    [House Hearing, 115 Congress]
    [From the U.S. Government Publishing Office]

    EXAMINING HHS'S PUBLIC HEALTH PREPAREDNESS FOR AND RESPONSE TO THE 2017

                                HURRICANE SEASON

    =======================================================================

                                    HEARING

                                   BEFORE THE

                  SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                         ONE HUNDRED FIFTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                OCTOBER 24, 2017

                                   __________

                               Serial No. 115-67

     [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

                                   __________

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                        COMMITTEE ON ENERGY AND COMMERCE

                              GREG WALDEN, Oregon
                                     Chairman
    JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
      Vice Chairman                        Ranking Member
    FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
    JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
    MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
    MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
    STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
    ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
    CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
    GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
    LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
    BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
    PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
    DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
    ADAM KINZINGER, Illinois             PETER WELCH, Vermont
    H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
    GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
    BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
    BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
    LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
    BILL FLORES, Texas                   JOSEPH P. KENNEDY, III,
    SUSAN W. BROOKS, Indiana                 Massachusetts
    MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
    RICHARD HUDSON, North Carolina       RAUL RUIZ, California
    CHRIS COLLINS, New York              SCOTT H. PETERS, California
    KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
    TIM WALBERG, Michigan
    MIMI WALTERS, California
    RYAN A. COSTELLO, Pennsylvania
    EARL L. ``BUDDY'' CARTER, Georgia
    JEFF DUNCAN, South Carolina

                  Subcommittee on Oversight and Investigations

                                    VACANCY
                                     Chairman
    H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
      Vice Chairman                        Ranking Member
    JOE BARTON, Texas                    JANICE D. SCHAKOWSKY, Illinois
    MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
    SUSAN W. BROOKS, Indiana             PAUL TONKO, New York
    CHRIS COLLINS, New York              YVETTE D. CLARKE, New York
    TIM WALBERG, Michigan                RAUL RUIZ, California
    MIMI WALTERS, California             SCOTT H. PETERS, California
    RYAN A. COSTELLO, Pennsylvania       FRANK PALLONE, Jr., New Jersey (ex
    EARL L. ``BUDDY'' CARTER, Georgia        officio)
    GREG WALDEN, Oregon (ex officio)

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. H. Morgan Griffith, a Representative in Congress from the
      Commonwealth of Virginia, opening statement....................     1
        Prepared statement...........................................     3
    Hon. Diana DeGette, a Representative in Congress from the state
      of Colorado, opening statement.................................     4
    Hon. Greg Walden, a Representative in Congress from the State of
      Oregon, opening statement......................................     6
        Prepared statement...........................................     7
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................     8
        Prepared statement...........................................     9

                                   Witnesses

    Robert P. Kadlec, M.D., Assistant Secretary for Preparedness and
      Response, U.S. Department of Health and Human Services.........    12
        Prepared statement...........................................    15
        Answers to submitted questions...............................   101
    Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug
      Administration.................................................    24
        Prepared statement...........................................    26
        Answers to submitted questions...............................   130
    Kimberly Brandt, Principal Deputy Administrator for Operations,
      Centers for Medicare and Medicaid Services.....................    40
        Prepared statement...........................................    42
        Answers to submitted questions...............................   138
    Stephen C. Redd, M.D., RADM, Director of the Office of Public
      Health Preparedness and Response, Centers for Disease Control
      and Prevention.................................................    50
        Prepared statement...........................................    52
        Answers to submitted questions...............................   146

                               Submitted Material

    Article entitled, ```Like Going Back in Time': Puerto Ricans Put
      Survival Skills to Use,'' New York Times, October 24, 2017,
      submitted by Ms. DeGette.......................................    95

    EXAMINING HHS'S PUBLIC HEALTH PREPAREDNESS FOR AND RESPONSE TO THE 2017
                                HURRICANE SEASON

                                  ----------

                           TUESDAY, OCTOBER 24, 2017

                      House of Representatives,
          Subcommittee on Oversight and Investigations,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:02 a.m., in
    room 2123, Rayburn House Office Building, Hon. Morgan Griffith
    (vice chairman of the subcommittee) presiding.
        Present: Representatives Griffith, Brooks, Collins, Barton,
    Walberg, Walters, Costello, Carter, Walden (ex officio),
    DeGette, Schakowsky, Castor, Tonko, Clarke, Ruiz, Peters, and
    Pallone (ex officio).
        Also Present: Representatives Olson, Bilirakis, Duncan,
    Green, Gonzalez-Colon, and Wasserman-Schultz,
        Staff Present: Jennifer Barblan, Chief Counsel, O&I; Ray
    Baum, Staff Director; Karen Christian, General Counsel; Kelly
    Collins, Staff Assistant; Zachary Dareshori, Staff Assistant;
    Lamar Echols, Counsel, O&I; Adam Fromm, Director of Outreach
    and Coalitions; Ali Fulling, Legislative Clerk, O&I, DCCP;
    Theresa Gambo, Human Resources/Office Administrator; Alex
    Miller, Video Production Aide and Press Assistant; Christopher
    Santini, Counsel, O&I; Jennifer Sherman, Press Secretary;
    Natalie Turner, Counsel, O&I; Hamlin Wade, Special Advisor,
    External Affairs; Everett Winnick, Director of Information
    Technology; Christina Calce, Minority Counsel; Jeff Carroll,
    Minority Staff Director; Tiffany Guarascio, Minority Deputy
    Staff Director and Chief Health Advisor; Chris Knauer, Minority
    Oversight Staff Director; Miles Lichtman, Minority Policy
    Analyst; Jon Monger, Minority Counsel; and C.J. Young, Minority
    Press Secretary.

    OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE
             IN CONGRESS FROM THE COMMONWEALTH OF VIRGINIA

        Mr. Griffith. I can go ahead and get started. I thank
    everybody. I appreciate it.
        We are here today to examine the Department of Health and
    Human Services' public health preparedness for and response to
    the 2017 hurricane season. In the last 2 months, Texas,
    Florida, Puerto Rico, and the U.S. Virgin Islands have been
    devastated by hurricanes.
        I first want to express our heartfelt sorrow for the
    millions of Americans impacted by these devastating storms and
    say that all members of this committee, on both sides of the
    aisle, stand with those affected by these hurricanes. I would
    also like to thank Dr. Burgess and Dr. Ruiz, both members of
    this subcommittee, who each recently visited Puerto Rico to
    assess the impact these hurricanes have had and continue to
    have on our fellow Americans.
        This committee has been conducting oversight of the Federal
    response to the recent hurricanes since shortly after Harvey
    made landfall in Texas. Unfortunately, I expect that our work
    here will continue for years to come. The committee's
    jurisdiction involves not just the public health issues we will
    be discussing today but also rebuilding the electrical grid,
    addressing environmental cleanup, and restoring
    telecommunications, to name only a few.
        The people of Puerto Rico and the U.S. Virgin Islands
    continue to face a long road to recovery and many are living
    without power and running water.
        I believe we are going to be joined today by Representative
    Jenniffer Gonzalez-Colon from Puerto Rico, someone who knows
    all too well about the difficult challenges her home is facing.
    Thank you for being here at this important hearing.
        From coordinating the overall Federal healthcare response
    to ensuring that individuals have the medical treatment they
    need to protecting the blood and pharmaceutical supply to
    granting emergency waivers and everything in between, HHS has
    been working with tirelessly to provide medical care and
    services to individuals affected by the storms. The
    overwhelming majority of healthcare facilities in the impacted
    areas went above and beyond to protect and treat those in
    harm's way, yet media reports indicate that some healthcare
    providers failed in their duty to protect their patients. There
    was a tragic situation at a nursing home in Florida where 14
    residents died after the facility lost its air-conditioning,
    and this, despite a hospital across the street that never lost
    power or cooling.
        The response in Puerto Rico and the U.S. Virgin Islands has
    involved numerous Federal agencies working together with each
    other and state and local officials. For example, before
    Hurricane Maria made landfall in Puerto Rico and every day
    since, HHS, the Department of Defense, the Department of
    Veterans Affairs, and the Federal Emergency Management Agency,
    or FEMA, have been coordinating with local emergency response
    officials to provide medical care and help reestablish the
    island's healthcare infrastructure. HHS has worked with Puerto
    Rico's Department of Health to prioritize resources needed for
    dialysis facilitates and has coordinated with FEMA to help
    ensure critical supplies are delivered where they are needed.
    Similar efforts are ongoing in the U.S. Virgin Islands as well.
        But many questions remain. Has the interagency response
    been effective from the perspective of HHS? Are the Federal
    policies causing delays in response efforts? Are we utilizing
    our resources in the most efficient and effective ways to help
    our fellow Americans in Puerto Rico and the U.S. Virgin Islands
    in particular?
        Finally, it is critical that we understand the public
    health challenges ahead. Mold formation is likely in nearly all
    the affected regions. As we have seen after Hurricane Harvey,
    there is an increased risk for the spread of infectious disease
    due to contaminated water. Media reports indicate that, 1 month
    after Hurricane Maria, over 1 million Americans are still
    without clean, safe drinking water. Rebuilding Puerto Rico and
    the U.S. Virgin Islands will take years. The healthcare systems
    are in dire condition, and most of the operational facilities
    need some degree of assistance. To make matters worse, the
    electrical grid has been devastated, which has significantly
    hampered recovery efforts. We still don't even know the full
    extent of the damage, let alone when our fellow citizens will
    have electricity and running water restored. We are trying to
    make sure we are doing everything possible to address the
    short- and long-term needs of those living in the areas
    impacted by Hurricanes Harvey, Irma, and Maria, especially in
    the face of the public health threats that have resulted and
    will continue to result from these storms.
        I would like to thank the witnesses for testifying here
    today, and I look forward to hearing your testimony.
        And with that, I will now yield 5 minutes for an opening
    statement to Ms. DeGette, the ranking member from Colorado.
        [The prepared statement of Mr. Griffith follows:]

                 Prepared statement for Hon. H. Morgan Griffith

        We are here today to examine the Department of Health and
    Human Services' public health preparedness for and response to
    the 2017 hurricane season.
        In the last 2 months, Texas, Florida, Puerto Rico, and the
    U.S. Virgin Islands have been devastated by hurricanes. I first
    want to express our heartfelt sorrow for the millions of
    Americans impacted by these devastating storms and say that all
    Members of this Committee on both sides of the aisle stand with
    those affected by the hurricanes.
        I would also like to thank Dr. Burgess and Dr. Ruiz, both
    members of this subcommittee, who each recently visited Puerto
    Rico to assess the impact these hurricanes have had, and
    continue to have, on our fellow Americans.
        This Committee has been conducting oversight of the federal
    response to the recent hurricanes since shortly after Harvey
    made landfall in Texas. Unfortunately, I expect that our work
    here will continue for years to come. The Committee's
    jurisdiction involves not just the public health issues we will
    be discussing today, but also rebuilding the electrical grid,
    addressing environmental cleanup, and restoring
    telecommunications, to name only a few.
        The people of Puerto Rico and the U.S. Virgin Islands
    continue to face a long road to recovery and many are living
    without power and running water. We are joined today by
    Representative Jenniffer Gonzalez-Colon from Puerto Rico--
    someone who knows all too well about the difficult challenges
    her home is facing. Thank you for being here for this important
    hearing.
        From coordinating the overall federal health care response,
    to ensuring that individuals have the medical treatment they
    need, to protecting the blood and pharmaceutical supply, to
    granting emergency waivers, and everything in between, HHS has
    been working tirelessly to provide medical care and services to
    individuals affected by the storms.
        The overwhelming majority of health care facilities in the
    impacted areas went above and beyond to protect and treat those
    in harm's way. Yet, media reports indicate that some health
    care providers failed in their duty to protect their patients.
    There was a tragic situation at a nursing home in Florida where
    fourteen residents died after the facility lost its air
    conditioning--and this despite a hospital across the street
    that never lost power or cooling.
        The response in Puerto Rico and the U.S. Virgin Islands has
    involved numerous federal agencies, working together with each
    other and state and local officials. For example, before
    Hurricane Maria made landfall in Puerto Rico and every day
    since, HHS, the Department of Defense, the Department of
    Veterans Affairs, and the Federal Emergency Management Agency,
    or FEMA, have been coordinating with local emergency response
    officials to provide medical care and help re-establish the
    island's health care infrastructure. HHS has worked with Puerto
    Rico's Department of Health to prioritize resources needed for
    dialysis facilities and has coordinated with FEMA to help
    ensure critical supplies are delivered where they are needed.
    Similar efforts are ongoing in the U.S. Virgin Islands, too.
        But many questions remain. Has the inter-agency response
    been effective, from the perspective of HHS? Are federal
    policies causing delays in response efforts? Are we utilizing
    our resources in the most efficient and effective ways to help
    our fellow Americans in Puerto Rico and the U.S. Virgin Islands
    in particular?
        Finally, it is critical that we understand the public
    health challenges ahead. Mold formation is likely in nearly all
    the affected regions. As we have seen after Hurricane Harvey,
    there is an increased risk for the spread of infectious disease
    due to contaminated water. Media reports indicate that one
    month after Hurricane Maria, over one million Americans are
    still without clean, safe drinking water.
        Rebuilding Puerto Rico and the U.S. Virgin Islands will
    take years. The health care systems are in dire condition and
    most of the operational facilities need some degree of
    assistance. To make matters worse, the electrical grid has been
    devastated which has significantly hampered recovery efforts.
    We still don't even know the full extent of the damage, let
    alone when our fellow citizens will have electricity and
    running water restored. We are trying to make sure we are doing
    everything possible to address the short- and long-term needs
    of those living in the areas impacted by Hurricanes Harvey,
    Irma, and Maria, especially in the face of the public health
    threats that have resulted--and will continue to result--from
    these storms.
        I would like to thank the witnesses for testifying here
    today and I look forward to hearing your testimony.

     OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF COLORADO

        Ms. DeGette. Thank you, so much, Mr. Chairman.
        This 2017 hurricane season has been one of the most
    damaging on record. Hurricane Harvey broke the record for the
    greatest amount of rain recorded from a single tropical storm
    or hurricane in the United States and inundated Houston and
    south Texas with more than 51 inches of rain. Hurricane Irma
    became the strongest Atlantic hurricane on record before it hit
    the Virgin Islands and Florida. And while these storms have
    been devastating, Hurricane Maria's impact on Puerto Rico and
    the U.S. Virgin Islands has been nothing less than
    catastrophic.
        Mr. Chairman, as you said, the scope of potential health
    risks that are caused by this ongoing crisis, it is still
    coming into focus, but it is clearly considerable. Over a month
    after Maria hit, the infrastructure in Puerto Rico and the
    Virgin Islands remains decimated. Nearly 80 percent of Puerto
    Rico still doesn't have power, and HHS reported that a
    substantial number of Puerto Rico's hospitals are either
    nonoperational or require diesel to run generators in order
    just to keep functioning.
        Over a third of Puerto Rican residents lack reliable access
    to potable water. Contaminated water is also spreading
    contagious diseases. And while I certainly appreciate the
    effort by volunteers, including physicians and nurses
    volunteering their time with the HHS DMAT teams, I am concerned
    that poor management of the hurricane response at a Federal
    level may be hindering response efforts. The Federal
    Government, I believe, probably does not have a complete
    picture of what healthcare challenges exist because, frankly,
    most of the island of Puerto Rico lacks adequate communication.
        I think that this committee needs to hold further hearings
    to address the status of all these vital services that you, Mr.
    Chairman, talked about. And I even think, as time goes on, we
    should have field hearings on Puerto Rico, in particular, but
    also the Virgin Islands, as much of the recovery effort, as you
    so accurately describe, involves the jurisdiction of this
    committee. I can't stress enough how important it is for us to
    send our staff down there to investigate this and how important
    it is for members to go and investigate this.
        I was part of a group of members that went after Hurricane
    Katrina to New Orleans to observe the recovery efforts. What we
    found through years of oversight on this subcommittee was this
    Washington's understanding regarding the situation on the
    ground was very different than we were able to observe
    firsthand when we went into the basement of Charity Hospital
    and we saw what happened to those records. When we had our
    field hearings--Congresswoman Blackburn was there and a bunch
    of the rest of us--and we saw what had happened to small
    business people down there in New Orleans, you just cannot
    substitute for that. And as we begin to think about our public
    response as Members of Congress, we need to see what we are
    doing on the ground.
        Mr. Chairman, last week, President Trump said the
    administration deserves a 10 for its response to the
    devastation of Hurricane Maria. Given the fact that most
    residents lack power, nearly a million Americans lack access to
    safe and reliable drinking water, and endless reports of near
    subsistence living for many, I find that statement to be
    breathtaking. I hope that our witnesses today are better
    prepared than that to talk about what is really happening on
    the ground and what we can do to address this unfolding crisis.
        I hope it will be the beginning of an ongoing and concerted
    effort to understand what is going on, and I would now like to
    yield the balance of my time to Representative Castor, who
    wants to talk, appropriately, about the health challenges
    facing her State of Florida.
        Ms. Castor. Well, I thank Ranking Member DeGette for
    yielding the time. This simply was a catastrophic hurricane
    season. And we have so many challenges ahead. I want to thank
    our witnesses who are here today. I want to thank all of my
    colleagues for holding this hearing. Hopefully this is just the
    first of many because this is going to be a very long recovery
    period.
        And after 75 lives lost in Texas, 75 lives lost in
    Florida--including 14 related to a nursing home, that were
    completely avoidable--we need to discuss that. We know that we
    have about 50 deaths in Puerto Rico so far, with the threat of
    bacterial infections growing. I am very concerned about Puerto
    Rico and the whole interplay between the folks that live there
    and the U.S. Virgin Islands and their migration and what that
    means for the health needs of everyone. And on the island, the
    drinking water issue is simply critical. So I look forward to
    your expert testimony today and the committee's work in the
    days ahead. Thank you.
        Ms. DeGette. I yield back.
        Mr. Griffith. The gentlelady yields back.
        I now recognize the chairman of the full committee, Mr.
    Walden of Oregon.

      OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF OREGON

        Mr. Walden. I thank the vice chairman for holding this
    hearing. I, too, want to express my deepest sympathy for those
    who have been impacted by these horrible storms, particularly
    our fellow citizens in Puerto Rico and the U.S. Virgin Islands.
    This committee stands ready to assist in whatever way we can.
    We will continue to be diligent in our oversight of the work
    that the agencies are doing and the needs of the people there.
    I am very pleased that Dr. Burgess, who chairs our Health
    subcommittee, has already been to Puerto Rico, visited some of
    the hospitals, looked at the healthcare issues. We know we have
    much more work to do, and we hope to hear from all of you today
    about what is out there ahead, where we have made progress,
    where there are still problems that we need to uncover and get
    better solutions to.
        Today, we are examining the Department of Health and Human
    Services' continuing efforts to protect the public health in
    Texas, Florida, Puerto Rico, and the U.S. Virgin Islands in the
    aftermath of Hurricanes Harvey, Irma, and Maria. This is the
    first in a series of hearings on the preparedness for and
    responses to Hurricanes Harvey, Irma, and Maria. And, in the
    coming weeks, we will also hold hearings before the Energy and
    Environment subcommittees on these matters. And as the vice
    chairman stated, this committee will be conducting oversight of
    the rebuilding of Puerto Rico and the U.S. Virgin Islands for
    years to come.
        The public health risk typically associated with natural
    disasters are varied and include heightened incidences of
    infectious diseases, diminished access to medical care, and
    long-term mental health trauma, just to name a few of the
    concerns we all need to be aware of. These risks can be
    particularly dangerous, especially for vulnerable populations,
    such as infants, dialysis patients, individuals who may be
    immunosuppressed, and, of course, the elderly.
        Tragically, we saw this in the aftermath of Hurricane Irma
    where 14 elderly residents, as we have heard before, of the
    Rehabilitation Center at Hollywood Hills in Florida lost their
    lives as a result of heat-induced death issues after the
    facility's air-conditioning system failed during the storm.
    Last week, this committee sent a bipartisan letter to the
    nursing home's owner requesting information on the facility's
    emergency preparedness plan, inspection history, and the steps
    it took to protect residents after its air-conditioning system
    stopped working.
        We will hear today that, while the three major hurricanes
    to impact the United States in 2017 were distinct events that
    presented and continue to present their own unique challenges,
    many of the protocols that are necessary to conduct an
    effective public health response are immutable. For example,
    Federal agencies responding to disasters must be able to
    communicate effectively with each other and with local, state,
    and territorial officials to identify any areas of need,
    ensuring that individuals have adequate access to basic
    necessities, such as food, water and medical supplies, critical
    in any public health protection effort. And as we head into a
    recovery phase, it is important we also carefully monitor
    patients as they transition from hospitals or under medical
    supervision back to their homes or other long-term living
    arrangements.
        News reports indicate more than 60 percent of Puerto Ricans
    are now homeless as a result of the devastating hurricanes. We
    need to make sure, when patients are discharged from the
    hospitals, that they have safe places to go and don't end up on
    the streets and then back into the hospital.
        However, following Hurricane Maria, various media reports
    have called into question whether the Federal Government is
    adequately meeting its obligation to protect the health and
    welfare of American citizens in Puerto Rico and the Virgin
    Islands. On this matter, I am eager to gain the perspective of
    our witnesses who have been on the ground in the areas that
    have been affected by the most recent hurricanes. Making sure
    that Americans in need get the assistance they require cannot
    and should not be a partisan matter. If certain agencies aren't
    pulling their weight, we want to know. If there are Federal
    laws or policies that are impeding the recovery efforts, we
    want to know as well.
        In addition, we also want to hear about any best practices
    that can be gleaned from the ongoing recovery efforts and can
    be utilized in response to any future natural disasters. So,
    again, thanks to you and your teams for being on the ground
    trying to do the best you can in these horrible circumstances,
    but we really need to know the facts, what is working, what is
    not, where there have been shortfalls, what are the lessons
    learned, and where do you need additional help to help our
    citizens.
        So, with that, Mr. Vice Chair, I yield back the balance of
    my time and look forward to the testimony of our witnesses.
        Before I do that, I would also like to welcome our newest
    member to the committee. Mr. Duncan was just approved by the
    House Conference this morning, Steering Committee last night,
    replacing Dr. Murphy.
        And Jeff, we are delighted to have you on board the
    committee. Thanks for being here today.
        [The prepared statement of Mr. Walden follows:]

                     Prepared statement of Hon. Greg Walden

        Thank you, Mr. Vice Chairman, for holding this important
    hearing. I too want to express my deepest sympathy for those
    impacted by these storms, particularly our fellow citizens in
    Puerto Rico and the U.S. Virgin Islands. This committee stands
    ready to assist in whatever way we can.
        Today we are examining the Department of Health and Human
    Services' continuing efforts to protect the public health in
    Texas, Florida, Puerto Rico, and the U.S. Virgin Islands in the
    aftermath of Hurricanes Harvey, Irma, and Maria.
        This is the first in a series of hearings on the
    preparedness for and response to Hurricanes Harvey, Irma, and
    Maria. In the coming weeks, we will also hold hearings before
    the Energy and Environment subcommittees. And, as the Vice
    Chairman stated, this committee will be conducting oversight of
    the rebuilding of Puerto Rico and the U.S. Virgin Islands for
    years to come.
        The public health risks typically associated with natural
    disasters are varied and include heightened incidences of
    infectious diseases, diminished access to medical care, and
    long-term mental health trauma, just to name a few concerns.
    These risks can be particularly dangerous for vulnerable
    populations such as infants, dialysis patients, individuals who
    may be immunosuppressed, and the elderly.
        Tragically we saw this in the aftermath of Hurricane Irma
    where 14 elderly residents of the Rehabilitation Center at
    Hollywood Hills in Florida lost their lives as a result of
    heat-induced health issues after the facility's air
    conditioning system failed during the storm. Last week, the
    committee sent a bipartisan letter to the nursing home's owner
    requesting information on the facility's emergency preparedness
    plan, inspection history, and the steps it took to protect
    residents after its air conditioning system stopped working.
        We will hear today that while the three major Hurricanes to
    impact the United States in 2017--Harvey, Irma, and Maria--were
    distinct events that presented, and continue to present, their
    own unique challenges, many of the protocols that are necessary
    to conduct an effective public health response are immutable.
    For example, federal agencies responding to disasters must
    communicate effectively with each other and with local, state,
    and territorial officials to identify any areas of need.
    Ensuring that individuals have adequate access to basic
    necessities such as food, water, and medical supplies is
    critical in any public health protection effort.
        As we head into a recovery phase, it is important that we
    also carefully monitor patients as they transition from
    hospitals or under medical supervision back to their homes or
    other long-term living arrangements. News reports indicate over
    60 percent of Puerto Ricans are now homeless as a result of the
    devastating hurricanes. We need to make sure when patients are
    discharged from the hospitals they have safe places to go and
    don't end up back at the hospital.
        However, following Hurricane Maria, various media reports
    have called into question whether the federal government is
    adequately meeting its obligation to protect the health and
    welfare of American citizens in Puerto Rico and the Virgin
    Islands. On this matter, I am eager to gain the perspective of
    our witnesses who have been on the ground in the areas that
    have been affected by the most recent hurricanes.
        Making sure that Americans in need get the assistance they
    require, cannot and should not be a partisan matter. If certain
    agencies are not pulling their weight, we want to know; if
    there are federal laws or policies that are impeding the
    recovery efforts, we want to know that as well. In addition, we
    also want to hear about any best practices that can be gleaned
    from the ongoing recovery efforts that can be utilized in the
    response to any future natural disasters.

        Mr. Griffith. Thank you, Mr. Chairman.
        Mr. Walden. I yield back.
        Mr. Griffith. Thank you, Mr. Chairman.
        I now recognize the ranking member of the full committee,
    Mr. Pallone of New Jersey.

    OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
                IN CONGRESS FROM THE STATE OF NEW JERSEY

        Mr. Pallone. Thank you, Mr. Chairman, and thank you for
    holding this hearing on this critical issue. And I hope that
    this hearing is the first of many hurricane-related hearings,
    as Congress needs to hear further from HHS and other agencies
    regarding the ongoing response and recovery efforts in all of
    the affected areas.
        I would also like to take a moment to recognize the
    Federal, state, and local responders who are working hard to
    address the many public health issues which exist as response
    and recovery continues in all of the areas that were impacted
    by these three major hurricanes.
        I know firsthand of the tragic devastation caused by such
    immense natural disasters. In 2012, my district was hit hard by
    Hurricane Sandy. I have never seen worse storm damage in our
    area in my lifetime. For many, the storm was a worst-case
    scenario: lost lives, homes flooded, and businesses lost. The
    fifth anniversary is coming up this weekend, and we still have
    a lot of people that are not back in their homes or their
    businesses.
        Our Nation is now experiencing historic levels of
    destruction and loss in Puerto Rico and the Virgin Islands, as
    well as in Florida, Texas, and along the Gulf Coast, in the
    wake of Hurricanes Maria, Irma, and Harvey. And while no two
    natural disasters are alike, the areas affected by these
    massive hurricanes have unique needs and challenges. While
    Congress continues to address the response in Florida and
    Texas, we must also work to ensure that Puerto Rico and the
    U.S. Virgin Islands receive the full and immediate support of
    the Federal Government as they recover. I recognize there are a
    number of ongoing challenges facing the residents of south
    Florida and the Gulf Coast, but much of the hearing today will
    likely to need to address the situation in Puerto Rico and the
    U.S. Virgin Islands. The reports coming from these areas
    indicate that hundreds of thousands of Americans continue to
    struggle to meet day-to-day needs, and I am particularly
    concerned that there are still reports that residents do not
    have access to food or medicine. As many as a million Americans
    lack access to reliable sources of clean water. Accounts from
    the areas affected by these storms paint a dire situation that
    completely contradict the often rosy stories that come from the
    President and the White House.
        Hurricanes Irma and Maria caused widespread flooding and
    destruction in Puerto Rico and the U.S. Virgin Islands,
    including critical damage to electrical grids,
    telecommunications systems, drinking water systems, and
    transportation infrastructure. Virtually all residents of
    Puerto Rico and the U.S. Virgin Islands have been impacted, and
    these infrastructure failures create acute public health
    issues. We have seen and heard reports of death, dehydration,
    and desperation as residents of Puerto Rico and the U.S. Virgin
    Islands continue to struggle in the post-apocalyptic landscape
    where fundamental health needs remain unaddressed even a month
    after Hurricane Maria and almost 2 months after Hurricane Irma.
        The lists of serious needs and challenges is long. Many
    hospitals still do not have reliable power. Many communities in
    Puerto Rico still lack safe drinking water, and people have
    resorted to drinking from questionable water sources. Where
    water service has been he restored, residents are still unsure
    if the water is safe. In a recent EPA briefing to the
    committee, we learned that crews going into communities to test
    for water quality were arriving only to find that people still
    lacked adequate food and drinking water.
        So Congress must provide ongoing support in the aftermath
    of these hurricanes to restore and rebuild, and I hope our
    witnesses today will help us understand what needs to be
    improved in the response and recovery efforts so that Congress
    can more effectively provide assistance and understand the
    impacts on public health, not just today but in the months and
    years to come.
        I also wanted to say something about the fact that many
    Puerto Ricans are actually coming from the island to our
    states, in particularly in New Jersey, in my district. And, my
    mayors and my elected officials locally are saying: You know,
    is there any kind of help for us? Because a lot of these people
    come here, and they don't have a lot of money. They need
    support as well. So that is also something we need to look
    into.
        I would like to yield the remainder of my time to Mr.
    Green.
        [The prepared statement of Mr. Pallone follows:]

                 Prepared statement of Hon. Frank Pallone, Jr.

        Mr. Chairman, thank you for holding this hearing on this
    critical issue. I hope that this hearing is the first of many
    hurricane related hearings, as Congress needs to hear further
    from HHS and other agencies regarding the ongoing response and
    recovery efforts in all of the affected areas.
        I also would like to take a moment to recognize the
    federal, state, and local responders who are working hard to
    address the many public health issues which exist as response
    and recovery continues in all of the areas that were impacted
    by these three major hurricanes.
        I know firsthand of the tragic devastation caused by such
    immense natural disasters. In 2012, my district was hit hard by
    Hurricane Sandy. I had never seen worse storm damage in our
    area in my lifetime. For many, the storm was a worst case
    scenario: lives lost, homes flooded, and businesses lost.
        Our nation is now experiencing historic levels of
    destruction and loss in Puerto Rico and the U.S. Virgin
    Islands, as well as in Florida, Texas and all along the Gulf
    Coast in the wake of Hurricanes Maria, Irma, and Harvey.
        No two natural disasters are alike, and the areas affected
    by these massive hurricanes have unique needs and challenges.
    While Congress continues to address the response in Florida and
    Texas, we must also work to ensure that Puerto Rico and the
    U.S. Virgin Islands receive the full and immediate support of
    the federal government as they recover.
        While I recognize that there are a number of ongoing
    challenges facing the residents of South Florida and the Gulf
    Coast, much of the hearing today will likely need to address
    the situation in Puerto Rico and the U.S. Virgin Islands. The
    reports coming from these areas indicate that hundreds of
    thousands of Americans continue to struggle to meet day-to-day
    needs.
        I am particularly concerned that there are still reports
    that residents do not have access to food or medicine and as
    many as a million Americans lack access to reliable sources of
    clean water.
        Accounts from the areas affected by these storms paint a
    dire situation that completely contradict the often rosy
    stories that come from the White House. Hurricanes Irma and
    Maria caused widespread flooding and destruction in Puerto Rico
    and the U.S. Virgin Islands, including critical damage to
    electrical grids, telecommunications systems, drinking water
    systems, and transportation infrastructure.
        Virtually all residents of Puerto Rico and the U.S. Virgin
    Islands have been impacted, and these infrastructure failures
    create acute public health issues. We have seen and heard
    reports of death, dehydration, and desperation as residents of
    Puerto Rico and the U.S. Virgin islands continue to struggle in
    a post-apocalyptic landscape where fundamental health needs
    remain unaddressed even a month after Hurricane Maria and
    almost two months after Hurricane Irma.
        The list of serious needs and challenges is long. Many
    hospitals still do not have reliable power. Many communities in
    Puerto Rico still lack safe drinking water, and people have
    resorted to drinking from questionable water sources. Where
    water service has been restored, residents are still unsure if
    the water is safe. In a recent EPA briefing to the Committee,
    we learned that crews going into communities to test for water
    quality were arriving only to find that people still lacked
    adequate food and drinking water.
        Congress must provide ongoing support in the aftermath of
    these hurricanes to restore and rebuild. I hope that our
    witnesses today will help us understand what needs to be
    improved in the response and recovery efforts, so that Congress
    can more effectively provide assistance and understand the
    impacts on public health, not just today but in the months and
    years to come.
        Thank you, I yield back.

        Mr. Green. Thank you, Mr. Chairman.
        I thank my colleague for yielding to me today.
        Our district in Houston, in Harris County, Texas, was
    heavily impacted by Hurricane Harvey. We actually had at least
    eight deaths in our district alone in a very urban area of
    Houston. But I thank the heroism and the tireless work of our
    first responders, public health professionals, community
    members, for helping fellow Texans and Houstonians during their
    time of need. I would also like to thank my colleagues for
    supporting our two supplementals so far, and there will be much
    more for, not just Texas, but Louisiana, Florida, Puerto Rico,
    the Virgin Islands, and a number of other disasters.
        The State of Texas and CMS need to work together to make
    sure we are taking advantage of every opportunity to help
    people in need, especially when it comes to Medicaid. I hope
    CMS will act expeditiously to get the necessary resources to
    our local hospital in Texas to help uninsured disaster victims.
    We shifted to recovery in Houston and the Texas Gulf Coast and
    are responding to public health concerns related to Harvey,
    including the spread of mold in flooded homes, businesses, and
    the spread of disease-carrying mosquitoes.
        We must also be fully responsive to the environmental
    impact of Harvey, including community members' possible
    exposure to toxic chemicals and wastewater. I look forward to
    hearing from our witnesses and working with our Federal public
    health agencies to fully address these pressing concerns. And
    in our office in Houston, we do a lot of casework on typically
    Social Security, Medicare, veterans, you name it. But now every
    staff member has casework with FEMA because it goes through the
    process. But we are working through it, again, with our Federal
    agencies helping us to make sure we can get people back to
    where they were before the storm.
        And thank my colleague, again, for yielding.
        I yield back my time.
        Mr. Pallone. And I yield back, as well, Mr. Chairman.
        Mr. Griffith. I thank the gentleman.
        I ask unanimous consent that the members' written opening
    statements be made a part of the record.
        Without objection, they will be entered into the record.
        Additionally, I ask unanimous consent that Energy and
    Commerce members not on the Subcommittee on Oversight and
    Investigations be permitted to participate in today's hearing.
        Without objection, so ordered.
        Further, just so everybody knows what we are doing, Mr.
    Duncan has joined the committee and the subcommittee. And we
    are glad to have him on our subcommittee. However, until a
    formal motion is made on the floor at approximately 12:30, the
    Parliamentarians tell us that we have to treat him as a member
    of the Energy and Commerce Committee but not yet on the
    Subcommittee on Oversight and Investigations. So he will be
    treated like all other members in that circumstance, which
    means he will go last. As the newest member of the committee,
    he would go last anyway, but we are just rubbing it in. No, but
    I did want to let everybody else know what the status was so,
    when they hear a motion later today on the floor, they will
    understand that that is what the Parliamentarians have told us
    that we need to do.
        But welcome to the committee and the subcommittee.
        Mr. Walden. Mr. Vice Chairman?
        Mr. Griffith. Mr. Chairman.
        Mr. Walden. I assume he knows, too, his other
    responsibilities for all the committee members: getting us each
    coffee----
        Mr. Griffith. We have heard tell of these stories.
        Mr. Walden [continuing]. Like Mr. Scalise----
        Mr. Griffith. That is correct.
        Yes. Thank you. We will make sure he is aware of those
    duties, Mr. Chairman.
        Finally, we welcome non-Energy and Commerce Committee
    members who are with us today or who may show up at a later
    time. Pursuant to House rules, Members not on the committee are
    able to attend our hearings--and we are glad to have them--but
    are not permitted to ask questions.
        I would like now to introduce our panel of witnesses for
    today's hearing.
        First, we have the Honorable Robert Kadlec, the Assistant
    Secretary for Preparedness and Response at the Department of
    Health and Human Services. Welcome. Next is the Honorable Scott
    Gottlieb, who serves as Commissioner of the U.S. Food and Drug
    Administration. Welcome. Then we have Ms. Kimberly Brandt, who
    is the Principal Deputy Administrator for Operations at the
    Centers for Medicare and Medicaid Services. Welcome. We are
    glad you are here. And finally, we have Rear Admiral Stephen
    Redd, who is the Director of the Office of Public Health
    Preparedness and Response at the Centers for Disease Control
    and Prevention.
        Thank you all for being here today and providing testimony.
    We are looking forward to the opportunity to examine the
    preparedness for and responses to the recent hurricanes.
        Now, as a part of what we do in this committee, we are
    holding an investigative hearing. And when doing so, it has
    been the practice of this subcommittee to take testimony under
    oath. Do any of you have objection to testifying under oath?
    Seeing none, the chair then advises you that, under the rules
    of the House and the rules of the committee, you are entitled
    to be accompanied by counsel. Do any of you desire to be
    accompanied by counsel during your testimony today?
        Seeing none, I will move forward.
        In that case, if you would please rise and raise your right
    hand, I will swear you all in.
        [Witnesses sworn.]
        Mr. Griffith. Hearing affirmative answers from all, I
    appreciate it. Thank you very much. You are now under oath and
    subject to the penalties set forth in title 18, section 1001,
    of the United States Code.
        You may now give a 5-minute summary of your written
    statement.
        And, obviously, we will begin with the Honorable Mr.
    Kadlec.

     TESTIMONY OF ROBERT P. KADLEC, M.D., ASSISTANT SECRETARY FOR
    PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
      SERVICES; SCOTT GOTTLIEB, M.D., COMMISSIONER, U.S. FOOD AND
        DRUG ADMINISTRATION; KIMBERLY BRANDT, PRINCIPAL DEPUTY
    ADMINISTRATOR FOR OPERATIONS, CENTERS FOR MEDICARE AND MEDICAID
      SERVICES; AND STEPHEN C. REDD, M.D., RADM, DIRECTOR OF THE
    OFFICE OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR
                     DISEASE CONTROL AND PREVENTION

                  TESTIMONY OF ROBERT P. KADLEC, M.D.

        Dr. Kadlec. Good morning, Mr. Vice Chairman, Ranking Member
    DeGette, and members of the subcommittee. It is a privilege to
    appear before you to discuss our Nation's medical and public
    health response to a series of unprecedented and nearly
    simultaneous Category 4 and Category 5 hurricanes that hit the
    U.S. mainland and its territories so far this season.
        HHS--and when I include that, it is the ASPR--the CMS, FDA,
    and CDC, as well as our interagency partners of FEMA, DHS, VA,
    and DoD, have pushed the boundaries in unprecedented ways to
    save lives and support the communities and people impacted by
    these major hurricanes. I recognize that, in some regions in
    Puerto Rico and the Virgin Islands, people are still facing
    dire conditions. I recently saw that for myself and the
    devastation firsthand and can assure you that HHS continues our
    response at 110 percent and will continue to work as hard as we
    can until conditions improve.
        Since this is my first time testifying before this
    committee as the ASPR, I will begin with a brief description of
    my view on the role of this position. After it was created
    almost 11 years ago in response to Hurricane Katrina by the
    Pandemic and All-Hazards Preparedness Act, its objective was to
    create unity of command by consolidating all HHS public health
    and medical preparedness and response functions under one
    person, the ASPR. I had the privilege of serving as a staff
    director of the subcommittee that drafted this legislation.
    ASPR's mission is simply to save lives and protect America from
    health security threats. On behalf of HHS, ASPR leads the
    public health and medical response to disasters and public
    health emergencies in accordance with the National Response
    Framework Emergency Support Function No. 8.
        Today, the threats facing our country are increasingly
    diverse and more lethal. Therefore, my main objective is to
    improve national readiness and response capabilities from 21st
    century threats. I aim to do that through four key priority
    areas and efforts: first, provide strong leadership; second,
    create a national disaster healthcare system; third, sustain
    robust and reliable public health security capabilities; and,
    finally, advance innovative medical countermeasure development.
        Hurricanes Harvey, Irma, Maria, and, lastly, Nate's near
    simultaneity and severity created unique challenges. Especially
    in Puerto Rico, no place, no person, no life was untouched.
    During my trip there, I was overwhelmed by the resilience of
    its citizens who are making do in extraordinarily difficult
    situations. Of the three major hurricanes to date, our strategy
    has been threefold: first, save lives; second, stabilize the
    healthcare system; third, restore healthcare services.
        In Puerto Rico, we're still responding. In other areas,
    recovery is underway. Here are just some of the many actions
    taken by ESFA partners:
        In order to save lives, ASPR activated the National
    Disaster Medical System, or NDMS, and deployed more than 2,500
    personnel from 21 states and hundreds of other Federal
    employees, including U.S. Public Health Service Commissioned
    Corps personnel, to communities impacted by these storms. In
    fact, in each of these storms, we deployed teams even before
    the hurricanes made landfall so they were ready to respond
    immediately. We cared for more than 15,000 patients in the
    affected states and territories and more than 10,700 in Puerto
    Rico alone. HHS has also sent 439 tons of medical equipment and
    supplies to the affected areas. HHS declared public health
    emergencies for impacted states and territories before landfall
    with each storm.
        ASPR and CMS proactively utilized the emPOWER tool to
    identify Medicare/Medicaid beneficiaries in each impacted area
    who rely on life-maintaining and assistive medical equipment as
    well as people who rely on dialysis and home health services.
    We evacuated more than 200 dialysis patients from the U.S.
    Virgin Islands. In Florida and St. Thomas, for the first time
    in its history, NDMS personnel joined urban search and rescue
    teams to locate and evacuate dialysis patients.
        HHS activated the Emergency Prescription Assistance Program
    in Puerto Rico, which provides free medications to disaster
    victims who cannot afford to pay.
        HHS deployed mental health teams and activated behavioral
    health hotlines, in partnership with SAMHSA, to aid people
    coping with the psychological effects of these storms.
        I'd like to show you a map. You can see it on your screens
    and you have paper copies in front of you. This illustrates the
    comprehensive approach to providing healthcare and DoD
    services--pardon me, medical services we implemented together,
    with our interagency partners at the VA and DoD, as well as the
    Puerto Rico Health Department.
        My overview of activities we took on behalf of Americans in
    distress is just a fraction of what we actually did. I have not
    and could not speak to all the work that HHS disaster medical
    assistance teams and Public Health Service Commissioned Corps
    personnel did. They are true American heroes who left their
    families, their medical and clinical practices to render aid,
    often in arduous circumstances.
        We're committed to the long period of recovery ahead. We
    also reflect on this experience by conducting a comprehensive
    after-action review to identify ways to improve our capacity to
    respond to future public health emergencies, be they naturally
    occurring or manmade.
        I thank you again for this opportunity to address these
    issues, and I'm happy to answer any questions that you may
    have.
        [The prepared statement of Dr. Kadlec follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. Thank you. Thank very much.
        Now 5 minutes for an opening statement for the Honorable--
    --

                   TESTIMONY OF SCOTT GOTTLIEB, M.D.

        Dr. Gottlieb. Thank you, Chairman Griffith, Ranking Member
    DeGette, members of the subcommittee. I appreciate the
    invitation to discuss the FDA's response to Hurricanes Harvey,
    Irma, and Maria. My remarks today are going to be focused on
    the impact of Maria on Puerto Rico because of the unique role
    the FDA has in the island's recovery and because of the
    enormous magnitude of the devastation that Maria caused to our
    fellow citizens.
        First and foremost, our commitment is to the people of
    Puerto Rico as they begin the long recovery from the
    overwhelming devastation. But FDA also has a broader mission in
    Puerto Rico: A substantial portion of the island's economic
    base is comprised of facilities that manufacture medical
    products. This includes many critical medical products. There
    are currently more than 50 medical device manufacturing plants
    in Puerto Rico. Collectively, they produce more than 1,000
    different kinds of devices. To date, we are especially focused
    on about 50 types of medical devices manufactured by about 10
    firms in Puerto Rico. These devices are critically important to
    patient care because they may be life-sustaining or life-
    supporting or the island may be the only manufacturing site for
    these devices.
        At the same time, we're focused on about 30 different
    medically important drugs and about 10 biological devices or
    biologics that are solely or primarily manufactured on the
    island. Fourteen of these products are sole-source, meaning
    they're manufactured only in Puerto Rico.
        To avert shortages of critical medical products, we have
    been working closely with our partners at FEMA, DHS, and, of
    course, HHS to troubleshoot challenges related to getting fuel
    for generators and raw ingredients for manufacturing processes,
    as well as the logistics to move finished products off the
    island. Our interventions have evolved as the nature of the
    risk has changed, and our response progresses. Early on, we
    helped individual firms secure landing rights for planes to
    ferry off finished products that were, in some cases, at risk
    of being destroyed by flooding warehouses. As days went on, we
    started to get more actively involved in helping facilities
    secure diesel fuel for generators. In the last week, we have
    been actively engaged in helping a few facilities that
    manufacture products critical to the blood supply secure small
    quantities of medical-grade gases that they use in their
    manufacturing processes. As the recovery efforts proceed, a lot
    of these challenges are being solved through better logistics
    and no longer require our active intervention.
        That's the good news. We have processes in place now that
    are helping guarantee supply of diesel fuel, raw manufacturing
    ingredients, and medical gases, and other critical components.
    But there will be other challenges that arise as this crisis
    evolves.
        The one that concerns us the most is long-term power. Many
    generators weren't meant to function for months on end.
    Moreover, a lot of the facilities can't return to full
    production on generator power alone. Most are producing at
    anywhere from 20 to 70 percent of their normal capacity based
    on our informal survey. They won't be able to resume full
    production until they get back on the power grid. And if they
    don't return to the grid by the end of this year, we're
    concerned that we could face multiple potential shortages
    unless we can also help these facilities temporarily ship more
    of their manufacturing off the island.
        But with my remarks, I'd like to give you a perspective on
    the human factor that we're seeing every day where we see the
    island's residents taking often heroic steps to keep supplies
    and critical products flowing and where the firms that
    manufacture these items are taking their own extraordinary
    steps as good corporate citizens to support these efforts. If
    we're going to avert major product shortages, it's going to be
    as a consequence of these efforts. I want to take a moment to
    take note of these activities and to support them.
        First and foremost, I want to take note of the Americans
    who reside in Puerto Rico. The medical product industry
    directly employs about 90,000 Puerto Ricans. And if we do avert
    critical shortages, it will be primarily because of our fellow
    citizens who returned to their post at this critical time, even
    as their own families were displaced and their lives
    devastated. We owe them all an enormous debt of gratitude.
        I also want to use this chance to take measure of the good
    corporate citizenship that FDA has been witness to. Even as we
    watched some companies take extraordinary efforts to maintain
    their production, they took equivalent steps to support their
    employees and the families of their workers, using their
    facilities as a way to deliver direct assistance to those
    harmed by Maria. Many of these manufacturing facilities are
    serving as disaster relief stations across the island. They are
    helping distribute FEMA aid to the outlying towns. Companies
    are distributing gasoline to their employees and general relief
    items like water, food, and batteries. Facilities have been
    using their cafeterias to feed employees and their families.
    One multinational drug company told us that they shipped
    thousands of generators to the island for distribution to their
    employees as part of hundreds of tons of relief aid and
    emergency supplies that they shipped by air and sea. We know of
    companies that have created financial programs to help
    employees rebuild their homes and resume their lives. Some of
    these programs include cash grants or matched donations they
    accept from employees across the globe as a way to help Puerto
    Rico employees rebuild their homes.
        I want to take a moment to recognize these efforts. These
    kinds of commitments are going to be a key part of helping
    Puerto Rico fully recover. We all need to do our part.
        Most of all, I want to recognize the resilience of the
    people of Puerto Rico and the fidelity to our public health
    mission. The FDA has a long history of operating on the island.
    It has been an integral part of our work. We owe the island's
    residents our steadfast and long-term commitment to a full
    recovery. Thanks a lot.
        [The prepared statement of Dr. Gottlieb follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. Thank you. I thank you for your testimony.
        And now I recognize Ms. Brandt for a 5-minute opening
    statement.

                      TESTIMONY OF KIMBERLY BRANDT

        Ms. Brandt. Thank you. Chairman Griffith, Ranking Member
    DeGette, and members of the subcommittee, thank you for the
    opportunity to discuss efforts by the Centers for Medicare and
    Medicaid Services, or CMS, to respond to the recent hurricanes.
        CMS plays an integral role in emergency response during
    these natural disasters. I have almost 20 years of experience
    working on Medicare and Medicaid issues. And even with that
    perspective, I was surprised at the depth and breadth of CMS'
    involvement in the hurricane response efforts.
        This is a role our agency takes very seriously, as
    evidenced by, even while I am here today, CMS Administrator
    Verma is in Puerto Rico assessing our on-the-ground efforts and
    gaining valuable insights from patients, providers, and local
    officials. Many people think of CMS, firstly, as a pair,
    reimbursing for the care delivered to our over 100 million
    Medicare/Medicaid and CHIP beneficiaries, and, secondly, as a
    regulator, overseeing and enforcing standards for the care
    delivered by millions of providers and suppliers. While CMS
    does not directly provide care to our beneficiaries, we do have
    a direct impact on the care they receive. And the last several
    weeks have allowed CMS to demonstrate the important role we can
    play in emergency preparedness and response efforts.
        One of CMS' most valuable emergency response tools is our
    ability to waive or modify certain program requirements, which
    CMS can do after the President declares a major disaster and
    the HHS Secretary declares a public health emergency. CMS is
    using the full breadth of this authority to ensure our
    beneficiaries have access to the care they need by providing
    flexibility to Medicare and Medicaid providers so they can
    deliver high-quality care to those who need it, when they need
    it, and where they need it. For example, we use waivers to
    allow Medicare providers to move patients between facilities
    and administer care in alternative locations and to expedite
    Medicaid enrollment for out-of-state providers. Already, we
    have approved nearly 100 waivers in total across the impacted
    disaster areas.
        Last month, I joined Administrator Verma on a visit to
    Houston, Texas, where we are able to speak to several of those
    impacted, including beneficiaries and providers who
    demonstrated how important these flexibilities were to them
    following an emergency. We want beneficiaries and providers to
    be able to focus on their immediate needs to provide urgent
    care without worrying about reimbursement policies, and we
    heard firsthand during our visit what a difference those
    flexibilities make.
        That is why CMS is taking an active listening approach and
    meeting and talking with stakeholders in all of the impacted
    areas on an ongoing basis to make sure we understand their
    needs and are able to meet them.
        One of the Administrator's top priorities has been to
    provide access to necessary care for one of our most vulnerable
    beneficiary groups, dialysis patients, during these challenging
    circumstances. One of the ways we have done this is using our
    authority to temporarily designate dialysis facilities licensed
    in locations impacted by the hurricanes--but that are not yet
    certified--to serve as a special-purpose renal dialysis
    facilities so they can provide care for Medicare beneficiaries.
    In fact, we were able to designate one of these facilities in
    Florida before the storm hit to ensure that patients were
    dialyzed in anticipation of the storm.
        In Puerto Rico and the U.S. Virgin Islands, CMS has been
    working closely with ASPR, the Kidney Community Emergency
    Response Program, and the End Stage Renal Disease Networks to
    monitor conditions before, during, and after the storms to
    predict and assess the impact to these extremely fragile
    patients. Here are two examples of our combined efforts: Under
    the direction of one of our CMS Commissioned Corps members, we
    are working with these partners to daily track the operational
    status of dialysis facilities in Puerto Rico and their status
    with respect to fuel, water, and other supplies, as well as
    developing delivery schedules for those supplies necessary for
    the facilities to treat the nearly 6,000 dialysis patients on
    the island.
        CMS also partnered with several of our Federal and local
    partners to arrange support for approximately 120 dialysis
    patients evacuated from the U.S. Virgin Islands to Atlanta when
    conditions were no longer safe in the Virgin Islands. This
    included working with staff on the ground in Atlanta from day
    one to greet and medically assess each patient as they arrived.
        Unfortunately, these recent events will not be the last
    public health emergencies our Nation faces. Making sure
    providers and suppliers are prepared for future disasters,
    whether it is a hurricane, wildfire, or disease pandemic, is
    essential to ensuring patient safety. That is why CMS requires
    all Medicare and Medicaid facilities to comply with basic
    health and safety requirements, including emergency
    preparedness standards, which we updated last fall. The updates
    include a more comprehensive approach to emergency planning and
    requiring facilities to more thoroughly address location-
    specific hazards. In addition, we required facilities to meet
    additional emergency training standards for staff and implement
    a communication system to contact patients, physicians, and
    other necessary persons to ensure continuation of patient care
    functions.
        While much has been done, there's still much to be done,
    particularly in Puerto Rico, where over 50 percent of the
    population is covered through a CMS program. Together, we must
    continue to think creatively about all the ways we can help
    ensure our beneficiaries have access to needed care, supplies,
    and prescriptions, even in the midst of emergencies and natural
    disasters. We appreciate the subcommittee's interest in these
    efforts and look forward to working with you throughout the
    recovery process.
        [The prepared statement of Ms. Brandt follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. Thank you very much for your testimony.
        I now recognize Rear Admiral Redd for 5 minutes for an
    opening statement.

                TESTIMONY OF STEPHEN C. REDD, M.D., RADM

        Dr. Redd. Good morning, Vice Chairman Griffith, Ranking
    Member DeGette, and distinguished members of the subcommittee.
        I am Rear Admiral Stephen Redd, Director of the Centers for
    Disease Control and Prevention's Office of Public Health
    Preparedness and Response. I appreciate the opportunity to be
    here today to discuss CDC's efforts and activities in response
    to the 2017 hurricanes.
        To address the impacts of these hurricanes, CDC has
    provided public health support to the coordinated Federal,
    State, local, territorial and Tribal responses. The focus of
    CDC's efforts have been in epidemiology and health
    surveillance, laboratory support, environmental and
    occupational health, and health communications.
        On August 30, 2017, CDC activated its emergency operation
    center to coordinate our response to Hurricane Harvey, and
    subsequently, we've expanded that activation to include
    Hurricanes Irma and Maria. Since the end of August, CDC has had
    approximately 500 staff members supporting the response.
    Additionally, we have deployed over 70 staff to the affected
    areas to provide on-the-ground support, including 34 to Puerto
    Rico and 12 to the U.S. Virgin Islands. To address immediate
    health concerns, CDC deployed Federal medical stations to serve
    as temporary, non-acute, medical care facilities. Each Federal
    medical station can accommodate up to 250 patients and includes
    a cache of medical supplies and equipment. HHS deploys medical
    teams to staff these facilities, and CDC has deployed six of
    these to Puerto Rico, four to Texas, and two to Florida.
        CDC has used syndromic surveillance to monitor health-
    related data that may signal disease outbreak. Our National
    Syndromic Surveillance Program has collaborated with ASPR's
    disaster medical assistance teams to collect data on patient
    encounters and works closely with the American Red Cross to
    monitor data on shelter populations so that health officials
    can respond quickly when that's called for.
        Surveillance during this response has indicated elevations
    in carbon monoxide poisoning. And this has led to increased
    messaging to prevent this condition and guidance on the safe
    operation of generators.
        Identifying and controlling public health--diseases of
    public health importance in Puerto Rico and the U.S. Virgin
    Islands are a priority. The Puerto Rico Department of Health
    sustained significant damage during Hurricane Maria, including
    damage to their laboratories. These laboratories are not able
    to conduct any public health tests. They're not able to confirm
    diagnoses of infectious or environmental diseases. CDC is
    working with the Puerto Rico Department of Health and FEMA to
    get these laboratories back in operation. And, in the meantime,
    we have arranged for packaging and shipment of clinical
    specimens of suspected priority infectious diseases, such as
    tuberculosis, leptospirosis, rabies, influenza, salmonella, to
    the U.S. mainland for testing. In fact, the first shipment of
    diagnostic specimens for leptospirosis recently arrived in
    Atlanta.
        Let me touch briefly on a few other components of our
    response. We've provided technical assistance to the affected
    areas to address health issues, such as food safety, water
    issues, including sewage. We've provided guidance on injury
    prevention from debris and drowning. We've helped with shelter
    assessments. We've provided guidance regarding the safety of
    responders, and we have developed and disseminated key public
    health messages to individuals in the affected areas.
        CDC recognizes that the full recovery from the recent
    hurricanes will take time, particularly in Puerto Rico and the
    Virgin Islands, where the damage has been extensive. But we're
    here to continue to provide that support.
        Thank you, again, for the opportunity to appear before you
    to discuss our response and recovery efforts, and I'd be glad
    to answer any questions you might have.
        [The prepared statement of Dr. Redd follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. Thank you all very much for your testimony.
        And I will now begin questioning by recognizing the
    chairman of the full committee, Chairman Walden, for 5 minutes
    for questions.
        Mr. Walden. Thank you, Vice Chairman.
        And I thank all of you for your testimony and the work that
    the people that you represent are doing in these terrible
    tragedies.
        And we all know there's more to be done, and it's hard, in
    the aftermath, to get it right. And we sure appreciate what
    you're doing.
        On behalf of the at-large Resident Commissioner from Puerto
    Rico, Jenniffer, thank you for joining us today. I know you're
    not able to ask questions as part of our committee rules, but I
    can on your behalf. So I appreciate your submitting some of
    these because I think they're really important to get on the
    record.
        So, Dr. Kadlec, I'm going to start with you. Puerto Rico
    remains in the response mode of saving lives and stabilizing
    healthcare services. What major milestones must be completed to
    progress from the response phase to the recovery phase? If you
    can just be fairly brief on that because I've got a couple
    other----
        Dr. Kadlec. Yes, sir, I think it has been highlighted by
    members of your committee. The power situation on the island
    does represent a significant limitation. Right now, we have
    about 60 percent of the 67 hospitals that are on the power grid
    and have reliable power. But there are 36 percent, total of 24,
    that still do not. And that's an important benchmark in terms
    of our ability. The other----
        Mr. Walden. What do you think the timeline is to get them
    the power they need?
        Dr. Kadlec. Sir, I really wouldn't be in a position to
    answer that. I think the U.S. Army Corps of Engineers is trying
    to move as aggressively as possible to do that. They have
    prioritized hospitals, health clinics, and dialysis centers on
    the top of the list to, basically, re-electrify with the grid.
    So I think the intent is to get them up as quickly as
    physically and humanly possible.
        The other part of the sustainment is also knowing about the
    operational status of those hospitals, because some of them
    have physical damage, to ensure that they can basically resume
    full functionality. It is, again, working closely with FEMA and
    with the Army Corps of Engineers. We performed assessments of
    those hospitals to identify which ones need physical repair.
        And then there are also issues that relate to supply-chain
    restoration, things like oxygen, which I think is a matter of
    topical interest here.
        Mr. Walden. All right. Thank you.
        Rear Admiral, thank you for being here and, again, for the
    work you're doing.
        How is the CDC Dengue Branch in Puerto Rico being utilized
    during this recovery effort? And then I have one more for you.
        Dr. Redd. Yes. The Dengue Branch was affected just like
    every other location in Puerto Rico. As of October 10th, the
    laboratory is back in operation. It's functioning at a low
    level under generator power right now. So I think it's more in
    the affected than in the response zone of the efforts at this
    point.
        Mr. Walden. When do you think it might be up to full
    operation?
        Dr. Redd. I think some of the issues that Dr. Kadlec raised
    would be germane to the full activation and operation of the
    Dengue Branch lab as well.
        Mr. Walden. All right. Particularly concerning is the
    damage to Puerto Rico Department of Health public health labs.
    To date, the labs are not able to conduct any public health
    testing, including the ability to confirm diagnoses of
    infectious and environmental diseases. What will it take to get
    them up and running? And, in their absence, what is happening
    to do this kind of lab work?
        Dr. Redd. Yes, sir. So restoring power is the first step.
    There is work with the Army Corps to identify the generator
    capacity needed to bring the laboratories back to power. There
    will be a second level of effort to determine what equipment
    can be salvaged and what equipment can't be salvaged. So we
    don't know the results of that assessment until the power is
    back. So it is going to be some time.
        Mr. Walden. You don't know a timeline on power?
        Dr. Redd. I think, for generators, we're talking weeks at
    the most.
        Mr. Walden. That they'll be running on generators or before
    they get them----
        Dr. Redd. Generators. Yes. And maybe less than that. So I
    can't say about the back on the grid. But there should be power
    to the labs within a relatively short period of time.
        In the meantime, we are working with the Department of
    Health in Puerto Rico to ship specimens to Atlanta for testing.
    And that's where the first shipment of leptospirosis cases has
    been shipped.
        Mr. Walden. And are you comfortable with that kind of
    arrangement to do the lab testing? Is that quick enough? Is it
    adequate enough?
        Dr. Redd. It's certainly not optimal. I think it's the best
    that we can do at this point in time. I think that what we
    really need is to be where those tests can be done in Puerto
    Rico and having the lab back up to full speed.
        Mr. Walden. But if it's going to be weeks before that can
    happen, is there a temporary sort of lab that could be flown in
    there?
        Dr. Redd. We've had quite a bit of discussion on that. I
    think that, in general, the feeling is that getting specimens
    to Atlanta for testing is going to be, since it's not going to
    be a very, very prolonged period of time, that this is a
    temporizing measure. It's not optimal, but it's the best that
    we can do under the circumstances.
        Mr. Walden. It works? You feel it works?
        Dr. Redd. Yes, sir.
        Mr. Walden. All right. My time has expired.
        Mr. Vice Chair, thank you for this hearing.
        Again, thank you for your testimony.
        Mr. Griffith. Thank you, very much, Mr. Chairman.
        I now recognize the ranking member of the subcommittee, Ms.
    DeGette of Colorado, for 5 minutes.
        Ms. DeGette. Thank you, so much, Mr. Vice Chairman.
        I just want to remind the panel: You all know very well
    it's now been over a month since Maria hit both the U.S. Virgin
    Islands and Puerto Rico. And, even now, there was just an
    article in The New York Times today which is entitled ``'Like
    Going Back in Time': Puerto Ricans Put Survival Skills to
    Use.'' And it's a very powerful article that talks about how
    people still don't have power. People are still eating canned
    foods. Elderly people are afraid to go outside because of
    gangs. And what it talks about is the way everybody is helping
    themselves is the neighbors are bonding together. And there's a
    fellow, the director of a local nonprofit, said most of the
    aid--the neighborhood, which appears to be in San Juan, not in
    the remote mountains, had received was from private citizens
    and celebrities. Quote: ``The government hasn't arrived here.''
        As I mentioned in my opening remarks, having been on this
    subcommittee when we investigated Katrina, it's wonderful to
    reflect back on what we've done. But it's more important to
    think about, A, how quickly we can do more. And, B, what we can
    do to improve our efforts in the future. And I just want to
    remind,, everybody, listening to a lot of this testimony, you'd
    think that everything was just swell. And I hope none of you
    intended to intimate that. And I know we're going to have a lot
    of questions about that.
        But, Commissioner Gottlieb, I kind of wanted to hone in
    with you about your testimony because, as you said, there are a
    lot of drugs and devices that are produced in Puerto Rico.
    There's 13 of them that are--drugs--that are only produced in
    Puerto Rico. Is that correct?
        Dr. Gottlieb. There's more than 13. There's probably
    somewhere in the nature of 40 sole-source drugs but only 14
    that we think are critical insofar as they are medically
    important and we couldn't find a therapeutic alternative. So
    we're focused on about 14 products.
        Ms. DeGette. About 14. And most of the plants where those
    drugs are being manufactured are relying on generators. Is that
    right?
        Dr. Gottlieb. That's right. I believe almost all, if not
    all, of the plants are on generator power.
        Ms. DeGette. On generator. Now, I think you testified that
    this is not a long-term solution. Is that right?
        Dr. Gottlieb. That's right, Congresswoman. There are some
    facilities that have substantial generators and probably could
    operate for a sustained period of time.
        Ms. DeGette. What do you mean by ``a sustained period of
    time''?
        Dr. Gottlieb. Some of them are very hardened. So I don't
    want to say that there aren't facilities there that couldn't
    operate, perhaps indefinitely, on generators. But that's the
    exception. Most of those facilities will not be able to operate
    for a sustained period of time.
        And if we get into the first quarter of next year and these
    facilities aren't back on the grid, we're going to have some
    concerns. And so we're trying to think now how we can work with
    our partners at HHS and the Army Corps of Engineers to
    prioritize a handful of the facilities that are critical.
        Ms. DeGette. And the reason you're going to have concerns
    is sort of twofold. Number one, the generators don't produce
    the kind of energy that they need to produce these products,
    right?
        Dr. Gottlieb. That's right.
        Ms. DeGette. And, number two, even if you can use it, it's
    going to be a reduced supply.
        Dr. Gottlieb. That's right. I know of one firm that's
    producing at 100 percent output right now, but they've dialed
    back certain portions of the facility. In most cases, these
    facilities can't operate at 100 percent production on their
    generators----
        Ms. DeGette. Right.
        Dr. Gottlieb [continuing]. And they certainly can't operate
    100 percent of their facilities on the generators.
        And the other point is that the generators themselves are
    going to start to break down. These weren't meant to operate--
    --
        Ms. DeGette. That's right. They are not meant to operate.
        Dr. Gottlieb. That's right.
        Ms. DeGette [continuing]. These plants.
        Now, let me just ask you quickly. On Friday, you released a
    statement that said the FDA is monitoring about 50 types of
    medical devices manufactured in Puerto Rico that are critically
    important to patient care, including everything from insulin
    pumps to pacemakers. Is this the same kind of problem that
    we're seeing with the drug manufacturers?
        Dr. Gottlieb. Same challenge. So these are 50 devices that
    we're monitoring, manufactured by 10 different firms. And it's
    a similar challenge. In some cases, the device manufacturing is
    more energy dependent and the facilities themselves need a more
    reliable flow from the grid. So, even as these facilities get
    put back on the grid, if the grid itself is unreliable, they
    might prefer to stay on their generator power for a longer
    period of time. And many of them also are going to want dual
    feeds off the grid. So it could be a while before some of these
    facilities could get the kind of connection to the grid that
    they need.
        Ms. DeGette. Mr. Chairman, let me just say, if anybody has
    any concern this is impacting all American families, my
    daughter, who is a Type 1 diabetic, just got a letter from
    Medtronic last week saying her new insulin pump was not going
    to arrive because of the problems we're having in Puerto Rico.
    So this is impacting every American, not just the Americans in
    the U.S. Virgin Islands and Puerto Rico. Thank you.
        And I'd like to ask unanimous consent to put that New York
    Times article into the record.
        Mr. Griffith. Without objection, so ordered.
        [The information appears at the conclusion of the hearing.]
        Mr. Griffith. I now recognize the vice chairman of the full
    committee, Mr. Barton of Texas, for 5 minutes for questions.
        Mr. Barton. Thank you, Mr. Chairman.
        I want to extend my personal welcome to our newest member,
    Mr. Duncan. He's an outstanding member of the Republican
    baseball team that I manage, like Mr. Costello. And I'm sure
    he'll do just as good, if not a better, job on the committee.
    So we're glad to have you, Jeff, and look forward to a bright
    future with you.
        Mr. Chairman, I appreciate this hearing. I know the primary
    focus is Puerto Rico and the Virgin Islands, but we had a
    hurricane in Texas too. We're a little bit more developed as a
    state, so our ability to endure it was possibly somewhat
    stronger. Having said that, there's still issues in Texas.
        My first question, I think, will be to Mr. Redd. In a
    normal year, there's a lot of mosquitoes in the Houston area.
    But, given the amount of water that was sustained and we still
    haven't had a freeze, so we still have that issue, what
    cooperation, if any, have you and your agency had on helping to
    minimize that problem in the Houston area specifically but the
    Gulf Coast generally?
        Dr. Redd. Yes. We operate as part of the combined Federal
    response here. We've worked with DoD through the FEMA managed
    response system to provide advice on what kind of mosquito
    control efforts would be most appropriate. And we've worked
    with that system. We don't do spraying ourselves, but we
    provide that expertise on mosquitoes.
        Mr. Barton. As far as you know, there's not an issue of not
    enough insecticide?
        Dr. Redd. That's correct. This is a problem that happens
    after virtually every hurricane which has a rain element to it.
    The types of mosquitoes that follow a hurricane typically
    aren't the ones that transmit disease. And there's pretty much
    a standard approach to that with CDC providing technical
    advice, DoD providing the equipment and actually doing the
    spraying in consultation with the local mosquito control
    districts.
        Mr. Barton. Similar question. I guess this would be to Dr.
    Kadlec.
        Is that correct?
        Dr. Kadlec. Yes, sir.
        Mr. Barton. Lots of Medicare patients in the Texas Gulf
    Coast area, and many of them have had to go to hospitals for
    treatment. Under current regulations, does CMS have the
    authority to reimburse these hospitals for the emergency
    treatment of Medicare patients?
        Dr. Kadlec. Sir, since we have a representative from CMS,
    I'll ask Ms. Brandt to maybe respond to that.
        Mr. Barton. Well, that's my fault. I should have directed
    it to her to start with.
        Ms. Brandt. No problem, sir. Thank you.
        We are currently working with state officials to work with
    them on the uncompensated care issues and to develop a plan so
    that we can make sure to appropriately reimburse those
    providers.
        Mr. Barton. Is there anything the State of Texas needs to
    supply CMS to get that put together fairly quickly?
        Ms. Brandt. Currently we are working with the State
    officials to do what's called a multistate 1115 waiver to allow
    them to request Federal matching dollars for an uncompensated
    care pool, and that would be for those people who have been
    displaced or who needed to receive care within the disaster
    area. So we are working with the state and hope to complete
    that in the foreseeable future.
        Mr. Barton. Well, I'm the co-chairman of the Texas
    Congressional Delegation Harvey Task Force. My Democrat co-
    chairman is Henry Cuellar. If there's anything the delegation
    needs to do to assist in that, if you'd let his office or my
    office know, we'll make sure that you get whatever information
    that you want.
        Ms. Brandt. We will certainly do so, and we will keep you
    apprised of that, sir.
        Mr. Barton. Thank you.
        And with that, Mr. Chairman, I yield back.
        Mr. Griffith. The gentleman yields back. Appreciate that.
        I now recognize the chairman of the full committee, Mr.
    Pallone of New Jersey, for 5 minutes for questions.
        Mr. Pallone. Thank you, Mr. Chairman.
        At a recent press event with the Governor of Puerto Rico,
    President Trump said that he would give his administration a 10
    on its response efforts in Puerto Rico. But I have to be honest
    with you, from what I hear from my mayors and council people
    and people that are coming into my district from Puerto Rico, I
    would give at best a 2 on a scale of 1 to 10.
        And my concern is, as I expressed a little bit in my
    opening statement, that this isn't only an issue of what's
    happening on the island, but also the people that are coming to
    the United States that have needs. And I don't think they would
    be coming here if they were able to stay in Puerto Rico.
        Just as an example, I'm looking at the Home News, which is
    my daily in New Brunswick, which is one of my towns in my
    district, and it says that when the Puerto Rican Governor
    visited with President Donald Trump on Thursday to ask for aid,
    he said that without immediate help from the United States to
    rebuild the island there would be a mass exodus to the mainland
    of the United States.
        And then we have a professor at Rutgers, which is in my
    district, who said that the number of Puerto Ricans who will
    move to the Garden State due to the storm will likely spike
    once people determine they can't stay on the island longer if
    power and access to running water, food, and Medicare do not
    improve.
        Now, I obviously would like people to come here if they
    can't get basic necessities on the island. But, I mean, this
    is--you know, the fact that the President would call this a 10
    is absurd, in my opinion.
        So let me start with Dr. Kadlec. Recent reports still
    indicate that nearly 80 percent of the Americans on the island
    are without electricity. One mayor reported that his city's
    ambulances had responded to at least four calls where a patient
    who had lost power for oxygen tanks or ventilators had died.
    Other reports have stated that hospitals have had to take in
    patients from medical centers where generators have failed.
        I'll tell you, when we had Sandy, I think our power was out
    for 2 weeks and it was impossible. I can't imagine going for
    months without power.
        So, Dr. Kadlec, a lack of reliable electricity has created
    serious risks to the health of American citizens in Puerto
    Rico. Would you agree with that?
        Dr. Kadlec. Sir, it's decremented the whole society there.
    So the answer is, yes, it is a risk to people.
        Mr. Pallone. All right. Well, I appreciate your honest
    response.
        Last Friday, CNN reported that a million Americans on the
    island or about 35 percent of all residents still lack access
    to running water. And I understand that without adequate
    drinking water or safe running water to provide basic hygiene,
    affected populations run the risk of serious gastrointestinal
    and related diseases. Again, in Sandy, I think I only went a
    couple days without a shower and I couldn't deal with it.
        So let me ask, I guess, Dr. Redd, would you agree that if
    nearly a million Americans lack access to reliable clean water
    that this poses a major health concern?
        Dr. Redd. Yes, sir.
        Mr. Pallone. All right. Thank you.
        This morning an article in The New York Times described the
    situation in Puerto Rico like going back in time. And WIRED
    Magazine previously reported that the breakdown in electricity
    and telecommunications systems had pushed Puerto Rico ``back a
    century or so.''
        Just yesterday, the FCC reported that nearly 70 percent of
    the island's cellphone towers are still out of service. Again,
    lack of communication, lack of cell towers, you can't even
    address emergencies if you can't communicate.
        So let me go back to Dr. Kadlec. Would you agree that a
    functioning communications system is also an essential
    component to reaching and communicating with Puerto Ricans to
    ensure that healthcare needs are met?
        Dr. Kadlec. Sir, it is. And we've done a lot to basically
    ensure that we have positive communications with those
    hospitals on the island, either by radio, cell communication,
    or landline.
        So we've really worked hard to maintain--we actually
    deployed National Guardsmen with satellite phones initially
    when there was no cell service on the island to ensure that we
    could keep positive contact.
        And to your point about the generators, sir, I think that's
    a fair one. But, quite frankly, sir, we've created a whole
    system to basically address that.
        And, in fact, when I was there the first week after the
    storm, Humacao, one of the hospitals where one of our DMAT
    teams was located, co-located, lost generator power. And they
    had several patients in the intensive care unit, actually a
    couple having surgery at the time, and we were able to transfer
    those patients safely without loss of life not only to our
    shelters where our DMAT teams were, but transport them through
    ambulances, Medevac helicopters.
        Mr. Pallone. Well, I appreciate that.
        Dr. Kadlec. The point is, so that we've gone to
    extraordinary steps to basically help----
        Mr. Pallone. All right. Well, I appreciate it.
        Let me just issue one thing as my time runs out. The
    President said it's a 10. I gave it a 2. Would you give me a
    number between 1 and 10?
        Dr. Kadlec. I'm not in the business to give you marks, but
    I can tell you we're working 110 percent even today to help
    those people, help our fellow Americans on that island.
        Mr. Pallone. I appreciate that.
        Thank you, Mr. Chairman.
        Mr. Griffith. Thank you so much.
        I now recognize the gentlelady of Indiana, Mrs. Brooks, for
    5 minutes for questions.
        Mrs. Brooks. Thank you, Mr. Chairman.
        And thank you to all of our panel members for being here.
        Dr. Kadlec, I want to talk a little bit more about the
    National Disaster Medical System that you've described. And I
    know you've only been on the job for a few months now. In fact,
    how many months have you been on the job?
        Dr. Kadlec. Sixty days.
        Mrs. Brooks. Sixty days. Tough first 60 days.
        Dr. Kadlec. It has been a baptism.
        Mrs. Brooks. And obviously you were very familiar with the
    organization prior to becoming in charge of ASPR. Are there
    reforms to the National Disaster Medical System that you're
    already considering, or are there challenges you've already
    faced, whether it's on the deployment, whether it is on the
    number of resources you have or the authorities you have? And
    if so, what are they?
        Dr. Kadlec. Ma'am, all the above. I think one of the things
    that this event demonstrated, because of the extraordinary
    nature, and to Representative DeGette's point, to go down there
    and actually see the devastation is pretty extraordinary. I've
    made five combat tours in Iraq, and I never saw anything like
    what I saw in Puerto Rico, number one.
        Number two is, that would kind of simulate what we'd
    probably expect if we had a nuclear detonation without the fire
    or the radiation. So the physical destruction to that island,
    as I said, affected everyone, and the psychological and
    physiological effects are pretty extraordinary.
        To that point, we were stretched in terms of our DMAT
    capabilities or NDMS capabilities to deploy. I give a lot of
    credit to those DMAT physicians, nurses, paramedics,
    pharmacists from your states who basically deployed down there
    on numerous occasions. We had people from Colorado who were at
    Harvey, Irma, and now Maria.
        And so the answer is, is that we probably need to do some
    creative thinking how to do that. We worked very well with the
    VA in Puerto Rico. We need to probably work better with DoD on
    that.
        But I think there are a lot of things we need to do to
    remove dependencies that require us to basically do ``Mother,
    May I'''s for transportation. We probably need a larger supply
    capability. And we need to move things faster and better.
        That said, we deployed before landfall, we had 150 people
    from our DMAT teams in San Juan riding out that storm. So we
    have extraordinary people doing extraordinary things. They're
    from your jurisdictions. They're American heroes. And we
    probably don't give them enough credit, and we certainly don't
    give them enough resources.
        Mrs. Brooks. And, Dr. Kadlec, with respect to the
    authorities of ASPR, has it been clear as to who is actually in
    charge of the response efforts, or do there need to be
    additional operational capabilities provided to ASPR?
        Dr. Kadlec. Ma'am, I think that's something that we're
    going to do an after-action and look at that. I'd like to say
    we were able to do pretty well. I think we can do better. But
    I'd like to hold an answer on that to work with your staff to
    identify those things. Again, to remove those dependencies, the
    ``Mother, May I'''s for ambulances, for air transportation, for
    a variety of things, are things that we need to resolve.
        Mrs. Brooks. Thank you.
        Ms. Brandt--and, again, I have some questions also provided
    by Representative Gonzalez--apparently, prior to the hurricane,
    retention of medical personnel has been a challenge to Puerto
    Rico. And so prior to Hurricane Maria, according to my
    colleague, almost a physician a day would leave the island,
    would not be practicing there, and it affected a number of
    specialists left in the territory. How is that impacting the
    short-term and long-term recovery efforts?
        And I actually received communication from a constituent of
    mine whose cousin was a specialist overseas at the time that it
    hit, and she had difficulties getting back on to the island to
    help her people.
        And so what is CMS doing relative to the physician
    retention issue?
        Ms. Brandt. Thank you for the question, and that is
    something that CMS is very concerned about and very aware of.
        In terms of the retention issue, we've been working with
    the Department of Health on the island and seeing what
    flexibilities we can do administratively to be able to lift any
    requirements that would make it easier for people to stay on
    the island or to work with them, to see what other types of
    programs that we have that would provide incentives for
    physicians and other medical personnel on the island. But
    ultimately that is a decision by the government of the island.
        In terms of allowing people to come in to assist with the
    efforts on the island, especially in wake of what has happened,
    we have waived many different regulations and other authorities
    that we have that would have limited out-of-state--or out-of-
    territory in this particular instance--providers to be able to
    come in and provide care, and have been working with the
    Department of Health on the island to see what else we can do
    to ensure that they have as much access to as many personnel as
    we can get them.
        Mrs. Brooks. Thank you for that flexibility.
        My time is up. I yield back.
        Mr. Griffith. I thank the gentlelady.
        I now recognize the gentlelady of Florida, Ms. Castor, 5
    minutes for questions.
        Ms. Castor. Thank you, Mr. Chairman.
        Over a month later, folks in Florida and all across the
    country are still reeling from the avoidable deaths in the
    nursing facilities in Florida. There are now criminal cases.
    There are civil cases. We're trying to figure out why in the
    heck Florida's governor has deleted voicemails that came
    directly from the center to his cellphone.
        But there's an important backstory here. In 2005, after
    Hurricane Katrina and the 215 deaths in nursing homes there,
    CMS and everyone determined, well, many skilled nursing centers
    are not prepared. So you went into rural development then to
    try to ensure that there is going to be an alternative power
    source available. I understand that it will be November when a
    CMS rule relating to alternative power sources for skilled
    nursing centers will come into being, will become effective.
        Why has it taken so long? And are you confident that it
    will do what we need to do?
        And I want to recognize my colleague, Congresswoman
    Wasserman Schultz from south Florida, and thank Congresswoman
    Wilson and the Florida delegation that has been pressing this
    issue as well.
        Ms. Brandt. Well, first of all, let me just state that from
    CMS's perspective, we share everyone's concern about the
    tragedy that happened at Hollywood Hills. That's an event that
    should not have occurred. And from a CMS perspective, our first
    and ultimate priority is ensuring that we have patient safety
    and patient protection at every one of the facilities that
    accepts Medicare and Medicaid beneficiaries.
        With respect to the rule itself, to clarify, the rule went
    into effect last year. We will begin serving against it in this
    November. So the rule actually went into effect last year, it's
    just that the actual surveys against it will go into effect
    starting next month.
        However, it is something that we think does go a long way
    toward addressing a lot of the concerns that have been raised
    by Hollywood Hills. But in light of the event there, we want to
    continue to look at it to see if we could do more.
        But some of the things it does that were pointed out as
    part of the problem at Hollywood Hills are ensuring that there
    is an emergency preparedness plan at every facility, ensuring
    that every facility has adequate backup supplies, such as
    generators and others, to be able to provide that there's a
    temperature between 71 to 81 degrees within the facility and
    that it doesn't go beyond that.
        We also are working to make sure that the appropriate staff
    are trained so they know what to do in the case of an
    emergency. Based on the reports that I've read of the incident
    at Hollywood Hills, several of the failings that led to the
    unfortunate set of circumstances were that the personnel did
    not respond to the emergency preparedness plan. The personnel
    were not adequately trained on the plan, and they weren't able
    to take steps accordingly. And those are things that we are
    going to be working with to ensure that, as I said, we survey
    people going forward, starting in November, that that's
    happening.
        Ms. Castor. Thank you. And I encourage you to do that on an
    expeditious basis because that timeframe is not acceptable.
        And, Ms. Brandt, health services provided under Medicaid
    play a critical role in how quickly families are able to
    recover from natural disasters. Following Katrina, the Bush
    administration took a number of actions to ease barriers to
    health insurance coverage through Medicaid. For example, CMS
    allowed for a temporary expansion of Medicaid eligibility in
    affected areas, a moratorium on eligibility redetermination,
    self-attestation of all Medicaid eligibility factors, and
    various waivers. And Congress in the Deficit Reduction Act
    acted to ensure that states were fully reimbursed at 100
    percent FMAP.
        Does CMS intend to take similar actions in response to
    Harvey, Irma, and Maria? What exactly, and what, if any,
    difference will there be between Puerto Rico and the U.S.
    Virgin Islands and the states and the mainland?
        Ms. Brandt. So multiple parts to the question.
        So with respect to the self-attestation in the eligibility
    requirements, we have already put in place all of those same
    flexibilities that were in place for Katrina to allow it, so
    that people have the flexibilities to self-attest, if they
    don't have their appropriate documentation, if it was lost in
    the floods or the winds or any of the other natural disasters.
    So that is already taking place.
        With respect to the uncompensated care pools that you
    mentioned, that is something that we're working with the Office
    of Management and Budget to work with Congress on because that
    is something that only Congress can address from a funding
    perspective.
        And then, with respect to how the states are treated
    differently than the territories with respect to that, we've
    basically been holding them all to having the same amount of
    waivers and the same amount of flexibilities across the board.
    But one of the things that we are watching is, as has been
    mentioned, the number of people leaving Puerto Rico and going
    to the states and making sure that we're working with the
    states that they're going to, to make sure those states are
    compensated for the care that they're providing to those
    evacuees.
        Ms. Castor. Good. I'll look forward to working with you
    more on it.
        And thank you to the panel.
        Mr. Griffith. Thank you very much.
        I now recognize the gentleman from Michigan, Mr. Walberg, 5
    minutes.
        Mr. Walberg. Thank you, Mr. Chairman.
        Thanks to the panel for being here.
        I have a few questions as well that Congressman Jennifer
    Gonzalez-Colon has asked to address, and they're important,
    because I think they address some concerns now, but even for
    future consideration.
        The first, would it be beneficial to postpone the Medicare
    Advantage enrollment period to January of 2018--I ask this of
    Ms. Brandt--given that 80 percent of the population is without
    electricity and telecommunications remains largely down
    throughout the island? What would be your answer to that?
        Ms. Brandt. We have been working to establish a special
    enrollment period for the citizens of Puerto Rico so that they
    have flexibility because we recognize that many of them may
    have trouble meeting the current enrollment period.
        Mr. Walberg. OK. So that is viable with that?
        Ms. Brandt. Yes.
        Mr. Walberg. OK. How are you ensuring that Puerto Rico has
    the medicine it needs?
        Ms. Brandt. On that one, I would defer to Dr. Kadlec
    because that's more of a supply chain issue. We simply pay for
    the prescriptions.
        Mr. Walberg. OK.
        Mr. Kadlec.
        Dr. Kadlec. So there have been several approaches to
    basically address medicines on the island. Probably the most
    important thing we did with the principal medical supplier on
    the island was provide them fuel to maintain their generator so
    they could keep refrigerated products and basically maintain
    their supply chain as well as making sure their trucks had gas
    to deliver it.
        We've also been monitoring the availability or the
    functionality of pharmacies. There are over 700 pharmacies on
    the island; 92 percent, 93 percent of them are open at the
    present time.
        We have worked with mainland distributors of temperature-
    sensitive items to ensure that they can basically push in
    there. Insulin is a very big one that we've worked with people
    as well as with the major transporters of materials in to make
    sure that those issues are--materials are prioritized.
        I'd also turn to Dr. Gottlieb because his agency has been
    very influential as well as working with mainland suppliers to
    bring in products. But we've been working at a variety of
    different ways.
        Our DMAT teams have caches that they take and provide
    pharmaceutical resupply to not only hospitals, to patients they
    see anywhere. We've done tailgate medicine where we've actually
    gone into areas that are rural, remote, and have been cut off.
    Done so by helicopter and altering vehicles to ensure that we
    can deliver medicines to people who need them.
        So we've gone through a variety of different lengths, some
    very straightforward and some pretty exotic to do so, but we've
    tried to meet whatever need is out there.
        Mr. Walberg. OK.
        Commissioner Gottlieb, could you respond to that as well,
    especially in context with the power problems and how we're
    keeping up with the pharmaceuticals?
        Dr. Gottlieb. The point that I'd add to the comments is
    just that there's a number of facilities that manufacture
    largely and predominantly for the island of Puerto Rico on
    Puerto Rico and we've prioritized those facilities.
        So in terms of how we've thought about our mission, we have
    prioritized manufacturers who supply critical products to the
    people of Puerto Rico. So there are some local manufacturers
    that, for example, provide sterilization services to the
    hospitals that fall within FDA's regulatory scope. And so early
    on we worked to prioritize getting those back online.
        Mr. Walberg. Mr. Gottlieb, one more question. It's been
    reported that medical oxygen production and access continues to
    be a challenge in Puerto Rico. Could you please update the
    committee both on the actions the FDA is taking to ensure that
    all patients and facilities that require oxygen are able to
    receive it as well, as the agency's actions to guard against a
    potential shortage of medical oxygen?
        Dr. Gottlieb. Yes, we've worked with our partners at HHS.
    I'm going to defer to them on this because they've played a
    more active role directly with these facilities.
        Dr. Kadlec. Sir, there are two principal suppliers of
    oxygen on the island. Both of them are back operational on the
    grid right now. There was a smaller supplier and then a very
    large supplier of oxygen, and they both suffered loss of
    electricity in the immediate aftermath of the storm.
        Again, barging in oxygen cylinders, it's not something you
    can fly in necessarily. But oxygen is not the only gas that's
    needed. CO2, nitrogen, argon, are all medical gases
    that are needed by manufacturers as well as the clinics out
    there.
        So we basically have been trying to move what we could. The
    USS Comfort, which is floating around the island on the western
    side, can produce oxygen. And so we were actually filling
    cylinders of oxygen using the Comfort's capabilities to
    basically provide that, as well as bring in liquid oxygen
    generators so that we could actually provide temporary filling.
        So right now I think we're on the right side of the oxygen
    problem. Both facilities are operational. And I think the
    supply should be sufficient as we go over time as the capacity
    and particularly the larger manufacturer comes full steam.
        Dr. Gottlieb. Just to build on that, I'll tell you there's
    a number of medical product manufacturers who use oxygen and
    nitrogen in their manufacturing processes. They've been able to
    secure the supply they need. In a few instances, historically,
    we had to prioritize getting some of those supplies onto the
    island or from the island.
        But in most cases they're sourcing that outside the island.
    That seems to be stable right now. We've moved past what I
    think is the critical phase of trying to work through this.
    Most of the facilities that need access to medical gases for
    their manufacturing processes are getting them now.
        Mr. Walberg. Thank you. I yield back.
        Mr. Griffith. I thank the gentleman.
        I now recognize the gentleman from California, Dr. Ruiz,
    for 5 minutes.
        Mr. Ruiz. Thank you, Mr. Chairman, for holding this
    hearing.
        By way of background, I'm a board certified emergency
    physician. I was trained by the Harvard Humanitarian Initiative
    on humanitarian disaster aid, including the International
    Committee of the Red Cross.
        And I was one of the first responders after the earthquake
    in Haiti and the medical director for the largest internally
    displaced camp in all of Port-au-Prince after that earthquake
    and worked hand in hand with the 82nd Airborne.
        I have seen firsthand the challenges that arise in the
    middle of a humanitarian crisis and the importance of having
    clarity and a plan and have clarity in coordinating among
    agencies, local government officials, and NGOs in the field.
        So while I am grateful that we are having a hearing on this
    issue with HHS, we need a fuller, more accurate view of what is
    happening in Puerto Rico with all stakeholders from all levels
    of government and all the different agencies, including
    clinical workers and NGOs and people that are actually on the
    field.
        Two weeks ago, I flew down to Puerto Rico to see the
    conditions for myself and do a needs assessment based on my
    training and my experience. I'm here to report to you what I
    saw and give you some helpful recommendations.
        One, the people of Puerto Rico are very hardworking, humble
    people with respect for themselves and their dignity, and
    they're doing everything possible to help one another, to get
    the job done, to take care of one another.
        Number two, the people who work in your agencies are giving
    110 percent. I have to give kudos to the DMAT teams that I
    spoke with firsthand. California 11 from Orange County and
    Sacramento did fabulous jobs. The HHS liaison was there doing
    an amazing job.
        I went further into the community and did not stay in San
    Juan and listen just to leaders. I listened to pediatricians on
    the ground, shelter coordinators, patients that were on the
    ground. And what I can tell you, these are the problems.
        One, there's a lack of clarity of leadership. I'm talking
    to high-level officials from all the different agencies, and
    I'm not going to mention names, but the folks in the Puerto
    Rican Government are saying that FEMA is running the show.
    People at FEMA are saying that we're taking orders from the
    Puerto Rican Government. I talked to people from HHS, and
    they're saying, we don't communicate very much with the needs
    with the DoD. And so there's a lack of clarity with who's
    actually running the show in Puerto Rico.
        Two, there's a lack of coordination. You're not going to
    get the full picture, folks, if you stay in San Juan. You're
    not going to get the full picture if your leadership and people
    making decisions are based in San Juan in a convention center
    with air conditioning and food and drinks and everything.
    You've got to get your butts out of San Juan into the remotest
    areas in Puerto Rico to talk to people and see firsthand.
        So the problem is that there's a lack of priorities and
    clarity in the metrics that you're using and what you're
    telling the American people what your efforts are.
        What does it mean when you say that bottles and food were
    delivered to all municipalities for PR purposes so that people
    get a sense that you're doing your job, when, in fact, what you
    should be talking about is capacity for food supply chains,
    capacity for electrical grid repairs, capacity to deal with the
    need?
        All of you have mentioned numbers and the numerators and
    the number of clinics and the number of people on the ground.
    But what you haven't mentioned is a denominator, the actual
    need. So of your hospital capacity, what is the capacity to the
    overall need that the people on the ground actually need?
        So this is my one recommendation. And I strongly agree that
    you will be able to better handle the situation on the ground
    with a lot more sense of urgency and realtime flexibility.
        Yes, keep your command center in San Juan, but create
    command posts on the ground with representatives from the HHS,
    the Army Corps of Engineers, the DoD, Department of Housing,
    Department of Homeland Security with FEMA, the representatives
    from the local grid, Federal and state counterpart, including
    NGOs and local mayors, so they can have daily briefing and
    problem solving as they arise on the ground.
        Let me give you an example. I went to one clinic. They had
    a generator fixed by FEMA. The local clinic didn't know that
    that generator that FEMA installed went down. They were without
    power for 2 days turning patients away. They didn't have a
    number to call the Army Corps of Engineers to determine whether
    they were on the queue.
        I went to a temporary shelter at a local school in one of
    the communities. They were going to close their doors on
    October 23 when school starts. The mothers tell me their
    children needed bottled water. There is a Department of Defense
    Army guy saying, ``Doc, we have a caseload of bottles, can we
    get authority to move them down?'' Hell, yes.
        So having command posts on the ground in every municipality
    where NGOs, local mayors, and everybody can hold each other
    accountable to address needs and realtime actions and cut the
    ``Mother, May I'''s, like you suggest, Dr. Kadlec, and just get
    the food and get the transportation, get the medicines that
    people need in realtime, addressing problems realtime, is what
    the people of Puerto Rico need, and there's a lack of sense of
    urgency when we talk about these issues.
        Your folks on the ground are doing an incredible job, but
    the urgency to meet the needs of 3.4 million people, water,
    food supply chain, electrical grids, those are your top three
    priorities to prevent unnecessary loss of life of Americans on
    the island.
        I feel very passionate about this because I took care of a
    woman who in front of me in a shelter had a seizure. I
    protected her airway. I tried to get her to emergency care.
    There was no oxygen. There was no medicine at this temporary
    shelter. We need to do a better job on the ground coordinating
    with different agencies so that we can save more lives and do
    what all your mandates are about to do.
        So I thank the people on the ground. They're incredible,
    incredible workers.
        Mr. Griffith. And we appreciate your passion.
        Mr. Ruiz. And I look forward to working with you more to
    make sure that we have command posts out in the field.
        Mr. Griffith. And we appreciate your passion and agree that
    we probably ought to get down there and get out and see things,
    and appreciate you and Dr. Burgess having both visited down
    there, and look forward to your input as the committee works
    further on these issues.
        I now turn to Mr. Costello of Pennsylvania for 5 minutes
    for questions.
        Mr. Costello. Thank you, Mr. Chairman.
        Dr. Kadlec, in your written testimony you mentioned that
    Puerto Rico faced public health and public health
    infrastructure challenges prior to Hurricane Maria's arrival,
    which exacerbated the hurricane's effects. Could you describe
    what some of these challenges were and how they adversely
    impacted the public health response efforts?
        Dr. Kadlec. Well, sir, I mean, I'd just make a quick
    comment. Remember that Puerto Rico sustained two hurricanes,
    not one. So the first, Hurricane Irma, took a wallop, again, on
    the northern side of the island where a lot of their public
    health infrastructure is, laboratories. I'll have to defer to
    Admiral Redd to talk more about some of the particulars there.
    But remember that there were two events on Puerto Rico, not
    one, and that was the challenge right there from the get-go.
        Admiral Redd.
        Dr. Redd. Thanks.
        I think that the nature of the event really is what
    stressed the system so much that it was so destructive. I think
    also some of the things that have been talked about earlier,
    about the migration of physicians and the overall waning of the
    number of providers, is really a risk factor for damage to the
    public health system.
        Mr. Costello. So are you saying that the infrastructure was
    sufficient and that even if the infrastructure was more
    improved than the condition that it was in, it wouldn't have
    mattered because the storm was so devastating?
        Dr. Redd. Well, I think whatever amount of destruction you
    sustain, it is changed from what you had before. So a stronger
    system before an event would mean you'd have a stronger system
    afterward. It wasn't 100 percent destruction. But the----
        Mr. Costello. I guess what I think I'm trying to drive at--
    I didn't mean to cut you off--was what kind of infrastructure
    improvements are necessary to make moving forward so that maybe
    a storm of lesser destructive magnitude, but still nevertheless
    damaging, there be a better response--there would be the
    ability to have a better response because better infrastructure
    was in place?
        Dr. Redd. Sure. Well, I think that some of the instances of
    damage, for example, if the laboratory had been constructed in
    such a way that it wouldn't have sustained as severe damage, if
    there had been a generator capability there that could have
    been stood up more quickly than what's going on now, those are
    the kinds of things that would have been able to bring the
    system back online more quickly.
        Mr. Costello. Could I ask you to supplement your answer in
    writing with any additional type of infrastructure elements?
        Dr. Redd. Sure. Happy to do so.
        Mr. Costello. Thank you.
        Dr. Kadlec, can you elaborate on how some of the lessons
    learned from previous natural disasters, such as Hurricane
    Katrina, improved HHS' response to the recent series of storms?
    And see, I just said series of storms, so it was more than one.
        Dr. Kadlec. Thank you, sir.
        I think one of the things from Katrina was basically unity
    of effort. To capitalize on Dr. Ruiz's comments earlier, one of
    the things that created the ASPR was the idea of a fragmented
    medical response.
        And so while I can't dispute the issues of field command
    posts, I can just say certainly and with great authority that
    throughout our efforts we were trying to work very closely not
    only with the Department of Health in Puerto Rico, which kind
    of sets the requirements for what they need that we try to
    service and satisfy, but working across not only the Department
    of Health and Human Services, as we show here our solidarity
    with CDC, FDA, and CMS, and other entities within HHS, but
    across the Federal Government with VA and DoD.
        So the uniqueness of that is displayed in Puerto Rico that
    wasn't displayed in Katrina where you had Veterans Affairs
    clinics and hospitals basically providing for not only veterans
    and their families, which is not typical, but also the general
    population, and doing so with combined DMAT assistance with our
    National Disaster Medical Service teams.
        So that just gives you a flavor of that. I think the other
    part of it is, is the lessons learned, that we saw it in Texas
    and we saw it in Florida that there are hospital preparedness
    grants, these grants that basically help hospitals prepare.
    First it was initially for hospitals, then it was coalitions of
    hospitals, that basically were able to demonstrate
    communications and capabilities within those coalitions that
    made them more sufficient and resilient to these effects.
        I'll give you an example, one in particular, which is
    pretty extraordinary, which is in Houston with Ben Taub
    Hospital, which, if you recall back several years ago, there
    were very bad floods, I think 2008 in Houston, that basically
    flooded out a lot of the hospital infrastructure in downtown
    Houston.
        Well, they took hospital preparedness grants that you
    authorized and appropriated against and basically ensured that
    they could not only withstand flooding, as they did, they
    developed water-tight doors to basically prevent that, but also
    a whole set of procedures and communications, that they could
    continue operations despite hurricanes, despite floods.
        And that was not only the case in Houston, but in Beaumont,
    Texas, where some of those same grants basically made sure that
    the hospital personnel had waders so they could go recover
    patients from the Cajun Navy that went out there to recover
    patients.
        So there are a lot of great lessons learned in this. One
    thing is about the capacity of Americans to not only help, but
    to volunteer, as we are witnessing in Puerto Rico right now.
    But the idea is that we're going to do a little bit more of a
    formal one to take advantage of these terrible events to see
    what we can do better.
        Mr. Costello. Thank you. And such a thorough response that
    you actually answered the question that I didn't get to ask as
    part of the answer to that question.
        Could I just ask you to supplement in writing any
    additional lessons learned, not an admission that you didn't do
    anything right, but sort of consistent with Congressman Ruiz's
    comments relative to what moving forward can be done in order
    to improve the next time a tragedy like this might occur so
    that we're better prepared. Because that's what we all want to
    do, be better.
        Dr. Kadlec. Sir, be happy to.
        Mr. Griffith. I thank the gentleman.
        And I now will recognize Ms. Schakowsky of Illinois for 5
    minutes for questions.
        Ms. Schakowsky. Thank you very much.
        Fourteen people died at the rehabilitation center in
    Hollywood Hills in Florida when it lost power and overheated
    from September 11 to September 13.
        Ms. Brandt, as seniors went into distress, workers
    struggled to provide 911 with basic information, including the
    address. It was also reported that the same facility had
    previously laid off hundreds of workers, including nurses.
        The nursing home stated that it employs ``full-time and
    part-time employees,'' but did not state if a nurse was present
    when those patients went into cardiac arrest.
        You could give me yes or no to these simple questions--did
    CMS find that there was a nurse onsite at this nursing facility
    from the 11th of September to the 13th?
        Ms. Brandt. We have a full report on that, Madam
    Congresswoman, which I'd be glad to get you. I don't know the
    specifics of if there was specifically a nurse. I can't answer
    that.
        Ms. Schakowsky. Is a nurse required to be present in a
    nursing home?
        Ms. Brandt. We have conditions of participation which
    require clinical staff to be present.
        Ms. Schakowsky. And are the requirements for nursing home
    disaster preparedness plans, is that a requirement?
        Ms. Brandt. That is a requirement, yes.
        Ms. Schakowsky. And were they followed?
        Ms. Brandt. According to the report that we got from our
    state facilities, they were not followed in this instance, and
    that is why the facility has been terminated from accepting
    Medicare and Medicaid patients.
        Ms. Schakowsky. So that's the consequence?
        Ms. Brandt. That is the consequence.
        Ms. Schakowsky. OK.
        I wanted to talk to Dr. Kadlec about the hospitals. A week
    after Hurricane Maria, HHS told the committee staff that most
    hospitals were damaged, faced major challenges in getting food,
    water. We've talked about that. And then, of course, more than
    a month after Hurricane Maria, Slate reported that surgery is
    being done by cellphone flashlight. There's pictures that show
    that, so, I guess, it's pretty well documented.
        And so what I wanted to know is do hospitals connected to
    the electric grid have access to the full regular power, or is
    it only being provided intermittently?
        Dr. Kadlec. Ma'am, it depends where those hospitals are.
    There have been some issues with reliability. I would have to
    turn you over to the U.S. Army Corps of Engineers to talk about
    what specific areas----
        Ms. Schakowsky. OK. So when you say all hospitals now are
    corrected to the grid, that doesn't mean that----
        Dr. Kadlec. No, ma'am. There's only 60 percent of the
    hospitals that are connected to the grid currently as of today.
        Ms. Schakowsky. And the others, are they operating on----
        Dr. Kadlec. They're operating on generators. And we're
    basically working with FEMA to actually have what we call N-
    plus-one, where they have two backup generators--they have a
    generator, a principal generator and a backup, so that if they
    need to switch, if the generator fails, they can go immediately
    to the next one. And, again, the plan is, is to basically have
    a 911 FEMA generator repair team to come out and fix the
    primary generator.
        Ms. Schakowsky. But as a consequence of all this, you would
    say that there is not 24/7 power at what percent of the
    hospitals?
        Dr. Kadlec. Well, 60 percent right now are on the grid,
    which would have regular power, and even then sometimes there's
    some reliability issues as it relates to transmission wires and
    distribution, that I have very little understanding of because
    I did very badly in electrical engineering. But I think the
    point is, is that there are hospitals out there that are on the
    grid and even those hospitals have generator backups.
        Ms. Schakowsky. OK. I wanted to turn for a minute to the
    Virgin Islands, Dr. Kadlec. I understand that Hurricane Maria
    tore the roofs off of the two largest hospitals in St. Croix
    and St. Thomas. So what is HHS doing to ensure that Americans
    in the Virgin Islands are receiving the healthcare that they
    need?
        Dr. Kadlec. Ma'am, immediately after the storms passed,
    both Irma and Maria had effects on both St. Thomas and St.
    Croix, where the hospitals are located. And then with the
    passing of those storms, the initial storm Irma, we basically
    just set up a DMAT team with its temporary shelter there. And
    that was replaced with a more capable Army support clearing
    medical station, which is a 40-bed mini-hospital that's there.
        And now we're in the midst of basically deploying a western
    shelter assembly so that would allow the physicians and nurses
    and healthcare practitioners on the Virgin Islands to go back
    to work and take care of their patients while the hospitals are
    being assessed by the Army Corps of Engineers to either be
    repaired or replaced. I think in the case of St. Thomas it's
    going to need to be replaced.
        So we've provided immediate care, we're providing the
    intermediate support, and then we're basically transitioning to
    a capability that would allow the healthcare workers on the
    Virgin Islands to go back to work, and then with that give time
    to basically repair or replace those hospitals.
        Ms. Schakowsky. Thank you. I yield back.
        Mr. Griffith. I thank the gentlelady.
        I now recognize Mr. Collins of New York for 5 minutes for
    questions.
        Mr. Collins. Thank you, Mr. Chairman.
        Thank you, all the witnesses, for coming.
        So, Dr. Kadlec, while we're operating the hospitals under
    generator power and the like, as people are being transitioned
    out of the hospitals, in many cases, in fact probably in most
    cases, the residents don't have power at home and they don't
    have running water.
        Could you perhaps explain what's going on relative to these
    patients leaving? And how are you and others now dealing with
    the fact that they're moving into an environment without power,
    and in many cases without running water?
        Dr. Kadlec. Sir, just to highlight a comment made earlier
    by Admiral Redd, there are six Federal medical stations that
    have been deployed to Puerto Rico. At the present time two are
    operational, two 250-bed facilities that are being staffed by
    VA workers as well as volunteers.
        In one case, from the Greater New York Hospital
    Association, a great example of a combined effort between our
    Federal and volunteer partners that are basically providing
    those kind of transition places for people who need additional
    medical support or care, don't need to be in the hospital but
    can't get home, go home for whatever reason. So we've set up
    those and have more in position as required to do so.
        Mr. Collins. Well, that's reassuring that you're basically
    assessing patients one by one to make sure that when they're
    released they're getting the care they need.
        Dr. Kadlec. Yes, sir.
        Mr. Collins. Another question, again back to the individual
    situations, is the report that the pharmacies are asking for
    cash payments because of a lack of ability to connect into
    insurance companies and the like. Yet, in many cases, the folks
    needing prescriptions filled don't have that cash.
        So whether the question should go to you or Dr. Gottlieb,
    how are we handling what at least has been reported?
        Dr. Kadlec. So in Puerto Rico there's a program called the
    Emergency Pharmacy Assistance Program, which provides free
    medications to individuals who can't pay for it. So that's been
    invoked so that people who don't have cash, would need
    medicines, can get it. That's one way.
        The other way is if they were to go to one of our DMAT
    facilities that are colocated in seven of the regions in Puerto
    Rico. They can get medicines from there as well. We'd provide
    prescriptions or medications as required.
        Mr. Collins. That's reassuring as well.
        Now, in some cases someone that's been on prescriptions,
    I'm assuming there's some difficulty even in a pharmacy
    contacting the physician's office. I know if I go to fill one
    and it's expired, they say, ``OK, we'll contact the physician.
    We'll get back to you.'' But, again, because of the lack of
    infrastructure, how is that being handled?
        Dr. Kadlec. Well, not only medicine but prescriptions are
    being basically filled out for people who seek them out. They
    have to basically present themselves either to one of our DMAT
    teams or military facilities or VA facilities and they will get
    a prescription, if not the medication itself.
        Mr. Collins. Again, I appreciate this is--you're basically
    taking what I would call a one-by-one-by-one approach, every
    situation is somewhat different, but I'm getting comfortable
    that you're taking care of people as best we can, given the
    limited infrastructure and in some cases doing things in an
    unusual way.
        Dr. Kadlec. Yes, sir.
        Mr. Collins. So, Dr. Gottlieb, Representative Gonzalez has
    asked me to ask you, on the FDA issue related to food and
    agriculture, what would be your overall assessment? And are
    there cases where the FDA is granting waivers and things of
    that sort, understanding it's not business as usual at all?
        Dr. Gottlieb. Thanks for the question, Congressman.
        We would typically grant waivers, for example, if crops
    that were damaged in a hurricane, if the producer was looking
    to divert crops intended for human consumption into animal
    feed. And we do process those waivers.
        In terms of what we're doing right now, we've already
    conducted, I believe, 20 not inspections, but site visits to
    various agricultural facilities and food production facilities
    to help them get back online.
        We've done this in the last week or so, even as our own
    employees down there have been devastated by the hurricane. We
    have about 100 employees on the island. We've conducted a total
    of, I believe, about 36 right now inspections of various
    medical product facilities and food production facilities to
    help them get back into production.
        Mr. Collins. Well, I want to thank you.
        And, Mr. Chairman, I'll yield back, but I guess I need to
    say, I'm really happy to hear of the response that we have in
    Puerto Rico given the fact that the island was devastated. It
    is an island nation. And while it's always easy to criticize
    response, what I'm hearing is a lot of actions have been taken
    one by one to make sure people are getting the services they
    need. We can't snap our fingers and rebuild an electric grid
    overnight, but everything I'm hearing is.
        And I would disagree with the member that was going to give
    them a 2 on a scale of 1 to 10. I also don't like to give
    grades, but I think that's a bit harsh, considering the
    devastation that the island withstood and the fact we've never
    seen anything like this before.
        So, again, I want to thank all four witnesses for coming
    here today. And I certainly am leaving today feeling much more
    comfortable about what's being done to take care of the tragedy
    that did occur on Puerto Rico.
        I yield back.
        Mr. Griffith. I thank the gentleman.
        I now recognize the gentleman from California, Mr. Peters,
    for 5 minutes for questions.
        Mr. Peters. Thank you, Mr. Chairman.
        When you get down at the end like this, a lot of questions
    have been asked already. So I wanted to ask you an open-ended
    kind of question from a perspective of prevention.
        So I think a lot about what we might do with respect to
    preparing communities to deal with earthquakes or fires or
    floods. But from a health perspective, I haven't really given
    that much thought. Do you have any thoughts about what you
    would have liked to have seen the Federal Government do or
    Puerto Rico do before this that would have mitigated the need
    to respond to the extent that we had? Anybody?
        Dr. Kadlec. So I would just comment that in all the three
    hurricanes, the major ones, Harvey, Irma, and Maria, that we
    were very aggressive in deploying our assets--people,
    capabilities, logistics--as far forward as we could safely in
    the case of Puerto Rico, actually putting people in harm's way
    to be there when things happened.
        You can never anticipate how things will unfold. And
    particularly Florida, if you recall, the turn of Irma that went
    from the east coast to the west coast, thankfully, and then
    that kind of deceleration of the storm just before it hit
    Tampa. That's a little bit of good luck. You can't always count
    on that.
        But I think one of the things that comes out of this is the
    importance for community resilience, individual resilience.
    Those are things that somehow, again, are not necessarily the
    domain of HHS, but I think FEMA and Department of Homeland
    Security often use October as preparedness month and ask people
    to see if they have a plan, if they have supplies, if they have
    the necessary things at home.
        I think these events highlight that element, that
    individual preparedness. No matter how good we may be, it's
    always going to be a circumstance that we may not be able to
    get to you immediately and you're going to have to provide for
    yourself and your family in the immediate term.
        Mr. Peters. From your perspective, though, so as the health
    agencies, including CDC, do you feel like you have input into
    what is the content of the outreach that's happening around
    October to tell people how to be ready, from your perspective?
        Dr. Kadlec. I'll have to defer to Admiral Redd to talk
    about CDC, but we do participate in these kind of interagency
    conversations. But, again, if you just wonder what kind of
    messaging you need, I think as we look to the threats of the
    21st century and my role in preparedness and response, the
    circumstances that we found ourselves in after 9/11 are clearly
    different today. The circumstances that we find ourselves in
    when this position, my position was created in 2006 are
    different today than they were then. And so I think the thing
    is, is part of it is keeping up with the rapidly changing
    threat environment.
        Mr. Peters. That is the premise of my question. My question
    is, are we keeping up with it? Is there something we need to be
    doing? Is there something reflecting back on?
        Dr. Kadlec. I'm going to take advantage of an opportunity
    to point out that the Pandemic and All Hazards Preparedness Act
    will be reauthorized hopefully in the spring of 2018, and I
    believe there should be things that reflect that changed threat
    environment.
        I think Mrs. Brooks mentioned the issue about the structure
    of the National Disaster Medical System. I've called for the
    idea of a national disaster healthcare system that would be
    basically built potentially on what has been proposed with the
    national trauma system to basically ensure that we have the
    capabilities the country needs to face whatever the threats may
    be in the future, whether they're natural or manmade.
        Mr. Peters. Right. Thank you.
        Let me turn to the admiral real quickly.
        Dr. Redd. Yes. The answer to your question, I think, is
    different depending on the horizon. I think that certainly
    since 9/11 there have been remarkable improvements in our
    ability to respond in a coordinated, cohesive way.
        One comment that I'd make is that these three different
    hurricanes were actually very different events, that in Texas
    was really a flooding event with not very much wind damage in
    the most populated areas. In Puerto Rico it was primarily a
    destructive wind event.
        And so I think the lesson from that is that really being
    adaptable is a critical capability. And I think that we are
    continuing to get better at being adaptable to the
    circumstances that we're confronting.
        Mr. Peters. Great. I want to thank the witnesses and yield
    my remaining time to Dr. Ruiz.
        Mr. Ruiz. Quick, because I just have a few seconds, but the
    idea of peripheral field command posts, would that be helpful
    to better coordinate on-the-ground realtime with all the
    stakeholders, Dr. Kadlec?
        Dr. Kadlec. Sir, it is, and we have that communications
    capabilities with our DMAT teams.
        Mr. Ruiz. So it can happen?
        Dr. Kadlec. It can happen. As it is, you defined a joint--
    --
        Mr. Ruiz. So, Dr. Redd, would that be a solution that would
    be worthy of pursuing?
        Dr. Redd. Yes, it would. And I think, just in a narrower
    way, from a surveillance standpoint, having hubs that could
    report in would be something that would be helpful to
    understand what the facts on the ground are.
        Mr. Ruiz. So I'm going to highly suggest that we start
    doing that as well.
        And another metric to count is unnecessary deaths,
    epidemiology. It's one thing to be killed by a falling branch
    or drowning from the river. The other thing is to die from not
    having medications that they could have had if it wasn't for
    the hurricane.
        So there's a lot of unidentified bodies and there's a lot
    of deaths occurring. We need a better way to count how many are
    due primarily and secondarily from the hurricane.
        Thank you.
        Mr. Griffith. Thank you for yielding back.
        I now recognize the gentleman from Texas, Mr. Olson, for 5
    minutes for questions.
        Mr. Olson. I thank the chair and welcome the chair as our
    new chairman of this subcommittee. I thank you for allowing me
    to participate in this hearing even though I'm not a member of
    the subcommittee. I'm here to talk about three aspects of
    Hurricane Harvey, I'll call them the three M's: mental health,
    mold, and mosquitoes.
        I moved to the Texas Gulf Coast in the summer of 1972. If
    you were there at that time and since then you hear of the
    legends of Hurricane Galveston in 1900. The worst natural
    disaster in our country's history, over 6,000 lives lost,
    probably 8,000 to 10,000 if you count them all. I was there for
    Hurricane Alicia in 2001, Ike in 2008.
        Harvey did more damage than those hurricanes combined. It
    hit us twice. It hit us once, got stopped, then came and hit us
    again.
        We faced many health challenges. The San Jacinto Waste Pits
    with Dioxin were breached, leaked out in the San Jacinto River.
    There were chemical spills, raw sewage spills, floating walls
    of fire ants, toxic smoke fires that got out of control. Flesh-
    eating bacteria took two lives, one in Galveston and one in
    Kingwood. A first responder in my district was infected but
    beat it with heavy, heavy antibiotics.
        Mental health became a big issue. I saw this firsthand. I
    was at a school there, elementary school hit by the tornado
    that hit Sienna Plantation called Scanlan Oaks. Talked to
    parents, school kids come to class. One young man came, very
    proud.
        ``The tornado hit my home. Knocked out my window as I was
    sleeping.''
        Mom came back, and I said, ``Man, he's doing great.''
        And she said, ``No, he's not.''
        He's greater at school. It's a great story. I beat the
    hurricane, the tornado. But since that hit his house, he can't
    sleep in his own bed. He crawls in with Mom and Dad just for
    security and safety b+ecause he fears for his life after what
    happened with Hurricane Harvey. And that's just one example of
    how our kids are traumatized by these events.
        And also the adults. We went through days and days of
    tornado warning, flood warning, the whole night for 3 nights,
    probably slept 4 hours over 3 days. Four days after Harvey
    cleared there was a little flash flood. Those alarms went off.
    People all around said, ``I kind of freaked out hearing those
    alarms again.''
        So my question is, what resources--probably you, Admiral
    Redd, and maybe you, Mr. Gottlieb--what resources are you
    providing our communities to address the mental health issues
    that they face because of Hurricane Harvey? What can be done
    for these people?
        Dr. Gottlieb. Well, I'll defer to my colleagues on the
    panel.
        In my role as FDA Commissioner with respect to what we've
    been focused on coming out of Hurricane Harvey in addition to
    there being some medical product facilities in the region, the
    predominant issue has been related to crop destruction and
    issues related to requests for waivers, for diversion of crops
    into animal feed.
        And going forward, we will probably have to take some steps
    to help with remediation of certain fields that might have been
    expose to heavy metals from the flooding. But we're primarily
    focused on issues related to the crops that were damaged in the
    aftermath of the hurricane.
        Mr. Olson. Thank you.
        Admiral Redd, do you have any comments on that, sir?
        Dr. Redd. On the mental health question in particular, I
    think that there are maybe three points. Well, four points.
        One is that these events are devastating and they have
    effects on everyone. Most of those effects are relatively
    short-term for most people. And I think for people, when those
    effects are not short-term, we need to be able to make sure
    that there is availability of services.
        The second point is really understanding the magnitude of
    that group of people that need long-term help.
        Let me think if I could remember my third point. I think
    that's it for me, is the two points.
        Dr. Kadlec. Sir, I'll add to his point, though, really
    quick, which is just simply that we've used the Public Health
    Commissioned Corps. They have behavioral health teams that
    basically are going out. They've been most recently deployed in
    the Virgin Islands.
        But also SAMHSA has provided a hotline to call for people
    who have had it. They've had 11,000 calls. And basically you
    can speak to a counselor on the phone to ask about their
    emotional issues and find some assistance and solace in that
    way.
        So there are some capabilities out there, and we've been
    working with--and, again, it's dependent on the local
    authorities to basically initiate these things. But we
    certainly stand ready to assist when it is appropriate.
        Mr. Olson. Thank you, sir.
        Come on, Admiral Redd, you are ready for your third point.
        Dr. Redd. Well, actually, there may be a couple more.
        But let me talk about mold. We're working closely with the
    Department of Health. When there's a flooding event, structures
    that are flooded will become moldy.
        We're actually doing three different things in mold. One is
    training of responders. The other is working on communication
    materials. And the third thing is working with the Department
    of Health to investigate the potential for an increase in
    infections due to invasive mold.
        Mr. Olson. I thank the witnesses and my chairman.
        Also remind me about our region, there's one thing that
    unites us: Beat L.A.
        I yield back.
        Mr. Griffith. I thank the gentleman.
        And I now recognize the gentlelady from New York, Ms.
    Clarke, for 5 minutes for questions.
        Ms. Clarke. Thank you so much, Mr. Chairman.
        I'd also just like to remind everyone that we're talking
    about territories that are in tropical climate and that these
    are tri-island territories. I hear people talk about Puerto
    Rico as though it's a monolith. There's also Vieques and
    there's Culebra. There's also three islands with respect to the
    U.S. Virgin Islands, and that is St. John, St. Thomas, and St.
    Croix.
        So I don't want us to see this as a monolith because each
    of these islands have their own identity, their own
    inhabitants, and I'm not hearing enough of a deep enough dive
    into what is happening with the inhabitants of all of these
    territories. Because it's not one singular event. It's an event
    that hit three separate geographic territories.
        I'm putting that out there because I'm going to want to
    hear more about what has happened in terms of response to those
    territories. We're not hearing at all about how the people of
    St. John are receiving healthcare, the people of Vieques are
    receiving healthcare. We're not hearing that information, and
    that is just as important.
        I'd like to start my question about the evacuation process.
    What assistance was provided to prepare and implement an
    adequate and efficient evacuation plan for those whose health
    are compromised? And was there coordination assistance provided
    to the local health departments in the wake of the hurricanes
    to track evacuees who were sent to other islands and/or the
    mainland?
        Dr. Kadlec. Ma'am, I can probably address that. In
    deference to your question, I would also just highlight our map
    that we provided which identifies where HHS has basically been
    providing augmentation support to St. John, as well as St.
    Croix and Virgin Islands. And also we had a presence on Vieques
    as well.
        But to your point about evacuation, again, for the
    complexity of this event--and, again, Irma struck St. Thomas
    first, and for which we were doing some unprecedented things.
        Using CMS' emPOWER database, we actually were able to send
    in our DMAT teams with urban search and rescue and identify
    dialysis patients on the island, which we recovered 120 of them
    and then evacuated them to relative safety in Puerto Rico until
    Maria hit, at which point in time we evacuated them literally
    the day of landfall of Maria, evacuated those patients to
    Miami, to a medical shelter there, where we could ensure that
    they were being cared for.
        In the cases of other patients who were evacuated from the
    Virgin Islands, they were evacuated through Atlanta, and,
    again, receiving care through there, through the local
    resources.
        And so throughout, the intent here is not only did we
    evacuate those dialysis patients, but sent them with a
    nonmedical attendant, a family member, so they would have
    someone to assist them along the way.
        At the present time, there's only been a handful of
    evacuations off the island to the mainland. There were two
    pediatric patients, intensive care patients, that were
    evacuated from San Juan to Miami soon after landfall.
        But what we've tried to do is basically maintain the health
    infrastructure on Puerto Rico, because we're hopeful that those
    people get better, and they need to be closer to family and
    support units there.
        So the way we addressed the problem in Puerto Rico is we
    created these seven regional hubs of hospitals that we
    augmented with our disaster medical assistance teams.
        We took the benefit of a level one trauma center in Centro
    Medico in San Juan, where we made it one, if you will, the
    eastern hub, a receiving hospital for high acuity or intensive
    care patients, and then used the USS Comfort as the other hub,
    the western hub, a mobile hub that we could basically run from
    basically from the top of Arecibo down to Ponce to collect
    patients, depending on their acuity, as required, and then have
    been able to use DoD assets, both ground ambulances and Medevac
    Dustoff helicopters, to provide response on the island, and
    then using Naval medical assets and rotary-wing and fixed-wing
    assets to fly them.
        Ms. Clarke. If there is a document that you have that just
    sort of outlines all of that, that would be great.
        Dr. Kadlec. Yes, ma'am.
        Ms. Clarke. If you can provide it to the committee.
        Dr. Kadlec. I can make that available to you.
        Ms. Clarke. I also wanted to talk about the public health
    challenges of these island territories. The islands will need
    the assistance of the Federal Government in the weeks, months,
    and years to come. What is the agency's position of the
    Medicaid cap as it relates to the Virgin Islands with its
    already-limited resources? And do you support a full Federal
    contribution as the Federal Government did for Katrina?
        Dr. Kadlec. Ma'am, I'll defer to Ms. Brandt.
        Ms. Brandt. Thank you for that question.
        That is certainly something that we are looking at, and we
    are exploring whether or not we would have the flexibility to
    do that. But the Federal match is set by Congress. It's
    statutory.
        Ms. Clarke. Yes. I'm asking about your recommendation.
    Right now you have these islands, island territories, where in
    one case, the U.S. Virgin Islands, their major employment is
    through tourism, right? No one's working. So are we requiring
    that government come up with a match or are we going to suspend
    it and do a full Federal contribution as we did for Katrina on
    the mainland?
        Ms. Brandt. Excuse me for not answering directly. We are
    pursuing that. We are working with the Office of Management and
    Budget to pursue that with congressional approval.
        Ms. Clarke. Wonderful. Thank you.
        I yield back, Mr. Chairman.
        Mr. Griffith. I thank the gentlelady.
        I now recognize the gentleman from Georgia, Mr. Carter, for
    5 minutes.
        Mr. Carter. Thank you, Mr. Chairman.
        And thank all of you for being here today. I appreciate
    your presence.
        I'm going to assume this goes to CMS, and that's Ms.
    Brandt.
        Can you help me here? I know the situation that exists with
    the nursing home situation in Florida. Are you going to now
    require nursing homes to have generators? Is that going to be a
    requirement? And can you very briefly tell me how that's going
    to work?
        Ms. Brandt. Sure. We actually have an emergency
    preparedness rule which was finalized last year that is going
    to be surveyed again starting next month. So that's when the
    state surveyors go out. It requires generators, it requires
    emergency preparedness plans, and it requires training on a
    continual basis.
        Mr. Carter. Will there be any kind of reimbursements for
    nursing homes? I've spent much of my professional career as a
    nursing home consultant, and I can tell you, they are pushed
    for trying to stay solvent as it is. Is there going to be any
    kind of help for them or is this just another government
    mandate?
        Ms. Brandt. That is certainly something that we are looking
    at, but I can't speak specifically to that at this time.
        Mr. Carter. OK. Thank you.
        Mr. Kadlec, there was an article in The Wall Street Journal
    the other day about the USN Comfort, the Naval ship, that was a
    medical ship, and how it was off the coast of Puerto Rico but
    it wasn't being utilized. And I just wanted to get your input
    on how we could do a better job in the future of making sure--
    from what I understand, it's a 250-bed hospital on the water,
    but only 150 beds were being utilized at one time?
        Dr. Kadlec. Yes, sir.
        Mr. Carter. What can we do to make that better? It's
    costing us $180,000 a day just to have it there. And those
    people desperately off of Puerto Rico need help.
        Dr. Kadlec. Yes, sir. And, again, to allude to Ms. Clarke's
    question before, part of our plan was basically to use the
    Comfort as a capability to deal with high acuity patients,
    intensive care patients, particularly in circumstances where
    hospitals on generators would fail, where we would need to
    urgently transfer critically ill patients somewhere. And so we
    were basically using the 50-bed ICU on the boat, sir.
        Mr. Carter. And we understand and appreciate that. But it
    seems like we could have made better use of it. And have we
    learned anything? Is there anything we can do differently to
    make it more accessible in the future?
        Dr. Kadlec. And so we are in the midst of actually looking
    how we can utilize it more, as more of a stationary platform,
    probably berth in one of the ports in Puerto Rico.
        Mr. Carter. Exactly. Make it more accessible.
        Dr. Kadlec. That has been an ongoing conversation with the
    Department of Health in Puerto Rico to assess how we can use
    that more to their needs.
        Mr. Carter. OK. Thank you.
        Dr. Gottlieb, it's my understanding that the FDA can
    declare on a shortage list medications that are not available
    and that they can be compounded. Is that true, they can be
    compounded by pharmacies if they're put on the FDA shortage
    list?
        Dr. Gottlieb. We don't typically look at the opportunity to
    compound as an alternative or solution for shortages. Our drug
    shortage staff would typically try to work to help get the
    approved product back in supply and might look to help source
    the same products from overseas manufacturing facilities that
    might be inspected by FDA.
        It is the case that in certain situations you might see
    practitioners go to approved compounding facilities, facilities
    that are compounding within the confines of the statute, to
    source certain products.
        Mr. Carter. OK. So you're actually increasing access to
    alternative medications? Is that what you're trying to do?
        Dr. Kadlec. Thanks to some of the new authorities that
    Congress gave us with respect to our drug shortage staff and
    our ability to identify shortages further out from the actual
    occurrence of a shortage, we've been taking steps to try to
    mitigate the shortages that have occurred, but also situations
    where we see the potential for products to tip into shortage.
        So we're looking out typically 1 to 2 months for what we
    think could potentially happen if production doesn't resume and
    taking steps to, for example, move temporarily certain
    manufacturing out of facilities that might be damaged or not up
    to full production to facilities in other markets that could
    help supply the U.S. market.
        Mr. Carter. Right. OK. I would ask you, as you continue on
    your process for the memorandum of understanding dealing with
    compounded medications, that you would take into consideration
    natural disasters and that there would be exceptions put in
    there where compounding pharmacies could be utilized so that
    they could get those medications to those patients in the case
    of natural disasters such as this.
        Dr. Gottlieb. And we would be happy to work with the
    Congressman as well. It might be something more appropriately
    addressed in the statute. I certainly look forward to working
    with you on that.
        Mr. Carter. And I will be glad to work on that if it needs
    to be addressed in the statute.
        One final question. I will just ask you, Dr. Gottlieb. Is
    the CDC supporting vaccinations to prevent Leptospirosis?
        Dr. Gottlieb. Well, I would defer to my CDC colleague.
        Mr. Carter. OK. Excuse me. I'm sorry.
        Dr. Redd. There's no vaccine for Leptospirosis.
        Mr. Carter. There is no vaccine for that right now?
        Dr. Redd. No.
        Mr. Carter. What about treatment for it?
        Dr. Redd. It's very treatable. It works better the earlier
    the disease is identified. So earlier treatment is more
    effective.
        Mr. Carter. Is that being supplied to Puerto Rico now?
        Dr. Redd. It is. The antibiotics that are used for
    treatment, they're not----
        Mr. Carter. Pretty common?
        Dr. Redd. Yes, they are. They're not anything special.
        Mr. Carter. OK.
        Dr. Redd. Penicillin and tetracycline.
        Mr. Carter. OK. Great. Well, tetracycline is not available
    as much as it ought to be.
        Dr. Redd. Depends on which variety.
        Mr. Carter. As Dr. Gottlieb will attest, unless you're
    getting it for fish tanks. I'm serious. Nevertheless, it is a
    problem.
        But thank you very much. And thank all of you again.
        And I yield back.
        Mr. Griffith. I now recognize the gentleman from New York,
    Mr. Tonko, for 5 minutes for questions.
        Mr. Tonko. Thank you, Mr. Chair.
        As ranker on the Subcommittee of Environment that reports
    to the standing Committee of Energy and Commerce, I have made
    clean drinking water a major effort to focus that I'm very
    appreciative the committee is responding to. We have recently
    reported a bill from the subcommittee and then standing
    committee. So, therefore, I want to address that concern, clean
    drinking water.
        There are many reports about a lack of safe drinking water
    in Puerto Rico. Unfortunately, neither FEMA nor the EPA is
    before us today. So, Dr. Redd, I'm hoping that you might be
    able to share some insights into the water situation in Puerto
    Rico and the Virgin Islands.
        Recent news reports have stated that roughly one-third of
    Puerto Rico has no reliable access to potable water at home.
    Because of this, we have heard reports of people drinking and
    bathing in rivers and streams in Puerto Rico.
        Last Tuesday, Puerto Rico's state epidemiologist, Carmen
    Deseda, announced that there have been some 74 cases of
    Leptospirosis reported on the island so far this month. Puerto
    Rico usually sees only 60 cases of this disease, as I'm
    informed, in a given year. Some reports have connected this
    outbreak to public use of contaminated water sources.
        So I ask, can you tell us about this whole concern about
    Leptospirosis, and what are its symptoms?
        Dr. Redd. Certainly. Leptospirosis is a bacterial
    infection. It's acquired, as you described, by drinking or
    being exposed to water that's contaminated with those bacteria.
    They infect many species of animals. And animal urine is the
    vehicle for transmission of the disease. So situations where
    there's a shortage of potable water or exposure to floodwaters
    that are contaminated with the bacteria are the settings for
    exposure.
        We are working closely with the Department of Health in
    Puerto Rico to determine whether those suspected cases actually
    are cases. We have specimens in the laboratory at CDC right now
    doing those tests. We are aware of one confirmed case that was
    diagnosed in a patient at the VA. So how large this outbreak
    actually is--if it's an outbreak--is something that really
    remains to be determined.
        The best way to control the outbreak is to prevent exposure
    to contaminated water, and that really is an issue that you've
    started with, with wider availability of potable water and then
    early treatment for people that have symptoms of fever,
    weakness, exposure to those things. And then, in the later
    stages, more characteristic is jaundice, yellowing of the skin,
    because of liver damage.
        For the question about the extent of the water supply
    system, I might refer to Dr. Kadlec on what the situation is,
    proportion of people that have access to potable water.
        Dr. Kadlec. So I can give you just basically down that
    we've been following: 25 out of the 115 public drinking water
    facilities are out of service. So, again, that's an intense
    issue of concern. And, again, prioritization in terms of
    reelectrification.
        But significantly, too, is 10 out of the 51 wastewater
    treatment facilities are out of service. So that gives you a
    rough estimate of what the situation for water is. But that's
    being followed by the U.S. Army Corps of Engineers.
        Mr. Tonko. Then back to the disease itself, like, is it
    normally treatable?
        Dr. Redd. It is treatable. It does have a significant
    mortality rate for severe cases, 5 to 15 percent fatality. So
    it's a serious disease that we need to take steps to try to
    prevent and when it's recognized treat promptly.
        Mr. Tonko. And how critical is it that patients be treated
    in a matter of days or hours after----
        Dr. Redd. Well, like many bacterial infections, the sooner
    treatment can be started, the more effective it is. So early
    recognition is very important. And some of that has to do with
    access to medical care.
        Mr. Tonko. Yes. And are there any other diseases or hazards
    associated with drinking and bathing in rivers and streams,
    particularly after these heavy rains and floodings that we saw
    in Puerto Rico? Are there other health concerns?
        Dr. Redd. There are. There are. So the conditions that can
    cause gastrointestinal illness are going to be more common in
    floodwater, wastewater that has sewage in it. There are also
    skin infections that could be more common when people become
    exposed to that. So really it's a variety of diseases, as well
    as something that's been alluded to earlier, the inability to
    wash your hands, do things that will have many other beneficial
    effects.
        Mr. Tonko. Thank you very much. I yield back.
        Mr. Griffith. I thank the gentleman.
        And I appreciate everybody bearing with me. I am going to
    reserve to go at the end.
        I now recognize Mr. Bilirakis from Florida for 5 minutes
    for questions.
        Mr. Bilirakis. Thank you, Mr. Chairman. Thank you for
    allowing me to sit in on the subcommittee.
        Secretary Kadlec, does the Hospital Preparedness Program
    currently allow states to use grant funds to help defray costs
    associated with procurement and maintenance of generators for
    assisted living facilities and skilled nursing facilities to
    support the development and sustainment of regional healthcare
    coalitions?
        Dr. Kadlec. Sir, the way the grants are structured, it is
    principally for healthcare facilities and for coalitions
    thereof. So as part of a plan of a coalition, that could be
    considered as part of it, but we don't dictate that as being
    part of it. We are looking to identify how these hospitals and
    hospital systems can become more resilient.
        But, in fairness to your question, sir, if I may get back
    to you on that, I can give you a more fulsome followup on that.
        Mr. Bilirakis. Yes. Please, that's very important, to see
    whether it's permissible.
        Dr. Kadlec. Yes, sir.
        Mr. Bilirakis. Because, again, in our area, there are small
    nursing facilities, but also ALFs, that do not have generators.
    And that's a priority, and that's what I'm concerned with.
        Dr. Kadlec. Sir, I'll get back to you on that.
        Mr. Bilirakis. Maybe they have 10 patients or less, and
    we've got to make sure they have the generators, the backup.
        And, Ms. Brandt, last Friday the committee sent a
    bipartisan letter to the owner of the rehabilitation center at
    the Hollywood Hills in Florida raising concerns, again, about
    the nursing home in Florida where 14 residents eventually died
    after the facility lost air conditioning in the wake of
    Hurricane Irma.
        There was apparently a fully functional hospital across the
    street. Unbelievable. And according to the Florida Agency for
    Healthcare Administration, the facility administrator and
    medical professionals didn't know to call 911 in an emergency.
        I can't understand this. What's wrong with these people?
    How could a nursing home be so unprepared for a medical
    emergency that 14 residents lost their life, especially when
    there's a hospital across the street? Can you answer that
    question, please----
        Ms. Brandt. Well, thank you for the question, sir.
        Mr. Bilirakis. Attempt to.
        Ms. Brandt. And, as you're aware. Hollywood Hills has been
    terminated from participation in the Medicare and Medicaid
    program.
        We make patient safety our number one priority for the
    residents of all of our Medicare and Medicaid facilities, and
    this was a complete management failure at Hollywood Hills,
    which is why they were terminated. They did not meet our
    conditions of participation for keeping the temperature at a
    reasonable level. They did not provide adequate care to the
    patients. As you mentioned, there was a hospital right across
    the street which they could have availed them.
        So they had several levels of what we call immediate
    jeopardy for patients, which is why they were terminated.
        Mr. Bilirakis. OK. Who is ultimately responsible for their
    safety?
        Ms. Brandt. In terms of the patient safety, the facility
    has the responsibility and the management of the facility has
    the responsibility to ensure that they are meeting emergency
    preparedness requirements, that they are providing adequate
    care to the patients. And we survey and hold the facilities
    accountable to those requirements.
        Mr. Bilirakis. OK. That's very important, the
    accountability, obviously, the supervision, is so important.
        What can CMS do to ensure a tragedy like this never happens
    again?
        Ms. Brandt. Well, one of the things that we have done, as I
    mentioned in my opening statement and in the written testimony,
    is that we have instituted an emergency preparedness role which
    requires that facilities have an emergency preparedness plan,
    that they train on that plan and make sure all employees are
    aware of it, and that they have adequate backup in place to
    allow--you mentioned the discussion of generators and other
    things--to ensure that they have adequate power supplies and
    other things to ensure that patient care can be provided, and
    that they have a plan for where the patients can go if it
    cannot be provided.
        Mr. Bilirakis. Well, what about Puerto Rico now? I
    understand that there are nursing homes operating without air
    conditioning and people are very unsafe. Who's responsible for
    this? Who's supervising this? Is it CMS? HHS? And, obviously,
    it's unacceptable. Can you respond to that?
        Ms. Brandt. Well, so, in situations like in Puerto Rico,
    where you have an almost unheard of position, where you have no
    water, you have no power, you have really no ability to provide
    it, we work with all of our partners.
        Dr. Kadlec and the ASPR team, as well as the FEMA teams and
    everyone on the ground works with not only Federal and state,
    but also the territory officials in Puerto Rico to pull
    together to get patients to a safe place.
        If they don't have the ability to provide that care, then
    we work together to get them transported to a safer place, such
    as the evacuees that Dr. Kadlec was talking about earlier from
    the Virgin Islands.
        Mr. Bilirakis. Thank you very much. I appreciate it.
        And I'll yield back, Mr. Chairman.
        Mr. Griffith. I thank the gentleman for yielding back.
        I now recognize Mr. Green, the gentleman from Texas, for 5
    minutes.
        Mr. Green. Thank you, Mr. Chairman.
        And coming from the Houston area, again, a very urban area,
    I heard today that we had our second death from a flesh-eating
    bacteria in Galveston County. That's to the south of us, where
    I'm at. But, also, to the north we had a 77-year-old lady in
    the Kingwood area, up in Congressman Poe's district, pass away.
    We have some great medical facilities. And that gentleman was
    actually at UTMB because it's infectious disease.
        Has that been prevalent in Puerto Rico or the Virgin
    Islands? Because I know we have a lot of standing water or at
    least we did have. And I'd like to ask if CDC----
        Dr. Redd. I'm not aware of cases that have occurred in the
    other hurricane-affected areas.
        The condition that you're describing is pretty infrequent
    in the U.S., about 600 to 700 cases per year over the last 4 or
    5 years of that disease occur. So it's not common. But the
    exposure to floodwaters is a risk factor for that condition.
        Mr. Green. OK. Thank you.
        Hurricane Harvey created so many serious environmental and
    public health issues, including evidence of compromised
    Superfund sites, and toxic spills, chemical fires, and high
    levels of air pollution. EPA confirmed that in the aftermath of
    Hurricane Harvey--we have a location called the San Jacinto
    Waste Pits in Harris County that's now in Congressman Babin's
    district--but welcome to the redistricting in Texas. It was in
    my district. It was in Ted Poe's district. So we changed those,
    but our constituents still contact all three of us.
        The analysis found that it was concentrations of 2,000
    times higher than the level in which the EPA required a
    cleanup. And the EPA administrator was there literally 2 weeks
    ago to visit that site, and the decision has been made to
    permanently clean up that facility there in east Harris County.
    So I was glad of that.
        Dr. Redd, what are the types of risks associated with
    substances such as this? It's a dioxin facility. It was dumped
    there in the '60s by a paper mill. We have responsible parties.
        But in both the State of Texas, Harris County and city of
    Baytown that's there, put signs up in both English, Spanish,
    and Vietnamese not to eat the crabs or the fish--but when I go
    out there, you can't find anybody that doesn't have a fishing
    pole--because the signs say, if you're an expectant mother or a
    small child, you shouldn't digest these crabs, but a lot of
    people still do.
        What are the types of risks that are associated with that
    other than problems with eating it?
        Dr. Redd. I'd like to respond to that question in a
    followup. I don't want to say anything that's incorrect here,
    and I think especially with the levels that we're seeing in
    that setting.
        Mr. Green. OK. Like I said, the decision has been made to
    clean it up. But my concern is a lot of my constituents who go
    out there and fish and crab, and I keep explaining to them, you
    need to pay attention to those signs.
        According to the Houston Health Department, there are
    millions of contaminants in floodwaters covering most of the
    city. Arsenic, lead, heavy metals in floodwater sediment also
    were repeatedly found.
        Dr. Redd, following Hurricane Harvey, what role did the CDC
    play in warning affected communities of possible water-borne
    risk and other public health risk.
        Dr. Redd. So, in general, in that part of the response, we
    were working in support of EPA. The kinds of things that we
    would do would be to try to make the kinds of warnings that you
    described, make sure people know those things. So, really,
    public health communications because of the flooding.
        Mr. Green. OK. Additionally, not just from industry, but
    about 50 drinking water systems were shut down following
    Hurricane Harvey and more than 160 systems issued boil water
    advisories. This is an issue also we're seeing in Puerto Rico,
    which is still issuing boil water notices. However, given the
    lack of power, some people are not able to boil the water.
        Dr. Redd, given that boiling water may not be an available
    option, what are some of the hazards of drinking potentially
    contaminated drinking water without boiling it? And how does
    the CDC communicate these hazards?
        Now, we may be over it, I hope, at least in southeast
    Texas, but, again, in the Virgin Islands and Puerto Rico.
        Dr. Redd. So the hazards that one would be exposed to
    drinking water that could be contaminated with sewage would be
    the things we've talked about before, gastrointestinal
    illnesses, the inability to do hand hygiene that prevents a lot
    of other diseases. And if there's Superfund site contamination,
    exposure to some of the materials in those waters.
        Just to bring back one other point, that's one of the
    reasons that having the public health laboratory in Puerto Rico
    online again is so important so that that testing can be done,
    and when water is safe to drink, it will be easier to confirm
    when that testing is available.
        Mr. Green. Thank you, Mr. Chairman. I know I'm out of time.
    But, you know, every year the upper Texas coast--I mean, every
    7 or 8 years we get a hurricane or a tropical storm. So, you
    know, hopefully it will be that long a time.
        But are we learning any lessons from Hurricane Harvey, both
    in southeast Texas, Louisiana, that could be applied in Puerto
    Rico or the Virgin Islands now? Or, hopefully, we are learning
    to be better prepared, particularly for our water system,
    because when they shut down, that's really a human need that we
    have to have.
        And, Dr. Kadlec, you had mentioned that.
        Thank you, Mr. Chairman, for letting me run over time.
        Mr. Griffith. I appreciate that, and thank you.
        That being said, I now recognize myself for 5 minutes, and
    this will be the end. So you're almost done.
        Dr. Gottlieb, black mold. All of the areas we've talked
    about, everybody knows there's going to be some black mold
    issues. But here's one of the issues that I'm not sure most
    Americans know. What are the symptoms? Because, obviously, if
    you see it, you're going to do something about it, or try to do
    something. But oftentimes it's a hidden concern.
        So what should people be on the lookout for? You want to
    take it.
        Dr. Gottlieb. I'd probably defer to CDC, if that's----
        Mr. Griffith. All right. That's fine.
        Dr. Redd. You're absolutely correct, Chairman, that
    flooding leads to mold contamination.
        There are two different hazards from exposure to mold. One
    is the worsening of allergic conditions. And that can be quite
    serious in the case of somebody that has asthma that's
    sensitive to mold. The other is, particularly for people who
    have weakened immune systems, infection from mold, that also
    can be very serious.
        Mr. Griffith. But how are they going to know? I recognize
    the seriousness. What are they going to be seeing?
        Dr. Redd. Well, I think when building materials have been
    damaged, if mold can grow on it, it will. And so really it's a
    question of remediation. In other words, for porous surfaces,
    removing those surfaces and rebuilding. And for surfaces that
    aren't porous, cleaning them. That's the guidance in those
    areas, is what CDC has been providing, working with the Texas
    Department of Health.
        Mr. Griffith. All right. I guess I'm concerned that if you
    don't see it, you don't know it's there. I know that you're
    going to start having some rasping, particularly if you have
    asthma. But what if you don't? Or what if you don't know about
    that? Isn't that one of the first ways you tell, is you start
    having some chest congestion?
        Dr. Redd. Well, I think for areas that have floodwaters,
    you can tell where that floodwater has been.
        Mr. Griffith. OK. So you just do remediation. All right.
        Dr. Kadlec, it's been a month. We have any hospitals in
    Puerto Rico that are not accepting patients?
        Dr. Kadlec. Sir, there are about three that were closed. So
    there are some that have been----
        Mr. Griffith. That aren't open.
        Dr. Kadlec [continuing]. Physically damaged to the point
    where they could not----
        Mr. Griffith. OK. And the ones that are open, are any of
    them refusing to accept patients?
        Dr. Kadlec. Sir, on a daily basis, I don't know what their
    census are, but it could be the circumstance where they defer/
    divert patients. So I can't give you an affirmative answer.
        Mr. Griffith. We've talked about dialysis before. Any other
    specialized treatments that are currently unavailable at
    various hospitals?
        Dr. Kadlec. Well, sir, dialysis is available through 46 of
    the 48 clinics on the island. Depending on the hospital, there
    may be some services that are not available. So I can't give
    you an affirmative, if I can take that for----
        Mr. Griffith. Let me ask you this. Because I read a report
    somewhere that even though dialysis was available, they were
    cutting short the treatment time period from what it normally
    would be. Is that still the case?
        Dr. Kadlec. Sir, it is, and we're looking to actually work
    that problem out in terms of lowering the stress on some of
    those clinics where they see fewer patients or defer patients
    to places that have more functionality.
        Mr. Griffith. All right. And that brings up the United
    States Navy Ship Comfort.
        Dr. Kadlec. Yes, sir.
        Mr. Griffith. It's sitting out there, hadn't had a whole
    lot of patients. And this is a question my colleague gave to us
    earlier--what is the approval process or the admission process
    to get on or to be approved for the Comfort?
        Dr. Kadlec. Yes, sir. The plan is very simple, is that the
    island was not cut in half, but based on the swath of the
    hurricane that came through, westward side, eastward side, on
    the east side referrals of any high acute patients, intensive
    care patients, that need to be made from hospitals that are on
    the east side of the island would go to Centro Medico, which is
    their level one trauma center, and that would be done through
    ground or rotary-wing transportation.
        The determination of whether those patients would be moved
    to Centro Medico, same as to the Comfort, would be based on
    decisions by the clinicians at Centro Medico that would review
    and talk to the doctors at the local hospitals to say: What is
    this patient suffering from? What kind of care do they need?
    What kind of service do they need?
        Mr. Griffith. And I appreciate that.
        Dr. Kadlec. So based on that, then they would be
    transferred to eastward----
        Mr. Griffith. One of my concerns, I recognize some might
    argue that it's good that you haven't sent more to the Comfort,
    I think we have got an asset down there we're not using.
        Dr. Gottlieb, biggest long-term concern that you have, both
    for Puerto Rico and otherwise? What's your biggest concern that
    FDA may be having?
        Dr. Gottlieb. Well, our biggest long-term concern right now
    from a public health standpoint is that we may face product
    shortages of critical medical products heading into the first
    quarter. We are going to do everything we can to head them off.
        My biggest long-term concern for the island of Puerto Rico
    is that if we don't do our job and help these facilities stand
    back up in a timely fashion we could start to see some of the
    production move out of the island, and I think that would put a
    strain on the Puerto Rican economy. And so part of our
    solidarity to the people of Puerto Rico is to make sure we
    maintain that production down there. It's an important part of
    the island.
        Mr. Griffith. And I appreciate that.
        I see that my time is up. I yield back.
        Ms. DeGette. Just following up on that. Also, it would take
    away good jobs from the island if those facilities start to
    close down. Is that right?
        Dr. Gottlieb. That's right. About 90,000 people are
    directly employed by the industry. These are very high-paying
    manufacturing jobs relative to other manufacturing jobs on the
    island. It's an important part. Depending on the estimates,
    it's anywhere between 20 to 30 percent of the GDP of Puerto
    Rico, a very important part of the island.
        Mr. Griffith. In conclusion, I want to thank all of the
    witnesses and the members who participated in today's hearing.
    I remind members that they have 10 business days in which to
    submit questions for the record. I ask that the witnesses all
    agree to respond promptly to the questions that they may
    receive after the hearing from members.
        I have to tell you, I learned a lot. This was a good
    hearing. Thank you all for participating. You all contributed
    greatly, and I think I have a better understanding.
        I do look forward--and maybe you all can suggest where we
    should go--but I do look forward at some point to the committee
    and the subcommittee perhaps visiting the islands to see what
    we've got and, perhaps, as well, the other areas that have been
    affected by the recent hurricanes.
        With that being said, the committee is adjourned.
        [Whereupon, at 12:38 p.m., the subcommittee was adjourned.]
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