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REVIEWING THE PRESIDENT’S FISCAL YEAR 2013 

BUDGET PROPOSAL FOR THE U.S. DEPARTMENT 

OF HEALTH AND HUMAN SERVICES 

HEARING 

BEFORE THE

COMMITTEE ON EDUCATION 

AND THE WORKFORCE 

U.S. HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

SECOND SESSION 

HEARING HELD IN WASHINGTON, DC, APRIL 26, 2012 

Serial No. 112–60 

Printed for the use of the Committee on Education and the Workforce 

( 

Available via the World Wide Web: 

www.gpo.gov/fdsys/browse/committee.action?chamber=house&committee=education 

or 

Committee address: http://edworkforce.house.gov 
(II) 

COMMITTEE ON EDUCATION AND THE WORKFORCE 

JOHN KLINE, Minnesota, Chairman 

Thomas E. Petri, Wisconsin 

Howard P. ‘‘Buck’’ McKeon, California 

Judy Biggert, Illinois 

Todd Russell Platts, Pennsylvania 

Joe Wilson, South Carolina 

Virginia Foxx, North Carolina 

Bob Goodlatte, Virginia 

Duncan Hunter, California 

David P. Roe, Tennessee 

Glenn Thompson, Pennsylvania 

Tim Walberg, Michigan 

Scott DesJarlais, Tennessee 

Richard L. Hanna, New York 

Todd Rokita, Indiana 

Larry Bucshon, Indiana 

Trey Gowdy, South Carolina 

Lou Barletta, Pennsylvania 

Kristi L. Noem, South Dakota 

Martha Roby, Alabama 

Joseph J. Heck, Nevada 

Dennis A. Ross, Florida 

Mike Kelly, Pennsylvania 

George Miller, California, 

Senior Democratic Member 

Dale E. Kildee, Michigan 

Robert E. Andrews, New Jersey 

Robert C. ‘‘Bobby’’ Scott, Virginia 

Lynn C. Woolsey, California 

Rube ́n Hinojosa, Texas 

Carolyn McCarthy, New York 

John F. Tierney, Massachusetts 

Dennis J. Kucinich, Ohio 

Rush D. Holt, New Jersey 

Susan A. Davis, California 

Rau ́l M. Grijalva, Arizona 

Timothy H. Bishop, New York 

David Loebsack, Iowa 

Mazie K. Hirono, Hawaii 

Jason Altmire, Pennsylvania 

Marcia L. Fudge, Ohio 

Barrett Karr, Staff Director 

Jody Calemine, Minority Staff Director 
(III) 

C O N T E N T S 

Page 

Hearing held on April 26, 2012 .............................................................................. 1 

Statement of Members: 

Kline, Hon. John, Chairman, Committee on Education and the Workforce 1 

Prepared statement of ............................................................................... 3 

Miller, Hon. George, senior Democratic member, Committee on Education 

and the Workforce ......................................................................................... 4 

Prepared statement of ............................................................................... 6 

Statement of Witnesses: 

Sebelius, Hon. Kathleen G., Secretary, U.S. Department of Health and 

Human Services ............................................................................................ 8 

Prepared statement of ............................................................................... 9 

Additional Submissions: 

Barletta, Hon. Lou, a Representative in Congress from the State of Pennsylvania, questions submitted for the record .............................................. 70 

Foxx, Hon. Virginia, a Representative in Congress from the State of 

North Carolina: 

Letter, dated March 6, 2012, from Congressman Boustany to Secretary Sebelius ....................................................................................... 22 

Questions submitted for the record ......................................................... 68 

Hinojosa, Hon. Rube ́n, a Representative in Congress from the State of 

Texas, question submitted for the record .................................................... 73 

Hunter, Hon. Duncan, a Representative in Congress from the State of 

California, question submitted for the record ............................................. 68 

Chairman Kline: 

Letter, dated March 8, 2012, to Secretary Sebelius from U.S. Senator 

Tom Coburn, et al .................................................................................. 60 

Letter, dated March 27, 2012, to Senator Coburn from Assistant 

Secretary George H. Sheldon, HHS ..................................................... 62 

Questions submitted for the record ......................................................... 66 

Mr. Miller, questions submitted for the record .............................................. 73 

Roby, Hon. Martha, a Representative in Congress from the State of 

Alabama, questions submitted for the record ............................................. 70 

Roe, Hon. David P., a Representative in Congress from the State of 

Tennessee, prepared statement of Peter Demos, Demos’ Restaurants ..... 64 

Secretary Sebelius, response to questions submitted for the record ............ 74 

Walberg, Hon. Tim, a Representative in Congress from the State of 

Michigan, questions submitted for the record ............................................ 69 

Wilson, Hon. Joe, a Representative in Congress from the State of South 

Carolina, question submitted for the record ............................................... 68 

Woolsey, Hon. Lynn C., a Representative in Congress from the State 

of California: 

Letter, dated March 26, 2012, from Assistant Secretary Jim R. Esquea, HHS .............................................................................................. 32 

Questions submitted for the record ......................................................... 72 

(1) 

REVIEWING THE PRESIDENT’S 

FISCAL YEAR 2013 BUDGET PROPOSAL 

FOR THE U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Thursday, April 26, 2012 

U.S. House of Representatives 

Committee on Education and the Workforce 

Washington, DC 

The committee met, pursuant to call, at 10:03 a.m., in room 

2175, Rayburn House Office Building, Hon. John Kline [chairman 

of the committee] presiding. 

Present: Representatives Kline, Petri, McKeon, Biggert, Wilson, 

Foxx, Roe, Walberg, DesJarlais, Hanna, Bucshon, Gowdy, Barletta, 

Roby, Heck, Ross, Kelly, Miller, Kildee, Andrews, Scott, Woolsey, 

Hinojosa, McCarthy, Tierney, Holt, Davis, Altmire, and Fudge. 

Staff present: Andrew Banducci, Professional Staff Member; 

Katherine Bathgate, Deputy Press Secretary; James Bergeron, Director of Education and Human Services Policy; Casey Buboltz, 

Coalitions and Member Services Coordinator; Molly Conway, Professional Staff Member; Cristin Datch, Professional Staff Member; 

Lindsay Fryer, Professional Staff Member; Ed Gilroy, Director of 

Workforce Policy; Benjamin Hoog, Legislative Assistant; Ryan 

Kearney, Legislative Assistant; Brian Newell, Deputy Communications Director; Krisann Pearce, General Counsel; Molly McLaughlin 

Salmi, Deputy Director of Workforce Policy; Mandy Schaumburg, 

Education and Human Services Oversight Counsel; Dan Shorts, 

Legislative Assistant; Todd Spangler, Senior Health Policy Advisor; 

Linda Stevens, Chief Clerk/Assistant to the General Counsel; 

Alissa Strawcutter, Deputy Clerk; Loren Sweatt, Senior Policy Advisor; Kate Ahlgren, Minority Investigative Counsel; Aaron 

Albright, Minority Communications Director for Labor; Tylease 

Alli, Minority Clerk; Ruth Friedman, Minority Director of Education Policy; Waverly Gordon, Minority Fellow, Labor; Brian 

Levin, Minority New Media Press Assistant; Richard Miller, Minority Senior Labor Policy Advisor; Megan O’Reilly, Minority General 

Counsel; Julie Peller, Minority Deputy Staff Director; Michele 

Varnhagen, Minority Chief Policy Advisor/Labor Policy Director; 

and Daniel Weiss, Minority Special Assistant to the Ranking Member. 

Chairman KLINE. A quorum being present, the committee will 

come to order. 
2 

Good morning, Madam Secretary, thank you for being with us 

today to discuss the policies and priorities of the Department of 

Health and Human Services. 

In his fiscal year 2013 budget, President Obama requests $932 

billion for the Department of Health and Human Services, one of 

the largest allocations for any Federal agency. Nearly $70 billion 

of this request is dedicated to various social services programs, including Head Start and Community Services block grants. 

While they support families nationwide, such programs are also 

vulnerable to waste and abuse of taxpayer resources. For example, 

a 2010 report by the Government Accountability Office revealed 

fraud in the Head Start program, including misleading taxpayers 

about the number of children enrolled to inflate the amount of Federal funds received. 

Despite a lengthy delay, I am pleased the Administration finally 

took steps to implement a 2007 law to strengthen Head Start and 

protect taxpayer dollars by requiring the lowest performing programs to re-compete for funding. I hope the department will continue to improve the accountability of this and other Social Services’ programs within its jurisdiction. 

While these programs and policies will be part of the discussion 

today, health care is undoubtedly at the forefront of the minds of 

many here. It is an issue continually raised by our constituents and 

inextricably linked to the strength of our economy. Congress continues to closely examine the 2010 health care law and its unprecedented regulatory process. What we have learned is deeply troubling. First, we have learned the law will fall far short of the President’s promise to lower health care costs. By any basic standard, 

whether the premiums families and employers pay, or the cost leveraged on taxpayers to finance government programs, health care 

costs are going up. 

The average cost of a family health insurance plan increased 9 

percent just last year. Charles Blahous, a public trustee of Medicare and Social Security, recently stripped away the budget gimmicks to reveal the law will add as much as $527 billion to the 

Federal deficit over the next decade. 

Patti-Ann Kanterman, Chief Financial Officer of her family 

owned business in Pennsylvania, recently told this committee exactly what the law did not do, quote—‘‘It did not reduce the costs 

of insurance. It did not reduce uncertainty of offering insurance.’’ 

It is worthwhile to note the President’s budget requests $111 billion increase for health insurance subsidies, perhaps an implicit 

recognition costs are accelerating faster than even he imagined. 

We have also learned the laws made it more difficult to hire new 

workers. According to the Congressional Budget Office, the law will 

cut 800,000 jobs from the nation’s workforce. This reflects the concerns raised by employers like Gail Johnson, president of a small 

business that offers early childhood education to families in Virginia. Ms. Johnson told the committee the 2010 law will, quote— 

‘‘slow or stall the growth of small and mid-size businesses as they 

struggle to absorb its new costs.’’ 

Finally, we learned the President’s pledge to the American people that they could keep their current health care plan was nothing 

more than empty rhetoric. The Administration has made it vir-
3 

tually impossible for employers to maintain their grandfathered exemption, which means employers must choose between losing the 

ability to manage coverage on behalf of their workers or complying 

with the law’s myriad requirements as costs skyrocket. 

The consequences of this health care law extend beyond an employer’s bottom line. They have consequences for workers as well. 

Brett Parker, with Bowlmor Lanes in New York City, has testified 

his kitchen staff will have to accept part-time hours due to the 

law’s employer mandate. Other workers confront similar changes, 

including lower wages and loss of coverage as employers grapple 

with the law’s regulations and mandates. 

Pennsylvania employer Will Knetch echoed the concerns of many 

when he said the law provides so many unknowns for the business 

community, it is scary. With 13 million searching for work, our nation simply cannot afford policies that create uncertainty and fear. 

Folks like Gail Johnson, Brett Parker, Patt-Ann Kanterman, these 

are America’s job creators and their personal experiences reveal the 

difficult reality now facing countless employers and workers. 

Madam Secretary, we realize your job is to administer Federal 

law to the best of your ability; however, Congress also has a responsibility to protect the best interests of the American people. 

Toward that end, we will continue to conduct aggressive oversight 

of the law and the related regulatory actions taken by the Administration. As such, effective oversight requires the timely cooperation 

of the Administration. 

It was disappointing to receive, just last week, answers to questions this committee asked 10 months ago. Adding insult to injury, 

the responses you provided are out of date and largely irrelevant 

to the current debate. If it takes this long for the Federal bureaucracy to answer basic questions, it is hard to believe it can effectively run our nation’s health care system. I hope you can provide 

an explanation for the delay and commit to doing better in the future. 

With that, I will now recognize my distinguished colleague, 

George Miller, the senior democratic member of the committee, for 

his opening remarks. 

[The statement of Chairman Kline follows:] 

Prepared Statement of Hon. John Kline, Chairman, Committee on 

Education and the Workforce 

In his Fiscal Year 2013 budget, President Obama requests $932 billion for the Department of Health and Human Services, one of the largest allocations for any federal agency. Nearly $70 billion of this request is dedicated to various social services 

programs, including Head Start and Community Services Block Grants. 

While they support families nationwide, such programs are also vulnerable to 

waste and abuse of taxpayer resources. For example, a 2010 report by the Government Accountability Office revealed fraud in the Head Start program, including misleading taxpayers about the number of children enrolled to inflate the amount of 

federal funds received. Despite a lengthy delay, I am pleased the administration finally took steps to implement a 2007 law to strengthen Head Start and protect taxpayer dollars by requiring the lowest performing programs to re-compete for funding. I hope the department will continue to improve the accountability of this and 

other social services programs within its jurisdiction. 

While these programs and policies will be a part of the discussion, health care 

is undoubtedly at the forefront of the minds of many here today. It is an issue continually raised by our constituents and inextricably linked to the strength of our 

economy. Congress continues to closely examine the 2010 health care law and its 

unprecedented regulatory process. What we have learned is deeply troubling. 
4 

First, we have learned the law will fall far short of the president’s promise to 

lower health care costs. By any basic standard—whether the premiums families and 

employers pay or the costs leveraged on taxpayers to finance government programs—health care costs are going up. The average cost of a family health insurance plan increased 9 percent just last year. Charles Blahous, a public trustee of 

Medicare and Social Security, recently stripped away the budget gimmicks to reveal 

the law will add as much as $527 billion to the federal deficit over the next decade. 

Patti-Ann Kanterman, chief financial officer of a family-owned business in Pennsylvania recently told this committee exactly what the law did not do: ‘‘It did not 

reduce the cost of insurance; it did not reduce uncertainty of offering insurance.’’ 

It is worthwhile to note the president’s budget requests a $111 billion increase for 

health insurance subsidies, perhaps an implicit recognition costs are accelerating 

faster than even he imagined. 

We have also learned the law has made it more difficult to hire new workers. According to the Congressional Budget Office, the law will cut 800,000 jobs from the 

nation’s workforce. This reflects the concerns raised by employers like Gail Johnson, 

president of a small business that offers early childhood education to families in Virginia. Ms. Johnson told the committee the 2010 law will ‘‘slow or stall the growth 

of small and midsized businesses as [they] struggle to absorb its new costs.’’ 

Finally, we learned the president’s pledge to the American people that they could 

keep their current health care plan was nothing more than empty rhetoric. The administration has made it virtually impossible for employers to maintain their grandfathered exemption, which means employers must choose between losing the ability 

to manage coverage on behalf of their workers or complying with the law’s myriad 

requirements as costs skyrocket. 

The consequences of this health care law extend beyond an employer’s bottom 

line; they have consequences for workers as well. Brett Parker with Bowlmor Lanes 

in New York City has testified his kitchen staff will have to accept part-time hours 

due to the law’s employer mandate. Other workers confront similar changes including lower wages and loss of coverage as employers grapple with the law’s regulations and mandates. Pennsylvania employer Will Knetch echoed the concerns of 

many when he said the law ‘‘provides so many unknowns for the business community; it is scary.’’ 

With 13 million searching for work, our nation simply cannot afford policies that 

create uncertainty and fear. Folks like Gail Johnson, Brett Parker, Patti-Ann 

Kanterman—these are America’s job creators, and their personal experiences reveal 

the difficult reality now facing countless employers and workers. 

Madam Secretary, we realize your job is to administer federal law to the best of 

your ability. However, Congress also has a responsibility to protect the best interests of the American people. Toward that end, we will continue to conduct aggressive oversight of the law and the related regulatory actions taken by the administration. 

As such, effective oversight requires the timely cooperation of the administration. 

It was disappointing to receive just last week answers to questions this committee 

asked 10 months ago. Adding insult to injury, the responses you provided are out 

of date and largely irrelevant to the current debate. If it takes this long for the federal bureaucracy to answer basic questions, it’s hard to believe it can effectively run 

our nation’s health care system. 

I hope you can provide an explanation for the delay and commit to doing better 

in the future. 

Mr. MILLER. Thank you, Mr. Chairman, and I join you in welcoming Secretary Sebelius back before the committee. 

From educating our youngest children at Head Start, to ensuring 

seniors access to health care through Medicare, the Department of 

Health and Human Services administers programs that make our 

nation stronger and healthier. HHS is also playing an essential 

role in implementing the Affordable Care Act. Proper implementation of this historic reform is vitally important. It has been 2 years 

since the Affordable Care Act was signed into law and 2 more years 

before it will be fully implemented. 

We never said the change would be everything—that it would 

change everything that is wrong with our health care system or fix 

things that people—everything that people would like, or as fast as 
5 

they would like. But we know the Affordable Care Act is already 

moving in the right direction. For decades, we debated about what 

to do about rising health costs faced by families, businesses and 

governments. 

I would remind Members and my colleagues that they have all 

been visited over the last decade of businesses, small and large, 

international and American-based, of which, complained about 

their dramatic rise in health care over that last decade. We think 

the Affordable Care Act will, in the long-term, lower those health 

care costs to businesses, families and to our economy and it will 

put American families back in charge of health care. But, for decades, we kicked the can down the road, costs continued to rise for 

millions of Americans lost access to the affordable coverage. 

The billion dollar insurance industry held American families hostage for too long. They denied coverage due to pre-existing conditions and they rescinded coverage in the middle of treatment. They 

forced families with stricken loved ones into bankruptcy because 

those patients had reached their previously unknown, lifetime coverage limit. 

But that finally changed with reform. And now the early successes of the law cannot be denied. The national trends are positive. I am also encouraged that I have been hearing from providers, 

insurers, patients and health systems in my state and district. 

California is one of the most proactive states in implementing the 

reform. The state has already activated its exchanges, the Accountable Care Organizations are being embraced by physician groups 

and insurers as a way to better coordinate care, leading to 

healthier outcomes and lower overall costs. 

For example, Blue Shield of California announced in October 

they would give out $20 million in grants to 18 California hospital 

heath systems, clinics and physician groups to form accountable 

care organizations, the incentives to reduce unnecessary hospital 

readmissions and save California public employees retirement system $15 million in reduced insurance premiums. Across the country we have seen similar successes. 

The Affordable Care Act is already working to put Medicare on 

stronger financial footing. The law provides new tools to combat 

fraud and abuse in the Medicare and Medicaid systems. They have 

helped the government recover a record amount of money, over $4 

billion since last year, in fraudulent payments. 

Additionally, the growth of Medicare costs have begun to slow. 

The average Medicare advantage premium is lower this year and 

the solvency of the Medicare Hospital Trust Fund has been extended until 2024. This is exactly the opposite of what opponents 

have predicted would happen. While there is more to be done to secure Medicare in the long-term, the Affordable Care Act has begun 

to show results—reforms should be allowed to work. 

Rather than ending Medicare guarantees, as my Republican colleagues have voted to do repeatedly, we must work to strengthen 

the program. Nor should we turn our backs on the reforms that are 

already directing the benefits of millions of Americans right now. 

Seniors are saving billions on medications, working families are no 

longer just one illness away from bankruptcy, because an insurance 

company drops coverage due to an arbitrary limit. 
6 

Children with pre-existing conditions are no longer denied coverage and more than two and one-half million young adults who 

aren’t offered coverage at work are now allowed to stay on their 

parent’s health plan. All of these reforms would disappear if the 

law were repealed. Repeal means working families going bankrupt 

because insurance companies end coverage when they get cancer. 

Repeal means sick children being denied coverage. Repeal means 

young adults in jobs that don’t offer health insurance, losing access 

to their parent’s coverage. The repeal means that all other patient’s 

rights set to go into law over the next 2 years would never happen, 

like completely ending the use of pre-existing conditions to deny 

care or pricing Americans out of coverage; like ensuring all Americans have access to quality and affordable health insurance that is 

not dependent upon whether your employer offers it or not. 

Mr. Chairman, the Affordable Care Act is making a difference. 

America has tried to pass meaningful health reform for nearly a 

century but we couldn’t make it happen until President Obama and 

the previous Congress made it a priority and got it done. Now is 

not the time to reverse course and go back to the days when the 

insurance companies were in charge. Our nation’s businesses can’t 

afford it, families can’t afford it and our government can’t afford it. 

Once again, Secretary Sebelius, thank you very much for making 

yourself available to the committee this morning and I look forward 

to your testimony. 

[The statement of Mr. Miller follows:] 

Prepared Statement of Hon. George Miller, Senior Democratic Member, 

Committee on Education and the Workforce 

Good morning Mr. Chairman. I join you in welcoming Secretary Sebelius back to 

the committee. 

From educating our youngest children in Head Start to ensuring seniors’ access 

to health care through Medicare, the Department of Health and Human Services 

administers programs that make our nation stronger and healthier. 

HHS is also playing a central role in implementing the Affordable Care Act. Proper implementation of this historic reform is vitally important. It has been two years 

since the Affordable Care Act was signed into law. And there are two more years 

to go before it is fully implemented. 

We never said we could change everything that’s wrong with our health care system, or fix things as fast as people would like. But we know the Affordable Care 

Act is already moving us in the right direction. 

For decades, we debated what to do about rising health costs faced by families, 

businesses and government. We debated how best to put American families, instead 

of insurance companies, back in charge of their health care. 

But, for decades, we kicked the can down the road. Costs continued to rise and 

millions of Americans lost access to affordable coverage. 

The billion-dollar insurance industry held American families hostage for too long. 

They denied coverage due to pre-existing condition. They rescinded coverage in the 

middle of treatment. They forced families with stricken loved ones into bankruptcy 

because those patients had reached a previously unknown lifetime coverage limit. 

But that finally changed with reform. And the early success of this law cannot 

be denied. 

The national trends are positive. 

I am also encouraged with what I am hearing from providers, insurers, patients 

and health systems in my state and district. 

California is one of the most pro-active states in the country implementing reform. 

The state has already activated its exchange. 

Accountable Care Organizations are being embraced by physician groups and insurers as a way to better coordinate care, leading to healthier outcomes at lower 

overall costs. 
7 

For example, Blue Shield of California announced in October that it will give out $20 million in grants to 18 California hospitals, health systems, clinics and physicians groups to form an Accountable Care Organization. 

And incentives to reduce unnecessary hospital readmissions saved the California Public Employees Retirement System $15 million in reduced insurance premiums. 

Across the country we have seen similar successes. 

The Affordable Care Act is already working to put Medicare on stronger financial 

footing. 

The law provides new tools to combat fraud and abuse in the Medicare and Medicaid systems. These have helped the government recover a record $4 billion last year in fraudulent payments. 

Additionally, the growth of Medicare costs has begun to slow. The average Medicare Advantage premium is lower this year. And the solvency of the Medicare hospital trust fund has been extended until 2024. 

This is exactly the opposite of what opponents predicted would happen. 

While there is more to be done to secure Medicare for the long-term, the Affordable Care Act has begun to show results. These reforms should be allowed to work. 

Rather than ending the Medicare guarantee as my Republican colleagues have 

voted to do repeatedly, we must work to strengthen the program. 

Nor should we turn our backs on the reforms that are also directly benefiting millions of Americans right now. 

Seniors are saving billions on their medications. 

Working families are no longer just one illness away from bankruptcy because of 

an insurance company that drops coverage due to an arbitrary limit. 

Children with pre-existing conditions are no longer denied coverage. 

And more than 2.5 million young adults who aren’t offered coverage at work are 

now allowed to stay on their parents’ health plan. 

All of these reforms would disappear if the law were to be repealed. 

Repeal means working families going bankrupt because of cancer and an insurance company that ends coverage. 

Repeal means sick children being denied coverage. 

Repeal means young adults, in jobs that don’t offer health insurance, losing access 

to their parents’ coverage. 

And repeal means that all the other patient rights set to go into law over the next 

two years would never happen. 

Like completely ending the use of preexisting conditions to deny care or pricing 

Americans out of coverage. Like ensuring all Americans have access to quality and 

affordable health insurance that is not dependent on whether your employer offers 

it or not. 

Mr. Chairman, the Affordable Care Act is already making a difference. 

America tried to pass meaningful health care reform for nearly a century but we 

couldn’t make it happen until President Obama and the previous Congress made it 

a priority and got it done. 

Now is not the time to reverse course and go back to the days where insurance 

companies were in charge. 

Our nation’s businesses can’t afford it. Families can’t afford it. And our government can’t afford it. 

Once again, thank you, Secretary Sebelius, for making yourself available to the 

committee. 

I look forward to your testimony. 

Chairman KLINE. I thank the gentleman. 

Pursuant to Committee Rule 7(c), all committee members will be 

permitted to submit written statements to be included in the permanent hearing record and, without objection, the hearing record 

will remain open for 14 days to allow statements, questions for the 

record and other extraneous material referenced during the hearing, to be submitted in the official hearing record. 

According to my script, it is now my time to introduce our witness. I think this is, indeed, one of those cases where our witness 

needs no introduction; everyone knows the Honorable Kathleen 

Sebelius, the Secretary of Health and Human Services. She has 

been before this committee before. We welcome her back again. 
8 

I am also supposed to remind everybody of the lighting system, 

which is there in front of you, Madam Secretary. It is the old 

green, yellow and red light system. Please give your testimony, in 

its entirety, of course. Everything will be submitted to the record— 

your entire written testimony. 

For my colleagues up here, however, once again, I will be making 

every effort to hold us to the 5-minute rule so that all members 

have a chance to engage in the discussion. 

And, with that, Madam Secretary, you are recognized. 

STATEMENT OF HON. KATHLEEN G. SEBELIUS, SECRETARY, 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Secretary SEBELIUS. Well, good morning, Chairman Kline and 

Ranking Member Miller and members of the committee. And I 

want to start by thanking you for the invitation to discuss the 

President’s 2013 Budget for the Department of Health and Human 

Services. 

Our budget helps to create an American economy built to last by 

strengthening our nation’s health care, supporting research that 

will lead to tomorrow’s cures, and promoting opportunity for America’s children and families, so everyone has a fair shot to reach 

their full potential. It makes the investments we need right now, 

while reducing the deficit in the long-term, to make sure that programs that millions of Americans rely on will be there for generations to come. 

I look forward to answering your questions about the budget but, 

first, I want to share a few highlights. Over the last 2 years, as 

Congressman Miller said, we have been working to deliver the benefits of the Affordable Care Act to the American people. Thanks to 

the law, more than 2.5 million additional young Americans are already getting coverage through their parent’s health plans. 

An estimated 32.5 million beneficiaries with Medicare have 

taken advantage of the recommended preventive services without 

co-pays or co-insurance. Small business owners are taking advantage of tax breaks on their health care premiums that allow them 

to expand the care and hire more employees. This year we will 

build on that progress, continuing to support states as they work 

to establish affordable insurance exchanges by 2014. 

Once these competitive marketplaces are in place, they will ensure that all Americans have access to quality, affordable health 

coverage. But we know that the lack of insurance is not the only 

obstacle to care, so our budget also invests in our health care workforce. The budget supports training more than 7,100 primary care 

providers and placing them where they are needed most. 

It also invests in America’s network of community health centers. 

The budget will help health centers provide access to quality care 

for 21 million people, 300,000 patients more than what could be 

served last year. The budget ensures that 21st Century America 

will continue to lead the world in biomedical research by maintaining funding for the National Institutes of Health. 

This budget also continues our Administration’s commitment to 

high-quality early education programs that put all of our children 

on a path to school success and opportunity. Increased funding for 

the 962,000 children in Head Start and the 1.5 million children in 
9 

federally funded childcare assistance program is not only an investment in higher test scores and graduation rates, we know it leads 

to more productive adults, stronger families and more secure communities. 

And our investments also support critical reforms in both Head 

Start and childcare programs to raise the bar on quality. For example, this year, for the first time, we will require Head Start programs that don’t meet important quality benchmarks to compete 

for funding. In order to make these vital investments, the budget 

recognizes the need to set priorities, make difficult trade-offs and 

ensure we use every dollar wisely; that starts with continuing support for President Obama’s historic push to stamp out waste, fraud 

and abuse in the health care system. 

Over the last 3 years, every dollar we have put into health care 

fraud and abuse control has returned more than $7.00. Last year 

alone, those efforts recovered more than $4 billion. Our budget 

builds on those efforts by giving law enforcement the technology 

and data to spot perpetrators early and prevent payments based on 

fraud from going out in the first place. The budget makes smart 

investments where they will have the greatest impact, helping to 

build a stronger, healthier and more prosperous America for the future. 

I want to, again, thank you, Mr. Chairman, for inviting me here 

this morning and I look forward to our conversation. 

[The statement of Secretary Sebelius follows:] 

Prepared Statement of Hon. Kathleen G. Sebelius, Secretary, 

U.S. Department of Health and Human Services 

Chairman Kline, Ranking Member Miller, and Members of the Committee, thank 

you for the invitation to discuss the President’s FY 2013 Budget for the Department 

of Health and Human Services (HHS). 

The Budget for the Department of Health and Human Services (HHS) invests in 

health care, disease prevention, social services, and scientific research. HHS makes 

investments where they will have the greatest impact, build on the efforts of our 

partners, and lead to meaningful gains in health and opportunity for the American 

people. 

The President’s fiscal year (FY) 2013 Budget for HHS includes a reduction in discretionary funding for ongoing activities, and legislative proposals that would save 

an estimated $350.2 billion over ten years. The Budget totals $940.9 billion in outlays and proposes $76.7 billion in discretionary budget authority. This funding will 

enable HHS to: Strengthen Health Care; Support American Families; Advance Scientific Knowledge and Innovation; Strengthen the Nation’s Health and Human 

Service Infrastructure and Workforce; Increase Efficiency, Transparency, and Accountability of HHS Programs; and Complete the Implementation of the Recovery 

Act. 

Strengthen health care 

Delivering benefits of the Affordable Care Act to the American People: The Affordable Care Act expands access to affordable health coverage to millions of Americans, 

increases consumer protections to ensure individuals have coverage when they need 

it most, and slows increases in health costs. Effective implementation of the Affordable Care Act is central to the improved fiscal outlook and well-being of the Nation. 

The Centers for Medicare & Medicaid Services (CMS) is requesting an additional 

$1 billion in discretionary funding to continue implementing the Affordable Care 

Act, including Affordable Insurance Exchanges, and to help keep up with the growth 

in the Medicare population. 

Expand and Improve Health Insurance Coverage: Beginning in 2014, Affordable 

Insurance Exchanges will provide improved access to insurance coverage for millions 

of Americans. Exchanges will make purchasing private health insurance easier by 

providing eligible individuals and small businesses with one-stop-shopping where 

they can compare benefit plans. New premium tax credits and reductions in cost- 
10 

sharing will help ensure that eligible individuals can afford to pay for the cost of 

private coverage through Exchanges. FY 2013 will be a critical year for building the 

infrastructure and initiating the many business operations critical to enabling Exchanges to begin operation on January 1, 2014. The expansion of health insurance 

coverage for millions of low-income individuals who were previously not eligible for 

coverage also begins in 2014. CMS has worked closely with states to ensure they 

are prepared to meet the 2014 deadline and will continue this outreach in FY 2013. 

Many important private market reforms have already gone into effect, providing 

new rights and benefits to consumers to put them in charge of their own health 

care. The Affordable Care Act’s Patient’s Bill of Rights allows young adults to stay 

on their parents’ plans until age 26 and ensures that consumers receive the care 

they need when they get sick and need it most by prohibiting rescissions and lifetime dollar limits on coverage for care. The new market reforms also provide for 

independent reviews of coverage disputes. Temporary programs like the Early Retiree Reinsurance Plan (ERRP) and the Pre-Existing Condition Insurance Plan 

(PCIP) are supporting affordable coverage for individuals who often face difficulties 

obtaining private insurance in the current marketplace. Additionally, rate review 

and medical loss ratio (MLR) provisions help ensure that health care premiums are 

kept reasonable and affordable year after year. The already operational rate review 

provision gives states additional resources to determine if a proposed health care 

premium increase is unreasonable and, in many cases, help enable state authorities 

to deny an unreasonable rate increase. HHS reviews large proposed increases in 

states that do not have effective rate review programs. The MLR provisions guarantee that, starting in 2011, insurance companies use at least 80 percent or 85 percent of premium revenue, depending on the market, to provide or improve health 

care for their customers or give them a rebate. 

Strengthen the Delivery System: The Affordable Care Act established a Center for 

Medicare and Medicaid Innovation (Innovation Center). The Innovation Center is 

tasked with developing, testing, and—for those that prove successful—expanding innovative payment and delivery system models to improve quality of care and reduce 

costs in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). 

The Innovation Center began operations in November 2010 and has undertaken an 

ambitious agenda encompassing patient safety, coordination of care among multiple 

providers, and enhanced primary care. These projects can serve as crucial stepping 

stones towards a higher-quality, more efficient health care system. 

HHS is also working to ensure that the most vulnerable in our Nation have full 

access to seamless, high-quality health care. The Affordable Care Act established a 

new office to more effectively integrate benefits and improve coordination between 

states and the Federal Government for those who are eligible for both Medicare and 

Medicaid. While Medicare-Medicaid beneficiaries make up a relatively small portion 

of enrollment in the two programs, they represent a significant portion of expenditures. HHS is currently supporting 15 states as they design models of care that better integrate Medicare and Medicaid services and is designing additional demonstrations to continue to improve care. 

CMS is currently offering three initiatives that will help spur the development of 

Accountable Care Organizations (ACOs) for Medicare beneficiaries. ACOs are groups 

of health providers who join together to give high-quality, coordinated care to the 

patients they serve. If an ACO meets quality standards, it will be eligible to share 

in savings it achieves for the Medicare program, and may be subject to losses, offering a powerful incentive to restructure care to better serve patients. 

Ensuring Access to Quality Care for Vulnerable Populations: Health Centers are 

a key component of the Nation’s health care safety net. The President’s Budget includes a total of $3 billion, including an increase of $300 million from mandatory 

funds under the Affordable Care Act, to the Health Centers program. This investment will provide Americans in underserved areas, both rural and urban, with access to comprehensive primary and preventive health care services. This funding 

will create 25 new health center sites in areas of the country where they do not currently exist and provide access to quality care for 21 million people, an increase of 

300,000 additional patients over FY 2012. The Budget also promotes a policy of 

steady and sustainable health center growth by distributing Affordable Care Act resources over the longterm. This policy safeguards resources for new and existing 

health centers to continue services and ensures a smooth transition as health centers increase their capacity to provide care as access to insurance coverage expands. 

Improving Healthcare Quality and Patient Safety: The Affordable Care Act directed HHS to develop a national strategy to improve health care services delivery, 

patient health outcomes, and population health. In FY 2011, HHS released the National Strategy for Quality Improvement in Health Care, which highlights three 

broad aims: Better Care, Healthy People and Communities, and Affordable Care. 
11 

Since publishing the Strategy, HHS has focused on gathering additional input from 

private partners and aligning new and existing HHS activities with the Strategy. 

HHS will enhance the Strategy by incorporating input from stakeholders and developing metrics to measure progress toward achieving the Strategy’s aims and priorities. Already, the Strategy is serving as a blueprint for quality improvement activities across the country. 

CMS will continue funding for the Partnership for Patients, an initiative launched 

in April 2011 that sets aggressive targets for improving the quality of healthcare: 

reducing preventable hospital-acquired conditions by 40 percent and preventable readmissions by 20 percent by the end of 2013, as compared to 2010. 

Support American families 

Healthy Development of Children and Families: HHS oversees many programs 

that support children and families, including Head Start, Child Care, Child Support, 

and Temporary Assistance for Needy Families (TANF). The FY 2013 Budget request 

invests in early education, recognizing the role high-quality early education programs can play in preparing children for school success. The request also supports 

TANF and proposes to restore funding for the Supplemental Grants without increasing overall TANF funding. 

Investing in Education by Supporting an Early Learning Reform Agenda: The FY 

2013 Budget supports critical reforms in Head Start and a Child Care quality initiative that, when taken together with the Race to the Top Early Learning Challenge, 

are key elements of the Administration’s broader education reform agenda designed 

to improve our Nation’s competitiveness by helping every child enter school ready 

for success. 

On November 8, 2011 the President announced important new steps to improve 

the quality of services and accountability at Head Start centers across the country. 

The Budget requests over $8 billion for Head Start programs, an increase of $85 

million over FY 2012, to maintain services for the 962,000 children currently participating in the program. This investment will also provide resources to effectively implement new regulations that require grantees that do not meet high quality benchmarks to compete for continued funding, introducing an unprecedented level of accountability into the Head Start program. By directing taxpayer dollars to programs 

that offer high-quality Head Start services, this robust, open competition for Head 

Start funding will help to ensure that Head Start programs provide the best available early education services to our most vulnerable children. 

The Budget provides $6 billion for child care, an increase of $825 million over FY 

2012. This funding level will provide child care assistance to 70,000 more children 

than could otherwise receive services without this increased investment; 1.5 million 

children in total. In addition to providing funding for direct assistance to more children, the Budget includes $300 million for a new child care quality initiative that 

states would use to invest directly in programs and teachers so that individual child 

care programs can do a better job of meeting the early learning and care needs of 

children and families. The funds would also support efforts to measure the quality 

of individual child care programs through a rating system or another system of 

quality indicators, and to clearly communicate program-specific information to parents so they can make informed choices for their families. These investments are 

consistent with the broader reauthorization principles outlined in the Budget, which 

encompass a reform agenda that would help transform the Nation’s child care system to one that is focused on continuous quality improvement and provides more 

low-income children access to high-quality early education settings that support 

children’s learning, development, and success in school. 

Improve the Foster Care System: The Budget includes an additional $2.8 billion 

over ten years to support improvements in child welfare. Additional resources will 

support incentives to states to improve outcomes for children in foster care and 

those who are receiving in-home services from the child welfare system, and also 

to require that child support payments made on behalf of children in foster care be 

used in the best interest of those children. The Budget also creates a new teen pregnancy prevention program specifically targeted to youth in foster care. 

Strengthen TANF and Create Jobs: The Budget would provide continued funding 

for the TANF program and would fund the Supplemental Grants for Population Increases. When Congress takes up reauthorization, we want to work with lawmakers 

to strengthen the program’s effectiveness in accomplishing its goals. This should include using performance indicators to drive program improvement and ensuring 

that states have the flexibility to engage recipients—including families with serious 

barriers to employment—in the most effective activities to promote success in the 

workforce. We also want to work with Congress to revise the Contingency Fund to 

make it more effective during economic downturns. 
12 

Keeping America Healthy: The President’s Budget includes resources necessary to 

enhance clinical and community prevention, support research, develop the public 

health workforce, control infectious diseases, and invest in prevention and management of chronic diseases and conditions. 

Preventing Teen Pregnancy: The Budget includes $105 million in the Prevention 

and Public Health Fund for the Office of the Assistant Secretary for Health for teen 

pregnancy prevention programs. These programs will support community-based efforts to reduce teen pregnancy using evidence-based models as well as promising 

programs and innovative strategies. The Budget also includes $15 million in funding 

for CDC teen pregnancy prevention activities to reduce the number of unintended 

pregnancies through science-based prevention approaches. 

Protect Vulnerable Populations: HHS is committed to ensuring that vulnerable 

populations continue to receive critical services during this period of economic uncertainty. 

Strengthen the nation’s health and human service infrastructure and work force 

Investing in Infrastructure: A strong health workforce is key to ensuring that 

more Americans can get the quality care they need to stay healthy. The Budget includes $677 million, an increase of $49 million over FY 2012, within HRSA to expand the capacity and improve the training and distribution of primary care, dental, 

and pediatric health providers. The Budget will support the placement of more than 

7,100 primary care providers in underserved areas and begin investments that expand the capacity of institutions to train 2,800 additional primary care providers 

over 5 years. 

Increase efficiency, transparency, and accountabiliy of HHS programs 

Living Within our Means: HHS is committed to improving the Nation’s health and 

well-being while simultaneously contributing to deficit reduction. The FY 2013 discretionary request demonstrates this commitment by maintaining ongoing investments in areas most central to advancing the HHS mission while making reductions 

to lower priority areas, reducing duplication, and increasing administrative efficiencies. Overall, the FY 2013 request includes over $2.1 billion in terminations and 

reductions to fund initiatives while achieving savings in a constrained fiscal environment. Many of these reductions, such as the $177 million cut to the Children’s 

Hospital Graduate Medical Education Payment Program, the $452 million cut to the 

Low Income Home Energy Assistance Program (LIHEAP), and the $327 million cut 

to the Community Services Block Grant (CSBG) were very difficult to make, but are 

necessitated by the current fiscal environment. 

The Administration remains supportive of CSBG’s important goals and the services it provides to low-income Americans. We have had to make tough choices to 

meet current fiscal targets. The 2013 Budget provides $350 million for CSBG, and 

proposes to strengthen the program to make sure that we are getting the most out 

of every dollar we spend. The Budget proposes that entities receiving funding from 

CSBG meet certain performance standards, and compete for funding if they fall 

below those standards. 

Regarding LIHEAP, the Administration proposes to adjust funding for expected 

winter fuel costs and to target funds to those most in need. The request is $3 billion, 

$452 million below the FY 2012 level and $450 million above both FY 2008 and the 

2012 request. With constrained resources, the Budget targets assistance where it is 

needed most. The request targets $2.8 billion in base grants using the state allocation Congress enacted for FY 2012. The request also includes $200 million in contingency funds, which will be used to address the needs of households reliant on home 

delivered fuels (heating oil and propane) should expected price trends be realized, 

as well as other energy-related emergencies. 

In September 2011, the Administration detailed a plan for economic growth and 

deficit reduction. The FY 2013 Budget follows this blueprint in its legislative proposals, presenting a package of health savings proposals that would save more than 

$360 billion over 10 years, with almost all of these savings coming from Medicare 

and Medicaid. Medicare proposals would encourage high-quality, efficient care, increase the availability of generic drugs and biologics, and implement structural reforms to encourage beneficiaries to seek value in their health care choices. The 

Budget also seeks to make Medicaid more flexible, efficient, and accountable while 

strengthening Medicaid program integrity. Together, the FY 2013 discretionary 

budget request and these legislative proposals allow HHS to support the Administration’s challenging yet complementary goals of investing in the future and establishing a sustainable fiscal outlook. 

Program Integrity and Oversight: The FY 2013 Budget continues to make program integrity a top priority. The Budget includes $610 million in discretionary 
13 

funding for Health Care Fraud and Abuse Control (HCFAC), the full amount authorized under the Budget Control Act of 2011 (BCA). The Budget also proposes to 

fully fund discretionary program integrity initiatives at $581 million in FY 2012, 

consistent with the BCA. The discretionary investment supports the continued reduction of the Medicare fee-for-service improper payment rate; investments in prevention-focused, data-driven initiatives like predictive modeling; and HHS-Department of Justice Health Care Fraud Prevention and Enforcement Action Team 

(HEAT) initiatives, including Medicare Strike Force teams and fighting pharmaceutical fraud. 

From 1997 to 2011, HCFAC programs have returned over $20.6 billion to the Medicare Trust Funds. Approximately $4.1 billion was recovered last year in FY 

2011, including $2.5 billion returned to the Trust Funds, and the current three-year 

return-on-investment of 7.2 to 1 is the highest in the history of the HCFAC program. The Budget proposes a 10-year discretionary investment yielding a conservative estimate of $11.3 billion in Medicare and Medicaid savings and 16 program 

integrity proposals to build on the Affordable Care Act’s comprehensive fraud fighting authorities for savings of an additional $3.6 billion over 10 years. 

Additionally, the Budget includes funding increases for significant oversight ac- tivities. The request includes $84 million for the Office of Medicare Hearings and 

Appeals, an increase of $12 million, to continue to process the increasing number 

of administrative law judge appeals within the statutory 90-day timeframe while 

maintaining the quality and accuracy of its decisions. The Budget also includes $370 

million in discretionary and mandatory funding for the Office of Inspector General 

(OIG), a 4 percent increase from FY 2012. This increase will enable OIG to expand 

CMS Program Integrity efforts in areas such as HEAT, improper payments, and 

focus on investigative efforts on civil fraud, oversight of grants, and the operation 

of new Affordable Care Act programs. 

Additionally, Durable Medical Equipment (DME) Competitive Bidding is providing competitive pricing, while continuing to ensure access to quality medical 

equipment from accredited suppliers, which will save Medicare $25.7 billion over 10 

years and help millions of Medicare beneficiaries save $17.1 billion in out-of-pocket 

costs over 10 years. The Budget proposes to extend some of the efficiencies of DME 

Competitive Bidding to Medicaid by limiting Federal reimbursement on certain 

DME services to what Medicare would have paid in the same state for the same 

services. This proposal is expected to save Medicaid $3.0 billion over 10 years. 

Completing implementation of the Recovery Act 

The American Recovery and Reinvestment Act provided $140 billion to HHS programs, of which $110 billion had been spent by grant and contract recipients by the 

end of FY 2011. The vast majority of these funds helped state and local communities 

cope with the effects of the economic recession. 

Thousands of jobs were also created or saved, including subsidized employment 

and training for over 260,000 people through the Temporary Assistance for Needy 

Families (TANF) program Emergency Contingency Fund. 

The Recovery Act provided states fiscal relief through a temporary increase in 

Federal matching payments of $84 billion for Medicaid and foster care and adoption 

assistance. 

HHS Recovery Act funds are also making long-term investments in the health of 

the American people and the health care system itself. Beginning in FY 2011 and 

continuing for the next few years, HHS will be investing more than $20 billion to 

support implementation of health information technology in the health care industry 

on a mass scale. This effort is expected to significantly improve the quality and efficiency of the U.S. health care system. In addition, $10 billion in Recovery Act funds 

were invested in biomedical research programs around the country, including a 

major effort to document genomic changes in 20 of the most common cancers and 

to build research laboratory capacity. Of more immediate impact, $1 billion has been 

supporting prevention and wellness programs, including projects in 44 communities 

with a total combined population of over 50 million aimed at reducing tobacco use 

and the chronic diseases associated with obesity. 

HHS has also met the challenges of transparency and accountability in the management of its Recovery Act funds. More than 23,000 grantees and contractors with 

Recovery Act funding from HHS discretionary programs have submitted reports on 

the status of their projects over the last 10 quarters. More than 99 percent of the 

required recipient reports have been submitted on time and are available to the 

public on Recovery.gov; non-filers have been sanctioned. Finally, HHS Recovery Act 

program managers are working hand-in-hand with the Secretary’s Council on Program Integrity to ensure that risks for fraud, abuse, and waste are identified and 

steps are taken to mitigate those risks. 
14 

Thank you for the opportunity to testify. I will be happy to answer any questions 

you may have. 

Chairman KLINE. Thank you, Madam Secretary. The health reform law, which we have just been discussing here, cuts $200 billion out of the Medicare Advantage program. As a result of these 

cuts, the Congressional Budget Office has estimated that 5 million 

fewer seniors will be enrolled in Medicare Advantage plans during 

the next decade. And that was a matter of some concern during the 

debate leading up to the passage of this bill. 

And, now, just this week, we have seen an alarming report from 

the Government Accountability Office, suggesting the Administration viewed these cuts to the health care of millions of seniors as 

a vulnerability and created a so-called ‘‘demonstration project,’’ to 

temporarily avert the damage. The GAO criticized the $8 billion 

program that will delay the impact of these cuts until next year. 

The GAO also reports that such a national program in size and 

cost is unprecedented and its design, quote—‘‘precludes a credible 

evaluation of its effectiveness.’’ 

The Wall Street Journal picked up on this and ventured that the 

purpose of the project is to, quote—‘‘give a program that is popular 

with seniors a temporary reprieve past election day.’’ It is in the 

interest of every single member of Congress to make sure that taxpayer dollars aren’t being spent to protect certain political interests. 

Madam Secretary, the GAO called on you to cancel this demonstration project. Is that your intent or are you going to continue 

forward with this project? 

Secretary SEBELIUS. Mr. Chairman, we have no intention of cancelling the project. And I think the good news is that Medicare Advantage programs are stronger than ever and, actually, cheaper 

than ever. We have more seniors enrolling in Medicare Advantage 

this year than ever before. We have more programs in the marketplace than ever before. Medicare Advantage programs, when the 

Affordable Care Act was passed, were paid at about 114 percent of 

fee-for-service Medicare. 

So the Affordable Care Act, over time, reduces that overpayment. 

We are now down to 107 percent, so rates, indeed, have come down 

in Medicare Advantage program. That not only benefits the seniors 

who choose those options, because they pay lower co-pays, but they 

have more options. And, for the first time ever since Medicare Advantage programs were created, we have instituted a demonstration to inform seniors about quality. 

Some of these plans are very high quality, others are not. And 

we have a 2-year demonstration plan running and I think the good 

news is we are seeing seniors migrate away from the lower quality 

plan to the higher quality plan. We are on track to totally eliminate the overpayment to Medicare Advantage Plan, as promised 

with the Affordable Care Act. Again, a benefit to seniors while 

keeping the choice that seniors have throughout this country. 

Chairman KLINE. The GAO pointed out that the demonstration 

project, rather than emphasizing those highly successful programs 

and rewarding them, basically was making the money available to 
15 

everybody, which would help provide those costs and encourage 

people to stay in. What is your response to that? 

Secretary SEBELIUS. Well, it is just not accurate. The plans are 

rated one through five stars. The three, four and five-star programs 

have gotten some additional incentives to offer quality outcomes. I 

think the bad news for America’s seniors is that for years not only 

did Medicare Advantage programs charge 14 percent more than 

fee-for-service, which added costs to every Medicare beneficiary, 

but there was no quality difference in health care outcomes. 

What we are determined to do is not only lower the costs but, 

actually, to make it very clear to the plans operating in the private 

marketplace that quality is important and that seniors should 

know which plans actually offer better outcomes than others. 

Chairman KLINE. Clearly, sharp differences between the Government Accountability Office and the Department, which we will continue to explore. I am about to run out of time and I just want to 

move quickly to another subject. The 2010 Head Start Impact 

Study found the advantages children gain from Head Start yielded 

only a few, significant, outcomes that lasted through the end of the 

first grade. 

Now, the third grade follow-up study was set to be completed last 

September. It has been delayed until later this year. Considering 

the data for this third grade study was completed in the spring of 

2008, what is the cause for the delay and what are your expectations? 

Secretary SEBELIUS. Well, Mr. Chairman, I know that the study 

is underway and that we anticipate completion on the timetable 

that you have just suggested. We think it is important to continue 

to monitor what is happening with outcomes. What we know is 

Head Start does make a difference and it does make a difference 

not only in the families, but in the children able to start school 

ready to learn. 

And we were really pleased to have an opportunity to work on 

additional curriculum issues with the Department of Education. I 

think, also, Mr. Chairman, for the first time ever in the history of 

the program, we felt it was important to recognize that Head Start 

programs operate in a variety of ways and some are lower performing and that is not good for our kids. 

So, for the first time ever, we have instituted a program where 

Head Start programs in the bottom quarter of the programs in the 

country are re-competing for funding, recognizing that we want all 

of our children in the highest quality programs possible. 

Chairman KLINE. Thank you, my time has expired. 

Mr. Miller? 

Mr. MILLER. Thank you very much. 

Madam Secretary, just to follow up on the Head Start question— 

one, thank you for pushing forward on the re-competing. I know it 

has been controversial and, in my case, it turns out it cuts very 

close to home. It is still the right thing to do. I think we will end 

up with better quality care. I think we will end up with more diligence by the Head Start providers knowing that this process is in 

place. 

And I think both the development of the children and the safety 

of the children will be dramatically improved because of that. I ap-
16 

preciate that some providers don’t like—they think they have the 

premier program. They don’t like the idea that they, somehow, are 

missing the mark and have to re-compete but I think that is important. 

I would also say that for years, you know, we have gone back and 

forth about what the improvement is in children’s ability to learn 

and the development of children in Head Start, but we also know 

that, very often, we take those children and we put them into an 

elementary system in first grade and we measure them at the end 

of first grade and we measure them at the end of fourth grade. 

And much of what we thought was the advantage is lost. And 

there is a pretty significant body of evidence suggesting that it was 

lost in first, second and third grade. They came there reasonably 

well prepared to learn but not much happened when they got to 

the public school system. And there is some concerns about that so 

I would just put that into the mix. 

I want to go back. I mentioned the development of the Accountable Care organizations. First, what I am quite surprised at, the 

extent to which in our area of California, Northern California, that 

these programs have been embraced by the insurers, by the big 

medical centers, the hospitals, both private and public, and large 

medical groups of doctors, specialists and across groups with a 

broad practice in this effort. 

The one that was run by CalPERS that we have pointed out— 

it reduced the number of patients hospitalized for 20 days or more 

by 50 percent and it reduced hospital admissions by 17 percent. It 

reduced the total number of inpatients’ days by 14 percent and produced a savings of, as we said, over $15 million. I think some $60 

million was returned to ratepayers in that instance. 

And, now, Blue Cross, Blue Shield and others are trying to set 

these up in other parts of the state. And both hospitals and physicians are coming to those, understanding that this provides for an 

improved coordination of care, better care, and drop in readmissions. 

Also, in the area, you have put forth this program to deal with 

the medical errors and falls and accidents, again, sponsored by a— 

participated in by a small group of hospitals. Now, almost all of the 

hospitals in the area have joined because of the dramatic savings. 

Just in respiratory complications, in terms of keeping the bed 

properly elevated, dramatically dropping. Pneumonias and complications and deaths from pneumonias, the trips and falls—dramatically reducing the number of falls, which end up in broken 

hips and bones and, in some case, death. 

So we see this joining and this rush into this process in terms 

of trying to develop better practices for patient care and cost in 

terms of taxpayers or families who are paying these premiums. So 

I, really, welcome what is taking place here. 

I put an amendment in the bill before Medicare had to pay certain providers within 30 days. I think that probably came to us by 

all the people that sell things to Medicare; they insisted they be 

paid in 30 days. And what we saw in some regions of the country, 

you had people who were billing Medicare off of fraudulently obtained lists and we were paying them within 30 days. And we 

didn’t even know who the hell they were. 
17 

I put in that you had to time to do due diligence—who is this 

person and are they really selling wheelchairs to people who need 

them or walkers to people who need them or what have you—and, 

of course, it turns out—and you have recovered, not just because 

of my amendment, but you have forestalled the payment of people 

and recovered almost $4 billion, which, I think, is a record in the 

Medicare program. 

I think we got a long ways to go but I am certainly encouraged 

by the trend line that we have seen over the last couple of years. 

And I have used up almost all your time but I think he is going 

to let you have a little bit more. 

[Laughter.] 

He is nicer to the witnesses than he is to us so—— 

Chairman KLINE. Did you have a question? 

Mr. MILLER. Yes, I would like a response—— 

Secretary SEBELIUS. Well—— 

Mr. MILLER [continuing]. On the fact that people are joining 

these accountable care and trying to initiate Accountable Care Organizations all across the country. But, certainly, dynamically, in 

California. 

Secretary SEBELIUS. Well, I think you raised two aspects of the 

bill which aren’t focused on as much, I think, as some of the insurance issues. One is the whole delivery system changes and the encouragement to use the best practices and, actually, try and take 

them to scale around the country. 

So the Partnership for Patients, which is, kind of, the umbrella 

title for two efforts that are underway right now: reducing the 

number of preventable readmissions by about 20 percent and reducing the number of hospital-required infections and errors by 40 

percent. Those two efforts over the next 5 years not only save lives 

but reduce health costs dramatically. 

We already have over 3,500 hospitals who are participating in 

those two efforts around the country, as well as doctor’s groups and 

employer groups and others, who are really excited about this 

focus. And this affects everybody, regardless of what kind of insurance you have. If you are in the hospital, 100,000 people a year die 

from what happens to them in the hospital; not what brought them 

to the hospital but what occurs while they are there. 

So lowering hospital-acquired infections and preventing by wraparound care, bundled care, coordinated care—people from having to 

cycle back into the hospital is good news, lower rates, lower costs 

and more patient care. 

And, Mr. Chairman, you also—I mean, Congressman Miller, you 

also mentioned the issue around the improper payments and our 

tools, now, to really look at what is happening in the fraud scene. 

We have a whole new predictive modeling technology built—the 

kind of technology that has been in the private sector for a very 

long time but missing from the public sector, which allows us not 

only to calibrate risk, but really watch what is happening. 

We have re-credentialed providers in the most likely areas for 

fraud; durable medical equipment, home health services. We are 

really watching billings very carefully and that has allowed us to 

be much more timely not only in stopping payments from going out 
18 

the door so we don’t do the old pay and chase, but actually discontinuing fraudulent providers from ever billing Medicare again. 

So it is a system that should have been in place a long time ago; 

it is now built and up and running. And I think it is going to yield 

huge results in the long term. 

Chairman KLINE. Thank you, Madam Secretary. 

The gentleman’s time has expired. 

Mrs. Biggert? 

Mrs. BIGGERT. Thank you, Mr. Chairman. 

Madam Secretary, many, many years ago I volunteered in Chicago on the Head Start program. It was the first year that it was 

in existence so it was a—and so I have always had a soft spot for 

Head Start. And I think that it has been a really good program. 

And I know that there has been problems with it and, recently, 

the Inspector General’s Office audited several of the Head Start facilities, resulting in a report that there are numerous violations of 

the Health and Safety requirement. In one case there were toxic 

chemicals that were found within reach of children. Another there 

was a machete; I don’t know what a machete was doing there but 

it was found on the stairway near the children’s play area. 

Why are there these problems not complying with the health and 

safety within the Head Start Program? 

Secretary SEBELIUS. Well, Congresswoman, I can assure you that 

we take the health and safety of the children in Head Start Programs or our childcare programs, or any place across the country, 

very seriously. There are thousands of Head Start Programs operating. As I say, some are enormously high-quality; others are not 

serving our children as well as they could, which is one of the reasons for the re-compete this year, for unannounced visits that we 

are making as a result of some of the issues GAO had found, programs not operating as well as they could. 

We have made about 172 unannounced visits at Head Start centers to really be able to monitor more closely what is going on a 

regular basis with these variety of sites. We have instituted new 

training guidelines, new updated rules and regs. So we are trying 

to identify issues that either would cause children to be in unsafe 

conditions or, certainly, to be in conditions where they are not 

being well prepared for a rigorous school curriculum, and move to 

correct those along the way. 

Mrs. BIGGERT. Thank you. Then, another issue—the diesel industry is responsible for thousands of jobs and is represented in my 

district. Are you concerned that incomplete information surrounding the diesel exhaust in miners study could unfairly harm 

this important industry? 

Secretary SEBELIUS. Well, I share your concern about jobs in any 

industry. And, as you know, there has been an 18-year study on 

diesel exhaust and the impact on miners, to evaluate lung cancer 

from diesel. We have in an unusual situation in this study, where 

there has been a court intervention that allowed certain, publically 

released, information to only be released after it was submitted to 

Congress and reviewed. 

We have complied with all of that information. So the studies are 

finally being published—peer review studies and journals. But, I 

think, the scope of this study is pretty extraordinary in terms of 
19 

the length of time that they followed and the peer reviewers are 

looking at the scientific data and reviewing that data. So I think 

that people will be able to make a judgment based on the publication of the data and look at what the science has found over that 

18-year period of time. 

Mrs. BIGGERT. Well, I hope that there will be the full transparency—I yield back, Mr. Chairman. 

Chairman KLINE. Thank the gentlelady. 

Mr. Kildee? 

Mr. KILDEE. Thank you, Mr. Chairman and Madam Secretary. 

As you both know, one of the strengths of Head Start is the close 

involvement of parents to the program to ensure that they have the 

tools they need to be their child’s first and best teacher. 

Can you tell the committee the current status of family literacy 

training and technical assistance, as required by the Head Start 

Act? What the department and the Office of Head Start are doing 

to promote and support family literacy, in the context of Head 

Start, so that multiple generations might benefit in the years to 

come. 

Secretary SEBELIUS. Well, Congressman, I think there is no question that the involvement of family in their child’s earliest, outside 

the home, educational opportunities has been, as you said, one of 

the real strengths of Head Start from the outset. And we are, certainly, proceeding in the family literacy program and involving 

family members. 

And I would tell you that, for the first time ever in a lot of the 

other early learning settings, there has been an incorporation of 

some of the hallmarks of the family involvement from Head Start 

into those programs. So we have been working closely with the Department of Education around everything from the race to the top 

for early learning challenges to looking at guidelines across the 

way. 

And, I think, there is a recognition that a curriculum for young 

learners is important to acquire the skills for school readiness but 

so are social, emotional, family skills, so is health care. And that, 

for the first time, is being incorporated across the board, regardless 

of the setting where the child would be involved. 

So I would say that not only is family involvement incredibly important in the Head Start Program, but it is beginning to be very 

recognized in all of the early childhood programs, whether they are 

run by the Department of Education or in a childcare setting or in 

a Head Start setting. 

Mr. KILDEE. Thank you, Madam Secretary. Another interest of 

mine—I was pleased to see that the fiscal year 2013 budget included an increase of $116 million for the Indian Health Services, 

to improve health outcomes of American Indian communities. What 

steps has your department taken to implement the Indian Health 

Care Improvement Reauthorization and Dissention Act that was 

included in the health care reform law? 

Secretary SEBELIUS. Well, Congressman, I know this is a strong 

priority of yours and one that we have taken very seriously in this 

Administration. The health gaps between the first Americans and 

the rest of the population are still staggeringly bad and we have 

focused additional resources, time and attention—and, I think, Dr. 
20 

Roubideaux heading the Indian Health Service has been a terrific 

leader. 

We are now making investments in the contract service area. We 

have new health care facilities coming on line, and staffing coming 

on line, with the health services. We are continuing with some facilities construction, including an IHS facility, which comes on line 

this summer in Barrow, Alaska. We are doing active budget consultations and very much involved in the Indian Health Improvement Act. 

It has been the involvement of tribal leaders, as we begin to implement the Affordable Care Act, because there are a number of 

tribal members who live on Indian land and use, and access, the 

Indian Health Services facilities. But there are lots of first Americans who live in urban settings, and live all over the country, who 

are eager to take advantage of the advantages of the Affordable 

Care Act that they have coming on-line. 

So we are working actively on everything from diabetes control, 

focus on suicide prevention, which is a huge issue in Indian country, new facilities, new contract services. And, as you say, this Administration has made an historic investment in the budget for the 

Indian Health Service. 

Mr. KILDEE. Thank you, Madam Chair, and I appreciate your 

commitment. 

Chairman KLINE. Thank the gentleman. 

Dr. Foxx? 

Ms. FOXX. Thank you, Mr. Chairman. 

Thank you, Madam Secretary, for the morning here today. Good 

morning. Madam Secretary, in February, you testified before the 

Ways and Means Committee about the Class Act. And you told 

Congressman Boustany that you had ‘‘no idea’’, quote—‘‘whether 

HHS secretly negotiated changes to the Class Act in early 2010, because there was certainly nobody from our department involved.’’ 

But, then, when the department’s report on the Class Act came 

out, it admitted that there were backroom negotiations with the advocacy groups to try to make the Class Act solvent. Could you tell 

me and this committee why you stated that the department was 

not involved in the backroom negotiations on Class, when your own 

department’s report admitted those negotiations took place? I assume you weren’t deliberately trying to mislead the Congress. 

Secretary SEBELIUS. Congresswoman, I never misled the Congress at all. The question dealt with—were there secret negotiations during the passage of the Affordable Care Act that involved 

Class. And my answer is absolutely accurate. 

We were charged, as you know, in the Affordable Care Act, with 

setting up a program that would have provided much-needed services and supports for those individuals who wanted to set aside a 

portion in their income and provide their own payment for homebased care. We were also charged with not beginning that program 

unless it was possible to certify to Congress that the program 

would be solvent for 75 years. 

During the course of the time between the time that the Class 

Act was passed and the time that we announced that we could not 

make that certification, there were numerous negotiations with all 

kinds of stakeholders, not just advocacy groups but insurers and 
21 

actuaries, looking at all sorts of modeling possibilities for whether 

or not there was a scenario under which we had both a legal authority and could justify the financing that would, indeed, allow 

this program to be up and running. 

They were fully reported to the committee when those studies 

were concluded. We did not make reports before the studies were 

concluded because, frankly, we didn’t know what the conclusions 

were. I think they’re very transparent, very above board. And, at 

the end of the day, without major legislative changes what we concluded was that the program designed to help people who wanted 

to stay in their own homes and provide their own care services out 

of a stream of income, was not able to be either certified as solvent 

or if, indeed, the premiums were high enough to make the program 

solvent, it wouldn’t serve the people it was designed to serve. 

So that is the report I made to Congress; it is the report I made 

to the President. And I don’t think there is anything inconsistent 

about either of those statements. 

Ms. FOXX. Well, I also understand that Congressman Boustany 

sent you a letter, which I am going to make a part of the record 

here, asking for a correction of the record of those statements and 

that you have not yet replied. It appears that you have a pattern, 

is this—as the Chairman said in his opening comments; it has 

taken us 10 months to get an answer from your department on information. 

What do you see as the responsibility of the Executive Branch to 

respond to members of Congress? And what do you think is a reasonable time, given the huge bureaucracy that you have here, to 

submit answers to questions that are given to you on things that 

should be readily available? 

Secretary SEBELIUS. Well, Congresswoman, we make every effort 

to respond in a fashion and, also, to gather the information requested. It probably doesn’t come as a big surprise that we get 

hundreds and hundreds of requests, often for thousands of pages 

of documents, and we have a lot of staff who do nothing else but 

gather documents, look at documents, try and be responsive. 

So we are on a full-time, 24/7, trying to be responsive as questions come in the door. And make sure that the answers that we 

get you are accurate information. And we will continue to do that. 

Ms. FOXX. Thank you, Mr. Chairman. 

Chairman KLINE. Thank the gentlelady. 

I understand she was requesting to enter Dr. Boustany’s letter 

for the record. 

[The information follows:] 
22 

CHARU::S \·V.130USTANY, JR MD 

qrongrc5s of t1)£ {!i;lmtco $tatcll 

l!Jou;;e 01 1\tpre5cnt,1t1bl'5 

Washiogton, 1!)1I!: 205lS--030 .. 

The Honorable Kathleen Sebelius 

Secretary 

March 6, 2012 

U.S. Department of Health & Human Services 

200 Independence Avc., S.W. 

Washington, DC 20201·0007 

Dear Secretary Sebelius: 

I write to follow up all our dialogue at last Tuesday's House Ways and Means Committee 

hearing regarding your Department's wit:: in the CLASS program. When I asked you about 

quotes in a joumal article suggesting your Department secretly negotiated changes to CLASS in 

early 2010, you gave the follmving response: 

'~I have no idea who \vas in the backroom with whom, and making deals, because that 

was certainly nobody from our Deparlment." 

Ho .... vever, your testimony appears to directly contradict your own Department's report on the 

CLASS program. Specifically, Appendix H from that report includes various options examined 

by your Department to make CLASS solvent. One option on pages 10 and 11 of that appendix. 

entitled "'Employment Earnings Amount;' notes that a $9,000 per year income threshold for 

CLASS eligibility '''will be consistent with \-",hat was negptiated 'with most ofthc advocacy 

organizations that lobbied for CLASS during the discussion oflegislative fixes (though the fixes 

were not included in the final hi!])." Further in that section, the same document notes that a 

$15.000 annual income threshold would be "a 'new' number that is high~r than the $9.000 that 

"'.'as negotiated w-jth the advocates and the Senate:' 

The CLASS repOli makes clear individuals from within the Administration negotiated 

"legislative fixes" to CLASS before the 1m:\" "vas enacted. despite the fact those changes v.'ere 

never incorporated into the tinallaw. 'fhesc statements are entirely consistent with Hmvard 

Gleckman's article in the December 2011 issue of Health Affairs, in which Mr. Gleckman 

,""rites: "the Obama Administration quietly negotiated a series of legislative fixes to the 

law ... aimcd at maintaining the long-nm stability of CLASS." 

I am greatly concemed by the yawning gap between your testimony last Tuesday and the report 

your Department previously released. At best it suggests your lack of familiarity with the details 

of your Department's operations - a troubling sign, given your integral role in implementing the 
23 

President's 2700-page health care law. At worst it is indicative of a distinct lack of candor, and 

potentially a desire to mislead Congress, 

Therefore, in order to set the record straight, I hope you can answer the following questions: 

1. Do you stand by your testimony of February 28, 2012, that no one - not a single personfrom within your Department was involved in negotiations regarding a package of 

legislative changes to the CLASS program with outside advocacy groups, Congressional 

staff, or both? 

2. If yes, why does Appendix H in the CLASS report specifically reference Administration 

negotiations "with most of the advocacy organizations" in an attempt to change the 

CLASS program before the health care bill was signed into law? 

3. If your Department did not negotiate legislative changes with advocacy organizations and 

the Senate, who in the Administration did? 

4. Why are these negotiations the Administration undertook regarding CLASS not 

mentioned at all in any oftbe CLASS-related documents that have thus far been provided 

to Congress? 

5. Where are the documents gennane to these secret negotiations the Administration 

undertook regarding the CLASS program? 

6. In an internal document dated January 4,2010, your Department noted that "it is possible 

the authority in the bill to modify premiums will not be sufficient to ensure the program 

is sustainable." When it became clear that the package of negotiated changes to CLASS 

would not be included in the final version of the bealth legislation, wby did you and your 

Department not raise these significant concerns about CLASS' solvency publicly hefore 

Congress voted to enact tbe legislation? 

7 . Was anyone within your Department, or anyone within the Administration. instructed not 

to provide infonnation to Congress about the serious solvency concerns the 

Administration recognized in its January 4, 2010 internal memo? 

As I mentioned during last Tuesday's hearing, I find your Department's responses to our prior 

inquiries disconcerting. That someone within the Administration negotiated a secret package of 

cbanges to the CLASS program before the health care law was enacted shows the Administration 

knew all along this program was unsustainable. That the Administration chooses not to release 

the docwnents surrounding those negotiations makes me question whether there was a deliberate 

"conspiracy of silence" regarding CLASS, whereby HHS staff and/or outside advocacy groups 

were instructed not to reveal the near certainty that CLASS would prove unsustainable, for fear 

that doing so would jeopardize passage of the entire health care law. 

It is critical that the record be set straight as soon as possible, and that the documents my 
24 

Chairman KLINE. Without objection, we will do that. 

Mr. Scott? 

Mr. SCOTT. Thank you, Mr. Chairman. 

Thank you, Madam Secretary. Madam Secretary, in the Chairman’s opening remarks, he talked about the effect that the ACA 

has on small businesses and suggested that there would be a devastating impact on small businesses when it comes into effect. I 

thought small businesses were exempt from the mandates, is that 

right? 

Secretary SEBELIUS. Yes, Congressman, certainly businesses 

under 50 have no employer responsibility under the Affordable 

Care Act but they are eligible for tax credits. So they are—many 
25 

small business owners are taking advantage of the tax credits, 

which allow them to pay for employee-based health care. 

Mr. SCOTT. So, let us slow up a minute—first of all, they are exempt. But if they voluntarily elect to provide insurance, there are 

tax credits that they would not be eligible for, but for the ACA, is 

that right? 

Secretary SEBELIUS. There not only are tax credits but, in 2014, 

when the new exchange markets are up and running, the estimate 

is that small business owners will be one of the major beneficiaries, 

given the fact that right now they are often paying 15 to 18 percent 

more in the private market for health insurance plans because they 

don’t have the large numbers to negotiate rates. 

They will be able to pick and choose out of a plan that puts them 

in a much larger pool, without having to change anything. 

Mr. SCOTT. And, so, they are exempt. And, if they provide insurance, they have got tax credits. And, if they provide insurance, they 

will be able to get it at a cheaper rate because they will be in a— 

get the big group markets rather than the small business rate. 

And, if they elect not to provide insurance because they are exempt, would they have access to insurance that they would not 

have, since their employer doesn’t provide it? 

Secretary SEBELIUS. Well, currently, as you know, Congressman, 

if an employer chooses not to provide coverage for employees, employees are, pretty much, on their own; they and their families are 

shopping in the individual market, the—— 

Mr. SCOTT. That is today? 

Secretary SEBELIUS. That is today. In the future, after 2014, 

those employees would be eligible, again, to participate in an exchange marketplace, be part of a larger pool, no pre-existing condition limitations, able to take advantage of tax credits, depending on 

their income, to pay a portion of their health plan. Right now, 

those employees are paying 100 percent out-of-pocket, which is 

often why a lot of working Americans have no coverage at all. 

Mr. SCOTT. So you disagree with the idea that this is bad for 

small business and would, instead, say this is actually good for 

small business? 

Secretary SEBELIUS. Well, I think, that at least the—I have an 

opportunity to visit with small business owners around the country. And what I hear from them is that having health insurance 

is often one of the best ways to recruit and retain high-quality employees. And that, time and time again, they lose those employees 

to either larger competitors or folks who can afford a better plan 

and a better package. 

And I would say that the small business market has disintegrated and not because of the Affordable Care Act. But it is on a 

death spiral; more and more small business owners have dropped 

coverage as rates have skyrocketed. So that we see this as not only 

stabilizing of the market, but giving some advantage to the entrepreneurs and small business owners who currently are out on their 

own trying to negotiate rates. 

Mr. SCOTT. Thank you. As you know, we are going to consider 

the student loan interest rate and there is a proposal to cut prevention funding. Are you familiar with that proposal? 

Secretary SEBELIUS. I am. 
26 

Mr. SCOTT. And exactly what would be cut if that offset is the 

one chosen? 

Secretary SEBELIUS. Well—— 

Mr. SCOTT. And why is that important? Why is that funding important? 

Secretary SEBELIUS [continuing]. I think that the Prevention 

Fund is a long overdue investment in some of the most significant 

efforts to keep our country healthy and well. It is a significant program to immunize our kids. What we know is that is an investment that returns about $10.00 for every dollar invested. It is a 

public health investment with laboratory capacity at the state and 

local level. 

We know that public health officials around the country would 

be laid off, reduce the availability of mental health and substance 

abuse. Some of the efforts around tobacco prevention and cessation, 

which can save thousands of lives, would be eliminated and discontinued. And, you know, right now, Congressman, America spends 

about eighty cents of every health dollar on dealing with chronic 

disease and illness and about eight cents of every health dollar on 

any kind of preventive effort. 

I think we are a great country. I think we can educate our kids 

and invest in health at the same time. And I think failing to invest 

in long-term strategies that will lower our health care costs, doom 

future generations to paying higher and higher health bills and 

getting mediocre results. 

Chairman KLINE. The gentleman’s time has expired. 

Dr. Roe? 

Mr. ROE. Thank the Chairman and thank the Secretary for being 

here today. 

And I think you and I totally agree that the single biggest issue 

preventing people from buying health insurance in this country, or 

having health insurance, is cost. I saw it in my practice. And, then, 

we had a group of people in our nation that couldn’t afford it because it cost too much. And that has been a great concern of mine 

is that—does this plan reduce the health care cost spending in the 

country? 

And we have held our Subcommittee on Health, Employment, 

Labor and Pensions—has held two subcommittee hearings, one in 

Evansville, Indiana and one in Butler, Pennsylvania, just a couple 

of months ago. And, let me share with you just some stories that 

I heard during these subcommittee hearings. And, really, someone 

from the Administration should attend these and listen. 

Just last week in my office, a young person, Peter Demos, from 

Murphysboro, Tennessee,—has five restaurants in his family and 

he has evaluated the Affordable Care Act and the Accountable Affordable Care Act. And he believes he has about 100—150 employees per restaurant. He is thinking about opening another restaurant in Clarksville, Tennessee, where I grew up. 

He said because of the cost of this—and he has had it analyzed— 

he is not going to open his Clarksville shop until he finds out what 

the Supreme Court does. And he has two restaurants that are marginal; sometimes they make a little money, sometimes they don’t. 

But the others have supported his business. He is going to close 
27 

those two restaurants. So we are looking at three to four hundred 

jobs with one person that is going to go away. 

Another IHOP owner in Evansville—he had 12 shops, 800 employees—‘‘Dr. Roe,’’ he said, ‘‘What do I do here? If I buy the essential benefits package, of which we don’t know what it is just yet, 

and I pay for that for all of my employees, I am upside down 

$7,000 per employee. But if I pay the penalty of $200,000, because 

I have more than 50 employees, which is not tax-deductible, it costs 

me $2,800. In this business,’’ he said, ‘‘I make $3,000 per employee,’’ which is pretty good, I think, in that restaurant business, 

‘‘it cost me all my profit.’’ 

I didn’t have an answer for him. Do you have an answer for either one of these owners? What do they do? 

Secretary SEBELIUS. Well, Dr. Roe, I think that there is no question that cost has eroded the private health insurance market over 

time. What we know is costs are up over the last decade about 115 

percent, which is why more and more business owners have 

dropped coverage and, particularly, small business owners and individuals. It is why we have about 50 million uninsured Americans 

today. 

And those costs continue to skyrocket with—— 

Mr. ROE. How do you—— 

Secretary SEBELIUS [continuing]. No end in sight. 

Mr. ROE. How do you talk to these restaurant owners? We know 

all that—what you said are facts, I agree with that. But how do 

you—what do you say to these folks that own these—and I could 

go on and on with stories that I heard in these hearings that we 

held. I didn’t have an answer for them. 

Secretary SEBELIUS. Well, I think, first of all, there is not a cost 

associated yet with the plans in the new exchanges because they 

haven’t been priced and packaged. That is—I don’t know what they 

are estimating but there is no costs. There is no—— 

Mr. ROE. There is a cost but no one has said what it is yet. 

Secretary SEBELIUS. Well, we don’t have a cost estimate by the 

insurance plans who will be offering these programs. That will become clear as we move forward. But, I think, the estimate is there 

is—based on no cost of doing nothing, there are employees right 

now who are opting in and out of these programs because of health 

insurance benefits that, often, these employers can’t compete with. 

There are employees who can’t come to work because they don’t 

have access to health care—— 

Mr. ROE [continuing]. I hate to interrupt you, but what do these 

folks say? 

Secretary SEBELIUS. Those costs are employer—— 

Mr. ROE. Look, I am an employer. I have been an employer for 

over 30 years. I understand all that. And that is one of the things 

a good health insurance plan allows; people to come into your business and retract them and keep them. I certainly understand that 

but how do you answer these folk’s questions that are going to 

close businesses and close down jobs? 

We will go on. The question I have, also, is why do you still think 

the majority of Americans oppose the Affordable Care Act? And, 

secondly, almost 80 percent oppose the mandate, why do you think 

that is? 
28 

Secretary SEBELIUS. I think there are still lots of misconceptions 

about what the Affordable Care Act does and doesn’t do that we 

are working to correct. I do think for a lot of people they have no 

idea what this is; they have health insurance, they are uncertain 

about how it is going to impact them and their family, and they 

really want to know ‘‘what happens to me.’’ 

We have had some considerable success with seniors who were, 

frankly, terrified during the course of the debate, told that Medicare Advantage plans would be done away with, that their premiums would skyrocket, that they would lose their doctors, that 

they couldn’t access hospital; none of that has happened; none of 

that is accurate and, in fact, they are beginning to take advantage 

of the benefits offered. And that begins to change people’s minds. 

So, once people connect with the benefits—I can tell you parents 

across this country who have young adults who are on their family 

health plan know the benefits of the Affordable Care Act. There are 

moms I see every day who have a child born with a pre-existing 

health condition, who knows that that child will never be locked 

out of the insurance market again. And that has provided peace of 

mind to those parents. 

So, as people begin to connect with the benefits, we are finding 

that their attitudes dramatically change. 

Mr. ROE. Mr. Chairman, can I submit some questions to her that 

would be—— 

Chairman KLINE. For the record? 

Mr. ROE. Yes, sir, for the record. 

Chairman KLINE. Yes, please, that would be fine. 

Mr. Tierney? 

Mr. TIERNEY. Thank you, Mr. Chairman. 

Thank you, Madam Secretary, for being here today. 

Secretary SEBELIUS. Good morning. 

Mr. TIERNEY. You are painfully aware, I am sure, this is a national debate that we are having with respect to the budget and 

reconciliation measures that are there, surrounded a lot about feelings that, you know, we can still give more money to the wealthy 

at the expense of struggling families, children and seniors. And not 

ask any in that category of ‘‘wealthy’’ to participate their fair share. 

And not look at the whole budget, just look at narrow portions 

of it, and not really focus on growth in jobs. And some, you know, 

have put forth this concept of subsidiarity or try to rationalize the 

Republican budget and some of these reconciliation bills. So I 

would like to read a letter into the record, if you will indulge me, 

and then ask you some questions about it. 

This is a letter from a sizeable number of theologians and religious scholars who were writing to the budget author for the Republican budget, Mr. Paul Ryan. They are welcoming him to 

Georgetown University, appreciating his willingness to talk about 

Catholic social teaching policy and dealing with urgent challenges 

facing the country. 

They cite themselves as members of the academic community at 

a catholic university. And they saw his visit, which was on April 

26 for election series, as an opportunity to discuss the Catholic social teaching in a role of public policy because he had talked about 

subsidiarity. 
29 

They go on to say, ‘‘However, we would be remiss in our duty to 

you and our students if we do not challenge your continuing misuse 

of Catholic teaching to defend a budget plan that decimates food 

programs for struggling families, that radically weakens protections for the elderly and the sick and gives more tax breaks to the 

wealthiest few.’’ 

This United States Conference of Catholic Bishops has wisely 

noted, in several letters to Congress, quote—‘‘A just framework for 

future budgets cannot rely on disproportionate cuts in essential 

services to poor persons.’’ Catholic bishops recently wrote that the, 

open quote—‘‘The House-passed budget resolution fails to meet 

these moral criteria.’’ 

In short, the letter says, ‘‘your budget’’, referring to Mr. Ryan, 

‘‘appears to reflect the values of your favorite philosopher, Ayn 

Rand, rather than the gospel of Jesus Christ. Her call to selfishness and her antagonism toward religion are antithetical to the 

gospel values of compassion and love. Cuts to the anti-hunger programs have devastating consequences. Last year, one in six Americans lived below the official poverty level and over 46 million 

Americans, almost half of them children, used food stamps for basic 

nutrition. 

We also know how cuts in Pell grants will make it difficult for 

low income students to pursue their educations at colleges across 

the nation, including Georgetown. At a time when charities are 

strained to the breaking point and local governments have a hard 

time paying for essential services, the Federal government must 

not walk away from the most vulnerable. While you offer an appeal 

that Catholic teachings subsidiarity as a rationale for cutting government programs, you are profoundly misreading church teaching. 

Subsidiarity is not a free pass to dismantle government programs 

and abandon the poor to their own devices. This often misused 

Catholic principle cuts both ways; it calls for solutions to be enacted as close to the level of local communities as possible, but it 

also demands that higher levels of government provide health 

subsidium, when communities and local governments face problems 

beyond their means, to address such an economic crisis—high unemployment, endemic poverty and hunger. 

According to Pope Benedict XVI, subsidiarity must remain closely 

linked to the principle of solidarity and vice versa, and it is signed 

by almost 90 people that are theologians and people—— 

So, Madam Secretary, my question for you is—in the budget proposal by the Majority, I think voted on by all of their members, 

that would cut $1.5 billion, according to the Office of Management 

and Budget, from Head Start. In your estimate, would that cut 

60,000 low-income children out of the program next year and 

200,000 out of the program by 2014? 

Secretary SEBELIUS. Yes, it would, sir. 

Mr. TIERNEY. And in childcare, that budget would mean a substantial cut to childcare assistance for more than 1.8 million, lowincome, working families who depend on it to try to get and keep 

jobs. By your estimate, would that be 60,000 families losing assistance next year alone? 

Secretary SEBELIUS. I think about 65,000. 
30 

Mr. TIERNEY. And on the Social Service Block Grant, that bill 

eliminates funding that would provide services like Meals on 

Wheels and childcare to 23 million children and seniors and Americans with disabilities, is that your estimate as well? 

Secretary SEBELIUS. Yes, sir. 

Mr. TIERNEY. You know, the Childcare Tax Credit, which used to 

be a bipartisan measure, Republican bill would end the refundable 

tax credit for families of 3 million children and increase taxes for 

those families by an average of $1,800 a year. By your estimate, 

would that tax increase fall on the backs of children from low-income families? 

Secretary SEBELIUS. I think that is correct, sir. 

Mr. TIERNEY. And the Supplemental Nutrition Assistance Program, that bill—the Republican bill, would cut $33 billion from 

that program. Would that affect approximately 2 million individuals, disproportionately from working families and seniors? 

Secretary SEBELIUS. I would have to defer to Secretary—for those 

numbers; that is not in our budget. But that sounds about correct. 

Mr. TIERNEY. All right. And, if the health care budget were to be 

entirely—the Program B, be entirely repealed, as some propose, 32 

fewer million Americans would get health insurance, is that right? 

Secretary SEBELIUS. That is correct. 

Mr. TIERNEY. And 2.5 million young adults who are now covered 

by their parent’s plan would lose that coverage? 

Secretary SEBELIUS. Yes, sir. 

Mr. TIERNEY. And 105 billion Americans would, once again, be 

subject to lifetime limit caps on their health insurance? 

Chairman KLINE. The gentleman’s time has expired. 

Mr. Walberg? 

Mr. WALBERG. Thank you, Mr. Chairman. 

And welcome, Madam Secretary. NIOSH and the NCI issued a 

press release addressing the results of the Diesel Exhaust and 

Miner Study; this study has been very controversial, I think we all 

could agree, especially some of its conclusions. I’m going to expand 

on what my colleague from Illinois addressed a bit earlier. 

This study concluded that diesel exhaust exposure of a surface 

mine produced higher risks of adverse health effects than to underground miners, with much higher levels of exposure. It also—and 

that is interesting that would be the case above-ground versus underground. It also concluded that heavy smokers, with the highest 

diesel exhaust exposures, have a lower risk for lung cancer than 

miners who didn’t smoke; another peculiar finding of this study. 

This study was also the subject of a 2001 court order that requires the agencies involved to provide all data requested by this 

committee. Now, to date, this still hasn’t happened, including requests made by Chairman Kline and myself, on three separate occasions, including at a hearing where you were with us almost a 

year ago. 

Furthermore, it took you an entire year to just reply, incompletely, to the question that we have asked last year. Now, these 

agencies have not provided all of the materials—why, Madam Secretary? 

Secretary SEBELIUS. Well, Congressman, NIOSH is in compliance 

with both the court order and, my understanding is, what the com-
31 

mittee has asked for. The underlying data has to be, according to 

the court order, submitted to the committee and then can be released. CDC and NIH will make the data publicly available after 

the 90-day review period of the committee is completed, in accordance with the court order. 

So we have published the first set of papers, delivered the underlying data—we now have, in the committee’s hands—your hands, 

the second data request. We cannot make it transparent and public 

until the committee’s review is completed. 

Mr. WALBERG. Well, I, respectfully, beg to differ with that. As far 

as the information we have requested, it has been willfully incomplete and inadequate to address the concerns that we, respectfully, 

submitted to you. Let me—— 

Ms. WOOLSEY. Will the Gentleman yield to your—— 

Mr. WALBERG. Briefly, I would yield. 

Ms. WOOLSEY [continuing]. Ranking member? 

Mr. WALBERG. Briefly, I would yield. 

Ms. WOOLSEY. For the record, we do have a letter here that is 

dated March 26, from the department, responding to those questions, that I would like to introduce into the—— 

[The information follows:] 
32 

i .. ~ DEPARTMENT Of HEALTH &. HUMAN Sf.RVICb 

.. ~~L.. 

The Ilonorahlc John Kline 

Chainm111 

\1arch 26. 2012 

Cummittl'c on Education and the Workforce 

t S. f IOllse of Representative:', 

~ 1 Xl R[)yburn Ilou-.c Office Building 

\\'ashington. DC :20515 

fhe llonorahlc Tim Walberg 

Chairman 

SubcoJ1lmiltcc un Workt()J"cc Protections 

COlllmittee on Lducdlion and the Work.force 

l'.S. Ilouse of.Rq)rC,clltati"'es 

\\"ashington. DC 

Off:C0 of the AssEsliH'l Secretary 

tor l.eglslatlQn 

W<lstllngton, D.C 20201 

Rc: \mional Canc..-r lnstitute/i\ationallnstitute of Occupational Safety and Health Study of 

Diesel F).h3LlSt l-h:alth Effects in Miners 

Dcar Chairmen Kline and Walberg: 

This i<; in folkm-up to llly Deccmb~T 30 letter. As requested by the Committr.:c. enclosed 

find 1"l':o:earch data underlying the final thrcc papers invoh'Cd in the Diesel ,"",xhaI!Slllcalttl 

1I1 Miners Study (Diesel Study) conducted by the National Cancer Institute (N( '[ ) of thc I\'<llional 

Institute" ofl-lealth and the National Institute for Occupational Safety and Health (!\IOSHi Mthe 

('cntcr~ /lW Disea"c Control and Prevcntion. As you kno\\'. on December 2. 2{J 1 I. we 

the Committee \\ilJ1 drafts orthe~e papers for a 90 da) ]"C\ie\\ period. a~ required 1"1) 

:-'cptemhcr 14.2011 order issued by the rifth Circuit Court of Appeals. I"he final tlln.'c pape!".' 

\\tTe publishl.'J on lvlarch 2. uner the completion oflhi;.. rniew periud. Two papl'r~ \\erc 

puhlished in thc JOllrnal of {he .\'alimwl Ca/lcer jmtilUlc. and one \\';:]~ puhli:-.hcd l!l 111<.' 

lllJlal., (If ()CCllfl(/fi()lIalj~l'gicl1e. For your cOll\cniencc, I have copic" ofthc:-.l.' papl.'f" 

\<, :Otl kllow. the pllhlic.ltion oftbese papers is the culmination ora l\\t'nl~ "tudy 

to diesel engine exhaust in ahout 12,000 miners. The Study j()und 3.11 

for lung cancer death with increasing leyels of exposure 10 diesel cxhau<,t 
33 

Mr. WALBERG. And I re-claim my time—I indicated that we received a response but, willfully, inadequate and incomplete. Let me 

go on to a next issue, Madam Secretary. 

I can’t believe that you believe that it is appropriate for the diesel study author to travel to France to request international government organization, in this case IARC, which is International 

Agency for Research on Cancer, to issue a finding that diesel exhaust should be labeled as a known human carcinogen. Can I assume that to be an accurate understanding, that you wouldn’t believe this would be appropriate for the author, an author of this 

study, to do such a thing? 
34 

Secretary SEBELIUS. Congressman, my understanding is that the 

World Health Organization is organizing a meeting in France. The 

International Agency on Research on Cancer—I have no prior 

knowledge about what is the testimony that will be presented but 

I do know that the researchers have been invited. We are very committed to sharing information and research findings with the World 

Health Organization. The United States is a very active member of 

that organization so I assume the researchers will participate. 

Mr. WALBERG. Recognizing the time here, the concern would be, 

for me, that the IARC’s findings trigger automatic U.S. government 

regulatory consequences for employers that cost millions of dollars 

to comply with. And I find it very unfair that, when those same 

regulated entities, like small businesses, don’t have a way to comment on IARC proceedings, that they are, in fact, blocked from participating, this is really back-door rulemaking. And can you condone the practice—— 

Chairman KLINE [continuing]. I am sorry; the gentleman’s time 

has expired. 

Secretary SEBELIUS. But, Mr. Chairman, could I respond? Because what has just been stated is just absolutely not correct. 

Chairman KLINE. Please. 

Secretary SEBELIUS. There is no international finding that automatically triggers anything. We have the responsibility, under the 

Centers for Disease Control and NIH, to produce findings about 

likely carcinogens and proven carcinogens. That doesn’t even trigger an automatic finding; that, really, is within another department’s jurisdiction. So we do the science, we publish the science. 

We have the responsibility for making that available. 

There are other agencies, the Environmental Protection Agency 

and others, who actually trigger the regulatory responses. And they 

are not automatically triggered; they go on that agency’s line-up 

list. So I have no idea. The International agency for Research on 

Cancer, to my knowledge, Congressman, has no impact, whatsoever, on an automatic triggering on anything that would impose 

any regulatory requirement—— 

Mr. WALBERG. Mr. Chairman if you might indulge me, I disagree 

with that but I am willing to be proven wrong. But we will follow 

this up with the Secretary—— 

Secretary SEBELIUS. I would be happy to. 

Chairman KLINE. Thank the gentleman. 

Thank you, Madam Secretary. 

Mr. Holt? 

Mr. HOLT. Thank you, Mr. Chairman. 

Thank you, Madam Secretary. It was earlier mentioned by one 

of our colleagues that there are so many uncertainties now in the 

health care field. I would just comment that the uncertainties that 

existed before the Affordable Care Act was passed were even greater. I mean, you know, where do 40 million people go for their 

health care and how will we redirect health care in America toward 

wellness and health outcomes? And how will we handle additional 

families trailing into bankruptcy by bad luck of illness or injury? 

But two things that were not uncertain before the health care 

law was passed was health care costs in America would go up 8 

percent a year, or more, and insurance companies would spend a 
35 

smaller and smaller fraction of the premiums that they collect on 

actually providing health care. And, with regard to the cost, there 

is an article by economist Peter Orszag in Bloomberg, that points 

out that health care spending in the past year rose by 4 percent. 

Now, that is high but that is half of what it used to be. 

And he says that this is not just because of economic reasons but 

it is because of structural reasons, with doctors and hospitals cutting back on unnecessary procedures, expanding their use of information technology, switching from fee-for-service to compensation, 

aimed at maximizing quality of treatment, and so forth. Do you, in 

fact, see some changes in health care costs already because of the 

Act? 

Two other things that I would like to ask you about on this subject is—the health care law provides assistance to states in doing 

rate review. And I am wondering whether State insurance commissioners and others are beginning to use that information. Further, 

I would like to ask if you have data that show that this medical 

loss ratio of 80 or 85 percent is about right or is this subject to further review. 

I have other questions but if you could answer those quickly, I 

would appreciate it. 

Secretary SEBELIUS. Well, Congressman, I can tell you that the 

major program that we are in charge of, probably the largest insurance program in the world, Medicare, which has about 49 million 

beneficiaries, was on a trend line growing at about 8 percent a 

year. And that rate of growth definitely has been slowed in the last 

two years. 

We are now at about 6.3 percent and the Trustee has certified 

the fact that that trend line is largely due to changes in the Affordable Care Act. And I think we can monitor that very closely. We 

do know that the rate review efforts underway in states around the 

country have been very beneficial. Time and time again, not only 

have insurance departments taken advantage of the encouragement to use some of the rate review funding to hire additional actuary staff, go to their legislators to request additional ability. 

As a former insurance commissioner, I know how important it is 

to have prior approval authority. So a company has to come 

through an insurance department process and—— 

Mr. HOLT. And would you say these will begin to have a—— 

Secretary SEBELIUS. They are having effects. 

Mr. HOLT [continuing]. Noticeable effects? 

Secretary SEBELIUS. We are watching rates be reconsidered, 

pulled back, reduced in states. And the 80-20 Rule—the medical 

loss ratio, I think, we will have pulled that shortly. But we have 

been monitoring it closely and beneficiaries will be getting rebate 

checks this year from companies who have not spent 80 percent of 

their dollars on health care costs. 

Mr. HOLT. Let me change to something else. In answer to Mr. 

Scott’s question, you talked about the Prevention Fund. It has been 

called, by the Speaker, a ‘‘slush fund.’’ 

Secretary SEBELIUS. Yes, yes. 

Mr. HOLT. Could you specifically say what this means for CDC, 

what this means for actual treatment? And, I believe, there is a 

particular benefit for women. 
36 

Secretary SEBELIUS. I am sorry, can you—— 

Mr. HOLT. Prevention Fund. 

Secretary SEBELIUS. Certainly. Well, I think, the Prevention 

Fund, again, is an enormously important effort that is long overdue. And you have talked about some of the—we have talked about 

some of the programs but, additionally, HIV/AIDS efforts have 

been enhanced; the, kind of, community transformation grants, 

which are really focused on systematic changes in 61 states and 

communities across the country; and a whole series of efforts to actually enhance critical programs to screen uninsured women for 

breast and cervical cancer; and tracking, and prevention of, birth 

defects, are part of the Prevention Fund efforts that are making a 

big difference. 

Chairman KLINE. Thank you, Madam Secretary. 

The gentleman’s time has expired. 

Dr. DesJarlais? 

Mr. HOLT [continuing]. For the record, if I may? 

Chairman KLINE. Yes, certainly. 

Mr. HOLT. Thank you. 

Mr. DESJARLAIS. Madam Secretary, I really appreciate your 

being here today and appreciate this opportunity to speak with you 

about some very important issues. I know we have spent a lot of 

time, over the past two years, arguing whether or not ‘‘Obamacare’’ 

is good, ‘‘Obamacare’’ is bad—you know, whose fault is it that various provisions aren’t working out the way they are supposed to be. 

But what I would really like to discuss with you today, and see 

if you would agree on one fact—that Medicare, according to CBO, 

Republicans, Democrats, AARP, is going broke in 10 years. Can we 

agree on that fact? 

Secretary SEBELIUS. The Trustees Report said that the funds will 

be exhausted, which means they will only be about 70 percent of 

the finances by 2024. 

Mr. DESJARLAIS. Okay, so you would say 12 years; that is not far 

off. We have another looming problem at the end of the year and 

that is the SGR, or the ‘‘doc fix.’’ We were looking at a 27 percent 

cut in pay to physicians. 

And I know, in my district, there are already concerns among 

seniors that it is getting more and more difficult to find access to 

physicians. And, in your opinion, what do you think will happen if 

that 27 percent cut is put in place next January? 

Secretary SEBELIUS. Unfortunately, Congressman, those numbers 

are a little low too; it is a 31 percent pay cut. And I think it would 

be enormously devastating to Medicare beneficiaries, who would 

lose their doctors, which is why the President has called for, every 

year, a permanent, long-term, fix to the SGR and would love to 

work with Congress to do just that, as opposed to kicking this 

can—— 

Mr. DESJARLAIS. Okay. 

Secretary SEBELIUS [continuing]. Two inches down the road. 

Mr. DESJARLAIS. And it would cost about $300 billion to just 

bring us back to even from the plan’s implementation back in 1997, 

is that right? We are about $300 in the hole? 

Secretary SEBELIUS. Yes—— 
37 

Mr. DESJARLAIS [continuing]. Okay, so we have got to come up 

with $300 just to pay for the past decade-plus. So, moving forward, 

not making that cut is going to be very expensive. We have got, 

about, a $500 billion cut to Medicare in the form of the IPAP. We 

are rapidly not looking very efficient and, yet, we have this huge, 

looming problem of, you know, 10,000 new Medicare recipients entering the program every day. 

I am talking with you today because we need to solve this problem. It doesn’t matter which side of the aisle you sit on, we all have 

parents, grandparents, maybe we are of Medicare age ourselves. So 

you said the President wants to work on an SGR fix. I would be 

happy to work with you. Our doctor’s caucus would be happy to 

work with you. 

We have got to solve this problem because these numbers are 

hard to even comprehend. And I just wondered what ideas you 

might have for us. 

Secretary SEBELIUS. Well, Congressman, I think that that would 

be encouraging. I think that, as you know, the SGR well pre-dates 

any discussion in 2010 and 2009 about an Affordable Care Act. It 

has nothing to do with it. It is based on the Balanced Budget Act. 

And, I think, fixing that in the long-term, looking at new ways to 

actually pay docs, is an important thing going forward. 

I would also just suggest that the $500 billion is not a cut to 

Medicare; it is an estimated slowdown in the growth rate, which 

we are seeing right now. That is where the $500 billion comes 

from. So Medicare costs will continue to rise, largely, as you say, 

because we have the beginning of the ‘‘baby boomers’’ coming into 

Medicare, more beneficiaries than ever. 

Mr. DESJARLAIS. Okay, let us shift just for a minute because, you 

know, we are obviously not going to solve that problem. To the 

issue of employers dumping their employees into the insurance exchanges. I have visited with several businesses in my district and 

I will just give a quick example of Belmont Industries—has about 

6,000 employees so they would fall into the $3,000 penalty. 

Right now, they pay about $12,000, per employee, for their 

health care benefits. So they would, literally, save about $9,000, 

per employee, and $34 million. You know, clearly, they would be 

rewarded for dumping these employers—or these employees into 

the exchange. What—what do you think the impact is going to be 

as we see this trend moving forward? 

Secretary SEBELIUS. Well, again, Congressman, the only real-life 

example that we have to look at has been the Massachusetts example, where the exchange program, the employer penalty and the 

subsidy, has provided a template for the Affordable Care Act. What 

happened in Massachusetts is more employers actually offer coverage today than did when the exchange started. They have not 

dumped employees. They have similar incentives in place. 

If one would speculate—we have a totally, as you know right 

now, voluntary market, where insurers—I mean, employers voluntarily are participating in an increasingly expensive and hard to 

predict insurance market. My sense is, based on the real-life model 

that is up and running, based on conversations with employers as 

we move along, that these same kind of incentives, keeping, retain-
38 

ing good employees around health care, will be in place in the future. 

And that employers will, actually, have an incentive to come 

back in the market because there will be a larger pool, no pre-existing conditions, they won’t be penalized for being small employers, 

and they will have market rates that they can control. 

Chairman KLINE. The gentleman’s time has expired. 

Ms. Fudge? 

Ms. FUDGE. Thank you, Mr. Chairman. 

And, thank you very much, Madam Secretary, for being here and 

to continue to show your knowledge of the Affordable Care Act and 

why it was so important that this Congress passed it. I, certainly, 

am concerned, though, about the recent reductions to Medicare 

payments and the effect that they will have on safety net hospitals, 

in particular. And the people that are served by safety net hospitals, of which, certainly, I have two, fairly large, ones in my district. 

The Middle Class Tax Relief and Job Creation Act was the latest 

piece of legislation to make it to the President’s desk with significant reductions in Medicare payments for hospitals. And then there 

is the cut proposed in the President’s budget, where the Administration proposes to reduce bad debt payment to 25 percent of the 

current 70 percent for all—from the current 70 percent for all eligible providers, including safety net hospitals. 

And this is done in order to save some $36 million over the next 

10 years. The Medicare payment cuts included in the Payroll Tax 

bill and the payment cuts proposed in the President’s budget, come 

on top of the sequester, where hospitals will see a 2 percent cut in 

their Medicare reimbursement for the next nine years. 

Safety net hospitals serve as America’s first line of defense for 

treating low-income and uninsured patients. Without a doubt, 

these cuts will adversely affect already financially weak safety net 

hospitals and the people they serve. Metro Health, which is in my 

district, is a safety net hospital that needs our support and not 

cuts. 

So my question is—why does it seem as though the Administration and this Congress are targeting the health care providers that 

can least afford it? And I want to ensure that safety net hospitals 

will be able to continue to meet the health care needs of the communities they serve. So could you just elaborate for me the thought 

process here and what is the plan going forward for safety net hospitals? 

Secretary SEBELIUS. Well, Congresswoman, I share your interest 

and concern about safety net hospitals who provide critical care in 

some of our most underserved areas. I think that the President 

shares that concern and we want to find ways to both reduce 

health care costs but, at the same time, not jeopardize that critical 

safety net. 

I would look forward to working with you on some specific issues 

that you find troubling in the budget. I do think that we are trying 

to find a balance of areas where there may have been opportunities 

to reduce overall payment levels and not jeopardize the quality of 

care. And that is really what we are trying to find is that right bal-
39 

ance. But, certainly, the provision of quality health care to underserved areas continues to be a very high priority. 

Ms. FUDGE. I would, certainly, look forward to continuing the 

conversation with you. The second question is—there were workforce demonstration projects, of course, as a part of the legislation. 

Now, these projects will, in fact, help low-income individuals, receiving training and entering health care professions, which you 

mentioned earlier in your testimony. 

Can you update the committee on the progress that has been 

made as a result of these projects? And, if you would, please highlight any specific goals HHS has regarding increasing the number 

of health workforce professionals. And, finally, please update me on 

any other dedicated funding that will address health workforce 

shortages. 

Secretary SEBELIUS. Certainly, Congresswoman. I think that the 

President, from the outset, recognized that additional health insurance and more affordable, available health insurance was a piece 

of the puzzle. But, without a competent, trained and appropriately 

placed workforce, it would be a huge misconnect between people 

who now have access to health care and that access. 

So, from the outset, really starting with the Recovery Act, there 

has been an effort to look at workforce training. We have tripled 

the number of National Health Service Corps members in the last 

3 years. And those members are nurse practitioners, docs, mental 

health techs, dentists, who are then placed in underserved areas in 

return for helping to pay down their student loans and student 

debt. A kind of win-win situation. 

There is a stream of funding specifically to recruit health workers out of minority communities that is new, thanks to the Affordable Care Act, and one that we are actively working on under the 

jurisdiction of the Health Resources and Services Administration. 

We are re-looking at what is defined as underserved areas to make 

sure that we have the most accurate data. 

So that, as new workers come around, we are working to re-designate graduate education slots to focus on primary care and preventive care and gerontology, areas that have been missing, so that 

we will be training more docs. The Affordable Care Act contains a 

couple of years of funding increases for doctors who serve Medicaid 

patients, paying them at the rate for Medicare patients, again, recognizing that the pay differential often is discouraging to health 

care providers serving in underserved areas. 

So we are trying to look at everything from training and recruitment to slots to placement. The additional work, which is 

under—— 

Chairman KLINE. I am sorry to interrupt, Madam Secretary. 

The gentlelady’s time has expired. 

Mr. Miller, you are recognized. 

Mr. MILLER. Thank you, Mr. Chairman. 

And I would just like to take a moment to recognize the presence 

in our hearing room today of Mr. Bill Payne, the brother of Donald 

Payne, our colleague on this committee and our colleague in the 

House. 

[Applause.] 
40 

Mr. Bill Payne is a distinguished public service as—servant in 

his own right. Welcome, thank you so much and many of us had 

the opportunity—the Speaker sponsored a wonderful memorial 

service yesterday for Donald and many of us had the opportunity 

to participate with you and your family. And we grieve the loss of 

your brother. 

Chairman KLINE. I thank the gentleman and I welcome Mr. 

Payne. 

I agree with Mr. Miller, the Ranking Member, it was, indeed, a 

moving and memorable service yesterday and we are very glad to 

have you here today. 

Dr. Bucshon? 

Mr. BUCSHON. Good morning. The first question I have is can 

you—and, based on some previous questions, can you give me what 

you consider a definition of a ‘‘small business,’’ because, based on 

some questioning from the other side, it seemed to me that your 

interpretation is that is 50 employees or less. 

Secretary SEBELIUS. A small business is—— 

Mr. BUCSHON [continuing]. Well, because the question was asked 

what the effect on small businesses is with the Affordable Care 

Act, and you focused on the fact that employers with 50 or less employees would not be affected or have all of these credits and exemptions. So, based on that interpretation, I got the impression 

that you considered a small business people that have 50 employees or less. Because that is a different description of what constitutes a small business from what we all know is really the truth. 

Secretary SEBELIUS. I don’t have any starting place of a definition. I think I was asked were employers under that level exempted. And my answer was yes. 

Mr. BUCSHON. Well, the question was small businesses and so 

my argument is that, yes, that is true, what you said about 50 employees or less. But I would argue that small businesses actually 

incorporates a much larger group of employers. And I can tell you 

from experience, talking to business owners in my district, that the 

Affordable Care Act will have a dramatic negative effect on businesses. 

And I know Dr. DesJarlais’ questioning about employers dropping their insurance. At least in southwest Indiana, I talk to small 

business people all the time that provide health insurance and they 

all say they don’t know anyone that they have talked to in southwest Indiana, I can speak for, that is not planning to drop their 

private health insurance for financial reasons and pay the penalty. 

The next question I have is—you talk a lot about quality when 

you are talking about savings rather than cuts. And, so, I 

wouldn’t—as a physician, I would like you to, kind of, tell me how 

an insurance company controls quality of health care. Because in 

my view, the quality of health care comes at the provider level and 

the insurance company, essentially, pays the bill. 

And, so, when you talk about quality and making—you know, 

with these Medicare Advantage plans, and you are looking for 

quality plans, and that is why you are cutting payments to those; 

you are not saving anything, you are cutting payments to programs 

that seniors really like. How are these insurance companies improving the quality of the health care, itself? That is my question. 
41 

Secretary SEBELIUS. Well, I would, certainly, not disagree that 

quality health care is at the provider level. I think that what we 

are trying to do is stop overpaying for plans that are currently paid 

at a rate of about 107 percent of fee-for-service, with no differentiation in the outcome of those patients. So diabetes management is 

no different in a Medicare Advantage. 

They may get a gym membership, they may get free glasses, but 

there is no apples to apples comparison between patients; there is 

no differential. So the additional financing is not providing additional incentives to providers who, actually, manage chronic disease 

better or help reduce preventable hospital stays, bundle care, coordinate care. 

Mr. BUCSHON. But you would have to agree that these Medicare 

Advantage plans provide a service that seniors want and that is 

why they enroll in them. So, yes, they do get more services and better—you know, as you know, a health insurance policy—one policy 

isn’t the same as the next. They cover certain things, they have got 

different co-pays. 

I mean, you would agree, and I know being in the health care 

industry, it is a very, very complicated system that most of us don’t 

really, truly understand. But I would argue that those programs 

provide more services, hence the reason that they are paid more. 

The last question is—can you describe your position on the ‘‘doc 

fix,’’ so to speak; the dramatic cuts in provider payment. 

But, then again, on your controlling the cost or savings, so to 

speak, you plan to limit reimbursement to providers based on, and 

I will read this, ‘‘rate of growth and productivity in the economy 

at large’’. So, if we would allow payments to go down under the formula, the SGR formula, or we cut payments—or allow the payments to come down, by limiting the growth, based on the general 

economy, I don’t see the difference; it is the same thing. 

Chairman KLINE. Excuse me; can we take that for the record, 

please? We are running—I am very mindful of your time, Madam 

Secretary. I have got other members to answer so if you could provide an answer to that for the record, please. 

Secretary SEBELIUS. Sure—— 

Chairman KLINE. Mrs. Davis? 

Mrs. DAVIS. Thank you, Mr. Chairman. 

And, Madam Secretary, thank you very much for joining us 

today. I wanted to turn to one area of disease prevention, where 

we know that trying to quantify the outcomes are very, very important. A bipartisan group of us in the House and Senate have been 

working on approaches to decrease instances of Type 2 diabetes. 

And, as you are aware, 79 million Americans have pre-diabetes, 

which puts them at risk in developing Type 2. And complications 

cost our nation somewhere in the area of about $218 billion every 

single year in health care costs. With about 25 percent population 

at risk, there is a national interest, I think, and I believe—I know 

how supportive you are in addressing these issues, in reducing the 

incidence of diabetes and having far better outcomes for people. 

The health bill included bipartisan legislation to establish the 

National Diabetes Prevention Program, which builds on evidencebased methods to give individuals at risk, guidelines on how to pre-
42 

vent Type-2 diabetes. And it is eligible for funding from the Prevention and Public Health Fund at HHS. 

Do you see continuing our combating instances of Type 2 diabetes as a national priority? And do you see that funding for the National Diabetes Prevention Program must come out of the Prevention Fund? And, if that is the case, is it at risk if we, essentially, 

scrap funding for that Prevention Fund? 

Secretary SEBELIUS. Well, I think, Congresswoman, you have just 

identified one of the clearly looming health threats, and present 

health threats, that is, I think, a target of the Prevention Fund 

funding. And we think diabetes efforts and, certainly, focusing on 

pre-diabetes to try and ensure that more Americans don’t end up 

with diabetes in the long-term, is an effort that not only lowers 

costs but saves lives in the long run. 

So we have, actually, not only invested—a number of the community transformation grant activities are focused directly on communities where there is a high prevalence of diabetes. And a number 

of the Beacon Community efforts, with some of the Electronic 

Health funding, are focused on diabetes efforts. 

We have special projects being run in tribal communities, where 

the diabetes rates are even higher than in the general population. 

And I would say that the Prevention Fund is an underlying health 

funding stream for just the kind of efforts that you are describing. 

And, of course, it would be at risk if the Prevention Fund is eliminated because there are no funds available, often, at the state and 

local levels. So this would continue to be a huge problem. 

We also have a Million Hearts effort, where we are trying to 

have partnerships with not only health care providers but some of 

the major drug companies, and others, around disease management 

issues that we think could save people from strokes and heart attacks in the future if we focus on some of the underlying causes 

of blood pressure control and cholesterol issues, that often also 

present themselves in diabetes care. 

So having those strategies in place, having Medicare, frankly, invest in prevention efforts—Medicare used to, you know, pay for an 

amputation but not for diabetes screening. Those screenings are 

now available without co pays and, we think, that is a huge step 

forward. 

Mrs. DAVIS. Yes. If, in fact, we were to really target that fund, 

are there any other ways that those issues would be addressed? 

Secretary SEBELIUS. Well, I think that it is very difficult, often, 

to have people in particularly difficult budget times, but even in 

good budget times, look at investments in longer term strategies. 

It hasn’t happened in the past. I am not very confident it would 

happen in the future, in spite of the fact that we pay the health 

results every day and we pay the costs for them. 

Mrs. DAVIS. I really appreciate that. I think one of the other 

things that we have seen on the Armed Services Committee is how 

important, just, preventive health care for young people is, actually, because if we are finding that far too many young people are 

not even able to be eligible for the military services today because 

of their health care. 

Secretary SEBELIUS. I think the data right now, which is really 

alarming, is about 30 percent of the age-eligible young men and 
43 

women aren’t, actually, physically eligible to even consider Armed 

Services as a possibility. 

Mrs. DAVIS. If you could help tie those issues together, I think 

that would be very helpful because I don’t think we want to turn 

around and find that we really have totally ignored this problem 

in the future. 

Secretary SEBELIUS. Well, certainly, the effort that the First 

Lady is leading around childhood obesity, the community efforts 

underway to look at what happens if you increase exercise, have 

more access to fresh fruits, your efforts in Congress to change the 

child nutrition guidelines around school breakfast and school lunch, 

is a start of the kind of prevention effort that would, hopefully, 

produce a lot fewer diabetics when they get to be 50. 

Mrs. DAVIS. Thank you. 

Secretary SEBELIUS. Thank you, ma’am. 

Chairman KLINE. The gentlelady’s time has expired. 

Mr. Gowdy? 

Mr. GOWDY. Thank you, Mr. Chairman. 

Good morning, Madam Secretary. 

Secretary SEBELIUS. Good morning. 

Mr. GOWDY. With respect to the HHS mandate, the most recent 

mandate, you said, and I quote—‘‘this decision was made after very 

careful consideration, including the important concerns some have 

raised about religious liberty. I believe the proposal strikes the appropriate balance between respecting religious freedom and increasing access to important preventive services.’’ There are only 

three balancing tests that I am aware of when it comes to matters 

of Constitutional significance; there is the rational basis balancing 

test for economic legislation, there is the intermediate, or mid-level 

scrutiny for gender-related Constitutional issues, and then there is 

the heightened, or strict scrutiny, when fundamental rights are involved.’’ 

And, given the fact that I am sure you can see that religious liberty is a fundamental right, which of those three Constitutional 

balancing tests were you making reference to when you said you 

‘‘balanced’’ things? 

Secretary SEBELIUS. Congressman, I am not a lawyer and I don’t 

pretend to understand the nuances of the Constitutional balancing 

tests. 

Mr. GOWDY. But you would agree—— 

Secretary SEBELIUS. I assume you are talking about the preventive services—— 

Mr. GOWDY. You would agree it is a legal issue, right? I mean, 

are we going to wind up in this—last time I was at the Supreme 

Court, I think you and I were there the same day during the oral 

argument. This mandate is going to wind up in the Supreme Court. 

To me, it is—we can talk about the politics all we want to, I 

want to talk about the law. I want to talk about balancing religious 

liberty with whatever else you think it is appropriate to balance it 

with because you used the word ‘‘balance.’’ Which of those three 

tests is the appropriate test for us to use when considering religious liberty? 

Secretary SEBELIUS. Again, Congressman, I am not going to 

wade into Constitutional law. I am talking about the fact that we 
44 

are implementing the law that was passed by the Congress, signed 

by the President, which directed our department to develop a package of preventive health services for women. We have done just 

that with the advice of the Institute of Medicine and promulgated 

that rule. 

Mr. GOWDY. Do you agree with me that government cannot force 

certain religious beliefs on its citizens? 

Secretary SEBELIUS. Yes, sir. 

Mr. GOWDY. And why can they not do that? 

Secretary SEBELIUS. Why can government not—— 

Mr. GOWDY. Yes. 

Secretary SEBELIUS [continuing]. Force religious beliefs? 

Mr. GOWDY. What is the basis of that? 

Secretary SEBELIUS. The separation of church and state. 

Mr. GOWDY. Well, it is the Constitution, right, the First Amendment? Can government decide which religious beliefs are acceptable and not acceptable? 

Secretary SEBELIUS. No, sir. 

Mr. GOWDY. And why can they not do that? 

Secretary SEBELIUS. It is part of our Constitution. 

Mr. GOWDY. It is a legal analysis. I mean, for me, this is not a 

political analysis; it is a legal analysis. So, before this rule was promulgated, did you read any of the Supreme Court cases on religious liberty? 

Secretary SEBELIUS. I did not. 

Mr. GOWDY. You would agree with me that our society has a 

compelling interest, not just an important interest, a compelling interest in having an educated citizenry, right? 

Secretary SEBELIUS. Yes, sir. 

Mr. GOWDY. Right. So when a state said you have to send your 

children to school until a certain age and a religious group objected 

because they did not want to send their children to school until 

that certain age, do you know who won? It went to the Supreme 

Court. 

Secretary SEBELIUS. I do not. 

Mr. GOWDY. The religious group won. I think the state has a 

compelling interest in banning animal sacrifice, whether it is compelling or just important is irrelevant for purposes of this discussion. When a state banned a practice of animal sacrifice and a religious group objected, it went to the Supreme Court. Do you know 

who won that? 

Secretary SEBELIUS. I do not, sir. 

Mr. GOWDY. The religious group won. I think the state has an 

important interest in having license tags on automobiles so law enforcement can know who they are dealing with. When a religious 

group objected to having a certain license tag on their cars, it went 

to the Supreme Court. Do you know who won? 

Secretary SEBELIUS. I do not. 

Mr. GOWDY. The religious group won. And, most recently, I happen to think government has a compelling interest in avoiding gender discrimination but this Administration took to the Supreme 

Court a case, Hosanna-Tabor, where a religious group wanted to 

decide who its teachers were, even if it meant gender discrimination. It was a nine to nothing opinion in favor of religious liberty. 
45 

So when you say you balanced things, can you understand why 

I might be seeking a Constitutional balancing instead of any other 

kind? 

Secretary SEBELIUS. I do, sir, and I defer to our lawyers to give 

me good advice on the Constitution. I do not pretend to be a Constitutional lawyer—— 

Mr. GOWDY. Is there a legal memo that you relied on, at least 

when a—— 

Secretary SEBELIUS. I relied on discussions. 

Mr. GOWDY. At least when an Attorney General Holder made 

his—appointments, there was a legal memo that he relied on. Is 

there one you can share with us? 

Secretary SEBELIUS. Attorney General Holder, clearly, runs the 

Justice Department and lives in a world of legal memos. 

Mr. GOWDY. Do you have attorney—— 

Chairman KLINE. I am sorry, but the gentleman’s time has expired. You can ask such a question for the record. 

Mr. Andrews? 

Mr. ANDREWS. Thank you, Mr. Chairman. 

Madam Secretary, you didn’t score well on the pop Constitutional 

law quiz, I am sorry. 

Secretary SEBELIUS. I got a kind of drift that—— 

Mr. ANDREWS [continuing]. But, more importantly, you did acknowledge the Constitutional principles that my friend just talked 

about because you put a religious exemption in the rule that you 

put forward. So we thank you for being sensitive to that. 

We have heard a lot of dark predictions this morning about terrible things that are going to happen as a result of the Affordable 

Care Act. And I think it is important that we get some context and 

look at the sources of those predictions and how they did on some 

of their prior predictions about the Affordable Care Act. 

We heard from your critics and critics of the Act that premiums 

would skyrocket in the private sector, as a result of the Act. But 

we hear from the Kaiser Family Health Foundation, this very 

morning, that the medical loss ratio provisions that you were overseeing will likely yield $1.3 billion dollars this year, in rebates to 

payers of health care premiums, because of the quality of the law. 

We heard it this morning, that the new IPAP would result, and 

I am quoting, in ‘‘$500 billion in Medicare cuts.’’ A more accurate 

statement is that if the growth of Medicare spending continues on 

the same, lower glide path that it has been on for the last 18 

months, my understanding is the IPAP provisions would never kick 

in because we would be below the projected growth rate and there 

wouldn’t be any IPAP decisions or recommendations. 

We heard, this very morning, that Medicare Advantage is in 

great peril and, literally, falling apart because of the Affordable 

Care Act. It is my understanding that your department released a 

report several weeks ago that said Medicare Advantage premiums 

are 7 percent lower than they were last year and enrollment is 10 

percent higher than it was last year. 

And then, finally, although we don’t hear much about them anymore, we heard for years about the death panels. Let me just ask 

you that question. Has your department formed a committee that 
46 

votes on whether any person in this country gets medical care or 

not? 

Secretary SEBELIUS. No, sir. 

Mr. ANDREWS. Are you obligated to do so under the law? 

Secretary SEBELIUS. Absolutely not. 

Mr. ANDREWS. Okay, well, we heard, you know, for months, that 

this was eminent. So, now, we are hearing this morning about a 

prediction that, unfortunately, may come true if Congress makes 

the wrong decision this week. And that is that the Prevention Fund 

that you oversee would be drained in order to make this Hobson’s 

choice between making college more affordable and making preventive health care available to people. 

Now, I want you to answer this question for us—if a young 

woman is at the age where she thinks it is the right time for her 

to start to get cervical and breast cancer screenings to take proper 

care of herself and she is uninsured, and she does not have a sufficiently high income in her pocket to pay for those tests and those 

screenings, is one of the sources that she might receive that screening from the Prevention Fund that we are talking about this morning? 

Secretary SEBELIUS. Yes. 

Mr. ANDREWS. What would she do if that Prevention Fund did 

not exist? Where would she get that cervical or breast cancer 

screening? 

Secretary SEBELIUS. It is possible that she could qualify for a 

program but what we know is, right now, unfortunately, there are 

millions of women in the situation that you have described and 

they go without the screening. What we know about breast cancer 

is that if it is found early, it has got a 90 percent survival rate. 

If, indeed, it is found later in the disease progression, the survival 

rate drops to less than 30 percent. So she would be in a very precarious situation, not being able to identify—— 

Mr. ANDREWS. She, sort of, just opts for the malignancy lottery. 

She hopes that she gets a winning ticket and doesn’t have that 

problem. Ten percent of the country’s health care expenses are attributable to obesity and Type 2 diabetes. Are there preventive 

services offered for Type 2 diabetes under this Prevention Fund 

that we are talking about? 

Secretary SEBELIUS. Yes, there are. 

Mr. ANDREWS. And what would happen to people if that fund 

were removed? Where would they get their services to begin to 

manage their diet and their exercise and their blood sugar, to avoid 

further complications? 

Secretary SEBELIUS. Again, we don’t have to look very far because the Prevention Fund is relatively new. So the kind of costs 

that not only are imposed upon people’s shortened lives and their 

family for loss of a loved one, and their reduced productivity to 

their employer, but the kind of health care costs are a part of what 

is driving health care in this country on an ever-increasing pace. 

We pay lots of money, private insurers, public insurers, hospitals, 

taxpayers, for chronic disease and diabetes and obesity and smoking are underlying those chronic diseases. So we know that anything that can reduce those chronic disease onsets will, indeed, 

save money, save lives, save productivity, in the long run. 
47 

Mr. ANDREWS. Thank you, Madam Secretary. 

Thank you, Mr. Chairman. 

Chairman KLINE. I thank the gentleman. 

Dr. Heck? 

Mr. HECK. Thank you, Mr. Chairman. 

And, thank you, Madam Secretary, for being here. I have enjoyed 

the discussion this morning and appreciated you acknowledging the 

difference between access to health insurance and the access to 

health care, in the answer to the question from my colleague from 

Ohio; certainly the two are not synonymous. And, with fewer 

health care practitioners, true access to health care will, obviously, 

be impeded. 

As you know, the Association of Medical Colleges projects that, 

by 2020, the U.S. will be facing a shortage of 91,500 physicians, 

both specialists and primary care docs. I am concerned that in a 

time when we need to grow the physician workforce, and we have 

heard you reference the investments in health care workforce in 

the Affordable Care Act, that the Administration is actually proposing cutting Medicare support, physician training and the critical 

services provided by teaching hospitals. 

It is estimated that the President’s proposal to cut Medicare IME 

payments by 10 percent will cost America’s teaching hospitals over 

$685 million annually and would severely impact their ability to 

train the next generation of physicians. So can you explain the Administration’s rationale behind this cut when, throughout the debate on the Affordable Care Act, and here this morning, we have 

heard about the new investments in growing the health care workforce? 

Secretary SEBELIUS. Well, again, Congressman, I think that the 

workforce issue is one that we have tried to focus on well before, 

even, the debate on the Affordable Care Act began because it is a 

situation that was looming in this country with an aging population and not nearly enough health care providers. 

And, so, we are really reassessing all the tools that we have 

throughout the department with graduate medical education, with 

Medicare, with the National Health Service Corps, with training of 

community health workers around some medical home models, 

with a variety of strategies to try and increase the pipeline of medical providers. And, not only increase our pipeline, but try and 

refocus on primary care providers, gerontologists, nurse practitioners, and others, who will deliver the kind of primary and preventive care we think is so important. 

Mr. HECK. Well, and I appreciate using all those tools but, the 

fact is, cutting IME reimbursements to teaching hospitals cuts the 

pipeline. We can give Pell Grants to get them through college. We 

can get them into the health profession’s Student Loan Re-payment 

Program after they are done but they still need to go to a residency 

program. And decreasing IME funding will result in fewer residency slots, which will result in fewer doctors. 

So, again, I am caught because there is a lot of talk about investing in health care workforce yet there is significant cuts to training 

the physicians of tomorrow. 

And, with that, Mr. Chairman, I would like to yield the rest of 

my time to my colleague from South Carolina, Mr. Gowdy. 
48 

Chairman KLINE. Let me interrupt for just a minute. We have 

had, apparently, an operator error in our light system. You have 

about 11⁄2 minutes. 

Mr. GOWDY. I thank the gentleman. 

Madam Secretary, I think the last time you were here I asked 

you about tort reform. And I don’t think it was the most recent 

State of the Union, it might have been the one before that, the 

President mentioned tort reform, specifically, in his State of the 

Union address. The House just passed H.R. 5, which is our version 

of tort reform. 

Do you know whether you or the Administration took a position 

on H.R. 5? And what forms of tort reform would you support? 

Secretary SEBELIUS. Congressman, I did not take a position on 

H.R. 5. I know that the President has said, from the outset, that 

he certainly opposes anything that imposes caps on injured patients and is also not supportive of programs that pre-empt the 

state court system. 

We have, underway, a series of efforts looking at strategies that 

both lower liability rates for practicing physicians, increase safety 

initiatives and compensate injured patients more promptly, that 

are yielding, actually, some very promising results. And I would be 

happy to provide that data to you. They are in place in hospital 

systems, in provider groups and in states across the country. 

Mr. GOWDY. What about tort reform for Medicare, Medicaid, TriCare, Federal Bureau of Prisons; things that are inherently Federal. I understand he doesn’t want to take over the state’s civil justice system but what about tort reforms? If 88 percent of all the 

payment comes from one of the Federal providers, what about tort 

reform that connects Medicare, Medicaid, Tri-Care, Federal Bureau 

of Prisons? 

Secretary SEBELIUS. I have no idea what you are putting under 

an umbrella of tort reform so that is an impossible question for me 

to answer—court claims act—— 

Mr. GOWDY. I am aware of that. 

Secretary SEBELIUS [continuing]. Where he provides a limit on 

any suit that is against a Federal entity so what—— 

Mr. GOWDY. Are you opposed to caps for non-economic damages 

in all instances, pain and suffering caps? 

Secretary SEBELIUS. Again, Congressman, you show me the bill 

and I would be happy to take—— 

Mr. GOWDY [continuing]. H.R. 5. 

Secretary SEBELIUS. We don’t really deal in the tort reform 

arena; that isn’t our area in Health and Human Services. We are 

trying to avoid errors to patients, though. We are trying to help 

hospital systems limit the number of cases where a lawsuit would 

be brought. 

I believe in prompt payment to victims. I, certainly, believe in 

helping health care providers have affordable rates in malpractice 

coverage. Most of that experience comes from former lives; it is not 

an area that I deal with day in and day out today. 

Chairman KLINE. Sorry, the gentleman’s time has expired. 

Ms. Woolsey? 

Ms. WOOLSEY. Thank you, Mr. Chairman. 
49 

Thank you, Madam Secretary, you are amazing. I know you 

know, and I am going to repeat what others have said; tomorrow 

the Republicans are going to bring to the floor legislation to postpone their student loan interest increase rate that is included in 

their Republican Ryan budget. That would raise the interest rate 

to 6.8 percent over the current 3.4 percent. 

In so doing—we are glad they want to postpone it—I am. But 

they want to pay for it out of the Prevention Fund; that is their 

offset. The Democrat offset would be to end tax subsidies for big 

oil companies. We think that is where you go for offsets, not from 

the people you are trying to help in the first place. 

Speaker Boehner refers to the Prevention Fund as a ‘‘slush 

fund.’’ Well, that slush fund is already—it is not a slush fund. That 

fund, that Prevention Fund, is already being accessed. And some 

of the—and you know what that fund provides for us. What I 

would like you to talk about—the other people have, kind of, 

missed this one. It is increasing child immunization and screening 

for newborns. 

What happens if these immunizations are not made available? 

What is going to happen to these children and our society at large? 

And what happens if newborns aren’t screened? Why do we care? 

Secretary SEBELIUS. Well, Congresswoman, what we know is that 

the Children’s Immunization Program, which is, I think, one of the 

great health successes of, frankly, the last century, to get our children into a situation where they now have resistance to a lot of 

deadly and infectious and preventable diseases. It is an investment 

that the health studies show returns about $10.00 for every dollar 

invested. 

It is significantly funded through the Prevention Fund; that plus 

the operators at—at the Centers for Disease Control and Prevention, who have public health laboratories in states across the country, to fund health professionals in states across the country so we 

can both track disease surveillance and prevent disease. It is a 

huge payoff. We know what happens in countries where the immunization rate is far lower and children die. 

Ms. WOOLSEY [continuing]. Children die. And, if newborns aren’t 

screened, what do you find—what do we learn when newborns are 

screened? 

Secretary SEBELIUS. Well, again, I think the screening is advantageous because what it does is highlight, at the very beginnings 

of life, what are the issues that may be complicating that child’s 

ability to succeed and have a healthy and prosperous life. So addressing it early, finding problems early is not only saving those 

children from potentially threatening disease but a lifetime of 

health issues. 

Ms. WOOLSEY. Thank you, and what impact would using that 

fund to offset—to do away with that fund, virtually, what impact 

would that have on community health centers? 

Secretary SEBELIUS. Well, I think that it has a significant impact 

across the board. And, I think, Congresswoman, your earlier issue 

raises just a false choice. In America, we should both invest in the 

education of our children and not allow student loan rates to double, as they are scheduled to do in July, which would make student 

loans far less affordable to working class families. 
50 

And we would have kids drop out of school and not access a college degree. And choose between that and keeping our children 

healthy in the first place so they can get to college. So I think there 

is a choice here that is not—there are, clearly, ways that student 

loans can be funded other than destroying the Prevention efforts, 

which are finally underway in this country, after decades of talking 

about them. 

Ms. WOOLSEY. Well, thank you, because I agree with you, of 

course. You know, the Affordable Care Act provides states with 

millions of dollars in grants to strengthen statewide insurance review programs. My state of California has benefitted, with $5.3 

million to fight unreasonable premiums. 

And the California department insurance recently reduced four 

rate increases, by an average of 9.65 percent, saving 87,000 Californians; a total of $1.66 million, per month, in premium increases. 

I think—— 

Chairman KLINE. The gentlelady’s time has expired. 

Mr. Ross? 

Mr. ROSS. Thank you, Mr. Chairman. 

Madam Secretary, thank you for being here. You know, when the 

President started his campaign for health care reform, he talked 

about a health care crisis. Over time, when it didn’t seem to be getting traction, it turned into a health care insurance crisis. And my 

question to you is—would you not agree that health insurance carriers are an indispensable party, in the aggregate, to the resolution 

of affordable and accessible health care in this country? 

Secretary SEBELIUS. That health care insurers are indispensable—— 

Mr. ROSS. Correct. 

Secretary SEBELIUS [continuing]. Is that the question? I think 

that is what the President believes, which is why he built the new 

system around the private health market. 

Mr. ROSS. Well, I don’t think he built it around the private 

health market because I want to make sure we understand. As 

much as I don’t like writing my premiums and as much as I think 

insurance companies are their own worst enemies, health insurance, as in every insurance, is private capital backing a risk. When 

the government gets involved in the business, it’s government dollars; it’s taxpayer dollars, covering that same risk or being part of 

that same risk. 

My question to you is, in light of where we are with this health 

care reform now before the Supreme Court, should we find a mandate to be un-Constitutional—and you have addressed affordability 

and accessibility in your opening, and you talked about market 

forces. But would it not be in the best interests of every American 

to have interstate sale of health insurance, over policies that can 

meet the demands of individual choice? Would that not create a 

competitive environment that would bring price stability and keep 

the government out of being in the business of funding health care? 

Secretary SEBELIUS. Congressman, I have been involved in the 

health insurance market for decades and what we have is a private 

health insurance market that, frankly, is fully able to operate in 

market strategies and decreasing in members’ year in and year out. 
51 

The health insurance rates skyrocket, fewer people, particularly, 

young and elderly people drop out—— 

Mr. ROSS [continuing]. Right. We can do assigned risk pools to 

take care of pre-existing conditions. 

Secretary SEBELIUS. [Off mike] 

Mr. ROSS. Yes, we can. We have done it in other areas. We can 

also require that there be more availability of choice to consumers 

by allowing for interstate sale. But, more importantly, we can 

incentivize wellness if we make it part of the choice that the consumer has. 

What we are doing here is the same thing we have done to the 

Student Loan Program and the health—we have nationalized it, 

suppressed the rates, and now we are telling the American public 

that if you want to have a student loan at all, you have got to come 

to the Federal government. We have taken away competition. We 

have taken away choice and we have taken away market forces 

that are absolutely necessary if the individuals are going to want 

to have the coverage they deserve at the price they want. 

Secretary SEBELIUS. Well, again, sir, I think you have 

mischaracterized what the new exchanges will do, which is offer 

competitive choice in a private market strategy around—it does get 

rid of some of the most onerous rules of insurance companies; they 

can’t any longer kick people out because of pre-existing conditions. 

They can’t charge women 15 to 20 percent more than they charge 

males for the same disease. They cannot operate with rules that rescind an insurance plan if you make a technical mistake. They 

can’t put a lifetime limit on caps but they will compete on the basis 

of price and quality. 

Mr. ROSS. How do I respond to my constituents who, back home, 

said, ‘‘I was told I could keep my doctor but now my doctor won’t 

keep me because of the reimbursement reductions that are being 

done in Medicare?’’ 

Secretary SEBELIUS. There have been no reimbursement reductions—— 

Mr. ROSS [continuing]. There will be. But we just argued over 

this 6 months ago, in trying to do a piecemeal approach to guaranteeing that our—— 

Secretary SEBELIUS. A long-term approach would be much preferable and we would love to work with you around a long-term approach. 

Mr. ROSS. And what are you saying about giving student loan 

forgiveness, then, to physicians out of school, that decide they want 

to sign a contract with the Federal government to handle Medicare 

patients? 

Secretary SEBELIUS. I am sorry, say—— 

Mr. ROSS [continuing]. Incentivize medical students to have a 

loan re-payment program if they will commit so many years to taking Medicare patients. 

Secretary SEBELIUS. Well, sir, right now we have 98 percent of 

doctors involved in Medicare and it hasn’t been a problem. The 

problem is that there is no long-term solution to the sustainable 

growth rate and that looms—— 

Mr. ROSS [continuing]. But I won’t get into that now. I want to 

ask you real quickly because—CBO Director, Doug Elmendorf, tes-
52 

tified that ‘‘Obamacare’’ would cost 800,000 jobs. March 13th of this 

year, CBO released a projection that the new health care law will 

cost $1.76 trillion over the next 10 years, nearly double the $940 

billion estimate provided when it was signed into law. 

Have you or anyone in your administration discussed this with 

the President? And how do you reconcile this increased exponential 

cost, in light of the fact that this economy doesn’t seem to be doing 

too well, either in revenue generation or in spending cuts? 

Secretary SEBELIUS. Sir, I am not sure of the precise quote. I 

know the 800,000 job loss is not, necessarily, a job loss; it was the 

projection by the Congressional Budget Office that more people 

would have the ability to retire earlier, choose other options, who 

are now job locked because they are terrified of losing—— 

Mr. ROSS. The cost was highly—— 

Secretary SEBELIUS [continuing]. Health coverage. The cost differential, I can get the quote. 

Mr. ROSS. [Off mike] 

Secretary SEBELIUS. The CBO continues to suggest that the Affordable Care Act will, indeed, reduce the deficit by over $100 billion the first decade and close to $1.1 trillion over the second decade; that is—those numbers continue to be updated and, so, I 

would be happy to respond in writing to what, exactly, you have 

quoted there. I don’t know. But the $1.1 trillion deficit reduction 

is an updated number from CBO. 

Chairman KLINE. The gentleman’s time is expired. 

Mr. Hinojosa? 

Mr. HINOJOSA. Thank you, Mr. Chairman. 

Secretary Sebelius, over the past 2 years, the Centers for Medicare & Medicaid Services, or CMS, have been working to implement new operating systems that will allow for CMS to process 

claims in compliance with the new HIPAA requirement. In January 

of this year, CMS began the processing of those electronic claims 

through HIPAA Version 5010. 

And it is my understanding from providers who have visited my 

office, that this change has been met with some reimbursement 

delays, in particular, for dual-eligible patients. Therefore, I would 

like to submit a question for the record to ask you to work with 

me and my staff to see what can be done to ensure these delays 

can be avoided in the future because they say that it has been, in 

some cases, taking 60 days to get paid. 

Madam Secretary, the Prevention and Public Health Fund is an 

opportunity to invest in the health services before people are sick, 

instead of paying for more costly care. This is important for racial 

and ethnic minorities, who continue to have higher uninsured rates 

and are less likely to gain access to health care when they really 

need it. What are the specific ways in which the fund is being used 

to mitigate the impact of these differences in access? 

Secretary SEBELIUS. Well, Congressman, first of all, we look forward to working with you around the—— 

Mr. HINOJOSA. Thank you. 

Secretary SEBELIUS [continuing]. Delayed billing issue and take 

a strong look at it because, certainly, the health care to, particularly, the poorest, oldest Americans is a high priority. In terms of 

the Prevention Public Health Fund, you are absolutely right that 
53 

identifying early, preventing causes and, even, dealing with disease 

at the earliest stage, is not only saving lives but saving dollars. 

So the Prevention Fund is investing in everything, as we have 

talked about, from immunization of kids to disease control to breast 

and cervical cancer screening for uninsured Americans; a whole series of strategies. Smoking cessation, which we know now that tobacco causes about 400,000 premature deaths a year in this country, has a huge toll on workforce productivity, and any effort to reduce the smoking rates pays off. 

I think, in the case of particularly the minority communities, the 

prevalence of chronic disease is significantly higher. Diabetes rates 

are higher, blood pressure issues are higher, obesity rates are higher. So efforts to, really, develop strategies that work, have access 

to prevention and care, supporting everything that we are doing, 

like public housing that gives, now, residents smoke-free options so 

they and their kids don’t have to live in situations of secondhand 

smoke, delivering clinical preventive services in a much more userfriendly fashion, are all ones that will save lives and lower costs. 

Mr. HINOJOSA. It is clear that health reform is making a difference for communities of color. Nearly 1.2 million young adults 

of a racial and ethnic minority background were able to get on 

their parent’s plan because of this Affordable Care Act. And we are 

very happy about that. This includes, nearly, 750,000 Latino adults 

under the age of 26. This is progress but we all know that an insurance card isn’t always enough. 

In fact, the Agency for Health Care Research and Quality reported that disparities in health care treatment between whites 

and minorities have worsened every year since the report was first 

made public. What investments does the President’s budget make 

to eliminate racial and ethnic disparities that affect access to quality care? 

Secretary SEBELIUS. Well, I think there is a series of strategies; 

more health centers in underserved populations, bringing health 

care providers to where people live, additional, I think, support for 

minority health workers, knowing that having culturally competent, language competent workers dealing with patients is incredibly important, certainly expanding insurance coverage. 

We know minority communities are far more likely to be uninsured than insured. So, looking forward to 2014, when there will 

be insurance coverage available at an affordable rate and that will 

have a huge impact on helping the health disparity situation. Additional research is in the budget on some of the health disparity 

strategies and, certainly, looking at the prevention, which now is 

available to seniors without co-pays, with Medicare it is available, 

with private insurance plans. So prevention will be front and center, in terms of health care responses. 

Mr. HINOJOSA. Thank you—— 

Chairman KLINE. I am sorry to interrupt. 

We are, Madam Secretary, mindful of your hard stop at 12:30. 

We have three more members with questions so we are going to be 

almost exactly on time. 

Mrs. Roby? 

Mrs. ROBY. Thank you, Mr. Chairman. 
54 

Thank you, Madam Secretary, for being here. As you may know, 

the Catholic TV station, the Eternal Word Television Network, 

EWTN, is located in my home state of Alabama. And EWTN does 

not fall under the small umbrella of the religious exemption of a 

religious employer, nor do many hospitals, charitable service organizations and universities. And I understand that you, along with 

the Administration, are working on a, quote—‘‘accommodation’’ for 

groups that fall in this category. 

But my question is—putting aside any future accommodation, 

why is EWTN, and similar religiously affiliated entities, not completely exempt from covering these services, especially when these 

drugs, such as the ‘‘morning-after pill’’ and services fundamentally 

contradict their moral belief? 

Secretary SEBELIUS. Congresswoman, the Affordable Care Act 

made it clear that, in the future, insurance policies should include 

health benefits essential to women’s health care and, often, they 

are missing. And, so, we asked the Institute of Medicine to give us 

an analysis of what were the key preventive health services for 

women. They included everything from domestic violence screening 

to maternity care to contraceptive coverage. 

We then looked to state law; 27 states in the country have mandatory contraceptive coverage. And we looked at the various kinds 

of exemptions that were currently present in the majority of states 

around the country—— 

Mrs. ROBY [continuing]. Let me, maybe, ask—— 

Secretary SEBELIUS [continuing]. That is why we developed 

the—— 

Mrs. ROBY. Right, let me get to it because I only have a short 

amount of time and this Chairman is pushing it. Why are you defining some religious organizations as acceptable for the full exemption and others as only religious enough to qualify under some 

other—— 

Secretary SEBELIUS [continuing]. Again, we were guided by the 

exemption that was in place; we didn’t invent this exemption. The 

exemption that was in place in the majority of states that had any 

religious exemption, and a number of them don’t have any, is what 

we proposed, with an additional issue that we, in the year and in 

the ANPRM that we have just issued, we will provide a series of 

strategies for religious employers who currently do not offer contraceptive coverage as part of their health plan, to have the opportunity to employ one of these strategies. 

The mandate is not to the employer; it is to the insurance company. Insurance companies will offer preventive services to women, 

at no cost to those women, and religious employers will not have 

to purchase, or refer, or pay for, that coverage. 

Mrs. ROBY. All right, well, let us—we have talked a lot this 

morning about the preventive care and, so, I just have, very quickly, a series of questions. And I want to make sure that we are very 

clear on those. And yes or no is good. Is your testimony that without the Preventative Fund, there would be no more screenings for 

children anywhere? 

Secretary SEBELIUS. Of course that isn’t. 

Mrs. ROBY. Okay. Isn’t it true that the statute does not direct 

preventive funds to any specific program? 
55 

Secretary SEBELIUS. It is the Prevention Fund and we have 

worked with bipartisan members of both—— 

Mrs. ROBY [continuing]. And isn’t it also true that the President’s 

very own budget made cuts to the Preventative Fund? 

Secretary SEBELIUS. The President’s budget did recommend, over 

10 years, a reduction in the Prevention Fund, certainly not an 

elimination of the Prevention Fund. 

Mrs. ROBY. But there were cuts to the Preventative Fund—— 

Secretary SEBELIUS [continuing]. There was a reduction in the 

Prevention Fund, made in the President’s budget, which would still 

leave about a billion-plus dollars a year to invest in these critical 

health programs. 

Mrs. ROBY. Okay. And, since I have a little bit more time, I am 

going to circle back. I wanted to make sure I got these questions 

in. All plans after 2014 are expected to include coverage for sterilization and contraception, including drugs that some believe can 

cause abortion, i.e. the ‘‘morning-after pill’’ that I have already 

mentioned. If an employer, such as EWTN, that I mentioned, the 

Catholic television station, has a moral objection to such coverage, 

what penalties will be imposed on the employers or, as you clarified, the insurance providers? 

Secretary SEBELIUS. Again, the mandate is not on the employer; 

this is a direct—— 

Mrs. ROBY [continuing]. What penalties will they suffer if these 

employers do not offer these services? 

Secretary SEBELIUS. Well, those plans won’t be certified to be 

sold in the market. 

Mrs. ROBY. Okay. 

Mr. Chairman, I yield back. 

Chairman KLINE. I thank the gentlelady. 

Mr. Kelly? 

Mr. KELLY. Thank you, Chairman. 

Ms. Sebelius, thanks for being here today. I had a question— 

early on, Dr. Roe had asked you some questions. We held a hearing, back in western Pennsylvania, regarding lawyers and their approach to the Patient Protection Affordable Care Act and the costs 

that were going to be involved. 

And maybe I misunderstood, but you said that the reason that 

there is a—that the people don’t know—there is a lot of misconceptions that are still out there. You still do believe there are a lot of 

misconceptions about the protection plan of the Affordable Care 

Act? 

Secretary SEBELIUS. I do. 

Mr. KELLY. Okay, why do you think there are so many misconceptions? 

Secretary SEBELIUS. Well, I think that there was about a yearand-a-half of mistruths and erroneous debate, that was driven by 

24/7 news coverage, and people still believe that there are elements 

of the law that not only were never part of the law in the first 

place, but they believe that those will come to pass. I find people 

every day who—— 

Mr. KELLY [continuing]. Yes, and I also do. And, maybe, part of 

reason is the rules haven’t been written yet. Let me read to you 

a part of the testimony from Will Knetch, who is the President of 
56 

Wendell August Forge: ‘‘I believe that we, as a nation, are about 

to walk into an unknown abyss that, humbly, I believe our country 

will face with full force and effect, the implementation of the 2010 

health care bill in 2013 and 2014. The sheer monstrous size of the 

bill intimidates most Americans and provides so many unknowns 

for the business community that it is scary.’’ And to verify it, he 

quoted Speaker Pelosi, during the voting on the bill, ‘‘We have to 

pass it so we can read it.’’ 

In other words, nobody really knows all the tentacles of this bill 

and that is bad for America and it is bad for business. Now, I 

would just contend to you that there is a lot of misconceptions, especially for people who have never run a business and, especially, 

for people who come here thinking that they know what is best for 

everybody at every step of the way. 

Is there some reason that, after 2 years, we still don’t have the 

rules and regulations because you really—if there is a misconception, it would be because this Administration never really made it 

clear what the rules and regulations are going to be. So that is not 

a matter of people sticking pins in a voodoo doll; this is a matter 

of an Administration that has never clearly, never clearly, put out 

what the rules are and never, really, clearly told employers what 

it was going to cost. 

Now, I know a little bit about that because every 2 weeks I do 

have to make a payroll. And it is not funded by the American taxpayers; it is funded by the success of my business. I can’t tell you 

how uncertain most employers are today as to what is it going to 

cost them as employers, as business owners. We still don’t know, 

do we? 

Secretary SEBELIUS. Sir, I would just—— 

Mr. KELLY [continuing]. Answer will be ‘‘yes’’ or it will be ‘‘no.’’ 

Secretary SEBELIUS. We are writing rules and regulations—— 

Mr. KELLY [continuing]. So we still don’t have the rules and regulations 2 years after the bill was passed? 

Secretary SEBELIUS. Excuse me, we do not have every rule—— 

Mr. KELLY [continuing]. Do not have the rules, is that the answer? 

Secretary SEBELIUS. We don’t have 100 percent of the rules—— 

Mr. KELLY. Okay, so we don’t really know what the costs are 

going to be? 

Secretary SEBELIUS. That is exactly what—— 

Mr. KELLY. So the misconceptions are based on the fact that the 

Administration has not yet come up with the rules and regulations? Passed the law, didn’t need one Republican vote to get it 

passed—and I hear how terrible the Republicans have been—— 

Secretary SEBELIUS. Well, there was a Republican vote but—— 

Mr. KELLY. Okay, all right. You and I can, maybe, agree on a lot 

of things. I would agree on this and I would say that any business 

owner is scared to death of this. They have absolutely no idea what 

it is going to cost them. Now, it is going to cost the business owner 

one of two ways; either increased costs to him or increased taxes. 

Is that a given? I mean, this money isn’t just going to fall out of 

the sky; this increased cost—this health care bill is going to cost 

an awful lot of money. 
57 

Secretary SEBELIUS. I think for any small business owner who 

currently is providing health coverage, the estimates are, by every 

economist who has looked at this, CBO, et cetera, is that costs will 

go down, not up. 

Mr. KELLY. We don’t have the rules yet. We don’t have the finals 

rules. We don’t know. You can’t draw a conclusion on something 

you don’t know—— 

Secretary SEBELIUS. I understand, but I keep being cited all 

kinds of people who have drawn all kinds of conclusions. We are 

working—— 

Mr. KELLY [continuing]. My question to you is if there are no 

rules and regulations, how can you—— 

Secretary SEBELIUS [continuing]. There are plenty of rules and 

regulations—— 

Mr. KELLY [continuing]. Excuse me, I am in the automobile business. Do you know what you are asking people to do? 

Secretary SEBELIUS. I do—— 

Mr. KELLY. You are asking people—I said I am in the automobile 

business. I would imagine that somewhere in your life you bought 

an automobile. Can you imagine walking into a place of business 

and saying, ‘‘I want to buy a car,’’ and the dealer saying, ‘‘Okay, 

fine, I have got a car for you, can’t tell you what is in it, can’t say 

how much it is going to cost you, can’t tell you how much the 

monthly payment’s going to be. But I want to go ahead and start 

paying for it today and 4 years from now you can take delivery.’’ 

Secretary SEBELIUS. And, well before people have access to the 

health care changes, they will know what they cost. 

Mr. KELLY [continuing]. I understand, but they don’t know. It is 

2 years later. I got to tell you, this is either inept, an inept Administration, or people who truly don’t actually know at all how to 

treat the American people fairly. This is going to fall on the backs 

of the American taxpayers; that is who it is going to fall on. 

This is not some benevolent monarchy that supplies all these 

wonderful services to people. The American taxpayers are the ones 

that pay for this. And I have only been here 15 months but I have 

never seen such a disconnect to the real world, in the way that 

things work inside the Beltway. There is such a lack of understanding as to what people have to do, in order to pay their fair 

share, play within the rules, and live within their means. So—— 

Chairman KLINE. The gentleman’s time has expired. 

Mr. Petri? 

Mr. PETRI. Thank you very much, Mr. Chairman. 

I have a couple of questions. First, I have heard from a number 

of constituents, including employers, in the area that I represent 

in Wisconsin, about the importance of health savings accounts. And 

health savings accounts offer a more affordable option that puts 

the consumer in control of their health care plan decisions. So I am 

concerned that some of the regulations being written to implement 

the Affordable Care Act, most importantly the medical loss ratio 

regulations, could jeopardize consumer access to these types of 

plans. 

Do you think consumer access to health savings account-type 

plans is important? And, as you write regulations for medical loss 

ratio and other components of the Affordable Care Act, are you tak-
58 

ing steps to ensure that health savings account plans are able to 

compete on a level playing field with other, more comprehensive, 

plans? 

Secretary SEBELIUS. Well, I think, Congressman, the impact that 

you may be referring to is on the so-called ‘‘mini med’’ plans, some 

of which are offered along with an HSA. There are no direct implications on the health savings account. But the ‘‘mini med’’ plans, 

which do not offer a full package of health insurance, are not currently subject to the medical loss ratio but they will no longer be 

insurance plans post-2014. 

Mr. PETRI. In another area, Section 9010 of the Act includes an 

annual fee on health plans. And I am concerned about two, possibly 

unintended, consequences of this fee. First, there are many managed care plans in my state and I am sure in others that serve exclusively to low-income individuals who are on Medicaid or who are 

dually eligible for Medicaid and Medicare. 

These types of plans were created to help coordinate care for 

these individuals, both to lower costs and to improve quality. Because the plan revenue comes directly from state Medicaid programs, the tax, as applied to these plans, will ultimately be paid 

by the state government and by the Federal government. So we are 

taxing ourselves, raising the costs of Medicaid. Are you concerned 

about this, sort of, anomalous situation? 

Secretary SEBELIUS. Well, certainly, Congressman, the access to 

health insurance for low-income Americans is in jeopardy. And we, 

certainly, don’t want to compound that situation. I think that the 

fee that is being looked at is a partial offset to the millions of new 

customers that health insurers are looking forward to serving 

through the insurance exchanges. 

So, we think, on balance, the number of new customers will far 

outweigh the modest fee going into the plans, because currently 

they are really on a situation where they are losing customers day 

in and day out as health costs spiral. But they are looking forward 

to, you know, 15, 17 million Americans who will be signing up for 

health insurance. 

Mr. PETRI. And, secondly, in connection with the fees, we have 

a lot of integrated health care providers in our state who offer their 

own health plans; Marshall Clinic and so on. These providers have 

been very effective at using their plans to coordinate care for patients to reduce costs and to improve quality. 

Concern is that this health plan fee will be disproportionately 

harmful to these plans because they are smaller and may be less 

able to absorb these additional costs. Do you have any concerns in 

that area? 

Secretary SEBELIUS. Well, I think that the kind of coordinated 

care strategy that often is available in an integrated health plan 

is exactly the kind of best practice that we are trying to encourage 

in systems across the country. And I have visited a number in your 

home state, which are some of the best, I think, in the country. 

On balance, I really think that the kind of more efficient care delivery is a strategy that, not only will pay off but—right now, we 

have got the financial incentives in the wrong places for the very 

plans you have described. We pay on volume and not on outcome. 
59 

So if you coordinate care, if you keep people healthier in the first 

place, if you reduce hospital admissions, you get penalized. 

I think what you will find is that those plans are exactly the 

strategies we are—in fact, they will be receiving enhanced payment 

through Medicare, through other strategies, going forward. So we 

are shifting a payment system that, I think, again, will not penalize those plans but, in fact, will appropriately pay for those plans 

for the first time. 

Chairman KLINE. The gentleman’s time has expired. It looks like 

the morning has expired. 

I want to thank the Secretary, again, for being here and sharing 

her time and expertise with us. 

I will recognize Mr. Miller for any closing remarks he may have. 

Mr. MILLER. Thank you very much. I am sorry Mr. Kelly left the 

room. This year, the automobile manufacturers put 15 million new 

cars on the road. I assume they didn’t just simply dump those on 

the automobile dealers. I assume they took time to ramp up the 

service department, to ramp up the sales department, to ramp up 

the warranties, to change their policies, and they knew that those 

cars were going to come on line in a period of time. 

Had we dumped 40 million uninsured people into this system on 

one day after we passed the legislation, I think there would have 

been a howl. The fact of the matter is, I think your department has 

done an amazing job in working with patients, with insurance companies, with hospitals, with doctors, with specialty people, with 

general practitioners, with all the health services, with the education institutions, so that, hopefully, in 2014, this nation will be 

ready for this. I can’t tell you, I hear all the time from people who 

are telling me, ‘‘Why did you wait until 2014?’’ because they want 

to go start their own business but they can’t risk health care for 

their spouse and their families. Maybe that is just in California, 

where we have a lot of innovative start-up companies, but I hear 

it all of the time from young people about job lock and that side. 

So I think you have done a very prudent job on that. 

We are out of time. You are out of time. I would just like to ask 

if I could prod you, in writing, for an update on how we are doing 

on complying with, and managing, mental health parity? I am getting more and more questions in the mental health community, 

and in my general community, about this. There is a great deal of 

concern. As you know, this was a very long struggle—— 

Secretary SEBELIUS. You bet. 

Mr. MILLER [continuing]. In the Congress to get this into—— 

Secretary SEBELIUS. And I would be glad to respond in writing. 

Thank you. 

Mr. MILLER. Thank you very much, Madam Secretary. Thank 

you for being here today. 

Chairman KLINE. I thank the gentleman. 

Again, I thank the Secretary—— 

Secretary SEBELIUS. Thank you. 

Chairman KLINE [continuing]. For being with us today. I think 

we have made it with—— 

Secretary SEBELIUS. It is brilliant. 

Chairman KLINE [continuing]. Twelve seconds to spare. There 

being no further business, the committee stands adjourned. 
60 

[Additional submissions of Chairman Kline follow:] 

t9.nitro ~tatts ~mat( WASHINGTON, DC 20510 

March 8, 2012 

Secretary Kathleen Sebelius 

U.S. Department of Health and Human Services 

200 Independence Avenue, SW 

Washington, D.C. 2020] 

Secretary Sebelius: 

We write to request the results oft!:e Head Start "Third Grade Follow-Up Study" that had 

been scheduled to be completed in September 2011, as well as information about the reasons 

why the release of that study has been delayed until September 2012. 

Congress and the American people deserve the opportunity to review the evidence about 

wheLher the Head Start program is benefiting the children that it serves. In 1998, Congress 

mandated that the Department of Health and Human Services conduct a national evaluation of 

the impact of Head Start on children served. In 2006, the Department awarded a follow-up 

contract to continue the evaluation of Head Start's impact through students' third grade year. 

We understand that the data collection for the "Third Grade Follow~Up" study was 

completed in the spring of2008. Four years s~ms to be a sufficient period of time for the 

Department and the researchers that conducted the data collection to analyze the results. 

Given the critical importance of understanding whether the Head Start program is 

benefitting the children it serves, we request the following information: 

.. Any reports (including drafts) that Westat or any other researchers involved with the project 

have conducted about the Third-Grade Follow Up study results. 

• Any reports (including drafts) that the Department has wr.tten analyzing the results of the 

Third Grade Follow-Up Study results. 

• An explanation why the Department decided to extend the Head Start study project period to 

September 2012 and further delay the release of this evaluation. 
61 

We also request that the Department brief our staffs about the status of this study and our 

questions. 

The American pcople--including the families. of the estimated 9Q4,OOO children currently 

enrolled--deserve to understand how this program is affecting the children it serves. 

We request an answer to this inquiry by March 16.2012. Thank you for your assistance. 

~aL f orn ,-_obu!'J1, :-'1D 

U.S. Senator 

Jl&Y/.t;:" Mike Enzi 

U.S. Senator 

'-~ Mvx~ Lamar Alexander 

U.S. Senator 

--==:: ~ ... --- Richard Burr 

1.1,S. Senator 

() / J?1 t/ r::;, r,:-Mccain U.S. Senator 
62 

DEPARTMENT OF HEALTH &. HUMAN SERVICES 

ADMINISTRATION FOR CHILDREN AND FAMILIES 

Office of the Assistant Secretary, Suite 600 

370 L'Enfant Promenade, S.W. 

Washington, D.C. 20447 

March 27, 2012 

The Honorable Tom Coburn, M.D. 

United States Senate 

Washington, D.C. 20510 

Dear Senator Coburn: 

Thank you for your letter concerning the follow-up of the Head Start Impact Study. Secretary 

Sebelius asked that I respond on her behalf. As noted in your letter, we anticipate a fall 2012 

release date for the third grade report. 

Congress gave us an ambitious mandate for evaluating Head Start, calling for an independent 

study that would be nationally representative, use rigorous random-assignment methods, and 

collect longitudinal data on a broad range of children's and families' outcomes. Congress 

directed us to assess not only the overall impact of Head Start but also variations in impacts 

among programs and children with different characteristics. 

The study first conccted data on three- and four-year-old children entering Head Start in the fall 

of2002. The children completed one year in Head Start by summer of2003, and we provided 

impact findings based on data from that spring in a report to Congress in 2005. The children 

completed their first grade year by the spring of 2006, and the study completed first grade data 

collection in summer 2006. Impact findings in the final required report to Congress were 

provided in January 2010, 

Data from the study are rich, and we have encouraged and supported the use of these data by 

other researchers, by placing the data collected through children's first grade year in a repository 

(http://www.researchconnections.org/childcarelresourcesl19525) for use by researchers. A 

number of rcsearchers have begun to use the data and publish their own analyses. In September 

2011, we awarded a grant to a consortium of researchers at New York University, MORe, and 

Harvard University to conduct analyses of the data focusing on questions that have posed 

particularly difficult methodological challenges. 

The Administration for Children and Families places a high value on transparency and openness 

in research and evaluation, as demonstrated by the comprehensive reports from this study already 

published (http://www.acf.hhs.gov/orograms/oore/hs/impact studylindex.html). We have 

ensured that reports from the study fully document methods used and comprehensively report 

findings. These detailed reports receive careful review to ensure that they are accurate, 

complete, and clear. 

While Congress specifically required studying children only through first grade, we have 

undertaken the third grade follow-up to continue learning from this important study. The foUow-
63 

[Additional submission of Mr. Roe follows:] 
64 

[Questions submitted for the record and their responses follow:] 
65 

rvf>ly 18,2012 

cc:\:~rVirrn:r": Uf\ EDuCJ\T!()~\; 

/\f\jf) Tl-1E V\!OFii<rOH,C(~ 

The Honorable Kathleen Scbclius 

Secretary 

United States Department of Hc('tlth and Human Sl!1 viees 

200 Independence A venue, SW 

Washington, D.C, 20201 

Denr Secretary Scbclius: 

Thank you for te!'ltifying at the committec's recent he,uing entitled, "Revieu,ing the President's 

Fiscal Yea/' 2013 Budget Pl'oposal/iJr the U5;. DepaJ'lmenf of Ilealth and HI/man Services," r appreciate roUl' participation. 

Enclosed arc additional questions submitted by committee members following the hearing. 

Please provide \vrittcn responses no later th~11FJ'lgay, ,JVlle 8 2012 for inclusioll in the.otlicj<Jl 

hearing ],(~C9rd. Responses should be sent to Cristin Datch ofthe committee staff. 

Thrmk you again for your contribution to the work of the committee. 

, JOHN KLINE /I Chairman 

Committee on Education and the Workforce 

Enclosures 
66 

The I Ionorable Kathleen Scbclius 

May 1 R, 2012 

Page 2 

Rep. John Kline (R-MN) 

1. The president's FY 2013 budget included 11 $11 J billion increase for health ins1lI'ancc 

subsidies, a 30 percent increase from last yem's budget. Given that there has been 110 

significant change in l<lw or economic nssumptions, is this increase due to an assumption 

that more people wil! lose their employer provided coverage and claim a s\'lbsidy than 

previously believed? 

2. Secretary Sebelius, we are all aware the Supreme Court reecntly heard oral argument:> 

regarding the constitutionality ofPPACA On the lnst day of oral arguments, Justice 

Kennedy alluded to the faet that it eould he judicial overreach to strike some parts of the 

law and leave others intact. The Court's opinion is expected in June. It is possible thc 

individual mandate, and potentially the entire law, could be found unconstitutional. 

Without debating the merits of the case, has the department hCgUll to prepare contingency 

plans for the possibility that the court wi!! strikc down all or pHrl oCPPACA? 

3. Recently, lIlTS announced the creation of the new Administration [01' Community Living 

that wi!] focus on strcngthcning assistance to seniors and people ,"vith disabilities. The 

committee has concerns regarding the efficacy o[ new offices. How will this ncw office 

help streamline service delivery 01' reduce duplication within the dcpartment? Will there 

be fewer federal employees working in these oftiees? 

4. The new Administration for Community Living proposes to consolidate the 

Administmtioll on Aging, the Office on Disability, and the Administration on 

Developmcntal Disabilities. The president's FY 2013 budget includes $1.95 billion for 

the Administration on Aging (AoA), an increase of $457 million over last year. The 

funding levels support 135 Full-Timc Equiv<l1ents, an increase of 14 employees. Why is 

III-IS requesting more funding ,md more FTEs if these offices are being consolidated? 

5. How will the new Administration for Community Living be fuuded? lIow will the funds 

be allocated amongst the various nging and disability programs? Does HHS have the 

<Hllhorily 10 er~at~ and fund this new agency without hmguage in <Ill appropriations bill? 

6. We ull(h.:rstand the new Administration for Community Living will share an 

administrator with thc subordinate Administration on Aging. How will the administrator 

serve effectively in these dual, overlapping roles? 

7. How will the new Administration luI' Community Living affect the department's plan for 

Oldcr Amcricans Act reauthorization? How will it affect the reauthorizatiotl of the 

Developmental Disabilities Assistance and Bill ofR..ights Act 0[2000? 

8. How can tht ocpnrtmcnt work to bettcr eoorciitlfltc services for the elderly across (III 

fedcral agencies? 

9. The president's FY 2013 budget proposal requests to move the Senior Community 

Service Emplo)'ment Progrmn (SeSEP) to IIlIS. This program ,:nls one of 47 duplicative 

workforce development programs identified by GAO in carly 2011. Why has the 
67 

The Honorable Kathleen Scbclius 

May 18,2012 

Page 3 

administration proposed to further fragment job training by moving this program out of 

the Depm1ment of Labor? Is the administration pl'Oposing this clwnge because it believes 

SCSEP is more about community service than workforce development? 

IO. 'l'he 20 10 reauthorization of the Child Abuse Prevention and Treatment Act (CAPTA) 

included a requirement thut J\CF conduct a study relating to immunity from prosecution 

for professional consultation in reporting instances of child abuse and neglect and submit 

a report (0 Congress. What is the status or this study? When will the report be submitted 

to Congress? 

11. What type of guid(lllee docs the department provide to Head Start and Early Head Start 

grantees on the appropriate w,e of funds fur conferences and events? I low docs the 

department monitor the use of funds for these (lctivitics? 

12. As you know, GAO released a report that highlighted egn::gious examples or waste and 

['raud in the I lead StHrt program in 2010, after which your department announced several 

reforms. Can you tell us how the department is implementing the promised changes? Cau 

you IdillS \Vith contidcncc IlInt enrollment fraud has becn eradicated in thL' program? 

13. As you mentioned in yom testimony, the department finally issued l'c-compctition rules 

tor HC(ld Stmt grantees as called for by the 2007 reauthoriz(ltion of the Head Stat1 Act. 

Despite being almost two years behind schedule, the cOlllmittee supports this effort to 

increase program quality. Last month, the re-competition process began tal' 97 service 

areas and is expected to include 100 additioml1 areas in the coming weeks. Can you tell 

us how the implementation is going thus hI'? 

14. The 2010 llead ,start Impact Study found the adv<lntages children gained from Head S\(llt 

yielded only a few significant outcomes that lasted through the end oftirst grade. The 

"Third Grade Follow-Up Study" was set to be completed last September, but has nov,' 

been delayed until later Ihis year. Considering data collection 101' the third grade study 

was completed in the Spring of2008, what is the cause for delay? Docs it havc anything 

to do with the implicalion:-; oftlw study's results for Head Start? 

15. Both YOll and Secrclary Duncan have requcsted $850 million for Race to the Top, 

induding "an ul1spceilil'd amount" that will be llsed [or the Early Learning Challenge 

competitive granl progwl11. What portion of Rm:.:c to the Top uo you rores(,.~c going 10 the 

Early Leall1ing Challenge? Why wasn't that included in your budget? 

l6. How docs the Race to the Top-Early Learning Challcnge ,""ark with existing carll' 

learning programs at (he stale level? How does it work with Head Start? 

17. The administration's budget requests ag(lin call for increascd spending on most health and 

human services progtams. What ellorts are you undertaking to make the department marc 

efficient? ('all you point to any real reductions in offices or staffing thall'etlect this 

eftort? 
68 

'I'he r lonorable Kathleen Sebdius 

May 18,2012 

Pagc4 

18, In recent ycurs, Congress has received numerous reports highlighting fraud and abuse in 

I11Hny health and human services programs, TIow arc you working to prevent waste and 

protect taxpayer daHnrs? 

19. How much money h<ls ACF and/or AoA spent 011 all cOllference~ and events ovcr each of 

the previowi four fiscal years? Please provide a brnlkdown of each e\'ent or conference 

plmmed by ACf and/or AoA since January 20,2009, and indic<lte which program the 

conference was associated with, what program office was the lead for the event, whether 

the cleparhn<.:nt contracted out plmming or management for either all or parl of a 

conference or event, hm'\' much the contract for these services was for, whcther the 

department has employees to plan events and conferenccs, and, ifso, why the scrvict:s 

were contracted out rather than planned by slaff. 

Rep. Jo" "Yil!;Qll(R·Sq 

I, During your testimony, you indicated Ihal "it is absolutely not corrcct" that TARe 

t1ndings trigger automatic regulatory consequences for regulated entities in the United 

States. Do YOll stand by that response, in light of the fact that ifTARC docs find that 

diesel cxhuust represents u known human carcinogen, the Occupational Safet), and Health 

Administration (OSHA) regulations (e.F.R. § 191 0.1200(d)(J), 191 O.1200(d)( 4)(ii» 

rcquire employcrs that utilize diesel engines to communicate this finding to employees 

via material safety dala sheets (MSDS)'! 

I. In your FY 2013 budget reqllest, you call for increased funding for new and duplicative 

programs, such as the Race to the Top-Early Lcarning Challenge and Child Care Quality 

Initiative. At the same time, programs like Head Start arc faced with examples of Wi:lste 

and fraud and revelations of horrific sarety violations among grantees, llow can you 

justify requesting funding tor new programs while your department is having a difficult 

lime overseeing its current programs? 

2. (jAO htls identified 69 separate early childhood edllcation and child t:are programs, 

totaling more than $25 billion and littered across 10 different federal agencies. What 

steps has the administration taken to ensure that the larger number of program.s isn't 

making it more difficult for low-income fnmilies to access services ,HId that the federal 

government isn't funding duplicative and inefficient programs? 

Rep. Duncan Hunter (R-Ct\) 

J. Private for-profi( organizations participate in statc preschool prograllls across the country. 

Many of these commercial organizations have a proven reputation of delivering highquality early child care <lnd cduc(ltional services. These providers, however, are deterred 

from participuting in Head Start because grantees aren't allowcd to keep administrative 

profits, Would you support allowing for-profit organizations to receive <l marginal profit 

on IIead Start grants as part of a broader effort to encourage greater competition and 
69 

The 1 Ionorablc Kathleen Sebelius 

Mol' 18,2012 

Page 5 

improvl: quality within the program'? How about if they can show an increase in student 

outcomes? 

Rep. Tim Walberg CR-MI) 

1. What is the operating 81atus of the Lake I .ynn mine tc!=;ting facility? 

2. In your testimony regarding the Diesel Exhaust in Miners Study (DEMS) conducted by 

NIOSH and NCI, you indicated to me that that the Department of Health and Human 

Services has complied with the committee's previous requests. However, the department 

has not yet fully complied with the cOlllmittee's multiple requests. When will the 

department release the following information to the committee and the representatives of 

the study pmticipants? 

A) }\I] information on vilal status of cneh cohort mcmber, including [allow-up, 

dale of death i;tnd cause of dt'(lth, 

B) All intonnatioll obtained in intcl'vie"ws, including smoking history (hoth active 

and passive), lifetime occupational history, medical history, fmllily medical 

history, 1lsual adult diet, and lise of respiratory protective equipment. 

C) The exposure datu files referred to in the fik, "DEMS_Di\TA_FILES", 

U) An identification of each hmg cancer case used in the case- conlrol study and 

the controls that were matched to the casco 

E) An identification of the specific cases included in each of the cohort study 

analyses. 

F) All data 011 exposures to other air contaminants including radon. asbestos, 

silica, respirable dust, and PAils from non-diesel sources, in a torm that wOllld 

permit reproducing the results in Table I of Silverman ct £1.1. (2012) and Table 2 of 

AtHield et al, (2012), 

G) The state mortality rates used in the 8MR analysis in Attfield et al. (2012). 

3. Occupational Safcty and Ilcalth Administration (OSIIA) regulations (C.F.R. § 

1910,1200(d)(3). 191 O.1200(d)(4)(ii» require American employers utilizing diesel 

engines to take specific actions if the French based International Agency for Research on 

Cancer, tinds that diesel cxhmlst is a known hum;:m carcinogen. Do YOll believe 

American employers should be permitted to have a voicc in thesc IARC proceedings'! If 

so, will you commit to taking <1 leadership lOle at IARC (0 insist that U.S. employers be 

able to commenl on this issue'? 

4. I understand that the Department of Health and Human Services, through the Centcrs for 

Disease Control anti/or other agencies have awarded a number of grants and/or funds to 

the International Agency for Research on Cr:U1cer (lARe) over the past sevcral years 
70 

The I Ionorable Kathleen Sebelius 

May 18, 2012 

Page 6 

Please provide a complete account orallY such grants in [lid, or other tnmsfers of funds 

originally obligated to the department or its agencies, since 2009. In <iccounling for this 

infonllHtioll, please provide a summary of each project or projects undertaken by IA RC 

as <l result of the funding provided by the department or its agencies and docllmentation 

requested by the depmtment and its agencies provided by TARe during I) the solicitation 

process for such funding and 2) federal oversight of the proj~ct~ undertaken by TARe, IlS 

a result orlhe gTants in aid or other funding provided by the government. 

Rep. Lou Barletta (R-l','ll 

I. Recent!y, the 2012 Medicare Trustee Report concluded that Medicare will go bankrupt 

by 2024. Doctors, hospitals, and patients in the II th district flrc concerned flbmlt these 

results. With an <!ging population, increased technology, and more complex medicfltiollS 

there continues to be a strong demand f(w medical services. In addition, the President's 

hcalthcm'e reform law reduced Medicare expenditures by more Ihan $500 hillion .. md the 

Health and Human Services' FY13 budget request calls for over .100 billion morc in cuts 

from Medicare and Medicaid. I low do you expect providers to address these Cllls? 

2. IIow is the U.S. Department oflIcalth and Human Services planning for the estimated 

mandatory cut!> that will take place under the current sequestration rules contained in the 

Budget Control Act? What process will the agency lise in dctennining thc necessary 

cuts'? Will you start with the programs that cost the most? What 31lnlysis has been done 

to estimate the impact on access to care? 

3. My district is homc to one of the largest vaccine companies ill the world, and as such J 

have a eOlleern ~boutlht;: proposed Clits to the 317 immunization program which provides 

the fedcral infrastructure funding for state and local immunization programs. What is the 

rationale for cutting this program and how will that impact the states' ability to purchase 

and distribute vaccines? 

Rep. Martha Roby (R-i\L) 

!. As part of the universal health insurance reform passed in2010, all health plans must 

nnw provide-at no ()ut~or-pocket cost 10 the rccipicnt~-ecrtaill "preventative services." 

Many of these services arc routine; however, it is the tenth govcrmnellHnandated service 

that puts various groups in a moral bind. Specifically, the mandated coverage must 

include "[a]11 Food and Drug Administration approved contraceptive methuds, 

sterilization procedurcs, and patient education and counseling fot' all women with 

reproductive capacity." 

Duc to public uproar, in Fcbl11ary, ITHS finalized the narrowly defincd exemption for the 

"religious employer"----ensuring that some, but not aH religious institutions, wit! not have 

to cover contraceptive services or refer employees to organizations thaI provide slleh 

services. This exemption only applies to a religious cntity if it primarily scn'cs peoplc of 

their own faith. It does not apply to faith-based organizations that serve people of all or 

no faith. 
71 

The Honorable Kathleen Scbclius 

May 18, 2012 

Page 7 

The Catholic TV Station, The Eternal Word Tclcyision Network (EWTN), is located in 

the state of Alabama. EWTN does not fall under the small umbrella of this religious 

exemption-nor do m,my hospitals, charitable service organizations, and universities. I 

understand that the Administration is working on an "accommodation" tor groups that 

fall under this category. 

P~ltting aside the future "acconunoclation," why is EWTN, and similnr religiollsly 

[lffiJiated entities, not exempt from covering these sel'vices---especially when these drugs 

and services fundamcntflily contradict thcir moral beliefs? Why is the administration 

defining some institutions us religiolls enough for a full exemption. others as only 

religious enough to qualify for a yet undefined accommodation and leaving still others 

with no religious protection aI all? 

2. Atkr 20 14, all health care plans arc expected to include coverage for sterili7.ation and 

contraception, including drugs that some believe can cause an abortion (e.g. the morning 

after pill). If an employer such as EWTN has a moral ol~iection to such coverage, and 

their moral objections remain even under the accolllillodation that you have said will be 

proposed at a later date, what penalties will be imposed on employers and insurance 

pwvidl.!fS [or no\ covering these services? 

A) What will happen to (Ill employer who cannot find an insurance plan that 

matches their values? If they wcre to fail to provide insurance, will that employer 

be fined or otherwise penalized? I-1m-\' much are the tines imposed? How will 

entities sueh as EWTN be penalized as a self-insured entity? 

B) What ifan cmploycr that o~iccts to certain coverage selr·insures (as in the case 

ofEWTN) or otherwise provides insurance to their employees and fails to include 

the coverage that they oppose? What would the tines be in that case? If they 

refuse to pay the fines \vill they be arrested? What <1ctions will be t<1ken? 

3. The US Conference ofCathoiic Bishops (USCCH) was recently denied a HHS grant to 

provide assistance to victims of human trafficking. FOl' the first time in the history of the 

progl'H!l1, the funding opportllllity announcement slated that "strong prcicrcllce" would he 

given to applicants that arc willing to direct clients to medical providers who can provide 

ur refer for the "full range of legally permissible gynecological and obstetric care." This 

language <ippearcd to be an erfOl! to make it more difficult for the lJSCCB to receive a 

grant under this program--even though they were the incumbent applicant and had 

received outstanding reviews throughout the years that they received funding for this 

program. An investigation conducted by the House of Reprcsentatives Ovcrsight and 

Governmenl Reform Committee revealed that even with this "preferencc" in the rcquest 

for proposals, independent reviewers gave USCCB onc o1'lhe highest scores on their 

application: 89 out of 110. Still, HilS denied funds to the usccn while funding 

proposals that received significantly lower scores, including scores of 69 and 74. Only 

olle orlhe three awardees received a score higher than USCCB. 
72 

The Honorable Kathleen Sebe!ius 

May IS,2012 

Page 8 

This question is regarding the III IS grant to [\lnd earc for victims who have been rcscued 

fl'Olll human trafficking. T am referring to the funding that \vas denied 10 the USCCB as 

fill entity. 

Wcre you briefed on the reproductive health lunguage in this request for proposals? Did 

you request 01' approve the reproductive health language? \Vcrc you briefed on the scores 

awarded to each applicant under Ihis program? Did you approve the decision to PHS!) 

over lJSCCR even though they had olle orthc higl1!.:st scoring applications? Could you 

please clarify how an entity that olTers H "full range" of services but at a lower quality 

level more efrectively assists trafficking victims and protects taxpayer doHars than an 

organil'ation that is more qualified I.Uld docs not fit HHS'g new definition of reproductive 

health? Did HHS base its decision to redcfine reproductive he<llth and give preference to 

such organizations on evidcnce-bascd research? 

As a result of the rcproductivc health requirement, have any trarfieking victims been 

referred to Planned Parenthood? Have any oCthe new f'unding recipients indicated that 

they have, or intend to, refer victims to Planned Parenthood dinies? 

The National Institute for Occupational SafcLY and Ht:alth (NIOSH) in conjunction with 

the National Cancer Institute (NCI) conducted the Diescf Exhaust in Miners Study 

(DEMS), \vhich was designed to evaluate the risk of death associated with diesel exhaust 

exposure, particularly a$ it nlay rell.lte to lung cancel'. 

I. What was the main result of the DEMS study? 

2. At the hearing it was asserted that this study found "that dicsel exhaust exposure ofa 

surface mine produced higher lisks of adverse health e!Tects than to underground miners, 

with much higher levels of exposure." Is this a correct clwraeterization of what this study 

found? 

3. At Ihe hearing it was asserted "that heavy smokers, wilh the highest diesel exhaust 

CXpOSUl'CS, have a lower risk for lung cancer than miners who didn't smoke ... " Is this an 

m.:curatc charactcri7Htion orthe :.>tudy findings? 

4. What mines and how many workers were covered in this study? 

5, Thl$ study was also the subject ura 2001 court urder that reqtdres the agencies involved 

to provide aU data requcsted by this committee. Arc there any rcquests f(x information 

submitted to the department from this committee that have not been complctely fulfilled? 

Arc you a\varc orany willful non compliance with these requests? 

6. NTOSH lenses the Lake Lynn Experimental Mine in southwest Pennsylvania. This 

facility, in which the U.S. governmenl has invested more than $40 mil!lon, is essential tor 

concluctillg mille safety research sucb as lal'gc~scaIe explosion trials. However, the lease 
73 

Questions Submitted for the Record by Mr. Miller 

Secretary Sebelius, each year an estimated 40 million American adults suffer from 

some type of mental illness. That is why passage of the Mental Health Parity was 

so critical. 

1. Can you give me an update on what the Department is doing to ensure that 

health plans are complying with Mental Health Parity? 

2. Can you please provide an update on guidance HHS has or will prepare for 

states to assist them implementing and enforcing Mental Health Parity? 

During the April 26th hearing you were asked about the Diesel Exhaust in Miners Study that was conducted by the National Cancer Institute and the National 

Institute for Occupational Safety and Health. 

1. Could you please clarify when the peer reviewed study was published in scientific journals? 
74 

Lastly, subsequent to the hearing on May 24, 2012, the Fifth Circuit Court of Appeals vacated and remanded a lower court order regarding the obligations of the 

Secretary to produce to the Committee certain documents and studies pertaining to 

the Diesel Exhaust in Miners Study. 

1. What did the Appeals Court find with regards to the Secretary’s compliance 

with the previous court orders to provide studies to this Committee? 

[Secretary Sebelius’ response to questions submitted follows:] 

DEPARTMENT OF HEALTH & HUMAN SERVICES 

Office of the Assistant Secretary 

for Legislation 

The Honorable John Kline 

Chairman 

Committee on Education and the Workforce 

House of Representatives 

Washington, D,C, 20515 

Dear Mr, Chairman: 

Washington, D.C, 20201 

December 17, 2012 

Thank you for the opportunity to complete the record for the April 26, 2012, hearing at 

which Secretary Sebelius testified on the FY 2013 Budget for the Department of Health 

and Human Services. Enclosed you will find the answers to your questions. 

I hope this information is helpful. If I may be of further assistance, please do 110t hesitate 

to contact me at 202-690-7627, 

Enclosure 

Sincerely, 

<&.' G. >:0 J. I/~ a:'R, ESqU;aU- \ 

Assistant Secretary for Legislation 
75 

Secretary Sebelius Questions for the Record 

House Committee on Edncation and the Workforce 

April 26, 2012 

The Honorable Jo.hn Kline 

1. The president's FY 2013 budget included a $111 billion increase for health insurance 

subsidies, a 30 percent increase from last year's budget. Given that there has been no. 

significant change in law or economic assnmptions, is this increase due to an assumption 

that more people wiUlose their employer provided coverage and claim a subsidy than 

previously believed? 

Answer: The increase does not reflect any fundamental change in our underlying assumptions 

regarding utilization of premium tax credits or the cost of providing coverage for a given person 

in the Exchanges. 

Instead about half of the change is attributable to legislative changes enacted in 2011, primarily 

the "Three Percent Withholding repeal and Job Creation Act" (P.L. 112-56) and, to a lesser 

extent, the "Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy 

Overpayments Act of2011" (P.L. 112-9). As you will recall, P.L 112-56 changed the Affordable 

Care Act by including certain Social Security income when determining eligibility for premium 

tax credits and Medicaid. Both CBO and the Administration scored a net decrease in overall 

health-related outlays due to this legislation. Health insurance premium tax credit outlays are 

projected to increase by about $60 billion over 10 years as a result of the health provisions of 

P.L. 112-56. However, looking only at the premium tax credit outlays is incomplete since 

savings accrue to Medicaid as well. 

The remaiuing difference is attributable to technical changes in the revenue estimating model 

that are designed to improve its accuracy. These changes inform all of the individual income tax 

modeling and were not implemented just for purposes of calculating the cost of the premium tax 

credit. 

2. Secretary Sebelius, we are all aware the Supreme Court recently heard oral arguments 

regarding the constitutionality of PPACA. On the last day of oral arguments, Justice 

Kennedy alluded to the fact that it could be judicial overreach to strike some parts of the 

law and leave others intact. The Court's opinion is expected in June. It is possible the 

individual mandate, and potentially the entire law, could be found unconstitutional. 

Without debating the merits of the case, has the department begun to prepare contingency 

plans for the possibility that the court will striI{e down all or part of PPACA? 

Answer: We are confident that the law will be upheld. There is clear and well-established legal 

precedent that Congress acted within its constitutional authority in passing the Affordable Care 

Act. 

3. Recently, HHS announced the creation of the new Administration for Commnnity Living 

that will focus on strengthening assistance to seniors and people with disabilities. The 
76 

committee has concerns regarding the efficacy of new offices. How will this new office help 

streamline service delivery or reduce duplication within the department? Will there be 

fewer federal employees working in these offices? 

Answer: Establishing a single HHS organization focused on community living will enhance and 

strengthen HHS efforts to support seniors and people with disabilities in their efforts to live 

independently, with dignity, in their communities. This action simply min'ors actions that many 

States have long since taken at their level to address the same needs, Including the 

Administration on Aging, the Administration on Developmental Disabilities and the Office on 

Disability in the new entity establishes a single organization to ensure consistency and 

coordination in community living policy across the Federal government. This is the next step 

following establishment of President Obama's Community Living Initiative "to ensure the fullest 

inclusion of all people in the life of our nation." 

The reorganization will strengthen our efforts to support community living, regardless of age. 

Existing programs intended to serve both older Americans and persons with disabilities, such as 

the Lifespan Respite Care program and the National Clearinghouse for Long Ternl Care 

Infornlation, will benefit from this integrated organization, while initiatives designed to meet the 

unique needs of seniors or people with disabilities will retain their distinct programs. 

The creation of ACL was carried out to improve HHS's ability to address the common needs of 

seniors and individuals with disabilities who seek to continue living independently in their 

communities. It was not an attempt to achieve efficiencies by reducing existing staff. As such, 

overall Federal stafflevels for the new Administration for Community Living are equal to the 

sum of the staffing levels for its predecessor agencies. 

4. The new Administration for Community Living proposes to consolidate the 

Administration on Aging, the Office on Disability, and the Administration on 

Developmental Disabilities. The president's FY 2013 budget includes $1.95 billion for the 

Administration on Aging (AoA), an increase of $457 million over last year. The funding 

levels support 135 Full-Time Equivalents, an increase of 14 employees. Why is HHS 

reqnesting more funding and more FfEs if these offices are being consolidated? 

Answer: The FY 2013 President's Budget for the AoA includes $1,978 million in budget 

authority. This represents a net increase of $7 million. The difference from your estimate reflects 

the comparable display of programs such as the Senior Community Service Employment 

Program and the State Health Insurance Assistance Programs, which were fIrst proposed for 

transfer in last year's President's Budget and are continued in this year's. The reorganization 

which resulted in the creation of ACL occurred after the FY 2013 President's Budget was 

submitted to Congress. The funding level for ACL includes the AoA budget and the $174 million 

requested for ADD and OD, the same amounts that were requested in the Adminstration for 

Children and Families and the Office of tile Secretary. 

The Administration is not proposing signifIcant increases in funding or staff in the establishment 

of ACL, but rather aligning programs and staff from AoA, ADD, and OD to ACL. 

2 
77 

5. How will the new Administration for Community Living be funded? How will the funds 

be allocated amongst the various aging and disability programs? Does HHS have the 

authority to create and fund this new agency without language ill an appropl"iations bill? 

Answer: As in prior years, ACL will be funded by a mix of discretionary and mandatory 

appropriations. The Secretary has the authority to administratively organize her department. 

ACL was created using the same authority that was used in the creation of the Administration for 

Children and Families. HHS first published a Federal Register notice creating an entity in the 

cunent year, followed by an administrative delegation of authority to that entity to draw from 

allocation accounts created to minor existing activities. The Department will continue to achieve 

the purposes identified in the appropriations bill. 

6. We understand the new Administration for Community Living will share an 

administrator with the subordinate Administration on Aging. How will the administrator 

serve effectively in these dual, overlapping roles? 

Answer: The role ofthe Assistant Secretary for Aging (ASA) has always been two-fold as 

outlined by Congress in Title II of the Older Americans Act, as the ASA administers Older 

Americans Act (OAA) programs, while collaborating across all federal agencies to broadly 

impact national policy that affects older adults. This second role will be emphasized with the 

new structure where the ASA in her role as the Administrator of ACL, will advise the Secretary 

on long-term care policy matters that impact older adults as well as individuals with disabilities. 

The ASA will continue to give equal priority to administering OAA programs. 

7. How will the new Administration for Community Living affect the department's plan for 

Older Americans Act reauthorization? How will it affect the reauthorization of the 

.Developmental Disabilities Assistance aud Bill of Rights Act of 2000? 

Answer: The Department is not recommending any proposed language changes related to the 

creation of the Administration for Community Living and the reauthorizations. 

8. How can the department worl, to better coordinate services for the elderly across all 

federal agencies? 

Answer: The ACL plans to build on existing coordination efforts such as the Partnership for 

Patients (to reduce hospital acquired conditions and preventable hospital readmissions); the 

Fraud Task Force and other elder rights initiatives; Multiple Chronic Conditions Framework; 

Aging and Disability Resource Centers; Veterans Directed Home and Community Based 

Services (VDHCBS); and Medicare outreach and enrollment efforts. 

9. The president's FY 2013 budget proposal requests to move the Senior Community 

Service Employment Program (SCSEP) to HHS. This program was one of 47 duplicative 

workforce development programs identified by GAO in early 2011. Why has the 

administration proposed to further fragment job training by moving this program out of 
78 

the Depaliment of Labor? Is the administration proposing this change because it believes 

SCSEP is more about community service than workforce development? 

Answer: The Senior Commuuity Service Employment Program is the only title of the Older 

Americans Act not administered by the Administration for Community Living. By transferring 

this program, ACL will both better coordinate this program with nutrition services, caregiver 

supportive services, and home and community based supportive services as well as realize better 

integration within the aging services network resulting from the transfer to ACL. In addition to 

creating jobs, this program empowers the elderly to take charge of their livelihoods and 

incorporates training and job counseling to improve seniors' job marketability. 

10. The 2010 reauthorizatiou ofthe Child Abuse Prevent ion and Treatment Act (CAPTA) 

included a requirement that ACF conduct a study relating to immunity from prosecution 

for professioual consultation in reporting instances of child abuse and neglect and submit a 

report to Congress. What is the status of this study? When will the report be submitted to 

Congress? 

Answer: Section 118 of the CAPT A Reauthorization Act of 20 1 0 requires a study to be 

conducted, in cOllSultation with certain experts, that examines how provisions for immunity from 

prosecution ffilder state and local laws and regulations facilitate and inhibit individuals 

cooperating, consulting, or assisting in making good faith reports, including mandatory reports, 

of suspected or Imown instances of child abuse or neglect and to submit a report on the study by 

December 20, 2011. We appreciate the value of such a study and report and are committed to 

meeting the requirement. However, as no funds were appropriated for these activities, additional 

time has been needed to identify existing resources and develop a workable approach to move 

forward. We anticipate completing this work and issuing a report in 2013. 

11. What type of guidance does the departmeut provide to Head Start and Early Head 

Start grantees on the appropriate use of funds for conferences and events? How does the 

department monitor the use of funds for these activities? 

Answer: During the review of the affilual refunding application, federal staff reviewed the 

grantee's budget narrative which should include an explanation of the proposed uses of federal 

funds for travel and conference fees. Federal staff are particularly interested.in assuring that 

grantees' proposed travel funds are reasonable and that the conferences are relevant to improving 

stafflmowlcdge and skills related to their jobs. If the proposed travel costs are not reasonable or 

the location of the conference appears unreasonably far from the grantee's home then federal 

staff would also qnestion and resolve any issues with those costs before the grant award was cut. 

During onsite monitoring visits the fiscal reviewer looks at budgeted cost such as travel or 

conference attendance to determine allowability and reasonableness. If those cost exceed 

appropriate thresholds then the evidence is sent to ORS for further evaluation. 

12. As you Imow, GAO released a report that highlighted egregious examples of waste and 

fraud in the Head Start program in 2010, after which your department announced several 
79 

reforms. Can yon tell ns how the department is implementing the promised changes? Can 

you tell us with confidence that enrollment fraud has been eradicated in the program? 

Answer: In FY 2010, GAO found that employees at 8 of 13 Head Start grantees disregarded 

applicant procedures and detennined erroneously that families were below the poverty line. In 

response to GAO's study, ACF made a series of commitments to strengthen its oversight of 

eligibility: 

• Implement a system of unannounced triennial reviews for 10 percent of grantees 

reviewed in FY 2011; 

• Develop an on-line complaint system for reporting waste and fraud in Head Start 

programs; 

• Draft regulations that require grantees to retain source documentation for children 

enrolled in the Head Start program; and 

• Improve the risk management process. 

ACF is implementing the changes as follows: 

ACF strengthened the monitoring protocol to contain more detailed evaluation of 

eligibility data and strengthened the interviews of parents and staff to detennine if 

programs had fraudulently or erroneously enrolled families. 

ACF also strengthened the erroneous payment study conducted randomly for 50 grantees 

each year by looking more closely at source documentation, thereby giving reviewers a 

broader spectrum to detelmine eligibility than before. 

ACF conducted 11 percent of the reviews for FY20 11 as unannounced-exceeding the 

target of 10 percent. 

ACF opened the line for public complaints and received 289 complaints from the public, 

16 of which were related to eligibility. ACF instituted an internal eontrol unit which 

handled and reviewed all complaints received. 

ACF developed a standardized fonn for conducting eligibility checks that could be used 

voluntarily by Head Statt grantees. 

ACF issued proposed regulations for eligibility that are scheduled to be final this fall. 

ACF believes that the heightened focus on erroneous payments and fraud related to eligibility 

was a warning for all grantees, and greater attention has been given to monitoring program 

integrity. Strengthening many of our systems has given us an increased ability to detect and 

resolve problems with eligibility in Head Start programs. We will continue to add improvements 

for detecting problems with eligibility moving forward. 

13. As you mentioned in your. testimony, the department finally issued fe-competition rules 

for Head Start grantees as called for by the 2007 reauthorization of the Head Start Act. 

Despite being almost two years behind schedule, the committee supports this effort to 

increase program quality. Last month, the re-competition process began for 97 service 

areas and is expected to include 100 additional areas in the coming weeks. Can you tell us 

how the implementation is going thus far? 

Answer: The process for Head Start grantees required to compete as a result of the Designation 

Renewal System (DRS) has begun with the publication of95 funding oppOltunity 
80 

announcements in April. An additional 100 funding opportunity announcements will be posted 

in mid-May. Competitions will be open for 90 days, and the panel review process will begin in 

Augnst. As the result of extensive grant reviewer recmitment efforts, OHS has selected 

approximately 500 highly-qualified reviewers to attend a comprehensive three day training in 

July. 

In order to minimize dismption of services to children, families, and staff, OHS plans to extend 

funding to the end of the 20 {2-20 13 school year for all CUlTent grantees required to re-compete 

under the DRS. This plan promotes continuity of services for children and families, and 

minimizes dismptions in communities by taking advantage of natural program breaks. The plan 

provides an opportunity for OHS to negotiate new awards and work with both incumbents and 

incoming grantees to ensure seamless transitions for children and families. 

14. The 2010 Head Start Impact Study found the advantages children gained from Head 

Start yielded only a few significant outcomes that lasted through the end of first grade. The 

"Third Grade Follow-Up Study" was set to be completed last September, bnt has now been 

delayed until later this year. Considering data collection for the third grade study was 

completed in the Spring of2008, what is the cause for delay? Does it have anything to do 

with the implications ofthe study's results for Head Start? 

Answer: We anticipate a fa112012 release date for the third grade report. As in all research and 

evaluation studies sponsored by the Department of Health and Human Services, the 

Administration for Children and Families (ACF) is committed to rigor and transparency in the 

conduct of this study. 

As background, Congress gave us an ambitious mandate for evaluating Head Start, calling for an 

independent study that would be nationally representative, use rigorous random-assignment 

methods, and collect longitudinal data on a broad range of children's and families' outcomes. 

Congress directed us to assess not only the overall impact of Head Start but also variations in 

impacts among programs and children with different characteristics. 

The study first collected data on three- and four-year-old children entering Head Start in the fall 

of2002. The children completed one year in Head Start by summer of 2003, and we provided 

impact findings based on data from that spring in a report to Congress in 2005. The children 

completed their first grade year by the spring of 2006, and the study completed first grade data 

collection in summer 2006. HHS provided first grade impact findings in January 2010 in the 

final required report to Congress. 

Data from the study are rich, and we have encouraged and supported the use of these data by 

other researchers, by placing the data collected through children's first grade year in a repository 

(http://www.researchconnections.org/childcare/resources/19525) for use by researchers. A 

number of researchers have begun to use the data and publish their own analyses. In September 

20 II, we awarded a grant to a consortium of researchers at New York University, MDRC, and 

Harvard University to conduct analyses of the data focusing on questions that have posed 

particularly difficult methodological challenges. 
81 

ACF' places a high value on transparency and openness in research and evaluation, as 

demonstrated by the comprehensive reports from tlus study already published 

(http://www.acf.hhs.gov/programs/opre/hs/impact studvlindex.html). ACF has ensured that 

reports from the study fully document methods used and comprehensively report findings. These 

detailed reports receive careful review to ensure that they are accurate, complete, and clear. 

While Congress specifically required studying children only through first grade, we have 

undertaken the third grade follow-up to continue learning from this important study. The followup study completed collecting data on children's third grade experiences and progress in the 

summer of2008. We look forward to the results of this follow-up. However, analyses of the 

third grade data are not complete for several reasons. The analyses of the first grade data took 

longer than anticipated, delaying the start of work on the third grade data. Analyses of large, 

complex data sets typically require a number of steps such as analyzing sample attrition, 

constructing statistical weights and developing composite measures, among others. 

There are also considerations specific to this study. As one of only a few studies ever conducted 

with a nationally representative randomized control design, this study has broken new ground 

and the researchers have had to explore new techniques to analyze the data. The collection of 

longitudinal data over several years further complicates the study. The researchers have taken 

time to consult with statisticians and other experts about how to address analytic challenges. As 

part of a serious effort to answer the questions Congress posed for the study, the Department 

supports this careful approach. 

15 . Both you aud Secretary Duncan have requested $850 million for Race to the Top, 

including "au unspecified amount" that will be used for the Early Learning Challenge 

competitive grant program. What portion of Race to the Top do you foresee going to the 

Early Learning Challeuge? Why wasu't that included iu your budget? 

Answer: We think it is critical to continue to invest in innovative approaches to education 

reform-including Race to the Top-Early Leaming Challenge. FY 2013 funds for Race to the 

Top would be used to deepen the Administration's investments (in the form of new competitions 

or continuation grants) in the program's five core reform areas and to address the unmet demand 

of States and districts that have demonstrated a commitment to implementing comprehensive and 

ambitious plans in these areas. The Department is continuing to consider the appropriate type of 

grant and award ranges, which will depend in part on the level ofFY 2013 appropriations. 

Because we had not yet made final decisions on the funding levels, we did not include that 

infolmation in the budget request. 

16. How does the Race to the Top-Early Learniug Challenge work with existing early 

learniug programs at the state level? How does it work with Head Start? 

Answer: The RTT -ELC grant competition focuses on improving early lealning and development 

for young children by supporting states' efforts to increase the number and percentage oflowincome and disadvantaged children in each age group of infants, toddlers, and preschoolers 

enrolled in high-quality early leaming and development programs; and designing and 
82 

implementing an integrated system of high-quality early learning and development programs and 

services. 

At its core, RTf - ELC represents an opportunity for states to focus deeply on their early learning 

and development systems for children from birth through age five. It is an opportunity to build a 

more unified approach to suppOlting young children and their families--an approach that 

increases access to high-quality early learning and development programs and services, and 

helps ensure that children enter kindergarten with the skills, knowledge, and dispositions toward 

learning they need to be successful. 

Thc RTT -ELC competition does not create new early learning and development programs, nor is 

it a vehicle for maintenance of the status quo. Rather, the RTf -ELC program supports the 

integrating and aligning of resources and policies across all of the state agencies that administer 

public funds related to early learning and development. This includes Head Start. 

Many early learning and development programs and services, such as child care providers, 

family child care homes, state preschool programs, Early Head Start and Head Start programs, 

Home visiting services, etc., co-exist within States. For states, the challenges to be addressed by 

RTf -ELC are to sustain and build on the strengths of these progranls, acknowledge and 

appreciate their differences, reduce inefficiency, improve quality, and ultimately deliver a 

coordinated set of services and experiences that support young children's success in school and 

beyond. 

Each state will involve representatives from Participating Early Learning Programs including 

Head Start, Early Childhood Educators or their representatives, parents and families, including 

parents and families of Children with High Needs, and other key stakeholders in the planning 

and inlplementation of the activities carried out under the grant. 

17. The administration IS budget requests again call for increased spending on most health 

and human services programs. What efforts are you undertaking to make the department 

more efficient? Can you point to any real reductions in offices or staffing that reflect this 

effort? 

Answer: HHS is committed to improving the Nation's health and well-being while 

simultaneously contributing to deficit reduction. The FY 2013 discretionary request 

demonstrates this commitment by maintaining ongoing investments in areas most central to 

advancing the HHS mission while making reductions to lower priority areas, reducing 

duplication, and increasing administrative efficiencies. Overall, the FY 2013 request includes 

over $2.1 billion in terminations and reductions to fund initiatives and provide net deficit 

reduction. Many of these reductions, such as the $452 million cut to the Low Income Home 

Energy Assistance Program, the $177 million cut to the Children's Hospital Graduate Medical 

Education Payment Program, and the $327 million cut to Community Services Block Grants, are 

necessitated by the current fiscal environment. The budget reflects the careful review we gave to 

every progran1, looking for opportunities to make them leaner and more effective, and includes 

some difficult cuts we would not have made if our nation's fiscal health and tight budget times 

did not require them. 
83 

HHS has also presented a package of legislative proposals for Medicare and Medicaid that would 

save over $300 billion over 10 years. Medicare savings would accrue by adjusting the structure 

of the Medicare benefit to encourage beneficiaries to seek value in their health care choices, and 

encouraging high-quality, efficient care, and increasing the availability of generic drugs and 

biologics. The Budget also includes proposals to make Medicaid more flexible, efficient, and 

accountable while strengthening Medicaid program integrity. 

Further, HHS continually seeks to identify and eliminate tumecessary costs, in the interest of 

ensuring that our resources are deployed in the most efficient manner. For instance, as part of the 

Administration's broader efforts to promote efficient spending, HHS is undertaking new 

measures to further reduce our spending on items such as travel, printing, professional services, 

supplies and materials, and employee information technology devices. Reducing spending in 

these categories will enable us to redirect resources to mission critical investments that more 

directly benefit our programs' targeted populations. 

18. In recent years, Congress has received numerous reports highlighting fraud and abuse 

in many health and human services programs. How are you working to prevent waste and 

protect taxpayer dollars? 

Answer: Preventing improper payments before they occur is a high priority of the 

Administration. RecovelY audits help CMS identify and address common causes of improper 

payments. Due largely to vulnerabilities uncovered by Recovery Auditor Contractors (also 

Imown as RACs), CMS is in the process of implementing Medicare payment system edits that 

will stop the payment of claims after a beneficiary's date of death, stop the payment of durable 

medical equipment while the beneficiary is receiving care in an inpatient setting, and stop the 

payment for individual services that should have been bundled into another payment. 

In addition, Medicare's claim processing contractors have been able to implement automated 

computer system edits to stop wasteful improper payments relating to medically Ulliil{ely claims 

and reimbursement for medications that exceed recommended dosages. 

Since passage of the Affordable Care Act, CMS has implemented numerous new tools Congress 

provided to reduce waste, eliminate fraud, and recover improper payments. We have already put 

in place new provider screening and enrollment criteria to help CMS keep lmscrupulous 

providers and suppliers out of our federal health care programs in the fIrst place, quicldy remove 

wrongdoers from the program when they are detected, and recover improper payments early in 

the process. We have also been using predictive analytics to prevent fraud and eliminate 

systemic vulnerabilities. We are confident these new tools will support us as we prevent fraud, 

waste, and abuse, and protect taxpayer dollars for years to come. 

ACF leadership is committed to building a culture of program integrity and has set tlte tone 

which depicts program integrity as a high priority. At the administration-level, ACF continues to 

strengthen its program integrity infrastructure by increasing communication, collaboration, and 

sharing best practices across HHS and ACF. At the program- level, ACF programs continue to 

strengthen its program integrity activities through monitoring of its grantees and information-
84 

sharing with its stakeholders. ACF remains committed to preventing waste and protecting 

taxpayer dollars. 

Examples of program integrity activities at the administration-level: 

• ACF formed its Program Integrity Internal Control Senior Assessment Team (PUC SAT), 

which consists ofleaders and staff from each office/program. The PIlC SAT fosters an 

environment that supports candid and constructive sharing of issues and solutions, where 

offices/programs are encouraged to proactively reach out to their peers across ACF that 

operate similar programs and face similar challenges. 

• ACF established a Program Integrity Core Team to facilitate Department-wide program 

integrity initiatives, serve as a liaison with the Department, and share infOimation and 

best practices with other HHS Divisions and ACF offices/programs. 

• ACF continued to take a proactive role in the OMBIHHS improper payment initiatives 

and negotiated plans and deliverables with HHS and OMB for Foster Care, Head Start, 

and Child Care). ACF's contribution to the Improper Payments initiative has been 

significant within ACF and to HHS' overall progress toward eliminating improper 

payments. 

• ACF conducted annual internal control assessments to determine the likelihood and 

impact to the ACF mission, if identified risks were to occur. Progranls assess the 

effectiveness of its interual controls and financial management systems in compliance 

with the Federal Managers Financial Integrity Act and OMB Circular A-123. ACF also> 

conducts annual assessments of its Grant Administration Tracking and Evaluation System 

to comply with applicable requirements. 

• ACF conducted program integrity risk assessments across high-priority programs to 

identify and address program vulnerabilities. Through this process, programs are gaining 

insight into the types anQ potential severity of risks within their programs and are 

beginning to re-evaluate, develop, and implement response strategies. 

• ACF has piloted the Single Audit Metrics Initiative. The objective of the initiative is to 

hold grantees accountable to ensure the deficiencies contained in Single Audits with 

unclean audit opinions are properly addressed and corrected in a timely manner. The 

metrics provide a tool to measure our success in improving ACF program integrity. In 

achieving this goal, ACF uses the Office of Management and Budget's MAX Data 

Collection System as a central repository to store and share audit-rclated information 

across ACF. ACF staff continued to conduct careful analyses of single audit findings 

within and across ACF grant programs, as well as across ACF grantees, to develop 

strategies for addressing chronic and pervasive internal control and compliance 

wealmesses in ACF grant progranls and the entities that administer them. 

• ACF has initiated a pilot using the Office of Head Start re-designation process to 

implement an additional phase to the application review process. Following the existing 

10 
85 

grant application review processes, which may identify applicants that pose a potential 

risk for administering a Head Start or Early Head Start program, the additional phase 

involves a [mancial review of grant applications to better inform the funding decisionmaking and assure that funding is made available to grantees who are financially able to 

perform work under the grant. The results of the fmancial review are to either 1) stop 

awarding grants to applicants with viability and/or capacity concems regarding the 

administration offederal nmds or 2) for ACF to impose special conditions upon a grantee 

to protect the taxpayer dollars. 

• As of the second quarter ofFY 2012, ACF reduced its outstanding debt collections by 

$13 million. These collections were derived from cash collections, settlements and other 

adjustments as a result of A-133 audits and program disallowances. In a continuous 

effort to reduce the outstanding debt owed to ACF, we are working closcly with the 

Department of Health and Human Services Office of Program Support Center and the 

Office of General Council to aggressively pursue the remaining outstanding debt. 

Examples of program integrity activities at the program-level: 

• ACF Office of Head Start (OHS) 

o Increased its focus on grantees by conducting 159 unannounced, on-site 

monitoring reviews. ACF found grantees that had unannounced reviews, 

compared to grantees that had announced reviews, were more commonly found to 

be noncompliant (findings that could easily be corrected) or deficient (findings 

that were more systemic or serious). ACF found that grantees with unannounced 

reviews had more findings per review, including a higher average number of 

deficiencies. Finally, ACF also found that over 35 percent of grantees with 

unaunounced reviews had six or more findings, compared to approximately 18 

percent of grantees with announced reviews. 

o In 2010, implemented new reporting features on the Early Childhood Learning 

and Knowledge Center (ECLKC) website, which provides Head Start 

communities and the public an easy way to contact OHS. A direct linlc to the 

HHS Office of Inspector General (ora) is also located on the website. OHS 

encourages anyone who suspects fraud, waste, misuse, or abuse of federal funds 

to submit their concems directly to the oro Hotline. 

o Conducted an additional 11 targeted fiscal reviews resulting in 8 pending 

disallowances. 

o Strengthened its partnership with the oro resulting in 24 additional program 

reviews to be conducted this fiscal year. On one year, the OHS took adverse 

actions on three grantee reviewed by the 010 that resulted in one temunation and 

two relinquishments. 

11 
86 

o Established the fmal rule for the Designation Renewal System that will limit Head 

Start grant awards to a five year project period and will require grantees to recompete for funds, if they are not providing high-quality services. 

• ACF Office of Child Care (OCC) 

o Initiated a National Program Integrity Conference Call Series with its state 

partners to address fraud prevention and internal controls, as well as provide a 

forum for state-to-state shaling of best practices. 

o Implemented a Program Integrity Self-Assessment tool for valious grantees. 

During site visits, OCC provides technical assistance and facilitates collaboration 

between program staff, fiscal staff and quality control units to assist grantees in 

fully evaluating the integrity of their programs and to address meaSllfes to reduce 

enOl'S. 

o Published the "Program Integrity, Financial Aceountability, Access to Child 

Care" program instruction to provide guidance to Child Care and Development 

Fund Lead Agencies on their roles and responsibilities in preserving program 

integrity and to provide recommendations to strengthen accolflltability. 

o Streamlined the En'or Rate Review process, which allows the grantees to conduct 

a more efficient and consistent review. 

o Expanded the Program Integrity and Accountability questions on the 

State/Territory/Tribal application for Federal flfllding to gain specific infomlation 

regarding grantees' accountability measures and program administration. 

o Revised the CCDF section of the government's guide for auditors (i.e., the OMB 

Circular A-133 Compliance Supplement) to strengthen financial and program 

integrity. 

o Convened a workgroup to consider revisions to the grantee financial report to 

capture data and track the efforts of grantees in detecting and recovering 

expenditures resulting from fraudulent activities. 

• ACF Office of Community Services (OCS) 

o In JlfllC 2010, delivered several presentations about the GAO's findings 

concerning LIHEAP enol'S and recommendations for LIHEAP program integrity 

and conducted the "Program Integrity: Internal Controls and Fraud Prevention 

Workshop" at the National Energy and Utility Affordability Conference 

(NEUAC). The goal of the workshop was to increase program integrity 

awareness among ACF grantees, particularly as it relates to ACF's Low Income 

Housing Energy Assistance Program (LIHEAP). This Conference was attended 

by over 600 participants representing nonprofit and government agencies, utilities 

12 
87 

and other institutions which provide, among other things, utility and fuel bill 

assistance for families in need. A similar session is planned for the June 2011 

NEUAC. 

Issued a formal memo strongly encouraging grantees to require social security 

numbers (SSNs) for all LIHEAP applicants and to verify those recipient identities 

through extemal databases, such as the Social Security Administration's 

database(s). 

o Released new programmatic guidance, a LIHEAP plan supplement documenting 

S tate program integrity systems, and initiated a new program integrity work 

group. 

o In 2010, released an Action Transmittal (AT) with a Model Plan format for 

grantees to use in submitting additional information on plans and strategies for 

ensuring program integrity. More recently, OCS released an AT in April 20 11 to 

provide guidance for FY 2012 plans. The AT requires all LIHEAP grantees to 

supplement their LIHEAP plans with a Program Integrity Assessment that 

discusses the program integrity protocols and systems cunently in place and what 

expected changes will be made to them in the upcoming year. 

o Convened a working group on LIHEAP program integrity in January 2011 to 

allow grantees and other stakeholders a forum to exchange best practices, propose 

implementation strategies, and develop metrics for evaluating success in 

addressing the GAO recommendations. The group has conducted monthly 

conference calls since January, and held the first in-person meeting in 

Washington, DC in May 2011. 

o Convened webinars and teleconferences with LIHEAP grantees to discuss the 

GAO report and OCS guidance on LIHEAP program integrity. 

o Consulted with the HHS DIG about the DIG investigation of LIHEAP and is 

working expeditiously to follow up on serious DIG audit findings from the A-133 

process. 

o In FY 2010, conducted five on-site compliance reviews, and as many are expected 

to be completed in FY 2011. OCS also updated its compliance review manual to 

include the new ACF guidance and GAO recommendations on program integrity. 

ACF staff provides additional one-on-one training and technical assistance to 

LIHEAP grantees on the program integrity guidance. 

19. How much money has ACF andlor AoA spent on all conferences and events over each 

of the previous fonr fiscal years? Please provide a breakdown of each event or conference 

planned by ACF and/or AoA since January 20,2009, and indicate which program the 

conference was associated with, what program office was the lead for the event, whether 

the department contracted ont planning or management for either all or part of a 

13 
88 

conference or event, how much the contract for these services was for, whether the 

department has employees to plan events and conferences, and, if so, why the services were 

contracted out rather than planned by staff. 

Answer: Please see attached spreadsheets which list the AoA and ACF conferences over the past 

four years. 

14 
89 

The Honorable Joe Wilson 

1. Duriug your testimony, you indicated that "it is absolutely not correct" that IARC 

findings trigger automatic regulatory consequences for regulated entities in the United 

States. Do you stand by that response, in light of the fact that if IARC does find that diesel 

exhaust represents a lmown human carcinogen, tbe Occupational Safety and Health 

Administration (OSHA) regulations (C.F.R. § 191 O.1200(d)(3), 191 O.1200(d)(4)(ii» require 

employers tbat utilize diesel engines to communicate this finding to employees via material 

safety data sheets (MSDS)? 

Answer: Questions related to the Department of Labor would best be directed to the Secretary of 

Labor, who is best able to present the views of that Agency. 

15 
90 

Tlie Honorable Virginia Foxx 

1. In your FY 2013 budget request, you call for increased funding for new and dnplicative 

programs, sucli as tlie Race to tlie Top-Early Learning Cliallenge and Cliild Care Quality 

Initiative. At tlie same time, programs like Head Start are faced witli examples of waste 

and fraud and revelations of liorrific safety violations among grantees. How can you justify 

requesting funding for new programs wliile your department is liaving a difficult time 

overseeing its current programs? 

Answer: The Administration is deeply committed to ensuring that high-need children from birth 

to age five enter kindergarten ready to succeed. This commitment is reflected in the FY 2013 

budget request, which invests in high-quality early education to help put children on the path to 

school success and bolster our Nation's competitiveness. The Administration is also committed 

to strong oversight of early education programs, and the quality investments in child care, Head 

Start designation renewal, and Early Learning Challenge grants will further strengthen the 

integrity of such activities. 

The FY 2013 budget request for the Department of Education (ED) requests $850 million for the 

Race to the Top, including Early Learning Challenge competitive grants to States and local 

communities to deepen the Administration's investments in ambitious improvements to early 

learning access and quality, and to address the unmet demand for these funds. The Department 

of Health and Human Services (HHS) budget request also includes a $300 million child care 

quality initiative to build on existing quality infrastmcture investments in the Early Learning 

Challenge by directly investing in programs and teachers to help them meet and maintain higher 

quality standards. 

In November of 20 11, the President announced important new steps to improve the quality of 

services and accountability at Head Start programs across the country. Head Start grantees that 

do not meet quality benchmarks are required to compete against other organization in their 

community for continued funding. Of the additional $85 million requested for Head Start in the 

FY 2013 budget request, $40 million would be used to support this effort by minimizing 

potential service dismptions in the transition between incumbent and new grantees. The request 

also includes funds for monitoring of new grantees to ensure that they meet Head Start's critical 

mission - to help children from low-income families achieve their full potential and help our 

country build tomorrow's workforce. 

2. GAO has identified 69 separate early childhood education and cliild care programs, 

totaling more than $25 billion and littered across 10 different federal agencies. What steps 

has the administration taken to ensure that the larger number of programs isn't making it 

more difficult for low-income families to access services and that the federal government 

isn't funding duplicative and inefficient programs? 

Answer: Cross-program coordination to ensure that children have access to high quality early 

learning and child care programs has been a priority and key focus for the Administration. Over 

the last three years, ACF has developed and implemented an integrated early childhood unit 

under the leadership of the Office of the Deputy Assistant Secretary for Early Childhood 

16 
91 

Development, which has become the focal point within HHS for early childhood activities at the 

Federal level. Within this structure, the Administration has taken several steps to improve 

coordination between the Office of Child Care (OCC) and Office of Head Start (OHS), such as 

establishing the National Center on Child Care Professional Systems and Workforce Initiatives 

(funded by both OCC and OHS) and implementing the Early Head Start for Family Child Care 

Demonstration Project, jointly coordinated by OCC and OHS. 

As you are aware, Head Start and the Child Care and Development Fund (CCDF) vary in 

structure, administration, and regulation that help Head Start and CCDF provide complementary 

and not duplicative services. To further focus on the issue of preventing duplicative services and 

reducing barriers to access, the OCC and the OHS have worked together to encourage 

collaboration at the grantee level in a variety of ways. By issuing guidance on aligning eligibility 

policies and providing technical assistance to States and communities, our offices arc working to 

ensure that more low-income children have access to high quality early learning. 

In addition to the Race to the Top - Early Learning Challenge, which is jointly administered by 

ED and HHS and supports the integration and alignment of resources and policies across all of 

the State agencies that administer public funds related to early learning and development, the 

Administration has many interagency and interdepartmental efforts to coordinate federally 

funded early care and education programs: 

• State Advisory Councils on Early Childhood Education and Care: The Improving Head 

Start for School Readiness Act of 2007 required that the Governor of each participating 

State designate or establish a council to serve as the State Advisory Council on Early 

Childhood Education and Care for children from birth to school entry. The State 

Advisory Councils will lead the development or enhancement of a high quality, 

comprehensive system of early childhood education and care that ensures statewide 

coordination and collaboration, while addressing how best to prevent duplicative services 

among the wide range of early childhood programs and services in the State, including 

child care, Head Start, Individuals with Disabilities Education Act preschool and infants 

and families programs, and pre-kindergarten programs and services. ACFawarded $100 

million in Recovery Act funding for State Advisory Councils to 45 States, District of 

Columbia, Puerto Rico, Virgin Islands, Guam, and American Samoa. 

• Early Learning Interagency Policy Board: The Secretaries of ED and HHS established the 

Early Learning Interagency Policy Board to improve the quality of early learning 

programs and outcomes for young children; increase the coordination of research, 

technical assistance and data systems; and advance the effectiveness of the early learning 

workforce among the major federally funded early learning programs across ED and 

HHS. 

• ACF/Child and Adnlt Care Food Program (CACFP) Workgroup: Convened by the Office 

of Management and Budget, the ACF/CACFP Workgroup brings together stafffi"om the 

Food and Nutrition Services (in USDA), OCC, and OHS to discuss possible collaboration 

around the CACFP. The workgroup has identified the following areas of collaboration: 

17 
92 

sharing the National Disqualified List, publishing joint infolmation memorandums on 

collaboration at the State and local level, and improving Tribal participation in CACFP. 

Finally, several of the CCDF principles for reauthorization included in the President's Budget 

request would streamline Federal, State, and local early care and education programs. For 

example, the Budget proposal supports promoting continuity of care for children and quality 

improvement for child care providers. 

18 
93 

The Honorable Duncan Hunter 

1. Private for-profit organizations participate in state preschool programs across the 

country. Many ofthese commercial organizations have a proven repntation of delivering 

high-quality early child care and educational services. These providers, however, are 

deterred from participating in Head Start becanse grantees aren't allowed to keep 

administrative profits. Would you support allowing for-profit organizations to receive a 

marginal profit on Head Start grants as part of a broader effort to encourage greater 

competition and improve quality within the program? How about if they can show an 

increase in student outcomes? 

Answer: The newly implemented regulation on the designation renewal system (DRS) will 

provide for-profit organizations an opportunity to apply for Head Start grants. There is adequate 

room for a for-profit organization to compete within the existing structure, and while they should 

not be disadvantaged, nor should they receive different incentives than a non-profit organization. 

While for-profit organizations are allowed to make a profit while they are a Head Start grantee, 

no portion of their profits can come directly from Department of Health and Human Services 

grant funds. Further we believe that a profit allowance as an incentive for their patiicipation is 

not appropriate. In this difficult fiscal enviromnent, we cannot prioritize using limited Federal 

dollars for organizations to keep profits rather than investing in quality improvements and 

increasing access for children from low-income families. 

We believe this new rule will lead to robust competition- we have estimated that roughly one 

third of CUlTent grantees will be required to compete under the DRS in the next several years in 

order to continue receiving Head Start funding. In addition, the DRS system was reqnired by 

Congress as a means to improve quality within the Head Start program. 

19 
94 

The Honorable Tim Walber ... 

1. What is the operating status of the Lake Lynn mine testing facility? 

Answer: The underground facility at Lake Lynn has been closed since the roof fall that occun'ed 

in October 2008, The surface testing labs, including the tire gallery and the detonation tube, 

have continued to operate. 

2. In your testimony regarding the Diesel Exhaust in Miners Study (DEMS) conducted by 

NIOSH and NCI, you indicated to me that that the Department of Health and Human 

Services has complied with the committee's previous requests. However, the department 

has uot yet fully complied with the committee's multiple requests. When will the 

department release the following information to the committee and the representatives of 

the study participants? 

A) All information on vital status of each cohort member, including follow-up, date 

of death and cause of death. 

B) All information obtained in interviews, including smoking history (both active 

and passive), lifetime occupational history, medical history, family medical history, 

usual adult diet, and use of respiratory protective equipment. 

D) An identification of each lung cancer case used in the case control study and the 

controls that were matched to the case. 

E) An identification of the specific cases included in each of the cohort stndy 

analyses. 

F) All data on exposures to other air contaminants including radon, asbestos, sHica, 

respirable dust, and PAHs from non-diesel sources, in a form that would permit 

reproducing the results in Table I of Silverman et al. (2012) and Table 2 of Attfield 

et a!. (2012). 

Answer: Requests A, B, D, E, and F are grouped together because they represent detailed 

information that could potentially identify individual participants in the study. Thus, the 

inibrmation can only be released with appropriate safeguards in place to protect the 

confidentiality of individual study participants. The Committee's 90-day review of data 

underlying the cohort mortality and case-control study papers will end on June 24, 2012. 

NIOSH and Ncr will make detailed datasets underlying these papers (NIOSH: cohort mortality 

study; NCI: case-control study) available to researchers pursuant to the execution of data transfer 

agreements. These datasets will not contain personal identifiers but will contain adequate detail 

to make replication of previously published findings possible. The level of individual data in the 

datasets could make specific subjects identifiable by celtain parties (such as employers). 

Therefore, researchers who apply for access to these datasets through data transfer agreements 

will need to have projects that are documented to have appropriate local human subjects 

protections in place, e.g., as evidenced by approval oflocal Institutional Review Boards (IRBs). 

C) The exposure data files referred to in the file, "DEMS_DATA_FILES." 

20 
95 

Answer: Item C was previously provided with data underlying the first four papers in the Diesel 

Study, which focused on assessment and reconstruction of exposures. 

G) The state mortality rates used in the SMR analysis in Attfield et al. (2012). 

Answer: The state mortality rates used in the SMR analysis in Attfield et a!. (2012) are available 

to the public at the following link: http://www.cdc.gov/nioshiLTAS/rates.html 

3. Occupational Safety and H;ealth Administration (OSHA) regnlations (C.F.R. § 

1910.1200(d)(3), 1910.1200(d)(4)(U» require American employers utilizing diesel engines to 

take specific actions if the French based International Agency tor Research on Cancer, 

finds that diesel exhaust is a Imown human carcinogen. Do you believe American 

employers should be permitted to have a voice in these lARC proceedings? If so, will you 

commit to taking a leadership role at fARC to insist that U.S. employers be able to 

comment on this issue? 

Answer: IARC is part of the World Health Organization (WHO) and operates through the 

participation of many countries. It conducts reviews tlu'ough a structured process that seeks out a 

diversity of opinion. http://monographs.iarc.frIENG/Preamble/CurrentPreamble.pdf fARC 

posted a list of attendees for its June 5 - June 12 meeting on Diesel and Gasoline Engine 

Exhausts and Some Nitroarenes http://monographs.iarc.frIENG/Meetings/voll 05-

participants.pdf The attendees that IARC has listed includes a number of very capable experts 

representing American employers. Aaron Cohen is an invited specialist. He is a principal 

scientist of the Health Effects Institute (HEI) which conducts research worldwide on the health 

effects of air pollution. The Institute's core funding comes in equal part from the U.S. 

Environmental Protection Agency and the makers of motor vehicles for sale in the United States. 

http://www.healtheffects.org/sponsors.htm John Gamble, Thomas Hesterberg (a full-time 

employee of Navis tar, Inc.), Roger McClellan, and John Carson Wall (Vice President - Chief 

Technical Officer of Cummins Inc., a manufacturer of diesel engines) were observers 

representing "The IARC Review Stakeholder Group," which represents the AAM (Alliance of 

Automobile Manufacturers), ACEA (European Automobile Manufacturers Association), AECC 

(Association for Emissions Control by Catalyst), API (American Petroleum Institute), 

CONCA WE (Conservation of Clean Air Water and Environment, the oil companies European 

association for environment, health, and safety in refining and distribution), EMA (Truck and 

Engine Manufacturers of America), IPIECA (International Petroleum Industry Environmental 

Conservation Association), MECA (Manufacturers of Emission Controls Association), and 

OICA (Intemational Organization of Motor Vehicle Manufacturers). Another observer, Timothy 

L. Lash, represents the Association of American Railroads. Thus, it appears American 

employers are well represented in the IARC evaluation of diesel exhaust. 

4. I understand that the Department of Health and Human Services, through the Centers 

for Disease Control and/or other agencies have awarded a number of grants and/or funds 

to the International Agency for Research on Cancer (IARC) over the past several years. 

Please provide a complete account of any such grants in aid, or other transfers of funds 

originally obligated to the department or its agencies, siuce 2009. Iu accounting for this 

information, please provide a summary of each project or projects undertaken by IARC as 

21 
96 

a result of the funding provided by the department or its agencies and documentation 

requested by the department and its agencies provided by IARC during 1) the solicitation 

process for such funding and 2) federal oversight of the projects undertaken by IARC, as a 

result ofthc grants in aid or other funding provided by the government. 

Answer: Since 2009, two components of the National Institutes of Health (NIH) have provided 

research funding to the International Agency for Research on Cancer (lARC). They are the 

National Institute on Dental and Craniofacial Research (NIDCR) and the National Cancer 

Institute (NCI). Below are descriptions of the research that is being funded and other details 

relevant to each project. 

In fiscal years 20 I 0 and 2011, NIDCR provided research funding to the International Agency for 

Research on Cancer (lARC) in support of two separate projects. The research abstract and 

public health relevance statements included in the summaries below were submitted by each 

applicant. 

The first project, supported by grant number R03 DE020 116, titled, Investigation of Genetic 

Variation ill the Alcohol Metabolism Gelles and Other Key Candidates in the IARC Multicenter 

Oral Cancer Study was submitted in response to Parent Announcement-07-4l8; NIDCR Small 

Grant Program for New Investigators (R03). The project was awarded to Dr. James Dowling 

McKay at the IARC. The solicitation process followed NIH policies and procedures, as does 

NIDCR oversight of the project. The research grant provides support for two years. The 

National Advisory Dental and Craniofacial Research Council was advised of the foreign 

component of this grant application at the September 24, 2009 meeting, and had no concerns or 

recommendations. State Department clearance for the foreign component was approved March 

9,2011. The Institutional Review Board at the University of Iowa approved the study on 

December 30, 2011. 

About 413,000 cancers of the oral cavity and pharynx are estimated to occur each year worldwide. While exposure to tobacco and alcohol are the major oral cancer risk factors, there is clear 

evidence that genetic susceptibility, with variation in the genes involved in metabolism of 

alcohol, also plays a role. The rARC Multicenter Oral Cancer Study was initiated in 1996 and 

has developed a multicenter case-control study of approximately 1600 cases and 1600 control 

individuals from nine different countries and three major ethnicities (European, Asian and 

African) to investigate oral11sk factors, notable exposure to human papillomavirus (HPV), 

tobacco and alcohol. Investigators associated with this study, and others, have shown that the 

genes involved in metabolism of alcohol, particularly the ADH gene, cluster on human 

chromosome 4, and may potentially play an important role in upper aerodigestive tract (UADT) 

cancers, and important subset of cancers affecting the oral cavity and pharynx. 

The specific aims for this project are: 1) Complete isolation of DNA from the stored biological 

material of the !ARC multicenter oral cancer study and develop a working DNA bio-repository; 

2) Select key genetic variants relevant to UADT cancer; 3) Genotype genetic variants in the 

IARC multicenter oral cancer study; and 4) Dcscribe variant effects in the IARC multicenter oral 

22 
97 

cancer study. This study will also confiml that genetic markers are associated with oral cavity 

and pharynx cancer susceptibility across the diverse ethnicities and investigate how these effects 

are modified by different environmental exposures in IARC multicenter oral cancer study, in 

particular exposure to HPV, alcohol and tobacco. 

PUBLIC HEALTH RELEVANCE: This study will provide more information about the role of 

key risk factors and genetic variations in the susceptibility to cancers of the oral cavity and 

pharynx. Such findings will provide significant benefits to efforts to prevent these devastating 

cancers in the U.S. population and world-wide. 

Budget Data: 

Project # 

lR03DE020116-0l 

5R03DE020116-02 

Amount (Dollars) 

87,375 

87,375 

FY 

2010 

2011 

The second project is supported by the NlDCR grant R03DE021098-01Al, "Risk Factor 

Differences by HPV Serology and Tumor DNA Among lNHANCE Participants," which was 

awarded to Dr. Elaine Smith at the University ofIowa. This application was submitted in 

response to NIDCR PAR-09-182 "Small Grants for Data Analysis," to support research that 

involves secondary data analyses using existing databases that contain infolmation about oral 

health conditions. The research grant provides support for two years. The solicitation process 

followed NIH policies and procedures, as does NIDCR oversight of the project. The National 

Advisory Dental and Craniofacial Research Council was advised of the foreign component of 

this grant application at the January 24, 2011 meeting, and had no concerns or recommendations. 

State department clearance for the foreign component was approved 3/09/2011. The Institutional 

Review Board at the University ofIowa approved the study on 12/30/2011. 

The purpose of the grant is to examine data collected through the International Head and Neck 

Cancer Epidemiology (INHANCE) Consortium established by the National Cancer 

Institute/IARC in response to limitations in research of rare tumors, including head and neck 

cancer (HNC). INHANCE is composed of large molecularlgenetic epidemiology studies of HNC 

worldwide. The investigators will examine the associations ofHNC and human papillomavirus 

(HPV), a known risk factor for a significant proportion ofHNC cases. There are several issues 

that remain unclear about HPV's relationship to HNC, tobacco use and alcohol use, which the 

INHANCE pooled analysis will better clarify. The aims oftl1is study are to: 1) Examine the 

association between HPV, tobacco, alcohol and riskofHNC to determine whether there are two 

HNC diseases, i.e., one risk group related to HPV infection and the other risk group related to 

tobacco/alcohol use; and 2) Compare tumor tissue HPV DNA + fmdings ill HNC cases for E61E7 

antibodies, evaluating tumor HPV DNA+/sero- to HPV DNA+/sero+ and DNA-/sero- cases. 

This aim will determine whether there are HPV -driven and HPV -independent HNC cases and 

whether HPV DNA+/sero- cases have risk factors similar to or different from HPV DNA+/sero+ 

or HPV DNA-/sero- cases. The rationale for this aim is that some patients with HNe HPV 

DNA+ tumors do not mount an immunologic response, suggesting that these cases have different 

risk factors and clinical outcomes than do HPV antibody positive cases. 

23 
98 

PUBLIC HEALTH RELEVANCE: This study will provide more information about treatment 

and prognosis of HPV -driven tumors, and help clarify whether there are two or more risk factor 

profiles for HNC. The findings will benefit the efforts to improve treatment efforts for the U.S. 

population. 

Budget Data: 

Project # 

lR03DE021098-01Al 

5R03DE021098-02 

Amount (Dollars) 

150,750 

151,000 

FY 

2011 

2012 

NCI has awarded a total of eight different grants (two of which had multiple funding years) to 

the IARC from FY 2009 through FY 2012. The following table provides the project title, core 

grant number, and funding by fiscal year for each of the eight core grants. 

In addition, the NCl also provides a small amount of support to IARC for training and the 

support of the development of cancer registries through other partners. 

Information regarding the solicitation process for each identified grant is provided in the 

summary of each project, which includes the title, grant number, Request for applications/ 

Program Announcement (RF AlP A), start and end dates, and project description for each funded 

year. Therefore, the two projects (core grant numbers 5UO I CA033 193 and 5RO 1 CA092039) 

with multiple funding years have multiple summaries, one for each funded year, which vary 

slightly in description as well as start and end dates. 

Each summary includes a link to the RF AlP A that each competitive application was submitted in 

response to by IARC. Several of the projects were unsolicited or investigator-initiated 

applications. In these cases, a link to the parent announcement is provided. 

The research abstract and public health relevance statements included in the summaries below 

were submitted byeach applicant. 

Project Title: Evaluation of Carcinogenic Risk to Humans 

Grant#: 5UOICA033193-30 

RFAlPA: Unsolicited or Investigator-Initiated 

Project Start: 9/1/1985 

Project End: 8/3112015 

Abstract 

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DESCRIPTION (provided by applicant): The IARC Monographs on the Evaluation of 

Carcinogenic Risks to Humans represent an international expelt-consensus approach to 

carcinogen hazard identification. The long-term objective is to critically review and evaluate the 

published scientific evidence on carcinogenic hazards to which humans are exposed. These 

include chemicals, complex mixtures, physical agents, biological agents, occupational exposures, 

and lifestyle factors. National and international health agencies use the rARC Monographs as a 

source of scientific information and as the scientific basis for their actions to prevent exposure to 

known, probable, and possible carcinogens. Each rARC Monograph contains a critical review 

of the published scientific literature and an evaluation of the weight of the evidence that an agent 

can increase the risk of cancer. Agents are selected for evaluation based on evidence of human 

exposure and some evidence of carcinogenicity. Agents can be re-evaluated if significant new 

data become available. The program also collaborates on scientific workshops to determine how 

to make the best use of contempormy studies to identify agents that playa role in cancer 

development and to understand their mechanisms. The Preamble to each volume ofIARC 

Monographs describes the principles and procedures that are followed, including the scientific 

criteria that guide the evaluations. Each IARC Monograph is developed by a Working Group of 

experts who conducted the original research, avoiding real or apparent conflicts of interests. 

Working Groups typically consist of 20-25 scientists from 8-12 countries, with expertise in 

cancer epidemiology, experimental carcinogenesis, and related disciplines. The Working Group 

meets to review and reach consensus on drafts prepared by the experts before the meeting, and to 

develop and reach consensus on the evaluations. Later, IARC scientists review the text and tables 

to ensure their scientific accuracy and clarity, and the volume is edited and published. Funds 

are requested to support two of the three volumes produced each year. 

Project Title: Evaluation of Carcinogenic Risk to Humans 

Grant#: 5UOICA033193-29 

RFAlPA: Unsolicited or Investigator-Initiated 

Project Start: 9/1/1985 

Project End: 8131/2015 

Abstract 

DESCRIPTION (provided by applicant): The IARC Monographs on the Evaluation of 

Carcinogenic Risks to Humatls represent an international expert-consensus approach to 

carcinogen hazard identification. The long-term objective is to critically review and evaluate the 

published scientific evidence on carcinogenic hazards to which humans are exposed. These 

include chemicals, complex mixtures, physical agents, biological agents, occupational exposures, 

and lifestyle factors. National and international health agencies use the IARC Monographs as a 

source of scientific information and as the scientific basis for their actions to prevent exposure to 

lmown, probable, and possible carcinogens. Each IARe Monograph contains a critical review 

of the published scientific literature and an evaluation of the weight of the evidence that an agent 

can increase the 11Sk of catlcer. Agents are selected for evaluation based on evidence of human 

exposure and some evidence of carcinogenicity. Agents can be re-evaluated if significant new 

data become available. The program also collaborates on scientific workshops to detennine how 

25 
100 

to make the best use of contemporary studies to identify agents that playa role in cancer 

development and to understand their mechanisms. The Preamble to each volume of IARC 

Monographs describes the principles and procedures that are followed, including the scientific 

criteria that guide the evaluations. Each IARC Monograph is developed by a Working Group of 

experts who conducted the original research, avoiding real or apparent conflicts of interests. 

Working Groups typically consist of 20-25 scientists from 8-12 countries, with expertise in 

cancer epidemiology, experimental carcinogenesis, and related disciplines. The Working Group 

meets to review and reach consensus on drafts prepared by the experts before the meeting, and to 

develop and reach consensus on the evaluations. Later, IARC scientists review the text and tables 

to ensure their scientific accuracy and clarity, and the volume is edited and published. Funds 

are requested to support two of the three volumes produced each year. 

Project Title: Evaluation of Carcinogenic Risk to Humans 

Grant#: 5U01CA033193-28 

RFAIPA: Unsolicited or Investigator-Initiated 

Project Start: 911/1985 

Project End: 8/31120 I 0 

Abstmct 

DESCRIPTION (provided by applicant): The IARC Monographs on the Evaluation of 

Carcinogenic Risks to Humans represent an international expert-consensus approach to 

carcinogen hazard identification. The long-term objective is to critically review and evaluate the 

published scientific evidence for all carcinogenic hazards to which humans are exposed. These 

include chemicals, complex mixtures, occupational exposures, lifestyle factors, and physical and 

biological agents. National and international health agencies use the TARC Monographs as an 

authoritative source of scientific information and as the scientific basis for their efforts to control 

cancer. Each IARC Monograph includes a critical review of the pertinent scientific literature and 

an evaluation of the weight of the evidence that an agent or exposure may be carcinogenic to 

humans. Agents arc selected for evaluation based on evidence of human exposure and some 

evidence of carcinogenicity. Agents can be re-evaluated if significant new data become 

available. The program also collaborates on scientific meetings on mechanisms of carcinogenesis 

and other topics pertinent to evaluations of carcinogenicity. A written Preamble to each volume 

of rAR.C Monographs describes the principles and procedures that are followed, including the 

scientific criteIia that guide the evaluations. Each IARC Monograph is developed by a working 

group selected on two principles: to invite the best-qualified experts and to avoid real or apparent 

conflicts of interests. Working groups typically consist of 20-25 scientists from 10-12 countries, 

with expertise in cancer epidemiology, experimental carcinogenesis, and related disciplines. The 

working group meets to review and reach consensus on drafts prepared by the experts before the 

meeting, and to develop and reach consensus on the evaluation. Later, rARC scientists review 

the text and tables to ensure their scientific accuracy and clarity, and the volume is edited and 

published. Funds are requested to support two of the three volumes produced each year. 

26 
101 

Pro.iect Title: Genetics of Tobacco and Alcohol Related Cancers 

Grant#: 5ROICA092039-07 

RF AJP A: Unsolicited or Investigator-Initiated 

Project Start: 10/112001 

Project End: 4/30/2012 

Abstract 

PUBLIC HEALTH RELEVANCE: Large genetic epidemiology stndies have the potential to 

identify individuals at particularly high risk of developing cancer, as well as helping identify 

why these cancers develop. By incorporating multiple large stndies of cancers related to tobacco 

and alcohol (specifically lung, and UADT cancer) we aim to provide knowledge that will inform 

future prevention efforts. 

DESCRIPTION (provided by applicant): During the first 30 months of the original grant (ROI 

CA 092039-01A2), we have successfully contributed to our understanding of the genetic 

epidemiology of lung cancer and upper aero digestive tract (UADT) cancer by identification of 

several genes that are very strongly associated with them, including CHEK2 and ADHIB. We 

have also demonstrated how genetic variants internct strongly with dietary and environmental 

exposures for these cancers. Given the enOffil0US increase in genetic infOlmation over the last 3 

years we plan to build on our initial results and comprehensively evaluate the role of genes in 5 

specific pathways for these cancers. To test the robustness of the positivc associations observed, 

we will conduct independent replication of fmdings in other large studies. We therefore propose 

a multistage study with the following specific aims: Stage 1 will involve a comprehensive 

evaluation of 5 candidate gene pathways among 2200 European case-control pairs oflung cancer 

and 1000 case-control pairs ofUADT cancer, involving over 1500 informative variants as well 

as inc.1usion of biologically relevant variants. Stage 2 will involve rapid replication of important 

positive results in other large independent European studies including (i) EPIC lung cancer based 

on 1200 lung cancer cases and 2400 controls, and (ii) the 'ARCAGE' Western European stndy of 

2000 case-control pairs ofUADT cancer. The choice of variants passing from Stage 1 to Stage 2 

will be based on hierarchical bayes approach incorporating genomic information such as 

sequence conservation. Important conftrmed genes will be resequenced and further replicated in 

a third fARC study ofUADT cancer from Latin American study comprising 2000 case-control 

pairs of head and neck cancer. As an important component of this proposal, we will conduct 

functional studies of the genes that are replicated inc.1uding differential mRNA expression. All 

results will be made available to the research commnnity of tobacco and alcohol related cancers 

via collaboration within 2 intemational consortia oflung cancer and head and neck cancers. 

Project Title: Genetics of Tobacco and Alcohol Related Cancers 

Grant#: 5RO 1 CA092039-06 

RFAJPA: Unsolicited or Investigator-Initiated 

Project Start: 10111200 I 

Project End: 4130/2011 

27 
102 

Abstract 

PUBLIC HEALTH RELEVANCE: Large genetic epidemiology studies have the potential to 

identify individuals at particularly high risk of developing cancer, as well as helping identify 

why these cancers develop. By incorporating multiple large studies of cancers related to tobacco 

and alcohol (specifically lung, and UADT cancer) we aim to provide Imowledge that will infonn 

future prevention efforts. 

DESCRIPTION (provided by applicant): During the first 30 months of the original grant (RO! 

CA 092039-01A2), we have successfully contributed to our understanding of the genetic 

epidemiology of lung cancer and upper aerodigestive tract (UADT) cancer by identification of 

several genes that are very strongly associated with them, including CHEK2 and ADHIB. We 

have also demonstrated how genetic variants interact strongly with dietary and environmental 

exposmes for these cancers. Given the enOlmous increase in genetic infoIDlation over the last 3 

years we plan to build on our initial results and comprehensively evaluate the role of genes in 5 

specific pathways for these cancers. To test the robustness of the positive associations observed, 

we will conduct independent replication of findings in other large studies. We therefore propose 

a multistage study with the following specific aims: Stage 1 will involve a comprehensive 

evaluation of 5 candidate gene pathways among 2200 European case-control pairs of lung cancer 

and 1000 case-control pairs ofUADT cancer, involving over 1500 infonnative variants as well 

as inclusion of biologically relevant variants. Stage 2 will involve rapid replication of important 

positive results in other large independent Emopean studies including (i) EPIC lung cancer based 

on 1200 lung cancer cases and 2400 controls, and (ii) the 'ARCAGE' Western European study of 

2000 case-control pairs ofUADT cancer. The choice of valiants passing from Stage 1 to Stage 2 

will be based on hierarchical bayes approach incorporating genomic infOlmation such as 

sequence conservation. ImpOltant confilmed genes will be resequenced and further replicated in 

a third IARC study ofUADT cancer from Latin American study comprising 2000 case-control 

pairs of head and neck cancer. As an important component ofthis proposal, we will conduct 

functional studies of the genes that are replicated including differential mRNA expression. All 

results will be made available to the research community of tobacco and alcohol related cancers 

via collaboration within 2 international consortia of lung cancer and head and neck cancers. 

Project Title: International Lung Cancer Consortium: Pooled Analysis of Genetic DeteIDlinants 

Grant#: 5R03CA133939-02 

RFAlPA: PAR06-294 

Project Start: 3/10/2008 

Project End: 2128/2010 

Abstract 

DESCRIPTION (provided by applicant): While it is apparent that lung cancer is predominantly 

caused by exposure to tobacco products, only a minority of heavy smokers will develop this 

disease. Familial aggregation has been observed in lung cancer with familial relative risk of2-

fold and a recent linkage analysis has revealed a possible susceptibility locus at 6q23-25. 

However, the exact inheritance mechanism of lung cancer is still largely undefined. Major gaps 

28 
103 

remain in knowledge oflung cancer genetics induding (i) the effect of positive family history of 

lung cancer, patticuiarly by histological type and among never smokers, and (ii) the contribution 

oflow and moderate penetrance genetic variants. Single studies are unlikely to be sufficiently 

powered to provide robust answcr to these questions highlighting the need for international 

collaboration across studies. The International Lung Cancer Consortium (ILCCO) is an 

international group oflung cancer researchers established in 2004 with the aim of sharing 

comparable data from ongoing lung cancer case-control and cohort studies. The overall 

objectives are to achieve greater power, especially for subgroup analyses, reduce duplication of 

research effort, replicate novel findings, and afford substantial cost savings through large 

collaborative efforts. We propose to conduct pooled analyses to evaluate the effect offamily 

history among never smokers, and conduct coordinated genotyping to investigate the 

contribution of low to moderate penetrance genetic variants. Our hypotheses are (i) positive 

family history of lung cancer' may differ by histological type and also by smoking status, and ii) 

common genetic variants influence lung cancer risk and attributable to at least part of the lung 

cancer cases. Our specific aims are (i) to combine data from 21 lung c"ancer studies to evaluate 

the contribution of positive family history of lung cancer to the risk of developing lung cancer 

overall, as well as by age of the proband, in never smokers and by histological subtype. We will 

also (ii) conduct coordinated genotyping on potential lung cancer susceptibility variants, which 

are nominated by ILCCO members and chosen based on the strength of the evidence, biological 

plausibility, and previous independent replications. Finally we will (iii) conduct pooled analysis 

of genotyping data, in order to confirm or refute the effect of these sequence variants on lung 

cancer overall, as well as in rare subgroups of interest including never smokers, young age of 

onset, familial cases and on histological subtypes. 

Project Title: One-carbon metabolism biomarkers and lung cancer risk 

Grant#: lUOICA155340-01AI 

RFAfPA: PAlO-067 

Project Start: 9/2312011 

Project End: 8/3112015 

Abstract 

PUBLIC HEALTH RELEVANCE: In the US over 225,000 lung cancer cases are diagnosed 

every year representing approximately 15% of all new cancer cases, and 28% of caucer deaths. 

Although the main risk factor of lung cancer is tobacco exposure, nearly half of all hmg cancer 

cases in the US occur among fonner and never smokers. We recently identified strong protective 

effects of elevated circulating levels ofB- vitamins (in particular vitamin B6, folate, and also 

methionine) in a large cohort including pre-diagnostic blood samples in participants from eight 

European countries. The proposed study includes equal numbers ofuever, fonner and current 

smokers, aims to clarify a potentially strong beneficial role of B-vitamins and related factors in 

lung cancer development. The study will be conducted in collaboration with over 20 cohorts, and 

may identify impOitant biomarkers for hmg cancer risk prediction, over and above that afforded 

infOimation on tobacco exposure. 

29 
104 

DESCRIPTION (provided by applicant): We have recently identified strong associations 

between circulating biomarkers of one-carbon metabolism (OCM) and lung cancer within the 

European Prospective Investigation and Cancer (EPIC) cohOlt, based on prospectively collected 

blood samples from 900 cases and 1,800 controls. The study strongly implicated important 

protective effects for both vitamin B6 and methionine independently of smoking status, resulting 

in 2.5-fold risk differences between the top and bottom 25% of the population for these vitamin 

measures combined (p=10-12). Repeat measures indicated that these effects were substantially 

under-estimated because of regression dilution. The main objectives of this expanded study are 

two-fold: i) to clarify the role ofB-vitamins and related mctors (the one-carbon metabolism 

pathway) in lung cancer etiology in a study population large enough to allow robust risk analyses 

stratified by smoking status, using both molecular epidemiology and genetic approaches, and ii) 

to measure the role of OCM biomarkers in lung cancer risk prediction in multiple cohorts. We 

have initiated a lung cancer consortitUn in collaboration with over 20 cohorts participating in the 

NCI Cohort Consortiunl, including in total 11,500 prospectively collected lung cancer cases with 

blood samples. This study will include equal proportions of 1,200 never, fOlmer, and cunent 

smoking case-control pairs recruited in US/European/Australian cohorts, as well as 1,500 casecontrol pairs recruited in Asian cohorts. We will also include 1,000 repeat samples from a 

subgroup to allow for correction of regression dilution bias, resulting in biochemical analysis of 

11,200 selUm/plasma samples. Circulating levels of up to 40 biomarkers of one-carbon 

metabolism will be measured in the whole study population, and we will quantify their 

association with subsequent lung cancer risk. Important analyses of a priori interest will include 

measmlng the association with risk among never and fonner smokers separately. These risk 

estimates will subsequently be used in risk prediction models, also taking regression dilution into 

account. Preliminary data from the EPIC cohort indicate that serum measures of methionine and 

vitamin B6 may identify up to 7-fold differences in life-time risk oflung cancer. Lung cancer 

remains a major health problem world-wide, and is responsible for 28% of all cancer deaths in 

the US. As well as elucidating the association between OCM biomarkers and Inng cancer, this 

initiative will create more detailed risk prediction models, over and above that afforded by 

detailed infonnation on tobacco exposure alone. The important work that will go into the 

constlUction of this consortium will also result in opportunities to initiate additional studies 

coucerning lung cancer etiology. 

Project TitIe: A New Approach to Identify Rare Genetic Variants Influencing Melanoma Risk 

Grant#: lR03CA156624-01Al 

RFAlPA: PAR08-237 

Project Start: 311/2012 

Project End: 2128/2014 

Abstract 

PUBLIC HEALTH RELEVANCE: Malignant melanoma is a rare tumor of melanocytes that, 

because of its aggressive nature, causes the majority of deaths related to skin cancer. Since tile 

mid-20th century, melanoma has become an important health problem in fair-skinned 

populations worldwide, since its incidence has climbed faster than any other type of malignancy. 

The goal of this study is the identification of new melanoma susceptibility genes and the 

30 
105 

characterization of the pathogenic sequence variants associated with increased risk of developing 

melanoma. Identification of susceptible individuals may aid in increasing sun protection and 

early detection ofmelanocytic tumors at the precancerous stage of the disease, altering attitudes 

toward sunlight and suntans, and protecting the skin from UV damage in populations at risk. 

DESCRIPTION (provided by applicant): A number of genome-wide association studies 

(GWAS) have successfully implicated common SNPs in the etiology of complex traits. Most 

variants identified so far confer relatively small increments in risk (1.l-1.5-fold), and explain oly 

a small proportion of familial clustering. Recent studies have demonstrated that common 

diseases can be due to dysfunctional variants with a wide spectmm of allele frequencies. So far, 

rare variants studies have been limited to a handful of phenotypes and genes, but the 

advancement of sequencing technologies should lead to widespread association studies of 

candidate genes and genomes. If rare variants have larger effects than common variants, this 

should aid in their detection. Also their identification should have a greater impact on risk 

assessment, disease prevention and treatment. However, the analysis of rare variants is 

challenging since methods used for common variants are underpowered. Previously, we used 

data from mutation screening of breast cancer patients and controls to demonstrate the ability to 

detect evidence of pathogenicity from both tmncating and splice junction variants and rare 

missense substitutions. The method involves stratifying rare missense substitutions observed in 

cases and/or in controls into a series of grades ordered from least to most likely to be 

evolutionarily deleterious, followed by a logistic regression trend test to compare the frequency 

distributions of the grades of variants in cases versus controls. The original model was developed 

to assess the pathogenicity of missense substitutions in breast cancer-related genes. Here we 

propose to test the efficiency of our analysis strategy to cutaneous malignant melanoma (CMM). 

To identify novel risk alleles, we will mutation screen the strongest candidate genes of the 

pigmentation pathway in over 1,300 cases and 1,300 matched controls from 10 European 

countries enrolled in the EPIC cohort. CMM provides a unique model for studies of gene-gene 

and gene-environmental interactions in the development of multifactorial diseases, since 

relationships between the major environmental factor (exposure to solar UV radiation) and 

known susceptibility genes are reasonably well understood. High-risk mutations in CDKN2A 

and CDK4 are canied by about 20-25% of melanoma-prone families. In contrast, some missense 

substitutions in the pigmentation gene MCIR have been proven to be modest-risk or 

intermediate-risk susceptibility alleles, and also to increase the peneirance ofCDKN2A 

mutations. Finally, two recent GW AS identified low- penetrance SNPs in MCIR or in genes of 

the same pathway. Associated SNPs will account for no more than 12% of the Familial Relative 

Risk. Thus, the majority of the genetic susceptibility to CMM remains to be explained. After 

validation of our method on strong candidates, massive parallel sequencing of genes of entire 

biochemical pathways is envisaged to generate a comprehensive picture of the lisk-frequency 

spectrum for pathogenic sequence variants involved in susceptibility to melanoma. 

Project Title: Genetic Analysis of a Large Multiplex Nasopharyngeal Carcinoma (NPC) Family 

Grant#: lUOICA165037-01 

RFAlPA: PAR08-237 

Project Start: 5/2512012 

31 
106 

Project End: 4/3012014 

Abstract 

PUBLIC HEALTH RELEVANCE: Genetic susceptibility, along with environmental factors 

such as suboptimal food preservation and exposure to EBV, are likely to playa role in the 

etiology of nasopharyngeal carcinoma (NPC). However, the identity of the genes involved in 

NPC susceptibility, particularly genes that confer an important genetic risk, remain elusive. This 

application aims to perform in depth genetic analysis of a large multiplex Malaysian pedigree to 

identify new genes involved in the susceptibility to NPC, with the genes of interest that arise to 

be validated and replicated in additional popUlations. 

DESCRIPTION (provided by applicant): Nasopharyngeal carcinoma (NPC) has an extremely 

heterogeneous geographical and ethnic distribution. Environmental factors such as suboptimal 

food preservation and exposure to EBV appear involved in the etiology ofNPC. Genetic 

susceptibility is also likely to be involved but the identity of the genes involved in susceptibiliy 

to NPC remains elusive. Isolated populations, particularly those with unusually high diseases 

prevalence, offer rare opportunities to investigate the genetic cause of human disease. The 

Bidayuh ethnic subgroup of Sarawak Malaysia has unusually high prevalence ofNPC. We have 

identified one exceptionally large Bidayuh multiplex pedigree in which 26 NPC cases can be 

traced back to a single founding village. We have focused extensive recruitment of the NPC 

cases allowing the collection of blood samples from 11 of the NPC cases, and can to infer 

genetic infOlmation for an additional 7 NPC cases. This application aims to perform 

comprehensive genetic analysis of this pedigree using a combination of high density genotyping 

and direct whole exome DNA sequencing. The genes of interest identitled in this exceptionally 

large pedigree will be validated and replicated in additional populations. 

Projeet Title: Pooled Genome-Wide Analysis of Kidney Cancer Risk 

Grant#: lUOICA155309-01Al 

RFAlPA: PAl 0-067 

Project Start: 9/14/2011 

Project End: 8/3112015 

Abstract 

PUBLIC HEALTH RELEVANCE: The incidence of kidney cancer has been increasing over the 

past decades and the disease has a very poor prognosis when diagnosed at an advanced stage 

(20% of the cases in the US). Apart from smoking, obesity and hypertension, much of the 

etiology of this disease remains to be identified. We propose to investigate genetic factors 

associated with kidney cancer onset and survival, looking at the genetic variants across the whole 

genome, and combining this with gene expression analysis of the tumor tissue. 

DESCRIPTION (provided by applicant): Renal cell carcinoma (RCC) is the 8th most common 

cancer in the US and the 10th most common form of cancer death, with over 34,000 cases and 

12,000 deaths each year. A sharp increase in the incidence of RCC was observed in recent 

decades witll some of the greatest increases happening in Central Europe and among the black 

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population in the US. Apmt fi'om smoking, obesity and hypertension, much of the etiology of 

this disease remains to be identified. There is increasing evidence that genetic factors influence 

susceptibility to RCC, although this hypothesis has been understudied. We have recently 

completed a genome-wide association study (GWAS) of RCC comprising 3,800 cases and 8,500 

controls. We now propose to extend this study by incOlporating an additional 3,800 cases and 

4,800 controls from a series of popUlation based case-control and cohort studies. Inclusion of 

cohort studies has been facilitated via the NCr cohort consortium initiative. In addition to its 

size, our study will be unique in several ways; (1) extensive clinicopathological information and 

survival of cases will be collected; (2) genome-wide analyses for the association between genetic 

variants and RCC will be conducted for both disease onset and survival; (3) a comprehensive 

biorepository of germline DNA and tumor DNA and fu"fA on at least 2,000 cases will be 

developed; (4) whole-genome gene expression profiling on fresh renal tissue and tumor tissue 

will be obtained to complement results obtained from the germline genotyping analyses. 

Project Title: Common and Rare Sequence Variants in Breast Cancer Risk 

Grant#: 5ROICA121245-03 

RF AlP A: Unsolicited 01' Investigator-Initiated 

Project Start: 9/30/2007 

Project End: 7!31/2010 

Abstract 

DESCRIPTION (provided by applicant); Combining data from segregation analyses and 

mutation screening studies, the established breast cancer susceptibility genes are responsible for 

an estimated 20%-25% of the genetic component of this disease. The genes andlor sequence 

variants responsible for the remaining genetic component of breast cancer risk have yet to be 

identified. Most of the current enthusiasm for SNPs and haplotype mapping are predicated on the 

assumption that conml0n modest risk variants are most important. However, few candidate 

associations between common SNPs and breast cancer risk have been independently reproduced. 

Thus the central question of this study; What is the relative contribution of common (usually 

modest-risk) sequence variants vs. rare (potentially higher-risk) sequence variants to the genetic 

attributable fraction of breast cancer? U Using an etlmically diverse series of 1,250 genetically 

high-risk breast cancer cases and 1,250 frequency-matched population controls, we propose a 

novel study designed to make a direct comparison between the ccmmon disease! common 

variant and common disease! rare variant models of genetic susceptibility. The study has two 

arms. In the first, we will genotype the cases and controls with all of the common- sequence 

variants that are known, or are found over the course of this study by the breast cancer genetics 

research community, to predict increased risk of breast cancer. In the second aIm, we will 

mutation screen the open reading frames of strong candidate susceptibility genes in both the 

cases and the controls. Analysis of the genotype and mutation screening data should provide an 

answer to the central study question. Our focus on early onset and familial cases will 

substantially increase power to detect risk conferred by deleterious sequence variants as 

compared to a study of similar size without these criteria, fl Results from this study are relevant 

to public health in three ways: (1) This study will provide a hypothesis test of genes, and 

mutations in them, that appear to confer moderately to dramatically increased risk of breast 

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108 

cancer. Measuring risk due to mutations in these genes is a key step that lies between initial 

indications that the gene plays a role in breast cancer susceptibility and bringing the gene into the 

clinical practice of cancer genetics. (2) Results from this study will bear on the future direction 

of clinical cancer genetics. The relative contribution that moderate risk versus modest risk 

sequence variants make to the attributable risk of breast cancer will have an impact on how the 

genetic information enters clinical practice. (3) Analysis of the genotype and mutation screening 

data will provide a comparison of risk attributable to the common variant and rare variant genetic 

models of cancer susceptibility. This is a question of major CUITen! interest and importance 

within the genetics research community. If we observe that the rare sequence variants account 

for as much or more risk than do common SNPs, it may be necessary to expand mutation 

screening from the realm of genetic epidemiology! family studies into larger scale popuiationbased studies. 

The competitive applications for each funded project were subject to federal oversight, including 

Just-in-Time procedures. These procedures allow cettain elements of an application to be 

submitted later in the application process, after review when the application is under 

consideration for funding. The standard application elements include other suppott infonnation 

for senior!key personnel; celtification of Institutional Review Board (JRB) approval of the 

project's proposed use of human subjects; verification of Institutional Animal Care and Use 

Committee (IACUC) approval of the project's proposed use of live vertebrate animals; and 

evidence of compliance with the education in the protection of human research participants' 

requirement. Other program-specific infomlation may also be requested using this procedure. In 

addition, progress reports were required annually as part ofthe non-competing continuation 

award process. NIH also requires all financial expenditure reports to be submitted using the 

Federal Financial Repott (FFR). An ammal FFR is required for awards to foreign organizations. 

Additional infonnation on the NIH Policy on Grants to Foreign Institutions can be fOlllld at: 

httn:l!grants.nih.gov!grants/policv!nihgpg 2011lnihgps ch16.htm# Toc271265275 

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The Honorable Lon Barletta 

1. Recently, the 2012 Medicare Trnstee Report concluded that Medicare will go bankrupt 

by 2024. Doctors, hospitals, and patients in the 11th district are concerned about these 

results. 'With an aging population, increased techuology, and more complex medications 

there continues to be a strong demand for medical services. In addition, the President's 

healthcare reform law reduced Medicare expenditures by more than $500 billion and the 

Health and Human Services' FY 13 budget request calls for over 300 billion more in cuts 

from Medicare and Medicaid. How do you expect providers to address these cuts'? 

Answer: There's no doubt that slowing the growth of Medicare spending will be a challenge, 

But doing so is essential in order to meet our collective commitments to our seniors and address 

our long-term budget deficits. The payment modifications included in Affordable Care Act 

targeted areas where spending was in excess of the cost of eftident, high-quality care and where 

payment incentives are expected to encourage providers to improve health care delivery. The 

President's Budget builds on the Affordable Care Act to encourage better health care delivery 

systems and to further address excess spending. This constitutes a sound, sustainable, and 

cautious approach to slowing the growth of Medicare. 

Experts agree that there is significant inefficiency in the health care sector. By attacking this 

inefficiency, providers will be able to absorb the relatively modest Medicare spending restraints 

included in the Affurdable Care Act. Provisions in the Affordable Care Act that promote 

delivery and payment innovations will further support these efforts and help providers realize 

additional productivity gains. 

In addition, the Affordable Care Act will vastly redllce the number of Americans without health 

insurance. As a result, providers will deliver far less uncompensated care, giving a major boost 

to their bottom lines. 

2. How is the U.S. Department of Health and Human Services planning for the estimated 

mandatory cuts that will take place under the current sequestration rules contained in the 

Budget Control Act? What process will the agency use in determining the necessary cuts? 

Will you start with the programs that cost the most? What analysis has been done to 

estimate the impact on access to care? 

Answer: The Administration believes that Congress should pass balanced deficit reduction 

legislation consistent with the President's Budget to avoid sequestration. In the event that 

Congress fails to pass bipartisan balanced deficit reduction legislation, the Congressional Budget 

Office (CBO) estimates that automatic sequestration would reduce non-defense discretionary 

programs by 7.8 percent on January 2, 2013, which would be applied to most HHS accounts. 

The deep discretionary cuts projected by CBO would have profound consequences on the 

Department's ability to protect Ameticans' health and safety and provide critical services to 

vulnerable populations. 

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3. My district is home to one of the largest vaccine companies in the world, and as such I 

have a concern about the proposed cuts to the 317 immunization program which provides 

the federal infrastructure funding for state and local immunization programs. What is the 

rationale for cutting this program and how will that impact the states' ability to pnrchase 

and distribute vaccines? 

Answer: The FY 2013 budget request includes funds for vaccine purchase to continue outreach 

to the hardest to serve populations, and critical immunization operatious and infrastructure that 

supports national, state, and local efforts to implement an evidence-based, comprehensive 

immunization program. The request also specifically directs $25 million towards continuation of 

the Billables Project, which allows public health departments to vaccinate and bill fcir fullyinsured individuals in order to maintain Section 317 vaccines for the most financially vulnerable 

and respond to time-urgent vaccine demands, such as outbreak response. The FY 2013 Budget 

will sustain the national immunization program vaccine purchase and immunization 

infrastructure. The Budget does not continue funding for one-time enhancements planned for FY 

2012 to modernize the immunization infrastructure through funding to the grantees for 

improving immunization health IT systems and vaccine coverage among school-age children and 

adults; expansion of the evidence base for immunization programs and policy; and enhancements 

to national provider education and public awareness activities to SUppOlt vaccination across the 

lifespan. Health reform expansion will further increase access to immunizations and decrease the 

number of uninsured and underinsured individuals served by the Section 317 Program, resulting 

in cost savings. 

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The Honorable Martha Roby 

1. As part of the universal health insurance reform passed in 2010, all health plans must 

now provide-at no out-of-pocl,et cost to the recipient-certain "preventative services." 

Many of these services are routine; however, it is the tenth government-mandated service 

that puts various groups in a moral bind. Specifically, the mandated coverage must include 

"[alII Food and Drug Administration approved contraceptive methods, sterilization 

procedures, and patient education and counseling for all women with reproductive 

capacity." 

Due to public uproar, in February, HHS finalized the narrowly defined exemption for the 

"religious employer"-ensuring that some, but not all religious institutions, will not have to 

cover contraceptive services or refer employees to organizations that provide such services. 

This exemption only applies to a religious entity if it primarily serves people of their own 

faith. It does not apply to faith-based organizations that serve people of all or no faith. 

The Catholic TV Station, The Eternal Word Television Network (EWTN), is located in the 

state of Alabama. EWTN does not fall under the small umbrella of this religious 

exemption-nor do many hospitals, charitable service organizations, and universities. I 

understand that the Administratiou'is worldng on an "accommodation" for groups that fall 

under this category. 

Puttiug aside the future "accommodation," why is EWTN, and similar religiously affiliated 

entities, not exempt from covering these services---especially when these drugs and services 

fundamentally contradict their moral beliefs? Why is the administration defining some 

institutions as religious enough for a full exemption, others as only religious enough to 

qualify for a yet undefined accommodation and leaving still others with no religions 

protection at all? 

Answer: After considering the many comments received on the amendment to the interim final 

l1lles providing for a religious exemption, the Departments issued tlnall1lles on Febl1lary 10, 

2012, retaining the same exemption authorily annouuced in August 2011. At the same time, we 

released guidance providing a one-year enforcement safe harbor for group health plans 

sponsored by certain non-profit organizations (and any associated group health insurance 

coverage) that, for religious reasons, do not provide contraceptive coverage and do not qualify 

for the current exemption. 

In annonncing this policy, the Administration committed to rulemaldng during this one-year 

enforcement safe harbor period to ensure women l1ave access to these important preventive 

services in fully insured and self-insured group health plans while proteeting the religious beliefs 

of additional religious organizations, 

On Mareh 21, 2012, HHS published an Advance Notice of Proposed Rulemaking (ANPRM) in 

the Federal Register, The comment period was open until June 19,2012. During this transition 

period, the Administration will continue to work with faith based organizations, insurers, and 

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other interested parties to develop rules that respect religious liberty and ensure access to 

preventive services for women. 

2. After 2014, all health eare plans are expected to include coverage for sterilization and 

contraception, including drugs that some believe can cause an abortion (e.g. the morning 

after pill). If an employer such as EWTN has a moral objection to such coverage, and their 

moral objections remain even under the accommodation that you have said will be 

proposed at a later date, what penalties will be imposed on employers and insurance 

providers for not covering these services? 

A) What will happen to an employer who cannot find an insurance plan that 

matches their values? If they were to fail to provide insurance, will that employer be 

fined or otherwise penalized? How much are the fines imposed? How will entities 

such as EWTN be penalized as a self-insured entity'? 

B) What if an employer that objeets to certain coverage self-insnres (as in the case of 

EWTN) or otherwise provides insurance to their employees and fails to include the 

coverage that they oppose? What would the fines be in that case? If they refuse to 

pay the fines will they be arrested? What actions will be taken? 

Answer: On February 10,2012, we issued regulations finalizing last summer's interim final 

regulations on the exemption fi'om the contraceptive coverage requirement for churches and 

similar organizations. The Federal Register publication also discusses the one-year transition 

period, which is detailed in separate guidance from the Departments. 

On March 21, 2012, an Advance Notice of Proposed Rulemaking (ANPRM) was published in 

the Federal Register, marking the next step in the Administration's effort to implement the policy 

announced by the President on February 10, 2012. This ANPRM presents potential policies and 

identifies questions to guide rulemaking that is intended to amend the preventive services 

regulations to guarantee women's access to recommended preventive services-including 

contraceptives-without cost sharing, while ensuring that additional religious organizations are 

not forced to pay for, provide, or anange the provision of any contraceptive item or service to 

which they object on religious grounds. We intend to develop a proposed and fmal policy 

through a collaborative process. 

3. The US Conference of Catholic Bishops (USCCB) was recently denied a HHS grant to 

provide assistance to victims of human traft'icldng. For the first time in the history of the 

program, the fuuding opportunity announcement stated that "strong preference" would be 

given to applicants that are willing to direct clients to medical providers who can provide 

or refer for the "full range of legally pemlissible gynecological and obstetric care." This 

language appeared to be an effort to mai{e it more difficult for the USCCB to receive a 

grant under this program---even though they were the incumbent applicant and had 

received outstanding reviews throughout the years that they received funding for this 

program. An investigation conducted by the House of Representatives Oversight and 

Government Reform Committee revealed that even with this "preference" in the reqnest 

for proposals, independent reviewers gave USCCB one of the highest scores ou their 

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application: 89 out of 110. Still, HHS denied funds to the USCCB while funding proposals 

that received significantly lower scores, including scores of 69 and 74. Only one of the three 

awardees received a score higher than USCCB. 

This question is regarding the HHS grant to fund care for victims who have been rescued 

from human tl'afficking. I am referring to the funding that was denied to the USCCB as an 

entity. 

Were you briefed on the reproductive health language in this request for proposals? Did 

you request 01' approve the reproductive health language'! Were you briefed on the scores 

awarded to each applicant under this program? Did you approve the decision to pass over 

USCCB even though they had one of the highest scoring applications? Could you please 

clarify how an entity that offers a "fulll'ange" of services but at a lower quality level more 

effectively assists trafficking victims and protects taxpayer dollars than an organization 

that is more qualified and does not tit HHS's new definition of reproductive health? Did 

HIlS base its decision to redefine reproductive health and give preference to such 

orgauizations on evidence-based research? 

As a result of the reproductive health requirement, have any trafficldng victims been 

referred to Planned Parenthood? Have any of the new funding recipients indicated that 

they have, or intend to, refer victims to Planned Parenthood clinics? 

Answer: HHS is committed to ensuring that trafficking victims receive the high quality, 

comprehensive case management services that they need to be healthy and supported as they retake control over their own iives. la light of the particular health risks posed to victims of human 

trafficking, HHS specified in the 2011 funding announcement that it would give a strong 

preference to applicants willing to offer all the services and referrals delineated in the program 

objectives, including offering "all victims referral to medical providers who can provide or refer 

for provision of treatment for sexually transmitted infections, family planning services and the 

full range of legally permissible gynecological and obstetric care, including but not linlited to 

exams, tests, and pre-natal services and non-directive health-related counseling." 

This preference reflects two realities. First, trafficking victims, many of whom are sex trafficking 

victims or have been sexually assaulted, can have a heightened interest in and need for the full 

range of medical refelTals. For example, multiple studies have found that trafficked women and 

adolescents report sexual and reproductive health needs as their most common and most 

prioritized health need (Zimmerman, C. (2003) The health risks and cOllsequences of trafficking in 

women and adolescents: Findings from a Europea1l study. London: London School of Hygiene & 

Tropical Medicine. Zimmel1llan, c., Hossain, M., Yun, K., Roche, B., Morison, L., & Watts, C. (2006). 

Stolen smiles: A summmy report on the physical and psychological health consequences of women alld 

adolescents trafficked iJl Europe. London: London School of Hygiene & Tropical Medicine.) 

Second, HHS funds only one grantee per geographic area. Therefore, we believed it was 

important that the single grantee serving human trafficking victims in a given area be able to 

provide the population access to information about the full scope of services and the referrals 

they might need to take control of their own lives. In FY 2011, HHS received applications from 

several organizations that had both the strong capacity to provide comprehensive case 

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management services and a willingness to ensure that all of the specified referrals and services 

would be provided. As a result, HHS made awards to grantees that are able to provide the full 

set of health-related infonnation and l'efelTals, consistent with the stated preference. These three 

organizations will enable trafficking victims to re-take control of their lives by making infOlmed 

health care decisions, in consultation with their doctors, based on the victim's own 

circumstances, values, and faith. 

We do not collect data on individual service referrals. Accordingly, we do not know whether 

victims have been referred to Planned Parenthood. 

On September 12,2011, Acting Assistant Secretary George Sheldon briefed me on the 

evaluation of the applications and the preliminary award decisions. As the Acting Assistant 

Secretary of ACF, of which the Office of Refugee Resettlement is a part, Mr. Sheldon made the 

final decision on grant awards. 

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The Honorable Lynn Woolsey 

The National Institute for OccupationaI'Safety and Health (NIOSH) in conjunction with 

the National Cancer Institute (NCI) conducted the Diesel Exhaust in Miners Study 

(DEMS), which was designed to evaluate the risk of death associated with diesel exhaust 

exposure, particularly as it may relate to lung cancer. 

1. What was the main I'esult of the DEMS study? 

Answer: DEMS showed a strong and consistent relationship between quantitative exposure to 

diesel exhaust and increased risk of dying oflung cancer after adjustment for smoking and other 

risk factors for lung cancer. This effect was strongest for underground workers, who had far 

greater exposure to diesel exhaust than surface-only workers. 

2. At the hearing it was asserted that this study found "that diesel exhaust exposure of a 

surface mine produced higher risks of adverse health effects than to underground miners, 

with much higher levels of exposure." Is this a correct characterization of what this study 

found? 

Answer: The Diesel Study did not evaluate surface mines. It evaluated workers at 8 U.S. nonmetal mining facilities with at least 50 employees and separately reported lung cancer mortality 

for workers at these mines who worked at the surface (always or prior to going underground) or 

who had ever worked underground. For ever-underground workers (who had heavier 

exposures), there was strong evidence of an exposure-response relationship, with the cohort 

mortality and nested case-control studies showing statistically significant increases in lung 

cancer risk with increasing exposure. Surface-only miners had lower levels of exposure and 

lower numbers of lung cancer cases, so the statistical power to evaluate for exposure-response 

relationships was less for this group. Still, the cohort mortality study showed some evidence for 

a relationship between exposure and lung cancer in this group, even at the lower levels of 

exposure that were present on the surface. In contrast, the case-control study did not confinn the 

presence of consistent exposure-response relationships for surface-only workers after adjustment 

for smoking and other lung cancer risk factors. 

3. At the hearing it was asserted "tbat heavy smokers, with the higbest diesel exhaust 

exposures, have a lower risk for lung cancer tban miners who didn't smoke .. .'. Is this an 

accurate characterization of the study findings? 

Answer: This question refers to the nested case-control study, which was the DEMS component 

that evaluated infonnation about smoking. Among nonsmokers and low-to-moderate smokers, 

the risk of lung cancer increased with increasing diesel exposure. In contrast, among miners who 

were heavy smokers (two or more packs per day), the risk of lung cancer death for those with the 

highest levels of exposure to diesel exhaust was attenuated. Their risk remained elevated but 

tapered off with increasing levels of exposure. As noted in the paper, this observation will 

require confinnation since little is known about the interaction between cigarette smoking and 

diesel exhaust exposure on lung cancer risk. The paper discusses a number of possible 

explauations for the tapering off ofrisle at high levels of diesel exhaust exposure. First, it is 

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possible that smokers are more likely to clear diesel exhaust particulate matter from their lungs 

than nonsmokers. This phenomenon has been reported among coal miners who are heavy 

smokers. Second, carcinogens in diesel exhaust and cigarette smoke may operate in the same 

metabolic pathway in the body. If so, they may compete with each other, resulting in a saturation 

of the pathway, thus diminishing the effects of either component. Additional research will be 

needed to confirm this fmding and learn more about its mechanistic implications. 

4. What mines and how many workers were covered in this study? 

Answer: Ten mining facilities were originally selected for study after an extensive feasibility 

study of U.S. non-metal mining facilities with at least 50 employees. Two facilities were later 

rejected because of incomplete personnel records. The remaining eight comprised one low-silica 

limestone, three potash, one salt (halite), and three trona (Na3H(C03)202H20 - a primary 

source of sodium carbonate) facilities. The facilities were located in Missouri (limestone), New 

Mexico (potash), Ohio (salt), and Wyoming (trona). Workers evaluated in the cohort mortality 

study included all non-administrative workers with 1+ years of tenure after dieselization. This 

came to a total of 12,315 individuals, of which 8307 worked ever-underground and 5848 worked 

at the surface only. 

5. This study was also the subject of a 2001 court order that requires tile agencies involved 

to provide all data requested by tllis committee. Are there any requests for informatiou 

submitted to tile department from this committee that have not been completely fulfilled? 

Are you aware of any willful non compliance witll tllese requests? 

Answer: The Department has complied with the court order. 

6. NIOSH leases tile Lake Lynn Experimental Mine in southwest Pennsylvania. This 

facility, in which tile U.S. government has invested more than $40 million, is essential for 

conducting mine safety researcll sucll as large-scale explosion trials. However, the lease is 

expiring and NIOSH will have to vacate tllis facility in September. What steps are being 

tal,en to acquire this property? Has an appraisal been completed? 

Answer: HHS lias been working diligently for many years to acquire the property, but has not 

yet found a viable pathway to complete this effort. Multiple appraisals have been completed, 

and HHS has made multiple offers to the property owners - all of which have been rejected. 

Absent any linther developments, NIOSH will need to vacate the property in September. 

7. Tile Occupational Safety and Health Act requires tile Secretary of Health and Human 

Services, after consultation witll the Secretary of Labor and otller agencies, to conduct 

directly, or by grants and contracts, education programs to provide an adequate supply of 

qualified personnel to carry out tile purposes of this Act. However, tile department's Fiscal 

Year 2013 budget eliminated all funding for the NIOSH Education and Resource Centers 

(ERCs), wllich is one of the key means by wllich HHS fulfills this mandate. 

A) Did thc Secretary of Labor or tile Assistant Secretary for the Occupational 

Safety and Healtll Administration agree that that funding for ERCs was no longer 

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necessary to assuring.an adequate supply of occupational safety and health 

professionals? 

Answer: We have no knowledge of statements by the Secretary of Labor or the Assistant 

Secretary for the Occupational Safety and Health Administration regarding the funding of the 

ERCs. 

B) In December 2011, the MiIlban\, Qnarterly published the "Economic Burden of 

Occupational Injury and Illness in the United States" which estimates that the 

annual direct and indirect costs of occupational disease and injury are at least $250 

billion per year_ This amount exceeds the individual cost of cancer, coronary heart 

disease, stroke, and diabetes_ In view of this economic burden, will the department 

reconsider the priority it is giving to it-aining programs for qualified personnel to 

help prevent oecupational injury aud disease, as part of its budget for Fiscal Year 

2013 or its development ofthe Fiscal Year 2014 budget? 

Answer: We aclmowledge·the continuing burden of occupational disease, death, and injury as 

demonstrated in the December 2011 study cited above. However, given the limited federal 

resources in a resource-constrained environment, the ERCs have been designated as a lowpriority program. Although the federal portion of these grants was eliminated in CDC's FY 2013 

budget request, CDC will continue to provide technical assistance to the ERCs as requested. 

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[Whereupon, at 12:31 p.m., the committee was adjourned.] 

Æ