[Senate Hearing 111-]
[From the U.S. Government Publishing Office]



 
 DEPARTMENTS OF LABOR, HEALTH, AND HUMAN SERVICES, AND EDUCATION, AND 
                 RELATED AGENCIES FOR FISCAL YEAR 2011

                              ----------                              


                       WEDNESDAY, MARCH 10, 2010

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 3:05 p.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Reed, Pryor, and Cochran.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF HON. KATHLEEN SEBELIUS, SECRETARY

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. The Subcommittee on Labor, Health, Human 
Services, Education and Related Agencies will come to order.
    Well, Madam Secretary, welcome back to the subcommittee. I 
first want to start by commending you for the outstanding work 
you're doing to help enact healthcare reform. We can see the 
finish line at last. And your leadership is one of the reasons 
that we can see that finish line.
    I know it will be tempting for Senators on both sides of 
the dais to want to debate the pros and cons of health reform 
with you today. But I would urge the subcommittee members to 
keep their focus on the subject of our hearing. And that is the 
President's proposed fiscal year 2011 budget for the Department 
of Health and Human Services (HHS).
    On the whole, there's much to like in the HHS budget. As we 
all know the President's budget holds the line on nonsecurity-
related spending overall in fiscal year 2011. But the President 
promised to use a scalpel, not an ax, to achieve that freeze. 
And HHS is one of the Federal agencies that would get an 
increase, 2.5 percent more than in fiscal year 2010.
    I was particularly pleased that the President included a 
major boost for efforts to root out fraud in Medicare and 
Medicaid. Reducing healthcare fraud and abuse has been a 
priority of mine for many years. And it will play a key role in 
bringing our long-term deficits under control. Significant 
increases were also proposed for the National Institutes of 
Health (NIH), for Head Start, childcare and a new caregiver's 
initiative that will help families take care of their elderly 
relatives.
    Other provisions in the budget raise cause for concern, 
however. For example, the President's budget would cut funding 
for the Centers for Disease Control and Prevention (CDC). The 
budget also includes a $1.8 billion cut to discretionary 
funding under the LIHEAP program. But overall, I think the 
President's budget is a good start. I look forward to 
discussing it in more detail with you during this hearing.
    I also want to add, Madam Secretary, how lucky you are to 
have an Assistant Secretary like Ellen Murray to advise you on 
all these issues. At last year's budget hearing she was sitting 
next to me on the dais. Today she is advising you. I can tell 
you from experience you're in very good hands. And I read it 
just as she wrote that for me right there.
    Senator Harkin. Now I turn to Senator Cochran.

                   STATEMENT OF SENATOR THAD COCHRAN

    Senator Cochran. Mr. Chairman, thank you very much for 
convening the hearing.
    Madam Secretary, we appreciate your being here to talk 
about the budget request. And we look forward to hearing your 
testimony.

                           PREPARED STATEMENT

    I ask unanimous consent that the balance of my remarks be 
placed in the record. I will also include a statement from the 
Chairman, Senator Inouye. He regrets that he could not be 
present.
    Senator Harkin. Thank you very much, Senator Cochran.
    [The statement follows:]
               Prepared Statement of Senator Thad Cochran
    Mr. Chairman, thank you for chairing this hearing to review the 
budget for fiscal year 2011 for the Department of Health and Human 
Services. We are pleased to welcome the Secretary of Health and Human 
Services, Kathleen Sebelius to her second appearance before our 
subcommittee, and we look forward to working with her to support our 
Nation's investment in healthcare, social services programs, medical 
research, and disease prevention.
    I am pleased that your budget includes a $1 billion increase for 
the National Institutes of Health. These additional dollars are 
essential if we are to continue to make scientific discoveries in 
cancer, autism, heart disease, and the many other maladies that plague 
so many Americans.
    I was also pleased to see your announcement last week regarding the 
$10 million in funds from the America Recovery and Reinvestment Act to 
help communities find ways to curb smoking and combat obesity, improve 
access to healthy foods, and increase physical activity.
    This subcommittee will be challenged to balance the competing needs 
of the programs contained in your $74 billion budget. We look forward 
to working with you to maintain our commitment to fiscal restraint 
while providing much needed increases for high-priority programs.
                                 ______
                                 
             Prepared Statement of Senator Daniel K. Inouye
    Secretary Sebelius, last October Dr. Mary Wakefield, the 
Administrator of the Health Resources and Services Administration, 
visited Hawaii and I would like to thank you for your support of her 
trip. She visited a number of Community Health Centers and toured 
several hospitals and educational facilities on the neighboring 
islands. The people of Hawaii were very grateful to host her visit and 
thankful for the opportunity to discuss critical healthcare concerns of 
the State. In addition she met with representatives from the National 
Kidney Foundation of Hawaii to talk about the increasing incidence of 
kidney disease among the Filipino population.
    Thank you again, and I will provide questions for the record to the 
subcommittee later.

    Senator Harkin. Again, Madam Secretary, welcome back to the 
subcommittee. And again, thank you for your leadership. And 
just by way of introduction, Kathleen Sebelius became the 21st 
Secretary of the Department of Health and Human Services on 
April 29, 2009.
    In 2003, she was elected Governor of Kansas and served in 
that capacity until her appointment as Secretary. Prior to her 
election as governor she served as a Kansas State Insurance 
Commissioner. She is a graduate of Trinity Washington 
University and the University of Kansas.
    Madam Secretary, welcome. Your statement will be made a 
part of the record in its entirety. And please proceed as you 
so desire.

              SUMMARY STATEMENT OF HON. KATHLEEN SEBELIUS

    Secretary Sebelius. Well, thank you very much, Chairman 
Harkin and Senator Cochran and members of the subcommittee. I 
am glad to be back to discuss the 2011 budget for HHS. I think 
the budget builds on many of the themes that President Obama 
laid out in his State of the Union Address this year, 
strengthening our healthcare system, laying the foundation for 
future growth, and rooting out waste and fraud to make programs 
even more effective.
    Under this budget we plan to make prudent investments in 
our Nation's health and long-term prosperity that members of 
this subcommittee and you, Mr. Chairman, have pushed for years 
in prevention, in wellness, in attacking healthcare fraud and 
supporting our children during those formative, early years and 
in biomedical research that leads to life saving cures to name 
just a few areas. So today I'd like to briefly highlight a few 
of these priorities. And then I look forward to our discussion 
about the issues in this budget.
    Mr. Chairman, as you pointed out many times, what we have 
today in America is a sick/cure system, not a healthcare 
system. And last February, under your leadership, we took a 
huge step in the direction to change the focus of that system. 
With the investments in the Recovery Act we made the single 
largest investment in prevention and wellness in American 
history including the almost $373 million in grants for 
promising local programs that we look forward to releasing in 
the next couple of weeks. Our budget for 2011 builds on this 
investment with new efforts to reduce the harmful effects and 
tremendous costs of chronic disease in the urban populations to 
create a new health prevention corps and prevent unintended 
pregnancies, among other programs that we intend to focus on.
    Senator Cochran, I know that the First Lady recently 
traveled to your home State of Mississippi as part of her 
initiative in the Let's Move campaign to end childhood obesity 
in a generation and highlighted some of Mississippi's very 
successful efforts in this area. And these are exactly the kind 
of promising approaches and strategies that we'd like to make 
sure and place around the country.
    Our budget makes a historic investment in fighting 
healthcare fraud. Again, Mr. Chairman, your subcommittee 
started us on this path 2 years ago with the first 
discretionary funding. We've built on that.
    When American families are struggling to make every dollar 
count we need to be just as vigilant in how we spend their 
money. The new fraud fighting funds will help us expand proven 
strategies like putting Medicare fraud strike forces in cities 
that are hubs for fraudulent activity. And they allow us to 
invest in promising new approaches like systems that will help 
us analyze claims data and suspicious activities in real time.
    When the budget takes effect it's going to be a lot harder 
for criminals to get rich stealing from our healthcare system 
and our seniors. And before you ask, Mr. Chairman, our budget 
does continue the Senior Medicare Control Program which you 
helped to start many years ago and is a great reserve of eyes 
and ears on the ground.
    A third area of focus that I want to highlight for the 
subcommittee is our Early Childhood programs. Again, building 
on the Recovery Act, our budget includes an increase of $1 
billion for Head Start, an extra $1.6 billion for childcare, 
creating room in childcare programs for 235,000 additional 
children. And with these increases we're putting a new focus on 
quality. The years 0 to 5 are at least as important as the 
years that children spend in kindergarten through the 12th 
grade, maybe more important according to the scientists. And 
there's no reason we shouldn't insist on the same high 
standards and the same rigorous focus on results.
    And finally the budget includes a very critical increase of 
nearly $1 billion for the NIH. And I want to thank Chairman 
Harkin and Senator Cochran, Senator Specter and others on this 
subcommittee for their steadfast support for NIH and its 
critical work discovering the building blocks of disease and 
developing the cures of the future. The budget is going to help 
these cures get to American families faster.
    So these are just a few areas in which our budget will 
employ new resources and new approaches to improve the lives of 
American families. I look forward to discussing some of the 
other priorities with you in a few minutes. But first I want to 
just clarify one point.

                           PREPARED STATEMENT

    The budget is intended to be a complement, not a 
substitute, for health insurance reform. The only way to 
increase health security and stability, bring down healthcare 
costs and give Americans better insurance choices is to pass 
comprehensive health insurance reform. Combined with a reform 
effort, the budget is a major step toward building a stronger, 
healthier America. But even then, we'll need your help 
improving the health, safety, and well being of the American 
people. It's a goal we can only achieve by working together. 
And no one has a more important role than Congress.
    So I appreciate the opportunity to be with you today and 
look forward to the discussion.
    [The statement follows:]
              Prepared Statement of Hon. Kathleen Sebelius
    Chairman Harkin, Senator Cochran, and members of the subcommittee, 
thank you for the invitation to discuss the President's fiscal year 
2011 budget for the Department of Health and Human Services (HHS).
    In his State of the Union Address, President Obama laid out an 
aggressive agenda to create jobs, strengthen opportunity for working 
families, and lay a foundation for long-term growth. His fiscal year 
2011 budget is the blueprint for putting that vision into action.
    At HHS, we are supporting that agenda by working to keep Americans 
healthy, ensuring they get the healthcare they need, and providing 
essential human services for children, families, and seniors.
    Our budget will make sure that the critical health and human 
services our Department offers to the American people are of the 
highest quality and are directly helping families stay healthy, safe, 
and secure--especially as we continue to climb out of a recession.
    It promotes projects that will rebuild our economy by investing in 
next-generation research and the advanced development of technology 
that will help us find cures for diseases, innovative new treatments, 
and new ways to keep Americans safe, whether we are facing a pandemic 
or a potential terrorist attack.
    But this budget isn't just about new programs or new priorities or 
new research. It is also about a new way of doing business with the 
taxpayers' money. Where there is waste and fraud, we must root it out. 
Where there are loopholes, we must close them. And where we have 
opportunities to increase transparency, accountability, and program 
integrity, we must take them. These are top priorities of the 
President. They are top priorities of mine. And our budget reflects 
that they are top priorities for my Department.
    The President's fiscal year 2011 budget for HHS totals $911 billion 
in outlays. The budget proposes $81 billion in discretionary budget 
authority for fiscal year 2011, of which $74 billion is within the 
jurisdiction of the Labor, Health and Human Services, Education, and 
Related Agencies Subcommittee.
    This budget is a major step toward a healthier, stronger America. 
But it is a complement, not a substitute for health insurance reform.
    This administration strongly believes that the only sure way to 
increase health security and stability, bring down healthcare costs, 
and give Americans better insurance choices is to pass comprehensive 
health insurance reform. To that end, the President has put forth a 
proposal that bridges the House and Senate bills and incorporates the 
best ideas of Republicans and Democrats.
    His proposal--which he has called on Congress to swiftly pass--will 
give American families and small business owners more control over 
their healthcare by holding insurance companies accountable. It will 
give Americans protection from insurance company abuses, create a new 
consumer-friendly health insurance marketplace, and begin to bring down 
costs for families, businesses, and Government. Reform is projected to 
reduce the deficit by about $100 billion in the first decade, and 
roughly $1 trillion in the second decade, and, by controlling 
healthcare costs, put the Federal Government on a path to fiscal 
responsibility.
    After meeting last week with the CEOs of America's largest 
insurance companies, who acknowledged that the current health insurance 
system fails to provide transparency and affordable coverage to all 
Americans, I am more convinced than ever that the only way to fix our 
broken health insurance system is to enact these common-sense reforms. 
And after more than 1 year of conversation, Americans deserve an up or 
down vote.
    My hope is that Congress will follow through on the hard work they 
have done over the last 12 months and send a bill to the President 
soon. But for now, I'd like to begin with a broad overview of my 
Department's 2011 budget priorities, many of which are aimed toward the 
same goals. Then I'll look forward to taking some of your questions.
Investing in Prevention
    Reducing the burden of chronic disease, collecting and using health 
data to inform decisionmaking and research, and building an 
interdisciplinary public health workforce are critical components to 
successful prevention efforts. The budget includes $20 million for the 
Centers for Disease Control and Prevention (CDC) Big Cities Initiative 
to reduce the rates of morbidity and disability due to chronic disease 
in up to 10 of the largest U.S. cities. These cities will be able to 
incorporate the lessons learned from implementing evidence-based 
prevention and wellness strategies of the American Recovery and 
Reinvestment Act of 2009 (Recovery Act) Communities Putting Prevention 
to Work Initiative. This Recovery Act initiative is key to promoting 
wellness and preventing chronic disease, and we appreciate the support 
of Congress, and particularly Chairman Harkin, in making these funds 
available. In March, HHS will award $373 million for the cornerstone of 
this initiative, funding communities to implement evidence-based 
strategies to address obesity, increase physical activity, improve 
nutrition, and decrease smoking. The Big Cities Initiative requested in 
fiscal year 2011 will allow us to build on the success of the Recovery 
Act.
    The budget also includes $10 million at CDC for a new Health 
Prevention Corps, which will recruit, train, and assign a cadre of 
public health professionals in State and local health departments. This 
program will target disciplines with known shortages, such as 
epidemiology, environmental health, and laboratory science.
    To support teen and unintended pregnancy prevention and care 
activities in the Office of Public Health and Science and CDC, the 
budget provides $222 million in funds. Of this, $125 million will be 
used for replicating programs that have proven effective through 
rigorous evaluation to reduce teenage pregnancy; research and 
demonstration grants to develop, replicate, refine, and test additional 
models and innovative strategies; and training, technical assistance 
and outreach. Also, provided in the request is $4 million to carry out 
longitudinal evaluations of teenage pregnancy prevention approaches, 
and another $4 million in Public Health Service evaluation funds for 
this activity. This also includes $22 million for CDC to reduce the 
number of unintended pregnancies through science-based prevention 
approaches. In addition, the fiscal year 2011 Adolescent Family Life 
(AFL) budget includes $17 million to provide support for AFL Care 
demonstration grants and research programs. In an effort to ameliorate 
the negative effects of childbearing on teen parents, their infants and 
their families, care grant community-based projects develop, test, and 
evaluate interventions with pregnant and parenting teens, and focus on 
ways to build and strengthen families.
    Behavioral health is essential to the well-being of all Americans. 
The budget includes an additional $135 million in the Substance Abuse 
and Mental Health Services Administration and Health Resources and 
Services Administration (HRSA) for innovative approaches to prevent and 
treat substance abuse and mental illness. These efforts include 
increases of $35 million for community-based prevention, $25 million to 
expand behavioral health services at health centers, and $17 million 
associated with homelessness prevention. An increase of $13 million 
will expand the treatment capacity of drug courts, and $33 million will 
strengthen our capacity to deter new drug threats and assess our 
progress in reducing substance abuse.
Reducing Healthcare Fraud
    When American families are struggling to make every dollar count, 
we need to be just as vigilant about how their money is spent. That's 
why the Obama administration is cracking down on criminals who steal 
from taxpayers, endanger patients, and jeopardize the future of our 
health insurance programs.
    Last May, President Obama instructed Attorney General Holder and I 
to create a new Health Care Fraud Prevention and Enforcement Action 
Team, which we call ``HEAT'' for short. HEAT is an unprecedented 
partnership that brings together high-level leaders from both 
departments so that we can share information, spot trends, coordinate 
strategy, and develop new fraud prevention tools.
    As part of this new partnership, we are developing tools that will 
allow us to identify criminal activity by analyzing suspicious patterns 
in claims data. Medicare claims data used to be scattered among several 
databases. If we wanted to find out how many claims had been made for a 
certain kind of wheelchair, we had to go look in several different 
places. This single, searchable database means that for the first time 
ever, we'll have a complete picture of what kinds of claims are being 
filed across the country.
    Our fiscal year 2011 budget includes $1.7 billion in funding to 
fight fraud, including $561 million in discretionary funds to 
strengthen Medicare and Medicaid program integrity activities, with a 
particular emphasis on fighting healthcare fraud in the field, 
increasing Medicare and Medicaid audits, and strengthening program 
oversight while reducing costs. We appreciate the subcommittee's 
support of past requests for fraud prevention; and building on the 
successes we have been able to achieve with those funds, we are now 
seeking an additional $250 million over the fiscal year 2010 level that 
we hope you can support.
    This investment will better equip the Federal Government to 
minimize inappropriate payments, pinpoint potential weaknesses in 
program integrity oversight, target emerging fraud schemes by provider 
and type of service, and establish safeguards to correct programmatic 
vulnerabilities. This multi-year discretionary investment will save 
$9.9 billion over 10 years.
    The budget also includes a set of new administrative and 
legislative program integrity proposals that will give HHS the 
necessary tools to fight fraud by enhancing provider enrollment 
scrutiny, increasing claims oversight, and improving Medicare's data 
analysis capabilities, which will save approximately $14.7 billion over 
10 years. Along with the $9.9 billion in savings from the discretionary 
investments, these new program authorities will save a total of $25 
billion in Medicare and Medicaid expenditures over 10 years.
Improving Quality of and Access to Healthcare
    At HHS, we continue to find ways to better serve the American 
public, especially those citizens least able to help themselves. We are 
working to improve the quality of and access to healthcare for all 
Americans by supporting programs intended to enhance the healthcare 
workforce and the quality of healthcare information and treatments 
through the advancement of health information technology (IT) and the 
modernization of the healthcare system.
    As Congress continues its work to provide security and stability 
for Americans with health insurance and expand coverage to those 
Americans who do not have insurance, HHS maintains its efforts toward 
achieving those goals through activities with the Children's Health 
Insurance Program (CHIP), health IT, patient-centered health research, 
prevention and wellness, community health centers, and the health 
workforce.
    The budget includes $3.6 billion for Centers for Medicare & 
Medicaid Services' (CMS) Program Management. To strengthen the ability 
of CMS to meet current administrative workload demands resulting from 
recent legislative requirements and continued growth of the beneficiary 
population, the funding provides targeted investments to revamp IT 
systems and optimize staffing levels so that CMS can meet the future 
challenges of Medicare, Medicaid, and CHIP while being an active 
purchaser of high-quality and efficient care.
    For example, $110 million will support the first year of a 
comprehensive Health Care Data Improvement Initiative (HCDII) to 
transform CMS's data environment from one focused primarily on claims 
processing to one also focused on state-of-the art data analysis and 
information sharing. Without this funding CMS would not be able to 
transform Medicare and Medicaid into leaders in value-based purchasing 
and in data sources for privacy-protected patient-centered health 
research. This funding is imperative for CMS to meet the needs of 
future growth, financial accountability, and data content and 
availability. The HCDII is the cornerstone of a business strategy that 
will optimize the delivery of efficient, high-quality healthcare 
services. CMS needs this funding to strengthen disaster recovery and 
security operations to protect against loss of data or services; to 
enable timely data sharing and analysis to fight fraud, waste, and 
abuse; and to transform payment processes to support quality outcomes.
    To strengthen and support our Nation's healthcare workforce, the 
budget includes $1.1 billion within the HRSA for a wide range of 
programs. This funding will enhance the capacity of nursing schools, 
increase access to oral healthcare through dental workforce development 
grants, target students from disadvantaged backgrounds, and place an 
increased emphasis on ensuring that America's senior population gets 
the care and treatment it needs.
    The budget includes an increase of $290 million to ensure better 
access to health centers through further expansions of health center 
services and integration of behavioral health into health centers' 
primary care system. This funding builds on investments made under the 
Recovery Act and will enable health centers to serve more than 20 
million patients in fiscal year 2011, which is 3 million more patients 
than were served in fiscal year 2008.
    The budget advances the President's health IT initiative by 
accelerating health IT adoption and electronic health records (EHR) 
utilization--essential tools for modernizing the healthcare system. The 
budget includes $78 million, an increase of $17 million, for the Office 
of the National Coordinator for Health Information Technology to 
continue its current efforts as the Federal health IT leader and 
coordinator. During fiscal year 2011, HHS will also begin providing an 
estimated $25 billion over 10 years of Recovery Act Medicare and 
Medicaid incentive payments primarily to physicians and hospitals who 
demonstrate meaningful use of certified EHRs, which will improve the 
reporting of clinical quality measures and promote healthcare quality, 
efficiency, and patient safety.
    The budget supports HHS-wide patient-centered health research, 
including an additional $261 million within the Agency for Healthcare 
Research and Quality over fiscal year 2010. HHS also continues to 
invest the $1.1 billion provided by the Recovery Act to improve 
healthcare quality by providing patients and physicians with state-of-
the-art, evidence-based information to enhance medical decision-making.
Promoting Public Health
    Whether responding to pandemic flu or researching major diseases, 
HHS will continue its unwavering commitment to keeping Americans 
healthy and safe.
    The budget includes more than $3 billion, an increase of $70 
million, for CDC and HRSA to enhance HIV/AIDS prevention, care, and 
treatment. This increase includes $31 million for CDC to integrate 
surveillance and monitoring systems, address high-risk populations, and 
support HIV/AIDS coordination and service integration with other 
infectious diseases. The increase also includes $40 million for HRSA's 
Ryan White program to expand access to care for underserved 
populations, provide life-saving drugs, and improve the quality of life 
for people living with HIV/AIDS.
    To improve CDC's ability to collect data on the health of the 
Nation for use by policy makers and Federal, State, and local leaders, 
the budget provides $162 million for health statistics, an increase of 
$23 million above fiscal year 2010. This increase will ensure data 
availability on key national health indicators by supporting electronic 
birth and death records in States and enhancing national surveys.
    The budget includes $222 million, an increase of $16 million, to 
address Autism Spectrum Disorders (ASD). Research at the National 
Institutes of Health (NIH) will pursue comprehensive and innovative 
approaches to defining the genetic and environmental factors that 
contribute to ASD, investigate epigenetic changes in the brain, and 
accelerate clinical trials of novel pharmacological and behavioral 
interventions, CDC will expand autism monitoring and surveillance and 
support an autism awareness campaign, and HRSA will increase resources 
to support children and families affected by ASD through screening 
programs and evidence-based interventions.
    The budget includes $352 million, an increase of $16 million, for 
CDC Global Health Programs to build global public health capacity by 
strengthening the global public health workforce; integrating maternal, 
newborn, and child health programs; and improving global access to 
clean water, sanitation, and hygiene. Specifically, CDC will expand 
existing programs and develop programs in new countries to provide 
workforce training in areas such as epidemiology and outbreak 
investigation, and to implement programs that distribute water quality 
interventions to create safe drinking water. In addition, CDC will 
integrate interventions, such as malaria control measures, expanded 
immunizations, and safe water treatment, to reduce newborn, infant, and 
child mortality. Additionally, the budget includes $6 million in the 
Office of Global Health Affairs to support global health policy 
leadership and coordination.
Protecting Americans From Public Health Threats and Terrorism
    Continued investments in countermeasure development and pandemic 
preparedness will help ensure that HHS is ready to protect the American 
people in either natural or manmade public health emergencies. The 
budget includes $476 million, an increase of $136 million, for the 
Biomedical Advanced Research and Development Authority to sustain the 
support of next-generation countermeasure development in high-priority 
areas by allowing the BioShield Special Reserve Fund to support both 
procurement activities and advanced research and development.
    Reassortment of avian, swine, and human influenza viruses has led 
to the emergence of a new strain of H1N1 influenza A virus, 2009 H1N1 
flu, that is transmissible among humans. On June 24, 2009, Congress 
appropriated $7.65 billion to HHS for pandemic influenza preparedness 
and response to 2009 H1N1 flu. HHS has used these resources to support 
States and hospitals, to invest in the H1N1 vaccine production, and to 
conduct domestic and international response activities. The budget 
includes $302 million for ongoing pandemic influenza preparedness 
activities at CDC, NIH, Food and Drug Administration, and the Office of 
the Secretary for international activities, virus detection, 
communications, and research. In addition, the use of balances from the 
June 2009 funds, will enable HHS to continue advanced development of 
cell-based and recombinant vaccines, antivirals, respirators, and other 
activities that will help ensure the Nation's preparedness for future 
pandemics. Previous appropriations for H5N1 allowed us to be better 
prepared for H1N1 than we ever would have been otherwise, and only by 
continued work on better vaccines, antivirals, and preparedness will we 
be ready for the next virus--which could well be a greater challenge 
than H1N1 has been.
Improving the Well-being of Children, Seniors, and Households
    In addition to supporting efforts to increase our security in case 
of an emergency, the HHS budget also seeks to increase economic 
security for families and open up doors of opportunity to those 
Americans who need it most.
    The budget provides critical support of the President's Zero to 
Five Plan to enhance the quality of early care and education for our 
Nation's children. The budget lays the groundwork for a reauthorization 
of the Child Care and Development Block Grant and entitlement funding 
for childcare, including a total of $6.6 billion for the Child Care and 
Development Fund, an increase of $800 million in the Child Care and 
Development Block Grant and $800 million in the Child Care Entitlement. 
These resources will enable 1.6 million children to receive child care 
assistance in fiscal year 2011, approximately 235,000 more than could 
be served in the absence of these additional funds.
    The administration's principles for reform of the Child Care and 
Development Fund include establishing a high standard of quality across 
childcare settings, expanding professional development opportunities 
for the childcare workforce, and promoting coordination across the 
spectrum of early childhood education programs. The administration 
looks forward to working with Congress to begin crafting a 
reauthorization proposal that will make needed reforms to ensure that 
children receive high-quality care that meets the diverse needs of 
families and fosters healthy child development.
    To enable families to better care for their aging relatives and 
support seniors trying to remain independent in their communities, the 
budget provides $102.5 million for a new Caregiver Initiative at the 
Administration on Aging. This funding includes $50 million for 
caregiver services, such as counseling, training, and respite care for 
the families of elderly individuals; $50 million for supportive 
services, such as transportation, homemaker assistance, adult daycare, 
and personal care assistance for elderly individuals and their 
families; and $2.5 million for respite care for family members of 
people of all ages with special needs. This funding will support 
755,000 caregivers with 12 million hours of respite care and more than 
186,000 caregivers with counseling, peer support groups, and training.
    Funding for the Head Start program, run by the Administration for 
Children and Families (ACF), will increase by $989 million to sustain 
and build on the historic expansion made possible by the Recovery Act. 
In fiscal year 2011, Head Start will serve an estimated 971,000 
children, an increase of approximately 66,500 children over fiscal year 
2008. Early Head Start will serve approximately 116,000 infants and 
toddlers, nearly twice as many as were served in fiscal year 2008. The 
increase also includes $118 million to improve program quality, and the 
Administration plans to implement key provisions of the 2007 Head Start 
Act reauthorization related to grantee recompetition, program 
performance standards, and technical assistance that will improve the 
quality of services provided to Head Start children and families.
    The budget proposes a new way to fund the Low Income Home Energy 
Assistance Program to help low-income households heat and cool their 
homes. The request provides $3.3 billion in discretionary funding. The 
proposed new trigger would provide, under current estimates, $2 billion 
in mandatory funding. Energy prices are volatile, making it difficult 
to match funding to the needs of low-income families, so under this 
proposal, mandatory funds will be automatically released in response to 
quarterly spikes in energy prices or annual changes in the number of 
people living in poverty.
Investing in Scientific Research and Development
    The investments that HHS is proposing in our human services budget 
will expand economic opportunity, but another critical way to grow and 
transform our economy is through a healthy investment in research that 
will not only save lives but also create jobs.
    The budget includes a program level of $32.2 billion for NIH, an 
increase of nearly $1 billion, to support innovative projects ranging 
from basic to clinical research, as well as including health services 
research. This effort will be guided by NIH's five areas of exceptional 
research opportunities: supporting genomics and other high-throughput 
technologies; translating basic science into new and better treatments; 
reinvigorating the biomedical research community; using science to 
enable healthcare reform; and focusing on global health. The 
administration's interest in the high-priority areas of cancer and 
autism fits well into these five NIH theme areas. In fiscal year 2011, 
NIH estimates it will support a total of 37,001 research project 
grants, including 9,052 new and competing awards.
Recovery Act
    Since the Recovery Act was passed in February 2009, HHS has made 
great strides in improving access to health and social services, 
stimulating job creation, and investing in the future of healthcare 
reform through advances in health IT, prevention, and scientific 
research. HHS Recovery Act funds have had an immediate impact on the 
lives of individuals and communities across the country affected by the 
economic crisis and the loss of jobs.
    As of September 30, 2009, the $31.5 billion in Federal payments to 
States helped maintain State Medicaid services to a growing number of 
beneficiaries and provided fiscal relief to States. NIH awarded $5 
billion for biomedical research in more than 12,000 grants. Area 
agencies on aging provided more than 350,000 seniors with more than 6 
million meals delivered at home and in community settings. Health 
Centers provided primary healthcare services to more than 1 million new 
patients.
    These programs and activities will continue in fiscal year 2010, as 
more come on line. For example, 64,000 additional children and their 
families will participate in a Head Start or Early Head Start 
experience. HHS will be assisting States and communities to develop 
capacity, technical assistance and a trained workforce to support the 
rapid adoption of health IT by hospitals and clinicians. The CDC will 
support community efforts to reduce the incidence of obesity and 
tobacco use. New research grants will be awarded to improve health 
outcomes by developing and disseminating evidence-based information to 
patients, clinicians, and other decision-makers about what 
interventions are most effective for patients under specific 
circumstances.
    The Recovery Act provides HHS programs an estimated $141 billion 
for fiscal years 2009-2019. While most provisions in HHS programs 
involve rapid investments, the Recovery Act also includes longer-term 
investments in health IT (primarily through Medicare and Medicaid). As 
a result, HHS plans to have outlays totaling $86 billion through fiscal 
year 2010.
Conclusion
    This testimony reflects just some of the ways that HHS programs 
improve the everyday lives of Americans. Under this budget, we will 
provide greater security for working families as we continue to recover 
from the worst recession in our generation. We will invest in research 
on breakthrough solutions for healthcare that will save money, improve 
the quality of care, and energize our economy. And we will push forward 
our goal of making Government more open and accountable.
    My Department cannot accomplish any of these goals alone. It will 
require all of us to work together. And I am eager to work with you to 
advance the health, safety, and well-being of the American people. 
Thank you for this opportunity to speak with you today. I look forward 
to answering your questions.

    Senator Harkin. Thank you very much, Madam Secretary. And 
we'll start 5-minute rounds, whoever is keeping this clock 
going here. Who keeps the clock going? There we go.

                        WASTE, FRAUD, AND ABUSE

    Madam Secretary again, I applaud you for your continued 
efforts in the waste, fraud, and abuse areas. We have figures 
that show how much money we save when we invest in that.
    I think for every $1 we spend we save $6 and that's real 
money. And the largest portion, the Medicare Integrity Program, 
we get $14 for every $1 we spend. So from the standpoint of 
just economics it's important, but also to provide more 
integrity of the programs. So I applaud you for that.

                      H1N1 EMERGENCY SUPPLEMENTAL

    Another thing I wanted to cover with you was the emergency 
supplemental funding we appropriated last year. We appropriated 
$7.65 billion to address the critical needs relating to the 
emerging H1N1 influenza virus. But in the 2011 budget request 
I've noticed you're using $555 million from this emergency 
supplemental for things that we usually fund in our annual 
appropriations bill. These are the annual costs for flu 
preparedness activities at CDC and in the Office of the 
Secretary.
    I understand it also includes staff salaries. These costs 
can hardly be called an emergency. Can you just tell me how you 
justify these emergency supplemental fundings for these types 
of ongoing costs?
    Secretary Sebelius. Mr. Chairman, it was our goal in 
seeking 2011 funding to be mindful of the budget situation and 
the President's desire not to increase discretionary funding 
for 3 years starting this year. And recognizing that, first of 
all the appropriations made by this subcommittee over time and 
certainly the supplemental funding helped us be very well 
prepared to face the pandemic that arrived here in April with a 
new vaccine, with a very robust outreach effort. But as you 
know when we requested supplemental funding it was still 
anticipated that we might need two doses per person. We were 
not at all certain how lethal the disease would be.
    We were building a contingency plan based on the best 
possible preparedness activities. What we found ourselves, as 
the second wave of the flu has dramatically decreased, that we 
are still working with State and local efforts to have people 
vaccinated. But we have additional funding and we thought 
rather than seeking new funds from the subcommittee process 
that we'd be more appropriate to use for ongoing flu efforts. 
The efforts they're being used for are pandemic efforts that, 
as you know, are underway year in and year out whether we're in 
the midst of a pandemic or not.
    So the CDC activities will continue on. Our work with State 
and local partners will continue on. The kind of staff support 
that you mentioned is part of the preparedness efforts that are 
underway year in and year out. But we just decided not to bank 
that money and then seek additional funds from the 
subcommittee, but use the funds that were available in an 
effort to be as prudent as possible.

                        EARLY CHILDHOOD PROGRAMS

    Senator Harkin. Very good. I appreciate that.
    As a matter of fact, one other area that I've been a long-
time supporter of is early childhood programs. On the education 
side I've talked a great deal with your counterpart, Secretary 
Duncan. As we both know many States have shown that children 
who receive high-quality, early childhood services are less 
likely to commit crimes, more likely to graduate from high 
school, more likely to hold a job and everything. But the key 
seems to be whether the services are indeed high quality.
    The National Head Start Impact Study released last month 
shows that most of the gains that children show after 
participating in these programs tend to wear off after first 
grade. And this is troubling. So we have to make sure that the 
quality of early childhood programs is consistently high.
    And could you just talk for a minute about how you plan to 
address the quality issue in the 2011 budget request?
    Secretary Sebelius. Absolutely. Mr. Chairman, I share your 
concern that it's always a key issue for parents to have their 
children in safe childcare situations. But I think more 
importantly or as important is to make sure that they are 
actually developing the skills that they're ready to learn once 
they hit kindergarten. And too often that doesn't happen in 
many of the childcare settings.
    So the study that you mention is a snapshot of some years 
ago of what the results were of Head Start programs. And I can 
assure you that there have been a number of investments in 
quality since that snapshot was taken. But even more 
importantly this year we share the notion that we have to 
greatly enhance quality.
    And too often there are somewhat erratic standards at the 
State level. Some States have set very high-quality standards. 
Others have not.
    So we are actually applying some of the funding this year 
for the additional Head Start money to quality standards that 
would be developed and implemented across the country to make 
sure that whether you're in Arkansas or Rhode Island or Iowa or 
Mississippi in a Head Start program that you would anticipate 
the same high-quality standards and that that would be part of 
the funding going forward.
    Senator Harkin. Is that $118 million?
    Secretary Sebelius. Yes, sir. I'm sorry. Yes, we didn't 
apply all of the funding to slots. We think quality 
enhancements nationwide are a critical part of this effort.
    Senator Harkin. Thank you, Madam Secretary. Senator 
Cochran.

                          LET'S MOVE CAMPAIGN

    Senator Cochran. Madam Secretary, thank you very much for 
being here to discuss the budget request before the 
subcommittee. We appreciate some of the highlights you outlined 
and of your intentions as Secretary to solve some of the 
problems that face many of us back in our States. And I noticed 
right away you're putting an emphasis on obesity and you have 
called attention to the fact that the First Lady came to 
Mississippi to talk about the Let's Move campaign, more 
activity, more healthy eating practices. And we surely need 
that in our State.
    And so I was pleased to see that the emphasis is being 
placed by your Department and also at the White House on doing 
something about this really big problem. In Mississippi we win 
the prize. We're number one in childhood and adult obesity.
    So we welcome these efforts. And we hope that we can work 
with the Department to put the money where the problem is and 
let you show us what can be done. And we need leadership. And 
we welcome that.
    Do you have any specific things to tell us about what the 
elements of this program might be?
    Secretary Sebelius. Well, Senator Cochran, in the Let's 
Move campaign the First Lady has really outlined four principal 
goals. And HHS will be involved in a number of them. More tools 
and information for parents to make good choices and that's 
everything from our Food and Drug Administration (FDA) looking 
at new, easier to read, easier to find food labeling to the CDC 
updating and clarifying nutrition standards.
    So parents who want to shop smarter, buy healthier food 
will be able to find it on a grocery shelf and not have to read 
some dense barcode on the back of a package. Pediatricians have 
stepped up saying that they are in agreement that every child 
who gets a checkup should have a body mass index. But more than 
just having the body mass index on a regular basis, 
pediatricians need to have a conversation with the parents 
about what it means. And literally write prescriptions for more 
exercise and/or healthier eating habits. Helping parents, 
again, to make some choices that matter.
    A second pillar is focused on schools where kids spend a 
lot of their time. The Department of Agriculture is working to 
upgrade what's fed to children in school breakfast and school 
lunch programs. And make it healthier and more nutritious 
working again with the CDC on nutrition guidelines.
    The physical education component of schools has kind of 
fallen off the radar screen in too many cases. And what we know 
from the Secretary of Education studies is that not only are 
children healthier, but they actually are better learners if 
they actually move around some during the course of the school 
day.
    So reinstituting physical education will be part of school. 
Working with soft drink manufacturers on marketing sugary 
beverages inside schools and a lot of activity has been done so 
far in terms of voluntarily removing high-sugar content drinks 
from schools and substituting water and juices. So that's kind 
of component number two.
    Number three is we've got 23 million Americans who live in 
so-called food deserts where they don't have access to fresh 
fruits and vegetables. So they may want to eat in a healthier 
manner, but they literally don't have any place within 2 miles 
of their home to go buy a piece of fruit or a fresh vegetable.
    So again the Department of Agriculture is not only doing 
mapping of those so-called food deserts. But looking at 
initiatives with local farmers, local grocers, to try and 
establish a different protocol. We have some dollars available 
in our budget for helping to subsidize some of those healthier 
choices and figure out if it's a price strategy or an access 
strategy.
    And the fourth component of Let's Move is let's see, I'm 
blanking on it for a moment. Parents and kids and--I'll get 
back to you on this and submit the information at a later date.
    [The information follows:]

    Physical Activity.--The fourth component of the Let's Move campaign 
is increasing physical activity. The administration will encourage 
children to be more physically active each day rather than spending 
more time watching TV and playing video games.

    Senator Cochran. Health centers. One thing to do is to use 
the health centers as a place--
    Secretary Sebelius. That--
    Senator Cochran. For the children that go to Head Start 
programs there, the parents can come in and visit with 
healthcare professionals who are there at those centers.
    Secretary Sebelius. Ok.
    Senator Cochran. We found in our State that bringing all 
these programs together in one location certainly helps a lot, 
particular to the very young, those who haven't started 
elementary school. And you can't start too early.
    Secretary Sebelius. Absolutely.
    Senator Cochran. I think a lot of these habits are formed 
very early. And I'm sure you are aware of that. One area of our 
State, the Mississippi Delta, has had great success in 
developing a Delta Health Alliance.
    And I hope that we can see funding directed to programs 
like that so that we can continue to see progress that can be 
made. Local medical centers using Mississippi Valley State 
University, Delta State University, University of Mississippi, 
and Mississippi State University, all have roles to play in our 
State in that effort. So thank you for getting off to such a 
good start in mapping out a plan of action.
    Secretary Sebelius. Well and Senator, I look forward to 
learning the lessons that are already being enacted in 
Mississippi. I know your governor and the First Lady of 
Mississippi have taken a real interest and effort in this area. 
And I absolutely agree that community health centers can play 
an enormously important role.
    Senator Cochran. Thank you.
    Secretary Sebelius. Thank you.
    Senator Harkin. Senator Reed.

              LOW INCOME HOME ASSISTANCE PROGRAM (LIHEAP)

    Senator Reed. Thank you, Mr. Chairman.
    Madam Secretary, thank you very much.
    The Chairman already alluded to the issue of LIHEAP funding 
which is critical not only to my State but to practically every 
State in both the cold winter States and the very, very hot 
summer States. The Chairman over the last few years, ensured 
that we've had very robust funding. This $2 billion reduction 
to the LIHEAP Block Grant will translate into a $13.6 million 
cut for Rhode Island, which is a sizable number for us.
    And also it undercuts the certainty of planning in terms of 
what monies they might have. I know you're creating a mandatory 
stream of funding with a trigger that will kick in when prices 
rise or when economic conditions worsen, but all of that I 
think will be discounted because it will be so difficult to 
anticipate these conditions. And essentially States will be 
planning for and allocating and getting a waiting list on the 
basis of a lower block grant.
    The other issue too, is that this trigger is going, I 
think, to be difficult to sort of estimate when it precisely 
kicks in. And also it's unclear to me what the formula for 
distribution is if the trigger kicks in. And by way of that, 
this January there was contingency money released to the 
States. Rhode Island actually got $4 million less than the 
previous year at a time when our employment sadly, is second or 
third in the Nation. So the subjectivity of distribution of 
this funding is going to, I think, contribute to significant 
concerns.
    My question, I think, is can we do better?
    One, in terms of the baseline number?
    Two, how do you specifically propose to resolve the trigger 
and the distribution formula?
    Secretary Sebelius. Well Senator, let me just start by 
saying I, first of all, not only appreciate the interest and 
leadership in the LIHEAP program in the past, but also 
recognize as a governor who distributed LIHEAP funds how 
essential it is to people who cannot pay their bills in the 
winter and some in the summer. So I know what a critical safety 
net that is.
    In terms of the distribution methodology this year which I 
know again, was a subject of some concern, particularly in the 
Northeast. We looked at two factors for the money that was 
distributed in January.
    One was the cost of heating oil, which had come down to 
some degree over where we had been in the previous year, but in 
addition to that, the number of States who were actually 
experiencing unusually cold winters. And there were States that 
were far more scattered than some patterns we had seen in the 
past. And added to that the unemployment index as an indicator 
of States in real economic hardship.
    And as you know 14 States were deemed to be, not by our 
count, but by the weather assessments, 5 percent colder during 
those winter months than had been experienced in the past. And 
we then distributed the money, some additional money to those 
14 States as well as a formula grant to the others based on 
what we were seeing. There still is a pot of money for the 
LIHEAP funding this year that is still being held anticipating 
either further distributions this winter or in the summer 
months having some real spikes in temperature that require 
additional distributions.
    In terms of the proposition for 2011 and the trigger 
proposal, there is a $3.3 billion discretionary fund, but then 
a $2 billion mandatory fund that would activate with a trigger, 
which would result actually in an increase in the overall 
LIHEAP funding for 2011, not a decrease in funding. And the 
combination trigger would be based on the analysis of the cost 
of energy plus an assessment of the poverty population in a 
State based on who is eligible for the Supplemental Nutrition 
Assistance Program. So it would be again, not our subjective 
look at it. But it would look at eligibility for the food and 
nutrition program combined with the heating oil prices for the 
winter.
    We anticipate that if energy prices are high and people are 
having a struggle paying their bills the trigger would be met. 
And again, having the poverty sensitivity would help enhance 
that ability and the formula would be divided according to the 
population. So I know that there was some discussion last year 
on our budget about a formula that just looked at the price of 
winter fuel.
    And we thought the addition of a recognition that this is 
an economic downturn and this is about people paying their 
bills. So, to look at who is in economic difficulty along with 
the price made a lot more sense and made the trigger a lot more 
sensitive.
    Senator Reed. Just two points because my time expired.
    One is let us go over so the numbers because I have an 
indication that if you look at the formula money plus the 
trigger money it won't be as much as previous years. But that 
might be my miscalculation.
    Secretary Sebelius. We would love to get the--yes. We'd 
love to get that.
    Senator Reed. The second point is even in the best of times 
when the economy is doing very well and the temperature is 
relatively mild, there are long, long waiting lists in my State 
and other States. So this notion of needing a trigger because, 
the demand only comes up during economic crises is not 
substantiated by the facts. But I thank the Chairman for his 
indulgence.
    Thank you, Madam Secretary.
    Secretary Sebelius. Well then Senator I would volunteer 
that we would love to work with you on this.
    Senator Reed. Well, thank you.
    Secretary Sebelius. First, getting you the numbers and 
making sure we're on the same page and then talking to you 
about--because I think we share the same goal that we don't 
want people struggling to pay their heating bills or having to 
turn off the heat when they can't pay them. So we want to work 
with you.
    [The information follows:]

                                                 LIHEAP FUNDING
                                            [In millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                                                                    Fiscal year
                                                                    Fiscal year        2011          Increase/
                                                                       2010         President's      decrease
                                                                   appropriation      budget
----------------------------------------------------------------------------------------------------------------
Discretionary...................................................           5,100           3,300          -1,800
Mandatory trigger \1\...........................................  ..............           2,000          +2,000
                                                                 -----------------------------------------------
      Total.....................................................           5,100           5,300            +200
----------------------------------------------------------------------------------------------------------------
\1\ For scoring purposes, $2 billion umed for fiscal year 2011.


    Senator Reed. Thank you, Madam Secretary. Thank you.
    Senator Harkin. Thank you very much. And I just personally 
want to thank you, Senator Reed, for your leadership in this 
area. You've been stalwart on that. And I look forward to 
making sure you get this all worked out for us.
    Senator Pryor.
    Senator Pryor. Thank you, Mr. Chairman. Madam Secretary, 
welcome once again to the subcommittee. It's always good to see 
you. I believe the administration has made a commendable effort 
to reduce waste, fraud, and abuse in healthcare programs both 
in its budget request and in its healthcare reform proposal.
    What support do you need from this subcommittee in the 
appropriations process as it moves forward to ensure that we're 
taking the necessary steps to end, as much as humanly possibly, 
waste, fraud, and abuse in our public health programs?
    Secretary Sebelius. Well, Senator, I'm glad you asked that 
question.
    First of all, let me just reiterate that I think the 
President takes this effort very, very seriously. It's one of 
the reasons he asked the Attorney General and me to, as Cabinet 
officers, convene a joint effort. And we are working very well 
with the Justice Department, and the strike forces now that are 
in seven cities are really paying off, big results.
    So the budget has a couple of requests.
    One is an additional $250 million in discretionary funding, 
which would allow us to expand the footprint of those strike 
forces. And as you heard Chairman Harkin say, we know that 
every dollar invested returns multiple dollars. And that's just 
dollars we get back in the door for prosecutions and can return 
to the fund and make the Medicare fund more solvent. I think 
there's an additional impact that is impossible to measure, 
which is that we discourage people from committing crimes in 
the first place by making it very clear that we intend to 
prosecute vigorously and come after them. So that's one piece 
of the puzzle.
    Another big piece of the puzzle is a data system request 
that is in for the CMS budget, about $110 million to begin a 
multiyear process to upgrade our system. What we miss right now 
is the ability to look at data sets in one system. Medicare is 
the biggest health insurance program, I think, in the world. We 
pay out--we pay more than $1 billion in claims to providers 
over the course of the year; more than $500 billion worth of 
benefits every year.
    We still have those data sets in multiple places. So it's 
impossible to check errant behavior unless you check six or 
seven systems. We have a plan that has been developed that by 
the end of 2011 we would be at a real time, one data set, 
flexible ability to share that data with law enforcement 
officers.
    To do the same thing that frankly major credit card 
companies can do, which is watch what's happening.
    Senator Pryor. Right.
    Secretary Sebelius. And immediately go after folks. And we 
need more boots on the ground.
    Senator Pryor. Yes. I think it's great that you say that. 
I'm glad to know that you're on top of that because when I was 
the State's attorney general we did the Medicaid fraud piece of 
enforcement.
    Secretary Sebelius. Yes.
    Senator Pryor. And on all those cases, you know, we would 
do these extensive investigations and all this but it was 
always after the fact.
    Secretary Sebelius. Pay and chase.
    Senator Pryor. Oftentimes it was 1 or 2 years later and 
some of these people you can never find again.
    Secretary Sebelius. Right.
    Senator Pryor. Or they've been doing this for so long 
you're never going to get the money back from them or whatever 
the case may be. I support the idea of trying to get to a point 
where we can go to real time. You mentioned credit card 
companies. But also other health insurance companies do that 
where they're able to look at claims in real time.
    I mean literally when someone is at the register they will 
get a prompt. I don't know how it works. But under what they're 
doing, the insurance company will be able to say, ``No, we need 
to check on this right now.''
    So it's out there. We can do this. We can do this a lot 
smarter. And I think we can save tens of billions of dollars 
every year by doing that.

             GEOGRAPHIC VARIANCE IN MEDICARE REIMBURSEMENT

    We have a concern in Arkansas on what we call geographic 
variance in Medicare reimbursement. You know that issue very 
well. And I'm sure in your home State you may have some of this 
as well.
    But if healthcare reform is enacted and I know that's not a 
certainty as we speak. But if it is, will you work to ensure 
that any geographic variations in reimbursement are fairly 
calculated and do not discriminate against rural America?
    Secretary Sebelius. Well, Senator, as you said, I'm very 
familiar with the difficulty often of providing quality health 
services in more rural areas. And the cost estimations have to 
be calculated about what it requires to do that. So I would 
love to work with you and other members. As you know, Senator, 
I like to refer to your State as ``Our Kansas.''
    So I think we are sister States and we----
    Senator Pryor. We have--and that's exactly right.
    Secretary Sebelius. But yes, I would very much like to work 
with you on that issue.
    Senator Pryor. Great.

                         PANDEMIC PREPAREDNESS

    The last question I have for this round is I know we've 
been through the H1N1 flu pandemic and I'm sure different 
people would agree or disagree about how well that was managed 
by the Federal Government. But what does the administration's 
budget doing to put us in an even better position this coming 
flu season and the years to come to handle either H1N1 or some 
other pandemic?
    Secretary Sebelius. Well, Senator, the ongoing efforts of 
pandemic planning continue. And the budget, I think, through 
the CDC, through our hospital preparedness grants, through our 
partnership efforts with State and local governments continues 
to ramp that up. I don't think there's any question of that--
and this subcommittee was really instrumental in helping those 
years of preparation so that this year when something hit we 
were really far more prepared than we would have been if we 
were facing it for the first time.
    We are in the process and I look forward, Mr. Chairman, to 
coming back to this subcommittee and others in an entire 
systemwide review. Not just H1N1, but really our whole 
countermeasures effort. We think it's appropriate to use this 
most recent situation as a way to say how prepared are we for 
whatever comes at us next, whether it's a pandemic that we get 
some warning for and know something about and know what kind of 
vaccine or a dirty bomb on a subway.
    What did we learn?
    Where are the gaps in the system?
    Where are the efforts that we need to move forward?
    We know we need more manufacturing capacity for vaccine. 
That was very clear.
    We know we need different technology for vaccine 
production. You know, the time table of growing virus in eggs 
is slow. And that needs to ramp up.
    But we need to look at the whole system. And that's 
underway. And we anticipate when you return from the break in a 
couple of weeks we will have an ability to report back on a 
whole range of lessons learned from H1N1.
    Senator Pryor. Great. Thank you, Mr. Chairman.
    Senator Harkin. Thank you, Senator Pryor.

           VACCINE PRODUCTION AND DISTRIBUTION INFRASTRUCTURE

    Just to follow up, if the pandemic did not happen, I am 
concerned that we then start to think, ``Welll, that was just a 
scare anyway. It really wasn't going to happen.''
    Now we fall into lethargic mode by thinking that we can 
delay implementation of preventative measures. You put your 
finger on it. We have to build the structures.
    Secretary Sebelius. You bet.
    Senator Harkin. That can respond more rapidly, cell-based 
systems so we can grow the viruses or RNA-based systems that, 
can even be more rapidly utilized. But as I understand it we 
only put one new one online. Is that right?
    Secretary Sebelius. We cut the ribbon in a plant in North 
Carolina just this year.
    Senator Harkin. Yes, that's right.
    Secretary Sebelius. And there is planning underway for the 
second plant.
    Senator Harkin. And that's going to be on track, on time? 
We have the funds for that?
    Secretary Sebelius. I think you have the funds for one 
additional plant the way the funding looks now instead of I 
think it was anticipated 5 or 6 years ago that the funds were 
being set aside for four plants.
    Senator Harkin. Well.
    Secretary Sebelius. And the cost of the North Carolina 
plant turns out that it exceeded what was estimated to be a 
number of years ago.
    Senator Harkin. Well, Madam Secretary, again, one of the 
problems for having these kinds of plants is the question, what 
do they do every year? I mean, if you don't have something 
that's confronting you, how do they keep viable? That's been 
the big problem with vaccine production.
    That's why I suggested, modestly, a year or two ago that 
perhaps what we ought to do on the Federal level is provide a 
free flu shot to every person in the country every year. Oh, I 
forget what the cost came in on that. And there was a cost to 
it.
    But then you balance it against how many people get sick 
just from annual flu, and are hospitalized, and the people that 
die from the flu--and you add that cost. Then we could see if 
you can really do great outreach programs with a free flu shot.
    First of all you keep these plants going because they have 
to meet the demand every year and if we have a pandemic that 
has a different strain, they can shift to that immediately.
    Second, you build up the infrastructure. If you do have a 
pandemic that is hitting us, one of the big problems is just 
getting it out through shopping centers and churches and 
schools and wherever, drug stores and every other place. And if 
you do that on an annual basis then you build up a really good 
infrastructure that's ongoing. And I think you also will build 
up more of a public support for these vaccinations.
    A lot of people don't get flu shots because, well, why? I 
don't know. They don't think they work or they've heard they 
shouldn't get them. They're afraid of getting them, that type 
of thing. And there are a lot of people in this country who are 
allergic to eggs who cannot get these shots because of the egg-
based production.
    Secretary Sebelius. Right.
    Senator Harkin. I haven't revisited that for some time, but 
again thinking about having a couple of plants that are cell 
based. How do we keep them energized? How do we keep--and we 
can't just leave them set there waiting for the next pandemic 
to come.
    So I would be interested in discussing that with you later 
on.
    Secretary Sebelius. Well I think that would be very 
helpful.
    Dr. Nikki Lurie, who is the Assistant Secretary for 
Preparedness and Response, has been charged with this whole 
countermeasures review. And certainly one of the issues is how 
we prepare for things we don't even know are coming. What sort 
of stockpile do we need against anthrax or unknown viruses that 
may head our way? What's the market for that? So we would love 
to continue that conversation with you.
    I think one of the lessons learned is the kind of 
distribution system that you just mentioned. This year, as you 
know, the H1N1 virus had a much younger target population. So 
we were trying to encourage vaccination of people who typically 
do not get a seasonal flu shot. They're too young or they 
typically don't get the flu.
    We've had an estimated 72 to 81 million people vaccinated, 
using an estimated 81 to 91 million doses, and people are still 
being vaccinated. And we used a lot of nontraditional sources, 
school-based clinics which hadn't been used for years and 
turned out to be very successful with kids. A lot of outreach 
with faith based groups. We went from a 40,000 site 
distribution system for the children's vaccines to 150,000 
sites for H1N1 vaccine
    And so we have a more robust distribution system, a more 
robust outreach system than has been in place, I would suggest, 
in a very long time in America. And that's, I think, very good 
news for whatever comes at us next.
    Senator Harkin. Well, I think we have to keep that----
    Secretary Sebelius. Right.
    Senator Harkin. Activated, some way.
    Secretary Sebelius. Yes.
    Senator Harkin. And that is what I'm concerned about. We've 
done that. But now it's faded out. And we may not do it next 
year. Then a couple years go by. And we may have to really gen 
it up again. That's why I focus on the annual flu.
    Secretary Sebelius. Well with 36,000 people a year dying 
from flu and 200,000 hospitalized--that's our annual flu data--
and that's pretty serious.

                 COMMUNITIES PUTTING PREVENTION TO WORK

    Senator Harkin. That's pretty serious. And it costs a lot 
of money.
    But I did have one more question. And not to make too far a 
leap from vaccinations to prevention, but this subcommittee put 
$1 billion in the stimulus bill for prevention activities at 
HHS.
    As you mentioned in your statement the cornerstone of that 
is a $373 million grant system to communities which I assume 
will be awarded sometime soon. I don't know when you might 
inform me of that. I understand that States and communities 
that are awarded this ARRA funding will be asked to implement 
their choice of a list of evidence based programs that your 
Department determined are the most likely to be effective.
    I asked my staff. I have not seen that list. If you have 
that could you share that with us? And where did you go to come 
up with this list of evidence-based programs that could be 
effective?
    Secretary Sebelius. Ah, Mr. Chairman, first of all, we'd be 
glad to share those data with you.
    [The information follows:]

                          Mapps Interventions

    Attached is the list of evidence-based MAPPS interventions (Media, 
Access, Point of decision information, Price and, Social support 
services) from which States and communities awarded ARRA funding for 
the ``Communities Putting Prevention to Work'' initiative will choose 
to implement. This list can be found at http://www.cdc.gov/
chronicdisease/recovery/PDF/MAPPS_Intervention_Table.pdf

     MAPPS Interventions for Communities Putting Prevention to Work

    Five evidence-based MAPPS strategies, when combined, can have a 
profound influence on improving health behaviors by changing community 
environments: Media, Access, Point of decision information, Price, and 
Social support/services. The evidence-based interventions below are 
drawn from the peer-reviewed literature as well as expert syntheses 
from the community guide and other peer-reviewed sources, cited below. 
Communities and states have found these interventions to be successful 
in practice. Awardees are expected to use this list of evidence-based 
strategies to design a comprehensive and robust set of strategies to 
produce the desired outcomes for the initiative.


----------------------------------------------------------------------------------------------------------------
                                               Tobacco                 Nutrition            Physical activity
----------------------------------------------------------------------------------------------------------------
Media................................  Media and advertising    Media and advertising    Promote increased
                                        restrictions             restrictions             physical activity \98\
                                        consistent with          consistent with          \99\ \103\ \106\ \126\
                                        Federal law \11\.        Federal law \53\ \54\    \127\
                                       Hard hitting              \55\ \56\ \57\ \58\     Promote use of public
                                        counteradvertising \12   \59\.                    transit \98\ \99\
                                        \ \13\ \14\ \15\.       Promote healthy food/     \103\ \106\ \126\
                                       Ban brand-name            drink choices \57\       \127\
                                        sponsorship \15\.        \58\ \60\.              Promote active
                                       Ban branded promotional  Counteradvertising for    transportation
                                        items and prizes \16\.   unhealthy choices \61\.  (bicycling and walking
                                                                                          for commuting and
                                                                                          leisure activities)
                                                                                          \98\ \99\ \103\ \106\
                                                                                          \126\ \127\
                                                                                         Counteradvertising for
                                                                                          screen time \98\ \99\
                                                                                          \103\ \106\ \126\
                                                                                          \127\
Access...............................  Usage bans (i.e., 100    Healthy food/drink       Safe, attractive
                                        percent smoke-free       availability (e.g.,      accessible places for
                                        policies or 100          incentives to food       activity (i.e., access
                                        percent tobacco-free     retailers to locate/     to outdoor recreation
                                        policies) \6\ \7\        offer healthier          facilities, enhance
                                        \102\.                   choices in underserved   bicycling and walking
                                       Usage bans (i.e., 100     areas, healthier         infrastructure, place
                                        percent smoke-free       choices in child care,   schools within
                                        policies or 100          schools, worksites)      residential areas,
                                        percent tobacco-free     \24\ \25\ \26\ \27\      increase access to and
                                        school campuses \5\      \28\ \29\ \30\ \31\      coverage area of
                                        \6\ \7\ \8\ \9\ \10\.    \32\ \33\ \34\ \35\      public transportation,
                                       Zoning restrictions \5\   \36\ \37\ \38\ \78\      mixed-use development,
                                        \6\ \7\.                 \79\ \80\ \81\ \82\      reduce community
                                       Restrict sales (e.g.,     \83\ \91\ \92\ \93\      design that lends to
                                        Internet, sales to       \94\ \95\ \96\ \97\.     increased injuries)
                                        minors, stores/events   Limit unhealthy food/     \136\ \137\ \138\
                                        without tobacco, etc.)   drink availability      City planning, zoning,
                                        \5\ \6\ \7\.             (whole milk, sugar       and transportation
                                       Ban self-service          sweetened beverages,     (e.g., planning to
                                        displays and vending     high-fat snacks) \34\    include the provision
                                        \5\ \6\ \7\.             \39\ \40\ \41\ \42\      of sidewalks, parks,
                                                                 \84\ \85\ \86\ \87\      mixed-use development,
                                                                 \88\.                    reduce community
                                                                Reduce density of fast    design that lends to
                                                                 food establishments      increased injuries)
                                                                 \32\ \43\.               \99\ \100\ \101\ \102\
                                                                Eliminate transfat        \105\ \106\
                                                                 through purchasing      Require daily quality
                                                                 actions, labeling        physical education in
                                                                 initiatives,             schools \113\ \114\
                                                                 restaurant standards     \115\ \116\ \117\
                                                                 \44\ \45\ \46\.          \118\ \119\ \120\
                                                                Reduce sodium through    Require daily physical
                                                                 purchasing actions,      activity in
                                                                 labeling initiatives,    afterschool/child care
                                                                 restaurant standards     settings
                                                                 \47\ \48\ \49\.         Restrict screen time
                                                                Procurement policies      (afterschool, daycare)
                                                                 and practices \25\       \107\ \108\ \109\
                                                                 \26\ \30\ \31\ \50\      \110\ \111\
                                                                 \51\.
                                                                Farm to institution,
                                                                 including schools,
                                                                 worksites, hospitals,
                                                                 and other community
                                                                 institutions \50\ \51\
                                                                 \52\.
Point of purchase/promotion..........  Restrict point of        Signage for healthy vs.  Signage for
                                        purchase advertising     less healthy items       neighborhood
                                        as allowable under       \25\ \26\ \62\ \63\      destinations in
                                        Federal law \17\.        \89\ \90\.               walkable/mixed-use
                                       Product placement \17\.  Product placement and     areas (library, park,
                                                                 attractiveness \25\      shops, etc.) \99\
                                                                 \26\ \62\ \63\ \89\      \100\ \101\ \106\
                                                                 \90\.                    \140\
                                                                Menu labeling \65\ \66\  Signage for public
                                                                 \67\ \68\.               transportation, bike
                                                                                          lanes/boulevards \99\
                                                                                          \100\ \101\ \106\
                                                                                          \140\
Price................................  Use evidence-based       Changing relative        Reduced price for park/
                                        pricing strategies to    prices of healthy vs.    facility use \133\
                                        discourage tobacco use   unhealthy items (e.g.,   \134\ \135\
                                        \1\ \2\ \3\.             through bulk purchase/  Incentives for active
                                       Ban free samples and      procurement/             transit \134\ \135\
                                        price discounts \4\.     competitive pricing)    Subsidized memberships
                                                                 \22\ \23\ \24\ \25\      to recreational
                                                                 \26\ \75\ \76\ \77\.     facilities \99\ \100\
                                                                                          \110\ \111\
Social support and services..........  Quitline and other       Support breastfeeding    Safe routes to school
                                        cessation services       through policy change    \104\ \112\ \128\
                                        \18\ \19\ \20\.          and maternity care       \129\ \130\ \131\
                                                                 \69\ \70\ \71\ \72\      \132\
                                                                 \73\ \74\.              Workplace, faith, park,
                                                                                          neighborhood activity
                                                                                          groups (e.g., walking,
                                                                                          hiking, biking, etc.)
                                                                                          \99\ \100\ \105\ \106\
----------------------------------------------------------------------------------------------------------------
\1\ Centers for Disease Control and Prevention. Reducing tobacco use: a report of the Surgeon General. Atlanta,
  GA: U.S. Department of Health and Human Services, CDC; 2000
\2\ Institute of Medicine. Ending the tobacco problem: a blueprint for the nation. Washington, DC: The National
  Academies Press; 2007.
\3\ Task Force on Community Preventive Services. Guide to community preventive services: tobacco use prevention
  and control. Am J Prev. Med., 2001;20(2 Suppl 1):1-87.
\4\ Loomis BR, Farrelly MC, Mann NH. The Association of retail promotions for cigarettes with the Master
  Settlement Agreement, tobacco control programmes and cigarette excise taxes. Tob. Control 2006; 15;458-63.
\5\ Centers for Disease Control and Prevention. Reducing tobacco use: a report of the Surgeon General. Atlanta,
  GA: U.S. Department of Health and Human Services; 2000
\6\ Institute of Medicine. Ending the tobacco problem: a blueprint for the nation. Washington, DC: The National
  Academies Press; 2007.
\7\ Task Force on Community Preventive Services. Guide to community preventive services: tobacco use prevention
  and control. Am J Prev. Med.2001;20(2 Suppl 1):1-87.
\8\ Pentz MA. The power of policy: the relationship of smoking policy to adolescent smoking. American journal of
  public health 1989;79(7):857-62.
\9\ Wakefield MA. Effect of restrictions on smoking at home, at school, and in public places on teenage smoking:
  cross sectional study. BMJ2000;321(7257):333-7.
\10\ Kumar R. School tobacco control policies related to students' smoking and attitudes toward smoking:
  national survey results, 1999-2000. Health education & behavior 2005;32(6):780-94.
\11\ National Cancer Institute. The role of the media in promoting and reducing tobacco use. Tobacco Control
  Monograph, No. 19; 2008.
\12\ Task Force on Community Preventive Services. Guide to community preventive services: tobacco use prevention
  and control. Am J Prev. Med., 2001;20(2 Suppl 1):1-87.
\13\ National Cancer Institute. The role of the media in promoting and reducing tobacco use. Tobacco Control
  Monograph, No. 19; 2008.
\14\ Institute of Medicine. Ending the tobacco problem: a blueprint for the nation. Washington, DC: The National
  Academies Press; 2007.
\15\ National Cancer Institute. The role of the media in promoting and reducing tobacco use. Tobacco Control
  Monograph, No. 19; 2008.
\16\ National Cancer Institute. The role of the media in promoting and reducing tobacco use. Tobacco Control
  Monograph, No. 19; 2008.
\17\ National Cancer Institute. The role of the media in promoting and reducing tobacco use. Tobacco Control
  Monograph, No. 19; 2008.
\18\ Fiore MC, Jaen CR, Baker, TB, et al. Treating tobacco use and dependence: 2008 Update. Quick Reference
  Guide for Clinicians. Public Health Service; 2008.
\19\ Task Force on Community Preventive Services. Guide to community preventive services: tobacco use prevention
  and control. Am J Prev. Med., 2001;20(2 Suppl 1):1--87.
\20\ Institute of Medicine. Ending the tobacco problem: a blueprint for the nation. Washington, DC: The National
  Academies Press; 2007.
\21\ Dietary Guidelines for Americans, 2005. U.S. Department of Health and Human Services and U.S. Department of
  Agriculture. Dietary Guidelines for Americans, 2005. 6th Edition, Washington, DC: U.S. Government Printing
  Office, January 2005. Foods Encouraged, Available at: http://www.health.gov/DietarvGuidelines/dga2005/document/
  html/chapter5.htm
\22\ French, S.A., M. Story, and R.W. Jeffery, Environmental influences on eating and physical activity. Annu
  Rev Public Health, 2001. 22: p. 309-35.
\23\ French SA, Wechsler H. School-based research and initiatives: fruit and vegetable environment, policy, and
  pricing workshop. Prev. Med., 2004 Sep;39 Suppl 2:S101-7.
\24\ Ayala G. et al., 2009--Evaluation of the Healthy Tienda project. The Public Health Effects of Food Deserts.
  Workshop Summary. Institute of Medicine and National Research Council, p. 49-51. http://www.iom.edu/
  Obiect.File/Master/62/082/Session%204%20920%20am%20Ayala.pdf.
\25\ Glanz K, Yaroch AL. Strategies for increasing fruit and vegetable intake in grocery stores and communities:
  policy, pricing, and environmental change. Prev Med., 2004 Sep;39 Suppl 2:S75-80. Review.
\26\ Nonas C, 2009. Health Bucks in New York City. The Public Health Effects of Food Deserts. Workshop Summary.
  Institute of Medicine and National Research Council, p 59-60. Available at http://www.iom.cdu/CMS/3788/59640/
  62040/62078.aspx
\27\ Bodor, J. N., Rose, D., Farley, T. A., Swaim, C., & Scott, S. K. (2007). Neighbourhood fruit and vegetable
  availability and consumption: the role of small food stores in an urban environment. Public Health Nutrition.
\28\ Gittelsohn J, Ethelbah M. Evaluation of the White Mountain and San Carlos Apache Healthy Stores Program, a
  multi-component intervention that included stocking healthier food items. Available at http://
  www.farmfoundation.org/news/articlefiles/450-Gittelsohn.pdf).
\29\ Morland K, Diez Roux AV, Wing S. Am J Prev. Med., 2006 Apr,30(4):333-9 Supermarkets, other food stores, and
  obesity: the atherosclerosis risk in communities study.
\30\ Larson, N., Story, M., & Nelson, M. (2009). Neighborhood Environments Disparities in Access to Healthy
  Foods in the U. S. American Journal of Preventive Medicine. 36(1):74-81.
\31\ Story M, Kaphingst KM, Robinson-O'Brien R, Glanz K. Creating healthy food and eating environments: policy
  and environmental approaches. Annu Rev Public Health. 2008;29:253-72.
\32\ Moore, L.V., et al., Associations of the local food environment with diet quality--a comparison of
  assessments based on surveys and geographic information systems: the multi-ethnic study of atherosclerosis. Am
  J Epidemiol, 2008. 167(8): p. 917-24.
\33\ Ward, D. S., Benjamin, S. E., Ammerman, A. S., Ball, S. C., Neelon, B. H., & Bangdiwala, S. I. (2008).
  Nutrition and physical activity in child care: results from an environmental intervention. Am J Prev. Med.,
  35(4), 352-356. Epub 2008.
\34\ IOM (2007). Nutrition Standards for Foods in Schools: Leading the Way Toward Healthier Youth Committee on
  Nutrition Standards for Foods in Schools. Washington, D.C., The National Academies Press.
\35\ Ritenbaugh C, Tuefel-Shone N, et al. A lifestyle intervention improves plasma insulin levels among Native
  American high school youth. Prev. Med., 2003;36:309-319.
\36\ Jaime, P.C. and K. Lock, Do school based food and nutrition policies improve diet and reduce obesity? Prev
  Med., 2009.48(1): p. 45-53.
\37\ Sorensen, G., Linnan, L., & Hunt, M. K. (2004). Worksite-based research and initiatives to increase fruit
  and vegetable consumption. Prev. Med., 39 Suppl 2, S94-100.
\38\ The Community Guide to Preventive Services. Obesity prevention through worksite programs. Available at
  http://www.thecommunitvguide.org/obesity/workprograms.html
\39\ Schwartz, M. B., Novak, S. A., & Fiore, S. S. (2009). The Impact of Removing Snacks of Low Nutritional
  Value From Middle Schools. Health Educ Behav, 5, 5.
\40\ Kubik, M.Y., et al., The association of the school food environment with dietary behaviors of young
  adolescents. Am J Public Health, 2003. 93(7): p. 1168-73.
\41\ Cullen, K.W. and I. Zakeri, Fruits, vegetables, milk, and sweetened beverages consumption and access to a
  la carte/snack bar meals at school. Am J Public Health, 2004. 94(3): p. 463-7.
\42\ Templeton, S.B., M.A. Marlette, and M. Panemangalore, Competitive foods increase the intake of energy and
  decrease the intake of certain nutrients by adolescents consuming school lunch. J Am Diet Assoc, 2005. 105(2):
  p. 215-20.
\43\ Ashe M, Jernigan D, Kline R, Galaz R. Land use planning and the control of alcohol, tobacco, firearms, and
  fast food restaurants. Am J Pub Health. 2003;93(9):1404-1408.
\44\ Mozaffarian D. Katan MB. Ascherio A. Stampfer MJ. Willett WC. Trans Fatty Acids and Cardiovascular Disease.
  New England Journal of Medicine. April 13, 2006. 354;15:1601-13.
\45\ Panel on Macronutrients, Institute of Medicine. Letter report on dietary reference intakes for trans fatty
  acids drawn from the Report on dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids,
  cholesterol, protein, and amino acids. Washington, DC 2003.
\46\ Trans Fat Regulation: NYC Department of Health and Mental Hygiene--Board of Health Approves Regulation to
  Phase Out Artificial Trans Fat. Available at: http://www.nyc.gov/html/doh/html/cardio/cardio-transfat-
  healthcode.shtml; How to Comply: What Restaurants, Caterers, Food-Vending Units, and Others Need to Know''
  Accessed June 24, 2009 http://www.nvc.gov/html/doh/downloads/ndf/cardio/cardio-transfat-bro.pdf
\47\ Sacks, FM et al. (2001) Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to
  Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. New England Journal of Medicine
  344(1):3-10.
\48\ City Purchasing Standards: New York City executive order for formal nutrition standards for all food
  purchased or served by New York City agencies including sodium. Available at: http://www.nyc.gov/html/doh/
  downloads/pdf/cardio/cardio-food-standards.pdf
\49\ New York City, Advocacy for External Efforts: Initiative to develop a voluntary partnership with industry
  leaders to reduce the level of sodium in processed and prepared foods nationwide. Available at: http://
  www.nyc.gov/litml/doh/html/cardio/cardio-salt-initiative.shtml
\50\ Joshi, A., & Azuma, A. (2008). Do Farm-to-School Programs Make a Difference? Findings and Future Research
  Needs. Journal of Hunger & Environmental Nutrition, 3, 2-3.
\51\ Zudrow D (2005) Food Security Begins at Home: Creating Community Food Coalitions in the South. Southern
  Sustainable Agriculture Working Group, pp 45-67, Available at: http://www.ssawg.org/cfs-handbook.html
\52\ Texas, Farm to Work program. Farm to Work Initiative of the Texas State Health Service provides a Farm to
  Work Toolkit. Available at http://www.texasbringinghealthyback.org/ and http://www.dshs.state.tx.us/obesitv/
  pdf/F2WToolkit1008.pdf
\53\ The Guide to Community Preventive Services--Obesity Prevention: Interventions to Reduce Screen Time http://
  www.thecommunityguide.org/obesity/screentime/index.html
\54\ Story M. French S. Food Advertising and Marketing Directed at Children and Adolescents in the US. Int J
  Behav Nutr Phys Act. 2004 Feb 10;1(1):3.
\55\ Chou SY, Rashad I, Grossman M. Fast-Food Restaurant Advertising on Television and Its Influence on
  Childhood Obesity. The Journal of Law and Economics, 2008:51; p 599-618
\56\ Coon KA, Tucker KL: Television and children's consumption patterns. A review of the literature. Minerva
  Pediatr 2002, 54:423-436.
\57\ WHO. 2004. Global Strategy on Diet, Physical Activity and Health. WHA 57.17. Geneva: WHO. Available at
  http://apps.who.int/gb/ebwha/pdf files/WHA57/A57_R17-en.ndf
\58\ Norwegian ministry of Children and Family Affairs, 2005. Norway enacted a ban on TV advertisements to
  children ages 12 years and younger in 1992. Available at http://www.regieringen.notenklep/b1d/Documents/
  Rcports-and-plans/Plans/2003-2/The-Norwegian-action-plan-to-reduce-comm.html?id-462256
\59\ Kwate, NOA. Take one down, pass it around, 98 alcohol ads on the wall: outdoor advertising in New York
  City's Black neighbourhoods. International Journal of Epidemiology. 2007; 36 (5): 988-990.
\60\ Evidence of impact of advertising on food and beverage purchase requests of 2-11 year olds and usual
  dietary intake of 2-5 year olds: IOM (2006), Committee on Food Marketing and the Diets of Children and Youth.
  Food Marketing to Children and Youth: Threat or Opportunity? Washington, D.C., National Academies Press.
\61\ Dixon HG, Scully ML, Wakefield MA, White VM, Crawford DA.The effects of television advertisements for junk
  food versus nutritious food on children's food attitudes and preferences. Soc Sci Med. 2007 Oct;65(7):1311-23.
\62\ Seymour JD, Yaroch AL, Serdula M, Blanck HM, Khan LK. Impact of nutrition environmental interventions on
  point-of-purchase behavior in adults: a review. Prev. Med., 2004 Sep;39 Suppl 2:S108-36. Review.
\63\ Glanz K, Hoelscher D. Increasing fruit and vegetable intake by changing environments, policy and pricing:
  restaurant-based research, strategies, and recommendations. Prev. Med., 2004 Sep;39 Suppl 2:S88-93.
\64\ Curhan, R.C., The effects of merchandising and temporary promotional activities on the sales of fresh fruit
  and vegetables in supermarket. Journal of Marketing Research 1974. 11: p. 286-94.
\65\ Bassett, M.T., et al., Purchasing behavior and calorie information at fast-food chains in New York City,
  2007. Am J Public Health, 2008. 98(8): p. 1457-9.
\66\ Simon, Jarosz, Kuo & Fielding. Menu Labeling as a Potential Strategy for Combating the Obesity Epidemic: A
  Health Impact Assessment. Los Angeles, CA: Los Angeles County Dept of Public Health; 2008
\67\ Burton S and Creyer EH. ``What Consumers Don't Know Can Hurt Them: Consumer Evaluations and Disease Risk
  Perceptions of Restaurant Menu Items.'' Journal of Consumer Affairs, 38(1): 121-45, 2004.
\68\ Kozup KC, Creyer EH and Burton S. ``Making Healthful Food Choices: The Influence of Health Claims and
  Nutrition Information on Consumers' Evaluations of Packaged Food Products and Restaurant Menu items.'' Journal
  of Marketing, 67(2): 19-34,2003.
\69\ Philipp BL et al. 2001. Baby-Friendly Hospital Initiative Improves Breastfeeding Initiation Rates in a US
  Hospital Setting. Pediatrics 108(3):677-681.
\70\ DiGirolamo AM, Grummer-Strawn LM, Fein SB. Effect of Maternity-Care Practices on Breastfeeding. Pediatrics
  2008 October I;122(Supplement_2):S43-S49.
\71\ Baby-Friendly USA. Implementing the UNICEF/WHO Baby Friendly Hospital Initiative in the U.S.; Available at:
  http://www.babyfriendlyusa.org/eng/index.html Accessed June 24,2009.
\72\ Cohen R, Mrtek MB. The impact of two corporate lactation programs on the incidence and duration of
  breastfeeding by employed mothers. American Journal of Health Promotion 1994;8(6):436-41.
\73\ Fein SB, Mandal B, Roe BE. Success of Strategies for Combining Employment and Breastfeeding. Pediatrics
  2008 October 1;122(Supplement_2):S56-562.
\74\ Health Resources and Services Administration. The Business Case for Breastfeeding Toolkit. HRSA 2008;
  Available at: http://ask.hrsa.govidetail.cfm?PublD=MCH00254&recommended=1 Accessed June 2, 2009.
\75\ French, S.A., Story, M., Jefferey, R.W., Snyder, P., Marla, E., Sidebottom, A., & Murray, D. (1997).
  Pricing strategy to promote fruit and vegetable purchase in high school cafeterias. J Am Diet Assoc, 97(9):
  1008-1010.
\76\ French, S.A., Jefferey, R.W., Story, M., Breitlow, K.K., Baxter, J.S., Hannan, P., & Snyder, M.P. (2001).
  Pricing and promotion effects on low-fat vending snack purchases: The CHIPS study. Am J Public Health, 91(1):
  112-117.
\77\ Hannan, P., French, S.A., Story, M., & Fulkerson, J.A. (2002). A pricing strategy to promote sales of lower
  fat foods in high school cafeterias: Acceptability and sensitivity analysis. Am J Hlth Prom, 17(1): I-6.
\78\ Cullen, K.W., Hartstein, J., Reynolds, K.D., Vu, M., Resnicow, K., Greene, N., et al., 2007. Improving the
  school food environment: results from a pilot study in middle schools. J. Am. Diet Assoc. 107 (3), 484-489.
\79\ Lytle, L.A., Kubik, M.Y., Perry, C., Story, M., Birnbaum, A.S., Murray, D.M., 2006. Influencing healthful
  food choices in school and home environments: results from the TEENS study. Prev. Med., 43 (1), 8-13.
\80\ Perry, C.L., Bishop, D.B., Taylor, G.L., Davis, M., Story, M., Gray, C., et al., 2004. A randomized school
  trial of environmental strategies to encourage fruit and vegetable consumption among children. Health Educ.
  Behay. 31 (1), 65-76.
\81\ Sahota, P., Rudolf, M.C., Dixey, R., Hill, A.J., Barth, J.H., Cade, J., 2001. Evaluation of implementation
  and effect of primary school based intervention to reduce risk factors for obesity. BMJ 323 (7320), 1027-1029.
\82\ Sahota, P., Rudolf, M.C., Dixey, R., Hill, A.J., Barth, J.H., Cade, J., 2001. Randomised controlled trial
  of primary school based intervention to reduce risk factors for obesity. BMJ 323 (7320), 1029-1032.
\83\ Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking
  water in schools for overweight prevention: Randomized, controlled cluster trial. Pediatrics 2009;123;e661-
  e667
\84\ Cullen, K.W., Hartstein, J., Reynolds, K.D., Vu, M., Resnicow, K., Greene, N., et al., 2007. Improving the
  school food environment: results from a pilot study in middle schools. J. Am. Diet Assoc. 107 (3), 484-489.
\85\ Cullen, K.W.,Watson, K., Zakeri, I., Ralston, K., 2006. Exploring changes in middle-school student lunch
  consumption after local school food service policy modifications. Public Health Nutr. 9 (6), 814-820.
\86\ Cullen, K.W., Watson, K. 2009. The Impact of the Texas Public School Nutrition Policy on Student Food
  Selection and Sales in Texas. Am J Public Health. 2009 Apr;99(4):706-12
\87\ Kubik M, Lytle L, Hannan P, Perry C, Story M. The association of the school food environment with dietary
  behaviors of young adolescents. Am J Public Health 2003;93:1168-73.
\88\ Stone, E.J., Osganian, S.K., McKinlay, S.M., Wu, M.C., Webber, L.S., Luepker, R.V., et al., 1996.
  Operational design and quality control in the CATCH multicenter trial. Prev.
\89\ French, S. A., Jeffery, R. W., Story, M., Breitlow, K. K., Baxter, J. S., Hannan, P. & Snyder, M. P. (2001)
  Pricing and promotion effects on low-fat vending snack purchases: The CHIPS study. Am. J. Public Health 91:112-
  117.
\90\ French SA, Story M, Fulkerson JA, Hannan P. An Environmental Intervention to Promote Lower-Fat Food Choices
  in Secondary Schools: Outcomes of the TACOS Study. Am J Public Health 2004;94:1507-12
\91\ Institute of Medicine. Local Government Actions to Prevent Childhood Obesity. Washington, DC: The National
  Academies Press; 2009.
\92\ Centers for Disease Control and Prevention. Recommended Community Strategies and Measurements to Prevent
  Obesity in the United States. MMWR 2009; 58(No. RR-07): 1-26.
\93\ Ed Bolen et al., Neighborhood Groceries: New Access to Healthy Food in Low-Income Communities, (San
  Francisco, CA: California Food Policy Advocates, 2003).
\94\ PolicyLink: Equitable Development Toolkit: Healthy Food Retailing provides an online tool that focuses on
  increasing access to retail outlets that sell nutritious, affordable food in low-income communities of color.
  http://www.policylink.org/EDTK/HealthyFoodRetailing
\95\ Gittelsohn, J., et al., Process Evaluation of Baltimore Healthy Stores: A Pilot Health Intervention Program
  With Supermarkets and Corner Stores in Baltimore City. Health Promot Pract, 2009.
\96\ Flournoy R and Treuhaft S (2005). Healthy food, healthy communities: improving access and opportunities
  through food retailing. Oakland, CA: PolicyLink.
\97\ Bitler, M., and S. J. Haider. An Economic View of Food Deserts in the United States. Research Conference on
  Understanding the Economic Concepts and Characteristics of Food Access. Washington, DC: USDA, Economic
  Research Service and University of Michigan National Poverty Center, 2009.
\98\ U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans. Available at:
  http://www.health.gov/PAGuidelines/
\99\ The Guide to Community Preventive Services: What works to Promote Health?. Oxford University Press, 2005,
  pp 80-113.
\100\ Kahn, E.B., Ramsey, L.T., Brownson, R.C., Health, G.W., Howze, E.H., Powell, K.E. et al. 2002. The
  effectiveness of interventions to increase physical activity. A systematic review by the U.S. Task Force on
  Community Preventive Services. American Journal of Preventive Medicine 22, S73-I 02.
\101\ Heath GW, Brownson RC, Kruger J, et al. The effectiveness of urban design and land use and transport
  policies and practices to increase physical activity: a systematic review. J Phys Act Health. 2006;3'suppl
  1):S55-S76.
\102\ Hoehner CM, Soares J, Parra DP, Ribeiro IC, Joshu C, Pratt M et al. 2008. Systematic review of physical
  activity interventions in Latin America. Am J Prev. Med., 34(3), 224-233
\103\ Roux L, Pratt M, Tengs TO, Yanagawa T, Yore M, et al., 2008. Cost Effectiveness of Community-based
  Physical Activity Interventions. Am J Prev. Med., 35(6), 578-588
\104\ Active Living Research Brief. Walking and biking to school, physical activity and health outcomes. May
  2009
\105\ Ramsey LT, Brownson RC. Increasing physical activity. Am J Prev. Med., 2002 (4S); 73-107
\106\ Centers for Disease Control and Prevention. Planning, implementing and evaluating interventions. Available
  at: http://www.cdc.gov/inccdphp/dnpa/physical/health_professionals/interventions/index.htm
\107\ The Guide to Community Preventive Services--Obesity Prevention: Interventions to Reduce Screen Time. http:/
  /www.thecommunityguide.org/obesity/screentime/index.html
\108\ New York City Amendments to the NYC Health Code (established limits on passive, sedentary TV viewing in
  group childcare services to 60 minutes or less per day. http://www.frac.org/pdf/
  nyc_cacfp_childcare_nutrphysactlaw.pdf
\109\ Delaware Child Care Policy to Improve Children's Health: regulatory changes through the Office of Child
  Care Licensing for all childcare in DE (center-based, family and after-school) that limit sedentary and media
  exposure to a maximum of 1 hour per day for children >2 years. http://www.nemours.org/department/nhps/policy-
  leader/child-care.html
\110\ Benjamin SE, Cradock A Walker EM, Slining M, Gillman MW. Obesity prevention in child care: a review of
  U.S. state regulations. BMC Public Health. 2008;8:188.
\111\ Kaphingst LM, Story M. Child care as an untapped setting for obesity prevention: State child care
  licensing regulations related to nutrition, physical activity, and media use for preschool-aged children in
  the United States. Preventing Chronic Disease. 2009;6:1.
\112\ Centers for Disease Control and Prevention. Kids Walk to School. Available at: http://www.cdc.gov/inccdphp/
  dnpa/kidswalk/
\113\ Kahn EB, Ramsey LT, Brownson RC, Heath GW, Howze EH, Powell KE. The effectiveness of interventions to
  increase physical activity: a systematic review. Am J Prev. Med., 2002; 22(4S): 73-107.
\114\ McKenzie TL, Nader PL, Strikmiller PK, Yang M, Stone EJ, Perry CL, et al. School physical education:
  effect of the Child and Adolescent Trial for Cardiovascular Health. Prev. Med. 1996 25:423-431.
\115\ Pangrazi RP, Beighle A, Vehige T, Vack C. Impact of Promoting Lifestyle Activity for Youth (PLAY) on
  children's physical activity. J Sch Health 73(8): 317-321.
\116\ Pate RR, Ward DS, Saunders RP, Felton G, Dishman RK, Dowda M. Promotion of physical activity among high
  school girls: a randomized controlled trial. Am J Public Health 2005; 95(9): 1582-1587.
\117\ Harrell JS, McMurray RG, Bangdiwala SI, Frauman AC, Gansky SA, Bradley CB. Effects of a school-based
  intervention to reduce cardiovascular disease risk factors in elementary-school children: The Cardiovascular
  Health in Children (CHIC Study. J Pediatr 1996; 128:797-805.
\118\ Reed KE, Warburton DER, Macdonald HM, Naylor P.1, McKay HA. Action schools! BC: a school-based physical
  activity intervention designed to decrease cardiovascular risk factors in children. Prev. Med., 2008; 46:525-
  531.
\119\ Webber LS, Catellier DJ, Lytle LA, Murray DM, Pratt CA, Young DR, et al. Promoting physical activity in
  middle school girls: Trial of Activity for Adolescent Girls. Am J Prev. Med., 2008; 34(3): 173-184.
\120\ Manios Y, Moschandreas J, Hatzis C, Kafatos A. Evaluation of a health and nutrition education program in
  primary school children of Crete over a three-year period. Prev. Med., 1999; 28:149-159.
\121\ Sallis JF, McKenzie TL, Conway TL, Elder JP, Prochaska JJ, Brown M et al. Environmental interventions for
  eating and physical activity: a randomized controlled trial in middle schools. Am J Prev. Med., 2003;24:209-
  17.
\122\ Kelder S, Hoelscher DM, Barroso CS, Walker JL, Cribb P, Shaohua H. The CATCH Kids Club: a pilot after-
  school study for improving elementary students' nutrition and physical activity. Public Health Nutrition 2005;
  8(2): 133-140.
\123\ Story M, Sherwood NE, Himes JH, Davis M, Jacobs DR, et al. An after-school obesity prevention program for
  African American girls: the Minnesota GEMS pilot study. Ethn Dis 2003; 13(1 suppl 1): S54 64.
\124\ Yin, et al. Medical College of Georgia Fitkid Project. Evaluation & the Health Professions 2005; 67-89.
\125\ Kien LC & Chiodo AR. Physical activity in middle school-aged children participating in a school-based
  recreation program. Arch Pediatr Adolesc Med 2003; 157:811-815.
\126\ Huhman M, Potter LD, Wong FL, Banspach SW, Duke JC, Heitzler CD. Effects of a mass media campaign to
  increase physical activity among children: year 1 results of the VERB campaign. Pediatrics 2005;116:e277-3284.
\127\ Huhman M, Bauman A, Bowles HR. Initial outcomes of the VERB campaign: tweens' awareness and understanding
  of campaign messages. J Prev. Med., 2008; 34(6S):S241-S248.
\128\ Cooper AR, Page AS, Foster U, Qahwaji D. Commuting to school: are children who walk more physically
  active? Am J Prev. Med., 2003;25:273-6.
\129\ Cooper AR. Physical activity levels of children who walk, cycle, or are driven to school. Am J Prev. Med.,
  2005;29:179-84.
\130\ Tudor-Locke C, Neff LJ, Ainsworth BE, Addy CL, Popkin BM. Omission of active commuting to school and the
  prevalence of children's health-related physical activity levels: the Russian Longitudinal Monitoring Study.
  Child Care Health Dev 2002;28:507-12.
\131\ Alexander LM, lnchley J, Todd J, Currie D, Cooper AR, Currie C. The broader impact of walking to school
  among adolescents: seven day accelerometry based study. BMJ 2005;331:1061-2.
\132\ Sirard J, Riner WJ, McIver K, Pate R. Physical activity and active commuting to elementary school. Med Sci
  Sports Exerc 2005;37:2062-9.
\133\ Managed-Medicare health club benefit and reduced healthcare costs among older adults. Nguyen HQ, Ackerman
  RT, Maciejewski M, Berke E, Patrick M. Williams B, LoGerfo JP, Prev. Chronic Disease, 2008 Jan 5(1) A14. Epub
  2007 Dec 15.
\134\ Economic interventions to promote physical activity. Application of the SLOTH model. Pratt, M, Macera CA,
  Sallis JF, O'Donnell M, Frank LD. Am J Prev. Med 2004, 27(S 1)
\135\ The economics of physical activity: Societal trends and rationales for interventions. Strum R, Am J Prev.
  Med., 2004, 27 (SI).
\136\ The built environment, neighborhood crime and constrained physical activity: An exploration of
  inconsistent findings. Foster, S, Giles-Corti B. Prev. Med., 2008, 47 (3) pp 241-251.
\137\ Unsafe to play? Neighborhood disorder and lack of safety predict reduced physical activity among urban
  children and adolescents. Molnar, S, Gortmaker, S, Bull F, Buka SL. Am J Health Prom 2004, 18(5) pp 378-386.
\138\ Parents' perceptions of neighborhood safety and children's physical activity. Weir, L, Etelson D, Brand D.
  Prev. Med 2006, 43(3) pp 212-217.
\139\ Besser LM, Dannenberg AL. Walking to public transit: steps to help meet physical activity recommendations.
  Am J Prev. Med., 2005; 29(4):273-80.
\140\ MMWR: Morbidity and Mortality Weekly Report. Recommended community strategies and measurements to prevent
  obesity in the United States. Centers for Disease Control and Prevention. July 24, 2009 58(RR07);1-26. http://
  www.cdc.gov/mmwr/preview/mmwrhtml/rr5807a1.htm


    Secretary Sebelius. And the community grants I think are 
about to go out the door in the next, I think somewhere in the 
next 2-week period of time the awards will be made. And the 
focus looking at not only the--we had a multidiscipline team, 
scientists from NIH, the surveillance folks from and public 
health folks from CDC, our Office of Public Health and Science, 
all looking at not only what the most serious cost drivers were 
for underlying disease conditions, but also what were effective 
strategies that had been measured and looked at.
    And the two focus areas for the community grants were 
determined to be smoking cessation efforts and efforts aimed at 
obesity as the two drivers for a large number of the chronic 
conditions that cause healthcare spending to rise and cause 
quality of life to go down. So the so-called list looked at 
measures that had existed across States and communities that 
were effective strategies, had been measured, had been proven 
effective. And we would be delighted to share those with you.
    But the community grants were available to either look at 
smoking cessation and/or obesity or both, one or the other or 
both. But those were the two kinds of targets. As opposed to 
spreading them out across the horizon that the focus on those 
two areas.
    And then the hope is, as you know, with the ARRA funding is 
to have kind of measurable results. So at the end of 2 years 
the goal is to have some strategies which really do either 
encourage young people from not smoking in the first place, 
decrease smoking dramatically and/or make a real dent in 
obesity. And then be able to come back and hopefully work with 
members of Congress to take some of those programs to scale.
    If we can find effective ways, effective strategies to deal 
with those two underlying conditions, we can dramatically 
change health outcomes and dramatically lower health costs.
    Senator Harkin. Very good. Thank you, Madam Secretary.
    Senator Cochran. Mr. Chairman.
    I think the Secretary has done a great job in presenting 
the budget request and answering our questions. It's a pleasure 
working with you in helping make sure that what we decide to 
appropriate is in the national interest and serves the public 
interest.
    Senator Harkin. Thank you.

                        WASTE, FRAUD, AND ABUSE

    I just had one other thing that I would bring up and that 
is this waste, fraud and abuse that, you mentioned. I have a 
partial list in front of me. I have an entire list that adds up 
to literally billions of dollars of fines and settlements paid 
by pharmaceutical companies.
    Secretary Sebelius. You bet.
    Senator Harkin. That have been ripping off Medicare and 
Medicaid.
    Secretary Sebelius. Yes, sir.
    Senator Harkin. So a lot of times we think about Medicare 
fraud and abuse, waste, you know you think well, there's 
somebody out there, some person out there that's putting in for 
something that they shouldn't get. Well, what about Pfizer? 
Pfizer just paid $2.3 billion, the largest----
    Secretary Sebelius. The largest----
    Senator Harkin [continuing]. Settlement in United States 
history.
    Secretary Sebelius. Yes.
    Senator Harkin. Now attorneys know that when you settle, 
you settle because you're afraid of what may happen if you 
actually go to court. That's why you settle. They settled $2.3 
billion, $668 million to Medicare, $331 million to Medicaid. 
That was just this year.
    Four other pharmaceutical companies, Mylan Pharmaceuticals, 
AstraZeneca, UDL and Ortho-McNeil, just paid $124 million to 
Medicaid this year. And Ethex was fined $23.4 million. Now all 
of these were done by the Attorney General's Office. And that's 
just this year.
    I can go back 6, 7, 8 years. Attorneys General in the Bush 
administration and others that went after these companies and 
got all these fines and settlements, hundreds of millions of 
big, big dollars. Well, that's good. I applaud the Attorneys 
General for doing that, both the present Attorney General and 
his predecessors.
    But what can we put in place so they don't do that in the 
first place? And I hope that your Department will look at that. 
How was it that these pharmaceutical companies got by with 
this? And some of them got by with it--this didn't just happen 
over a couple of months. I mean they've been doing it for 
years.
    Then all of a sudden someone catches them. The Department 
of Justice asks for them. That takes a long time, couple years. 
And then they finally build a case. They get the evidence. And 
then they either get fined or they get settled.
    So I hope and this is just--I don't know if you want to 
respond to this or not, but I would really be looking forward 
to working with you on how you can build systems up that just 
don't allow these kinds of big bucks to be taken out of the 
system over long periods of time.
    Secretary Sebelius. Well, I couldn't agree with you more, 
Mr. Chairman. I think that in the case of the Pfizer 
settlement, it was a situation where they were improperly 
marketing and prescribing a drug specifically in violation of 
the authority that they had been given by the FDA. And it not 
only was a case of, you know, driving profits for their 
company, but also putting patients in jeopardy. I don't think 
there's any question that patients were being inappropriately 
prescribed a drug that they knew was not going to work for the 
situation that they had.
    So it's kind of a double concern. It not only involved 
dollars, but it involved patient safety. And I can guarantee 
that the new FDA leadership takes that very seriously, and has 
enhanced the efforts to make sure that off market products are 
not allowed and that we follow up much more vigorously. But 
also I think, again, having a settlement like this puts a 
number of manufacturers on notice that we are taking this very 
seriously. And intend to make sure that they are appropriately 
using the authority that they've been given.
    Senator Harkin. Is there a good working relationship 
between you and FDA on issues like this?
    Secretary Sebelius. Oh, absolutely, absolutely. And the 
drug safety and the drug protocol is something I think they 
take very seriously. And we're very involved in this effort as 
is our Inspector General. I mean, this was again, a 
collaborative effort.
    You're right. It took a number of years. The good news is 
that money went right back in to both the Medicare Trust Fund 
and the Medicaid funds for States. States got a share of those 
returns. And I think it helps make those more solvent for the 
future.
    Senator Harkin. Madam Secretary, thank you very much. 
That's very reassuring.
    Senator Cochran. Thank you, Mr. Chairman. I join you in 
thanking the Secretary for your cooperation with our 
subcommittee. We look forward to working with you as we go 
through this fiscal year. Thank you very much.
    Secretary Sebelius. Thank you, Senator.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Harkin. Thank you, Senator Cochran.
    Thank you, Madam Secretary.
    If there is nothing else that you would like us to 
consider----
    Secretary Sebelius. Mr. Chairman, we look forward to 
working with you. Thank you very much.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
               Questions Submitted by Senator Tom Harkin
                           project bioshield
    Question. Madam Secretary, I would like to commend your the 
Department of Health and Human Services (HHS) for including in its most 
recent broad agency announcement for medical countermeasure development 
a clear articulation of the Department's scenario-based medical 
countermeasure requirements for anthrax and smallpox. For several 
years, industry has been concerned regarding the lack of clearly 
articulated evidence-based requirements. This public articulation of 
the requirements is very welcome; however, it raises important concerns 
about the resources that remain in the Project BioShield Special 
Reserve Fund (SRF). Are the remaining SRF funds sufficient to procure 
technologically appropriate countermeasures for the identified 
requirements?
    Answer. The Assistant Secretary for Preparedness and Response 
(ASPR) has plans for the $2.4 billion remaining in the SRF, including 
anticipated procurements of countermeasures for the threat areas of 
anthrax, botulism, smallpox, and acute radiation syndrome illnesses. 
Under Biomedical Advanced Development Authority (BARDA) advanced 
research and development program there are numerous medical 
countermeasures under development. Some of these programs may mature 
enough before the end of fiscal year 2013 to become eligible for late-
stage development and procurement under Project BioShield. These 
medical countermeasures address threat areas such as anthrax, smallpox, 
botulism, acute radiation syndrome, and chemical agent nerve analysis.
    Question. How does HHS anticipate balancing the needs to continue 
funding advanced development activities with the need to continue 
stockpiling products to meet these stated requirements?
    Answer. In early December, I directed my Department to conduct a 
full review of the public health emergency medical countermeasure 
enterprise, which is the program that ultimately translates the ideas 
from the research bench into approved products that the United States 
can depend upon in the event of naturally occurring emerging diseases, 
pandemic diseases, or threats from chemical, biological, radiological, 
and nuclear (CBRN) agents. The MCM enterprise review is examining how 
policies affect every step of the medical countermeasure development, 
manufacturing, and stockpiling process, finding ways to improve and 
implement necessary changes. The goals of the review are to enhance the 
medical countermeasure development and production process, increase the 
number of promising discoveries going into advanced development, and 
provide more robust and rapid product manufacturing. HHS senior 
leadership with those of other Departments like the Department of 
Defense (DOD) meets regularly to discuss the medical countermeasure 
portfolios for CBRN and flu programs across the Federal Government and 
HHS toward understanding and achieving strategic goals and meeting 
product requirements.
    Question. Does HHS have a long-term strategy for how it plans to 
replenish the SRF or otherwise devote funding to the procurement of 
countermeasures for these identified requirements?
    Answer. HHS has initiated a long-term strategy for development and 
procurement of CBRN medical countermeasures that coordinates with DOD 
quadrennial strategy and planning for medical countermeasures. This 
strategy will be informed by the findings and recommendations of the 
medical countermeasure review that is nearing completion. Initiatives 
resulting from the medical countermeasure review will inform the budget 
process and assist in the balancing of resources for medical 
countermeasures with those of other high-priority initiatives at HHS.
                        medical countermeasures
    Question. Last summer, in the face of the H1N1 pandemic, HHS moved 
with remarkable speed to approve new influenza vaccines and approve 
emergency-use authorization for medical products critical to protecting 
Americans. The entire Department responded to this threat as if it were 
a matter of national security. While the process was not without its 
problems in general it was fast, efficient and remarkably transparent. 
I am concerned that this same sense of urgency is not being applied to 
medical countermeasures being developed to prevent or mitigate the 
threats that have been identified as critical national security 
priorities but have not yet materialized. The intentional release of 
CBRN agents or the detonation of a nuclear device will come with little 
or no warning, we as a Nation must have already developed and 
stockpiled safe and effective countermeasures if we are to respond to 
these types of threats. What measures has HHS taken to ensure the 
efficient and timely review of medical countermeasures for CBRN 
threats?
    Answer. In early December, I directed my Department to conduct a 
full review of the medical countermeasure process from the research 
bench into approved products that the United States can depend upon in 
the event of naturally occurring emerging diseases, pandemic diseases, 
or threats from CBRN agents. This review was initiated, based in part 
by observations of our national response capability at that time for 
the 2009 H1N1 influenza pandemic, and by procurement actions to develop 
an approved next-generation anthrax vaccine under the BioShield 
authorities. The executive leaders within HHS, including those from the 
ASPR, Centers for Disease Control and Prevention (CDC), Food and Drug 
Administration (FDA), and the National Institute of Allergy and 
Infectious Diseases, have worked diligently toward completing a 
comprehensive review of the medical countermeasure enterprise, which 
will be provided to me soon.
    Question. Does BARDA or the NIH provide funding resources to the 
FDA to help offset the cost associated with pre-biologics license 
application (pre-BLA) or pre-new drug application (pre-NDA) regulatory 
activities? Could additional funds improve the ability of FDA to 
providing timely review and responses to companies that are under 
contract with the Federal Government to develop products that the 
national security apparatus of the U.S. Government has identified as 
critical unmet needs?
    Answer. BARDA and the National Institutes of Health (NIH) do not 
provide funding to FDA to help offset the cost associated with pre-BLA 
or pre-NDA regulatory activities. Currently, the administration is 
conducting a comprehensive review of the Public Health Emergency 
Medical Countermeasure Enterprise, including medical countermeasure 
development priorities and resources, which includes FDA's resources to 
robustly engage with partners throughout a product's developmental 
lifecycle. FDA places a top priority on regulatory inquiries and 
submissions from sponsors and U.S. Government partners that are engaged 
in developing products that have been identified as meeting a critical 
need.
    Question. How extensively has the leadership of the FDA and the 
staff responsible for reviewing medical countermeasures been briefed on 
the national security threat assessments for CBRN agents? How many FDA 
employees that are involved in the review of medical countermeasures 
being developed under contract with BARDA and NIH have the appropriate 
security clearances necessary to allow them to receive classified 
briefings?
    Answer. FDA leadership has been briefed and is very aware of the 
national security threat assessments for CBRN agents. FDA leadership is 
briefed by the HHS Office of Security and Strategic Information, and 
FDA has an employee assigned to that Office. In addition, FDA's Office 
of Criminal Investigations, within the Office of Regulatory Affairs, 
works with the intelligence community to obtain information and briefs 
FDA's leadership as needed. Across FDA's three Centers that review 
medical countermeasure products, 106 employees that have been or in the 
future may be involved in medical countermeasure-related reviews have 
received special clearances to review classified documents related to 
product review submissions.
                       early childhood education
    Question. Madam Secretary, you and Secretary Duncan have been 
working very closely in the area of early childhood education. How do 
you see the collaboration continuing? What lessons has HHS learned 
about approaches to supporting at-risk children and their families that 
can be carried over into K-3 education?
    Answer. Because quality early childhood education spans the ages of 
birth to age 8 and involves the transition of children from early 
childhood programs into our Nation's schools, continued collaboration 
between the two Departments is essential. Secretary Duncan and I have 
been working very closely, and we have a number of joint efforts 
currently underway. We have formed working groups consisting of the 
best minds in both Departments to address the most pressing issues in 
the early childhood field, including creating a more educated, better-
trained early childhood workforce; better connecting the early 
education and health systems; and improving the way data are collected 
and used to improve early childhood systems at the State level; and 
coordinating Federal research and evaluation efforts in the area of 
early childhood. The two Departments are currently co-hosting listening 
sessions across the country to hear from the foremost experts and early 
childhood practitioners concerning these issues. The Departments 
consult regularly on the early childhood initiatives underway in each 
Department and will continue to collaborate on future initiatives and 
legislation that are vital to the development and education of our 
Nation's youngest children.
    Historically, HHS's approach to supporting the early education of 
at-risk children has been to foster growth in all developmental 
domains. In addition to emphasizing early education domains, such as 
literacy and early math, a strong focus on health, nutrition, and 
social-emotional development, for example, is essential in efforts to 
prepare children for school. This is a vital lesson that can be carried 
over into K-3 education. Children who miss school for health-related 
reasons or cannot attend to what is being taught cannot be successful 
in school. In addition, HHS has been very successful in promoting 
family involvement and support as two essential elements of high-
quality early education for at-risk families. Parents whose children 
attend the Head Start program, for example, not only receive services 
and parenting support as part of their child's participation in the 
program, but also are active partners in the child's education, 
weighing in on the curriculum selection and staffing decisions. The 
support that families receive, and the sense of empowerment they feel, 
play a role in positively affecting children's school readiness 
outcomes.
    Question. How many States have applied for State Advisory Council 
funding to date and how do you plan to encourage States to implement 
that requirement of the Head Start Act?
    Answer. We have received six applications for State Advisory 
Council funding. One of these six States has received its funding and a 
second State is about to receive its funding.
    We have been in communication with all 50 States, the 5 
territories, and the District of Columbia and all but a few have 
indicated that they are actively working on completing their 
application. Several intend to submit their applications in May, but 
the majority of States have indicated target submission dates in June 
and July--knowing they have until August 1, 2010 to submit.
    We are mailing a communication to the Governors during the week of 
May 3 asking them to indicate their intent to apply and the target date 
for submittal of their application. We hope to get all responses by the 
end of May and have asked Governor's to fax back their responses by May 
25 allowing us sufficient time to request States to submit an addendum 
to their initial application if they are interested in an additional 
supplemental award subject to the availability of funds.
    Question. I understand that HHS is in the process of writing 
regulations to implement the 2007 amendments to the Head Start Act. 
Where is HHS in this process? When do you expect the new performance 
standards to be released for comment?
    Answer. HHS is in the process of revising the performance standards 
to ensure that they reflect the most recent evidence on the components 
of a high-quality early childhood program. During the revision process, 
the Office of Head Start conducted listening sessions with each of the 
12 regions, including American Indian/Alaska Native and Migrant and 
Seasonal Head Start, as well as a parent focus group and a national 
stakeholder group in order to incorporate input from grantees. HHS 
expects to publish a Notice of Proposed Rulemaking (NPRM) for public 
comment before the end of the year.
    HHS also is drafting a regulation that establishes a designation 
renewal system to determine if a Head Start agency is delivering a 
high-quality and comprehensive Head Start program. HHS expects to 
publish an NPRM by this fall.
                        breast cancer screening
    Question. Secretary Sebelius, the President's budget would cut $4 
million from the National Breast and Cervical Cancer Early Detection 
Program (NBCCEDP). If I'm doing the figures correctly, that funding 
level would result in 7,000 fewer cancer screenings next year. Is that 
true? How do you expect to transition this program as new legislation 
is enacted to extend insurance and preventive screenings in particular?
    Answer. The fiscal year 2011 President's budget requests $211 
million for the NBCCEDP, which is $4 million below fiscal year 2010. 
This reduction is part of a CDC-wide effort to achieve efficiencies in 
travel and contracting and to maintain the program's impact with the 
goal of funding the same the number of cancer screenings. Thus, the 
proposed travel and contract reductions will not have any programmatic 
impact on the NBCCEDP activities. Regarding the provisions in the 
Affordable Care Act that extends coverage for recommended cancer 
screening services, CDC is actively exploring innovative ways to 
increase and improve cancer screenings. These approaches include using 
policy and systems change strategies; improving case management and 
care coordination, tailoring outreach to underserved communities; 
improving quality assurance of screening services; enhancing 
surveillance to monitor screening use and quality; and increasing 
education and awareness for the public and providers. CDC is also 
working to identify what the remaining uninsured population may be 
beyond 2014 and looking to define potential roles that State and local 
health departments could play in quality assurance and delivery of 
preventive services.
                            blood disorders
    Question. The President's budget proposes consolidating a number of 
programs in the CDC. In particular, I'm concerned about the plan for 
funding around blood disorders? Can you give me some details on CDC's 
plans for the blood disorders programs in fiscal year 2011? What 
activities will be supported and at what funding level?
    Answer. The fiscal year 2011 President's budget requests $20 
million for a program that realigns CDC's Blood Disorders Program to 
address the public health challenges associated with blood disorders 
and related secondary conditions. Rather than fund a disease-specific 
program for specific categories of blood disorders, the new program 
uses a comprehensive and coordinated agenda to prioritize population-
based programs targeting the most prevalent blood disorders. This 
public health approach will impact as many as 4 million people 
suffering with a blood disorder in the United States versus 
approximately 20,000 under the current programmatic model. This 
approach builds upon the successful collaboration CDC has with the 
national network of hemophilia treatment centers as well as the 
thrombosis and thalassemia centers. In fiscal year 2011, CDC plans to 
focus on the following three areas of greatest burden and unmet need: 
deep vein thrombosis and pulmonary embolism, hemoglobinopathies (such 
as sickle cell disease and thalassemia), and bleeding disorders. By 
using this broader approach, CDC anticipates increased program 
efficiencies by merging and re-designing data collection systems from 
those that focus on single disorders to a single system that collects 
data needed for monitoring health outcomes for multiple disease and 
disorders.
                              tobacco lab
    Question. Madam Secretary, as you know, last year the Family 
Smoking Prevention and Tobacco Control Act became law. That bill gave 
authority to the HHS to regulate tobacco for the first time, however, 
that bill would not have been possible without the detailed information 
gathered by the smoking lab at the CDC. I understand the FDA is working 
on developing their own laboratory to test tobacco products. What 
functions do you foresee FDA taking over and what functions will CDC 
retain? How are the CDC and the FDA coordinating the transition?
    Answer. FDA is responsible for the regulation of tobacco products 
and the administration of the Family Smoking Prevention and Tobacco 
Control Act, among other statutes. FDA executes its regulatory and 
public health responsibilities in four areas: protecting the public 
health, scientific standard-setting and product review, compliance and 
regulation, and public education and outreach. Comparatively, CDC 
performs research and surveillance to further the scientific 
understanding of how chemical composition and product design influence 
the health consequences of tobacco products, to provide a scientific 
basis for evaluating risk, and to aid public health officials in 
evaluating the effectiveness of tobacco control measures. As we move 
forward, CDC will continue to perform these functions. As FDA 
implements this historic piece of legislation, CDC and FDA are 
coordinating efforts, which include developing new methods for 
evaluating the constituents and ingredients in tobacco products; 
evaluating the impact of regulatory actions; and testing tobacco 
products and constituents.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye
                     community health centers (chc)
    Question. Senator Burdick and I were instrumental in the 
establishment of the National Institute for Nursing Research (NINR) and 
for 25 years the Institute has been dedicated to improving the health 
and healthcare of Americans through the funding of nursing research and 
research training. Since it was established, the Institute has focused 
on promoting and improving the health of individuals, families, 
communities, and populations. How does the (National Institutes of 
Health) NIH plan to further expand this critical arm of research?
    Answer. The fiscal year 2011 budget request includes $150.2 
million, and increase of $4.6 million above the fiscal year 2010 
appropriation, for the National Institute of Nursing Research (NINR). 
NINR continues to support and advance innovative research studies in 
self-management, symptom management, caregiving; health promotion and 
disease prevention; research capacity development; technology 
integration; and end-of-life research. NINR has begun to develop their 
next strategic plan which is scheduled for release early in fiscal year 
2012. Stakeholder input, a priority setting process, and public health 
concerns will shape the direction of NINR.
    Question. At my request, the University of Hawaii at Hilo 
established the College of Pharmacy. The College of Pharmacy's 
inaugural class of 90 students began in August 2007, will graduate in 
2011, and will hopefully stay in Hawaii to meet the growing demand for 
pharmacists. Historically, Hawaii's youth interested in becoming 
pharmacists would travel to the mainland for school, and not return. It 
is my vision that the people of Hawaii will have educational 
opportunities in the health professions that will in turn increase 
access to care to residents in rural and underserved communities. Has 
there been any discussion on establishing schools of allied health in 
remote communities to meet the growing needs for healthcare and improve 
access to care in rural America?
    Answer. HRSA programs work to increase access to healthcare in 
rural America through the training of allied health professionals. For 
example, the Area Health Education Centers (AHEC) Program encourages 
the establishment and maintenance of community-based training programs 
in off-campus rural and underserved areas in an overall effort to 
attract students into health careers with an emphasis on careers in the 
delivery of primary care to underserved populations. The program works 
to train culturally competent health professionals who will return to 
their home communities and provide healthcare to the underserved. In 
fiscal year 2008, the AHEC Program provided education and training to 
approximately 4,000 allied health students in community-based rural 
training sites.
    Question. America faces a shortage of nurse faculty, further 
complicating the problems of the nursing shortage. According to a study 
conducted by the American Association of Colleges of Nursing in 2008, 
schools of nursing turned away 49,948 qualified applicants to 
baccalaureate and graduate nursing programs. The top reason cited for 
not accepting these potential students was a lack of qualified nurse 
faculty. This element of the shortage has created a negative chain 
reaction--without more nurse faculty, additional nurses cannot be 
educated; and without more nurses, the shortage will continue. What 
efforts has the Department of Health and Human Services (HHS) made to 
address the shortage of qualified nurse faculty?
    Answer. HRSA's principal tools for addressing the nurse faculty 
shortage are the Nurse Faculty Loan Program (NFLP) and the Advanced 
Education Nursing (AEN) Program. The NFLP makes grants to schools that 
provide low-interest loans to nurse faculty students and then cancel a 
portion of the loans when the individual completes a service 
commitment. The AEN program provides grants to nursing schools to 
develop and operate advanced practice nursing training programs, as 
well as to provide traineeship support to students. During the latest 
reporting period covering academic year 2008-2009, fiscal year 2008, 
133 schools participated in the NFLP facilitating the graduation of 223 
students qualified to fill nurse faculty positions. During the same 
period, 194 NFLP graduates reported employment as nurse faculty. In 
fiscal year 2009, 149 schools participated with an estimated 1,100 
students receiving loans to support their education to become faculty. 
Grantees report that the NFLP has facilitated the graduation of 764 
students qualified to fill nurse faculty positions.
    The NFLP also received funding under the American Recovery and 
Reinvestment Act (ARRA). In fiscal year 2009, these funds were used to 
provide additional support to 65 (included in the 149) schools of 
nursing to support an estimated 500 additional students for a total of 
1,600 students receiving funding from regular appropriations and ARRA. 
In fiscal year 2010, the remaining ARRA funds will be used to make an 
estimated 700 additional loans.
    In fiscal year 2009, 160 AEN Program grants were awarded to schools 
of nursing. Twenty-one of the projects focused specifically on 
innovative teaching and learning content to prepare nurse educators. We 
estimate that 160 grants will be awarded in fiscal year 2010.
    Question. Using Hawaii as an example, what happens when a State is 
unable to pay health plans contracted to provide access to care for 
Medicaid beneficiaries? In this particular case, the Governor has 
apparently refused to release funds necessary to draw down Federal 
matching funds designated for the State's Medicaid Program. Does the 
department have any remedies in place to mandate that the States make 
funds available to ensure access to care for Medicaid beneficiaries?
    Answer. Our goal is to address payment issues before they impact 
Medicaid beneficiaries' access to care. In any case where Centers for 
Medicare & Medicaid Services (CMS) hears a State is contemplating a 
payment delay, our regional office staff work with the States to 
understand the impact of any delays on plans and beneficiaries and, 
where appropriate, to identify alternative approaches. We are aware 
that Hawaii is planning to delay its contractual payments to Medicaid 
managed care organizations (MCOs) in order to postpone payments to the 
next State fiscal year. The CMS is working aggressively with the State 
to share our concerns and ensure that the delayed payments to the MCOs 
do not result in the MCOs' inability to pay their network providers or 
otherwise impact beneficiary access.
    Question. With your increased focus on prevention, it seems as 
though a natural partnership would be with the community health centers 
whose focus is on public health and prevention. Has the department 
explored any collaborative partnership ideas with the Centers for 
Disease Control and Prevention (CDC) and the CHCs?
    Answer. HRSA convened a 3-day meeting with CDC in November of 2009 
to explore opportunities for continued collaboration. HRSA has been 
working closely with CDC on the HHS Healthy Weight Initiative as well 
as the Tobacco Prevention and Control Initiative. Additionally, HRSA is 
partnering with CDC on improving HIV screening and testing within 
health centers.
    Question. In regards to partnerships, rural areas in States like 
Hawaii and Alaska may have community health centers and/or an Indian 
Health Service (in Alaska) or Tribal Health facility. What, if any, 
type of collaboration has taken place in ensuring rural residents 
receive healthcare closest to home?
    Answer. HHS works with each health center organization to identify 
the need for primary care services for the underserved and vulnerable 
populations in their respective service areas. HHS encourages health 
centers to identify additional existing primary care providers in the 
area, and to collaborate with them so that the target populations 
receive appropriate levels of care for their needs. Nationally, there 
are 7 jointly funded CHC and Urban Indian Health Clinics. In addition, 
19 tribal entities currently receive section 330 health center funding 
to provide care within their communities.
    Question. On November 21, 1989, section 218 of Public Law 101-166 
stated that the NIH building No. 36 is hereby named the Lowell P. 
Weicker Building and on May 30, 1991, the NIH dedicated building 36 to 
Governor Weicker. During NIH campus renovations, the Weicker building 
was destroyed to make room for a Neuroscience Research Center. Has the 
NIH given any consideration to preserving the honorable recognition of 
Governor Lowell P. Weicker?
    Answer. NIH is currently reviewing the status of existing 
facilities on our campus, including the naming of buildings. However, 
naming another building for Senator Weicker, or any individual, 
requires congressional action.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
                workforce/sustainable growth rate (sgr)
    Question. I was glad to hear you talk about the need to support and 
strengthen our healthcare workforce. I know how important it is to 
ensure that our workforce needs are met. As we work to ensure quality, 
affordable healthcare coverage for all Americans, we must make sure 
there are enough qualified professionals to provide that care. This is 
why I led the charge to write a strong workforce title in the HELP 
healthcare reform bill. I was also glad to hear in your testimony 
particular focus on ensuring that America's senior population gets the 
care and treatment it needs. And one of the greatest barriers to that 
is the unfair and inequitable way that Medicare reimburses doctors and 
providers using the deeply flawed SGR formula. I have heard from so 
many doctors across my home State of Washington who have had to re-
evaluate their ability to treat Medicare patients. Some have decided to 
turn away new Medicare patients, while others have been forced to drop 
them all together. We need to do something about this. The President's 
budget includes $371 billion over 10 years to address physician 
payments. The budget seems to assume that Congress will pass a serious 
of short-term patches rather than a single permanent fix, and it 
reflects zero growth in the fee schedule. But short-term solutions 
aren't enough. Without a more equitable and accurate system of 
reimbursement, doctors will continue to worry about being paid for 
doing their job, and seniors will find it harder and harder to access 
the care they need. This is especially true in areas like my home State 
of Washington where doctors and hospitals are penalized for treating 
patients efficiently and well. So my questions are: What is the 
administration's policy on a long-term fix to the SGR?
    Answer. The administration supports comprehensive, but fiscally 
responsible reforms to the physician payment formula. We also believe 
that Medicare and the country need to move toward a system in which 
doctors face incentives for providing high-quality care rather than 
simply ``more'' care--a principle reflected in the Affordable Care 
Act's (ACA) payment and delivery reforms.
    I look forward to working with you and your colleagues in Congress 
to reform Medicare's payment methodology for physicians' services to 
address these concerns in a sustainable and responsible manner.
    Question. Why was a long-term solution for this problem not 
addressed in the President's fiscal year 2011 budget?
    Answer. The President's fiscal year 2011 budget request reflected 
the likely cost of providing zero percent annual payment updates for 
physicians--an honest budgeting approach to reflect the expected cost 
of truly addressing this policy. To that end, the fiscal year 2011 
budget includes an adjustment totaling $371 billion over 10 years 
(fiscal year 2011-fiscal year 2020) to reflect the administration's 
best estimate of future congressional action, based on Congress' 
repeated interventions on scheduled physician payment reductions in 
recent years. However, this adjustment does not signal a specific 
administration policy. Rather, the administration intends to continue 
to work with Congress to jointly develop a long-term solution to the 
physician reimbursement formula.
                                title x
    Question. I was pleased to hear you mention in your testimony the 
investment the President's budget makes in science-based teen-pregnancy 
prevention initiatives. Another proven program that helps prevent 
unintended pregnancies is the title X program, which is the only 
Federal program exclusively dedicated to family planning and 
reproductive-health services. Publicly funded family-planning services 
have helped reduce the rates of unintended pregnancy and abortion in 
the United States, and in fact, the Centers for Disease Control and 
Prevention (CDC) has included family planning on its list of the top 10 
most valuable public-health achievements of the 20th century. I was 
pleased to see that the President's budget again calls for an increase 
in title X funding. Do you agree that, in order to reduce the need for 
abortion, we must invest in valuable family planning services?
    Answer. Yes, publicly funded family planning services provided 
under the title X program play an important role in preventing teen and 
unintended pregnancy. During 2008, family planning services were 
provided through title X-funded clinics to more than 5 million 
individuals, 24 percent of whom were under the age of 20. It is 
estimated that the contraceptive services provided through the title X 
family planning program helped to prevent almost 1 million unintended 
pregnancies during 2008.
                 teen-pregnancy prevention initiatives
    Question. Last year's fiscal year 2010 omnibus eliminated funding 
for rigid abstinence-only-until-marriage programs, which by law were 
required to have nonmarital abstinence promotion as their ``exclusive 
purpose'' and were prohibited from discussing the benefits of 
contraception. In sharp contrast, the new approach--championed by this 
subcommittee--will focus on programs that have demonstrated their 
effectiveness, and all funded programs will be required to be age 
appropriate and medically accurate. The next step is for administration 
officials to draft the more detailed rules and regulations to determine 
which specific programs get funded. When is the Office of Adolescent 
Health (OAH) expected to release its request for proposals and how will 
it determine which programs are eligible for funding under this new 
initiative? How do you anticipate distributing the funds?
    Answer. OAH has released three Funding Opportunity Announcements 
(FOA). The ``Tier 1'' FOA for replicating programs that have proven 
effective through rigorous evaluation was released on April 2, 2010. 
Applicants may apply in 1 of 4 funding ranges:
  --Range A.--$400,000 to $600,000 per year
  --Range B.--$600,000 to $1,000,000 per year
  --Range C.--$1,000,000 to $1,500,000 per year
  --Range D.--$1,500,000 to $4,000,000 per year
    The ``Tier 2'' FOA for innovative approaches to teen pregnancy 
prevention was released on April 9, 2010, in conjunction with the 
Administration for Children and Families (ACF) Personal Responsibility 
Education Program funds reserved for innovative youth pregnancy 
prevention strategies. Applicants may apply in 1 of 2 funding ranges:
  --Range A.--$400,000 to $600,000 per year
  --Range B.--$600,000 to $1,000,000 per year
    A third FOA, which will also use Tier 2 funds in collaboration with 
CDC, provides funds for demonstrating the effectiveness of multi-
component, community-wide approaches to teenage pregnancy prevention; 
was released on May 4, 2010. Applicants may apply in 1 of 2 funding 
ranges:
  --Range A.--$750,000 to $1,500,000 per year
  --Range B.--$300,000 to $700,000 per year
    All three FOA's will be subject to a competitive peer-review 
process.
    Under a contract with the Department of Health and Human Services 
(HHS), Mathematical Policy Research (MPR) conducted an independent, 
systematic review of the evidence base. This review defined the 
criteria for the quality of an evaluation study and the strength of 
evidence for a particular intervention. Based on these criteria, HHS 
has defined a set of rigorous standards an evaluation must meet for a 
program to be considered effective and therefore eligible for funding 
under this announcement.
    Applicants were requested to review the list of evidence-based 
curriculum and youth development programs which HHS identified as 
having met these standards. A summary listing of these interventions 
was published in appendix A of the FOA. Program models listed in 
appendix A are eligible for replication under this funding 
announcement. Applicants that wish to replicate a program that is not 
on the list in Appendix A, may apply to do so, but a set of stringent 
criteria, described below, must be met.
    More detailed information about the review process and the programs 
eligible for replication is available at: http://www.hhs.gov/ophs/oah.
    If an applicant wants to apply to replicate a program model that is 
not on the list in appendix A, all of the following criteria must be 
met to qualify for funding under this FOA:
  --The research or evaluation of the program model that the applicant 
        seeks to replicate was not previously reviewed.
  --There is research on or evaluations of the program model that meet 
        the screening and evidence criteria used for the review of the 
        other program models.
  --The application must include all relevant research and evaluation 
        information.
  --The application must be submitted by May 17, 2010 to provide for 
        the time that will be needed to review the evidence submitted.
    Tier 1 final award decisions will be made by the Director of the 
OAH. Tier 2 final award decisions will be made collaboratively by the 
Director of OAH and the Commissioner of ACYF. In making decisions, the 
Director and the Commissioner will take into account the score and rank 
order given by the Objective Review Committee, and other considerations 
as follows:
    The availability of funds.
  --Representation of evidence-based teenage pregnancy prevention 
        programs across communities, including varied types of 
        interventions and evidence-based strategies.
  --Geographic distribution nationwide.
  --Inclusion of communities of varying sizes, including rural, 
        suburban, and urban communities.
  --Feasibility of evaluation plan (for applications in Tier 1 Ranges C 
        and D and Tier 2).
  --Inclusion of a range of populations disproportionately affected by 
        teenage pregnancy.
    Question. In determining which programs or group of programs are 
(or are not) effective, both the quality of a study and the magnitude 
of a program's impact are crucial. A large body of evidence shows that 
more comprehensive approaches--those that encourage abstinence, but 
also contraceptive use for young people who are having sex--can be 
effective. But rigid, moralistic, abstinence-only-until-marriage 
programs of the type promoted under previous Federal policy have been 
found in study after study not to be effective. How will the 
administration define a program as effective or promising?
    Answer. Under a contract with HHS, MPR conducted an independent 
systematic review of the evidence base for programs to prevent teen 
pregnancy. This review defined the criteria for the quality of an 
evaluation study and the strength of evidence for a particular 
intervention. Based on these criteria, HHS has defined a set of 
rigorous standards an evaluation must meet in order for a program to be 
considered effective and therefore eligible for funding as an evidence-
based program under Tier 1 of the new teenage pregnancy prevention 
program. The MPR review had four steps:
  --Find Potentially Relevant Studies.--Studies were identified by a 
        review of reference lists from earlier research syntheses, a 
        public call for studies to solicit new and unpublished 
        research, a search of relevant research and policy 
        organizations' Web sites, and keyword searches of electronic 
        databases. Nearly 1,000 potentially relevant studies were 
        identified.
  --Screen Studies To Review.--To be eligible for review, a study had 
        to examine the effects of an intervention using quantitative 
        data and statistical analysis. It had to estimate program 
        impacts on a relevant outcome-sexual activity (for example, 
        delayed sexual initiation), contraceptive use, sexually 
        transmitted infections (STIs), pregnancy, or births. The study 
        had to focus on United States youth ages 19 or younger and have 
        been conducted or published since 1989. A total of 199 studies 
        met these screening criteria.
  --Assess Quality of Studies.--Impact studies that met the screening 
        criteria were reviewed by trained MPR staff and assigned a 
        rating of high, moderate, or low based on the rigorous and 
        thorough execution of their research designs. The high rating 
        was reserved for random assignment studies with low attrition 
        of sample members and no sample reassignment. The moderate 
        rating was given to quasi-experimental designs with well-
        matched comparison groups at baseline, and to certain random 
        assignment studies that did not meet all the criteria for the 
        high rating.
  --Assess Evidence of Effectiveness.--A framework was developed for 
        grouping programs into different evidence categories, based on 
        the impact findings of studies meeting the criteria for a high 
        or moderate rating. HHS then defined which of these categories 
        would be eligible for funding. To qualify for funding, a 
        program had to be supported by at least one high- or moderate-
        rated impact study showing a positive, statistically 
        significant impact on at least one priority outcome (sexual 
        activity, contraceptive use, STIs, pregnancy, or births), for 
        either the full study sample or key subgroup (defined by gender 
        or baseline sexual experience).
    In total, 28 programs met the funding criteria, reflecting a range 
of program models and target populations. Of those programs, 20 had 
evidence of impacts on sexual activity (for example, sexual initiation, 
number of partners, or frequency of sexual activity), 9 on 
contraceptive use, 4 on STIs, and 5 on pregnancy or births.
    Question. As the President's principal advisor on health-related 
matters, how do you plan to work with the President to promote 
responsible sex education for young people?
    Answer. I have made reducing teen and unintended pregnancies one of 
my areas for key interagency collaborations at HHS. I have identified 
the several strategies to reduce teen and unintended pregnancy that are 
comprehensive in nature, cross organizational boundaries, and focus on 
the evidence of what works both in the public health and social 
services arenas.
    In addressing these strategies, HHS will draw upon the expertise of 
the public health and human services parts of HHS, including the ACF, 
the Office of the Assistant Secretary for Planning and Evaluation 
(ASPE), the CDC, the Health Resources and Services Administration 
(HRSA), the National Institutes of Health (NIH), the newly created OAH 
and the Office of Population Affairs (OPA) within the Office of Public 
Health and Science. Key among the strategies are:
  --Invest in Evidence-based Teen Pregnancy Reduction Strategies and 
        Continue To Develop the Evidence-based Practice.--HHS will 
        employ a comprehensive, evidence-based approach to reducing 
        teen pregnancy. Under the newly funded Teen Pregnancy 
        Prevention Program, HHS will fund the replication of models 
        that have been rigorously evaluated and shown to be effective 
        at reducing teen pregnancy or other behavioral risk factors as 
        well as research and demonstration projects designed to test 
        innovative strategies to prevent teen pregnancy. By conducting 
        high-quality evaluations of both types of approaches--those 
        replicating evidence-based models and innovative strategies--
        this initiative will expand the evidence base and uncover new 
        ways to address this issue. Additional funding made available 
        under the ACA will provide formula grants to States to fund 
        evidence based models and test new strategies as well. ACF, 
        ASPE, CDC, OAH, and OPA will each play a critical role in these 
        efforts.
  --Target Populations at Highest Risk for Teen Pregnancy.--HHS efforts 
        will focus on demographic groups that have the highest teen 
        pregnancy rates, including Hispanic, African-American, and 
        American Indian youth, and target services to high-risk, 
        vulnerable and culturally under-represented youth populations, 
        including youth in foster care, runaway and homeless youth, 
        youth with HIV/AIDS, youth living in areas with high teen birth 
        rates, delinquent youth, and youth who are disconnected from 
        usual service delivery systems.
        sexually transmitted diseases (stds) prevention in teens
    Question. Unintended teen pregnancy is not the only negative sexual 
health outcome facing America's young people. One young person every 
hour is infected with HIV and young people ages 15-25 contract about 
one-half of the 19 million STDs annually, even though they make up only 
one-quarter of the sexually active population. By focusing the funding 
only on teen pregnancy prevention, and not including the equally 
important health issues of STDs and HIV, it seems that an opportunity 
has been missed to provide true, comprehensive sex education that 
promotes healthy behaviors and relationships for all young people, 
including lesbian, gay, bisexual, and transgender youth. So many 
negative health outcomes are inter-related and educators on the ground 
know that they best serve young people when they address the inter-
related health needs of young people. What is the administration's 
position on making this a comprehensive prevention initiative that 
addresses the inter-related health needs of adolescents, including 
unintended pregnancy, STD, and HIV prevention?
    Answer. As the review of the evidence revealed, 28 programs met the 
funding criteria, reflecting a range of program models and target 
populations. And these results also support the inter-relatedness of 
health needs of adolescents. Of those 28 programs, 20 had evidence of 
impacts on sexual activity (for example, sexual initiation, number of 
partners, or frequency of sexual activity), 9 on contraceptive use, 4 
on STIs, and 5 on pregnancy or births.
    Addressing the health needs of adolescents is very important to me. 
Specifically, I have made reducing teen and unintended pregnancy and 
supporting the National HIV/AIDS strategy two of my key areas for 
interagency collaborations at HHS. (As well as a strategic initiative 
to prevent and reduce tobacco use that includes national campaigns to 
prevent and reduce youth tobacco use.) I have identified the following 
set of strategies to reduce teen and unintended pregnancy.
    In addressing these strategies, HHS will draw upon the expertise of 
the public health and human services parts of the Department, including 
the ACF, ASPE, CDC, HRSA, NIH, the newly created OAH, and OPA within 
the Office of Public Health and Science.
  --Invest in Evidence-based Teen Pregnancy Reduction Strategies and 
        Continue To Develop the Evidence-based Practice.--HHS will 
        employ a comprehensive, evidence-based approach to reducing 
        teen pregnancy. Under the newly funded Teen Pregnancy 
        Prevention Program, HHS will fund the replication of models 
        that have been rigorously evaluated and shown to be effective 
        at reducing teen pregnancy or other behavioral risk factors as 
        well as research and demonstration projects designed to test 
        innovative strategies to prevent teen pregnancy. By conducting 
        high-quality evaluations of both types of approaches--those 
        replicating evidence-based models and innovative strategies--
        this initiative will expand the evidence base and uncover new 
        ways to address this issue. Additional funding made available 
        under the ACA will provide formula grants to States to fund 
        evidence based models and test new strategies as well. ACF, 
        ASPE, CDC, OAH, and OPA will each play a critical role in these 
        efforts.
  --Target Populations at Highest Risk for Teen Pregnancy.--HHS efforts 
        will focus on demographic groups that have the highest teen 
        pregnancy rates, including Hispanic, African-American, and 
        American Indian youth, and target services to high-risk, 
        vulnerable, and culturally under-represented youth populations, 
        including youth in foster care, runaway and homeless youth, 
        youth with HIV/AIDS, youth living in areas with high teen birth 
        rates, delinquent youth, and youth who are disconnected from 
        usual service delivery systems.
  --Increase Access to Clinical Services--HHS will ensure access to a 
        broad range of family planning and related preventive health 
        services, including patient education and counseling; STI and 
        HIV prevention education, testing, and referral. Services can 
        be provided through community health centers, title X family 
        planning clinics, and public programs. HHS-funded health 
        services under the title X family planning program will 
        encourage family participation in the decision of minors to 
        seek family planning services and provide counseling to minors 
        on ways to resist attempts to coerce them into engaging in 
        sexual activity.
                        antimicrobial resistance
    Question. The World Health Organization (WHO) has identified 
antimicrobial resistance as one of the three greatest threats to human 
health. Two recent reports demonstrate that there are few candidate 
drugs in the pipeline to treat infections due to highly drug-resistant 
bacteria. One of these reports, for example, found only 15 
antibacterial drugs in the development pipeline, with only 5 having 
progressed to clinical trials to confirm clinical efficacy (phase III 
or later). Are there any plans to create a seamless approach to the 
research and development of new antibacterial drugs, particularly those 
designed to combat gram-negative infections, to ease the transition 
across the spectrum of enterprise from basic research to product 
development and procurement? What other actions can NIH/National 
Institute of Allergy and Infectious Diseases (NIAID) take to ensure 
that these needed new antibacterial drugs become available as soon as 
possible?
    Answer. The NIAID conducts and supports basic research to identify 
new antimicrobial targets and translational research to apply this 
information to the development of therapeutics; to advance the 
development of new and improved diagnostic tools for infections; and to 
create safe and effective vaccines to control infectious diseases and 
thereby limit the need for antimicrobial drugs.
    NIAID provides a broad array of pre-clinical and clinical research 
resources and services to researchers in academia and industry designed 
to facilitate the movement of a product from bench to bedside. By 
providing these critical services to the research community, NIAID can 
help to bridge gaps in the product development pipeline and lower the 
financial risks incurred by industry to develop novel antimicrobials. 
NIAID is attuned to the need for antimicrobials for Gram-negative 
bacteria and is working with several biotechnology companies and 
pharmaceutical companies to develop novel agents. NIAID also is 
conducting studies to inform the rational use of existing antimicrobial 
drugs or alternative therapies to help limit the development of 
antimicrobial resistance.
    In addition, development of broad spectrum antibiotics is a key 
program in the portfolio of medical countermeasures that HHS' 
Biomedical Advanced Development Authority (BARDA) uses to address the 
medical consequences of biothreats like anthrax, plague, tularemia, or 
enhanced bacterial threats that are antibiotic resistance. BARDA's 
efforts focus on development of these products toward licensure and 
stockpiling after NIAID and industry have shown proof of principle for 
the antibiotic candidates. BARDA supports industry in the advanced 
development of new antibiotics through cost-reimbursement contracts. 
BARDA continues to look for new and improved ways to support 
development of new antibiotics to treat newly emerging bacterial 
pathogens with antibiotic resistance.
                       vaccine-preventable deaths
    Question. We have been extremely successful in reducing the number 
of vaccine-preventable deaths in children. Unfortunately, we still have 
around 45,000 such deaths each year in adults. Millions of American 
adults go without routine and recommended vaccinations because our 
medical system is not set up to ensure adults receive regular 
preventive healthcare, which costs us about $10 billion annually in 
direct healthcare costs. What plans does CDC have for programs to 
increase the numbers of adults who receive vaccinations each year?
    Answer. One area of focus of CDC's adult immunization efforts is to 
increase influenza vaccination rates among healthcare workers. CDC is 
collaborating with the Centers for Medicare and Medicaid Services to 
explore public reporting of influenza vaccination rates among this high 
risk population as a quality performance measure for healthcare 
institutions. CDC is also working with State immunization programs to 
maintain the number of providers and partnerships that were developed 
out of the H1N1 response, including obstetricians and gynecologists, 
internists, pharmacists, and school-located vaccination clinics.
                                 ______
                                 
            Questions Submitted by Senator Mary L. Landrieu
     fostering connections to success and increasing adoptions act
    Question. Last year, Congress passed the Fostering Connections to 
Success and Increasing Adoptions Act with the intention of reforming 
the foster care and child welfare system. Many States have reported 
difficulties in implementing the provisions outlined in the bill and 
are looking for additional guidance from the Department of Health and 
Human Services (HHS). What is HHS doing to help States implement these 
reforms? How can we continue to provide reforms to transform the child 
welfare system so that it is efficient and promotes permanent placement 
of children in families rather than long-term foster or institutional 
care?
    Answer. HHS is committed to ensuring the safety, permanency, and 
well-being of children, particularly those who are at risk of entering 
or are already in the child welfare system. To that end, we are working 
hard to implement the many reforms made through the Fostering 
Connections to Success and Increasing Adoptions Act.
    We have issued a number of policy guidance documents and program 
instructions on Fostering Connections and continue to address 
additional questions from States and tribes. For example, we have 
issued detailed guidance on how a State or tribe can take up the option 
of the new Title IV-E Guardianship Assistance Program and submit claims 
for Federal reimbursement.
    HHS is also focused specifically on implementing a number of 
initiatives to achieve permanency in a timely manner for children so 
that they do not end up in long-term foster or institutional care. For 
example, the President's new fiscal year 2010 long-term foster care 
initiative is a $20 million, 5-year demonstration grant program 
engaging States, localities, tribes, and private organizations in 
implementing innovative intervention strategies aimed at reducing the 
number of children who stay in foster care for extended periods of 
time. In addition to funding services, the initiative awards grantees 
bonus funding for demonstrating improvement in the outcomes for 
children who have been in foster care for an extended period of time or 
who are at risk of remaining in foster care for long periods. We will 
conduct a rigorous national cross-site evaluation of the demonstration 
to determine whether this approach is successful and can be replicated. 
HHS also continues to work in collaboration with States to engage in 
program improvement efforts that reduce barriers to permanency as 
identified through the Child and Family Service Reviews. Further, HHS 
is actively engaged in raising the profile of the needs of children in 
need of permanency through our support for the AdoptUsKids initiative. 
This initiative focuses on the adoption of older youth and other 
children who remain in foster care for the longest periods. As of March 
2010, more than 12,000 foster children previously featured on the 
initiative's Web site found permanent, adoptive homes.
    Finally, we are providing assistance to States and tribes on 
Fostering Connections and permanency initiatives through a 
comprehensive network of training and technical assistance partners. 
This network includes National Resource Centers and regional 
Implementation Centers that focus on in-depth and long-term 
consultation and support to States and tribes to execute strategies to 
achieve sustainable, systemic change for greater safety, permanency, 
and well-being for families.
    We look forward to working with the subcommittee on additional 
reforms that may achieve permanency for our Nation's most vulnerable 
children.
                         mental health services
    Question. Providing mental health services in the wake of a 
disaster and during the recovery is critical to the community, however, 
the system seems to be fragmented. How can we coordinate the work so 
that children especially can get the support that they need?
    Answer. Emergency Support Function (ESF) #8 of the National 
Response Framework, the Federal Government's guiding principles for a 
unified national response to disasters and emergencies, lays out the 
principles for providing public health and medical services during 
disasters and emergencies. These services explicitly include mental and 
behavioral health. The Office of the Assistant Secretary for 
Preparedness and Response (ASPR) in its coordination role for ESF #8 
actively works with ESF #8 partners to identify and address mental 
health needs, including those of children that are appropriate for 
Federal assistance. During a response, the Emergency Management Group 
(EMG) utilizes behavioral health subject matter experts within the ASPR 
Division of At-risk, Behavioral Health, and Community Resilience to 
provide guidance, assist with triage of State requests for assistance, 
and support coordination efforts as needed between the EMG, HHS 
Operating Divisions like the Substance Abuse and Mental Health Services 
Administration (SAMHSA), ESF #8 partners like the American Red Cross, 
and affected States' Disaster Behavioral Health Coordinators.
    Additionally, in order to provide the needed mental health services 
and supports following a disaster and into the recovery period, the 
Federal Emergency Management Administration (FEMA) and SAMHSA 
coordinate to support State and local mental health networks through 
financial support, training, and technical assistance.
    FEMA funds several grants targeted to areas with Presidentially 
declared disasters for which SAMHSA--through its Emergency Mental 
Health Management and Traumatic Stress Services Branch at the Center 
for Mental Health Services--provides technical assistance, program 
guidance, and oversight. Among these funding opportunities are Crisis 
Counseling Assistance and Training Program (CCP) grants to increase 
local mental health staff and provide outreach and education for States 
which have identified a gap in mental health resources following a 
disaster. CCP Immediate Services Program grants to State mental health 
authorities to provide up to 60 days of funding for services 
immediately following the declaration of a disaster, and CCP Regular 
Services Program grants can provide an additional 9 months of support 
following a disaster. Supplementary funding is also available for 
special circumstances.
    In ongoing efforts, SAMHSA collaborates with FEMA to provide 
training--including annual trainings--to State mental health staff to 
develop crisis counseling training and preparedness plans and to 
encourage State-to-State information exchange. SAMHSA also maintains 
the Disaster Technical Assistance Center and the Disaster Behavioral 
Health Information Series to provide toolkits and a readily available 
source of information--including information specifically focused on 
children and adolescent mental health--to assist States, territories, 
and local entities in delivering effective mental healthcare during 
disasters.
    Additionally, the National Commission on Children and Disasters 
(NCDD) was established to carryout a comprehensive study to examine and 
assess the needs of children as they relate to preparation for, 
response to, and recovery from disasters. Through its interim report 
released last October, NCDD identified gaps and shortcomings in the 
provision of mental health services to children in disasters and made 
recommendations that will be used to inform legislative and executive 
branch policies and programs.
    In order to address the concerns of NCDD, HHS' ASPR has established 
a monthly meeting with the Commissioners to discuss HHS's progress. 
Additionally, this month, the ASPR and the Assistant Secretary for 
Children and Families will begin convening an HHS Working Group on 
Children and Disasters to facilitate communication and collaboration 
across the Department to improve the coordination of services for 
children--including mental and behavior health services--before, 
during, and after disasters and emergencies.
                        community health centers
    Question. The primary care community health centers created to fill 
the need after Hurricane Katrina have proved to be an extremely 
successful model to keep the uninsured and under-insured out of the 
emergency room. How can we provide ongoing support for successful 
programs like this?
    Answer. The fiscal year 2011 President's budget request includes an 
increase of $290 million for the Health Center program to continue the 
American Recovery and Reinvestment Act investment in 127 Health Center 
New Access Points as well as the services initiated under the Increased 
Demand for Services grants to health centers nationwide. This funding 
level will also support the development of approximately 25 new access 
points, increasing access to comprehensive primary healthcare services 
to an estimated 150,000 additional health center patients. 
Additionally, this level will support an estimated 125 service 
expansion grants to expand the integration of behavioral health into 
existing primary healthcare systems, enhancing the availability and 
quality of addiction care at existing health centers.
                           healthcare reform
    Question. What is your perspective on healthcare reform, its impact 
on State budgets, and the cost of healthcare for those who currently 
have insurance?
    Answer. Health insurance reform ensures a strong Federal-State 
partnership and does not strain State budgets. Specifically, health 
insurance reform: provides new, additional funding to States to support 
coverage expansions; strengthens States' roles in insurance oversight, 
delivery system reform, and prevention; reduces Medicaid and Medicare 
costs; reduces State uncompensated care; ends the ``hidden tax'' to 
finance care for the uninsured; eliminates the need for most State-
funded coverage programs; creates jobs, spurs the local economy and 
generates tax revenues; and invests in community health centers.
    In terms of healthcare costs for families: In its analysis, the 
nonpartisan Congressional Budget Office confirmed that lower 
administrative costs, increased competition, and better pooling for 
risk will mean lower average premiums for American families:
  --Americans buying comparable health plans to what they have today in 
        the individual market would see premiums fall by 14 to 20 
        percent.
  --Most Americans buying coverage on their own would qualify for tax 
        credits that would reduce their premiums by an average of 
        nearly 60 percent--even as they get better coverage than what 
        they have today.
  --Those who get coverage through their employer today will likely see 
        a decrease in premiums as well.
  --And Americans who currently struggle to find coverage today would 
        see lower premiums because more people will be covered.
                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin
                           medicaid coverage
    Question. An article in the New York Times on March 15, 2010, 
entitled, ``As Medicaid Payments Shrink, Patients Are Abandoned,'' 
highlighted what I have been hearing from Illinois providers for some 
time now. In this difficult economy, States are squeezing payments to 
providers in Medicaid at the same time the economy is fueling 
continuous growth in enrollment. As a result, patients are finding it 
increasingly difficult to locate doctors and dentists who will accept 
their Medicaid coverage. Many of the providers in Illinois tell us they 
cannot afford to take Medicaid patients. As a result, many delay care 
or forego it altogether, or end up going to hospital emergency rooms. 
Can you speak to the importance of provider payments in Medicaid, the 
impact on patient care, and any consideration the Department of Health 
and Human Services (HHS) has given to providing additional incentives 
to States to increase their payment rates?
    Answer. The administration recognizes the importance of adequate 
Medicaid provider payment rates and is pleased that the Health Care and 
Education Reconciliation Act of 2010 increases Medicaid payments to 
primary care physicians for calendars years 2013 and 2014. As a former 
Governor, I understand the tough choices States have to make when 
facing a difficult economy. However, I also recognize that Medicaid 
provider payment rates can affect access to care, and therefore is an 
area ripe for examination. I expect the newly formed Medicaid and CHIP 
Payment Advisory Commission will provide helpful guidance to enable us 
to undertake more robust consideration of Medicaid rates so that we can 
ensure all Medicaid beneficiaries have access to the healthcare 
providers they need.
                    critical access hospitals (cah)
    Question. CAHs are, by definition, critically important to rural 
communities throughout Illinois. Within CAHs, there is a heavy reliance 
on anesthesia services provided by certified registered nurse 
anesthetists (CRNA). CRNAs are the sole anesthesia providers in the 
vast majority of rural hospitals. Without CRNA services, many U.S. 
rural and CAHs would not be able to offer care. Recent rulings by the 
Centers for Medicare and Medicaid Services (CMS) have denied rural 
hospitals' claims for tens of thousands of dollars each in annual 
Medicare funding that they had come to rely upon to serve their 
communities. In addition, due to recent reclassifications of certain 
CAHs from rural to urban and as being located in a ``Lugar'' county, 
CMS has denied ``pass-through'' payment to these facilities for CRNA 
services. Can you advise the subcommittee on the potential for 
revisiting the CMS policy of denying reimbursement for on-call costs of 
CRNA services in the Rural Pass-through Program and the policy of 
denying payments to CAHs that have recently been reclassified as urban 
and in Lugar counties?
    Answer. With respect to on-call costs of CRNA services in CAHs, 
section 1834(g)(5) of the Social Security Act (SSA) states that in 
determining the reasonable costs of outpatient CAH services, the 
Secretary recognizes as allowable costs amounts for ``physicians, 
physician assistants, nurse practitioners, and clinical nurse 
specialists who are on-call (as defined by the Secretary) to provide 
emergency services but who are not present on the premises of the 
critical access hospital involved.'' The statute is explicit in 
allowing Medicare payment for on-call costs only of these designated 
practitioners and only for emergency services in CAHs. Accordingly, CMS 
does not have the authority to pay for on-call costs of CRNA services.
    With respect to pass-through payments for CRNAs, in the fiscal year 
2011 hospital inpatient prospective payment system (IPPS) proposed rule 
published on May 4, we are proposing to permit urban hospitals that 
have been classified as rural under section 1886(d)(8)(E) of the SSA to 
be paid on the basis of reasonable costs for anesthesia services and 
related care furnished by a qualified nonphysician anesthetist. We are 
not proposing to change our policy that would permit Lugar hospitals to 
be paid reasonable costs for such services. As stated in the proposed 
rule, Lugar facilities are considered urban under section 1886(d) of 
the SSA, and therefore, we do not believe it would be consistent with 
the statute to permit these facilities, which are not considered rural, 
to be paid on the basis of reasonable costs for CRNA services.
                      health professions programs
    Question. The University of Illinois at Chicago (UIC) is the 
largest medical school in the United States, and it houses the largest 
component of minority students in the country, including the largest 
single training center for Latino medical students and third largest 
for African-American students. In fact, 70 percent of the minority 
physicians in Chicago and 60 percent of those in the State were trained 
at UIC. I commend the administration's investment in the Minority 
Centers of Excellence program and the Health Career Opportunity 
Program, increasing funding for these two programs for the first time 
in years. What other plans does HHS have to ensure a diverse healthcare 
workforce and for a robust health professions pipeline programs at 
Health Resources and Services Administration (HRSA) in fiscal year 
2011?
    Answer. The administration prioritizes increasing the diversity of 
the health professions workforce and views it as a key strategy for 
increasing access to healthcare and reducing health disparities. In 
fact, HHS invested $50 million of the $200 million in American Recovery 
and Reinvestment Act (ARRA) funds designated for workforce programs in 
programs that specifically focus on increasing the diversity of the 
workforce. More than 50 percent of students in HRSA's Bureau of Health 
Professions-funded training programs are from minority and/or 
disadvantaged backgrounds. This year HRSA engaged its stakeholders to 
discuss strategies for increasing the diversity of the health 
professions workforce and for measuring the effectiveness of these 
strategies. In fiscal year 2011, HRSA will continue to implement 
program improvements that can result in a more diverse workforce.
    Question. I have noted that health professionals graduating from 
the minority health professions schools have a propensity to practice 
in medically underserved areas, many times community health centers. 
However, the existing Graduate Medical Education Program does little, 
if anything, to promote the practice of residents in underserved areas 
or in settings outside of the traditional hospital. What can we do to 
highlight this relationship and strengthen the pipeline from the 
minority health institutions to the community health centers with 
financial resources already allocated?
    Answer. With a looming shortage of primary care professionals and 
increased attention on preventive medicine, we acknowledge the value of 
training more residents in nonhospital sites and it is our intent to 
make sure Medicare medical education rules encourage and facilitate 
this kind of activity.
    Medicare permits hospitals to receive indirect medical education 
and other medical education payments for those residents training in 
nonhospital sites if the hospital incurs ``all or substantially all the 
costs'' of the training at those sites. The Affordable Care Act (ACA) 
clarifies this standard by requiring hospitals to pay stipends and 
benefits for trainees in nontraditional settings. The ACA also provides 
other avenues to encourage training in nonhospital settings, including 
financial support for teaching health centers, increased funding for 
primary care, and a 5-year, $230 million program to support the 
expansion of primary care residency programs in community-based 
teaching health centers.
    Question. The workforce shortages in State and local health 
departments have been well-documented. The President's budget for 
fiscal year 2011 includes a new proposal for a Health Prevention Corps 
(HPC). Can you elaborate about how this proposal will help address 
workforce shortages in State and local health departments, and how the 
Centers for Disease Control and Prevention (CDC) plans to recruit a 
diverse work force into this field?
    Answer. The fiscal year 2011 President's budget requests $10 
million for the HPC, which will recruit, train, and place participants 
in State and local health departments to fill positions in disciplines 
with documented workforce shortages. While HPC participants are 
learning on the job, they will also provide direct service to their 
health department and the State or local jurisdiction, such as by 
participating in public health surveillance activities, supporting 
outbreak investigations or environmental health assessments, or 
identifying important biologic specimens. CDC plans to ensure diversity 
among the HPC participants by recruiting strategically through social 
networking, student associations (including minority student 
associations), college career counselors, student and school listservs, 
alumni associations, and university/college organizations.
                      childhood obesity prevention
    Question. I'm very pleased to see that childhood obesity prevention 
has been an important priority for this administration and particularly 
the First Lady. CDC has invested in research and strategic partnerships 
to develop best practices in nutrition and physical activity. How has 
the CDC partnered with school systems to put this information into 
practice, and what additional steps could be taken in the future to 
ensure that this information is disseminated effectively?
    Answer. CDC supports a variety of programs and activities that 
address childhood overweightness and obesity in school and community 
settings. For instance, CDC's Division of Adolescent and School Health 
provides funding and technical support to 22 State departments of 
education and one tribe to address critical health issues, including 
obesity. CDC also supports school-based activities that contribute to 
obesity prevention and control efforts, such as promoting a systematic, 
data-driven approach to implementing evidence-based school health 
policies and programs, and developing and disseminating tools to help 
schools implement these practices.
    In addition, communities funded through the Healthy Communities 
Program and the Recovery Act Communities Putting Prevention to Work 
Program are partnering with school district leaders and staff to 
address childhood obesity through nutrition and physical activity 
strategies. These programs aim to promote wellness and to provide 
positive, sustainable health change by advancing policy, systems, and 
environmental change approaches, with a strategic focus on obesity 
prevention.
                        community health centers
    Question. As you know, through the ARRA, we made a historic 
investment in our Nation's community health centers. While this 
investment is reaping benefits in communities across the Nation--
including more than 35 health centers in Illinois, we know that there 
is still tremendous unmet need in health centers across the country. 
One demonstration of this need was in the competition for Facility 
Investment Program (FIP) funding available to health centers for large-
scale construction projects through ARRA. Although more than 600 
applications were submitted, only 85 could be approved. Those 
applications are still valid, and I am interested in the potential for 
funding these high-scoring, but unfunded applications. In addition, can 
you project how many jobs could be created if Congress were to provide 
additional funds for health center FIP funding in the range of $2 
billion.
    Answer. As you note, significant interest has been expressed in the 
Health Center Facility Investment Program that was funded through the 
ARRA. The ACA includes an additional $1.5 billion (for fiscal year 2011 
through fiscal year 2015) for investments in health center facilities. 
We envision health centers that applied for ARRA funding being eligible 
for receipt of this funding. At this point, it is difficult to project 
how many jobs will be created through the expenditure of this funding.
                     medicare secondary payer (msp)
    Question. Recently, I have heard concerns regarding the MSP system 
and a beneficiary's privacy. It seems that the current system is making 
it very difficult for many beneficiaries to settle cases and receive 
their settlement funds in the same timeframe as non-Medicare 
beneficiaries. The MSP reporting requirements in section 111 of the 
Medicare and Medicaid Extension Act of 2007 gave the Secretary 
discretion to establish the rules governing this new reporting process. 
I understand that those rules require beneficiaries to provide their 
social security number (SSN) or Medicare health information claim 
numbers (HICN) number to third parties as part of this reporting 
process. In light of our concerns of identity theft and the fact that 
HHS advises beneficiaries to keep these numbers private, what can be 
done so that beneficiaries do not have to disclose this information?
    Answer. HHS and CMS are committed to protecting the identity of 
Medicare beneficiaries and ensuring that they are able to access their 
healthcare benefits in a secure way. The HICN, also known as the 
Medicare number, serves as a beneficiary's identification number for 
Medicare entitlement. An individual may become entitled to Medicare 
through Social Security based on his or her own earnings or that of a 
spouse, parent, or child. HICNs reflect the social security number 
(SSN) of the individual who is entitled to Medicare, preceded or 
followed by a suffix that pertains to the specific beneficiary. 
Therefore, while in many cases a beneficiary's HICN includes their 
personal SSN, it is not always the case.
    Since the MSP process requires CMS to re-examine all billing and 
payments made by Medicare on behalf of a beneficiary, it would be 
impossible to perform this search without using a beneficiary's 
Medicare number, or the HICN. However, I want to assure you that we 
have strong guidelines and procedures in place to ensure that 
beneficiaries are protected from unauthorized disclosure of their 
personal information.
                                 ______
                                 
                Questions Submitted by Senator Jack Reed
              low income home assistance program (liheap)
    Question. I am deeply concerned about the proposed $2 billion cut 
in the LIHEAP block grant, which represents a $13.6 million reduction 
in funding for the State of Rhode Island. While the budget proposal 
calls for the creation of a so-called mandatory ``trigger'' fund to 
make up the difference, there is no certainty that the gap in the block 
grant will be filled for each State. Is it a certainty that the 
mandatory fund will be triggered in fiscal year 2011?
    Answer. Under current economic estimates, substantial mandatory 
funding will be triggered in fiscal year 2011 under the 
administration's legislative proposal. We estimate that $2 billion will 
be released, bringing total LIHEAP funding to $5.3 billion, an increase 
of $200 million above fiscal year 2010.
    Question. If the mandatory fund is triggered, how can States be 
assured that they will not see a cut from the level of funding they 
received in fiscal year 2010 in the absence of any kind of funding 
formula?
    Answer. Under our legislative proposal, the administration would 
determine a State allocation of triggered mandatory funds. A funding 
formula was not proposed because we believe having discretion over 
State allocations provides flexibility necessary to respond to the 
unique aspects of each heating or cooling season. Since we expect 
substantial funds to be triggered by an overall increase in the 
percentage of households receiving Supplemental Nutrition Assistance 
(SNAP) we would expect that States where SNAP usage has increased the 
most would see increased funding compared to fiscal year 2010. The 
discretion provided by the proposal would allow us to address unique 
circumstances. For example, if two States had the same increase in SNAP 
usage, the one experiencing severe weather could receive additional 
funds.
    Question. How are States supposed to plan their programs without a 
clear sense of how much funding they will receive? Why is it not 
simpler and more predictable to fully fund the block grant?
    Answer. Since LIHEAP funding is currently subject to an annual 
appropriation, States must currently plan their programs without 
knowing how much discretionary funding they will receive. LIHEAP 
appropriations are frequently not enacted until mid-winter, several 
months after States begin their heating programs. Under our legislative 
proposal, however, most mandatory funding would be allocated to the 
States at the beginning of the Federal fiscal year, as they start their 
heating programs.
    Question. In the out-years, the budget shows a significant decline 
in funding that will be released under the trigger. Given the 
administration's commitment to capping nonsecurity discretionary 
spending and the reduced baseline established for the block grant in 
this budget (again, $2 billion less than fiscal year 2009 and 2010), it 
will be difficult to make up for the shortfall that will occur on the 
mandatory side. Indeed, it appears that this proposal would lock-in a 
cut to overall LIHEAP funding in future years. How does the 
administration plan to ensure that the program does not experience such 
a cut? Will you propose increased funding for the block grant in future 
years?
    Answer. The administration believes that the $5.3 billion requested 
for LIHEAP is appropriate given the circumstances predicted for fiscal 
year 2011. These circumstances include a significant increase in energy 
prices and a 48 percent increase in the proportion of U.S. households 
receiving SNAP. After fiscal year 2011, current predictions show more 
stable energy prices and significant decreases in the proportion of 
households receiving SNAP. Based on these predictions, the amount of 
mandatory funding that we would project to be released by the trigger 
proposal also declines significantly. Should energy prices increase 
rapidly, and/or SNAP participation remain high, the trigger would 
automatically provide a higher level of mandatory funds. While current 
economic estimates show declining mandatory funding after fiscal year 
2011, the trigger proposal ensures that the amount of mandatory LIHEAP 
funding will be higher automatically if there is an increase in need
            vaccinations--section 317 immunization program.
    Question. In 2009, the Centers for Disease Control and Prevention 
(CDC) submitted a report to Congress which illustrated that the section 
317 immunization program requires additional funding to carry out its 
essential public health mission of protecting Americans from 
preventable diseases. I am pleased that the American recovery and 
Reinvestment Act (ARRA) began to address this funding need. For the 
first time, entire families in some States received the Tetanus-
Diphtheria-Pertussis vaccine. In other States, children were able to 
receive their annual influenza vaccine in their school, which helped 
keep children in the classroom, not sick at home. With the success that 
we have seen over the past year, how did you reach the decision to not 
maintain this enhanced funding level in the proposed fiscal year 2011 
budget?
    Answer. The support that the ARRA provided to CDC's section 317 
Immunization Program was one-time funding. The fiscal year 2011 
President's budget requests $579 million, which is +$17 million above 
fiscal year 2010. CDC will continue support for the purchase of vaccine 
and for State immunization infrastructure and operations so that public 
health departments can provide vaccine underinsured and uninsured 
children and adults. With these efforts, CDC plans to keep childhood 
immunization rates at record high levels in the United States.
                     healthcare worker vaccination
    Question. Healthcare workers are in direct contact with individuals 
who are often highly susceptible to contracting other diseases and 
conditions. As such, ensuring that health workers, not just patients, 
receive vaccinations are not just a matter of wellness, but also 
patient safety. Unfortunately, we know from a recent reports that only 
40 percent of health workers nationwide, for example, receive annual 
flu vaccinations. Recognizing that this was a problem, hospitals in my 
State of Rhode Island are required to report flu vaccination rates of 
health workers to the Department of Health. Individual health workers 
actually accept or decline (for a specified reason) their vaccine at 
their place of employment, which has increased the rate of vaccination 
in just the past few years. What could be done at the national level to 
increase vaccination rates among healthcare workers?
    Answer. Mandatory healthcare personnel influenza vaccination 
requirements and public reporting of healthcare personnel influenza 
vaccination status has been used to increase coverage rates at the 
healthcare institution and State-levels. CDC is currently working with 
Centers for Medicare and Medicaid Services (CMS) to assess the 
effectiveness and feasibility of establishing a mechanism for public 
reporting of influenza vaccination coverage among healthcare personnel 
by making this a national quality performance measure for healthcare 
institutions.
                  title vii health professions funding
    Question. We know that a strong healthcare workforce will help to 
meet the healthcare needs of patients around the country. And, as we 
work to pass health reform legislation, we know that the number of new 
individuals who will, for the first time, have access to primary care 
doctors will create even greater strain on the system. For this reason, 
I was pleased that the ARRA provided an additional $200 million to 
train a new generation of healthcare workers. This investment will also 
make a significant economic impact. In 2008, medical schools and 
teaching hospitals had a combined $512 billion impact on the national 
economy. And each trained and practicing primary care doctor, for 
example, has a $1.5 million impact on the economy. How will you work to 
prioritize funding increases that directly impact job creation and 
economic recovery?
    Answer. Health Resources and Services Administration (HRSA) is 
coordinating with the Department of Labor (DOL) to ensure investments 
in health workforce are complimentary, reduce shortages in health 
professions, and provide economic opportunities. HRSA and DOL will soon 
submit to the Congress a joint strategic plan for how they will invest 
their resources in fiscal year 2010 and beyond. One key area of 
emphasis is building career ladders in the healthcare sector. Career 
ladder programs allow individuals to expand their skills and increase 
their income. In fiscal year 2010, Congress appropriated funds for HRSA 
to implement an initiative to improve training for nursing aides and 
home health aides. This initiative will generate more economic 
opportunities for individuals who pursue these careers. According to 
Bureau of Labor statistics, these two occupations are among the fastest 
growing.
                      the hemophilia program (cdc)
    Question. The President's budget for fiscal year 2011 proposes to 
eliminate CDC's Blood Disorders Division and establishes a new program 
described as ``a public health approach to blood disorders.'' The 
explanation provides few details on what existing activities will be 
maintained or changed and what new activities will be initiated. Can 
you provide a detailed explanation of CDC's new approach, with a 
particular emphasis on how it will impact the cost-effective research, 
treatment, and surveillance conducted under the Hemophilia Program, as 
well as a description of how the $20.4 million will be spent?
    Answer. The fiscal year 2011 President's budget requests $20 
million for a program that realigns CDC's Blood Disorders Division to 
address the public health challenges associated with blood disorders 
and related secondary conditions. Rather than fund a disease-specific 
program for specific categories of blood disorders, the new program 
uses a comprehensive and coordinated agenda to prioritize population-
based programs targeting the most prevalent blood disorders. This 
public health approach will impact as many as 4 million people 
suffering with a blood disorder in the United States versus 
approximately 20,000 under the current programmatic model. In fiscal 
year 2011, CDC plans to focus on the following three areas of greatest 
burden and unmet need: deep vein thrombosis and pulmonary embolism, 
hemoglobinopathies (such as sickle cell disease and thalassemia), and 
bleeding disorders. CDC has a long and robust history of partnership 
with a national network of 135 hemophilia treatment centers that has a 
documented history of improved health outcomes for hemophilia patients. 
CDC plans to continue this national network for the hemophilia 
population as well as those suffering from the most prevalent blood 
disorders.
             ocean state crohn's and colitis area registry
    Question. The President's budget eliminates a very successful 
program at the CDC focused on Crohn's disease and ulcerative colitis--
painful and debilitating diseases. The CDC program supports much-needed 
epidemiology research on these disorders which has been conducted 
exclusively in Rhode Island through the Crohn's and Colitis Foundation 
of America (CCFA). A substantial Federal investment has already been 
made in connecting more than 22 physicians groups and hospitals in 
Rhode Island that are engaged in the research. And CDC Director and 
Administrator Dr. Frieden wrote in a recent letter that, ``[w]e have 
been pleased with the success of our collaboration with CCFA'' and 
``the registry is meeting its aim to gain insight into the etiology of 
IBD, to learn why the course of illness varies among individuals, and 
determine what factors may improve outcomes.'' If these statements are 
accurate, what is the rationale for eliminating this successful program 
and how can we work together to ensure that existing efforts are 
maintained with adequate Federal funding?
    Answer. For fiscal year 2011, the President's budget does not 
continue the specific $686,000 provided in fiscal year 2010 for 
Inflammatory Bowel Disease (IBD) as the request seeks to eliminate 
duplicative programs that take narrow, disease-specific approaches 
rather than a broader public health approach. CDC will continue to 
provide technical assistance to partners who are researching the 
natural history of IBD and factors that predict the course of the 
disease. This research includes studies examining provider variation in 
the treatment of Crohn's disease, disparities in mortality for IBD 
patients, disparities in surveillance for colorectal cancer associated 
with this disease, and variation in outcomes in relation to race.
                                 ______
                                 
                Question Submitted by Senator Mark Pryor
                               abstinence
    Question. The Consolidated Appropriations Act, 2010, established a 
funding stream for a new Teen Pregnancy Prevention Program. The 
Conference Report included language providing $110,000,000 for a new 
teenage pregnancy prevention initiative. The Conference Report 
underscored the value of abstinence: ``The conferees intend that 
programs funded under this initiative will stress the value of 
abstinence and provide age-appropriate information to youth that is 
scientifically and medically accurate.'' It is my understanding that 
Arkansas and other States' programs dedicated to abstinence education 
would likely be able to apply for funds from a $25 million pool of 
research and development grant program funding, but no guarantee exists 
that these programs would receive continued funding and they could be 
eliminated.
    Answer. Twenty-eight different programs met the funding criteria, 
reflecting a range of program models and target populations, some 
included abstinence components. States such as Arkansas may select one 
of these models and apply under tier 1 or may apply under the tier 2 
innovative approaches pool from either the Teen Pregnancy Prevention 
funds in OS or the Personal Responsibility Education Program (PREP) 
innovative strategies funds in ACF. Additionally, the department of 
Health and Human Services is still determining the funding process for 
the PREP evidence-based replication programs which totals approximately 
$55 million and is designed to educate adolescents on a number of 
personal responsibility areas including abstinence. In addition, the 
Patient Protection and Affordable Care Act includes $50 million in 
annual mandatory funding for States to provide abstinence education, 
which may be a source of support for these programs.
                                 ______
                                 
              Questions Submitted by Senator Arlen Specter
             american recovery and reinvestment act (arra)
    Question. Madam Secretary, the Department Health and Human Services 
(HHS) fiscal year 2011 budget presented provides an increase of $1 
billion. While this would appear to be a satisfactory amount, when 
taking into account the stimulus funding provided for the National 
Institutes of Health (NIH) which will be coming to an end this year, 
the reduction is catastrophic. The stimulus funds have brought a 
resurgence of scientists to labs to find cures to the greatest maladies 
of our times. Given the need to continue this funding please explain 
HHS's thinking behind this $1 billion increase.
    Answer. The fiscal year 2011 budget request does not fully continue 
the one-time ARRA funding expected to be obligated in fiscal year 2010. 
NIH planned for most of the research supported by the ARRA to be 
completed in 1 or 2 years, or to supplement and accelerate ongoing 
research. However, NIH does plan to use part of its $1 billion budgeted 
increase in fiscal year 2011 to continue specific initiatives begun or 
expanded with ARRA funds. Examples of such projects being continued 
with fiscal year 2011 funds include using The Cancer Genome Atlas to 
catalog all of the reasons why normal cells become malignant; 
shortening the time it takes to develop and test new cancer treatments 
through the Accelerating Clinical Trials of Novel Oncologic Pathways 
Program; sequencing candidate genes to identify genetic contributors to 
autism spectrum disorder; and strengthening the NIH Basic Behavioral 
and Social Sciences Opportunity Network initiative.
    Question. Last year, President Obama signed an executive order to 
expand the number of embryonic stem cell lines that are eligible for 
Federal funding. Last year $143 million (including ARRA funds) was 
spent on human embryonic research by the NIH. Do you believe that 
funding level was sufficient and what we can expect for fiscal year 
2011?
    Answer. Funding levels have not been the limiting factor in the 
support of human embryonic research. The major limitations have been 
the restrictions on the number of stem cell lines available for 
research and the quantity of applications submitted. President Obama's 
Executive Order 13505 of March 9, 2009, removing previous Federal 
restrictions, and NIH's new stem cell research guidelines of July 7, 
2009, implementing the Executive Order has gone a long way in 
addressing these past limitations. Currently, NIH has formally approved 
64 human embryonic stem cell lines to be eligible for Federal research 
support. NIH estimates it will spend at least $126 million in fiscal 
year 2011 on human embryonic stem cell research, an increase of $38 
million, or 43 percent, more than fiscal year 2008 levels.
    I would also mention that on February 26, 2010, NIH announced a new 
initiative to use its Common Fund resources beginning in fiscal year 
2010 to establish an intramural Induced Pluripotent Stem Cell Center to 
drive the translation of scientific knowledge about stem cell biology 
into new cell-based treatments. The capability of transforming human 
skin fibroblasts and other cells into induced pluripotent stem cells 
could lead to major advances in therapeutic replacement of damaged or 
abnormal tissue without risk of transplant rejection.
    With this opening up of Federal support for human embryonic stem 
cells, and with the development of induced pluripotent stem cells, 
researchers will have an unprecedented opportunity in fiscal years 2010 
and 2011 to understand the earliest stages of human development, and to 
explore powerful new therapeutic approaches to Parkinson's disease, 
type 1 diabetes, spinal cord injury, and a long list of rare genetic 
diseases.
                            medicare part d
    Question. Prior to Medicare Part D, when Medicaid was the primary 
payer of medications in long-term care, pharmacies were required to 
provide a credit for unused medication in most States. As a result, 
pharmacies looked for ways to reduce or reuse the medications, which 
helped curb the amount of waste. However, since the inception of 
Medicare Part D, which has no mechanism to provide a credit for unused 
medication, waste has grown significantly, costing taxpayers billions 
and contaminating our water supplies. Because of the current 
reimbursement system in Part D, long-term care pharmacies have no 
incentive to reduce medication waste. Is medication waste in long-term 
care something the agency is paying attention to and what steps can the 
agency take to eliminate this waste? Are you considering any 
incentives, such as higher dispensing fees for long-term care 
pharmacies and/or technology and research grants?
    Answer. Thank you for the question Senator Specter. Centers for 
Medicare and Medicaid Services (CMS) shares your concern regarding the 
wasteful dispensing of prescription drugs in long-term care settings. 
We have been addressing medication waste concerns as we work toward 
implementing the provision in the Affordable Care Act (ACA) which we 
worked on with Congress to ensure that prescription drugs are dispensed 
with a higher degree of efficiency. The ACA requires part D plans to 
implement waste reduction techniques beginning with the 2012 plan year. 
We are in the process of consulting with key stakeholders such as 
pharmacists, nursing homes, and plans as we develop utilization 
management techniques that will reduce the waste associated with the 
dispensing of 30-day refills in long-term care settings.
                         bioproduction facility
    Question. On May 20, 2009, we met to discuss the establishment of a 
facility to develop and manufacture biologics. Since that time we have 
seen the production of H1N1 vaccine fall woefully short, missing the 
delivery date for vaccines by months. A public/private manufacturing 
and development facility would help ensure access to vaccines and other 
medical countermeasures for Americans. I have worked with Biomedical 
Advanced Research and Development Authority (BARDA) to move this 
project forward and they have indicated their support. Could you 
explain why funding for this important project was not included in your 
budget?
    Answer. HHS is currently conducting a review of medical 
countermeasure (MCM) development, which will examine domestic 
manufacturing capacity for pandemic influenza vaccines and other MCMs. 
HHS is also working with the Department of Defense in order to 
coordinate countermeasure facility needs.
    The fiscal year 2010 budget for BARDA includes $5 million to 
support the initial planning phase of core services (formerly called 
bioproduction facilities). HHS plans to solicit proposals and award 
contracts to support architectural and mechanical engineering concept 
design for potential facilities. The goal will be to evaluate the 
potential of strategic partnerships between the Federal Government, 
major biopharmaceutical companies, and smaller biotech companies to 
create domestic-based, flexible, multi-product manufacturing facilities 
focused on providing countermeasure services. Priority services would 
include the advanced development and manufacturing of biological 
medical countermeasures with limited or no commercial markets.
                            anthrax vaccine
    Question. It is my understanding that the Department has a 
requirement and need to contract for additional doses of the Food and 
Drug Administration (FDA) licensed anthrax vaccine because the number 
of the doses in the Strategic National Stockpile currently are well 
below the total needed to meet HHS's 75 million anthrax vaccine dose 
requirement and the shelf-life dates for using the earlier stockpiled 
anthrax vaccine doses have expired and others will continue to expire. 
It is also my understanding that with the termination of an earlier 
contract and delays in the development of new experimental anthrax 
vaccines, HHS now estimates that it will take at least 8 years before 
potential development and FDA licensure of new anthrax vaccines. Given 
that many Government and other experts are saying that the number one 
WMD threat is anthrax and there is a continuing need for protecting 
first responders and citizens from another potential anthrax attack 
with both vaccines and drugs, what are your plans and timing for 
contracting for additional doses of the current FDA licensed vaccine to 
replenish the stockpile and move toward meeting the 75 million dose 
stockpile requirement?
    Answer. The medical countermeasure review will propose enhancements 
to the countermeasure production process, addressing promising 
discoveries, advanced development, robust manufacturing, including for 
MCMs for anthrax threats.
    The Centers for Disease Control and Prevention (CDC) currently has 
a contract in place with Emergent for procurement of additional 14.5 
million doses of FDA-licensed anthrax vaccine in order to move toward 
meeting the 75 million dose stockpile requirement, and is receiving the 
full production capacity of this vaccine.
    BARDA terminated on December 7, 2009 a solicitation under Project 
BioShield RFP for rPA anthrax vaccine after multiple technical 
evaluation panels determined that none of the proposal from Offerors 
were able to meet the maximum statutory requirement of reaching FDA 
licensure within 8 years. On the same day, BARDA issued special 
instructions under their broad agency announcement to support advanced 
development of next generation anthrax vaccines including rPA vaccine 
candidates. Proposals were received, reviewed, and are currently under 
contract negotiations with an expectation to issue contract awards in 
fiscal year 2010.
    Question. Given the delays and uncertainties with the development, 
procurement, manufacture, and availability associated with vaccines in 
general and most recently for the pandemic vaccine, would it not be 
prudent now for HHS to enter into negotiations as early as possible for 
procurement of a multi-year supply of the anthrax vaccine for the 
stockpile to assure that we are better prepared to respond to an 
anthrax attack or multiple attacks?
    Answer. CDC currently has a contract, with a multi-year contracting 
mechanism to ensure preparedness, in place with Emergent for 
procurement of additional 14.5 million doses of FDA-licensed anthrax 
vaccine in order to move toward meeting the 75 million dose stockpile 
requirement, and is receiving the full production capacity of this 
vaccine.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Same here. The subcommittee will stand 
recessed. Thank you, Madam.
    [Whereupon, at 3:58 p.m., Wednesday, March 10, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]
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