[Senate Hearing 118-]
[From the U.S. Government Publishing Office]


 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2024

                              ----------                              


                       WEDNESDAY, MARCH 22, 2023

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2:36 p.m., in room SD-138, Dirksen 
Senate Office Building, Hon. Tammy Baldwin (chairwomen) 
presiding.
    Present: Senators Baldwin, Murray, Reed, Shaheen, Merkley, 
Manchin, Capito, Moran, Hyde-Smith, Britt, and Collins.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF HON. XAVIER BECERRA, SECRETARY


               opening statement of senator tammy baldwin


    Senator Baldwin. Good afternoon. I want to welcome everyone 
to the Senate Appropriations Subcommittee on Labor, Health, and 
Human Services, Education, and Related Agencies.
    It is our first hearing on the Biden Administration's 
fiscal year 2024 budget request. And it is an honor to serve as 
the Chair of this subcommittee and follow in the footsteps of 
Chair Murray's incredible leadership over the past 8 years. I 
am also looking forward to working together with Ranking Member 
Capito, as we both take on new roles on this subcommittee.
    The Labor HHS (Health and Human Services) bill includes 
important investments that touch the lives of every American. 
We won't agree on everything, but I am committed to working 
together to find common ground, and make progress for 
Wisconsinites, West Virginians, and communities across this 
country. I look forward to the hard work of finding compromise, 
and marking up a bipartisan Labor HHS bill later this year.
    Today, I am happy to welcome Secretary Becerra for our 
hearing on the Administration's fiscal year 2024 budget 
request, for the Department of Health and Human Services. These 
hearings provide an important opportunity to assess our 
country's needs for the coming year. It is critical that we 
strengthen our non-defense investments that support a stronger 
economy, keep our communities healthy, and safe, and strengthen 
and expand our workforce.
    Secretary Becerra, this budget highlights the need for 
continued investments in substance use, and mental health 
services, access to childcare, biomedical research, public 
health, home energy assistance, and so much more. These are 
bipartisan priorities, and let me be clear, there is no way to 
make progress on these fronts without steady increases in non-
defense priorities, like we have worked together to provide in 
recent years regardless of which party controlled the Congress.
    In fiscal year 2023, this subcommittee provided significant 
funding for 988 behavioral health crisis programs, childcare, 
maternal health, substance use treatment and prevention, and 
biomedical research. We also provided over $600 million to end 
the HIV/AIDS epidemic, and over $300 million in targeted 
investments to combat the maternal mortality crisis.
    Secretary Becerra, I am very pleased to see that this 
year's budget request calls for additional investments to 
improve access to, and integrate mental and behavioral 
healthcare services, to bolster behavioral healthcare, 
workforce development programs, and mental health crisis 
services, to ensure that we are better prepared for and able to 
rapidly respond to emerging biological threats by investing in 
vaccine preparedness, and medical countermeasures development, 
and enhancing domestic and global disease surveillance.
    This budget prioritizes and puts additional investments in 
strengthening the core public health infrastructure and 
workforce nationwide to improve readiness for the next public 
health crisis. It supports biomedical research and innovation 
to better develop diagnostics, improve treatments and precision 
care for patients. It expands the Title X Family Planning 
Program, which helps so many patients, particularly women of 
color, get birth control, cancer screenings, STD (Sexually 
Transmitted Diseases) screenings, and other essential 
healthcare, and it reduces maternal mortality and morbidity.
    Alarming new data from the National Center for Health 
Statistics last week, revealed that our country's maternal 
mortality rate climbed dramatically during the pandemic. This 
marks the third year in a row that the rate of Americans dying 
of medical conditions caused by, or aggravated by pregnancy, 
has increased. The data show that 1,205 women died in 2021, up 
from 861 in the year 2020, an increase of 40 percent. This 
spike is significant for all racial and ethnic groups, but the 
trend in disparity continues. The mortality rate for Black 
women is roughly 2.6 times higher than the rate for White 
women.
    This increase in deaths is devastating and unacceptable, 
and demonstrates how the Department has chronically and acutely 
fallen short of its mission to the public.
    Secretary Becerra, HHS must do better. And I expect to hear 
from you about how this budget is going to help us accomplish 
that. I also want to learn about the proposed increases for 
advancing health equity and public health programs. As we face 
the aftermath of COVID, and how it has exacerbated our Nation's 
healthcare challenges, we can't lose sight of the lessons 
learned over the last 3 years, we must maintain the 
preparedness, and biodefense capabilities that we built during 
the pandemic. We must strengthen our health workforce, and 
public health system, and invest in our domestic manufacturing 
and research capacity to be prepared when the next public 
health emergency strikes.
    I also want to hear about the administration, how you are 
working to address our Nation's mental health and substance use 
disorder crises, which have gotten also, so much worse during 
the pandemic.
    In my State of Wisconsin, there were over 1,427 opioid-
related deaths in 2021, a 16 percent increase over 2020, and a 
70 percent increase over the number of deaths in 2018. I know 
my colleagues are seeing similar grim statistics in their 
States.
    Of particular interest, I will want to know what the 
administration is doing to curb the tragic increase in 
overdoses and poisonings, due to fentanyl. This drug is 
wreaking havoc across the country, and we must partner to take 
an all-of-government approach to prevent it from coming into 
our communities, we must reduce use, and misuse, and overturn 
the overdoses, with drugs like naloxone.
    Finally, Mr. Secretary, the two of us have talked about 
what HHS is doing to ensure that migrant children entering the 
Department's care receive the services they need, and are 
placed in safe and appropriate homes and protected from 
exploitation. These kids are fleeing incredibly dangerous 
situations in their home countries, risking their lives because 
their situation is so dire, and seeking relief in the United 
States.
    Health and Human Services has a vital role to play to make 
sure these kids have the opportunity to learn and grow like all 
other children, and that the families who care for them have 
the support they need. We have seen record increases in the 
number of unaccompanied kids during each of the last three 
administrations. Making sure these kids are safe and cared for 
is not a partisan issue, and I look forward to more discussions 
about what this budget does to ensure that.
    I look forward to your testimony, and appreciate your being 
here today. In a quick moment I will turn it over to Ranking 
Member Capito for her open opening remarks.
    Following Senator Capito's opening statement, we will hear 
from you, Secretary Becerra. And after that all Senators will 
each have 5 minutes for their questionings.
    Senator Capito.


               statement of senator shelley moore capito


    Senator Capito. Thank you, Chair Baldwin. It is great to 
have our first kickoff hearing. Appreciate your leadership. We 
have worked together in the past. There is no reason we can't 
do that here on the Labor, HHS Subcommittee. And so we have 
both been on this subcommittee for several years, and I know we 
have a great vision.
    Speaking of new roles, I would like to take a moment to 
recognize Senators Murray and Collins, who are the new Chair 
and Ranking Member of the Full Committee--and Vice Chair, 
Senator Collins is the Vice Chair. They are committed to 
returning to regular order to write and pass appropriations 
bills in a bipartisan and timely manner. I wholeheartedly 
support this approach, and this budget hearing is a necessary 
first step for the process.
    Secretary Becerra, we served in the House together. It is 
very nice to see you. And thank you for your communications 
with me. I appreciate the give and take. This is an important 
opportunity for us to hear about the HHS budget proposal, and 
better understanding the priorities.
    First, the success of our process depends on finding common 
ground, as our Chair just enumerated. Unfortunately, this 
budget appears to be another bloated, partisan request that 
simply spends too much money, after the record level of 
spending that we have seen over the past few years.
    Simply put, the budget should not be enacted. I don't think 
it will be. We can't afford to ramp up base discretionary 
spending by a whopping 13 percent, at a time when we should be 
looking at common goals to improve the health of Americans 
across the Nation, the budget further wades into polarizing 
issues such as repealing the Hyde Amendment, proposing 
additional flawed climate change activities, doubles funding 
for controversial gun violence research, and increases funding 
for family planning by almost 80 percent.
    But I am really disappointed, not about what was included, 
but what wasn't included. Programs and activity that typically 
enjoy bipartisan support receive little or no attention in this 
budget, and are flat-funded. For instance, there are no new 
resources specifically for Alzheimer's research at NIH 
(National Institutes of Health), the CDC's (Centers for Disease 
Control and Prevention) Alzheimer's activities; nor the 
Administration for Community Living Alzheimer's Disease 
Program.
    I would note in the audience today we have a lot of 
Alzheimer's advocates, of which I am, they are a great 
champion, and one of their little signs said, ``More time--I 
wish I had had more time with both of my parents as they 
suffered with this horrible disease.''
    Similarly, the budget stalls funding for the Children's 
Hospital's Graduate Medical Education Program, and Diabetes 
Prevention; we have a huge problem with diabetes throughout the 
country, particularly in our State. And I was surprised to see 
that the budget, yet again, requests mandatory funding for 
pandemic preparedness and response, as our Nation, thankfully, 
moves past the COVID-19 public health emergency, Congress will 
now need to better understand how HHS is ramping up--or ramping 
down programs that received emergency supplemental and 
mandatory resources to avoid funding cliffs in the future.
    Not only that, but this subcommittee also has a 
responsibility to provide oversight, and ensure accountability 
of the Federal dollars that have already been spent. A new 
mandatory program is, basically, a non-starter.
    That being said, there are a few notable areas of the 
budget that address important national priorities that will 
have to be explored in more detail. One of these is a focus on 
biomedical research, which the Chairwoman talked about, that 
has long enjoyed bipartisan support.
    The budget devotes significant resources for the third year 
for the Advanced Research Projects Agency for Health, better 
known as ARPA-H. Additionally, the budget proposes additional 
resources for the Cancer Moonshot, a cross-cutting initiative 
that touches several HHS agencies, including CDC, CMS (Centers 
for Medicare and Medicaid Services), and the National Cancer 
Institute at NIH.
    Far too many of us have been touched by cancer. West 
Virginia, my home State, is especially hard hit, racking above 
the national average in both new cancer diagnoses and deaths.
    Substance abuse challenges continue to face the Nation, and 
I don't think have received enough mention in this budget, 
while the budget repeats many of the unattainable funding 
levels for substance abuse programs from the previous 2023, the 
White House Budget's overview rarely mentions fentanyl or 
opioids.
    My home State has been in the crosshairs of this opioid and 
addiction crisis for several years now. We continue to lead the 
country in overdose deaths per capita. Since fiscal year 2018, 
the subcommittee has increased resources towards opioid 
prevention, and treatment programs by more than $4 billion. I 
know we need to shape the programs we have got, so I want to 
know how these funds and programs are moving the needle in the 
addiction crisis.
    Without a doubt, our jobs will be challenging. And your job 
is very challenging, given the economic and financial 
constraints that we find ourselves in. It is my hope we can 
come together in a responsible way to find areas of 
efficiencies, and focus in these areas of Government.
    And thank you, again, for being here.
    Senator Baldwin. Now, we turn to your testimony, Secretary 
Becerra.


                summary statement of hon. xavier becerra


    Secretary Becerra. Chairwoman Baldwin, and Ranking Member 
Capito, thank you for the invitation to chat with you about the 
budget.


               health and human services accomplishments


    A lot has happened in the year since I last spoke before 
this committee about budgets, more than 16 million Americans 
have secured health insurance through the Affordable Care Act, 
Marketplaces, that is an all-time high, altogether more than 
300 million Americans now carry insurance to cover their 
healthcare, another historic high.
    The President's new lower-cost prescription drug law has 
capped insulin at $35 per month, and made preventative 
vaccines, like the flu, COVID, and shingles vaccines available 
for free under Medicare.
    Moving forward, this new law gives us the right to finally 
negotiate lower prescription drug prices for Americans. And to 
cap it all off, the Biden-Harris administration has safely and 
effectively executed the largest adult vaccine--vaccination 
program in U.S. history, achieving nearly 700 million shots in 
the arms of Americans during the COVID pandemic, all without 
charge.


       fiscal year 2024 health and human services budget request


    The fiscal year 2024 budget proposes $144 billion in 
discretionary funding, and $1.7 trillion in mandatory funding 
for HHS. It positions us to tackle the urgent challenges we 
face, including a growing behavioral health crisis, and future 
public health threats.
    It also funds operations, a mission-critical infrastructure 
needed to build a healthier America, moving the Nation from an 
illness care system to a wellness care system. An illness care 
system leaves our most vulnerable families behind. A wellness 
care system invests in providing the full spectrum of 
healthcare to all Americans; illness care allows the price of 
prescription drugs to skyrocket, wellness care starts by 
prescribing fruits, vegetables, and exercise. It treats food as 
medicine.
    Illness care requires you to get a referral by your family 
physician to see a specialist for mental health services; 
wellness care, on the other hand, lets you get mental 
healthcare the minute you walk through the door of your family 
physician's office. Illness care, well, it forces hard-working 
Americans to deplete their life savings to get the long-term 
care that they need. Wellness care, it invests early in long-
term care, like in-home care, so our older adults, and 
Americans with disabilities can thrive, at home, and in their 
communities.
    Our budget invests in wellness care. We invested more than 
$30 billion to prepare us for the next COVID or public health 
crisis, including a billion dollars to replenish the Nation's 
Strategic National Stockpile.
    On behavioral health, too many of our loved ones are dying 
from suicide or overdose, so we increase access to crisis care, 
we grow the behavioral health workforce, and we beef up 
substance use services. We are also gearing up to handle more 
than six million additional contacts from people who are 
experiencing a mental health crisis, through 988, the three-
digit Suicide Prevention Lifeline we stood up last year.
    This budget covers 2 million adults left out of Medicaid by 
their home States, and extends tax credits that will make 
healthcare more affordable for millions of Americans.
    It will also ensure that expanded postpartum Medicaid 
coverage for a new mom and her baby is here to stay. The 
President's budget not only strengthens Medicare for today's 
seniors, but also protects and strengthens it for the next 
generation. We also take care of our family members in this 
budget, investing $600 billion in childcare and preschool 
programs, and $150 billion to strengthen Medicaid, home and 
community-based services.
    This budget funds the Cancer Moonshot, and ARPA-H, it 
invests in Title X Family Planning programs, essential to so 
many families. It delivers on commitments made as part of the 
National Strategy for hunger, nutrition, and health, it opens 
more community health centers, and important to me; as a former 
Attorney General, it bolsters our Health Care Fraud and Abuse 
Detection and Enforcement work.
    And the President's budget honors our responsibilities to 
Indian Country, with more than $2 billion in new resources in 
2024. Last year, for the first time, you gave the Indian Health 
Service Advanced Appropriations, providing the same protection 
against budget uncertainty that other health services receive. 
We hope to build on that progress this year.
    This budget reflects the President's, and our values and 
commitments, it helps begin the move from a Nation focused on 
illness care, to one about wellness care, and most importantly, 
it ensures health and wellness are within reach for all 
Americans.
    On behalf of the women and men of HHS, we look forward to 
working with you. And I thank you for letting me come before 
you today.
    [The statement follows:]
                  Prepared Statement of Xavier Becerra
    Chair Baldwin, Ranking Member Capito, and Members of the 
Subcommittee, thank you for the opportunity to discuss the President's 
Fiscal Year (FY) 2024 budget for the Department of Health and Human 
Services (HHS). I am pleased to appear before you today, and I look 
forward to continuing to work with you to serve the American people.
    It is my great pleasure to serve as the head of the Department of 
Health and Human Services--a department full of dedicated civil 
servants who work tirelessly to meet our mission of enhancing the 
health and well-being of the American people. We know this goal is also 
shared by all of you, and we are excited about working with you to fund 
key initiatives that will enable us to continue to meet that mission.
    The FY 2024 budget proposes $144 billion dollars in discretionary 
funding and $1.7 trillion dollars in mandatory funding to continue the 
work of the Department and make major investments in several critical 
areas. Our country faces numerous healthcare challenges--and HHS is at 
the center of addressing many of these issues--including the need to 
transform behavioral healthcare; prepare for future public health 
threats; support unaccompanied children and refugees; expand access to 
healthcare especially in rural America; address the needs of those most 
at risk; improve the health and well-being of our children, families, 
and seniors; grow and retain the health workforce; and advance and 
sustain medical research capabilities. We also continue to focus on 
additional priorities like protecting Medicare, expanding insurance 
coverage, decreasing drug costs, meeting the health needs of Indian 
Country, and making critical investments in improving our regulation of 
food and drugs.
                  transforming behavioral health care
    In response to the current behavioral health crisis, HHS makes 
substantial investments in services to provide more Americans with 
access to the care they need when they need it. The 9-8-8 National 
Suicide Prevention Lifeline operates 24/7 to provide access to trained 
counselors to people in crisis. In the FY 2024 budget, the Substance 
Abuse and Mental Health Services Administration (SAMHSA) will dedicate 
an additional $334 million to the 9-8-8 program to meet an expected 
volume of 9 million contacts. Investing in the crisis response 
continuum more broadly is critical to ensuring that the system is 
responsive at any time and in any place. The budget builds on previous 
investments to provide $100 million for mobile crisis response to 
expand partnerships with 9-8-8 local crisis centers, community 
providers, 9-1-1 centers, and first responders to promote health-first 
responses to mental health, suicidal, and substance use crisis events.
    One in 4 adults in the United States had a mental illness and 46 
million Americans had a substance use disorder in the past year.\1\ To 
address these challenges, the budget continues to invest in the 
nation's mental health infrastructure and to further integrate 
behavioral healthcare into healthcare, social services, and early 
childhood systems. The FY 2024 budget proposes to increase the 
Community Mental Health Services Block Grant by $645 million and 
proposes to increase the Substance Use Prevention, Treatment, and 
Recovery Services Block Grant by $700 million. The budget converts the 
Certified Community Behavioral Health Clinics demonstration to a 
permanent program to further ensure access to comprehensive behavioral 
healthcare for all who need it.
---------------------------------------------------------------------------
    \1\ ``Facts about Suicide'', Centers for Disease Control and 
Prevention.
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    The budget invests in the behavioral health workforce, providing an 
increase of $190 million at the Health Resources and Services 
Administration (HRSA) for workforce development and an additional $17 
million at SAMHSA for minority fellowships. Additionally, the FY 2024 
budget expands Medicare coverage of, and payment for, additional 
behavioral health professionals. The budget supports more than 27,000 
mental health and substance use disorder trainees and providers.
    To develop new approaches to addressing mental health and substance 
use disorders, the FY 2024 budget includes an additional $200 million 
for the National Institutes of Health (NIH) to prioritize innovative 
mental health research and treatment, with the agency allocating a 
portion of these resources to launch a new precision psychiatric 
initiative. NIH will also continue to invest over $1.8 billion in 
research on opioid misuse, addiction, and pain disorders, including the 
Helping to End Addiction Long-term (HEAL) initiative. HEAL aims to 
develop innovative treatments for opioid addiction and chronic pain and 
associated health disparities. The budget also includes proposals to 
modernize and expand Medicare's mental health benefits and improve 
behavioral health for the private insurance market, with an emphasis on 
improving access, promoting equity, and fostering innovation.
               preparing for future public health threats
    On February 11th, HHS renewed the COVID-19 Public Health Emergency 
(PHE) for what we expect will be the final time. The nation has made 
tremendous progress: the Administration effectively implemented the 
largest adult vaccination program in U.S. history, with nearly 270 
million Americans receiving at least one shot of the COVID-19 vaccine. 
Second, we made available to the American public 1.16 billion COVID 
tests at no cost. And we were able to provide over 23 million 
therapeutic courses of treatment to Americans. According to the 
Commonwealth Fund, 2 years of COVID vaccinations saved over 3 million 
lives, in addition to preventing more than 18.5 million 
hospitalizations.
    The FY 2024 budget prioritizes preparedness for the next health 
crisis. The budget includes $20 billion in mandatory funding, available 
over 5 years, across the Administration for Strategic Preparedness and 
Response (ASPR), Centers for Disease Control and Prevention (CDC), Food 
and Drug Administration (FDA) and NIH to support the President's plan 
to transform the Nation's capabilities to prepare for, and respond 
rapidly and effectively to, future pandemics and other biological 
threats. This includes investments in enhancing early detection and 
warning systems, advancing, and securing safe and effective supplies 
and medical countermeasures, and strengthening public health systems 
and core capabilities. For ASPR, the budget includes $1 billion in 
discretionary funding for the Biomedical Advanced Research and 
Development Authority (BARDA) to develop innovative medical 
countermeasures, $995 million for the Strategic National Stockpile, and 
$400 million to bolster the medical supply chain and create medical 
countermeasures that address key preparedness gaps. The FY 2024 budget 
also includes $10.5 billion in discretionary funding for the CDC to 
protect health, safety, and security at home and abroad. Additional 
strategic investments, including at the FDA and the NIH, are proposed 
to bolster our national preparedness posture as we ready ourselves for 
the next public health threat--no matter its origin. These funding 
proposals are paired with a suite of legislative proposals that would 
provide HHS with authorities to enable HHS to respond to future threats 
nimbly and effectively.
             supporting unaccompanied children and refugees
    Children presenting at the border without a parent or guardian, and 
refugees arriving in our nation, must be cared for in a safe and 
humanitarian manner. At HHS, we will continue to do our part to protect 
the safety and wellbeing of unaccompanied children by providing them 
appropriate child-centered care while they are in our custody; placing 
them in the custody of parents, relatives, and other appropriate 
sponsors after thorough vetting; and providing post-release services 
including safety and wellbeing calls. HHS already provides post-release 
services to more than 40 percent of children released from our care, 
nearly double the percentage receiving services when the Biden 
Administration took office and is on track to provide services to 
nearly 60 percent of children by the end of this fiscal year, and all 
children within the next two years.
    The FY 2024 budget provides $5.5 billion for unaccompanied children 
and $1.7 billion for refugees and other new arrivals eligible for 
benefits. In addition, to address the inherent uncertainties in 
budgeting for these populations, the budget includes a discretionary 
contingency fund, which would provide additional resources if either 
population exceeded certain levels, and is estimated to provide $2.8 
billion in FY 2024. The fund expands on the unaccompanied children 
contingency fund that Congress enacted in FY 2023. These services and 
resources are critical to our country, and I would like to thank 
Congress for your continued dedicated support.
                 protecting the health of all americans
    The Administration aims to reduce maternal mortality and morbidity, 
through proposals such as the ``Birthing-Friendly'' hospital 
designation which drives improvements in maternal health outcomes. The 
budget includes $1.9 billion for HRSA Maternal and Child Health 
programs, an increase of $205 million, directing $276 million toward 
reducing maternal mortality and morbidity and $185 million to the 
Healthy Start program to reduce racial disparities in maternal and 
infant health outcomes. The budget also provides $30 million for NIH to 
continue the Implementing a Maternal health and PRegnancy Outcomes 
Vision for Everyone (IMPROVE) initiative to support research focused on 
interventions for preventable maternal mortality and morbidity and 
associated risk factors that contribute to health disparities in 
maternal care. The budget further includes $3 million for NIH's 
continued research on the effects of COVID-19 on individuals during 
pregnancy, lactation, and the postpartum period. The budget also 
requires states to provide 12 months of postpartum coverage through 
Medicaid and the Children's Health Insurance Program.
    HHS is also committed to protecting and strengthening access to 
reproductive healthcare. The budget provides $512 million to the Title 
X family planning program to address increased need for family planning 
services for approximately 4.5 million individuals, with 90 percent 
having family incomes at or below 250 percent of the Federal poverty 
level. Title X is the only Federal grant program dedicated solely to 
providing individuals with comprehensive family planning and related 
preventive health services in communities across the United States.
    The budget also includes an additional $63 million to strengthen 
access to healthcare in rural communities, including a $20 million 
increase in funding for opioids response and $30 million for new 
initiatives to support rural hospital sustainability. There is a $80 
million increase in discretionary funding for Health Centers, which 
provide healthcare services to underserved populations across the 
country, along with substantial increases on the mandatory side. The 
budget proposes a pathway to doubling the program's funding with a 
critical three-year down payment on this goal.
              expanding and retaining the health workforce
    The health workforce plays a vital role in responding to public 
health needs. As the demand for healthcare workers increases, HHS 
remains committed to strengthening, expanding, and retaining the 
workforce. The FY 2024 budget provides $2.7 billion for HRSA workforce 
programs, including $947 million in mandatory resources, to expand 
workforce capacity across the country. The discretionary budget 
includes $28 million for a new program to support innovative approaches 
to address healthcare workforce shortages and strengthen retention 
efforts. The budget also provides $25 million for a program to support 
the adoption of workplace wellness in healthcare facilities including 
hospitals, rural health clinics, community health centers, and medical 
professional associations. The budget includes $106 million within CDC 
to support public health training and fellowship programs to strengthen 
the existing workforce as well as support a pipeline of personnel ready 
and able to address public health threats. In addition to these 
investments, HHS prioritizes diversifying the healthcare workforce to 
better serve all communities and build a more equitable healthcare 
system.
  improving the well-being of children, families, seniors, and people 
                           with disabilities
    Early childhood programs have a return of up to $9 for every $1 
spent due to the positive long-term health, educational, and social 
impacts on vulnerable children. The budget includes $13 billion for 
Head Start, an increase of $1.1 billion, to provide comprehensive early 
learning and development services to roughly 760,156 slots for eligible 
children and pregnant women. Within this total, $440 million is 
included for a cost-of-living adjustment for Head Start workers, and 
$575 million is included to further improve compensation. Collectively, 
these investments ensure that families have access to high-quality 
services by retaining and supporting the workforce. In addition, the 
budget includes a legislative proposal to expand tribal, migrant, and 
seasonal Head Start eligibility.
    The budget likewise invests in child care, critical to both working 
parents, and particularly mothers, and children. For the discretionary 
Child Care and Development Block Grant, the budget provides for an 
investment of $9 billion, an increase of nearly $1 billion over the FY 
2023 enacted funding level.
    The President's Budget also includes a new initiative that expands 
access to high-quality early care and education. The budget includes a 
mandatory proposal to invest $400 billion over 10 years in high-quality 
child care, and $200 billion over 10 years in universal preschool. This 
funds states to expand access to high-quality child care to more than 
16 million young children and dramatically expand access to and 
increase the quality of preschool so that all of the approximately four 
million 4-year-old children in the United States have access to high-
quality preschool, while also charting a path to expand free school to 
3-year-olds. Implementing the child care and universal preschool 
proposals concurrently saves $24.3 billion over 10 years and is 
reflected in the estimated child care costs.
    The COVID-19 pandemic revealed that millions of children, families, 
seniors, and people with disabilities are living with food insecurity. 
The increased need for nutrition programs has not abated, and the FY 
2024 budget supports the Administration's National Strategy on Hunger, 
Nutrition, and Health by including $137 million across HHS to reduce 
hunger, food insecurity, and malnutrition. Within the $137 million, the 
budget includes $12 million at the Administration for Community Living 
(ACL) for nutrition services for older adults and people with 
disabilities and $72 million to expand CDC's State Physical Activity 
and Nutrition program, which implements evidence-based strategies to 
reduce chronic disease. In addition, the budget proposes to increase 
funding at NIH for nutrition research. Further, within ACL, the budget 
includes $1.3 billion for Nutrition Programs for older adults, to 
provide healthy meals served in both home-delivery and congregate 
settings. These programs enable seniors to live in their homes 
independently and help them stay engaged with critical community-based 
supports.
    HHS is likewise committed to ensuring that seniors and people with 
disabilities have the essential resources and services they need. In 
addition to providing nutrition services in older adults and people 
with disabilities through ACL as previously mentioned, the budget also 
expands Medicare coverage for nutrition and obesity counseling 
services, and includes a new pilot project on medically tailored meals. 
The FY 2024 budget also makes key investments in the Elder Justice 
Adult Protective Services program. As noted above, the budget also 
includes a $150 billion mandatory investment over 10 years in improving 
and strengthening Medicaid home and community-based services and 
provisions to improve safety and quality in our nation's nursing homes.
    The budget extends the solvency of the Medicare Hospital Insurance 
Trust Fund by at least 25 years without cutting benefits. The budget 
builds on efforts in the Inflation Reduction Act to lower prescription 
drug prices. It also invests $8 billion to enhance Medicare benefits, 
such as preventing diabetes, expanding access to behavioral health 
services and community health workers, improving the quality and safety 
of long-term care services, expanding coverage for nutrition and 
obesity counseling, eliminating hepatitis C, and advancing equity. 
Additionally, the budget aligns income and asset determination 
processes for Medicare low-income assistance programs, easing 
administrative burdens for states and removing enrollment barriers for 
individuals.
                  advancing science to improve health
    As President Biden has said, ``cancer does not care if you're a 
Republican or a Democrat,'' which is why the President and First Lady 
reignited the Cancer Moonshot 1 year ago. HHS is committed to leading 
the public sector in pursuit of cutting the cancer death rate by 50 
percent over the next 25 years and supporting families, their 
caregivers and family members, living with and surviving cancer.
    NIH will continue to build on the Cancer Moonshot's momentum by 
supporting projects that will deliver important insights into 
preventing, detecting, and treating cancer. The FY 2024 budget includes 
$716 million in discretionary resources for dedicated Cancer Moonshot 
activities at NIH. In addition to the FY 2024 resources, the budget 
also proposes to reauthorize the 21st Century Cures Act Cancer Moonshot 
through 2026 and provide $2.9 billion in mandatory funding in 2025 and 
2026, $1.45 billion each year. To support the goals of the Cancer 
Moonshot, the FY 2024 budget includes an additional $183 million for a 
total of $839 million to support cancer prevention and control programs 
across CDC, including screening programs, tobacco prevention, Human 
Papillomavirus (HPV) prevention and analysis of cancer clusters, and 
laboratory and environmental health activities. An additional 
investment of $20 million for HRSA is also provided, to expand 
partnerships between federally funded health centers and NCI-Designated 
Cancer Centers to facilitate access to lifesaving cancer screening and 
early detection services for medically underserved populations. The 
budget also includes $108 million within IHS to address specialized 
cancer care needs in tribal communities. The budget also proposes to 
create a new Cancer Care Quality Reporting Program for all Medicare 
providers furnishing cancer care services. This unified program would 
enable the Centers for Medicare & Medicaid Services (CMS) to assess and 
compare cancer care delivered through multiple provider types, drive 
improvements in the quality of cancer care, and standardize data 
collection to identify and address potential inequities in care.
    The budget will prioritize innovative mental health research and 
treatment and the NIH climate change initiative. NIH will continue to 
invest funds to address the opioid crisis, end HIV, and advance other 
research areas, such as improving health disparities and inequities 
research, as well as continuing the agency's progress towards a 
universal influenza vaccine. NIH's budget also continues support for 
the All of Us and Brain Research Through Advancing Innovative 
Neurotechnologies (BRAIN) initiatives, both started by the 21st Century 
Cures Act.
    The budget also invests in high-impact research advances that drive 
innovation through the Advanced Research Projects Agency for Health 
(ARPA-H). As an independent research entity, ARPA-H will be able to 
accelerate health breakthroughs with the potential to transform 
important areas of health and medicine. The budget provides $2.5 
billion for the agency's approach to prevent, detect, and treat cancer 
and other diseases such as diabetes and dementia. ARPA-H will advance 
high-potential, high-impact biomedical and health research that cannot 
be readily accomplished through other existing research or commercial 
activity.
    In keeping with the Agency for Healthcare Research and Quality's 
(AHRQ) mission to provide evidence-based research, data, and tools to 
improve healthcare quality, the FY 2024 budget includes $564 million to 
support AHRQ's research on health costs, quality, and outcomes to make 
healthcare safer, more accessible, equitable and affordable for all 
Americans. Included are additional resources to further Long COVID 
care, primary care, and diagnostic safety research.
      promoting effective and efficient management and stewardship
    To protect against potential information technology threats and to 
coordinate information sharing across the public health sector, the FY 
2024 budget prioritizes cybersecurity enhancements. The budget provides 
an increase of $88 million above FY 2023 enacted for cybersecurity 
initiatives in the Office of the Chief Information Officer, for a total 
of $188 million in FY 2024. At this funding level, the Cybersecurity 
Program will support greater Department-wide and interagency 
information technology capability and security development, including 
directing $50 million for investment in a robust Zero Trust 
architecture to continue to secure HHS's cybersecurity posture.
    As Federal stewards, it is our duty to ensure that taxpayer dollars 
are spent appropriately through the delivery of quality services, and 
through preventing waste, and abuse. Continued investment in the 
Department's operational needs will ensure HHS's ability to carry out 
its mission to enhance and protect the health and well-being of all 
Americans while appropriately shepherding our resouces. General 
Departmental Management (GDM) supports the Secretary's role as chief 
policy officer and general manager of HHS in administering and 
overseeing the organizations' programs, and activities of the 
Department. Unfortunately, since FY 2012, HHS leadership has managed 
growing responsibilities with fewer resources and staff. The budget 
would begin to reverse the steep 24 percent decline in GDM ``Federal 
funds'' which fund oversight and management staff, representing 228 
full-time equivalents.
    Two operating divisions face particular challenges with respect to 
their own administrative funding. The CMS Program Management 
discretionary appropriation has not kept pace with the growth in 
enrollments, responsibilities, and complexity within Medicare and 
Medicaid, putting both beneficiaries and taxpayers at risk. A 
substantial funding increase is needed to meet fundamental 
responsibilities to our seniors. The FY 2024 Budget requests an 
increase of $425 million for Program Management to keep pace with 
eligibility and claims processing for people with disabilities, 
strengthen nursing home oversight, reduce prescription drug prices, 
advance health equity, improve healthcare quality, and conduct Medicaid 
eligibility determinations as the public health emergency winds down. 
Likewise, ACL requests an additional $17 million to keep pace with 
growing programming to improve access to care and community supports 
for older adults and people with disabilities and to meet the needs of 
a rapidly aging population: ACL has had roughly 200 staff since 2018, 
yet its grants have doubled in value and increased by more than 50 
percent in number.
    The budget provides $75 million for new projects to improve the 
customer experience for Americans at significant points in their lives. 
For example, CMS, with other Federal partners, will test ways to 
improve access to benefits for people facing financial shock--such as 
loss of income--by working to improve underlying eligibility data 
services and systems. ACF and partner agencies will also continue and 
expand demonstrations to improve service delivery and to help states 
adopt leading practices in delivering benefits to ease application 
burden, lower time to access benefits, and improve cross-enrollment 
rates. CMS and the Social Security Administration (SSA) will also 
jointly pilot efforts to improve the Medicare enrollment experience. 
For people new to Medicare there are other customer service focused 
improvements that would align income and asset determination processes 
for Medicare low-income assistance programs, easing administrative 
burdens for states and removing enrollment barriers for individuals.
    The Nonrecurring Expenses Fund permits HHS to transfer unobligated 
balances of expired discretionary funds into an account for information 
technology and facilities infrastructure acquisitions necessary for the 
operations of the Department. Since FY 2013, the fund has allocated 
over $6.5 billion in capital investment projects across HHS. For FY 
2024, HHS is proposing to use $650 million from the fund for 
information technology and infrastructure projects across the 
Department, including at IHS, NIH, and CDC. These proposed investments 
will ensure aging systems and facilities do not compromise the 
Department's ability to carry out its mission.
    To support more effective use of health data, the budget also 
includes $104 million in Public Health Services Act Evaluation set-
aside funds for the Office of the National Coordinator for Health 
Information Technology (ONC). These funds will support more equitable 
access to healthcare data by updating health information technology and 
data standards for interoperability. ONC will also work to improve the 
secure exchange of electronic health information between patients and 
providers, and lead coordination efforts between key Federal and 
industry partners in health information technology.
    HHS values the importance of protecting individuals seeking 
services from HHS programs, from discrimination based on race, color, 
national origin, sex, age, disability, and religion. The privacy and 
security of individuals' health information is a critical part of HHS's 
work. The FY 2024 budget provides the HHS Office for Civil Rights (OCR) 
a much needed $78 million to carry out its important work. OCR is 
projected to have 80,000 cases in FY 2024, up from about 45,000 in FY 
2020, yet its budget authority has been essentially flat over this 
period, and essentially flat for over a decade. Since FY 2017 OCR has 
received a 28 percent increase in Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) complaints, and a 100 percent 
increase in HIPAA large breach reports, while enforcement staff 
decreased by 45 percent due to not receiving increases in its annual 
appropriations.
    HHS has also made robust investments in new discretionary and 
mandatory Health Care Fraud and Abuse Control funding to provide 
oversight of CMS health programs, strengthen the HHS Office of 
Inspector General investigations, and protect beneficiaries against 
healthcare fraud, yielding a combined return-on-investment of $19.7 
billion over 10 years. Our comprehensive program integrity legislative 
package includes a significant new investment in the mandatory Health 
Care Fraud and Abuse Control program, expands nursing home oversight, 
and promotes good governance.
                               conclusion
    I want to thank the Committee for inviting me to discuss the 
President's FY 2024 budget for HHS. The budget represents the continued 
investment in the health, growth, protection, and vitality of the 
American people. With adequate funding in these critical areas, we can 
support the forward mobility of our country and continue to make stride 
towards a brighter future. Thank you for your dedication and 
partnership in our shared goal to improve the health, safety, and well-
being of our nation.

    Senator Baldwin. Thank you, Secretary Becerra.
    We will start our round of questioning. I will take the 
prerogative to go first.
    Our communities continue to struggle with the opioid 
crisis. Just last year nearly 108,000 Americans died from a 
drug overdose; that is a record high. Reversing this trend has 
only become harder because of the growing prevalence of 
fentanyl in our communities. Fentanyl can be fifty times 
stronger than heroin, and a hundred times stronger than 
morphine. And it is increasingly involved in the vast majority 
of accidental fatal overdoses. So how are HHS programs adapting 
to the new challenges of substance use and abuse that we are 
seeing?

                SUBSTANCE USE INVESTMENTS AND ACTIVITIES

    Secretary Becerra. Madam Chair, this budget, you will see, 
invests some $11 billion, including some $10 billion in 
discretionary funding, for programs that try to target opioids 
and overdose-related activities. It is a significant increase 
over previous years, and it complements the work that we have 
done to establish a new strategy when it comes to drug overdose 
and treatment, where we don't only try to prevent people from 
taking up a drug, but also beyond the treatment. We worry about 
harm reduction, to make sure that we are preventing people from 
harming themselves before they finally can get the treatment 
they need.
    And then finally, we are trying to focus a great deal more 
of our time and resources, to ensure that there is post 
treatment services available in the community, so once you 
finish the treatment you don't fall off the wagon. And we keep 
you as a productive member of society.
    Senator Baldwin. Drilling down a little bit more deeply, 
and I just want to reflect that just in the time that I have 
been in the United States Senate I feel like I have seen the 
opioid epidemic, the substance use disorder crisis really 
change, fundamentally. And especially, obviously, I just 
referenced fentanyl, but I am also particularly concerned about 
the increase in overdose deaths among really young adults.
    Throughout the country the average age of opioid overdose 
victims has been dropping, spurred by the abundance of 
fentanyl, and again what I refer to as accidental fatal 
overdoses.
    So what is HHS doing, specifically, focused on our children 
and young adults, to prevent young people from seeking out 
illicit, or fake pills, and make life-saving--what are you 
doing to make life-saving overdose reversal drugs available to 
under-resourced communities?

                    REACHING YOUNG PEOPLE IN CRISIS

    Secretary Becerra. Madam Chair, we are doing the best we 
can right now to reach out with our States as partners, to try 
to get to where kids are. The 988 Program is a perfect example 
of how we are trying to reach children, young people today in 
ways that we hadn't before. And so it shouldn't surprise anyone 
that the most effective tool today to reach a young person who 
is experiencing a mental health crisis, is not to give them a 
phone so they can call 988, it is to let them text, or chat to 
us, because that is what we have seen a dramatic increase in, 
is the texts and chats that we are getting, principally, from 
young people.
    Then, of course, what we want to do is, to the degree 
possible, offer them peer support. We know that sometimes it is 
tough for young folks to talk to adults. We know that sometimes 
they are afraid to talk to adults, but to their peers, they 
seem to open up a great deal more. So whether it is providing 
the resources to actually know how to reach them, and then 
provide them with the most-friendly way to discuss their 
concerns; we are going to do all we can to try to get our young 
Americans.
    Senator Baldwin. Thank you. It was brilliance for the 
Federal Communications Commission to figure out that we needed 
to be able to text 988, not just call 988.
    Secretary Becerra. Yes.

                       988 & THE LGBTQ COMMUNITY

    Senator Baldwin. And I was so pleased to learn they were 
doing that. I want to stick with 988 for a moment. Recent data 
from the CDC shows that teens who identify as lesbian, gay, 
bisexual, transgender, or questioning, are experiencing high 
levels of mental health distress.
    In 2021, almost half of LGBTQ students reported seriously 
considering suicide, including more than half of transgender or 
non-binary youth. Nearly one in four LGBTQ youth attempted 
suicide, and nearly three in four reported persistent feelings 
of sadness or hopelessness. These are startling numbers, and we 
must redouble our efforts to support these children and young 
adults.
    I have been glad to work with you and the Department in 
creating a pilot within the suicide prevention Lifeline, which 
is now 988, to provide particular services to LGBTQ youth. And 
so I am asking: What kind of need are you seeing for crisis 
service among LGBTQ youth? And how has the Specialized Service 
Pilot--help support this population?
    Secretary Becerra. Madam Chair, our budget actually calls 
for support, funding support for specialized services for 
LGBTQI+ communities. And so we are already working on that. We 
know that, in many respects, the population within that 
community is at far greater risk of suicide. And so we are 
already targeting there. And we look forward to working with 
you to try to expand that scope.
    Senator Baldwin. Thank you.
    Senator Capito.

                 SUBSTANCE USE PREVENTION AND TREATMENT

    Senator Capito. Thank you. Secretary Becerra, I am very 
interested in the Substance Use Prevention and Treatment; the 
prevention aspect of this. I know the DEA (Drug Enforcement 
Administrations) has an initiative going called, ``One Pill Can 
Kill''. And what kind of things are you doing, and how does 
this budget reflect a larger impact on the prevention side of 
this enormous issue?
    Secretary Becerra. Yes. And Senator Capito, thank you for 
your dedication to this particular issue as well. We are doing 
things that have been proven effective, where evidence shows us 
that they help save lives. So for example, until a year, and a-
yeay-and-a-half ago, we would not support a program if it was 
providing fentanyl strips to drug users, because many thought 
that that was a way of increasing drug use.
    It is our way of trying to prevent someone from using a 
drug that they are not aware is laced with fentanyl. And so we 
are going to try to do the things that have proven themselves, 
by the evidence, to be effective, so we can provide, during 
that scope of prevention, treatment, harm reduction, and post-
treatment services, a continuity of the services that they need 
so they can get off of the drugs and get back to their life.
    Senator Capito. Yes. I think some of the harm reduction, at 
least in my State, has been subject to some controversy if they 
are not well managed. So you have to be very, very careful with 
those programs.

                         UNACCOMPANIED CHILDREN

    Let me talk about the unaccompanied children, the UACs that 
HHS is in charge of. I was really stunned, and maybe you were 
too, to read the article by The New York Times that talked 
about the youth, a number of unaccompanied children who were 
placed by HHS with sponsors, who were supposed to be vetted, 
who were then found packing cereal boxes, and roofing, and 
other kinds, slaughterhouses. I was surprised to read that they 
go to school in some cases, and then work all night. I mean 
very barbaric kinds of situations that were reflected in this 
article.
    What is your vetting process? Are you trying to fast track 
it too fast? Why has this, you know--are the sponsors, I noted 
in here one of them wasn't the relative that the person was 
supposed to be coming to--that the child was supposed to come 
and live. What are you doing to ensure that you are placing 
every child in an appropriate placement?
    Secretary Becerra. Thank you for the question. And let me 
try to encapsulate what this program is for the unaccompanied 
migrant kids. We receive these children from the Department of 
Homeland Security, which is not supposed to hold them because 
they only have detention facilities for adults.
    Senator Capito. Right.
    Secretary Becerra. We then take these children and offer 
them the care that you would expect to offer any child, 
children are children. And so we offer them care, while we try 
to place them in a more appropriate setting, because no one 
believes that a large government-funded congregate care setting 
is the best for a child. And so we make every effort to find a 
sponsor who would care for that child and do it well.
    And so we go through that vetting process, background 
checks, and the rest. And more than 90 percent--about 90 
percent of the cases we are placing a child with a family 
member, whether it is the parent, aunt, uncle, sometimes an 
older sibling, but in about 90 percent of the cases we are 
placing them with a family member.
    There are fewer cases, far fewer cases where it is not a 
family member, sometimes it is a known friend, acquaintance, 
someone that the parents say, please, that is the person we 
would like you to place them with. But rarely do you see a case 
of a placement that hasn't gone through a vetting, where a 
family----
    Senator Capito. But what kind of follow up do you do? 
Because obviously this is reflected in this article, is that 
you are falling short in more than a few areas.
    Secretary Becerra. Actually, I don't think the article 
speaks to our process of vetting, it speaks to the process that 
kids are going to work at a very young age.
    Senator Capito. Well, I don't think it--it doesn't sound to 
me like they were doing it voluntarily. It sounds like they are 
in a home, they are in a sponsor, and like I said, one of them 
is a relative, and they are encouraged, and you have to go 
work, and so obviously it is not the right sponsor, if you are 
going to tell a 13-year-old you have got to go pack cereal at 
night.
    Secretary Becerra. And those kids that apparently are 
reported on never called us and said: We are being exploited, 
we are being taken advantage of, and this was not what we were 
expecting. And so what we do is, again, we try to place them 
with someone we believe will be a responsible sponsor of them.
    Senator Capito. Yes. I mean, I think we need to do a better 
follow up here on the--certainly on the ones that are suspect, 
and certainly around the industries, and others that are 
exploiting our--any child. I mean, I think we agree that is 
abominable.
    Secretary Becerra. I don't think anyone disagrees with 
that.
    Senator Capito. Right.
    Secretary Becerra. That we should do the best we can with 
any child.

                          ALZHEIMER'S DISEASE

    Senator Capito. Right. Let me talk about Alzheimer's and 
the Leqembi decision that was made by CMS to not move forward 
with the approval, that only very limited, and I understand 
from my Alzheimer's advocates, really cuts out Rural America as 
well, because we can't access the trials, and the clinical 
trials, like you can and more compacted, and more urban areas. 
We have trouble with healthcare delivery systems.
    I mean, I can speak from personal experience, which I 
probably should quit doing, but with my parents we couldn't 
even find a gerontologist, hardly, in our area that could help 
me understand them. And so anyway, other agencies have taken a 
different approach than CMS. The VA (Department of Veterans 
Affairs) announced last week that it would cover this for our 
veterans. We are desperate for something to help. This has 
been--gone through clinical trials. It has positive science 
behind it. Why is that decision being made?
    Secretary Becerra. Well, a couple of things. First, the VA 
has made some moves to include it, but it also has restrictions 
and exclusions. It is not just a straight out approval. The 
second part is the clinical trials have not been done in this 
particular case. This was an accelerated approval which is 
still requiring, FDA (Food and Drug Administration) is still 
requiring that the manufacturer of the drug provide clinical 
evidence that it works.
    They went ahead and gave a conditional approval, but they 
are still waiting to get the evidence from clinical trials, and 
that is where CMS is saying, that is the kind of information we 
need, the clinical trials showing success, so that we can move 
under the standards that guide CMS, which are different from 
the standards that guide FDA, in making determinations for a 
particular drug.
    Senator Capito. It is interesting that you would phrase it 
that way, because my understanding is that there have been 
clinical trials, that there is science-based evidence, that 
this does move the needle. You know, it doesn't cure anything, 
I don't want anybody listening thinking it could do that, but 
this is something that we all obviously have our eye on. You, I 
am sure, received many letters, one from me.
    Secretary Becerra. Yes.
    Senator Capito. In this area. So I think. My time is way 
over.
    Secretary Becerra. Thank you.
    Senator Baldwin. Senator Merkley, you just arrived. But in 
the spirit of going back and forth between the Majority of 
Minority, you would be next, if you are ready.
    Senator Merkley. Okay. I will jump right in, although I 
just came from Foreign Affairs. So if I ask you a question 
totally off topic, you will know my mind is still where it was 
2 minutes ago.

                           FLORES REGULATIONS

    I wanted to start by asking you about the new Flores 
Regulations. The Department of Health and Human Services has 
the opportunity to codify the best practices and improve the 
treatment of children who are in Government custody through the 
Flores Settlement. And I think you are working on new 
regulations, and wanted to check in on how they are going, 
because it is so important that we treat children well.
    Secretary Becerra. Senator, we were just discussing the 
situation with children, the migrant children that are placed 
under our custody, and then are released to a sponsor. We would 
agree with you, a child is a child, and we have to do our best 
with any child. And so we are going through that review.
    The Flores Settlement requires us to--well, one of the 
things that the Flores Settlement requires is that we find a 
placement for this child, and not keep them in our custody any 
longer than necessary. And so we are going to be going through 
that.
    We want to thank Congress for the resources you gave us, so 
that we could actually go about trying to ensure that there is 
some follow up for these children, because once we have placed 
them in the care of a sponsor we essentially lose custody of 
that child. And so the more authorities you give us, and of 
course the resources, the better we could do the follow-up with 
these kids.
    Senator Merkley. I am very pleased to hear it. And I 
introduced bill, the Children's Safe Welcome Act, which we have 
shared with your team, which was designed to kind of lay out 
the gold standard, and I hope you will take a look at that bill 
as you put these together.
    Secretary Becerra. I will take a look.

                     STANDARDS FOR VAPING PRODUCTS

    Senator Merkley. The next thing I wanted to address, was to 
have you address vaping, and the standards that are established 
for candy-flavored, fruit-flavored vaping. And this goes way 
back. When I first came to the U.S. Senate, Oregon and Ohio 
where the experimentation grounds for the tobacco industry for 
new products; and they had tobacco toothpicks, they had tobacco 
breast strips, and they had tobacco mints. And to tell you how 
far those go back, the mints were in a case that was shaped 
like a flip phone, a cell phone, so if you remember those ages, 
just 14 years ago.
    But none of those caught the market, but vaping did, and 
has led to the addiction of, probably at this point, millions 
of children. Time and time again, with both administrations, 
both Democratic and Republican administrations, we have failed 
to get the regulations in place to control this seductive 
strategy to addict a new generation of children to nicotine, 
with really lifelong health consequences. So can you fill me in 
and tell me that this time will be different?
    Secretary Becerra. I want to tell you that it absolutely 
will be different. I was the Attorney General in California, 
and we sued some of these vaping companies, because we could 
prove that they were marketing to children, and so now, as 
Secretary, we are taking every action we can.
    It is a partnership. We work with the Department of Justice 
to help us do the enforcement against these vaping companies. 
And as you know, there have been, literally, millions of 
applications by these companies to be able to sell different 
products. Unfortunately, every one of those applications has to 
be gone through thoroughly otherwise we end up in court.
    And at this stage, the vast majority, substantially, more 
than nine out of every ten of those applications has been 
disposed of. We still have several large ones, but as, you 
know, Senator, we are now caught in court. The companies are 
using every tool at their disposal, including lawsuits, to keep 
us from moving forward.
    Senator Merkley. Okay. Well, I encourage you to persist 
aggressively, given the consequences of failure, and we 
certainly have a deeply entrenched company, or companies, 
determined to keep addicting children.
    I heard a knock, am I out of time? No.
    Senator Baldwin. You have a full----
    Senator Merkley. I have a full minute?
    Senator Baldwin [continuing]. 50 seconds left.

            MATERNAL AND CHILD HEALTH BLOCK GRANTS (TITLE V)

    Senator Merkley. Mr. Secretary, can you clarify whether or 
not Title V, the Maternal and Child Health Block Grant's funds 
can be used for stillbirth prevention activities?
    Secretary Becerra. Senator, I will confirm that, but I see 
no reason why it could not. But let me confirm that for you.
    Senator Merkley. Okay. I am going to keep working to pass 
the Maternal and Child Health Stillbirth Prevention Act, to 
clarify in statute. But I think you already do have the power, 
and I think it is a very important area to be pursued around 
the country. Thank you so much.
    Secretary Becerra. Thank you very much.
    Senator Merkley. I yield back 17 seconds.
    Senator Baldwin. Thank you. Next we have Senator
    Hyde-Smith.
    Senator Hyde-Smith. Thank you Chair Baldwin, and Ranking 
Member Capito, and thank you Mr. Secretary for being here 
today.

                      HOSPITAL BOARDING CHALLENGES

    The concerns in Mississippi are very similar to many other 
States, many hospitals are experiencing unbelievable financial 
and workforce restraints, and many have forced to end services 
in order to keep their doors open. There is a hospital in the 
Mississippi Delta that has had to stop any OB (Obstetrics), 
intensive care units, all of that has come to a close, for them 
just to offer, you know, primary care. But those services are 
very vital because the closest OB is like 45 minutes to an hour 
away. As they lose the ability to care for the more complex 
patients in their communities, the hospitals often have to 
transfer these patients hours away.
    And upon discharge many of these patients require, of 
course, post-acute care, and long-term acute care hospitals and 
rehabilitation hospitals have become less willing to accept 
these patients without the backup of their local hospitals. So 
I am sure you hear this all the time.
    But then the staffing challenges have significantly 
affected the ability for these facilities to continue on, and 
we are seeing longer stays in these tertiary care hospitals, 
because the locals cannot back them up. Hospitals get paid on a 
diagnosis-related group payment as you are well aware of, DRG, 
which typically covers a normal stay for that respective 
diagnosis.
    So patients are staying longer, and they are exceeding 
those DRG payments, and hospitals are losing money hand over 
fist. More patients are boarded, so to speak, in the ER 
(emergency room) waiting rooms on room beds. And they are just 
walking out of the ERs without being seen. Patients are held 
longer in their smaller hospitals, while waiting for bed 
placements in a larger hospital. We have all these issues that 
I am sure you have heard from many others.
    How do we overcome a financial challenge that was made 
worse by COVID and inflation; inflation that we are seeing, not 
only in Mississippi, but all across the Nation? And have you or 
the Agency considered establishing a temporary per diem payment 
targeted to hospitals, to help address this?
    Secretary Becerra. Senator, everything you have said I have 
heard, not just in States like yours, but when I was further up 
north in some of the Northwestern States they have large spans 
where there are very few physicians and healthcare providers. 
It is the same everywhere, distance has caused a real issue, 
telehealth was a saving grace during COVID, but that doesn't 
resolve it all.
    My wife who is an OB-GYN tells me about how, in Sacramento, 
California, she will see patients who are coming from the very 
northern reaches of our State because the facilities there are 
not equipped to handle the needs of an OB patient. And so what 
you are speaking to is something that everyone is trying to 
figure: How do we get resources and commitments into these 
communities?
    One of the things we are trying, and we look forward to 
working with you on this, if you are interested, is we are 
trying to make sure that graduate medical education slots, the 
slots where you send a resident into a practice, that maybe we 
could try to get some of these into communities that haven't 
always had these teaching slots available, because the evidence 
shows that if you locate a student who is in the Residency 
Program, by the time they finish that Residency Program in that 
community, they often stay there, and develop their practice 
there.
    And so we would like to see, for example, if we could 
encourage people to locate in communities because that is where 
they are getting their resident training, and have them stay 
there as a result. The other thing we are doing, again small, 
but still can be helpful, are Public Health Service Corps. But 
there are programs that we have that have loan forgiveness, or 
complete deferral, where, if you commit to 5 years of service 
in an underserved area, as you just described, we will pay for 
your 4 years of medical school education.
    And we are trying to do what we can to direct some folks 
into some of these communities. On top of that of course, you 
see some of the money that is devoted specifically for rural 
healthcare providers. Still, small potatoes, overall, but it is 
an effort to try to keep those facilities alive.
    Senator Hyde-Smith. So are you saying the temporary per 
diem is not being considered?
    Secretary Becerra. I would have to get back to you, I am 
not sure if that is one of the considerations. I would suspect 
that one of those issues with the temporary per diem would be 
the cost. Where would the money come from to do that?
    Senator Hyde-Smith. But you would let us know if----
    Secretary Becerra. Absolutely.
    Senator Hyde-Smith [continuing]. That is in the plans, or 
if that is even something that anybody is working on at the 
office.
    Secretary Becerra. We will follow up with your staff.
    Senator Hyde-Smith. We hear from the hospitals, and they 
are thinking that may be a solution. And they asked me. And I 
said, well, I will have the opportunity to ask him. So I would 
appreciate it if you would do that.
    Secretary Becerra. We will follow up with you.
    Senator Hyde-Smith. And my time is out.
    Senator Baldwin. Senator Manchin.
    Senator Manchin. Thank you, Senator. And thank you, Madam 
Chairwoman, appreciate the consideration.

                  DOMESTIC MANUFACTURING SUPPLY CHAIN

    And Secretary, thank you for being here. Appreciate it very 
much. Domestic manufacturing, I think you and I have talked 
about this before, that is needed to supply our chains, our 
supply chain is not caught off guard again, especially for 
life-saving essential medication. I was pleased to see your 
Department established the Office of Assistant Secretary for 
Preparedness to better help build out the United States 
manufacturing industrial base, and invest in long-term 
capabilities to better respond to emerging biological threats.
    Your budget request is $400 million, I think, to bolster 
the medical supply chain, but there has been about $10 billion 
that was approved for that before. Can you tell me if there is 
any money left from that that we could apply to this, or how 
the $400 million will be spent?
    Secretary Becerra. Senator, we have had discussions of this 
before. Most of that money was either--went out the door, or is 
on the verge of being obligated for services that are still 
related to COVID. In order for us to really increase our 
capacities with the domestic supply chain, we will need some 
resources. And that is where the President's budget does 
actually identify that as one of the things we would really 
like to do, because it is not just a matter of meeting our 
supply needs, it is also creating domestic manufacture of that 
product.

                              JESSE'S LAW

    Senator Manchin. Second, I am going to into drugs right 
now. Senator Capito and I, on the Jesse's--what we call Jesse's 
Law, Jessica Grubb's Legacy Act; I know you have heard us talk 
about this before. We passed that bill quite some time ago, it 
came in, and the CARES Act in 2020. I was pleased to see the 
Department issue proposed regulations last fall. What is 
Department's time line to implement the Final Rule of the 
Jessica Grubb's Legacy Act, this young girl who lost her life 
to drug overdose?
    Secretary Becerra. You are getting granular on me, Senator. 
Let me get back to you, so I don't give you the wrong time line 
on that.
    Senator Manchin. I hope it is quicker than what it has 
been.
    Secretary Becerra. Yes. I know you are hoping it is 
quicker. So we will get back to you.

                             DRUG OVERDOSES

    Senator Manchin. Okay. The LifeBOAT Act; let me ask you 
this. You know, with the drugs that we have in the situation 
right now, we lost 106,000 Americans last year. Over the last 
10 years we have lost more Americans to drug overdoses, opioid 
addiction, than we have in any wars we have ever fought, all of 
them accumulated together.
    With that being said, it is time for us to take, with the 
deaths that we have, take a realistic approach. The LifeBOAT 
Act simply says this: A penny per milligram for all 
manufacturers. If you think you need to put this much product 
in the market, then at least pay so we can use it just so we 
can get people cured, if you will, this, every penny of this 
goes towards treatment centers, and treatment centers could be 
in every part of the country.
    I have been trying, and trying, and trying, and everyone, 
for whatever reason, we haven't had any success. Have you heard 
about this? I think you and I have talked about it. Does it 
make sense to you? Was it tight?
    Secretary Becerra. Anything that gets us the resources to 
catch up to this plague makes sense, because we are losing 
ground on occasion, and we need to get ahead of this. And so 
any way that we could try to figure how to fund this, would be 
instrumental in saving lives.
    Senator Manchin. Would you all be able to support something 
such as that?
    Secretary Becerra. We certainly would take a close look, 
because you are trying to get resources, and we need resources 
to make it work.

                    PHARMACEUTICAL BENEFIT MANAGERS

    Senator Manchin. Let me speak about PBMs (pharmaceutical 
benefit managers) then. Let us speak PBMs, okay. PBMs, 80 
percent, the amount of money that they receive and the way they 
are able to control and classify on drugs to the highest 
sourcing, the highest drug prices, because they get a better 
rebate. How did we allow this to happen? And how do we stop it?
    Secretary Becerra. Senator, you have been in this business 
for a while, and I was in this body as well. I think we know 
that there are some folks who are very clever and creative in 
how they do this work. The middlemen have always skimmed money 
off the top, and it is a matter of how we can try to keep the 
resources where they are most needed, with consumers, not with 
middlemen.
    Senator Manchin. Well, for the PBM, pharmaceutical benefit 
managers, they are basically middlemen right now, as we are 
reducing price. And finally, the Inflation Reduction Act, the 
amount of money that we were able to save by negotiating on 
certain drug prices, that money is being able to help bring 
down prices as being used directly for reducing the price. What 
more can we do if we expanded that? How much quicker can we do 
this?
    Secretary Becerra. Transparency would be very helpful to 
see how they are operating. And as you know, the difficulty 
here is that the moment we try to do something, we likely find 
ourselves in court. And so we are trying to move this dial, and 
we look forward to your help in that.
    Senator Manchin. Okay. Back to the PBMs the drug 
formularies, are they the ones that set the drug formularies?
    Secretary Becerra. Well, those formularies are worked out 
with CMS, and others, that we take comment from.
    Senator Manchin. So they are not totally in control 
directly on that. And why are we getting so many of the higher 
priced drugs approved on the market, basically, for use other 
than the lower priced or generics?
    Secretary Becerra. We get that--I don't know if you have 
the time to go into the specifics of that.
    Senator Manchin. Okay.
    Secretary Becerra. But we can try to get back to you on 
that.
    Senator Manchin. I would love to get back with you on that 
one. PBMs, my number one concern, about the high prices of 
drugs.
    Secretary Becerra. Look forward to working with you.
    Senator Manchin. Okay.
    Senator Baldwin. We are joined by our Full Committee Chair, 
and Ranking Member, continuing with the back and forth, I will 
next recognize Vice Chair Collins for her questions.
    Senator Collins. Thank you very much, Madam Chair. Senator 
Moran has been here longer, I know, but more important he has 
to get back to another committee, so I will yield to him.
    Senator Baldwin. So I am----
    Senator Collins. But I do have questions.
    Senator Baldwin. Okay. And both the Chair and Vice Chair 
have already been gracious in yielding time to other members.
    So Senator Moran, take it away.
    Senator Moran. Chairwoman, thank you. And thank you to the 
Chair and Vice Chair of the Committee. I hope this is the 
evidence that I expect it to be of the amount of cooperation on 
both sides of the aisle, in the effort to get us through our 
legislative process and appropriations.

                         LIVER ALLOCATION RULE

    Secretary, the front page of The Washington Post today, 
about a joint investigation the paper conducted into the Liver 
Allocation Rule that was implemented in 2010 of 2020. Since 
that rule was announced in 2018 my former colleague, Senator 
Roy Blunt, and I have continually flagged for your Department, 
how harmful and unfair the rule is to the Midwest and the 
South.
    The results of The Washington Post investigation prove that 
we were correct. Quoting from The Washington Post story, ``The 
analysis from data from Federal health authorities found sharp 
declines in life-saving surgeries in Puerto Rico and seven 
States, all but one Southern and Midwestern; Kansas, Alabama, 
Louisiana, North Carolina, South Dakota, Iowa, and 
Pennsylvania.''
    Mr. Secretary, I raised this topic with you the first time 
you were in front of this committee. The analysis in addition 
to what is in addition to what we learned in 2021 from internal 
conversations between United Network for Organ Sharing and a 
New England OPO (Organ Procurement Organizations) that proved 
intentional collusion against Americans living in health 
professional shortage areas. All of these facts, combined, are 
more than enough to halt the Liver Allocation Rules 
implementation, and for HHS to rethink its over 30-year 
relationship with UNOS (United Network for Organ Sharing).
    Today's announcement, the Health Resources and Service 
Administration is proposing--so there is the good news--is 
proposing to divide up the OPTN (Organ Procurement and 
Transplantation Network) contract, and open competition for 
contracts to new organizations to step, and it is certainly a 
step in the right direction. I am hoping that the Department is 
finally, in my view, taking the life and death battles of 
Americans, the battles they are facing through the current OPTN 
system, seriously.
    To that end, HHS, the 2024 budget request is $67 million 
for Modernization Transplant Network. Could you please confirm 
your Department's commitment to working with my office, with 
Congress, to improve the OPTN system for all Americans, and 
fill the details in on the $67 million dollar modification--
excuse me--modernization request?
    And are you able to commit to this subcommittee that in 
addition to the important announcement from HRSA (Health 
Resources and Services Administration) today about rebuilding 
our Nation's transplant infrastructure, organ allocation; organ 
allocation formulas will be on the table for a complete 
overhaul, resulting in a more equitable formula?
    Secretary Becerra. Senator, probably the best way to put it 
is: You had me at hello, on that one. Simply because you have 
been ringing this bell for quite some time, we took a little 
time but we wanted to make sure we could do it right. And so I 
am glad you heard about our announcement, we are going to open 
up the process so that this one contractor doesn't believe that 
it owns this shop. And we are hoping that through competition, 
we are going to really be able to open this up in a way that 
lets the best of those who could offer this service take over 
the contract.
    Secondly, we are going to do everything we can to add 
transparency into the way this works, because as you just 
pointed out, you had to go dig for this information to find out 
that there may have been fraud and abuse. We are going to try 
to move towards much more transparency, especially with the 
data that they are collecting, because we don't have full sight 
of where they are sending organs, how they are doing it. And 
the more we have the data the more we can show whether they are 
doing it the right way or not.
    And so open up the process to the best bidder, make sure we 
have transparency, and then you mentioned, the President is 
calling for $67 million. So we can do principally one thing, 
catch up with the times, because the technology that is being 
used is too outdated. When we can transmit and communicate with 
folks around the world instantaneously, there is no reason why 
organ transplantation information cannot be made available 
quickly as well, because these organs have a certain shelf 
life. And so we are going to try to do what we can to make sure 
that no organ goes to waste, and we have to make sure that we 
bring in an infrastructure that can accommodate that.
    Senator Moran. Mr. Secretary, you know as a member of 
Congress, that you get people who bring you problems, and we do 
things, like we call ``casework'', and this started out a bit 
like that, but it became evident, and I am glad the Department 
now is apparently seeing this. This is really about life and 
death. And the analysis that we have seen, indicate there are 
people who have died in those States because of the allocation 
process that was put in place by a process that was far from 
even satisfactory.
    So I thank you. Is there anything that you are not doing 
that I should insist you do?
    Secretary Becerra. Please bird-dog this. It is not easy. We 
are trying to--you know, it is not easy to make the boat--the 
big ship switch direction. And there will obviously be those 
who lobby to keep the status quo. And so please persist, 
persist.
    Senator Moran. I will do that.
    Secretary Becerra. Amen.
    Senator Moran. Thank you.
    Secretary Becerra. Thank you.
    Senator Baldwin. Chair Murray.
    Senator Murray. Well, thank you very much, Chair Baldwin, 
Ranking Member Capito. It is really great to be back at this 
subcommittee, which is in great hands, with two women I am very 
glad to have as colleagues as well. And I am looking forward to 
working alongside the Chair and the Ranking Member, and all 
members of this subcommittee, as we return to regular order, 
and work to find common ground to build a stronger economy, and 
make our communities safer.

                             WOMEN'S HEALTH

    And today's hearing really offers a really important 
reminder, that when it comes to making our country safe and 
strong, investing in our families, and workers, is really key 
to our economic success. Defense spending is absolutely 
important, but it is only part of the equation, because our 
families across this country, being safe includes knowing they 
can get healthcare that they need, it means addressing the 
devastating maternal mortality crisis, and the opioid epidemic.
    It means training and retaining a strong healthcare 
workforce. It means building a robust public health system so 
we can prevent and respond to threats like dangerous disease 
outbreaks, and making sure that women, in every corner of this 
country, can get the healthcare and family planning services 
that they need.

                           CHILD CARE CRISIS

    And while these health challenges make people less safe, 
there is also the childcare crisis. And Mr. Secretary you know; 
Madam Chairman you know, this is really important, this is 
straining our parents' budgets, it is forcing them out of the 
workforce, we have to solve this crisis, which is why I will 
continue to raise this as a top priority of mine. And I am 
going to be reintroducing my Child Care for Working Families 
Act fairly shortly.
    I also want to note, Secretary Becerra, we need to live up 
to our obligation to care for the migrant children in our 
Nation's custody. I am going to be working hard with all of my 
colleagues to make sure we draft a funding bill that provides 
the investments that keep our families safe and healthy, and 
our economy strong.
    So welcome to this committee. I do have some questions.
    The Child Care Stabilization Program, it was created by 
Democrats in the American Rescue Plan, it has been an 
incredibly successful program, in my State, over 6,800 
providers received funding, and that has helped us with over 
184,000 children, in my State alone. And stabilization funds 
kept those providers' doors open, they supported wages and 
benefits for workers, and critical operational costs. But as we 
know this funding is set to end, and the childcare crisis is 
still with us.
    Secretary Becerra, the President has proposed a significant 
investment in both mandatory and discretionary funding for 
childcare. Can you tell us about the current state of the 
childcare sector, and why this significant investment is 
needed?
    Secretary Becerra. I have to begin, Senator, by first 
saying, thank you for helping us ensure that we could come to 
you with a decent budget. And so thank you for the work that 
you have done over the years on this subject.
    The second thing I will say is this probably explains it 
all when it comes to childcare. You can still make more money 
flipping burgers than you can working, caring for our next 
generation of leaders. I just don't understand it, how it is 
that we expect someone who is taking care of the people we love 
most, our children, less than we pay someone to go to 
McDonald's and flip burgers.
    That essentially, points out why childcare is in such a 
difficult state. We don't pay enough, yet it is still too 
expensive for most families to afford it, only one in seven 
families is able to send a child to childcare. And so you can 
understand why the President is committed to this. These are 
hundreds of billions of dollars that the President is trying to 
commit, because that is what it will take.
    He is also making a commitment to pre-K, and to Head Start. 
He would like to see every child who is 4 years of age have 
access to pre-K.
    And so, my mom used to say it best, ``Mejor prevenir que 
remediar'': better to prevent than to remediate. We know if we 
start early with our kids, they are going to have a chance to 
grow up strong. Frederick Douglass said it better, ``Easier to 
build strong children than to repair broken men.'' We are 
letting a lot of kids become broken, and then we try to repair 
them. Let us build them strong at the beginning, investing in 
childcare does it.

                       MATERNAL MORTALITY CRISIS

    Senator Murray. Well, thank you for that. And let me ask 
you about a report that the CDC released, it is really 
shocking, on the alarming maternal mortality crisis in our 
Nation, which found that the maternal mortality rate has risen 
40 percent since 2020. Can you tell me how the Department's 
existing work is going? And what the additional investments in 
maternal health in this budget will do?
    Secretary Becerra. We have really zeroed in here. You are 
aware that today we have challenged every State to offer to a 
woman and her new baby postpartum care, not just for 60 days 
under Medicaid, but for 365 days. So we just got the 30th 
State, Oklahoma, just came on board. But that means there are 
still 20 States in America that are not offering this care. 
That is hundreds of thousands of women who are about to deliver 
who will only have postpartum care for 60 days. And we know 
that in many cases the woman, the mother, or the baby will have 
an outcome, including death, that will leave America hurting.
    And so we believe expanding access to Medicaid, we are 
concentrating monies directly on maternal healthcare. We know 
the crisis is biggest in the African and Indigenous communities 
of our country, and so we are going directly where we know 
these women are.
    Senator Murray. Thank you. Thanks very much. Thank you, 
Madam Chair.
    Senator Baldwin. Vice Chair Collins.
    Senator Collins. Thank you so much Madam Chair.
    Secretary Becerra, welcome. You may have noticed this week 
that there is a sea of purple in Washington D.C.
    Secretary Becerra. Okay. Yes.

                          ALZHEIMER'S DISEASE

    Senator Collins. And that purple is worn by advocates for 
those who are suffering from Alzheimer's disease, are afflicted 
with it themselves, or are caring for someone, or who have lost 
someone to this devastating disease. I know that is true of 
both your family and my family as well.
    So it is with great disappointment that the CMS is 
blocking, and acting as a roadblock for patient access to drugs 
that could be very helpful to these patients particularly, in 
the early stages of this devastating disease. I just do not 
understand CMS's misguided and outright unprecedented decision 
to not cover a whole class of Alzheimer's drugs.
    It is not CMS's job to second guess the drug approvals of 
the FDA. That is not what CMS is supposed to do. So last month 
I led a bipartisan letter signed by 20 Senators, bipartisan, 
asking HHS and CMS to reconsider the restrictive coverage 
requirements in light of the FDA's accelerated approval. And I 
am disappointed that I haven't received an answer to that 
letter which was sent more than a month ago.
    Secretary Becerra. I am sorry.
    Senator Collins. I am also perplexed why CMS does not 
respond to a letter from the American Academy of Neurology that 
was sent on February 2, that says that the questions CMS has 
raised have been answered in a massive, successful clinical 
trial, and a peer-reviewed publication reviewing the results of 
that trial. And that was Phase III data.
    So CMS promised to expeditiously look at the data, and yet 
we just get silence. Furthermore, 200 Alzheimer's researchers 
have also written to CMS, and said there is no question, but 
that this drug should be allowed for patients who are receiving 
Medicare.
    It is not enough, as I believe Senator Capito pointed out 
earlier, to say you can get it if you are in a clinical trial, 
that is of so little help to States like ours, where there may 
not even be a clinical trial going on, or there may be one that 
is far away from most of the people in the State. So I am just 
asking you to tell CMS to let this drug be used; and let people 
get access to it when the patient and his or her clinician 
agrees it is the appropriate treatment. That is all we are 
asking.
    Secretary Becerra. Senator, I don't know if there was a 
particular question, other than to ask CMS. And certainly CMS 
has had to review this, many of the people who are at CMS who 
went through this process, have also had loved ones who have 
gone through illnesses like Alzheimer's. I myself, I had 
mentioned this, and my wife have gone through this.
    There is no doubt that we want to get to the types of life-
saving treatments that Americans can benefit from. The 
difficulty here is that we have to remember that the process 
that the Food and Drug Administration uses is different from 
the process that--legally, that the Centers for Medicare & 
Medicaid Services must use to make their determinations. And 
while it may not make a lot of sense to folks, and it is, you 
have to go into the weeds to understand the distinction, there 
is a legal distinction, and CMS has to remain consistent in the 
way it treats any drugs.
    And so I will absolutely make sure I take back the 
information. CMS has said that as soon as they collect the 
evidence that lets them believe that they now can move to a 
different level, a different stage, they would. If FDA were to 
give approval, standardized approval to the drug, they could 
then make further progress in broadening the scope of access. 
But CMS is trying to use the standard as it has in place to 
legally follow its obligations, and when it makes a 
determination for Medicare.
    Senator Collins. Well, I would just suggest to you that CMS 
now has all the evidence that it can possibly need to grant 
that approval, given this clinical trial which was considerable 
and produced good results, and the 200 researchers. CMS needs 
to stay in its lane. FDA is in charge of drug approval, not 
CMS.
    Secretary Becerra. Senator, if you will allow me, even FDA 
is asking the drug manufacturer to continue to provide evidence 
of the efficacy of the drug. They have not said, with finality, 
that this drug is safe and effective. They are still waiting 
for more evidence to come in.
    Senator Collins. Well, I don't know what more--I know my 
time has expired--but I don't know what more evidence you could 
need than a Stage III clinical trial. And it is just extremely 
frustrating, as is the fact that the President's budget does 
not provide additional funding, specifically targeting 
Alzheimer's research. And that is something I hope we can 
correct. Thank you.
    Senator Baldwin. Thank you. Senator Shaheen.
    Senator Shaheen. Thank you, Madam Chair. And thank you to 
Ranking Member Capito. Congratulations to both of you on your 
new roles on this subcommittee. And it is nice to have the Vice 
Chair of the Appropriations Committee here as well; and the 
Chair, with Senator Murray. So thank you all.

                   LOWERING PRESCRIPTION DRUG PRICES

    Secretary Becerra, thank you for being here, and for your 
testimony this afternoon. I wanted to ask you about insulin 
because it is something that Senator Collins and I have been 
very concerned about, as the Co-Chairs of Diabetes Caucus in 
the Senate. And as you know, last session of Congress we put a 
$35 cap for Medicare beneficiaries on out-of-pocket costs for 
insulin. Do we have any data yet that shows what the impact of 
that has been? And can you also address why that is not enough, 
why we still need additional action on insulin affordability?
    Secretary Becerra. We are beginning to collect the data, 
Senator. And what I can tell you is the stories I am hearing, 
the anecdotal stories from actual insulin users, is perhaps the 
best evidence, when they find out that they only have to pay 
$35.
    I had a woman, I believe, it was--I am going to get this 
wrong, because I have been to many States, North Carolina I 
believe; she was shocked when she only paid $35, she was 
accustomed to paying about $117 for her insulin for the month. 
She went back to the insurance: that I think I owe you some 
money. And she had to be told: No, that is the cost now. 
Because in December she had paid the higher price; in January, 
all of a sudden, magically, it was lower.
    It is affecting a lot of folks. But in your State of New 
Hampshire, this is probably going to add up for this year, for 
someone on insulin, on Medicare, to about $536 that they will 
get to keep in their pocket.
    Senator Shaheen. Well, that is very good news. And I assume 
that, long term; it is also going to be helpful in terms of the 
costs of treating diabetes, because if people are able to get 
their insulin without having to worry about episodes that would 
put them in the hospital, in the long term it is going to save 
the system money. Do we have any of that data yet? And are we 
collecting it?
    Secretary Becerra. We absolutely do, because we know people 
ration their insulin to make it last for the month. We know 
that people will skip their insulin shots, because they don't 
have enough to last them for the month. That changes now, 
because now it is only $35 for the full month.
    And as you know, the President in the State of the Union 
Address said: It is great that this is available to the 67 
million people on Medicare, but what about the rest of America. 
And today, the three largest manufacturers of insulin have 
agreed that they will drop their prices of insulin. And this is 
a result of the Inflation Reduction Act that you all passed, 
and the limits you put on insulin.
    Senator Shaheen. And I think that is very good news. I am 
not confident, however, that that is going to address the 
problem that everybody is facing, so I think we still need 
further Government action on that, to make sure that everybody 
has those out-of-pocket expenses capped in a way that ensures 
they can get access to insulin.

                            OPIOID EPIDEMIC

    One of the other issues that we are very concerned about in 
New Hampshire is the opioid epidemic, which because of 
fentanyl, has gotten exponentially worse. And as you know, the 
State opioid response grants are particularly important to 
States across this country.
    As you and SAMHSA continue your work on the SOR allocation 
formulas, can you commit to working with my office, with Chair 
Baldwin, who I know is concerned about this because she and I 
worked on ensuring that SAMHSA (Substance Abuse and Mental 
Health Services Administration) is looking at the cliff that 
States might be facing if those opioid response grants got 
reduced dramatically?
    Secretary Becerra. Senator, the President in his budget, 
calls for $2 billion to go to SOR (State Opioid Response 
Grants) grants, because they have been effective, and we don't 
want to find that a center can provide services for 5 months 
out of the year, but has to close down after May. Or that they 
can't reopen during the hours of the day when people come most. 
And so what we are finding is that, we have to work hard to 
make sure that States can keep people coming, believing that 
this is going to be a continuation of service.
    So they will take advantage of it. And so we look forward 
to working with you and your colleagues to make sure that we 
make this work right. And that no State finds that it is 
running out of money at the wrong time, and faces a cliff of 
funding when they need it most.
    Senator Shaheen. And Senator Capito and I worked on 
legislation to try to encourage providers to prescribe non-
opioid--pain, well, for pain; but we are not talking about 
medications, if they are not opioids, we would be talking about 
devices or something else. Can you talk about what you can do, 
as a Department, to try to encourage providers to look at 
something other than opioids when they are prescribing for 
pain?
    Secretary Becerra. Then, that is where we would turn to the 
best practices, where the evidence shows that they are 
effective, the FDA would be the agency that would make sure 
that a particular device or medication would be safe and 
effective for use. And I think a lot of us understand that we 
need to find other ways to provide pain therapy so that no one 
feels like they have to get on these very addictive 
medications, like opioids, in order to be able to survive the 
pain that they face.
    Senator Shaheen. Well, thank you. Thank you, Madam Chair.
    And I would encourage the Department to think about ways in 
which they can make sure that providers understand that there 
are other alternatives other than opioids.
    Secretary Becerra. Yes.
    Senator Baldwin. And next, I recognize a new member of the 
Appropriations Committee, Senator Britt, welcome.
    Senator Britt. Thank you so much, Madam Chairman and 
Ranking Member, congratulations to both of you. It is an honor 
to serve on your committee.
    Mr. Secretary, thank you for your time, and being here. 
Many of the questions that I have had on various issues have 
already been answered, so I am going to actually kind of take 
up something that I saw Senator Capito talked about, and dig a 
little bit deeper into it.

                         UNACCOMPANIED CHILDREN

    The Department's fiscal year 2024 budget request includes 
$5.5 billion in baseline funding for the UAC Program, for 
unaccompanied migrant children, along with a request of $2.8 
billion contingency funds to help address unaccompanied minors 
and other refugee issues throughout fiscal year 2024. But as 
has been mentioned here today, the UAC program is plagued by 
deficiencies, poor management, which combined with this 
administration's reckless and irresponsible policies, encourage 
illegal immigration, and I believe, have put the lives of 
children and their well-being at risk.
    We are spending a lot of money on a program that just isn't 
working very well. I believe it is not a lack of funding, it is 
departmental policy and management failures that are our 
problem. In light of the piece in The New York Times last 
month, as well as many other well-documented reports regarding 
issues with the UAC Program, I want to ask you about some 
specifics here, that I believe HHS could and should address.
    On March 31, 2021, HHS's Office of Refugee Resettlement, 
ORR, issued Field Guidance that waived background check 
requirements for adult household members and alternative adult 
caregivers, identified in a sponsor care plan submitted by 
Category 2 sponsors. As you know, Category 2 sponsors include 
certain relatives of a child other than a parent.
    So the Department put in place a policy that allowed a 
waiver of background checks for other adults in the households 
of those relatives, that strikes me as deeply irresponsible. In 
light of recent events, can you tell me if the March 31, 2021, 
Field Guidance is still in effect?
    Secretary Becerra. Senator, first congratulations to you.
    Senator Britt. Thank you. I appreciate.
    Secretary Becerra. And I look forward to working with you 
in the future. On this particular question, I won't try to 
refute some of the things that you have said that I think are 
inaccurate about the program, because the men and women at HHS 
work very, very hard to protect these kids. Thousands of kids 
that have passed through our hands as we care for them, and we 
do everything we can to not only care for them while they are 
in our custody, but find them a very secure placement.
    Senator Britt. Yes, sir. And I don't believe that it is 
actually the people at HHS. I said it is the management and the 
policies. And so the policy of not checking the background of 
these individuals in a home that we are putting a child in, my 
question is, is that still the case?
    Secretary Becerra. Right. And I think you have not stated 
it properly.
    Senator Britt. Okay.
    Secretary Becerra. Because we do, do background checks.
    Senator Britt. Good.
    Secretary Becerra. So the sponsor of any child has to go 
through background checks.
    Senator Britt. Okay, and not the sponsor but anyone in 
their household.
    Senator Becerra. And so if the sponsor is one of the 
immediate relatives, so for example, if it is the parent----
    Senator Britt. Right.
    Secretary Becerra [continuing]. Then we, in order to get 
the child to the parent, because again, what we are always 
told, whether it is through the courts, or whether it is 
through the best advice, the professionals who know about the 
best interest of a child, they say: It is better to have a 
child with someone who loves them, than have them in a 
federally sponsored congregate care setting.
    And so we place them with the child's parent if we can. And 
if it is a child's parent, for example, we will not do the full 
background checks of those who are in the household, assuming 
that the parent is going to be responsible for the child to 
make sure that anyone in the house will also take care of the 
child.
    Senator Britt. So if it is not a parent though, just so you 
and I are on the same page, so that we are speaking the same 
language here.
    Secretary Becerra. Yes.
    Senator Britt. If it is not a parent that you are placing 
them with, do you do a background check of the other 
individuals in that home?
    Secretary Becerra. It will depend on who that individual 
that we are looking at as the sponsor would be, because the 
further removed you get from the parent, the more we have to 
have a sense of security that the person who is going to be 
responsible as the sponsor can indeed take care of that child. 
And so it would really be based on that.
    Senator Britt. Okay. I just want to let the record reflect, 
obviously, if is it a parent, a parent knows what is best for a 
child and that is what we have to know, but if it is not a 
parent we need to be checking into everyone in that household. 
What we have seen happen to these children is completely and 
totally unacceptable. There are so many who have been forced 
into sex trafficking, have been forced into labor trafficking, 
of which we know--we have got to make sure that we are taking a 
look, and that we are trying to keep them safe.
    And so the Field Guidance, then, I guess is not in effect 
then; the March 31, 2021, Field Guidance?
    Secretary Becerra. I will get back to you on the Field 
Guidance. But I am not aware of any sex trafficking of the kids 
that we have been able to place with a sponsor. If you can 
provide us with the evidence that there has been sex 
trafficking----
    Senator Britt. Certainly. Absolutely.
    Secretary Becerra [continuing]. I would love to see that.
    Senator Britt. Absolutely. And so the decisions to 
terminate any of those things, I certainly, I would love to 
follow up with, and I will submit some questions for the record 
for that as well. And so when you are looking at the different 
things that are occurring also too--I only have 14 seconds 
left--guys, I have got to learn how to do this quicker.
    Senator Baldwin. Negative-14.
    Senator Britt. Oh negative-14. Okay. Guys, thank you for 
your time. I have a number of other questions within that 
line----
    Secretary Becerra. We can follow up.
    Senator Britt [continuing]. That I would love to get to the 
bottom of. These children, it is a passion for me, as a mama of 
two school-aged children, that we are making sure that we are 
not putting them in harm's way.
    Secretary Becerra. I thank you for your passion.
    Senator Britt. Thank you.
    Senator Baldwin. We will have the opportunity for a second 
round of questions, and obviously an opportunity to submit 
questions for the record.
    Senator Reed, it is now your turn.
    Senator Reed. Thank you very much, Madam Chairman.
    Secretary Becerra, great to see you; I had the privilege of 
serving with you in the House, and you are doing a superb job 
as the Secretary. So thank you.

                                 ARPA-H

    We spoke on the phone a few weeks ago about the growing 
importance of research into RNA (Ribonucleic acid), that was 
the real driving force between the COVID vaccine, and as I 
indicated on the phone, Brown University in Rhode Island, is 
establishing itself as one of the leaders in RNA research. They 
are putting up an extraordinary amount of money for facilities, 
et cetera. At the same time, ARPA-H is quickly standing up, 
hopefully, making the RNA project one of their first and most 
important objectives.
    So could you give me a sort of a read out of where we are? 
And also, going forward, keep me posted? And as I said, I think 
Brown is really the place where the Academia and ARPA-H can 
meet.
    Secretary Becerra. Senator, I communicated the information 
you--we discussed to the folks at ARPA-H, Dr. Wegrzyn, the 
Director is--she just recently, for example, announced that one 
of the three sites for ARPA-H will be based here in the DMV 
(District of Columbia, Maryland, Virginia). And what we know is 
that she is going to use a hub and spoke model, as she has 
mentioned, where it is not going to be a heavy footprint in any 
one particular place, because what they are looking for is, all 
these creative ideas that sometimes are generated by the 
smallest of business but they have a great idea they just don't 
have the capital.
    And from what I can tell you, they are beginning to receive 
solicitations for grants, they have hired some of the program 
managers who will be in charge of the projects. And we can make 
sure that the folks at Brown are in touch with the correct 
program managers within ARPA-H, to make sure that their 
proposal is considered.

                            SUICIDE AND 988

    Senator Reed. Thank you very much, Mr. Secretary. Let me 
turn quickly to an issue that is extremely troubling. That is 
suicides in the United States, particularly with young people. 
It is a public health crisis. Recently with the cooperation of 
many people on this panel, we were able to get through the 988 
number, which is a simplified way to seek out counseling 
support, just to speak to someone else.
    Can you talk about the President's budget request for the 
988, and all the associated support, and how that funding could 
be used to increase awareness to young people, especially? And 
also, I might add, young people, I have a 16-year-old, they 
don't use telephones the way we used to do. They don't dial.
    Secretary Becerra. Yes.
    Senator Reed. I don't know what they do, but a text, text 
is the thing. So are we going to get into the text world too?
    Secretary Becerra. Yes. Senator, I still don't understand 
it, how someone, especially someone who is going through a real 
crisis, thinks it is easier and better to text, than to 
actually speak to a live person but that is--and it is working. 
And I have got to tell you, we have seen a dramatic increase in 
the number of texts that we have received.
    By the way, I need to say thank you to you and your 
colleagues, because it was the Federal Government's resources 
that helped stand up the Text and Chat functions within 988. 
The States, and we keep asking the States to come forward, 
because there are some States that have actually created a 
permanent stream of funding for their 988 operations.
    Remember, 988 is not a national suicide prevention 
lifeline, it is a nationwide system that brings together the 
States. And we, because of the resources you gave us, were able 
to glue it together. But it still requires resources, and we 
are doing the Text and Chat function, we help stand up and 
expand a Spanish language function, so those who are limited in 
English can communicate as well. We are doing something that is 
specialized for LGBTQI+ communities as well. There is a line 
that has been stood up in the State of Washington for Native 
American community members.
    And so we are finding that everyone is trying to figure out 
how they can really reach folks. And the President's budget 
continues his dramatic commitment to 988, by putting in several 
hundred million to make it work. Because people are calling, 
and it is kind of sad that people are calling, because that 
means people are hurting. But at least they are calling.
    Senator Reed. Thank you very much. Just a final point; I 
think you have also reached out to the veterans community, the 
specialized line.
    Secretary Becerra. Yes, we did. Yes, the special----
    Senator Reed. I commend you and your implementation. Many 
times, we do things, and they don't really get implemented. You 
have done a superb job.
    Secretary Becerra. Thank you very much.
    Senator Reed. Thank you, Mr. Secretary. Thank you, Madam 
Chair.
    Senator Baldwin. Thank you. We are now going to start a 
second round of questions. There may just be a handful of us 
coming around for a second round, but I will begin. And I am 
going to begin on a theme you were just talking about, and that 
I ended on, which is this continued focus on the 988 telephone 
number.
    Since it was launched last summer, there has really been a 
dramatic increase in folks who reached out to it. I know when 
former Senator Gardner and I introduced the legislation we were 
like: Who memorizes a 10-digit phone number.
    Secretary Becerra. Yes.

                                  988

    Senator Baldwin. And has it, like, available, handy when 
they are in crisis. But the budget that you are here discussing 
does request another significant increase in funding to be able 
to respond to an estimated 9 million contacts that will occur 
in fiscal year 2024. Some of the people who called need 
referrals in their own communities across the Nation for 
additional crisis intervention services after the initial phone 
call or text chat.
    How does this budget, not just bolster the local crisis 
centers, but also help the Nation's crisis system, so that 
people who need follow up can receive that care in their own 
communities?
    Secretary Becerra. Great question, Senator, because that is 
the next big hurdle, is making sure people are receiving the 
post-contact services, and sufficient services. And so the 
great thing about 988, is it lets us bring that person in, 
start to find out what they need, and then direct them to the 
services that will help. Before then, it was usually the 
emergency room that would take a lot of these individuals. And 
so we are able to better make sure that we are sending them to 
the right place.
    The other thing that we are finding; and I don't think 
anyone really thought of this. I don't know if you did when you 
all were thinking about this. The great thing about 988, we are 
getting people who were afraid to call 911, because they 
thought that law enforcement would come and respond, and that 
is the last thing they wanted.
    And so we are getting more and more people who are actually 
communicating. And so that the beauty of it is that people have 
responded. They have taken up 988. Now, we have got to make 
sure we follow through. We did a very good job of making sure 
if you called you wouldn't get a busy signal, or be put on 
hold, but now we have to make sure that once you do talk to 
that professional, we guide you to the next professional, may 
be in person, but somehow we do the follow-up care.

                         UNACCOMPANIED CHILDREN

    Senator Baldwin. Next, I want to return to another topic 
that has been addressed, and that is the follow up for 
unaccompanied children. And just very specifically, because you 
have gotten so many questions about this, you walk through the 
steps that HHS has taken to ensure that kids are placed, first 
of all, with appropriate family members or sponsors, and the 
challenges associated with that. But then moving forward, what 
are you doing? And what are you asking to be enabled to do 
through this budget to expand services for children after they 
have been released from the DHHS part of their care? And what 
can we do in fiscal year 2024 to support that greater follow 
up?
    Secretary Becerra. I am glad we are doing follow-up 
questions, because that gives you this opportunity to ask that 
question. People, I think, misunderstand the role of HHS, and 
our jurisdiction. We receive these kids because the Department 
of Homeland Security cannot keep them. They are immigrant 
individuals that would, typically, be held by DHS, Department 
of Homeland Security. Except for the fact that they are 
children and they are not with an adult.
    So since they are detached from adult, they need to have 
someone who can take care of them, provide them custody. And 
that is where they come to our care, because we are the Agency 
that deals with healthcare and kids.
    We then have jurisdiction with the statutes, the laws that 
you have passed, to actually care for these children. We care 
for the children, but because of the laws and court rulings, we 
are obligated to find them a better place to stay instead of in 
a large congregate setting. We do that by trying to vet a 
sponsor. Oftentimes, it is the parent himself or herself, 
oftentimes it is an immediate family member, aunt, uncle, older 
sibling.
    We do everything we can to get them as close to an 
immediate family member as possible. Rarely do we assign a 
child to someone who is not known to the child. There has to be 
a compelling reason to do that. Our background checks also get 
more intense, the less it is a parent who would get that child.
    But the moment we find that suitable sponsor that has gone 
through the background checks, and we place that child, our 
jurisdiction has actually ended. The jurisdiction we have is to 
try to do--and this is what we started doing ourselves, and now 
you have provided us with some money, is to do a post-release 
check, to find out how they are doing.
    But the child doesn't have any obligation to respond, the 
sponsor doesn't have an obligation to respond. Under the laws 
that you all have passed, we don't have the jurisdiction to 
say: Hey, get back to us. We also, of course, don't have 
jurisdiction to say: Employer, you can't hire these kids. And 
so if folks would understand the roles that we play, the 
Department of Labor has said how they are going to try to get 
more aggressive when it comes to child labor enforcement.
    And we are going to start working together, DOL (Department 
of Labor) and HHS, to make sure that if they are getting signs 
that there is somebody who is using kids to do labor in places 
that it is dangerous that they can let us know, confidentially, 
because they are doing investigations, and then we can try to 
check to find out if that individual happens to be someone who 
is trying to become a sponsor; that way we never will release 
that child to that sponsor.
    Thank you for giving me a chance to sort of explain the 
process, because I think some people believe that we continue 
to have jurisdiction to continue to care for children even 
after placement.
    Senator Baldwin. Senator Capito.

                           MEDICARE ADVANTAGE

    Senator Capito. Thank you, Mr. Chairman. Earlier this year, 
I helped to lead a bipartisan letter of 60 of my colleagues, in 
support of the Medicare Advantage Program. Medicare Advantage 
is a critical choice for seniors in West Virginia, 43 percent, 
and it is growing every year, are in Medicare Advantage, 
189,000. Most of the beneficiaries of Medicare Advantage spend 
approximately 40 percent less than Medicare fee-for-service 
beneficiaries, which is critical because 53 percent of those 
beneficiaries are below, annual incomes below $25,000, so cost 
is an issue.
    In the 2024 Advance Notice for Medicare Advantage, CMS 
proposed changes that I believe, and my colleagues believe, 
hence with 60, anytime we can get 60 on a letter that tells you 
something, could result in beneficiaries experiencing higher 
out-of-pocket costs for prescription drugs, for a very popular 
program that people have adjusted to and really, really like, 
and want, and request.
    Can you provide assurances that the proposed policy changes 
will not lead to increased beneficiary costs, or disruption of 
Medicare Advantage to seniors in 2024?
    Secretary Becerra. Senator, I absolutely can provide 
assurance that the benefits that Medicare provides that are 
administered, whether it is through the Medicare Managed Care 
Program, what is called Medicare Advantage, or whether it is 
provided through the traditional Medicare Program, called Fee-
For-Service, that the benefits that Medicare calls for in the 
law, are not changed, are not diminished, and therefore should 
not be cut.
    If they are cut, it is not because the Federal Government 
has asked for them to be cut. It is because the provider has 
decided to make cuts in certain areas. They are not allowed to 
make cuts to Medicare benefits, they may change the package of 
benefits that they provide within a particular plan, and may 
change out certain benefits but they are not allowed, under 
law, to cut Medicare benefits from any beneficiary. And if they 
tell you they are going to have to, then I say to you right out 
front, that is an unequivocal untruth.
    Senator Capito. Well, I am asking you the cost issue 
though. Will the changes that you make, or that you want to 
make in the Medicare Advantage program result in higher cost to 
the Medicare Advantage recipient, and the person who has chosen 
those programs?
    Secretary Becerra. Absolutely not, we are actually 
providing more money this year for the Medicare Advantage plans 
than we did last year.
    Senator Capito. So what is causing the stir then?
    Secretary Becerra. Well, they don't like that they are not 
getting as much money as they are accustomed to getting, and 
that----
    Senator Capito. Well, how could they not be getting as 
much, if you are getting more?
    Secretary Becerra. Well, they have been getting very large 
increases, year-over-year. And that is because they oftentimes, 
as you have perhaps heard, they over code. They list someone as 
being more ill, more sick than they are, and as a result of the 
higher coding, they can bill a higher rate.
    They don't like that we are going in and saying: No, we 
want to make sure it is an appropriate coding. So if someone 
has diabetes, okay, we will reimburse you for the diabetes 
care, but you have got to show us that you are giving diabetes 
care. And not just say it, then not provide the care, and still 
bill Medicare.
    Senator Capito. Well, I just think the satisfaction numbers 
alone of Medicaid Care Advantage, are big. And again personal 
experience with this, with both my parents being on Medicare 
Advantage Plan, easy to do, easy to understand, and out-of-
pocket costs very, very low; so we have got our eye on that 
one. And a quick question I have on----
    Secretary Becerra. And Senator, if I just may?
    Senator Capito. Yes, you can. Yes.
    Secretary Becerra. There are absolutely plans that are 
doing well, doing the right thing, and doing well by their 
patients, absolutely.

                         PANDEMIC PREPAREDNESS

    Senator Capito. Oh. Thank you. The last question I have is: 
the budget includes a proposal for $20 billion in new mandatory 
funding for pandemic preparedness and response. So I want to be 
clear here, I am supportive of efforts to bolster our Nation's 
pandemic preparedness and response, but I am concerned that 
this is sending mixed messages, because HHS came to us last 
year for $82 billion, so now it is down to $20 billion other--
you know, what is the difference in this request? Because it 
wasn't granted because it was just--for a lot of reasons. I 
will leave it like that.
    Secretary Becerra. Honest truth, we could use the $80 
billion, we don't expect that you all will give us the $80 
billion, we hope that you would at least give us the $20 to $30 
billion, because in order to prepare--let us put it this way, 
to prepare it takes a lot of work. We saw how much we had to 
spend once we were in the pandemic, we could absolutely use 
that money to prepare, to get States better prepared. But we 
want to be realistic. What will you move with? We think that 
$20- to $30 billion is a good place to go that gets us at least 
in a place where we are preparing.
    Senator Capito. And I would just, last comment, the 
pushback on the original request last year, a lot of it was: 
You are sitting on a bunch of COVID dollars that are still not 
going to be spent out for several years, why can't we, you 
know, repurpose those?
    Secretary Becerra. Yes.
    Senator Capito. I think that is a legitimate question, I 
will leave it to that. Thank you.
    Secretary Becerra. Okay.
    Senator Baldwin. Senator Moran.

                      MEDICAL RESEARCH INVESTMENTS

    Senator Moran. Thank you, Chairwoman. I would first like to 
acknowledge, as several of my colleagues have done, the purple 
in the audience, thank you much for your presence, and for the 
rounds of conversations you have had, and with me and my staff, 
and with others across the Senate.
    I hope that you know, that your efforts on Capitol Hill do 
matter, and you should take great pride in the fact that they 
have mattered. This subcommittee, in particular, it has new 
leadership this year, but I have no doubt, will make every 
effort to prioritize the funding of medical research, and in a 
significant way, prioritize the funding of research to find the 
cure, delay, the drug that so desperately is needed by 
Alzheimer's patients and their families.
    So thank you for your advocacy. It is something that I 
would speak on behalf of my colleagues, that we are all proud 
of ourselves, although the real credit belongs to you and many 
others for the success, a bipartisan success that has occurred 
now, I think, for 5 years, maybe we are on our 6 year, in which 
those of us still on the committee, and those who preceded us, 
have made certain that this topic is something that matters to 
us, because it makes such a difference.

                      STRATEGIC NATIONAL STOCKPILE

    Mr. Secretary, the Strategic National Stockpile. You and I 
had this conversation in last year's appropriation process. And 
I want to ask a couple of questions. I understand, and you 
indicated in your testimony a year ago, that you understand the 
importance of maintaining a Strategic National Stockpile. I 
appreciate that acknowledgment.
    This committee has acknowledged, as well, that there is a 
need for the funding for that stockpile to be increased, but we 
have been hesitant to have a significant, meaningful increase 
because we don't have the information that we need to do so. We 
have been unable to do oversight because of lack of 
information. And so I would ask you or the administration for 
strategic preparedness and response, if you would provide me, 
this subcommittee, a detailed and comprehensive update on the 
SNS (Strategic National Stockpile) since COVID-19 depleted it; 
is that something that is doable?
    Secretary Becerra. I don't see anything in the request that 
would be confidential or non-disclosable, so let me get back to 
you. But I think we can respond.

         ADMINISTRATION FOR STRATEGIC PREPAREDNESS AND RESPONSE

    Senator Moran. And the second part of that, the second 
question in a part of this conversation is: How can ASPR 
(Administration for Strategic Preparedness and Response) work 
better with Congress, and specifically this subcommittee, to 
achieve our mutual goal of a well-stocked, and carefully 
managed stockpile.
    Secretary Becerra. Thank you for the question. By the way, 
I hope that your staff will follow up with us because the work 
that ASPR is doing, our administrator and the Agency first 
strategic preparedness and response has been phenomenal. If I 
were to ask anyone in this room: Can you name me the date when 
the--there was a Warp Speed transition from the Department of 
Defense on COVID, to the Department of Health and Human 
Services?
    I doubt there is anyone in this room who could tell you 
when it happened, because it was seamless. And it is because 
the folks at ASPR handled this with professionalism, they have 
been doing this work since 2021, when they took over after Warp 
Speed transitioned over to HHS from DoD (Department of 
Defense). And it has gone very well.
    I mentioned close to 700 million shots in arms, as a result 
of the COVID vaccine. I would love to have Administrator Dawn 
O'Connell, speak to you and your staff directly, or to any 
members of the staff, because we have depleted the stockpile, 
and we need to get back to--for example when we did Mpox, 
monkeypox, we used a lot of the smallpox vaccines that we are 
storing in the event smallpox should ever hit this country, 
because that vaccine also worked against the monkeypox, against 
Mpox, we started using some of that vaccine.
    We need to replenish that. We have got no money to address 
Mpox, and so we took that out of the stockpile, to replenish 
those smallpox vaccines will cost money, but we need to. And so 
I absolutely want you to have sight, because neither you nor I 
wants to be caught flat-footed if we find that our stockpile is 
depleted. So we will follow up.
    Senator Moran. Thank you. I appreciate you expanding. 
Certainly COVID was an important component of the necessity for 
vaccines, but this is broader than that.
    Secretary Becerra. Yes.
    Senator Moran. You mentioned monkeypox, there is a whole 
array in today's dangerous, adversarial face--circumstance we 
face in the world, and we need to be fully prepared.
    My final question Chairwoman is, ASPR recently released its 
industrial base expansion platform. This is the desire that 
many of us have, to see that we are not dependent upon some 
other country to provide us with the necessary ingredients for 
a product to be stockpiled. Do you think there is a similar 
pathway to increase the opportunities for smaller biotechnology 
and manufacturing companies to offer their supplies to SNS?
    Secretary Becerra. The answer is yes. And by the way, 
Senator, great question, because it points out why it is so 
essential that we receive money that $20- to $30 billion that 
we are asking for with regard to COVID, because that will help 
us replenish some of the accounts that were depleted as a 
result of COVID, including, of course, the stockpile.
    Remember that the stockpile maintains supplies of product 
and material that expire, and if we don't keep those supplies 
replenished, we may have something in our storage units but it 
really won't serve the true purpose. And so there is so much 
that goes on, that goes well beyond COVID, as you said. And 
absolutely, one of the things we would love to do, as we were 
trying to get the dollars, the $80 billion dollar request for 
COVID to replenish funds, would have given us a chance to 
actually start working on domestic production, because ASPR 
could have focused some resources, on actually trying to, you 
know, stand up that domestic production.
    But we are so caught right now, we are trying to just 
backfill our reserves that it makes it tough to even consider 
try to help domestic production really launch in this country.
    Senator Moran. I hope my conversation indicates to those 
who are listening to you and I having this conversation, that 
there is an interest in finding ways to be helpful.
    Secretary Becerra. 150 percent.
    Senator Moran. Thank you.
    Senator Baldwin. Well, thank you, to my colleagues; thank 
you, Secretary Becerra, for being here today. I think we had a 
good discussion. And I am looking forward to working with the 
Department, and Members of the Subcommittee as we start this 
2024 appropriations process.

                     ADDITIONAL COMMITTEE QUESTIONS

    Questions for the record are due by next Wednesday, March 
29. And I would certainly appreciate and expect DHHS's response 
within 30 days of that.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
            Questions Submitted to Secretary Xavier Becerra
              Questions Submitted by Senator Tammy Baldwin
    Question. Over 20 percent of Wisconsin counties are considered a 
maternity care desert. Last year, HRSA determined over 6,300 Maternity 
Care Target Areas exist nationwide.
    What does HRSA need to support the maternal healthcare workforce 
and make sure that more women are able to access care?
    Answer. As noted, HRSA has identified Maternity Care Target Areas 
(MCTAs) and scored them to rank those with the greatest need for 
maternity care health professionals. The National Health Service Corps 
(NHSC) is utilizing these scores in making loan repayment awards to 
maternal health practitioners (e.g., OB/GYNs, Family Medicine 
physicians who practice obstetrics regularly, and Certified Nurse 
Midwives) who agree to serve in MCTAs. HRSA's FY 2024 Budget includes a 
request for $965.6 million, which includes $175.6 million in 
discretionary funding, for the NHSC including to support the placement 
of maternal health providers in MCTAs.
    Question. HRSA's FY24 budget includes a request for $175.6 million 
in discretionary funding for the NHSC, with $25 million set aside for 
mental and behavioral health providers. What is the estimated funding 
need for maternity care providers?
    Answer. In FY 2023, the NHSC will for the first time use the new 
MCTA designation to distribute maternity care health professionals who 
will receive loan repayment in exchange for their service. A MCTA is a 
geographic area within a primary care Health Professional Shortage Area 
(HPSA) that has a shortage of maternity care health professionals. The 
higher the MCTA score, the greater the need for maternity care health 
professionals. The NHSC Loan Repayment Program will review and approve 
applications from maternity care health professionals by descending 
MCTA score and in consideration of the program funding priorities. 
Using this methodology, HRSA will make loan repayment awards to 
maternity care health professionals in the areas with the greatest 
needs until the funds are exhausted. Since HRSA is still accepting 
applications, we cannot estimate the total funding needs associated 
with MCTAs.
    Question. The FY2024 President's Budget includes $400 million for 
new flexible funding to rapidly develop vaccines, therapeutics and 
diagnostics, support emergency manufacturing of critical medical 
countermeasures and supplies, and expand the domestic medical supply 
chain.
    How does HHS plan to invest in domestic manufacturing with this 
funding? How much of this funding does HHS estimate would go toward 
domestic manufacturing?
    Answer. The Administration for Strategic Preparedness and Response 
(ASPR) is investing in securing a strong domestic manufacturing base to 
produce essential products such as medical equipment, pharmaceuticals, 
vaccines, and personal protective equipment (PPE). Since the beginning 
of the COVID-19 response, ASPR has supported over 87 contracts to build 
and sustain domestic manufacturing of critical medical supplies and to 
produce medical countermeasures (MCMs) on U.S. soil. The $400 million 
requested in the FY24 President's Budget for this work will also ensure 
we are able to maintain the capabilities built and used extensively 
during the COVID-19 pandemic to strengthen medical countermeasure 
development and manufacturing. In addition, with ASPR's reorganization 
in February 2022, ASPR established the Industrial Base Management and 
Supply Chain (IBMSC) Office to ensure we have dedicated, full-time 
staff devoted to addressing this long-term challenge.
    Funds could support purchasing domestically made product for 
inclusion in the Strategic National Stockpile (SNS), reducing reliance 
on foreign production. The $400 million Pandemic Preparedness and 
Biodefense request will ensure the Biomedical Advanced Research and 
Development Authority (BARDA) has ready resources to immediately scale 
up manufacturing of vaccine, diagnostic, and therapeutic prototypes at 
the first indication of an outbreak. The requested funding would also 
accelerate advanced development and additional manufacturing of medical 
countermeasures for clinical trials and, when appropriate, patient care 
as part of an emergency response.
    Question. How would this strengthen our national security and 
biodefense capabilities?
    Answer. The recent COVID-19 and mpox responses emphasized the 
importance of flexible funding that is available for immediate actions 
as public health threats emerge. At the start of the mpox outbreak, the 
SNS was only able to deliver to five sites in each jurisdiction, 
resulting in each jurisdiction having to forward distribute the 
products to their hospitals and vaccination clinics. While such a 
system is more than enough for the high-consequence, large-scale 
chemical, biological, radiological, nuclear, and explosive events that 
the SNS typically plans for, there was increased burden on the 
jurisdictions in this nationwide mpox response. Incorporating lessons 
learned and being able to pivot and address needs in real time is 
critical to advancing and securing national preparedness. If 
appropriated, the $400 million for Pandemic and Biodefense would 
strengthen not only advanced development and additional manufacturing 
of medical countermeasures, but also when appropriate, address and 
strengthen patient care as part of an emergency response.
    Ultimately, lack of readily available funding, as we saw with the 
H1N1 influenza and COVID-19 pandemics, can delay development of 
critical MCMs by weeks or even months until supplemental funds are 
appropriated. Paying for initial response efforts may require movement 
of funding from other ongoing development efforts for high priority 
threats, potentially impacting the nation's preparedness for those 
threats. Having this readily available funding at the start of an 
outbreak is essential for a robust and rapid response, especially to 
achieve the bold timelines outlined in the American Pandemic 
Preparedness Plan.
    Question. HHS recently recognized the organizations that serve as 
hubs in the new public-private health information sharing framework 
called TEFCA. This marks important progress toward interoperability, 
but we must work to ensure that providers treating our most vulnerable 
and underserved patients are able to benefit from this framework.
    What resources do providers, including those that serve underserved 
communities, need to join TEFCA?
    Answer. The Trusted Exchange Framework and Common Agreement (TEFCA) 
establishes a floor for universal interoperability across the country 
through a network of networks. To establish nationwide exchange of 
health information, TEFCA creates common ``rules of the road'' to 
ensure trust and to create efficiency. Therefore, the Common Agreement, 
which will be signed by the Recognized Coordinating Entity (RCE) and 
each Qualified Health Information Network (QHIN), provides certain 
flow-down provisions that the QHINs will be required to include in 
their contracts with their Participants (which could be providers) and 
that those Participants will be required to include in their contracts 
with their Subparticipants (which also could be providers). All 
Participants and Subparticipants will be required to sign a contract 
that includes these flow-down provisions before engaging in TEFCA 
exchange activities.
    In many cases, providers, including those that serve underserved 
communities, will be able to meet the above contractual requirements 
via modifications to existing contracts they have with entities that 
will become a TEFCA QHIN, Participant, or Subparticipant (e.g., a data 
sharing agreement with a Health Information Exchange or with their 
electronic health record (EHR) vendor). Providers will also generally 
be able to leverage existing technical connections with those same 
entities. In these cases, any new legal and technical costs could be 
relatively small.
    Providers that are not currently engaging in data sharing would 
need to make investments to become a QHIN, Participant, or 
Subparticipant under TEFCA. This would include fees for participation 
in a network, legal costs associated with signing a data sharing 
contract, and both technical and human capital costs (e.g., updates to 
their existing EHR systems, developing new interfaces, and employing 
health information technology (IT) staff to enable and support the 
technology). These costs would include both upfront investments and 
ongoing costs.
    The structure of TEFCA, with multiple QHINs as the foundation, will 
enable providers to choose from multiple options for connecting to the 
network of TEFCA-compliant QHINs. We believe this competitive 
marketplace of QHINs will benefit entities joining TEFCA, including 
providers, by allowing such entities to find and select a QHIN that 
fits their technical and cost needs.
    We understand that costs related to electronic exchange of health 
information continue to be a challenge, particularly for small and 
rural providers. For instance, the costs for updating EHR systems or 
developing interfaces are significant challenges to providers' ability 
to electronically exchange health information because they often lack 
financial resources to afford more advanced EHR systems or pay for 
additional features to be added to their system.
    We are also aware that the cost and availability of health IT staff 
is a barrier to electronic exchange of health information. For many 
practices, it is difficult to afford or find staff with health IT 
knowledge to support an infrastructure that is capable of electronic 
exchange of health information, particularly in rural areas of the 
country. In a 2019 survey of office-based physicians by the Centers for 
Disease Control and Prevention's (CDC) National Center for Health 
Statistics, 37 percent of physicians responded that the lack of health 
IT staff was a barrier in their ability to electronically exchange 
health information.
    Recent data indicates that another need for healthcare 
organizations in relation to joining TEFCA is simply a lack of 
awareness about TEFCA itself. In a 2022 survey of hospital IT leaders, 
about half of respondents said they were not aware of TEFCA, and 
substantially more respondents from small, rural, and independent 
hospitals, and hospitals that are not currently participating in an 
interoperability network, indicated they were not yet aware of TEFCA. 
We believe that a substantial fraction of other healthcare 
organizations (i.e., healthcare organizations other than hospitals) 
require additional information about TEFCA as well, particularly 
organizations with fewer resources, paralleling what we see among 
hospitals.
    Question. What is HHS doing to make these resources available?
    Answer. ONC and the TEFCA Recognized Coordinating Entity (RCE) are 
committed to effectively educating and engaging healthcare providers 
and organizations about TEFCA. ONC and the RCE will continue to host 
public feedback sessions to provide information and educational 
resources to interested parties and elicit input from those parties as 
TEFCA is implemented and matures.
    ONC and the RCE will continue to develop educational resources that 
are designed to inform interested parties about how TEFCA will work and 
how it may reduce their costs related to electronic exchange of health 
information. For instance, the RCE published the Informational Resource 
for Flowing Down Common Agreement Provisions into Framework Agreements, 
which is intended to assist QHINs, Participants, and Subparticipants in 
complying with their Common
    Agreement flow-down obligations. We believe this resource, along 
with others the RCE has published, will save entities interested in 
joining TEFCA significant time, resources, and legal fees.
    As noted in the question, on February 13, 2023, the first set of 
six QHIN applicants were accepted for onboarding to TEFCA. Once fully 
onboarded, the organizations would officially be ``designated'' as 
QHINs. ONC expects these entities, and potentially other candidate 
QHINs, would engage in significant marketing activities, which would 
also be a means of disseminating information to providers that are 
currently not aware of TEFCA.
    Concerning financial resource needs, per State Medicaid Director's 
Letter #18-007, State Medicaid agencies were advised that enhanced 
Federal technology funding under section 1903(a)(3) of the Social 
Security Act (SSA) ``could include any state investments in supporting 
Section 4003 of the [21st Century] Cures Act,\1\ both in terms of the 
design, development and implementation of such connections as well as 
the maintenance and operations of such connections.''
---------------------------------------------------------------------------
    \1\ Public Law 114-255, Section 4003 includes the requirement for 
ONC to develop or support TEFCA.
---------------------------------------------------------------------------
    TEFCA could potentially address some of the financial challenges 
that providers face in other ways as well. In a 2019 survey of office-
based physicians, the two most commonly cited barriers to 
interoperability were difficulty exchanging health information with 
providers using different EHR vendors (reported by 85 percent of 
respondents), and that exchange involves the use of multiple systems or 
portals (reported by 73 percent of respondents).\2\ TEFCA is designed 
to help address both of these barriers. TEFCA will make it possible to 
significantly reduce the number of connections that healthcare 
providers need to make to get the health information they seek. As a 
result, once implemented, participating providers could have a reduced 
need to develop costly interfaces or connections to exchange health 
information with multiple other healthcare providers. This could be 
particularly helpful for small providers or those that serve rural 
areas of the country, as it could make exchange less costly and give 
providers potentially more options.
---------------------------------------------------------------------------
    \2\ Pylypchuk Y., J. Everson, D. Charles, and V. Patel. (February 
2022). Interoperability Among Office-Based Physicians in 2015, 2017, 
and 2019. ONC Data Brief, no.59. Office of the National Coordinator for 
Health Information Technology: Washington DC.
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    While we believe outreach and education and the potential use of 
Medicaid funding could help providers participate in TEFCA, including 
those that serve underserved communities, we are cognizant that these 
efforts do not address all resource needs for such providers, 
particularly those that are not currently engaging in electronic 
exchange of health information. These include expected network fees, 
legal and technical costs, as well as IT staffing shortages and gaps in 
broadband access that pose particular challenges to electronic exchange 
of health information for small and rural providers. Addressing such 
challenges will be essential to the widespread use and adoption of 
TEFCA by providers in underserved communities.
                                 ______
                                 
               Question Submitted by Senator Jeff Merkley
    Question. Mr. Secretary, I appreciate the $122 million increase for 
the Maternal and Child Health Block Grant included in the President's 
Budget. However, I remain concerned that as many as 35 states are not 
using this block grant funding for stillbirth prevention activities 
even though it is an allowed use of funds--despite the fact that an 
estimated 1 in 4 stillbirths in the United States are potentially 
preventable.
    Mr. Secretary, can you clarify whether or not Title V--Maternal and 
Child Health Block Grant funds can be used for stillbirth prevention 
activities?
    Answer. Yes, stillbirth prevention and reporting activities are 
currently authorized under the existing Title V Maternal and Child 
Health (MCH) Block Grant statute and states are currently supporting 
stillbirth prevention activities. For example, as of 2022, 47 state 
Title V programs supported or partnered with fetal-infant mortality 
reviews (FIMRs) and Child Death Reviews (CDRs) to better understand the 
causes of fetal/infant deaths and to inform recommendations for changes 
to prevent deaths and reduce fetal and infant mortality.
                                 ______
                                 
              Questions Submitted by Senator Brian Schatz
    Question. I am concerned we are facing a telehealth cliff in 2024. 
My bill, the CONNECT for Health Act, would ensure permanent expansion 
of Medicare telehealth coverage. At the same time, I have questions 
regarding CMS's implementation of key elements of telehealth payment 
policy, and worry that these decisions may hamper our healthcare system 
as it permanently transforms to a hybrid of virtual and in-person care.
    Audio-only services. There are a variety of high-value, low-tech 
telehealth modalities that benefit patients' access to care, including 
audio-only services. CMS could modify the definition of ``interactive 
telecommunications systems'' in regulations and program instruction to 
ensure that providers can utilize all appropriate means and types of 
technologies to furnish telehealth services. However, CMS stated in the 
CY23 Physician Fee Schedule (PFS) Final Rule that its regulatory 
interpretation of ``telecommunications system'' generally precludes 
audio-only services except under certain circumstances.
    What clinical guidelines and peer-reviewed evidence is CMS using to 
draw the distinction outlined in the PFS to determine when to cover and 
exclude care modalities from the Medicare telehealth services list?
    Since CMS has already determined that it can update its definition 
of ``interactive telecommunications systems'' in certain circumstances, 
what, if any, additional statutory authorities does CMS need to ensure 
continued coverage?
    Answer. Requests for adding services to the list of Medicare 
telehealth services may be submitted on an ongoing basis. First, CMS 
determines whether or not the requested services are similar to the 
current list of telehealth services. Our review of requests that are 
not similar will include an assessment of whether the service is 
accurately described by the corresponding code when delivered via 
telehealth and whether the use of a telecommunications system to 
deliver the service produces demonstrated clinical benefit to the 
patient. Requestors submit evidence indicating that the use of a 
telecommunications system in delivering the candidate telehealth 
service produces clinical benefit to the patient. The evidence 
submitted should include both a description of relevant clinical 
studies that demonstrate the service furnished by telehealth to a 
Medicare beneficiary improves the diagnosis or treatment of an illness 
or injury or improves the functioning of a malformed body part, 
including dates and findings, and a list and copies of published peer 
reviewed articles relevant to the service when furnished via 
telehealth. Our evidentiary standard of clinical benefit does not 
include minor or incidental benefits.
    Historically, CMS has not proposed any permanent modifications to 
the definition of ``interactive telecommunications system'' to allow 
for use of audio-only communications technology due to our 
interpretation of the statutory requirements, as well as concerns over 
program integrity and quality of care. Specifically, CMS has been 
concerned that the use of audio-only communications technology for 
Medicare telehealth services could lead to inappropriate 
overutilization and we believed that video visualization of the patient 
generally was necessary to fulfill the full scope of service elements 
of the codes included on the Medicare telehealth list.
    However, in 2020, Congress enacted the Consolidated Appropriations 
Act, 2021, which included a provision that removes the geographic 
restrictions for Medicare telehealth services for the diagnosis, 
evaluation, or treatment of a mental health disorder, and adds the 
patient's home as a permissible originating site for these telehealth 
services. Given considerations related to experience during the PHE and 
implementation of this provision, CMS believed it was appropriate to 
revisit our regulatory definition of ``interactive telecommunications 
system'' beyond the circumstances of the PHE to allow for the inclusion 
of audio-only services under certain circumstances. We also believe 
that mental health services are different from most other services on 
the Medicare telehealth services list in that many of the services 
primarily involve verbal conversation where visualization between the 
patient and furnishing physician or practitioner may be less critical 
to provision of the service.
    Therefore, we finalized a change in the definition of interactive 
telecommunications system to include audio-only communications 
technology when used for telehealth services for the diagnosis, 
evaluation, or treatment of mental health disorders furnished to 
established patients when the originating site is the patient's home. 
Outside of the circumstances of the PHE, we continue to believe that 
our longstanding regulatory interpretation of the Medicare statute that 
``telecommunications system'' generally precludes the use of audio-only 
technology for purposes of Medicare telehealth services with the 
exception under certain circumstances of telehealth services to 
diagnose, evaluate, or treat a mental health disorder (including 
treatment of a diagnosed SUD or co-occurring mental health disorder). 
We would be happy to provide technical assistance on any legislation 
that would update the statute to include coverage of audio-only E/M 
services.
    Question. Direct supervision. Residents and other trainees should 
be exposed to telehealth, as this is now an essential component of 
clinical practice. There are successful models at academic medical 
centers and other training settings where clinicians provide direct 
supervision through virtual presence. I am discouraged that in its CY23 
Physician Fee Schedule, CMS has chosen to terminate the supervision 
flexibilities granted during the public health emergency.
    What is CMS's rationale for taking this stance regarding direct 
supervision?
    What information could stakeholders provide CMS to demonstrate that 
this temporary exception should be made permanent in future 
rulemakings?
    Answer. During the Public Health Emergency (PHE) for COVID-19, CMS 
temporarily modified the regulatory definition of direct supervision, 
which requires the supervising physician or practitioner to be 
``immediately available'' to furnish assistance and direction during 
the service, to include ``virtual presence'' of the supervising 
clinician through the use of real-time audio and video technology. 
Under our currently finalized policies, CMS will continue to permit 
direct supervision through a virtual presence through the end of the 
year in which the PHE ends (through December 31, 2023). We continue to 
gather information on this topic, and we appreciate the information 
provided by commenters in the CY 2023 Physician Fee Schedule Rule. We 
believe allowing additional time to collect information and evidence 
for direct supervision through virtual presence will help us to better 
understand the potential circumstances in which this flexibility could 
be appropriate permanently, outside of the PHE for COVID-19.
    Question. Protecting provider privacy. The architects of Medicare 
systems never envisioned that a provider would be practicing from their 
home. However, today it is commonplace and used as a strategy to reduce 
provider burnout. I am concerned that when providers furnish care from 
their homes, CMS will soon require that they publicly report their home 
address as the practice location.
    How is CMS considering alternate strategies and changes to its 
systems so that providers can report practice locations, safeguard 
privacy, and ensure completeness of information to process claims?
    What information could stakeholders provide CMS to demonstrate that 
it should alter its current systems?
    Answer. During the Public Health Emergency (PHE) for COVID-19, CMS 
allowed practitioners to render telehealth services from their home 
without reporting their home address on their Medicare enrollment while 
continuing to bill from their currently enrolled location. This waiver 
will continue through December 31, 2023. CMS is open to receiving 
information from providers and other interested parties regarding the 
reporting of practice locations.
    Question. Native Hawaiians and Pacific Islanders are 
underrepresented in all national health surveys. The limited data that 
are available demonstrate that NHPI people face persistent, 
disproportionate morbidity and mortality compared with other 
demographic groups. The paucity of data has restricted our 
understanding of the range and depth of health issues facing the NHPI 
population, and therefore curtailed the policies and programs that 
might mitigate these disparities. While the National Health Interview 
Study is fielded annually, it has been a decade since the sole Native 
Hawaiian and Pacific Islander National Interview Study was conducted. I 
believe it is past time to collect high- quality data on the NHPI 
population.
    What novel insights were identified on NHPI health in the 2014 
Native Hawaiian and Pacific Islander National Health Interview Study?
    Answer. In 2014, to fill the Native Hawaiian and Pacific Islander 
(NHPI) health statistics data gap, the CDC's National Center for Health 
Statistics (NCHS) fielded the Native Hawaiian and Pacific Islander 
National Health Interview Survey (NHPI NHIS). The NHPI NHIS made it 
possible, for the first time, to calculate unprecedentedly reliable, 
precise, releasable statistics on the health conditions, health 
behaviors, and healthcare access and utilization for the U.S. NHPI 
population as a whole and for disaggregated NHPI groups. This survey 
yielded benefits in three key areas: comparison across race groups, 
creation of NHPI-focused chartbooks, and increased capacity for 
researchers.
Comparison Across Race Groups
    The 2014 NHPI NHIS data were uniquely valuable because they were 
comparable to the 2014 NHIS data, which made it possible to compare 
outcomes among all five of the federally recognized race groups. Using 
2014 NHPI NHIS data, it was possible to do the following:
  --Clearly distinguish health disparities between NHPI and Asian 
        populations, long obscured in combined ``Asian and Pacific 
        Islander'' (API) statistics or unreliable NHPI statistics.
  --Identify similarities of the NHPI population with the Black and 
        African American population, long obscured by combined API 
        statistics and unreliable NHPI statistics.
  --Understand the differences among the disaggregated NHPI population 
        groups, including Native Hawaiian, Samoan, and Guamanian or 
        Chamorro populations.
  --Identify the social determinants of health and healthcare access 
        and utilization across the life course in the NHPI population.
NCHS NHPI NHIS Chartbooks: Thousands of unprecedented insights
    NCHS created a set of visually oriented and estimate-dense 
reference chartbooks with disaggregated NHPI statistics for a broad 
range of health measures, as requested by the NHPI community 
stakeholders during the 2014 NHPI NHIS planning period. These 
chartbooks made it easy to compare statistics across Federal race 
groups and among disaggregated NHPI groups for over 50 health condition 
and health behavior measures and 15 healthcare access and utilization 
measures. Estimates were presented for single race and multiple race 
NHPI populations, and in some cases, by age group as well. The 
chartbooks include graphical charts with accompanying bullet-points 
that state what is shown in the chart. As a result, the chartbooks 
provide accessible insights for a variety of audiences.
    Below are selected examples from the chartbooks. All statistics 
refer to the United States in 2014.
  --Asthma
    --Ever, Children: The percentage of Native Hawaiian children under 
            age 18 who ever had diagnosed asthma was 24.3 percent, 
            higher than the percentage among all Pacific Islander 
            children (9.5 percent) and single-race Asian children (9.6 
            percent) and higher but not significantly different from 
            single-race Black or African American children (18.4 
            percent).
    --Current, Adults: The percentage of Native Hawaiian adults aged 18 
            and older who had asthma (13.3 percent) was higher than the 
            percentage of all U.S. adults (7.4 percent) and single-race 
            Asian adults (4.9 percent), and higher than but not 
            significantly different from the percentage among all 
            Pacific Islander adults (5.8 percent).
  --Lower back pain: Among all NHPI adults aged 18 and older, the 
        percentage with lower back pain was 28.3 percent, which was 
        similar to the percentages among all U.S. (28.1 percent, 
        single-race white (28.7 percent), single-race Black or African 
        American (28.5 percent), and single-race American Indian and 
        Alaska Native (AIAN) (29.0 percent) adults, and higher than the 
        percentage among single-race Asian adults (17.6 percent. The 
        percentage of Samoan adults with lower back pain was 37.0 
        percent, which was higher than the percentages among Native 
        Hawaiian (28.4 percent), Guamanian or Chamorro (23.6 percent), 
        and Other Pacific Islander (24.2 percent) adults.
  --Cancer: The percentage of NHPI adults aged 18 and older with any 
        cancer was 5.7 percent, which was significantly higher than the 
        percentage among single-race Asian adults (3.3 percent).
  --Help with personal care from other persons: Among all NHPI adults 
        aged 65 and over, the percentage who need help with personal 
        care from other persons was 11.8 percent, which was higher than 
        the percentage among all U.S. adults (6.6 percent), slightly 
        more than double the percentage among white adults (5.8 
        percent), similar to the percentage among Black (11.1 percent) 
        and Asian (10.4 percent) adults, and lower than but not 
        significantly different from AIAN adults (15.6 percent).
  --Uninsured: The percentage of Native Hawaiian adults aged 18--64 
        without health insurance coverage at the time of interview was 
        8.6 percent, which was lower than the percentages among all 
        Pacific Islander (18.2 percent), Samoan (16.1 percent), 
        Guamanian or Chamorro (15.1 percent), and Other Pacific 
        Islander (21.3 percent) adults. It was also lower than the 
        percentage among single-race Asian adults (12.8 percent) and 
        single-race Black or African American adults (18 percent). The 
        percentage of Pacific Islander adults 18-64 without health 
        insurance was similar to the percentage among single-race Black 
        or African American adults.
  --Unmet dental need due to cost: Among adults, the percentage of all 
        NHPI adults with an unmet dental need due to cost in the 12 
        months (12.3 percent) was higher than the percentage of single-
        race Asian adults with such unmet need (7.2 percent).
  --Pneumococcal Vaccination: NHPI adults aged 65 and over were less 
        likely to had ever received a pneumococcal vaccination (52.0 
        percent) compared with all U.S. adults aged 65 and over (62.3 
        percent). Native Hawaiian adults aged 65 and over were less 
        likely to have ever received a pneumococcal vaccination (50.2 
        percent) compared with all Pacific Islander adults aged 65 and 
        over (69.4 percent).
NHPI Health Research
    The NHPI NHIS has also increased capacity for researchers, 
scientists, and other health professionals. Researchers have used the 
2014 NHPI NHIS public use data set, the first publicly available, 
nationally representative single-year NHPI health dataset, to examine 
the distribution, inter-relationships, and sociodemographic correlates 
of a wide range of health outcomes. This research has appeared in over 
100 peer review publications and conference presentations, including 
The American Journal of Public Health, Cancer, Sleep, and Obesity, and 
professional meetings of organizations such as the American Public 
Health Association, the Gerontological Society of America, and the 
Population Association of America. This work has increased awareness of 
NHPI health and health disparities.
    Question. How would re-fielding the survey glean new information on 
NHPI health?
    Answer. If the NHPI NHIS were to be fielded again, the new 
estimates produced would illuminate how NHPI health outcomes, health 
behaviors, healthcare access, and healthcare utilization have changed 
in the decade since the first NHPI NHIS. The resulting estimates, when 
compared with NHIS estimates for other race groups, would also 
illuminate what progress has been made in reducing health disparities 
between the NHPI population and other U.S. population groups, and 
reveal which disparities have stayed the same or increased. This 
information can inform policymakers efforts to target resources to 
improve the health of the NHPI population.
    NCHS could produce chartbooks similar to those produced using the 
2014 NHPI NHIS data. In addition, or instead, NCHS could produce 
interactive online dashboards with similar information.
    Re-fielding the NHPI NHIS would make it possible to identify 
current risk and protective factors for the full range of health and 
healthcare outcomes in the NHPI population. Those insights can then be 
used to design evidence-based, successful programs and policies, which 
can reduce illness and suffering, reduce health disparities, increase 
well-being, and ensure that limited health-related resources are used 
efficiently and effectively.
    Question. What funding would be needed to re-field this survey, and 
for what activities?
    Answer. CDC estimates that it would cost approximately $5.5 million 
to field a survey that would be comparable to the 2014 NHPI NHIS. This 
is a professional judgement, technical estimate. This estimate does not 
take into consideration competing budget priorities and constraints 
that must be considered when the President's Budget is developed. If 
additional resources were appropriated for this purpose, this funding 
could support the following activities:
Staff at Census Headquarters
  --Identify the NHPI frame and sample, using the American Community 
        Survey (ACS). The frame will consist of all people in the most 
        recent available year of the ACS reported to have an NHPI 
        racial identity, alone or in combination with one or more other 
        racial identities.
  --Update the addresses of the sample members who moved since their 
        ACS participation.
  --Modify the NHIS instrument in the limited ways necessary to 
        implement the planned sample control logic and to meet the 
        requirements of the authority governing follow-back surveys 
        that use the ACS as a frame.
  --Update the content and design of the outreach materials and 
        respondent materials and print those materials.
  --Hire extra Field Representatives (FRs) in areas of high NHPI 
        population concentration. Note: The interviewers who would 
        collect the NHPI NHIS data are called Census Field 
        Representatives (FRs).
  --Prior to data collection, update the NHPI NHIS FR training and 
        conduct that training.
  --Conduct focus groups with the FRs midway through the field period 
        and provide a written refresher training midway through the 
        field period. These efforts are designed to support culturally 
        competent field work and to improve data quality.
  --After data collection, produce the NHPI NHIS data sets and 
        documentation, including the tools needed to calculate accurate 
        estimates (weights and variance estimation variables).
  --After data collection, conduct a data quality analysis and write a 
        report on the results.
Census Field Staff
  --Participate in the training and focus groups as required.
  --Visit the homes of sample members, explain the survey, and gain 
        informed consent.
  --As necessary, work to encourage reluctant respondents to 
        participate.
  --Conduct the NHPI NHIS interviews.
    Larger sample size translates into higher likelihood that the 
resulting estimates are reliable and releasable, and higher likelihood 
that results can be disaggregated to the level desired by the NHPI 
communities, including disaggregating NH from PI.
    Question. How would the Center for National Health Statistics 
collaborate with the Office of Minority Health and the Census Bureau on 
this effort?
    Answer. The team at the U.S. Census Bureau which works with NCHS to 
plan and collect the data for the annual NHIS, and who did the same for 
the 2014 NHPI NHIS, would work with NCHS on the next iteration of the 
NHPI NHIS. NCHS would work with that team to complete the tasks 
described in the answer to question 3.
    In addition to collaboration with the Census Bureau and OMH, NCHS 
will work closely with the NHPI community. The NHPI communities devoted 
a remarkable level and diversity of support to the 2014 NHPI NHIS. NCHS 
is extremely grateful to the community members, organizations, and 
leaders who contributed their expertise, time, and effort during the 
development and outreach phases. In any future iterations of the 
survey, NCHS will again work closely with the communities, with 
respect, humility, and gratitude.
    Question. What methodological approaches could be taken to ensure 
greater representation of NHPI populations in national health surveys 
moving forward, and at more frequent intervals?
    Answer. The National Health Interview Survey (NHIS) is the United 
States' gold standard source for information on the health of the U.S. 
civilian noninstitutionalized population. The NHIS is one of the few 
sources of national NHPI health data. However, because NHPI sample 
sizes are so small, many NHPI health statistics are unreliable and are 
not released for public use. For example, the NHIS statistics for such 
important topics as cancer, chronic pain, mental health measures, and 
disability among NHPI adults are rarely releasable. Also, it is almost 
never possible to calculate reliable, releasable national health 
statistics for disaggregated NHPI groups such as Native Hawaiians and 
Samoans. To address this issue, in 2023, NHIS began producing some 
statistics for detailed race and ethnic populations using 3 years of 
NHIS data. While highly useful in many ways, these estimates obscure 
changes over time. In addition, because they are only estimates for 
single-race people, and more than half of the NHPI population also 
identifies as one or more other races, they only tell part of the 
story. This is why greater representation of NHPI populations in 
national health surveys is crucial. Obtaining greater representation of 
NHPI populations in the high quality, representative national surveys, 
which serve as the basis for evidence-based policy, such as the NHIS, 
is challenging. To understand why, it is necessary to note why the NHPI 
population is considered ``hard-to-survey'':
  --First, the NHPI population is numerically small and geographically 
        concentrated (a substantial fraction lives in certain states 
        and areas, while the rest are widely dispersed across the 
        country). Because the population is numerically small, in any 
        given area of the country in which the NHPI population is not 
        concentrated, there are very few NHPI people. Therefore, using 
        traditional oversampling strategies would require a very large 
        number of households to be screened to identify one household 
        with one or more residents who identify as NHPI. This screening 
        is a resource-intensive process.
  --Second, on average, the NHPI population is even more reluctant to 
        participate in Federal surveys than the rest of the U.S. 
        population.
Methodological Options
    The way to ensure larger NHPI sample sizes in national health 
surveys, at more frequent intervals, is to implement special sampling 
and surveying methods at regular intervals, with feasible options as 
follows:
  --Option 1: The best method would be to establish permanent recurring 
        the robust and high- quality survey methods employed in the 
        2014 NHPI NHIS and establish an agreement for NCHS to use the 
        ACS at regular intervals to identify the NHPI sample for these 
        surveys.
  --Option 2: Another option, with more drawbacks, is a periodic NHPI 
        oversample in areas with high density of NHPI population. Such 
        a sample, designed to triple the NHPI annual sample size, would 
        do nothing to increase the sample size of the NHPI population 
        who live in non-concentrated regions. It also would likely 
        yield a sample size inadequate for calculation of many NHPI 
        health estimates. Both factors would limit the utility of the 
        resulting dataset for identifying disparities between the NHPI 
        population and other Federal race groups. In addition, the 
        sample size obtained from this method would be inadequate for 
        calculating single year Native Hawaiian estimates, single year 
        Pacific Islander estimates, and disaggregated Pacific Islander 
        population estimates, all of which are of great interest 
        because of the diversity within the NHPI population. Most 
        crucially, there is the chance that this method would not yield 
        an adequate NHPI sample to calculate any reliable NHPI health 
        estimates.
    CDC collects data on certain small populations through sponsorship 
of survey questions, provided by other Federal agencies.
    Adequate sample size is needed for all federally recognized race 
groups to calculate single year reliable and releasable statistics for 
all sub-populations.
    Question. We are facing an acute children's mental health crisis in 
Hawaii, as the state has one of the highest rates of untreated 
depression among youth in the country. Contributing to these issues is 
a small workforce relative to the considerable need and too often, this 
results in delayed care.
    In light of this crisis in Hawaii and nationwide, how does the 
proposed FY24 President's Budget redirect mental health resources to 
children and youth?
    Answer. HRSA has several programs that provide mental health 
resources to children and youth, including expanding the mental health 
workforce. The FY 2024 President's Budget invests $387.4 million, an 
increase of $190.3 million above the FY 2023 Enacted level for 
Behavioral Health Workforce Development Programs, to support training 
for 18,000 providers. The increased resources will support the 
Behavioral Health Workforce Education and Training Programs for 
Professionals and Paraprofessionals, which include a focus on children, 
adolescents, and youth transitioning to adult care who are at risk for 
behavioral health disorders.
    The FY 2024 President's Budget request also supports the Opioid-
Impacted Family Support Program, which trains paraprofessionals to 
support children and families impacted by opioid use disorder and other 
substance use disorders in underserved areas.
    The FY 2024 President's Budget includes $13 million for the 
Pediatric Mental Health Care Access Program (PMHCA) to support 
statewide or regional pediatric mental healthcare telehealth access 
programs. These resources, combined with American Rescue Plan Act and 
Bipartisan Safer Communities Act funding, will allow the program to 
fund up to 65 awards in states, jurisdictions, and Tribal organizations 
across the country.
    HRSA's PMHCAP integrates behavioral health into pediatric primary 
care through state or regional networks of pediatric mental healthcare 
teams. These teams provide tele-consultation, training, technical 
assistance and care coordination. With this support, pediatric primary 
care providers can diagnose, treat and refer children to the care they 
need for behavioral health concerns. The telehealth technologies 
promote long-distance clinical healthcare, clinical consultation, and 
patient and provider education, helping to address challenges in 
accessing psychiatrists, developmental- behavioral pediatricians, and 
other behavioral health clinicians who treat behavioral concerns in 
children and adolescents.
    The FY 2024 President's Budget also includes $40 million to 
integrate behavioral health support in non-traditional community 
settings. Grants will support communities that are traditionally 
underserved or are part of a Mental Health Professional Shortage Area 
to engage and train community-based organizations (CBOs) to identify 
and address the mental health and substance use disorder (SUD) care 
needs of mothers and children.
    Th FY 2024 President's Budget also request resources to more than 
double the current Health Center Program investments in behavioral 
health services through a new $700 million behavioral health service 
expansion funding opportunity, and includes a legislative proposal to 
require all health centers provide mental health and substance use 
disorder services under Section 330 of the Public Health Service Act.
    Question. What is HRSA's Bureau of Health Workforce plan to address 
increased demand for pediatric behavioral health services at a time of 
severe workforce shortages?
    Answer. As noted above, the FY 2024 President's Budget invests 
$387.4 million, an increase of $190.3 million above the FY 2023 Enacted 
level, to grow the behavioral health workforce through Behavioral 
Health Workforce Development Programs. These programs have a particular 
focus on preparing a workforce to provide care to children, youth and 
youth transitioning to adult care.
    In addition, in FY 2023, HRSA is implementing new Pediatric 
Specialty Loan Repayment Program (LRP) which will offer the repayment 
of education loans to support pediatric medical subspecialists and 
pediatric surgical specialists, and child and adolescent mental and 
behavioral healthcare providers working full-time in or serving a HPSA, 
medically underserved area (MUA), or medically underserved population 
(MUP).
    Question. How does the FY24 President's Budget address the shortage 
of pediatric mental health beds at children's hospitals, and public and 
private hospitals?
    Answer. HRSA supports important training at children's hospitals 
which expands their capacity to provide care. In FY 2022, the 
Children's Hospitals Graduate Medical Education (CHGME) Program issued 
a total of $356 million in funds to 59 freestanding children's teaching 
hospitals across 29 states, including DC and Puerto Rico.
    This critical program is up for reauthorization in FY 2023. In FY 
2024, the President's Budget requests $385 million to allow the CHGME 
Program to continue funding 59 awards to current eligible children's 
hospitals. The Budget Request will enable HRSA to continue to support 
approximately 8,000 physician FTEs by making payments for direct and 
indirect expenses associated with operating approved graduate medical 
residency training programs.
    Question. Safety net providers (i.e., community health centers and 
rural health clinics) are the backbone of the U.S. healthcare system 
and serve as critical healthcare access points for vulnerable 
populations. Therefore, it is essential that these providers take full 
advantage of incentives, including those authorized by the Inflation 
Reduction Act, which can increase resiliency in the face of climate 
change-intensified extreme weather events.
    How has HHS communicated with safety net providers to ensure that 
federally qualified health centers, lookalikes, rural health clinics, 
critical access hospitals, and disproportionate share hospitals are 
fully leveraging IRA tax credits to invest in upgrades that will 
improve climate resilience and prevent facility closure during extreme 
weather events?
    Answer. HRSA regularly communicates with its safety net provider 
partners to share up-to-date information on a variety of resources to 
support their operations. The HRSA-supported National Training and 
Technical Assistance Partner (NTTAP) Capital Link is developing a 
publication and hosting a webinar for health centers to be released 
prior to June 30, 2023. The publication is titled ``Financing Sources 
for Resilient federally Qualified Healthcare Facilities'' which will 
include information about how health centers can utilize Inflation 
Reduction Act (IRA) tax credits in developing solar microgrids to 
remain operational during power outages. Upon the publication's 
release, a corresponding webinar will be hosted to elaborate on this 
topic, providing advice and insights from organizations that have 
successfully supported microgrid programs.
    CMS recognizes the importance of safety net providers and 
protecting the vulnerable populations that they serve. To prepare for 
current and future disasters, CMS has developed an inventory of 
Medicaid and Children's Health Insurance Program (CHIP) flexibilities 
and authorities available to states in the event of a disaster to 
support Medicaid and CHIP operations and ensure continuity of coverage 
for people served through Medicaid and CHIP programs during times of 
crisis. CMS stands ready to assist with technical support and provide 
flexibilities with resources and waivers to ensure healthcare 
facilities can continue to operate and provide access to care to those 
impacted by extreme weather events.
    Additionally, HHS has hit the ground running issuing initial 
guidance regarding implementation of provisions of the Inflation 
Reduction Act under its jurisdiction. The department prioritizes 
transparency and robust stakeholder engagement in our policy and 
operational activities and strives to communicate clearly to our safety 
net providers to ensure they are receiving the resources provided under 
the Act.
    Question. What additional resources and incentives does HHS believe 
are needed to ensure safety net providers are equipped to respond to 
climate change in their communities, such as promoting care planning 
for individuals with complex care needs who are particularly 
susceptible during extreme weather events?
    Answer. With healthcare delivery constituting roughly 20% of US 
GDP, I believe achieving extreme event resilience for the nation's 
health system, including community health and behavioral health 
centers, safety net hospitals, and other provider types beyond 
hospitals, will ultimately require investment for more direct technical 
assistance and further development of supports to meet the needs 
identified by safety net providers, support for health sector climate 
resilience work; training a sufficient workforce to lead such work; 
geospatial hazard forecasts integrated with population health 
information; and technical assistance for benchmarking high performers 
and identifying best practices for resilience planning. The HHS Office 
of Climate Change and Health Equity (OCCHE) is working all of these 
important issues. For FY23 and FY 24, the President's Budget requested 
$3 million for OCCHE, while the FY 24 President's Budget includes an 
additional $1.65 million for the Office of Environmental Justice.
    Examples of OCCHE's ongoing projects include (1) working through 
partnerships to develop ``resilience hubs'' on the ground to support 
communities addressing health disparities year-round and also serve as 
resources in times of weather extremes and disasters and (2) supporting 
safety net providers in navigating the many opportunities created by 
the Inflation Reduction Act through webinars, meetings with provider 
organizations, application assistance, and the Office's ``Quickfinder'' 
resource on leveraging the historic legislation. OCCHE will also be 
introducing a new resilience resource for use in clinical and social 
services settings in the coming weeks.
    Question. The Inflation Reduction Act included provisions that 
eliminated cost sharing for Medicare Part D and Medicaid vaccines. This 
went a long way to ensuring adults have access to recommended vaccines 
and I commend the department for the work to implement these important 
changes. The President's FY 2024 Budget includes a new proposal to 
provide access to recommended vaccines for adults who do not have 
insurance coverage.
    Why is this program being proposed, and why is vaccine access for 
uninsured adults important?
    Answer. The FY 2024 President's Budget proposes the establishment 
of a Vaccines for Adults (VFA) program to support high vaccination 
coverage among adults and reduce the spread of preventable disease by 
beginning to expand access to vaccines for uninsured adults. 
Ultimately, the program aims to reduce vaccination coverage 
disparities, improve outbreak control of vaccine-preventable diseases, 
and enhance and maintain the infrastructure needed for responding to 
future pandemics.
    Adult vaccination coverage in the United States has remained 
relatively low for all recommended vaccines, with approximately 20 
percent of adults 19 and older having received all Advisory Committee 
on Immunization Practices (ACIP)-recommended vaccines, based on a 
composite measure assessed using data from the 2018 National Health 
Interview Survey. Just 46.1 percent of those 19 and older received 
influenza vaccine, which is recommended annually for all persons 6 
months of age and older. Income level, race, ethnicity, geographic 
location, and insurance status all influence vaccination uptake. 
Improving vaccine coverage overall, as well as among those experiencing 
health disparities, will require a comprehensive public health approach 
that includes a robust adult immunization infrastructure.
    Vaccines are routinely recommended as preventative care across the 
lifespan. However, adults visit healthcare settings with less frequency 
than children and many times without a primary healthcare provider to 
provide continuity of care. Though insurance status alone does not 
predict adult vaccination rates, using influenza coverage as an 
indicator, only 16.2 percent of adults without health insurance 
received the influenza vaccine during the 2017-2018 influenza season, 
while 49.4 percent of adults with health insurance were vaccinated over 
the same period. A prior study suggested that adults with an out-of-
pocket payment of $30 for the influenza vaccine are 58 percent less 
likely to get vaccinated than adults without any out-of-pocket 
payment.\3\
---------------------------------------------------------------------------
    \3\ https://www.cdc.gov/vaccines/imz-managers/coverage/
adultvaxview/pubs-resources/NHIS-2017.html.
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    The Vaccines for Children (VFC) program was established in 1994 to 
ensure that all uninsured children under age 19 (along with children 
who are Medicaid-enrolled, underinsured, or American Indian or Alaska 
Native) have access to all vaccines recommended by ACIP. Following the 
introduction of VFC, vaccination rates for children under 19 years of 
age increased across all races, ethnicities, and income groups, and 
disparities among race and ethnic groups narrowed over time. No 
national counterpart to the VFC program exists for all uninsured 
adults. While CDC supports adult vaccination through the discretionary 
section 317 immunization program, to date, these activities have 
focused on rapid vaccination of uninsured adults in outbreak settings. 
Therefore, creating a separate Vaccines for Adults program for 
uninsured adults, would provide sustained support for immunizations 
from year to year.
    The COVID-19 pandemic has highlighted the importance of a strong 
adult immunization program for uninsured adults. The VFA program has 
been proposed to provide vaccines for uninsured adults who might not 
otherwise be vaccinated because of an inability to pay. If authorized 
and funded by Congress, this initiative would cover ACIP recommended 
vaccines for uninsured adults, including the COVID-19 vaccine.
    Question. How does the FY24 President's Budget seek to leverage and 
build on the state and local relationships established in response to 
COVID to improve access to routine vaccinations, particularly in this 
proposed program?
    Answer. During the COVID-19 pandemic, the Federal Government has 
invested critical resources into vaccine data systems, vaccine safety, 
and vaccine equity partnerships, including adult providers, such as 
pharmacies. The proposed Vaccines for Adults program would build upon 
these relations to help improve access to ACIP-recommended vaccines for 
uninsured adults.
    In addition, in 2020, CDC launched the Partnering for Vaccine 
Equity (P4VE) program to advance equity in adult immunization for 
racial and ethnic minority groups through partnerships that drive 
community-level action. While the program initially focused on urgent 
disparities in COVID-19 and influenza vaccination rates, it has built a 
far-reaching network of national, state, and local partners that are 
improving equity by reaching people directly in their communities, 
equipping ambassadors and influential messengers, and engaging people 
online and though social media.
    Since its launch, the program has provided over $156 million in 
funding to approximately 500 partners at the national, state, and local 
levels working in over 225 cities and all 50 states.
    The FY 24 President's Budget for CDC's discretionary immunization 
programs would be a critical investment to strengthen and expand 
immunization programs at the state, local, and jurisdictional level, 
particularly as it relates to vaccine confidence and equity. Improving 
vaccine confidence will require sustained and tailored approaches so 
that funded partners can address the full range of vaccine confidence 
and demand activities. Vaccine confidence and demand activities are 
also explicitly tied and prioritized to improve adult immunization 
rates; therefore, investments in vaccine confidence will contribute to 
successes in adult vaccination coverage and access, including the 
proposed VFA program.
    The FY 24 President's Budget for CDC's discretionary immunization 
programs would also be used to increase overall base grantee awards to 
sustain and modernize other critical areas of immunization 
infrastructure. These investments are all tied to strengthening 
immunization access and increasing coverage of routine vaccination, 
including modernizing Immunization Information Systems, increasing the 
jurisdictional immunization workforce to respond to increasing demands 
in outbreak preparedness, health equity, and communications, and 
supporting routine immunization ``catch-up'' work and campaigns, 
primarily for routine childhood immunizations.
    Question. How can state and local partners and community 
stakeholders help with catch-up activities for routine immunizations?
    Answer. To more effectively address declines in routine 
immunizations resulting from the COVID-19 pandemic, CDC launched the 
Let's RISE (Routine Immunizations on-Schedule for Everyone) initiative 
in January 2023. Let's RISE supports vaccination catch-up across the 
lifespan and focuses on developing a framework and working with 
healthcare personnel, health departments, public health and community 
partners, schools, and day care centers to address pandemic-related 
declines in vaccinations. The Let's RISE initiative focuses on 
prioritizing and targeting existing resources and activities to 
communities/schools that have fell behind on their vaccinations. The 
Let's RISE campaign is designed to equip partners and healthcare 
providers with actionable strategies, resources, and data to support 
getting all Americans back on schedule with their routine 
immunizations.
    CDC also continues to publish reports and hold regular meetings 
with partners, including state and local health departments and 
community partners, to share strategies for preventing and addressing 
vaccine misinformation. Achieving rapid vaccination catch-up is only 
possible with the continued coordination efforts between public and 
private public health partners at the local, state, and Federal levels.
    During the COVID Response, community-based organizations played a 
critical role in educating and assisting individuals overcome barriers 
to getting the vaccination. In part through American Rescue Plan Act 
funding, these organizations were able to hire outreach workers from 
their community. This includes events such as pop-up, school-based, 
and/or family vaccination clinics supported enhance access to COVID-19 
vaccination sites.
    Question. How would this proposed program increase routine 
vaccinations in rural and underserved areas?
    Answer. Adults aged 18-64 living in rural communities are more 
likely to be uninsured and less likely to have private insurance 
compared to those in metropolitan communities (58 percent vs. 73 
percent). The Vaccines for Adults program is critical to improving 
vaccine access and equity, particularly for rural Americans. The 
program would include enrolled providers, which could include 
pharmacies and other trusted healthcare providers. Pharmacies are 
readily accessible in communities--with most Americans living within 
five miles of a pharmacy. Recognizing this, the Federal Government made 
pharmacies a key part of its COVID-19 vaccination strategy. As of April 
13, 2023, more than 301.9 million doses of COVID-19 vaccine have been 
administered and reported by Federal Retail Pharmacy Program 
participants in the United States. This includes eight million doses 
administered onsite to residents and staff of long-term care facilities 
in the early days of the COVID-19 vaccination program.
    Building upon this successful public-private partnership, the 
Vaccines for Adults program would continue to use the enrolled provider 
model, leveraging the 64 state, local, and territorial existing 
immunization awardees to recruit providers, which could include 
community health centers, rural health clinics, local public health 
departments, private healthcare providers, and pharmacies.
    A Vaccines for Adults Program could be administered in a similar 
manner as CDC's Vaccines for Children (VFC) program. The VFC federally 
funded program provides vaccines at no cost to eligible children (i.e., 
Medicaid-enrolled, uninsured, underinsured, and American Indians/Alaska 
Natives through age 18 years) who might not otherwise be vaccinated 
because of inability to pay. Such capacity could support uninsured 
adults from rural and underserved areas in the same manner.
    There are considerable opportunities in rural areas in particular 
to expand vaccine access and uptake through trusted providers in the 
community like FQHCs and rural health clinics.
                                 ______
                                 
             Questions Submitted by Senator Joe Manchin III
    Question. West Virginia has the second highest rate of Medicare 
beneficiaries in the country, with almost 25 percent of the state's 
population on Medicare. Ensuring that this program is stable and able 
to cover benefits for our seniors is paramount to keeping the promise 
we made--that after a lifetime of hard work, seniors deserve to retire 
with dignity and peace of mind. The Congressional Budget Office 
predicts that the Medicare Hospital Insurance Trust Fund will be 
insolvent by 2033, the Medicare Trustees had previously predicted it 
could be as soon as 2028. I was proud to support the Inflation 
Reduction Act, to finally allow Medicare to negotiate the price of 
drugs. Your budget proposes utilizing the savings from these 
negotiations to help shore up the Medicare Hospital Insurance Trust 
Fund.
    Can you describe what would happen if the Medicare Hospital 
Insurance Trust Fund were to become insolvent?
    By using the savings produced from the Inflation Reduction Act, how 
many years do you expect to extend solvency by?
    Answer. Medicare is a key pillar of our healthcare system and we 
are committed to strengthening the program both now and in the future. 
Thanks to our efforts, this year's Medicare Trustees Report estimated 
that the solvency of the Medicare Hospital Insurance (HI) Trust Fund 
has been extended by 3 years--until 2031--since last year's report. If 
the HI Trust Fund's assets are depleted, Medicare could pay health 
plans and providers of Part A services only to the extent allowed by 
ongoing tax revenues--and these revenues would be inadequate to fully 
cover costs. The percentage of expenditures covered by non-interest 
income is projected to be 89 percent in 2031. Adoption of the proposals 
in the President's FY 2024 Budget would extend Medicare solvency by at 
least 25 years, without cutting benefits or raising costs for people 
with Medicare. These proposals include modifying the Net Investment 
Income Tax and dedicating its revenues to the HI Trust Fund and 
including key reforms to the tax code to ensure high-income individuals 
pay their fair share into the Medicare HI Trust Fund. Furthermore, the 
Budget builds on the Inflation Reduction Act's new Medicare Drug Price 
Negotiation Program by increasing the number of drugs subject to 
negotiation and making drugs eligible for negotiation sooner after 
their launch. The savings from this proposal, which are $160 billion 
over 10 years, are credited to the HI Trust Fund.
    Question. West Virginia, and the country, continue to face 
workforce shortages across the healthcare industry. This is especially 
true in rural areas of the state that already face significant issues 
with access to care. These shortages span across the healthcare 
spectrum: nurses, behavioral healthcare workers, EMS, direct care 
workers, and so many others. Your budget requests an increase of $190 
million for workforce development programs.
    Can you describe how your budget would not just train, but also 
help rural providers recruit and retain health providers?
    Answer. HRSA's loan repayment programs are valuable tools in 
distributing the health workforce to high needs areas. The NHSC and 
Nurse Corps provide loan repayment to providers in exchange for their 
service in high need communities and therefore helps attract and retain 
providers to work in rural communities.
    The FY 2024 President's Budget invests $965.6 million in the NHSC, 
an increase of $547.7 million. The request will maintain the field 
strength of over 20,000. Approximately 37 percent of NHSC clinicians 
work in rural areas.
    The FY 2024 President's Budget invests $92.6 million in the Nurse 
Corps program. As of September 30, 2022, more than 800 Nurse Corps 
members are serving in rural communities. Out of the Nurse Corps 
members that HRSA continues to track following their service 
commitment, 18 percent currently work in a rural community.
    HRSA also helps rural communities recruit clinicians by hosting 
NHSC job fairs to connect clinicians with sites and by supporting the 
National Rural Recruitment Retention Network (3RNet) which links 
together practice sites and tribal partners with providers who want to 
practice in rural areas.
    The FY 2024 President's Budget also invests $28 million for a new 
program to address growing concerns around healthcare workforce 
shortages-- this initiative would stimulate and develop innovative 
approaches to recruiting, supporting, and training new providers, with 
an emphasis on meeting the needs of underserved and rural communities. 
The Health Care Workforce Innovation Program will help grow the 
healthcare workforce by funding new, leading edge health profession 
education and training models that will expand the supply of healthcare 
professionals in underserved and rural areas. New approaches funded 
through this competitive initiative will aim to combat systemic 
barriers to educational opportunity, while also advancing innovative 
solutions to increase matriculation in and graduation from health 
professionals training programs, as well as the number of individuals 
who chose to provide clinical care upon graduation.
    In addition, the FY 2024 President's Budget invests a total of $416 
million for the HRSA Federal Office of Rural Health Policy (FORHP), 
which is $63 million above FY 2023 Enacted, for grants to increase 
healthcare access, strengthen healthcare networks, and focus on 
quality- of-care improvements for Critical Access Hospitals, small 
rural hospitals, and Rural Emergency Hospitals. This includes a request 
of $13 million for the Rural Residency Planning and Development Program 
to fund an additional 15 new awards and increased technical assistance 
to support creation of new rural residency programs that recruit and 
retain new physicians in rural areas. Additionally, the FY 2024 
President's Budget for rural health includes $10 million for a new 
Rural Health Clinic Behavioral Health Initiative to expand access and 
increase workforce for behavioral health and mental health services in 
rural communities.
    Question. What can the Department do to help ensure rural hospitals 
and healthcare professionals in places like West Virginia can access 
rural healthcare workforce development and training programs?
    Answer. HRSA's FORHP supports technical assistance to support the 
establishment and operation of rural residency training programs. The 
Rural Residency Planning and Development Technical Assistance (RRPD-TA) 
Program provides webinars, Technical Assistance advisors, and toolkits 
to RRPD grantees. Limited free resources are available via the HRSA 
funded RuralGME.org portal to other organizations interested in rural 
residency development, such as the new and improved Rural GME Hospital 
Analyzer tool.
    In addition, several of the HRSA workforce training programs 
include funding priorities for grant applicants who will benefit rural 
communities. The Primary Care Training and Enhancement (PCTE) Program 
aims to strengthen the primary care workforce by supporting training 
for future primary care clinicians and faculty and promoting primary 
care practice, particularly in rural and underserved areas. Through the 
PCTE Program, HRSA provided direct financial support to almost 12,000 
individuals who received training in medically underserved/rural areas.
    Many of HRSA's nursing workforce programs also include a particular 
focus on rural service. For example, the Advanced Nursing Education 
Programs increase the number of qualified nurses in the primary care 
workforce by funding enhancements of training and practice of advanced 
nurses and traineeships for nursing students. Grant applications with 
projects that substantially benefit rural or underserved populations or 
help public health nursing needs in state or local health departments 
receive a funding preference. Another example is the Nurse Education, 
Practice, Quality and Retention (NEPQR) Programs, which aim to increase 
the number of nursing students exposed to meaningful clinical 
experiences and training in medically underserved and rural 
communities, who will then be more likely to choose to work in these 
settings upon graduation.
    Additionally, the NHSC and Nurse Corps programs improve the 
distribution of health professionals to underserved areas. Of the more 
than 20,000 NHSC participants, 36.8 percent serve in a rural community, 
and of the more than 3,900 Nurse Corps participants, 21.3 percent are 
currently serving in a rural community. The NHSC program also includes 
the NHSC Rural Community Loan Repayment Program, which supports those 
working to combat the opioid epidemic in rural communities. The total 
number of NHSC clinicians serving in rural communities has increased by 
59 percent between FY 2017 and FY 2020.
    Participants in HRSA's workforce programs who choose to serve at 
HRSA-funded Health Centers, Rural Health Clinics and small rural 
hospitals often decide to continue to serve in these communities after 
their service obligation ends.
    Question. The Health Resources and Services Administration (HRSA), 
which administers these programs, does not recognize several Critical 
Access Hospitals in West Virginia as rural, what is your Department 
doing to ensure rural hospitals and health centers are accurately 
recognized and made eligible for this funding?
    Answer. FORHP uses the Office of Management and Budget (OMB)'s list 
of counties designated as part of a Metropolitan Statistical Area (MSA) 
as the basis for determining whether an area is considered rural for 
purposes of its rural health grant programs. FORHP also designates 
census tracts within MSAs as rural for grant purposes using Rural-Urban 
Commuting Area (RUCA) codes from the Economic Research Service (ERS) of 
the U.S. Department of Agriculture (USDA).
    Beginning with FY 2022 Rural Health grants, FORHP expanded its 
existing rural definition by adding outlying MSA counties with no 
Urbanized Area (UA) population to its list of areas considered rural.
    We continue to collaborate with our Federal partners, including the 
USDA's ERS, to find ways to improve the definitions we use. Currently, 
of the 55 counties in West Virginia, we recognize 52 counties as rural 
or partially rural. For those CAHs in West Virginia that lie outside of 
FORHP-delineated rural areas, we would note the recent eligibility 
expansion for FORHP's rural healthcare services outreach grants. Now 
entities outside of FORHP-delineated rural areas, including all WV 
CAHs, are eligible to receive these grants.
    Question. The drug epidemic continues to ravage our country, in 
particular my home state of West Virginia. The national average of drug 
overdose rate is roughly 31 deaths per 100,000 persons with West 
Virginia ranking number one with over 90 deaths per 100,000 persons. We 
know we need to do more. I have continually fought for a set aside in 
funding to go to states with the highest rate of overdose, like West 
Virginia, where it is desperately needed. This epidemic is continually 
changing, from prescription opioids, to heroin, and now fentanyl. 
Fentanyl is a particularly deadly synthetic opioid, up to 50 times 
stronger than heroin and 100 times stronger than morphine. And now 
we're finding counterfeit pills, like Adderall or Percocet, laced with 
fentanyl in lethal doses.
    What is your department doing to address the rise in illicit 
fentanyl?
    Answer. The Department of Health and Human Services (HHS)'s 
Substance Abuse and Mental Health Services Administration (SAMHSA) is 
focused on using evidence-based strategies to save lives, including 
distribution and training for how to administer naloxone and 
distribution of fentanyl test strips (FTS) as well as expanding 
medications for opioid use disorder (MOUD) to the most under resourced 
communities, to address this crisis and prevent further overdose 
deaths. One key policy change directly related to addressing the rise 
in illicit fentanyl was that the CDC and SAMHSA announced on April 7, 
2021, that certain Federal funding could be used to purchase fentanyl 
test strips to help address the overdose crisis.\4\
---------------------------------------------------------------------------
    \4\ Federal Grantees May Now Use Funds to Purchase Fentanyl Test 
Strips, SAMHSA (Apr. 7, 2021), https://www.samhsa.gov/newsroom/press-
announcements/202104070200.
---------------------------------------------------------------------------
    SAMHSA's Fiscal Year 2024 Budget request includes several 
noteworthy programs intended to address this issue. The first program 
is the Strategic Prevention Framework for Prescription Drugs (SPF-Rx). 
SAMHSA requested an additional $5 million, which will be used to reach 
more underserved populations, ensuring that they receive important 
technical support for decreasing prescription drug misuse. In our FY24 
budget request, SAMHSA also requested $50 million for a new Community 
Harm Reduction and Engagement Initiative, which will help support 
services such as distribution of FTS, to 330,000 people.
    Additionally, SAMHSA funds the First Responders--Comprehensive 
Addiction and Recovery Act (FR-CARA) program that trains and equips 
firefighters, law enforcement officers, paramedics, emergency medical 
technicians, and volunteers in other organizations to respond to 
adverse overdose-related incidents, including how to administer 
naloxone. During the program's recent project period, each state 
developed a strategic action plan for combatting opioid misuse and 
deaths related to heroin and illicit fentanyl.
    Another program that SAMHSA administers is the Grants to Prevent 
Prescription Drug/Opioid Overdose-Related Deaths (PDO), which supports 
training for first responders and other key community sectors on the 
prevention of prescription drug/opioid overdose-related deaths and 
teaches participants how to implement secondary prevention strategies, 
including the purchase and distribution of naloxone to first 
responders. Since the program began, PDO grantees have conducted 48,975 
trainings, and has trained 167,683 individuals on naloxone usage and 
administration. Collectively, PDO grantees have distributed 323,286 
naloxone kits with grant funds and administered naloxone 36,925 times.
    SAMHSA's Medication-Assisted Treatment-Prescription Drugs and 
Opioid Addiction (MAT-PDOA) grants provide resources to help expand and 
enhance access to medications for opioid use disorder (MOUD). Access to 
MOUD is key to decreasing illicit opioid use and prescription opioid 
misuse, including the use of illicit fentanyl or substances laced with 
fentanyl. Evidence has demonstrated that MOUD, in the form of 
buprenorphine and methadone, is associated with significant reductions 
in overdose mortality by over 50%.\5\ There are currently two active 
MAT-PDOA cohorts of grantees totaling $93,897,952 for 156 grantee 
organizations.
---------------------------------------------------------------------------
    \5\ Wakeman SE, Larochelle MR, Ameli O, et al. Comparative 
Effectiveness of Different Treatment Pathways for Opioid Use Disorder. 
JAMA Netw Open. 2020;3(2):e1920622. doi:10.1001/
jamanetworkopen.2019.20622.
---------------------------------------------------------------------------
    Finally, SAMHSA's State Opioid Response (SOR) program addresses the 
opioid crisis by increasing access to MOUD including the three FDA-
approved medications for the treatment of opioid use disorder (OUD), 
reducing unmet treatment need, and reducing opioid overdose related 
deaths through the provision of prevention, treatment, and recovery 
activities for OUD (including prescription opioids, heroin and illicit 
fentanyl and fentanyl analogs). These grants are awarded to states and 
territories via formula. The SOR program also includes a set-aside for 
states with the highest mortality rate related to drug overdose deaths. 
The most recent SOR application, also required states to develop a 
naloxone saturation plan, to aid in the distribution and saturation of 
naloxone in the community.
    Question. I appreciate the Department's efforts towards 
implementing the Jessica Grubb's Legacy Act. The Legacy Act was passed 
as part of the CARES Act in March 2020. This law reduces barriers for 
treating persons with substance use disorder and allows medical 
professionals to access the vital information they need to properly 
coordinate the care of their patients with substance use disorder. I 
was pleased to see the Department issue proposed regulations last fall 
to finally implement this law, and improve care coordination for 
patients with substance use disorder.
    What is the Department's timeline to implement the final rule of 
the Legacy Act?
    Answer. HHS anticipates publishing a final rule on the proposed 
modifications to the confidentiality of substance use disorder records 
(42 CFR part 2), as required by section 3221 of the Coronavirus Aid, 
Relief, and Economic Security (CARES) Act, in the last quarter of 2023.
    Question. Vaccines are vital to protecting and preserving the 
health and economic well-being of older adults, the chronically ill, 
and entire communities. Every year, thousands of turn to their trusted 
community pharmacists to receive their vaccinations. Community 
pharmacists are often the only health provider in rural areas, making 
them an important part of the healthcare system, and ensuring our 
seniors receiving their vaccines. Under the Public Readiness and 
Emergency Preparedness Act or PREP Act--pharmacists were given the 
authority to provide recommended vaccinations for children ages 3-18. 
The PREP Act declarations made it clear that these authorities would 
continue until October 1, 2024.
    Mr. Secretary, can you please confirm that you plan to keep this 
public health authorization for pharmacists to provide childhood 
vaccinations for ages 3-18, in place until October 1, 2024?
    Answer. As HHS Secretary, my role is to implement the law. The 
Department will follow all applicable laws as they relate to any issue.
    Question. Osteopathic medicine is the fastest growing medical field 
in the country according to the U.S. Bureau of Health Professions. 
Osteopathic medical schools currently educate more than 35,000 
physicians --25% of all U.S. medical students. Osteopathic medicine 
provides all of the benefits of modern medicine including prescription 
drugs, surgery, and the use of technology to diagnose disease and 
evaluate injury. It also offers the added benefit of hands-on diagnosis 
and treatment through a system of treatment known as osteopathic 
manipulative treatment. Do students gain significant experience 
training in diverse healthcare settings, such as community hospitals 
and other health facilities. In many schools, a community-based primary 
care rotation in a rural or underserved area is a fourth-year training 
requirement.
    What HHS programs or initiatives address the services provided by 
Doctors of Osteopathic Medicine (DOs) or Colleges of Osteopathic 
Medicine
    Answer. All of HRSA's Bureau of Health Workforce programs that 
support medical training are available to Colleges of Osteopathic 
Medicine. Similarly, DOs are eligible to participate in all HRSA 
programs available to physicians, such as the NHSC.
    HRSA funds the Rural Residency Planning and Development Program 
(RRPD) to support creation of new rural residency programs. For the 
purposes of this funding, rural residencies are allopathic and 
osteopathic physician residency programs. A number of grantees past and 
present have developed or are developing partnerships with Colleges of 
Osteopathic Medicine. One RRPD grantee, the Cherokee Nation Family 
Medicine Rural Residency Program in Tahlequah, Oklahoma, has also 
achieved Osteopathic Recognition from the Accreditation Council for 
Graduate Medical Education.
    The FY 2024 President's Budget request also includes $5 million for 
the Maternal and Child Heath Bureau to support a new Training for 
Health Care Providers program to fund up to 10 training grants to 
institutions of higher learning, which include accredited schools of 
osteopathic medicine. The program aims to:
  --Develop and provide evidence-informed training and curricula to 
        support maternal health providers in addressing bias through 
        both experiential and instructor-led learning;
  --Engage faculty and trainees in research to expand the evidence base 
        on strategies to address bias among maternal health providers; 
        and
  --Engage community-based organizations and individuals with lived 
        experience in the development, implementation and evaluation of 
        training and research activities.
                                 ______
                                 
          Questions Submitted by Senator Shelley Moore Capito
Implementation of the Technical Reset to Advance the Instruction of 
        Nurses (TRAIN) Act (Section 4143 of the Consolidated 
        Appropriations Act (CAA) for fiscal year 2023)
    Question. The TRAIN Act ensures eligible hospital-based nursing 
schools and other allied health training programs be held harmless for 
excess funds inadvertently disbursed by the Centers for Medicare & 
Medicaid Services as part of Medicare Advantage Nursing and Allied 
Health Professional Education Payments in past years. CMS recently 
issued a Transmittal Notice (number 11904/change request 13122) that 
lays out a very complicated formula that describes how the nursing and 
allied health schools will be repaid. My office and Senator Brown's 
office worked closely with CMS on the language that is now section 4143 
of the CAA to ensure full reimbursement of the clawed back funds for 
the impacted schools. Why is this full reimbursement not occurring? 
What will CMS do to correct and ensure these schools are made whole?
    Answer. CMS is working to clarify any confusion and is committed to 
implementing this provision of the CAA, 2023 correctly. CMS commits to 
engaging with interested Congressional offices upon implementation.
Infant Formula Shortage
    Question. With the knowledge that only four companies make up 
approximately 90% of the infant formula market, what is the 
Administration doing to diversify the market?
    Answer. FDA is a food safety agency and works to support improved 
nutrition, including for our youngest consumers, and we have very 
limited authority and ability to impact market concentration and 
monitor supply chains in real time. FDA is committed to doing 
everything within our authorities to ensure the safety and availability 
of infant formula. For instance, when the shortage became apparent, FDA 
sought to help increase the availability of safe and nutritious infant 
formula in the U.S. market by temporarily exercising enforcement 
discretion, on a case-by-case basis, for certain requirements that 
apply to infant formula. Twelve manufacturers brought their infant 
formula products into the U.S. market under this flexibility. Recently, 
in order to facilitate longer-term availability of such infant formula 
and help diversify manufacturers providing infant formula in the U.S. 
market, FDA issued a Transition Plan guidance that outlines a path for 
interested firms marketing infant formula in the U.S. under the 
exercise of enforcement discretion to bring those products into 
compliance with all U.S. requirements. As a result, the number of 
manufacturers providing formula to the U.S. market has doubled, and in-
stock rates have generally returned to pre-recall levels. Further, on 
March 28, 2023, FDA released its Immediate Strategy to Increase the 
Resiliency of the U.S. Infant Formula Market, detailing the Agency's 
plans for improving the resiliency of the supply.
    FDA is also committed to reviewing new infant formula submissions, 
recognizing that new infant formula entrants are able to help increase 
the diversity of the infant formula market. In 2022, there were a total 
of 152 complete submissions for FDA review, of which 44 were new infant 
formula submissions and 81 were before first processing reviews 
(involving only minor changes in formula or processing).
    While FDA is doing what we can within our authorities, preventing 
future shortages will likely require attention from other Federal 
agencies, including those with responsibility over market 
concentration, as well as those that have tremendous purchasing power 
in the market. Currently, the Federal Trade Commission is conducting a 
review of the market in which FDA has provided additional information, 
as has the U.S. Department of Agriculture regarding the Special 
Supplemental Nutrition Program for Women, Infants and Children. Most 
recently, the Food and Drug Omnibus Reform Act of 2022 required 
manufacturers to provide notification regarding certain events that may 
cause supply disruptions and to create risk redundancy plans to ensure 
increased resiliency in the event of future disruptions. Effectively 
diversifying this market requires a whole of government approach 
because FDA has limited charge over supply chain issues.
    Question. Can you tell us what the Administration is doing to 
equalize treatment between foreign and new domestic entrants? Moreover, 
how quickly can this occur?
    Answer. Foreign and new domestic entrants are treated the same, 
regardless of the manufacturer's location. FDA will continue to work 
with all manufacturers currently marketing infant formula in the U.S. 
market, including infant formulas subject to FDA's enforcement 
discretion, as well as with manufacturers who seek to enter the U.S. 
market, to ensure timely and thorough review of submissions. Any 
product new to the U.S. marketplace receives a detailed review so 
Americans can be assured that these products are safe and nutritionally 
adequate.
    In each case where FDA has exercised enforcement discretion, FDA 
has conducted a careful review of information pertaining to safety and 
nutritional adequacy of an infant formula product prior to its entrance 
into U.S. commerce. Under a guidance \6\ issued in September 2022, FDA 
provided a pathway for manufacturers of infant formula products that 
received a letter of enforcement discretion based on the May 2022 
guidance,\7\ which outlined flexibilities to market certain infant 
formula products including via importation, to continue marketing these 
products while they work toward meeting all applicable FDA 
requirements. Under the September 2022 guidance, the period of 
enforcement discretion for these products was extended for firms that 
express interest in and take steps toward remaining on the U.S. market.
---------------------------------------------------------------------------
    \6\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-infant-formula-transition-plan-exercise-
enforcement-discretion.
    \7\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-infant-formula-enforcement-discretion-
policy.
---------------------------------------------------------------------------
    FDA will also continue to regularly inspect infant formula 
manufacturing facilities to ensure appropriate oversight of infant 
formula manufacturing and fulfill the new requirement for annual 
inspection of registered infant formula facilities. The Agency believes 
these efforts are essential to increasing production, both domestic and 
foreign, in support of a consistent, safe, and nutritionally adequate 
infant formula supply with a diversity of manufacturers. FDA typically 
conducts routine surveillance inspections of infant formula facilities 
on an annual basis, and the Agency is committed to continuing this for 
all infant formula facilities, both domestic and foreign. In 
circumstances where inspectional observations warrant or compliance 
follow-up is needed, a re-inspection may be conducted within a shorter 
interval. In 2022, FDA conducted inspections at all 24 domestic infant 
formula facilities scheduled for inspection, as well as all 6 foreign 
infant formula facilities that served the U.S. market. These efforts 
would be further buoyed in the years ahead by additional funding FDA is 
requesting in the FY 2024 President's Budget.
    Question. Can you address what other measures are actively being 
taken to ensure that a tragedy such as this never happens again?
    Answer. FDA has taken a great number of measures to reduce the 
potential of a similar incident occurring in the future. However, it 
should be noted that it is not possible to completely prevent another 
outbreak and industry remains concentrated in the U.S. Further, the 
infant formula industry ultimately has the primary responsibility to 
produce safe, nutritious, and high-quality infant formula.
    Since February 2022, the Agency has had ongoing and extensive 
engagement with the infant formula industry to identify and implement 
opportunities to strengthen preventive control practices and engage on 
the development and refinement of the FDA's Strategy to Help Prevent 
Cronobacter sakazakii Illnesses Associated with Consumption of Powdered 
Infant Formula (released November 15, 2022). FDA food safety experts 
have engaged with industry, state, international, and other partners 
to: explore environmental factors that may contribute to contamination 
in facilities; review issues related to specific foodborne hazards to 
identify potential mitigation measures or knowledge gaps; review 
regulations to identify provisions that may be strengthened; identify 
prevention measures that can be taken to reduce future incidences of 
foodborne illness; and identify knowledge gaps to expand our 
understanding of food safety issues and limit recurrences of underlying 
root causes responsible for contamination.
    Already, the Agency is seeing actions advanced through the 
prevention strategy that will help to prevent recurrence of 
contamination. FDA food safety experts have advanced a charge through 
the National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF) to gain scientific insight on possible industry and public 
health interventions to address Cronobacter infections associated with 
powdered infant formula. The Agency has engaged with the National 
Academy of Science, Engineering and Medicine (NASEM) to examine and 
report on challenges in the supply, market competition, and regulation 
of infant formula in the U.S.
    Furthermore, on March 28, 2023, FDA released its Immediate Strategy 
to Increase the Resiliency of the U.S. Infant Formula Market detailing 
the Agency's plans for improving the resiliency of the supply. This is 
the first step toward issuing, with input from the NASEM, a long-term 
strategy in 2024 to improve preparedness and explore new approaches to 
help facilitate entry of new manufacturers to increase supply and 
mitigate future shortages.
    FDA will continue to build on these efforts throughout FY 2023 as a 
result of $7.5 million in additional funding provided by Congress for 
infant formula-related activities. This is enabling the Agency to hire 
16 new full-time equivalents (FTE) in the Center for Food Safety and 
Applied Nutrition. FDA's FY 2024 request contains an additional $21 
million to further expand its work in this area.
    However, the infant formula industry needs to take its 
responsibility to produce safe food more seriously. FDA has reviewed 
conditions during recent inspections of powdered infant formula 
manufacturers and has identified numerous areas for improvement across 
the infant formula industry. The Agency outlined these areas for 
improvement in a March 8, 2023, letter, which was a call to action for 
all members of the infant formula industry to help protect our most 
vulnerable population by, among other things, evaluating established 
systems of production and in-process controls and ensuring that 
appropriate controls are implemented at any point, step, or stage in 
the production process where control is necessary to prevent 
adulteration of infant formula. In addition, the infant formula 
industry is now required to establish and implement risk redundancy 
plans, to minimize the impact of any future disruptions in production. 
Industry must ensure they are producing formula consistent with high 
U.S. food safety standards and maintaining their facilities so recalls 
and shutdowns are minimized.
Tardive Dyskinesia (TD)
    Question. The Fiscal Year (FY) 2022 Consolidated Appropriations Act 
included report language encouraging HHS to prioritize the importance 
of screening for, diagnosing, and treating TD and to report to Congress 
outlining resources. Could you please provide an update on what steps 
HHS has taken to fulfill this request from Congress, which agency or 
office is leading this effort, and when the report to Congress should 
be expected?
    Answer. Tardive dyskinesia (TD) is a serious, persistent, and 
disruptive involuntary movement disorder characterized by 
uncontrollable, abnormal, and repetitive movements of the face, torso, 
and/or other body parts. TD may be disruptive to people's lives due to 
the symptoms themselves and the impact they have on emotional and 
social well-being.
    TD is caused by prolonged use of treatments that block dopamine 
receptors in the brain. These treatments include antipsychotic 
medications commonly prescribed to treat mental illnesses such as 
schizophrenia, bipolar disorder, and depression, and certain anti-
nausea medications. In individuals with TD, these treatments are 
thought to result in irregular dopamine signaling in a region of the 
brain that controls movement. Though most cases of TD occur after an 
individual has taken a prescribed medication for years, some may occur 
with shorter use.\8\ Often physicians will try to stop, reduce, or 
modify antipsychotic treatment; however, there is little evidence to 
support the efficacy of this practice. In 2017, the U.S. Food and Drug 
Administration approved valbenazine (Ingrezza) and deutetrabenazine 
(Austedo) as treatments for TD.
---------------------------------------------------------------------------
    \8\ rarediseases.org/rare-diseases/tardive-dyskinesia/
?filter=complete-report.
---------------------------------------------------------------------------
    NIH supports basic scientific research and clinical trials research 
that, through different approaches, may enable a more complete 
understanding of the causes of TD. These projects have included 
investigations of the neural structures implicated in TD, novel 
treatments for various mental illnesses that could be used in place of 
current dopamine blocking treatments that can lead to TD, and 
approaches for monitoring and treating drug side effects, including TD. 
Taken together, this work may yield important insights to improve the 
lives of those living with the disorder.
Access to Care for Obesity
    Question. The Committee previously encouraged CMS to ensure 
beneficiary access to care for obesity if it was determined to be 
clinically appropriate by a patient's physician. How has CMS addressed 
this issue to ensure access to therapies, including anti-obesity 
medications, for Medicare beneficiaries who struggle with obesity and 
comorbid chronic conditions?
    Answer. As detailed by the White House National Strategy of Hunger, 
Nutrition, and Health,\9\ the Administration set a goal of ending 
hunger and increasing healthy eating and physical activity by 2030 so 
fewer Americans experience diet-related diseases--while reducing 
related health disparities. Integrating nutrition and health can 
optimize Americans' well-being and reduce healthcare costs. Currently, 
only a limited number of Medicare beneficiaries are seeking nutrition 
and obesity counseling services. The President's FY 2024 Budget 
includes a proposal to expand access to additional beneficiaries with 
nutrition or obesity-related chronic diseases and make additional 
providers eligible to furnish services.
---------------------------------------------------------------------------
    \9\ https://www.whitehouse.gov/wp-content/uploads/2022/09/White-
House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf.
---------------------------------------------------------------------------
    Currently, Medicare covers an array of services that aim to address 
obesity. For example, obesity screenings, intensive behavioral therapy 
for obesity for the prevention or early detection of illness or 
disability, bariatric surgical procedures, and diabetes screenings and 
participation in a diabetes prevention program are covered under 
Medicare in certain cases.
    Under current law, the Medicare statute excludes ``agents when used 
for anorexia, weight loss, or weight gain'' from the definition of a 
Part D drug in section 1860D-2(e) of the Social Security Act. Despite 
this statutory exclusion, Part D sponsors wishing to provide coverage 
of prescription weight loss agents may do so as a supplemental benefit 
to enhanced alternative Part D plans, as they can with other 
prescription drugs that are excluded from the definition of a Part D 
drug.
Mental Health/988 Lifeline
    Question. This Subcommittee has made great investments in suicide 
prevention activities and has supported, at every turn, the effort to 
launch the three-digit, 988 Lifeline that started last summer. In fact, 
Congress provided a four-fold increase of nearly $400 million in FY2023 
to support these critical activities, on top of roughly $270 million 
provided through emergency supplemental and mandatory funding across 
the last few years. The budget requests yet another substantial 
increase of nearly $334 million without much detail. What is the true 
driver of these increased costs? Please provide a breakdown of 
requested increase by activity.
    Answer. The 988 Suicide and Crisis Lifeline's successful launch in 
July 2022 has generated a significant increase in month-to month 
contacts to the Lifeline. Moving to an easy-to-remember number provided 
an easier way to access a strengthened and expanded network of crisis 
call centers. The 988 Lifeline data for March 2023 showed an increase 
in overall volume compared to March 2022. The 988 Lifeline answered 
164,337 more contacts (calls, chats and texts) and significantly 
improved how quickly contacts were answered. The average speed to 
answer across all contacts decreased from 168 seconds to 36 seconds. In 
March 2023 vs. March 2022, calls answered increased by 47%, chats 
answered increased by 136%, and texts answered increased by 1299%.
    In FY 2023, Lifeline volume is expected to continue to increase to 
6 million contacts. Further, national data indicate an alarming trend 
of increased suicidality in adults and youth. Provisional data from 
CDC's National Center for Health Statistics indicate that the number 
and the rate of suicides in the United States increased by 4% from 2020 
to 2021, after two consecutive years of decline in 2019 and 2020. In 
addition, results from SAMHSA's 2021 National Survey on Drug Use and 
Health (NSDUH) indicate that approximately 12.3 million adults aged 18 
or older had serious thoughts of suicide in the past year, and 1.7 
million attempted suicide. Data from the NSDUH also indicated that 
approximately 3.3 million youth aged 12 to 17 had serious thoughts of 
suicide, and nearly 900,000 youth attempted suicide. In sum, the need 
for the Lifeline, suicide prevention, and crisis care services 
continues to rise nationwide, hence the need for more resources to 
combat it.
    The requested FY24 Lifeline increase will fund local crisis call 
centers, support network operations, enable critical media campaigns, 
and maintain the 988 Behavioral Health Crisis Coordinating Office 
operations. Additionally, funds within the network operations budget 
will be invested in services for specialized populations, including 
people who are LGBTQI+, and services for Spanish speakers. The FY24 
President's Budget request for the Lifeline is detailed by activity 
below:
  --An increase of $3 million for the 988 Behavioral Health Crisis 
        Coordinating Office.
  --An increase of $287.9 million for 988 network crisis centers and 
        back-up centers to respond to calls, texts, and chats; provide 
        referrals to crisis care services; and to enhance regional and 
        local response capacity tailored for diverse communities. This 
        funding also supports specialized services, technical 
        assistance, and administrative overhead costs.
  --An increase of $43.5 million to support a national public awareness 
        and behavior change communications campaign focused on 
        populations known to be at high risk of suicide, building upon 
        formative research launched earlier in FY 2022, including 
        targeted national campaigns focused on promoting help seeking 
        behavior.
    Question. How much of the FY2023 appropriation for the 988 Lifeline 
is staying within SAMHSA for administration, beyond the $10 million set 
aside for the 988 Coordinating Office, and how much of the FY2023 
appropriation is funding state and local crisis centers versus the 
contractor administering the system? Please provide a breakdown of 
FY2023 988 Lifeline obligations by activity.
    Answer. For FY 2023, the $501,618,000 appropriated for the 988 
Lifeline will be obligated as follows:
  --$348,118,000 for to support the capacity of 988 network crisis 
        centers and back-up centers to respond to calls, texts, and 
        chats and provide referrals to crisis care services. This 
        funding also supports specialized services, technical 
        assistance, and administrative overhead costs.
  --$140,000,000 for administering and overseeing network operations, 
        training, and infrastructure. This funding will be directed 
        toward the 988 administrators.
  --$7,000,000 is for the 988 & Behavioral Health (BH) Crisis 
        Coordination Office to provide technical assistance to states, 
        and crisis centers; strategic planning, performance management, 
        evaluation, and oversight; and will be allocated to support 
        formal partnerships, convenings, and cross-entity coordination.
  --$6,500,000 will be allocated to support a national public awareness 
        and behavior change communications campaign to conduct 
        targeted, foundational work to better understand the needs of 
        populations at high risk of suicide and to continue other 
        critical communication efforts supporting public awareness and 
        education on 988.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran
    Question. Mr. Secretary, COVID revealed the inadequacies of our 
domestic capacities and supply chains, particularly relating to the 
development and production of biological products such as vaccines. I 
was pleased that the Department created a new industrial base expansion 
office and that BARDA issued a request for information last year about 
creating a biomanufacturing surge capacity rapid response network in 
response to this issue. Can you tell the Subcommittee the status of 
these efforts, and particularly how much funding has been allocated?
    Answer. Using over $16 billion provided across COVID-19 emergency 
supplementals, ASPR's Industrial Base Management and Supply Chain 
(IBMSC) Office has awarded over 87 contracts to support manufacturing 
domestic supplies, including masks, gloves, gowns, diagnostics, and 
advanced manufacturing of drug substances and drug products. We are 
currently manufacturing much more PPE domestically than previous 
capacity allowed; however, continued sustainment of these capacities, 
as requested in the FY 2024 Budget, is required to ensure these 
manufacturing capacities remain. This includes capacity for PPE final 
products as well as some of the raw materials, such as Nitrile 
Butadiene Rubber (NBR) and other key chemicals necessary for 
manufacturing the nitrile gloves. This also includes manufacturing 
capacities for diagnostics and drug products. These efforts support the 
Make PPE in America Act portion of the Infrastructure Investment and 
Jobs Act, which requires that all raw materials for PPE purchased by 
HHS, VA, and DHS be made in the United States. These efforts to 
streamline and clarify Federal Government demand signals mentioned 
above will also help manufacturers achieve economies of scale, thus 
narrowing cost differentials while promoting supply chain resilience.
    The SNS is also working to ensure compliance with the Make PPE in 
America Act. Purchasing critical MCMs and PPEs domestically reduces the 
risk of relying on international partners. We learned during the COVID-
19 pandemic that the supply chain can fail; having an SNS that relies 
on foreign manufacturing and production of critical products is not the 
best choice for national security. When and where possible, the SNS 
looks to domestic sourcing for products to include in the stockpile. 
The FY 2024 Budget requests funding for SNS to implement requirements 
outlined in the Make PPE in America Act. While domestic material is 
generally more expensive than internationally sourced product due to 
manufacturing protocols, requirements, and to adhere to production 
policies and regulations, relying on foreign sourcing is not the best 
preparedness posture and we experienced this first hand during the 
COVID-19 response. CMS recognizes that hospitals may incur additional 
costs when purchasing domestic NIOSH-approved surgical N95 respirators. 
Therefore, CMS finalized our FY 2023 proposal to provide payment 
adjustments under the IPPS and OPPS that would reflect, and offset, the 
additional marginal resource costs that hospitals face in procuring 
domestically made NIOSH-approved surgical N95 respirators. Under this 
policy, these payments would be provided biweekly as interim lump-sum 
payments to the hospital and would be reconciled at cost report 
settlement. The rule also outlines the information that would be 
collected on the cost report to determine payments under this policy, 
which would apply to cost reporting periods beginning on or after 
January 1, 2023.
    The $400 million requested in FY 2024 for Pandemic Preparedness and 
Biodefense will support continued investments to strengthen and 
maintain domestic manufacturing capacity. In addition, the FY 2024 
Budget requests authority for acquisition, construction, or alteration 
of non-federally owned facilities that would allow ASPR to continue to 
onshore and build domestic manufacturing capacity for critical 
components of the medical supply chain in partnership with the private 
sector. COVID-19 emergency supplemental legislation provided similar 
authorities which ASPR has used to support the construction of new 
factories nationwide for COVID-19 related medical supplies.
    This authority is requested as part of a suite of legislative 
proposals to provide the authorities HHS needs to enhance early 
detection and response to public health threats and supply disruptions; 
build domestic manufacturing capacity for and otherwise advance safe, 
effective supplies and medical countermeasures; facilitate a response-
ready workforce; and enhance recovery.
    Question. Will any of the increase for ASPR or BARDA provided in 
the FY2023 Omnibus be used for these efforts?
    Answer. It is important to note that the increase in FY 2023 
Omnibus funding for BARDA will not be used to support domestic 
manufacturing efforts. The additional funding will advance the 
development of medical countermeasures (MCMs) across BARDA's threat 
areas, support transformative science and technology to strengthen 
national and global health security through BARDA Ventures, and help 
the program maintain a world-class workforce that continues to respond 
to the COVID-19 pandemic as well as numerous other PHEs and outbreaks 
caused by CBRN and pandemic influenza threats.
    Related to investments in domestic manufacturing, BARDA was able to 
respond swiftly to the COVID-19 pandemic, awarding 27 capacity 
expansion efforts during FY20--FY22 to mitigate bottlenecks in the 
domestic supply chain and reduce our dependence on foreign suppliers of 
the ingredients, raw materials, and consumables required during vaccine 
manufacturing. These efforts, including expanding domestic capacity or 
onshoring production of critical raw materials, manufacturing 
consumables, and expansion of fill/finish manufacturing, increased 
capacity for sterilization of components, vials, and needles and 
syringes. To meet the requirement of achieving domestic capacity 
expansions to support 600 million vaccine doses in six to 9 months, 
BARDA awarded 11 Technology Investment Agreements, 14 Cooperative 
Agreements, and two FAR-based contracts that allow for cost-sharing 
between the USG and industry partners. Most awards include a negotiated 
10-year priority access period post-construction that allows the USG 
access during future public health emergencies (PHEs).
    Question. What funding requested in the FY2024 budget will be used 
for these efforts?
    Answer. ASPR is investing in securing a strong domestic 
manufacturing base infrastructure to produce essential products such as 
medical devices, pharmaceuticals, and personal protective equipment. 
With the reorganization in February 2022, ASPR established the IBMSC 
Office and is requesting funds in the FY 2024 President's Budget to 
support this office and its important work.
    The $400 million requested in the FY24 President's Budget will also 
ensure we are able to maintain the capabilities built and used 
extensively during the COVID-19 pandemic to strengthen development and 
manufacturing of medical countermeasures and other critical medical 
products. Funds could also support purchasing domestically made product 
for inclusion in the SNS, as well as other actions to sustain demand 
for domestically manufactured products, thus reducing reliance on 
foreign production. The $400 million Pandemic Preparedness and 
Biodefense request will ensure BARDA has ready resources to immediately 
scale up manufacturing of vaccine, diagnostic, and therapeutic 
prototypes at the first indication of an outbreak. The requested 
funding would also accelerate advanced development and additional 
manufacturing of medical countermeasures for clinical trials and, when 
appropriate, patient care as part of an emergency response.
    Approximately $50 million is requested as part of BARDA's FY24 
Advanced Research and Development funding, which will allow some 
initial effort to begin to address the gap in domestic, commercial-
scale MCM production capabilities by supporting nominal access to 
domestic commercial-scale fill/finish capabilities. Furthermore, under 
ASPR, the SNS manages and delivers lifesaving MCMs when and as needed 
during public health emergencies and disasters. The SNS is the largest 
federally owned repository of pharmaceuticals, critical medical 
supplies, Federal medical stations (FMS), and medical equipment 
available for rapid delivery to support Federal, state, and local 
responses to health security threats. The FY 2024 President's Budget 
requests $995 million for the SNS, an increase of $30 million above FY 
2023 enacted. The increased funding will be used to sustain current 
product lines and to procure targeted countermeasures previously 
supported by BARDA that lack a significant commercial market. These 
funds will ensure the SNS's assets are available and ready to protect 
America from 21st century health threats in FY 2024. In addition, when 
and where possible, the SNS is seeking to award contracts with domestic 
manufacturers, to reduce reliance on foreign production. Funds could be 
used for some of these investments in FY24 and beyond. While domestic 
material is generally more expensive than internationally sourced 
product due to manufacturing protocols, requirements, and to adhere to 
production policies and regulations, relying on foreign sourcing is not 
the best preparedness posture and we experienced this first hand during 
the COVID-19 response.
    Question. The budget request includes $400 million in new funding 
for ASPR to rapidly respond to future pandemics, and support just-in-
time development, manufacturing, and procurement of innovative medical 
countermeasures, as well as to make investments to expand and sustain 
the domestic manufacturing capacity of the medical supply chain. Can 
you discuss how this funding would be allocated in FY2024?
    What is the Department's implementation plan for advancing research 
and development partnerships with the private sector to ensure we have 
the tools necessary to respond to the next outbreak?
    Answer. The $400 million requested in the FY24 President's Budget 
will also ensure we are able to maintain the capabilities built and 
used extensively during the COVID-19 pandemic to strengthen medical 
countermeasure development and manufacturing. Funds could also support 
purchasing domestically made product for inclusion in the SNS, reducing 
reliance on foreign production. The $400 million Pandemic Preparedness 
and Biodefense request will ensure BARDA has ready resources to 
immediately scale up manufacturing of vaccine, diagnostic, and 
therapeutic prototypes at the first indication of an outbreak. The 
requested funding would also accelerate advanced development and 
additional manufacturing of medical countermeasures for clinical trials 
and, when appropriate, patient care as part of an emergency response.
    Within ASPR, BARDA has partnered with private industry since 2006 
to advance the development of MCMs across its chemical, biological, 
radiological, and nuclear (CBRN) threats, pandemic influenza, and 
emerging infectious disease portfolio. BARDA has partnered with more 
than 400 different academic and industry partners, which has resulted 
in 71 FDA-approved vaccines, therapeutics, and diagnostics supported by 
BARDA. In addition to providing funding, BARDA has subject matter 
experts with decades of experience that work hand in hand with industry 
partners to help expedite MCM development. Should additional funding be 
provided to support pandemic preparedness, this same model would be 
leveraged.
    If you have constituents interested in speaking with BARDA or 
IBMSC, please know that we have two programs called TechWatch and IBx 
Connect that can facilitate conversations about their product, 
technology, or capabilities and explore potential partnering 
opportunities.
    TechWatch meetings include representatives from across the Federal 
Government, allow companies to get insight on how their solution could 
fit within the Federal Government, and better prepare them for a formal 
proposal submission.
    For more information, please visit https://
medicalcountermeasures.gov/Request-BARDA-TechWatch-Meeting/. Or https:/
/aspr.hhs.gov/IBxConnect/Pages/default.aspx.
    Question. How much FY2023 funding has been devoted to these 
efforts?
    Answer. Funding in FY23 will generally support ongoing MCM 
development. Going forward into FY24, the $400 million requested in the 
FY24 President's Budget will ensure we are able to maintain the 
capabilities built and used extensively during the COVID-19 pandemic to 
strengthen the domestic manufacturing base. In addition, the $400 
million Pandemic Preparedness and Biodefense request will ensure HHS 
has ready resources to immediately scale up manufacturing of vaccine 
and therapeutic prototypes at the first indication of an outbreak. The 
requested funding would also accelerate advanced development and 
additional manufacturing of medical countermeasures for clinical trials 
and, when appropriate, patient care as part of an emergency response.
    Question. Secretary Becerra, while we may not know what the next 
outbreak will be, the Department can be developing disease-agnostic 
tools and platforms now to be ready for whatever may come. Will any of 
the $2.5 billion NIH increase or $205 million BARDA increase provided 
by this Subcommittee last year be used for such activities?
    Will any of the new $400 million proposed in the budget request 
within ASPR be used for platform-based, threat agonistic activities? 
Please describe in detail.
    Answer. BARDA will continue to support threat-agnostic medical 
countermeasures to achieve its mission to make available MCMs that 
address CBRN threats, pandemic influenza, and emerging infectious 
diseases. FY23 funding will support the development of novel host-based 
therapeutic approaches that are agnostic to pathogen and address severe 
forms of disease and sepsis. Novel host-based diagnostic approaches to 
address disease severity and identify health deterioration in a number 
of clinical settings (pre-hospital, hospital, post-discharge) and 
threat-agnostic diagnostics for use in the early days of novel disease 
outbreak will also be supported. More than $25 million is expected to 
be utilized for these efforts in FY23 using annual funding.
    Question. Mr. Secretary, since the bipartisan Orphan Drug Act was 
enacted 40 years ago, rare disease and cancer patients have benefitted 
from the development of over 600 new treatments. This is a tremendous 
achievement, though there's more work to be done. Too many patients 
living with rare diseases and cancers still have no treatments 
available to them. Unfortunately, Democrats' so-called Inflation 
Reduction Act threatens the continued success of the Orphan Drug Act. 
Specifically, it does not protect from the law's price-setting scheme 
therapies that treat two or more orphan diseases. As a result, we 
already know of two companies that have cited the IRA as a reason not 
to continue rare disease drug development.
    Will you commit to doing what you can via guidance and rulemaking 
to ensure that the pipeline of life-altering therapies continues for 
patients living with rare diseases and cancers?
    Answer. FDA remains strongly committed to doing what we can via 
guidance for industry and stakeholder engagement activities to maintain 
and promote the robustness of the development pipeline for safe and 
effective drugs and biological products to treat patients with rare 
diseases, including rare cancers. FDA has published more than 18 
guidances since 2018 on topics that are highly relevant to drug and 
biological product development for rare diseases, including rare 
cancers. Some recent examples include:
  --2023 Draft Guidance for Industry: Clinical Trial Considerations to 
        Support Accelerated Approval of Oncology Therapeutics \10\
---------------------------------------------------------------------------
    \10\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/clinical-trial-considerations-support-accelerated-
approval-oncology-therapeutics.
---------------------------------------------------------------------------
  --2023 Draft Guidance for Industry: Considerations for the Design and 
        Conduct of Externally Controlled Trials for Drug and Biological 
        Products \11\
---------------------------------------------------------------------------
    \11\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/considerations-design-and-conduct-externally-
controlled-trials-drug-and-biological-products.
---------------------------------------------------------------------------
  --2022 Guidance for Industry: Human Gene Therapy for 
        Neurodegenerative Diseases \12\
---------------------------------------------------------------------------
    \12\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/human-gene-therapy-neurodegenerative-diseases.
---------------------------------------------------------------------------
  --2022 Draft Guidance for Industry: Tissue Agnostic Drug Development 
        in Oncology \13\
---------------------------------------------------------------------------
    \13\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/tissue-agnostic-drug-development-oncology.
---------------------------------------------------------------------------
    Question. Nearly 800,000 people in the United States have End Stage 
Renal Disease, with over 550,000 needing dialysis, a procedure to 
remove waste products and excess fluid from the blood, to live. This 
process must take place several times a week, and cannot be missed, 
even in times of national emergency.
    Since inclusion of dialysis machines in the SNS can help prepare 
the U.S. to care for patients needing dialysis during future 
emergencies, what steps are you taking to ensure these devices are 
included in the SNS or that the Administration for Strategic 
Preparedness and Response is prepared to provide dialysis care during 
disasters and public health emergencies?
    Answer. The SNS makes stockpiling decisions based on the Department 
of Homeland Security's (DHS) material threat determinations, the ASPR 
requirements process, and available funding. There is not currently a 
material threat determination related to dialysis.
    However, ASPR does have a program, the HHS emPOWER Program 
(emPOWER), that is at the forefront of innovating and harnessing the 
power of Federal health data, artificial intelligence (AI), and 
Federal-to-community level partnerships to protect health and save 
lives, including aiding those individuals who are dependent on dialysis 
machines and in-facility dialysis treatments. emPOWER is a partnership 
between ASPR and the Centers for Medicare & Medicaid Services (CMS) 
that provides Federal data, mapping, and AI tools to help communities 
protect the health of at-risk Medicare beneficiaries, including 
individuals who rely on electricity-dependent durable medical and 
assistive equipment devices, or essential healthcare services (i.e., 
facility-based dialysis, home oxygen tank services, home healthcare 
services, and at-home hospice services).
    In a disaster or emergency, authorized state or territorial public 
health authorities that meet certain requirements may submit a 
disclosure request for official review and approval of a minimum 
necessary HHS emPOWER Emergency Response Outreach Individual Dataset to 
support critical life-saving assistance and response outreach public 
health activities. The dataset includes limited individual level data 
and healthcare provider and supplier information for Medicare 
beneficiaries who have a claim for one or more types of electricity-
dependent durable medical equipment and certain cardiac implantable 
devices, or one or more of the above-mentioned types of essential 
healthcare services. The dataset has been used by public health 
authorities to activate emergency plans and communications, deploy 
response assets and resources, and conduct life-saving outreach with 
authorized partners in the event of emergencies and disasters.
                                 ______
                                 
              Questions Submitted by Senator John Kennedy
    Question. The Coronavirus Aid, Relief, and Economic Security 
(CARES) Act established this $178 billion fund to reimburse eligible 
healthcare providers for increased expenses or lost revenue 
attributable to COVID-19. According to a report published by the 
Government Accountability Office (GAO), providers began returning 
unused funds, with most returns stemming from automatically issued 
payments based on eligibility determination rather than on their 
necessity-based applications. As of February 28, 2022, GAO reported 
that $9.8 billion from previous disbursement from both general and 
targeted distributions had been returned to the Health Resources and 
Services Administration (HRSA). In addition to this, HRSA has begun 
their own payment integrity oversight including post-payment reviews, 
recovery of overpayments and audits. As of February 2022, nearly $27.4 
million had been identified for recovery from ineligible providers.
    How much has been returned as of March 2023?
    Where are these returned funds now?
    If these returned funds have already been used, where did they go?
    Answer. As of February 1, 2023, approximately $11.3 billion in PRF 
payments have been returned by providers. All of the returned funds 
have been re-allocated--for example, for additional provider payments.
    Question. Congress created the 340B program over 30 years ago to 
help low-income and other vulnerable patients access more affordable 
medicines. The goal of the program is to enable safety-net providers 
(Disproportionate Share Hospitals (DSH) Hospitals, Community Health 
Centers, federally Qualified Health Centers, ect) to help low-income 
and other vulnerable patients access more affordable medicines and 
healthcare services. Participating entities, such as large, well-
resourced hospitals, have taken advantage of the program's lack of 
clarity and reporting requirements at the expense of the patients that 
the program is meant to serve.
    What are the current reporting requirements for participating 
entities in terms of how they spend the money they receive through the 
program?
    Answer. The FY 2024 President's Budget includes a proposal to 
require covered entities to report to HRSA how the savings achieved 
through the Program benefit the eligible patients they serve and 
provide HRSA regulatory authority to implement this requirement.
    While the current 340B Program statute does not include specific 
authority to require covered entities to report on how 340B Program 
savings are used, many covered entities are HHS grantees and have 
specific requirements under the terms of their grants for how to use 
savings generated from the 340B Program.
    HRSA employs a number of approaches to oversee covered entity 
compliance of the 340B Program including annual recertification to 
ensure compliance, program audits and maintaining auditable records.
    Finally, HRSA's strategy includes quarterly DSH checks, review of 
contracts with State/local government for eligibility, contract 
pharmacy agreement requirements, and a self-disclosure process for 
reporting potential violations of 340B Program requirements.
    Question. If none, how do you ensure that these funds are actually 
being spent on low- income patients as the program intended?
    Answer. See response to 30a above.
    Question. What are your recommendations for improving the 340B 
program to ensure low income individuals are actually benefitting?
    Answer. As discussed above, The FY 2024 President's Budget proposes 
to require covered entities to annually report to HRSA how savings 
achieved through the Program benefit the communities they serve and 
provide HRSA with regulatory authority to implement this requirement. 
The Budget also proposes explicit regulatory authority to strengthen 
compliance and transparency related to the use of contract pharmacies.
    Question. In February CMS released a 2024 Medicare Advanced Notice 
that proposed changes to the Medicare Advantage risk adjustment model 
by removing up to 2,000 codes for conditions like depression, 
cardiovascular disease, rheumatoid arthritis, and diabetes. The 
proposed policies included in the notice would reduce payments to 
Medicare Advantage, raise costs, and reduce benefits for beneficiaries. 
I am very concerned about the impact of these changes on the more than 
452,000 Medicare beneficiaries in Louisiana who are in MA. According to 
reports, because of these changes, plans will have less resources from 
CMS and therefore will have to make a terrible choice between 
increasing beneficiary premiums, reducing supplemental benefits, such 
as dental coverage, or doing both. Estimates are that premiums could 
increase $45 a month. Specifically, I am concerned that the outlook for 
my home state of Louisiana is worse: Louisiana is estimated to be the 
3rd highest in the nation in terms of the related reductions of $62.35 
per member per month or a total of $748.26 per year.
    How do you propose that beneficiaries on fixed incomes find another 
$62 a month to pay for an increase in premiums at a time when they are 
facing unprecedented inflation and high costs of everything?
    How do you answer the beneficiaries who are calling me worried that 
the Biden Administration is cutting their Medicare and taking away 
much- needed services, like transportation, meals, and dental care?
    Answer. Core Medicare benefits, such as hospital care and physician 
visits, are guaranteed in Medicare Advantage like they are in Medicare 
fee-for-service. Regardless of the payment update, Medicare Advantage 
plans must cover those core Medicare benefits. We expect Medicare 
beneficiaries to continue to have a broad array of choices of MA plans 
with supplemental benefits. CMS anticipates stable premiums and 
benefits for beneficiaries in 2024, as seen previously in years with 
comparable updates. Historical experience shows plans compete in this 
highly competitive market to keep premiums down and maintain 
supplemental benefit levels, with beneficiary choice remaining strong.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. More than 550,000 kidney patients in the United States 
receive dialysis to remain alive, including more than 7,600 people in 
Mississippi. Approximately 85% of dialysis care takes place ``in 
center,'' meaning that kidney failure patients must travel to a 
dialysis clinic three times a week, for 3-4 hours at a time, just to 
survive. This interferes with patients' ability to hold down employment 
or spend time with their families, it requires patients to abide by 
strict dietary restrictions, and is a very physically draining 
experience that leaves patients fatigued, washed-out, and at-risk for a 
series of serious complications including cardiovascular disease and 
death. Home dialysis, however, allows patients more flexibility in when 
and how often they dialyze. With proper training and support, patients 
can dialyze every day, at nighttime when they sleep, or really whatever 
time works best for them. More frequent dialysis means patients have 
fewer dietary restrictions, allowing higher quality of life. It can 
also be gentler on the body and reduce the highs and lows that leave 
in-center patients feeling so wiped out all the time.
    Despite this, fewer than 15% of U.S. kidney patients utilize home 
dialysis. Many patients do not even have this choice, as only 54% of 
dialysis facilities are certified to offer home dialysis.
    Access to home dialysis is rife with racial and ethnic inequalities 
as well, with home dialysis ranging from 18% for White patients, 11% 
for Hispanic/Latinos, and 10% of Black/African Americans. The ESRD 
Conditions for Coverage (or CfCs, as they're known) contribute to low 
patient access to home dialysis. These burdensome and outdated 
regulations require that registered nurses conduct home dialysis 
training, even as there's a universal shortage of trained nurses. The 
regulations also have significant ``bricks and mortar'' requirements 
that make it challenging for companies who want to deliver home 
dialysis to enter the marketplace. Given the ongoing nurse staffing 
shortage and recent innovations in dialysis technology, it is 
imperative that the CfCs--which haven't been updated since 2008--be 
reopened to provide more innovation and options for patients, including 
patients in rural communities like those in Mississippi, while still 
ensuring patient safety, which I believe the newer technology would 
permit.
    What is your administration planning to do to amend these outdated 
and archaic rules and to expand access to home dialysis?
    Answer. At the beginning of the COVID-19 Public Health Emergency 
(PHE), CMS used emergency waiver authorities and various regulatory 
authorities to enable flexibilities so providers could rapidly respond 
to people impacted by COVID-19, as well as limit exposure to and spread 
of the virus. In recognition of the critical importance of maintaining 
access to dialysis treatment, CMS utilized a number of these regulatory 
authorities during the PHE, including reducing administrative burden 
for providers, bolstering the dialysis workforce, expanding Medicare 
telehealth for End Stage Renal Disease (ESRD) patients and providers, 
and establishing Special Purpose Renal Dialysis Facilities (SPRDF) to 
address access to care issues.
    Additionally, CMS has assessed which flexibilities would be most 
useful in a future PHE, such as natural and man-made disasters and 
other emergencies, to ensure a rapid response to future emergencies, 
both locally and nationally, or to address the unique needs of 
communities that may experience barriers to accessing healthcare. CMS 
is continuing to collaborate with Federal partners and the healthcare 
industry to ensure that the healthcare system is holistically prepared 
for addressing future emergencies.
    Finally, the Innovation Center's ESRD Treatment Choices (ETC) Model 
is an innovative payment model that aims to test whether greater use of 
home dialysis and kidney transplantation for Medicare beneficiaries 
with ESRD will reduce Medicare expenditures, while preserving or 
enhancing the quality of care furnished to beneficiaries with ESRD. The 
ETC Model uses payment adjustments to offer the incentive to 
participating ESRD facilities and Managing Clinicians to work with 
beneficiaries and caregivers in the choice of treatment modality, and 
to provide additional resources to support greater utilization of home 
dialysis and kidney transplantation. The Model began on January 1, 2021 
and is scheduled to run through June 30, 2027. In the Model's first 
year (2021), 2,434 ESRD facilities and 3,641 Managing Clinicians 
participated, with nearly 100,000 beneficiaries attributed to ETC 
Participants. Results from that year showed that 81 percent of ESRD 
facilities and 72 percent of Managing Clinicians improved their home 
dialysis rate compared to the first benchmark year (July 2019-June 
2020).
    Question. About half a million Americans rely on dialysis, and 
about 13 percent of these patients rely on home hemodialysis Studies 
show that patients are highly satisfied with their home dialysis, and 
that home dialysis can lead to better outcomes for patients, including 
improved survival rates. Because so many Americans rely on dialysis, an 
innovative home dialysis system was included as part of the Strategic 
National Stockpile (SNS) in 2020. SNS is the supply of drugs, vaccines, 
medical products, and related accessories that can be deployed during a 
public health event.
    Since inclusion of home dialysis machines in the SNS can help 
prepare the U.S. care for patients needing dialysis during future 
emergencies?
    What steps are you taking to ensure these devices are included in 
the SNS?
    Answer. The SNS makes stockpiling decisions based on DHS's material 
threat determinations, the ASPR requirements process, and available 
funding. There is not currently a material threat determination related 
to dialysis.
    However, ASPR does have a program, the HHS emPOWER Program 
(emPOWER), that is at the forefront of innovating and harnessing the 
power of Federal health data, artificial intelligence (AI), and 
Federal-to-community level partnerships to protect health and save 
lives, including aiding those individuals who are dependent on dialysis 
machines and in-facility dialysis treatments. emPOWER is a partnership 
between ASPR and CMS that provides Federal data, mapping, and AI tools 
to help communities protect the health of at-risk Medicare 
beneficiaries, including individuals who rely on electricity-dependent 
durable medical and assistive equipment devices, or essential 
healthcare services (i.e., facility-based dialysis, home oxygen tank 
services, home healthcare services, and at- home hospice services).
    In a disaster or emergency, authorized state or territorial public 
health authorities that meet certain requirements may submit a 
disclosure request for official review and approval of a minimum 
necessary HHS emPOWER Emergency Response Outreach Individual Dataset to 
support critical life-saving assistance and response outreach public 
health activities. The dataset includes limited individual level data 
and healthcare provider and supplier information for Medicare 
beneficiaries who have a claim for one or more types of electricity-
dependent durable medical equipment and certain cardiac implantable 
devices, or one or more of the above-mentioned types of essential 
healthcare services. The dataset has been used by public health 
authorities to activate emergency plans and communications, deploy 
response assets and resources, and conduct life-saving outreach with 
authorized partners in the event of emergencies and disasters.
    Question. CMS reimbursement needs to keep up with inflation: The 
latest consumer price index measure showed that healthcare experienced 
a 7.7% increase in overall cost, primarily driven by increased wages. 
In rural areas, this margin grew significantly more due to the demand 
for nurses and the lack of supply. On the reimbursement side, CMS has 
not increased its rate of provider pay to match this increase to 
inflation, resulting in an overall reduction in provider reimbursement 
while meeting an all-time high number of compliance measures as 
required by CMS and other insurers.
    What can be done to increase CMS payments to physicians to help 
them to overcome the financial devastation that inflation has caused in 
healthcare?
    Answer. Annual Medicare physician payment updates have been set in 
statute since 2015. CMS does not have the authority to use a different 
update. For CY 2024, the update in physician payments set by Congress 
is an increase of 1.25 percent over CY 2023. If Congress wants to 
change the law, we would be happy to provide technical assistance.
    Question. Much attention has come recently to issues with provider 
burnout, but little has been done to address the underlying issue. Most 
of provider burnout is due to an overwhelming number of non-critical 
tasks required of medical staff while they still care for the sick. 
Such tasks include entering social determinants of health codes, 
meeting compliance measures in the clinic or hospital, meeting value-
based outcome measures, attending cybersecurity trainings, handling 
downloads and denials of services, fighting Medicare and private 
insurance audits, and much more. They are doing this while fewer 
available providers are eligible to provide support and more patients 
are needing care. The burnout we are facing is not something that will 
be resolved with `more meetings' or even `more time off.' Rather, it 
will be solved with allowing providers to care for patients in a more 
flexible way without the concern of meeting arbitrary benchmarks and 
requirements and without having to constantly defend themselves against 
payers attempting to pay them less than what is owed for the services 
provided.
    What steps can be taken to decrease the regulatory burden of 
healthcare policy as well as to eliminate the reduction of provider 
payments through downcodes, denials, audits and prior authorization 
requirements?
    Answer. In addition to these Centers for Medicare & Medicaid 
Services (CMS) activities, the Office of the National Coordinator for 
Health Information Technology (ONC) is working to better enable 
providers to interact with healthcare plans and other payers for the 
automated, electronic completion of prior authorization tasks.\14\ 
Further, ONC recently proposed rulemaking to advance interoperability, 
improve transparency, support the access, exchange, and use of 
electronic health information, enhance health IT certification, and 
reduce burden and costs.\15\ In 2020, the U.S. Department of Health and 
Human Services (HHS) released a comprehensive Strategy on Reducing 
Regulatory and Administrative Burdens Relating to the Use of Health IT 
and EHRs \16\ to reduce the regulatory and administrative burden 
related to the use of health IT, including EHRs. The report's 
strategies, recommendations, and policy shifts aim to give clinicians 
more time to focus on what matters--caring for their patients. ONC, 
CMS, and HHS as a whole are working to implement strategies identified 
within the report to reduce burden and advance interoperable health IT.
---------------------------------------------------------------------------
    \14\ https://www.healthit.gov/topic/laws-regulation-and-policy/
request-information-electronic-prior-authorization-standards-
implementation-specifications.
    \15\ https://www.govinfo.gov/content/pkg/FR-2023-04-18/pdf/2023-
07229.pdf.
    \16\  https://www.healthit.gov/topic/usability-and-provider-burden/
strategy-reducing-burden-relating-use-health-it-and-ehrs.
---------------------------------------------------------------------------
    CMS is committed to reducing unnecessary administrative burden by 
advancing interoperability and national standards, and its Office of 
Burden Reduction & Health Informatics serves as a focal point for 
burden reduction, national standards and interoperability, and to 
engage our stakeholders to inform solutions. CMS has continued to seek 
public input on barriers to accessing healthcare and related challenges 
to inform our work and better support the populations we serve.
    Prior authorization has a role in healthcare, in that it can ensure 
that covered items and services are medically necessary and covered by 
the payer. However, patients, providers, and payers alike have 
experienced burden from the process. It has also been identified as a 
major source of provider burnout, and can become a health risk for 
patients if inefficiencies in the process cause care to be delayed. In 
the Medicare and Medicaid Programs; Patient Protection and Affordable 
Care Act; Advancing Interoperability and Improving Prior Authorization 
Processes for Medicare Advantage Organizations, Medicaid Managed Care 
Plans, State Medicaid Agencies, Children's Health Insurance Program 
(CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified 
Health Plans on the federally-Facilitated Exchanges, Merit-Based 
Incentive Payment System (MIPS) Eligible Clinicians, and Eligible 
Hospitals and Critical Access Hospitals in the Medicare Promoting 
Interoperability Program proposed rule (87 FR 76238) issued last 
December, CMS proposed a number of policies to help make the prior 
authorization process more efficient and transparent.
    CMS proposed requiring impacted payers to build and maintain a 
Prior Authorization Requirements, Documentation, and Decision 
Application Programming Interface (PARDD API) that would automate the 
process for providers to determine whether a prior authorization is 
required, identify prior authorization information and documentation 
requirements, as well as facilitate the exchange of prior authorization 
requests and decisions from their electronic health records (EHRs) or 
practice management system. CMS proposed requiring impacted payers to 
include a specific reason when they deny a prior authorization request. 
CMS proposed requiring certain impacted payers to send prior 
authorization decisions within 72 hours for expedited (i.e., urgent) 
requests and seven calendar days for standard (i.e., non-urgent) 
requests. CMS also proposed requiring impacted payers to publicly 
report certain prior authorization metrics by posting them directly on 
the payer's website or via publicly accessible hyperlink(s) on an 
annual basis. The comment period for this proposed rule closed on March 
13, 2023, and CMS is considering comments received for final 
decisionmaking.
    Question. The rate of Medicare beneficiaries that have moved to 
Medicare Advantage has grown each year since the inception of the 
program. As of January, 2023, 46% of Medicare beneficiaries have 
signed-up for a Medicare Advantage (MA) Plan. The challenge with these 
plans is that they are not subject to the value-based care promoted 
through CMS, as they are a private plan funded with Medicare dollars. 
Although possibly beneficial in theory, the MA plans do not provide the 
same level and guarantee of benefits as original Medicare, they pay 
providers less, and often times will actually mislead clients. This is 
ultimately hurting both providers and patients, while primarily only 
proving to be an `advantage' to the companies providing the policies. 
Although reversing course on MA plans would be very difficult given the 
number of patients using them, a strict requirement of guarantees 
payment, reduction of downcodes and denials, and significant patient 
education is needed in order to allow for a positive outcome. 
Otherwise, all of the work from CMS with Medicare will become secondary 
to the wishes of the private system using CMS dollars to fund what is 
largely an inferior product.
    Is there a process in place to better educate the public on the 
pros and cons of Medicare Advantage plans?
    Answer. On December 27, 2022, CMS published the Contract Year (CY) 
2024 Medicare Advantage and Part D proposed rule. As part of this 
proposed rule, CMS took critical steps to protect Medicare 
beneficiaries from confusing and potentially misleading marketing while 
also ensuring they have accurate and necessary information to make 
coverage choices that best meet their needs. The proliferation of 
certain television advertisements generically promoting enrollment in 
MA plans has been a specific topic of concern. To address these 
concerns, CMS proposed to prohibit marketing that does not mention a 
specific plan name. In addition, CMS proposed to prohibit plans from 
using, in communications activities and materials, the Medicare name, 
CMS logos, or products and information from the Federal Government in a 
way that is misleading. In the rule, CMS also proposed reinstating 
important protections that prevent predatory behavior and finalized 
changes that strengthen the role of plans in monitoring agent and 
broker activity. CMS also proposed requirements to further protect 
Medicare beneficiaries by ensuring they receive accurate information 
about Medicare coverage and are aware of how to access accurate 
information from other available sources. The comment period for the 
proposed rule closed on February 13, 2023. CMS is taking into 
consideration comments received for final decisionmaking.
    Question. Is there a plan in place to ensure that Medicare 
Advantage plans provide the same or greater level of benefits to 
patients while providing the same or greater benefits to providers for 
service, in comparison to original Medicare?
    Answer. Under the statute, Medicare Advantage plans are required to 
cover the same benefits available under Original Medicare (with some 
exceptions), referred to as ``basic benefits.'' The CY 2024 Medicare 
Advantage and Part D proposed rule proposes clarifications for clinical 
criteria guidelines to ensure people with Medicare Advantage receive 
access to the same medically necessary care they would receive in 
Original Medicare. CMS proposes clarifying rules related to acceptable 
coverage criteria for basic benefits by proposing to require that 
Medicare Advantage plans must comply with national coverage 
determinations (NCD), local coverage determinations (LCD), and general 
coverage and benefit conditions included in Original Medicare 
regulations. CMS also proposes that when coverage criteria are not 
fully established, Medicare Advantage organizations may create internal 
coverage criteria based on current evidence in widely used treatment 
guidelines or clinical literature made publicly available to CMS, 
enrollees, and providers.
    Question. One in three seniors die from Alzheimer's or a related 
form of dementia. Bi-partisan groups of members in Congress have 
written to the Administration about concerns over the National Coverage 
Determination policy and its impact on access to Alzheimer's 
therapeutics and diagnostics. This new class of Alzheimer's treatments 
gives families hope that they will have more quality time with their 
loved ones before the disease takes hold. CMS has declined to open the 
National Coverage Determination to start the process for access so 
these changes are not forced to jump through all these CMS requirements 
after FDA determines that they should be approved.
    What is your agency doing for these patients with life threatening 
conditions?
    Why are patients with Alzheimers having to jump through hurdles to 
access lifesaving drugs?
    Answer. Alzheimer's disease is a devastating illness that affects 
millions of Americans and their families. CMS is committed to helping 
people get timely access to treatments and improving care for people 
with Alzheimer's disease and their families. CMS has a responsibility 
to ensure that people with Medicare have appropriate access to 
therapies that are reasonable and necessary for use in the Medicare 
population. Moreover, in the final National Coverage Determination, we 
do not restrict the setting of approved clinical trials to ensure that 
anti-amyloid monoclonal antibodies that receive FDA approval based upon 
evidence of efficacy from a direct measure of clinical benefit may be 
given to a broader patient population.
    Question. Dialysis is a procedure that removes waste products and 
excess fluid from the blood and it is critically important to the over 
550,000 people with kidney failure in the U.S. These patients need to 
dialyze several times per week. Roughly 14% do so at home, but the 
remainder dialyze in centers, sitting next to other patients and 
attended to by healthcare staff. Studies show that patients who are 
able to undergo dialysis at home rather than in a center are able to 
spend more time with loved ones, spend less time traveling and waiting 
for appointments, participate more in work and other activities, and 
experience improved health outcomes. Individuals receiving maintenance 
dialysis are particularly vulnerable to COVID-19 and sadly, the COVID 
pandemic was the first time since 1980 that the population of people 
with End Stage Renal Disease declined, with mortality up by 17% among 
dialysis patients. In the event of future emergencies there should be 
improved access to home dialysis units to help these vulnerable 
individuals protect their health from infection.
    What actions is the Department taking to ensure patient's continued 
access to their dialysis during emergencies, and to home hemodialysis 
to keep them safe from infections?
    Answer. At the beginning of the COVID-19 Public Health Emergency 
(PHE), CMS used emergency waiver authorities and various regulatory 
authorities to enable flexibilities so providers could rapidly respond 
to people impacted by COVID-19, as well as limit exposure to and spread 
of the virus. In recognition of the critical importance of maintaining 
access to dialysis treatment, CMS utilized a number of these regulatory 
authorities during the PHE, including reducing administrative burden 
for providers, bolstering the dialysis workforce, expanding Medicare 
telehealth for End Stage Renal Disease (ESRD) patients and providers, 
and establishing Special Purpose Renal Dialysis Facilities to address 
access to care issues.
    Additionally, CMS has assessed which flexibilities would be most 
useful in a future PHE, such as natural and man-made disasters and 
other emergencies, to ensure a rapid response to future emergencies, 
both locally and nationally, or to address the unique needs of 
communities that may experience barriers to accessing healthcare. CMS 
is continuing to collaborate with Federal partners and the healthcare 
industry to ensure that the healthcare system is holistically prepared 
for addressing future emergencies.
                                 ______
                                 
              Questions Submitted by Senator John Boozman
    Question. As you know, the healthcare workforce is essential to 
maintaining access to high-quality, safe, and equitable care. However, 
the healthcare workforce is faced with shortages across the board. 
Arkansas ranks among the lowest in the number of available physicians 
per capita and more than 500,000 Arkansans live in an area lacking an 
adequate number of health professionals to serve the population. 
Furthermore, an aging population presents an even greater future 
challenge. In 2017, the majority of the nursing workforce was close to 
retirement, with more than half aged 50 and older, and almost 30% aged 
60 and older. Hospitals faced similar demographic trends for 
physicians, with data from the Association of American Medical Colleges 
indicating that one-third of practicing physicians will reach 
retirement age over the next decade.
    Can you talk about the Administration's views with respect to the 
need to fund various healthcare workforce programs to address current 
and future workforce needs?
    Answer. Healthcare workforce needs are a pressing challenge across 
the country and the Budget makes a number of important investments to 
help grow the healthcare workforce. The FY 2024 President's Budget 
invests $2.7 billion for workforce programs, which includes $947 
million in mandatory funding to expand workforce capacity across the 
country.
Highlights include:
  --$965.6 million, an increase of $547.7 million, for the NHSC to 
        maintain a field strength of over 20,000 clinicians practicing 
        in rural and underserved communities in return for scholarships 
        and loan repayment.
  --$387.4 million, an increase of $190.3 million, for Behavioral 
        Health Workforce Development Programs to support training for 
        18,000 providers.
  --$112.6 million for Advanced Nursing Education, an increase of $17 
        million, to grow and diversify the maternal and perinatal 
        health nursing workforce.
  --$28 million for a new program to address modernizing health 
        workforce training to address healthcare workforce shortages
  --$91.9 million, an increase of $32.5 million to expand, enhance, and 
        modernize nursing education programs.
  --$157 million in mandatory funding for FY 2024 for the Teaching 
        Health Center Graduate Medical Education program to support 
        over 1,400 resident full-time equivalent slots in community -
        based ambulatory settings.
    With respect to workforce programs in rural areas specifically, the 
FY 2024 Budget includes a request of $13 million for the Rural 
Residency Planning and Development (RRPD) Program to support creation 
of new rural residency programs to recruit and retain new physicians in 
rural areas. Recognizing the issue of workforce shortages you raised in 
Arkansas, HRSA has provided roughly $2.25 million through the RRPD 
program to expand rural residency training programs in the 
state.Question. According to the CDC, rates of suicide among farmers 
are 1.5 times higher than the national average. Farming communities are 
essential in Arkansas with almost 50,000 farms across the state. I 
appreciate Congress and the Administration's support for expanding 
access to mental healthcare. However, I fear that farmers are often 
left out of the conversation.
    How is the Administration tailoring its mental health response to 
ALL Americans, especially the farmers that are core to our nation's 
agricultural mission?
    Answer. On July 16, 2022, the U.S. transitioned to the 988 Suicide 
& Crisis Lifeline, which is a new, easier way to reach the service 
formally known as the National Suicide Prevention Lifeline. 988 offers 
24/7 access to trained crisis counselors who can help people 
experiencing mental health-related distress, including suicidal 
ideation. People can call or text 988 or chat 988lifeline.org for 
themselves or if they are worried about a loved one who may need crisis 
support. 988 serves as a universal entry point so that no matter where 
an individual lives in the U.S., they can reach a trained crisis 
counselor who can help.
    In addition, SAMHSA also administers multiple suicide prevention 
grant programs focused on youth and adults. SAMHSA administers the 
Garrett Lee Smith (GLS) State/Tribal Youth Suicide Prevention and Early 
Intervention Program, which is available to states or Tribes, and the 
GLS Campus Suicide Prevention Grant Program, which is available to 
institutions of higher education. GLS State/Tribal grantees, most 
recently Michigan and Tennessee, have included a focus on agriculture 
community youth as part of their population of focus. For adults, 
SAMHSA administers the National Strategy for Suicide Prevention (NSSP) 
grant program and the Zero Suicide program. The NSSP grant program 
supports the implementation of the 2021 Surgeon General's Call to 
Action to Implement the National Strategy for Suicide Prevention, with 
an emphasis on older adults, adults in rural areas, and American Indian 
and Alaska Native adults. The program supports a broad-based public 
health approach to suicide prevention and aims to raise awareness of 
the resources available to prevent suicide. The program also promotes 
help seeking behavior; establishes referral processes and improves 
outcomes for individuals at risk for suicide; and enhances 
collaboration with key community stakeholders. The Zero Suicide program 
supports health systems to implement the Zero Suicide intervention and 
prevention model, a comprehensive, multi-setting approach to suicide 
prevention in health systems.
    Further, SAMHSA funds the Suicide Prevention Resource Center 
(SPRC), which advances suicide prevention infrastructure and capacity 
building through consultation, training, and resource development. The 
SPRC website has a dedicated page for resources focused on rural 
communities.
    SAMHSA also administers the Rural Emergency Medical Services (EMS) 
Training grant program. The purpose of this program is to recruit and 
train EMS personnel in rural areas with a particular focus on 
addressing substance use disorders (SUD) and co-occurring disorders 
(COD) when a person has both substance use and mental disorders. 
Recipients are expected to train EMS personnel on SUD and COD, trauma-
informed, recovery-based care for people with such disorders in 
emergency situations and, as appropriate, to maintain licenses and 
certifications relevant to serve in an EMS agency. In 2023, SAMHSA is 
requiring the grant recipients to train EMS personnel on the use of 
motivational interviewing to engage those individuals who use 
substances, and/or who suffer mental health conditions, and to provide 
referrals to treatment and harm reduction services.
    SAMHSA also funds the Mental Health Technology Transfer Center 
(MHTTC) program. This program has developed several resources to 
support mental health in rural communities. For example, the MHTTC 
developed the Depression, Alcohol and Farm Stress: Addressing Co- 
Occurring Disorders in Rural America practical guide. This guide offers 
resources specific to screening for co-occurring disorders experienced 
by farmers, farmworkers and farm families in rural communities. The 
guide uses a case scenario to illustrate the most common barriers 
encountered in identifying co-occurring disorders and underscores the 
unique needs of rural communities that are home to agricultural 
producers.
    In addition, the MHTTC created the Addressing Suicide Disparity in 
Rural Communities webinar. The 4-hour seminar gave providers and anyone 
providing mental health support to individuals a working knowledge, 
resources, and community-based solutions for addressing suicide in 
rural communities. Participants learned about the signs and symptoms of 
suicide, the impact of stigma on seeking and maintaining treatment, the 
role of harm reduction, and suicide postvention for providers and 
families.
    Finally, the MHTCC also has produced a collection of resources 
specifically aimed at addressing mental health conditions caused by 
farm stress called Farm Stress and Mental Health Resources and a 
webinar called Improving Mental Health Care by Understanding the 
Culture of Farming and Rural Communities, which aimed at addressing the 
mental health crisis and unique stressors caused by the COVID-19 
pandemic within the farming and rural/frontier communities.
    Question. I am very concerned about infant mortality. 
Unfortunately, Arkansas struggles with a high infant mortality rate. 
Arkansas--7.38 infant deaths per 1k live births. Overall US--5.4 infant 
deaths per 1k live births. And the overall U.S. infant mortality rate 
is much higher compared to countries with a similar GDP.
    How does the Administration plan on addressing these alarmingly 
high rates of infant mortality?
    Answer. HRSA advances infant health in its broader investments such 
as the Title V Maternal and Child Health Services Block Grant Program, 
which supports or partners with fetal-infant mortality reviews (FIMRs) 
and Child Death Reviews (CDRs) to reduce fetal and infant mortality.
    Community and state CDR and FIMR teams are supported by the HRSA-
supported National Fetal, Infant, and Child Death Review Center 
Program, which aims to increase their capacity to collect high-quality 
uniform data, translate data into action at the community, state, and 
national levels, and expand fetal, infant, and child death reviews to 
additional states, territories and tribes.
    The Maternal, Infant and Early Childhood Home Visiting Program also 
helps reduce infant mortality by linking families to appropriate 
newborn healthcare, providing education and support to new parents on 
caring for infants, facilitating connections with health, social 
services and child development professionals, and preventing child 
abuse and neglect.
    In addition, HRSA has targeted investments to address infant 
mortality, including:
  --The Healthy Start Program, which provides grants to high-risk 
        communities with infant mortality rates at least 1.5 times the 
        U.S. national average, as well as high rates of other poor 
        perinatal outcomes (e.g., low birthweight and preterm birth). 
        Healthy Start provides and/or facilitates access to care and 
        needed services to improve the health of mothers and children 
        through the first 18 months after birth. In FY 2022, the 
        program provided 101 grants to community-based projects.
  --The Catalyst for Infant Health Equity Program, which aims to reduce 
        disparities in infant mortality and support action plans that 
        focus on improving community systems and services that 
        influence health outcomes. In FY 2022, HRSA awarded $4.5 
        million to counties with high disparities in infant death 
        rates.
  --A new Enhanced Healthy Start grant program that will award up to 
        $13.1 million to communities who are not already covered under 
        the Healthy Start program with the highest rates of perinatal 
        health disparities in the country.
    Healthcare workforce needs are a pressing challenge across the 
country and the Budget makes a number of important investments to help 
grow the healthcare workforce. The FY 2024 Budget invests $2.7 billion 
for workforce programs, which includes $947 million in mandatory 
funding to expand workforce capacity across the country.
Highlights include:
  --965.6 million, an increase of $547.7 million, for the NHSC to 
        maintain a field strength of over 20,000 clinicians practicing 
        in rural and underserved communities in return for scholarships 
        and loan repayment.
  --$387.4 million, an increase of $190.3 million, for Behavioral 
        Health Workforce Development Programs to support training for 
        18,000 providers.
  --$112.6 million for Advanced Nursing Education, with an increase of 
        $17 million, to grow and diversify the maternal and perinatal 
        health nursing workforce.
  --$28 million for a new program to address modernizing health 
        workforce training to address healthcare workforce shortages
  --$91.9 million, an increase of $32.5 million to expand, enhance, and 
        modernize nursing education programs.
  --$157 million in mandatory funding for FY 2024 for the Teaching 
        Health Center Graduate Medical Education program to support 
        over 1,400 resident full-time equivalent slots in community-
        based ambulatory settings.
    Lastly, supporting working families is a priority for this 
Administration. On December 29, 2022, the President signed the 
Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act 
into law, extending the Fair Labor Standards Act's reasonable break 
time and space protections to pump breast milk at work to an estimated 
9 million workers. Our partners at the Department of Labor's Wage and 
Hour Division are working hard to ensure that nursing employees receive 
these pump at work protections.
    In FY 2024, The National Institutes of Health (NIH) will provide an 
estimated $111 million to support research aimed at reducing infant 
mortality. The Eunice Kennedy Shriver National Institute of Child 
Health and Human Development (NICHD) supports a Maternal-Fetal Medicine 
Units (MFMU) Network that performs randomized controlled trials and 
observational studies to investigate the safety and efficacy of 
obstetric treatments and management strategies. Studies focus on high-
risk pregnancies to reduce maternal, fetal, and infant mortality and 
morbidity, especially preterm births, fetal growth abnormalities, and 
maternal complications.
    NICHD's Neonatal Research Network (NRN), founded in 1986, conducts 
collaborative, multi-site clinical trials and observational studies 
involving newborns and lactating people, providing evidence to guide 
clinical practice. Its purpose is to improve healthcare and outcomes 
for newborns. This includes finding ways to increase survival chances 
without neurodevelopmental impairment for infants born premature, low-
birth weight, or with other serious conditions.
    Additionally, NICHD's Safe to Sleep program educates caregivers 
about ways to reduce the risk of Sudden Infant Death Syndrome (SIDS) 
and other sleep-related causes of infant death.
    Question. In relation to developing Dietary Guidelines for 
Americans (DGA) for 2025-2030, HHS recently stated that alcohol ``will 
be examined in a separate effort, led by HHS that supports work on this 
topic.''
    What process will HHS employ to ensure its ``separate effort'' will 
operate in a fully transparent manner?
    Answer. The Interagency Coordinating Committee on the Prevention of 
Underage Drinking (ICCPUD) led by the Substance Abuse and Mental Health 
Services (SAMHSA) will support a technical subcommittee to review 
evidence on alcohol intake and health and make recommendations on adult 
alcohol consumption to be included in the Dietary Guidelines for 
Americans. A subcommittee report will be published and available to the 
public.
                                 ______
                                 
               Questions Submitted by Senator Marco Rubio
    Question. As a parent, I send my children to school each day to 
learn how to read, how to write, how to do math--in short, I want them 
to learn critical skills for their future. Today, however, woke 
activists are infiltrating our classrooms and preying on our children 
through the promotion of so-called ``gender-affirming care.'' It is no 
longer enough for an adolescent to self-describe as gay or lesbian of 
their own accord. Activists are now brainwashing vulnerable youth--
particularly those struggling with gender dysphoria-- into thinking 
that in order to be happy, they need to consider dangerous treatments 
like puberty blockers and irreversible surgeries. The vast majority of 
individuals with gender dysphoria eventually lose their desire to 
identify with another sex. Moreover, a young adult's brain development 
does not stop until approximately 25 years old. Taking all this into 
consideration, I have serious concerns with your department's decision 
to use taxpayer dollars and manipulate Federal laws to support crazy 
practices under the guise of ``gender-affirming care'' for children.
    Can you explain ``the science'' behind what happens when an 11-year 
old takes puberty blockers, particularly when these drugs are not 
approved by the FDA for the purposes of gender transition?
    How does ``the science'' justify imposing the negative social, 
psychological, and physical consequences of failed ``gender-affirming'' 
procedures--which include an increased risk of depression and cancer--
on children?
    Answer. The Department of Health and Human Services (HHS or 
Department) is committed to supporting the health and well-being of all 
families and children of all beliefs and backgrounds. HHS believes that 
all children and adults should be afforded life-saving, medically 
necessary care, including youth who identify as Lesbian, Gay, Bisexual, 
Transgender, Queer, Intersex (LGBTQI+).
    Major medical associations in the United States, including the 
American Medical Association, the American Academy of Pediatrics, 
American Academy of Child and Adolescent Psychiatry, the Pediatric 
Endocrine Society, and the Society for Adolescent Health and Medicine, 
have found that gender-affirming care is medically necessary, safe, and 
effective care for transgender and nonbinary people.\17\ Gender-
affirming care is life-saving care, it includes counseling and mental 
healthcare. It is also suicide-prevention care.\18\ Gender-affirming 
care is a specialized model of care, tailored to the specific needs of 
the patient. Gender affirming care is in line with current standards of 
care, and healthcare providers make individualized medical judgments 
about what evidence-based treatments are appropriate for a particular 
patient.
---------------------------------------------------------------------------
    \17\ Transgender Legal Defense and Education Fund Trans Health 
Project. Medical Organization Statements. (2023.) Available at: https:/
/transhealthproject.org/resources/medical-organization-statements/.
    \18\ Tordoff, Diana M., Jonathon W. Wanta, Arin Collin, Cesalie 
Stepney, David J. Inwards-Breland, and Kym Ahrens. ``Mental health 
outcomes in transgender and nonbinary youths receiving gender-affirming 
care.'' JAMA network open 5, no. 2 (2022): e220978-e220978.
---------------------------------------------------------------------------
    Question. Secretary Becerra, earlier this year, under your 
supervision, the FDA removed a crucial protection requiring women to 
consult with a doctor before receiving a prescription for the chemical 
abortion drug mifepristone. The serious medical risks of mifepristone 
are well-documented. More than a third of women who take this drug show 
up to the emergency room due to serious complications. Under the guide 
of ``expanding access,'' the FDA is allowing profit-hungry online 
pharmacies to push the drug on women without first consulting with a 
doctor. In-person visits are essential for physicians to rule out 
extremely dangerous factors like an ectopic pregnancy or a Rh-negative 
blood type. For decades, Democrats have purported to help women decide 
whether to have an abortion with their doctor. Now, the FDA proposes to 
remove doctors from the equation.
    Is the Biden Administration more concerned with increasing abortion 
or protecting women's health as it weighs decisions over the regulation 
of chemical abortion pills?
    Answer. FDA stands behind its determination that mifepristone is 
safe and effective under its approved conditions of use for medical 
termination of early pregnancy, and believes patients should have 
access to medications that FDA has determined to be safe and effective 
for their intended uses. Under FDA's approved conditions of use, 
mifepristone may only be dispensed by or under the supervision of a 
certified prescriber, or by a certified pharmacy on a prescription 
issued by a certified prescriber. As part of its Congressionally-
mandated role to approve and regulate medications, FDA has made an 
independent, evidence-based determination that mifepristone may be 
safely dispensed in person or by mail on a prescription issued by a 
certified prescriber.
    Question. How does the Department of Health and Human Services 
(HHS) justify removal of the in-person distribution requirement for 
mifepristone given the substantial medical evidence on the drug's 
health risks?
    Answer. FDA stands behind its determination that mifepristone is 
safe and effective under its approved conditions of use for medical 
termination of early pregnancy, and believes patients should have 
access to medications that FDA has determined to be safe and effective 
for their intended uses. Under FDA's approved conditions of use, 
mifepristone may only be dispensed by or under the supervision of a 
certified prescriber, or by a certified pharmacy on a prescription 
issued by a certified prescriber. As part of its Congressionally-
mandated role to approve and regulate medications, FDA has made an 
independent, evidence-based determination that mifepristone may be 
safely dispensed in person or by mail on a prescription issued by a 
certified prescriber.
    Question. How does HHS justify permitting mail-in pharmacies to 
distribute mifepristone on legal grounds given that Federal law bars 
the United States Postal Service and private carriers from mailing 
abortion drugs (18 U.S.C. Sec. Sec. 1461--1462)?
    Answer. FDA stands behind its determination that mifepristone is 
safe and effective under its approved conditions of use for medical 
termination of early pregnancy, and believes patients should have 
access to medications that FDA has determined to be safe and effective 
for their intended uses. Under FDA's approved conditions of use, 
mifepristone may only be dispensed by or under the supervision of a 
certified prescriber, or by a certified pharmacy on a prescription 
issued by a certified prescriber. As part of its Congressionally-
mandated role to approve and regulate medications, FDA has made an 
independent, evidence-based determination that mifepristone may be 
safely dispensed in person or by mail on a prescription issued by a 
certified prescriber.
    Question. The failure to include the Hyde Amendment in HHS' FY24 
proposed budget is incredibly alarming. This is the third time 
President Biden has excluded this critical bipartisan protection 
against taxpayer-funded abortions with more than 40 years of precedent. 
The 80 percent increase in Title X family planning funding is also 
concerning when Democrats and the Biden Administration have made it 
clear those dollars would fund abortion providers. There is no human 
right more fundamental or more sacred than the right to life, and 
funding Planned Parenthood and other abortion clinics is a blatant 
attack on the right to life.
    Does the Biden Administration support taxpayer-funded abortion?
    When Congress rejects the President's radical proposal and includes 
the Hyde Amendment in future spending bills, will you follow the law 
and ensure that Federal Medicaid dollars are not used to finance 
abortion?
    Answer. As HHS Secretary, my role is to implement the law. The 
Department will follow all applicable laws as they relate to abortion 
and any other issue.

                          SUBCOMMITTEE RECESS

    Senator Baldwin. And with that this hearing is adjourned.
    [Whereupon, at 4:19 p.m., Wednesday, March 22, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]