, collaborated with HHS partners and 

several non-government organizations, along with local physicians and providers, to 

provide transportation, meals, and other support for approximately 120 dialysis patients 

evacuated from U.S. Virgin Islands to Atlanta. In addition, staff identified hotels near 

dialysis centers where HHS is paying for these residents to stay until they can return 

home safely. 

• Coordinated across the Agency and with State partners to address questions, provide 

information, and facilitate payment of services for Medicare and Medicaid beneficiaries 

who were evacuated across State/territory lines. 

• Participated in a series of meetings with top HHS officials to discuss Harvey recovery 

efforts and the current status of preparation for Hurricane Irma. 

• Joined key officials from across HHS, including CMS Administrator Verma, in site visits 

and/or stakeholder calls to talk with patients and health officials in affected areas, 

including Texas, Florida, and Puerto Rico to hear firsthand how they have been impacted 

by the storms and how CMS can help respond. 

As the areas impacted by Hurricanes Harvey, Irma, Maria, and Nate continue to rebuild and 

recover from the devastation caused by these storms, CMS will continue to work hard to provide 

states, providers, and beneficiaries with the flexibility they need. 

CMS Emergency Preparedness Efforts 

CMS is committed to ensuring the safety of the millions of Medicare and Medicaid beneficiaries 

who rely on the U.S. healthcare system every day. This means making sure facilities that provide 

care arc prepared and able to do so, even in emergencies and natural disasters. That is why CMS 

requires that all facilities seeking participation in Medicare and Medicaid comply with basic 

health and safety requirements set forth in the Medicare Conditions of Participation (CoPs). For 

example, these CoPs incorporate requirements for long-term care facilities for infection control, 

quality of care, nursing services, and many others, including emergency preparedness standards 

such as requiring Medicare-certified nursing homes to have a generator if they have residents on 

6 
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electricity-dependent life support systems, and are also required to conduct appropriate 

installation and maintenance.3 

Last fall, CMS updated and improved the emergency preparedness requirements for providers 

participating in Medicare and Medicaid.4 For example, we now require facilities to usc an "allhazards" risk assessment approach in emergency planning to identify and address locationspecific hazards and responses.5 In addition, we require facilities to develop and maintain an 

emergency preparedness training and testing program for new and existing staff, including 

annual refresher training, along with a communications system to contact appropriate staff, 

patients' treating physicians, and other necessary persons in a timely manner to ensure 

continuation of patient care functions. The new standards became effective on November 15, 

2016, and surveys to evaluate compliance with the new requirements will begin November 15, 

2017. More information, including interpretive guidelines, Frequently Asked Questions, and 

surveyor training materials can be found on our website.6 

Moving Forward 

The areas affected by Hurricanes Harvey, Irma, Maria, and Nate will continue to encounter 

significant and unique challenges as they face the task of rebuilding. We must continue to think 

creatively about all the ways we can help and make a difference for all those depending on us to 

ensure they have healthcare and access to needed supplies and prescriptions. 

This hurricane season has forced us to think outside of the box for creative ways to support and 

communicate with those serving the communities impacted by the storms, and CMS stands ready 

to work with our partners across the Federal government and, most importantly, with local 

communities, healthcare providers, and patients. CMS will continue to build upon our recent 

experiences from these significant storms to improve our readiness for the next natural disaster. 

We appreciate the Subcommittee's interest in these efforts, and look forward to working with 

you throughout the recovery process. 

3 42 CFR §483.73(e). 

' https://www.gpo.gov/fdsys/pkg/FR-20 16-09-16/pdf/20 16-21404.pdf 5 42 CFR §483.73(d)(2), 42 CFR §483.73(e), and 42 CFR §483.73(e)(3) 6 https://www.cms.goviMedicare/Provider-Enro11ment-and-Certification/SurveyCertEmergPrep/Emergency-PrepRule.html. 

7 
50 

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-theground 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 shipVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
51 

ment 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:] 

52 


27737.032

Centers for Disease Control and Prevention 

2017 Hurricane Response 

House Energy and Commerce Oversight and Investigations Subcommittee Hearing 

October 24, 2017 

Testimony 

Witness: RADM Stephen C. Redd, MD 

Testimony- House Energy and Commerce Committee, Oversight and Investigations Subcommittee 

Good morning Chairman, Ranking Member, and other distinguished members of the 

subcommittee. I am Rear Admiral Stephen C. Redd, Director of the Centers for Disease Control and 

Prevention's (CDC) 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. 

From late August to early October of this year, the President approved several emergency and 

major disaster declarations in accordance with the Stafford Act for the hurricane-affected states and 

territories. This authorized the Department of Homeland Security's Federal Emergency Management 

Agency (FEMA) to coordinate all disaster relief efforts. Under the National Response Framework (NRF), 

FEMA is the lead agency and CDC, along with our HHS counterparts here today, is serving in a 

supporting role to FEMA. As a part of the NRF, HHS leads the Emergency Support Function-S, Public 

Health and Medical Services, under which CDC operates. CDC's responsibilities include providing public 

health support to supplement state, tribal, territorial and local resources in response to public health 

and medical disasters and/or during potential health and medical emergencies. 

CDC prepares for emergency events by helping our state, local, tribal and territorial partners 

strengthen their public health preparedness systems for emergency events. CDC's Public Health 

Emergency Preparedness Program (PHEP) is our single largest cooperative agreement program that 

Page 1 of7 
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27737.033

provides critical funding, guidance, and technical assistance to help partners prepare for public health 

emergencies. Since August 2002, the PHEP cooperative agreements have assisted public health 

departments across the nation, targeting the development of emergency-ready public health 

departments that are flexible and adaptable. Each state and territory impacted by Hurricanes Harvey, 

Irma, Maria, and Nate are PHEP recipients. 

Since 2002, States and Territories funded under PHEP have continued to focus on strengthening 

critical public health preparedness capabilities. For example, in FY 2017, Texas planned to dedicate 

approximately 90 percent of their PHEP funding in the critical public health preparedness capabilities 

of Community Preparedness, Medical Material Management & Distribution and Public Health 

laboratory Testing. The State's past experience with flooding disasters has helped Texas ensure the 

safe evacuation of residents, especially residents in need of special assistance during an evacuation 

who otherwise would have been left behind. Florida planned to focus approximately 80 percent of 

their FY 2017 funding to Community Preparedness, Public Health Surveillance & Epi Investigation and 

Public Health lab Testing. The US Virgin Islands proposed to use approximately 60 percent of their FY 

2017 PHEP funds on Emergency Operations Coordination, Public Health Surveillance & Epidemiology 

Investigations and Community Preparedness. Puerto Rico planned to dedicate over 60 percent of their 

PHEP funds to Public Health laboratory Testing, Information Sharing, and Medical Countermeasure 

Dispensing. 

Immediately following a hurricane, the Federal, state, and territorial response includes 

coordinating and managing resources to provide immediate relief, in particular restoring physical 

infrastructure, which includes infrastructure needed to provide healthcare. Once public health and 

other officials have identified and addressed the immediate public health and healthcare needs, the 

impacted areas enter the recovery phase when critical capabilities are identified and key activities are 

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implemented to assist communities with recovering effectively over time. The recovery phase can last 

from months to years. 

CDC continues to work in affected areas from Hurricanes Harvey, Irma, and Maria. Texas was 

primarily impacted by the flooding caused by Hurricane Harvey and is now in the recovery phase. This 

is also the case in Florida which was heavily impacted by Hurricane Irma. However, the U.S. Virgin 

Islands, which sustained severe damage from both Hurricanes Irma and Maria, is just now entering the 

recovery phase, and Puerto Rico is still in the response phase from the devastation caused by 

Hurricane Maria. 

On August 30, 2017, CDC officially activated its Emergency Operations Center to address the 

public health impact of Hurricane Harvey and then expanded the activation to include the subsequent 

Hurricanes, Irma and Maria, as they approached the states and territories. Since August 31 ", CDC has 

approximately 500 staff members who have provided scientific and technical assistance and additional 

logistics, staffing, communications, analytics, management, and other support functions. Additionally, 

we have deployed approximately 73 staff to the impacted areas to provide on the ground support. To 

fully address the impact of the 2017 hurricanes, we are providing a full spectrum of public health 

technical support to Federal, state, local, territorial, and tribal entities, including on-site support. The 

focus areas for the effort are epidemiology and health surveillance, environmental and occupational 

health, and public health communications. 

To address immediate health concerns, CDC deploys at the direction of the Department and via 

the Strategic National Stockpile (SNS), Federal Medical Stations (FMS) to serve as temporary non-acute 

medical care facilities. Each FMS can accommodate up to 250 people and contains a cache of medical 

supplies and equipment. HHS deploys medical teams to staff the FMS. As of October 161

h, for Hurricane 

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Maria, CDC/SNS has deployed six 250-bed Federal Medical Stations in Puerto Rico. For Hurricane 

Harvey, CDC/SNS deployed four to Texas and two to Florida for Hurricane Irma. 

CDC applies syndromic surveillance to monitor health-related data that precede diagnosis and 

signal a probable disease case or outbreak. Syndromic surveillance uses existing data systems as an 

early warning system of disease outbreaks, water or food contamination or other event, for example, 

spikes in school absenteeism or emergency department visits. Our National Syndromic Surveillance 

Program collaborates with the Assistant Secretary for Preparedness and Response's Disaster Medical 

Assistance Teams (DMAT) to collect all data on DMAT patient encounters. The total number of 

encounters received for Texas was approximately 5,400 and for Florida, approximately 1,700. Most 

encounters for Texas and Florida were related to bites, stings, injuries, musculoskeletal pain, various 

respiratory symptoms, treatment of existing chronic conditions, and medication refills. From Puerto 

Rico and the US Virgin Islands, CDC has received data from approximately 1,300 total encounters. The 

common chief complaints have been related to musculoskeletal pain, injuries due to cuts/lacerations, 

and normal health maintenance for existing chronic diseases. CDC also works closely with the American 

Red Cross to monitor data on shelter population, so that health officials can quickly detect if healthrelated issues arise. 

CDC is also providing technical assistance to affected states and territories to address various 

other health issues such as food safety; water issues including sewage and wastewater; injury 

prevention from debris and drowning; disease or insect vector control; hazardous waste; shelter 

assessments; and indoor air quality issues such as carbon monoxide and mold. CDC's Geographic 

Information Systems (GIS) mapping team is working with the Florida Department of Health to identify 

the total number of private inundated (flooded) water wells. We are also working with FEMA and the 

Department of Defense to make recommendations to the Puerto Rico Department of Health (PRDH) 

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for vector control measures post Hurricane Maria. For example, CDC is supporting local vector control 

in Puerto Rico by providing technical assistance to the Puerto Rico Vector Control Unit (VCU). Through 

this effort, CDC is advising the VCU on messaging strategies to encourage community participation in 

the clean-up of trash that may serve as potential mosquito breeding sites. CDC has also recommended 

safe water storage with lids or screens to prevent egg-laying by mosquitoes and the continued use of 

repellant. The Puerto Rico VCU will incorporate this guidance into their messaging campaign and 

consider the dissemination of repellant to the public. We are also working with Puerto Rico and US 

Virgin Islands on disinfection of water cisterns. 

Identifying and controlling diseases of public health importance in Puerto Rico and the U.S. 

Virgin Islands is a priority. Of concern, the PRDH sustained significant damage during Hurricane Maria, 

including to their laboratories. To date, the labs are not able to conduct any public health testing 

including the ability to confirm diagnoses of infectious and environmental diseases. CDC is working 

with PRDH and FEMA to get the Puerto Rico public health labs back in operation. In the meantime, CDC 

is assisting with arranging for packaging and shipping of clinical specimens for suspected priority 

infectious diseases to the continental U.S. for testing and reporting. 

CDC has provided guidance and technical assistance regarding the safety of responders, 

including respiratory protection and immunization recommendations. For instance, in Puerto Rico, 

responders were informed of safety hazards associated with exposure to carbon monoxide from power 

generators, use of protective clothing and boots to prevent cuts and exposure to contaminated water, 

and the importance of personal hygiene and handwashing. We have also provided technical assistance 

to state and territorial partners and responder organizations who planned to deploy to Puerto Rico or 

U.S. Virgin Islands on a variety of topics including proper occupational health and safety precautions 

for handling human remains, mold remediation, and preventing heat stress. 

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27737.037

Another critical component to a successful recovery is the ability to quickly disseminate 

potential lifesaving public health messages, tools and resources to a wide and diverse audience. CDC's 

Health Communications Task Force has the responsibility of developing and disseminating key 

messaging and resources to individuals in the impacted areas. In coordination with federal partners, 

CDC is disseminating social media messages and public service announcements over operating radio 

stations and flyers to all residents and mainstream media in English, Spanish, and other languages as 

requested. CDC and our HHS colleagues are amplifying each other's messages. 

CDC developed a suite of safety messages covering several critical topics, including generator 

safety and carbon monoxide poisoning. CDC is in the process of providing safety fact sheets and flyers 

to Puerto Rico and the US Virgin Islands for a communications campaign. These messages were also 

distributed electronically through partners, friends, family, and social media. The Health 

Communications Task Force also focuses on reaching key clinician audiences with Health Alert Notices 

and clinician outreach newsletters, and has been successful in reaching approximately one million 

people in a short period of time. For example, given that many healthcare providers are not familiar 

with signs and symptoms of carbon monoxide poisoning, CDC provided clinical information about how 

to diagnose carbon monoxide poisonings. 

CDC continues to respond to requests from federal, state, tribal, territorial, and local partners 

on critical public health recovery efforts. For example, the Texas Department of State Health Services 

requested CDC's assistance for an investigation to explore possible invasive mold infections following 

widespread flooding and indoor mold growth from Hurricane Harvey. CDC will assist the investigation 

by: {1) identifying cases of invasive mold infections at Houston area medical centers to help inform the 

response; {2) characterizing mold exposures of immunocompromised patients in flood damaged areas 

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to improve public health and clinical messaging; and (3} assessing the extent of mold in households of 

immunocompromised patients, to the extent possible. CDC is in communication with public health 

officials in each area to determine short and long-term gaps and requirements to support their 

recovery activities. 

CDC recognizes that the full recovery from the recent hurricanes will take some time, 

particularly for Puerto Rico and the Virgin Islands where the damage is extensive, but we are here to 

continue providing support. We will continue to work with FEMA, and all of our federal partners, over 

the next several years during this long period of recovery. Thank you again for the opportunity to 

appear before you today to discuss CDC's hurricane response and recovery efforts. I would be glad to 

answer any questions you may have. 

Page 7 of7 
59 

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? 

60 

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’: 

61 

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. 

62 

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. 

63 

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. 

64 

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, 

65 

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. 

66 

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 amVerDate Nov 24 2008 14:23 Sep 14, 2018 Jkt 037690 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-67 CHRIS
67 

bulances, 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 

68 

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 

69 

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 

Gonza ́lez-Colo ́n 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. 

70 

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 

71 

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 

72 

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 highlevel 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. 

73 

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. 

74 

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. 

75 

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. 

76 

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 

77 

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. 

78 

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 

79 

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. 

80 

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? 

81 

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. 

82 

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 shortterm, 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. 

83 

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 

84 

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? 

85 

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. 

86 

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? 

87 

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 

88 

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 

89 

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. 

90 

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. 

91 

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? 

92 

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 

93 

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? 

94 

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.] 

[Material submitted for inclusion in the record follows:] 

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10/24/2017 'Like Going Back in Time': Puerto Ricans Put Surviva!Ski!ls to Use· The New York Times 

~btNtltt!Jork~lmt~ https:/inyti.ms/2zAren3 

'Like Going Back in 

Time': Puerto Ricans 

Put Survival Skills to Use 

Using generators, rationing and even bonfires, Puerto 

Ricans have had to get creative to survive weeks without 

power or regular water and food after Hurricane Maria. 

By CAITLIN DICKERSON and LUIS FERRE-SADURNI OCT. 24, 2017 

SAN JUAN, P.R. A grandmother turned a school bathroom sink into a bath. Neighbors are 

piling into a garage for communal meals prepared on an old gas stove. A 79-year-old man made a 

bonfire out of fallen tree branches to cook. 

More than a month after Hurricane Maria tore through Puerto Rico on a path of destruction 

that spared no region, race or class, residents of the island have found their creativity stretched to 

the limit as they try to function without many amenities of the modern world. 

It is not just water and electricity that are in scarce supply. Cellphone service ranges from 

spotty to nonexistent. Cars are damaged and roads blocked. For many, work and school still have 

not resumed, so they wander the streets, play board games and sit around telling stories by 

candlelight. 

"It's like going back in time," said Kevin Jose Sanchez Gonzalez, 25, who has been living in 

darkness since Sept. 5, the day before a previons storm, Hurricane Irma, began to chip away at 

Puerto Rico's electrical grid. 

Crammed into homes three or four families at a time, living on canned and freeze-dried food 

without any means of turning it into a hot meal, and sleeping in shelters, Puerto Ricans have been 

learning to make do, sometimes in extreme ways. 

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10/24/2017 'Like Going Back In Time': Puerto Ricans Put Survival Skills to Use· The New York Times 

A Home in a Tool Shed 

As the sun set in the shantytown of La Perla in Old San Juan, Ramon Marrero, 79, slumped onto 

the unwashed cot inside his brother's tool shed, where he had lived since Maria claimed his home. 

A single light bulb illuminated the other contents of the bare, musty room: two plastic chairs 

piled with clothes, canned fnlit and vegetables, and a single gas burner. 

Mr. Marrero, a community elder known to his neighbors as Don Ramon, draped a towel over 

his bare back to fend off the mosquitoes. Earlier, he had walked to the post office to charge his 

cellphone and mobile battery pack. 

The only electricity he had seen since the storm came from an extension cord connected to a 

shared generator donated by Luis Fonsi, the Puerto Rican pop singer who filmed the video for the 

hit song "Despacito" in La Perla. 

Mr. Marrero was hesitant to plug in the light bulb or his electric fan- only one could be used 

at a time -because he was afraid to overheat the machine or take energy from his neighbors. 

Residents of the barrio say they were left to clear garbage and other debris on their own after 

the storm because municipal workers had failed to show up. Like Mr. Marrero, they were using 

fallen branches to fuel bonfires for cooking. 

Lore] Cuba no, the director of a local nonprofit, said most of the aid the neighborhood had 

received was from private citizens and celebrities like Mr. Fonsi. "The government hasn't arrived 

here," she said. 

Fear in the Darkness 

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10/24/2017 'Like Going Back in Time'; Puerto Ricans Put Survival Skil1s to Use~ The New York Times 

Georgia Lopez Ortiz, 92, is one of many elderly residents of the Luis Llorens Torres housing 

project who have been too scared to walk outside since Maria wiped out the streetlights. The 

notoriously crime-ridden development is the largest in the Caribbean, and is dominated by rival 

gangs. Residents say it has become even more dangerous in the dark. 

Ms. Ortiz's washing machine does not work, so she has been hand-washing clothes in a 

bucket. She cannot cook, so her daughters bring her food every few days. 

When aid groups visit, she throws a rope through the security bars that enclose her patio, and 

uses it to pull up packages of water and dried goods. 

Raquel Mercado, 69, lives in a cramped one-room apartment with her 37-year-old son. Her 

car has not worked since it was flooded during the storm, so she has not been able to get to a bank 

to withdraw cash or to a pharmacy to refill her prescriptions. 

She is selling snacks out of her apartment to bring in some money. 

"What else is there to do?" Ms. Mercado said. "We're stuck here." 

Baseball, Wine and Long-term Guests 

A baseball game blared from speakers connected to a projector screen in Maricarmen del 

Llano's living room. The adults drank red wine as they cleaned up from a dinner of fried chicken 

and mashed potatoes. 

Even in the well-off parts of the island, though, life is not quite normal. 

For the last month, seven extended family members, including a newborn, have been living 

with Ms. del Llano, a school psychologist; her husband, a veterinarian; and their two children, 

ages 7 and 9. 

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10/24!2017 'Uke Going Back in Time': Puerto Ricans Put Survival Skills to Use· The New York Times 

The whole house is running off a powerful generator. Overnight, they use the machine to run 

air-conditioning in each bedroom. 

Tangle Sobrino, Ms. del Llano's cousin and the newborn's mother, is getting ready to move 

back home with her husband, a lawyer, and their two other young children. They were preparing 

to purchase a $5,200 generator. 

"Our reality is not the norm," Ms. Sobrino said, referring to the many Puerto Ricans for 

whom recovery was much further off. 

From Good Life to Discomfort 

The storm also revealed what had been carefully hidden cracks in the upper echelons of 

Puerto Rican society, which has been imploding during a decade-long recession. 

Inside her two-story home with multiple balconies and a pool, Maria Julia Martinez's 

stainless-steel refrigerator, espresso machine and toaster oven have been gathering dust. The 

family's flooring business had tanked in recent years, and they could not use the appliances 

because they did not have $2,000 to fix their broken generator in the backyard. 

They have a much smaller generator that could support a couple of small appliances at a 

time, but to save gas money and prevent it from breaking down, the family runs the machine only 

at night. They use a propane camping stove and a barbecue to prepare food. 

When Ms. Martinez's husband cranked on the small generator one night last week, she ran 

off to do a couple of laundry loads on the efficiency cycle. Afterward, the entire family, including 

their pets, went to sleep on mattresses set up on the floor of their upstairs master bedroom. A 

small air-conditioning unit in the room provided a respite from the rest of their home, which felt 

like a dark and steamy cave all day and night. 

"This is living in hell," Ms. Martinez said. She acknowledged that despite their discomfort, 

her family was still much better off than most people on the island. "I feel bad for feeling bad." 

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10/24/2017 'Like Going Back In Time': Puerto Ricans Put Survival Skllls to Use· The New York Ttmcs 

A New Level of Poverty 

Inside the elementary school classroom that has become their temporary home, Iris Perez 

and her two adult daughters sat in plastic chairs, slapping mosquitoes on their exposed arms and 

legs and staring blankly, as if it was too hot to speak. 

Like nearly half of Puerto Ricans, they had been living in poverty before the storm. But Maria 

swept away their ocean-side home, and banished them to a new level of destitution. 

This emergency shelter was better than the last; here there were showers and the family had 

the classroom to itself. Before, the women - along with Ms. Perez's brother, son-in-law, and two 

young granddaughters - had slept next to other families and bathed with cups of water, filled up 

in the bathroom sinks. 

Hand-washed clothing hung from fluorescent lights on the ceiling. A bookshelf had become a 

medicine cabinet, with deodorant and baby shampoo stacked in front of school books. Filing 

cabinets were diaper changing stations. 

Nashali Reyes, Ms. Perez's oldest daughter, was seven months pregnant, and worried about 

contracting the Zika virus. Her 2-year-old daughter Charyliz bobbed around the classroom with a· 

blanket and bottle in her hands, seemingly unbothered by the bug bites on her face, which had 

become swollen and infected because she was allergic. 

"It doesn't matter what we do," Ms. Reyes said, gesturing to a bottle of repellent. They had to 

keep the windows and doors open, they said, to maintain a livable, if extremely uncomfortable, 

temperature. 

A message written on a white board reminded them to keep their temporary home clean. 

"Welcome," it said in Spanish, "May God bless you." 

Communal Living 

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10/24/2017 'like Going Back in Time': Puerto Ricans Put Survival Skills to Use· The New York Times 

Felix Cruz was holding court for his neighbors at a dining table in his garage. His home had 

been transformed into a motel and soup kitchen of sorts, because of his two extra bedrooms and 

large furniture, including a couple of sofa beds where people were crashing. 

Most of the neighborhood's residents are retired and living on fixed incomes. They cook and 

eat communally using a 40-year-old gas stove that has been dragged out of storage and scraped 

clean of cockroach eggs and mold. 

They have been cr~mming their food into a small freezer in Mr. Cruz's backyard, opening it as 

little as possible to preserve the cold air. 

The neighbors pooled money to pay for gas to power a small generator that could support a 

couple of fans, and are eating two meals a day, usually rice and whatever meat is on sale. 

They eat on fine china, even though doing dishes in the dark is a pain, to try to distract 

themselves from their discomfort. 

"It was difficult before because food was expensive, electricity was expensive, and now it's 

even worse," Mr. Cruz said. He pointed to Alma Gonzalez, 67, one of the neighbors he said had 

become like family. "When she has money, she pays. When I have money, I pay. That's life." 

Correction: October 24, 2017 

An earlier version of this article contained an imprecise translation of a message at a shelter that was 

written in Spanish. The message said "May God bless you," not "God has blessed you." 

You can follow Caitlin Dickerson on Twitter @itscaitlinhd, and Luis Ferni-Sadurnf at @luisferre. 

t!ibc~ew!jorkt!iintt!l 

Connect the dots all year. 

Save up to 75% on the subscription of your choice and gain unparalleled 

insight from reporters in 140+ countries worldwide. 

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GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR .. NEW JERSEY 

RANKING MEMBER 

C!Congrtss of tbt ~nittb ~tatts 

~ouse of l\tpresentatibts 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE ButLDING 

WASHINGTON, DC 20515-6115 Majority (202)225-2927 

Mlnotity{202)225-3641 

November 9, 2017 

The Honorable Robert P. Kadlec, MD 

Assistant Secretary for Preparedness and Response 

Department of Health and Human Services 

200 Independence Avenue, S.W., Room 639-D 

Washington, DC 2020I 

Dear Dr. Kadlec: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

October 24, 2017, to testify at the hearing entitled "Examining HHS's Public Health Preparedness for and 

Response to the 2017 Hurricane Season." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (1) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To faoilitate the printing ofthe hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, November 28, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 205 I 5 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~ Greg Walden 

Chairman 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachments 
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Questions for the Record 

Robert Kadlec, MD 

U.S. Department of Health and Human Services 

Assistant Secretary for Preparedness and Response 

House Energy and Commerce Subcommittee on Oversight and Investigations 

Examining HHS's Public Health Preparedness for and Response to the 2017 Hurricane 

Season 

Tuesday, October 24, 2017 

Unless Otherwise Noted, Responses Accurate as of December 19, 2017 

Rep. Greg Walden: 

1. Does the U.S. Department of Health and Human Services (HHS) have access 

to real-time information about the status of hospitals and other health care 

providers in the affected regions? 

HHS uses multiple sources of information to gain information about the status of 

hospitals and other healthcare facilities. 

Because a national health care facility monitoring and reporting system does not exist, 

state and local officials often times have the best source of information. In some states 

like Texas, the reporting system is highly developed. In other areas, like Puerto Rico, it is 

not. When state and local governments do not have real-time information, HHS must rely 

on a wide range of resources to provide as near real-time information as possible. 

For example, the Centers for Medicare & Medicaid Services' (CMS) Kidney Community 

Emergency Response (KCER) Program coordinates regular calls with the dialysis 

community. This call includes dialysis facilities, renal networks, private sector partners, 

and Federal, state, territorial, and local officials. Through this effort, HHS can learn 

about the real-time status of dialysis facilities directly from the providers and via renal 

network administrators in the impacted area. 

CMS also reaches out to state survey and certification offices to obtain an updated report 

on the status of facilities. This includes hospitals, skilled nursing facilities, dialysis, and 

others as deemed appropriate based on the emergency. The information that CMS 

collects is geospatially mapped to the Office of the Assistant Secretary for Preparedness 

and Response's (ASPR) GeoHEALTH platform to provide all responders and leaders 

with a consistent update about health care infrastructure. 

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In addition to the role CMS plays, the ASPR's Division of Fusion captures, analyzes, and 

interprets information before, during, and after an emergency, to ensure that decisionmakers receive timely and updated situational analysis and information. Fusion's efforts 

related to this specific effort included monitoring social media to determine status of 

facilities. The Health Resources & Services Administration (HRSA) maintains contact 

during and after emergencies with health centers. 

While maintaining true real-time information remains challenging, HHS pursues all 

avenues to get the most timely and accurate information to ensure patients receive the 

care they deserve. 

a. How does HHS obtain information about the status of health care providers 

in the affected regions? 

With data from CMS, ASPR's Geographic Information System (GIS) shares 

information with state and local partners through static maps or by directly 

networking with their own GIS tool, if available. Additionally, ASPR uses open 

and social media sources for health care facility status updates and provides this 

information through a social media report. This information is currently used 

only for situational awareness purposes and not for designating an official 

status. 

b. Can yon provide information about: (a) whether the health care system in 

Texas is stabilized; and (b) the percentage of hospitals in Texas that are fully 

operational? 

While Hurricane Harvey presented significant chaJienges to the health care system in 

Texas; the system proved very resilient. Lessons learned from previous storms 

combined with Federal and private investments in resiliency programs prevented 

significant damage. 

The health care system in Houston, Texas, has remained stable since October 2017. 

Of its 652 licensed general and specialty hospitals, two are still closed post-Hurricane 

Harvey with no immediate plans to reopen. This means that 99.7 percent of hospitals 

in Houston are fuJiy operational at this time. 

Information about the two hospitals that remain closed: 

• East Houston Regional Medical Center is a Hospital Corporation of 

America (HCA) facility that has sustained damage from multiple flood 

events in recent years. HCA closed the facility, moved physicians and 

staff, and redirected patients to other area HCA facilities. They are 

assessing how to best serve the community going forward and may build a 

new facility, but have no plans to reopen the currently vacated facility. 

• Care Regional Medical Center in Aransas Pass remains closed. The 

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facility was damaged during Harvey's initial landfall and has not reopened. 

There have been multiple discussions between the Federal Emergency 

Management Agency (FEMA) and HHS about available support to help it 

reopen. While the facility was insured, it is a privately-owned, for-profit 

hospital. The regional health care coalition in the area, Coastal Bend 

Regional Advisory Council, has worked with the local emergency medical 

service (EMS) provider and other area facilities (including a free-standing 

emergency department associated with Corpus Christi Regional Medical 

Center that is 12 miles away from the Care Regional site) to address any 

gaps that may have emerged as a result of Care Regional's closure. 

c. Can you provide information about: (a) whether the health care system in 

Florida is stabilized; and (b) the percentage of hospitals in Florida that are 

fully operational? 

Florida's health care system has stabilized since Irma, but the state continues to face an 

increased demand for care and bed space as a result of the evacuees from Puerto Rico, 

including dialysis patients evacuated to Florida to receive specialized care. One hospital 

in particular, Fishermen's Community Hospital in Marathon, Florida, is still recovering 

from significant hurricane impact. It anticipates operating from a mobile hospital unit for 

the foreseeable future. At least one small hospital in the state was damaged by the 

hurricane and did not re-open. However, it was in the process of closing prior to the 

storm. 

d. During the hearing, the Office of the Assistant Secretary for Preparedness and 

Response (ASPR) testified that 60 percent of hospitals in Puerto Rico were 

connected to the grid as of that date. Can you provide information about: (a) 

the percentage of hospitals in Puerto Rico that are now connected to the grid; 

and (b) the percentage of health care providers in Puerto Rico that still do not 

have power? 

As of April2, 2018, only one of Puerto Rico's 68 hospitals is operating on generator 

power. The details on the number of providers remaining without power is not available 

at this time. 

e. During the hearing, ASPR testified that the U.S. Army Corps of Engineers 

was assessing the hospitals in the U.S. Virgin Islands that were destroyed by 

Hurricanes Irma and Maria. Can you provide information about: (a) 

whether the U.S. Army Corps of Engineers has completed this assessment 

and, if so, the findings of the assessment; and how long it will take to restore 

the health care system in the U.S. Virgin Islands. 

At the request ofFEMA, via the Mission Assignment (MA) process, and through the 

Unified Coordination Group (UCG), the U.S. Army Corps of Engineers (USACE) 

conducted initial assessments of the impacted facilities in the United States Virgin 

Islands (USVI). These initial assessment reports were provided to FEMA for further 

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direction. Both hospitals will need significant rebuilds and short, mid, and long-term 

solutions are being worked out with the local government to restore health care 

services. 

2. HHS, in coordination with federal partners including the Federal Emergency 

Management Agency (FEMA), pre-deployed a significant amount of federal 

assets in response to the recent hurricanes. According to ASPR's testimony, 

HHS sent 439 tons of medical equipment and supplies to the affected areas. 

How does HHS decide the type and amount of medical equipment and 

supplies to send to an affected region? 

HHS decides what type and the amount of medical equipment and supplies to send based 

on the state, territorial, local, or tribal planning assessments for future operations; and 

assessments conducted on the ground by HHS officials. State and territorial health 

leadership must approve assets HHS recommends deploying. HHS equipment and 

supplies are configured to support HHS response teams and provide full wrap-around 

services and sustainment for responders. This includes comprehensive health care and 

services, mortuary support, and incident management support in the affected areas. HHS 

pre-deployed assets to Texas, Florida, and Puerto Rico so that the materials and personnel 

were ready to meet the needs of Americans immediately after the storm passed. 

a. Did HHS send similar types and amounts of medical equipment and supplies 

to each of the affected regions following Hurricanes Harvey, Irma, and 

Maria? 

Yes, the National Disaster Medical System (NDMS) and United States Public Health 

Service (USPHS) officers who deployed to each of the three responses used similar 

equipment, supplies, and assets for their operation. Equipment and supplies are 

packaged and maintained as a part ofHHS' preparedness posture. ASPR manages 

and maintains over $70 million in response materials and supplies including vehicle 

fleets; medical, laboratory, pharmacy, and mortuary caches; communication kits; and 

shelter systems. 

In addition, HHS's Strategic National Stockpile (SNS) deployed Federal Medical 

Stations (FMS). FMSs are non-emergency medical centers that can provide care for 

displaced persons with special health needs. These needs include chronic health 

conditions, limited mobility, or mental health issues that cannot be met in a shelter for 

the general population. 

b. Once the assets have been sent to the affected regions, what, if anything, needs to 

be done for the affected regions to use the assets? 

HHS response assets are configured for rapid deployment and setup in the field by trained 

HHS responders. Assets are managed and utilized by Federal responders, not by local 

officials, during response operations. 

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c. How long on average did it take HHS to get the medical equipment and supplies to 

the affected regions? 

HHS maintains regional warehouses to ensure resources are available quickly and 

without delay. During the response to Hurricanes Harvey, Irma, and Maria, initial 

resources (both equipment and personnel) arrived and were pre-staged in the anticipated 

impact area prior to the storms making landfall. 

d. Did HHS encounter any delays in using federal assets to respond to the hurricanes 

because of paperwork or other administrative issues? Ifso,arethereany areas 

where the federal government could streamline the processes associated with asset 

deployment? 

HHS is still working on after action reports that will include successes and challenges 

encountered in the response. HHS will work to correct these challenges and notify 

Congress if congressional action is needed. 

3. What are some of the biggest challenges HHS faced in executing the Agency's 

public health and medical preparedness and response functions following the 

recent hurricanes? 

ASPR has helped save hundreds of lives, treated thousands of patients, and has provided 

critical medical response resources and assets to impacted communities as a result of 

Hurricanes Harvey, Irma, and Maria. After each response, including these most recent 

response efforts, ASPR conducts a corrective action process to assess lessons learned and 

to evaluate the implementation of public health and medical activities as part of National 

Response Framework (NRF) Emergency Support Function (ESF) #8 responsibilities. 

ASPR is currently engaged in evaluating the most recent response efforts and is 

developing a corrective action process and lessons learned report. This information is 

shared through the annual budget justification process. 

a. What plans does HHS have to address these challenges? 

HHS will execute plans to address any challenges that are identified in the after action 

reports. 

b. What can we do to improve health care provider preparedness for these types of 

emergencies? 

In 2015, ASPR and CMS launched the HHS emPOWER initiative to provide public 

health and health care facilities, first responders, and emergency managers with 

timely information about electricity and health care service community-based 

populations. This information has helped hospitals, emergency medical services, and 

other health providers better anticipate, plan for, and respond to the needs of these 

individuals. 

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ASPR incorporated CMS' conditions of participation for seventeen types of providers 

and suppliers that are essential for continuity of care in the event of a disaster. 

Specifically, the CMS final rule 3178-F "Emergency Preparedness Requirements for 

Medicare and Medicaid Participating Providers and Suppliers," 81 FR 63860 (2016), 

requires initial onboarding training for health care providers according to their role in 

response and recovery, as well as follow-up training to ensure provider knowledge of 

emergency plans remains current. It also requires exercises for both inpatient and 

outpatient facilities to ensure that providers are readily able to execute and 

operationalize their emergency and communications plans in the event of an 

emergency or disaster. The implementation of this rule will make significant 

progress in preparedness. 

ASPR is also open to other potential ways to educate and prepare health care 

providers for emergencies and disasters. This could include, for example, training as 

part of medical education programs or through continuing education credits that are 

required for medical provider certifications. ASPR supports the notion of a 

standardized, national training program of core competencies in health care and 

public health preparedness. Such a curriculum would ensure that health care 

providers receive the same basic, foundational training no matter where they are 

located and where they work. This would facilitate the ability of health care 

providers to serve as surge staff at other facilities. 

Disaster behavioral health knowledge and skills are limited to mostly health care 

providers. As such, it is important to ensure that training is available within the 

disaster context and part of health care provider staff development plans, such as 

psychological first aid. It is also important to ensure the health and well-being of the 

health care workforce during and after a disaster. Workforce resilience can be 

enhanced through training and guidance. For example, ASPR developed a plan with 

the National Association of County and City Health Officials called Building 

Worliforce Resilience Through the Practice of Psychological First Aid (Link: 

htt;p://nacchopreparedness.org/building-workforce-resilience-through-the-practice-ofpsychological-first-aid/1. 

Additionally, at the local level, options included coordinating with local pharmacies 

and other non-governmental organization partners. For example, CDC coordinated 

with local pharmacies to support vaccine delivery to affected jurisdictions. 

4. In the past few months, we have seen three major hurricanes devastate multiple 

regions of the United States and its territories. How have these experiences 

impacted staffing at ASPR? 

ASPR staff was stretched to the limit, but performed extraordinary tasks despite the 

unprecedented hurricane season. Before the storm, ASPR had numerous openings for 

fulltime employees. This created a situation where some staff hit annual and weekly pay 

caps responding to the hurricanes. Additionally, some staff worked seven days a week. 

Filling the emergency response related positions within ASPR is a tQp priority. In 

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addition to fulltime staff shortages, there were significant openings in NDMS intermittent 

Federal employees. Some NDMS members were forced to deploy multiple times with 

some deploying for over 100 days. Filling the vacancies ofNDMS members is also a 

high priority. 

a. Does HHS, and ASPR more specifically, have sufficient resources 

available to handle future responses? 

Under ESF8, HHS has deployed approximately 2,500 personnel to support response 

and recovery efforts with respect to Hurricanes Harvey, Irma, and Maria. Among the 

HHS personnel deployed are NDMS team members and headquarters and regional 

staff who support incident command, logistics, and liaison efforts. While ASPR had 

sufficient staff to meet requirements, many staff worked well above the 40 hour work 

week. Currently, ASPR has a number of vacancies (both at headquarters and 

throughout its NDMS system). ASPR is actively recruiting qualified persons to fill 

these positions. However, direct hire authority (as requested in the supplemental 

appropriation delivered to Congress in November 2017 to support ongoing response 

operations) can help expedite this process. 

While HHS has met all requests and requirements of the response and continues to 

support ongoing recovery efforts in the impacted communities; resource shortfalls are 

possible for some types of future responses. The threats facing the nation from 

im::reased natural disasters to threats from state and terrorist actors force ASPR and 

HHS operating divisions to prepare for situations that few could have imagined years 

ago. For the nation to be truly prepared for all threats, additional resources, to include 

staff, training, supplies/equipment, and supporting information technology systems, 

are necessary. 

5. The Department of Health and Human Services (HHS) is the primary agency 

for ESF#8 related to public health and medical services, including all-hazard 

public health consultation, technical assistance, and support and potable 

drinking water, solid waste disposal, and other environmental issues related 

to public health. 

a. Please detail all activities HHS engaged in under this function regarding 

potable drinking water, solid waste disposal, and other environmental 

issues related to public health under this authority for Hurricanes Harvey, 

Irma, and Maria. 

Hurricane Harvey 

HHS/CDC provided technical assistance, consultation, and support while serving on a 

multi-agency working group comprising representatives from the U.S. Environmental 

Protection Agency (EPA), Federal Emergency Management Agency (FEMA), U.S. Army 

Corps of Engineers (USACE), and the Texas Department of State Health Services 

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(DSHS). The purpose of the working group was to identify and discuss post-storm 

potable water infrastructure challenges and develop solutions for bringing impacted water 

systems to pre-storm functionality. 

HHS/CDC worked with EPA, FEMA, and Texas DSHS to develop guidance for 

addressing contaminated household water wells that were inundated by Hurricane 

Harvey's floodwaters. HHS/CDC also worked with the Association of Public Health 

Laboratories (APHL) to assess laboratory capacity in Texas to process microbial well 

water samples and develop a written inventory that was used in household water 

sampling activities. In addition, HHS/CDC worked with EPA, FEMA, and Texas DSHS 

to convene a working group to plan and oversee efforts to test and disinfect household 

water wells in the Hurricane Harvey inundation zone. Several thousand wells have since 

been tested and disinfected under the working group's oversight. 

Hurricane Irma 

HHS/CDC conducted environmental health and safety assessments of special and 

medical needs shelters throughout south Florida following Hurricane Irma. Findings and 

corrective action suggestions were provided to shelter managers and/or appropriate 

shelter staff. 

Per request by the Florida Department of Health, HHS/CDC deployed a subject-matterexpert to provide on-site technical assistance, consultation, and support on a wide range 

of environmental health recovery issues following Hurricane Irma including, but not 

limited to, monitoring and controlling selected mosquito-borne diseases in severely 

impacted counties and extremely active areas; training on mold awareness and mitigation 

efforts to reduce health impacts; and providing access to potable water by monitoring 

hurricane-related impacts to drinking water facilities and boil water advisories. 

Hurricane Maria 

According FEMA' s November 17, 2017 Hurricane Maria report, 83 percent of water 

treatment plant in Puerto Rico are operational, and 85 percent of clients of the Puerto 

Rico Aqueducts and Sewers Authority (PRASA) have access to drinking water. 

However, due to inconsistencies in the power-grid, treatment plant pumps have had 

difficulty maintaining pressure throughout the distribution lines. Combined with 

unknown line breaks and potential for contamination entry, Puerto Rico and St. Croix are 

still under a boil water advisory. The boil water notice has been lifted for St. Thomas and 

St. John. 

b. Please detail the interactions between HHS and the U.S. Environmental 

Protection Agency or State/Territorial agencies with primary enforcement 

authority for Federal environmental laws in support ofESF#8 for 

Hurricanes Harvey, Irma, and Maria. 

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EPA participated in daily coordination calls and provided updates, when applicable, on 

related issues in communities impacted by Hurricanes Harvey, Irma, and Maria. 

c. Please detail any funding requests or technical recommendations made to or 

denied by the Federal Emergency Management Agency for addressing 

water, waste water, solid waste, or other environmental issues related to 

public health under this function. 

Hurricane Harvey 

A recommendation was made to FEMA to pay for the cost of household well water 

testing and disinfection in the Hurricane Harvey inundation zone. FEMA approved and 

provided payment for this request. 

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Rep. Gus Bilirakis 

1. Would you discuss the current DMA Tstaffing shortage- has this been 

ongoing or a new development? 

a. What is driving this shortage? 

In 2016, ASPR conducted a Threat and Hazard Identification and Risk 

Assessment (THIRA). The THIRA identified new threats and risks requiring 

appropriate mitigation strategies and associated training. Using the THIRA as a 

base, NDMS conducted an extensive analysis of the organization to ensure 

capabilities could meet missions. Among other items, NDMS reviewed staffing 

considerations to ensure capabilities could meet requirements. NDMS personnel 

are now required to meet specific fitness standards to ensure they are able to 

respond, as required, in austere environments. As NDMS implemented these 

standards, some personnel resigned. In addition, some vacancies within the 

NDMS system are due to the natural rotation (NDMS volunteer personnel no 

longer want to be rostered due to personnel commitments, etc.). 

It is important to note that each new NDMS staff member who serves on a 

DMAT team must go through the normal extensive Federal hiring process. This 

process as of late, has taken significantly longer within HHS resulting in a large 

number of vacancies within the system. The hiring freeze also created a backlog. 

b. How can we address these problems? 

NDMS has completed its analysis of requirements, position description updates, 

and has initiated the hiring process to fill the current shortages of qualified 

personnel. However, direct hire authority (as requested in the supplemental 

appropriation delivered to Congress in November 2017 to support ongoing response 

operations) can help expedite the hiring process. Direct hiring authority would allow 

ASPR to fill current vacancies and ensure that an adequate number of personnel can 

continue to support impacted communities and provide effective real time response. 

2. How is priority evacuation status determined? 

a. When authorities are deciding which health care facilities to evacuate, do 

they currently take into consideration locations with a history of violations 

and ensuring these residents are not sheltering in place with bad actors 

placing them at a high-risk of sustaining injury or death? 

Patient placement and prioritization is a local decision. ASPR does not detennine at 

which facilities patients are placed. The Federal Government supports the response 

efforts of the states and territories according to the needs and direction of the states 

and territories. 

b. If no, should they? 

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Under federalism, these issues fall under the decision making authorities of the state, 

territory, local, and tribal governments. 

3. Are there disaster Memorandum of Understanding between agencies like 

the US Postal Service and ASPR to deliver important health information 

following a crisis? 

The U.S. Postal Service (USPS) and the Office of the Assistant Secretary for 

Preparedness and Response (ASPR) do not have a memorandum of understanding 

to address this area of health information delivery. The USPS will deliver materials for a 

fee based on the number of addresses. CDC was able to contract with USPS to hand 

deliver a one-page flyer with public health messaging to every residence on the U.S. 

Virgin Islands (USVI). The flyers were very well received by the residents of US VI. 

CDC sought to replicate this activity in Puerto Rico, but the cost of printing and shipping 

flyers from Atlanta at that time was cost prohibitive. 

However, HHS has a number of internal public health communication platforms across 

its various operating divisions (OpDiv) and staff divisions (StaffDiv), such as the Centers 

for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration 

(FDA), the Centers for Medicare & Medicaid Services (CMS), and the Health Resources 

and Services Administration (HRSA), for sharing important health information during 

disasters. ASPR also facilitates a number of voluntary partnerships with private sector 

health care partners who also communicate regularly with their clients. 

4. Would you discuss how we can best streamline agency coordination to 

prevent bureaucratic overlap and redundancies which can lead to waste 

and unnecessary delays and hamper the effectiveness of response? 

a. ASPR leads, on behalf of HHS, the National Response Framework ESF#8 Public 

Health and Medical Service responsibilities. As part of those responsibilities, ASPR 

is responsible for coordinating the Federal response. After action reports will provide 

more detailed information on the changes that may be needed; however ASPR is 

already working with the Department of Defense, Department of Veterans Affairs, 

and other partners within HHS to better coordinate activities for future responses. 

b. With a coordinated, interagency response, are there interagency goals 

that drive response and preparedness strategies? 

Interagency goals are driven by the National Response Framework (NRF) 

and its associated Emergency Support Functions (ESF). ASPR leads ESF 

#8 on behalf of HHS, which focuses on public health and medical aspects 

of the response, including the nation's health care system. The 

Administration for Children and Families (ACF) leads HHS's support of 

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FEMA-ARC led ESF #6, which concentrates on mass care and sheltering 

services. ASPR also supports ESF #6 in coordination with ACF. 

c. If so, what are these goals? 

The shared goal of the interagency is "a secure and resilient nation with capabilities 

required across the whole community to prevent, protect against, mitigate, respond to, 

and recover from the threats and hazards that pose the greatest risk." 

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Rep. Frank Pallone 

1. As the Committee considers preparedness issues in light of hurricanes and 

other recent mass casualty events, can ASPR please confirm whether the 

Agency believes that existing competitive grant funds for trauma care are 

sufficient to allow us to adequately respond to these events or should the 

Committee consider reimbursement through CMS to provide these critical 

resources? 

Grant programs are an essential part of developing a health care system that is prepared 

and ready to respond to disasters and public health emergencies. However, grant funding 

is modest compared to the overall budget of key stakeholders including emergency 

medical service (EMS) providers, home health providers, and hospitals. Health care 

systems are primarily focused on creating value for patients with chronic medical 

conditions and are not focused on high consequence, low probability events. It is 

important to align regulation, certification, payment, and quality measurement initiatives 

with grant funded efforts to develop a community based approach. 

Trauma systems are the foundation upon which a broader system of care to manage allhazards can be built. Aligning grant funded efforts to develop coordinated community 

responses with regulatory and payment reform efforts could strengthen the preparedness 

of the nation's health care system. 

2. What has HHS done to ensure that rural communities and the islands of 

Culebra and Vieques have access to proper medical attention? 

For the more rural parts of Puerto Rico, HHS provided tents, generators, and air 

conditioning units to allow diagnostic and treatment centers to move out of their damaged 

structures and into safer locations. HHS also leads a task force to connect these centers 

with the Federal Emergency Management Agency (FEMA) to ensure they have access to 

assistance. Lastly, HHS worked with the Department of Defense (DoD) and the U.S. 

Corps of Engineers (USACE) to ensure they had communications access and an adequate 

number of generators early in the disaster. In regard to Culebra, Puerto Rico, HHS 

connected the community with the non-governmental organization (NGO) health care 

task force to ensure medical teams visited the island and provided medical care as 

needed. However, there was no formal request from Puerto Rico for the community of 

Culebra. 

3. The widespread devastation in Puerto Rico caused by Hurricane Maria had a 

direct effect on pharmaceuticals and medical device manufacturing facilities 

located on the Island. Has HHS partnered with the suppliers of life-saving 

medicines to treat Puerto Rico's residents? What has the agency done to 

ensure facilities are well-equipped to ensure consistent production for 

residents in Puerto Rico and the rest of the nation? 

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During the initial response to Hurricane Maria, HHS staff from the Critical Infrastructure 

Protection (CIP) team worked at HHS headquarters and deployed to Puerto Rico to serve 

as private sector liaisons. These responders worked closely with staff on the HHS 

Incident Response Coordination Team, Puerto Rico's DOH, the Puerto Rico Electric 

Power Authority (PREP A), the Food and Drug Administration, National Voluntary 

Organizations Active In Disaster, the FEMA National Business Emergency Operations 

Center, and the Department of Homeland Security's (DHS) Office oflnfrastructure 

Protection staff in order to find resources to assist the unique needs of the private 

sector. Many of the needs concerned the health care product supply chain, including drug 

and medical device manufacturing; product distribution in Puerto Rico; and product 

distribution from Puerto Rico to the continental United States and other 

markets. Examples of activities the team coordinated include: 

• Prioritizing the landing of aircraft carrying medical supplies and drugs for both 

donations and normal distribution networks; 

• Finding space onboard departing aircraft to move supplies and drugs off the island; 

• Coordinating civilian and military resources to transport liquid oxygen supplies to the 

island after loss of power to local medical oxygen manufacturing facilities; 

• Sharing information with Puerto Rico's electric utility, PREP A, to recommend 

prioritization of key health care infrastructure including hospitals, clinics, 

manufacturing facilities, and blood distribution hubs; and 

• Coordinating private sector entities on the island to share resources with each other. 

4. There are varying reports on the total amount ofhospitals in Puerto Rico. 

For instance, FEMA bas reported a total of 67 hospitals. DOD bas indicated 

there are 69. Can you confirm the total number? How many of those are 

fully operational? How many hospitals, dialysis centers and civilian health 

facilities have power fully restored and bow many are relying on 

generators? 

ASPR's health care facility database identified 69 hospitals in Puerto Rico. This number 

matched the Puerto Rico DOH's list, and was used in the very early stages of the 

response. Through a significant amount of work conducting on-site assessments, it was 

determined that one of those hospitals was not a hospital but a specialty ward within a 

hospital. As assessments were completed, the last number reported was 68. 

a. Follow-up: are there sufficient health care personnel in each of these hospitals 

and facilities to treat patients? 

The best source of current information regarding staffing issues would be the Puerto 

Rico DOH and the Puerto Rico Hospital Association. 

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5. The amount of patients being treated by the USNS Comfort as compared to its 

capacity is dismal. The USNS Comfort can receive up to 1, 0 0 0 patients. How 

many patients has the ship served on a daily basis since arriving on Puelto 

Rico? Why is one of the largest medical facilities in the United States fleet 

being underutilized? 

Although the USNS Comfort can be configured and staffed as a 1 ,000-bed trauma 

hospital for combat missions, it was deployed to Puerto Rico in a Defense Support of 

Civil Authorities (DSCA) mission in a tailored humanitarian 250-bed configuration. The 

USNS Comfort could have expanded to 1,000 beds if additional support was needed; the 

U.S. Government and DoD never received a request to increase USNS Comfort's 

operational 250-bed configuration. The ship was sent to support civilian authorities (the 

Puerto Rico Department of Health [DOH] in coordination with Centro Medico and HHS). 

Shortly after arrival, the USNS Comfort promptly received multiple high-acuity, critical 

care/ICU patients from two Puerto Rican hospitals that had catastrophic generator 

failures. Additionally, the presence ofUSNS Comfort in San Juan after October 27, 

2017, enabled a disaster medical assistance triage area with HHS and the Puerto Rico 

DOH that provided care to patients. Over the course of a 44-day relief mission (October 

3 -November 15, 20 17), 6,003 outpatients were seen in both tents and on board the ship 

at the USNS Comfort location. The ship saw an average of 139 patients per day. A total 

of l ,993 patients were seen onboard the ship due to levels of care that exceeded initial 

triage capabilities, conditions requiring levels of care that exceeded the onshore treatment 

capabilities, or because they were directly referred to the ship via the Puerto Rico DOH 

medical operations center. A total of 290 patients were admitted to the USNS Comfort as 

inpatients. 

a. When did the USNS Comfort arrive in Puerto Rico? 

October 3, 2017. 

b. When did the USNS Comfort begin accepting patients? 

October 3, 2017. 

c. Follow-up: What is the process for patients in need of medical care to be 

treated there? 

Upon USNS Comfort's arrival to San Juan on October 3, 2017, the JFO Medical 

Operations Center (MOC), located in the San Juan Convention Center, was 

established in order to unify all patient related agencies in one location. Led by Joint 

Forces Land Component Command (JFLCC), it was also used to expedite requests 

from the Puerto Rico DOH through Centro Medico to HHS and the DoD. The MOC 

was manned 24/7 by members of Puerto Rico DOH, HHS, the Joint Force Maritime 

Component Commander (CTF-189), and the Joint Force Land Component 

Commander. 

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The initial agreed upon protocol was for all requests to be funneled through Puerto 

Rico's Level I Trauma Center, Centro Medico, which would analyze its 

capability/capacity to care for patients. If the request was to exceed Centro Medico's 

capability/capacity, the patient transfer request from Centro Medico's administration 

would come to the MOC for action. The MOC, with all its personnel, would assess 

the request and coordinate with USNS Comfort for acceptance and receipt of 

patient. This was done to ensure that the USNS Comfort had the medical capability to 

care for the patient. This protocol lasted for a period of two weeks and was modified 

due to Centro Medico's inability to keep up with local demands, hence the 

establishment of a new protocol. 

The primary intent of the new protocol was to gain flexibility, responsiveness, and 

efficiencies required to expeditiously address patient movement requests to the USNS 

Comfort, the U.S. Army Combat Support Hospital, and the U.S. Air Force 

Expeditionary Medical System in Puerto Rico. The new procedure, approved by the 

Puerto Rico DOH, allowed all operational regional hospitals to bypass Centro Medico 

and call the MOC directly. This new process improved DoD's ability to accept 

patients. 

The MOC, when notified that a patient needed to be moved, always reviewed a 

patient condition to determine which DoD or civilian hospital was best equipped for 

further treatment. 

d. How has FEMA communicated this information to Puerto Rico's 

Department of Health, hospitals, and other health facilities? 

Defer to FEMA 

6. What are HHS, CDC, and other involved federal agencies doing to ensure 

local Puerto Rico government employees have the necessary health and safety 

equipment to protect themselves during their ongoing relief and recovery 

work? 

HHS is coordinating with the Occupational Safety and Health Administration 

(OSHA) to support occupational safety and health issues that arise during the 

response. HHS is aware that OSHA's National Alliances agreed to donate personal 

protective equipment (PPE), including gloves, hard hats, and reflective vests, to help 

protect volunteers and workers performing hurricane recovery and clean-up efforts in 

Puerto Rico and the U.S. Virgin Islands (USVI). 

Within HHS, the Centers for Disease Control and Prevention (CDC) developed 

health communication materials that provide information to employers, workers, and 

volunteers responding to Hurricane Maria on ways to stay protected from a variety of 

response and recovery hazards. Shortages such as the low number of respirators in 

the USVI had been reported. HHS is working to understand the reason for the 

shortages. HHS engaged the commercial supply chain partners to better understand 

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current personal protective equipment (PPE) shortages and inform commercial 

decision making and activities to improve access in Puerto Rico and USVL 

a. Which federal government agencies are responsible for providing needed 

Personal Protective Equipment (PPEs) to relief and recovery workers? 

Federal Medical Station (FMS) sets include PPE as part of the equipment and 

supplies necessary to establish and operation each station, and the FMS sets 

deployed for the 2017 hurricane responses were fully stocked and included PPE. 

There is no single agency officially responsible for providing PPEs during an 

emergency. The employers of health care workers are responsible (and 

accountable by OSHA regulations and state and local laws) to ensure that their 

employees have access to necessary PPE. To support the needs of relief and 

recovery workers, HHS has provided training to worker camps and larger work 

sites to ensure the workforce understands the requirements and what it can do to 

protect themselves. In addition, local health departments and OSHA conduct 

periodic site assessments about the use and provision of PPE for relief and 

recovery workers. 

7. If power is still out in January, how would this impact the following areas? 

a. Hospital services 

As of December 12,2017 (the last date where this data was reported) all68 hospitals 

in PR are open with seven operating on generator power. Hospitals operating on grid 

power may lose grid power if the grid remains unstable. Of the hospitals running on 

generator power, the generators may need to be replaced if they are operating for long 

periods oftime. 

b. Health clinics 

As of January 24, 2018, 69 of 83 (83 percent) non-mobile HRSA-funded health 

center service delivery sites were operating on grid power. Health centers operating on 

grid power may lose power if the grid remains unstable. Of the 14 sites running on 

generator power, the generators may need to be replaced if they are operating for long 

periods oftime. 

c. Water filtration 

HHS defers to EPA. 

d. Wastewater 

HHS defers to EPA. 

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8. What is the current status of the following services in Vieques, Culebra, St. 

Croix, St. Thomas, and geographically remote parts of Puerto Rico in each 

ofthe following areas: 

a. Hospital Services 

Schneider Regional Medical Center on St. Thomas and Governor Juan F. Luis 

Hospital on St. Croix are both operating on grid/utility power and water, but at 

significantly reduced capacity and capability. An interim/temporary facility is being 

explored in order to allow each facility to effect repairs/replacement, but no solid 

timeline has yet been established. 

b. Health Clinics 

As of January 24, 2018, HRSA-funded health centers on Culebra, Vieques, St. 

Thomas, and St. Croix report that they are open. 

• Healthpromed (HPM) Foundation Inc. (Culebra) and HPM Foundation Inc. 

Municipality (Vieques) are both open and operating on generator power. 

• St. Thomas East End Medical Ceriter (St. Thomas, USVI) has one HRSA-funded 

health center service delivery site in scope, which is open and operating on grid 

power. 

• Frederiksted Health Care, Inc (St. Croix, USVI) has five HRSA-funded health 

center service delivery sites in scope, and all are open. Four are on grid power, 

and one (St. Croix Education Complex School Health Center) is on generator 

power. 

As of January 24, 2018, six other geographically remote HRSA-funded health center 

service delivery sites are operating on generator power. 

• Concilio de Salud Integral de Loiza, Inc (Loiza) 

• Corporacion de Servicios de Salud y Medicina Avanzada (Las Piedras) 

• Salud Integral en Ia Montana, Inc (Toa Alta) 

• Neorned Center Inc (Aguas Buenas) 

• Prymed Medical Care, Inc. (Ciales) 

• Prymed Medical Care, Inc. (Vega Baja) 

All other geographically remote sites are operating on grid power. 

c. Water Filtration 

HHS defers to EPA on this issue. 

d. Wastewater treatment 

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HHS defers to EPA on this issue. 

9. If roads and transportation infrastructure remains disrupted through next 

year, how would that impact the supply of products in the following areas to 

geographically remote areas in Puerto Rico as well as Vieques and Culebra: 

a. Pharmacy services 

b. Medical supplies 

For both pharmacy services and medical supplies, the transportation issues that 

barred the delivery of medical products and pharmaceutical products have been 

cleared. However, a handful offacilities in central Puerto Rico have had 

roadways washed away and are awaiting bridge repairs to reduce future impacts. 

10. When do you expect all medical services to be fully and readily available on 

St. Thomas and St. Croix? 

a. How long will HHS staff be on the ground in these areas, providing medical 

services? 

ASPR will remain on the ground as long as it takes to fulfill the mission, as 

requested by USVI. 

b. What medical services are currently available? What medical services 

available before the hurricanes are not available, and when will those 

services be restored? 

The DOH for USVI has the most up to date assessment of what is available and 

needed. HHS is available to aid efforts and specific tasks as requested by USVI. 

11. Mental and behavioral health impacts of the storm: 

a. What actions have been taken to address the mental and behavioral health 

impacts of the storm? 

During the 2017 hurricane response, HHS deployed more than 210 mental health 

officers and behavioral health staff to the impacted areas. The mental health teams 

conducted more than 7,000 force protection contacts, acute interventions, and 

assessments in shelters and operation centers for survivors and field staff. The 

officers focused on conducting broad assessments and addressing acute behavioral 

health needs, as well as working with community providers to facilitate identifying 

recovery needs and determining how to address them moving forward. HHS formed 

a Recovery Task Force that has a behavioral health-specific working group to 

determine ongoing and anticipated mental and behavioral health needs, in addition to 

implementation strategies to consider. 

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HHS also engaged in numerous support activities through the Substance Abuse and 

Mental Health Services Administration's (SAMHSA) disaster-related initiatives. 

SAMHSA, in coordination with partners such as CDC, the Health Resources Services 

Administration (HRSA), and ASPR, provided behavioral health technical assistance, 

consultation, coordination, and disseminated resources to state, territory, local, tribal, 

and non-governmental organizations responding to the disasters. CDC, working in 

collaboration with SAMHSA, created materials for children to be distributed at 

schools on coping with stress. The SAMHSA-funded Disaster Distress Helpline has 

responded and addressed 10,061 calls and texts from the impacted areas. SAMHSA 

also provided grant flexibilities for the impacted regions to meet needs caused by the 

storms. 

Efforts have been underway to ensure that clients on medication-assisted treatment 

for substance use could continue treatment by granting permission for service 

providers to issue take-home medications and to allow guest dosing in impacted 

areas. SAMHSA provided staff to the Secretary's Operation Center, Joint Field 

Offices and Emergency Operation Centers in impacted regions to assure behavioral 

health continuity, connection to SAMHSA programs, and workforce protection 

services. FEMA, in partnership with SAMHSA, administers the federally funded 

supplemental program Crisis Counseling Assistance and Training Program grants to 

areas impacted by the storms. This program hires and trains local crisis counselors to 

conduct outreach, brief interventions, and provide referral for survivors. This 

program hires and trains local crisis counselors to conduct outreach, brief 

interventions, and referral to survivors. Programs are up and running in all areas. 

b. What have these assessments concluded? 

Behavioral health continues to be a priority as hurricane affected areas begin recovery 

efforts. Behavioral Health Liaison Officers worked as part of the Incident Response 

Coordination Team and worked with deployed Mental Health Teams throughout the 

response to determine current and emerging behavioral health needs. CDC also 

included mental health questions in community surveillance tools. 

Overall, assessments have concluded that high levels of anxiety and grief resulted 

from the storms, including anger and frustration. People with pre-existing conditions 

struggled without access to care. The establishment of crisis counseling outreach 

programs has allowed states, territories, and localities to access data about the 

evolving behavioral health needs of their communities as the recovery continues. 

c. What mental health services is HHS currently providing in affected areas, and 

how long will these services be available? 

In collaboration with ASPR, FEMA andSAMHSA administer the Federal award for 

the Crisis Counseling Assistance and Training Program which hires and trains local 

crisis counselors to conduct outreach, brief interventions, and make referrals for the 

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survivors. These programs are up and running in all hurricane affected areas and will 

operate for nine months from the date of award. 

d. What current actions is HHS taking to address long-term mental health 

issues stemming from this storm? 

Working through the ASPR-Ied HHS Recovery Task Force, SAMHSA has convened 

an interagency workgroup of HHS entities with interest in behavioral health, the 

Behavioral Health Recovery Workgroup, to find ways to incorporate state 

programing and meet ongoing recovery needs. ASPR is including mental and 

behavioral health as a priority area for Recovery Support Function efforts and will be 

including field staff with behavioral health expertise as part of ongoing technical 

assistance and guidance being provided to the affected states and territories. An 

emphasis on assisting affected localities in ensuring access to support and treatment 

will be part of these efforts. 

21 
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Rep. Jan Schakowsky 

1. Following up 

a. What is HHS, CDC, and other federal agencies doing to ensure local 

Puerto Rico government employees have the necessary health and safety 

equipment to protect themselves during their ongoing relief and recovery 

work? 

Federal Medical Station (FMS) sets include PPE as part of the equipment and 

supplies necessary to establish and operate each station, and the FMS sets 

deployed for the 2017 hurricane responses were fully stocked and included PPE. 

The Department of Health and Human Services (HHS) is coordinating with the 

Occupational Safety and Health Administration (OSHA) to support occupational 

safety and health issues that arise during a response. HHS is aware that OSHA's 

National Alliances agreed to donate personnel protective equipment (PPE), 

including gloves, hard hats, and reflective vests, to help protect volunteers and 

workers performing hurricane recovery and clean-up efforts in Puerto Rico and 

the U.S. Virgin Islands (USVI). The Centers for Disease Control and Prevention 

(CDC) has developed public health communication materials that describe how 

employers, workers, and volunteers responding to Hurricane Maria can stay 

protected from a variety of response and recovery hazards. 

b. Have these issues been addressed in Puerto Rico? 

Shortages and low supplies of respirators in USVI have been reported. HHS has 

engaged commercial supply chain partners to better understand current PPE 

shortages and inform commercial decision makers and guide activities for 

improving access in Puerto Rico and USVI. 

c. Which federal government agencies are responsible for providing needed 

PPEs to recovery workers? 

There is no single agency responsible for providing PPE during an emergency. 

The employers of the workers are responsible (and accountable by OSHA 

regulations and state and local laws) to ensure that their employees have PPE. To 

support the needs of relief and recovery workers, HHS has provided training to 

worker camps and larger work sites to ensure the workforce understand the 

requirements and what they can do to protect themselves. In addition, the local 

health departments and OSHA conduct periodic site assessments about the use 

and availability of PPE for relief and recovery workers. 

22 
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Rep. Kathy Castor 

1. I also heard from these health professionals that water sanitation is one of the 

biggest issues in Puerto Rico rightnow, which is leading to gastrointestinal issues 

as well as systemic infections. How is the Administration helping get clean water 

to Puerto Rico, especially to remote areas? Additionally, bow is HHS working 

with health professionals on the ground to treat illnesses stemming:fian the lack of 

clean water? 

CDC/ ATSDR field staff in Puerto Rico have facilitated contacts between EPA and the 

Puerto Rican authorities. We also currently have a representative on a workgroup dealing 

with water quality. 

CDC is working with EPA and public health officials to identify health risks and prevent 

illnesses from unsafe water and to restore public health capacity. CDC conducted basic 

water testing immediately following the hurricane and EPA followed up with additional 

testing for fecal contamination. 

Both CDC and EPA have worked with Puerto Rico and the U.S. Virgin Islands (USVI) to 

educate home-and business owners of methods of treating their household water to 

reduce their risk of waterborne disease. 

2. Physicians have told me they are seeing other health issues such as asthma, COPD, 

conjunctivitis, scabies, diabetes, and hypertension being exacerbated due to lack of 

medications, power, transportation and supplies, increased air pollution from 

generators and unsanitary living conditions. Is HHS monitoring this situation, and 

what steps are being taken to address these additional health issues? 

ASPR led health care facility assessments in Puerto Rico. These assessments focused on 

predominantly structural integrity issues. 

CDC headquarter staff recommended additional island wide active surveillance to track 

disease outbreaks. CDC was able to partner with Department of Veterans Affairs health 

care facilities in Puerto Rico to establish a sentinel surveillance system in three of the 

largest facilities on the island. This system provided situational awareness for Federal 

and territorial partners on infectious disease syndromes and exacerbation of chronic 

diseases. This system provided information in places where power and internet 

connectivity did not allow for routine surveillance information to be transmitted. The 

CDC team abstracted over 13,800 medical charts, provided weekly reports to all partners, 

and briefed leadership on findings. It provided concrete information about syndromic 

influenza illnesses and leptospirosis, both high priority pathogens of concern to the 

community and our partners. Additionally, the system identified exacerbation of mental 

health issues attributable to the hurricanes and individuals with symptoms and exposure 

suggestive of carbon monoxide poisoning, prompting further engagement of clinical and 

23 
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27737.069

public health partners. This system was in place from the end of October 2017 to the end 

of January 2018. 

CDC also published a Health Alert Network (HAN) Health Advisory: Advice for Health 

Care Providers Treating Patients in or Recently Returned from Hurricane-Affected Areas, 

including Puerto Rico and the U.S. Virgin Islands. This advisory reminded clinicians 

assessing patients iri or recently returned from hurricane-affected areas to be vigilant for 

certain infectious diseases, including leptospirosis. 

In addition, CDC worked with PRDH and CDC Foundation to create a laboratory 

transport system, for key diseases of concern (flu, TB, leptospirosis). Since October 20, 

20 17, CDC received samples from over 1,1 00 patients with suspected leptospirosis, TB, 

and influenza in Puerto Rico. Testing is ongoing, and results continue to be reported to 

the Puerto Rico Department of Health. 

CDC communicated generator-use safety messages in multiple languages through print, 

broadcast, internet and social media and other channels such as Clinician Outreach 

Communication Activity call (COCA) and a Health Alert Notice. Thousands of safe 

generator-use and Carbon Monoxide (CO) poisoning awareness door hangers and flyers 

have been distributed in hurricane-affected areas. CDC has provided technical assistance 

to Texas and Florida for CO poisoning surveillance. CDC has also provided technical 

assistance to Puerto Rico, USVI, and the American Academy of Pediatrics on public 

messaging to prevent CO poisoning. 

CDC staff have deployed to Texas, Puerto Rico, and USVI to support state.and territorial 

health departments in monitoring and addressing health issues related to air pollution 

from improper generator use and mold in flood-damaged buildings. CDC has several 

guidance documents for homeowners, workers, and clinicians about mold remediation, 

personal protective equipment, and cleanup, and mold safety for medically vulnerable 

populations and patients with asthma. These have been developed, updated, translated to 

multiple languages, and distributed online and in print to all affected areas. 

HHS's Strategic National Stockpile (SNS) deployed six Federal Medical Stations (FMS) 

into Puerto Rico. FMSs are non-emergency medical centers that can provide care for 

displaced persons with special health needs. These needs include chronic health 

conditions, limited mobility, or mental health issues that cannot be met in a shelter for the 

general population. As of November 17, 2017 all FMS in Puerto Rico had officially been 

signed over to the Puerto Rico Department of Health. 

CDC also continues to provide technical assistance to PRDOH regarding immunization 

program activities and supports vaccine needs. As part of this effort, SNS has procured 

$2.3 million worth of vaccines and ancillaries to support PRDOH vaccination programs 

targeted to protect people from vaccine preventable disease. CDC is also coordinating 

with HHS to procure vaccines to support immunization program efforts in US VI. 

24 
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27737.070

To date, CDC has not received requests from Puerto Rico to support disease surveillance. 

CDC stands ready to support epidemiological and surveillance activities for infectious 

and non-infectious diseases, as needed for Puerto Rico. 

On November 12, 2017, CDC personnel deployed to assist in investigations of disease on 

as requested by USVI. The CDC team will assist USVI Department of Health with 

patient screening guidance and rapid diagnostic tests for both diseases, leptospirosis and 

melioidosis, that will supplement pre-existing arbovirus disease syndromic surveillance 

activities. The team will also assist in the coordination of shipping diagnostic samples to 

CDC for confirmatory testing, investigating confirmed and probable cases of 

leptospirosis and melioidosis in an attempt to discover the exposures that led to infection, 

and conducting public and clinician outreach and education regarding leptospirosis and 

melioidosis. In addition, CDC has placed posters about leptospirosis within clinics and 

hospitals around the island. Over a million fact sheets were distributed to residents of 

Puerto Rico and USVI letting them know about the risk for infectious diseases following 

a natural disaster and what precautions to take. Once power began to be restored these 

public health messages were further distributed via radio and social media messaging. 

25 
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27737.071

Rep. Pete Olson 

1. After tackling 3 Hurricanes in a short period of time, what strain s have you seen on 

your current resources. Also, what additional resources do you need to provide 

these communities the help that they need? 

In responding to the three hurricanes, the Office of the Assistant Secretary for 

Preparedness and Response (ASPR) deployed approximately 2,500 National Disaster 

Medical System (NDMS) personnel, deployed 944 tons of equipment and logistics, and 

treated 36,370 patients. However, responding to three near simultaneous hurricanes has 

resulted in ASPR significantly drawing resources from its medical caches, logistics 

equipment, and NDMS teams. ASPR is currently understaffed for day-to-day logistical 

requirements supporting hurricane response and recovery efforts. 

Direct hiring authority would allow ASPR to fill current vacancies and ensure that an 

adequate number of personnel can continue to support impacted communities and 

provide effective real time response. 

Deploying multiple teams of U.S. Public Health Service (USPHS) staff as mental health 

officers, some for two or three deployment periods, created a strain on available assets. 

This resulted in assets in the field being stretched to the limits of existing capacity. 

26 
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27737.072

Rep. Gus Bilirakis 

1. 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? 

Hospital Preparedness Program (HPP) funds may not be used for this purpose. HPP 

awardees and their sub-recipients may provide funding to individual hospitals or other 

health care entities, as long as the funding is used for activities to advance regional, 

health care coalitions (HCC), or health care system-wide priorities, and are in line with 

the Office of the Assistant Secretary for Preparedness and Response's (ASPR) four health 

care preparedness and response capabilities. 

HPP funding to individual health care entities shall not be used to meet Centers for 

Medicare & Medicaid Services (CMS) conditions of participation, including CMS-3178-

F Medicare and Medicaid Programs, Emergency Preparedness Requirements for 

Medicare and Medicaid Participating Providers and Suppliers. CMS-3178-F requires 

providers and suppliers to meet the following conditions of participation: 

• Development of an emergency plan. Develop an emergency plan based on a 

risk assessment using an all-hazards approach focusing on capacities and 

capabilities that are critical to preparedness for a full spectrum of emergencies or 

disasters specific to the location of a provider or supplier. HPP funding may not 

be provided to individual health care entities to meet this requirement; however, 

ASPR encourages HCCs to provide technical assistance to their individual 

members to assist them with the development of their emergency plans. HCCs 

are permitted to use HPP funding to develop the staffing capacity and technical 

expertise to help their members meet this requirement. 

• Develop policies and procedures. Develop and implement policies and 

procedures based on the plan and risk assessment. HPP funding may not be 

provided to individual health care entities to meet this requirement; however, 

ASPR encourages HCCs to provide technical assistance to their individual 

members to assist them with the development of policies and procedures. HCCs 

are permitted to use HPP funding to develop the staffing capacity and technical 

expertise to help their members meet this requirement. 

• Develop and maintain a communication plan. Develop and maintain a 

communication plan that complies with both Federal and state law. Patient care 

must be well-coordinated within the facility, across health care providers, and 

with state and local public health departments and emergency systems. HPP 

funding may not be provided to individual health care entities to meet this 

requirement; however, ASPR encourages HCCs to provide technical assistance to 

their individual members to assist them with the development of a communication 

plan that integrates with the HCC's communications policies and procedures. 

27 
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27737.073

HCCs are permitted to use HPP funding for costs associated with adding new 

providers and suppliers to their HCC who are seeking to join coalitions to 

coordinate patient care across providers, public health departments, and 

emergency systems (e.g., hiring additional staff to coordinate with new HCC 

members, providing communications equipment and platforms to new members, 

conducting communications exercises, securing meeting spaces, etc.). 

• Develop and maintain training and testing program. Develop and maintain 

training and testing programs, including trainings, and conduct drills and 

exercises or participate in an actual incident that tests the plan. HPP funding may 

not be provided to individual health care entities for individual health care 

organizations' trainings and exercises. HPP funding may be used to plan and 

conduct trainings and exercises at the regional or HCC level. 

Medicare skilled nursing facilities and Medicaid nursing facilities are required to have 

back up power. This requirement was established before the CMS Emergency 

Preparedness Final Rule, and is set out at 42 C.F.R. 483.90(b). 

28 
130 


27737.074

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!ongrt~~ of tbt 1tntttb ~tate~ 

;!>oust of l\tptt5tntatibt5 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN House OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

The Honorable Scott Gottlieb, MD 

Commissioner 

U.S. Food and Drug Administration 

10903 New Hampshire A venue 

Silver Spring, MD 20993 

Dear Dr, Gottlieb: 

Majority {202) 225-2927 

Minority (202) 225-3641 

November9, 2017 

Thank you for appeariog before the Subcommittee on Oversight and Investigations on Tuesday, 

October 24, 2017, to testify at the hearing entitled "Examining HHS's Public Health Preparedness for and 

Respcnse to the 2017 Hurricane Season." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format ofyourresponses to these questions should be as follows: (1) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, November 28, 2017. Your respcnses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali,Fulling@mail.house,gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

f&voW~ 

Greg Walden 

Chairman 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
131 


27737.075

j U.S. FOOD & DRUG , ......... . \ 

~ 

t# ADMINISTRATION 

The Honorable Greg Walden 

Chairman 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, D.C. 20515 

Dear Chairman Walden: 

APR 2 7 2018 

Thank you for providing the Food and Drug Administration (FDA or the Agency) with the 

opportunity to testify at the October 24, 2017 hearing before the Subcommittee on Oversight and 

Investigations, House Committee on Energy and Commerce, entitled "Examining HHS' Public 

Health Preparedness for and Response to the 2017 Hurricane Season." This letter is a response 

for the record to questions posed by the committee. 

If you have further questions, please let us know. 

U.S. Food & O'ug Adrrinistration 

10903 New Hampshire Avenue 

Silver Spring, IVD 20993 

www.fda.gov 

Sin~~~ 

Jo Martin 

Pn ipal Associate Commissioner 

for Legislative Affairs 
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27737.076

Page 2- The Honorable Greg Walden 

Your questions have been restated in bold below, followed by our responses. 

The Honorable Greg Walden 

1. Approximately how many of the pharmaceutical and medical device manufacturing 

facilities in Puerto Rico are still operating on generator power? 

a. How much longer can the facilities using generator power continue to rely on 

generator power? 

As of October 24, 2017, we believe most, if not all, facilities are operating on generator 

power. While generators allowed many facilities to restart production, they are not a 

long-tenn solution. 

Updates on this status can be found on FDA's website. 

b. Has the Food and Drug Administration (FDA) identified any preservation 

concerns or access Issues associated with temperature-controlled 

pharmaceuticals, and if so what is it doing to address them? 

FDA has undertaken swift and extensive efforts to prevent or limit the loss or shortage of 

multiple drugs critical to American patients due to challenges related to refrigeration, 

storage, and transportation. We have also been working closely with manufacturers to 

relocate products, and have been following critical infrastructure work done by our 

federal partners including: clearing roads to reach facilities; helping manufacturers 

procure fuel to keep generators running; and securing permissions to allow planes to land 

in Puerto Rico and fly critical products to the continental United States. 

c. How many pharmaceutical and medical-device manufactUring facilities in 

Puerto Rico are fully functional? 

As of October 24, 2017, we do not believe that many of the medical product facilities are 

fully functional. For pharmaceuticals, most are producing at anywhere from 20 percent to 

70 percent of their nonnal capacity based on our own informal survey. One finn is 

producing at I 00 percent of pre-hurricane output but they have dialed back certain other 

portions of the facility. 

Updates on this status can be found on FDA's website. 

d. As the crisis in Puerto Rico has evolved have any new challenges arisen for 

pharmaceutical and medical device manufacturing facilities in Puerto Rico? If 

so, what steps is FDA taking to address those issues? 

FDA is prioritizing its work with facilities that make critically important medical 

products to prevent or limit the impact of nationwide shortages. FDA is actively working 

with several companies who have requested assistance from FDA because their 
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27737.077

Page 3- The Honorable Greg Walden 

manufacturing facilities in Puerto Rico were impacted by the hurricanes. And, we are 

working closely with the Federal Emergency Management Agency (FEMA) and other 

government partners as well. 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 fly out finished products that were in some cases at risk of 

being destroyed by flooding warehouses. We are also working- with other government 

partners -to help facilities obtain fuel to keep generators running and, in certain cases, 

medical-grade gases that are used by some manufacturers. 

A key challenge for the medical products facilities is obtaining access to the power grid. 

Many generators are old and not meant to function for months on end, and many facilities 

cannot return to full production on generator power alone. 

As of October 24, 2017, we continue to be in contact with all firms that manufacture 

medical products we consider critical, where a falloff in production and an ensuing 

shortage could have public health implications. FDA is working to prevent and mitigate 

shortages of critically important medical products. We believe we have a good 

understanding of the potential risks and are taking steps to mitigate them. We are 

working with some companies to import medically necessary drugs from alternate 

manufacturing sites approved by a designated regulatory body, expediting review related 

to the import of medically necessary drugs from manufacturing sites that are not FDA 

approved, expediting review and approval of other dosage forms and generic versions, 

and approving production test methods to allow faster release of drug products to the 

market. 

The Honorable Gus Bilirakis 

1. What challenges still exist for Florida and what are your post-storm 

recommendations? 

FDA recognizes that Hurricane Irma has led to hardships for many, and impacted drug and 

device manufacturers, as well as food and agriculture operations in Florida. 

FDA has been working closely with drug and device manufacturers in all the affected areas 

to help prevent or mitigate a shortage, both before and after Hurricane Irma. 

Crops and agriculture that were impacted by Hurricane Irma include citrus, avocados, 

tomatoes, sweet com, bell peppers, sugarcane, cotton, and dairy from Florida. FDA has 

provided guidance to the industry regarding the safety evaluation of flood affected crops for 

human and animal consumption, as well as guidance for food manufacturers, warehouses, 

and transporters of food affected by floods or power outages. 

Additionally, local intermittent blood shortages occurred in areas of Florida impacted by the 

storms. However, the AABB Interorganizational Task Force on Domestic Disasters and Acts 

of Terrorism, of which FDA is an active member, ensured areas impacted by the storms had 

sufficient levels of safe blood products on hand to meet local medical support requirements, 

primarily through coordination networks comprised of non-profit independent national and 

regional blood centers. 
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Page 4- The Honorable Greg Walden 

2. What resources are available to communities like mine impacted by Irma? 

FDA recognizes that these hurricanes have presented unique challenges for those in the 

affected areas, and the Agency is committed to working with those who were impacted, as 

well as with our Federal and state partners, to help prevent or mitigate issues. 

FDA has conducted assessments of the impact of Hurricane Irma on FDA-regulated firms 

and industries. For Hurricane Irma, FDA's Florida District Incident Management Team 

(IMT) conducted more than 2,380 post-storm assessments, and FDA staff remains available 

to answer any questions and provide assistance when appropriate. 

The Honorable Frank Pallone, Jr. 

1. The widespread devastation In Puerto Rico caused by Hurricane Maria had a direct 

effect on pharmaceutical and medical device manufacturing facilities located on the 

island. Has FDA partnered with the suppliers of life-saving medicines to treat Puerto 

Rico's residents? What has the agency done to ensure facilities are well-equipped to 

ensure consistent production for residents in Puerto Rico and the rest of the nation? 

As an agency dedicated to promoting public health, and as fellow Americans, the staff at 

FDA are doing all they can to support the immediate needs of those affected by the 

destruction of these devastating storms. We are also working closely with our HHS 

colleagues and Federal partners to address the unique challenges facing Puerto Rico. FDA 

continues to work closely with medical product manufacturers to ensure availability of 

products that meet rigorous FDA standards for safety and efficacy. FDA is focusing on 

facilities that make critically important medical products to prevent or limit the impact of 

nationwide shortages. 

Our interventions have evolved as the nature of the risk has changed and our response 

progresses. We are working closely with FEMA and other government partners. Early on we 

helped individual firms secure landing rights for planes to fly out finished products that were 

in some cases at risk ofbeing destroyed by flooding warehouses, we have also worked to 

help facilities obtain fuel to keep generators running and, in certain cases, medical-grade 

gases that are used by some manufacturers, and to help local manufacturers who provide 

sterilization services to hospitals to get back online. 

2. During your testimony before this Committee on October 24 you stated that Puerto 

Rican pharmaceutical plants manufacturer 30 products that are considered "critical 

medicines" and that of those 30, 14 are sole-source products meaning that there are 

no alternative drug products available. 

a. Are all plants which manufacture the 30 critically-important products operatiug 

at full capacity today? 
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Page 5- The Honorable Greg Walden 

As of October 24, 2017, we do not believe any of the medical product facilities are fully 

functional. Most are producing at anywhere from 20 percent to 70 percent of their normal 

capacity based on our own informal survey. One firm is producing at 100 percent of prehurricane output but they have dialed back certain other portions of the facility. We 

continue to monitor the situation and provide assistance as appropriate. 

Updates on this status can be found on FDA's website. 

b. Has the FDA evaluated how long each such plant can continue to operate under 

current conditions? 

Our focus continues to be on plants that make critically important products and we are 

taking steps to try to mitigate the shortages that have occurred but are also looking at 

situations where we see the potential for a product to tip into shortage. We are typically 

looking out one-to-two months for what we think could potentially happen if full 

production does not resume. 

c. What contingency plans has the FDA considered in the event that power and other 

capabilities are not restored by the first quarter of next year? 

As of October 24, 2017, we continue to be in contact with all the firms that manufacture 

medical products we consider critical, where a falloff in production and an ensuing 

shortage could have public health implications. The FDA is working to prevent and 

mitigate shortages of critically important medical products. We believe we have a good 

understanding of the potential risks and are taking steps to mitigate them. We are 

working with some companies to import medically necessary drugs from alternate 

manufacturing sites approved by a designated regulatory body, expediting review related 

to the import of medically necessary drugs from manufacturing sites that are not FDA 

approved, expediting review and approval of other dosage forms. and generic versions, 

and approving production test methods to allow faster release of drug products to the 

market. 

3. On October 20 you released a statement that Puerto Rican manufacturers produce 

50 types of medical devices that are critically important to patient care because they 

are life-sustaining and/or because they are produced by the only manufacturer ofthat 

device type. According to your statement, blood-related medical devices are of 

particular concern. 

a. Are all plants which manufacture the 50 types of medical devices operating at 

full capacity today? 

As of October 24, 2017, we do not believe that many of the medical product facilities are 

fully functional. We continue to monitor the situation and provide assistance as 

appropriate. 

Updates on this status can be found on FDA's website. 
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Page 6- The Honorable Greg Walden 

b. Has FDA evaluated how long each plant can continue to operate under current 

conditions? 

Our focus is on plants that make critically important products and we are taking steps to 

try to mitigate the shortages that have occurred but are also looking at situations where 

we see the potential for a product to tip into shortage. We are typically looking out oneto-two months for what we think could potentially happen if full production does not 

resume. 

c. What contingency plans has the FDA considered in the event that power and other 

capabilities are not restored by the first quarter of next year? 

As we continue to monitor at-risk devices, FDA will take other steps as appropriate to 

mitigate the potential for shortages, including considering, when necessary, importing a 

device from outside of the U.S. or allowing manufacturers to shift production to 

alternative sites. 

4. What is the status of delivery of essential medical products to geographically remote 

areas such as Vieques, Culebra, St. Croix and St. Thomas? 

FDA works with manufacturers to assess and address the overall, national supply of medical 

products. Regarding localized transportation and distribution of essential medical products, 

FDA defers to the HHS Assistant Secretary for Preparedness and Response. 

The Honorable Jan Schakowsky 

1. Following up, in the aftermath of disasters like these devastating hurricanes, 

government should provide relief and recovery workers with required health and 

safety protections and Personal Protective Equipment (PPEs) to ensure workers' 

health is not compromised during current and on-going clean-up and future 

rebuilding. Unfortunately we have heard that this is causing problems in Puerto Rico. 

We know that Puerto Ricans in both the private and public sector want to do the work 

needed to help rebuild their lives, homes, communities and their Commonwealth. 

Government workers are willing and eager to help address short-term needs - even 

when working as assigned by the Puerto Rico government is outside their longstanding responsibilities and expertise. Nonetheless workers simultaneously want to 

protect their own health and safety and avoid unnecessary health problems. The longterm medical problems flowing from the tragic events on September 11, 2001 and the 

resulting cleanup efforts at· Ground Zero and on the Pile taught us the vital 

importance of providing appropriate health and safety equipment and training to 

workers in conditions that are dangerous or uncertain. 

a. What is HHS, CDC, and other federal agencies going to ensure local Puerto Rico 

government employees have the necessary health and safety equipment to protect 

themselves during their ongoing relief and recovery work? 
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27737.081

Page 7- The Honorable Greg Walden 

b. Have these issues been addressed in Puerto Rico? 

c. Which federal agencies are responsible for providing needed PPEs to recovery 

workers? 

FDA defers to the Centers for Disease Control and Prevention to answer these questions. 

The Honorable Pete Olson 

1. After tackling 3 Hurricanes in the short period of time, what strains have you seen on 

your current resources? Also what additional resources to you need to help provide these 

communities that help that they need? 

FDA has spent about $3 million as of mid-October for hurricane response activities. We continue 

to use funding from our current budget to pay for staff time, travel, and supplies. We are working 

with the Administration to determine additional funding needs to help pay for repair of FDA 

facilities and equipment damaged by Hurricanes Harvey, Irma, and Maria. 
138 


27737.082

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR .. NEW JERSEY 

RANKING MEMBER 

C!ongrtss of tbt Wnfttb ~tatts 

J>ou~t ot l\tptt~tntatlbe~ 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN House OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority (202) 225-2927 

Minority (202} 225-3641 

November 9, 2017 

Ms. Kimberly Brandt 

Principal Deputy Administrator for Operations 

Centers for Medicare and Medicaid Services 

7500 Security Boulevard 

Baltimore, MD 21244 

Dear Ms. Brandt: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

October 24, 2017, to testicy at the hearing entitled "Examining HHS's Public Health Preparedness for and 

Response to the 2017 Hurricane Season." 

Pursuant to the Rules of the Committee on Energy and Commerce. the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (1) the name oftbe 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmitta1letter by the close of business on Tuesday, November 28, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

~ Greg Walden 

Chairman 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
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Kim Brandt's Hearing on 

"Examining HHS's Public Health Preparedness for and Response to 

The 2017 Hurricane Season" 

E&CO&I 

October 24, 2017 

The Honorable Gus Bjljrakjs 

1. The "alternate/backup power" provision ofthe Emergency Preparedness Rule is final 

next month, what is the size of the pool of providers that are currently 'out of 

compliance' with this rule? 

a. Why despite having a year to comply, are these providers still out of compliance with 

this rule? 

Answer: Patient safety is a top priority at CMS, and we expect it to be the top priority in every 

single facility that participates in the Medicare and/or Medicaid program, including nursing 

homes. In order to become certified by CMS, a nursing home must meet basic health and 

safety requirements included in the Social Security Act and the Medicaid Requirements for 

Long Term Care Facilities. We expect facilities to meet these requirements at all times, even 

in emergencies. For long-term care facilities, including nursing homes, these requirements 1 

incorporate requirements for infection control, quality of care, nursing services, and many 

others, including numerous emergency power2 and preparedness3 standards. For example, 

they are required to have emergency power systems adequate enough to supply power for 

lighting all entrances and exits; equipment to maintain the fire detection, alarm and 

extinguishing systems; and life support systems, such as ventilators, in the event that normal 

electrical supply is interrupted. When life support systems are used, the facility must 

provide emergency electrical power with an emergency generator that is located on the 

premises. In addition, the long-term care facility must have an emergency plan, and must 

implement emergency and standby power systems based on that emergency plan. 

Our requirements also outline resident rights. Every resident has a right to a safe, clean, 

comfortable and homelike environment, including receiving treatment and supports for daily 

living safely. For example, all CMS-certified long-term care facilities must provide comfortable 

and safe temperature levels; for those initially certified after October 1990, this is specifically 

defined as 71 to 81 degrees Fahrenheit. Facilities are expected to meet these requirements at all 

times, even during emergencies. 

Using lessons learned from previous natural disasters, CMS updated and improved existing 

emergency preparedness requirements in our Requirements for nursing homes and other 

providers participating in Medicare and Medicaid by issuing an Emergency Preparedness Final 

1 42 CFR Part 483 

2 42 CFR §483.73(e) 3 42 CFR §483.73 
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Rule. 4 In our updates, we clarified that long-term care facilities, including nursing homes, must 

store emergency fuel and associated equipment and systems, and introduced additional testing 

requirements for their emergency and stand-by-power systems. 5 The new standards became 

effective on November 15,2016. Surveys to evaluate compliance with the new requirements 

will begin November 15,2017, at which time we will assess whether additional resources are 

needed by facilities. 

Transparency is an important part of CMS' s patient safety work and CMS is committed to making 

sure that patients, their families and policymakers have the information they need about the health 

care facilities we oversee. CMS's Nursing Home Compare Website6 contains resident quality of 

care and staffing information for more than 15,000 Medicare and Medicaid nursing homes around 

the country. The website includes detailed reports on health inspections, life safety code inspections 

and any identified noncompliance deficiencies. 

b. How are inspections prioritized: By provider size? By season? (testing northern 

providers during winter; southern providers during summer) By non-compliance 

history? 

Answer: Certain Medicare participating facility types have statutorily-mandated survey 

frequencies: each individual nursing home must be surveyed at least every fifteen months; each 

home health agency must be surveyed at least every three years; and hospice facilities must be 

surveyed at least once every three years. Hospitals are also surveyed at least once every three 

years. In addition, surveys are conducted in response to complaints received from patients, 

providers, facility staff, or others who have concerns about a facility within our oversight. 

Complaint surveys can be performed at any time of the year, with the actual timing dependent on 

the severity ofthe allegation. 

The Honorable Frank Pallone. Jr. 

1. The Centers for Medicare and Medicaid Services (CMS) have established a special 

open enrollment period for hurricane victims. Since Puerto Rico receives medical 

coverage and benefits differently from U.S. states, what efforts are being made to 

ensure affected people in Puerto Rico are receiving aid? 

Answer: CMS established a Federal Health Insurance Exchange special enrollment period, 

allowing certain individuals impacted by these hurricanes who experienced a qualifying life 

event to select a new 2017 Exchange plan or make changes to their existing plan at any time 

through December 31, 2017. In addition, individuals who reside in, or move from, areas affected 

by a hurricane in 2017 will be eligible for a special enrollment period that extends the 2018 

Annual Open Enrollment Period through December 31,2017. CMS also established a Medicare 

Part C and D special enrollment period, allowing individuals affected by the hurricanes to enroll 

in, dis-enroll from, or switch, Medicare health or prescription drug plans. It is available from the 

4 https://www.gpo.gov/fdsys/pkg/FR-20 16-09-16/pd£'20 16-21404.pdf 5 42 CFR §483.73(e) 6 httos://www.medicare.gov/nursinghomecomparelsearch.html 

2 
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27737.085

start of the incident period and runs through the end of the calendar year. 

In addition, we are dedicated to making sure all of our program beneficiaries impacted by the 

hurricanes are able to access their needed treatments and supplies. This is why we are using our 

waiver authority to give beneficiaries, providers, suppliers, and states the flexibility they need to 

meet emergency health situations. For example, CMS established a hotline to assist healthcare 

providers in Puerto Rico, the U.S. Virgin Islands, and several affected states in receiving temporary 

Medicare billing privileges, making sure providers will be appropriately reimbursed for their 

critical services. CMS also gave Medicare providers in locations impacted by the hurricanes the 

flexibility to move patients between facilities, administer care in almost any location, and approve 

out-of-state or out-of-network providers as needed, in order to ensure continuity of care. 

2. There has been outward migration from the Island to mainland states. Those affected 

are still eligible for benefits. What efforts are being made to ensure that Puerto 

Ricans displaced by Hurricane Maria know about the enrollment period in the 

mainland and how to apply? Are any outreach efforts and materials being provided in 

Spanish? 

Answer: CMS is committed to making sure our beneficiaries have access to necessary treatment, 

even when they have been evacuated. CMS has released materials in Spanish7 in order to make sure 

those who are still eligible for enrollment in Medicare through a Special Enrollment Period are 

informed. In addition, Medicare Beneficiaries and Exchange consumers can receive information 

about Special Enrollment Periods in English or Spanish by contacting the 1-800- MEDICARE or the 

Exchange Call Center. We are also working with our partners on the ground to see how we can 

better meet the needs of those in affected areas, including outreach efforts in Puerto Rico. 

Addendum: On December 22, 2017, CMS released an FAQ addressing coverage issues for displaced 

Puerto Rican Medicaid, traditional Medicare, and Medicare Advantage beneficiaries in Florida. 8 In 

addition, a Spanish translation of the FA Q will soon be available on the CMS website. 

3. CMS extended open enrollment until December 31,2017, for all Medicare beneficiaries 

and for those enrolled in plans through the Federal Health Insurance Exchange. It 

appears, however, that power and communications systems may continue to be 

severely restricted through that time period, and possibly into the first quarter of next 

year and beyond. What steps is CMS taking to ensure that affected individuals in 

Puerto Rico and the U.S. Virgin Islands will be able to obtain coverage even if 

electricity and/or Internet services are not restored by the end of the year? 

7 Examples at https://www.cms.gov/Newsroom!MediaReleaseDatabase/Press-releases/2017-Press-releases· 

items/20 17-10-30-3 .html#, https://www .cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/20 17 -Pressreleases-items/20 17 -09-12.html, https://www.cms.gov/Newsroom!MediaReleaseDatabase/Press-releases/20 17-

Press-releases-items/20 17 -09-ll.html, https://www.cms.gov/Newsroom!MediaReleaseDatabase/Pressreleases/2017-Press-releases-items/20 17-09-08-2.html, 

https://www .ems. gov/Newsroom/MediaReleaseDatabase/Press-releases/20 17 -Press-releases-items/20 17-09-08-

3.html 

8 https://www.cms.gov/About-CMS/Agency-lnformation!Emergency/Downloads/Questions-and-Answers-for· 

displaced-Puerto-Ricans-in-Fiorida-Englishpdf.pdf 
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Answer: CMS is committed to making sure our beneficiaries have access to necessary treatment. 

Working with our partners on the ground in Puerto Rico and the U.S. Virgin Islands, we will 

continue to assess how we can best accommodate their needs. 

Addendum: On December 19, 2017, CMS announced an extension until March 31, 2018for the 

Medicare Part C and Part D special enrollment period allowing individuals affected by the 

hurricanes to enroll in, disenroll from, or switch plans in the event they were unable to make an 

election during another qualifYing election period. 

4. CMS has taken a number of actions to improve open enrollment in the Marketplaces 

and in Medicare, but to date, Medicaid has been largely absent from Administration 

activity. This is concerning given that, in Puerto Rico for example, more than half of 

the population receive their health coverage through Medicaid. Similarly, in both 

Florida and Texas, more than half of all births are financed by the Medicaid 

program, and more than I in every 3 children is covered through Medicaid. Given the 

volume and special needs for those with Medicaid coverage in Hurricane affected 

areas, what steps does CMS plan to take to provide clear guidance on disaster- related 

Medicaid coverage that addresses administrative burdens? For example, similar to 

the Administration's response during Hurricane Katrina, will this Administration 

take actions such as permitting a simplified Medicaid application or allowing for selfattestation for a temporary period of time for Hurricane victims in the absence of 

documentation? 

Answer: CMS is dedicated to making sure all of our program beneficiaries impacted by the 

hurricanes are able to access their needed treatments and supplies. This is why we are using our 

waiver authority to give beneficiaries, providers, suppliers, and states the flexibility they need to 

meet emergency health situations. There is considerable flexibilitY for states and territories to 

streamline and simplify enrollment in both Medicaid and CHIP in emergency situations. For 

example, for a limited time period: 

• States and Territories have flexibility to permit enrollment of new applicants based on 

self-attestation of necessary information if regular verification sources and processes are 

not available, allowing eligibility criteria to be verified post-enrollment. 

• Use of hospitals, providers and other qualified entities identified by the state to make 

presumptive eligibility determinations is also available to facilitate enrollment and ensure 

immediate coverage. 

• States and territories also can extend deadlines for renewals when emergency 

circumstances prevent them from meeting ordinary deadlines. 

States generally have flexibility to suspend premiums, enrollment fees and other cost sharing charges 

for beneficiaries impacted by a hurricane. CMS is available to provide states with technical 

assistance to ensure that needed state plan amendments or other authorities are in place. 

The Honorable Jan Schakowsky 

1. Following up, in the aftermath of disasters like these devastating Hurricanes, government 

should provide relief and recovery workers with required health and safety protections 

4 
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27737.087

and Personal Protective Equipment (PPEs) to ensure workers' health is not compromised 

during current and ongoing clean- up and future rebuilding. Unfortunately, we have heard 

that this is causing problems in Puerto Rico. 

We know Puerto Ricans in both the private and public sector want to do the work needed 

to help rebuild their lives, homes, communities, and their Commonwealth. Government 

workers are willing and eager to help address short-term needs- even when working as 

assigned by the Puerto Rico government is outside their long-standing employee 

responsibilities and expertise. Nonetheless, workers simultaneously want to protect their 

own health and safety and avoid unnecessary health problems. The long-term medical 

problems flowing from the tragic events on September 11, 2001 and the resulting cleanup 

efforts at Ground Zero and on the Pile taught us the vital importance of providing 

appropriate health and safety equipment and training to workers in conditions that are 

dangerous or uncertain. 

a. What is HHS, CDC, and other federal agencies doing to ensure local Puerto Rico 

government employees have the necessary health and safety equipment to protect 

themselves during their ongoing relief and recovery work? 

b. Have these issues been addressed in Puerto Rico? 

c. Which federal government agencies are responsible for providing needed PPEs to 

recovery workers? 

Answer: CMS defers to the Centers for Disease Control and Prevention (CDC) and other HHS 

offices and components to respond to this question. 

The Honorable Kathy Castor 

1. A number of health professionals from the University of South Florida in my Congressional 

District traveled to Puerto Rico recently to see how they could support the health care 

needs of our fellow citizens there and a few will be going back in early November. One 

main concern of the physicians who went to Puerto Rico was how long it took to get the 

Emergency Medical Assistance Compact (EMAC) into place, which would allow medical 

professionals from the State of Florida to go to Puerto Rico and be able to practice under 

their Florida license. 

a. Did you hear similar concerns from health professionals in other states? 

b. What role does the federal government play in these compacts? 

c. How can the federal government facilitate quick approval of these compacts to allow 

health professionals from other states to assist states or territories that have been 

impacted by a natural disaster? 

Answer: The Emergency Medical Assistance Compact (EMAC) is a state-to-state mutual aid 

system under which states contract with other states or territories to send personnel, equipment 

5 
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27737.088

and commodities to assist with response and recovery efforts in other states/territories. Although 

CMS does not have a role in EMAC, there are many things CMS can do to help providers 

continue to take care of patients following disasters. For example, the Section 1135 waiver 

authority enables CMS to waive or modify certain Medicare, Medicaid, CHIP, Stark Law, and 

EMT ALA requirements, including certain deadlines, quality reporting requirements, conditions 

of participation, and certification requirements. Providers can now submit waiver requests to the 

state survey agency or the CMS regional office,9 and they will be evaluated to ensure that they 

meet the requirements set out under the law. CMS has made all approved waivers and hurricane 

related information, such as Frequently Asked Questions and Presidential declarations, available 

on its website. 10 

In each of these emergency events, CMS is using our waiver authority to maintain access to care for 

Medicare and Medicaid beneficiaries by supporting the ability of providers, suppliers, hospitals, and 

other healthcare facilities that participate in those programs to provide timely care to as many people 

impacted by the storm as possible. For example, using our waiver authority, CMS: 

• Gave Medicare providers in locations impacted by the hurricanes the flexibility to move 

patients between facilities, administer care in alternative locations, and approve out-ofnetwork providers as needed to ensure continuity of care. 

• Expedited Medicaid enrollment for out-of-state providers. This means providers can be 

reimbursed for services provided to beneficiaries who have been evacuated from locations 

impacted by the hurricanes, and allows reimbursement to providers who go into impacted 

areas to provide relief. 

Though not a part ofEMAC, CMS staff in Region II coordinated with the Puerto Rico Department 

of Health to develop and facilitate a process for credentialing of nurses and technicians from the 

mainland to provide relief for island health care personnel who were either working extended hours 

or were unable to get to work, especially in dialysis facilities on the island. 

Addendum: On November 28, 2017, CMS approved a Medicaid waiver for the Puerto Rico Disaster 

Relief demonstration, which authorizes Puerto Rico to provide off-island medical coverage to 

Medicaid beneficiaries who are eligible for the Federal Emergency Management Agency (FEMA) 

Transitional Shelter Assistance Program who are temporarily relocated to New York and Florida. 

The effective date of the demonstration is November 13, 2017, and the waiver expires January 18, 

2018. 11 

The Honorable Pete Olson 

1. After tackling 3 Hurricanes in a short period of time, what strains have you seen on your 

current resources? Also, what additional resources do you need to provide these 

communities the help that they need? 

9 httos:/ /www.cms.gov/ About-CMS/ Agency-Information/Emergency/Downloads/Requesting-an-1135-WaiverUpdated-11-16-2016.pdf 

10 https://www .cms.gov/ About-CMS/ Agency-lnformation/Emergency/Hurricanes.html 11 https:/ /www.medicaid.gov/medicaid/section-lll5-demo/demonstration-and-waiver-list/?entry=44 731 

6 
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Answer: Our approach to disaster preparedness and response has been informed by CMS's 

experience responding to Hurricane Katrina and other recent significant disasters. For example, 

the devastation of Hurricane Harvey taught us valuable lessons that allowed us to respond even 

more quickly for Hurricanes Irma and Maria. 

HHS is working with the Administration to identif'y needs as they arise. To date, OMB has sent 

two emergency supplemental requests to Congress. The initial request included funding for 

organizations providing rapid emergency response, like FEMA's Disaster Relief Fund and the 

federal flood insurance program. We know that there are significant health care needs in the 

areas impacted by these hurricanes, including in Puerto Rico, and we look forward to working 

with Congress on how you can help us address these needs. 

7 
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27737.090

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

€ongreS'S' of tbe mnfteb ~tateS' 

;!}oun of l\.epresentattbes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RA VB URN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority !202)225-2927 

Minority (202)225-3841 

November 9, 2017 

Rear Admiral Stephen C. Redd, MD 

Director 

Office of Public Health Preparedness and Response 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329 

Dear Admiral Redd: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Tuesday, 

October 24, 2017, to testify at the hearing entitled "Examining HHS's Public Health Preparedness for and 

Response to the 2017 Hurricane Season." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) tlie complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Tuesday, November 28, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fullin!!®mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee, 

Sincerely, ~ 

rt11 

Chairman 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
147 


27737.091

Questions for the Record 

Rear Admiral Upper Half Stephen C. Redd, M.D. 

Director of the Office of Public Health Preparedness and Response, Centers for Disease Control 

and Prevention 

U.S. Department of Health and Human Services 

House Energy and Commerce Subcommittee on Oversight and Investigations 

Examining HHS's Public Health Preparedness for and Response to the 2017 Hurricane Season 

Tuesday, October 24, 2017 

The responses are current as of November 2017 

The Honorable Greg Walden 

1. According to the Centers for Disease Control and Prevention's (CDC) testimony on 

October 24, 2017, laboratories in Puerto Rico are not able to conduct any public health 

tests because of damage sustained during Hurricane Maria. As a result, the CDC is lending 

support and arranging clinical specimens for suspected priority infectious diseases-such as 

tuberculosis, leptospirosis, rabies, influenza, and salmonella-to be sent to the U.S. mainland 

for testing. To date, how many specimens has CDC sent to the U.S. mainland for testing? 

Since October 20, 2017, CDC has received specimens for testing various priority patbogens from 

Puerto Rico. CDC reports tbese results to tbe Puerto Rico Department ofHealtb (PRDOH) for 

official confirmatory test results reporting. The PRDH is then responsible for publically 

reporting the results. As ofNovember 25, 2017, CDC has assisted PRDOH with: 

Leptospirosis testing from 324 suspect cases, of which 42 have been identified as either a 

confirmed or probable case of leptospirosis. 

Tuberculosis (TB) testing from 59 suspect cases, of which 21 have been confirmed. 

Influenza testing from 65 suspect cases, of which 48 have been confirmed. 

a. Approximately how long does it take for CDC to receive a diagnostic result for the 

samples it sends to be tested on the U.S. mainland? 

CDC receives shipments of specimens three times a week from Puerto Rico for confirmatory 

disease testing. Actual testing times vary depending on the sample type and test being 

performed. Average testing times range from two to five days. For TB testing, tests are 

performed at multiple public health labs and some samples require repeat testing. 

b. What, if any, infectious diseases have been detected through the testing of these 

specimens? 

Please see the response to Question I above. 

c. Do the laboratories in Puerto Rico have generator power yet? If not, when does CDC 

expect the laboratories in Puerto Rico to be at least partially functional? 

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As of November 27th, Puerto Rico Department of Health's (PRDOH) San Juan main facility 

which includes eight individual laboratories, is currently all powered by generators. 

PRDOH' s satellite laboratories in Mayaguez and Ponce have power through the electrical 

grid. As of November 6th, PRDOH's satellite laboratory in Arecibo had power through a 

generator. 

PRDOH's laboratories sustained significant damage during Hurricane Maria. It is important 

to note that there may be other reasons besides a lack of power, such as damaged testing 

supplies or equipment, which prevent the laboratories from operating as they did prior to the 

hurricane. 

CDC will continue to work with PRDOH and other Federal agencies to re-establish 

important public health infrastructure such as disease surveillance and laboratory diagnostics. 

d. Has CDC assessed what, if any, equipment from the laboratories can be salvaged? 

As part of the work to get the public health laboratory back in operation, CDC experts 

deployed to Puerto Rico to assess immediate laboratory needs, including equipment and 

supplies that have been damaged and need to be fixed or replaced. CDC has also partnered 

with the Association of Public Health Laboratories to conduct a laboratory assessment to 

understand the current status of laboratory activities, prioritize activities to restore essential 

testing services, and determine long-term needs. This assessment identified a need for critical 

lab supplies and equipment to replace what was damaged during the hurricane. CDC is 

working with the CDC Foundation, in accordance with agency statutory authority, to fulfill 

these needs. 

2. What disease risks have been detected by CDC's National Syndromic Surveillance 

Program in the affected regions? 

CDC's National Syndromic Surveillance Program receives diagnosis codes reported by deployed 

Disaster Medical Assistance Teams during this hurricane response. The majority of patient 

encounters in Puerto Rico and U.S. Virgin Islands (USVI) by the Disaster Medical Assistance 

Teams have been related to injuries or existing chronic disease. 

Additionally, CDC's hurricane response is working with PRDOH to help provide leptospirosis, 

tuberculosis, and influenza diagnostic testing. CDC reports these results to PRDOH for official 

confirmatory test results reporting. These results are then officially and publically reported by 

PRDOH. As of November 25, 2017, CDC has assisted PRDOH with: 

• Leptospirosis testing from 324 suspect cases, of which 42 have been identified as either a 

confirmed or probable cases of leptospirosis. 

• TB testing from 59 suspect cases, of which 21 have been confirmed. 

Influenza testing from 65 suspect cases, of which 48 have been confirmed. 

In addition to the National Syndromic Surveillance Program, CDC has provided diagnostic 

testing to confirm the presence of leptospirosis, tuberculosis, and influenza cases in Puerto Rico. 

Moreover, CDC has numerous other disease surveillance programs that capture conditions of 

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public health importance. Of note, there may be lags in any identified conditions being 

confirmed and reported by PRDOH. 

3. During the Agency's hurricane response efforts, has CDC identified any scarcities of 

medical supplies, such as vaccines, that could hinder the public health response efforts? If 

so, could you please elaborate? 

As part of this response effort, CDC's Strategic National Stockpile has procured $143,000 worth 

of vaccines to support Puerto Rican vaccination programs targeted to protect adults from vaccine 

preventable disease. CDC is also coordinating with HHS to procure vaccines to support 

immunization program efforts in USVI. 

CDC defers questions related to pharmaceutical shortages due to the hurricanes to the FDA. 

The Honorable Gus Bilirakis 

1. Can you discuss public health surveillance post-storm? 

To understand the burden of diseases in hurricane-affected areas, public health authorities rely on 

surveillance systems and the ability to conduct laboratory tests for specific diseases. In Puerto 

Rico and the U.S. Virgin Islands (USVI), surveillance and lab capacity have been greatly 

diminished due to Hurricane Maria. Identifying and controlling diseases of public health 

importance in hurricane-affected areas is a top priority for CDC and HHS. Through the 

Epidemiology and Laboratory Capacity cooperative agreement, CDC supports 64 jurisdictions 

(including all 50 states and U.S. territories) to help with prevention and surveillance efforts and 

build laboratory capacity for addressing infectious diseases. Puerto Rico Department of Health's 

(PRDOH) infrastructure sustained significant damage during Hurricane Maria, including to their 

laboratories. To date, the laboratories have only been able to conduct limited public health 

testing. 

CDC provided in-the-field technical assistance and leadership to USVI, including two 

Community Assessments for Public Health Emergency Response (CASPERs). The CASPERs 

assessed immediate community needs, behavioral and physical health status, and vector control 

concerns to inform ongoing response and recovery efforts. On November 12, 2017, a CDC team 

deployed to USVI to assist in investigations of disease as requested. The CDC team is assisting 

the US VI Department of Health with patient screening guidance and rapid diagnostic tests for 

leptospirosis and melioidosis to supplement pre-existing surveillance activities. The team is also 

assisting in the coordination of shipping diagnostic samples to CDC for confirmatory testing, 

investigating confirmed and probable cases of leptospirosis and melioidosis in an attempt to 

discover the exposures that led to infection, and conducting public and clinician outreach and 

education regarding leptospirosis and melioidosis. CDC has also provided on-the-ground 

technical consultation to USVI regarding vector control. 

In Puerto Rico, CDC's Dengue Branch resumed testing for arboviruses like Zika, dengue, and 

chikungunya in early October. This arbovirus disease surveillance supports preventing the spread 

of vector borne diseases in Puerto Rico by initiating mosquito surveillance in forests, open fields, 

swamps, and high- and low-density urban areas to determine mosquito densities and advise local 

and federal authorities on control measures. CDC has also developed and implemented a system 

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for transporting leptospirosis, influenza, and tuberculosis specimens from Puerto Rico 

laboratories to the continental United States for testing. 

As part of the work to get the public health laboratory back in operation, CDC experts have 

deployed to Puerto Rico to assess immediate laboratory needs and have provided essential 

laboratory supplies. CDC has also partnered with the Association of Public Health Laboratories 

(APHL) to conduct a comprehensive assessment oflaboratory needs. This assessment is critical 

to help ensure long-term laboratory capacity and positive health and public health outcomes of 

residents in Puerto Rico. 

Syndromic surveillance is used to monitor health-related data that precede diagnosis and signal a 

probable disease case or outbreak. This surveillance system uses existing data as an early 

warning system of disease outbreaks, and water or food contamination. As part of response 

activities, CDC's National Syndromic Surveillance Program (www.cdc.gov/nssp) has partnered 

with Disaster Medical Assistance Teams (DMAT) in affected areas to collect all data on DMAT 

patient encounters. CDC has also partnered with the Department of Veterans Affairs (VA) to 

develop an enhanced surveillance system for Puerto Rico's main VA medical center and the 

island's two largest VA community-based outpatient clinics to monitor priority diseases of 

epidemic potential. 

As part of the response to Hurricanes Irma and Maria, since September 2017 the Epidemiology 

Surveillance Task Force has been tracking infectious and non-infectious diseases in the affected 

states and territories using the methods below: 

Syndromic surveillance using Disaster Medical Assistance Teams and Department of 

Defense data, 

Department of Veterans Affairs Medical Center data for selected illnesses and injuries, 

Hurricane-related deaths through online media reports, 

Shelter surveillance, and 

Poison control center reports. 

a. What public health and health care delivery challenges still exist? 

This has been a challenging hurricane response and recovery effort. Especially in the territories, 

significant damage from the hurricanes has caused problems with water supplies, sanitation, food 

supply, electricity, transportation, shelter, communications, security, medical care, and mosquito 

control. Additionally, each of the affected areas-Texas, Louisiana, Georgia, Florida, Puerto 

Rico, and USVI-have distinct characteristics and challenges based on both their situation 

before the storms and the severity and characteristics of the three different hurricanes. The 2017 

hurricanes that have hit the U.S. have been unusually frequent and intense compared to previous 

hurricane seasons. Hurricane Harvey took a serious toll on Texas, resulting among other things, 

in major mold issues from the extensive flooding. Florida was heavily impacted by Hurricane 

Irma, which took out more than 60 percent of the state's power after the storm, prompting many 

residents to use generators, and leading to many cases of potential carbon monoxide (CO) 

poisoning/death. For example, CO poisoning during Irma was attributed to 17 deaths (15 in 

Puerto Rico, one in South Carolina and one in North Carolina); and of the total poison exposure 

calls to National Poison Data System (NPDS), 16 were during Harvey, 165 during Irma, and six 

during Maria. 

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Infrastructure challenges in Puerto Rico and USVI before the storms compounded the 

devastating impact of Hurricanes Irma and Maria. For example, prior to the storms, power 

outages in Puerto Rico were common, as a result of aging energy infrastructure. 

Communicable disease outbreaks of diarrhea and respiratory illness can occur when water and 

sewage systems are not working, and personal hygiene is hard to maintain as a result of a 

disaster. Crowded living conditions in shelters can also create conditions for infectious disease 

outbreaks. It is critical for the public health system to quickly set up tracking systems that 

monitor illnesses in hurricane-affected areas. CDC is working closely with Puerto Rico and 

USVI, and other Federal agencies to re-establish important public health infrastructure such as 

disease surveillance and laboratory diagnostics. 

b. Have previous public health hazards (like Zika) been heightened? If so, bow do we 

proactively address during our recovery process? 

Significant damage from the hurricanes has caused problems with water supplies, sanitation, 

food supply, electricity, transportation, shelter, communications, security, medical care, and 

mosquito control. Post-hurricane environmental conditions may pose an increased risk for the 

spread of infectious diseases among persons in or recently returned from hurricane-affected 

areas. Contaminated drinking water and reduced access to safe water, food, and shelter in some 

areas may create conditions for outbreaks of infectious diseases such as leptospirosis, hepatitis 

A, typhoid, vibriosis, Zika, dengue, chikungunya, and influenza. 

Post-hurricane transmission of mosquito-borne diseases such as Zika remains a threat. CDC's 

Dengue Branch, located in Puerto Rico, and the PRDOH Laboratory have resumed testing since 

the hurricanes. CDC resumed testing on October 9'h, and PRDOH resumed testing in early 

November. 

The Dengue Branch has tested almost 3,000 blood and urine samples from its enhanced 

surveillance site in southern Puerto Rico from cases with onset dates between September and 

November. 

CDC is also working with PRDOH to prevent the spread of vector borne diseases in Puerto Rico. 

Mosquito surveillance in forests, open fields, swamps, and high- and low-density urban areas 

will determine mosquito densities and form the basis for control measures. 

Moreover, CDC is providing technical assistance to the CDC-funded Puerto Rico Vector Control 

Unit. Through this assistance, CDC is informing messaging strategies to encourage community 

participation in cleaning up trash where mosquitoes, like Aedes aegypti-the mosquito species 

that transmits Zika, dengue, and chikungunya can lay eggs. For safe water storage, CDC has 

recommended that containers be covered with lids or screens to prevent mosquitoes from laying 

eggs. The Vector Control Unit has procured and begun disseminating insect repellent to 

communities. 

To assist the USVI, CDC's Atlanta lab has provided surge testing of arboviruses (viruses spread 

by insects). To date, one post-hurricane case of Zika has been reported in the USVI to CDC, 

although there can be significant storm-related reporting lags of testing results. CDC has also 

provided on-the-ground technical consultation to the USVI regarding vector control. The USVI 

is currently conducting mosquito surveillance. 

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CDC will continue to work with the Puerto Rico and USVI departments of health on requests for 

support of vector-borne disease prevention, as requested. 

The Honorable Frank Pallone, Jr. 

1. There have been 51 deaths officially associated by Hurricane Maria, as reported by the 

Puerto Rico government. The Center for Disease Control has confirmed three deaths due 

to leptospirosis. To date, the island has reported 76 possible cases of the disease. What is 

the Department of Health and Human Services (HHS) doing to prepare for the potential 

onslaught of disease caused by contaminated drinking water and the spread of 

leptospirosis? 

CDC is working with the Environmental Protection Agency (EPA) and public health officials to 

identify health risks and prevent illness from unsafe water and to restore public health capacity. 

CDC conducted basic water testing immediately following the hurricane and EPA followed up 

with additional testing for fecal contamination. Both CDC and EPA have worked with Puerto 

Rico and the U.S. Virgin Islands (USVI) to educate home and business owners on methods of 

treating their household water to reduce the risk of waterborne disease. 

On October 24, 2017, CDC released a CDC Health Advisory to advise health care providers 

treating patients in or recently returned from hurricane-affected areas, including Puerto Rico and 

USVI, to be vigilant in looking for certain waterborne and vector-borne infectious diseases that 

hurricane affected populations may be at particular risk for, such as leptospirosis, Zika, dengue, 

and chikungunya. 

CDC also coordinated with the Puerto Rico Department of Health (PRDOH) to provide updated 

guidance on preventing the spread of infectious diseases targeted for medical care providers and 

healthcare facilities. CDC developed 17 fact sheets, adapted and translated for general audiences 

in Puerto Rico, to include safe food and water, leptospirosis, coping after a disaster, safe use of 

generators, handwashing, conjunctivitis, mosquito control, mold clean up, cleaning cisterns, 

scabies, and diarrhea. To improve overall disease and prevention communication, CDC has 

issued key messages for the public about preventing leptospirosis and other diseases. CDC has 

developed and is frequently updating hurricane key messages. The key messages can be found 

on CDC's website at https://www.cdc.gov/disasterslhurricanes/index.html. 

In addition to the health communication materials disseminated to the public and clinicians, on 

November 12, 2017, CDC personnel deployed to assist in investigations of disease as requested 

by US VI. The CDC team is assisting the USVI Department of Health with patient screening 

guidance and rapid diagnostic tests for leptospirosis and melioidosis. The team is also assisting 

in the coordination of shipping diagnostic samples to CDC for confirmatory testing, investigating 

confirmed and probable cases of leptospirosis and melioidosis in an attempt to discover the 

exposures that led to infection, and conducting public and clinician outreach and education 

regarding leptospirosis and melioidosis. 

To assist PRDOH with laboratory testing, CDC developed and implemented a system for 

transporting specimens from Puerto Rico laboratories to the continental United States for 

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confirmatory testing of select diseases, including leptospirosis. As recovery continues, CDC 

expects to gain more clarity on the status of infectious diseases in Puerto Rico and USVI and 

stands ready to assist with the surveillance and infrastructure needs of the Puerto Rico and USVI 

health departments, as needed. 

2. What are HHS, CDC, and other involved federal agencies doing to ensure local Puerto Rico 

government employees have the necessary health and safety equipment to protect 

themselves during their ongoing relief and recovery workers? 

CDC is working with the Occupational Safety and Health Administration (OSHA) to support 

occupational safety and health issues that arise during the response. CDC is aware that OSHA's 

National Alliance partners agreed to donate Personal Protective Equipment (PPE), including 

gloves, hard hats, and reflective vests, to help protect volunteers and workers performing 

hurricane recovery and clean-up efforts in Puerto Rico and USVI. CDC has developed a key 

messages document that provides information on how employers, workers, and volunteers 

responding to Hurricane Maria can protect themselves from a variety of response and recovery 

hazards. CDC is aware of reports of shortages and reduced inventories of respirators in the U.S. 

Virgin Islands; we are working to determine the causes for the shortages, and we spoke with the 

organizations representing PPE manufacturers and distributors to understand if any shortages 

existed in the supply chain. 

a. Which federal government agencies are responsible for providing needed Personal 

Protective Equipment (PPEs) to relief and recovery workers? 

There is no single agency officially responsible for providing personal protective 

equipment during an emergency. If existing stockpiles and government procurement of 

commercially available supplies are insufficient to meet relief and recovery demands, 

CDC maintains supplies of PPE in the Strategic National Stockpile that may be deployed 

to support such requirements. 

3. What precautionary measures and/or infrastructure is currently in place to treat potential 

disease outbreaks in geographically remote areas? 

CDC's Dengue Branch, located in Puerto Rico, has been helping prevent the spread of vectorborn diseases in Puerto Rico through mosquito surveillance in forests, open fields, swamps, and 

high- and low-density urban areas. CDC has not otherwise received requests from Puerto Rico to 

support disease surveillance in Puerto Rico. CDC has also provided on-the-ground technical 

consultation to USVI regarding vector control, and USVI is currently conducting mosquito 

surveillance. 

Public health surveillance provides the information necessary to determine that a disease 

outbreak is occurring. CDC is working with the Department of Veterans Affairs, , the Disaster 

Medical Assistance Teams, and Department of Defense to establish public health surveillance in 

Puerto Rico. To date, CDC has not received requests from Puerto Rico to support disease 

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surveillance or epidemiology support. CDC stands ready to support epidemiological and 

surveillance activities for infectious diseases as needed for Puerto Rico. 

Although overall challenges still exist, progress is being made, as evidenced by CDC's Dengue 

Branch, located in Puerto Rico, and the PRDOH laboratory being able to resume mosquito-borne 

disease testing of specimens since the hurricanes. CDC's Atlanta laboratory has also provided 

surge arbovirus testing support to USVI. To date, CDC has not received requests from Puerto 

Rico to support disease surveillance outside of the CDC's Dengue Branch's surveillance 

activities. To further support the Puerto Rico Department of Health, CDC continues to transport 

specimens from Puerto Rico laboratories to the continental United States for confirmatory testing 

of select diseases, including leptospirosis, influenza, and tuberculosis. As recovery continues, 

CDC expects to gain more clarity on the status of infectious diseases in Puerto Rico and USVI, 

and stands ready to assist with surveillance and infrastructure needs of the Puerto Rico and USVI 

health departments as needed. 

4. What percentage of the population of Puerto Rico and the U.S. Virgin Islands currently 

has access to potable water through their tap? Is the CDC certain that, where water service 

has been restored, that the water is safe to drink? 

According to FEMA's November 17, 2017 Hurricane Maria report, 83 percent of water 

treatment plants in Puerto Rico are operational, and 85 percent of clients of the Puerto Rico 

Aqueducts and Sewers Authority (PRASA) have access to drinking water. However, due to 

inconsistencies in the power-grid, treatment plant pumps have had difficulty maintaining 

pressure throughout the distribution lines. Combined with unknown line breaks and potential for 

contamination entry, Puerto Rico and St. Croix are still under a boil water advisory. According 

to the U.S. Virgin Islands Water and Power Authority (WAPA), the boil water notice was lifted 

for St. Thomas and St. John on November 7, 2017. CDC continues to work with EPA and 

Puerto Rico and USVI health authorities to monitor municipal water quality. Based on the water 

meeting safe standards, W AP A and EPA will make the decision when to lift the boil water notice 

in St. Croix. 

The Honorable Jan Schakowsky 

1. Following up, in the aftermath of disasters like these devastating Hurricanes, government 

should provide relief and recovery workers with required health and safety protections and 

Personal Protective Equipment (PPEs) to ensure workers' health is not compromised 

during current and ongoing clean-up and future rebuilding. Unfortunately, we have heard 

that this is causing problems in Puerto Rico. 

We know Puerto Ricans in both the private and public sector want to do the work needed 

to help rebuild their lives, homes, communities, and their Commonwealth. Government 

workers are willing and eager to help address short-term needs -even when working as 

assigned by the Puerto Rico government is outside their long-standing employee 

responsibilities and expertise. Nonetheless, workers simultaneously want to protect their 

own health and safety and avoid unnecessary health problems. The long-term medical 

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problems flowing from the tragic events on September 11, 2001 and the resulting cleanup 

efforts at Ground Zero and on the Pile taught us the vital importance of providing 

appropriate health and safety equipment and training to workers in conditions that are 

dangerous or uncertain. 

a. What is HHS, CDC, and other federal agencies doing to ensure local Puerto Rico 

government employees have the necessary health and safety equipment to protect 

themselves during their ongoing relief and recovery work? 

CDC is coordinating with the Occupational Safety and Health Administration (OSHA) to 

support occupational safety and health issues that arise during the response. CDC is aware 

that OSHA's National Alliance partners agreed to donate PPE, including gloves, hard hats, 

and reflective vests, to help protect volunteers and workers performing hurricane recovery 

and clean-up efforts in Puerto Rico and the U.S. Virgin Islands. CDC has developed a key 

messages document that describes messages for how employers, workers, and volunteers 

responding to Hurricane Maria can protect themselves from a variety of response and 

recovery hazards. 

b. Have these issues been addressed in Puerto Rico? 

Shortages and low supplies of respirators in Puerto Rico and USVI have been reported. CDC 

spoke to the professional associations representing PPE manufacturers and distributors to 

learn if there were true PPE shortages. They reported no shortages at the time. 

c. Which federal government agencies are responsible for providing needed PPEs to 

recovery workers? 

There is no single agency responsible for providing personal protective equipment during an 

emergency. If existing stockpiles and government procurement of commercially available 

supplies are insufficient to meet relief and recovery demands, CDC maintains supplies of 

PPE in the Strategic National Stockpile that may be deployed to support such requirements. 

The Honorable Kathy Castor 

l. I also heard from these health professionals that water sanitation is one of the biggest issues 

in Puerto Rico right now, which is leading to gastrointestinal issues as well as systemic 

infections. How is the Administration helping get clean water to Puerto Rico, especially to 

remote areas? Additionally, how is HHS working with health professionals on the ground 

to treat illnesses stemming from the lack of clean water? 

CDC's /Agency for Toxic Substances and Disease Registry field staff in Puerto Rico have 

facilitated contacts between the Environmental Protection Agency (EPA) and the Puerto Rican 

authorities. We also currently have a representative on a workgroup dealing with water quality. 

CDC is working with EPA and public health officials to identify health risks and prevent 

illnesses from unsafe water and to restore public health capacity. CDC conducted basic water 

testing immediately following the hurricane and EPA followed up with additional testing for 

fecal contamination. 

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Both CDC and EPA have worked with Puerto Rico and the U.S. Virgin Islands (USVI) to 

educate home-and business owners of methods of treating their household water to reduce their 

risk of waterborne disease. 

2. Physicians have told me they are seeing other health issues such as asthma, COPD, 

conjunctivitis, scabies, diabetes, and hypertension being exacerbated due to lack of 

medications, power, transportation and supplies, increased air pollution from generators 

and unsanitary living conditions. Is HHS monitoring this situation, and what steps are 

being taken to address these additional health issues? 

Identifying and controlling diseases of public health importance in Puerto Rico and USVI is a 

top CDC and HHS priority. Of concern, the Puerto Rico Department of Health sustained 

significant damage during Hurricane Maria, including to their laboratories. CDC is working with 

the Puerto Rico Department of Health and the Federal Emergency Management Agency (FEMA) 

to get the public health laboratory back in operation. Additionally, given the extensive hurricane 

damage and limited power and communications, regular timely and comprehensive disease 

surveillance is not yet possible. CDC's National Syndromic Surveillance Program, in 

coordination with the HHS Assistant Secretary for Preparedness and Response (ASPR), and 

Disaster Medical Assistance Teams, are routinely monitoring approximately 115 syndromic 

surveillance data groupings. These medical data come from on-the-ground patient-provider 

contacts that provide awareness of disease trends to help guide response actions. 

CDC has been communicating generator-use safety messages in multiple languages through 

print, broadcast, internet, social media and other channels. Thousands of safe generator-use and 

Carbon Monoxide poisoning awareness door hangers and flyers have been distributed in 

hurricane-affected areas. CDC has provided technical assistance to Texas and Florida for 

Carbon Monoxide poisoning surveillance. CDC has also provided technical assistance to Puerto 

Rico, USVI, and the American Academy of Pediatrics on public messaging to prevent Carbon 

Monoxide poisoning. · 

CDC staff have deployed to Texas, Puerto Rico and USVI to support state and territorial health 

departments in monitoring and addressing health issues related to air pollution from improper 

generator use and mold in flood-damaged buildings. CDC has several guidance documents for 

homeowners, workers, and clinicians about mold remediation, personal protective equipment, 

and cleanup, and about mold safety for medically vulnerable populations and patients with 

asthma. These have been developed, updated, translated to multiple languages, and distributed 

online and in print to all affected areas. Tens of thousands of copies of Eight Tips For Mold 

Clean Up have been distributed in multiple languages. Also available is the Homeowner's and 

Renter's Guide for Mold Cleanup After Disasters; a tool developed jointly by CDC, EPA, 

FEMA, the Department of Housing and Urban Development, and the National Institutes of 

Health based on experience with Hurricane Sandy and earlier storms. CDC has provided over 

I 00,000 copies of an activity book for children on flooding and mold safety in a recovery 

environment. 

CDC's Strategic National Stockpile deployed six Federal Medical Stations into Puerto Rico. 

Federal Medical Stations are ~on-emergency medical centers that could provide care for 

displaced persons with special health needs. These needs included chronic health conditions, 

limited mobility, or mental health issues that cannot be met in a shelter for the general 

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population. As of November 17, 2017 all Federal Medical Stations in Puerto Rico had officially 

been signed over to the Puerto Rico Department of Health. As ofNovember 14,2017, the 

Strategic National Stockpile had provided more than $2.5 million in supplies, totaling more than 

339 tons of cargo, to support public health needs resulting from Hurricane Maria. These supplies 

included 81 tons of supplies for Disaster Medical Assistance Teams; $475,000 in additional 

medical supplies purchased for Puerto Rico; 177,000 bottles of water; and 42,000 meals ready to 

eat. In addition, a total of 115 CDC Strategic National Stockpile staff have supported 

procurement, shipping logistics, inventory management, warehouse operations in Puerto Rico, 

and site surveys for the Federal Medical Stations. 

CDC also continues to provide technical assistance to the Puerto Rico Department of Health 

regarding immunizations program activities and support for vaccine needs. As part of this effort, 

the Strategic National Stockpile, has procured vaccines worth more than $143,000 along with 

$37,000 in purchased ancillary supplies, to support Puerto Rican vaccination programs. As of 

November 15,2015, CDC committed an additional $2.24 million to meet additional vaccine 

requirements. 

On November 12, 2017, a CDC team deployed to USVI to assist with patient screening guidance 

and rapid diagnostic tests for leptospirosis and melioidosis. The team will also assist in the 

coordination of shipping diagnostic samples to CDC for confirmatory testing to discover the 

exposures that led to leptospirosis and melioidosis infection, and will conduct public and 

clinician outreach and education. 

The Honorable Pete Olson 

1. After tackling 3 Hurricanes in a short period of time, what strains have yon seen on your 

current resources. Also, what additional resources do you need to provide these 

communities the help that they need? 

Since August 31, over 580 CDC staff members have supported the hurricane response. CDC is 

also providing technical assistance to federal, state, local, territorial, and tribal partners to save 

lives, minimize adverse health and medical effects, and stabilize public health and medical 

infrastructure. Communicable disease outbreaks of diarrhea and respiratory illness can occur 

when water and sewage systems are not working and personal hygiene is hard to maintain as a 

result of a disaster. Crowded living conditions in shelters can also create conditions for infectious 

disease outbreaks. It is critical for the public health system to quickly set up tracking systems 

that monitor illnesses in hurricane-affected areas. These systems provide an early warning that 

enables prompt public health response, including vaccinations and interventions to remove 

threats from water and food. While CDC cannot engage in the full range of comprehensive 

hurricane recovery activities without the supplemental appropriations request, CDC is providing 

the following support to areas affected by these hurricanes: 

• Environmental health surveillance and laboratory testing to identify environmental 

hazards such as chemical spills and mold 

Crisis communications (including translating critical messages into multiple languages), 

media support, webinars, Clinician Outreach and Communication Activity (CoCA) calls, 

and other partner outreach 

• Vaccination supplies 

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Laboratory capacity assessments and diagnostic testing 

Subject matter expertise as requested. 

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