[Senate Hearing 115-390] [From the U.S. Government Publishing Office] S. Hrg. 115-390 NOMINATION HEARING ======================================================================= HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED FIFTEENTH CONGRESS FIRST SESSION ON NOMINATIONS OF LANCE ROBERTSON, BRETT GIROIR, M.D., ROBERT KADLEC, M.D., ELINORE F. McCANCE-KATZ, M.D. AND JEROME ADAMS, M.D. __________ AUGUST 1, 2017 __________ Printed for the use of the Committee on Health, Education, Labor, and Pensions [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] Available via the World Wide Web: http://www.govinfo.gov __________ U.S. GOVERNMENT PUBLISHING OFFICE 26-535 PDF WASHINGTON : 2019 ----------------------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Publishing Office, http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, [email protected]. COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS LAMAR ALEXANDER, Tennessee, Chairman MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania SUSAN COLLINS, Maine AL FRANKEN, Minnesota LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado SUSAN M. COLLINS, Maine SHELDON WHITEHOUSE, Rhode Island BILL CASSIDY, M.D., Louisiana TAMMY BALDWIN, Wisconsin TODD YOUNG, Indiana CHRISTOPHER S. MURPHY, Connecticut ORRIN G. HATCH, Utah ELIZABETH WARREN, Massachusetts PAT ROBERTS, Kansas TIM KAINE, Virginia LISA MURKOWSKI, Alaska MAGGIE HASSAN, New Hampshire TIM SCOTT, South Carolina David P. Cleary, Republican Staff Director Lindsey Ward Seidman, Republican Deputy Staff Director Evan Schatz, Minority Staff Director John Righter, Minority Deputy Staff Director (ii) C O N T E N T S ---------- STATEMENTS TUESDAY, AUGUST 1, 2017 Page Committee Members Alexander, Hon. Lamar, Chairman, Committee on Health, Education, Labor, and Pensions, opening statement......................... 1 Murray, Hon. Patty, a U.S. Senator from the State of Washington, opening statement.............................................. 5 Young, Hon. Todd, a U.S. Senator from the State of Indiana....... 7 Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode Island......................................................... 7 Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana... 23 Collins, Hon. Susan M., a U.S. Senator from the State of Maine... 27 Murphy, Hon. Christopher, a U.S. Senator from the State of Connecticut.................................................... 28 Warren, Hon. Elizabeth, a U.S. Senator from the State of Massachusetts.................................................. 32 Hassan, Hon. Margaret Wood, a U.S. Senator from the State of New Hampshire...................................................... 34 Casey, Hon. Robert P., Jr., a U.S. Senator from the State of Pennsylvania................................................... 37 Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin.. 39 Witnesses Robertson, Lance, Nominated to be Assistant Secretary for Aging, Edmond, OK..................................................... 8 Prepared statement........................................... 10 Giroir, Brett, M.D., Nominated to be Assistant Secretary for Health, College Station, TX.................................... 11 Prepared statement........................................... 13 Kadlec, Robert, M.D., Nominated to be Assistant Secretary for Preparedness and Response, Alexandria, VA...................... 14 Prepared statement........................................... 15 McCance-Katz, Elinore F., M.D., Nominated to be Assistant Secretary for Mental Health and Substance Use, Cranston, RI.... 17 Prepared statement........................................... 18 Adams, Jerome, M.D., Nominated to be Surgeon General of the Public Health Service, Fisher, IN.............................. 19 Prepared statement........................................... 21 Additional Material Statements, articles, publications, letters, etc. Burr, Hon. Richard, a U.S. Senator from the State of North Carolina, prepared statement............................... 50 Letters of support for: Lance Robertson.......................................... 52 Brett Giroir, M.D........................................ 110 Robert P. Kadlec, M.D.................................... 124 Elinore McCance-Katz, M.D................................ 128 Jerome Adams, M.D........................................ 163 (III) Response by Lance Robertson to questions of: Senator Murray........................................... 177 Senator Sanders.......................................... 179 Senator Casey............................................ 180 Senator Franken.......................................... 182 Senator Bennet........................................... 183 Senator Whitehouse....................................... 183 Senator Baldwin.......................................... 184 Senator Murphy........................................... 184 Senator Warren........................................... 185 Senator Hassan........................................... 188 Response by Brett Giroir, M.D. to questions of: Senator Murray........................................... 189 Senator Sanders.......................................... 190 Senator Franken.......................................... 191 Senator Bennet........................................... 191 Senator Whitehouse....................................... 192 Senator Baldwin.......................................... 192 Senator Warren........................................... 193 Response by Robert Kadlec, M.D. to questions of: Senator Murray........................................... 197 Senator Sanders.......................................... 200 Senator Casey............................................ 200 Senator Franken.......................................... 201 Senator Whitehouse....................................... 202 Senator Baldwin.......................................... 204 Senator Murphy........................................... 205 Senator Warren........................................... 205 Response by Elinore F. McCance-Katz, M.D. to questions of: Senator Murray........................................... 211 Senator Sanders.......................................... 212 Senator Casey............................................ 212 Senator Franken.......................................... 214 Senator Bennet........................................... 214 Senator Whitehouse....................................... 215 Senator Baldwin.......................................... 217 Senator Murphy........................................... 217 Senator Warren........................................... 220 Response by Jerome Adams, M.D. to questions of: Senator Murray........................................... 223 Senator Sanders.......................................... 226 Senator Casey............................................ 227 Senator Franken.......................................... 227 Senator Bennet........................................... 227 Senator Whitehouse....................................... 228 Senator Warren........................................... 229 NOMINATION HEARING ---------- TUESDAY, AUGUST 1, 2017 U.S. Senate, Committee on Health, Education, Labor, and Pensions, Washington, DC. The committee met, pursuant to notice, at 2:30 p.m., in room SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander, chairman of the committee, presiding. Present: Senators Alexander, Murray, Collins, Cassidy, Young, Casey, Bennet, Whitehouse, Baldwin, Murphy, Warren, Kaine, and Hassan. Opening Statement of Senator Alexander The Chairman. The Senate Committee on Health, Education, Labor, and Pensions will please come to order. Before we get down to today's business, which is to consider five of the President's nominees, I want to begin the hearing by saying that while we have not always had hearings on nominees for these positions that I especially appreciate Senator Murray's agreeing that we will mark-up these nominees, or we will consider them for mark-up, tomorrow. I appreciate that very much. I wanted to say a few words first about healthcare, and then give Senator Murray a chance to say a word about that, if she wishes. Then we will go on to the business at hand, which is the hearing for these five nominees. This committee, which is the Senate's health committee, will hold hearings beginning the week of September 4, 2017 on the actions Congress should take to stabilize and strengthen the individual health insurance market so that Americans will be able to buy insurance at affordable prices in the year 2018. We will hear from State insurance commissioners, from patients, from Governors, healthcare experts, and insurance companies. Committee staff will begin work this week working with all committee members to prepare for these hearings and discussions. The reason for these hearings is that unless Congress acts by September 27--when insurance companies must sign contracts with the Federal Government to sell insurance on the Federal exchange next year--millions of Americans with Government subsidies in up to half our States may find themselves with zero options for buying health insurance on the exchanges in 2018. Many others, without Government subsidies, will find themselves unable to afford health insurance because of rising premiums, co-pays, and deductibles. There are a number of issues with the American healthcare system, but if your house is on fire, you want to put out the fire, and the fire in this case is the individual health insurance market. Both Republicans and Democrats agree on this. Our committee had one hearing on this subject on February 1, and we will work intensively between now and the end of September in order to finish our work in time to have an effect on the health insurance policies that will be sold next year in 2018. I am consulting with Senator Murray to make these hearings bipartisan and to involve as many members of the committee as is possible; all who want to be involved. I will be consulting with Senator Hatch and Senator Wyden so that the Finance Committee is aware of any matters we discuss that might be within its jurisdiction. In these discussions, we are dealing with a small segment of the total health insurance market. Only about 6 percent of insured Americans buy their insurance in the individual market. Only about 4 percent of insured Americans buy their insurance on the exchanges. While these percentages are small, they represent large numbers of Americans including many of our most vulnerable Americans. We are talking about the roughly 18 million Americans in the individual market. About 11 million of them buy their insurance on the Affordable Care Act exchanges. About 9 million of those 11 million Americans have Affordable Care Act subsidies. Unless we act, many of them may not have policies available to buy in 2018 because insurance companies will pull out of collapsing markets. Just as important, unless we act, costs could rise once again making healthcare unaffordable for the additional 9 million Americans in the individual market who receive no Government support. Roughly 2 million of them buy their health insurance on the Affordable Care Act exchanges, but do not qualify for a Government subsidy and roughly 7 million buy their insurance outside of the exchanges. This means they have no Government help paying for their premiums, co-pays, and deductibles. As we prepare for these discussions, I have also urged the President to temporarily continue the cost-sharing reduction payments through September so that Congress can work on a short-term solution for stabilizing the individual market in 2018. Cost-sharing reduction subsidies reduce co-pays, and deductibles, and other out-of-pocket costs to help low-income Americans who buy their health insurance on the exchanges. That would be those who make under 250 percent of the Federal poverty level, or roughly $30,000 for an individual or $60,000 for a family of four. Without payment of these cost-sharing reductions, Americans will be hurt. Up to half of the States will likely have bare counties with zero insurance providers offering insurance on the exchanges, and insurance premiums will increase by roughly 20 percent, according to America's Health Insurance Plans. In my opinion, any solution that Congress passes for a 2018 stabilization package would need to be small, bipartisan, and balanced. It should include funding for the cost-sharing reductions, but it also should include greater flexibility for States in approving health insurance policies. It is reasonable to expect that if the President were to approve continuation of cost-sharing subsidies for August and September--and if Congress in September should pass a stabilization plan that includes cost-sharing for 1 year--it is reasonable to expect that the insurance companies in 2018 would then lower their rates. They have told us. In fact Oliver Wyman, an independent observer of healthcare, has told us that lack of funding for the cost-sharing reductions would add 11 to 20 percent to premiums in 2018. If the President over the next 2 months, and Congress over the next year, takes steps to provide certainty that there will be cost-sharing subsidies, that should allow insurance companies to lower the premiums that they have projected. In fact, many insurance companies have priced their rates for 2018 at two different levels; one with cost-sharing and one without cost-sharing. It is important not only that the President approve temporary cost-sharing for August and September, but that we, in a bipartisan way, find a way to approve it at least for 1 year so we can keep premiums down. This is only step one in what we may want to do about health insurance and the larger question of healthcare costs. We will proceed step by step. A subsequent step would be to try to find a way to create a long term, more robust individual insurance market. For the short term, our proposal is that by mid-September see if we can agree on a way to stabilize the individual insurance market to keep premiums down and to make affordable insurance available to all Americans. We need to put out the fire in these collapsing markets wherever these markets are. I think it is reasonable for the President to do that for 2 months and then for us to act during the month of September. Senator Murray, if you have any comments on our hearings, I would welcome them, and then we will go to the business at hand. Senator Murray. Thank you very much, Chairman Alexander. I think it is really clear that the path to improving healthcare, lowering premiums, and increasing access and quality has to be through working across the aisle, and bringing patients and families into the process, and coming together to find common ground. There is a lot of work we need to do for patients and families we represent, especially when it comes to the uncertainty in the markets and threats from the Administration, and the potential for significant premium increases if we do not act. Chairman Alexander, I want to say I really appreciate your work with me on this and your commitment to getting a result for all of our constituents, particularly when it comes to the cost-sharing subsidies and that we do not cutoff premiums and spike those for patients and families. I think I speak for all of us on this side that we look forward to bipartisan hearings, and hearing from patients and stakeholders, and working with colleagues both on this committee and off to work together in a bipartisan manner to stabilize the healthcare market and reduce premiums for our families. Thank you very much for your work on this. The Chairman. Thank you, Senator Murray. This committee has proved it works best when it works that way. She made an important point I did not make. A number of Senators have approached us who are not Members of the committee who want to be a part of what is happening. We are going to find ways, both this month and next month, to make sure that they have an opportunity to be updated on and participate in our discussions as much as possible. The first nominee we will hear from today is Mr. Lance Robertson, the nominee to be Assistant Secretary for Aging. In this role, he will oversee grants to States to support Meals on Wheels and provide Medicaid recipients homecare and financial management. He is currently State Director of Oklahoma's Aging Services, a position he has held for the past decade. He has received broad support from national and State groups. We received his ethics paperwork on June 30, concluding he is in compliance with applicable laws and regulations governing conflicts of interest. The committee received his committee paperwork on July 10. Welcome, Mr. Robertson. Next, we will hear from Dr. Brett Giroir, who has been nominated to be the Assistant Secretary for Health. He will oversee many public health programs including promoting biomedical research regulation and integrity; encouraging vaccinations to protect Americans against outbreaks of vaccine-preventable diseases, something this committee in a bipartisan way has strongly supported; and helping respond to the opioid abuse crisis. Last year, Congress provided $1 billion over 2 years in State grants to address that crisis in the 21st Century Cures bill that came out of this committee. He is the founder and CEO of Health Science and Biosecurity Partners, and an Adjunct Professor of Pediatrics at Baylor College of Medicine in Houston. He was nominated on May 25. We received his paperwork on May 30, and his Office of Government Ethics paperwork on June 5. The Office of Government Ethics has approved his nomination. Then, we have Dr. Robert Kadlec, who has been nominated to serve as Assistant Secretary for Preparedness and Response. This role was created under the Pandemic and All-Hazards Preparedness Act to lead the Nation in emergency preparedness and response to protect Americans in the event of public health emergencies and disasters. It is vital in ensuring that we are prepared at the Federal, State, and local levels for the next public health threat, whether natural, such as Ebola or Zika, or a bioterror attack. He served as Deputy Staff Director for Senator Burr on the Intelligence Committee. President Trump nominated him on July 11. We received his ethics paperwork on July 19 and his committee paperwork July 25. The next nomination is Dr. Elinore McCance-Katz to be Assistant Secretary for Mental Health and Substance Use. In 1992, the Substance Abuse and Mental Health Services Administration was established within the Department of Health and Human Services to, ``Reduce the impact of substance abuse and mental illness on American communities.'' The 21st Century Cures Act last year, which Senator Murphy and Senator Cassidy played such a large role in, made some significant changes to the agency. It directs the Assistant Secretary to focus on evidence-based practices, ensure the agency's grants are used effectively, improve the recruitment of mental health and substance abuse professionals, and collaborate with the criminal justice system to improve services. She is currently the chief medical officer for the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities, and Hospitals. She was nominated on June 15. The committee received her completed paperwork on June 26. OGE concluded she is in compliance with the conflicts of interest. Finally, we will hear from Dr. Jerome Adams, the nominee for Surgeon General. He will also serve as medical director in the Regular Corps of the Public Health Service. The Surgeon General is often called the Nation's doctor and in the past, Surgeons General have addressed important issues such as preventing chronic diseases, supporting breast feeding, nutrition and exercise, and mental health. Today, he is Indiana's State Health Commissioner. He was nominated June 29. We received his ethics paperwork July 7 and his committee paperwork July 24. We are holding the hearing today because our democratic members requested it, even though many of these nominees for these positions have not had hearings over the last several years. Having said that, I want to thank Senator Murray for agreeing to mark-up the nominees tomorrow. I am going to call on Senator Young and Senator Whitehouse when I introduce the witnesses before they speak, because they want to also introduce you. Senator Murray. Opening Statement of Senator Murray Senator Murray. Thank you very much, Chairman Alexander. Thank you to all of our nominees for joining us today. I am looking forward to discussing your vision for the roles you have been asked to fill. As my colleagues know well, I have repeatedly stressed the importance of a thorough and complete vetting process for nominees, and this naturally includes ample time to examine nominees' qualifications, and experience, and record of previous statements or decisions. I am also very interested in whether a nominee has demonstrated a commitment to putting everyday people first. I want to know if they are going to put science and facts ahead of politics and ideology. Critically, I want to know if they will truly be independent and will do the right thing no matter how much pressure is put on them by their bosses. I am going to have several questions on this today as well as questions to submit for the record. I do want to take just a minute to address some initial concerns, because I am deeply troubled by actions President Trump and Secretary Price have taken on the issue areas for which every one of these nominees will be responsible, if confirmed. One thing I am going to want to understand today is how they will address these issues. Dr. Kadlec, if confirmed, you would hold a critical job overseeing our Nation's efforts to prevent, prepare for, and respond to public health emergencies and natural disasters. So far, the Trump administration has failed to prioritize preparedness efforts, which I believe has left us vulnerable to public health threats. I will want to hear from you how much you would stand up to the Administration on this, given you have been an outspoken voice on the need to increase investments in our preparedness efforts at HHS. Dr. McCance-Katz, I am concerned this Administration has delayed some very critical steps that could help provide immediate relief for families suffering from the opioid epidemic. The role to which you have been nominated for was created by this committee, as Chairman Alexander mentioned, thanks to Senators Murphy and Cassidy. It reflects a bipartisan commitment to this issue, as well as larger priorities regarding mental health and substance abuse. If confirmed, you would be the first person to ever serve in this role, so I will want to hear from you how much you would put patients and families first in that role. Mr. Robertson, we are in desperate need of a strong advocate for older Americans and for people with disabilities in this Administration. I know you have been an outspoken advocate for older Americans back in your home State of Oklahoma. I will want to hear more about your commitment to protect and defend the rights of people with disabilities and advocate for investments for all of ACL's programs including the disability programs. Dr. Adams, President Trump's firing of the previous Surgeon General just halfway into his term shows to me a lack of respect for that office and for the independence of science. You and I have talked about this. I have made my concerns known, but I want to make clear today the next Surgeon General must be an advocate for science and facts, and must be able to stand up and correct misinformation coming out of this Administration. Dr. Giroir, I am deeply concerned with many actions that have been taken this year by the office you have been nominated to lead and this is particularly true with regards to attacks on women's health and the rights of women. First and foremost, President Trump has proposed underfunding the Title X Family Planning Program and signed it into law. That law states to block Planned Parenthood and other qualified women's health providers from receiving title X funds. We know he has appointed radical anti-choice individuals throughout the Administration, including within the office you will be charged to lead and just recently, he proposed gutting the Teen Pregnancy Prevention Program. I want to be clear from the outset, it would be unacceptable to confirm someone who would seek to continue those actions and be unwilling to stand up to ideological attacks on women. I have some varied concerns here. I will be asking you direct questions about that today. We have a lot to cover, Mr. Chairman. I appreciate you doing this hearing and working with you to move nominations tomorrow. I really want to say I appreciate you being willing to work with us on healthcare. I think we have shown time and again that we can work through some tough problems and comprise. I am ready to get to work and I know our side is as well. Thank you. The Chairman. Thanks, Senator Murray. I think we are too. I am going to turn to Senator Young and then to Senator Whitehouse. Senator Young to make some comments about Dr. Adams, Senator Whitehouse about Dr. McCance-Katz, and then we will hear from the nominees. Senator Young. Statement of Senator Young Senator Young. Thank you, Chairman, for this opportunity to say a few words of support of my very good friend, Dr. Jerome Adams. Dr. Adams, congratulations on your nomination to be the next Surgeon General of the United States. Congratulations to your family, who is here to support you along the way. In the past few years, Dr. Adams has served us Hoosiers well as the Indiana State Health Commissioner. I, along with Senator Donnelly, believe he has the experience and demonstrated leadership to promote public health nationwide and bring awareness to some of our most pressing public health challenges as our Nation's top physician. I want to submit for the record a letter of support from Senator Donnelly and I, as well as statements of support from our Governor, Eric Holcomb, the Indiana Black Legislative Caucus, the American Medical Association, the Association of State and Territorial Health Officials, and Ascension. The Chairman. Without objection. Senator Young. Without objection. [The information referred to may be found in Additional Material.] Senator Young. I look forward to hearing Dr. Adams' testimony and I yield back. The Chairman. Senator Whitehouse. Statement of Senator Whitehouse Senator Whitehouse. Thank you, Chairman, for the opportunity to join you in welcoming Dr. Elinore McCance-Katz to the committee. As you mentioned, Dr. McCance-Katz is an addiction psychiatrist. She currently serves as the chief medical officer at Rhode Island's Department of Behavioral Healthcare, Developmental Disabilities and Hospitals affectionately known in Rhode Island as BHDDH. She is also a professor of Psychiatry and Human Behavior and Behavioral and Social Sciences at Brown University in Providence. I have spoken to a number of Rhode Islanders who have been impressed by Dr. McCance-Katz's work in our State. She has helped expand access to medication-assisted treatment, stabilized psychiatric services at Eleanor Slater Hospital, served as an expert advisor to the Governor's Opioid Overdose Prevention and Intervention Task Force, and much more. Thank you, doctor, for your willingness to take on this new and important role. I look forward to hearing your testimony. If I may take a moment also to welcome Dr. Kadlec, who we know from Senator Burr's staff, and whose interest in and passion for bioterror preparedness and protection is well- established and most welcome. To Dr. Adams, who comes extremely well-recommended by our director of health in Rhode Island, Nicole Alexander-Scott. Thank you, Chairman. The Chairman. Thank you, Senator Whitehouse. We will have testimony from the five nominees. We welcome you. We welcome your families, some of whom are here, and you are welcomed to acknowledge them, if you would like to. If you could keep your remarks to about 5 minutes, we would appreciate it because that will leave more time for Senators to ask you questions. Mr. Robertson, let us start with you. STATEMENT OF LANCE ROBERTSON, NOMINATED TO BE ASSISTANT SECRETARY FOR AGING, EDMOND, OK Mr. Robertson. Good afternoon. Thank you, Mr. Chairman, Ranking Member Murray, and members of the Senate Health, Education, Labor, and Pensions Committee for allowing me to appear before you today. I am honored to be here with my fellow nominees and I am grateful for your consideration of my nomination to serve as the Assistant Secretary on Aging and the Administrator of the Administration for Community Living or ACL. I look forward to discussing how we can advance that organization's ongoing successful work in serving seniors and individuals living with a physical and/or intellectual and developmental disability. I appreciate the wisdom many of you and your staff members shared with me in advance of this hearing. I would like to thank so many family members, friends, and colleagues who have supported me through this nomination. As the Chairman allowed us to do, I would like to recognize and especially thank my wife of 23 years, who is with me today, Lori and then also the tremendous support from our daughters Brooke and Kaitlyn. ACL's mission, and I quote, is to, ``Maximize the independence, well-being, and health of older adults, people with disabilities across the lifespan, and their families and caregivers,'' and that is timely and critical. ACL represents populations that number more than 140 million Americans and these populations continue to grow. Ensuring choice, independence, and meaningful community inclusion is the hallmark of ACL's work and my life's mission. As Assistant Secretary, my vision would involve a four- pronged strategy, an overarching strategy that positively impacts all populations. The first strategy is to improve access to information about long-term services and supports. Many Americans are unsure where to turn when confronted with an illness, a disability, service need, or when they stumble into the role of caregiver. The next strategy focuses on supporting caregivers. The informal caregiver, and the service he or she provides, is the epicenter of the long-term services and support system. Our Nation must recognize how critically important it is that we help these 44 million unpaid family caregivers whose work to the care system is valued at $470 billion a year. Under my leadership we will continue to bolster evidence- based solutions and build support systems that work. We will continue to seek ways to meet caregivers where they are and equip them with the tools needed to be successful in their roles. The third strategy is dedicated to strengthening elder justice. Far too many Americans are exploited and abused, and we must continue to aggressively fight this growing epidemic. Strong momentum can be seen through the work of the multiagency Elder Justice Coordinating Committee, the recent release of innovation grants funded through ACL, and the bipartisan congressional caucus focused on this important issue. The final strategy is increasing our network's business acumen. Nonprofit aging and disability community-based organizations work hard every day to feed, support, transport, and assist individuals. These organizations are the backbone of our effort to promote independence, well-being, and quality of life for older adults and people living with disabilities. If confirmed, I look forward to working with the great team at ACL. As a collective body, ACL boasts a cadre of intelligent, committed, and impressive individuals. I look forward to listening, learning, and working together, if confirmed. As you fulfill your important role of confirming nominees, I am certain you look for individuals who not only have the requisite experience and skills, but preferably convince you that their commitment is unmatched and possibly even galvanized by personal experience. I humbly submit to you that I meet such criteria with nearly a quarter century of public service experience, a graduate degree in public administration, holding national leadership roles, and comprehensive experience in directing aging and disability network programs. I am humbled and appreciative of the endorsements that I have received from organizations across the aging and disability networks. It is my hope that when you review these letters of support, it will assure you of the abilities I will bring to this position, if I am confirmed. Having been partially raised by my grandparents, served as a caregiver, and having a niece living with significant disability affords me a personal view of ACL's important work. Never does a day go by that I am not impressed with the resiliency of those we serve. In most cases, particularly through programs offered by ACL, these individuals just need a little help: a meal, assistance with employment, transportation to the doctor, a referral to a community organization, a bit of respite, et cetera. We help by supporting the least expensive and preferred home and community-based care where it is desired. I believe wholeheartedly in our work to offer choices, empower people, and support families across the care spectrum. We help Americans live healthy, productive, and independent lives in their community. Our work is vital. In closing, I wish to thank President Trump for his nomination, support, and confidence and I am excited to work under Secretary Price's leadership, if confirmed. Thanks to each of you for the outstanding leadership and passion you provide each day on behalf of our great country. If confirmed, I look forward to working with you and your staff. Mr. Chairman, thank you for the opportunity to be with you today. [The prepared statement of Mr. Robertson follows:] Prepared Statement of Lance Robertson Thank you Chairman Alexander, Ranking Member Murray, and members of the Senate Health, Education, Labor, and Pensions (HELP) Committee for allowing me to appear before you today. I am honored to be here with my fellow nominees and am grateful for your consideration of my nomination to serve as the Assistant Secretary on Aging and Administrator of the Administration for Community Living (ACL). I look forward to discussing how we can advance that organization's ongoing successful work in serving seniors and individuals living with a physical and/or intellectual and developmental disability. I appreciate the wisdom many of you and your staff members shared with me in advance of this hearing. I would also like to thank so many family members, friends, and colleagues who have supported me through this nomination. I wish to especially thank my wife of 23 years, Lori, who joins me here today. I am grateful beyond words for her unwavering love and support and that of our daughters Brooke and Kaitlyn. ACL's mission of maximizing ``the independence, well-being, and health of older adults, people with disabilities across the lifespan, and their families and caregivers'' is critical. ACL currently serves more than 140 million Americans and this population continues to grow. Ensuring choice, independence, and meaningful community inclusion is the hallmark of ACL's work and my life's mission. As Assistant Secretary, my vision would involve a four-pronged, overarching strategy that positively impacts all populations. 1. The first strategy is to improve access to information about long-term services and supports that are available both with publicly funded and private-sector resources. Many Americans are unsure where to turn when confronted with an illness, disability, service need, or when they stumble into the role of a caregiver. 2. The next strategy focuses on supporting caregivers. The informal caregiver and the service he or she provides is the epicenter of the long-term services and supports system. Our Nation must recognize how critically important it is that we help the 44 million unpaid family caregivers whose work to the care system is estimated at $470 billion a year. Under my leadership we will continue to bolster respite vouchers, promote evidence-based solutions, and build support systems that work. We will continue to seek ways to meet caregivers where they are and equip them with the tools needed to be successful in their roles. 3. The third strategy is dedicated to strengthening elder justice. Far too many older adults are exploited and abused, and we must continue to aggressively fight this growing epidemic. Strong momentum can be seen, however, through the work of the multi-agency Elder Justice Coordinating Committee, the recent release of innovation grants funded through ACL, and the new bipartisan congressional caucus focused on this issue. 4. The final strategy is increasing our network's business acumen. Non-profit aging and disability community-based organizations work hard every day to feed, support, transport and assist individuals. These organizations are the backbone of our effort to promote independence, well-being and quality of life for older adults and people living with disabilities. If confirmed, I look forward to working with the great team at ACL. As a collective body, ACL boasts a cadre of intelligent, committed and impressive individuals. As you fulfill your important role of confirming nominees, I am certain you look for individuals who not only have the requisite experience and skills but preferably convince you that their commitment is unmatched and possibly even galvanized by personal experience. I humbly submit to you that I meet such criteria with nearly a quarter century of public service experience, a graduate degree in public administration, holding national leadership roles, and comprehensive experience in directing aging and disability network programs. I am humbled and appreciative of the endorsements that I have received from organizations across the aging and disability networks. It is my hope that when you review the letters of support it will assure you of the abilities that I would bring to this position if I am confirmed. Having been partially raised by my grandparents, served as a caregiver, and having a niece living with significant disability affords me a personal view of ACL's important work. Never does a day go by that I'm not impressed with the resiliency of those we serve. In most cases, particularly through programs offered by ACL, these individuals just need a little help--a meal, assistance with employment, transportation to the doctor, a referral to a community organization, a bit of respite, etc. We help by supporting the least expensive and preferred home and community-based care where it is desired. I believe whole-heartedly in our work to offer choices, empower people, and support families across the care spectrum. We help Americans live healthy, productive and independent lives in their community. Our work is vital. I wish to thank President Trump for his nomination, support and confidence and I am excited to work under Secretary Price's leadership if confirmed. Thanks to each of you for the outstanding leadership and passion you provide each day on behalf our great country. If confirmed, I look forward to working with you and your staff. Mr. Chairman, I thank you for the opportunity to be with you today. The Chairman. Thank you, Mr. Robertson. Dr. Giroir. STATEMENT OF BRETT GIROIR, M.D., NOMINATED TO BE ASSISTANT SECRETARY FOR HEALTH, COLLEGE STATION, TX Dr. Giroir. Chairman Alexander, Ranking Member Murray, members of the committee. Thank you for the invitation to testify before you here today. I am especially grateful to the many committee members who spent time meeting with me individually to engage in truly substantive discussions about important health issues facing our Nation. I am honored to appear before you as the President's nominee to be the Assistant Secretary for Health, and I am very pleased to be joined here today by my wife, Jill, of 32 years; my mother Freida, a retired police officer and cancer survivor; and our younger daughter Madeline. Not here today is our older daughter Jacqueline, who just recently delivered our first grandchild, Isabel; her husband Erik, an Iraq veteran; and my late father Frank, also a police officer and a veteran, who would have been truly honored to be here today. As this committee well knows, the Assistant Secretary for Health is the senior advisor to the Secretary of Health and Human Services on issues of public health and science. Component offices--including the Office of the Surgeon General, the National Vaccine Program Office, the Office of Disease Prevention and Health Promotion, the President's Council on Fitness, Sports and Nutrition, and the Offices of Adolescent Health, Minority Health, Women's Health, Population Affairs, and HIV/AIDS and Infectious Disease Policy--provide leadership and coordination across the U.S. Government for a vast array of science and public health issues that touch nearly every single American. Should I be fortunate enough to gain your confidence and be confirmed, I will be a passionate advocate for policies, programs, research, and innovative solutions to enhance the health of all Americans, and especially support initiatives that reduce our current disparities in mortality and suffering. There are no silver bullets, but I believe the pathway is clear, emphasize prevention and early detection by empowering individuals and groups; embrace science and data; welcome new data; listen to all stakeholders, especially those with diverse viewpoints; foster an innovative environment that maximizes the creativity of academia and the private sector; remain humble; and as a physician, I always focus on patients and their families. Because of my parents' emphasis on education, I became the first member of my family to attend college and graduated from Harvard University. I chose to attend medical school in Dallas at the University of Texas Southwestern Medical Center, not only for their renowned faculty, but for the opportunity to provide compassionate care to patients at one of our Nation's preeminent safety net public hospitals, that is, Parkland Memorial Hospital. I completed a residency and chief residency in pediatrics and then a fellowship in pediatric critical care medicine. I remained on the faculty at UT Southwestern for 10 years, becoming a tenured professor, associate dean, and chief medical officer at Children's Medical Center where I was privileged to care for thousands of critically ill children and their families. My career then took an unexpected turn when I was recruited by the Defense Advanced Research Projects Agency, also known commonly as DARPA. I joined a science and technology assessment committee, and ultimately DARPA itself as the Deputy Director, and then the Director of the Science Office. I learned very quickly that when the Government can effectively collaborate with academic and industry partners, there can be unimagined advances in medicine and human health. In this regard, one of the most meaningful accomplishments of our DARPA team was the development of a revolutionary prosthetic upper limb that restored near-normal human capabilities, and could be controlled by muscles, by nerves, or even directly by the brain. Following my assignment at DARPA, I have remained dedicated to disease prevention, patient empowerment, and the development of new vaccines and treatments for infectious diseases and cancer. I am called to the Assistant Secretary for Health position for one reason, and that is to do whatever I can to enhance the health of our Nation. To do so will require broad collaboration, public engagement, and bold initiatives. I will do everything also in my authority and ability to support, advance, and advocate for the Commissioned Corps of the U.S. Public Health Service, which for more than 200 years has been America's warriors against disease with the enduring mission to protect, promote, and advance the health and safety of our Nation. I thank you again for the opportunity to appear before you and welcome your questions. [The prepared statement of Dr. Giroir follows:] Prepared Statement of Brett Giroir, M.D. Chairman Alexander, Ranking Member Murray, members of the committee, thank you for the invitation to testify before you today. I am especially grateful to the many committee members who spent time meeting with me individually to engage in substantive discussions about important public health issues facing our Nation. I am honored to appear before you as the President's nominee to be Assistant Secretary for Health, and am pleased to be joined here by my wife of 32 years, Jill, my mother Freida--a retired police officer and cancer survivor--and our younger daughter Madeline. Not here today is our older daughter Jacqueline, who just recently delivered our first grandchild, her husband Erik--an Iraq veteran--and my late father Frank, also a police officer and a veteran, who would have been truly honored to attend this hearing. As this committee well knows, the Assistant Secretary for Health is the senior advisor to the Secretary of Health and Human Services on issues of public health and science. Component offices--including the Office of the Surgeon General, the National Vaccine Program Office, the Office of Disease Prevention and Health Promotion, the President's Council on Fitness, Sports and Nutrition, and the Offices of Adolescent Health , Minority Health, Women's Health, Population Affairs, and HIV/ AIDS and Infectious Disease Policy--provide leadership and coordination across the U.S. government for a vast array of science and public health issues that touch nearly every single American. Should I be fortunate enough to gain your confidence and be confirmed, I will be a passionate advocate for policies, programs, research, and innovative solutions to enhance the health of all Americans, and especially support initiatives that reduce our current disparities in mortality and human suffering. There are no silver bullets, but the pathway is clear: elevate prevention and early detection by empowering individuals and groups; embrace science and welcome new data; listen to all stakeholders especially those with diverse viewpoints; foster an innovative environment that maximizes the creativity of academia and the private sector; remain humble; and always focus on patients and their families. Because of my parent's emphasis on education, I became the first member of my family to attend college, and graduated from Harvard University. I chose to attend medical school in Dallas at the University of Texas Southwestern Medical Center in Dallas, not only for their renowned faculty, but mainly for the opportunity to provide compassionate care to patients at one of our Nation's preeminent safety net public hospital--Parkland Memorial Hospital. I completed a residency and chief residency in pediatrics and then a fellowship in pediatric critical care medicine. I remained on the faculty at UT Southwestern for 10 years, becoming a tenured professor, associate dean, and chief medical officer at Children's Medical Center where I was privileged to care for thousands of critically ill children and their families. My career then took an unexpected turn, when I was recruited by the Defense Advanced Research Projects Agency, commonly known as DARPA. I joined a science and technology assessment committee, and ultimately DARPA itself as the Deputy Director, and then Director, of the Science Office. I rapidly realized that when the government collaborates with academic and industry partners, there can be unimagined advances in medicine and human health. In this regard, one of the most meaningful accomplishments of our DARPA team was the development of a revolutionary prosthetic upper limb that restored near-normal human capabilities, and could be controlled by muscles, nerves, or even directly by the brain. Following my assignment at DARPA, I have remained dedicated to improving disease prevention, patient empowerment, and the development of new vaccines and treatments for infectious diseases and cancer. I truly feel called to the Assistant Secretary for Health position for one reason, and that is, to do whatever I can to enhance the health of our Nation. To do so will require broad collaboration, public engagement, and bold initiatives. I will also do everything in my power and abilities to support and advance the Commissioned Corps of the U.S. Public Health Service, which for more than 200 years, has been America's warriors against disease, with the mission to protect, promote, and advance the health and safety of our Nation. I thank you again for the opportunity to appear before you and welcome your questions. The Chairman. Thank you. Is it Giroir? Dr. Giroir. Yes, sir. The Chairman. I said it right. Good. Thank you. I did not want to say it wrong. Thank you very much. Dr. Kadlec. STATEMENT OF ROBERT KADLEC, M.D., NOMINATED TO BE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, ALEXANDRIA, VA Dr. Kadlec. Thank you, Chairman Alexander, and Ranking Member Murray, members of the Senate HELP Committee. It is a privilege to appear before you today as you consider my nomination for the position of Assistant Secretary for Preparedness and Response. Mr. Chairman, there are many I need to thank for this opportunity; President Trump and Secretary Price for their confidence in my abilities and nominating me for this position. The many who have encouraged, and supported, and assisted me through this process, and my family--my wife Ann, daughters Margaret and Samantha, who are rising high school seniors and who are currently on the Bataan Death March of college tours. They have supported me and will enable me to take on this responsibility, should I be confirmed. I would also like to acknowledge classmates, colleagues, friends, and fellow committee staff who are here or watching from their offices. I want to specifically recognize my colleagues at the Senate Intelligence Committee who, like many congressional staff, get far too little recognition for their dedicated, selfless, and important service to our Nation. The prospect of becoming the ASPR is both exciting and daunting. Having been a HELP Committee staffer who assisted drafting the original position description under the great leadership of Senator Richard Burr and the late Senator Ted Kennedy, I have firsthand insight into the rationale of why HHS and the Nation needed someone to be in charge of coordinating medical and public health preparedness and response. A decade ago, incidents like September 11, the anthrax letters, Hurricane Katrina, and the potential for a deadly influenza all demanded that we improve the Federal Government's ability to assist State and local health authorities, and mobilize the private sector in responding to future events. The need now is as real and urgent as it was then. The mission of ASPR can be distilled in just a couple of words, and that is, to save lives. I can conceive of no greater duty or higher calling than this. If confirmed, I will fully accept the responsibility to do everything reasonable and appropriate to prepare for and respond to the spectrum of threats that endanger Americans, our national security, and our way of life. If confirmed, I pledge to you my all in pursuit of this mission and will work 24-7-365 to fulfill the ASPR's duties. Having spent the last 2\1/2\ years on the Senate Intelligence Committee, I have had the unique privilege to learn in exquisite detail the many threats and challenges that confront our country, in particular those emerging as clear and present dangers today. The threat landscape before us is more diverse and more lethal than the one after September 11. When I last sat in this hearing room in 2006 as a HELP staffer, ISIL did not exist; North Korea did not possess both the nuclear weapons, and the missiles and means to attack our homeland; the use of chemical weapons by terrorists and by the Syrian government on defenseless citizens was a concern, not a routine occurrence; and the risks of cyber warfare were still largely hypothetical. Today, all these and other challenges exist in a way that makes the mission of ASPR more important. If confirmed, there are five priority issues that I will pursue. First, provide strong leadership. Lead the capable and dedicated men and women of ASPR, provide them clear policy direction, improve their threat and situational awareness, advocate for, and secure, adequate resources for the ASPR mission. Second, create a national contingency healthcare system that better organizes, trains, and equips our State and local healthcare systems, facilities, and providers to ensure that they cannot only better respond to routine emergencies, but to extraordinary events that are likely to occur. Here we have an opportunity to better integrate Emergency Medical Services, the tip of the spear of our national medical response, into these efforts, and to increase effective coordination across HHS and the Federal departments, such as the Department of Defense and the Department of Veterans Affairs, to support State and local responders. Third, support CDC and the sustainment of robust and reliable public health security capabilities that include an improved ability to detect and diagnose infectious diseases and other threats, as well as the capacity to rapidly characterize and attribute them. Fourth, reinvigorate and advance an innovative medical countermeasure enterprise. We must capitalize on advances in biotechnology and science to develop and maintain a robust stockpile of safe and efficacious vaccines, medicines, and supplies to respond to emerging disease outbreaks, pandemics, and chemical, biological, radiological, and nuclear incidents or attacks. Finally, work with you and your staff on the reauthorization of the Pandemic and All-Hazards Preparedness Act in 2018 to further strengthen our Nation's readiness and response for 21st century threats. I would like to close by simply thanking you for your consideration and the prospect of continuing to serve our great Nation, if confirmed. [The prepared statement of Dr. Kadlec follows:] Prepared Statement of Robert Kadlec, M.D. Chairman Alexander and Ranking Member Murray, members of the Senate HELP Committee, it is both a privilege and special opportunity to appear before you today as you consider my nomination for the important position of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS). Mr. Chairman there are many I need to thank for this opportunity: President Trump and Secretary Price for their confidence in my abilities and nominating me for this position; the many who have encouraged and assisted me through this process; and my family--my wife Ann, daughters Margaret and Samantha--who have supported me and will enable me to take on this responsibility should I be confirmed. I would also like to acknowledge classmates, colleagues, friends and fellow committee staff who are here or watching from their offices. I want to specifically recognize my colleagues at the Senate Intelligence Committee who, like many congressional staff, get far too little recognition for their dedicated, selfless and important service to our Nation. As I sit here, the prospect of becoming the ASPR is both exciting and daunting. Having been a HELP Committee staffer who assisted drafting the original position description under the great leadership of Senator Richard Burr and the late Senator Ted Kennedy, I have firsthand insight into the rationale why HHS and the Nation needed a single leader to be responsible for coordinating medical and public health preparedness and response. Ten years ago, incidents like the September 11, 2001 attacks on our country, the deadly anthrax letters, Hurricane Katrina, and the potential for an influenza pandemic all demanded that we improve the Federal Government's ability to assist State and local health authorities and mobilize the private sector in responding to future events. The need now is as real and urgent as it was then. To distill the ASPR mission to just a couple of words, it is to ``save lives.'' As a physician, I can conceive of no greater honorable duty or higher calling than this. If confirmed, I fully accept the responsibility to ensure that we do everything reasonable and appropriate to prepare for and respond to a spectrum of 21st century threats that endanger Americans, our national security, and our way of life. If confirmed, I pledge to you my all in pursuit of this mission and will work 24-7-365 days a year to fulfill the ASPR's duties. Having spent the last 2\1/2\ years working on the Senate Intelligence Committee, I have had the unique privilege to learn in exquisite detail the many threats and challenges that confront our country, in particular those emerging as clear and present dangers today. The threat landscape before us is more diverse and more lethal than the one that we confronted after September 11. When I last sat in this hearing room in 2006 as a HELP staffer ISIS did not exist; North Korea did not possess both nuclear weapons and the missiles to attack our homeland; the use of chemical weapons by terrorists and by the Syrian Government on defenseless citizens was a concern, not a routine occurrence; and the risks of cyber warfare were still largely hypothetical. Today, all these and other challenges exist in a way that makes the mission of ASPR more important and urgent. We must redouble our readiness efforts and improve capabilities for these and other threats. There are five priority issues that I will pursue if confirmed. First, provide strong leadership, including clear policy direction, improving threat and situational awareness, advocating for and securing adequate resources. Second, seek the creation of a ``national contingency health care'' system. There is an urgent need to better organize, train and equip our State and local healthcare systems, facilities and providers to ensure that they cannot only better respond to routine emergencies but to extraordinary events that are likely to occur. Here we have an opportunity to better integrate Emergency Medical Services, the ``tip of the spear'' of our national medical response into these efforts and to increase effective coordination across HHS and the Federal departments, such as the Department of Defense and the Department of Veterans Affairs, to support State and local responders. Third, support the sustainment of robust and reliable public health security capabilities that include an improved ability to detect and diagnose infectious diseases and other threats, as well as the capacity to rapidly characterize and attribute them. Fourth, re-invigorate and advance an innovative medical countermeasures enterprise. We must capitalize on advances in biotechnology and science to develop and maintain a robust stockpile of safe and efficacious vaccines, medicines and supplies to respond to emerging disease outbreaks, pandemics, and chemical, biological, nuclear and radiological incidents and attacks. Finally, work with you and your staff on the reauthorization of the Pandemic and All-Hazards Preparedness Act in 2018 to strengthen our Nation's readiness and response for 21st century threats. Last, I simply wish to thank you all for your consideration and the prospect of continuing to serve our great Nation. The Chairman. Thank you, Dr. Kadlec. Dr. McCance-Katz, welcome. STATEMENT OF ELINORE F. McCANCE-KATZ, M.D., NOMINATED TO BE ASSISTANT SECRETARY FOR MENTAL HEALTH AND SUBSTANCE USE, CRANSTON, RI Dr. McCance-Katz. Chairman Alexander, Ranking Member Murray, and members of the committee. I am honored to be here today. I want to thank you for inviting me here today to consider my nomination as Assistant Secretary for Mental Health and Substance Use. I come from a family that has placed service to our country as their highest calling, starting with my late grandfather, William J. McCance, who served in World War II and participated in both the North African and the D-Day invasions. My father, William Thomas McCance, is a career Navy submarine force veteran who rose to the highest enlisted ranks as Master Chief Hospital Corpsman. My mother, Anna McCance, as the wife of a navy chief of the boat, comforted and cared for the families of sailors on the submarines on which my father served, faithfully demonstrating that spouses also share in the defense of our Nation. I am happy to have my husband, Michael Katz, sitting behind me, here with me today, as well as my daughters, Anna and Heather. Our son, Josh, could not be here today, but they have all been a source of support and joy to me. Service to our country was modeled to me in my family, and I look forward to continuing this tradition, if I am confirmed. I am a psychiatrist, and I am sub-specialized in addiction psychiatry. From my 30 years of caring for patients, I have had the opportunity to learn a significant amount about mental and substance use disorders. I have also had the opportunity to work in both State and Federal Government, so I have unique insight into the challenges the current regulatory regime poses for assisting people with these illnesses; experiences that I believe have helped prepare me to implement the statutes enacted by Congress and signed into law by the President. Our country faces very serious challenges in mental health and substance use, and the position for which I am being considered heralds a new era in the treatment and care needs of Americans through recent landmark legislation including the 21st Century Cures Act and the Comprehensive Addiction and Recovery Act. These laws, in addition to other congressional legislative guidance, will allow more effective use of Federal funds at SAMHSA and coordination of funding initiatives at other agencies to better serve Americans. If confirmed, I would prioritize two areas, addressing the opioid epidemic and focusing on those with serious mental illness. Our Nation is afflicted by a crisis of opioid addiction, overdose, and death. Sadly, to a large extent, this is a crisis that has grown out of ill-informed and misguided attempts to address issues of pain. Data from the National Survey on Drug Use and Health tell us that 54 percent of mis-users obtained opioid medications free from friends and relatives, while 34 percent admit to misusing opioids prescribed by their doctor for pain management. The data teaches us important lessons about prevention and treatment issues. We must educate Americans on safe and appropriate use of pain medications. Innovative approaches to healthcare practitioner training should address effective pain management, identification, and treatment of substance use disorders, as well as frequently co-occurring mental disorders. Increasing access to care and recovery services is critically important to addressing the opioid epidemic. Evidence-based, medication-assisted treatment, peer specialists, and a growing array of community supports are essential underpinnings of recovery and form the basis of a collaborative care model that can best serve Americans. For too long, the care and treatment needs of the most seriously mentally ill Americans have been neglected. SAMHSA national survey data indicate that 35 percent of Americans with the most serious mental illnesses receive no treatment whatsoever. In addressing this, SAMHSA must assure that program funding supports evidence-based early intervention, treatment, and recovery services. We are fortunate to have stakeholders from many complementary disciplines who are ready and willing to collaborate to help meet this goal. We must focus on evidence- based services including psychiatric care, medication, and psychotherapy treatments in collaboration with peer support and other community-based services designed to provide the resources needed to assure the best possible outcomes. We must also work to include the families of those with serious mental illness in the discussion of their loved one's needs. If confirmed, I would look forward to working with Congress and stakeholder groups on how to share information urgently needed to assure care and safety of a person, while also paying attention to their privacy needs and their rights. If confirmed, I will be attentive to the concerns of Congress. I look forward to your guidance and input, and I will work very hard to implement Congress' vision informed by stakeholders and enacted through legislation. I look forward to answering your questions. [The prepared statement of Dr. McCance-Katz follows:] Prepared Statement of Elinore F. McCance-Katz, M.D. Chairman Alexander, Ranking Member Murray, and members of the committee, I am honored to be here today. I want to thank you for inviting me here today to consider my nomination as Assistant Secretary for Mental Health and Substance Use. I come from a family that has placed service to our country as their highest calling, starting with my late grandfather, William J. McCance, who served in World War II and participated in both the North African and the D-Day invasions. My father, William Thomas McCance, is a career Navy submarine force veteran who rose to the highest enlisted ranks as Master Chief Hospital Corpsman. My mother, Anna McCance, as the wife of a Navy Chief of the Boat, comforted and cared for the families of sailors on the submarines on which my father served-- faithfully demonstrating that spouses also share in the defense of our Nation. I am happy to have my husband, Michael Katz, here with me today as well as my daughters, Anna and Heather. My son, Josh, could not be here. They have all been a source of support and joy. Service to our country was modeled to me in my family and I look forward to continuing this tradition, if I am confirmed. I am a psychiatrist, and I am subspecialized in Addiction Psychiatry. From my 30 years caring for patients, I have had the opportunity to learn a significant amount about mental and substance use disorders. I have also had the opportunity to work in both State and Federal Government, so I have unique insight into the challenges the current regulatory regime poses for assisting people with these illnesses--experiences that I believe have helped prepare me to implement the statutes enacted by Congress and signed into law by the President. Our country faces very serious challenges in mental health and substance use, and the position for which I am being considered heralds a new era in the treatment and care needs of Americans through recent landmark legislation including the 21st Century CURES Act and the Comprehensive Addiction and Recovery Act. These laws, in addition to other congressional legislative guidance, will allow more effective use of Federal funds at SAMHSA and coordination of funding initiatives at other agencies to better serve Americans. If confirmed, I would prioritize two areas: addressing the opioid epidemic and focusing on those with serious mental illness. Our Nation is afflicted by a crisis of opioid addiction, overdose and death. Sadly, to a large extent, this is a crisis that has grown out of ill-informed and misguided attempts to address issues of pain. Data from the National Survey on Drug Use and Health tell us that 54 percent of mis-users obtained opioid medications free from friends and relatives while 34 percent admit to misusing opioids prescribed by their doctor for pain management. The data teaches important lessons about prevention and treatment issues. We must educate Americans on safe and appropriate use of pain medications. Innovative approaches to healthcare practitioner training should address effective pain management, identification and treatment of substance use disorders as well as frequently co-occurring mental disorders. Increasing access to care and recovery services is critically important to addressing the opioid epidemic. Evidence-based medication-assisted treatment, peer specialists and a growing array of community supports are essential underpinnings of recovery and form the basis of a collaborative care model that can best serve Americans. For too long, the care and treatment needs of the most seriously mentally ill Americans have been neglected. SAMHSA national survey data indicates that 35 percent of Americans with the most serious mental illnesses receive no treatment whatsoever. In addressing this, SAMHSA must assure that program funding supports evidence-based early intervention, treatment and recovery services. We are fortunate to have stakeholders from many complementary disciplines who are ready and willing to collaborate and help meet this goal. We must focus on evidence-based services including psychiatric care, medication and psychotherapy treatments, in collaboration with peer support and other community-based services designed to provide the resources needed to assure the best possible outcomes. We must also work to include the families of those with serious mental illness in the discussion of their loved one's needs. If confirmed, I would look forward to working with Congress and stakeholder groups on how to share information urgently needed to assure care and safety of a person while also paying attention to their privacy rights. If confirmed, I will be attentive to the concerns of Congress. I look forward to your guidance and input, and I will work very hard to implement Congress's vision informed by stakeholders and enacted through legislation. I look forward to answering your questions. The Chairman. Thank you, Dr. McCance-Katz. Dr. Adams. STATEMENT OF JEROME ADAMS, M.D., NOMINATED TO BE SURGEON GENERAL OF THE PUBLIC HEALTH SERVICE, FISHER, IN Dr. Adams. Chairman Alexander, Senator Murray, members of the committee. Thank you for the invitation to testify today. I also wish to thank President Trump, Vice President Pence, Governor Holcomb, and the Indiana congressional delegation, friends, and supporting organizations, and my family. Especially my very well-dressed mother and father, who you see behind me, and my beautiful little daughter, Millie. I had to pay her a whole lot to do that. [Laughter.] I am taking her to your office afterwards to get Good Humor, Chairman Alexander. He has a whole ice cream refrigerator in his office, in case you all did not know. [Laughter.] And my wonderful wife, Lacey, without whose support I would not be here today. Thank you, honey. Both the position of Surgeon General, and the U.S. Public Health Corps that the Surgeon General leads, are integral to our national health education and response capabilities. The U.S. Public Health Corps is an elite team of over 6,500 highly qualified health professionals. The Corps serves as our national health army, deploying whenever man-made or natural crises place our public's health at risk. Whether we are facing infectious diseases like Ebola and Zika, or natural disasters like Hurricane Katrina, or human- caused tragedies like the opioid epidemic, our country and world deserve and need this ready to respond army of health experts. Many people call the U.S. Surgeon General the Nation's top doctor. This title does not do justice to the professions represented in the Health Corps: nurses and doctors, dentists and therapists, scientists, and some of the country's best doctors. The further suggestion that as a top doctor, I can be all things to health does not give proper consideration to the vital role partnerships play in the success of this position. The position of Surgeon General carries with it a tremendous power to convene and to facilitate important health and wellness discussions. Therefore, the real power of the position comes from the wide array of national health crusaders that can be mobilized if the platform is used properly. I would next like to share with you why I feel I can uniquely contribute to the role of Surgeon General. Not only have I earned a Master's Degree in Public Health with an emphasis in chronic disease prevention from Berkeley, but I have served as the Indiana State Health Commissioner, in essence the Surgeon General for Indiana, for the past 2\1/2\ years. In that role, I have personally overseen our State's response to Ebola and Zika, and a rural HIV outbreak related to injection drug use, and also overseen the State's Health and Human Services and Tobacco Cessation Commissions, the State's Public Health Laboratory, and its Health Care Quality and Regulatory division. I also continue to practice as a physician anesthesiologist at Eskenazi Health, a Level One trauma center and a safety net hospital, and serve as clinical associate professor of anesthesia at Indiana University School of Medicine. In these dual roles as both clinician and educator, I see the impact of health policy decisions on both providers and patients each and every day. My final and toughest, but also my most important, job is serving as father and mentor to my 7-, 11-, and 13-year-old children. That means for every policy decision, I not only sympathize, but empathize with all parents regarding the potential impact. With a bit more of your indulgence, I will briefly address what I hope to be my priorities, if confirmed. Our Nation is facing a crisis. The addictive properties of opioids are a scourge on our country. Secretary Price has declared the opioid epidemic and the untreated mental illness, which lie at the root of much of the current situation, as top priorities. I share his urgency, and feel I bring to this discussion a unique perspective, and a proven track record of partnering with various groups to address the problem. If confirmed, I also hope to make wellness, and community, and employer engagement centerpieces of my agenda. We will not successfully tackle the opioid epidemic, or obesity, or healthcare access and cost, if we continue to focus downstream. Too much of our focus is on providing care after a person has already developed a disease, but this frequently represents many missed opportunities for prevention. Our health starts in the communities where we live, learn, work, play, and go to school. We need to partner with communities and empower them to implement local solutions to their toughest problems. I know it may sound like a cliche, but if confirmed, I truly hope to make America healthier. Healthy people and communities are more productive, and profitable, and in turn attract more jobs and prosperity. Unfortunately, however, American prosperity and competitiveness are being compromised by America's poor health. Major corporations know this, and in many ways, they are doing better than our own health institutions to address the health and wellness of their employees. We must work with the business community to share best practices and to reach beyond the workplace. Our goal should be to truly develop and rebuild communities around wellness and prosperity. I would like to close my remarks by saying I cannot promise you that we will be in agreement on all health and health policy matters. The truth is we will not. I cannot promise you that the office of the Surgeon General can fix all of the health and healthcare problems plaguing our Nation. What I can, in fact, promise you is my unwavering commitment to finding the best, and presenting the best scientific evidence, in both internal policy discussions and external educational endeavors. I promise you I will continue my strong and well-documented track record of reaching out to everyone regardless of their politics, beliefs, culture, or geography. I promise you that, if confirmed, I will truly seek to be the Surgeon General for all of our United States to the best of my ability, a champion for everything our country aspires to be in terms of health and wellness. I look forward to your questions, and thank you for the opportunity, Mr. Chairman and Madam Ranking Member. [The prepared statement of Dr. Adams follows:] Prepared Statement of Jerome Adams, M.D. Chairman Alexander, Ranking Member Murray, members of the committee: Thank you for the invitation to testify before you today. I also wish to thank President Trump and Vice President Pence, Governor Holcomb and the Indiana congressional delegation, my family, friends, and supporting organizations. It is a tremendous honor and opportunity to appear before you today as the President's nominee to be our Nation's next Surgeon General. If confirmed I would serve as our country's 20th Surgeon General, representing 180 years of public health leadership from the position. I assure you I do not take this legacy lightly. Both the position of Surgeon General, and the U.S. Public Health Corps that the Surgeon General leads, are an extremely important component of our national health education and response capabilities. The Commissioned Corps of the U.S. Public Health Service Corps is one of the seven uniformed services, and is an elite team of over 6,500 highly qualified health professionals. The Health Service Corps serves as our national health army, ready to deploy whenever a man-made or natural crisis has placed our public's health at risk. Whether we are facing infectious diseases like Ebola and Zika, or natural disasters like earthquakes and Hurricane Katrina, or human- caused tragedies like 9/11 and the opioid epidemic, our country and our world deserve and need this ready-to-respond army of health experts. This army deserves and needs a qualified leader--the U.S. Surgeon General. Many people call the U.S. Surgeon General the Nation's ``Top Doctor.'' This moniker doesn't do justice to the diversity of professions represented in the Health Corps--nurses, pharmacists, therapists, scientists, and many others, in addition to some of the country's best doctors. The further insinuation that one person can be all things to health also doesn't give proper consideration to the vital role partnerships play in the success of this position. The position of Surgeon General carries with it a tremendous power to convene supporters (as well as detractors), and to facilitate important health and wellness discussions. The power of the position comes not merely from the individual occupying it, but rather from the even wider array of health crusaders that can be mobilized from a multitude of sectors across our country, if the platform is used properly. Having shared a little of what I think the position of Surgeon General represents, I'd next like to share with you why I feel I can make a unique contribution in this role. The position of Surgeon General must have ``specialized training or significant experience in public health programs.'' Not only have I earned a Master's Degree in Public Health with an emphasis in Chronic Disease Prevention from UC Berkeley, but I have served as the Indiana State health commissioner-- in essence the surgeon general for Indiana--for the past 2\1/2\ years. In that role, I have overseen our State's response to Ebola, Zika, and a rural HIV outbreak related to injection drug use, and also overseen Indiana's tobacco cessation efforts, the State's Public Laboratory, and its Health Care Quality and Regulatory division. In addition to serving as Health Commissioner, I continue to practice as a physician anesthesiologist at Eskenazi Hospital--a level one trauma center with a busy obstetrical service--and serve as Clinical Associate Professor of Anesthesia at Indiana University School of Medicine. In this dual role as both clinician and educator, I see the impact of health policy decisions on both providers and the patients we serve, and I have been honored to receive awards from my institution and peers for my ability to educate, empower, and excite, our next generation of health leaders. My final and toughest, but also my most important, job is to serve as father and mentor, to my 7-, 11-, and 13-year-old children. My status as a father is significant as you consider my nomination, because for every policy discussion I take part in, I not only sympathize, but empathize, with parents regarding the potential impact. When making decisions, I literally have no choice but to think about both the immediate impact on our Nation's children--my own children included--and the world I am leaving for future generations. With a bit more of your indulgence, I will now briefly address what I hope to be my priorities if I'm confirmed. Our Nation is facing a drug crisis. The addictive properties of prescription opioids is a scourge in America and it must be stopped. Secretary Price has declared addressing the opioid epidemic, and untreated mental illness, which lie at the root of much of the current situation, as among his top priorities. I share the Secretary's urgency at addressing this crisis and feel I bring to this discussion a unique perspective, and a proven track record of bringing together various groups to address the problem. I also would make wellness and community and employer engagement a centerpiece of my agenda, if confirmed. We will not successfully tackle the opioid epidemic, or obesity, or healthcare access and cost, if we continue to focus on how we handle these problems after they've taken hold. Much of our national focus is on providing care after a person has already developed a disease, but far too often this represents multiple missed--and more cost-effective--opportunities to have mitigated or even prevented the problem. We also won't be able to solve these problems from Washington, DC. Our health starts in the communities where we live, learn, work, play, and go to school. We need to get out into those communities, learn about their obstacles and successes, share best practices, and help empower them to implement local solutions to their toughest problems. I know it may sound like a cliche but if confirmed, I hope to make America healthier. Healthy people and communities are more productive, and profitable, and in turn attract more jobs and prosperity. Poor health, however, is proving to be a drag on our country's prosperity and worldwide competitiveness. Major corporations know this, and in many ways are doing better than our own health institutions to address the health and wellness of their employees. We need to work with the business community in a reciprocal relationship, to share best practices, and go beyond the workplace. Our goal should be to truly develop and rebuild communities around wellness, and prosperity. I'd like to close my remarks by saying that I can't promise you that we will be in agreement on all health and health policy matters-- we won't. I can't promise you that the office of the Surgeon General can fix all of the health and healthcare problems plaguing our Nation. What I can in fact promise you is my unwavering commitment to finding and presenting the best scientific evidence, in both internal policy discussions, and external health education endeavors. I promise you that I will continue my strong and well-documented track record of reaching out to EVERYONE--regardless of their politics, beliefs, culture, or geography. I promise you that, if confirmed, I will truly seek to be the Surgeon General for all of our United States--to the best of my ability a champion for everything our country aspires to and can be in terms of health and wellness. I look forward to your questions, and, if confirmed, I look forward to working closely with all of you to improve our country's health. The Chairman. Thank you, Dr. Adams. Thanks to each of you. We will now go to a 5-minute round of questions for the witnesses. We will begin with Senator Cassidy and then go to Senator Murray. Statement of Senator Cassidy Senator Cassidy. Thank you all and I have had a chance to speak with many of you. Dr. Giroir, I actually know how to pronounce your name; that comes from being from Louisiana. Dr. Adams, I enjoyed our conversation. Dr. McCance-Katz, of everybody, you are the one I am most interested in because Senator Murphy and I heard from stakeholders across the country that our Nation's response to mental illness and addiction was failing. We spend billions of dollars and it was failing. You have a great pedigree and I know you have worked in SAMHSA, but it is a big, dysfunctional organization. You cannot throw them under the bus, but I will. What would be your approach, if you can be just specific? How are we going to make it better for the mentally ill person, so that her one episode of psychosis becomes her only episode of psychosis? Dr. McCance-Katz. Thank you for that question, Senator Cassidy. There are a number of things that we need to do. One thing that is really critical is that we need to increase the number of healthcare providers, mental healthcare providers in this country. We will probably never have enough psychiatrists or addiction psychiatrists. There are just not that many being produced every year. Senator Cassidy. So, then? Just because I only have a couple of minutes. Dr. McCance-Katz. Yes. Senator Cassidy. If that is the case, what do we do to mitigate that? What do we do to expand the effectiveness of those whom we have, knowing that the development of a workforce takes years and we have a problem now? Dr. McCance-Katz. Yes, and so we can train allied health professionals much more rapidly than psychiatrists: nurse practitioners, advanced practice registered nurses, physician assistants. Senator Cassidy. I accept that. Moving on from workforce development, what next? I do not mean to be rude. I just have a few minutes and he is about to rap me. Dr. McCance-Katz. Yes. Also, innovative ways of delivering care such as telemedicine where physicians can be extended through those allied health professionals to lots of areas in the country. Senator Cassidy. Kind of a build out of manpower and woman power shortage. Dr. McCance-Katz. Yes. Senator Cassidy. Moving beyond healthcare worker shortage, what next? Dr. McCance-Katz. To integrate mental health and substance use disorder treatment into primary care settings. Senator Cassidy. The 21st Century Cures, in our bill that Senator Murphy and I had, had that provision to further integrate addressing things such as same day rule, allowing Medicaid to pay both. May I ask, what next? Because all of that, I think we give the tools and the license, if you will, through 21st Century Cures. I think what we are just yearning for is leadership within the Department that will begin to effect these changes. We have given you these tools. Share further about your approach, please. Dr. McCance-Katz. I will just finish by saying that one of the roles of SAMHSA is to disseminate all of this and to speak to the medical community and to American communities about these issues. I think that in doing all of those things, focusing on all of those things, we will be able to expand treatment. Senator Cassidy. That sounds--I think I might have asked the previous director, and he or she may have given the same answer. I do not mean to be harsh. It just is incredible frustration about the lack of a coordinated, efficient, effective response on the Federal bureaucracy side. Particularly, perhaps, one thing we are asking is that you will coordinate across all Federal agencies different services. Any thoughts on how best to execute that? Dr. McCance-Katz. That is one of the parts of the position that was very important to me in reading about it. I think that one of the first things I will be doing is convening with the other Federal agencies that have funding in substance use and mental disorders care, and determining what they are doing, and whether these programs work. One of the things we are going to have to do is look at metrics and determine whether some of the programs we have really work. These things take time to do, but we can do it, and we can make use of the expertise within and also from our communities to help us to do that. States also, they know their communities best, and SAMHSA knows what is going on in States, and so can help in that way as well to disseminate. Senator Cassidy. In some cases, SAMHSA was apparently giving grants to organizations which were skeptical of medications. That would be counterproductive. By the way, I hope I did not seem rude. You are going to have no bigger advocate on this committee to support you except maybe Senator Murphy because we are both incredibly invested in your success. I hope I did not come across as brusque. Dr. McCance-Katz. No. Senator Cassidy. We just feel passionately about the need to address this problem in our society. We thank you all for taking your jobs and thank you in particular. Thank you. The Chairman. Thank you, Senator Cassidy. Thank you, again, for the work that you and Senator Murphy did with Senator Murray, and I, and others last year on the 21st Century Cures bill. A bill is not worth the paper it is written on unless it is implemented properly. We will be watching. Senator Murray. Senator Murray. Thank you very much. Dr. Giroir, let me start with you. If you are confirmed, you are going to oversee both the Office of Population Affairs, which administers Title X Family Planning grants, and the Office of Adolescent Health, which manages the Teen Pregnancy Prevention Program. As I said earlier, I am very concerned by the actions taken by both of these under this Administration. Recently, the Administration notified the grantees that run Teen Pregnancy Prevention programs of plans to terminate their grants 2 years early. These are competitive. They are evidence- based programs. They have reached hundreds of thousands of people nationwide and trained thousands of healthcare professionals. I, along with Senators Baldwin and Booker, led over 30 Senators in writing to Secretary Price to request information on that decision. We have not gotten an answer yet. I wanted to ask you, if you are confirmed, do you commit to providing information to me and other concerned Senators about why the Administration is trying to terminate these grants when they are meant to continue for an additional 2 years? What do you plan to do regarding the Teen Pregnancy Prevention Program? Dr. Giroir. Thank you very much, Senator Murray, for that question. First of all as a pediatrician, I share your concern about teen pregnancy. The good news is that since 2007, the rates of teen pregnancy have been reduced by about 50 percent. The bad news is that in 2015, we still had over 250,000 pregnancies of teen mothers and there are long-term consequences both for the young mother and also for the children. To answer your first question, you have my commitment to work with you and provide information. I think public health is a common goal for all of us. We have to work together. Public health is a team sport. You have, certainly, my commitment as does everyone on the committee. As part of the second part of the question, you certainly have my commitment. The budgetary justification from the Administration stated that the programs in the Teen Pregnancy Program did not significantly influence the drop in teen pregnancy rate. That is all I know about the rationale. Senator Murray. Do you believe that? Dr. Giroir. I have not been able to review the evidence or the assessments that were made in order to achieve that conclusion. The only information I have is the public review, which was very well done in 2015, that looked at the first 5 years of the program. The program was evidence-based. It was community- based. There were many programs that were successful. There were many programs that could not be repeated, but even the lack of repeatability of a program is information we need to know. We need to know what works and does not work. Once I have more information, I look forward to engaging in this discussion vigorously. If fortunate enough to be confirmed, this is certainly very high on my agenda. Senator Murray. I appreciate that. I just want to say for over 40 years, the title X program has provided family planning services across the country. In 2015, the health centers under title X provided nearly 800,000 PAP tests, nearly 5 million tests for sexually transmitted infections, and 1.1 million HIV tests. The Guttmacher Institute estimates that for every dollar invested in family planning, taxpayers save $7. Supporting the title X programs, to me, is really common sense and maintaining the funding for that is one of my top priorities. I wanted to ask you, do you believe that all providers who qualify to provide the services should be considered for inclusion in that program? Dr. Giroir. Thank you for that question, and I know how that is intended. I will absolutely implement the laws as is passed by Congress and given to me faithfully and as they are intended. If there are restrictions that are passed down to me, I am obliged to follow the laws as passed down to me. It is my intent to assure that everyone who needs these services, they are critically important services. They do prevent disease. They prevent cancer. They provide early detection, that those are allowed to be given to women across the board in an affordable way and in an accessible way. Senator Murray. OK. I just have a few seconds, so I am just going to ask for yes or no answers. Making sure that science is priority over politics is important in every one of the offices that you hold. We have seen under this Administration a Surgeon General who was fired before the end of his term. We have seen promotion of theories that have been disproven about immunizations. We have seen hostile efforts to combat HIV and AIDS. Six members of the Presidential Advisory Council on HIV/AIDS felt they had no choice but to quit. I want to make sure that each one of you understands that picking science over politics is a critical part, and I just want a yes or no from each of you. Will you commit to publicly supporting and advocating for science over politics and ideology? I will just go down the row. Dr. Adams. Dr. Adams. An emphatic yes, Senator. Senator Murray. Dr. McCance-Katz. Dr. McCance-Katz. Yes. Absolutely. Senator Murray. Dr. Kadlec. Dr. Kadlec. Yes. Absolutely. Senator Murray. Dr. Giroir. Dr. Giroir. Absolutely, yes. Senator Murray. Mr. Robertson. Mr. Robertson. Yes, Senator Murray. Senator Murray. OK. Thank you very much to all of you. The Chairman. Thank you, Senator Murray. Senator Collins. Statement of Senator Collins Senator Collins. Thank you, Mr. Chairman. Dr. Kadlec, as a member of the Intelligence Committee, I want to thank you for your service there on the staff and let you know how much your expertise will be missed, but I feel like we are giving you up for an even greater cause. Congratulations to you. To Dr. Adams, I want to say that I am certain that it was your testimony before the Aging Committee last year, which I Chair, that led to your appointment to be the next Surgeon General. Dr. Adams. I am absolutely certain of that too, Senator. Senator Collins. That was the right answer. [Laughter.] Dr. McCance-Katz, we discussed in my office the terrible opioid epidemic that my State is struggling with along with so many others. The epidemic affects people of all ages, but it is especially heartbreaking when it affects newborns. According to the CDC, Maine has among the highest rate of Neonatal Abstinence Syndrome in the country. We know that hospital costs for newborns born to addicted mothers average $66,700 nationally compared to $3,500 for those who are without NAS, and most of those costs are paid by the Medicaid program. Even more tragic, I always worry what happens to these children after they go home, these babies who are born to addicted mothers. What special efforts should be undertaken to direct programs toward helping pregnant women who are addicted? Dr. McCance-Katz. There are programs across the country that are for pregnant postpartum women. Those programs have services coordinated for women with childcare issues, and with addiction issues, and they have been very effective. In terms of Neonatal Abstinence Syndrome, we are learning a great deal about how best to treat that. We know that women who have opioid addiction, who do not get medication-assisted treatment, have much higher rates of obstetrical adverse events up to, and including, miscarriage and fetal death. If the standard of care is to give a pregnant woman, who is opioid dependent, medication-assisted treatment, that would be either methadone or buprenorphine. We are starting to learn that not only is methadone effective, but buprenorphine is as effective. There are studies that show that buprenorphine treatment is associated with less severe symptoms of neonatal abstinence, as well as fewer hospital days. Recently, I will say in the last year, we have heard of a new treatment called presumptive treatments, so we do not wait until the infant shows symptoms of neonatal abstinence, which can prolong and make the course more difficult, but start to treat presumptively if we know the mom has been on opioids. Making those kinds of best practices available across this country will do a great deal to address neonatal abstinence syndrome and to reduce the effects on these infants and their families, their moms and their family members. Senator Collins. Thank you. Mr. Robertson, when there is a situation where there is an opioid crisis within a family and the parents are unable to care for the child, it is the grandparents who often come to the rescue. I was listening to your testimony and learning about your own experience in being raised by your grandparents. The number of these kinship families is increasing across the Nation. In Maine alone, the number of such families increased by 24 percent between 2010 and 2015 due to the opioid crisis. We held a hearing in the Aging Committee, Senator Casey and I, and a clear message from that hearing was the need for kinship parents to have greater access to information about the resources that are available to assist them. Senator Casey and I have introduced the Supporting Grandparent Raising Grandchildren Act. It creates a Federal taskforce charged with the development and distribution of information designed to help kinship parents. We think this would help families navigate the school system, plan for their family's financial future, address mental health issues, and build support networks. Do you think that such legislation would be helpful? Mr. Robertson. Thank you, Senator Collins, for that question, and certainly for your ongoing advocacy for caregivers to include grandparents raising grandchildren. I cannot thank you enough for, again, the opportunity to expose an issue that often, in our communities, goes unrecognized or unnoticed and that is that cadre of individuals who offer that kinship care--many grandparents and others who are raising children. You are absolutely right. I think their biggest challenge on Day One is to begin navigating the systems, whether that is the school system, or the medical system, or many other systems they must navigate to successfully raise those children. I think our society depends on it and I know at ACL, we have some programs dedicated to help kinship families and grandparents who are raising grandchildren. Certainly, that would be a priority for me, not just in a professional role, but also with my personal experience as well, and I know that Senator Casey feels the same way as well. I cannot thank you both enough for your championing of caregivers in general and know that I will be right there alongside you doing all that I can. Senator Collins. Thank you. The Chairman. Thank you, Senator Collins. Senator Murphy. Statement of Senator Murphy Senator Murphy. Thank you, Mr. Chairman. I want to thank the Chairman and Senator Murray for their work in helping to pass, at the end of last year, the legislation which authorizes the position for which Dr. McCance-Katz is being nominated for. I look forward to supporting her through the process. The weight on your shoulders will be great as the first Assistant Secretary for Substance Use and Mental Health, but I know that you will be up to the job. I wanted to ask you a question about a subject that we talked about in my office, and that is the sections of the bill which authorizes your positions on the issue of parity, making sure that the insurance companies are covering mental illness. The President's Commission on Combating Drug Addiction and the Opioid Crisis just released their interim report, and in it are recommendations on increasing parity enforcement, especially when it comes to these non-quantitative treatment limitations. I just wanted to ask you to talk for a moment about the steps that your office and the steps that SAMHSA and HHS can take to increase enforcement of the parity law, especially when it comes to these non-quantitative treatment limitations. The ways in which the bureaucracy is often used to restrict someone's access to the mental health or substance abuse system, especially now given that it is part of the President's Commission's recommendations. Dr. McCance-Katz. Thank you, Senator Murphy, for that question. The issue of parity for the treatment of mental and substance use disorders has been an ongoing problem. We hear frequently about families and their loved ones who cannot access the care that they need for any number of reasons. The inability to access payment for those services that they need is certainly a very common theme that is, unfortunately, heard too much. One of the things that I would want to do is spend some time with CMS around issues of how treatment is paid for at this time, and various ways that we might look at facilitating the care of individuals with mental and substance use disorder. Often, there are not a lot of treatment options available. When there are not a lot of treatment options available, there tend to be limits placed that are not appropriate, but are placed because insurers and payers are not as familiar with those interventions. By working collaboratively with CMS, I think that we can come up with some different ways of paying for services and different kinds of services. What do I mean by that? There are often two types of treatments: hospitalization or community outpatient programs. What we need are levels of care and those levels of care can be very difficult to get services paid for. There are economies and efficiencies to be had, and they can be less costly. Senator Murphy. I just want to get another question. I appreciate that. I just would recommend to you that you have new enforcement powers under this piece of legislation. Working collaboratively with CMS is great, but you have new enforcement powers, guidance that you can issue, audits that you can conduct along with other partners named in the legislation. I look forward to working with you on that. Dr. McCance-Katz. Senator, I look forward to your guidance. This would be something that would be very important for me to be made aware of, and I will certainly do those things. Senator Murphy. Thank you very much. Dr. Adams, you have an impressive list of organizations that have endorsed you. Two of them are the American Public Health Association and the American Medical Association, both of which have listed the epidemic of gun violence in this country as a public health hazard. I appreciate our conversation about that in which you noted that you, yourself, are a gun owner. I wanted to ask you about the ability of your office, the ability of you as Surgeon General to address this issue as a public health hazard, as it has been named by several of the leading public health and medical organizations in the country. Dr. Adams. Thank you very much for the question, Senator, and I appreciated the opportunity to speak with you and your staff. As I did mention to you, the caveat is that I am a gun owner and I have my lifetime gun permit. I also work in a Level One trauma center, took care of a gentleman last week who was shot six times. I see it each and every day. I think what we have to do is separate the tool from the perpetrator. Cars are not a public health problem. Car accidents are a public health problem. Guns and gun owners are not inherently a public health problem, but the violence that results absolutely is. There are evidence-based programs, some good ones out in Colorado, where they are bringing law enforcement, gun owners, and the public health community together to look at solutions to lowering the violence. It is not just homicides; it is also suicides. There are more suicides than there are homicides in this country. I think that there are lots of partners out there, if we are just willing to stop demonizing each other and really work together to look at evidence-based programs that help lower violence in children and throughout the country. Senator Murphy. I appreciate your answer. The Chairman. We are running out of time. Senator Murphy. Thank you, Mr. Chairman. I hope you will just look at the evidence that suggests that the propensity to commit a crime with a gun is directly connected to the likelihood that a gun is in close proximity to you. It is a little bit deeper than the problem that you suggest. Thank you, Mr. Chairman. The Chairman. Thank you. Dr. Adams. I look forward to following up with you. The Chairman. Thank you, Senator Murphy. Senator Young. Senator Young. Thank you, Mr. Chairman. Dr. Adams, I commend you for the partnerships I have seen you develop with law enforcement and other stakeholders, and for the evidence-based programming that you catalyzed, that you helped bring to bear as Indiana's State Health Commissioner. I am speaking specifically about the opioid epidemic that afflicted Austin, IN. I represented Scott County, IN when I was a Member of Congress, so I spent a lot of time on the ground there with you discussing this crisis. You helped educate me. You led in a very big way. This was one of the worst documented HIV outbreaks in the entire country. Many here present, colleagues and others who are watching, read about this crisis in the ``New York Times''. The response to it, both by our Federal Government in partnership with State authorities like yourself, is serving as a national model in a positive way in so many ways as we look to continue tackling this opioid epidemic. What lessons, Doctor, were learned from your experience with this HIV outbreak following the opioid crisis in Scott County? What can we do to prevent crises like this working with folks like you in the future? Dr. Adams. I think the biggest lesson that I learned is that the science and the evidence is necessary, but it is not always sufficient to motivate change. One of the things that was really successful for both me and Vice President Pence, then Governor Pence, was to go down to the community and to listen to the folks down there. Not demonize them because of the beliefs that they had. Not to call them bad people because of what was going on in their community. Find out why they thought it was happening and how they thought they could solve the problem. I remember I had a beer and a sandwich with the sheriff, and the sheriff shared with me his concern about the possibility of starting a syringe exchange program, but also his concern about the revolving door of his jail. I spoke with him about how we can utilize a syringe exchange program as a touch point to connect people to care. We have connected over 100 people from that HIV outbreak in Scott County to addiction and recovery services. We have given Hepatitis C testing. We have provided HIV testing. We have connected people with job training. I always want to lead with the science and represent the science, both as a physician and, if I am confirmed, as Surgeon General. I also want to listen to what stakeholders are saying and what my patients, if you will, the people of this country are saying and speak to them in a way that resonates with what their goals are. That is the lesson that I learned. I think partnerships, again, are the key. One of the great things about the Surgeon General position is you do get to go out into communities. I hope that for everyone on this committee, you all will invite me to your communities if you feel, and I should be confirmed, and that we can talk about this opioid epidemic because no one has the solution alone. The solution is going to look different in each and every community throughout the country. What worked in Scott County is not the same thing that is going to work in different areas of this country. Thank you so much for the opportunity. Senator Young. You always took great care, as you still do today, to get a command of the details. You understand that every context is different and every crisis has its unique features. In Scott County, IN and dealing with this opioid epidemic, you were looking at the evidence base related to syringe exchange programs. Dr. Adams. Yes. Senator Young. Right? This is an evidence-based practice, but you understood, based on your consultation with various stakeholders, that Scott County, IN was different than other areas where this intervention had been used. Could you speak to that uniqueness of Scott County and how you adapted the syringe exchange model to these unique circumstances? Dr. Adams. Thank you for the opportunity there. I grew up on the East Coast, trained at U.C. Berkley, and now live in the Midwest. I was fortunate to grow up on a family farm. Folks do not understand that a lot of the science is developed in urban areas. Then when we try to apply it to rural areas, we have to understand that there are different cultures, different beliefs, and different barriers. There are not as many physicians around. We had to work with a lot of the folks from the Federal Government and State Government to provide access to care in Scott County, IN. I think that understanding, again, that not all environments are the same and that we cannot impose our beliefs, even if they are based in science, on people without first sitting down with them and having a conversation with them. That is the key. That is the real key to success, whether you are talking about HIV, or hepatitis, or opioids. Senator Young. We are out of time here. You had those conversations. You persuaded people of the merits of the science and you improved health and saved lives in the process. I commend you for that. I am going to be voting affirmatively for your confirmation. Thank you. Dr. Adams. It all started with lunch with the sheriff. Thank you. The Chairman. Thank you, Senator Young. Senator Warren. Statement of Senator Warren Senator Warren. Thank you, Mr. Chairman. Thank you all for being with us today and your willingness to serve. I want to followup on where Senator Young started and that is, I want to talk about another part, though, of tackling the opioid crisis. That means making sure that people have access to treatment. As Senator Murphy noted, the law says that insurers must cover treatment for mental health and for substance use disorders on a par with the coverage provided for physical health treatment. Insurance policies are required to treat mental health needs and addiction the same way they treat broken bones or a busted knee. They are all medical conditions. They all get covered. That is the law, but it does not always play out that way on the ground. A 2015 study found that nearly twice as many respondents were denied coverage for mental health treatment as for other medical treatment, and the numbers are not great on addiction either. Let me start there. Dr. McCance-Katz, you have been nominated as Assistant Secretary for Mental Health and Substance Use. Is trouble getting insurance coverage for mental health or addiction treatment a problem in effectively treating these disorders? Dr. McCance-Katz. Coverage is a problem for many. Access to care is a problem perhaps, I would say, for most. Senator Warren. For most. OK. Dr. McCance-Katz. With these issues. Senator Warren. I want to underline this because I think it is really important that we do more to make sure that insurance companies follow the law. Right now, patients are often on their own trying to do battle with insurance companies. We are not helping them out by backing them up in these battles. When I helped create the Consumer Financial Protection Bureau, the CFPB, we had a problem with consumer financial products like credit cards, and mortgages, and student loans where lenders just did not follow the law. CFPB set up a complaint system. We tracked those complaints and it helped make sure that companies address those complaints, and we made it all public. Anybody can go online at CFPB.gov, and they can search and see what companies follow the law and see what companies do not. Let me ask you this, Dr. McCance-Katz. Do you think that making sure that insurance companies follow the law, when it comes to parity for mental health conditions and addiction treatment, would help in our efforts to tackle the opioid crisis? Dr. McCance-Katz. I do. I do believe that. I believe that there has been a history of--I think the word ``capricious'' is not too strong--restrictions on the kinds of evidence-based treatments that people should have access to. You and I discussed this when we met and I believe that people should have access to knowledge based on what their peers and community members have experienced to help them to make decisions. In doing that, that can bring a simple kind of enlightenment, if you will, to insurers as to how they need to do things in a way that better serves Americans and follows the law. Senator Warren. Good. I like that. In fact, another way to say it is it helps make the market work better because everybody can see right out there in public. You had a place to file a complaint, what happened to that complaint, which insurers are getting lots of complaints, and which insurers are not, and trying to change their behavior. I think that is, at least, one way to try to take the parity that is in the law and make it a reality for families who are struggling with this. Congressman Kennedy and I introduced a bill for this in the last session and it had an online portal to be able to track complaints about failure to cover mental health and addiction coverage. I think we can go even further, making sure that patients actually get responses to their complaints and making the data public about which insurance companies are the worst offenders. Dr. McCance-Katz, if you are confirmed, I hope we can continue to work together on this. I think we could do a lot of good for a lot of families. Thank you. Dr. McCance-Katz. I would look forward to it, Senator. Senator Warren. Thank you, Mr. Chairman. The Chairman. Thank you, Senator Warren. Senator Hassan. Statement of Senator Hassan Senator Hassan. Thank you, Mr. Chair and Ranking Member Murray. Good afternoon to all of the nominees. Congratulations on your nominations and thank you to all the family members who are here, too, for supporting your loved ones. We need all hands on deck in this business and we appreciate you very much. Dr. McCance-Katz, I wanted to just start with a couple of more questions. New Hampshire has been terribly hard hit by the opioid, fentanyl, and heroin epidemic. The science certainly tells us, and I think your statements today have supported this, that medication-assisted treatment like buprenorphine plays an important role in recovery along with access to other services and supports. I have been concerned that Secretary Tom Price has been critical about medication-assisted treatments suggesting it is not very effective. Recently, during a trip to West Virginia, Secretary Price said, ``If we are just substituting one opioid for another, we are not moving the dial much.'' I know that you have been supportive of medication-assisted treatment in the past and here today. You have called it an effective form of care and you have argued that healthcare providers should educate themselves on medication-assisted treatment. Do you agree with Secretary Price's sentiments? If not, how would you address the concerns he has raised? Dr. McCance-Katz. Yes, thank you for that question, Senator Hassan. I have not had the opportunity to speak with Secretary Price about his comments, but here is what I thought when I read--as I did in the paper--his comments. Senator Hassan. Right. Dr. McCance-Katz. Just giving an opioid is not treatment. That is not going to solve the problem. Senator Hassan. Right. Dr. McCance-Katz. You have to have other psychosocial services in place. They include individual counseling, family therapy, group therapy, peer supports, community supports. Those things need to be in place with those opioid therapies in order for a person to be successfully treated. If you look at the diagnostic criteria for opioid use disorder, what you will see is that two of those criteria are addressed by the opioid therapy, and that is tolerance and withdrawal. Senator Hassan. Right. Dr. McCance-Katz. By addressing tolerance and withdrawal, we then give people the ability to engage in the psychosocial therapies that they need to then move on and get into productive lives. Senator Hassan. I thank you for that. Like all of us, I have time constraints. I also think it is fair to say, and I am hoping for a yes or no answer here, that it is also really important that people have access to an integrated healthcare system if they are going to successfully control their substance use disorder. Is that fair? Dr. McCance-Katz. Yes, ma'am. Senator Hassan. Thank you. Dr. Giroir, welcome, and it was very nice to visit with you. Dr. Giroir. Thank you. Senator Hassan. Some time ago, I think. You have spoken about the value of vaccines, and in your career, you have been successful in getting funding for mass production of vaccines. On the other hand, at least at one point in time, President Trump has seemed to perpetuate a conspiracy theory around vaccines, including saying that they were linked to autism. Dozens of studies, following hundreds of thousands of children around the world, have shown no connection between vaccines and autism. I am interested if you agree with President Trump on this issue? Do you believe that vaccines can cause or contribute to autism? Dr. Giroir. Thank you, sincerely, for this question. As a pediatrician, I want it to be very clear that vaccines save lives. They are the most important public health advance of our time, and they are not associated, with a high degree of medical certainty, with any form of autism. Senator Hassan. Thank you. Dr. Giroir. That is done by epidemiological studies that you referred to with hundreds of thousands of children being followed. There have also been experimental studies with nonhuman primates to show that the vaccine regimen, when given to animals, do not induce behaviors of autism. We are getting more and more evidence from research by the NIH and NIH-funded investigators that the brain abnormalities of autism start very early in fetal life. It is absolutely incompatible with autism. I am a pediatric care physician. Senator Hassan. Yes. Dr. Giroir. I took care of children who suffered and died of vaccine-preventable diseases including measles and whooping cough. I have also seen diseases disappear because of vaccines like H. influenzae B. There will be no stronger advocate for vaccines than I will be, but I also think we need to continue to support the FDA in monitoring vaccine safety so we can give honest and transparent assurance to the population that vaccines will remain safe in the future. Senator Hassan. I appreciate that very much. To the other nominees, I do have some questions that I will submit for the record. Dr. Giroir, to your last answer, I am the granddaughter of a pediatrician who started practicing in 1921. He could talk a lot about what it was like before penicillin and vaccines. I am very grateful for your work. Thank you. The Chairman. Thank you, Senator Hassan. Senator Whitehouse. Senator Whitehouse. Thank you, Chairman. Welcome to all of you. Dr. Kadlec, I particularly look forward to working with you, and I want to thank you for the terrific work you have already done to try to make sure our country is prepared for bioterror threats. I want to recognize Senator Burr and Senator Casey, who have been really good bipartisan leaders in that. I know that there is work to be done. I look forward to working with you on that. Dr. McCance-Katz, welcome. Great to have a Rhode Islander here. We have recently passed the Comprehensive Addiction and Recovery Act. We, shortly after the passage of that, agreed on a billion dollars that would be put through to fund and support for opioid treatment and intervention. The first half billion went through already and the States are in the process of distributing that. We hope very much that the second half will move in September when we have our next piece of funding legislation. When we do, I hope that you will consider working within the Administration to see to it that those funds are distributed in some manner consistent with the new goals and principles of CARA. I do not think we are going to be able to direct the funding to be consistent with CARA through appropriations. But, I do believe that HHS has the authority to say that grant applications will be considered based on how well they align with CARA's principles, and I hope that you would support an Administration effort to align on that point. Dr. McCance-Katz. Yes, I do. Senator Whitehouse. Good. Dr. Adams, welcome. We had a great conversation in my office and I wanted to followup on it because I think one of the areas where we have enormous bipartisan potential here is in that very delicate, tender, and important period when a person is nearing the end of their life and has to make decisions about how much treatment they wish to undergo versus how much time they want to spend with their families, and how much comfort care versus intervention they will choose. What many of us have seen as circumstances in which, like getting your sleeve caught in the machinery, unintendedly you are dragged off and before you know it, the healthcare system is doing lots of things to you that you did not want. Because the expression of your views was not either timely, or complete, or filled every box, very often people are taken on very unpleasant journeys at a time when, really as human to human, the last thing we can do for people is to honor their wishes on their way out. I think, by and large, we do a terrible job of doing that. To that end, Senator Collins has really showed a lot of passion and leadership in the Aging Committee. Senator Isakson has been outstanding on this. We have a huge group called C- TAC, the Coalition to Transform Advanced Care, which is truly a who's who of the American corporate and interest group power structure. Faith communities are gathering around this issue all around the country. I want to particularly commend the Dioceses in my home State. Everywhere you go, you hear from regular folks who have come across this problem and remember tragedies in their family. There is a big opportunity here and I wanted to ask you to consider having it be one of the ``bully pulpit sermons'' of your tenure as Surgeon General to help catalyze that enormous potential to help Americans get the care that they want. If it is a lot of care, great; get a lot of it. If it is not, get the care that you want and get your promises and your wishes honored at that time. I think we can help with that and I hope that you can help us with that. Dr. Adams. Thank you, Senator. I really appreciate you saying that. One of my priorities is prevention and I can tell you as a physician, the absolutely worst and wrong time to be having a discussion with someone about their end of life wishes is when they have a tube in their mouth, and they are on a ventilator, and they cannot communicate. You are correct. We consistently fail our citizens in this regard and there are best practices out there. In Indiana, we led the way with physician orders for scope of treatment. You all have similar forms in your States. Senator Whitehouse. We have in Rhode Island and Gunderson Lutheran does a great job up in Wisconsin. There is a lot of good leadership. Dr. Adams. Exactly. I think partnering with the faith-based community is ever so important; the hospital associations in our States and nationally; the medical associations, the AMA, and the Indiana State Medical Association in our State. In other States, I think we can bring together stakeholders and go after some low hanging fruit here, and help people reach the end of life with dignity. Ultimately die according to their wishes and not according to a doctor or a medical professional doing something that they would not otherwise want. Senator Whitehouse. Thank you very much. My time is up. The Chairman. Thanks, Senator Whitehouse. Senator Casey. Statement of Senator Casey Senator Casey. Thank you, Mr. Chairman. I want to start by saying how much we appreciate what Chairman Alexander and Ranking Member Murray agreed to with regard to bipartisan hearings before we started today. I was not here for the announcement, but know of the substance of it, and I think the country is grateful to hear that news, and we are appreciative of that. I want to thank Senator Collins for her reference to our grand-families bill. Mr. Robertson, we are grateful for your words about that as well. Dr. Giroir, I wanted to start with a little known part of the Affordable Care Act that I fought hard to make sure was part of the law. It is called the Pregnancy Assistance Fund which was both authorized and had an appropriation attached to it in the bill for 10 years, $250 million over 10 years. To provide support, in this case, in the form of competitive grants to States and to tribes, a few tribes across the country, in addition to States to provide a seamless network of supportive services to young families. Since 2010, the Office of Adolescent Health has awarded these grants to 27 States and 4 Tribes to improve the educational health, social, and economic outcomes for expectant and parenting teens, young women, fathers, and their families. It has been funded in a multiyear fashion in the three previous times that the grantees have been awarded money. The programs are already making a difference since the time it has been implemented. Folks who participate are more likely to complete high school, even with a pregnancy. More likely go to higher education and less likely to have a repeat unwanted pregnancy. I was surprised to learn that this fund--the Pregnancy Assistance Fund--which recently the announcement was for 15 States getting the grants and one tribal entity, but now it has been proposed as a 1-year grant. It is puzzling since Congress had provided funding through fiscal year 2019 starting in 2010. The funding opportunity announcement indicated that funding would be for 3 years. I guess my question on this is, do you agree that it is unusual to provide a 1-year grant when Congress has provided funding through 2019 and the funding opportunity announcement was listed as 3 years? Do you have any sense of that or do you think that makes sense? Dr. Giroir. Thank you for that question. I am certainly aware of the Pregnancy Assistant Fund and I think we can all agree that the goals of providing assistance to pregnancy that could be troubled both physically or having long-term effects is absolutely something critical that we need to focus on. I would certainly hope that aside from the very important, but relatively limited scope of this program, that this type of program would be available across the country because everyone understands that the prevention of problems, as you have heard, are much more important. I cannot comment on whether it is usual or unusual because I have not been involved in this specific decision. It is something I would certainly look at. One thing of concern is that many research programs where you are gathering data, may have multiple years in order to have validity of the data independent of whether they are servicing the patients or not. It is something I know. I know the principles of the program are very important and should be throughout the healthcare system. It is something I would look at once, if I were confirmed, because I do not have firsthand knowledge of what was the decision tree to shorten that program and the grants. Senator Casey. I would also ask, Doctor, your commitment to continuing the program and especially continuing it as a multiyear program. Dr. Giroir. At this point, because I have not been involved in discussions, you certainly have my commitment that this area is extremely important, and I understand the value of it, and will argue for such programs to be scaled, and they should be across the country. I am not in a position to commit to support this program as this program, in and of itself, until I really get within HHS and have discussions. We have not been able to have those kinds of discussions about the rationale, whether this is being moved into a different program or under another auspice, but you have my commitment to give it high priority. As a pediatrician, this area of work is very high priority for me and you also have my commitment that I understand the importance of this type of program. Senator Casey. Thank you, and we will followup. Thank you, Mr. Chair. Dr. Giroir. Thank you. The Chairman. Thanks, Senator Casey, and thank you for your comments. Senator Baldwin. Statement of Senator Baldwin Senator Baldwin. Thank you, Mr. Chairman, and Ranking Member Murray. I also want to appreciate and recognize the opening statements regarding our path forward on the things that we need to do in our healthcare system. I welcome the opportunity for hearings and input. I welcome the opportunity to work across the party aisle. I hope you will give us assignments before the end of the week. I do not want to wait until the first week in September, but I want you to know that I stand ready to do my part to work with you to find solutions that stabilize our insurance markets, that lower health costs, and improve coverage for our constituents. Thank you both for setting that tone and direction. I am going to follow the suit of most of my colleagues in talking about the opioid, and heroin, and now fentanyl epidemic across this country and in my State. I hosted a large number of roundtables and stakeholder meetings across the State in urban, and suburban, and rural settings to learn as much as I can. As we have discussed, there are several measures and steps that Congress has taken that I am proud of, and yet the crisis grows worse. I have several questions on this. I met recently with a constituent, Jesse Heffernan, of Appleton, WI. He is in long-term substance use and mental health recovery since 2001. His experience inspired him to start something called the Recovery Corps Program. It is modeled after AmeriCorps and the idea is to integrate recovery coaches into the entire substance use disorder care spectrum. He recently received some funding to pilot his program with a Wisconsin health system. I heard the exchange, Dr. McCance-Katz, with Senator Cassidy about expansion of the very limited resources we have and how we really need to do that. To improve clinical treatment, we have to do more to break down silos also. How would you expand and prioritize local efforts to integrate peer support and recovery services into the substance use disorder spectrum? Dr. McCance-Katz. Thank you, Senator Baldwin, for that question. There are a number of programs now that train peers. They are peer professionals and they are being integrated into treatment programs across the country. There are many demonstration programs of that at this point. What we can do at a Federal level is to help disseminate what those programs look like. I believe that every State is different, every community is different. States know best what their communities need. What they need is access to the information as to how to establish these kinds of programs. I personally believe that peers are really an essential part of recovery just as important as treatment. Senator Baldwin. I was glad to hear you reference that in your opening statement. We had a chance to talk about that. Dr. McCance-Katz. Yes. Senator Baldwin. I want to move onto a question for Dr. Adams. This past weekend, I had the opportunity to visit a V.A. Medical center in my State at Tomah, WI. Sadly, a few years back, Tomah had been an outlier with regard to over-prescribing opioids. Working with colleagues in the Senate, I authored and we passed the Jason Simcakoski Memorial Opioid Safety Act. Actually, I toured and got reporting on the implementation of this Act. The facility has significantly reduced its reliance on opioids in treating pain and provided hopeful alternatives to the veterans they serve. It tells me that one of the keys to fighting our opioid epidemic is the engagement of prescribers and health professionals, retraining to the latest guidelines of the CDC. Your role provides a real platform to do that, and I would ask you how you would see your leadership in that regard? Dr. Adams. Thank you, Senator, very much. I want to, first of all, say thank you for your courage and your leadership. As someone who has often been the only minority in the room, I really sincerely appreciate what you have accomplished and what you have done. For those who may be watching and you do not know, Senator Baldwin is the first openly gay Senator. Growing up as the only one in the room, I know how it feels. To your point, or to your question, I think the Surgeon General's position has a tremendous opportunity to bring folks together. I have done it, not just as surgeon general, not even just as Indiana's State Health Commission, but as a physician. As a leader in the American Medical Association partnering with the Hospital Association, partnering with other entities to try to bring the right folks together to make sure we are educating people. As an anesthesiologist, a physician anesthesiologist, I teach people every day about proper prescribing and the dangers of over-prescribing. One of my clinical focuses is on alternatives to opioid pain management. I think we need to look at how we are paying for different modalities to make sure the easy choice is also the right choice. Far too often, the easy choice is just to give out 60 Vicodin. We need to make the right choice the easy choice for physicians. I intend to go out to communities, to medical schools, to dental schools, to nursing schools because we cannot forget the prescribing community is more than just physicians and partner with all the folks who are part of this chain. It is not just one group that we want to point our finger at, but we all are part of this problem. I apologized, when I came before the committee on aging, to all the committee for the part that I and my colleagues played in the opioid epidemic. I go around telling folks, ``I do not care if you are 1 percent responsible or 99 percent responsible, what I care about is what you bring to the table in terms of a solution.'' Hospitals, providers, legislators all can play a part in this solution. I look forward to the opportunity, if confirmed, to being a convener, to bring those folks together. Thank you. The Chairman. Thank you, Senator Baldwin. I think some Senators may have additional questions. Senator Murray. Senator Murray. I just have one additional, Dr. Kadlec. I did not want you to get off free here. Dr. Kadlec. Thanks for noticing, ma'am. Senator Murray. As a staffer to Senator Burr, I know that you played a key role in drafting the Pandemic and All-Hazards Protections Act, which critically addressed both domestic and international public health preparedness capacity and capability. We have often seen this tested in recent years. I was really concerned when I saw the President's 2018 budget request, which proposed significant cuts to CDC's public health emergency preparedness grants to health departments and to the Hospital Preparedness Program, which you would oversee if you are confirmed. The 2018 request proposes eliminating hospital preparedness funding from 26 jurisdictions including my home State of Washington. Do you agree with the proposed cuts to those programs? Dr. Kadlec. Ma'am, I was not part of those discussions or deliberations, so I cannot give you color commentary to what may have happened or what was represented there. I can only assure you one thing, that I will be an advocate for these programs and I will fight very hard to basically represent them in the policy halls in HHS with Secretary Price and the White House when the time comes. I have done it before in OMB, and I have done it before in the White House, and I certainly have not had the chance in HHS yet, but I am looking forward to it, if confirmed. I do have to tell you this, ma'am, is that we do have to do some things, as raised by the Chairman, in terms of creating certainty around funding for some of these programs. As is for the health insurance programs, the same are required for preparedness, whether it is for public health preparedness, hospital preparedness, or for the development of countermeasures. That kind of certainty is required to ensure that the State and local authorities--the private sector can do the things that they need to do to ensure that, God forbid, when these things happen, and they will as you know, ma'am, that we can do that. The only assurance I can give you right here, right now is that if you support me, I am going to be a fighter for these things. I know that States like yours have often led the way on these issues, and I am certainly respectful of that. Also will commit to the idea of, again, advocating for the programs and for your constituents on these issues. Senator Murray. Thank you. Thank you very much. I appreciate that. The Chairman. Senator Warren, did you have additional comments? Senator Warren. I do, but I yield to Senator Hassan? The Chairman. Senator Hassan, do you have additional? Senator Hassan. Thank you. Thank you, Senator Warren. To the Chair and Ranking Member, also, count me in. Obviously, I think all of us are eager to work on a bipartisan process on healthcare and we are very, very grateful for your leadership to both of you. Dr. Kadlec, I do not have a question for you, but as a former Governor, I can tell you I am right there with you on the importance of preparedness, and certainty, and funding for preparedness. You have an ally here and I look forward to that work. Dr. Kadlec. Thank you, ma'am. Senator Hassan. Dr. Adams, I wanted to explore another area with you. Last year, the former Surgeon General issued a report concluding that the use of electronic cigarettes, also called e-cigarettes, pose a risk to Americans particularly to our youth and our young adults. The Surgeon General's report called for action to reduce e- cigarette use among young people, including actions by Federal, State, and local governments. Just last week, though, the FDA announced it would delay what is called the deeming rule to review products like e- cigarettes that are on the market. Under the deeming rule, FDA could take into account, for instance, the impact of e- cigarette flavors like cotton candy and bubblegum on the product's appeal to youth. It is an important tool that the FDA has to protect children and the public health. I am worried that delaying the deeming rule is contradictory to what the 2016 Surgeon General's report called for. Do you agree? Dr. Adams. I was not privy to the discussion within the FDA, Senator, but I do thank you for the question. It is an important one. Decreasing the number of people who are consuming both tobacco- and nicotine-related products is of utmost importance from a public health point of view. I think it is important that we distinguish between never smokers and current smokers. There is actually a debate going on in the public health community worldwide about the benefits of e-cigarettes and vaping, and I think it is because people are confusing the two. Senator Hassan. Just because we are constrained for time, I think this, though, is very specific. Because when you think about it--while we can talk about the value or not of e- cigarettes and vaping for somebody who might be trying to quit the nicotine habit with regular cigarettes--this is about flavoring e-cigarettes in a way that will get young people hooked on the habit in one form or another to begin with. Can we agree that that is harmful? Dr. Adams. We can absolutely agree and I want to do everything possible to prevent young people from starting down the pathway of nicotine addiction. I commit to working with you and, if confirmed, with the FDA to make sure we do that. Senator Hassan. Thank you. Here is a question for both Dr. Adams and Dr. Giroir. It goes back to one of the other mentions of this that, I think, Senator Murray made. The Office of the Assistant Secretary for Health directs the Presidential Advisory Council on HIV/AIDS. On June 16, 2017 six members of the Presidential Advisory Council on HIV/AIDS announced their resignation in ``Newsweek''. Here is what they said. Here are the quotes. ``The Trump Administration has no strategy to address the ongoing HIV/AIDS epidemic, seeks zero input from experts to formulate HIV policy. And most concerning, pushes legislation that will harm people living with HIV and halt or reverse important gains made in the fight against this disease.'' They also said that they could not effectively fight HIV/ AIDS, and this is their quote, ``Within the confines of an advisory body to a President who simply does not care.'' Further, there is also not yet a director of the White House Office of National AIDS Policy. Dr. Giroir and Dr. Adams, I am interested on your thoughts about how you would address the concerns expressed by these advisory council members and what you see as your role in making sure that we are confronting and having a robust HIV/ AIDS policy and program in this country that can help people living with the disease. Why do I not start with Dr. Giroir? Dr. Giroir. Thank you for that question. I read that in the papers as well and I took it quite personally. I took it personally because much of the complaint was because of a lack of leadership in the office. This office is under the office of the Assistant Secretary for Health. Senator Hassan. Right. Dr. Giroir. I remain in waiting, if confirmed, for that position. Senator Hassan. Sure. Dr. Giroir. One of the first things I will do will be to speak with those individuals to assure them that there is a national HIV strategy. I have not discussed it within the office, but it is a very robust one. There has been tremendous gains. I am absolutely committed to moving forward with those gains, as well as the other important viral diseases that are under that office's purview. Many of you have spoken to me about Hepatitis C. Senator Hassan. Sure. Dr. Giroir. A very important disease with millions affected and millions still left untreated, even though there is a potential cure for it. All I can say, if fortunate enough to be confirmed, is that office will have all the attention that I can give it. We will look very critically at the advisory committee to make sure that it is appropriately staffed so that we get a diversity of opinions grounded in science to move the successes we have had with HIV even further. Senator Hassan. Thank you. I know I am out of time, but perhaps, Dr. Adams, if you could just address it. Dr. Adams. Mr. Chairman, if you do not mind. Senator Hassan. I am out of time, but I would ask the question of both Dr. Adams and Dr. Giroir. The Chairman. If we do a third round, you can. Senator Hassan. Perfect. Yes, that is fine. The Chairman. Let us let the other Senators have their 5 minutes. Senator Hassan. Thank you. The Chairman. For Senators' knowledge, we have two votes at 5 p.m. Senator Warren. Senator Warren. Thank you, Mr. Chairman. I want to continue our focus on the opioid. Last year, more than 2,000 people died in Massachusetts alone. This is powerfully important to me, and to the people I represent, and to everybody who sits on this committee, and I think in the United States Senate. Dr. Adams, as Indiana Health Commissioner, you saw the epidemic up close when you dealt with the HIV outbreak in Scott County, IN. There has been a lot of discussion about that today, several references to your work there. You established a syringe exchange program, which was illegal in Indiana at the time when you first recommended it. The consequence is that you helped save lives and helped contain that outbreak. I just want to ask you a question, Dr. Adams. Why did you press for such a program even though it was controversial and, in some quarters, politically unpopular? Dr. Adams. Thank you so much for the opportunity to answer that question. I pressed for it because it was the right thing to do. It was the scientifically sound thing to do. It was what I felt was necessary to save lives and stop disease transmission. As I mentioned earlier, I also recognized that the knowledge base oftentimes is not enough and that we had to partner. The most important thing, as I mentioned earlier, that the Governor and I did was to go down to Scott County and talk to folks. I do not want to take up your time, but I do want to say very quickly. Ask yourself if I said to you, ``I am going to open up a syringe exchange program across the street from where you live.'' The first thing you are going to say is, ``Oh, no. You are not.'' Then you are going to say, ``Come down and explain to me why this is necessary.'' Senator Warren. Right. Dr. Adams. Partnerships are critical. The science has to be there, but it has to be given in a sympathetic and empathetic way. Senator Warren. The way I read this, your response, is you said you are willing to do something that is innovative, data- based even if it turns out to be politically controversial. Dr. Adams. I feel a trap coming, Senator. Senator Warren. No, no. [Laughter.] No, we can be friends here, Dr. Adams. Dr. Adams. We are friends. Senator Warren. Good, good. Here is what I am going to ask you. Are you aware that the American Medical Association recently endorsed developing pilot facilities where people who use their own drugs can do so safely under medical supervision? Dr. Adams. I am. I was there when they debated it. Senator Warren. What is your view on that? Dr. Adams. My view on that is that the science is not quite there to the extent that it is for syringe exchange programs, but we have two natural pilot programs, one in Massachusetts and, I believe, one in Seattle and I look forward to carefully reviewing the data. Even if we do have compelling data, just as I said with syringe exchange programs, we still have to come back to local control and local conversations. Senator Warren. Reviewing the data, and studying it, and perhaps expanding the studies of supervised injection facilities as a public health tool in the fight against the opioid epidemic. Dr. Adams. I think it is one of many tools that should be considered in the tool chest and communities need to be leading that conversation about whether it is right for their community. Senator Warren. We need a Surgeon General who is also going to lead that conversation. Dr. Adams. I would love that conversation across the country and quite frankly, across the world because of the unfortunate HIV outbreak that occurred in Scott County. Senator Warren. Thank you, Dr. Adams. You were right. I hope that we very much are friends because you are an evidence-based, committed physician even if it is politically unpopular. I think that is what we need right now in addressing the opioid crisis. We truly do need all hands on deck whether they are politically acceptable or not politically acceptable. We have got to do what the evidence tells us may have an effect. We study it, we find out, and then we follow through. I think that is powerfully important and that is what I want to see in a Surgeon General. Thank you, Dr. Adams. I will be submitting other questions for the record. I am going to yield back my time, Mr. Chairman. The Chairman. Senator Warren, that is the second time you have done that today. [Laughter.] Senator Warren. Well, you know. The Chairman. I commend you as a succinct professor, as a terrific addition to the committee. I admire Dr. Adams for seeing where you were going too. I have a couple of questions. Dr. Giroir, I talked with you earlier, and with Secretary Price, and with Secretary Perry, and Seema Verma about using the Government's super computers to identify waste, fraud, and abuse which seemed like a no-brainer. There was basically a pilot program done at CMS in the Obama administration--which if we began to look for waste, fraud, and abuse using the same techniques that we used to look for terrorists in a needle in a haystack sort of search--that we might get some good results. According to ``The Economist,'' as much as $272 billion across the entire health system is swindled each year and some, ``Criminals are switching from cocaine trafficking to prescription drug fraud because the risk-adjusted rewards are higher, the money is still good, the work safer, and the penalties lighter.'' Are you willing to try to take another look at using our super computers and our data at CMS to identify waste, fraud, and abuse in the system? Dr. Giroir. Mr. Chairman, thank you for that question. I think it opens an even broader discussion--in that I was in the Department of Defense for a period of time. We worked very closely with DOE. We have to break down the silos between the tremendous capabilities we have among our Government agencies. The Department of Energy has super computers, not only super computers but the world's best expertise on how to program and ask questions. What can be done by collaborating with the Department of Energy for CMS, for the V.A. health system, for understanding risk behaviors and outcomes cannot be understated. This is something, certainly, I want to do and want to promote, which is the work among the interagency. I actually spent quite a period of time talking to national leaders on the science side in the Department of Energy, and what they told me was quite surprising to me. Not only do they want to work on health problems, not just this problem of fraud and abuse, but on health problems. The complexities of the health problems that they have to deal with are making them more capable of dealing with their primary missions of nuclear security. This is a win-win across the board. The Chairman. Yes, I would hope. I would imagine that the pushback from CMS will be, ``These computer people do not know enough about healthcare.'' That is true, but they can learn it. They can learn enough. To find criminals in the haystack stealing money that could be better spent caring for people, just as they have learned how to use computers to catch terrorists who might be trying to blow us up. Dr. Giroir. I have not spoken to CMS, but I think you are exactly correct. The Chairman. Will you pursue this? Dr. Giroir. I absolutely will pursue it. The Chairman. You have at least two cabinet members and Senator Blunt and I are very interested in this. Seema Verma seems interested. She has had other things to do the last few weeks. Dr. Giroir. We have to understand that the tools of mathematics and big data analysis cross all disciplines. The Chairman. Good. Dr. Kadlec, I want to give you a chance. We talked about how the primary purpose of ASPR is to lead the public health emergency preparedness and response. The question Senator Burr often says here, ``who is in charge?'' What are you going to do about the ``who is in charge?'' question when it comes to a public health emergency? Dr. Kadlec. Sir, I would just simply say, if confirmed, I would be in charge for clarity, No. 1. No. 2, it is really important to work with my colleagues. The Chairman. Do you have an understanding with others, who think they might be in charge, that you are in charge? Dr. Kadlec. Sir, I think that is an issue that is set with Secretary Price right from the get go. The Chairman. Yes. Dr. Kadlec. As I see it. The Chairman. I agree with you about that. Hyman Rickover, we have never had anyone die from a nuclear reactor on a submarine or the ships since Rickover started it in the 1950s, and it is because he told the captains in his interview that, ``You have two responsibilities. One is the ship, one is the reactor, and if anything happens with the reactor, your career is over.'' There have been a lot of good careers and there has never been a death as the result of a reactor. Who is on the flagpole makes a difference. Dr. Kadlec. Yes, sir. It does. Sir, I would consider myself to be that, but it takes more than one person to make this work. Clearly people like Dr. Fitzgerald at the CDC, folks at the FDA, clearly these colleagues here are all going to have something to add and collaborate with on these issues particularly Dr. Giroir and Dr. Adams. My interest is really building a team, or to help build a team, under Secretary Price to kind of do the things 24-7-365 that nobody else really has the bandwidth to do honestly on a day-to-day activity unless something bad happens. My job is to think of those bad things and work with a tremendous group of people at ASPR right now and kind of do the arduous, predictive work that has to be done well in advance of a crisis to ensure we have the means. Sir, I will end my comments with a caution--which is one that General Schoomaker, former Chief of Staff of the Army and former Commander of Special Operations Command often used-- which was, ``Do not confuse enthusiasm with capability.'' The one thing I need, sir, to give you confidence in and for Senator Murray as well, and your other members here, and Secretary Price, is that we have the capabilities. Job one for me--first, when I hit the ground--is really to evaluate, kick the tires on the capabilities that we have and to see if they are sufficient to deal with the likely crises we may encounter. To Senator Murray's point, funding will always be important. Right now, we spend about two-thirds of what we spend on a single aircraft carrier for preparedness and response. That imagery is kind of important to me because you do not get very far on two-thirds of an aircraft carrier. The Chairman. Thank you, Dr. Kadlec. I let the time run over, but that is both my rounds of questions. Dr. Kadlec. Thank you, sir. The Chairman. I have remarks from Senator Burr who could not be here today, expressing his support for Dr. Robert Kadlec's nomination for Assistant Secretary for Preparedness and Response. I ask for consent for his remarks to be submitted for the record, and they will be introduced. [The information referred to may be found in Additional Material.] The Chairman. I also ask consent to introduce 43 letters of support for Mr. Lance Robertson, 8 for Dr. Brett Giroir, 2 for Dr. Kadlec, 25 for Dr. McCance-Katz, and 10 for Dr. Jerome Adams into the record, and they will be introduced. [The information referred to may be found in Additional Material.] Are there other questions before we conclude? Senator Hassan. Senator Hassan. Perhaps we could just let Dr. Adams speak to the earlier question about HIV and AIDS policy and then I am all set. The Chairman. Sure. Dr. Adams. Dr. Adams. Thank you for the question. I very quickly and briefly will say, I oversaw the response to the largest HIV outbreak related to injection drug use in the history of the United States as declared by CDC Director Tom Frieden. I am supported by the Damien Center, which is the largest provider of HIV care in the State of Indiana. There is a letter of endorsement from them. The best thing that you can do to help improve what some people perceive as a lack of direction in regards to HIV care is to confirm this panel, including Dr. Giroir and I, so that we can get to work. Senator Hassan. Thank you very much. Dr. Adams. Thank you. The Chairman. Thank you, Senator Hassan. Senator Murray. Mr. Chairman, could I---- The Chairman. Senator Murray. Senator Murray [continuing]. Could I just say? I know there may be some additional questions and due to the uncertainty and timing on when we are voting on these, I would just ask all the nominees to respond. If we could work out a time that we could make sure that we get answers back to those questions. The Chairman. It might be hard to do it by tomorrow. Senator Murray. I totally understand that. The Chairman. We will work it out. Senator Murray. We will work it out. The Chairman. Yes, that is the way we will do that. First, let me thank each of you for being here and congratulate you on your nominations. If you are confirmed, this will complete Senate approval of all of the Assistant Secretary positions in the Department of Health and Human Services in the Trump administration. There will be a full team ready to go to work as far as we are concerned. We have talked a lot today about implementing laws. We have been pretty busy the last couple of years in this committee on mental health, on 21st Century Cures, on electronic healthcare records, a whole variety of health-related issues. We know the laws are not worth anything unless they are implemented properly, so we hope and expect that if Senators ask questions--I had a little discussion with Senator Warren about this the other day involving another department--if Senators ask questions, we would like for you to answer them. If you feel you cannot, or the question is unreasonable, well then, I would call the Senator and say, ``Look. I got this from your office. Maybe somebody is writing letters under your name,'' or something like that. [Laughter.] Do not ignore the question. It is perfectly understandable if you cannot answer a question for some reason. Why, just call the Senator and say, ``Here is my problem,'' and discuss it with that person because it is important for us to be able to communicate with you. It fills all the Assistant Secretary positions under our jurisdiction, maybe I did not say it that way, but that is what I meant. If there are any other Assistant Secretaries who are not confirmed, it is not our fault. [Laughter.] Senator Murray has agreed that we can go ahead with the mark up tomorrow, and then hopefully, you might be confirmed, and in your jobs soon thereafter. Senators who wish to ask additional questions of the nominees, questions for the record, are due at a time that Senator Murray and I will agree on. For all other matters, the hearing record will remain open for 10 days. Members may submit additional information for the record within that time. We will meet again, tomorrow, at a time convenient for Senators for an executive session to consider these nominations and additional nominations up for consideration. Thank you for being here today. The committee stands adjourned. [Additional Material follows.] ADDITIONAL MATERIAL Prepared Statement of Senator Burr Mr. Chairman, when Senator Ted Kennedy and I designed the role of the Assistant Secretary for Preparedness and Response (ASPR) under the Pandemic and All-Hazards Preparedness Act, we envisioned an official solely focused on the singular 24/7 mission of making sure we are prepared for the public health threats we may face, whether naturally occurring like Ebola and H1N1, or the result of a deliberate attack on our country. The role of the ASPR was designed to answer the simple and critical question: Who is in charge? It is critical for the individual serving as the ASPR to recognize this singular focus, and execute the role of the ASPR with a daily vigilance. We cannot wait until a threat is upon us to respond, and the ASPR serves to prepare for and respond to these threats in order to save American lives. Put simply, Dr. Robert Kadlec is well-prepared for and well-suited to fulfill every aspect of this role. Dr. Kadlec brings with him a deep and thorough understanding of the role served by the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. He has had the opportunity to serve in numerous biosecurity, intelligence, and policy positions that will inform his work as the ASPR. Notably, he has served under President Bush as an advisor on the Homeland Security Council and on my staff in the Senate Select Committee on Intelligence. His years of honorable service show his dedication to country and his work in the White House, military service, and leadership of the Senate Select Committee on Intelligence have helped to shape and grow his unique understanding of the threats faced by our country. Each of the steps he has taken throughout his noteworthy career will be valuable assets should he be confirmed as the next ASPR, and each of the goals he outlines in his statement are consistent with the vision Senator Kennedy and I worked to get signed into law over a decade ago. The first goal Dr. Kadlec mentions is providing strong leadership and clear direction. While the statute clearly defines who is in charge during a public health emergency, there have been multiple instances in recent public health crises where the coordination and communication roles of the ASPR were not operationalized effectively. I am pleased that this is his first priority and goal, and I am confident that Dr. Kadlec will bring to the role of ASPR the dedication, vigilance, and urgency it requires. Further, another critical role of the ASPR is to oversee the Biomedical Advanced Research and Development Authority (BARDA), which brings forward medical countermeasures to prevent and respond to emerging infectious disease outbreaks and other chemical, biological, radiological and nuclear threats. Bringing these medical countermeasures through the research, development, approval, and procurement processes is a long, difficult, and often risky task for manufacturers and innovators in this space. In order to realize the full potential of the medical countermeasure enterprise in our country, we must ensure that the Federal Government is sending a clear signal that we are a good-faith and willing partner in this endeavor. Dr. Kadlec has the firsthand knowledge necessary to achieve this goal, and will provide industry the confidence needed to invest in much-needed medical countermeasures to address the threats facing our Nation today and tomorrow. Ultimately, the ASPR must properly coordinate and communicate with other officials throughout the Administration and manage all of the tools at our disposal to effectively and efficiently prepare for and, if necessary, respond to a chemical, biological, radiological, or nuclear attack. This will only grow more challenging in the years to come and Dr. Kadlec is uniquely prepared for this challenge. I urge each of my colleagues to support Dr. Kadlec's nomination. He is the right person to serve as the next Assistant Secretary for Preparedness and Response. I thank the Chair. Letters of Support lance robertson [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] ______ Response by Lance Robertson to Questions of Senator Murray, Senator Sanders, Senator Casey, Senator Franken, Senator Bennet, Senator Whitehouse, Senator Baldwin, Senator Murphy, Senator Warren and Senator Hassan senator murray Question 1. As the Assistant Secretary for Aging, you will also serve as the Administrator for the Administration for Community Living (ACL). This agency was created in 2012 by bringing together the Administration on Aging, the Office on Disability, and the Administration on Developmental Disabilities. The purpose of the agency, therefore, is to address the full spectrum of community living, health care, and long-term service and support needs for both the aging and disability populations. However, your professional experience has largely been established by administering aging service programs. Describe your professional experience working with individuals with disabilities and their families and the disability service providers and programs in Oklahoma. How have you bridged the silos that are often created between aging and disability service programs in State government? How will you ensure equity in resource allocation between programs for people with disabilities and programs for older adults in ACL? Answer 1. As I mentioned in my testimony, having a close family member who lives with a significant disability and a mother who is a career Intellectual and Developmental Disabilities case manager has given me a personal view of the importance of ACL's work for people with disabilities. Through my work as president of the National Association of States United for Aging & Disability (NASUAD), we decided to include a ``D'' in the organization's name to fully reflect our work and commitment to the disability community. Together, we are better able to leverage learnings and best practices for meeting those similar needs. Further, the disability and aging communities together have a larger voice than either community on its own. Silos are not helpful within any organization, and I look forward to working effectively at ACL to better unify our populations and strengthen our programs. Question 2. The President's 2018 budget proposal called for a number of cuts to and restructuring of programs for individuals with disabilities and their families. Specifically, the President's budget recommended a cut of $23 million to the Independent Living program, thereby eliminating funding for the Independent Living State Grants program. The House Appropriations Committee fiscal year 2018 Labor, Health, Human Services, and Education bill restores this funding to the Independent Living program. What efforts will you take to ensure the Centers for Independent Living and the Statewide Independent Living Councils have the necessary funding and administrative support to fulfill their responsibilities as required by the Rehabilitation Act of 1973, and fully implement the new core transition services required by the Workforce Innovation and Opportunity Act (WIOA)? Answer 2. The work of the Centers for Independent Living and the Statewide Independent Living Councils is important. I look forward to working with ACL team members, HHS leaders, and Congress to ensure these programs are funded in the most responsible way. Question 3. The President's 2018 budget proposal called for the merging of several disparate disability programs, namely the State Councils on Developmental Disabilities, the State Independent Living Councils, and the State Advisory Boards on Traumatic Brain Injury into the Partnership for Innovation, Inclusion, and Independence. The House Appropriations Committee fiscal year 2018 Labor, Health, Human Services, and Education bill does not consolidate these programs. Do you agree that each of these programs plays a unique role in facilitating the mission of ACL? Would you support an effort to consolidate these programs to save money? Answer 3. The work of all three entities is important. The ultimate goal is achieving the highest possible outcomes with the programs and for the populations we serve. I look forward to being a part of the coming conversation and working with all parties to deploy whatever is decided and following the guidance given by the President and Congress. Question 4. Older adults and people with disabilities experience unique barriers during a crisis. As the director of the Aging Services Division in Oklahoma, how did you engage individuals, service providers, and communities in emergency preparedness? How will you ensure emergency preparedness and response programs are accessible to all individuals with disabilities? Answer 4. Oklahoma ranks as one of the top States in disaster declarations, giving me ample exposure to the importance of emergency preparedness. For the past decade, I have served on several of our State's top preparedness committees and many of my staff members are directly tied to response plans. Building on the plans ACL already has in place is critical, and my commitment to ensuring the safety of the populations we serve during a time of crisis is very strong. I look forward to working with the Assistant Secretary for Preparedness and Response (ASPR) to make sure that programs are accessible to all individuals. Question 5. WIOA transferred the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDLIRR) from the Department of Education's Office of Special Education and Rehabilitative Services (OSERS) to ACL. NIDILRR's mission is to generate new knowledge and promote its effective use to improve the abilities of people with disabilities to perform activities of their choice in the community. What is your position on evidence-based programs and policy? As director of the Aging Services Division in Oklahoma, how have you used data to make program and policy decisions? Answer 5. NIDLIRR has a commendable history of producing important work, generating new knowledge, and contracting with partners to provide assistance to people with disabilities for activities of their choice in the community. Evidence-based programs and policies are important to ACL, and I will certainly continue that focus. Question 6. The President's 2018 budget proposal called for an elimination of the Senior Community Service Employment Program (SCSEP). The House Appropriations Committee 2018 Labor, Health, Human Services, and Education bill transfers the program to ACL and also cuts $100 million in funding. The SCSEP is the only employment program targeted for older adults and has been successful in assisting millions of low- income job seekers find work. Answer 6. If confirmed as the Assistant Secretary for Aging, will you commit to protecting the SCSEP and advocate for robust funding to ensure the program reaches all eligible older adults who experience barriers to employment? I am committed to removing barriers to employment, regardless of age or disability. Ensuring that everyone who wants to work has as many opportunities as possible to do so is a critical element of supporting the ability of all people to live their lives as integrated members of their communities. Increasing access and eliminating barriers to employment has been part of ACL's mission since its creation, and I look forward to continuing that important work. Question 7. The Leadership Council of Aging Organizations (LCAO) wrote a letter opposing ACL's proposal to eliminate LGBT older adults from the National Survey of Older American Act Participants. Do you agree with LCAO that, ``ACL must continue collecting data on whether the aging network is reaching LGBT older adults in order to ensure the maximum inclusion of LGBT older adults in programs funded under the Older Americans Act?'' As the Assistant Secretary for Aging, would you stand up for LGBT individuals and prevent any systematic effort by this Administration to eliminate data necessary for the full inclusion of the LGBT community in Federal programs? Answer 7. Throughout its existence, ACL has been committed to ensuring that all people touched by or eligible for our programs have access to the high quality services and supports they need to be able to live where they choose and with the people they choose, and to fully participate in their communities, and I share that commitment. We will continue to work with grantees and stakeholders in the aging and disability networks to help them best serve older adults and people with disabilities, particularly those with the greatest social and economic needs. Question 8. As you know, the Older Americans Act specifically establishes the role of the Assistant Secretary for Aging with a direct reporting relationship to the Secretary of the Department of Health and Human Services (HHS). In the dual role for which you are nominated, how do you anticipate being a leader and advocate on behalf of the Older Americans Act and the Aging Services Network, while also providing stewardship of the programs and services that both older adults and individuals with disabilities rely upon? Answer 8. I know from the State perspective that bringing together aging and disability work at the Federal level has worked remarkably well. The aging and disability networks have embraced the concept and have committed to making it successful. There are a lot of similarities in the services and supports older adults and people with disabilities need to live independently. Together, we are better able to leverage learnings and best practices for meeting similar needs. Further, the disability and aging communities together have a larger voice than either community on its own. At the same time, neither network loses the unique elements of its individual mission. When there are issues that affect both people with disabilities and older adults, we can join forces to address them in a consistent and holistic way. There also are issues that affect only older adults, or only people with disabilities. I am committed to ensuring that ACL continues to develop and manage programs that best serve each population individually, as well. Question 9. As a result of the Americans with Disabilities Act and the U.S. Supreme Court's decision in Olmstead v. L.C., there has been a national trend toward deinstitutionalization and community inclusion of older adults and people with disabilities. Do you agree with the Supreme Court's ruling that it is discrimination to deny people with disabilities services in the most integrated setting possible? Do you agree that for older adults and people with disabilities, having the option to live and receive services in their homes and communities can be vital to their well-being? If confirmed, will you defend and broaden access to home and community-based services and supports for both older adults and people with disabilities? Answer 9. I am fully committed to implementing the laws passed by Congress that provide ACL with tools to assist older and disabled Americans to live where they choose and with the people they choose, and to participate as they choose in their communities. For this to be possible, home- and community-based services and supports must be robust enough that individuals with even the most complex medical and behavioral needs who desire to live in the community can be appropriately and effectively supported in their own home- or other community-based settings. While this has been demonstrated in many communities, it is not reality everywhere. ACL advocates for the expansion and coordination of home- and community-based services and improvements in quality so that older adults and people with disabilities have more and better options about how and where to receive the long-term services and supports they need. I look forward to continuing that work. Question 10. The President's 2018 budget proposal called for a number of cuts to programs for older adults and people with disabilities under ACL, raising questions whether this Administration values the programs ACL supports. If confirmed, will you be a vocal advocate internally for funding for ACL and push back in future budget cycles against cuts to programs that support these communities? Answer 10. I have been an advocate for older adults and people with disabilities throughout my career. I look forward to continuing that role at the Federal level to help ensure the long-term sustainability of the critical programs that support older adults and people with disabilities and help them live independently. senator sanders Question 1. Mr. Robertson, this position plays a pivotal role in assessing, planning and advocating for a variety of programs and initiatives that are aimed at improving the health, health care, wellness and lives of older individuals. As you know, as most Americans age, they do so wanting to age in their own homes. Often times, this means that they will require a variety of critically important support services--like meal programs, community-based care, and assistance provided to their care givers--many of which you strongly advocated for in your previous positions. In fact, your past positions on the importance of supporting and robustly funding these programs show that you understand how vital they are to older people, especially to those who are trying to age at home. Unfortunately, based on the budget he proposed, President Trump seems far less supportive of these types of very important programs. How do you plan to ensure that the very programs that you have expressed strong support for in the past-- programs that make a very real difference to millions of older Americans--do not get drastically cut or eliminated altogether in this Administration? What are your plans to ensure that older Americans will have the support services that they need to age with dignity in their own homes? Answer 1. ACL's work to help older adults and people with disabilities live independently in their communities has never been more important. There are 65 million people age 60 and older. All but a tiny percentage of them live in non-institutional settings, as do nearly 57 million people with disabilities. Older Americans are one of the fastest-growing demographic groups in the country. Maintaining service levels in the face of a growing population is always a challenge. I believe that the use of innovation and evidence-based practices will be critical to keeping these programs vital, and to meeting the evolving needs of older Americans. Question 2. In detail, please share the top three efforts or initiatives that you plan to launch to address the unique and pressing health and health care issues facing people with disabilities during this time when the current health care system is being reformed? Answer 2. I am looking forward to working with my colleagues at ACL and throughout HHS to learn more about the programs and initiatives already in place. The strategy I shared in my testimony applies to both older adults and people with disabilities. For both populations, navigating the systems of services and support, identifying what is available, and understanding how to access those services, can be overwhelming. We have to streamline that process and ensure the needs of the person are kept at the forefront of our focus. Families and friends play a critical role in supporting older adults and people with disabilities alike. Supporting those people is essential to helping older adults and people with disabilities continue living independently in the community. It is imperative that we ensure the community-based organizations, that form the aging and disability networks, are able to survive in the increasingly complex health care environment. ACL has been investing in helping the networks develop the business acumen necessary to integrate the services they provide into the overall health care spectrum. I believe that work is absolutely critical. senator casey Question 1. During the campaign, President Trump said that he would ``do everything in [his] power to protect LGBT citizens.'' As we have seen, the President and the Administration are failing to live up to that promise. Last week, over Twitter, President Trump announced transgender individuals would be banned from serving in the military. Sadly, that is far from the only Administration action that would have adverse consequences for LGBT Americans. In April, ACL eliminated sexual orientation and gender identity questions on two important surveys that are used to assess Older Americans Act and disabilities programs. Mr. Robertson, if you are confirmed, will you ensure that ACL programs meet the needs of the entire LGBT community and will you commit to collecting data on both sexual orientation and gender identity on ACL surveys that are used to assess the effectiveness of ACL programs? Answer 1. I am committed to working with the aging and disability networks to help them best serve older adults and people with disabilities, particularly those with the greatest social and economic needs. I am committed to better understanding these issues and ensuring that ACL's programs serve all people, including LGBT older adults and people with disabilities. Question 2. The President's budget included language that would merge several disability programs, including the State councils on independent living and the State developmental disabilities councils, which are authorized under separate statutes and are currently administered by ACL. At the same time, the administration has significantly recommended cutting the funding for these programs. The greater disability community is very concerned about this proposal. Do you support this approach and how would you merge these programs while ensuring congressional intent is maintained? Given that you do not have extensive experience with the disability community, do you commit to personally reaching out to them to obtain their input on this proposal? Answer 2. I support the idea of delivering services that help to achieve independence, productivity, integration, self-determination, and inclusion in the community while eliminating silos that make it harder for people to access the services they need. It is critical that we work closely with the aging and disability networks to ensure we are best meeting the needs of the people we serve. I look forward to working with you to implement the law faithfully and to give full consideration to the input from our partners across the disability communities. Question 3. While the number of older Americans is growing exponentially daily, aging programs have been cut or flat lined in the President's proposed budget. How are you going to ensure that vital programs important to aging Americans are protected, are not subject to arbitrary drastic cuts, and grow according to the needs of seniors during your tenure in this Administration? Answer 3. I have been an advocate for older adults and people with disabilities throughout my career, and I look forward to continuing that role at the Federal level to help ensure the long-term sustainability of the critical programs that support older adults and people with disabilities and help them live independently. Maintaining service levels in the face of a growing population is always a challenge. I believe that the use of innovation and evidence- based practices, such as the flexibility Congress provided to allow up to 1 percent of ACL's nutrition funding to explore innovative ways to provide services, or the requirement that preventive health dollars be used for evidenced-based approaches, will be critical to keeping these programs vital and to meeting the evolving needs of older Americans. Question 4. During your opening statement at the hearing on August 1 you stated that your goal is to provide services for those who are aging and those with disabilities via the least expensive means possible. You did not mention the quality of those services. Why not? How is quality of services important for those who are aging and those with disabilities? How will you balance the demands of cost efficiency and quality of services? Answer 4. Establishing quality standards and ensuring our programs meet them is absolutely critical. Many of ACL's programs already have outcome measures related to service quality. This must of course be woven into the fabric of everything we do. Question 5. During your opening statement at the hearing on August 1 you mentioned four goals you would work to achieve if you were confirmed as Assistant Secretary for Aging and Administrator of Community Living. These included (a) access to treatment and service information, (b) support for caregivers, (c) elder justice, and (d) increasing the network's business acumen. How will you plan to ensure everyone who wants to receive care in their homes and communities can do so? Will you commit to reviewing these goals with the aging and disability communities and amending the goals depending upon the needs identified by the communities? Answer 5. Since its creation, ACL has advocated for the expansion and coordination of home- and community-based services and improvements in quality so that older adults and people with disabilities have more and better options about how and where to receive the long-term services and supports they need. I am excited to continue this work as the ACL administrator. To do that most effectively and efficiently, we have to work together across all levels of government, within the aging and disability networks, and with all potential partners to establish strategies for meeting these goals. Through my work at the State level and as a leader within NASUAD, I have spent many years working in partnership with my colleagues in other organizations to do exactly that. I am looking forward to continuing to work with my colleagues in the disability community to ensure we are doing the right things to best serve the greatest number of people with the greatest needs. Question 6. While a number of the goals you identify for ACL address aging concerns, they do not specifically call out the needs for individuals with disabilities and their families. There are many barriers that people with disabilities face, including continued prejudice and discrimination in services, employment, treatment and supports. How will you ensure ACL prioritizes people with disabilities as well as aging issues? Answer 6. The strategy I shared in my testimony applies to both older adults and people with disabilities. For both populations, navigating the systems of services and support, identifying what is available, and understanding how to access those services, can be overwhelming. We have to streamline that process and ensure the needs of the person are kept at the forefront of our focus. Families and friends play a critical role in supporting older adults and people with disabilities alike. Supporting this community is essential to helping older adults and people with disabilities continue living independently in the community. It is imperative that we ensure the community-based organizations that form the aging and disability networks are able to survive in the increasingly complex healthcare environment. ACL has been investing in helping the networks develop the business acumen necessary to integrate the services they provide into the overall healthcare spectrum. I believe that work is absolutely critical. Question 7. Your experience with the disability community at a national level is very limited. How will you go about engaging the community and learning what issues are most important to the community? Will you commit to personally have quarterly meetings with leaders of the disability community for at least the first 18 months of your tenure? Answer 7. I look forward to getting to know my colleagues in the disability field and I am committed to working closely with them to ensure we are best meeting the needs of the people we serve. I expect to establish an ongoing dialog, and we will meet as frequently as necessary. Question 8. This Administration has proposed cutting Medicaid funding both through repealing the PPACA and through the budgeting process. The latest budget bill coming out of the House of Representatives calls for $1.4 trillion in cuts to Medicaid. Included in ACL's mission is the statement that, ``All Americans--including people with disabilities and older adults--should be able to live at home with the supports they need, participating in communities that value their contributions.'' After unpaid family supports, Medicaid is the largest funder of home and community-based long-term services and supports. It makes it possible for individuals to live in their own homes, independently move about their communities, and obtain and retain jobs. How will you advocate for protecting Medicaid funding and how will you ensure the mission to have all Americans who are aging and/or have disabilities, live at home in their communities? Answer 8. ACL's work to help older adults and people with disabilities live independently in their communities has never been more important. There are 65 million people age 60 and older. All but a tiny percentage of them live in non-institutional settings, as do nearly 57 million people with disabilities. Both populations are growing, and older Americans are one of the fastest-growing demographics in the country; by 2020, there will be more than 77 million people over the age of 60. I have been an advocate for older adults and people with disabilities throughout my career. I look forward to continuing that role at the Federal level to help ensure the long-term sustainability of the critical programs that support older adults and people with disabilities and help them live independently. Question 9. ACL recently published three requests for comments in the Federal Register, for both aging and disability datasets, regarding the removal of data collection elements on Sexual Orientation and Gender Identity (SOGI). Both Office of Management and Budget and Healthy People 2020 recognize the need for collecting data on this underrepresented group as a way to measure unmet need. Will you commit to restoring the LGBTQ questions to these surveys? Answer 9. I am committed to working with the aging and disability networks to help them best serve older adults and people with disabilities, particularly those with the greatest social and economic needs. I am committed to better understanding these issues and ensuring that ACL's programs serve all people, including LGBT older adults and people with disabilities. Question 10. Over the last several months, I have sent multiple letters to HHS about the Administration's ongoing efforts to undermine and sabotage the Affordable Care Act through executive action. HHS has failed to provide responses to many of my letters. If HHS has responded, the response letters have been wholly inadequate and have not been responsive to my requests. If you are confirmed, do you commit to respond in a timely manner to all congressional inquiries and requests for information from all Members of Congress, including requests from Members in the Minority? Answer 10. Yes, I will appropriately respond to all Member requests. I look forward to working with all Members of Congress to address the needs and concerns of older adults and people with disabilities. senator franken Question 1. Do you support the use of Medicaid home and community- based services for both older adults and people with disabilities? What will you do to make sure seniors and people with disabilities can stay in their communities and remain independent as long as possible? Answer 1. Since its creation, ACL has advocated for the expansion and coordination of home- and community-based services and improvements in quality so that older adults and people with disabilities have more and better options about how and where to receive the long-term services and supports they need. I am excited to continue this work. Question 2. How will you work with Congress to shape the next Older Americans Act legislation? What priorities do you think the legislation should address? Answer 2. We need to tackle one of the most critical issues facing us today--the role of the aging services network and its capacity to truly partner with the healthcare system in order to provide and partner in an integrated service delivery model. I look forward to working with the aging network and Congress to this end. senator bennet Question 1. Many chronic diseases are preventable or better managed when caught early. When they are not, there is a large cost burden on our society. The American Diabetes Association estimates that the economic cost of diabetes was nearly $250 billion in 2012, a 41 percent increase since 2007. In Medicare, 15 percent of the sickest enrollees that often have multiple chronic conditions, account for 50 percent of Medicare spending. What is your strategy around prevention so that certain chronic diseases are avoided or better managed in order for us to improve outcomes and save Medicare dollars? Answer 1. Under Title III-D of the Older Americans Act, ACL supports a number of evidence-based programs that help older adults maintain their health and wellness. This includes programs that help older adults learn to effectively manage chronic diseases like diabetes, programs that help prevent falls, and other such programs. Centers for independent living and university centers of excellence on developmental disabilities offer similar programs for people with disabilities. Programs like these that use evidence-based models help to avoid the far higher costs associated with advancing disease, and I look forward to continuing to build on these efforts. senator whitehouse Question 1. President Trump's budget eliminates Senior Corps, a program that engages a quarter of a million older adults who volunteer almost 75 million hours of service each year to community programs that serve seniors, children, veterans and others. Although the Assistant Secretary for Aging does not oversee Senior Corps, the Administration for Community Living has a memorandum of understanding with the Corporation for National and Community Service to promote volunteerism by older adults and people with disabilities. Do you believe the elimination of Senior Corps will benefit seniors? Will you advocate within the administration for funding for programs like Senior Corps that help keep seniors engaged in their communities? Answer 1. I believe strongly in the value that older adults provide to their communities, and I believe we are stronger when we harness the power of everyone's talents. ACL is different from many Federal agencies in that advocacy is explicitly included in several of the statutes that authorize its programs. I am looking forward to continuing that role at the Federal level to help ensure the long-term sustainability of the critical programs that support older adults and people with disabilities and help them to fully participate in their communities. Question 2a. President Trump's budget cuts almost $80 million from disability programs within the Administration on Community Living, which is overseen by the Assistant Secretary for Aging. The President himself has publicly mocked a disabled person. Do you believe these budget cuts will lead to better outcomes for people with disabilities? Answer 2a. I support the idea of delivering services that help to achieve independence, productivity, integration, self-determination and inclusion in the community while eliminating silos that make it harder for people to access the services they need. I look forward to working with ACL team members, HHS leaders, and Congress to ensure these programs are funded in the most responsible way. Quesion 2b. Please list three things you will do if confirmed to support disabled Americans and the Federal programs that serve them. Answer 2b. I am looking forward to working with my colleagues at ACL and throughout HHS to learn more about the programs and initiatives already in place. The strategy I shared in my testimony applies to both older adults and people with disabilities. For both populations, navigating the systems of services and support, identifying what is available, and understanding how to access those services, can be overwhelming. We have to streamline that process and ensure the needs of the person are kept at the forefront of our focus. Families and friends play a critical role in supporting older adults and people with disabilities alike. Supporting those people is essential to helping older adults and people with disabilities continue living independently in the community. It is imperative that we ensure the community-based organizations that form the aging and disability networks are able to survive in the increasingly complex health care environment. ACL has been investing in helping the networks develop the business acumen necessary to integrate the services they provide into the overall health care spectrum. I believe that work is absolutely critical. senator baldwin Question 1. In 2012, the Administration on Aging (AOA) issued new guidance on the definition of the term ``greatest social need'' in the Older Americans Act that included ``individuals isolated due to sexual orientation or gender identity.'' Do you support AOA's guidance that States can classify LGBT older adults as a greatest social needs population? Please explain your answer. Should ACL do more to ensure States are assessing and meeting the needs of the LGBT older adult population? What, if anything, did you do as the director of the Aging Services Division in Oklahoma to both assess and meet the needs of LGBT older adults under your tenure? Answer 1. I am committed to working with the aging and disability networks to help them best serve older adults and people with disabilities, particularly those with the greatest social and economic needs. I am committed to better understanding these issues and ensuring that ACL's programs serve all people, including LGBT older adults and people with disabilities. Question 2a. I am concerned with ACL's proposals to eliminate data on key demographic populations, including LGBT older adults as well as transgender older adults, from this year's National Survey of Older Americans Act Participants. This critical survey is used to evaluate the effectiveness of the Older Americans Act programs funded through HHS, including who is able to access the programs. Answer 2a. Older LGBT and transgender individuals face many challenges including financial insecurity, social isolation, discrimination, and barriers to access for aging and accessibility services. I believe that removing sexual orientation and gender identity questions from these surveys will limit HHS's ability to address these issues. In fact, NASUAD sent a statement to ACL addressing their data collection efforts on LGBT individuals which reads, ``. . . we believe that there is opportunity to improve the data collection regarding the needs and prevalence of different populations served by the aging network [and] recommend that ACL continue to refine this data collection in order to provide meaningful analysis rather than eliminate the questions.'' While, I am encouraged that HHS has decided to retain the sexual orientation question, I remain very troubled by the proposed elimination of the gender identity question. Further, I am concerned that these actions reveal a troubling pattern by HHS to rollback efforts to improve community care and address health disparities for these vulnerable populations. Question 2b. Do you believe HHS and ACL should do more to improve data collection on LGBT individuals? Will you commit to enhancing ACL's efforts to collect data on LGBT older adults and people with disabilities? Answer 2b. I am committed to working with the aging and disability networks to help them best serve older adults and people with disabilities, particularly those with the greatest social and economic needs. I am committed to better understanding these issues and ensuring that ACL's programs serve all people, including LGBT older adults and people with disabilities. Question 3. Former HHS Secretary Kathleen Sebelius played a leading role in establishing ACL and stated that, ``. . . we now recognize that LGBT older adults also represent a community with unique needs that must be addressed''. Do you agree with this statement? Answer 3. I am committed to working with the aging and disability networks to help them best serve older adults and people with disabilities, particularly those with the greatest social and economic needs. senator murphy Question 1. As you may know, State Health Insurance Assistance Programs (SHIPs) play an essential role in helping Medicare beneficiaries, who are often low-income or have complex health conditions, navigate make informed decisions about their Medicare coverage. Answer 1. In Connecticut, the SHIP program, known as CHOICES, helped 34,200 seniors, people with disabilities, and family caregivers last year find the health care program that works for them and their families. Connecticut received over $676,000 in Federal funding last year through the SHIP program. There are five regional offices that administer the program. SHIP counselors provide personalized, one-on-one assistance to seniors and their families that cannot be replicated by 1-800-MEDICARE or other broad outreach activities, because it is often the Medicare beneficiaries with the most complex cases and fewest resources who seek their help. SHIP counseling assistance can save individual Medicare beneficiaries hundreds, or even thousands, of dollars every year, and, as a result, can save some seniors from having to choose between paying for their health care and essentials such as their rent or groceries. Unfortunately, Federal funding for SHIPs has been targeted for elimination or reduced funding over the years. As Assistant Secretary of Aging, will you advocate for adequate Federal funding for the State Health Insurance Assistance Program (SHIP) in light of the need for critical SHIP services for seniors-- particularly low-income seniors navigating an increasingly complicated Medicare system? For older adults, people with disabilities, and their families, navigating the systems of services and support, identifying what is available, and understanding how to access those services can be overwhelming. Similarly, determining the best Medicare elections for individual situations can be challenging, and many people who are eligible for Medicare need assistance understanding the various options. I look forward to working with all parties to ensure that older adults, people with disabilities, and their families understand the choices and services available to them and how to access them. Question 2. A recent report by the National Academies of Sciences, Engineering and Medicine found that close to 18 million Americans of working age help disabled or older family members or friends with activities of daily living on an ongoing basis. In Connecticut, 1 in 6 residents are providing care for a relative, and 70 percent believe they will at some point. The report forecast that the numbers of family caregivers will continue to rise, not taking into account any potential cuts to Medicaid that would likely exacerbate our country's caregiving crisis. As you may know, family caregiving obligations have a substantial economic impact, as workers in this situation often have to take time off from jobs, cut back on working hours, or leave the paid workforce altogether. Unfortunately, this lowers their future Social Security benefit, threatening their own retirement. Studies indicate that on average, total wage, private pension, and Social Security losses due to caregiving add up to more than $300,000. In Connecticut, an estimated 459,000 caregivers in 2013 spent 427 million hours providing nearly $6 billion in unpaid caregiving. I believe that family caregivers deserve our gratitude, not punishment for taking time off to care for a loved one. That's why, after hearing concerns from family caregivers around Connecticut, I introduced the Social Security Caregiver Credit Act, which would add a credit to caregivers' lifetime earnings to determine how much they should receive in Social Security benefits. By creating a Social Security Caregiver credit, caregivers who had to leave the workforce entirely, or continue to work with significantly reduced hours, would receive modest retirement compensation. What specific initiatives will you, as Assistant Secretary on Aging and Administrator of the Administration for Community Living, undertake to facilitate family caregiving? Answer 2. As I shared in my testimony, my vision includes a strategic focus on supporting caregivers. Informal caregivers of individuals with disabilities and older adults and the services and supports they provide them are the epicenter of the long-term services and supports system. Under my leadership we will continue to promote evidence-based solutions, and build support systems that work. We will continue to seek ways to meet caregivers where they are and equip them with the tools they need to be successful in this important role. senator warren Medicaid According to the Centers for Medicare and Medicaid Services (CMS), 8.3 million low-income seniors and people with disabilities receive health care coverage through both Medicare and Medicaid, making them ``dually eligible.'' People who are dually eligible receive financial assistance to help pay their premiums, out-of-pocket costs, nursing facility care, eyeglasses, and hearing aids.\1\ Medicaid also provides the backbone for coverage of long-term services and supports (LTSS), including home and community-based services (HCBS) that help seniors and people with disabilities live independently.\2\ Two-thirds of Americans living in nursing homes rely on Medicaid.\3\ --------------------------------------------------------------------------- \1\ Centers for Medicare and Medicaid Services, ``Seniors & Medicare and Medicaid Enrollees'' (online at: https://www.medicaid.gov/ medicaid/eligibility/medicaid-enrollees/index.html). Accessed August 1, 2017. \2\ Erica L. Reaves, MaryBeth Musumeci, ``Medicaid and Long-Term Services and Supports: A Primer,'' Kaiser Family Foundation (December 15, 2015) (online at: http://www.kff.org/medicaid/report/medicaid-and- long-term-services-and-supports-a-primer/). \3\ Ina Jaffe, ``Nursing Homes Worry Proposed Medicaid Cuts Will Force Cuts, Closures,'' NPR (June 28, 2017) (online at: http:// www.npr.org/sections/health-shots/2017/06/28/534764940/proposed- medicaid-cuts-likely-to-put-pressure-on-nursing-homes). --------------------------------------------------------------------------- President Trump has supported legislation that would cut Medicaid by more than $700 billion, converting it to a per capita cap or block grant system.\4\ His budget proposal for fiscal year 2018 (FY18) also proposed an additional cut to Medicaid of over $600 billion.\5\ --------------------------------------------------------------------------- \4\ Philip Bump, ``By 2026, Annual Medicaid Cuts under the Senate Health-Care Replacement Plan are Steeper than Under Repeal,'' Washington Post (July 19, 2017) (online at: https:// www.washingtonpost.com/news/politics/wp/2017/07/19/by-2026-annual- medicaid-cuts-under-the-senate-health-care-replacement-plan-are- steeper-than-under-repeal/?utm_term=.27c6f093a793); Danielle Kurzleben, ``GOP Health Plan Would Leave 23 Million More Uninsured, Budget Office Says,'' NPR (May 24, 2017) (online at: http://www.npr.org/2017/05/24/ 529902300/cbo-republicans-ahca-would-leave-23-million-more-uninsured). \5\ Iris J. Lav, Michael Leachman, ``The Trump Budget's Massive Cuts to State and Local Services and Programs,'' Center on Budget and Policy Priorities (June 13, 2017) (online at: https://www.cbpp.org/ research/state-budget-and-tax/the-trump-budgets-massive-cuts-to-state- and-local-services-and). --------------------------------------------------------------------------- As Assistant Secretary for Aging, as well as the Administrator for Community Living (ACL), you will be responsible for addressing the concerns and advancing the interests of America's seniors and people with disabilities. Question 1. Do you agree that Medicaid plays an essential role in ensuring that seniors and people with disabilities can get access to affordable high-quality services that allow them to live independently at home and in their communities? Answer 1. Medicaid plays an essential role along with other public and private resources at the Federal, State and local level and support provided by family members and other caregivers to assist individuals to live independently and participate fully in society. Question 2. Do you agree that hundreds of billions of dollars in cuts to Medicaid would have a negative impact on the ability of seniors and people with disabilities to access health care? Answer 2. Medicaid plays an essential role along with other public and private resources at the Federal, State and local level and support provided by family members and other caregivers to assist individuals to live independently and participate fully in society. Long-term services and supports The Assistant Secretary for Aging oversees the Administration on Aging (AOA), which includes the Office of Elder Justice and Adult Protective Services and the Office of Long-Term Care Ombudsman Programs. These two offices work together to advocate for the rights and protection of the elderly and adults with disabilities from ``abuse, neglect, self-neglect, or financial exploitation.''\6\ The Long-Term Care Ombudsman Program works to resolve problems and promote policies that protect patients in LTSS settings, including assisted living facilities. This program is required to identify and investigate complaints of residents in LTSS settings, provide administrative and legal services for residents, and ``analyze, comment on, and recommend changes in laws and regulations pertaining to the health, safety, welfare, and rights of residents.''\7\ --------------------------------------------------------------------------- \6\ Administration for Community Living, ``Supporting Adult Protective Services'' (online at: https://www.acl.gov/programs/elder- justice/supporting-adult-protective-services). Accessed August 1, 2017. \7\ Administration for Community Living, ``Long-Term Care Ombudsman Program'' (online at: https://www.acl.gov/node/68). Accessed August 1, 2017. Question 3. Do you agree that America's seniors, people with disabilities, and their families deserve to know that when they or their loved ones are in a nursing home or assisted living facility, it is a safe, high-quality care facility? Answer 3. All people have the right to live their lives with dignity and respect, free from abuse of any kind, regardless of the setting. Question 4. Nursing homes are regulated at the State level and via CMS, and CMS has established the Nursing Home Compare Web site to provide information to help seniors and families choose the facility that best suits their needs. How does the AOA work with CMS to ensure that seniors have access to this and other information that they need? What other actions does the AOA take to improve the quality of nursing home care? If confirmed, what additional steps will you take to improve the quality of nursing home care? Answer 4. CMS and ACL work closely together on several nursing home initiatives to support quality care, including initiatives to reduce the misuse of antipsychotic medications, reduce inappropriate discharge and evictions, and to foster person-centered care practices. ACL has also worked with its National Ombudsmen Resource Center to develop consumer education materials for individuals and their families regarding residents' rights and other provisions related to the revised nursing home regulations in order to inform consumers and to support quality, individualized care. Question 5. The Federal Government pays for care in assisted living facilities via Medicaid waiver programs that allow payments for such care. However, there is limited or no Federal oversight of these facilities. What actions does the AOA currently take to improve the quality of care in assisted living facilities and to ensure that seniors have access to the information they need to choose the best facility for their needs? Answer 5. State Long-Term Care Ombudsman programs offer complaint resolution services, information and assistance, and training to both consumers and staff of assisted living facilities. In assisted living, board and care, and other residential care communities, Ombudsman programs most frequently work on complaints such as, medication errors, food concerns, improper eviction or inadequate discharge, lack of dignity or respect for residents, poor staff attitudes and building or equipment hazards or need for repair. Through the National Ombudsman Resource Center technical assistance and training related to assisted living facility settings is provided through Web materials and through webinars and other training. Question 6. What additional steps do you believe that AOA can take to ensure that the care provided to seniors at Assisted Living Facilities is both high quality and cost-effective? Answer 6. Key steps include further promoting person-centered care practices and educating and training facility staff on the indicators of and how to report abuse, neglect and exploitation. Question 7. Will you commit to advocating on behalf of seniors and people with disabilities living in nursing homes or assisted living facilities, including advocating for robust funding and policies that ensure consumer protections? Answer 7. ACL is different from many Federal agencies in that advocacy is explicitly included in several of the statutes that authorize its programs. The Long-Term Care Ombudsman in every State works with residents of long-term care facilities, including nursing homes, to protect their rights and resolve disputes. Further, State Long-Term Care Ombudsmen also serve as advocates for people living in facilities, providing input on State and local legislation and policy that affects facilities. Question 8. What specific steps will you take to ensure that seniors and people with disabilities, as well as their families, know about the Long-Term Care Ombudsman Program and the services it provides? Answer 8. ACL will continue to promote the Long-Term Care Ombudsman Program and its services and supports in partnership with national, State and local grantees and stakeholders. This includes ensuring information and referral through phone, internet, and in-person contact with individuals with disabilities, older adults, and their families and caregivers. Social media is an area where a new and additional form of outreach is occurring. Question 9. Between 2010 and 2014, more than 100 cases of abuse, medical malpractice, or wrongful death related to skilled nursing facilities were forced into arbitration.\8\ Forced arbitration clauses--often buried in confusing paperwork signed under duress--bar residents from taking these facilities to court. Last fall, the Centers for Medicare and Medicaid Services (CMS) banned skilled nursing facilities from compelling new residents to enter into such agreements, but a new CMS proposal rescinds that ban, allowing SNFs to take advantage of our Nation's most vulnerable citizens through this predatory and opaque practice.\9\ Do you agree that arbitration should be transparent and agreed to voluntarily, without threat of being turned down or kicked out from residence of a skilled nursing facility where a patient would like to receive services? --------------------------------------------------------------------------- \8\ Jessica Silver-Greenberg, Michael Corkery, ``In arbitration, a `privatization of the justice system' '' The New York Times (November 1, 2015) (online at: http://www.nytimes.com/2015/11/02/business/ dealbook/in-arbitration-a-privatization-of-the-justice-system.html). \9\ Virgil Dickson, ``CMS Lifts Ban on Nursing Home Arbitration Agreement,'' Modern Healthcare (June 5, 2017) (online at: http:// www.modernhealthcare.com/article/20170605/NEWS/170609949). --------------------------------------------------------------------------- Answer 9. All people have the right to live their lives with dignity and respect, free from abuse of any kind, regardless of the setting. State Health Insurance Assistance Program (SHIP) The Administration on Aging oversees the State Health Insurance Assistance Program (SHIP), which ``provides Medicare beneficiaries with information, counseling, and enrollment assistance.''\10\ --------------------------------------------------------------------------- \10\ Administration for Community Living, ``State Health Insurance Assistance Program (SHIP)'' (online at: https://www.acl.gov/node/162). Accessed August 1, 2017. --------------------------------------------------------------------------- Medicare provides quality health care coverage to millions of American seniors and Americans with disabilities. State Health Insurance Programs help direct individuals to the right care options by providing support and information for beneficiaries. SHIPs help beneficiaries enroll in the Medicare plans that are right for them, resolve billing issues, report fraud, and otherwise help beneficiaries navigate the Medicare system. These programs operate in all 50 States. In recent years, 7 million individuals were provided assistance with Medicare through SHIPs.\11\ However, President Trump's budget proposal for fiscal year 2018 proposed gutting the program.\12\ --------------------------------------------------------------------------- \11\ ``NCOA Issue Brief: FY 2018 Medicare SHIP Funding,'' National Council on Aging (July 2017) (online at: https://www.ncoa.org/ resources/ncoa-issue-brief-fy18-medicare-ship-funding/). \12\ ``President's FY 2018 Budget Eliminates Key Federal Programs Supporting Older Adults and Caregivers,'' Area Agency on Aging (May 24, 2017) (online at: http://info4seniors.org/presidents-fy-2018-budget- eliminates-key-Federal-programs-supporting-older-adults-caregivers/). Question 10. Do you agree that SHIP is an important program for seniors and individuals with disabilities? Answer 10. For older adults, people with disabilities, and their families, navigating the systems of services and support, identifying what is available, and understanding how to access those services can be overwhelming. Similarly, determining the best Medicare elections for individual situations can be challenging, and many people who are eligible for Medicare need assistance understanding the various options. I look forward to working with all parties to ensure that older adults, people with disabilities, and their families understand the choices and services available to them and know how to access them. Question 11. Will you advocate for these individuals by supporting the continued funding of SHIPs? Answer 11. For older adults, people with disabilities, and their families, navigating the systems of services and support, identifying what is available, and understanding how to access those services, can be overwhelming. Similarly, determining the best Medicare elections for individual situations can be challenging, and many people who are eligible for Medicare need assistance understanding the various options. I look forward to working with all parties to ensure that older adults, people with disabilities, and their families understand the choices and services available to them and how to access them. senator hassan Question 1. As you know, President Trump's budget proposal include steep cuts to a number of important programs that make meaningful community inclusion possible for individuals who experience disabilities. These cuts include billions of dollars from Medicaid and significant reductions to programs across the government that assist individuals who experience disabilities, including cuts to the Administration for Community Living, such as the elimination of funding for State Councils on Developmental Disabilities. Will you stand up against the President to protect funding for vital programs that support individuals who experience disabilities? Answer 1. I have been an advocate for older adults and people with disabilities throughout my career. I look forward to continuing that role at the Federal level to help ensure the long-term sustainability of the critical programs that support older adults and people with disabilities and help them live independently. In addition, I believe that the use of innovation and evidence- based practices will be critical to keeping these programs vital and to meeting the evolving needs of older Americans and those with disabilities. Question 2. In our one-on-one meeting, you and I discussed that a marked difference between individuals who are aging and those with a disability is fully integrated employment. Individuals with disabilities have a labor participation rate of around 20 percent, which is less than a third of the labor participation rate of individuals without a disability. What do you think the Administration for Community Living can do to help ensure more individuals who experience disabilities become gainfully employed? Answer 2. ACL strives to assure that older adults and people with disabilities do not face barriers to employment. Ensuring that everyone who wants to work has opportunities to do so is a critical element of helping people to live their lives fully integrated into their communities. Increasing access and eliminating barriers to employment has been part of ACL's mission since its creation, and I look forward to continuing that important work. Question 3. While Governor of New Hampshire, I signed a law which made New Hampshire the first State to eliminate the payment of sub minimum wage for individuals who experience disabilities. Do you support the closure of sheltered workshops and ending the practice of paying a sub minimum wage to individuals who experience disabilities? Answer 3. Ensuring that everyone who wants to work has full opportunities to do so is a critical element of helping people to live their lives fully integrated into their communities. Increasing access and eliminating barriers to employment has been part of ACL's mission since its creation, and I look forward to continuing that important work. Response by Brett Giroir, M.D., to Questions of Senator Murray, Senator Sanders, Senator Franken, Senator Bennet, Senator Whitehouse, Senator Baldwin and Senator Warren senator murray Question 1. The Office of the Assistant Secretary for Health (OASH) has a key role to play with regards to our Nation's response to both HIV and hepatitis. What is your vision and plans to continue our Nation's response to these public health issues? Will you continue to implement the National HIV/AIDS Strategy and the National Viral Hepatitis Action Plan? Will you commit to focusing efforts on areas where we know more needs to be done while sustaining and building on programs and activities that have been proven effective? Answer 1. If confirmed, it is my intent that OASH will continue its strong leadership role in implementing and extending both the National HIV/AIDS Strategy and the National Viral Hepatitis Action Plan. There is much work to be done to reduce the number of new infections with increased prevention, diagnosis, and treatment. While we have made enormous progress, we should strive to do more. Question 2. Secretary Price has indicated that combating childhood obesity is among his top three clinical priorities, and yet we've seen little action from the Administration on this issue. In fact, Secretary Price praised FDA's recent delay in implementing key menu labeling requirements. Under his watch, we've also seen a delay in important deadlines for updating the nutrition facts panel on packaged food. What role does access to accurate and comprehensive nutrition information play in supporting families' healthy eating efforts? What role does such information play in combating childhood obesity? What would your priorities be with regards to addressing childhood obesity? Answer 2. As a pediatrician--and exercise enthusiast--with programmatic experience in obesity and diabetes, I fully support the Secretary's prioritization of childhood obesity as one of his top objectives. If confirmed, I plan to work alongside the Secretary in developing, coordinating, and implementing effective initiatives to reduce childhood obesity through the programs that the Office of the Assistant Secretary for Health administers. In terms of food labeling, I certainly agree that it is important to provide parents and children with meaningful, easily understood information. Question 3. Recent outbreaks have underscored the dangers of delaying or avoiding recommended vaccines. If confirmed, you would oversee the National Vaccine Program Office (NVPO). What do you view as the key priorities for NVPO? Can you describe specific strategies NVPO can take to improve vaccine usage? What can NVPO do to increase adolescent and adult vaccination rates? HPV vaccination rates remain much lower than other adolescent vaccines, even though the vaccine prevents infections that can lead to cancer. What can be done, including by NVPO, to improve adolescent HPV vaccination rates specifically? Answer 3. Vaccines save lives. They are the most important health innovation of modern times. If confirmed, I will be a passionate advocate for vaccines while working to continue our effective and transparent monitoring systems to provide American families assurance that vaccines remain safe. While no public health intervention, including vaccinations is 100 percent risk-free, vaccines are the gold standard of disease prevention. It's our job to provide parents high- quality, scientifically accurate information so that they can feel confident in the safety of the vaccines we recommend for American children. Question 4. Will you provide continued support for the current revision of our Physical Activity Guidelines and similarly, would you find ways under the current fiscal environment to optimize communication and release of those guidelines? Answer 4. As a fitness enthusiast, I understand the importance of physical fitness for healthy living. If confirmed, I will work collaboratively with the relevant agencies, including the CDC and NIH, to ensure that Americans have scientifically sound information about physical fitness and will support efforts to continue developing research initiatives to improve our evidence base. Question 5. The National Public Health Commissioned Corps is key to the defense of public health in our country and played an important role in Katrina, Ebola, and many other national and global crises. How will you work to elevate the National Public Health Commissioned Corps and their expertise in a modern way to assist in the response during the next public health emergency? What do you view as the greatest assets of the Corps? Answer 5. I am proud of the honorable and hard-working members of the Commissioned Corps. They are certainly an impressive and dedicated group of professionals. I look forward to working with them more to advance the President's and the Secretary's public health agenda and to protect the health of all Americans. Question 6. Title X is the only Federal grant program dedicated solely to providing individuals with comprehensive family planning and related preventive health services. It is designed to prioritize the needs of low income families or uninsured people, including those who are not eligible for Medicaid. These individuals may not otherwise have access to these health care services. It promotes positive birth outcomes and healthy families by enabling individuals to decide the number and spacing of their children. Secretary Price has warned current multi-year title X grant recipients that their funding ends after this year, mid-way through the grant period, and they must compete again for funding that they have already been awarded. As Assistant Secretary for Health, you would oversee multiple grant making programs. Can you assure future grant recipients that if they receive grants for a certain term of years, the agency will not act to prematurely terminate those grants, which the recipients rely on to serve the highest need populations? Can grant recipients trust that they can rely on the funding they have been awarded by you? Answer 6. If confirmed, I commit to implementing the laws passed by Congress and signed by the President effectively and faithfully, and following the grant making rules and procedures of the Department. Question 7. HHS regional offices are incredibly important to the work the Department does in States and communities. How do you view the role of regional offices in supporting the priorities of the Department? Answer 7. It is certainly true that the majority of the Nation's wisdom does not reside inside the borders of Washington, DC. I will definitely seek counsel and intelligence from the field, including from Departmental offices as well as, and perhaps especially, from State and local public health agencies and officials who are doing the bread-and- butter public health work protecting Americans every day. senator sanders Question. As you know, one in five Americans between the ages of 19 and 64 years, cannot afford the medicines that their doctors prescribe to them. Additionally, more than 7 in 10 Americans support the idea of being able to purchase prescription drugs that are imported from Canada. In detail, please share your position on drug importation from Canada? Are you familiar with the recent CBO analysis that has shown that importation would save the government $6.5 billion over 10 years? What would it mean for the health outcomes of the 35 million Americans who currently are unable to afford their medicines? Answer. The President and the Secretary have made reducing the financial pain at the pharmacy counter a major priority. As we carry out that initiative, the safety and quality of medicines that Americans take, as well as their affordability, will be our guide. senator franken Question 1. The President's proposed budget and actions taken so far have sought to undermine the very programs that you will be charged with supporting. What will you do to ensure that public health and effective prevention measures remain a top priority at the Department of Health and Human Services? Answer 1. Preventable diseases and chronic diseases account for a majority of American health disparities and healthcare expenditures. Protecting the public's health will of course involve a strong commitment to prevention, and the President's budget recognizes this reality. If confirmed, I will work to keep prevention at OASH a top priority. senator bennet Question 1. I was recently in Otero County, CO where drug overdoses have been increasing. The entire community was engaging to address the rise in opioid abuse. This included coordinating hospitals, the courts, schools and foster care services. Even when we see a decrease in prescription overdoses, it is usually countered with an increase in heroin overdoses. In the 1960s, more than 80 percent of heroin users started with heroin. In contrast, currently, about 80 percent of heroin users first started using prescription opioids. What are practical steps you plan to take to address the opioid crisis? How can we ensure that Americans are not becoming addicted in the first place while making it easier for people who currently have an addiction to obtain access to treatment? Answer 1. The Secretary has laid out a robust five-point plan for combating the opioid epidemic, grounded in expanding access to treatment, prevention and recovery services, promoting the use of overdose-reversing drugs, better and more real-time data, innovative research to develop new products in addiction prevention and treatment, and better provider practices when it comes to pain management. I am fully committed to helping him implement his plan--it is the right one and we must step up the fight to protect American communities from the terrible scourge of opioid addiction and overdose. Question 2. As you know, ``super bugs,'' or bacteria that are resistant to multiple antibiotics, are increasingly becoming a public health threat. Antibiotic innovation is failing to keep up with patient needs. This has left many patients struggling with severe and life- threatening infections without effective treatment options. At the same time, economic challenges have caused most pharmaceutical companies to stop investing in research and development for antibiotics. Last year, I worked with Senator Hatch to pass the PATH Act in 21st Century Cures. The bill created a new drug approval pathway to streamline access and encourage innovation for lifesaving antibiotics. What else can we do to encourage the research and development of antibiotics that treat life-threatening infections? Overuse of antibiotics is a main driver of antibiotic resistance. As the Assistant Secretary for Health, how would you help reduce inappropriate or excessive antibiotic use? Answer 2. You are absolutely right about the threat represented by antimicrobial resistance. If confirmed, I intend to engage in a personal way to support the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), which is overseen by OASH, as well as the important work on this issue being done by CDC, FDA, ASPR, and other Federal partners. Question 3. Many chronic diseases are preventable or better managed when caught early. When they are not, there is a large cost burden on our society. The American Diabetes Association estimates that the economic cost of diabetes was nearly $250 billion in 2012, a 41 percent increase since 2007. In Medicare, 15 percent of the sickest enrollees that often have multiple chronic conditions, account for 50 percent of Medicare spending. What is your strategy around prevention so that certain chronic diseases are avoided or better managed in order for us to improve outcomes and save Medicare dollars? Answer 3. Preventable diseases and chronic diseases account for a majority of American health disparities and healthcare expenditures. There is clearly room for additional focus on preventive care to improve health and competitiveness, while being fiscally responsible and preserving our safety net and entitlement programs for future generations. If confirmed, I will work to keep prevention at OASH a top priority. senator whitehouse Question 1. The Centers for Disease Control and Prevention estimates that two million people develop antibiotic-resistant infections in the United States every year, resulting in at least 23,000 deaths. The Assistant Secretary for Health oversees the Presidential Advisory Council on combating Antibiotic-Resistant Bacteria, which will expire on September 30 unless it is extended by Executive order of the President. Do you believe the Presidential Advisory Council on combating Antibiotic-Resistant Bacteria has done effective work? If not, why not? Will you encourage the President to continue this important council and its work to combat antibiotic resistance? Answer 1. If confirmed, I intend to engage in a personal way to support the Presidential Advisory Council on Combating Antibiotic- Resistant Bacteria (PACCARB), which is overseen by OASH, as well as the important work on this issue being done by CDC, FDA, ASPR, and other Federal partners. Question 2. As the Assistant Secretary for Health, you would oversee the National Vaccine Program Office. You've been vocal about your support for childhood vaccinations, and their safety and importance to public health. President Trump, however, has repeated disproven claims about the dangers of vaccines--a position that seems at odds with your informed professional judgment. Will you work to ensure that only scientifically accurate information about vaccines is communicated to the public and to others in the Administration? Answer 2. Vaccines save lives. They are the most important health innovation of modern times. If confirmed, I will be a passionate advocate for vaccines while working to continue our effective and transparent monitoring systems to provide American families assurance that vaccines remain safe. While no public health intervention, including vaccinations is 100 percent risk-free, vaccines are the gold standard of disease prevention. It's our job to provide parents high- quality, scientifically accurate information so that they can feel confident in the safety of the vaccines we recommend for American children. Question 3. The Assistant Secretary for Health oversees the Office of Population Affairs, which administers the title X family planning program and provides guidance on a range of reproductive health topics. President Trump's pick to lead this office is someone who has called contraceptives ``medically irresponsible,'' despite the fact that she has no medical training. She has also said that the birth control pill doesn't work, despite overwhelming evidence to the contrary. In your professional opinion, are the statements above about contraception true? Do you believe statements like these should be used to inform policies of the Department of Health and Human Services? What will you do as Assistant Secretary for Health to ensure the Department's policies on women's health are guided by science rather than ideology? Answer 3. I look forward to working with HHS staff if I am confirmed. I am committed to promoting the public's health and applying evidence and common sense to our policymaking process. senator baldwin Question. There has been incredible progress in the fight against HIV/AIDS over the last 30 years. Through investments in HIV prevention, hundreds of thousands of new infections have been prevented, savings billions of dollars in treatment costs. While HIV prevention efforts are working, there are still an estimated 37,600 new infections each year. Similarly, hepatitis C (HCV) kills nearly 20,000 people in the United States each year and complications, and HCV-associated deaths now exceed the number of deaths from 60 other nationally notifiable diseases. Rates of new cases of HCV have increased nearly threefold from 2010, particularly as the opioid epidemic proliferates. Can you please discuss how you would continue our Nation's response to these public health issues? Will you continue to implement the National HIV/AIDS Strategy and the National Viral Hepatitis Action Plan? Answer. If confirmed, it is my intent that OASH will continue its strong leadership role in implementing both the National HIV/AIDS Strategy and the National Viral Hepatitis Action Plan. There is much work to be done to improve over the status quo and reduce the number of new infections with increased prevention, diagnosis, and treatment. While we have made enormous progress, we should strive to do more. senator warren Evidence-Based Reproductive Health The Assistant Secretary for Health oversees multiple offices within the Department of Health and Human Services that promote the reproductive health of women, men, and teens across the Nation, including the Office of Women's Health, the Office of HIV/AIDS and Infectious Disease Policy, the Office of Population Affairs, and the Office of Adolescent Health. National reproductive health experts agree that evidence-based, scientifically accurate sexual education is critical to the control of sexually transmitted infections (STIs), including HIV/AIDS, as well as to the reduction in teen pregnancy rates: according to the Guttmacher Institute, ``comprehensive sex education programs . . . have been shown to delay sexual debut, reduce frequency of sex and number of partners, increase condom or contraceptive use, or reduce sexual risk-taking.'' \1\ To the contrary, ``abstinence-only'' sex education programs have proven to be ineffective, if not detrimental, to efforts to reduce teen pregnancy and STI rates.\2\ --------------------------------------------------------------------------- \1\ Heather D. Boonstra, ``What Is Behind the Declines in Teen Pregnancy Rates?'' Guttmacher Institute (September 3, 2014) (online at https://www.guttmacher.org/gpr/2014/09/what-behind-declines-teen- pregnancy-rates). \2\ Sexuality Information and Education Council of the United States, ``What the Research Says . . . Abstinence--OnlyUntil--Marriage Programs'' (online at http://www.siecus.org/index .cfm?fuseaction=Page.ViewPage&PageID=1195). --------------------------------------------------------------------------- As the Assistant Secretary for Health, it is essential that you understand--and act upon--the plethora of evidence showing that abstinence-only education does not promote the Department's mission to ``enhance and protect the health and well-being of all Americans.'' \3\ --------------------------------------------------------------------------- \3\ U.S. Department of Health and Human Services, ``About HHS'' (online at https://www.hhs.gov/about/index.html). Question 1. Do you agree that policies demonstrated to increase the number of unintended pregnancies and STIs among teenagers should not be supported by HHS? Answer 1. If confirmed, I intend to develop and implement evidence- based policies and programs to, among other things, decrease unintended pregnancies, and STDs among all Americans, especially among teenagers. Question 2. As HHS Assistant Secretary for Health, would you commit to implementing and expanding evidence-based programs that improve teenagers' reproductive health? Answer 2. See above. Question 3. Please provide a detailed description of steps you would take as HHS Assistant Secretary for Health to improve teenagers' access to evidence-based reproductive health education and services. Answer 3. See above. Teen Pregnancy Prevention Program Though teen pregnancy has reached historic lows, around 25 percent of teen girls in the United States will become pregnant by age 20.\4\ To combat teen pregnancy rates, the Office of Adolescent Health administers the Teen Pregnancy Prevention (TPP) Program, an ``evidence- based program that funds diverse organizations that are working to prevent teen pregnancy across the United States.''\4\ Since the program's implementation in 2010, teen childbearing has declined by 35 percent nationwide, suggesting that the program is ``highly effective.'' \5\ --------------------------------------------------------------------------- \4\ The National Campaign to Prevent Teen and Unplanned Pregnancy, ``Fast Facts: Teen Pregnancy in the United States'' (April 2016) (online at https://thenationalcampaign.org/sites/ default/files/resource-primarydownload/ fast_facts_teen_pregnancy_in_the_united_states .pdf). \5\ U.S. Department of Health and Human Services, Office of Adolescent Health, ``Teen Pregnancy Prevention Program (TPP)'' (online at https://www.hhs.gov/ash/oah/grant-programs/teen-pregnancy- prevention-programtpp/index.html). --------------------------------------------------------------------------- Despite the effectiveness of the TPP Program, the Office of Adolescent Health announced on July 5, 2017, that it would cut short all 81 TPP grants and defund TPP grantees on June 30, 2018.\6\ OAH provided no rational for this decision. On July 21, I joined my Senate colleagues in sending a letter to Secretary Price, requesting detailed information on the justification behind OAH's decision.\7\ --------------------------------------------------------------------------- \6\ Christine Dehlendorf, ``Successful teen pregnancy prevention program threatened by funding cuts,'' STAT News (April 20, 2017) (online at https://www.statnews.com/2017/04/20/successful-teen- pregnancy-prevention-programthreatened-funding-cuts/). \7\ Christine Dehlendorf, ``Successful teen pregnancy prevention program threatened by funding cuts,'' STAT News (April 20, 2017) (online at https://www.statnews.com/2017/04/20/successful-teen- pregnancy-prevention-programthreatened-funding-cuts/). Question 4. As Assistant Secretary for Health, would you commit to re-implementing the TPP grants that OAH cut short without explanation on July 5th? Answer 4. If confirmed, I commit to implementing the laws passed by Congress and signed by the President effectively and faithfully, and following the grant making rules and procedures of the Department. I also believe that the reasoning for decisions be transparent to Congress and the American people. Question 5. Will you commit to ensuring that Secretary Price, through the Office of Adolescent Health, provides a detailed response to the July 21st letter requesting OAH's justification for shortening TPP Program grant agreements? Answer 5. See above. Title X Family Planning Program The Assistant Secretary for Health oversees the Office of Population Affairs, which runs the Title X Family Planning Program (Title X). The title X program funds basic reproductive health services--including cancer screenings, STI testing, and birth control-- to over 4 million low-income Americans every year.\8\ --------------------------------------------------------------------------- \8\ U.S. Senate Committee on Health, Education, Labor, & Pensions, ``Murray, Senate Dems Challenge Trump Administration Over Move to Slash Teen Pregnancy Prevention; Dems Say Action `Short-Sighted,' Will Make it Harder to Prevent Unintended Pregnancies'' (July 21, 2017) (online at https://www.help.senate.gov/ranking/newsroom/press/murray-senate- dems-challenge-trump-administration-overmove-to-slash-teen-pregnancy- prevention-dems-say-action-short-sighted-will-make-it-harder-to- preventunintended-pregnancies-). --------------------------------------------------------------------------- In recent years, some States have attempted to exclude reproductive health centers that also provide abortion services from receiving title X funds. In December 2016, the Obama administration issued a rule clarifying that title X recipients cannot be barred from receiving funds ``on bases unrelated to their ability to provide title X services effectively.'' \9\ In spite of the critical services that title X provides, a Republican Congress--after calling in Vice President Pence for a tie-breaking vote--nullified this rulemaking through the Congressional Review Act.\10\ --------------------------------------------------------------------------- \9\ Planned Parenthood Action Fund, ``Title X: America's Family Planning Program'' (online at https://www.plannedparenthoodaction.org/ issues/health-care-equity/title-x). \10\ Health and Human Services Department, Compliance With Title X Requirements by Project Recipients in Selecting Subrecipients (December 19, 2016) (online at https://www.federal register.gov/documents/2016/12/19/2016-30276/compliance-with-title-x- requirements-byproject-recipients-in-selecting-subrecipients). --------------------------------------------------------------------------- Teresa Manning, Deputy Assistant Secretary for Population Affairs, has stated that ``contraception doesn't work'' and that ``its efficacy is very low.'' \11\ She has also--incorrectly--stated that a ``dominant . . . mechanism of the morning-after pill is the destruction of a human life already conceived.''\12\ --------------------------------------------------------------------------- \11\ Colin Dwyer, ``Trump Signs Law Giving States Option to Deny Funding for Planned Parenthood,'' NPR (April 13, 2017) (online at http://www.npr.org/sections/thetwo-way/2017/04/13/523795052/trump- signs-law-giving-states-option-to-deny-funding-for-planned-parenthood). \12\ Juliet Eilperin, ``Trump picks antiabortion activist to head HHS family planning section,'' Washington Post (May 2, 2017) (online at https://www.washingtonpost.com/news/powerpost/wp/2017/05/01/trump- picks-antiabortionactivist-to-head-hhs-family-planning-program/?utm_ term=.292889b81423). --------------------------------------------------------------------------- If confirmed as Assistant Secretary for Health, it will be your responsibility to ensure that the Office of Population Affairs makes policy decisions regarding title X based on scientific evidence--not falsehoods. Question 6. Do you believe that ``contraception doesn't work'' and that ``its efficacy is very low''? Answer 6. I look forward to working with HHS staff if I am confirmed. I am committed to promoting the public's health and applying evidence and common sense to our policymaking process. Question 7. Do you believe that emergency contraception is akin to ``the destruction of human life already conceived''? Answer 7. See above. Question 8. As Assistant Secretary for Health, would you push back against attempts in the Office of Population Affairs to implement policies based on inaccurate, scientifically disproven assumptions about contraception, regardless of efforts by others in the administration to implement policies based on falsehoods? Answer 8. See above. Question 9. As Assistant Secretary for Health, would you advocate for adequate funding for the title X program? Answer 9. See above. Question 10. As Assistant Secretary for Health, would you advocate for increased funding for the title X program? Answer 10. See above. Question 11. As Assistant Secretary for Health, would you revive efforts within the Department to ensure that States do not deny title X funding to health providers for reasons other than their ability to provide reproductive health services? Answer 11. See above. Contraception and the Affordable Care Act Section 2713 of the Affordable Care Act (ACA) requires qualified health plans to cover ``preventive services'' for women (considered an ``essential health benefit'') without imposing cost-sharing.\13\ ``Preventive health services,'' for women, include FDA-approved contraceptive methods, with some limited exceptions for religious organizations.\14\ --------------------------------------------------------------------------- \13\ Juliet Eilperin, ``Trump picks antiabortion activist to head HHS family planning section,'' Washington Post (May 2, 2017) (online at https://www.washingtonpost.com/news/powerpost/wp/2017/05/01/trump- picks-antiabortionactivist-to-head-hhs-family-planning-program/?utm_ term=.292889b81423); Planned Parenthood, ``The Difference Between the Morning-After Pill and the Abortion Pill'' (online at https:// www.plannedparenthood.org/files/3914/6012/8466/ Difference_Between_the_MorningAfter_Pill_and_the_Abortion_Pill.pdf). \14\ Kaiser Family Foundation, ``Preventive Services for Women Covered by Private Health Plans under the Affordable Care Act'' (December 20, 2016) (online at http://files.kff.org /attachment/Fact-Sheet-Preventive-Servicesfor-Women-Covered-by-Private- Health-Plans-under-the-Affordable-Care-Act). --------------------------------------------------------------------------- Prior to the full implementation of the ACA, one in five women reported that they ``put off or postponed preventive services''-- including contraception--due to cost.\15\ As a result of the ACA, over 55 million women with private health insurance have guaranteed coverage of these preventive services with no co-pays.\16\ And since the ACA was implemented, women have saved $1.4 billion in out-of-pocket cost spending for oral contraceptives. Yet in May 2017, a leaked rule from the Department suggests that HHS may be planning to overhaul the limited exceptions to the ACA's contraceptive mandate, creating a ``very, very broad exception for everybody'' that would ``allow[] any employer to seek a moral or religious exemption from the requirement.'' \17\ --------------------------------------------------------------------------- \15\ HealthCare.gov, ``Preventive care benefits for women'' (online at https://www.health care.gov/preventive-carewomen/). \16\ Kaiser Family Foundation, ``Preventive Services for Women Covered by Private Health Plans under the Affordable Care Act'' (December 20, 2016) (online at http://files.kff.org/attachment/Fact- Sheet-Preventive-Services-for-Women-Covered-by-Private-Health-Plans- under-the-Affordable-Care-Act). \17\ Adelle Simmons, Jessammy Taylor, Kenneth Finegold, Robin Yabroff, Emily Gee, and Andrew Chappel, ``The Affordable Care Act: Promoting Better Health for Women,'' ASPE Issue Brief (June 14, 2016) (online at https://aspe.hhs.gov/sites/default/files/pdf/205066/ACA WomenHealthIssueBrief.pdf). --------------------------------------------------------------------------- As the Assistant Secretary for Health, you would oversee the Office on Women's Health, which ``coordinates women's health efforts across HHS and addresses critical women's health issues.'' \18\ --------------------------------------------------------------------------- \18\ Dylan Scott and Sarah Kliff, ``Leaked regulation: Trump plans to roll back Obamacare birth control mandate,'' Vox (May 31, 2017) (online at https://www.vox.com/policy-and-politics/2017/5/31/15716778/ trump-birth-controlregulation). Question 12. As Assistant Secretary for Health, would you work with the Office on Women's Health and other Department partners to oppose policies that would reduce women's access to contraceptive services? Answer 12. I am fully supportive of women's access to healthcare services. The system we ought to have in place is one that equips women and men to obtain the healthcare and preventive services that they need at an affordable price. Question 13. As Assistant Secretary for Health, what initiatives would you prioritize to ensure that women's access to preventive health services, including contraception, breast and cervical cancer screenings, and STI screening, is maintained and expanded? Answer 13. See above. HIV/AIDS Programs The Assistant Secretary for Health oversees the Office of HIV/AIDS and Infectious Disease Policy. Along with the Office of HIV/AIDS and Infectious Disease Policy, the Office of the Assistant Secretary for Health provides ``management and support services'' for the President's Advisory Council on HIV/AIDS (PACHA).\19\ Yet in June 2017, six members of PACHA resigned, stating that the ``Trump Administration has no strategy to address the on-going HIV/AIDS epidemic, seeks zero input from experts to formulate HIV policy, and--most concerning--pushes legislation that will harm people living with HIV and halt or reverse important gains made in the fight against this disease.'' \20\ --------------------------------------------------------------------------- \19\ U.S. Department of Health and Human Services, Office on Women's Health, ``Who we are'' (online at https://www.womenshealth.gov/ about-us/who-we-are). \20\ HIV.gov, ``What is PACHA?'' (online at https://www.hiv.gov/ Federal-response/pacha/about-pacha). Question 14. As Assistant Secretary for Health, would you prioritize HIV/AIDS initiatives and provide support to PACHA? Answer 14. Access to care for HIV/AIDS and related conditions is vital for the health of such patients. If confirmed, I commit to working within the capabilities of OASH to improve access to care for HIV/AIDS patients, as well as for all those in need of prevention or treatment services. Question 15. As Assistant Secretary for Health, will you commit to ensuring that all Americans maintain access to existing levels of care for HIV/AIDS and related conditions?\21\ --------------------------------------------------------------------------- \21\ Scott Schoette, ``Trump Doesn't Care About HIV. We're Outta Here,'' Newsweek (June 16, 2017) (online at http://www.newsweek.com/ trump-doesnt-care-about-hiv-were-outta-here-626285). --------------------------------------------------------------------------- Answer 15. See above. Question 16. Will you commit to expanding access to care for HIV/ AIDS patients? Answer 16. See above. Question 17. As Assistant Secretary for Health, will you commit to maintaining existing levels of funding for HHS programs within your purview that combat HIV/AIDS? Answer 17. See above. Inclusion of Women and Underrepresented Minorities in Clinical Trials The Assistant Secretary for Health aims to ``optimize the Nation's investment in health and science to advance health equity and improve the health of all people'' and oversees the Office of Women's Health (OWH) and the Office of Minority Health (OMH).\22\ These two offices are responsible for promoting the health of women and racial and ethnic minorities and helping coordinate efforts across HHS and other Federal agencies to support policies and programs that reduce health disparities. --------------------------------------------------------------------------- \22\ Office of the Assistant Secretary for Health, ``Office of the Assistant Secretary for Health (OASH)'' (online at: https:// www.hhs.gov/ash/index.html). --------------------------------------------------------------------------- Disparities in biomedical research are one factor exacerbating existing health disparities. Clinical trials are an essential component of drug innovation and development, and data from clinical trial research is used to shaping health care decisions, including coverage decisions. In July 2016, the OMH awarded a grant to ``develop and begin implementing an education program on clinical trials that educates and recruits minorities and/or disadvantaged populations, particularly groups underrepresented in clinical research.''\23\ --------------------------------------------------------------------------- \23\ Department of Health and Human Services Office of Minority Health, ``HHS Office of Minority Health Awards $2M to Help Reduce Lupus Related Health Disparities'' (July 5, 2016) (online at: https:// minorityhealth.hhs.gov/omh/content.aspx?ID=10338). Accessed August 1, 2017. Question 18. Do you agree that the inclusion of women and minorities in clinical trials is important to developing new drugs and therapeutics, improving medical treatments, and addressing health disparities? Answer 18. As a physician and scientist, I have spent my career focusing on this area and believe it is vital that we strike the right balance between inclusiveness of potentially affected populations in clinical trials with the need to speed cures to patients. We have to work harder to achieve both goals. It is important for all Americans to know if they are eligible for clinical trials, and to particularly focus on rare diseases and minority populations. If confirmed, I commit to seek a broad diversity of opinions and include them in the public health decisionmaking process, consistent with my role. Question 19. As Assistant Secretary of Health, what specific steps will you take to educate women and minorities about clinical trials? What specific steps will you take to help recruit them for the trials? Answer 19. See above. Question 20. Do you agree that women and minority health concerns should be tightly integrated within all aspects of the Federal Government's approach to health care and health research, including in the development of policy and programs? Answer 20. See above. Question 21. As Assistant Secretary of Health, what specific steps will you take to ensure that women and minorities are included in public health decisionmaking processes? Answer 21. See above. Combating Antibiotic Resistance The 2014 National Strategy for Combating Antibiotic-Resistant Bacteria brought together the Secretaries of Health and Human Services, Agriculture, and Defense to declare that, ``the misuse and over-use of antibiotics in health care and food production continue to hasten the development of bacterial drug resistance, leading to the loss of efficacy of existing antibiotics.'' \24\ Through this initiative, we've made some significant progress establishing policies that better protect lifesaving antibiotics. --------------------------------------------------------------------------- \24\ ``National Strategy for Combating Antibiotic-Resistant Bacteria,'' The White House (September 2014) (online at: https:// www.whitehouse.gov/sites/default/files/docs/carb_national _strategy.pdf), p.4. --------------------------------------------------------------------------- There is strong and growing evidence that antibiotic use in food animals can lead to antibiotic resistance in humans, yet the use of medically important drugs in food animals continues to grow. According to the FDA, ``Domestic sales and distribution of medically important antimicrobials approved for use in food producing animals increased by 26 percent from 2009 through 2015, and increased by 2 percent from 2014 through 2015.'' \25\ --------------------------------------------------------------------------- \25\ Food and Drug Administration, ``2015 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals'' (December 2016) (online at: http://www.fda.gov/downloads/ForIndustry/ UserFees/AnimalDrugUserFeeActADUFA/UCM534243.pdf). Question 22. Do you agree that curbing the misuse and over-use of antibiotics in health care and food production should be a public health priority? Answer 22. If confirmed, I intend to engage in a personal way to support the Presidential Advisory Council on Combating Antibiotic- Resistant Bacteria (PACCARB), which is overseen by OASH, as well as the important work on this issue being done by CDC, FDA, ASPR, and other Federal partners. Question 23. As Assistant Secretary for Health, what specific steps will your office take to prevent the development of bacterial drug resistance? Answer 23. See above. Response by Robert Kadlec, M.D., to Questions of Senator Murray, Senator Sanders, Senator Casey, Senator Franken, Senator Whitehouse, Senator Baldwin, Senator Murphy and Senator Warren senator murray Question 1. During the last reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), this committee included key provisions to ensure the unique needs and considerations of ``at-risk individuals'' are incorporated into preparedness and response activities and planning. Do you think these needs have been sufficiently incorporated into ASPR's activities? What more could be done to ensure the needs of at-risk individuals are met? What populations do you view as being at especially high risk in the event of a public health emergency? Answer 1. The reauthorization of PAHPA in 2013 provided additional authorities to address the needs of at-risk individuals. ASPR continues to work with its Federal, State, local, and community partners to better integrate the needs of at-risk populations, particularly those with access and functional needs, into its planning and its preparedness and response activities. ASPR does this by providing guidance and ensuring State and local public health grants include preparedness and response strategies to address at-risk population needs; ensuring the Strategic National Stockpile considers the needs of at-risk populations; overseeing the progress of, and considering the recommendations of, the Advisory Committee on At-Risk Individuals and Public Health Emergencies and many other work groups; and by developing training and best practices for preparing for, and responding to, the needs of at-risk individuals prior to, during and after a public health emergency. ASPR also created the Nation's first interactive map that integrates big data on healthcare, real-time weather data, and Geographic information system (GIS) to help communities prepare for the needs of over 2.5 million people who rely on electricity-dependent medical equipment and other critical medical devices in every zip code. At-risk populations are those that could experience more severe effects from a disaster or attack. Easily identified are the very young and old or individuals with pre-existing disorders or chronic conditions, which place them at greater risk for detrimental health effects in a disaster or public health emergency. Regardless of the underlying factor, as President John F. Kennedy noted, society will judge how well we address at-risk and vulnerable populations and afford them the appropriate care whatever the circumstance. I plan to fully assess ASPR's current activities, and determine what ASPR is doing well, and what should be improved. Assisting at-risk populations will be incorporated into any improvements made to the work ASPR performs. Question 2. The more rapidly we can detect an emerging infectious disease threat, the more effectively we can protect the public from the spread of disease. This requires well-resourced tools, including a highly skilled public health workforce, state-of-the-art surveillance and diagnostic techniques, and research to deliver effective medical countermeasures. What gaps do you believe exist in our outbreak preparedness and response capabilities, and how should they be addressed? Answer 2. Since its creation, ASPR has helped coordinate the public health emergency, public health preparedness and response activities across HHS. The Hospital Preparedness Program (HPP) helps prepare our local medical workforce to prepare for public health threats as well as provide situational awareness in the event of an emergency. We must continue to buildupon the foundation at ASPR in these areas. Part of the evolution at ASPR in this area should be the creation of a ``national contingency health care'' system. There is an urgent need to better organize, train and equip our State and local healthcare systems, facilities and providers to ensure that they cannot only better respond to routine emergencies, but also to extraordinary events that are likely to occur. Here we have an opportunity to better integrate Emergency Medical Services, the ``tip of the spear'' of our national medical response into these efforts, and to increase effective coordination across HHS and the Federal departments, such as the Department of Defense and the Department of Veterans Affairs, to support State and local responders. To achieve this, we need to support the sustainment of robust and reliable public health security capabilities that include an improved ability to detect and diagnose infectious diseases and other threats, as well as the capacity to rapidly characterize and attribute them. Question 3a. One of the issues we have seen time and again is that the response to major crises, like the Ebola outbreak, Zika outbreak, and Flint water contamination, crosses agency lines. As you are well familiar, ASPR is intended to be the health lead during major disasters. How do you envision the coordinating role of ASPR? Answer 3a. The Assistant Secretary for Preparedness and Response serves as the Secretary's principal advisor on all matters related to Federal medical preparedness, response, and recovery for public health emergencies, as well as activities throughout HHS including human services. The Secretary has expressed a passionate commitment to public health security and resiliency and has high expectations for ASPR and its role in emergencies and disasters that affect HHS's health, public health, and human services mission. In this position, I will be the leader for preparing for and responding to emergencies and disasters, including public health emergencies, which implicate HHS's mission. I intend to maintain visibility and accessibility in order to direct coordination, within HHS and across other Federal agencies, to prevent duplication or uncoordinated efforts. The challenges we face today demand more effective Federal coordination to assist State and local health authorities and fully mobilize the private sector in response to such disasters and emergencies, especially public health emergencies. It will be my priority to integrate and support the capabilities of the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, the Public Health Service Commissioned Corps, and other agencies as well as increase coordination with external partners such as the Departments of Defense, Homeland Security, Veterans Affairs, and State and local responders, among others. Question 3b. How would you work with the directors of the Centers for Disease Control and Prevention (CDC) and other relevant agencies both within and outside of the Department of Health and Human Services (HHS) to ensure appropriate management of a disaster response? Answer 3b. Appropriate management of response and recovery activities is contingent on both strong leadership and the fostering of effective routine, pre-crisis working relationships with the CDC Director and other senior leaders inside and outside of HHS. These relationships need to be framed by clear and documented expectations of ASPR's and others' roles and responsibilities, and a governance approach that can be effective in fully utilizing the equities and capabilities of each individual agency to elicit a more effective response effort. Additionally, I believe practice makes perfect. That is why I plan to increase the number of public health emergency exercises ASPR coordinates to ensure we are ready across HHS and other departments to respond when called upon. ASPR coordinates and collaborates across HHS through the Disaster Leadership Group (DLG). The DLG brings together senior leaders from across HHS, including the Director of CDC (or her representative(s)), to make decisions on policy issues that affect medical and public health systems during disasters which includes coordination on issues that impact national health security. Question 3c. How will your office work with the White House--which has not prioritized public health preparedness--to ensure coordination and avoid duplication of efforts? Answer 3c. ASPR has an impressive cadre of medical, public health, and other professionals, with both technical and policy expertise, who work closely with the National Security Council (NSC) staff through Policy Coordination Committees in preparedness matters and during responses. This ensures that ASPR provides the public health preparedness and response expertise that NSC needs to align these efforts with overarching administration policies. ASPR has worked closely with NSC to develop a series of frameworks for responding to emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats that delineate the roles and responsibilities of the NSC and the Federal departments and agencies. Question 4. In light of the growing threat of antibiotic resistance, how can the United States play a leadership role in combating this threat to national and international security? In what ways do you think the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has helped or will help to combat the spread of antimicrobial resistance (AMR)? Answer 4. I believe antibacterial drugs underpin every facet of modern medicine and public health emergency preparedness and response. Antibiotics would be relied upon in the event of an attack with a bacterial threat agent like anthrax or pneumonic plague, but also in events where prolonged hospitalization was required or a patient's immune system was impaired (e.g., exposure to immune-compromising agents, burn injury, radiation exposure). ASPR's Biomedical Advanced Research Development Authority (BARDA) has advanced six antibiotic candidates into Phase III clinical development. The U.S. Food and Drug Administration (FDA) review of one will be complete by the end of August and may represent the first BARDA supported antibiotic to enter the market. CARB-X in its first year has supported 18 different companies developing 17 candidate therapies and one point of care diagnostic that is capable of determining if an individual has viral or bacterial pneumonia. The 17 candidates are quite novel in their approach. There are 8 novel classes, 10 novel bacterial targets, and 5 nonantibiotic- based approaches that are capable of treating the infection. Collectively, the purpose of CARB-X is to build and maintain a robust preclinical pipeline of novel antibacterial therapies that will mature into promising candidates for advanced development support and eventual FDA approval. Question 5. As I'm sure you know, last week Texas officials reported the first local case of mosquito-transmitted Zika since last fall. If confirmed, this would be the first case of nontravel-related Zika within the continental United States this year. The Zika virus presents a number of discrete challenges to any public-health response--for example, only about one-fifth of people infected with the virus experience symptoms. It is additionally the first mosquito- transmitted virus in history with the ability to cause birth defects, including microcephaly. Do you believe a robust family planning support network is necessary to your ability to address the Zika pandemic? If so, how do you respond to agency attempts to reduce access to family planning services? If not, why not? Answer 5. The challenge from the Zika virus remains an active ongoing concern for HHS. The risk it poses to pregnant females demands our best efforts to understand the risks to the unborn. We have to pursue a firm understanding of the etiology of all forms of the disease and a better understanding of the spectrum of complications that occurs in exposed babies. Until we have a vaccine that FDA has licensed as safe and effective, our best efforts must be focused on protecting expectant mothers from being exposed. Family planning support is only one arm of that effort. Aggressive environmental surveillance for Zika- infected mosquitos, eliminating their breeding grounds, and reducing the risk of pregnant women being exposed is our best course of action until we have a vaccine. senator sanders Question 1. Climate change is a serious threat to human health. Climate change can harm our health by threatening the quality and safety of our water supply and by increasing the risk and spread of vector-borne disease, extreme weather events and air pollution. Vulnerable populations--including low-income communities, communities of color, the elderly, young children, and those with chronic illnesses--bear the greatest burden of injury, disease and death related to climate change. President Trump has stated that ``nobody really knows'' whether climate change is real, yet the overwhelming scientific evidence shows that not only are climate change and its associated negative health impacts occurring, it also points to human activity as the primary cause of global warming over the past 50 years. How would you characterize the health threats posed by climate change and what will you do to address these threats? What can the Federal Government do to make sure State and local health departments have the tools and resources they need to protect the public from the immediate and long-term health threats associated with climate change? Answer 1. ASPR identifies, analyzes, prepares for, and responds to changing or emergent threat landscapes across an array of risk areas including natural and human-caused disasters and public health emergencies. This includes provision of technical assistance and guidance to key partners such as State and local public health agencies as well as participation in interagency efforts to ensure that public health concerns are appropriately integrated into overall planning and preparedness. Specific weather and climate-related public health concerns may include changing the severity or frequency of health problems that are already affected by climate or weather factors and unanticipated health threats in places where they have not previously occurred. senator casey Question 1. Many existing medical countermeasures (MCMs), including both vaccines and therapeutics, are only approved for use in adults, and lack pediatric formulations, dosing information or safety information. This poses serious challenges to our ability to protect children in the event of a disaster or disease outbreak. What steps can you take, if confirmed, to collaborate with industry, academia, Federal agencies and other BARDA partners to ensure that all MCMs available include appropriate pediatric formulations or doses, as appropriate? Answer 1. ASPR's Biomedical Advanced Research and Development Authority (BARDA) continues to pursue and support expanding the indications of medical countermeasures (MCMs) to address ``at-risk'' individuals, including children, as mandated under the Pandemic and All-Hazards Preparedness Act. Many of the products that have been developed under Project BioShield (PBS) or for pandemic preparedness can be administered to pediatric populations or have ongoing or planned pediatric trials to expand their label indications. In addition, the Strategic National Stockpile has numerous products that can be administered to pediatric patients. Some of the products may have to be administered under an Investigational New Drug (IND) or through the issuance of an Emergency Use Authorization (EUA) by the FDA. ASPR also participates in the National Advisory Committee on Children and Disasters. Protecting children will be a priority issue during my tenure as ASPR. Question 2. During our meeting, we talked about the role of the ASPR in our public health preparedness efforts, and you shared some suggestions for steps you might take to improve coordination among Federal agencies, such as supporting a staff member at CDC to liaise between the CDC Director and yourself. What other steps would you take to ensure maximum coordination between Federal agencies and State and local partners, both vertically and horizontally? How would you ensure that all of HHS's agencies working on preparedness and response are learning from previous emergency responses? Answer 2. What I learned about creating more effective coordinated responses comes from my time in U.S. special operations at a particular formative period after the failure at DESERT ONE. One of the findings of the Holloway Commission was that the stove piping and the lack of integration in planning and operations contributed to the failure. I personally saw and experienced this in the mid-1980s. Creating greater transparency by exchanging personnel, jointly working on planning for emergencies, and committing to regular joint exercises goes a long way to overcoming parochialism and uncoordinated efforts and to better integrated operations. In special operations, commanders must commit to this. It starts at the top. Having not been at the Department, I do not mean to suggest that the same kind of problems exist at the Department, or between ASPR and CDC, but these lessons would guide my efforts to ensure maximum coordination between agencies. Question 3. There is a saying in health care, ``children are not small adults.'' This holds true when we are talking about public health preparedness and biodefense. The Hospital Preparedness Program (HPP) is administered by the Assistant Secretary for Preparedness and Response and provides funding to every State and territory to support health system preparedness, whether the system is responding to a pandemic, a terrorist attack or a natural disaster. HPP is the primary Federal funding program for hospital emergency preparedness and has provided critical resources to improve health care surge capacity. Can you describe how you plan to use the existing Federal funding mechanisms through the Hospital Preparedness Program (HPP) to ensure that the States and cities receiving HPP funding are prepared to meet the needs of children? Answer 3. In 2016, the Hospital Preparedness Program (HPP) began an intensive effort to revise its core guidance, namely the 2017-22 Health Care Preparedness and Response Capabilities. Throughout the revision process, ASPR engaged the American Academy of Pediatrics and the Children's Hospital Association to ensure that the needs of children are optimally integrated into HPP's planning guidance. In addition, in HPP's fiscal year 2017 funding opportunity announcement, awardees were required to submit a joint letter of support with their jurisdiction's Emergency Medical Services for Children (EMSC) program, detailing how the two programs will work together during this budget period to meet the needs of children during emergencies. HPP and EMSC also have a joint performance measure to evaluate awardees' capabilities to respond to pediatric emergencies. The specific program measure is the percent of hospitals with an emergency department recognized through a statewide, territorial, or regional standardized system that are able to stabilize and/or manage pediatric medical emergencies. I will continue ASPR's work with the HPP to ensure that it will meet the needs of pediatric patients in public health emergencies and disasters. Question 4. Over the last several months, I have sent multiple letters to HHS about the Administration's ongoing efforts to undermine and sabotage the Affordable Care Act through executive action. HHS has failed to provide responses to many of my letters. If HHS has responded, the response letters have been wholly inadequate and have not been responsive to my requests. If you are confirmed, do you commit to respond in a timely manner to all congressional inquiries and requests for information from all Members of Congress, including requests from Members in the Minority? Answer 4. I intend to respond appropriately to all Member requests. senator franken Question 1. You have called for increased attention to public health and for funding for preparedness efforts. The President's budget proposed an emergency fund for infectious disease response but it drew its funding from transfers from existing programs. Would that emergency fund be sufficient for preparedness efforts? Based on your experience are additional funds needed? If so, what funding level would be ideal for such a fund? Answer 1. The fiscal year 2018 President's Budget requests the authorization of the ``Federal Emergency Response Fund,'' to support the following priorities for domestic preparedness and global health: 1. To prevent, prepare for, or respond to a chemical, biological, radiological, or nuclear threat, and, 2. To prevent, prepare for, or respond to an emerging infectious disease. The Fund may be used for a public health threat or emergency that the Secretary of HHS determines has significant potential to occur. As such, the Fund may be used for preparedness efforts and to prevent a public health emergency. The Fund provides flexibility to the Secretary of HHS to address potential threats at earlier stages, thereby reducing the likelihood of a more severe impact on the health and security of American citizens. Public health and medical emergencies are unpredictable in nature, specifically with regard to the scope and magnitude of potential disease, injury, or death. Consequently, emergency supplemental appropriations, such as those used to respond to the Ebola and Zika outbreaks, could still be needed. However, the fund provides the Secretary of HHS the capability to respond quickly and nimbly, while the needs and resources of an emergency supplemental are determined. As the new Assistant Secretary for Preparedness and Response, it will be one of my top priorities to ensure our public health, health system, and scientific research infrastructures are strong. This will be critical to mitigating the impact of potential public health emergencies, as well as to improve the overall health and well-being of U.S. citizens. To this end, I will actively identify where additional investments are needed and work with my HHS and Administration colleagues to communicate those needs to Congress. senator whitehouse Question 1a. Preparedness for a naturally occurring global disease outbreak presents distinctly different challenges than preparedness for an intentional bioweapon attack. What are the key differences in being adequately prepared for a pandemic disease outbreak versus a bioweapon attack? Answer 1a. The basic capabilities required to prepare and respond to naturally occurring pandemics and bioweapon attacks are generally similar. For example, both require strong public health systems that are able to detect an event and respond with appropriate medical and non-medical interventions. Each also has unique differences. The scale, scope, and speed needed for a response to a bio-attack differ significantly from a naturally occurring pandemic. In addition, the national security consequences of a bio-attack are of greater consequence. Pandemic disease outbreaks generally affect populations across geographic and healthcare delivery system boundaries. In contrast, bioweapon attacks may be more localized, but can also immobilize entire healthcare delivery systems. A major difference, however, is that an adversary using a biological weapon is intent on affecting our national will, our economy and confidence in our government. In doing so, they would likely try to achieve maximum psychological and physical effects and use other attack modalities such as cyber and/or conventional weapons as well. As a result, pandemic disease outbreaks and bioweapon attacks differ in requirements for support and operational coordination. From an operation's standpoint, ASPR's preparedness for both an emerging infections disease and bioweapon attack must be multifaceted. ASPR requires clinical, pharmaceutical, and non-pharmaceutical tools to build capacity at the State, local, healthcare sector, and private sector levels. ASPR must have the capacity to develop (with its governmental and industry partners) the medical countermeasures necessary to respond to biological threats, to build the tools to support the immediate consequences of a biological threat, and to support States and communities in recovering from and mitigating the risk of future biological threats. Question 1b. What immediate steps will you take to improve our preparedness for both types of emergencies? Answer 1b. I will immediately work with government partners to assess our current capabilities for responding to global disease outbreaks and intentional bioweapon attacks that pose a threat to our homeland. Global disease outbreaks are different for an intentional bioweapon attack, primarily in timing. Global disease outbreaks occur in waves that potentially provide some time to prepare, unlike an intentional bioweapon attack that would be an acute event with numerous individuals exposed in a very short timeframe requiring an immediate response. However, both types of emergencies require preparedness efforts to ensure an appropriate response. For global outbreaks such as pandemic influenza, ASPR's Biomedical Advanced Research and Development Authority (BARDA) maintains stockpiles of pre-pandemic influenza vaccine, bulk product, and adjuvant that may be quickly manufactured into vaccines and antiviral drugs. To prepare for a bioweapon attack, ASPR works with its government partners to develop and stockpile medical countermeasures to address the negative health impacts of exposure to various threat agents. These include vaccines, therapeutics, and diagnostics. For example, ASPR/BARDA is supporting the development of early, in-home diagnostic technologies to be able to rapidly identify an outbreak, as well as platform-based production systems that will enable a more rapid medical countermeasure response to a known or unknown threat. One area that will receive my initial serious evaluation is our ability to rapidly distribute the medical countermeasures we have in our stockpile. Additionally, ASPR is working with its U.S. Government stakeholders to develop the first-ever National Biodefense Strategy, a comprehensive plan for how the United States will work across the executive branch to prepare for, prevent, detect, respond to, and recover from biological events, regardless of their source. I am committed to both the development of the Strategy, as well as to working within the Department to ensure that both ASPR and the Department take the necessary steps to implement the Strategy. Question 1c. How would you describe this administration's current level of preparedness for a pandemic and for a bioweapon attack? Answer 1c. I intend to conduct a rapid assessment of the State of biodefense preparedness upon my entry on duty as the ASPR. Question 2a. BARDA uses its ``TechWatch'' program to work with smaller companies on the development of medical countermeasures, but I have heard from companies in my State that BARDA and other divisions of HHS could do more to support small companies in this space. How would you instruct BARDA to improve its engagement with small, innovator companies? Answer 2a. Capitalizing on the rapidly advancing biotechnology and life science is an essential element of a strategy to not just keep even with, but get ahead of the threats confronting the Nation. I will ensure that BARDA continues to invest in innovative technologies to address some of the most serious threats faced by our Nation. The TechWatch program has been successful in providing, to companies of all sizes, the opportunity to meet face-to-face with BARDA. BARDA's mission is to support advanced research and development. In case technologies are not mature enough for consideration for BARDA, other PHEMCE partners such as the National Institutes of Health and the Department of Defense are invited to the meetings to provide additional avenues for potential partnerships. ASPR continues to exceed its small business goals and will invest in companies that have promising technologies, regardless of their size. BARDA subject matter experts work closely with all companies to support development of candidate products, especially those companies that may not have much experience in developing products. Question 2b. In addition to the TechWatch program, ASPR holds a yearly BARDA Industry Day which provides everyone the opportunity to interact with BARDA and ASPR's Office of Acquisitions, Management, Contracting, and Grants. This venue provides opportunities for companies to ask questions regarding how to work with the Federal Government. The 21st Century Cures Act contains a provision called the Strategic Investor Initiative that offers new opportunities for ASPR and BARDA to invest in promising new technologies. I will ensure that we implement this provision and that the initiative receives the appropriate priority and resourcing to be successful. How will you ensure BARDA's development and procurement activities don't overlook small innovator companies that have less experience working with Federal partners? Answer 2b. Please see (a) above. Question 3. You have long advocated for a strong Federal role in, in your words, ``confronting the risk from deliberate biological threats.'' Although many programs overseen by the ASPR were spared from proposed cuts in the President's fiscal year 2018 budget, in my view the Trump administration has done little else to demonstrate its commitment to biodefense. Will you advocate for robust funding for and the prioritization of biodefense work within HHS and with other members of the administration? Answer 3. ASPR plays a critical role in preparing the Nation to face biological threats. My previous experience as Deputy Staff Director of the Senate Intelligence Committee and numerous other roles, have made clear the need for strong national biodefense capabilities. The threats we face are real, and the Department of Homeland Security has identified, through the material threat assessment, those of greatest concern. To prepare for these threats, we must continuously invest in the development of new medical countermeasures and ensure we are sustaining the production of countermeasures already developed. The Trump administration recently announced its intention to draft an updated national biodefense strategy. I look forward to being a part of that policy discussion and ensuring a comprehensive strategy with an accompanying implementation and resource plan is produced. Question 4a. Antibiotic resistance is a growing threat to our health security. The Centers for Disease Control and Prevention estimates that two million people develop antibiotic-resistant infections in the United States every year, resulting in at least 23,000 deaths. Do you believe combating antibiotic resistance is a matter of national preparedness? Answer 4a. Antibiotics underpin nearly every facet of modern medicine, and their continued effectiveness would be heavily relied upon in a mass public health emergency. Antibiotic resistance is a matter of national public health and a national security concern. Antibiotics would be relied upon in the event of an attack with a bacterial threat agent-like anthrax or pneumonic plague, but also in events where prolonged hospitalization was required or a patient's immune system was impaired (e.g., exposure to immune-compromising agents, burn injury, radiation exposure). The development of new antibiotics will remain a priority for me. ASPR will continue to make progress in mitigating the threat posed by drug resistant infections through a number of mechanisms, including ASPR's Biomedical Advanced Development Authority's (BARDA) clinical stage program, which has progressed six candidate antibiotics into Phase III clinical development, and CARB-X's novel public-private partnership aimed at building an innovative preclinical stage pipeline of antibacterial therapies, diagnostics, and vaccines,. There are a number of ways the Federal Government can spur innovation in antibiotic research and development. Currently, the Federal Government provides push incentives that lower the research and development costs for new antibiotics. While push incentives are helpful, in order to adequately address the market challenges that BARDA's industry partners face developing and marketing new antibiotics, completely new business models are needed. These models need to create a strong pull incentive that provides a known return on investment for the development of an antibiotic that addresses unmet medical need(s). If companies can rely on a certain level of return on their investment, it will drive additional private sector investment in research and development for this critical area. Under my leadership, ASPR will work to develop and implement such business models. Question 4b. As ASPR, will you prioritize the development of new antibiotics? Answer 4b. Please see (a) above. Question 4c. How can the Federal Government best encourage investments in antibiotic research? Answer 4c. Please see (a) above. senator baldwin Question 1. Our country has recently seen some of the most extreme public health outbreaks--from Ebola to Zika--and we know that the next outbreak could be right around the corner or just a plane ride away. I am particularly concerned about our country's preparedness efforts for pandemic influenza. In 2004, we saw a dangerous shortage of influenza vaccine in the United States due, in part, to disruptions in vaccine production overseas, and we saw a deadly pandemic of H1N1 in 2009. Dr. Kadlec, what lessons did we learn from these experiences and how will you strengthen and maintain our stockpile of vaccines before we face the next influenza pandemic? Answer 1. The H1N1 influenza pandemic of 2009 and the more recent public health emergencies for Ebola and Zika have shown that pandemic influenza and emerging infectious diseases are serious and unpredictable. The disease can spread rapidly and, in most cases, funding to rapidly ramp-up response is dependent upon supplemental funding that often takes months to approve. This is why a Public Health Emergency Fund is essential for a quick response. Although the amounts in such a Fund may not be sufficient to complete the job, such funds would allow for efforts to begin immediately. The most effective mitigation requires deployment and vaccination before the peak of virus spread. The faster we can initiate product development and manufacturing activities, the quicker a vaccine will be available. ASPR's Biomedical Advanced Research and Development Authority (BARDA) has supported new cell- and recombinant-based technologies for pandemic influenza vaccines that have received U.S. Food and Drug Administration (FDA) approval. ASPR/BARDA-supported development of adjuvanted pandemic influenza vaccine technologies serve to increase the number of vaccine doses that will be available by reducing the amount of antigen that is necessary to generate a protective immune response. ASPR/BARDA and its Federal partners are funding and conducting clinical trials to evaluate the safety and immunological response of pre-pandemic influenza vaccine stockpiles to make sure they remain safe and effective after long-term storage. This element of the strategy is particularly important. By working closely with our CDC and NIAID partners who identify potential pandemic influenza strains emerging globally, BARDA can commission the initial production of a pre-pandemic stockpile that (1) demonstrates the ability to produce an effective vaccine against that potential strain, and (2) creates an emergency stockpile that permits an immediate response should that strain emerge as a pandemic. ASPR/BARDA is also developing novel antiviral drugs and novel influenza therapeutics to mitigate the emergence of antiviral drug resistance often observed in influenza. The most important lesson learned is that an immediate response is necessary to mitigate the spread of disease. senator murphy Question 1. In the event of a pandemic, it is critical for the public health to be able to respond quickly and in a way that does not adversely impact the rest of the health care delivery system. To that end, we must ensure there are an appropriate number of drug delivery devices available to deploy therapies to patients in real time. The Biomedical Advanced Research and Development Authority (BARDA) has the ability to manage this with existing contracts, but without regular task orders to maintain a viable level of product at-the-ready, I'm concerned we won't be prepared. How will you ensure BARDA not only has contracts in place to provide a sufficient amount of drug delivery devices, but that BARDA also issues task orders against those contracts so that an adequate level of product is always on hand? Answer 1. ASPR's Biomedical Advanced Research Development Authority (BARDA) maintains indefinite deliverable/indefinite quantity (IDIQ) contracts with producers of ancillary supplies for vaccine delivery. Periodically, ASPR/BARDA issues task orders to procure additional ancillary delivery supplies to refresh outdated inventory that is maintained for rapid response for pandemic preparedness. I plan to continue this approach to ensure these materials will be available when needed for a pandemic response. senator warren Pandemic Flu The Department of Health and Human Services (HHS) would lead the Federal Government response to a pandemic flu. Before leaving the Centers for Disease Control and Prevention (CDC) in January 2017, the former Director, Dr. Thomas Frieden, stated his concerns about such a pandemic, noting that the greatest public health threat we face is ``always for an influenza pandemic,'' and that ``[I]f the resistant organisms emerge in one part of the world, they will inevitably come to other parts of the world.''\1\ --------------------------------------------------------------------------- \1\ Lena H. Sun, ``Outgoing CDC Chief Talks about Agency's Successes--and His Greatest Fear,'' Washington Post (January 16, 2017) (online at: https://www.washingtonpost.com/news/to-your-health/wp/2017/ 01/16/outgoing-cdc-chief-talks-about-the-agencys-successes-and-his- greatest-fear/?tid=a inl&utm_term=.8ca1cf116944). --------------------------------------------------------------------------- President Trump's fiscal year 2018 budget proposal included $1.3 billion in cuts for the CDC and substantial cuts for key public health programs including $107 million in cuts for the CDC's Public Health Emergency Preparedness Cooperative Agreements, $2 billion in State Department global health assistance.\2\ President Trump's budget--and legislation attempting to repeal the Patient Protection and Affordable Care Act (ACA) would eliminate the Prevention and Public Health Fund and impose substantial cuts to the Medicaid program. --------------------------------------------------------------------------- \2\ Facher, Lev, ``HIV programs, mental health: 8 ways Trump's new budget might affect public health,'' STAT (May 24, 2017) (online at: https://www.statnews.com/2017/05/24/trump-public-health/). Question 1. Do you agree with Dr. Frieden about the risks of a pandemic flu outbreak? Answer 1. I have the greatest respect for Dr. Frieden, as I have known him since he was New York City's Public Health Commissioner. I would note that influenza is not the only pandemic threat. As we have witnessed, SARS and MERS (alpha coronaviruses) also represent potential pandemic threats. I would also add that a deliberate re-introduction of smallpox, either from retained cultures or synthetically produced, would present an equal or potentially greater risk. Question 2. What impact could substantial budget cuts have on pandemic flu preparedness? Answer 2. ASPR has invested significantly to establish domestic preparedness and response capacity and capabilities for an influenza pandemic. Substantial budget cuts could have an immediate impact on the Nation's preparedness posture and, in the very near term, risk investments made in the past decade on infrastructure and medical countermeasure development and stockpiling. State and local jurisdictions and the U.S. healthcare system rely on ASPR's Hospital Preparedness Program (HPP) funding to prepare for all hazards, including pandemic influenza. Substantial budget cuts to HPP could lead to a diminished capability to enhance preparedness across the public health and medical continuum. Without the proper funding, there may be limited ability to validate plans, processes or procedures through exercises and to evaluate and identify strengths, gaps and shortfalls which could enhance preparedness. Question 3. What specific HHS programs under the purview of the Office of the Assistant Secretary for Preparedness and Response receive funding that is used for pandemic flu preparedness? Answer 3. ASPR's Biomedical Advanced Research and Development Authority (BARDA) uses HHS funds to develop and procure medical countermeasures for pandemic influenza preparedness, including vaccines, adjuvants, antiviral drugs, diagnostics, respiratory protection devices, and ventilators. ASPR's Hospital Preparedness Program (HPP) receives funding to prepare the Nation's healthcare system for all hazards, including pandemic influenza. HPP enables healthcare systems to save lives during emergencies that exceed day-to-day capacity of health and emergency response systems. HPP promotes a sustained national focus to improve patient outcomes, minimize the need for supplemental State and Federal resources during emergencies, and enable rapid recovery. Last, the international division within ASPR's Office of Policy and Planning receives pandemic influenza funding which supports preparedness and response to pandemic influenza and other emerging infectious diseases with simultaneous domestic and international health security impacts. Question 4. How are these funds used in each program? Answer 4. See (3) above and the following: HPP grants enable recipients to prepare their healthcare systems to save lives through the development and sustainment of regional healthcare coalitions (HCCs) that incentivize diverse and often competing healthcare organizations with differing priorities and objectives to work together. Events that cause a surge in patients require healthcare facilities, including those that are not part of the same corporate network, to work together as part of a coalition to ensure that patients receive optimal and timely care. HPP grants enable HCCs to enhance surge capacity within hospitals, alternate care systems, and outpatient clinics to increase the number of patients that can be cared for during an emergency. ASPR's international division also utilizes pandemic influenza funding. Question 5. What impact will the President's budget have on funding in each of these program areas? Answer 5. As I have not been inside the Department, I have not been involved in budget discussions. In the role of the ASPR, I plan to ensure that we efficiently execute the Department's core preparedness program missions. Question 6. How will you address the impact of these proposed cuts? Answer 6. Budget and funding reductions, across government, are a reality during times of fiscal restraint. I intend to approach this challenge as an opportunity to creatively find new efficiencies in our operations and collaborate with partners to achieve the highest levels of readiness. This effort requires coordination within ASPR, HHS, and across the government to pinpoint areas where we can maximize the effective use of preparedness funding to get ``more bang for the buck''. ASPR will remain committed to preparing States, local jurisdictions, and healthcare systems for emergencies by providing substantive preparedness and response technical assistance to them, and by connecting them with resources and subject matter experts through ASPR's Technical Resources Assistance Center and Information Exchange (TRACIE). TRACIE provides evidence-based applications, technology, and proven best practices to help States and communities build enhanced capacity and improve their knowledge and effectiveness. In addition to TRACIE, HHS's emPOWER map provides de-identified data on populations reliant on lifesaving electricity-dependent medical equipment and healthcare services to inform disaster response. We will use these resources and others to support both Federal partners and partners at the State, local, tribal, and territorial levels in preparing for, mitigating, and responding to emergencies and disasters. Question 7. Specifically, what would be the impact of elimination of the Prevention and Public Health Fund on pandemic flu preparedness? Answer 7. It is important that we prepare for all threats, including pandemic flu. I am not aware of the extent to which current preparedness efforts are funded by the Prevention and Public Health Fund. I plan to be a strong advocate for ensuring that the agency has the resources it needs to address all threats. Question 8. How would you address these potential cuts if they are imposed on the Agency by the White House and Congress? Answer 8. Budget and funding reductions, across government, are unpleasant but necessary during times of fiscal restraint. I intend to approach this challenge as an opportunity to creatively find new efficiencies in our operations and reduce duplicative and unnecessary spending. This effort requires coordination to pinpoint areas within ASPR, HHS, and across the government where we can consolidate funding and responsibilities and more effectively and efficiently use our resources. Question 9. What do you believe are the most important steps needed to insure that the Nation is prepared for a potential pandemic flu outbreak? Answer 9. All aspects of pandemic influenza preparedness, response, mitigation, and recovery strategies are essential to our national preparedness. I believe the important steps to ensure our Nation is prepared for a pandemic flu outbreak include maintaining and improving our surveillance systems; improving processes for delivery, dispensing, and administration of medical countermeasures; advancing healthcare system surge capacity through greater coordination of inpatient and community-based healthcare service delivery; and having a dedicated workforce, trained and ready to operate when needed. Pandemic Flu and Hiring Freeze In January 2017, President Trump issued a Federal hiring freeze, resulting in 700 vacancies at the CDC. While the hiring freeze has since been lifted, Secretary Price has left the hiring freeze in place at the Department of Health and Human Services, of which the CDC is a part.\3\ What will be the long- and short-term impacts on pandemic flu preparedness of President Trump's hiring freeze? --------------------------------------------------------------------------- \3\ Ranking Members Pallone and Engel letter to President Trump on the hiring freeze and impacts on preparedness (July 26, 2017) (online at: https://democrats-foreignaffairs.house.gov/sites/ democrats.foreignaffairs house.gov/files/Pallone- Engel%20CDC%20%staffing%20letter%200 72617.pdf). Question 10. Does this Executive order apply to the Assistant Secretary for Preparedness and Response (ASPR)? Answer 10. I am aware of the hiring freeze issued by the President that was administered across the government. The Executive order, and the guidance issued by the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) on the Executive order, included exemptions to the hiring freeze for positions relating to public health/safety and national security. My understanding is that HHS created and implemented a process to exempt such positions from the hiring freeze. I also understand that the hiring freeze, to the extent applicable, has now been lifted. Question 11. Has the Executive order prevented ASPR from hiring any employees since it was put in place in January 2017? Answer 11. I have not been privy to ASPR's hiring decisions during my confirmation process. Question 12. Will this Executive order cause ASPR to reduce the projected number of staff employed by the agency to address pandemic flu preparedness and other emergencies? Answer 12. The Executive order, and the guidance issued by the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) on the Executive order, included exemptions to the hiring freeze for positions relating to public health/safety and national security. My understanding is that HHS created and implemented a process to exempt such positions from the hiring freeze. I also understand that the hiring freeze, to the extent applicable, has been lifted. Question 13a. Has the OMB provided clear guidance and a clear timeline on implementation of the exemption process? In the event of a pandemic flu outbreak, will you exempt any positions at ASPR from the hiring freeze because they are necessary ``to meet national security or public safety responsibilities''? Answer 13a. The Executive order, and the guidance issued by the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) on the Executive order, included exemptions to the hiring freeze for positions relating to public health/safety and national security. My understanding is that HHS created and implemented a process to exempt such positions from the hiring freeze. I also understanding that the hiring freeze, to the extent applicable, has been lifted. Question 13b. How many positions will be exempted in this manner? Please provide a detailed list of these positions. Answer 13b. The Executive order, and the guidance issued by the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) on the Executive order, included exemptions to the hiring freeze for positions relating to public health/safety and national security. My understanding is that HHS created and implemented a process to exempt such positions from the hiring freeze. I also understand that, as of June 2017, to the extent applicable, the hiring freeze was lifted and ASPR has been able to resume hiring for all requested positions. Question 13c. Does the exemption apply to prevention personnel engaged in preparedness activities, or does it only apply to an emergency once a pandemic has begun? Answer 13c. The Executive order, and the guidance issued by the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) on the Executive order, included exemptions to the hiring freeze for positions relating to public health/safety and national security. My understanding is that HHS created and implemented a process to exempt such positions from the hiring freeze. My understanding is that the exemption process applied to both preparedness and emergency response personnel. Pandemic Flu and Regulatory Freeze On January 20, 2017, President Trump imposed an Executive order freezing all regulations in progress,\4\ and on January 30, 2017, he issued a second Executive order, imposing a new requirement that ``whenever an executive department or agency publicly proposes . . . a new regulation, it shall identify at least two existing regulations to be repealed.'' \5\ OMB guidance on this order allows exemptions ``for emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters, or otherwise.'' \6\ It is not clear how those exemptions will apply to regulation or guidance from CDC or other HHS agencies and programs, whether they apply to prevention efforts, or how they will be implemented in the event of a pandemic flu outbreak. --------------------------------------------------------------------------- \4\ Reince Priebus, ``Memorandum for the Heads of Executive Departments and Agencies,'' White House Office of the Press Secretary (January 20, 2017) (online at: https://www.whitehouse.gov/the-press- office/2017/01/20/memorandum-heads-executive-departments-and-agencies). \5\ ``Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs,'' White House Office of the Press Secretary (January 30, 2017) (online at: https://www.whitehouse .gov/the-press-office/2017/01/30/presidential-executive-order-reducing- regulation-and-controlling). \6\ Mark Sandy, then-Acting Director of the Office of Management and Budget, ``Memorandum: Implementation of Regulatory Freeze,'' White House Office of the Press Secretary (January 24, 2017) (online at: https://www.whitehouse.gov/the-press-office/2017/01/24/implementation- regulatory-freeze). Question 14. In previous outbreaks, has the ASPR needed to impose any new regulations--either to address short-term concerns, to respond to ``lessons learned'' during the outbreak, or to prevent future outbreaks? Answer 14. It is my understanding that ASPR compiles lessons learned following every emergency. With those lessons in hand, we can work to inform decisionmakers about what is needed to help us better prepare for the next response. My intent is to ensure these lessons learned can be collected quickly and be evaluated and shared across Federal agencies and with State and local authorities. Question 15. Would the Executive orders imposing a regulatory freeze and requiring the repeal of two existing regulations for every new regulation put in place potentially prevent ASPR from imposing similar regulations in a future pandemic flu outbreak? Answer 15. HHS already has the powers and authorities necessary to address a pandemic influenza outbreak, or other public health emergency, under the Public Health Service Act. However, each emergency is different. If confirmed, you have my commitment that we will conduct a thorough review following every emergency to pinpoint areas for improvement, including any obstacles that need to be addressed. Question 16. Has OMB provided clear guidance and a clear timeline on implementation of the Executive order's exemption process ``for emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters, or otherwise?'' \7\ In the event of a pandemic flu outbreak, will these exemptions be necessary for ASPR to impose new regulations? --------------------------------------------------------------------------- \7\ Mark Sandy, then-Acting Director of the Office of Management and Budget, ``Memorandum: Implementation of Regulatory Freeze,'' White House Office of the Press Secretary (January 24, 2017) (online at: https://www.whitehouse.gov/the-press-office/2017/01/24/implementation- regulatory-freeze). --------------------------------------------------------------------------- Answer 16. Under the Public Health Service Act, ASPR has the powers and authorities necessary to fulfill its mission during a public health emergency like pandemic influenza. With that in mind, I will welcome any opportunities for improvement and efficiencies provided by the Administration or Congress. Vaccines Question 17. President Trump has linked vaccines to autism and has embraced vaccine ``skeptics.'' Do you believe that there is any scientific or medical validity to President Trump's concerns about vaccine safety? If so, please indicate which sources lend scientific or medical validity to his concerns. Answer 17. There is abundant evidence that vaccines are safe. They remain a cornerstone of public health and biodefense strategies. Question 18. Are you concerned that President Trump's statements may dissuade members of the public from receiving flu or other vaccines? Answer 18. Vaccinations are a critical component of our national health resiliency and national security. With that in mind, I am very confident in the U.S. Food and Drug Administration's work to uphold vaccine safety and efficacy. ASPR works with its industry partners and FDA to ensure that all vaccines manufactured under the Biomedical Advanced Research Development Authority (BARDA) are safe and effective to protect the American people. While BARDA does issue contracts to stockpile some items prior to FDA approval, data on patient safety of the therapies or vaccines are reviewed prior to stockpiling. Coordination in Response to Public Health Emergencies The Assistant Secretary for Preparedness and Response (ASPR) focuses on preparedness and public health emergency response.\8\ The President's hiring freeze and fiscal year 2018 budget request would impact the U.S.'s ability to properly respond to a public health emergency or disaster, such as pandemic flu, Ebola, or a bioterrorist attack.\9\ --------------------------------------------------------------------------- \8\ U.S. Public Health Emergency Web page, ``Office of the Assistant Secretary for Preparedness and Response (ASPR)'' (online at: https://www.phe.gov/about/aspr/pages/default.aspx). \9\ Emily Baumgaertner, ``Trump's Proposed Budget Cuts Trouble Bioterrorism Experts,'' New York Times (May 28, 2017) (online at: https://www.nytimes.com/2017/05/28/us/politics/biosecurity-trump- budget-defense.html); Blue Ribbon Study Panel on Biodefense Strategy statement on proposed closure of biodefense laboratory (July 12, 2017 (online at: http://www.biodefense study.org/news-item/blue-ribbon-study-panel-on-biodefense-statement-on- proposed-closure-of-biodefense-laboratory); Jeff Schlegelmilch, ``5 Ways the President's Budget Blueprint Could Change the Way We Respond to Disasters,'' The Hill (May 3, 2017) (online at: http://thehill.com/ blogs/pundits-blog/homeland-security/331818-5-ways-the-presidents- budget-blueprint-could-change-the). Question 19. What would substantial budget cuts mean for the Administration's ability to coordinate across departments and agencies in the event of a public health emergency, such as pandemic flu, Ebola, or a bioterrorism attack? Answer 19. Without the proper funding, there may be limited ability to validate plans, processes or procedures through exercises and to evaluate and identify strengths, gaps and shortfalls which could enhance preparedness. Question 20. What would a hiring freeze mean for the Administration's ability to coordinate across departments and agencies in the event of a public health emergency? Answer 20. Currently, there is no Administration hiring freeze. Should a hiring freeze be implemented in the future, it is likely that there would be exemptions for public health/safety and national security personnel. I would expect HHS to implement such exemptions. ASPR needs a trained, qualified and credentialed team to effectively and efficiently manage response and recovery operations. I will work with partners throughout HHS to ensure ASPR has the workforce it needs to prepare and respond to public health emergencies. Question 21. The ASPR plays an important role in coordinating agencies and departments involved in the response to a public health emergency. Does the ASPRs coordinating role change depending on whether the emergency event originates domestically or internationally? Answer 21. ASPR is the Secretary's principal advisor on all matters related to manmade and naturally occurring public health emergencies. This includes medical preparedness, response, recovery, as well as activities throughout HHS including human services. ASPR, on behalf of the Secretary, is also the Emergency Support Function--8 (ESF-8) Coordinator under the National Response Framework. The ASPR's role in protecting the health security of our Nation is the same whether the threat starts within or outside our borders. Gene Editing and Synthetic Biology Researchers in Canada recently reported that they reconstructed the currently extinct horsepox virus, an evolutionary relative of the smallpox virus, using commercially available genetic material.\10\ The researchers are partnering with New York-based Tonix Pharmaceuticals to develop a safer human smallpox vaccine, and potentially new cancer therapeutics, highlighting the dual-use potential of this and related research and development.\11\ --------------------------------------------------------------------------- \10\ Kai Kupferschmidt, ``How Canadian Researchers Reconstituted an Extinct Poxvirus for $100,000 Using Mail-Order DNA,'' ScienceInsider (July 6, 2017) (online at: http://www.sciencemag.org/news/2017/07/how- canadian-researchers-reconstituted-extinct-poxvirus-100000-using-mail- order-dna). \11\ Jeff Bessen, ``GMOs Lead the Fight Against Zika, Ebola and the Next Unknown Pandemic,'' AP (July 27, 2016) (online at: https:// apnews.com/a86a1ba205154be4b175a1c11406332e/gmos-lead-fight-against- zika-ebola-and-next-unknown). --------------------------------------------------------------------------- The advent of easy-to-use and relatively cheap biotechnological tools, such as rapid DNA sequencing and gene editors, underlines the importance of developing a national biodefense strategy, including a plan for emergency preparedness and development of medical countermeasures. Last month, the White House announced it is developing such a comprehensive biodefense strategy,\12\ as required by the fiscal year 2017 (FY 2017) National Defense Authorization Act (NDAA).\13\ The bill charges the Secretaries of Defense, Health and Human Services (HHS), Homeland Security, and Agriculture to develop a strategy and implementation plan to address our Nation's biodefense, including ``prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation.'' --------------------------------------------------------------------------- \12\ Jonathan Landay, ``White House Developing Comprehensive Biosecurity Strategy: Official,'' Reuters (July 20, 2017) (online at: http://www.reuters.com/article/us-usa-security-biodefense- idUSKBN1A52HZ). \13\ S. 2943, National Defense Authorization Act for Fiscal Year 2017, Section 1086 (online at: https://www.congress.gov/bill/114th- congress/senate-bill/2943/text). Question 22. Do you agree that research, such as that using gene editing and synthetic biology technologies, is essential to advancing the development of medical countermeasures? Answer 22. As the ASPR, I will consider the implications and potential advancements that would result from all of the latest technologies. Like any new technologies, their potential and implications need to be evaluated. It will be a subject that I will carefully monitor going forward. Question 23. What steps will you take to work across agencies and departments and with other stakeholders to ensure that dual-use research, such as that using gene editing and synthetic biology technologies, is conducted in a responsible and ethical manner, while also promoting and supporting such research? Answer 23. ASPR has been a leader in the effort to determine how to manage and balance the need for scientific research and discovery with respect to potential bioterror and pandemic agents, and the potential risks posed by this type of research. HHS policies provide a mechanism for ongoing oversight and review of high risk research to help ensure that important research can proceed, while minimizing safety and security risks. I look forward in my role to participating and contributing to this important task. Response by Elinore F. McCance-Katz, M.D., to Questions of Senator Murray, Senator Sanders, Senator Casey, Senator Franken, Senator Bennet, Senator Whitehouse, Senator Baldwin, Senator Murphy and Senator Warren senator murray Question 1. Access to mental health and substance use disorder screening and assessment, and to the full spectrum of evidence-based therapeutic services, is necessary to recognize and appropriately address mental health and substance use disorder needs for all individuals. Untreated mental health disorders lead to higher rates of family dysfunction, poor school performance, juvenile incarceration, substance use disorder, unemployment, and suicide. For example, in 2012, more than 5,000 children and youth aged 10 to 24 died by suicide, making it the second-leading cause of death in this age range. Behavioral health needs are often identified and addressed in different settings, not just primary or behavioral health care settings. For example, social workers often identify behavioral health needs in schools. How do you plan to support and strengthen these activities, especially outside primary or behavioral health care settings? Answer 1. Given my previous work at SAMHSA, I am aware of the agency's long-tenured investment in treating children in their communities and in natural settings. Concurrently, SAMHSA has invested in prevention and treatment programs for young people that have a strong evidence base. Moving these programs and practices to settings beyond primary and behavioral health care settings is critical. The 21st Century Cures Act also provides instruction and funding to address issues related to behavioral health in children and families outside of healthcare settings. I will work with Federal partners and national stakeholder groups such as the National Alliance on Mental Illness (NAMI) and Mental Health America, both of which are grassroots, community-based organizations that can help with outreach in community settings and dissemination of education about issues related to behavioral health in communities. I will also be looking to States and Congress as partners in helping SAMHSA consider how best to serve our families. Question 2. You have mentioned the importance of incorporating psychosocial variables when engaging the mentally ill. There is concern that taking too rigid a view of evidence-based practices will overlook critical aspects of everyday life, such as stable housing, education, obtaining and maintaining an occupation. If confirmed as the Assistant Secretary for Mental Health and Substance Use, how will you ensure psychosocial variables are included in the dissemination of research findings and evidence-based practices to service providers? In addition, how will the new National Mental Health and Substance Use Policy Laboratory (NMHSUPL) promote evidence-based practices and service delivery models that address psychosocial variables? Answer 2. There is a research base for assertive community treatment programs that include assisting with psychosocial needs including housing, education and employment and even more basic needs, such as how to shop for food and other necessities which are associated with positive outcomes. My goal is to see psychiatric medical care and psychosocial service providers work together to assure that Americans receive the spectrum of services necessary for recovery. The National Mental Health and Substance Use Policy Laboratory (NMHSUPL) was newly stood up as a result of the 21st Century Cures Act to promote evidence-based practices and service delivery models, including those that address psychosocial variables. I look forward to working with my colleagues at SAMHSA in establishing processes for coordinating across SAMHSA programs and the Center for Behavioral Health Statistics and Quality, and engaging a wide range of stakeholders including Federal partners, providers, patients, research institutions and others to ensure that SAMHSA policy is guided by the best evidence and information about the state of the behavioral health field. Question 3. For over 40 years the Minority Fellowship Program (MFP) at the Substance Abuse and Mental Health Services Administration (SAMHSA) has been leading efforts to reduce health disparities and improve behavioral health care outcomes for racial and ethnic populations. The program was recently authorized in the 21st Century Cures Act, which we passed last year. Can you elaborate on how you will ensure the program continues as authorized and on the importance of having a behavioral health workforce in reducing health disparities? Answer 3. The behavioral health workforce continues to have major shortages of professionals and care providers that serve minority communities. It is vital that we continue to build the behavioral health workforce pipeline. I look forward to supporting programs that increase the behavioral health workforce and improve behavioral health care outcomes for racial and ethnic populations. senator sanders Question. The President's budget includes extremely drastic cuts to the Substance Abuse and Mental Health block grants during a time when other behavioral health programs also are being considered for funding cuts. This has the potential to dismantle our country's mental health and substance abuse system, and to walk back the progress we have made around mental health and substance abuse care in the last decade. If confirmed, and as the first Assistant Secretary for Mental Health and Substance Abuse, what are you planning to do to strengthen the service system and improve access to critically needed substance abuse, mental and behavioral health services? Answer. I plan to review current programs and determine those that are producing positive results for individuals with substance use disorders and serious mental illness. I will be a strong advocate for the programs that are working. senator casey Question 1. Substance use disorder, including the opioid epidemic, continues to be one of the most pressing public health problems facing our country. Given what we know about the impact of exposure to traumatic events in childhood, including an increased vulnerability to substance use disorders, what ongoing initiatives or new efforts might SAMHSA support to address this critical issue in a comprehensive and coordinated way? Answer 1. There is evidence showing a strong correlation between opioid addiction and traumatic experiences, particularly early childhood adversity. There are multiple strategies that SAMHSA can implement to address addiction in a comprehensive and coordinated way, building on existing mechanisms. For example, SAMHSA convenes, in partnership with the Department of Labor, an Interagency Trauma Workgroup, consisting of multiple departments and agencies. This workgroup coordinates collaborative interdepartmental efforts focusing on prevention and treatment of mental and substance use disorders that may be associated with trauma and is expanding their work to address the connection between early adversity, trauma and opioid use and misuse. In taking on this leadership role in SAMHSA, I will continue to work with the national stakeholder groups representing providers, people living with mental and substance use disorders, and families that can provide input to SAMHSA regarding whether there are other actions that could be taken to better address issues related to childhood adversity, challenges, and trauma. We can review State models that have had success in addressing these issues and disseminate that information nationally, as well as explore what actions in this area other agencies, such as the Departments of Labor, Education, and Housing and Urban Development, may have pursued. Question 2. The Administration has proposed massive cuts to Medicaid through its budget proposal and through efforts to repeal the ACA. The House's budget bill proposes cutting $1.4 trillion from Medicaid. As you know, Medicaid is the primary funder for public mental health treatment and the availability of mental health services is sorely lacking. Do you support these proposed cuts to Medicaid and how will you advocate for more mental health services in an environment that is proposing to cut massive amount of funding for the services? Answer 2. I support the goal of ensuring that all Americans have access to affordable coverage that best meets their needs and those of their families, including mental health services. I am committed to advocating on behalf of those needing these services. I would see a significant part of my role as Assistant Secretary for Mental Health and Substance Use as working closely with the States and others to improve efficiencies in these programs and to focus the use of funds on evidence-based practices to maximize their reach and impact. Question 3. Dr. McCance-Katz, the President's budget included drastic cuts to both the Substance Abuse and Mental Health block grants at a time when other behavioral health programs are also being considered for funding cuts. This has the potential to dismantle our country's mental health and substance abuse system. As Assistant Secretary, and more specifically as the first Assistant Secretary for Mental Health and Substance Use, what are you planning to do to strengthen the service system and improve access to critically needed behavioral health services? Answer 3. One of my goals as the Assistant Secretary for Mental Health and Substance Use will be to address the integration of care, specifically behavioral health and primary care. I look forward to meeting with stakeholders across the Department and governmentwide, such as the Centers for Medicare & Medicaid Services, to explore opportunities to develop strategies for better alignment and integration of behavioral health and primary care. One of my primary goals will be to reach out to Federal agencies and to providers about the need to both integrate and co-locate these services. Question 4. What is your view of the role and importance of behavioral treatment approaches and peer support versus psychotropic medication in the treatment of mental health and substance use disorders? Answer 4. I don't see behavioral treatment approaches/peer support and psychotropic medication treatment as mutually exclusive. My goals include focusing on both psychiatric treatment, which is essential to restoring one's mental capacity and psychosocial services, which are essential to assisting a person in recovery. In leading SAMHSA, I am committed to reinforce the understanding that psychiatric care and the use of medications along with behavioral treatment is critical to patient care. Question 5. How do you plan to incorporate and learn from the wide range of stakeholders in the mental health and substance use field-- including providers, consumers, and researchers--to help inform your vision for the agency during your tenure in this Administration? Answer 5. I think it is of paramount importance to engage a wide range of stakeholders to help inform SAMHSA's efforts. I plan to listen and learn from stakeholders in a variety of ways including one-on-one conversations, addressing major conferences and allowing time for questions and answers, reaching out to key coalitions such as the Mental Health Liaison Group and the Parity Implementation Coalition, and visiting prevention, treatment and recovery support organizations. I have been a practicing psychiatrist and a funded researcher and have worked in State government both in California and Rhode Island. I have sought out stakeholders to inform my approach to psychiatry and addiction psychiatry and will continue to seek stakeholder input. I see these groups representing providers, consumers, and families as essential to my success and to helping to assure that SAMHSA is doing the best it can to meet the needs of Americans with mental and substance use disorders. As a clinical researcher, I will continue to keep up to date on research progress and findings and to use SAMHSA to help to disseminate these findings so that States/communities can make use of evidence-based practices in their programs. Question 6. Will you commit to responding to monitoring and oversight questions from all committee members and be responsive to our requests for information? Answer 6. I am fully committed to responding appropriately to congressional oversight inquiries and to work cooperatively with committee Members and staff to provide accurate and timely responses. Question 7. During the questioning at the August 1 hearing you mentioned that health insurance plan benefits is a reason why many individuals do not receive adequate mental health treatment. What will you do to ensure mental health coverage parity and to expand access to mental health and substance abuse treatment for those who need it? Answer 7. My understanding is that SAMHSA has already begun efforts to provide States support through technical assistance, access to national experts, individualized coaching, and product development. I am encouraged that SAMHSA led these efforts in collaboration with DOL and CMS (CMCS/CCIIO) and, with the opportunities afforded by the 21st Century Cures Act and the momentum of the Parity Policy Academies, I look forward to continuing to lead efforts in assisting States in advancing parity implementation. Question 8. Over the last several months, I have sent multiple letters to HHS about the Administration's ongoing efforts to undermine and sabotage the Affordable Care Act through executive action. HHS has failed to provide responses to many of my letters. If HHS has responded, the response letters have been wholly inadequate and have not been responsive to my requests. If you are confirmed, do you commit to respond in a timely manner to all congressional inquiries and requests for information from all Members of Congress, including requests from Members in the Minority? Answer 8. I am fully committed to responding appropriately to congressional oversight inquiries and to work cooperatively with committee Members and staff to provide accurate and timely responses. senator franken Question 1. Can you highlight some of the benefits and successes that have stemmed from mental health block grant funds? President Trump's budget recommends cuts to the mental health block grant. How would these reductions affect access to services for people with mental illness and substance use disorders, especially at a time when the country is facing an opioid epidemic? Answer 1. The mental health block grant funds have enabled States to provide evidence-based services to those with mental illness and substance use disorders. I believe that people with mental illness and substance use disorders need access to services, and I will be a champion for ensuring that they are able to receive these services. Question 2. Can you describe which patients, from your perspective, may be able to benefit most from peer support services? Based on your review of the evidence, at which stage of treatment are these peer support services appropriate for different population groups? Answer 2. I believe that peer professionals will, over the coming years, become a standard resource available to people struggling with mental and/or substance use disorders. Those who participate in training programs gain skills in how to work as part of a care team and support all aspects of a person's treatment plan including psychiatric care. This psychiatric care often includes psychotropic medications that are, in my view as a psychiatrist, very valuable. While the evidence base is nascent, there are studies that show the benefit of peer involvement in a person's care. A person available within the community to assist a person in accessing the recommended treatments and resources and serving as a source of support is valuable. senator bennet Question 1a. I was recently in Otero County, CO where drug overdoses have been increasing. The entire community was engaging to address the rise in opioid abuse. This included coordinating hospitals, the courts, schools and foster care services. Even when we see a decrease in prescription overdoses, it is usually countered with an increase in heroin overdoses. In the 1960s, more than 80 percent of heroin users started with heroin. In contrast, currently, about 80 percent of heroin users first started using prescription opioids. What are practical steps you plan to take to address the opioid crisis? Answer 1a. I am committed to helping Secretary Price advance his five-point plan to address the opioid epidemic. As a leader in the field of addiction psychiatry, I plan to engage in each strategy: strengthening public health surveillance, advancing the practice of pain management, improving access to treatment and recovery services, including medication-assisted treatment, targeting availability and distribution of overdose-reversing drugs, and supporting cutting-edge research. I am also aware that both the 21st Century Cures Act and the Comprehensive Addiction and Recovery Act provided specific actions that SAMHSA and other HHS and Federal agencies can undertake to address the crisis, and I will be working across the government to implement these. In addition, I plan to prioritize prevention initiatives in the form of education of the American people and continue to advocate for training of healthcare practitioners so that they can receive the DATA waiver and prescribe buprenorphine/naloxone for opioid use disorder. Question 1b. How can we ensure that Americans are not becoming addicted in the first place while making it easier for people who currently have an addiction to obtain access to treatment? Answer 1b. Prevention and treatment are both key components to addressing the opioid crisis. I know the Department has issued the Opioid State Targeted Response grants that will help States address treatment for those struggling with addiction. An important part of prevention is the education of providers and the American people-- people need to know about the dangers presented by such activities. senator whitehouse Question 1. The President has proposed deep cuts to SAMHSA programs. Do you believe cutting funding for SAMHSA will benefit people with mental health and substance use disorders? Answer 1. I believe that we should ensure that resources spent are truly benefiting Americans with mental health and substance use disorders. I commit to being an advocate for programs that are proven to work and provide help to those in need. Question 2. As you know, the opioid epidemic is currently one of the biggest public health challenges facing Rhode Island and the States of many of my colleagues. Last Congress, we passed The Comprehensive Addiction and Recovery Act (CARA), a law I co-authored. CARA authorizes several important SAMHSA programs, including programs to treat pregnant and post-partum women struggling with addiction, medication-assisted treatment programs, naloxone training programs, and peer-to-peer recovery programs. I was pleased that these programs received funding as part of the fiscal year 2017 appropriations bill, and hope they will continue to receive funding in the coming years. Do you support the full funding of the programs authorized by CARA, and will you work within the Administration and with Congress to ensure funding these programs is a priority? Answer 2. CARA is an important law that will help SAMHSA to address the opioid epidemic head-on. I look forward to implementing these programs and will work to ensure that they are implemented consistent with the CARA. Question 3. You have previously written that SAMHSA spends too much time on peer support and recovery services. Do you support SAMHSA's current programs related to peer support and recovery services? As Assistant Secretary for Mental Health and Substance Use, will you prioritize SAMHSA's peer support and recovery work? Answer 3. I believe that peer professionals will, over the coming years, become a standard resource available to people struggling with mental and/or substance use disorders. Those who participate in training programs gain skills in how to work as part of a care team and support all aspects of a person's treatment plan including psychiatric care. This psychiatric care often includes important psychotropic medications. While the evidence base is nascent, there are studies that show the benefit of peer involvement in a person's care. A person available within the community to assist a person in accessing the recommended treatments and resources and serving as a source of support can be valuable. Evidence-based medical treatment of serious mental illness must be a major focus for SAMHSA. I will prioritize the full spectrum of evidence-based services to assist those with serious mental illness and substance use disorders. This will include openly embracing evidence- based medical treatment of these disorders as well as psychosocial supports, which include peers. Question 4. You have written favorably about the Affordable Care Act's expansion of mental health and substance use disorder coverage. In the aftermath of last week's votes, I hope that the Senate can begin working in a bipartisan way to improve our health care system, without jeopardizing the coverage gains we've made under the ACA. As the Senate continues its work to reform our health care system, maintaining health insurance coverage for mental health and substance use disorders will be a priority of mine. If asked for your expertise on this issue, will you advocate for policies that help expand access to mental health and substance use services? Answer 4. I will be a strong advocate for people with mental health and substance use disorders and will advocate for policies that promote access to coverage and the critical services on which these patients rely. Question 5. As Assistant Secretary for Mental Health and Substance Use, how will you approach the prevention of and screening for mental illness and behavioral disorders in children? Answer 5. Mental illness, emotional and behavioral disorders tend to have their onset in adolescent and young adult developmental periods and increasingly we are realizing that early signs of these disorders appear even earlier in childhood, but often go unrecognized by practitioners. There is burgeoning research documenting the capacity to link results of early childhood screening with later problematic behaviors, including mental disorders, substance use disorders, problematic school behavior and subsequent involvement with the juvenile justice system. Child, family, societal human and fiscal costs have been documented. As Assistant Secretary, it is clear that we will need to look at behavioral health as a two-generational issue and that screening for these issues in children and families needs to be the standard of care. Question 6a. As you know, key members of the behavioral health community--psychologists, community mental health centers, and psychiatric hospitals, among others--are not eligible to receive incentive payments for adopting certified electronic health record (EHR) technology under the Medicare and Medicaid EHR Incentive Programs (Meaningful Use). Last year's SAMHSA ``Leading Change'' report included health information technology as one of six ``Strategic Initiatives.'' Will you continue to make the dissemination and effective use of health IT among behavioral health providers a priority within SAMSHA? Answer 6a. I plan to continue to make dissemination and effective use of Health IT among behavioral health providers a priority within SAMHSA especially in rural and extremely rural areas across the Nation. Question 6b. As Assistant Secretary, in what ways will you promote the use of health IT among behavioral health providers? Answer 6b. As Assistant Secretary, I plan to coordinate on Department-wide initiatives focused on IT integration and will assist with outreach to the behavioral health provider community. Question 7. The Mental Health Parity and Addiction Equity Act (MHPAEA) was passed in 2008, and although it has been fully implemented, enforcement continues to be a problem. What steps will you take to improve Federal enforcement of mental health parity? Answer 7. I will continue to ensure that SAMHSA supports efforts at mental health parity implementation. SAMHSA's leadership and partnership with States, providers, and consumers positions the agency uniquely to provide guidance and support in the advancement of MHPAEA. Question 8a. In Rhode Island, you created the Centers of Excellence program, which brings together doctors, nurses, counselors, peer professionals, and others to provide patient-centered care to individuals receiving medication-assisted treatment. As you know, the medication is just one part of medication-assisted treatment, and additional services are often needed to support recovery. As Assistant Secretary for Mental Health and Substance Use, how would you evaluate promising treatment models being used at the State level? Answer 8a. In developing the model for the Centers of Excellence (COE) for Rhode Island, we also determined outcomes that would help to inform whether these programs were providing the impact and benefit we hoped for. These variables include: number of people referred into COE treatment, number of people who complete admission/induction (engagement), number of people receiving medication-assisted treatment (MAT), number of successful discharges to community office-based opioid use disorder providers, number of negative toxicology screens (opioid), number of opioid toxicology screens obtained, number of negative toxicology screens (all other illicit substances), number of toxicology screens obtained (all other illicit substances), number of patients admitted to the emergency department, number of hospitalizations over course of treatment, and number of patients remaining in COE until referral to another provider (retention). These types of variables can be generalized to substance use disorder treatment programs to assess effectiveness. SAMHSA can explore with States how to develop systems to collect such data. Question 8b. How would you share those models with other States or communities that could benefit from them? Answer 8b. A major and important function of SAMHSA is to be a repository of epidemiological data, evidence-based practices, and promising models. SAMHSA has information reported to it by the States and can facilitate dissemination in a number of ways such as: informational webinars and dissemination through other information technology tracks, written documents, and use of SAMHSA national programs that provide training and peer support including provider clinical support systems and addiction technology transfer centers as examples. senator baldwin Question 1. As HHS implements the 21st Century Cures Act, I hope that, if confirmed, you would pay close attention to the mental illness with the highest mortality rate--eating disorders. The eating disorder provisions included in the law, derived from the bipartisan Anna Westin Act of 2015 (H.R. 2515/S. 1865), were designed to improve eating disorder early detection by our health professionals, increase access to quality and affordable treatment for eating disorders under mental health parity, and provide the public with resources to help prevent and identify the disorder. Taking swift action to implement these provisions is critical to ensuring meaningful access to treatment for men and women with an eating disorder, specifically by incorporating the eating disorders parity rulemaking into existing mental health parity regulations. Will you commit to swiftly advancing the rulemaking process to implement the eating disorders mental health parity provisions? Answer 1. I recognize the importance of provisions enacted by Congress and reflected in the 21st Century Cures Act emphasizing that Mental Health Parity and Addiction Equity Act (MHPAEA) requirements should fully apply to eating disorders. My understanding is that in June 2017, HHS published a guidance/frequently asked questions document that notes the applicability of parity provisions to eating disorders, citing the 21st Century Cures Act and requesting public comment regarding ``whether any additional clarification is needed regarding how the requirements of MHPAEA apply to treatment for eating disorders.'' I will ensure SAMHSA will work with CMS and DOL to review comments and to develop further guidance on these issues as necessary. Question 2. As a physician, can you discuss the importance of intermediate level of care benefits for the treatment of severe eating disorders? Answer 2. People with eating disorders require high-quality health care. Several levels of specialty care may be best for people with eating disorders. The goal is to help the person get to a normal weight and normal eating. The best treatment option depends on the severity of the disorder and the person's past response to treatment. An intermediate level of care, such as day treatment or partial hospitalization, can address medical conditions and provide psychological support. This can be done as a transition from inpatient to outpatient care. It can also be an alternative to inpatient care. senator murphy Question 1. As you know from your past experiences in Connecticut, my State has a proud history of the recovery movement. As I mentioned in our meeting, some groups have been critical of your nomination based on some of your past writings regarding the recovery model. Can you discuss the balance that needs to be struck between medication and recovery supports? Also, can you explain the role that you believe peers should play? Answer 1. I believe that for those with serious mental illnesses, such as schizophrenia and bipolar disorder, who experience hallucinations and delusions--which are prominent symptoms in these disorders and which can be associated with behaviors that can cause serious harm to the people affected and/or others--medical treatment including psychotropic medication and psychiatric care must be available. There is a large evidence base supporting medication treatment, and it is the standard of care for those with these types of symptoms associated with serious mental illness. However, I also strongly support psychosocial interventions including peer support to provide encouragement, assistance in getting services needed, and to provide a model for recovery instilling hope (all of this is predicated on the idea that the peers are supportive of medical care recommended for the individual). I do not believe that either medical interventions or peer support alone provide for all of the needs of persons affected by serious mental illness. Therefore, I will continue to encourage partnerships between medical services and recovery-support services-- indeed, I see medical services as a recovery support. Question 2. I was fortunate to work with Chairman Alexander, Ranking Member Murray and Senator Cassidy on the mental health bill that eventually was passed in the 21st Century Cures Act. One of my top priorities in that bill was SAMHSA's integration program because studies have shown that despite overall gains in life expectancy, individuals with serious illnesses is attributable to acute and chronic co-morbid physical conditions, such as heart disease. I know the Mathematica interim evaluation of this program recently showed substantial improvements in physical health outcomes among clients who have chronic physical health conditions at enrollment and positive trends in functional improvement and substance use. I am hopeful that the changes that we made in the Cures Act will also improve the outcomes for grantees and lead to States breaking down barriers that can discourage integration. Unfortunately, the administration has proposed eliminating funding for the program in its budget request. Can you talk about the importance of integrating mental health and physical health care and why the administration would zero out this funding? Answer 2. I consider the integration of physical and behavioral health services to be very important to improving health outcomes. I have not been privy to discussions about the budget prior to my confirmation, so I cannot speak to the budget request. I have worked in integrated-care systems in my clinical practice, and I have supported and encouraged establishment of integrated healthcare systems in my government work. I will continue to do so. I also believe that we must integrate the treatment of mental and substance use disorders given the high rates of co-occurring disorders and look forward to reviewing the data on Certified Community Behavioral Health Centers (CCBHCs), which SAMHSA has worked to establish with the States. Question 3. As you know, Congress has put a focus on the needs of individuals with early serious mental illness. As SAMHSA noted in its fiscal year 2018 budget justification, ``The majority of individuals with serious mental illness experience their first symptoms during adolescence or early adulthood, and there are often long delays between the initial onset of symptoms and receiving treatment. The consequences of delayed treatment can include loss of family and social supports, reduced educational achievement, incarceration, disruption of employment, substance abuse, increased hospitalizations, and reduced prospects for long-term recovery.'' Most recently, Congress increased this setaside from 5 percent of the Mental Health Block Grant to 10 percent. There are promising models targeted to this population, including Yale's Specialized Treatment for Early Psychosis (STEP) program. STEP patients are hospitalized nearly 50 percent less than other patients and when they do need a hospitalization, the length of stay averages 6 fewer days than standard treatment. Additionally, approximately one-third more STEP patients were engaged in vocational training and these individuals were more involved in outpatient mental health treatment. Can you describe the importance of programs like STEP and what Congress and SAMHSA should be doing to scale their reach? Answer 3. There are now a number of evidence-based approaches that can successfully provide services and supports to individuals experiencing a First Episode Psychosis (FEP). These approaches, based on the evidence-based Coordinated Specialty Care (CSC) model, have a number of common elements including an interdisciplinary team approach that focuses on the comprehensive needs of the patients served by providing rapid access to high-quality treatment and offering support in areas such as employment and education. SAMHSA can help to scale the reach of these programs through dissemination of information about this approach and findings related to use of these approaches from research studies and from States' experiences. SAMHSA has a long track record of making such information available and will continue this important function going forward. Similarly, SAMHSA leadership, given opportunities, can speak to the benefit of these programs as another means of information dissemination. Question 4. Will you prioritize the treatment of emerging serious mental illnesses, such as schizophrenia and bipolar disorder, and substance use disorders in transitional age youth? If so, how? Answer 4. There has been an increasing amount of clinical research, such as the North American Prodrome Longitudinal Study, examining the prodromal phase in order to understand and develop interventions to mitigate psychosis. Transitional-age youth and young adults who present with prodromal symptoms are at increased risk for developing clinical psychosis, which can be one of the most chronic, debilitating features of serious mental illness. Early detection and intervention in people at risk for developing psychosis can be successful in delay of the first episode and reducing the severity of illness. I believe this is an important area for continued research and focus. SAMHSA, working collaboratively with NIMH, can assist with dissemination of the evidence base for prodrome and approaches/interventions designed to ameliorate these symptoms and improve the quality of life for young people at high clinical risk for psychosis. Question 5. Mass violence events, like the tragedy that occurred in my State at Sandy Hook Elementary School, have lasting effects on our children, families, and the community at-large. Federal programs like the SAMHSA-administered National Child Traumatic Stress Initiative have played an important role in supporting the acute and long-term mental health needs of our community as we continue to recover from this terrible tragedy. How will you guide SAMHSA's efforts to strengthen our national capacity to prevent and respond to traumatic events like this? Answer 5. SAMHSA's strength comes from its collaboration, coordination, and communication with community, State, regional, and Federal partners in all phases of response and recovery. SAMHSA further works to ensure behavioral health is meaningfully addressed in local, regional, State, and Federal response plans and provides tools and guidance to ease its inclusion. I will ensure that SAMHSA continues to update and disseminate tools describing best practices, informational materials, and fact sheets addressing aspects of response and recovery. I will explore and evaluate grant programs that address needs which cannot be met in other ways and make sure that lessons from those programs guide our best practices and inform disseminated materials as well. I will also support evidence-based early intervention programs that SAMHSA has overseen in the States. I will support ongoing technical assistance to States as they seek the best and most appropriate interventions for their communities including education about serious mental illness, recognition of potential illness, and how to access resources. I will continue to encourage healthcare-practitioner education and explore mechanisms for increasing the number of psychiatrists, physicians, and allied providers who are trained to provide mental health services in communities. I will openly and actively endorse recovery supports including psychiatric medical care for those struggling with serious mental illness. Question 6. Recent research has shown that there is a link between childhood exposure to trauma and subsequent substance use problems. In what ways can you ensure that issues related to child and adult trauma are part of substance use disorder and opioid programs that you will oversee in your role as the Assistant Secretary for Mental Health and Substance Use? Answer 6. SAMHSA has provided significant leadership in the area of child and adult trauma. Screening tools, interventions, and informational materials, and a framework for addressing trauma and implementing a trauma-informed approach in multiple health and human service systems has been well-articulated with increasing uptake in different sectors. This framework and associated interventions can more intentionally and systematically be implemented in our substance use disorder and opioid specific programs. Further, substance use disorder treatment programs must include evaluation of both substance use and mental disorders (as well as assessment of physical illnesses) given the high rates of co-occurring mental disorders in those with primary substance use disorders (approximately 40 percent). Assessment for mental disorders should include assessment for trauma and trauma- associated mental disorders. SAMHSA can use its existing training programs, such as the Providers Clinical Support Systems and the Addiction Technology Transfer Centers, to disseminate best practices in these areas. Further, SAMHSA can prepare and disseminate special topic trainings in this area. SAMHSA has a strong record of high-quality presentations with national experts that are well attended by practitioners and the public. Question 7. Mental Health America's recent launch of a national certification program for peer support specialists shows that creating a workforce of peers will be a key ingredient in the future of mental health and substance use care delivery. Do you support an effort to add peer workers to the care workforce and, if so, how would you support this effort? Answer 7. I believe that for those with serious mental illnesses, such as schizophrenia and bipolar disorder, who experience hallucinations and delusions--which are prominent symptoms in these disorders and which can be associated with behaviors that can cause serious harm to the people affected and/or others--medical treatment including psychotropic medication and psychiatric care must be available. There is a large evidence base supporting medication treatment, and it is the standard of care for those with these types of symptoms associated with serious mental illness. However, I also strongly support psychosocial interventions including peer support to provide encouragement, assistance in getting services needed, and to provide a model for recovery instilling hope (all of this is predicated on the idea that the peers are supportive of medical care recommended for the individual). I do not believe that either medical interventions or peer support alone provide for all of the needs of persons affected by serious mental illness. Therefore, I will continue to encourage partnerships between medical services and recovery-support services-- indeed, I see medical services as a recovery support. senator warren Medicaid As the Nation's first Assistant Secretary for Mental Health and Substance Use Disorders, you will play a central role in efforts to guarantee and expand access to behavioral health services. In combination with the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), the Affordable Care Act (ACA) and Medicaid expansion have provided critical guarantees of access to behavioral health services. Medicaid covers a disproportionate share of individuals with individuals with mental illness--22 percent of adults with mental illness and 26 percent of adults with serious mental illness received Medicaid coverage in 2015. President Trump has supported legislation that would cut Medicaid by more than $700 billion, converting it to a per capita cap or block grant system. His budget proposal for fiscal year 2018 (FY 18) also proposed an additional cut to Medicaid of over $600 billion. You have previously emphasized the role of the ACA and Medicaid expansion in reducing barriers to addiction treatment. Question 1. Do you agree that Medicaid plays an essential role in ensuring that individuals with mental health and addiction disorders can access medically necessary treatment? Answer 1. Yes, Medicaid provides access for eligible people with mental health and addiction disorders to receive medically necessary treatment. Question 2. Do you agree that hundreds of billions of dollars in cuts to Medicaid would have a negative impact on the ability of individuals with mental health and addiction disorders to access health care? Answer 2. I support the goal of ensuring that all Americans have access to affordable coverage that best meets the needs of themselves and their families, including mental health services. I see a significant part of my role as Assistant Secretary for Mental Health and Substance Use as being an advocate for those with mental and substance use disorders and to address their treatment and recovery service needs. Opioid Epidemic At the core of the opioid epidemic has been the over-prescribing and misuse of addictive and dangerous prescription painkillers. CMS reported that generic Vicodin was prescribed to more Medicare beneficiaries than any other drug in 2013--more than blood pressure medication, more than cholesterol medication, more than acid reflux medication. The National Institute on Drug Abuse has estimated that over 70 percent of adults who misuse prescription opioids get the medication from friends or relative, so efforts to reduce the amount of unused medications in the home is a powerful new tool to tackle prescription drug abuse. The Comprehensive Addiction and Recovery Act, passed in July 2016, includes a bipartisan provision that I worked on with Senator Capito which empowers patients to talk to their physicians and pharmacists about partially filling their prescription medications in order to reduce the amount of unused opioids in circulation. In Massachusetts, more 2,000 individuals died from opioid overdoses in 2016. The illicit distribution, sale, and increased use of fentanyl, a dangerous synthetic opioid that is more potent than heroin, has further contributed to this public health crisis--particularly in New England States like Massachusetts. A November 2016 study by the Massachusetts Department of Public Health found that of the opioid- related fatalities in the State in which toxicology screens were available, 74 percent of individuals tested positive for fentanyl. Question 3. Do you believe that reducing the number of unused medications in the home is an important tool in tackling the misuse of prescription medications? Answer 3. Yes. Providing education to both prescribers and patients is important to reduce the number of unused medications in the home and the risks of misuse that come with it, especially with regard to opioid medication. Question 4. What will you do to work with other agencies and the physician community to address the overprescribing and misuse of addictive prescription medications, while still ensuring that patients who need pain medication can receive it? Answer 4. Secretary Price has made the opioid epidemic one of the Department's top clinical priorities. I look forward to working across agencies to ensure that physicians are educated on the clinical guidelines for the prescribing of opioids. I have worked for a number of years at the interface of pain management and addiction. I was the former medical director of SAMHSA's national training and mentoring program, Providers' Clinical Support System for Opioids (PCSS-O). I have worked with patients and their families on reducing unsafe opioid use in the context of ongoing pain. I believe SAMHSA has a major role to play in educating providers and the public. I would welcome the opportunity to work with Congress on this important issue. Question 5. How will you work with States, physicians, pharmacists, and patient groups to increase awareness about partial-fill policies? Answer 5. I look forward to coordinating across agencies to ensure that States, physicians, pharmacists, and patient groups are aware of partial-fill policies. Question 6. You have advocated for Medication-Assisted Treatment (MAT) as an important evidence-based addiction treatment. How will you work to ensure that other influential health officials in the Administration understand the value of this treatment? Answer 6. I know that HHS is committed to bringing everything the Federal Government has to bear to address the health crisis opioids pose. The first pillar of the HHS opioid strategy is to improve access to treatment and recovery services, including medication-assisted treatment (MAT), and all health officials in the Administration understand the value of this treatment. I look forward to working with both my Federal colleagues as well as members of the HELP Committee to continue to advance MAT as a component of evidence-based addiction treatment. While MAT alone is not enough, MAT addresses tolerance and withdrawal and gives many people the ability to participate in counseling, psychotherapy, and other necessary recovery supports that form the basis of a comprehensive recovery program. Question 7. As Assistant Secretary, what specific steps will you take to build on HHS's efforts to support communities that are dealing with the impact of fentanyl use on the rise in fatal overdose rates? Answer 7. I will help coordinate HHS' efforts to assist States and communities to identify synthetic opioid-related overdose deaths including potential clusters and respond with prevention and treatment strategies. Syringe Exchange Programs and Supervised Injection Facilities Syringe exchange programs are locations where individuals can go to get sterile needles and syringes and safely disposed of used items, as well as get education on safer practices and even treatment for other medical, social, or mental health needs. The CDC, the Institute of Medicine, among other scientific organizations, report that needle exchanges are ``highly effective in preventing the spread of HIV/ AIDS.'' Question 8. As Assistant Secretary for Mental Health and Substance Abuse, would you advocate for the use of Federal funds to support syringe exchange programs? Answer 8. People who inject drugs are at increased risk of acquiring and transmitting HIV, viral hepatitis, and other blood-borne infections. The opioid epidemic has focused attention on the dangers of sharing needles, as evidenced by the HIV outbreak in rural Indiana in 2015. Under current law, in some jurisdictions, people who inject drugs can access sterile needles and syringes through syringe services programs (SSPs) and through pharmacies without a prescription. In addition, current law gives States and local communities, under limited circumstances, the opportunity to use Federal funds to support certain components of SSPs. I look forward to working with Congress on this issue and other avenues to address the health crisis opioids pose and to improve the health of intravenous drug users. Question 9. Research has also shown the benefits of Supervised Injection Facilities (SIFs), where people can use their own drugs, under medical supervision. Research indicates that SIFs help reduce HIV and hepatitis transmission risks, prevent overdose deaths, and increase the number of people seeking out addiction treatment. Would you commit to advocate for studying safe injection facilities as a tool in the fight against the opioid epidemic? Answer 9. I am aware that the American Medical Association (AMA) approved a resolution calling for the development of pilot SIFs, and that there are sites proposed in Seattle, San Francisco, and New York, to name a few. There is much we don't yet know about the effectiveness of SIFs in saving lives and/or in encouraging people who use intravenous drugs to seek treatment, and what little research data is available does not, at least at this time, appear promising in the role of these programs to assist people to treatment. Peer Support You have said before that ``SAMHSA has supported programs that provide little help to those in greatest need,'' giving the example of SAMHSA putting ``a major emphasis on developing a `peer workforce,' through which individuals with mental disorders offer support to those experiencing an acute episode of mental illness.'' \1\ However, literature reviews have shown the effectiveness of peer support programs for individuals with mental health and addiction disorders.\2\ --------------------------------------------------------------------------- \1\ McCance-Katz, Elinore, ``New Hope for the Mentally Ill,'' National Review (November 22, 2016) (online at: http:// www.nationalreview.com/article/442382/donald-trump-mental-illness- needs-more-aggressive-treatment). \2\ ``Peer Support: Why it Works,'' National Coalition for Mental Health Recovery (April 2014) (online at: https://www.ncmhr.org/ downloads/References-on-why-peer-support-works-4.16.2014 .pdf). Question 10. Why do you believe that peer support is not helpful in treating mental illness? Answer 10. I believe that peer professionals will, over the coming years, become a standard resource available to individuals struggling with mental and/or substance use disorders. I think they have a role in the continuum of care. However, as a practicing psychiatrist for 30 years who has run the Rhode Island State hospital system for the last 2 years, I can say with great certainty that those with serious and persistent mental illness--a population that receives little attention yet suffers greatly and, untreated, can be at substantial risk to themselves and sometimes others--need evidence-based psychiatric interventions to assist them in their recoveries. Peers are a part of the recovery process, but peers cannot impact psychosis, hallucinations, and/or delusions. I am committed to embracing the spectrum of recovery services including medical treatment for those in need along with the use of peers as appropriate. Question 11. Do you believe that peer support is helpful in any context? Answer 11. I believe that peer support is an important component of recovery. As a physician, I can provide medical care onsite which lasts for a very brief period. Peers can be far more available as part of a treatment team and as supporters in the community. They can help patients to obtain the medical, psychotherapy interventions, and other recovery resources recommended. They provide emotional support and, through their own recoveries, can provide hope. The value of such services cannot be underestimated. Question 12. You have been supportive of other community-based programs in treating behavioral health disorders at SAMHSA.\3\ Which community-based programs do you believe are useful? --------------------------------------------------------------------------- \3\ McCance-Katz, Elinore, ``What is SAMHSA's Role in Today's Healthcare System?'' SAMHSA (May 29, 2014) (online at: https:// blog.samhsa.gov/2014/05/29/what-is-samhsas-role-in-todays-healthcare- system/#.WYHieoTytGo). --------------------------------------------------------------------------- Answer 12. I support the integration of behavioral health and primary care and the integration of treatment for mental disorders and substance use disorders. I support programs that provide case management and wrap-around services including assistance with vocational/educational needs, housing, and assistance with legal issues as needed. I support opioid treatment programs that expand to provide primary care and mental health services. I support recovery housing and programs for pregnant and post-partum women with opioid use disorder. I support crisis intervention programs designed to avoid emergency department visits and hospitalizations. All of these programs could involve peer specialists. Question 13. Would you commit to further studying and considering the usefulness of peer support programs? Answer 13. There is accumulating data on the value of peer support programs and, yes, I would commit to further controlled research studies aimed at determining the usefulness of peer support programs-- for who and under what conditions. Response by Jerome Adams, M.D., to Questions of Senator Murray, Senator Sanders, Senator Casey, Senator Franken, Senator Bennet, Senator Whitehouse and Senator Warren senator murray Question 1. Earlier this year, a woman in Nevada died from an infection that was resistant to all 26 antibiotics that are available in the United States. The Centers for Disease Control and Prevention (CDC) have estimated that antibiotic resistant infections infect over two million and kill 23,000 Americans each year. A recent report found that if we don't take action, drug-resistant infections will kill more people worldwide than diabetes and cancer combined by 2050. Do you agree that antibiotic resistance is a significant threat to human health, and if so, how will you work to reduce this threat as Surgeon General? What role does the Surgeon General's office play in ensuring antibiotics are used effectively and appropriately? Answer 1. The issue of antibiotic resistance poses a serious threat to public health and clinical care. HHS has been a leader across the government in implementing a range of interventions. I am prepared to work to address antibiotic-resistant bacteria with my colleagues across the Administration to continue to advance these efforts. In particular, I believe the Surgeon General is well-positioned to engage with the medical community to encourage antibiotic stewardship and appropriate antibiotic prescribing, and to help patients and the public understand how to appropriately use antibiotics. Question 2. In December, the Surgeon General issued a report that concluded use of e-cigarettes by youth and young adults is a public health concern. It found that use of e-cigarettes by youth is now more common than use of regular cigarettes and that e-cigarettes come in a wide array of fruit and candy flavors and are marketed in ways that appeal to youth. Yet, last week, the Food and Drug Administration (FDA) announced they would delay current deadlines for review of these products. Do you share the view that e-cigarette use by young people is a public health concern that requires action at the Federal, State, and local levels? Do you agree that FDA has an important role to play to reduce youth use of e-cigarettes? What can CDC and other Federal agencies do to address this public health concern? What role should the Surgeon General play in raising awareness of this problem and spurring the adoption of policies and programs that will reduce youth use of e- cigarettes and all tobacco products? Answer 2. Protecting and improving public health is at the core of the Department's mission. While serving as the Indiana State Health Commissioner, I have overseen Indiana's tobacco cessation efforts. I look forward to working with the FDA, CDC, and other Federal agencies to protect our children and significantly reduce tobacco-related disease and death. Question 3. Do you plan to continue the efforts of the National Prevention Council and implementation of the National Prevention Plan? Answer 3. As Surgeon General, my commitment is to prevention. I believe it is the best way to improve the health of Americans and decrease the burden on our health system. Once in the office, I will work with stakeholders and Department leaders to evaluate the National Prevention Council and National Prevention Strategy to ensure goal alignment with the Department to better serve the American people. Question 4. How will you support CDC's Office for Smoking and Health and ensure they have the capacity to continue with and optimize their prevention and cessation efforts, particularly their extremely successful Tips from a Former Smoker campaign? Answer 4. Recognizing the important role of CDC's Office on Smoking and Health, I will work with the CDC Director, Dr. Brenda Fitzgerald, to collaborate and communicate the available scientific information on tobacco use and related diseases to the public, consistent with my role as Surgeon General. Question 5a. For the first time in two decades, life expectancy in the United States has declined. Death rates among middle-aged Caucasians in the South are increasing, largely due to drug overdoses, liver disease, and suicide. Deaths due to chronic conditions such as diabetes and heart disease have also stopped falling after years of improvement. These conditions are all fully preventable. How will your office work with the CDC and others within the Department of Health and Human Services (HHS) to address these preventable conditions? Answer 5a. I believe it is critically important for all of the agencies within the Department to work together in a coordinated fashion to address preventable conditions. I look forward to serving as Surgeon General and working to bridge the efforts of the various agencies to improve the health of Americans, consistent with my role and responsibilities. Question 5b. How will this work be challenged by the current budget environment, considering the proposed deep cuts in the President's budget to the CDC and the repeated threats to the Prevention and Public Health Fund? Answer 5b. It is important that the Office of the Surgeon General support efforts to prevent disease and encourage individuals to make informed choices about their health. I am committed to working hard in my role to advocate for prevention at HHS. Question 6. Many health conditions and significant racial and ethnic disparities are heavily influenced by various social and environmental factors that typically exist outside of the health care context. For example, sub-standard housing that promotes mold, moisture, and pest infestations can trigger asthma. As Surgeon General, how would you help make sure HHS is a leader in actively bridging the divide between clinical care and community conditions? Answer 6. Tackling disparities such as these is always a challenge, especially when taking into account social and environmental factors that exist outside of the health care context. As I said in my opening statement, we need to get out into our communities and learn about their obstacles and successes, share best practices, and help empower them to implement local solutions. I am committed to working with partners at the Federal, State, and local level to end disparities. Question 7. Surgeons General have often depended on the Dietary Guidelines for Americans (DGA) to promote healthy eating for families across the country. Do you support development of the evidence-based DGAs? As you know, the DGAs are currently under review and the review process might be subsequently changed. Do you support the current process in place to review the evidence that is the underpinning for the DGAs? How would you optimize communication of the DGAs to the American public? What do you feel the appropriate role for industry and other stakeholders is in the process of developing the DGAs? Answer 7. The Dietary Guidelines are science-based recommendations that give Americans advice on building healthy eating patterns that can help prevent chronic diseases and promote and advance their health and well-being. The focus of the Dietary Guidelines is on preventing diet- related health conditions, such as obesity, diabetes, and heart disease rather than treating these and other diseases. The Dietary Guidelines should be grounded in the strongest available scientific evidence and represent our current understanding of the connections between food and health. The development process includes input from an independent group of nutrition and medical experts and practitioners to inform each edition of the Dietary Guidelines, public comment, and exhaustive systematic review of the literature and current science. Question 8. At your confirmation hearing you stated that ``guns and gun owners aren't inherently a public health problem, but the violence that results absolutely is.'' What public health interventions do you think are needed to address gun violence and, as Surgeon General, how would you work to promote such interventions? Answer 8. When addressing the challenge of violence in our communities, we must look at the underlying issues--such as untreated mental illness--and address them. As I reiterated in my opening statement, I share the Secretary's urgency of addressing untreated mental illness, especially serious mental illness. I will work to ensure that we are identifying indicators of violent behavior so as to promote appropriate interventions, consistent with my role as Surgeon General. Question 9. Infant mortality is often an indicator for the health of a society and the efficacy of its policies. According to the CDC, the infant mortality rate in the United States in 2014 was 6.1. This means that 6 out of 1,000 infants born will not live to see their first birthday. The rate is the higher than 25 other developed countries. This is an unsettling statistic. You have been very involved in efforts to reduce the number of infant deaths in Indiana, which had one of the highest infant mortality rates for individual States. How would you translate these efforts to the Federal level? Maternal mortality rates in the United States, while improving overall, have also fallen behind those of other countries. If confirmed as Surgeon General, how would you work to improve the maternal mortality rate in the United States? Answer 9. As Surgeon General, I would draw upon my experience in Indiana to build relationships across HHS, the States, and local communities to identify strategies that are working to improve infant and maternal mortality. Many States, much like Indiana, are facing a multitude of health challenges that are reflected in these rates. I am committed to working with all levels of government and impacted communities to better address these two important health concerns. Question 10. The African-American infant mortality rate is twice the white infant mortality rate. In 2013, the Secretary's Advisory Committee on Infant Mortality included in the National Prevention Strategy a recommendation on this topic. What recommendations would you offer clinicians to address this health inequity in the African- American community? Answer 10. This issue is of great concern to me as a physician and a parent. I feel one important step to improving infant mortality in any community, but especially the African American community, is collaboration and engagement across the community. By leveraging interagency, public-private, and multi-disciplinary collaboration and partnerships, we can work together to identify targeted strategies to reduce infant mortality in the African American community. This is a multifaceted problem. Clinicians cannot fully address this problem without the help of other partners. To achieve any level of success, it will require clinicians working together and with other stakeholders across all disciplines to identify models and best practices appropriate for the communities we serve. Question 11. There unfortunately has been a history of reproductive coercion in this country, particularly among Black and Latina women. The Surgeon General's office frequently makes recommendations on ways that Americans can improve their health outcomes. Do you have any recommendations to make sure that all women have the ability to choose the birth control--and provider--of their choice? Answer 11. As Surgeon General, I would look forward to ensuring that women and men can obtain the health care that they need at an affordable price. Question 12. When you committed to me that you would stand up for vaccines, you told me that you will stand up for science where the science is settled. You also said there are topics on which people think the science is settled but it is not. Can you please elaborate on what those topics are and what the outstanding questions are? Answer 12. As Surgeon General, science will always guide and be reflected in my efforts. I will also convene and work with partners to make sure that, where there remains scientific debate, we can talk to each other, and come up with a direction that is best for, and accepted by, the American people. The Department has a responsibility to ensure that the American people are receiving the most up-to-date, science- based information, and also to make sure we listen to and work with all citizens--not just the ones we happen to agree with. Question 13. For decades, the Surgeon General has been an outspoken voice on the health risks posed by smoking, particularly among children and teens. As noted above, the Surgeon General has recently spoken out about the risks posed by e-cigarettes. In Indiana, you have led several public campaigns to warn of the dangers of tobacco, stating ``quitting smoking is the single best thing you can do for your health.'' Yet, according to your Public Financial Disclosure Report (OGE Form 278e), prior to your nomination you were invested in some of the largest manufacturers of tobacco products, including e-cigarettes: Altria Group Inc., British American Tobacco PLC, Philip Morris International Inc., and Reynolds American Inc. with holdings totaling between $5,005 and $75,000. Please explain how you reconcile the past work from the Office of the Surgeon General--and your own work--about the public health risks posed by tobacco with your decision to hold stock in some of the world's largest tobacco companies? Answer 13. The majority of my investments are held in managed accounts with the investment decisions made by the account managers. I hold several smaller investment accounts where I control the investments with the advice of my financial advisor. My advisor and account managers make decisions that they deem best for my portfolio, and which are unknown to me. Following my confirmation, all of my accounts will be moved to accounts under my full control. As you mention, my commitment to tobacco prevention and cessation is well- documented. Question 14. You have spoken extensively about your experience with the opioid epidemic and the resultant HIV outbreak in Indiana. You testified before Congress that ``[t]argeted marketing by the pharmaceutical industry encouraged providers to use opioids more aggressively to treat chronic, non-terminal pain'' and you called on the pharmaceutical industry to be held accountable for its role in expanding access to opioids. Yet, according to your Public Financial Disclosure Report (OGE Form 278e), prior to your nomination you were invested in companies that are some of the largest manufacturers of opioids in the country, including Allergan, Pfizer, and Novartis. In fact, the State of Ohio recently brought a lawsuit against Allergan, among others, for their role in the opioid epidemic. Please explain how you can reconcile your work speaking out about the dangers of the opioid epidemic, specifically your calls to hold the pharmaceutical industry accountable, with your decision to hold stock in some of the Nation's largest opioid manufacturers? Answer 14. The majority of my investments are held in managed accounts with the investment decisions made by the account managers. I hold several smaller investment accounts where I control the investments with the advice of my financial advisor. My advisor and account managers make decisions that they deem best for my portfolio, and which are unknown to me. Following my confirmation, all of my accounts will be moved to accounts under my full control. As you mention, my commitment to combating the opioid epidemic is well- documented. senator sanders Question 1. As you know, this Nation has been and remains plagued by health disparities. These disparities not only are well-documented as it pertains to health status and health outcomes, but also in the stark differences that exist between different populations in access to reliable, affordable health care. These disparities not only carry a significant human health toll, but a financial one, as well. As Surgeon General, please share in detail how do you plan on leveraging the influence of the office to help make significant strides in ongoing efforts to reduce and even eliminate some of our most pressing health disparities? Also, please share how you plan to work to reduce health disparities while President Trump is seeking to cut or eliminate the very programs that are vital to this effort. Answer 1. As Indiana Health Commissioner, one of my main areas of focus was on health disparities impacting health outcomes, such as infant mortality disparities by race and geography. As Surgeon General, I would ensure health disparities continues to be an area of focus through my communication and convening platforms. I would spotlight community and employer engagement on evidence-based programs and policies that are reducing health disparities across our Nation in order to increase their reach. Question 2. There are dire and often immediate public health challenges that can be direct results of the lack of access to screening, treatment and care for substance abuse, HIV and other STI testing, and needle exchange programs. These are issues, as you know, that hit rural communities extremely hard, and were highlighted when Scott County, in your own State of Indiana, experienced an HIV outbreak that has since been linked to opioid misuse and needle sharing. As you know, when this HIV outbreak occurred, then-Governor Pence refused to support needle exchange programs. Additionally, more than 60 percent of rural counties--including Scott County--did not have enough physicians qualified to prescribe buprenorphine--an FDA-approved medication to treat opioid use disorder. In detail, please share your perspective about the importance of the Federal Government's support for programs like needle exchange and HIV screening, as well as the Federal Government's role in assisting States and local communities to expand access to treatment for substance use disorders in rural, underserved areas, like Scott County? Additionally, in detail, please share your thoughts about the impact that defunding Planned Parenthood--which provides not only HIV and STI screening and testing, but also mental health and substance abuse counseling and treatment to millions of vulnerable Americans--will have on efforts to prevent what happened in Scott County from happening in other rural communities across the country. Answer 2. Our Nation is in the midst of an unprecedented opioid epidemic. I share Secretary Price's tremendous sense of urgency to combat this public health threat. As Secretary Price outlined in April 2017, HHS is implementing a comprehensive strategy to reduce opioid abuse, addiction, and overdose, including the provision of comprehensive services such as substance abuse treatment, testing for HIV and hepatitis C, and, where appropriate and effective, access to sterile syringes, consistent with Federal, State, and local laws, for people who inject opioids and other drugs. Building on my first-hand experiences addressing these complex issues in Indiana, I look forward to advancing these efforts and helping communities to implement local solutions to their toughest problems. I also look forward to working with partners across HHS to leverage community health centers in this effort. This critical resource plays a vital role in health care delivery, especially in rural communities. senator casey Question 1. In your opening testimony at the August 1 hearing you stated the importance of prevention activities to address many of the public health problems in our country. As you know, the Affordable Care Act has a significant prevention fund that has been targeted for defunding by the Administration. How will you advocate for continuation of this program and funding within the Administration? Answer 1. A primary focus of the Surgeon General is prevention. I look forward to getting into my position and evaluating programs that are already in place. As you mentioned, I am eager to ensure that prevention is a key focus. Question 2. Over the last several months, I have sent multiple letters to HHS about the Administration's ongoing efforts to undermine and sabotage the Affordable Care Act through executive action. HHS has failed to provide responses to many of my letters. If HHS has responded, the response letters have been wholly inadequate and have not been responsive to my requests. If you are confirmed, do you commit to respond in a timely manner to all congressional inquiries and requests for information from all Members of Congress, including requests from Members in the Minority? Answer 2. As Surgeon General, I look forward to working with you and Members of Congress on both sides of the aisle. I am eager to maintain an ongoing dialog with Congress as we work to improve the health of all Americans. senator franken Question 1. Can you explain why it is essential and in the best interest of the Nation's public health to have an independent Surgeon General whose sole focus is promoting and advancing evidence-based public health practices rather than the political agenda of the administration in which the Surgeon General serves? Answer 1. It is important for a Surgeon General to be an independent and unbiased authority. Question 2. The Surgeon General's office has produced landmark reports over the years that have been tremendously influential, including last year's report on addiction. What would your priority issues be and how do you intend to utilize previous work of the office to advance your goals? Answer 2. As detailed in my submitted confirmation testimony, my priorities will be (1) addressing the opioid epidemic, (2) promoting wellness and prevention, and (3) engaging the business community to improve health. All of the previous reports of the Surgeons General will have relevance to and overlap with my priorities--particularly previous reports on addiction and smoking. My intent is to buildupon the work of previous holders of this position, to make America healthier. Question 3. As Surgeon General, you will help lead the Public Health Commission Corps. What plans do you have to utilize this group to fight the opioid epidemic and other public health crises? Answer 3. The USPHS Commissioned Corps is comprised of approximately 6,500 licensed, public health and safety professionals (doctors, nurses, mental health providers, etc.) trained to respond individually or as part of a larger Federal disaster response. As Surgeon General, I look forward to working with the Commissioned Corps to advance the President's and Secretary's public health agenda and to protect the health of all Americans. Question 4. The President, while on his campaign echoed the concerns raised by anti-vaccine organizations. What will you do to educate the President, his administration, and the public about the importance of vaccines? Answer 4. There is no doubt that vaccines have played a significant role in improving public health in our country. I will work to ensure that patients have confidence in the immunizations recommended by the Department. senator bennet Question 1a. I was recently in Otero County, CO where drug overdoses have been increasing. The entire community was engaging to address the rise in opioid abuse. This included coordinating hospitals, the courts, schools and foster care services. Even when we see a decrease in prescription overdoses, it is usually countered with an increase in heroin overdoses. In the 1960s, more than 80 percent of heroin users started with heroin. In contrast, currently, about 80 percent of heroin users first started using prescription opioids. What are practical steps you plan to take to address the opioid crisis? Answer 1a. The opioid epidemic is one of the greatest health threats in recent history. To be successful in ending this crisis, we must focus on a comprehensive strategy that addresses the underlying drivers of the epidemic and brings together public health, public safety, community members, faith-based organizations, and many other elements of society. As Surgeon General, I would build on my experience in Indiana, to partner with the medical community to increase the use of evidence-based addiction treatment, including medication-assisted treatment, and support individuals in recovery. A key aspect of this work is communication and convening, and the Surgeon General is well- positioned to bring stakeholders together on this pressing issue. I look forward to carrying out these efforts. Question 1b. How can we ensure that Americans are not becoming addicted in the first place while making it easier for people who currently have an addiction to obtain access to treatment? Answer 1b. Prevention is a key part of the strategy to combat the opioid epidemic. As Surgeon General, I would build on efforts already underway at HHS to support community-based prevention programs, and work with the medical community to improve opioid prescribing--too often a starting point of addiction for many Americans. At the same time, the data are clear that most people who have opioid addiction do not receive treatment for it. Thus, to turn the tide on the epidemic, I would advance efforts to expand access to treatment, including the full spectrum of medication-assisted treatment. Question 2. Many chronic diseases are preventable or better managed when caught early. When they are not, there is a large cost burden on our society. The American Diabetes Association estimates that the economic cost of diabetes was nearly $250 billion in 2012, a 41 percent increase since 2007. In Medicare, 15 percent of the sickest enrollees that often have multiple chronic conditions, account for 50 percent of Medicare spending. What is your strategy around prevention so that certain chronic diseases are avoided or better managed in order for us to improve outcomes and save Medicare dollars? Answer 1. The Office of the Surgeon General's primary function is to translate science to ensure the American public is aware of the most practical and evidence-based information to prevent disease. For example, the Surgeon General's Call to Action on Walking and Walkability focuses on increasing physical activity. The Office also highlights active living and healthy eating as standards to improve chronic diseases. The Healthy Aging in Action report (HAIA) developed by the National Prevention Council addresses best practices for longevity and improving health costs for seniors. I plan to carefully review recommendations such as these and determine the best way during my tenure as Surgeon General to promote prevention of chronic disease. senator whitehouse Question 1a. You are well aware of the toll the opioid epidemic has taken on families across the country. Evidence shows that medication- assisted treatment can reduce cravings and withdrawal symptoms among people suffering from opioid addiction, and help them stop using opioids and get back to living productive lives. Despite this evidence, Secretary Price has claimed that medication-assisted treatment is ineffective, just substituting one opioid for another. Do you agree with Secretary Price's statements about medication- assisted treatment? Answer 1a. There are many years of rigorous research documenting the effectiveness of medication-assisted treatment. Like Dr. Price, I am committed to ensuring that people struggling with opioid addiction have access to evidence-based care, including the full spectrum of medication-assisted treatment. Question 1b. What do you see as the role of medication-assisted treatment in combating the opioid epidemic? Answer 1b. To turn the tide on the epidemic, we must have a comprehensive strategy. A critical component of that is to expand access to treatment, in particular all forms of medication-assisted treatment. I am prepared to use the role of Surgeon General to help educate providers, patients, and the public about opioid addiction, what treatments are available, and how people can access treatment. Question 2. You have referred to antibiotic resistance as ``one of the biggest health threats we face'' and have encouraged the responsible prescribing of antibiotics. The Centers for Disease Control and Prevention estimates that two million people develop antibiotic- resistant infections in the United States every year, resulting in at least 23,000 deaths. As Surgeon General, will you prioritize combating antibiotic resistance, preventing healthcare-acquired infections, and raising awareness about this public health threat? Answer 2. HHS has been a leader across the government in implementing a broad range of activities to curb antibiotic resistance. As Surgeon General, I will work with my colleagues across the Administration to continue to advance these efforts. In particular, I believe the Surgeon General is well-positioned to engage with the medical community to encourage antibiotic stewardship and appropriate antibiotic prescribing and to help patients and the public understand the appropriate role antibiotics play in our health and health care system. I look forward to helping raise the visibility of this important issue. senator warren Reproductive Health The U.S. Surgeon General, the Nation's top doctor, is responsible for offering Americans ``the best scientific information available on how to improve their health and reduce the risk of illness and injury.'' Reproductive and sexual health are critical components of overall wellness. Currently, a key priority of the Surgeon General is the ``National Prevention Strategy,'' which aims to enhance ``health and well-being'' by ``integrating recommendations and actions across multiple settings to improve health and save lives.'' The National Prevention Strategy includes recommendations for reproductive and sexual health and prioritizes support for ``effective sexual health education, especially for adolescents,'' the ``early detection of HIV, viral hepatitis, and other STIs,'' and the ``increased use of preconception and prenatal care.'' Reproductive health centers--including Planned Parenthood clinics-- are critical to these efforts. Each year, Planned Parenthood's 600 health centers serve nearly five million people, providing 295,000 Pap tests, 320,000 breast exams, and 4.2 million STI tests. In addition, Planned Parenthood offers evidence-based, medically accurate sex education to 1.5 million teens annually. Republicans often claim that federally qualified health centers (FQHCs) could fill the gaps in reproductive health care access that would result from a defunding of Planned Parenthood. Recent analysis by the Guttmacher Institute, however, demonstrates that this claim is patently false. The analysis points out FQHC sites providing contraceptive care would need to dramatically increase their contraceptive client caseloads, taking on an additional two million patients nationwide, in order to fill the gap should the Republican Congress choose to cut Planned Parenthood health centers out of the family planning safety net. Question 1. As Surgeon General, would you continue to promote the National Prevention Strategy, including its recommendations on reproductive and sexual health? Answer 1. Reports and strategies often need to be updated to best reflect changing evidence. I plan to carefully review all of the recommendations of the NPS and determine the best way during my tenure as Surgeon General to promote reproductive and sexual health. Question 2. Do you agree that policies demonstrated to increase the number of unintended pregnancies and STIs among teenagers should not be supported by HHS? Answer 2. As Surgeon General, I commit to working to decrease unintended pregnancies and STIs among all citizens. Question 3. As Surgeon General, would you commit to promoting evidence-based programs that improve teenagers' reproductive health? Answer 3. Yes. Question 4. Do you agree that Planned Parenthood health clinics are essential to Federal efforts to promote effective sexual health education, increase STI detection, and improve reproductive health care? Answer 4. Women's health is very important to me. As Surgeon General, I would strive to ensure that both women and men have access to the quality health care they need. Question 5. Do you agree that FQHCs cannot fill the gaps left if Planned Parenthood health clinics no longer received Federal funding? Answer 5. As Surgeon General, I will work to ensure all women have access to affordable, high quality health services, consistent with my role as Surgeon General. Zika Response The Surgeon General is also responsible for offering the public ``facts on emerging public health threats'' and ``list[ing] steps individuals can take to protect themselves and their families.'' The Zika virus is one such ``emerging public health threat'': infection during pregnancy can result in microcephaly, a severe brain defect, as well as miscarriage and stillbirth. According to the Centers for Disease Control and Prevention (CDC), ``[o]ffering family planning services, including information and access to the full range of contraceptive methods, is a primary strategy to reduce the number of unintended pregnancies affected by Zika virus infection.'' Question 6. As Surgeon General, would you commit to providing the American people with evidence-based, scientifically and medically accurate information about Zika prevention--including information on ``the full range of contraceptive methods--regardless of any partisan efforts to restrict information on and access to contraceptive services? Answer 6. As Surgeon General, I will communicate the full range of evidence-based, scientifically and medically accurate information on all public health topics, including Zika prevention, to help patients make informed decisions about their health. Question 7. As Surgeon General, would you oppose efforts by the Trump administration to reduce access to contraception, including efforts to defund Planned Parenthood health clinics? Answer 7. As Surgeon General, my role is to communicate evidence- based health information to the public. I would work with my public health and clinical partners to raise awareness about evidence-based prevention, including efforts to reduce preventable causes of morbidity and mortality, including infant mortality and teenage pregnancy. Opioid Epidemic The opioid epidemic is a public health crisis. In Massachusetts alone, an estimated 2,000 people died from opioid overdoses in 2016. Addressing addiction and substance use is one of the Surgeon General's top priorities. In 2016, the Surgeon General worked to promote a national campaign that urged health care professionals and prescribers to talk with one another about best prescribing practices. In the same year, the Surgeon General presented a report, ``Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health,'' which included a series of recommendations on preventing and treating addiction. This report also provided a look into the country's current ``treatment gap,'' which has helped inform policymakers as they work to find solutions and slow the rise in fatal overdose rates. At the core of the opioid crisis has been the over-prescribing of addictive prescription painkillers. CMS reported that generic Vicodin was prescribed to more Medicare beneficiaries than any other drug in 2013--more than blood pressure medication, more than cholesterol medication, more than acid reflux medication. The National Institute on Drug Abuse has estimated that over 70 percent of adults who misuse prescription opioids get the medication from friends or relative, so efforts to reduce the amount of unused medications in the home is a powerful new tool to tackle the prescription drug epidemic. The Comprehensive Addiction and Recovery Act, passed in July 2016, included a bipartisan provision that I worked on with Senator Capito that empowers patients to talk to their physicians and pharmacists about partially filling their prescription medications in order to reduce the amount of unused opioids in circulation. In addition to the impact that prescription drug use has had on the opioid epidemic, the illicit distribution and sale of fentanyl, a dangerous synthetic opioid that is more potent than heroin, has contributed to this public health crisis--particularly in New England States like Massachusetts. A November 2016 study by the Massachusetts Department of Public Health found that of the opioid-related fatalities in the State in which toxicology screens were available, 74 percent of individuals tested positive for fentanyl. Question 8. What will you do to work with other agencies and the physician community to address the over prescribing and misuse of prescription medications, while still ensuring that patients who need pain medication can receive it? Answer 8. I firmly believe that most physicians want to do what is best for their patients and to relieve suffering without putting their patients and families in harm's way. Ensuring that patients with pain receive high-quality, evidenced-based pain care must be an essential component of the response to the opioid epidemic. As Surgeon General, I would engage with the medical community, government partners, and State and local stakeholders to ensure that policies and programs aimed at reducing opioid abuse, addiction, and overdose do not penalize patients with legitimate medical needs. Question 9. You have been supportive of Indiana's recent partial fill legislation. In the role of Surgeon General, would you work with States, physicians, pharmacists, and patient groups to increase awareness about Federal partial fill policies? Answer 9. Yes. Question 10. Will you support the findings of the report, ``Facing Addiction in America,'' and will you continue to inform the Administration and Congress about the need to fight the opioid epidemic? Answer 10. It is clear to me that the Administration and Secretary Price have taken an early and aggressive approach to combating the opioid epidemic. I look forward to working with partners across the Administration and external stakeholders to build on the progress that has been made in recent years. The Surgeon General's Report on Alcohol, Drugs, and Health can serve as a science-based resource to help advance evidence-based policies and programs to reduce the burden of opioid addiction. Question 11. What do you believe are the next steps in tackling this opioid crisis? Answer 11. At all levels of government and in communities across America, health care professionals, parents, people in recovery, first responders, and many others are taking action to reduce the harms associated with opioid abuse, addiction, and overdose. I look forward to leveraging the Office of the Surgeon General to build on these efforts. In particular, I believe the Surgeon General is well- positioned to engage with the medical community to encourage the appropriate use of opioids and to advance evidence-based pain care, and to help raise awareness of addiction and spur efforts to reduce stigma around addiction among patients, providers, and the public. Question 12. You have advocated for Medication-Assisted Treatment (MAT) as an important evidence-based addiction treatment. How would you work to ensure that other influential health officials understand the value of this treatment? Answer 12. There are many years of rigorous research documenting the effectiveness of medication-assisted treatment. Yet, despite the evidence base, the vast majority of people with an opioid addiction do not receive treatment for it. Expanding access to medication-assisted treatment is a key part of the response to the opioid epidemic. I am prepared to use the role of Surgeon General to help educate providers, patients, and the public about opioid addiction, what treatments are available, and how people can access treatment. Question 13. What do you plan to do to build on HHS's efforts to address a specific component of the opioid epidemic, the illicit sale and use of fentanyl? Answer 13. The emergence of illicitly made fentanyl and fentanyl analogs, largely coming from China, has accelerated the ongoing opioid epidemic in the United States. As Surgeon General, building on my experiences in combating the opioid crisis in Indiana, I will work collaboratively with experts across HHS and with our partners in law enforcement to raise awareness about the dangers of illicit fentanyl and fentanyl analogs in our communities, encourage the broader use of naloxone to reverse overdoses, and use the platform of the Surgeon General to reduce stigma around opioid addiction--a key barrier to getting people into treatment and stopping their drug use. In addition, I will work with the medical community to curb the inappropriate prescribing of opioid pain medications, which was the starting point for many Americans now addicted to heroin and illicitly made fentanyl. Tobacco Tobacco, the leading cause of preventable death in the United States, is traditionally one of the Surgeon General's top priorities. The Surgeon General's 2016 report, ``E-Cigarette Use Among Youth and Adults,'' concluded that the use of e-cigarettes among youth and young adults was a public health concern, and suggested a number of policies to impose stricter regulation of e-cigarettes. However, in July 2017, the FDA announced that it would further delay deadlines for e-cigarettes, cigars, and other previously unregulated tobacco products to come into compliance with the 2016 FDA deeming rule that imposed stricter oversight of these products. Question 14. As Surgeon General, would you continue to promote the recommendations of the Surgeon General's 2016 report on e-cigarette use? Answer 14. Reports and strategies often need to be updated to best reflect changing evidence. While the aforementioned report is only a year old, at the time of its release there was controversy in the public health community about the evidence on e-cigarettes. Since the Report's release, a large volume of research that further expands our understanding of e-cigarettes has been published. I plan to carefully review all of the recommendations of the 2016 report and this new research to determine the best way during my tenure as Surgeon General both to promote harm reduction for current smokers and to prevent smoking initiation, especially among youth. Question 15. Do you agree that stricter FDA oversight of e- cigarettes, cigars, and other previously unregulated tobacco products could improve public health outcomes? Answer 15. Protecting and improving public health is at the core of the Department's mission. While serving as the Indiana State Health Commissioner, I have overseen Indiana's tobacco cessation efforts. I look forward to working with the FDA, CDC, and other Federal agencies to protect our children and significantly reduce tobacco-related disease and death. Combating Antibiotic Resistance The 2014 National Strategy for Combating Antibiotic-Resistant Bacteria brought together the Secretaries of Health and Human Services, Agriculture, and Defense to declare that, ``the misuse and over-use of antibiotics in health care and food production continue to hasten the development of bacterial drug resistance, leading to the loss of efficacy of existing antibiotics.'' Through this initiative, we've made some significant progress establishing policies that better protect lifesaving antibiotics. There is strong and growing evidence that antibiotic use in food animals can lead to antibiotic resistance in humans, yet the use of medically important drugs in food animals continues to grow. According to the FDA, ``Domestic sales and distribution of medically important antimicrobials approved for use in food producing animals increased by 26 percent from 2009 through 2015, and increased by 2 percent from 2014 through 2015.'' Question 16. Do you agree that curbing the misuse and over-use of antibiotics in health care and food production should be a public health priority? Answer 16. Yes. Question 17. As Surgeon General, what specific steps will your office take to prevent the development of bacterial drug resistance? Answer 17. HHS has been a leader across the government in implementing a broad range of activities to curb antibiotic resistance. As Surgeon General, I will work with my colleagues across the Administration to continue to advance these efforts. In particular, I believe the Surgeon General is well-positioned to engage with the medical community to encourage antibiotic stewardship and appropriate antibiotic prescribing and to help patients and the public understand the appropriate role antibiotics play in our health and health care system. I look forward to helping raise the visibility of this important issue. [Whereupon, at 4:45 p.m., the hearing was adjourned.] [all]