[Senate Hearing 116-316]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 116-316
 
                     PRESIDENT'S FISCAL YEAR 2020 
                         HEALTH CARE PROPOSALS

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

                                HEARING

                               before the

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 14, 2019

                               __________
                               
                               
                               
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                               
                               

                                     
                                     

            Printed for the use of the Committee on Finance
            
            
            
                           ______                      


             U.S. GOVERNMENT PUBLISHING OFFICE 
42-240 PDF           WASHINGTON : 2020 
             
            
            


                          COMMITTEE ON FINANCE

                     CHUCK GRASSLEY, Iowa, Chairman

MIKE CRAPO, Idaho                    RON WYDEN, Oregon
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   ROBERT MENENDEZ, New Jersey
JOHN THUNE, South Dakota             THOMAS R. CARPER, Delaware
RICHARD BURR, North Carolina         BENJAMIN L. CARDIN, Maryland
JOHNNY ISAKSON, Georgia              SHERROD BROWN, Ohio
ROB PORTMAN, Ohio                    MICHAEL F. BENNET, Colorado
PATRICK J. TOOMEY, Pennsylvania      ROBERT P. CASEY, Jr., Pennsylvania
TIM SCOTT, South Carolina            MARK R. WARNER, Virginia
BILL CASSIDY, Louisiana              SHELDON WHITEHOUSE, Rhode Island
JAMES LANKFORD, Oklahoma             MAGGIE HASSAN, New Hampshire
STEVE DAINES, Montana                CATHERINE CORTEZ MASTO, Nevada
TODD YOUNG, Indiana

             Kolan Davis, Staff Director and Chief Counsel

              Joshua Sheinkman, Democratic Staff Director

                                  (ii)


                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Grassley, Hon. Chuck, a U.S. Senator from Iowa, chairman, 
  Committee on Finance...........................................     1
Wyden, Hon. Ron, a U.S. Senator from Oregon......................     2

                         ADMINISTRATION WITNESS

Azar, Hon. Alex M., II, Secretary, Department of Health and Human 
  Services, Washington, DC.......................................     5

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Azar, Hon. Alex M., II:
    Testimony....................................................     5
    Prepared statement...........................................    47
    Responses to questions from committee members................    52
Grassley, Hon. Chuck:
    Opening statement............................................     1
    Prepared statement...........................................   178
Wyden, Hon. Ron:
    Opening statement............................................     2
    Prepared statement with attachments..........................   179

                             Communications

Center for Fiscal Equity.........................................   187
National Association of Chain Drug Stores (NACDS)................   190

                                 (iii)


                     PRESIDENT'S FISCAL YEAR 2020 
                         HEALTH CARE PROPOSALS

                              ----------                              


                        THURSDAY, MARCH 14, 2019

                                       U.S. Senate,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 10:15 
a.m., in room SD-215, Dirksen Senate Office Building, Hon. 
Chuck Grassley (chairman of the committee) presiding.
    Present: Senators Crapo, Roberts, Cornyn, Thune, Isakson, 
Toomey, Scott, Cassidy, Lankford, Daines, Young, Wyden, 
Stabenow, Cantwell, Menendez, Carper, Cardin, Brown, Casey, 
Whitehouse, Warner, Hassan, and Cortez Masto.
    Also present: Republican staff: Brett Baker, Health Policy 
Advisor; Erin Dempsey, Health Policy Advisor; Ryan Martin, 
Senior Human Services Advisor; Stuart Portman, Health-care 
Policy Advisor; and Karen Summar, Chief Health Policy Advisor. 
Democratic staff: Anne Dwyer, Senior Health Policy Counsel; 
Michael Evans, General Counsel; Peter Gartrell, Investigator; 
Matt Kazan, Senior Health Policy Advisor; and Arielle Woronoff, 
Senior Health Policy Counsel.

 OPENING STATEMENT OF HON. CHUCK GRASSLEY, A U.S. SENATOR FROM 
              IOWA, CHAIRMAN, COMMITTEE ON FINANCE

    The Chairman. Good morning, everybody, including our 
witness and all the members of the committee.
    So I welcome Mr. Azar, our Secretary for HHS. I appreciate 
his coming before the committee to talk about Health and Human 
Services proposals in the President's budget for fiscal year 
2020.
    Congress decides how much the government spends and how to 
allocate these resources. The President gets to have his say, 
and it is our duty to consider those recommendations, or 
another way I sometimes say it is that, a President proposes, 
but Congress disposes.
    We are here to discuss the part of the President's budget 
and the recommendations in regard to programs in the Department 
of Health and Human Services. These programs impact the day-to-
day lives of many people in Iowa and throughout the country, 
adding up to about 130 million people just on Medicare and 
Medicaid.
    Human services programs administered by HHS help millions 
of families in need while promoting upward mobility. The 
programs this committee oversees spend over $1 trillion and 
take hundreds of millions of dollars to administer. The 
President's budget proposal aims to tackle a number of pressing 
challenges. It looks to get a better handle on the opioid 
epidemic. And it looks to improve child welfare outcomes. This 
committee has been active on these issues and others, of 
course, and has a role in overseeing that HHS implements the 
laws that Congress has passed in these areas.
    The budget of the President also strives to lower the high 
cost of prescription drugs, which I have not heard a person on 
this committee say is not important. It is always a necessity 
to be working in that direction, and we have not done enough. I 
share that goal with the President's budget and look forward to 
working with my colleagues on this committee to find ways to 
make medications more affordable in Medicare and Medicaid while 
protecting taxpayers who fund these programs.
    We all know that last June, President Trump and Secretary 
Azar laid out something to help reduce drug costs for patients. 
And I think they deserve tremendous credit for taking that 
route. Their sustained efforts have helped to make big drug 
pricing policy changes possible that probably have not been 
done yet. This committee is working on it as well.
    The budget serves as a reminder that Congress needs to act 
to make sure that Medicaid and Medicare are around for future 
generations. Putting these programs, then, on a sustainable 
financial path while ensuring patients can get the care they 
need is obviously hard work, and we do not tackle it enough, 
sometimes not at all.
    And I have said many times, regardless of the issue, the 
legislative heavy lifting needs to be done in a bipartisan 
manner to achieve a lasting solution. This hearing, then, 
provides an opportunity to talk about issues important to our 
constituents and the entire Nation.
    So whether you agree or disagree with the specific policy 
proposals in the budget, it is important that we engage with 
this Secretary on these issues. So we appreciate, Mr. 
Secretary, your being here to perform the time-honored 
tradition of testifying on the budget, which enables us to 
execute our duty to consider the President's proposals. I look 
forward to a robust discussion.
    Senator Wyden?
    [The prepared statement of Chairman Grassley appears in the 
appendix.]

             OPENING STATEMENT OF HON. RON WYDEN, 
                   A U.S. SENATOR FROM OREGON

    Senator Wyden. Thank you very much, Mr. Chairman. Mr. 
Chairman, you know I always want to try to find common ground 
on health-care issues, and you and I have been able to do that 
in the past.
    Mr. Secretary, I wish it was not the case, but it does seem 
to me that the Trump administration has what amounts to an 
inexhaustible supply of destructive health-care ideas that harm 
the vulnerable. I am going to start with the Arkansas paperwork 
requirements. I describe it that way because, with the 
President's blessing, Arkansas went ahead with this right-wing 
experiment there.
    They said it was all about work requirements, but it is 
really about paperwork and reducing coverage. Eighteen thousand 
people in Arkansas have lost their health care. They are people 
who want to work, people who are working.
    The administration was asked on Tuesday, Mr. Secretary, why 
so many people in Arkansas have lost coverage. The Trump 
administration has been basically clueless about all those 
people losing coverage. And now they are talking about making 
it mandatory in every State.
    It does not make people healthier. It is not about 
promoting work. It is a back-door scheme to kick people off 
their Medicaid coverage by putting mountains of paper between 
patients and doctors. And it seems that there is one sort of 
far-right experiment after another.
    You have these Governors and Attorneys General suing HHS to 
get the Affordable Care Act ruled unconstitutional. This legal 
argument would not wash virtually anywhere. But instead of 
defending the law, as is the long-standing bipartisan practice, 
the Trump Justice Department said, ``We are on board.'' In 
fact, they focused their attack on unraveling pre-existing 
condition protections, want them ruled unconstitutional.
    The brief is so absurd, colleagues, three career 
officials--career officials, people who do not do politics--
said they would not put their names on it. One even resigned. 
After a political appointee agreed he would be the public face 
of this attack, he got a nomination to the Sixth Circuit Court 
of Appeals.
    Now when you talk about pre-existing conditions--a number 
of my colleagues on our side have been very eloquent on this--
you have to talk about junk insurance. The fight against junk 
insurance goes back decades. For me it was going back to the 
days when you had Medigap supplements--which were not worth the 
paper they were written on--targeting seniors.
    More recently, there was a similar effort in the private 
insurance market. The Trump administration said, ``We are not 
in the business of cracking down anymore. Let us bring the junk 
insurance back so scam artists are free to sell bargain-
basement plans on the individual market that do not cover the 
care people need.''
    Next the Trump administration wants to fillet the Medicaid 
program by block-granting it and capping it. This idea, 
colleagues, is so bad, it harms so many people that nobody 
could even--on the other side--move such an approach in this 
committee room when we had a hearing on it.
    Not only would it put essential care on the chopping block 
for millions--including kids, people with disabilities--in my 
view this block grant approach is a surefire way to create a 
nationwide crisis of nursing home closures, because Medicaid 
pays for something like two out of three nursing home visits.
    Now the administration is reportedly exploring how to 
block-grant Medicaid by administrative fiat. The administration 
cut the open season for health insurance in half and a variety 
of other approaches that would make it harder for people to 
sign up for coverage. The budget takes away middle-class tax 
credits, and the list of sabotage just goes on and on.
    So, as I touched on at the beginning, it is really stunning 
how creative the Trump administration has been in making health 
care worse in America.
    I would like to take a brief look at the pharmaceutical 
checklist and compare the President's promises to what we have 
actually seen him deliver. On the campaign trail, the President 
went after the pharmaceutical companies all-in. And in 2017 he 
said, ``Drug makers are getting away with murder.'' But 2 years 
in, he sure does not look like he is getting anything 
resembling a passing grade.
    The President once said he wanted to let Medicare negotiate 
to bring down drug prices. Now, colleagues, those are his 
words; the President said we have to negotiate to bring down 
prices--nowhere to be found in the budget, nothing in the 
budget that forces the manufacturers to lower their prices. So 
there has not been any concrete action to back it up.
    I am going to follow with just two last issues quickly. 
First, on the separation of migrant children from their 
parents, last year the Secretary came before the committee, 
told us that HHS was on the case, the kids were accounted for, 
and reunification would proceed smoothly. The Secretary said, 
``With just basic keystrokes, within seconds, they could find 
any child in their care.'' Based on available evidence, that is 
just not the case.
    Reports suggest that the government cannot account for the 
whereabouts of potentially thousands of kids who are in its 
care. HHS documents that were recently released show that there 
were thousands of allegations of sexual abuse inflicted on kids 
in government custody.
    So you have a trio of Secretaries in the Trump 
administration sending reassuring messages, but behind the 
scenes, these kids were just battered by chaos. And certainly 
these abuse allegations are very troubling. It is a horrifying 
scandal. And right now--and I am very pleased the chairman and 
I are working on this in a bipartisan way--I am concerned that 
the administration wants to intimidate and silence journalists 
trying to expose it.
    The chairman has been the leader of the Whistleblower 
Caucus, and I appreciate him working with me on that.
    Finally, an issue dealing with foster care: in January the 
Trump administration gave South Carolina a green light for 
religious discrimination in its foster care program. The 
announcement came with the assurance that it would only be one 
State, that this was a unique set of circumstances, that there 
was not going to be any discrimination, and that was how it was 
rolled out.
    Then the President got up at the National Prayer Breakfast 
and said that he was looking at making this policy national. In 
my view, this road heads directly towards taxpayer-funded 
discrimination on religious grounds.
    The first victims of the discrimination will be people who 
want to step up and provide safe and loving homes for foster 
kids, people who are Jewish, people who are Catholic, who are 
Muslim, who choose to practice no religion, LGBTQ Americans, 
potentially others. The next victims will be vulnerable 
youngsters, since the policy would limit the number of foster 
homes available to them.
    There are also alarming questions about what this would 
mean for Jewish kids and Catholic kids who would wind up in 
settings that are hostile to their faiths. And we talked at the 
hearing--and there can be differences of opinion on this--but 
as a Jewish kid, a first-generation Jewish kid, these questions 
are not an abstract kind of a matter for what I remember 
growing up Jewish was all about. And I certainly want to know 
what it would mean for LGBTQ kids.
    So there is a lot to dig into, Mr. Chairman. And I look 
forward to pursuing these issues here in the committee and 
looking for bipartisan solutions.
    The Chairman. Thank you very much.
    [The prepared statement of Senator Wyden appears in the 
appendix.]
    The Chairman. Our witness, the Secretary, served as General 
Counsel of HHS from 2001 to 2005, and then turned to being 
Deputy Secretary of HHS from 2005 to 2007. He has earned a 
bachelor's degree from Dartmouth College and his law degree 
from Yale University.
    Secretary Azar, we welcome you, and proceed with your 
statement.

  STATEMENT OF HON. ALEX M. AZAR II, SECRETARY, DEPARTMENT OF 
           HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Secretary Azar. Thank you very much, Chairman Grassley and 
Ranking Member Wyden. Thank you for inviting me to discuss the 
President's budget for fiscal year 2020.
    It is an honor to have led the Department of Health and 
Human Services over the roughly 14 months since I appeared 
before this committee as a nominee. The men and women of HHS 
have delivered remarkable results in that time, including 
record new and generic drug approvals, new affordable health 
insurance options, and signs that the trend in drug overdose 
death is beginning to flatten and decline.
    The budget proposes $87.1 billion in fiscal year 2020 
discretionary spending for HHS while moving toward our vision 
for a health-care system that puts American patients first. It 
is important to note that HHS had the largest discretionary 
budget of any nondefense department in 2018, which means that 
staying within the caps set by Congress has required difficult 
choices that I am sure many will find quite hard to countenance 
today.
    Today I want to highlight how the President's budget 
supports a number of important goals for HHS. First, the budget 
proposes reforms to help deliver Americans truly patient-
centered affordable health care. The budget would empower 
States to create personalized health-care options that put you, 
as the American patient, in control and ensure you are treated 
like a human being and not a number. Flexibilities in the 
budget would make this possible while promoting fiscal 
responsibility and maintaining protections for people with pre-
existing conditions.
    Second, the budget strengthens Medicare to help secure our 
promise to America's seniors. The budget extends the solvency 
of the Medicare Trust Fund for 8 years, while the program's 
budget will still grow at a 6.9-percent annual rate.
    In three major ways, the budget lowers costs for seniors 
and tackles special interests that are currently taking 
advantage of the Medicare program. First, we propose changes to 
discourage hospitals from acquiring smaller practices just to 
charge Medicare more.
    Second, we address overpayments to post-acute providers.
    Third, we will take on drug companies that are profiting 
off of seniors and Medicare. Through a historic modernization 
of Medicare Part D, we will lower seniors' out-of-pocket costs 
and create incentives for lower list prices. We also protect 
seniors by transferring funding for graduate medical education 
and uncompensated care from Medicare to the general Treasury 
fund, so all taxpayers, not just our seniors, share these 
important costs.
    I want to acknowledge the substantial work of this 
committee on drug pricing in particular, including work to 
lower out-of-pocket drug costs. Thanks to legislation on 
pharmacy gag clauses that this committee sent to President 
Trump's desk, America's pharmacists can now always work with 
patients to get them the best deal on their medications.
    I also want to note that today HHS is publishing voluminous 
new data on price increases taken from 2016 to 2017 on drugs 
paid for by Medicare and Medicaid. These data shed light on the 
kind of abusive behaviors we are addressing with the 
President's budget and his drug pricing blueprint.
    Since the blueprint's release, we have seen results 
including significantly fewer price increases taken by brand 
drug companies and consumer price inflation for prescription 
drugs going negative in 2018. But there is more work to be 
done, and I believe there are many, many areas of common ground 
on drug pricing where we can work together to pass bipartisan 
legislation.
    Finally, the budget supports HHS's five-point strategy for 
the opioid epidemic: better access to prevention, treatment and 
recovery services that are targeting the availability of 
overdose reversing drugs, better data on the epidemic, better 
research on pain and addiction, and better pain management 
practices.
    The budget provides $4.8 billion toward these efforts, 
including the $1-billion State opioid response program, which 
we have focused on access to medication-assisted treatment, 
behavioral support, and recovery services.
    The budget also invests in other public health priorities 
including fighting infectious disease at home and abroad. It 
proposes $291 million as the first year of funding for 
President Trump's plan to use the effective treatment and 
prevention tools we have today to end the HIV epidemic in 
America by 2030.
    I want to conclude by saying that this year's budget will 
advance American health care and help deliver on the promises 
we have made to the American people. And I look forward to 
working with this committee, as we have always done on our 
shared priorities, and I look forward to your questions today.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Secretary Azar appears in the 
appendix.]
    The Chairman. Can I remind my colleagues, since I have two 
hearings I have to chair today on the subject of the budget, we 
are going to have 5-minute rounds. But I hope people will not 
extend beyond the 5 minutes.
    Mr. Secretary, the Family First Prevention Services Act, 
which is meant to keep people out of foster care--I have two 
questions. One, what is your agency doing to make sure States 
know about this new policy, as well as others that were part of 
Family First?
    Secretary Azar. Thank you, Mr. Chairman.
    As you know, the Family First Act sets very aggressive 
timelines. And our efforts to educate the States include 
regional listening sessions with States and tribes, formal 
requests for public comment, site visits in many States to 
observe effective community-based prevention programs, national 
webinars, in-person discussions with our relevant grant 
clusters, participation in child welfare professional 
membership or association meetings, and individual meetings and 
calls with State and county child welfare leaders.
    The Chairman. Do you know how many States are taking 
advantage of the new opportunity? And if you cannot give us 
that figure, would you please answer in writing?
    Secretary Azar. I do not have that at my fingertips, but we 
will get that to you in writing.
    The Chairman. Okay.
    Iowa has 38,000 people in small markets, 23,000 people in 
individual markets that have been called ``grandmothered 
plans.'' These plans provide health insurance for small 
business owners, including farmers in my State. These people 
like their plans. The grandmothered plans have been extended 
four times, and the last extension expires at the end of the 
year.
    So I am concerned about these 60,000 people and their 
health insurance. Will you consider extending the grandmothered 
plans for as long as possible, or even considering making the 
plans permanent?
    Secretary Azar. So, Chairman Grassley, we appreciate your 
continued advocacy on behalf of grandmothered plans, and I 
share your concerns. We certainly do not want to do anything 
that adds to the disruption that the Affordable Care Act has 
already caused, especially for the people of Iowa.
    Iowa has been very hard hit by the changes in the 
individual market, especially its small business people and its 
farmers. The grandmothered plans have served a very important 
role for them.
    That policy is currently under review as part of the annual 
cycle. But please rest assured in knowing that I personally, 
and the President, want to avoid any disruption to those 
individuals if we can do so.
    The Chairman. Okay.
    My last issue deals with the fact that, in the past several 
months, I have written to NIH, your OIG, and the Department of 
Justice regarding foreign threats to taxpayer-funded medical 
research and intellectual property.
    Last month the Inspector General released a report on the 
National Institutes of Health's handling of U.S. genomic data. 
This data is extremely valuable for ongoing research. In 
addition to the value of the data, there is a risk that this 
data can fall into the wrong hands. The OIG report found that 
NIH did not consider national security risks when permitting 
and monitoring foreign principal investigators' access to 
United States citizens' genomic data.
    The IG further noted that the National Institutes permitted 
access to genomic data to for-profit entities, including 
companies from China, even though the FBI has identified those 
companies as having ties to the Chinese government. The 
Inspector General also found that NIH did not verify that 
foreign researchers had completed information security 
training. I am very concerned about this OIG report. I, of 
course, hope you are as well.
    Will you commit to working with my office and NIH as we 
continue to work on this issue to make sure privacy as well as 
national security concerns are addressed?
    Secretary Azar. We absolutely will. We share your concerns. 
And we are always working to safeguard intellectual property 
and sensitive data and other U.S. national interests, including 
by prioritizing the OIG recommendations to ensure that security 
policies keep current with our emerging threats and to make 
training and security plans a requirement.
    The NIH recently did establish a working group to the 
advisory committee of the Director to address how to mitigate 
these concerns. And we look forward to continuing to work with 
you and the committee on these issues.
    The Chairman. Okay. I will reserve my 16 seconds. Proceed.
    Senator Wyden. Mr. Chairman, first of all, thank you very 
much for bringing up Family First as your initial question.
    Colleagues, this is a transformation in foster care. And 
you have people like Marian Wright Edelman of the Children's 
Defense Fund who said it has been her dream for 30 years. And 
she has colleagues who are very conservative who would probably 
echo her words.
    So you are bringing that up with the Secretary, and I have 
talked with him as well. We have to accelerate the timetable, 
colleagues. That is what the chairman's question was all about. 
So I want to associate myself with your remarks, Mr. Chairman.
    When we get this in place, colleagues, this is going to be 
a genuine transformation in foster care in America.
    Mr. Secretary, I want to start my questions by quoting your 
boss. President Trump keeps promising better health care for 
more people. In September of 2015, for example, the President 
said, ``I am going to take care of everybody. Everybody is 
going to be taken care of much better than they are taken care 
of now.''
    So I want to start by quoting the President of the United 
States. The fact is that coverage has gone down on his watch. 
It has gone down according to the survey data that I have in my 
hand.
    Mr. Chairman, I would ask unanimous consent to make that 
survey data part of the record.
    The Chairman. Without objection.
    [The survey appears in the appendix on p. 181.]
    Senator Wyden. And the survey data indicates that 7 million 
fewer Americans have insurance today than before the President 
was elected. For the first time in a decade, the rate of 
uninsured children has actually gone up. So I have entered the 
polling data that I am citing into the record.
    The President said he was going to take care of everybody 
and everybody was going to do better. Mr. Secretary, do you 
have any reaction to that? How is the President's promise being 
followed up on? The survey data indicates 7 million fewer 
Americans have insurance coverage.
    Secretary Azar. I mean, is it not fascinating? I thought 
the Affordable Care Act was taking care of everything also.
    Senator Wyden. Well, it is kind of hard with all the 
sabotage. But if you would answer the question, 7 million fewer 
people have insurance coverage now than when the President 
started. And the President said everybody was going to get a 
better deal. So on his watch, coverage went down.
    Secretary Azar. Well, the President does want everyone to 
have access to affordable health care, and that is why we keep 
proposing reforms in our budget, as well as keep trying to make 
reforms under the Affordable Care Act, as long as it is there, 
to make more affordable options available.
    You know, for instance, I have approved 7 waivers, 1332 
waivers to States for reinsurance pools that have brought 
premiums down by 9 to 30 percent. Our marketing activities--by 
being more efficient and relying more on the insurance 
companies to do the marketing, we have actually reduced that 
expense which comes out of user fees that go into the premium 
base for our citizens.
    And that actually has pulled premiums down for them as a 
result of our actions. We have stabilized the marketplace. The 
premiums actually went down this year for the first time ever. 
We had more plans enter the marketplace since 2015.
    So I think we all share the goal of expanding affordable 
options for individuals as well as in the employer space, which 
now is at 178 million Americans getting their insurance through 
their employers.
    Senator Wyden. I just want the record to show, colleagues, 
that the President said everybody is going to be taken care of 
much better. I asked the Secretary to respond to the fact that 
there has been, on the President's watch, a net increase of 
about 7 million adults without coverage, and we have not gotten 
any response to that.
    Now, Mr. Secretary, I want to ask you about these junk 
plans. And I think you and I have talked about this. For me 
this goes back to the days when people got junk sold to 
supplement Medicare. We finally got that changed.
    We were trying to improve the coverage in the individual 
market. Now there have been changes in the rules where, for 
example, junk plans can discriminate against people with pre-
existing conditions.
    I have the text of the rule here. It says in the definition 
of short-term limited duration coverage, ``It is not subject to 
requirements regarding guaranteed availability and guaranteed 
renewability.''
    Why would you want to turn back the clock and move us back 
to the days when we had junk insurance? That is in the final 
rule in my hand.
    Secretary Azar. So short-term limited duration plans, as 
you know, were expressly provided for under the Affordable Care 
Act and continued in the Obama administration. We simply 
restored them as a more viable option for people. People need 
to go in with their eyes open, and that is why we put those 
kinds of disclosures in there.
    They do not have to have all the coverage. We are seeing, I 
believe, some short-term plans that do offer pre-existing 
coverage. Some do not.
    So we are continuing to provide more options to people. It 
is a 50- to 70-percent lower price. Your junk could be to a 
farmer in Iowa, a lifeline to some form of coverage.
    Senator Wyden. I am over my time.
    I only want to say that not only did we get rid of some of 
the junk insurance in the past, the Obama people did try to 
tighten up the rule. You are going in the other direction.
    Thank you, Mr. Chairman.
    The Chairman. Senator Cornyn?
    Senator Cornyn. Thank you, Mr. Chairman.
    Thank you, Mr. Secretary, for being here. I want to follow 
up a little bit on Chairman Grassley's question about security 
protocols at institutions that are doing taxpayer-funded 
research.
    As you know, China in particular has been enormously 
aggressive, not only in terms of stealing intellectual 
property, but trying to exploit vulnerabilities in our country 
when it comes to foreign investment. We have reformed the 
CFIUS, the Committee on Foreign Investment in the United 
States, in a bipartisan way to try to address that.
    But what I would like to hear a little bit more from you 
about is what sort of standards should Congress and the 
administration insist upon for institutions that are the 
recipients of taxpayer funding to do research? As you noted, it 
is not just intellectual property, it is data--and our 
adversaries are vacuuming up as much as they can get by any 
means available.
    So is this something that you think Congress ought to look 
at and act on?
    Secretary Azar. We obviously would welcome any partnership 
with Congress, and, Senator, we would be happy to get you more 
detail than I am able to provide in a quick response. But we 
are taking this very seriously. It is an immense challenge.
    And the NIH Director sent out information to grantees on a 
couple of issues; for instance, primary investigators or other 
investigators under R01 NIH-funded grants receiving duplicate 
payments, for instance, from other entities, which need to be 
disclosed and accounted for and considered as to whether they 
should be eligible. Individuals on peer review bodies receiving 
payments from foreign entities, for instance--similar guidance 
there to make sure they were enforcing the rules clearly.
    I think some of these institutions have not been enforcing 
the rules, and we have been trying to get very clear with them 
about what is required if you are receiving Federal money in 
terms of foreign interference and foreign funding.
    Senator Cornyn. Well, I know from experience that some of 
the institutions in my State, while the FBI does make 
counterintelligence briefings available, they are really not 
set up to try to provide, on a comprehensive basis, the 
information that these institutions need about how to protect 
themselves against the foreign and outside threat. And this is 
not just foreign countries. These are cyber-criminals and 
others as well.
    But I have had more than one of my constituents in Texas at 
a major institution, basically, come to me and say, we have 
been exploited in ways that we never were prepared for or never 
really aware of. So I think it is a matter of grave concern, 
and we look forward to working with you and the administration 
and colleagues on both sides of the aisle to protect that data 
and that intellectual property and the privacy of the American 
people.
    You were recently quoted--this is on the question of kidney 
innovation. We know that there are a lot of people who suffer 
from kidney disease, presumably because of high blood pressure, 
a lot of it associated with symptoms of their diabetes which is 
not adequately controlled. And of course, we know millions of 
people are on dialysis on a regular basis.
    You said, ``It is the epitome of a system that pays for 
sickness rather than health, and this administration is intent 
on shifting those priorities.'' I want to work with you on 
that. But if you can just maybe summarize here, quickly, sort 
of what your thoughts are about kidney innovation.
    Secretary Azar. Well, there has been very little kidney 
innovation, actually, in the last several decades. And that is 
quite disturbing. We have been entirely too content to place 
individuals on dialysis and to have that be actual facility 
dialysis, which is a brutalizing process for individuals. It is 
necessary, but 3/4 days a week going in, being sapped, 
essentially becoming disabled because the energy flow comes out 
of you from that process.
    We have globally low rates of home dialysis. Whether 
peritoneal dialysis or otherwise, we should get our home 
dialysis rates up. But most importantly, we need to get people 
transplanted. We need more kidneys. We need to increase the 
flow, and we need to fix the financial incentives in our 
system.
    Right now every financial incentive in our system is 
towards dialysis, not towards transplantation and long-term 
survivorship. And you get what you pay for.
    Senator Cornyn. Well, I am really happy to see your focus 
on that. And again, I really would like to work with you, and I 
am confident this is something we could do together.
    Finally, biosimilar competition--we have heard from CEOs a 
few weeks ago about the role of patents and limiting 
competition for certain drugs, including biologics. Can you 
talk to us a little bit about what we can do to encourage more 
competition for biosimilars?
    Secretary Azar. We are fully committed on biosimilar 
competition and creating a genuine biosimilar marketplace. And 
we are open to all ideas and working with Congress on that.
    I am very concerned when it comes to biologic products 
about the evergreening of patents and expanding patent estates. 
I am not an expert in intellectual property, but it disturbs 
me. There is a deal, which is, you should have the exclusive 
right to practice your invention for a time period, but things 
are just going on and evergreening too long and preventing the 
entry of biosimilars into the marketplace. And I am concerned a 
great deal about that, as is the President.
    Senator Cornyn. Thanks for your indulgence.
    The Chairman. Senator Stabenow?
    Senator Stabenow. Well, thank you, Mr. Chairman and Ranking 
Member.
    And, Mr. Secretary, it is good to see you again. Let me 
first start out--and this is not where I want to spend the 
majority of my time.
    But I do want to say that I am deeply concerned about 
maternal and child health programs. There are seven that have 
been eliminated. I had an extensive, robust conversation with 
the Acting OMB Director yesterday in a budget hearing about 
that, but also the attempts to cap, block-grant, cut the 
Medicaid program.
    I certainly will rigorously oppose. We have more than 
675,000 people in Michigan enrolled in Healthy Michigan who 
would lose their health care, and 1.2 million children getting 
coverage through Medicaid, which is about half of our kids. Two 
out of three seniors in nursing homes rely on Medicaid.
    But what I want to talk about--because we have differences, 
but it is also our job to find common ground, and you mentioned 
common ground in your statement. So I want to actually spend my 
time talking about an area where we can move forward in a 
positive way and have common ground, and that is related to 
mental health and addiction.
    When I leave this hearing, Senator Roy Blunt and I will be 
doing a press conference with law enforcement, community 
leaders, health leaders, to roll out the next step in expanding 
the Excellence in Mental Health and Addiction Treatment Act. 
One out of five people in our country will have a serious 
mental health issue during their lifetime, and we know the 
majority of deaths under age 50 are drug overdoses. This is 
incredibly serious, as you know.
    And I want to just give a shout-out. Our current bill is 
co-
sponsored by Senators Wyden, Ernst, Schumer, Gardner, 
Whitehouse, Sullivan, Klobuchar, and Tillis, supported by 
Senators Menendez, Casey, and Cortez Masto on the committee. 
And we are adding people in pairs, Republican and Democrat. So 
I expect many more people to be added.
    Basically, this is a transformative way to permanently 
address mental health and addiction services by indicating that 
we want this to be treated not in terms of grants--when the 
grant runs out, you no longer get care--but a permanent part of 
our health-care system, like we do community health centers. 
And so you and I have talked about this, but we created quality 
standards for behavioral health services in the community like 
we did for Federally Qualified Health Centers.
    And now we have started the process of showing that this 
funding can work. I want to thank you. In your budget, you do 
have some funding related to this. We need to structurally take 
the next step: 24-hour crisis services and outpatient care 
coordination, care working with law enforcement, emergency 
rooms, veterans groups.
    We have found that the eight-State demonstration project 
that we were able to get funding for has actually worked beyond 
what we had even hoped for. And we do not quite have 2 years' 
worth of data yet.
    We have 11 more States that put together quality plans and 
want to now do this. And we know that if we can help them get 
this set up that they will be able to incorporate it into their 
own plans as they move forward. So it is a matter of quality 
standards and helping them get going.
    And I would just mention that we have an assistant police 
chief from Oklahoma who is joining us today at the press 
conference talking about how they used to spend hours in the 
emergency room at the local hospitals with somebody having a 
problem. And now they can go to the psychiatric 24-hour crisis 
center.
    So I could go on further, but I want to just ask you, 
Secretary Azar, can you give us an update on the activities at 
HHS related to both the demonstration program and the grant 
awards?
    Secretary Azar. So, thank you very much for your questions, 
Senator Stabenow, and thank you for your personal leadership 
and championship on this issue.
    The Excellence in Mental Health legislation that you 
discussed would extend CMS's demonstration for Certified 
Community Behavioral Health Clinics and permit additional 
States to participate. We support efforts to increase access to 
and improve quality of community behavioral health services 
through CCBHCs. These facilities provide a comprehensive, 
coordinated range of evidence-based behavioral health services 
certified by the State.
    Our budget, as you mentioned, includes $150 million for 
SAMHSA to continue the Certified Community Behavioral Health 
Clinic's expansion grant program, which supports the CCBHCs in 
Michigan. And we look forward to working with you on the 
important legislative package that you discussed.
    Senator Stabenow. Thank you.
    And, Mr. Chairman, I am looking forward to working with you 
and other members of the committee. I would welcome other co-
sponsors as well. This is a very important step in really 
showing that we are serious about community mental health and 
addictions.
    Senator Roberts. Would the Senator yield?
    Senator Stabenow. Yes, I would be happy to, for my 
distinguished chairman on the Agriculture Committee.
    The Chairman. Do not take a lot of time, please.
    Senator Roberts. I just want to be added as a co-sponsor. I 
thought I was, but I guess I was not, because you did not read 
my name.
    Senator Stabenow. I am thrilled. Thank you.
    The Chairman. You are added as a co-sponsor.
    Senator Cantwell?
    Senator Cantwell. Well, I am happy to be added with Senator 
Roberts if that is the----
    Senator Stabenow. Excellent. All right. Here we go.
    All right. Mr. Chairman, we are on a roll. Could we 
continue? Thank you.
    The Chairman. Can they not communicate it to you silently?
    Senator Cantwell. Thank you, Mr. Chairman.
    Senator Stabenow. Thank you.
    Senator Cantwell. Secretary Azar, we have had a couple of 
chances in settings with our colleagues to discuss both drug 
pricing and health care at large in the context of the 
administration's interest in bringing market forces to the 
table. So you have said a couple of times at these meetings 
that you do believe in creating negotiations as a tool to help.
    And I see in your budget you include a Medicaid 
prescription drug demonstration that is also empowering States 
to do that. Is that correct?
    Secretary Azar. Absolutely, to allow State Medicaid 
programs to figure out alternative approaches to negotiating 
formularies and securing discounts that may be superior to what 
we have even in our statutory rebate structure.
    Senator Cantwell. Great.
    And so our State, the State of Washington, is looking at a 
Netflix model as it relates to the hep C drug. So that would be 
something that you would see as a like program in negotiating?
    Secretary Azar. We are very supportive of these alternative 
approaches. Louisiana and Washington are looking at approaches 
where you basically would do a subscription-type arrangement 
with one or more drug companies to basically provide access to 
patients who meet clinical criteria, but at a fixed, capitated 
amount so the State can have predictability in its budget.
    I think it is very innovative. I am very excited about 
these kinds of developments. We are very supportive.
    Senator Cantwell. Great.
    I do not know if you stayed up late at night to watch the 
replay of the drug manufacturers here before the Senate a week 
or two ago, but I am not sure they did themselves any favors.
    When I asked them whether they were for market forces, they 
pretended that those are not market forces, and that they--
well, they did not say that. They said those are their 
inflicted--I do not know their exact term, but they made it 
sound like they had no alternatives.
    And obviously the alternative is, they do not have to 
participate. They do not have to participate. If they do not 
want to give a discount, if they do not want access to that 
market, they do not have to participate.
    On that point, the basic health plan, I believe the 
administration has chosen to--at least as it relates to New 
York and Minnesota--continue to allow those programs. Does that 
not also represent an ability for States to negotiate, bringing 
together a market of interest that is harder to serve, and 
basically bundling them up, and then attracting insurers? Is 
that not a similar model?
    Secretary Azar. I apologize. I did not know about a change 
in view on the work of ours on the basic health plan. I know 
that is a passion of yours.
    If we could talk offline about that, I would be very happy 
to do so.
    Senator Cantwell. Okay.
    Secretary Azar. I just am not as familiar on changes there.
    Senator Cantwell. Well, I do not think there is--I am not 
sure that there is a change. I am just asking you if you think 
that represents--just like the drug negotiation, in empowering 
States to negotiate on price--do you think that represents a 
similar model?
    Secretary Azar. As a general matter, we want to be 
empowering States to run programs in their jurisdiction as they 
see fit so that they can make the kind of value choices. You 
know, we have approved very innovative demonstrations, for 
instance in Maryland, that would be very different than what, 
perhaps, Washington might do. And we want to respect different 
models, try different models.
    Senator Cantwell. Well, I think the distinction here I am 
trying to make is that when you block-grant something but you 
do not give the power to people--look, we see that the 
challenges of a baby boomer population reaching retirement and 
people living longer are going to cause a bigger demand in our 
budget.
    So we want tools that are going to help us reduce those 
costs. And being able to negotiate or bundle people up and 
create that negotiating power and then allowing people to--if 
the manufacturers or the providers do not want to participate, 
they do not have to participate. But it at least gives us 
market forces.
    And I just want to clarify that you are for those market 
forces.
    Secretary Azar. I generally am in favor as long as it is 
consistent with whatever the values of a State are in making 
choices to enhance market forces.
    Senator Cantwell. Right.
    Secretary Azar. Because like you said, we often talk about 
the drug market as if it is a free market and a competitive 
market. It does not function like a competitive market. 
Actually what I am trying to do is bring real market forces to 
bear, because it is not functioning that way.
    Senator Cantwell. I think the next thing that we have to do 
is that--it is very hard to get, you know, CBO scoring on these 
things, but I definitely think that we need to work harder at 
drawing some data and information about how these really would 
help from even a Federal perspective. And obviously they have 
been quite successful in the case of Minnesota and New York in 
driving down costs to the population.
    So we look forward to working with you on that.
    Thank you, Mr. Chairman.
    The Chairman. The Senator from Delaware.
    Senator Carper. Thanks, Mr. Chairman.
    Mr. Secretary, welcome. It is good to see you. Thank you 
for being here and for your leadership at the Department. And 
to the people who are with you, thank you. Welcome.
    Several weeks ago at the table where you are sitting we had 
six or seven CEOs from drug companies, pharmaceutical companies 
in this country and from around the world. And they agreed--I 
asked them all to think about three principles with respect to 
trying to achieve more cost-effective drugs, a better value 
from those drugs that are being developed, and finally, steps 
that we need to take to make sure that we do not take away the 
incentives for investors to invest in pharmaceuticals.
    I asked them all to give me their perspectives on three 
different factors, and I am going to just mention those to you 
again. I just wrote them down.
    One of those was the idea of eliminating rebates to PBMs. 
That was one. Second was creating and implementing value-based 
arrangements. And the last one was increasing the transparency 
industry-wide with respect to how the industry sets prices.
    Those were the three issues that I raised that day. And I 
asked them all to just think about them and to say whether or 
not they thought those were ideas that they could agree on and 
would recommend that we try to agree on.
    And they all did. They all said, ``We agree,'' and we went 
right down the line, and they said, ``We all agree with that.'' 
I would just ask the same question of you.
    Secretary Azar. So, of course, we have been pushing on all 
of those fronts. So on the rebate rule that I proposed--and I 
would love to get the support of and work with this committee 
on getting rid of rebates and having discounts go to patients 
when they show up at the pharmacy. Just for our seniors in Part 
D, that is $29 billion a year of rebates going to pharmacy 
benefit managers that could go to the patient starting January 
1st when they show up at the pharmacy.
    It is just an incredible change. And it would bring 
transparency, as you just mentioned, because then these 
discounts, these negotiations, would not be behind-the-scenes 
deals, they would be transparent. And I think we could actually 
see a virtuous cycle of price competition at the pharmacy 
counter, instead of right now these perverse incentives to 
higher list prices as the means of competing.
    Senator Carper. Okay.
    Secretary Azar. Second, on value-based arrangements, we are 
all in on that. We are working on how we can provide guidance 
and further pathways.
    Senator Cantwell just mentioned one, which is that Netflix-
type model that we have tried to open pathways for, but other 
value-based arrangements. We want to work with you on that.
    And generally, transparency--we are in favor of that 
transparency around pricing practices. We are happy to work 
with you on efforts there.
    Senator Carper. Sometimes we need to be mindful of 
unintended consequences of the things that we do here. And 
would there be any unintended consequences that you can think 
of from implementing the policy with respect to rebates?
    Secretary Azar. So what we are doing right now with rebates 
is, the rebates go to these middlemen, and they are used to 
lower premiums for----
    Senator Carper. Do any of them go to middlewomen?
    Secretary Azar. Well I--fair question.
    Senator Carper. Perhaps.
    Secretary Azar. Pharmacy middlemen and women. Okay. 
[Laughter.]
    They can be used to somewhat subsidize premiums for 
everybody. It is a very perverse notion of insurance, because 
what happens is, we are denying access to the discounts to 
these sick people who show up at the pharmacy and have drug 
expense, to subsidize lower premiums for the un-sick people, 
sort of the opposite of how insurance is meant to work.
    Senator Carper. I like that word, ``un-sick.''
    Secretary Azar. So under our proposal, we have been very 
transparent with the different estimates and said there could 
be as much of it as a $2 to $5 per-month increase in premiums 
as a result of that. But the average drug in Part D is $300. 
The average rebate is 26 to 30 percent.
    That means that, for anyone using a drug with an average 
rebate on it, in the first fill of that drug they would save a 
hundred bucks, and that is almost twice what the maximum 
premium impact could be under even our actuaries' most extreme 
analysis.
    So it is something we have to think about, and that is even 
if that happens, because I think these PBMs are going to 
actually work to keep their premium costs flat as they always 
do. It is a very price-sensitive market in terms of purchasing 
plans. They want to hit the benchmark and do not want to be 
beaten out by competition.
    I think they will pull that out of pharma companies. I 
think that is where the money will come from to keep premiums 
flat.
    Senator Carper. You may have just answered this question, 
but I am going to ask it anyway. How much would Part D premiums 
and the burden on Federal taxpayers increase as a result of 
eliminating rebates to PBMs?
    Secretary Azar. So we put out three different actuarial 
analyses in our proposed rule; we wanted to be transparent. 
Actuaries can add and can do math. They are not really good at 
predicting human behavior or especially what companies do in an 
economic system. So the estimates range from, I believe, $100 
billion of savings up to $200 billion of cost. That is a $300-
billion wide margin.
    We wanted to be transparent. I believe premiums will not go 
up, and as a result we will save money on this program. But we 
wanted to be transparent that there is the risk that other 
things could happen.
    Senator Carper. Okay. Thanks.
    Do you also support the elimination of drug company rebates 
in the private health insurance market?
    Secretary Azar. I do because, if we can get rid of rebates, 
list prices will come down. We have very big classes of drugs 
right now where there are huge rebates, 50-, 60-, 70-, 80-
percent rebates. And there will be no reason for these 
artificially inflated list prices if we get rid of rebates.
    Senator Carper. Okay.
    Did you include this policy in your budget?
    Secretary Azar. That is not formally in the budget because, 
of course, we proposed the Part D rebate rule.
    I think 30 States follow what we do on the anti-kickback 
statutes, so I think just our actions alone will dominate the 
commercial space because they will follow us.
    Senator Carper. Good.
    Mr. Chairman, my time has expired.
    I am going to follow up with a question for the record on 
increasing transparency, and another one about asking you to 
think out loud about the transparency laws that I think 
California has recently adopted and implemented--so, for the 
record.
    Thank you.
    The Chairman. Senator Daines?
    Senator Daines. Thank you, Mr. Chairman.
    In Montana, we are facing a meth crisis. In fact, it is a 
Mexican meth crisis. And it is devastating our families and our 
communities. Unfortunately, it is our children who end up 
entering the child welfare system, and they are among the 
hardest hit.
    Statewide, roughly one-third of our children in foster care 
in Montana are there because of meth use by their parents. In 
fact, last year my legislation--it was the Child Protection and 
Family Support Act. It was passed into law as part of the 
Family First Act to help children stay with their families as 
they receive substance abuse treatment.
    I have seen firsthand the benefits, just a few weeks ago in 
Billings at the Rim Rock Treatment Center, where mothers 
seeking treatment are kept with their children under 
supervision, instead of being separated.
    Secretary Azar, how is the Children's Bureau working with 
agencies like SAMHSA and CMS to coordinate implementation of 
Family First?
    Secretary Azar. So, thank you for your leadership on the 
Child Protection and Family Support Act. The Family First 
legislation, as Senator Wyden mentioned, is so important. It 
really gives us very valuable tools, instead of incentivizing 
the outplacement into foster care, to keep kids together if we 
can make a safe home for them. And it is such an aggressive, 
comprehensive package of legislation. It has really been a 
whole across-the-department effort of our Administration for 
Children and Families, as you said, working with SAMHSA, 
working with CMS to support all the very aggressive timelines 
in the statute.
    Senator Daines. I can tell you too, the feedback I am 
receiving on the ground back home is just remarkable. I was 
literally in a facility there where you had moms with little 
bassinets and cribs and little bunk beds there with their 
children under supervision, and just heard great feedback. This 
is the right path to take here to help these moms who are 
suffering addiction issues.
    How is HHS prioritizing the meth crisis? Meth seizures in 
Montana doubled year-over-year. We just got the data here last 
month. We have a truly--it is a Mexican cartel meth crisis; 
high potencies, 90-plus percent on this meth. It is no longer 
the homegrown meth. It is cartel meth that is so potent.
    How are they partnering together to fight the epidemic in 
places like Montana?
    Secretary Azar. So, obviously the $4.8 billion that we have 
for the opioid crisis, there are major elements of that that 
deal with just broad substance use disorder. So as we, for 
instance, open up the door to our institutions for mental 
disorders--the IMD waiver procedure to allow for more than 15 
beds in an inpatient facility--that is broadly applicable to 
substance use disorder and serious mental illness. And so that 
is helpful.
    So many of our other programs here go in that direction. 
Now a lot of the grants, the State opioid response grants, are, 
of course, by Congress set to focus on opioid use. But again, 
the capabilities there and just the national focus on addiction 
and treatment, I believe help with meth also, although it is 
not directly targeted.
    Senator Daines. Yes, and I tell you the linkage of what is 
going on right now with meth in Montana and violent crime, it 
is stressing our systems across the State.
    I want to shift gears, Secretary Azar. I know you have 
heard of the recent scandal involving Stanley Weber. He was a 
former Indian Health Service pediatrician who sexually abused 
Native American boys on multiple Indian reservations, including 
the Blackfeet Reservation in Montana. Mr. Weber has been 
convicted in Montana. He faces additional charges in South 
Dakota for his unspeakable crimes. He has destroyed the lives 
of children he has abused. And despite repeated warnings signs, 
report of suspicions, IHS chose instead to turn a blind eye 
while Mr. Weber continued his horrific behavior for decades. It 
is a clear systemic breakdown of the worst nature.
    Moving forward, Mr. Secretary, how will you ensure that all 
allegations against Indian Health Service employees are 
thoroughly investigated so that monsters like Mr. Weber are 
handled appropriately?
    Secretary Azar. Thank you for raising that, Senator. This 
situation, the conduct of course is unacceptable and 
intolerable. But the failure to root that out and deal with it 
in a timely manner is also unacceptable.
    So we have two investigative measures under way. I have 
asked the Office of the Inspector General to look at the 
processes, procedures, and personnel involved as well as a 
systemic approach.
    How can we ensure this does not happen again and have open 
systems of reporting? What, if anything, in our culture at the 
IHS allowed that to happen and go on and not be dealt with the 
way it should have been?
    In addition, IHS is going through a procurement now to have 
an independent outside government entity do the same type of 
audit and evaluation, because I agree with you: there are 
cultural dimensions when something like this happens that have 
to be fixed. And Admiral Weahkee has been determined that not 
only those directly responsible, but those who may have allowed 
it to happen should also----
    Senator Daines. Thank you, Mr. Secretary.
    In closing, I am going to be introducing the Jobs Act with 
Ranking Member Brady today to make needed reforms to the 
Temporary Assistance for Needy Families, the TANF program. It 
will bolster work requirements and help more families move from 
poverty to prosperity.
    We have seen in the President's budget proposal, the 
President agrees that stronger work requirements must be a 
priority of this Congress. I look forward to working with you, 
Mr. Secretary, on this important issue.
    Secretary Azar. Absolutely. Thank you.
    The Chairman. Senator Whitehouse?
    Senator Whitehouse. Thank you, Mr. Chairman.
    Secretary Azar, I have given your staff the map that I 
showed you before the hearing. I have a copy of it here, but I 
think you will probably do better looking at it there.
    This is an area that you know, because you used to live 
right down here. You did some time in New Haven, as I 
understand it.
    Secretary Azar. I did 3 years of time.
    Senator Whitehouse. If you go right up the road, up 95 here 
to Norwich, New London, you get to a Connecticut hospital 
called Backus Hospital. And of course, in New Haven you have 
Yale New Haven Hospital. Those hospitals have a 1.25-plus wage 
index.
    And here is Westerly Hospital in Rhode Island. The distance 
from Westerly Hospital in Rhode Island to Backus Hospital in 
Norwich is about 12 minutes according to Google.
    Westerley gets reimbursed at 1.04. There is a 20-percent 
differential in how the Connecticut hospital, 12 minutes away, 
is compensated compared to Rhode Island Hospital across our 
borders.
    And, if you go to the other side, here is Saint Anne's 
Hospital in Fall River. Saint Anne's hospital is compensated at 
1.35. And Saint Anne's hospital is 5 minutes from the Rhode 
Island border. Well, maybe 6 or 7, but it is very close to the 
Rhode Island border.
    This is a labor market. People go across State boundaries 
to work in different hospitals. They go across the State 
boundaries to get service in different hospitals. For some 
patients and emergencies, you are quicker from Rhode Island to 
Saint Anne's than you are to Rhode Island Hospital.
    So it boggles my mind why your organization is imposing a 
20-percent hit on Rhode Island Hospital compared to its 
Connecticut neighbor 12 minutes away, and a 30-percent hit on 
Rhode Island compared to our neighbors there 6 minutes from our 
border. Some of this is baked into the system.
    But just a few years ago, we had an imputed rural floor 
index that at least kept us at 1.15, 1.14 basically on average. 
We were still the least reimbursed State in this area, and your 
organization decided to punch our hospitals in the face with a 
10-percent cut that you did administratively, that you did 
without any means for us to repeal it; that is entirely within 
your organization's discretion. And I would really like to have 
it fixed, because I do not think you could defend why Saint 
Anne's should be paid 30 percent more than Rhode Island 
Hospital, why Backus should be paid 20 percent more than 
Westerly Hospital.
    With differentials that big, it affects the survivability 
of these hospitals. It affects their ability to pay for nurses 
and get the best hires to come and work for them at that lower 
rate. And of course, it is ridiculous when you think that the 
service area is completely overlapping.
    So please, can you take a look at this? We have gotten 
hammered, I think, unfairly, unjustifiably, and without 
recourse.
    Secretary Azar. Thank you. I appreciate your concern and 
your passion for Rhode Island providers. And I do appreciate 
that you recognize so much of the absurd----
    Senator Whitehouse. We were already the cheapest. Why kick 
us in the face?
    Secretary Azar. And I appreciate that you recognize that so 
much of the absurdity of the wage index is baked into statute. 
We are going through a process now that we have opened--asked 
for comment on a revision to the whole wage index system.
    Unfortunately, by statute----
    Senator Whitehouse. For the record, I have no confidence in 
the process. I have no confidence that it will lead to a 
result. I have no confidence that it will be done timely. I 
have no confidence in it whatsoever.
    And I do not know what you are being told by your people, 
but I have zero confidence in that process producing anything 
resembling a solution to this problem. And I do not know how 
you can defend a 30-percent differential from like 10 minutes 
apart.
    Let me ask one other thing. I just have a few seconds.
    There are States that are working on improving the nature 
and experience of end-of-life care, called Advanced Care. They 
run into problems with the 2-night 3-day rule. For a dying 
patient, that makes no sense. They run into problems with the 
curative-
palliative boundary; that makes no sense with a dying patient.
    And they run into problems with respite care rules where 
the respite is, you take granny and you have to drag her off to 
a hospital rather than bring in a home care worker to help. It 
would be cheaper, less disruptive, less painful for the family.
    So I will follow up on this.
    Secretary Azar. Please do.
    Senator Whitehouse. But there is an opportunity here to 
offer waivers and let States compete to take advantage of those 
waivers. And States that are working with this population will 
be able to prove that they save money and they make a more 
humane and better family experience out of this particularly 
intimate time of life.
    Secretary Azar. We would be very happy to work with you on 
that. That all seems to be very common-sense as far as I can 
tell.
    Senator Whitehouse. From as far as I can tell too. Yes, 
sir. Thank you.
    The Chairman. Senator Brown?
    Senator Brown. Thank you, Mr. Chairman.
    Mr. Secretary, thank you for the progress you have made on 
tobacco. Given the Commissioner's recent announcement that he 
will be leaving, I would like to get your commitment to 
continuing those efforts, and I would really appreciate ``yes'' 
or ``no'' answers to the following five or six questions.
    Will you commit to reducing nicotine in cigarettes to non-
addictive levels?
    Secretary Azar. Absolutely. That is the nicotine rule that 
we will be working on. The Commissioner laid out an agenda on 
nicotine reduction in tobacco products, yes.
    Senator Brown. Will you commit to continuing efforts to 
prohibit menthol cigarettes and flavored cigars?
    Secretary Azar. We just, actually yesterday, announced a 
ban on flavored cigars that will go into effect once the 
guidance is effective. And I think within 30 days after that we 
would end enforcement----
    Senator Brown. And menthol cigarettes?
    Secretary Azar. And on menthol cigarettes we have initiated 
a process with an advanced notice of proposed rulemaking. The 
legal issues on withdrawal of menthol from tobacco are more 
complex. We need to go through a very stringent evidence 
process on that.
    I am deeply concerned about menthol in cigarettes, but it 
is a trickier issue. But I am very concerned about the 
addictive nature of it, especially some of the recent studies 
about the attractiveness of menthol to certain subpopulations.
    Senator Brown. Thank you, and I appreciate those 
substantive answers. I need them shorter if they can be.
    Will you continue to raise the alarm about youth use of 
cigarettes?
    Secretary Azar. Absolutely.
    Senator Brown. Will you commit to moving forward with the 
effort to restrict flavors in cigarettes and issuing a final 
guidance in a timely manner?
    Secretary Azar. Yes, on the e-cigarettes, the flavoring in 
e-cigarettes, yes. We will be driving that forward with full 
vigor. And the Commissioner's agenda--just to be very clear, 
his agenda on tobacco and cigarettes is my agenda.
    Senator Brown. Okay; good to hear that.
    Will you commit to taking more aggressive action to protect 
kids from flavored e-cigarettes if the current proposal fails 
to reduce youth use of e-cigs?
    Secretary Azar. I think we were very clear that even if we 
see data this summer--with the next round of data that we may 
have to take even more aggressive steps.
    Senator Brown. And you, of course, will hold the next FDA 
Commissioner accountable on these important priorities?
    Secretary Azar. Absolutely.
    Senator Brown. Good.
    Now I have questions that will be a little more difficult 
for you.
    You have a copy of the HHS budget and brief in front of 
you. If you would turn to page 100, halfway down the page you 
propose implementing mandatory work requirements in Medicaid 
for able-bodied working-age individuals--mandatory work 
requirements in Medicaid for able-bodied working-age 
individuals.
    The term ``able-bodied adult'' in this paragraph--can you 
please define it for me?
    Secretary Azar. I think it is a common-sense definition. We 
have used that in some of the waivers that we have already 
implemented, that we have approved for States. I believe it 
would be consistent with that.
    I do not know that our budget actually laid out a 
definition----
    Senator Brown. I'm sorry, Mr. Secretary, to interrupt. 
``Common-sense definition'' does not work. We have asked you in 
a hearing to define ``able-bodied.'' You have not given a 
definition.
    We have asked in QFRs as a follow-up to your confirmation. 
You have proposed a policy requiring every State to implement 
work requirements on a population that you still have not 
precisely defined. We need that definition.
    Secretary Azar. I would point you to the waivers that we 
have approved in, I believe eight States, on the definition of 
the individuals who would be subject to those community 
engagement requirements. The budget does not define that. It 
calls for Congress to act. That would certainly be a subject 
that we would work with Congress on if that were to move in 
Congress.
    Senator Brown. Well, help me understand who these able-
bodied adults are. Does your definition of able-bodied adult 
include an individual suffering from addiction?
    Secretary Azar. It should not--non-elderly, non-disabled, 
non-pregnant working-age adults. And I think in all of the 
eight waivers that we have approved, we have excluded 
individuals who would be unable to work because of substance 
use disorder.
    I believe that is the case. I cannot speak to what is in 
the budget proposal in terms of--I do not know that we have 
specified in detail as opposed to just the broad thematic 
approach of work requirements, community engagement 
requirements, and harmonizing those across all public welfare 
programs.
    Senator Brown. How about an able-bodied woman who gave 
birth less than 3 months ago?
    Secretary Azar. I believe, I just, you know, I want to 
respond to you in writing, because I do not want to 
accidentally--I do not want to give you an accidental 
reassurance on some of these details that I am afraid I do not 
have with me at the moment. But we will be glad to get you 
information on that.
    Senator Brown. An able-bodied person who is disabled?
    Secretary Azar. Disabled should--I believe I just said that 
the individual has to be non-disabled, is my information.
    Senator Brown. So is the sheer definition----
    Secretary Azar. How one is able-bodied, I believe it is 
sort of inherent in the definition on the able-bodied aspect 
here that they would be non-disabled is my understanding.
    Senator Brown. Now does your definition of ``able-bodied 
adult'' include a full-time home care worker who makes minimum 
wage, she qualifies for Medicaid, but she does not have the 
time to refile complicated and burdensome paperwork to 
demonstrate proof of employment on a monthly basis? If she does 
not, she gets kicked off.
    Is that a person who is able-bodied?
    Secretary Azar. Any individual receiving free health care 
certainly ought to be able to supply information about their 
compliance with community engagement. That seems very little to 
ask for someone receiving free health care.
    I would refer you to the exemptions that we have in our 
State plans, including the exemptions in the Arkansas plan. So 
if a beneficiary lives at home with his or her minor dependent 
children, 17 or under, they are exempt. If they are caring for 
an incapacitated person, they are exempt. If they are pregnant 
or 60 days postpartum, exempt; substance abuse disorder, 
exempt; any mental condition----
    Senator Brown. I hear that. I have to wrap up.
    I appreciate it, Mr. Chairman. We have seen how work 
requirements in Arkansas have ripped coverage away from tens of 
thousands of Americans without any reportable increase in 
employment.
    You admitted during testimony this week you do not know why 
the 18,000 individuals in Arkansas lost coverage. I will tell 
you why. It is because this administration has made a conscious 
decision--the opposite of dignity of work--has made a conscious 
decision to kick hard-working ``able-bodied Americans'' off 
their insurance coverage when they are unable to meet the 
paperwork and bureaucratic requirements, not as a way to 
improve employment rates or promote health, but as a way, 
ultimately, which your department is all about, to pay for 
permanent tax cuts for the rich.
    That is the outcome of your policy. You have seemed to fit 
this definition so that you can do that.
    The Chairman. Senator Hassan?
    Senator Hassan. Well, thank you, Mr. Chairman. And I want 
to thank you and the ranking member for having this hearing. 
And thank you, Secretary Azar, for being here.
    Look, I have some concerns about the HHS budget that I will 
get to in a minute, but I want to start with one area where we 
have some real common ground, which is ending surprise medical 
bills. Surprise medical bills happen, as you know, when 
patients receive unexpected and often massive bills, often for 
receiving care that they did not realize was considered out-of-
network.
    I have been working with a bipartisan group of Senators to 
end this practice, including Senators Cassidy, Bennet, Young, 
and Carper from this committee. I understand that HHS is also 
interested in working on surprise medical billing, and some of 
our staff have already met with members of your team to discuss 
solutions to this issue. We appreciate those conversations.
    Will you commit to continue working with our bipartisan 
group of Senators to address surprise medical billing?
    Secretary Azar. Absolutely. We are deeply committed to 
solving this problem, and I appreciate your and Senator 
Cassidy's leadership.
    Senator Hassan. Thank you.
    And can we also count on HHS to provide timely technical 
assistance as we finalize our legislative proposals?
    Secretary Azar. Yes, absolutely.
    Senator Hassan. Thank you for that commitment.
    I know I speak for our full working group when I say we 
look forward to finding a bipartisan solution to this issue.
    Now, let us move on to the budget. I appreciate that this 
budget extends access to Medicaid for new mothers suffering 
from opioid use disorder and maintains funding for State opioid 
response grants, although we could really use more of that 
funding. Experts have said that it will cost hundreds of 
billions of dollars in sustained investment to address this 
crisis.
    How much do you think it will cost over the next 10 years?
    Secretary Azar. In terms of the consequences of the opioid 
crisis?
    Senator Hassan. Providing treatment and further prevention 
recovery services, the kids who are affected, grand-families?
    Secretary Azar. You know, Senator, I want to do justice to 
such an important question. I do not--I could not give you an 
estimate of that. We did propose the $4.8 billion, the 
continuation of our bipartisan work together in the budget.
    Senator Hassan. And I understand that. Right.
    And I am going to move on. I do not mean to be rude, but 
time is limited.
    Because the real question is, do you really think that the 
funding in this budget is adequate to address the problem?
    Secretary Azar. I do believe that we are making progress. 
On every measure, we are making progress. It is going to be a 
long fight.
    Senator Hassan. Well, and that gets me to my next point. We 
did not get here to this point with this epidemic overnight. 
You and I have talked about that.
    It is going to take years of sustained investment to truly 
turn the tide of the epidemic. Moreover, while I appreciate--as 
I have just said--that there is funding specifically targeted 
toward combating the opioid crisis in this budget, the budget 
would also slash programs that are absolutely critical to 
fighting this crisis, as well as undermining critical health-
care services for millions of Americans and thus, harm our 
efforts to combat this crisis.
    So here is what this budget would do. It would lead to 
millions more being uninsured. It would cut and cap the 
traditional Medicaid program.
    And for people who are not as familiar with that, not only 
does that impact an awful lot of people in nursing homes, it 
impacts some of our most vulnerable people who depend on 
Medicaid. And as we have a larger population of people who are 
surviving longer, happily, with very complex medical 
conditions, but who cannot work, that is really a devastating 
cut for them.
    And this budget would end Medicaid expansion, which experts 
on the front lines of the opioid crisis have said is the number 
one tool at our disposal to combat the opioid epidemic. It 
certainly is in my State.
    In States that have expanded Medicaid, as we did on a 
bipartisan basis in New Hampshire when I was Governor, 
hardworking people have better access to health care, including 
substance use disorder treatment that they need to live 
healthy, productive lives.
    In the last year, States across the country, including 
deeply conservative ones, have voted by referenda to authorize 
Medicaid expansion in their States. So, why does this budget 
say to the millions of Americans who support Medicaid 
expansion, whose lives have been changed by Medicaid expansion, 
who voted for Medicaid expansion at the ballot box--why does 
this budget say to them, ``Your voices do not matter''?
    Secretary Azar. So we replace the Medicaid expansion with a 
new $1.2-trillion grant program to States to actually allow 
your State and others to custom-design an insurance approach 
here that we think could allow a real focus on those 
populations that most need it, whether it is the traditional 
Medicaid populations of aged and disabled, pregnant women and 
children, those suffering from substance use disorder, as 
opposed to more the blunderbuss, ``give Medicaid to anybody who 
happens to meet the income threshold.''
    You could actually allow a much more targeted, focused 
approach.
    Senator Hassan. And I----
    Secretary Azar. That is our philosophy.
    Senator Hassan. Yes, and I have seen some examples of folks 
trying to do that that have not worked. Medicaid expansion is 
working.
    And I just will finish up to Senator Brown's point. There 
are a lot of people who got Medicaid coverage who had lost 
their jobs, let us say lost their health insurance coverage 
during the recession, then got sick because they could not get 
their medicine or could not get their treatment, and they could 
not work. Medicaid expansion coverage got them healthy again, 
and they are back at work. And then they are moving off of 
Medicaid into the private insurance market, which is exactly 
the trajectory we want.
    I can tell you instance after instance in New Hampshire 
where being eligible for health-care coverage when you are 
struggling and at some of the worst, most difficult times of 
your life has actually helped people back into the job market.
    The work requirements, and this ending of Medicaid 
expansion, are totally counterproductive to that.
    Thank you, Mr. Chairman.
    The Chairman. Senator Thune?
    Senator Thune. Thank you, Mr. Chairman.
    Mr. Secretary, thanks for being here. And I would like to 
associate myself with the comments I understand were made by 
Senator Daines regarding the IHS and this recent story about a 
provider out there being involved with some very criminal 
activities. And so I hope that you will work very, very hard to 
get to the bottom of that, and make sure that appropriate 
actions are taken to ensure not only that these people are 
brought to justice, but that this sort of thing never happens 
again.
    And then there is a broader issue I would just like to ask 
you about, because you and I have had this conversation several 
times about the ongoing concerns with the quality of care of 
South Dakota Indian Health Service facilities. And while it is 
not a problem that can be fixed overnight, it is one that I 
expect the administration to be working on to address.
    And unfortunately, facilities in South Dakota continue to 
be a significant issue. So what I would like to know is--and 
maybe you can speak and reiterate what you did earlier about 
the issue I mentioned at the beginning. But could you also talk 
about specific steps that HHS, I guess I should say, is taking 
to improve care at IHS facilities and what investments the 
proposed HHS budget makes toward that goal?
    Secretary Azar. Absolutely, Senator. Thank you.
    And I will not, in the interest of time, repeat about Dr. 
Weber, but just the disgust and dismay that that happened, 
continued to happen, was not dealt with. And we are working to 
ensure we change the culture, and it would bring outside voices 
in to make sure we learn how to make sure that could not happen 
again. So just absolutely horrific; should not have happened.
    We have prioritized in a budget that makes very difficult 
choices--we actually prioritize the IHS budget. We prioritized 
direct care delivery to our Alaska Native and American Indian 
patients.
    We invest $5.9 billion in discretionary funding for IHS, 
which is an increase of $391 million above the continuing 
resolution level and $140 million above fiscal year 2019 
enacted. Admiral Weahkee created the first-ever quality and 
oversight office directly under him, and I am actually 
surprised that it was the first time we had this. We were 
running a hospital system. We should have had a quality and 
safety, constant quality improvement culture and office around 
that. We have created that.
    We have dedicated $58 million towards certification 
remediation, really focused on the South Dakota facilities that 
you have mentioned, to ensure a collaborative relationship and 
preparedness for working with CMS to make sure they are always 
meeting accreditation standards, so that they could have a leg 
up.
    I think we have $10 million in our budget focused on 
recruiting and retention, because, of course, it is about 
getting quality individuals into these facilities. The people 
always are the centerpiece that make the difference in it.
    I have asked for external reviews, and we are, of course, 
open to any ideas you have on how we can improve the quality 
and safety performance. We owe that to any patient in our 
facilities.
    Senator Thune. Well, we have legislation that we have 
introduced up here that we hope eventually gets acted on--it is 
in the Indian Affairs Committee--which makes a number of 
reforms to IHS. That is something we have been working on for a 
long time.
    But it just strikes me that we have got to come up with 
some new models, some new way of dealing with this, because it 
is just--intergenerationally, these problems do not get any 
better and in fact, worsen over time. And we have had some 
specific examples in emergency facilities in the last few years 
we had to shut down, just because there have been so many 
violations and areas where care, when it is being provided, is 
actually putting people at risk, and we are losing people as a 
result of this.
    The IHS in its current form, incarnation, has just been a 
complete failure. And when it comes to taking care of the 
people whom they are tasked with caring for in Indian country--
and I, for one, am certainly willing to entertain new ideas. I 
know there are some thoughts about perhaps getting providers, 
hospitals who are willing to come and serve some of our 
reservation and tribal communities under contract, but whatever 
it takes to just get out of this rut we are in and come up, 
literally, with a new model, a new way of delivering services 
that does justice to the people who live in our reservation 
communities.
    I am certainly open to those, and I hope that you and your 
staff will be willing to entertain and look at new ways of 
tackling and addressing this challenge as well, because we are 
doing a disservice to people in Indian country. And that has 
got to change.
    So I have a couple of other questions, Mr. Chairman, I 
would like to perhaps submit for the record. I know my time is 
up, but I certainly wanted to make those points about the IHS.
    Secretary Azar. And, Mr. Chairman, could I just clarify? I 
believe it is $8 million for recruiting and retention, not 10. 
I think I said 10.
    And I appreciate your concern about the particular 
facilities, but I would like to--I just do not want to say I 
have seen it personally. There are so many dedicated men and 
women of the Indian Health Service who, in Alaska and the lower 
48, do deliver high-quality care for people.
    We have our challenges. We have our issues. We want to fix 
them, but I do want to say that we are a vital part of Indian 
communities. And the people are so dedicated. And we need to 
fix the problems, but I do want to respect those who are really 
doing the job so well.
    Senator Thune. And I think there are--I do not dispute that 
at all. I think there are some really terrific people who care 
deeply, and are trying to do a good job.
    It just seems that, in our part of the country in the 
northern plains, in our tribal communities, they seem to be the 
exception rather than the rule there. And we have a really hard 
time not only recruiting, but retaining people in these 
communities.
    So we need professionals who can go out and serve. And it 
is important that we provide the incentives, the right 
incentives to do that. We have legislation that would do that, 
and I know that you all are focused on it as well, but it has 
got to change.
    Thank you.
    The Chairman. Senator Lankford?
    Senator Lankford. Thank you, Mr. Chairman.
    Mr. Secretary, thank you for being here. Thanks for all the 
work that went into this.
    I need to ask a couple of questions. You and I have spoken 
multiple times about DIR fees and that retroactive clawback 
process that has been so painful for independent pharmacies 
around the country as they are trying to be able to provide 
pharmaceuticals to people who need them, especially in rural 
areas.
    You have done a proposed rule. Myself and several others 
have come in and backed you on that one. Can you give us any 
update on that, or where things are going with that rule?
    Secretary Azar. So that rulemaking, of course, is pending. 
I believe the comment period is closed, and so we are working 
on the final on that.
    What that would do in the proposal is ensure that the 
patient is getting the full benefit of whatever the lowest 
reimbursement level from a pharmacy benefit manager to the 
pharmacy would be. As a result, we think that would--and I have 
heard from pharmacists--effectively change this retrospective 
DIR approach that is hurting so many community pharmacists.
    Senator Lankford. And the rebates are not getting to the 
patient----
    Secretary Azar. They are not.
    Senator Lankford [continuing]. At the end of the day. And 
so that is part of the challenge as well.
    Last year, you and I spoke at, actually, an Appropriations 
hearing, and I was on this same song at that point with you as 
well, about DIR fees. You had mentioned that the Office of 
Inspector General, you were going to talk to them about doing a 
study on that one.
    Do you have any updates on that study or a knowledge of the 
timeline?
    Secretary Azar. Yes. So that study is underway, and I 
believe it is close to being wrapped up and getting out.
    Senator Lankford. Okay. That would be terrific.
    Let me shift subjects with you. In your budget, you 
mentioned some reforms on 340B, trying to be able to help get 
towards more targeted low-income patients.
    But there are not a lot of details on it. Can you help fill 
in the blanks for me a little bit about what you are thinking 
on 340B and that program?
    Secretary Azar. You bet. So first, we have asked for 
plenary regulatory authority for HRSA within the 340B program. 
We just are not able to actually regulate in that program right 
now. And we need the ability to do that to conduct appropriate 
oversight and ensure and demand transparency.
    We have asked for a user fee program from the beneficiaries 
of the hospitals and entities that could benefit from the 340B 
program to actually fund our work in providing that type of 
oversight. We also have asked that those entities that are 
taking advantage of the 340B program live up to their 
commitment to deliver charity care to individuals. By not 
sharing with them the savings from our drug pricing program, we 
have reduced the reimbursement and the spread that hospitals 
are getting in the drug program.
    We have reduced that and saved seniors $320 million a year. 
But we have to plow those savings back to all facilities, and 
we, in the budget, have proposed that those savings should only 
go to facilities that are dedicating 1 percent, minimum, to 
charity care.
    Senator Lankford. So, 1 percent is an exceptionally low 
threshold. I have heard that number thrown around a lot. What 
percentage of providers do you think are out there that could 
not meet the 1-percent threshold of charity care right now? Let 
us say they do charity care, but how many could meet a 1-
percent threshold?
    Secretary Azar. I do not have that data. I fear that it is 
not all of them, which is rather astounding.
    Senator Lankford. Right.
    Well, that would be a concern, obviously, long-term. If you 
are saying you are doing charity care and cannot handle a 1-
percent number, then you are not doing significant charity 
care, and we need to be able to discuss that.
    Let me shift one more time to the biosimilar area. And I 
know that Senator Cornyn brought up some of these things, but I 
want to be able to drill down a little bit more on this.
    Between the biosimilar program and a recommendation that is 
out there that your budget includes--a zero dollar cost sharing 
on generics and biosimilars for low-income beneficiaries in 
Medicare Part D--would that make sense to actually expand in 
the part B area as well?
    Secretary Azar. I have not studied that question, but we 
want to incent the adoption of biosimilars. Figuring out 
whether it is cost sharing or is it around provider 
reimbursement on biosimilars in Part B, I am happy to work with 
you on that.
    Whatever it takes, we want to ensure that we can create a 
viable, profitable biosimilar industry here that shifts share 
to it the way we have done with the generic industry.
    Senator Lankford. So there have been some concerns that the 
incentives currently in place, especially in the Part B world, 
are not to use the biosimilars, to do the biologic, and that 
there is a higher reimbursement amount and a higher 
reimbursement percentage in Part B for the biologic.
    How does that get balanced out long-term? Where do you 
think that needs to go?
    Secretary Azar. So right, with Part B, because you get paid 
ASP, average sales price, plus 6 percent, if you have a higher 
price--which would be the branded product--you, the physician, 
get reimbursed more for using that drug than if you use a 
lower-cost biosimilar.
    It is perverse. And we need to solve--that is a part of 
what we are proposing with our foreign reference pricing, the 
international pricing index model.
    That is part of what we changed in the reimbursement model 
that we did in Part B in this administration to actually make 
biosimilars more price-competitive against the branded product, 
not discriminated against.
    Senator Lankford. Right.
    There are some concerns--and Scott Gottlieb had mentioned 
he had some concerns that there was just noise in the 
marketplace between biologics and biosimilars, saying 
biosimilars do not live up to the standard. Many companies have 
both, but there is an intentional effort to try to make it 
noisier and seem like they are not as safe, biosimilars and 
such.
    Do you perceive that in the marketplace as well?
    Secretary Azar. I perceive that, although increasingly the 
big pharma companies are actually getting into biosimilars.
    Senator Lankford. They are doing both.
    Secretary Azar. So I think that will get mitigated over 
time.
    The Chairman. Senator Casey?
    Senator Casey. Thank you, Mr. Chairman.
    Mr. Secretary, thank you for being here. I appreciate the 
time that we spent recently with members of the committee 
talking about lowering drug prices. And I appreciate the work 
that both branches of government are trying to do.
    You are a native of my home State, a Johnstown native who 
went to great schools and did well and now is serving in 
government. We are always happy to see a Pennsylvanian do well, 
and I say that not just for reference, but for connection to a 
series of questions I have on Medicaid.
    As you might know, in our State--I think this is generally 
true in most States--but in Pennsylvania Medicaid is roughly a 
40, 50, 60 program. Forty percent of the kids, 50 percent of 
people with disabilities--about half of anyone with a 
disability is covered by Medicaid--and the 60 is actually a 
lower number. It is actually a little higher than that. Seniors 
who are in a nursing home get the benefit of Medicaid.
    In the 40 percent of kids covered by Medicaid in 
Pennsylvania, the number is even higher if a child has a 
disability. It is 60 percent of children with disabilities. So 
obviously, it is a huge concern to Pennsylvanians whenever we 
are talking about cuts to Medicaid, or even changes to 
Medicaid. It can be beyond disruptive for a family with a child 
with a disability.
    You know as well that we have a lot of rural communities in 
our State. Forty-eight of the 67 counties are rural. A lot of 
them have rural hospitals that would be not just compromised, 
but a lot of hospitals would close if there are massive cuts to 
Medicaid.
    I think, generally, across the country we found out in 2017 
that Medicaid is not a ``them'' program. It is an ``us'' 
program. It is our kids who have disabilities. It is our 
seniors, our families.
    The opioid epidemic, I think, focused people's attention on 
solutions. One of the solutions to good treatment was Medicaid 
expansion. Unfortunately, the budget proposal seeks to cut, not 
just to cut it, but to eliminate Medicaid expansion.
    To give you a sense of what that means in Pennsylvania, we 
have more than 80,000 people, almost 81,000 at last count, who 
get treatment for mental illness or a substance use disorder 
circumstance. And that happens to be the category where opioid 
treatment finds itself.
    When you look at counties in our State, your home county of 
Cambria County where Johnstown is, just think about it this 
way: 65 percent of the people in Pennsylvania got health care 
after the Affordable Care Act, sixty-five percent under 
Medicaid expansion. In Cambria County, it is 72 percent.
    So to say that I and many others will fight these cuts with 
an unyielding passion is an understatement. We are going to 
fight this battle. We will fight your department. We will fight 
the administration. We will fight anyone, and we are going to 
win this battle.
    So I would urge you and the President and the budget 
meisters to reconsider eliminating Medicaid expansion, to 
reconsider block-granting. And that leads me to my question.
    First question: is Health and Human Services right now in 
conversations with or negotiations with any State regarding 
block-granting of Medicaid or per capita caps on Medicaid, 
which are very similar?
    Secretary Azar. So we have discussions with States where 
they will come in and suggest ideas like--I do not know about 
any, perhaps per capita, but there may be States that have 
asked about block-granting, per capita, restructurings around, 
especially, expansion populations.
    Senator Casey. So let me just stop you there.
    Secretary Azar. It is at their instigation.
    Senator Casey. Yes, the answer is ``yes,'' you are having 
those conversations. Do you know how many States?
    Secretary Azar. I do not know exactly how many.
    Senator Casey. Would you commit, and I think you should 
commit--a little hint there--to inform us about those 
negotiations or conversations, but also to make the documents 
that pertain to those conversations and negotiations public?
    Secretary Azar. I do not think it would be proper. I think 
it would actually--it violates our ability to work with a 
Governor and a State as they try to consider different 
approaches to allow those interactions to be----
    Senator Casey. Well, here is the problem if you do not 
disclose that you are having those conversations or are not 
making the documents public. People who have a concern about 
block-granting Medicaid--and they are in the tens and tens of 
millions--do not know what is happening. They will find out 
about it after the ink is dry.
    We need to know what is happening in those conversations, 
even if it is out of Pennsylvania, and if it is not. But we 
need to make sure that the documents are made public, and that 
folks out there who care about this program know that those 
conversations are taking place.
    The Chairman. Senator Cassidy?
    Senator Cassidy. Thank you.
    As I open up, Secretary Azar, I am going to kind of touch 
on several things my colleagues across the aisle have said.
    First, will you clarify, there has been this number tossed 
around about Arkansas's work requirement dis-enrolling 15,000 
people. Will you clarify that, please?
    Secretary Azar. Thank you. I really appreciate that.
    So we had in Arkansas--under their waiver program, 18,000 
individuals, approximately, did not comply with the work 
requirements. That means they did not submit the required 
forms, or they did not do the work.
    We see churn like this in State Medicaid programs all the 
time, people coming in and out of the Medicaid program. Here is 
a key fact: only 1,000 of those 18,000 people appealed their 
disqualification based on compliance with community 
enrollment--only 1,000. Only 1,452 of those 18,000 people even 
reapplied for Medicaid when the open enrollment period came 
again.
    That seems a fairly strong indication that the individuals 
who left the program were doing so because they got a job. This 
booming economy provided opportunities, and they have insurance 
elsewhere and did not need the Medicaid program.
    We see this in Medicaid all of the time, and it is why 
enrollment nationwide in Medicaid is down.
    Thank you for asking about that.
    Senator Cassidy. Yes.
    Well, I will also point out, when you have record-low 
unemployment for high school dropouts, and record-low 
unemployment for people of color and veterans and women, it may 
be that people are moving into something which provides 
benefits, which is our goal.
    Secondly, let me just talk a little bit about Medicaid. My 
colleague from Pennsylvania just talked about the per-
beneficiary payment or per-capita cap, which, by the way, is 
how the Federal Employees Health Benefits program works. The 
insurance company gets a certain amount of money per enrollee 
based upon certain factors, and then they live within that.
    It is a reform used by almost every single major insurance 
company, but we do not use it for Medicaid. I guess the 
importance of that is that Medicaid, as we know, is 
cannibalizing State budgets.
    The ranking member spoke of his concern regarding this. I 
will point out that Oregon just had to pass a 6-year tax on 
hospital insurance plans and others to raise $430 million 
because the Medicaid budget is so expansive. And the Governor 
is exploring taxes upon employers.
    At some point, everybody has to say, ``Let us have a 
reform.'' I am not entirely sure I agree with where you are 
going with it, but I applaud you for acknowledging that 
Medicaid is just chewing up State budgets and the Federal 
budget, and we are not going to be able to treat patients if 
the program is not sustainable.
    I say that as a fellow who for 25 years treated the 
uninsured in Medicaid. If the program is not sustainable, that 
is false compassion. I will just say that once more.
    Now, let me ask you this kind of more mundane thing, if you 
will. I really like what you are doing with price transparency. 
But one of the pushbacks has been that that may not be 
meaningful to a patient. They are just wondering what they are 
going to be on the hook for.
    Now I understand that there is a blue-button or a real-time 
benefit analysis piece of software that people can put on their 
smartphone and tap it, and immediately know what they are on 
the hook for when a procedure is ordered. But it has just not 
yet been deployed.
    What is CMS's role in the deployment of that? And any 
holdups, and why the holdup?
    Secretary Azar. So the blue-button 2.0 approach actually 
gets you access through an API environment where other web 
designers can provide you access to your Medicare claims 
information.
    The exciting new tool is actually the electronic real-time 
benefit tool that we have put in the Part D program, where we 
have proposed that you would actually, as a patient, be able to 
know before you walk into the pharmacy, and actually when your 
doctor is writing a prescription, what you would pay out of 
pocket for that drug, that you would have the right to know 
that information across the board. We want people to have the 
right to know what you would pay out of pocket before you go 
in.
    Senator Cassidy. So that will be Part D. I applaud that. 
Oftentimes, a physician does not know that.
    Secretary Azar. Absolutely.
    Senator Cassidy. So what about moving beyond Part D, and to 
oh, I am going to have my colonoscopy at the general hospital 
versus my colonoscopy at the ambulatory surgical center, 
because it is a lot less at the ambulatory surgical center.
    So what about extending that beyond just drugs?
    Secretary Azar. So I am very interested in looking at that, 
and the Office of the National Coordinator's Interoperability 
and Information Blocking regulation is part of the proposal 
there. We actually asked for feedback on that question of 
moving towards that type of negotiated discount price 
transparency, so you know what you will pay out of pocket 
before you receive a service.
    Senator Cassidy. And any time frame as to when that might 
be executed?
    Secretary Azar. That would be the regular rulemaking 
processes. So it will take some time. We are in the comment 
period right now, which would be a 60-day comment period.
    Senator Cassidy. Okay.
    Thank you, sir.
    The Chairman. Senator Menendez?
    Senator Menendez. Mr. Secretary, I want to join my 
colleague from Rhode Island who earlier approached you on the 
question of the rule floor. This is a critical issue to us. 
This is the first administration in which we have not gotten at 
least an extension as we try to figure out a long-term solution 
to the problem. And it is unacceptable.
    And so at this point, you know, we have tried the nice way. 
At this point, you know, we are going to have to look at what 
our options are on nominations and other things. So I just hope 
we can get there, and get there quickly, because there is a 
real consequence to New Jersey hospitals and to the people who 
have to attend them.
    Let me just ask you this. A Federal judge in California has 
ordered the administration to take responsibility for all 
children who were separated from their parents at the U.S.-
Mexico border and placed with relatives or sponsors after July 
1st of 2017.
    The order comes on the heels of a January Inspector General 
report of the Department that found there were thousands more 
children separated from their parents than the 2,800 that are 
already acknowledged by the administration. Independent of the 
IG report, were you aware of other children who may have been 
separated, outside of the 2,800 reported to the Federal court?
    Secretary Azar. So HHS's ORR program always receives 
children who are separated, because DHS will set first--they 
are separated----
    Senator Menendez. I am talking in this time period. I am 
talking about this specific set of circumstances. I am not 
talking about generic----
    Secretary Azar. No, but that would be subject to the 
court's order. There are always children who are separated and 
sent to us by DHS because the--DHS checks on the putative 
parents. They find them not to be parents. They find the 
parents to have committed felonies that are covered by the 
TVPRA, or there may be another child welfare----
    Senator Menendez. Thousands were not sent because of 
felonies. Let us not get into that.
    Secretary Azar. And again, the IG speculated that there may 
have been thousands, not that they found them.
    But what we are working with the court on is the question--
every child that was in our care as of June 26th, the date of 
the court's order, was in the original class and is accounted 
for in terms of where they are and where the parents are, and 
reconnected, except we have four who remain to be connected, 
and that is because----
    Senator Menendez. When were you aware of those cases?
    Secretary Azar. Of which cases?
    Senator Menendez. Outside of the 2,800.
    Secretary Azar. Probably in the context of the IG's report 
mentioning that. But also I became aware later, in the course 
of these controversies, that there had been some efforts in 
2017----
    Senator Menendez. So, before the IG's report, you were not 
aware?
    Secretary Azar. No, I am not saying that. I cannot remember 
when there was public reporting or discussion about the fact 
that DHS had done a pilot or pilots of a zero-tolerance 
referral policy that also led to separations.
    I was not aware of that at the time. I was not at the 
Department for some of it, and then was not aware of it at the 
time.
    Senator Menendez. I am talking about the time period that 
you were in the Department, Mr. Secretary. I am not talking 
about some other time.
    Can you submit to me in writing what are the exact steps 
that HHS is taking to ensure that these families that have been 
separated are identified and reunified?
    Secretary Azar. Well, here is what is important to 
remember. Almost every child whom we put through a sponsorship 
program goes to a relative. So these children were not in our 
care as of June 26, 2017.
    They were placed with family members. And we will work with 
the court on appropriate procedures. If by chance there is a 
parent who is not connected with their child--I am not aware of 
it--but if there is, we will absolutely work to ensure that 
they are connected.
    These kids should be with relatives under every 
circumstance.
    Senator Menendez. I will reiterate to you my request. You 
are great as a lawyer. I happen to be a lawyer too. I am not 
going to let you burn all my time.
    My request is very simple. Will you submit in writing the 
exact steps that you are taking to ensure these families are 
identified and reunited?
    Secretary Azar. I believe that is possible, because it 
would be consistent with our status reports to the court.
    Senator Menendez. In February 2018, when you appeared 
before the House, you told Representative Castor that you would 
instruct HHS agencies to conduct gun violence research. Last 
year, the fiscal year 2018 Omnibus included clarifying language 
that the Dickey Amendment does not bar the Centers for Disease 
Control and Prevention from studying gun violence.
    Is the CDC conducting gun violence research?
    Secretary Azar. So that is not, I believe, an accurate 
representation of what I actually said last year. What I said 
was what you unnecessarily, I think, clarified in the statutory 
language. I made it very clear that I saw nothing in the Dickey 
Amendment that would prevent or ban CDC from conducting 
research on violence, including gun violence research, and the 
CDC Director confirmed that.
    Senator Menendez. Let me get to my question. My question is 
very simple. Is the CDC conducting gun violence research?
    Secretary Azar. We need Congress to fund that, if Congress 
wishes to fund that. CDC does not have a bucket of money like 
the NIH does for just general R01 peer review projects.
    Senator Menendez. So the answer is ``no.'' And then you 
need money. Is that it?
    Secretary Azar. If Congress wishes to fund gun violence 
research, we will faithfully implement it if it is funded at 
CDC. That is----
    Senator Menendez. Thank you.
    Secretary Azar. I am sorry, Mr. Chairman.
    When I referred to the date of the court's order, I said 
June 26, 2018. I think I should have said June 26, 2017. It was 
June 26, 2018. I just wanted to be very clear.
    The Chairman. Senator Cortez Masto?
    Senator Cortez Masto. Thank you.
    Mr. Secretary, let me follow up on that. According to 
internal agency documents, HHS has received more than 4,500 
complaints of sexual abuse of unaccompanied minors from 2014 to 
2018. And almost 200 of these are contractor staff on minor 
allegations of sexual assault.
    Disturbingly, the reports like this are not new. Please 
tell me what you are doing, and what the agency is doing, to 
ensure the safety of these children.
    Secretary Azar. Absolutely.
    Any sexual misconduct or sexual abuse involving these 
children is absolutely unacceptable. Let us be very clear about 
that. And we need policies, procedures, training, everything to 
ensure that does not happen.
    Over the last 4 years, including the previous 
administration--we get about a thousand allegations a year of 
sexual misconduct. That is three categories. One would be 
inappropriate sexual behavior. That could be one child saying 
something, a bad word to another child, sexual harassment, and 
then, of course, the core category of sexual abuse.
    And as you mentioned, over 4 years, with I think 182,000 
children in our care, we have received 178 allegations of 
potential sexual abuse between a staff member of a grantee and 
one of the minor children. Many of those proved to be 
unsubstantiated once investigated. And we will be, I think, in 
the next several weeks hopefully, reporting out some more 
information about the levels of substantiation there.
    But we have put in place a Sex Abuse Prevention National 
Coordinator at ORR. We have a committee around that person. 
Every report of sexual misconduct must be reported within 4 
hours. Sexual abuse must be reported to, as relevant, Federal, 
State, local law enforcement, and Child Protective Services 
authorities.
    Where we find a substantiated finding, we take action on 
that. You know, there was the one instance that you may have 
seen the video of, the pulling of the hair, the video. Before 
that ever became public, we had swooped in, investigated that, 
worked with the State.
    We shut down that facility, removed the kids. We shut down 
another facility of that grantee and removed the kids. And we 
stopped placement at six others of those facilities, wound 
those down. And now for those facilities to come back online, 
they actually will have to go through relicensing by the State 
licensing authority.
    So, if you have ideas of ways we can do it better, I am all 
open. We want to ensure--one case is too many. Absolutely.
    Senator Cortez Masto. Thank you.
    And so, for that reason, please provide me with the 
policies and protocols----
    Secretary Azar. We will.
    Senator Cortez Masto [continuing]. And what you are doing 
to ensure the safety, particularly of the contractors that you 
are working with as well, and how they are identifying the 
individuals that work for them----
    Secretary Azar. I will be very glad to do that.
    Senator Cortez Masto. Thank you.
    Secretary Azar. Thank you for asking about it. I think we 
all share the views that, if we can do anything better, we are 
open to any approaches and ideas to ensure that----
    Senator Cortez Masto. Thank you. I look forward to working 
with you further on that.
    Let me jump back to the budget itself, because I do have 
concerns about repealing the ACA and replacing it with the 
Graham-Cassidy bill.
    In the State of Nevada, under a Republican Governor, the 
Affordable Care Act has been an incredible benefit. We had the 
Governor create a Silver State Health Care Exchange. He 
expanded Medicaid. And because of that, the ACA had a bigger 
impact in rural areas in Nevada than it did in some of our 
cities. In fact, the uninsured rate among low-income Nevadans 
dropped by 28 percent in rural Nevada, compared to a 19-percent 
drop in the uninsured rate in our State's metro areas.
    So what policies in this budget would make up for the more 
than 10-percent increase in the number of rural Nevadans 
without health insurance if the ACA is to be repealed as this 
budget requests?
    Secretary Azar. So our proposal, and of course Congress 
would have to adopt it--it is a proposal--would be that we 
would take away the Medicaid expansion and the Affordable Care 
Act individual exchange programs, and actually replace them 
with a $1.2-trillion State-based grant program that would give 
the States tremendous flexibility to come up with approaches.
    They would have to protect against pre-existing conditions, 
for instance, invisible or visible risk pooling, common-sense 
mechanisms----
    Senator Cortez Masto. So let me ask you this, because I 
appreciate that. In my State, we had already looked at the 
Graham-
Cassidy bill. It does not support it. It does not help the 
State of Nevada. It does not address this.
    So what flexibility are you giving to any of the Governors 
who have concerns about this change and the impact it is going 
to have to their State and their individuals living there? Is 
there flexibility?
    Secretary Azar. Well, of course, Congress would have to 
pass all of this that is proposed in the budget for there to be 
any need for that discussion. At this point, we are working 
with Governors and States under 1332 to just make things work.
    I have granted seven reinsurance waivers so far to States.
    Senator Cortez Masto. I appreciate that, and I have seen 
that. And I know that is something the Governors had requested.
    But the concern is, in particular, this block-granting and 
the cuts that is going to make to Medicaid.
    And I echo my colleague, his concerns about the block grant 
and the impact in the communities. And listening to the 
Governors, they know better. They know better the impacts that 
they are going to have.
    And so, I look forward to working with you on this. I know 
it is a challenge, but I think we should be listening to the 
people in those States that are really impacted by this. And I 
appreciate you being here today. Thank you.
    Secretary Azar. Thank you.
    The Chairman. Senator Young?
    Senator Young. Welcome to the committee, Secretary Azar. I 
am so grateful for your hard work and thoughtfulness, and for 
the work of your team. I have really enjoyed working with you. 
So thank you.
    Last week at the National Kidney Foundation's Kidney 
Patient Summit, you spoke about the burden that kidney disease 
places on both patients and the Medicare program, and how the 
administration is ``going to look at how we can deliver more 
organs for transplants.''
    In the President's budget, I saw the administration is 
requesting more funding for HRSA's organ transplant program, 
but I do not see much else on transplantation. So that does 
concern me. There are over 113,000 Americans currently waiting 
for a transplant in the United States.
    According to recent reports, if HHS implemented system-wide 
reforms to our organ donation system, there is a potential to 
recover up to 28,000 more organs per year, saving thousands of 
lives and billions in taxpayer funds.
    So, Mr. Secretary, my question for you is, what is the 
administration planning on doing in terms of increasing 
transplantation?
    Secretary Azar. Well, Senator Young, thank you for your 
leadership on the issue of transplantation. It is a commitment 
shared by the President. He is deeply concerned about 
increasing organs available for transplantation. And if you 
have suggestions on ways, either through legislation or 
administrative practice, that we can improve the availability 
and supply of organs, we are glad to work with you on that.
    One of the things that I announced that we want to work on 
in kidney transplantation in particular is ruling more kidneys 
in as available. You know, the last time the rules were set for 
acceptability of kidneys, it was in an era before, say, we had 
hep C treatments, just to give you one example.
    Senator Young. Yes.
    Secretary Azar. So we rule out organs, and we rule out 
donors, perhaps, all too fast. We need to update that, and we 
are going to update that.
    We have also got to improve our living donor programs. We 
need to think about appropriate ways that we can support living 
donors who are giving into the system. So whether that is wages 
or health care or other benefits that are appropriate, we are 
looking at that and look forward to any ideas you have there.
    Senator Young. Well, I am glad you have ideas that you just 
volunteered to me. We do have some additional systemic ideas 
that we have pulled together from different stakeholders. I 
would like to dialogue in the future with you and your team 
about those. Perhaps some of them can be implemented.
    Are there any additional tools that you need from Congress 
in order to implement the things you just mentioned to me, or 
to implement other reforms in this area?
    Secretary Azar. We might, especially around the issue of 
supporting donors, because of the valuable consideration 
requirements that were put in for the right reason, of course, 
to prevent the buying and selling of organs. But we do need to 
look and see whether any of our statutory provisions get in the 
way of good common-sense approaches to support individuals who 
are kind enough to basically do a living donation.
    Senator Young. Okay. Thank you, Mr. Secretary.
    Earlier this year, CMS announced it had decided to 
recertify LiveOnNY, which is a federally certified organ 
procurement organization, despite persistent under-performance 
for decades. This decision comes after CMS had announced in 
June of last year that they would not recertify the Organ 
Procurement Organization for continued poor performance.
    LiveOnNY's poor performance is nothing new. The 
organization was first faced with decertification by CMS in 
2014 for failing to meet performance requirements, but was 
later recertified anyway. So this goes back pre-Trump 
administration. It goes back a number of years. The 
organization's leadership and its trade association then 
admitted that the CMS performance measures were ``self-
reported and unaudited'' and that the ``accuracy and 
consistency of OPO data cannot be assured.''
    So the current OPO data and evaluation systems have allowed 
LiveOnNY and other OPOs around the country to evade any 
meaningful oversight or remediation, leaving patients waiting 
for life-saving organs that may never come. This has impacted 
me and some of my friends personally, Mr. Secretary.
    So does HHS have the systems in place to objectively 
evaluate OPO performance or to enforce a decertification when 
appropriate? And to be clear, when I say it has impacted me, it 
has impacted people I know.
    But do you have systems in place to objectively evaluate 
performance?
    Secretary Azar. So we do regularly survey our Organ 
Procurement Organizations to determine compliance with our 
regulations. We hold them accountable for failure. And where 
there is failure, they do need to come up with corrective 
action plans and bring themselves into compliance.
    But if there are approaches that we can use to tighten up 
our oversight of OPOs and ensure higher-level performance, we 
would always be willing to work with you and have those or seek 
legislation that would give us the authority to impose those.
    The Chairman. Senator----
    Senator Young. So just to close--and thank you, Mr. 
Chairman.
    The Chairman. Please, go ahead quickly.
    Senator Young. I would recommend, respectfully, Mr. 
Secretary, that HHS consider changing CMS performance metrics 
by which OPOs are evaluated to make the criteria objective and 
verifiable.
    Thank you.
    The Chairman. Senator Scott?
    Senator Scott. Thank you, Mr. Chairman.
    And, Mr. Secretary, thank you for being here this morning, 
or this afternoon at this point.
    I want to associate myself with Senator Young's comments as 
they relate to liver transplants and to recognize the important 
fact that both the southeast, as well as the Midwest, are 
places where the donation rate is very high, and the current 
system has provided for us to have the resources necessary, the 
organs necessary, to meet the needs in our regions.
    And changing that system could be to the detriment of the 
very regions that produce the highest donation rate. So I want 
to associate myself with those comments.
    I would also like to say ``thank you'' for the waiver for 
Miracle Hill Adoption. There is no doubt that, as the ranking 
member will have a chance to speak after I am finished, he may 
have a different opinion than I on this topic.
    It is incredibly important. There is nothing more American 
than religious liberty. To allow for adoption agencies in every 
State to practice and to adhere to their core principles and to 
participate in the adoption space is critical. It is essential. 
And at the same time, we recognize that people of different 
faiths have adoption agencies that will be able to take 
advantage of such a waiver, if the waiver is given to other 
States. This is a good thing.
    I think what you all have done is reinforce the primary 
premise of what helped found this Nation of religious liberty. 
The important space in the adoption arena only makes it more 
valuable because of the number of kids who would be negatively 
impacted without the waiver that you have given to South 
Carolina, to Miracle Hill.
    I am trying to create a little insulation as I finish my 
comments on this issue before my ranking member has a chance to 
try to dissect it and have a different take on this. But 
without any question, religious liberty in the adoption space 
is essential to placing more kids in good homes in this Nation.
    So what you have done is help kids around this country, and 
specifically in South Carolina, and hopefully we become a model 
for other States who would seek such a waiver.
    On the sickle cell disease front, I had a chance last week 
to meet with Dr. Collins, who had some exciting news. And he 
told me to do what I have not done in a very long time, watch 
more TV.
    He suggested that on ``60 Minutes'' there was going to be 
an amazing report about new therapies coming forward in the 
sickle cell space, in the rare disease space. I think that the 
excitement in his voice and the optimism about the future as it 
relates to rare diseases, it was palpable. I hope that as we 
move forward, what we will see from HHS are the type of 
resources necessary for folks who are disproportionately on 
Medicaid--who have sickle cell--having access to the therapies.
    And so my question is, does your agency have the tools and 
authorities needed to leverage new and innovative payment 
models for drugs that provide a cure for certain conditions, 
specifically conditions like sickle cell disease?
    Secretary Azar. You know, it is a very insightful question. 
We are all excited about that story we saw on ``60 Minutes.'' 
We are excited about the research that we are seeing by the 
pioneers at NIH.
    I think Dr. Collins and I are both convinced that, within 
the next 5 years, we may literally see a cure for sickle cell 
anemia.
    Senator Scott. Fantastic.
    Secretary Azar. But--and for other gene therapies--it will 
come at a cost.
    Senator Scott. Absolutely.
    Secretary Azar. And it will be a big cost. And I do not 
think our systems are well-adapted to, say, million-dollar 
curative therapies, or half-a-million-dollar curative 
therapies.
    And I would love to work with Congress on approaches to 
deal with that. We have some authorities. We will certainly use 
them as best we can to deal with that, but this is a major 
challenge, these types of very expensive curative therapies 
that will come. And our system was not built for that.
    Senator Scott. No, it was not.
    I will say that, having had a relationship with the Medical 
University of South Carolina, which has done a really good job 
of treating patients, particularly youth with sickle cell, the 
lifetime expense of the disease would be reduced substantially 
if we could figure out a model for the disease up front, 
eliminating it.
    I will close with my last seconds on the issue of DSH 
payments. I am sure you are aware that, with the new model 
coming out, the cuts in the DSH payment could have a 
catastrophic impact on States like South Carolina, where we 
could see a 34-percent cut in payments to our State.
    I hope that you guys will take a closer look at the model 
that you will use to spread the cuts that will be seen around 
the country and that have a profound impact on our State.
    Secretary Azar. Thank you, Senator.
    Senator Scott. Thank you, Mr. Secretary.
    Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Senator Cardin?
    Senator Cardin. Thank you, Mr. Chairman.
    Secretary Azar, welcome. It is always good to have you 
here.
    This is a hearing where we get a chance to, at least, 
understand and express our concerns in regards to the 
President's budget. And I do recognize Congress has a 
reputation for expressing its own views on the budget. We do 
not always follow the President, but I think the President's 
budget is extremely important, because it does express 
priorities of the administration.
    So let me just raise a couple specific budget issues so you 
know my views. To me, the Medicaid cut is outrageous.
    I have served in the State legislature. I know the 
pressures on State budgets. Turning this over to a block grant, 
removing the expansion of Medicaid under the ACA, it is going 
to have a major impact on health care among Marylanders who are 
the most vulnerable, our seniors, and it will nationwide.
    So I do not want this hearing to go by without you 
understanding how deeply concerned I am about the Medicaid 
cuts.
    I feel the same on the Medicare side. And you try to 
connect the Medicare cuts to some specific policies that I do 
not think are going to work, and I just really raise those 
issues.
    On the Medicaid budget, for one moment, I just really want 
you to follow up on this, because I do believe we probably had 
the same view on this. And I think the budget may be 
inconsistent.
    I am worried about the proposal running counter to the 
prudent layperson standard in regards to emergency health care. 
We have long established through law and through practice and 
Medicaid and Medicare that if you should go to the emergency 
room because of your symptoms, then you will be reimbursed 
under the private health insurance or government health 
insurance.
    And yet, you are looking at waiver authority in regards to 
co-
payments for emergency room care that is not needed. I want to 
make sure that does not run afoul of the prudent layperson 
standards. And I would just urge you to make sure that is the 
case.
    I think we have an agreement. I do not think we will be in 
disagreement there. But the way the rules can be interpreted--
when someone has chest pain, sweating, et cetera, thinks he is 
having a heart attack, then ends up now having to pay a higher 
copay because he did not have a heart attack, and then realizes 
maybe he should have had a heart attack in order to get his 
bills paid.
    So I have just hope that we could follow up on that issue.
    Secretary Azar. I am happy to. As you describe it, I 
suspect we would be in alignment in thinking about the common-
sense approach and application there. But I am happy for us to 
follow up on that together.
    Senator Cardin. I appreciate that, because, again, some of 
the technicians can run afoul of some of our policies, so that 
is helpful.
    I quite frankly do not understand the philosophy for the 
National Institutes of Health, NIH cut that is in this budget. 
The last time I checked, I think it was one out of 10 or one 
out of 11 worthwhile projects at NIH that are being funded. It 
is so exciting, the work that they are doing in regards to 
health-care outcomes and saving us money long-term, better 
quality life, et cetera.
    It also leads to a lot of private-sector activity, which is 
good for our economy. What was the rationale for the NIH cut?
    Secretary Azar. So, as I said in my opening statement, the 
cuts here are difficult, and they are from an overarching 
budget environment of trying to achieve the caps deal that 
Congress and President Obama struck for the 2020 year's caps.
    We, as a very large discretionary budget, as well as with 
NIH being the largest portion of our discretionary budget, we 
got a 12-percent cut across our department on discretionary. We 
applied that to NIH with 12 percent, tried to wall off opioids 
and opioid research as well as the pediatric cancer initiative.
    But we all value NIH. We value the work. I am sure we can 
economize if Congress were to work with the administration on a 
change in overall caps or Congress takes a different approach. 
We are obviously going to work with you on that.
    Senator Cardin. And I accept that explanation, which means 
it is illogical, your cut, and you will work with us to make 
sure that we not only restore that, but provide some additional 
funding for NIH.
    So I appreciate your honesty in that answer. And I will 
interpret it the way---- [Laughter.]
    Secretary Azar. That would not be my interpretation. I 
support the proposal that we have----
    Senator Cardin. I hear you. I think I will quit while I am 
ahead on that exchange, and I am going to declare victory.
    In regards to one last issue, I raise the issue of 
restrictions on the title 10 grant programs as they relate to 
family planning and preventive health care.
    There have been areas where we understand the 
administration's position in regards to restrictions on 
abortion. We do not necessarily agree with that, but I would 
hope that we could reach an accommodation on family planning 
and preventive health care where common-sense policies need to 
be in place at the Federal level in order to make sure women 
can get the health care that they need and deserve. And I look 
forward to working with you on this issue, and hope that we can 
reach some better accommodation.
    Thank you, Mr. Chairman.
    Senator Scott [presiding]. Thank you, sir.
    Ranking Member Wyden, please.
    Senator Wyden. Thank you, Mr. Chairman.
    Mr. Secretary, on the foster care front, I think we are 
working to really up our game on Family First, and your folks 
have reached out, and I appreciate that.
    We have a problem on this other issue with respect to South 
Carolina. And I think anybody who is watching this knows that 
one of my favorites here in the United States Senate is Senator 
Scott. And he and I really like to find common ground, not 
spend our day shouting at each other.
    I just want to make sure everybody understands what 
concerns me so much about what is going on in South Carolina. I 
think Senator Scott made an important point. He said, ``Nothing 
is more American than religious liberty.'' I surely agree with 
that.
    Nothing also is more un-American than religious 
discrimination. And that is what I believe is going on with 
this Miracle Hill program in South Carolina.
    Now, the administration has initiated this effort by 
allowing 
taxpayer-funded faith-based foster care agencies in South 
Carolina to cite religious beliefs as justification for denying 
foster children placements in safe and loving homes.
    Senator Scott, Mr. Chairman, if I could just place those 
documents in the record, that would be good.
    Senator Scott. Yes.
    [The documents appear in the appendix beginning on p. 183.]
    Senator Wyden. Great.
    And so my question to you, Mr. Secretary, is, do you think 
placing a Jewish foster child in a Christian home that teaches 
the child everything he or she believes is wrong is the best 
placement for that child?
    Secretary Azar. Of course, we do not support any 
restriction on placement of children. But what we do support 
is, these children need to find homes, and we support as many 
providers as possible being engaged. And faith-based providers 
are the bedrock of some of our most difficult placements in 
terms of disabled, hard-to-place children.
    They always historically have been, and that is why the 
Roman Catholic Diocese of Charleston as well as the Coalition 
for Jewish Values supported the accommodation that we provided 
at the request of the Governor of South Carolina. It was not at 
our initiation. It was at the Governor's request to provide 
this exemption, this waiver to allow them to continue to work 
with co-religionists.
    It is not an animus towards any group or other entities or 
individuals. And in fact, they are required--if they cannot 
work with individuals who come forward, this Miracle Hill 
organization, they would be required to refer those individuals 
to the State placement foster care authority or two other 
foster care providers, of which there are many in the State of 
South Carolina, who would be willing to work with them.
    Our focus is on the kids and child welfare. And we need 
more people as foster parents, not fewer, not excluding based 
on our views, but rather including.
    But I appreciate your concern. This is about these 
balances.
    Senator Wyden. Well, that is not the experience, for 
example, of Jewish parents in South Carolina. We got a press 
story from a Ms. Beth Lesser saying that she was the only 
Jewish person at one of these orientation sessions, and she 
said it was humiliating to essentially be told, Christian's 
over here, Jewish folks somewhere else.
    And Senator Scott, when I am done, is going to make a good 
suggestion in my view, which is that nobody is shouting around 
here. And I have enormous respect for Senator Scott, and he and 
several of our colleagues would like to have thoughtful 
discussions about this and would be happy to include you.
    I just will tell you, I am very troubled about this because 
I am a Jewish kid, first-generation Jewish kid. If my parents 
had been killed in an automobile accident, in South Carolina I 
might have been placed in one of these homes where everybody 
would tell me everything I learned was wrong. So we've got to 
do better here.
    Let me just do something for the record really quickly. 
Then I think Senator Scott is going to make a suggestion that I 
very much like.
    Last night we got, late in the evening, a response to a 
letter I sent you detailing potential conflicts of interest 
involving members of the federal pain task force. And I will 
just tell you I felt that the letter was very insufficient. I 
am concerned about individuals and organizations we are looking 
into having substantial financial ties to opioid manufacturers.
    I would like you to tell me this morning--and I will put 
this in the record so you have a copy--that you will commit to 
giving me individual detailed answers to the nine questions 
within 10 days, because we just got something last night, and 
it was not even close to responsive to the questions.
    Can I have that commitment that we will get answers in 10 
days?
    Secretary Azar. I have not seen the incoming or the 
outgoing. I was aware of the issue, but I do not know the scope 
and breadth of the request. I can assure you I will talk to the 
team and see what we can get you and as quickly as we can.
    I just cannot make that commitment, not knowing the 
incoming or the outgoing. We will get you as much as we can as 
quickly as we can.
    Senator Wyden. We share a bipartisan concern about opioids. 
It is going to be a lot harder to tackle the scourge of opioids 
if we just sit back and let rampant financial conflict drive so 
many of these decisions. So I need answers, and I hope--I 
understand that you are not up on the substance. I hope I will 
get them back within 10 days. We gave you all a lot of time 
originally.
    Senator Scott. Thank you, sir.
    Secretary Azar. Mr. Chairman, could I beg your indulgence?
    When one is giving these remarks--I want to make sure. 
There was an exchange with Senator Menendez, and I just wanted 
to make sure to clarify because----
    Senator Scott. Certainly.
    Secretary Azar [continuing]. When one is speaking quickly 
or getting interrupted, and I just--on the Ms. L class 
expansion, which is the court proceeding in San Diego that we 
are subject to, the Joint Status Report that HHS filed with the 
court reports on children who were in our custody as of June 
26, 2018. I think I said that, but I just want to be clear 
about that, that we are not at this point gathering data on the 
expanded class because the court has not yet ordered a remedy.
    While the court expanded the class, it has not ordered a 
remedy. And the court is considering what the appropriate 
remedy for that new class is because none of those children is 
currently in our custody.
    I think I said that, but I've got a lot of people who watch 
just to make sure. I always want to be completely accurate and 
make sure the Senators are getting--that I do not accidentally 
misstate something.
    So I appreciate your indulgence.
    Senator Scott. Thank you.
    One comment on Senator Wyden's comments. I think there is a 
chance for people of good conscience, be it Senator Lankford, 
myself, Senator Wyden, and others to sit down and have a 
conversation about religious liberty at the adoption space, and 
how we move forward.
    I do think it is important for us to recognize the 
important truth in this country, that when it comes to 
religious liberty and government funding, whether it is Pell 
Grants going to private schools that have a religious 
affiliation or child-care programs that have a religious 
affiliation, or the workplace that has religious affiliation, 
the one thing that we have always done as a Nation is to 
protect folks and their worship and their ability to practice 
their faith and their principles as they see fit.
    With 4,000 kids in South Carolina in foster care, we should 
not discriminate against a religious group because they want to 
adhere to their core convictions. I think that is incredibly 
important.
    I will make a statement by Chairman Grassley that he 
wanted--I'm sorry?
    Senator Wyden. Could I just respond really quickly for a 
wrap-up on that?
    Senator Scott. Certainly.
    Senator Wyden. Again, I very much welcome this idea of a 
discussion with Senator Scott, myself, Senator Lankford.
    I want people to know, though, what Jews who want to be 
foster parents in South Carolina are facing at Miracle Hill. 
During the orientation, Ms. Beth Lesser was asked her religion. 
She was told she could not work with Miracle Hill because it 
placed children only with people who were Evangelical 
Christians.
    Senator Scott. And, Senator Wyden, I do not want to go back 
and forth on this topic, but I will say that it is critically 
important for us to recognize that the Coalition of Jewish 
Values agreed with the exception, and this will be a 
conversation we will have to have on another day.
    Let me just close with the comments from Chairman Grassley 
relating to unaccompanied children. This is from his written 
statement that I wanted to read before you left.
    ``A number of my colleagues have pointed out their concerns 
about recent reports that employees at HHS facilities have 
sexually and physically abused unaccompanied migrant children 
in their care.
    ``Let me be very clear, any sexual misconduct--any sexual 
misconduct--especially that involving vulnerable children at 
government facilities, is unacceptable and horrific.
    ``According to reports, this has gone on as far back as 
2014. Regardless of the administration, Congress takes this 
issue seriously and will hold the government accountable.
    ``That is why I''--Senator Grassley--``along with Senator 
Feinstein have now sent two letters to HHS and the Inspector 
General calling for an immediate investigation. We sent our 
first letter in July, and just again last week.
    ``I expect answers and a full investigation. If the abuse 
has been perpetrated by contractors, they need to be fired 
immediately and their contracts terminated.
    ``Secretary Azar, I appreciate your attention to this 
issue, and I expect your agency's continued cooperation with 
our oversight efforts. Thank you, Secretary Azar, for your 
attendance and participation today.''
    I ask that any member who wishes to submit questions for 
the record please do so by close of business Thursday, March 
28th.
    With that, this hearing is adjourned.
    [Whereupon, at 12:32 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


        Prepared Statement of Hon. Alex M. Azar II, Secretary, 
                Department of Health and Human Services
    The mission of the U.S. Department of Health and Human Services 
(HHS) is to enhance and protect the health and well-being of all 
Americans by providing for effective health and human services and by 
fostering sound, sustained advances in the sciences underlying 
medicine, public health, and social services. This work is organized 
into five strategic goals, and is unified by a vision of our health-
care, human services, and public health systems working better for the 
Americans we serve. By undertaking these efforts in partnerships with 
States, territories, tribal governments, local communities, and the 
private sector, we will succeed at putting Americans' health first.

    Since I testified before this committee in 2018, the HHS team has 
delivered impressive results. This past year saw HHS, the Department of 
Labor, and the Department of Treasury open up new affordable health 
coverage options, at the same time the Affordable Care Act (ACA) 
exchanges were stabilized, with the national average benchmark premium 
on HealthCare.gov dropping for the first time ever. According to a 
report by the Council of Economic Advisers, actions taken by the 
administration, along with the elimination of the individual mandate 
penalty, are estimated to provide a net benefit to Americans of $453 
billion over the next decade.

    Congress worked with the administration to deliver new resources 
for fighting the opioid crisis, allowing HHS to make more than $2 
billion in opioid-related grants to States, territories, tribes, and 
local communities in 2018. Prescriptions for 
medication-assisted treatment options and naloxone are up, while legal 
opioid prescribing is down. HHS also worked to bring down prescription 
drug prices, including by setting another record for most generic drug 
approvals by FDA in a fiscal year and working with Congress to ensure 
pharmacists can inform Americans about the 
lowest-cost prescription drug options.

    The President's fiscal year (FY) 2020 budget supports HHS's 
continued work on these important goals by prioritizing key investments 
that help advance the administration's commitments to improve American 
health care, address the opioid crisis, lower the cost of drugs, and 
streamline Federal programs, while reforming the Department's programs 
to better serve the American people.

    The budget proposes $87.1 billion in discretionary budget authority 
and $1.2 trillion in mandatory funding for HHS. It reflects HHS's 
commitment to making the Federal Government more efficient and 
effective by focusing spending in areas with the highest impact.

    HHS's fiscal year 2020 budget reflects decisions not just to be 
prudent with taxpayer dollars, but also to stay within the budget caps 
Congress created in the budget Control Act. With the largest non-
defense discretionary appropriation of any cabinet agency in 2019, HHS 
must make large reductions in spending in order to stay within 
Congress's caps, set a prudent fiscal course, and provide for other 
national priorities. This budget demonstrates that HHS can prioritize 
its important work within these constraints, and proposes measures to 
reform HHS programs while putting Americans' health first.
   reform, strengthen, and modernize the nation's health-care system
Reforming the Individual Market for Insurance
    The budget proposes bold reforms to empower States and consumers to 
improve American health care. These reforms return the management of 
health care to the States, which are more capable of tailoring programs 
to their unique markets, increasing options for patients and providers, 
and promoting financial stability and responsibility, while protecting 
people with pre-existing conditions and high health-care costs.

    The budget includes proposals to make it easier to open and use 
Health Savings Accounts and reform the medical liability system to 
allow providers to focus on patients instead of lawsuits.
Lowering the Cost of Prescription Drugs
    Putting America's health first includes improving access to safe, 
effective, and affordable prescription drugs. The budget proposes to 
expand the administration's work to lower prescription drug prices and 
reduce beneficiary out-of-pocket costs. The administration has proposed 
and, in many cases, made significant strides to implement bold 
regulatory reforms to increase competition, improve negotiation, create 
incentives to lower list prices, reduce out-of-pocket costs, improve 
transparency, and address foreign free-riding. Congress has already 
taken bipartisan action to end pharmacy gag clauses, so patients can 
work with pharmacists to lower their out-of-pocket costs. The budget 
proposes to:

          Stop regulatory tactics used by brand manufacturers to 
        impede generic competition;
          Ensure Federal and State programs get their fair share of 
        rebates, and enact penalties to prevent the growth of 
        prescription drug prices beyond inflation;
          Improve the Medicare Part D program to lower seniors' out-
        of-pocket costs, create an out-of-pocket cap for the first 
        time, and end the incentives that reward list price increases;
          Improve transparency and accuracy of payments under Medicare 
        Part B, including imposing payment penalties to discourage pay-
        for-delay agreements; and
          Build on America's successful generic market with a robust 
        biosimilars agenda, by improving the efficient approval of safe 
        and effective biosimilars, ending anti-competitive practices 
        that delay or restrict biosimilar market entry, and harnessing 
        payment and cost-sharing incentives to increase biosimilar 
        adoption.
Reforming Medicare and Medicaid
    Medicare and Medicaid represent important promises made to older 
and vulnerable Americans, promises that President Trump and his 
administration take seriously. The budget supports reforms to make 
these programs work better for the people they serve and deliver better 
value for the investments we make. This includes a plan to modernize 
Medicare Part D to lower drug costs for the Medicare program and for 
Medicare beneficiaries, as well as proposals to drive Medicare toward a 
value-based payment system that puts patients in control. The budget 
also provides additional flexibility to States for their Medicaid 
program, putting Medicaid on a path to fiscal stability by 
restructuring its financing, reducing waste, and focusing the program 
on the low-income populations Medicaid was originally intended to 
serve: the elderly, people with disabilities, children, and pregnant 
women.
Paying for Value
    The administration is focused on ensuring Federal health programs 
produce better care at the lowest possible cost for the American 
people. We believe that consumers, working with providers, are in the 
best position to determine value. The budget supports an expansion of 
value-based payments in Medicare with this strategy in mind. That 
expansion, along with implementation of a package of other reforms, 
will improve quality, promote competition, reduce the Federal burden on 
providers and patients, and focus payments on value instead of volume 
or site of service. Two of these reforms are: (1) a value-based 
purchasing program for hospital outpatient departments and ambulatory 
surgical centers; and (2) a consolidated hospital quality program in 
Medicare to reduce duplicative requirements and create a focus on 
driving improvements in patients' health outcomes. Advancing value in 
Medicare, along with the other reforms in the budget, will extend the 
life of the Medicare trust fund by 8 years, while also helping to drive 
value and innovation throughout America's entire health system. 
Furthermore, in December the administration released a report entitled 
Reforming America's Healthcare System Through Choice and Competition, 
which contains a series of recommendations to improve the health-care 
system by better engaging consumers and unleashing competition across 
providers.
 protect the health of americans where they live, learn, work, and play
Combating the Opioid Crisis
    The administration has made historic investments to address opioid 
misuse, abuse, and overdose, but significant work must still be done to 
fully turn the tide of this public health crisis. The budget supports 
HHS's five-part strategy to:

          Improve access to prevention, treatment, and recovery 
        services, including the full range of medication-assisted 
        treatments;
          Better target the availability of overdose-reversing drugs;
          Strengthen our understanding of the crisis through better 
        public health data and reporting;
          Provide support for cutting edge research on pain and 
        addiction; and
          Improve pain management practices.

    The budget provides $4.8 billion to combat the opioid overdose 
epidemic. The Substance Abuse and Mental Health Services Administration 
(SAMHSA) will continue all opioid activities at the same funding level 
as FY 2019, including the successful State Opioid Response Program and 
grants, which had a special focus on increasing access to medication-
assisted treatment--the gold standard for treating opioid addiction. At 
this level, the budget also provides new funding for grants to 
accredited medical schools and teaching hospitals to develop substance 
use disorder treatment curricula.

    In FY 2020, the Health Resources and Services Administration (HRSA) 
will continue to make investments to address substance use disorder, 
including opioid use disorder, through the Rural Communities Opioid 
Response Program, the National Health Service Corps, behavioral health 
workforce programs, and the Health Centers Program.

    Medicare and Medicaid policies and funding will also play a 
critical role in combating the opioid crisis. The budget proposes 
allowing States to provide full Medicaid benefits for 1 year postpartum 
for pregnant women diagnosed with a substance use disorder. The budget 
also proposes to set minimum standards for Drug Utilization Review 
programs, allowing for better oversight of opioid dispensing in 
Medicaid. Additionally, it proposes a collaboration between the Centers 
for Medicare and Medicaid Services and the Drug Enforcement 
Administration to stop providers from inappropriate opioid prescribing.
The Ending HIV Epidemic Initiative
    Recent advances in HIV prevention and treatment create the 
opportunity to not only control the spread of HIV, but to end this 
epidemic in America. By accelerating proven public health strategies, 
HHS will aim to reduce new infections by 90 percent within 10 years, 
ending the epidemic in America. The budget invests $291 million in FY 
2020 for the first phase of this initiative, which will target areas 
with the highest infection rates with the goal of reducing the number 
of new diagnoses by 75 percent in 5 years.

    This effort focuses on investing in existing, proven activities and 
strategies and putting new public health resources on the ground. The 
initiative includes a new $140-million investment in the Centers for 
Disease Control and Prevention (CDC) to test and diagnose new cases, 
rapidly link newly infected individuals to treatment, connect at-risk 
individuals to Pre-Exposure Prophylaxis (PrEP), expand HIV 
surveillance, and directly support States and localities in the fight 
against HIV.

    Clients receiving medical care through the Ryan White HIV/AIDS 
Program (RWHAP) were virally suppressed at a record level of 85.9 
percent in 2017. The budget includes $70 million in new funds for RWHAP 
within HRSA to increase direct health-care and support services, 
further increasing viral suppression among patients in the target 
areas. The budget includes $50 million in HRSA for expanded PrEP 
services, outreach, and care coordination in community health centers. 
Additionally, the budget also prioritizes the reauthorization of RWHAP 
to ensure Federal funds are allocated to address the changing landscape 
of HIV across the United States.

    For the Indian Health Service (IHS), the budget includes $25 
million in new funds to screen for HIV and prevent and treat hepatitis 
C, a significant burden among persons living with HIV/AIDS. The budget 
also includes $6 million for the National Institutes of Health's 
regional Centers for AIDS Research to refine implementation strategies 
to assure effectiveness of prevention and treatment interventions.

    In addition to this effort, the budget funds other activities that 
address HIV/AIDS including $54 million for the Minority HIV/AIDS Fund 
within the Office of the Secretary and $116 million for the Minority 
AIDS program in SAMHSA. These funds allow HHS to target funding to 
minority communities and individuals disproportionately impacted by HIV 
infection.
Prioritizing Biodefense and Preparedness
    The administration prioritizes the Nation's safety, including its 
ability to respond to acts of bioterrorism, natural disasters, and 
emerging infectious diseases. HHS is at the forefront of the Nation's 
defense against public health threats. The budget provides 
approximately $2.7 billion to the Public Health and Social Services 
Emergency Fund within the Office of the Secretary to strengthen HHS's 
biodefense and emergency preparedness capacity. The budget also 
proposes a new transfer authority that will allow HHS to enhance its 
ability to respond more quickly to public health threats. Additionally, 
the budget supports the government-wide implementation of the 
President's National Biodefense Strategy.

    The budget supports advanced research and development of medical 
countermeasures against chemical, biological, radiological, nuclear, 
and infectious disease threats, including pandemic influenza. The 
budget also funds late-stage development and procurement of medical 
countermeasures for the Strategic National Stockpile and emergency 
public health and medical assistance to State and local governments, 
protecting America against threats such as anthrax, botulism, Ebola, 
and chemical, radiological, and nuclear agents.
             strengthen the economic and social well-being 
                    of americans across the lifespan
Promoting Upward Mobility
    The budget promotes independence and personal responsibility, 
supporting the proven notion that work empowers parents and lifts 
families out of poverty. To ensure Temporary Assistance for Needy 
Families (TANF) enables participants to work, the budget includes a 
proposal to ensure States will invest in creating opportunities for 
low-income families, and to simplify and improve the work participation 
rate States must meet under TANF. The budget also proposes to create 
Opportunity and Economic Mobility Demonstrations, allowing States to 
streamline certain welfare programs and tailor them to meet the 
specific needs of their populations.

    The budget supports Medicaid reforms to empower individuals to 
reach self-
sufficiency and financial independence, including a proposal to permit 
States to include asset tests in identifying an individual's economic 
need, allowing more targeted determinations than are possible with the 
use of a Modified Adjusted Gross Income standard alone.
Improving Outcomes in Child Welfare
    The budget supports implementation of the Family First Prevention 
Services Act of 2018 and includes policies to further improve child 
welfare outcomes and prevent child maltreatment. The budget also 
expands the Regional Partnership Grants program, which addresses the 
considerable impact of substance use, including opioid use, on child 
welfare.
Strengthening the Indian Health Service
    Reflecting HHS's commitment to the health and well-being of 
American Indians and Alaska Natives, the budget provides $5.9 billion 
for IHS, which is an additional $392 million above the FY 2019 
Continuing Resolution. The increase supports direct health-care 
services across Indian Country, including hospitals and health clinics, 
Purchased/Referred Care, dental health, mental health, and alcohol and 
substance abuse services. The budget invests in new programs to improve 
patient care, quality, and oversight. The budget fully funds staffing 
for new and replacement facilities, new tribes, and Contract Support 
Costs, ensuring tribes have the necessary resources to successfully 
manage self-governance programs.
            foster sound, sustained advances in the sciences
Promoting Research and Prevention
    NIH is the leading biomedical research agency in the world, and its 
funding supports scientific breakthroughs that save lives. The budget 
supports strategic investments in biomedical research and activities 
with significant national impact.

    NIH launched the Helping to End Addiction Long-term (HEAL) 
initiative in April 2018 to advance research on pain and addiction. 
Toward this goal, NIH announced funding opportunities for the historic 
HEALing Communities Study, which will select several communities to 
measure the impact of investing in the integration of evidence-based 
prevention, treatment, and recovery across multiple health and justice 
settings. The budget provides $500 million to continue the HEAL 
initiative in FY 2020.

    The budget supports a targeted investment in the National Cancer 
Institute to accelerate pediatric cancer research. Cancer is the 
leading cause of death from disease among children in the United 
States. Approximately 16,000 children are diagnosed with cancer in the 
United States each year. While progress in treating some childhood 
cancers has been made, the science and treatment of childhood cancers 
remains challenging. Through this initiative, NIH will enhance drug 
discovery, better understand the biology of all pediatric cancers, and 
create a national data resource for pediatric cancer research. This 
initiative will develop safer and more effective treatments and provide 
a path for changing the course of cancer in children.

    The new National Institute for Research on Safety and Quality 
(NIRSQ) proposed in the budget will continue key research activities 
currently led by the Agency for Health-care Research and Quality. These 
activities will support researchers by developing the knowledge, tools, 
and data needed to improve the health-care system.
Addressing Emerging Public Health Challenges
    CDC is the Nation's leading public health agency, and the budget 
supports its work putting science into action.

    Approximately 700 women die each year in the United States as a 
result of pregnancy or delivery complications or the aggravation of an 
unrelated condition by the physiologic effects of pregnancy. Findings 
from Maternal Mortality Review Committees indicate that more than half 
of these deaths are preventable. The budget supports data analysis on 
maternal deaths and efforts to identify prevention opportunities.

    The United States must address emerging public health threats, both 
at home and abroad, to protect the health of its citizens. The budget 
invests $10 million to support CDC's response to Acute Flaccid Myelitis 
(AFM), a rare but serious condition that affects the nervous system and 
weakens muscles and reflexes. With this funding, CDC will work closely 
with national experts, health-care providers, and State and local 
health departments to thoroughly investigate AFM.

    The budget also provides $100 million for CDC's global health 
security activities. Moving forward, CDC will implement a regional hub 
office model and primarily focus their global health security capacity-
building activities on areas where they have seen the most success: lab 
and diagnostic capacity, surveillance systems, training of disease 
detectives, and establishing strong emergency operation centers. In 
addition, CDC will continue ongoing efforts to identify health 
emergencies, track dangerous diseases, and rapidly respond to outbreaks 
and other public health threats around the world, including continuing 
work on Ebola response.

    The budget also strengthens the health security of our Nation by 
continuing CDC's support to State and local government partners in 
implementing programs, establishing guidelines, and conducting research 
to tackle public health challenges and build preparedness.
Innovations in the Food and Drug Administration
    FDA plays a major role in protecting public health by assuring the 
safety of the Nation's food supply and regulating medical products and 
tobacco. The budget provides $6.1 billion for FDA, which is an 
additional $643 million above the FY 2019 Continuing Resolution. The 
budget includes resources to promote competition and foster innovation, 
such as modernizing generic drug review and creating a new medical data 
enterprise. The budget advances digital health technology to reduce the 
time and cost of market entry, supports FDA opioid activities at 
international mail facilities to increase inspections of suspicious 
packages, strengthens the outsourcing facility sector to ensure quality 
compounded drugs, and pilots a pathogen inactivation technology to 
ensure the blood supply continues to be safe. FDA will continue to 
modernize the food safety system in FY 2020.
       promote effective and efficient management and stewardship
    Almost one quarter of total Federal outlays are made by HHS. The 
Department employs more than 78,000 permanent and temporary employees 
and administers more grant dollars than all other Federal agencies 
combined. Efficiencies in HHS management have a tremendous impact on 
Federal spending as a whole.
Advancing Fiscal Stewardship
    HHS recognizes its immense responsibility to manage taxpayer 
dollars wisely. HHS ensures the integrity of all its financial 
transactions by leveraging financial management expertise, implementing 
strong business processes, and effectively managing risk.

    In an effort to operate Medicare and Medicaid efficiently and 
effectively, both to rein in wasteful spending and to better serve 
beneficiaries, HHS is implementing actions such as enhanced provider 
screening, prior authorization, and sophisticated predictive analytics 
technology, to reduce improper payments in Medicare and Medicaid 
without increasing burden on providers or delaying Americans' access to 
care or to critical medications. HHS continues to work with law 
enforcement partners to target fraud and abuse in health care, and the 
budget increases investment in health-care fraud and abuse activities. 
The budget includes a series of proposals to strengthen Medicare and 
Medicaid oversight, including increasing prior authorization, enhancing 
Part D plans' ability to address fraud, and strengthening the 
Department's ability to recoup overpayments made to States on behalf of 
ineligible Medicaid beneficiaries.
Implementing ReImagine HHS
    HHS eagerly took up the call in the administration's Government-
wide Reform Plan to more efficiently and effectively serve the American 
people. HHS developed a plan--``ReImagine HHS''--organized around a 
number of initiatives.

    ReImagine HHS is identifying a variety of ways to reduce Federal 
spending and improve the functioning of HHS's programs through more 
efficient operations. For example, the Buy Smarter initiative 
streamlines HHS's procurement process by using new and emerging 
technologies.
                               conclusion
    Americans deserve health care, human services, and public health 
programs that work for them and make good use of taxpayer dollars. The 
men and women of HHS are committed, innovative, hardworking public 
servants who work each day to improve the lives of all Americans. 
President Trump's FY 2020 budget will help advance us toward that goal, 
accomplish the Department's vital mission, and put Americans' health 
first.

                                 ______
                                 
       Questions Submitted for the Record to Hon. Alex M. Azar II
               Questions Submitted by Hon. Chuck Grassley
                                medicare
    Question. The budget proposes a policy change that would require 
the Centers for Medicare and Medicaid Services (CMS) to report 
providers who have been sanctioned for abusive prescribing of 
controlled substances to the Drug Enforcement Administration (DEA). I 
applaud the idea of coordination between agencies to root out abusive 
practices, especially those that harm patients. Has your Department had 
discussions with DEA about how it would use the CMS-reported 
information required by this proposal?

    Answer. Today, if CMS revokes a provider's billing privileges based 
on improper/abusive prescribing practices, a provider's DEA Certificate 
of Registration will not be impacted. Following the Medicare 
revocation, the provider can opt out of the Medicare program, even 
though the provider's status has been revoked, and elect to order, 
refer, and/or prescribe to Medicare beneficiaries.

    Under the proposal, CMS will be required to report all Medicare 
revocation actions or preclusion list placements to the DEA that are 
based totally or in part on abusive prescribing of controlled 
substances. In turn, the DEA would be able to use this data to consider 
revocation of a provider's DEA certification of registration.

    CMS's and the DEA's combined efforts will prevent abusive 
prescribers, many of whom have histories of patient harm based on 
improper prescribing, from continuing to prescribe to Medicare 
beneficiaries, and more generally, to patients across the United 
States. We would be pleased to partner with the DEA on these efforts.

    Question. The budget proposal to revoke or deny the enrollment 
needed to participate in Medicare of an individual who had a leadership 
role in an entity that was sanctioned highlights how an individual can 
``reinvent'' him or herself and engage in similar nefarious activity 
under a new corporate entity. This is a problematic scenario that we 
should prevent. To help us understand the real-world implications, can 
you provide examples of how this has happened or can happen?

    Answer. Currently, CMS cannot penalize an entity based on an 
affiliation that its owners, managing employees, officers, and/or 
directors had with a previously sanctioned Medicare entity. As a 
result, providers and suppliers that abuse the Medicare program evade 
revocation from the program by ``reinventing'' themselves under a new 
business's corporate umbrella.

    For example, a provider or supplier may engage in inappropriate 
billing, exit Medicare prior to detection, and then change its name or 
business identity in order to reenroll in Medicare under this new 
identity. In another example, an entity may own or manage several 
Medicare providers and suppliers and one of the providers or suppliers 
may be involved in abusive behavior with the approval or at the 
instigation of that owner or managingentity. If the abusive provider's 
or supplier's enrollment is revoked, the owning/managingentity can 
shift its behavior to another of its enrolled entities.

    Question. The budget proposal that would allow physicians to earn a 
5-percent bonus for participating in an Advanced-Alternative Payment 
Model (A-APM) based on the actual amount of revenue they have at risk 
in A-APMs is an interesting alternative to the qualifying revenue 
thresholds in statute. The proposal would allow more physicians to 
receive a bonus while those who would have otherwise met the current 
law thresholds would receive a smaller bonus. To help us further 
evaluate this proposal, can you provide detail on how the number of 
physicians who qualify and the amount of the bonus they earn would 
differ under the proposal compared to current law?

    Answer. The President's FY 2020 budget proposes to modify how the 
5-percent incentive payment is determined in order to better reward 
clinicians who participate in the Advanced Alternative Payment Models 
(APMs) track of the Quality Payment Program (QPP). Instead of receiving 
a 5 percent incentive payment on all physician fee schedule (PFS) 
payments if they meet or exceed certain payment or patient thresholds, 
clinicians would receive a five percent incentive payment on PFS 
revenues received through the Advanced APMs in which they participate.

    Under the current structure of the QPP, some clinicians who 
participate in Advanced APMs may not be eligible for an incentive 
payment simply because they do not meet arbitrary thresholds. While 
most Advanced AMP participants are able to meet the 25-percent 
threshold, CMS estimates that only 15 percent of Advanced AMP 
participants will meet a 75-percent payment threshold starting in 2021. 
Clinicians have to invest their time and financial resources to 
participate in an Advanced APM. Thus, if clinicians are not rewarded 
for that investment by becoming QPs, it will likely discourage 
participation in these APMs going forward.

    This proposal removes these arbitrary thresholds and directly 
rewards clinicians along a continuum based on their level of 
participation in Advanced APMs. All clinicians who participate in 
Advanced APMs would be Qualifying APM Participants (QPs) and would be 
rewarded with an incentive payment. The 5-percent incentive payment 
would be based on the amount of the clinician's payments that are tied 
to an Advanced APM. Thus, the more the clinician participates in an 
Advanced APM, the higher the incentive payment will be.

    Question. The Medicare physician payment system appropriately 
focuses on accountability and value, but it's important that physicians 
are assessed fairly based on their geographic area. I have long held 
that the geographic adjustment applied to the components that determine 
the physician fee payment amount disadvantage physicians in Iowa (and 
other more rural areas). While I continue to engage on how CMS makes 
these statutorily required adjustments, I want to highlight a situation 
that seems to hit Iowa physicians twice. Medicare pays physicians in 
Iowa less than average because of how the agency applies geographic 
adjustments. However, CMS strips away those geographic adjustments--
essentially assuming physicians in all areas are paid the average 
amount--when assessing physicians on the amount of care they provide. 
Can you explain why this physician cost of care assessment uses an 
amount that is in excess of what Iowa physicians are actually paid?

    Answer. As required by the statute, CMS reviews and, if necessary, 
adjusts the Geographic Practice Cost Indexes (GPCIs) at least every 3 
years. CMS updated the GPCIs in the CY 2017 Medicare Physician Fee 
Schedule final rule, and, as with other updates, this update is done 
with opportunity for public comment through notice and comment 
rulemaking. In the CY 2019 PFS proposed rule, CMS included a comment 
solicitation regarding the GPCIs. Any changes to the GPCIs based on the 
comment solicitation would be discussed in future rulemaking.

    When assessing physicians on the cost of care such as through the 
measures in the cost performance category in the Merit-based Incentive 
Payment System (MIPS), we use a payment standardization process to 
adjust the allowed charge for a Medicare service to facilitate 
comparisons of resource use across geographic areas. The payments 
included in the MIPS cost measures (Total Cost of Care, Medicare 
Spending Per Beneficiary and episode-based measures) are payment-
standardized to preserve differences that result from health-care 
delivery choices, exclude geographic differences, and exclude payment 
adjustments from special Medicare programs.

    The allowed amounts for Medicare services can vary across 
geographic areas due to several factors that are not necessarily 
representative of differences in utilization, such as regional 
differences in labor costs and practice expenses, differences in the 
relative price of inputs in local markets where a service is provided, 
extra payments from Medicare in medically underserved regions, policy-
driven payment adjustments such as those for teaching hospitals. In 
order to make service use comparisons, standardization is used to 
transform the actual spending amounts into a standardized amount that 
excludes these adjustments. Payment standardization assigns a 
comparable amount for an item or service to facilitate cost comparisons 
and limit observed differences in costs to those that reveal 
differences in spending that result only from care decisions and 
resources use. Payment standardization also removes any Medicare 
payment differences due to adjustments for geographic differences in 
wage levels or policy-driven payment adjustments, such as those for 
teaching hospitals.

    Question. I appreciate your ongoing focus on addressing the opioid 
crisis and the attention to this issue is evident from the budget 
proposals. A provision in the SUPPORT for Patients and Communities Act 
(Public Law 115-271), section 6082, encouraged CMS to review Medicare 
payment systems to assess whether policies may incentivize use of 
opioids over non-opioid alternatives. CMS took a step toward increased 
availability of non-opioid treatments by providing coverage of an 
injectable alternative in the 2019 payment rules for hospital 
outpatient departments. I am aware that CMS has received requests for 
additional payment system changes that similarly would expand 
availability alternatives such as nerve blocks and other treatments. Is 
CMS considering further changes to expand non-opioid alternatives 
consistent with section 6082 of the SUPPORT for Patients and 
Communities Act?

    Answer. In the Calendar Year 2019 Outpatient Prospective Payment 
System and Ambulatory Surgical Center rule, CMS examined our packaging 
policy for non-opioid pain management options as recommended by the 
President's Commission on Combating Drug Addiction and the Opioid 
Crisis and based on feedback from stakeholders. For our evaluation, we 
used available data to analyze the utilization patterns for specific 
drugs that were packaged to determine whether the packaging policy has 
reduced the use of the drugs. Based on the analysis, we proposed and 
finalized to separately pay for non-opioid drugs that function as a 
surgical supply in the ASC setting, which currently is only Exparel.

    We also solicited comments in last year's proposed rule on other 
non-opioid alternative treatments besides Exparel, such as devices, 
that might be affected by packaging policies and whether these items 
warranted separate payment. We received a number of comments on this 
topic. We noted in the final rule that we plan to take these comments 
and suggestions into consideration for future rulemaking and look 
forward to working with stakeholders as we further consider suggested 
refinements to the payment systems. We also noted that we will continue 
to analyze this issue of access to non-opioid alternatives as we 
implement section 6082 of the SUPPORT Act.

    CMS is also consulting with the Pain Management Best Practices Task 
Force as required under the SUPPORT Act. The Task Force released its 
final report recently identifying a number of changes related to 
payment for alternatives.
                             human services
    Question. Improving access to prevention, treatment, and recovery 
services is a big part of HHS's strategy to address the opioid crisis. 
The Family First Prevention Services Act, which became law last year, 
helps do this by letting States use foster care dollars to support 
family-based residential treatment centers--meaning more kids can stay 
with their parents instead of being separated and placed in foster 
care. HHS has not yet reported how many States are taking advantage of 
this new opportunity to keep families together.

    Family First lets States use foster care funding to help dollars to 
help support family-based residential treatment centers, which will 
mean more kids can stay with their parents instead of being separated 
and placed in foster care. What is your agency doing to make sure 
States know about this new policy, as well as others that were part of 
Family First? Can you let me know how many States (and which States) 
are taking advantage of this new opportunity?

    Answer. The First Prevention Services Act (FFPSA) provides an 
important opportunity for States and tribes participating in the title 
IV-E program to use title IV-E foster care maintenance funds. 
Specifically, to use funds supporting the placement of children with 
their parents in a licensed family-based residential treatment facility 
for substance abuse. This provision just became effective on October 1, 
2018 (fiscal year 2019).

    The Children's Bureau in the Administration for Children and 
Families (ACF) informed title IV-E agencies about this opportunity and 
other FFPSA provisions through an Information Memorandum (ACYF-CB-IM-
02) issued on April 12, 2018. On July 9, 2018, the ACF Children's 
Bureau issued Program Instruction ACYF-CB-PI-18-07, which provided 
guidance to title IV-E agencies on revising their title IV-E plans in 
order to address provisions amended by FFPSA. In particular, their 
foster care, adoption assistance, and guardianship assistance programs. 
This issuance included instructions on the title IV-E plan amendments 
that States and tribes must complete to claim title IV-E foster care 
maintenance payments for children placed with parents in a licensed 
family-based residential substance abuse treatment facility.

    In July 2018, the Children's Bureau hosted five calls for all title 
IV-E agencies, and one call specifically for interested tribes, to walk 
through ACYF-CB-PI-18-07 and answer questions about the new title IV-E 
requirements. Forty-five title IV-E agencies and six tribes 
participated in the calls.

    On November 30, 2018, the Children's Bureau issued Program 
Instruction ACYF-CB-PI-18-12, which alerted title IV-E agencies of 
revisions made to the CB-496 title IV-E Program Quarterly Financial 
Report to accommodate changes in the title IV-E program, per FFPSA. The 
revised CB-496 form now includes a specific line for title IV-E 
agencies to report claims for foster care maintenance payments made for 
children placed with parents in licensed family-based residential 
substance abuse treatment facilities. It also provides an additional 
line to report the average monthly number of children on whose behalf 
such payments are being made. The updated form went into effect for 
claims submitted for the first quarter of Fiscal Year 2019 (October 1, 
2018-December 31, 2018).

    Currently, based on the first two financial quarters of fiscal year 
2019, only one State (Utah) has reported claims for this type of 
placement.

                                 ______
                                 
      Questions Submitted by Hon. Mike Crapo, Hon. Richard Burr, 
                          and Hon. Rob Portman
    Question. CMS recently released a proposed decision memo on 
coverage for CAR-T cell therapies for Medicare patients through a 
National Coverage Determination (NCD). Coverage with Evidence 
Development (CED) provides CMS with the opportunity to assess these new 
treatments in the older, more complex Medicare population and ensure 
that the government pays for care that provides value to patients.

    The current patient criteria only include individuals that have 
relapsed or refractory cancer. However, the CAR-T pipeline continues to 
grow, potentially expanding the eligible patient population to more 
types of patients. How does CMS plan to incorporate newly FDA-approved 
first-line therapies and indications into the CED framework to 
appropriately target the coverage decision to the full range of seniors 
that stand to benefit from the product?

    We have heard concerns that NCDs are often static and unable to 
adapt to new information. With the desire to balance patient safety and 
access in mind, will you update the coverage determination to reflect 
new data in the future, given the evolving nature of the CAR-T therapy?

    Equal access to innovative care close to home is critical for 
cancer patients, especially those who are seniors and may have more 
difficulty traveling long distances for care. How does the CMS coverage 
decision ensure that all facilities that meet CMS and FDA criteria to 
administer CAR-T cell therapies are able to receive payment?

    The National Coverage Decision of Coverage with Evidence 
Development is a welcome step in improving Medicare beneficiary access 
to CAR-T therapy. Another key component of this access is providing 
viable payment models for these innovative products. CMS provided some 
insight into agency thinking as a part of the FY 2019 Hospital 
Inpatient Prospective Payment System (IPPS) rule last year, but stated 
that, ``given the relative newness of CAR-T cell therapy, the potential 
model, including the reasons underlying our consideration of a 
potential model described in greater detail in the CY 2019 OPPS/ASC 
proposed rule, and our request for feedback on this model approach, we 
believe it would be premature to adopt changes to our existing payment 
mechanisms. . . .'' What are the outstanding policy considerations at 
CMS in determining the path forward on CAR-T payment? Will these 
considerations be a part of the FY 2020 IPPS rule?

    Answer. CMS has proposed to cover FDA-approved CAR-T cell therapy, 
which is a new form of cancer therapy that uses a patient's own immune 
system to fight the disease, under ``Coverage With Evidence 
Development.'' Currently, there is no national Medicare policy for 
covering CAR-T cell therapy, so local Medicare Administrative 
Contractors have discretion over whether to pay for it. The proposed 
National Coverage Determination would require Medicare to cover the 
therapy nationwide when it is offered in a CMS-approved registry or 
clinical study, in which patients are monitored for at least 2 years 
post-treatment. Evidence from the registries and studies would help CMS 
identify the types of patients that benefit from CAR-T cell therapy, 
informing a future decision by the agency regarding the types of cases 
in which Medicare would cover the treatment with no registry or trial 
requirement. CMS is currently reviewing comments on this proposed 
National Coverage Determination. On May 17, 2019, CMS announced a delay 
in finalizing the National Coverage Determination but noted that the 
determination is forthcoming.

    After consideration of public comments on the FY 2019 Hospital 
Inpatient Prospective Payment System proposed rule, CMS approved a new 
technology add-on payment for FY 2019 for CAR-T cell therapy.

    Addendum: In the FY 2020 IPPS rule, CMS proposed to continue the 
IPPS new technology add-on payments for CAR-T cell therapy for FY 2020. 
Under the proposal, if finalized, the FY 2020 new technology add-on 
payment for CAR-T cell therapy would increase from 50 percent of the 
estimated costs of the new technology to 65 percent. That is, the 
maximum add-on would increase from $186,500 to $242,450. We also invite 
public comments on other payment alternatives for CAR-T cell therapies, 
such as eliminating the cost-to-charge ratio in calculating the new 
technology add-on payment for KYMRIAHTM and YESCARTATM 
by making a uniform, rather than a maximum, add-on payment. 
KYMRIAHTM and YESCARTATM are the only two CAR-T 
cell therapies with FDA approval.

                                 ______
                                 
    Question Submitted by Hon. Pat Roberts and Hon. Debbie Stabenow
    Question. As you know, oral health is a critical component of 
overall health and wellness, and ensuring coverage of dental care has 
the potential to reduce costs while improving outcomes. Without dental 
coverage, many individuals and families are forced to forgo preventive 
care, which can lead to emergency room visits and expensive procedures 
down the road. Given the importance of expanding access to dental care, 
we wrote to Administrator Verma on December 18 urging CCIIO to fix a 
Federal health insurance marketplace issue and provide Americans with 
the option of purchasing dental coverage independent of medical 
coverage on the marketplace. This solution is consistent with existing 
statute and will increase access to dental care and protect consumers 
from the unintended termination of their dental coverage. What progress 
has CMS made in fixing the Marketplace issue?

    Answer. Thank you for your letter regarding the independent 
purchase of stand-alone dental plans (SADPs) on the Federally 
Facilitated Exchanges (FFEs).

    For consumers seeking to purchase coverage with advance payments of 
the premium tax credit (APTC), 26 U.S.C. Sec. 36B(b)(3)(E) provides 
that, for purposes of calculating an eligible taxpayer's premium tax 
credit (PTC), if an individual enrolls in both a qualified health plan 
(QHP) and an SADP, the portion of the premium for the SADP attributable 
to the pediatric dental essential health benefit is included as premium 
payable for a QHP. The vast majority of consumers who purchase coverage 
on the Federally Facilitated Exchanges receive financial assistance, in 
the form of APTC (87 percent) and cost-sharing reductions (54 percent), 
to offset the cost of their coverage.

    To ensure that we pay APTC appropriately for consumers who choose 
to enroll in an SADP, we require the exchange to conduct an eligibility 
determination and to condition the APTC applicability to an SADP on a 
consumer's enrollment in an SADP that includes the pediatric dental 
essential health benefit. Accordingly, HealthCare.gov links purchases 
of SADP and QHP coverage by consumers receiving APTC for allocation of 
APTC first to medical coverage and then to SADP coverage.

    We believe that the substantial investment required to alter 
HealthCare.gov to allow separate purchases of SADPs for consumers who 
are not eligible for APTC and who are not purchasing medical coverage 
would have little return for consumers and SADP issuers, given that 
such consumers generally can enroll in SADPs without APTC outside of 
the FFEs.

                                 ______
                                 
                Questions Submitted by Hon. John Cornyn
                         biosimilar competition
    Question. The committee held a hearing with industry CEOs several 
weeks ago. I asked a question about the role of patents in limiting 
competition for certain drugs, in particular biologics. I was told that 
patents are not blocking biosimilar competition.

    I am not sure I agree with that, but for the sake of argument, can 
you share with the committee the specific changes that you can make 
administratively--or legislatively through the BPCIA--that could bring 
more balance to the playing field between biologics and biosimilars?

    Answer. Recognizing that this is a crucial time in the emergence of 
biosimilars, FDA announced its Biosimilars Action Plan (BAP) last year 
to advance biosimilar development and approval, and facilitate access 
to lower-cost biological products to treat a growing number of chronic 
and life-threatening conditions. Under the BAP, FDA is focusing its 
efforts on: advancing the science and policies to make the development 
of biosimilars more efficient; increasing the acceptance of 
biosimilars; and taking action against regulatory gaming that can deter 
or delay competition.

    Not only are we making the biosimilar development and review 
process more efficient and predictable, under the BAP, we are also 
taking new steps to communicate with patients, payers, and providers to 
improve the understanding of biosimilar and interchangeable products.

    Of course, the FDA's efforts to improve biosimilar competition will 
be less impactful if rebate walls discourage payers from adding 
biosimilars to their formularies. By proposing to replace rebates with 
upfront discounts, plans will have more incentive to seek drugs with 
lower prices instead of those with higher rebates, which will 
dramatically lower the costs patients face for a number of high-cost 
drugs.

    We are calling out abuses of the system that impede competition and 
are doing our part to fix them. We will act where appropriate to deter 
gaming of FDA requirements that unfairly delay competition among 
biologics. We are continuing to coordinate with the Federal Trade 
Commission, a vital partner in our efforts to address anti-competitive 
behavior in the drugs and biologics marketplace.

    We continue to evaluate additional steps necessary to strike the 
appropriate balance between encouraging ongoing innovation in biologics 
while also facilitating the robust competition that can reduce costs to 
patients.
                     drug pricing--medicare part d
    Question. The President's budget proposes a new benefit design for 
Part D beneficiaries that establishes an out-of-pocket maximum for 
beneficiaries and shifts Medicare's liability in the catastrophic phase 
from 80 percent to 20 percent in 2021.

    Earlier this year, The Wall Street Journal reported that Medicare 
overpaid drug plans $9.1 billion between the start of the Part D 
program in 2006 and 2015.

    Were there considerations made to address the risk corridors? Do 
you believe these changes in benefit design will remedy the issue 
raised in that article?

    Answer. The Part D benefit creates a perverse incentive structure 
for plans, in which drug price increases shift more drug spending into 
the catastrophic phase, where Medicare pays 80 percent of costs. That 
is why the President's budget proposes to modernize the Part D benefit 
structure. Under the President's budget, Part D plan sponsors' 
liability for drug costs incurred in the catastrophic phase of the Part 
D benefit would increase over 4 years from 15 percent under current law 
to 80 percent. Beneficiary coinsurance in the catastrophic phase would 
decrease from 5 to 0 percent. The President's proposal could provide a 
greater incentive for sponsors to manage drug costs.

    In addition, in January 2019, the Center for Medicare and Medicaid 
Innovation announced a new model, the Part D Payment Modernization 
Model, to test an innovative payment model under Part D. Under the 
model, participating Part D plans will take on greater risk for 
spending in the catastrophic phase of Part D, creating new incentives 
for plans, patients, and providers to choose drugs with lower list 
prices. Our proposal to replace rebates with upfront discounts also 
seeks to better align incentives for Part D sponsors to encourage drugs 
with lower prices instead of those with higher rebates.

    As the Department continues its work to advance President Trump's 
commitment to lower prescription drug prices, additional improvements 
to the Part D benefit design, such as risk corridors, may be 
considered.
                           kidney innovation
    Question. The Center for Medicare and Medicaid Services (CMS) is 
the primary payer for dialysis care and plays a leading role in 
encouraging innovation in the delivery of dialysis care for Medicare 
patients with End-Stage Renal Disease (ESRD.) The standard of care for 
these patients had significant legged behind other disease States when 
it comes to innovation. The way Medicare pays for dialysis care--via a 
bundled payment system under which a ``single payment'' is made for all 
renal dialysis services--fails to adequately account for the prospect 
of innovation, thus resulting in a disincentive to improve upon the 
standard of care. The evidence is staggering. No real innovation has 
occurred in the treatment of ESRD patients since dialysis was 
introduced nearly 50 years ago.

    I appreciate and share your commitment to improving the standard of 
care for dialysis patients through the adoption of incentives to 
promote drug innovation. CMS's proposed expansion of the Transitional 
Drug Add-on Payment Adjustment is a promising first step. I understand 
that CMS has broad statutory authority to add devices to this 
transitional payment adjustment.

    Can you comment on the need for new technology payment incentives 
in the Medicare ESRD payment system and commit to engaging with me to 
find ways to encourage medical device innovation in dialysis care 
specifically?

    Answer. We are committed to encouraging innovation particularly in 
treatment of kidney disease and ESRD. In the interest of supporting 
innovation, ensuring appropriate payment for all drugs and biologicals, 
and as a complement to the Transitional Drug Add-on Payment Adjustment 
(TDAPA) proposals, CMS solicited comments in the CY 2019 ESRD PPS 
proposed rule on whether CMS should expand the outlier policy to 
include composite rate drugs and supplies. With regard to composite 
rate supplies, an expansion of the outlier policy could support use of 
new innovative devices or items that would otherwise be considered in 
the ESRD PPS bundled payment. CMS specifically requested feedback about 
how such items might work under the existing ESRD PPS outlier framework 
or whether specific changes to the policy to accommodate such items are 
needed. It received a number of comments from stakeholders on this 
issue. CMS will take these comments into account as it consider any 
changes to the outlier policy and other payment adjustments such as 
TDAPA for future rulemaking.

    We are also doing some work through the CMS Center for Medicare and 
Medicaid Innovation to test payment models related to kidney care. The 
Comprehensive ESRD Care (CEC) Model, which started in 2015 and runs 
through 2020, is designed to identify, test, and evaluate new ways to 
improve care for Medicare beneficiaries with ESRD. Through the CEC 
Model, CMS is partnering with health-care providers and suppliers to 
test the effectiveness of a new payment and service delivery model in 
providing beneficiaries with person-centered, high-quality care. The 
Innovation Center is also considering additional models related to 
management of chronic kidney disease and ESRD.

    The Department also recently reported in the Spring Agenda the two 
NPRMs are under development that relate to kidney care. One through CMS 
focused on Organ Procurement Organization evaluation and metrics and 
the other through HRSA is geared toward expanding the National Living 
Donor Assistance Center.
                              home health
    Question. The FY 2020 budget proposes to lower annual Medicare 
payment updates to home health agencies, among other post-acute care 
(PAC) providers, beginning in FY 2020 through 2024, leading up to the 
establishment of a unified PAC payment system in 2025.

    Budgets should reflect what is in the best interest of our 
taxpayers, and keeping patients that need medical care in the lowest 
cost setting, in the comfort of their own home when possible, is where 
they will be best supported and most comfortable.

    Should we not be encouraging increased access to lower cost 
settings, such as home health? I am particularly concerned that home 
health providers, especially rural providers in Texas, will be unable 
to or will have difficulty providing home health access to Medicare 
beneficiaries if further cuts to their services are imposed.

    Answer. The budget proposes that skilled nursing facilities, home 
health agencies, and inpatient rehabilitation facilities will receive a 
lower annual Medicare payment update from FY 2020 to FY 2024 and, 
beginning in FY 2025, a unified post-acute care payment system would 
span all four post-acute care settings, with payments based on episodes 
of care and patient characteristics rather than the site of service. 
Part one of the proposal, reducing the annual payment update for post-
acute care providers, is intended to more closely align payment with 
costs for these providers given their historically high Medicare profit 
margins. The proposal stipulates that any update should not go below 
zero in a given year, after factoring in current statutory or other 
reductions.

    Part two of the proposal would convert the payment systems for 
post-acute care from four separate systems into one unified system that 
bases payment on patient characteristics rather than the site-of-
service. The conversion to a unified post-acute care payment system 
would be budget neutral in its first year, maintaining estimated 
Medicare payments that would otherwise have been expended in FY 2025. 
Payment rates would be set prospectively on an annual basis, with 
episode grouping and pricing based on the average cost for providing 
post-acute care services for a diagnosis, and would be risk-adjusted. 
The Secretary would have authority to adjust payments based on quality 
of care, geographic differences in labor and other costs, and other 
factors as deemed appropriate.
                                  gme
    Question. Secretary Azar, as a country we are facing both supply 
and demand issues in regard to provider access. The patient load for 
the average clinician has grown considerably particularly in 
underserved areas and by 2030, experts predict a national physician 
shortage ranging between 40,800 to 104,900.

    What is the administration's plan to address?

    Answer. The President's Fiscal Year (FY) 2020 budget requests 
resources to address physician shortages in underserved areas. The FY 
2020 budget provides $760 million in mandatory and discretionary 
resources for HRSA health workforce programs. The budget prioritizes 
funding for health workforce programs requiring service commitments in 
underserved areas, training health-care professionals to deliver 
integrated behavioral health services, and the National Center for 
Health Workforce Analysis. The FY 2020 President's budget, the budget 
requested funding for the National Health Service Corps (NHSC), which 
supports clinicians who demonstrate a commitment to serve our Nation's 
medically underserved populations at NHSC-approved sites located in 
Health Professional Shortage Areas. In addition, the President's budget 
includes funding for the Teaching Health Center Graduate Medical 
Education (THCGME) program. The THCGME program increases healthcare 
access in underserved communities by supporting primary care medical 
and dental residency programs in community-based ambulatory patient 
care settings. The President's budget includes $126.5 million in 
funding for the THCGME program in each of FY 2020 and FY 2021, for a 
total of $253 million over 2 years.

    The FY 2020 budget also proposes to reform graduate medical 
education spending from Medicare, Medicaid, and the Children's Hospital 
Graduate Medical Education Program into a single grant program for 
teaching hospitals. Total funds available for distribution in FY 2020 
would equal the sum of Medicare and Medicaid's 2017 payments for 
graduate medical education, plus 2017 spending on Children's Hospital 
Graduate Medical Education, adjusted for inflation. This amount would 
then grow at the CPI-U minus one percentage point each year. Payments 
would be distributed to hospitals based on the number of residents at a 
hospital (up to its existing cap) and the portion of the hospital's 
inpatient days accounted for by Medicare and Medicaid patients. The new 
grant program would be jointly operated by the Administrators of CMS 
and the Health Resources and Services Administration. This grant 
program would be funded out of the general fund of the Treasury. The 
Secretary would have authority to modify the amounts distributed based 
on the proportion of residents training in priority specialties or 
programs (e.g., primary care, geriatrics) and based on other criteria 
identified by the Secretary, including addressing health-care 
professional shortages and educational priorities. These changes 
modernize graduate medical education funding, making it better 
targeted, transparent, accountable, and more sustainable.

    Question. Knowing of these statistics, several Senators and I sent 
a letter last fall regarding the Centers of Medicare and Medicaid 
Services' (CMS) existing authority to extend flexibility to residency 
and fellowship programs when setting graduate medical education (GME) 
caps. The CMS Administrator responded in kind with its solution for 
consolidating Federal medical education programs but no real glide path 
for addressing the looming shortage that awaits patients to come.

    Can we get your commitment to utilize this authority, which was 
granted back in 1997?

    Answer. We share your goal of improved support for hospitals' 
efforts to train more residents in underserved areas. To this end, 
Fiscal Year 2020 President's budget includes a proposal that would 
consolidate Federal GME spending from Medicare, Medicaid, and the 
Children's Hospitals GME program into a single grant program for 
teaching hospitals, and direct funding toward physician specialty and 
geographic shortages areas. Patients and providers would be well served 
by these commonsense reforms and the new grant program would be 
operated jointly by CMS and the Health Resources and Services 
Administration. We will take your comments into consideration as we 
develop policies for future rulemaking.

                                 ______
                                 
                 Questions Submitted by Hon. John Thune
    Question. As we discussed in the hearing, the Indian Health 
Service's employment and transfer of abusive health-care providers 
cannot ever be allowed to happen again. You and Rear Admiral Weahkee 
have committed publicly to getting to the bottom of the situation with 
Stanley Patrick Weber. Has the Department selected the outside party 
and begun the independent review that has been discussed? What process 
changes has HHS made to its process for credentialing providers as a 
result of this issue?

    Answer. The Indian Health Service (IHS) began the acquisition 
process for an external medical quality assurance review in October 
2018. IHS intended to post this solicitation earlier, but the timeline 
was extended as a result of the 35-day lapse in appropriations that 
started on December 22, 2018. In February 2019, a request for proposal 
was published for this work. On May 10, 2019, IHS awarded a contract to 
Integritas Creative Solutions, LLC to conduct a medical quality 
assurance review to examine whether laws, policies and procedures have 
been followed with regard to protecting patients from sexual abuse. The 
final report from the contractor will (a) identify facts relating to 
IHS's policies and procedures regarding the reporting of allegations of 
sexual abuse of IHS patients by clinical staff, (b) identify past 
process or system failures and their causes, and (c) make 
recommendations for improvement and employee accountability.

    The IHS has implemented a credentialing and privileging system that 
is being used for all new applicants and all re-applications. The 
system standardizes and streamlines the credentialing process across 
the IHS. Privileging and performance evaluations of IHS practitioners 
will be tracked in the new system to help address issues related to 
quality care and patient safety.

    Question. As we've talked about in the past, with the ties between 
the VA and Indian Health Service's electronic health record systems, we 
need to ensure that IHS is making plans to move forward now that the VA 
will be transitioning systems. You've shared that a request for 
information was issued in late 2017 and that work would continue 
through 2018 on determining the appropriate next steps for IHS 
modernization. This year's budget requests $25 million to transition 
EHR systems. Has the Department completed its analysis of the RFI and 
determined a path forward? What is the timeline?

    Answer. The Department's Health Information Technology (HIT) 
Modernization Research Project began in September 2018 and will 
conclude in September 2019. This project will inform IHS with 
constructive options to modernize its HIT infrastructure. The project's 
timeline is as follows:

          Project Planning and Strategy--completed November 2018.
          Convene an Expert Advisory Panel on IHS HIT--completed 
        January 2019.
          IHS, Tribal, and Urban Indian Organization Facility HIT 
        Assessment--completed April 2019.
          HIT Community of Practice--completed April 2019.
          HIT Analysis and Recommendations--scheduled to be completed 
        by June 2019.
          HIT Initiatives Roadmap and Strategy--scheduled to be 
        completed by September 2019.

    The Department's research project will inform additional planning 
and the development of a detailed timeline for the modernization of its 
electronic health record system. The 2020 budget request will help IHS 
complete the detailed planning work and tribal consultation necessary 
to make a final decision.

    Question. Many members of this committee are engaged in ensuring 
rural communities have access to needed care. As the budget focuses on 
the transition to value-based care, how has the Department engaged 
rural providers, and what options have you explored to help them 
overcome some of the challenges that may exist in pursuing reforms like 
this?

    Answer. The immediate office of the Secretary has created a senior 
inter-departmental Rural Health Task Force to (1) identify rural 
hospitals at risk of closure, encourage the development of care models 
that are economically viable and sustainable in rural communities, and 
ensure HHS policies and programs are aligned to help encourage and 
sustain such models of care; (2) encourage greater uptake of 
statutorily permitted telemedicine services (i.e., under Medicare) in 
rural communities; (3) identify other HHS actions that could be taken 
to help to save or preserve access to care in rural communities, such 
as addressing Medicare and Medicaid payment rates that affect rural 
providers; and (4) identify ways to improve access to care in rural 
communities by encouraging States to adopt policies which allow ``mid-
level'' practitioners practice to the maximum of their licensure.

    Some of the priorities of the Task Force have already been met. For 
example, historic changes have been made to expand access to telehealth 
and covered services across the Medicare program, including virtual 
check-ins and stand-alone telephone consultations with clinicians at 
Rural Health Clinics and Federally Qualified Health Centers. Medicare 
Advantage plans now offer telehealth services as part of their basic 
benefit package.

    To engage rural providers and encourage participation in 
alternative payment models, CMS is also expanding value-based payment 
arrangements that cater to the unique needs of rural communities. The 
new CMS Primary Cares Initiative was recently announced, which offers 2 
pathways--Primary Care First and Direct Contracting--and four voluntary 
model options to test how payment is made for primary care. 
Transitioning to a value-based payment model will allow rural providers 
to focus on their local health needs such as maternal health, chronic 
diseases and substance use disorders, which we believe, will in turn, 
drive better health outcomes.

    CMS is also working with providers to remove undue unnecessary 
burdens that prevent them from administering care in rural areas. As a 
result of added flexibilities for clinicians in small practices, 93 
percent of participating providers have received a positive payment 
adjustment.

    HHS has made rethinking, and improving, rural health a priority, 
and the President's budget reflects that by supporting these efforts, 
including the work of community health centers.

    Question. Thank you for the work the administration has done to 
advance telehealth over the last year, particularly for including it as 
a priority in CMS's Rural Health Strategy. It's great to see the 
implementation of committee-passed provisions on stroke, substance use 
disorder, and home dialysis, as well as the option to reimburse for 
virtual check-ins in last year's fee schedule. Are there other 
initiatives CMS is currently considering within its existing authority 
to expand telehealth? Have you identified any new areas where 
congressional action is needed to address statutory barriers?

    Answer. CMS is working to facilitate innovation in the health-care 
delivery system across all its programs. Health-care innovation is 
serving as a catalyst to improving quality of care, enhancing access to 
care, increasing efficiency in the system, and lowering health-care 
costs. Supporting and furthering telehealth is a critical part of CMS's 
efforts to promote innovation. The President's budget includes a 
proposal to provide a Medicare Priority Care (MPC) per-beneficiary per-
month (PBPM) payment for all Medicare fee-for-service (FFS) 
beneficiaries, which would be paid to eligible primary care providers. 
Providing such payments with the envisioned flexibility to provide care 
in the time and manner the clinician believes most appropriate, which 
might include telehealth, is one way the administration has proposed to 
make telehealth more broadly available while limiting burden and 
focusing on the patient-provider relationship.

    CMS continues to add services to the list of Medicare telehealth 
services that can be furnished at authorized originating sites. In the 
calendar year 2019 Medicare Physician Fee Schedule final rule, CMS 
expanded the list of Medicare telehealth services for 2019 to include 
HCPCS codes G0513 and G0514 (Prolonged preventive service(s)) to the 
list of Medicare telehealth services. Although Medicare telehealth 
requirements generally must be met in order for Medicare to pay for 
telehealth services, section 1115A(d)(1) of the Social Security Act 
permits waiving those requirements as may be necessary solely for 
purposes of testing models under section 1115A. CMS continues to 
explore how best to structure waivers of telehealth requirements as 
necessary for purposes of testing models under section 1115A of the 
Social Security Act, taking into account stakeholder and Model 
participant feedback.

    In the Medicare Advantage Value-Based Insurance Design model that 
Congress expanded under the Bipartisan Budget Act of 2018, plans may 
increase the use of telehealth by proposing access to telehealth 
services to meet certain requirements for network adequacy as long as 
an in-person option remains.

    Additionally, the Emergency Triage, Treat, and Transport (ET3) 
Model adds a reimbursement opportunity for a provider to treat in place 
using telehealth.

                                 ______
                                 
      Question Submitted by Hon. John Thune and Hon. Sherrod Brown
    Question. Thank you to CMS for working to implement a host of 
policies included in the SUPPORT for Patients and Communities Act (Pub. 
L. 115-271) in the 2019 Medicare Physician Fee Schedule. As you know, 
section 2002 of the same law provides for increased screening for 
substance use disorder among Medicare beneficiaries during the Welcome 
to Medicare exam and annual wellness visits after January 1, 2020. Is 
CMS on track to issue implementing regulations for section 2002 in the 
2020 Physician Fee Schedule this summer?

    Answer. CMS appreciates Congress's efforts to address the opioid 
epidemic. CMS is working diligently to implement the provisions of the 
SUPPORT Act.

                                 ______
                                 
                Questions Submitted by Hon. Rob Portman
    Question. The IMD exclusion is set to be lifted on October 1st of 
this year, but before this, HHS is supposed to release guidance on how 
States can implement these changes. Can you provide an update on the 
efforts to operationalize these IMD reforms, and can you provide any 
recommendations to the States on what steps they can be taking to 
prepare for these changes?

    Answer. More psychiatric treatment options are needed, and that 
includes more inpatient and residential options that can help stabilize 
Americans with serious mental illness when necessary. And while 
different forms of treatment work for different patients, the decades-
old restriction on Medicaid reimbursement for inpatient treatment at 
institutions for mental diseases (IMDs) has been a significant barrier 
to inpatient psychiatric treatment. That is why, last November, CMS 
sent a letter to State Medicaid Directors outlining both existing and 
new opportunities for States to design innovative service delivery 
systems for adults with serious mental illness and children with 
serious emotional disturbance.

    The SUPPORT for Patients and Communities Act (Pub. L. 115-271) 
included a provision that provides State Medicaid programs with the 
option to cover care in certain IMDs, which may be otherwise 
nonreimbursable under the Federal IMD exclusion, for Medicaid 
beneficiaries aged 21-64 with a substance use disorder for fiscal years 
2019 to 2023. CMS is developing guidance to issue to States regarding 
this option, and hopes to publish a letter to State Medicaid Directors 
this fall. CMS has also been providing technical assistance prior to 
issuing guidance to the few States who have contacted it.

    We believe States are evaluating this provision and CMS's waiver 
options around IMD coverage to determine the best course of action for 
their State.

    Question. Over the past 3 years, Congress has taken considerable 
efforts to fund our response to the opioid crisis. The epidemic is 
continuing to evolve, and we are seeing an influx of other drugs like 
meth creeping into Ohio. Given that CARA and Cures funding and programs 
have traditionally been used to target opioid abuse, are you committed 
to allowing these funds to be used to address the abuse of other drugs 
as well?

    Answer. Addressing the opioid epidemic is a top priority of this 
administration, and we appreciate the tools Congress has provided by 
passing legislation such as the SUPPORT for Patients and Communities 
Act (Pub. L. 115-271). This law was enacted on October 24, 2018, and 
CMS is implementing a number of new initiatives under that law that aim 
to increase options for treating beneficiaries with opioid use disorder 
or other substance use disorders, ensure prescriber accountability and 
improved safety for patients across CMS programs, and illuminate 
Medicaid prescribing data.

    CMS has issued several Informational Bulletins outlining State 
approaches and effective practices for addressing the opioid epidemic 
within Medicaid. In November 2017, CMS issued guidance to States 
announcing a new policy to allow States to design demonstration 
projects that increase access to treatment for opioid use disorder 
(OUD) and other substance use disorders (SUD). Through this updated 
policy, States will be able to pay for a fuller continuum of care to 
treat SUD, including critical treatment in residential treatment 
facilities that Medicaid is unable to pay for without a waiver.

    The SUPPORT for Patients and Communities Act (Pub. L.115-271) built 
upon this concept and included a provision that provides State Medicaid 
programs with the option to cover care in certain IMDs, which may be 
otherwise nonreimbursable under the Federal IMD exclusion, for Medicaid 
beneficiaries aged 21-64 with a substance use disorder for fiscal years 
2019 to 2023. CMS is developing guidance to issue to States regarding 
this option, and hopes to publish a letter to State Medicaid Directors 
this fall. CMS has also been providing technical assistance prior to 
issuing guidance to the few States who have contacted it. We believe 
States are evaluating this provision and CMS's waiver options around 
IMD coverage to determine the best course of action for their State. 
Finally, in February 2019, CMS issued guidance \1\ to States on 
mandatory and optional items and services for non-opioid treatment and 
management of pain that may be provided in the State Medicaid program.
---------------------------------------------------------------------------
    \1\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib022219.pdf?linkId=639350
89.

    In addition, the SUPPORT for Patients and Communities Act 
establishes a new Medicare benefit category for opioid use disorder 
treatment services furnished by opioid treatment programs (OTP) under 
Medicare Part B, beginning on or after January 1, 2020. In the Calendar 
Year 2019 Medicare Physician Fee Schedule, CMS sought information 
regarding services furnished by OTPs, payments for these services, and 
additional conditions for Medicare participation for OTPs that 
stakeholders believe may be useful for CMS to consider for future 
---------------------------------------------------------------------------
rulemaking to implement this new Medicare benefit category.

    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) is also fully committed to the prevention of, treatment of, 
and recovery from all harmful substances. We recognize that the use of 
methamphetamines and other drugs are rising in some areas of the 
country and is a critical concern. Many of SAMHSA's grant programs 
allow--and, indeed, encourage--grantees to select priority substances 
based on their own data. The Substance Abuse Block Grant asks States to 
provide SAMHSA with their primary prevention targeted priority areas. 
Ohio, for example, has indicated its 2019 priority areas to be alcohol, 
marijuana, prescription drugs, and heroin. Other States have indicated 
priority areas to be methamphetamines, cocaine, inhalants, or tobacco. 
The Strategic Prevention Framework--Partnerships for Success grantees 
also target alcohol and up to two other substances identified as areas 
of need. And, in an effort to distribute funds to communities, as well 
as States, SAMHSA has initiated a new funding opportunity, which will 
focus on community-driven efforts to advance substance abuse 
prevention, allowing communities and counties to apply for funds 
directly. As with the programs above, grantees will be able to choose 
among various target substances, including methamphetamine.

    The Comprehensive Addiction and Recovery Act (CARA), the 21st 
Century Cures Act, and the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and 
Communities Act were passed by Congress specifically to address the 
opioid crisis. This focus on opioids has seen successes in a short time 
and promises more to come. In 2017, first-time heroin use was less than 
half of what it was in 2016, and more Americans are getting the 
treatment they need. The opioid crisis is not over yet; we must 
continue to address this crisis in big and meaningful ways to see even 
more positive results.

    While the primary goal of SUPPORT, CARA and Cures Acts funding is 
the development of strategies and programs to address the opioid 
crisis, SAMHSA recognizes that many individuals struggle with more than 
one substance and that poly-drug use is common; when individuals with 
opioid use disorder served with these funds have co-occurring 
challenges with other substances, such as methamphetamine use disorder, 
the comprehensive treatment services offered address both conditions.

    Question. The budget notes that HHS has been collecting data from 
the JW modifier since January 1, 2017 and proposes to make public some 
of this data. Can any of that data be shared now? Does HHS believe that 
excessively large vial sizes, and the subsequent wasted product from 
the unused dose, contribute to increased costs for patients and the 
health-care system without delivering improved results?

    Answer. For dosing based on body surface or body weight, it is 
impossible to develop a vial size for each and every dose. FDA aims to 
have the applicant develop a range of vial sizes that minimizes the 
volume remaining after a patient is dosed, because if a significant 
amount of drug is remaining a healthcare provider may be tempted to try 
to extract that remainder and use it or combine it with other 
remainders to dose a second patient. As described in FDA's guidance for 
industry, Allowable Excess Volume and Labeled Vial Fill Size in 
Injectable Drug and Biological Products (June 2015), FDA may request 
justification when there are questions about the appropriateness of the 
proposed labeled vial fill sizes in an application. In recommending a 
range of vial sizes, we also consider the potential that having 
multiple vial sizes available can raise the risk of medication errors 
(as the healthcare provider is selecting a vial amongst many on a 
shelf).

    There may be a financial incentive for manufacturers to produce and 
providers to purchase drugs in larger packaged dosages than typically 
needed, because Medicare Part B pays for these discarded drugs and 
biologics up to the amount included in a package or vial, in addition 
to the amount administered to the beneficiary. Since January 1, 2017, 
providers and suppliers have been required to report discarded drugs 
and biologicals on their Part B claims with the JW modifier. This 
budget proposal would make public which Part B drugs have the highest 
reported drug wastage using data gathered from these claims. Publicly 
reporting this information will allow for a better understanding of 
which drugs would benefit from different packaging to reduce wastage 
and we anticipate making this information available soon.

    Question. I have several questions related to unaccompanied minors 
crossing the border, an issue that I know we all have concerns towards. 
I've chaired three Permanent Subcommittee on Investigations hearings on 
the topic, and we've released two reports on it. From these hearings, 
We learned HHS was not doing background checks on the sponsors. We 
wrote reports, held hearings, and undertook numerous staff briefings. 
As a result of those efforts, HHS and DHS began requiring fingerprint 
background checks for parents and other sponsors, as well as other 
adult household members, under a Memorandum of Agreement. My questions 
are, first: is the Memorandum of Agreement still in place?

    Answer. Yes, though implementation has been modified through HHS 
operational directives.

    Question. Is it correct that the usage of sponsor background 
information to run enforcement operations led to a backlog of children 
in HHS care?

    Answer. In December 2018, ORR found that the MOA correlated with an 
increase in the average length of care, without enabling ORR to 
identify new child welfare risks. ORR issued an operational directive 
that suspended fingerprinting and biometric background checks of all 
household members of potential sponsors based on ORR's finding.

    ORR has never conducted immigration enforcement actions again UAC 
sponsors.

    Question. Is it true that in an effort to handle this problem, HHS 
decided to stop doing fingerprint background checks on some of the 
sponsors, and all of the adult household members?

    Answer. ORR implemented operational directives in December 2018 and 
March 2019 related to the MOA. Copies are attached.

    Question. Can you clarify which sponsors do get fingerprints 
background checks?

    Answer. Category 1 sponsors no longer undergo a fingerprint 
background check as part of the sponsor suitability process, unless: a 
public records check reveals possible disqualifying information; there 
is a documented risk to the safety of the child; the child is 
especially vulnerable; or the case is being referred for a home study.

    Category 2 and 3 sponsors still undergo fingerprint background 
checks.

                                 ______
                                 
              Question Submitted by Hon. Patrick J. Toomey
    Question. As I have said many times, Congress must at some point 
come to acknowledge that no government program can grow faster than the 
economy indefinitely without eventually causing a fiscal crisis. Our 
largest Federal entitlement programs seem destined to test this simple 
mathematical fact, as Social Security, Medicare, and Medicaid are all 
projected to grow faster than GDP for the foreseeable future.

    I commend you for putting forth this budget that at least tries to 
start a conversation about reforming some of these programs. In 
particular, it attempts to give States flexibility to grow and contract 
the Medicaid program in response to exogenous impacts on eligibility 
but limits per beneficiary growth to a reasonable measure of inflation. 
I want to thank the administration for continuing to endorse this idea 
and embracing a discussion on how we can make this program sustainable 
for the long-term.

    At the same time, doing something about this issue has proven 
difficult even in times of unified government. I hope I am wrong, but 
this reality, combined with the change in the party of control in the 
House, all but ensures these changes will remain theoretical for at 
least the duration of this Congress.

    In the absence of broader reforms, there have been some States that 
have requested the ability to ``partially'' expand Medicaid. This would 
consist of extending coverage forable-bodied, working-age adults up to 
100 percent of the Federal poverty line, instead of the 138 percent of 
FPL required today in order to receive the enhanced Federal matching 
rate of reimbursement created by the Patient Protection and Affordable 
Care Act.

    My office requested an estimate from the Centers for Medicare and 
Medicaid Services Office of the Actuary (OACT) as to what the impact on 
the Federal deficit would be if all States were given the option to 
partially expand. In their best estimate as to how States and consumers 
would react to such a change, OACT estimated that some States would 
roll back the expansion from 138 percent FPL to 100 percent. In those 
States, OACT assumes 60 percent of former Medicaid beneficiaries 
between 100 and 138 percent FPL would enroll in individual market 
plans, but 40 percent would forgo coverage despite being eligible for 
generous subsidies in the exchanges. Even with these behavioral 
assumptions, OACT estimated that overall allowing ``partial'' Medicaid 
expansion would increase the Federal deficit by over $30 billion.

    Furthermore, such a change in policy would increase pressure on 
States who have not expanded Medicaid to do so. If all of these States 
were to expand to 100 percent, OACT believes that would cost the 
Federal Government almost $600 billion over 10 years.

    I think we need to continue conversations on how we can make health 
care more accessible for individuals that currently struggle to afford 
it, including the uninsured. However, I continue to believe that 
Obamacare's Medicaid expansion, which perversely provides much higher 
Federal matching funds for the coverage of working age, able-bodied 
adults without dependents than the traditional Medicaid population of 
the aged, disabled, children, and families, is the wrong way to 
accomplish that goal.

    Is the administration considering allowing States to partially 
expand Medicaid at the enhanced matching rate of reimbursement in the 
absence of broader reforms? If so, how would this action be consistent 
with your broader goals of making this program sustainable and focusing 
it on the most needy?

    Answer. The Medicaid program is an important source of health 
coverage for many Americans, and we must put it on a stable long-term 
sustainable footing for this and future generations. That is the 
challenge we have as we seek to empower the States and provide the 
right incentives to deliver quality services while ensuring the 
sustainability of the program. The administration believes strongly in 
the important role that States play in fostering innovation in program 
design and financing, and HHS is currently considering how to respond 
to States' renewed interest interested in changing their Medicaid 
expansion eligibility levels. Waiver applications are considered on a 
State-by-State basis, and CMS will continue to work with States 
interested in pursuing section 1115 demonstrations that promote the 
objectives of Medicaid and approve them when appropriate. However, 
giving States the flexibility to refocus the program on the populations 
Medicaid was intended to serve--the elderly, people with disabilities, 
children, and pregnant women--will help put Medicaid on a path to 
fiscal stability and is a key focus in the budget.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
                     work requirements in medicaid
    Question. The President's FY 2020 budget proposes to terminate 
Medicaid coverage for all ``able-bodied, working age individuals'' who 
do not meet a work requirement. Despite the fact that work requirements 
clearly violate the purpose of title XIX of the Social Security Act, 
the Centers for Medicare and Medicaid Services (CMS) continues to 
approve section 1115 waivers to allow for the imposition of work 
requirements in State Medicaid programs. Arkansas was the first State 
to implement work requirements last year, leading to18,000 people being 
kicked off their health coverage.\2\ Secretary Azar told the House 
Energy and Commerce Subcommittee that the Department does ``not yet 
have data as to why they fell off the program,'' yet the President's 
budget would force this failed experiment on every State.\3\
---------------------------------------------------------------------------
    \2\ https://www.kff.org/medicaid/issue-brief/state-data-for-
medicaid-work-requirements-in-arkansas/.
    \3\ House Energy and Commerce Subcommittee hearing on ``Fiscal 2020 
Budget Request for the Department of Health and Human Services,'' March 
12, 2019.

    When discussing the 18,000 people disenrolled from Arkansas 
Medicaid for failing to meet the paperwork requirements, Secretary Azar 
explained that only 1,452 of those individuals reapplied in January 
when they became eligible again. He said that this was ``a fairly 
strong indication that the individuals who left the program were doing 
so because they got a job . . . and they have insurance elsewhere and 
didn't need the Medicaid program.'' Please provide evidence to support 
Secretary Azar's claim that most individuals left the program because 
they got jobs. Of the people that gained employment, what percentage 
---------------------------------------------------------------------------
have health insurance comparable to Medicaid coverage?

    Answer. CMS continuously works with States to use data to inform 
its work as they pursue and implement waivers that include community 
engagement requirements. Currently, Arkansas publishes monthly 
enrollment reports that include the number of individuals who did not 
comply with the community engagement requirement, and subsequently, how 
many have been terminated due to their noncompliance for 3 consecutive 
months. The State has recently issued a report that, since the 
requirement went into effect, 4,384 Arkansas Work Participants found 
employment. In addition, the State reported that more individuals had 
their coverage terminated for other reasons than failing to meet the 
community engagement requirement, including an increase in household 
income, moving out of the State, and failing to return requested 
information. This type of ``churn'' is not uncommon in Medicaid. 
According to the latest report, published in February, nearly 90 
percent of the 116,229 beneficiaries subject to the requirement were 
compliant either due to work, training, or another activity for the 
month of February.

    Question. On March 14, 2019, CMS released new monitoring metrics 
tools for demonstrations that include work requirements. While this 
guidance represents a step toward proper oversight of section 1115 
demonstrations, it still fails to address the fundamental problem that 
the Arkansas work requirements demonstration does not appear to have an 
approved evaluation plan or evaluator. In follow-up to our February 
19th letter to Secretary Azar, please provide an update on the status 
of the evaluation for each approved section 1115 demonstration that 
includes work requirements, including approval of the State's 
evaluation plan and the State's progress in hiring the evaluator.

    Answer. CMS reviews all section 1115 demonstration applications to 
ensure they include a comprehensive monitoring and evaluation plan. To 
help States meet the criteria of CMS's application approval process, in 
March, CMS released new State tools and guidance that provide standard 
monitoring metrics and recommended research methods geared specifically 
for section 1115 demonstrations that test innovative approaches to 
Medicaid eligibility and coverage policies. Eligibility and coverage 
demonstrations specifically allow States to test new policy approaches 
such as requiring work or community engagement among working age 
adults, providing premium assistance to purchase private coverage, and 
engaging certain beneficiaries through incentives and disincentives for 
meeting certain program requirements. These programs are designed to 
determine whether these approaches lead to targeted outcomes like 
increased employment, successful transitions to private coverage, 
better financial independence, and improved beneficiary health and 
well-being.

    For each approved 1115 demonstration, States must provide CMS with 
regular reporting on key monitoring metrics upon implementation. States 
are also required to conduct evaluations by partnering with an 
independent evaluator. States are required to submit an evaluation 
design to CMS for approval following approval of the final 
demonstration. These monitoring and evaluation tools and guidance were 
designed to support these activities and were developed by CMS through 
a rigorous process with subject matter experts, a State monitoring 
advisory group, and contributions from experts in the field of 
evaluation research.

    CMS will provide support to States to use and adopt these tools 
through individual technical assistance and through forums like our 
Community Engagement Learning Collaborative. CMS will provide specific 
instruction on these tools and guidance through a series of technical 
assistance sessions for States.

    CMS approved the first 1115 demonstration with community engagement 
requirements in January 2018. Since that time, CMS has approved 
demonstrations with community engagement requirements in an additional 
8 States. While States are in various stages of implementing these 
programs, no program has yet been implemented long enough for CMS to 
have sufficient levels of data to analyze results. CMS will continue 
working with States to gather and evaluate this data, and it looks 
forward to using what it learns to inform future efforts.

    Question. The President's budget proposal to mandate work 
requirements in Medicaid includes estimated savings of $130.4 billion 
over 10 years. The nonpartisan Kaiser Family Foundation has estimated 
that expanding the Arkansas experiment nationally could result in up to 
4 million people losing access to health coverage, most of whom would 
be either working or exempt from the work requirements.\4\ Please 
provide the estimates used to determine the savings for the President's 
budget proposal, including: the number of individuals who would be 
subject to the mandate; the number of individuals who would lose 
coverage for failure to meet the work requirements; the number of 
individuals who would lose coverage for failure to complete the 
paperwork even though they met the requirements for work or would have 
qualified for an exemption; and the basis for these estimates of 
disenrollment.
---------------------------------------------------------------------------
    \4\ https://www.kff.org/medicaid/issue-brief/implications-of-a-
medicaid-work-requirement-national-estimates-of-potential-coverage-
losses/.

    Answer. The President's FY 2020 budget includes a proposal that 
would improve consistency between work requirements in federally funded 
public assistance programs, including Medicaid and Temporary Assistance 
for Needy Families (TANF), by requiring that able-bodied, working-age 
individuals find employment, train for work, or volunteer (community 
service) in order to receive welfare benefits. This would enhance 
service coordination for program participants, improve the financial 
well-being of those receiving assistance, and ensure federally funded 
public assistance programs are reserved for the most vulnerable 
populations. CMS' Office of the Actuary estimates this proposal to save 
$8.3 billion in FY 2020, $55.6 billion over 5 years, and $130.4 billion 
over 10 years.
          greater paperwork burden for medicaid beneficiaries
    Question. In a speech at the Federation of American Hospitals 2019 
Public Policy Conference earlier this month Administrator Verma 
discussed the Patients over Paperwork initiative, which was launched in 
2017 ``to focus all of CMS on finding opportunities to modernize or 
eliminate rules and requirements that are outdated, duplicative or 
getting in the way of good patient care.''\5\ Yet the President's FY 
2020 budget is filled with proposals that specifically increase 
paperwork and get in the way of good patient care.
---------------------------------------------------------------------------
    \5\ https://www.cms.gov/newsroom/press-releases/speech-remarks-
administrator-seema-verma-federation-american-hospitals-2019-public-
policy-conference.

    Work requirements put mountains of paperwork between patients and 
their doctors and essentially serve as a backdoor scheme to kick people 
off Medicaid. The nonpartisan Kaiser Family Foundation examined the 
implications of extending work requirements nationally and found that 
the majority of people kicked off Medicaid would lose coverage due to 
the burdensome documentation requirements, not the work requirements. 
Please describe how work requirements fit with the goals of the 
Patients over Paperwork initiative, which are stated on the CMS website 
as: reduce unnecessary burden; increase efficiencies, and improve the 
---------------------------------------------------------------------------
beneficiary experience.

    Answer. As part of the waivers CMS has granted, it has set careful 
guardrails that require States to protect their most vulnerable 
beneficiaries, and only required community engagement from 
beneficiaries whose circumstances allow them to participate. We are 
also attentive to the paperwork burdens imposed on both beneficiaries 
and States, although we believe the benefits of setting the right 
incentives can far outweigh these costs. All of these costs and 
benefits will be carefully evaluated for each waiver we approve.

    Beyond this demonstration opportunity, this administration 
encourages all State Medicaid directors and stakeholders to think about 
how they can promote community engagement. In setting up the 
demonstrations, CMS is building on a robust academic literature that 
shows community engagement, such as employment, can have substantial 
benefits for well-being. Finding work is associated with significant 
improvements in mental and physical health--and programs set up to 
improve Americans' health should, where feasible, reflect that.

    Question. Establishing more frequent eligibility redeterminations 
would put unnecessary paperwork between eligible Medicaid beneficiaries 
and their providers. Failing to complete the renewal paperwork, not 
increased income, was the primary reason people lost coverage under 
Indiana's Medicaid waiver in 2017.\6\ The churn from dis-enrolling and 
re-enrolling eligible individuals not only disrupts the patient-
provider relationship and continuum of care, but also increases 
administrative costs for States The President's FY 2020 budget proposal 
includes $45.6 billion in savings from allowing States to increase the 
frequency of Medicaid eligibility redeterminations. Please provide the 
estimates used to determine the savings for this proposal, including: 
the total number of individuals who would lose Medicaid coverage due to 
this change; the number of parents and children who would lose 
coverage; the number of individuals losing coverage who would become 
uninsured; the number of individuals who would likely become Medicaid 
eligible again within 3 months or less; and the increase in 
administrative costs due to more frequent redeterminations and the 
corresponding increase in dis-enrolling and re-enrolling beneficiaries.
---------------------------------------------------------------------------
    \6\ https://www.cbpp.org/research/health/locking-people-out-of-
medicaid-coverage-will-increase-uninsured-harm-beneficiaries.

    Answer. Current regulations prohibit States from conducting 
Medicaid eligibility redeterminations more than once every 12 months 
for individuals eligible based on MAGI financial eligibility. This 
proposal would provide States with the flexibility they have asked for 
to allow States the option to conduct more eligibility redeterminations 
for MAGI populations to ensure that their Medicaid programs are focused 
on the individuals that need it most. It will also ensure that 
individuals who have incomes that exceed the Medicaid income 
eligibility threshold are not taking advantage of scarce Federal 
resources by staying on Medicaid when they are no longer eligible. The 
President's FY 2020 budget estimates $45.6 billion in savings over 10 
years.
                  children's health insurance coverage
    Question. For the first time in a decade, the number of uninsured 
children in the United States is going up. According to data from the 
American Community Survey an additional 276,000 children were uninsured 
in 2017. This change reverses 10 years of improvement in access to 
coverage for kids. Focusing in on most vulnerable children, last year 
the number of children covered by Medicaid and the Children's Health 
Insurance Program (CHIP) dropped by nearly 600,000 according to CMS 
enrollment data. Unfortunately, the data do not indicate that these 
children moved to private insurance coverage. Several proposals in the 
President's FY 2020 budget would introduce new barriers to coverage, 
such as more frequent redeterminations, new asset tests, and more 
restrictive up-front verification of immigration status.

    Do you think that the American Community Survey results and the CMS 
enrollment data are accurate?

    If these data are accurate, how concerned are you that the number 
of uninsured children is going up? Isn't it inconsistent with the goals 
of the Medicaid and CHIP programs to have the number of uninsured 
children increase?

    Would you agree that more government red tape, like increasing the 
frequency of eligibility redeterminations, is likely to further depress 
enrollment of children in Medicaid and CHIP?

    Answer. CMS is aware of the Medicaid and CHIP enrollment declines 
that States have reported for the past few months. There are a number 
of possible factors that could contribute to these enrollment declines, 
and CMS is looking closely at the impact those drivers may be having on 
enrollment. Some of the enrollment decline may be attributed to the 
improved economy but CMS is continuing to look at other factors to 
ensure that eligible people can continue to be enrolled. Regarding 
whether increasing the frequency of eligibility redeterminations is 
likely to further depress enrollment in Medicaid and CHIP, current 
regulations prohibit States from conducting Medicaid eligibility 
redeterminations more than once every 12 months for individuals 
eligible based on MAGI financial eligibility. The FY 2020 President's 
budget allow States the option to conduct more eligibility 
redeterminations for MAGI populations to ensure that their Medicaid 
programs are focused on the individuals that need it most. It will also 
ensure that individuals who have incomes that exceed the Medicaid 
income eligibility threshold are not taking advantage of our scarce 
Federal resources by staying on Medicaid when they are no longer 
eligible.

    In addition, there are a number of factors that impact enrollment 
in Medicaid and CHIP, including: the economy, State eligibility system 
functionality, and State operations (e.g., ability to receive and 
process applications and conduct timely redeterminations annually or 
when there is a change in circumstance that may affect eligibility). 
Some of these considerations, such as a strong economy, State systems 
and operational issues, and reducing backlog of delayed 
redeterminations may account for the FY 2018 decline in Medicaid and 
CHIP enrollment, among others. Each of the factors may impact States 
and their enrollment trends differently. For example, States 
experiencing losses in Medicaid and CHIP enrollment may also be 
experiencing a decrease in unemployment rates, indicating an improving 
economy may account for the enrollment decline. While in other States, 
enrollment declines may actually be influenced by State system and 
operational issues. More information can be found at https://
www.medicaid.gov/chip/downloads/fy-2018-childrens-enrollment-
report.pdf.
                           program integrity
    Question. Medicaid and CHIP beneficiaries lead complex lives. They 
are individuals with complex medical conditions, disabilities, and 
substance use disorders; individuals who are homeless or face housing 
instability; elderly individuals in long-term care facilities; and 
infants and children in low-income families. The purpose of Medicaid 
and CHIP is to provide health care for these individuals. It is 
important that we protect the fiscal integrity of these programs while 
not placing unnecessary barriers and government red tape between 
eligible beneficiaries and this essential coverage.

    Evidence suggests that most Medicaid improper payments result from 
insufficient provider documentation, not beneficiary ineligibility.\7\ 
Establishing new barriers to eligibility, like the President's FY 2020 
budget proposal to eliminate the reasonable opportunity period for 
verification of citizenship and immigration status, primarily serve to 
prevent eligible beneficiaries from accessing the coverage to which 
they are entitled.
---------------------------------------------------------------------------
    \7\ https://ccf.georgetown.edu/2018/04/19/measuring-medicaids-
mistakes-estimating-improper-payments/.

---------------------------------------------------------------------------
    How does CMS define improper payments?

    What percent of these improper payments are due to insufficient 
documentation?

    Answer. An improper payment occurs when a payment should not have 
been made, Federal funds go to the wrong recipient, the recipient 
receives an incorrect amount of funds, or the recipient uses Federal 
funds in an improper manner. In addition, when an agency's review is 
unable to discern whether a payment was proper as a result of 
insufficient or lack of documentation, this payment should also be 
considered an error.

    Since FY 2014, the Medicaid improper payment estimate has been 
driven by errors due to State non-compliance with provider screening, 
enrollment, and National Provider Identifier (NPI) requirements. The 
majority of improper payments have been cited on claims where a newly 
enrolled provider had not been appropriately screened by the State, a 
provider did not have the required NPI on the claim, or a provider was 
not enrolled.

    For FY 2018, Medicaid payments for which there was insufficient or 
no medical documentation to support the payment as proper accounted for 
approximately 9 percent ($3.4 billion) of Medicaid improper 
payments.\8\
---------------------------------------------------------------------------
    \8\ https://www.hhs.gov/sites/default/files/fy-2018-hhs-agency-
financial-report.pdf.

    Question. What percent of the improper payments are attributable to 
true fraud where payment should still have not been made if sufficient 
---------------------------------------------------------------------------
documentation was provided?

    Answer. Improper payments do not necessarily represent expenses 
that should not have occurred. Instances where there is insufficient or 
no documentation to support the payment as proper are also cited as 
improper payments. A majority of Medicaid improper payments were due to 
instances where information required for payment was missing from the 
claim and/or States did not follow the appropriate process for 
enrolling providers. However, these improper payments do not 
necessarily represent payments to illegitimate providers and, if the 
missing information had been on the claim and/or had the State complied 
with the enrollment requirements, then the claims may have been 
payable. A smaller proportion of improper payments are considered a 
known monetary loss to the program, which are claims where HHS 
determines the Medicaid payment should not have been made, or should 
have been made in a different amount.

    Question. In the case of improper payments related to erroneous 
eligibility determinations under section 1903(u) of the Act since 1992, 
has CMS attempted to recoup any improper payments? If so, please 
identify the overpayment amount and the recoveries by State and year.

    What are the State-by-State Medicaid eligibility error rates since 
the PERM program began tracking this metric in 2008?

    What are the State-by-State Medicaid eligibility error rates for 
traditional eligibility pathways versus the newly eligible expansion 
pathway created by the ACA since the expansion in 2014?

    What additional statutory authorities, if any, have you indicated 
would be beneficial for the purpose of enforcing section 1903(u)?

    Answer. As you know, the Federal-State partnership is central to 
the success of the Medicaid program, and CMS plays a critical role in 
ensuring that States are compliant with Federal statute and regulations 
and that only eligible individuals are enrolled in Medicaid. CMS 
continuously works to strengthen Medicaid program integrity efforts to 
ensure that taxpayer dollars are spent appropriately.

    As part of CMS's strategy to improve program integrity and increase 
oversight of States' beneficiary eligibility determinations, CMS is 
auditing the States previously found to be high risk by the OIG to 
examine how these high risk States determine eligibility for Medicaid 
benefits. These States are New York, Kentucky, and California. CMS also 
carefully reviewed the November 2018 Louisiana Legislative Auditor's 
report on wage verification practices and the subsequent report 
released in December 2018 on the State's eligibility determination 
practices for the expansion population as a result of the number of 
findings identified by the State auditor's reviews. CMS will also audit 
Louisiana in the coming weeks. The objectives of the audits are to 
determine whether beneficiary eligibility was adjudicated appropriately 
for the new adult group and whether services for beneficiaries in the 
new adult group were assessed the correct Federal Medical Assistance 
Percentage (FMAP).

    CMS does not have statutory authority to recoup overpayments for 
eligibility errors that may be identified through these audits, as that 
would require a statutory change to section 1903(u) of the Social 
Security Act (the Act). The Fiscal Year (FY) 2020 President's budget 
includes a legislative proposal that would provide CMS with broader 
authority to issue disallowances and extrapolate based on future audits 
to recoup Federal resources from States that enrolled ineligible 
beneficiaries or misclassified beneficiaries. In addition, the budget 
proposal would eliminate the current three percent threshold for 
States' eligibility-related improper payments, incentivizing States to 
take swift action to correct eligibility-related errors.

    Prior to a CMS regulation published in July 2017, any identified 
improper payments based on eligibility determinations were subject to 
recovery only under section 1903(u) of the Act, which governed the 
traditional MEQC program. Section 1903(u) instructs the Secretary to 
issue disallowances with respect to the portion of a State's erroneous 
payments that exceed a 3 percent error rate, though the Secretary may 
waive all or part of the disallowance if a State demonstrates that it 
cannot reach the 3 percent allowable error rate despite a ``good faith 
effort.'' In 1992, States prevailed at the HHS Departmental Appeals 
Board (DAB) in challenging the disallowances based on the traditional 
MEQC program. The DAB concluded that the MEQC sampling protocol and the 
resulting improper payment rate calculation were not sufficiently 
accurate to provide reliable evidence to support a disallowance under 
section 1903(u). As such, although the traditional MEQC program 
remained in place, CMS provided States with the ability to implement 
MEQC pilots that were focused on prospective improvements in 
eligibility determinations rather than disallowances. The MEQC pilots 
were an alternative way for States to meet the ``good faith effort'' 
exception to section 1903(u), and a majority of States elected this 
alternative approach due to the pilots' flexibility to target specific 
problematic or high-interest areas.

    Today, while CMS does not have authority to recoup overpayments 
identified in the new eligibility audits discussed above, CMS does have 
authority to issue disallowances, and, in certain circumstances, States 
are required to return overpayments. By virtue of CMS's July 2017 
rulemaking, the PERM program has been configured to satisfy the 
requirements of section 1903(u) of the Act (as opposed to the 
traditional MEQC program that, as we note above, the DAB found failed 
to yield evidence sufficiently reliable to support a disallowance), 
thus establishing CMS's authority to issue PERM eligibility-related 
disallowances and clarifying the ``good faith effort'' exception. As a 
result of that rulemaking, CMS will once again measure the current 
improper payment rate for the eligibility component of the PERM 
program, beginning with the FY 2019 reporting. Under the PERM program, 
each State is reviewed on a rolling 3-year basis to produce an annual 
national improper payment rate for the Medicaid program. Current 
regulations will allow CMS to begin to issue potential disallowances to 
States based on PERM program findings in FY 2022, when all States have 
been reviewed once under the revised rule and allowed a chance to 
implement prospective improvements in eligibility determinations to 
demonstrate a ``good faith effort.''

    Also as part of that July 2017 rulemaking, CMS implemented a 
revised MEQC program that uses State-directed reviews in the two off-
cycle PERM years to address Medicaid beneficiary eligibility 
vulnerabilities. Under this revised program, should States find active 
cases for which eligibility determination errors were made, they are 
required to assess the financial implications of the error during the 
three-month period after the erroneous eligibility date and will be 
require to return the Federal share of any overpayments made as a 
result of these erroneous eligibility determinations through the 
quarterly CMS-64 and CMS-21 reporting processes.

    National PERM eligibility improper payment rates for the time 
period FY 2008 through FY 2014 covered review periods for eligibility 
determinations made prior to the implementation of the Patient 
Protection and Affordable Care Act (PPACA) (Pub. L. 111-148). With the 
implementation of PPACA, State eligibility determination processes and 
the eligibility review methodology have changed drastically. In light 
of changes to the way States adjudicate eligibility for applicants for 
Medicaid and CHIP under PP ACA, CMS did not conduct the eligibility 
measurement component of the PERM program for FY 2015 through FY 2018 
in order to enable us to update the eligibility component measurement 
methodology in the July 2017 rulemaking. For reporting years FY 2015 
through FY 2018, the 2014 national eligibility improper payment rate 
was used as a proxy rate, and all States conducted a pilot program with 
rapid feedback for improvement (known as the Medicaid and CHIP 
Eligibility Review Pilots) to maintain oversight of State eligibility 
determinations. Revisions made in the July 2017 rulemaking include 
updates to the review elements; the review process, including Modified 
Adjusted Gross Income (MAGI) methodologies and use of electronic data 
sources; and the use of a Federal contractor as the entity performing 
the reviews. As noted above, beginning with the FY 2019 reporting, CMS 
will again measure a national improper payment rate for the eligibility 
component of the PERM program. This information is scheduled to be 
reported in November of 2019.
             graham-cassidy-heller-johnson budget proposal
    Question. In the President's proposed FY 2020 budget, the 
administration makes clear that it once again intends to bring back the 
failed Graham-Cassidy-Heller-Johnson proposal, legislation that would 
gut the Affordable Care Act's consumer protections--legislation that 
the American people clearly rejected.

    Please describe how the Graham-Cassidy-Heller-Johnson legislation 
differs from the proposal in the budget.

    The Graham-Cassidy-Heller-Johnson legislation included a provision 
allowing insurance companies to charge older Americans more for their 
health care. Would the administration's legislative proposal, modeled 
closely after the Graham-Cassidy-Heller-Johnson bill, also include this 
age tax? Please describe what age rating limits would be placed on 
insurers. What is the projected impact on older Americans' insurance 
premiums?

    The President's budget proposal requires States to allocate at 
least 10 percent of their grant to funding protections for people with 
pre-existing conditions. Please describe how the Department determined 
10 percent to be an appropriate allocation amount.

    Answer. The administration believes that States are better situated 
to address the health-care needs of their citizens and this proposal 
puts the States in the driver's seat. The administration is also 
committed to empowering States and consumers to reform their health 
insurance markets. The President's budget supports a two-part approach 
starting with enactment of legislation modeled closely after the 
Graham-Cassidy-Heller-Johnson bill that include Market Based Health 
Care Grants. The second part of the budget proposal includes additional 
reforms to make the system more efficient and to address unsustainable 
health-care spending trends, including proposals to align the growth 
rates for the Market-Based Health Care Grant Program and Medicaid per 
capita cap and block grant with the Consumer Price Index for All Urban 
Consumers (CPI-U).

    Under the budget proposal, States will be required to allocate at 
least 10 percent of their grant funding to ensure protections for high-
cost individuals, including those with pre-existing conditions. This 
demonstrates the importance of ensuring protections for individuals 
with pre-existing conditions and that all Americans have access to 
affordable, high value care, including those with pre-existing 
conditions.
             1332 and short-term limited duration insurance
    Question. Congress enacted section 1332 of the Affordable Care Act 
to provide States with the flexibility to improve coverage, 
affordability, and comprehensiveness of benefits. Consistent with these 
goals, States must prove that their waivers meet specific guardrails. 
Last year, HHS released new guidance and examples on section 1332 which 
weakened pre-existing condition protections and suggested some ideas 
for waivers that would allow a State to provide less comprehensive, 
less affordable coverage.

    Will HHS approve a section 1332 waiver proposal if it would provide 
less comprehensive or less affordable coverage? Please describe the 
circumstances in which you will approve a section 1332 waiver if it 
provides less comprehensive or less affordable coverage.

    Please explain whether the administration's new section 1332 
examples would allow taxpayer dollars to go to short-term limited-
duration insurance.

    Answer. On October 24, 2018, the Department of Health and Human 
Services and the Department of the Treasury (the Departments) published 
new 1332 guidance that replaced the December 2015 guidance. The new 
guidance will permit States to more readily take advantage of the 
flexibility allowed by the statute. The guidance ensures that State 
residents who wish to retain coverage similar to that provided under 
the PPACA can continue to do so, while permitting a State waiver plan 
to also provide access to other options that may be better suited to 
consumer needs and more attractive to many individuals. The Departments 
believe that the new guidance will lower barriers to innovation and 
encourage States to implement waiver plans that will strengthen their 
health insurance markets by providing a variety of coverage options.

    Section 1332 waivers are optional; States are free to choose to 
apply for a waiver or continue to have their markets subject to 
applicable PPACA rules. The October 2018 guidance does not create 
binding rights or obligations, but instead provides transparency to 
States and the public regarding the manner in which the Departments 
intend to use their discretion when they review State applications. 
Additionally, each section 1332 waiver application will be considered 
in its entirety to evaluate whether it meets the statutory guardrails, 
regulations, and guidance. This requirement to meet all statutory 
guardrails includes instances where a State waiver application proposes 
to make available alternative coverage options like short-term, 
limited-duration plans. The Departments cannot assess whether or not a 
proposal meets the guardrails until we receive a specific proposal from 
a State. The Departments wish to work with States to develop their 
ideas and ultimately implement these programs to benefit consumers.

    A 1332 waiver cannot undermine coverage for people with pre-
existing conditions. Moreover, any section 1332 waiver will need to 
carefully account for any impact on the individual market risk pool and 
guarantee that access to coverage is at least as comprehensive and 
affordable as would exist without the waiver.
                       lower tax credits proposal
    Question. In the ``Patient Protection and Affordable Care Act; HHS 
Notice of Benefit and Payment Parameters for 2020,'' your Department 
proposed to modify the formula for indexing the tax credits that help 
patients and families buy insurance. This proposal could also raise the 
maximum out-of-pocket cost-sharing limit that people have to pay.

    Please describe how the Department expects the proposed change in 
the premium adjustment calculation will impact premiums and out of 
pocket costs for consumers.

    Please describe how the Department expects the proposed change in 
the premium adjustment calculation will impact consumer enrollment.

    Answer. In the 2020 Notice of Benefit and Payment Parameters 
Proposed rule, we proposed a premium adjustment percentage of 
1.2969721275 for the 2020 benefit year, including a proposed change to 
the premium measure for calculating the premium adjustment percentage. 
The annual premium adjustment percentage sets the rate of increase for 
several parameters detailed in the PPACA, including: the annual 
limitation on cost sharing, the required contribution percentage used 
to determine eligibility for certain exemptions under section 5000A of 
the code, and the employer shared responsibility payments under 
sections 4980H(a) and 4980H(b) of the code.

    The proposal in the 2020 Notice of Benefit and Payment Parameters 
proposed rule to use private health insurance premiums (excluding 
Medigap and property and casualty insurance) in the premium adjustment 
percentage calculation would result in a faster premium growth rate 
measure than if we continued to use employer-sponsored insurance 
premiums as was used for prior benefit years. In the proposed rule, we 
proposed a required contribution of 8.39 percent using the proposed 
premium adjustment percentage in, whereas we would have proposed a 
required contribution of 8.18 percent if employer-sponsored insurance 
premiums continued to be used in the premium adjustment percentage 
calculation for the 2020 benefit year. Additionally, we proposed a 
maximum annual limitation on cost sharing of $8,200 for self-only 
coverage, whereas we would have proposed a maximum annual limitation on 
cost sharing of $8,000 for self-only coverage if employer-sponsored 
insurance premiums continued to be used in the premium adjustment 
percentage calculation for the 2020 benefit year.

    The CMS Office of the Actuary estimates that the proposed change in 
methodology for the calculation of the premium adjustment percentage 
may have the following impacts between 2019 and 2023:

          Net premium increases of approximately $181 million per 
        year, which is approximately one percent of 2018 benefit year 
        net premiums, for the 2020 through 2023 benefit years. Net 
        premiums are calculated for Exchange enrollees as premium 
        charged by issuers minus APTC.
          A decrease in Federal PTC spending of $900 million in 2020 
        and 2021, and $1 billion in 2022 and 2023, due to an increase 
        in the PTC applicable percentage and a decline in Exchange 
        enrollment of approximately 100,000 individuals in benefit year 
        2020, based on an assumption that the Department of the 
        Treasury and the IRS will adopt the use of the same premium 
        measure proposed for the calculation of the premium adjustment 
        percentage in this rule for purposes of calculating the 
        indexing of the PTC applicable percentage and the required 
        contribution percentage under section 36B of the code. We 
        anticipate that enrollment may decline by 100,000 individuals 
        in benefit year 2020, and enrollment would remain lower by 
        100,000 individuals in each year between 2020 and 2023 than it 
        would if there were no proposed change in premium measure for 
        the premium adjustment percentage for the 2020 benefit year.
                             human services
    Question. Recent news reports suggest that the Office of Refugee 
Resettlement (ORR) failed to ensure unaccompanied children are properly 
protected against sexual abuse and exploitation. In your testimony to 
the Senate Finance Committee, you stated that ORR had investigated 
grantee facilities that had a substantiated allegation(s) of staff-on-
minor sexual abuse and, in the case of at least one grantee, had shut 
down one or more facilities and removed the children. You also noted 
that this would then require those facilities, if they were to reopen 
and house unaccompanied children, to go through re-licensing by the 
State licensing authority.

    How do you identify which grantee facilities should be 
investigated? In cases where the findings require it, describe the 
process for transferring detained children and closing the facility. 
What is the role of the State in this process?

    Answer. Care providers must report sexual abuse, sexual harassment, 
or inappropriate sexual behavior that occurs in ORR care within four 
hours after learning of the allegation. Care provider facilities must 
follow State licensing requirements to report allegations of sexual 
harassment and inappropriate sexual behavior.

    Care providers report allegations of sexual abuse to CPS, the State 
licensing agency, HHS/OIG, and the FBI. If an allegation involves an 
adult, the care provider must notify local law enforcement.

    CPS and State licensing authorities investigate allegations of 
sexual abuse according to State law, and the FBI and the HHS/OIG 
investigate allegations according to Federal laws and procedures. CPS 
or the State licensing authority may, during the course of their 
investigations, develop a safety plan or recommend other steps to 
ensure the safety of an impacted child.

    ORR has no formal investigative authority, but reviews every report 
of sexual abuse submitted by care provider facilities to ensure that 
care providers comply with ORR regulations and policies. ORR also 
reviews allegations to ensure that care providers respond appropriately 
to the allegations using child welfare principles.

    If ORR determines that UAC are not safe with a care provider 
following an allegation, ORR issues a ``stop placement'' directive so 
that no unaccompanied alien children are placed at the facility. ORR 
then removes all children from the facility and transfers them to other 
facilities with available capacity. ORR and the care provider continue 
to cooperate with any investigations by law enforcement, CPS, or 
licensing authorities. ORR may also monitor the facility and issue 
corrective actions, as appropriate. ORR resumes placement after the 
issues identified in the corrective actions are satisfactorily 
resolved.

    How many facilities has ORR shutdown since 2014 and what was the 
reason for each shutdown? For each case, also detail where the children 
were transferred to.

    Answer. Since October 2014, ORR has issued a stop placement and 
transferred remaining UAC from one care provider due to a substantiated 
allegation of sexual abuse. In 2017, following reports of a staff 
member sexually assaulting unaccompanied alien children at Southwest 
Key Casa Kokopelli, ORR issued a stop placement and transferred the 
remaining children to other local care providers. The majority of 
children were transferred to Southwest Key Phoenix.

    Question. How many facilities were investigated by ORR but were 
allowed to remain operational? For each case, how is ORR ensuring that 
facilities make changes that ensure children are properly protected 
against sexual abuse and exploitation?

    Answer. ORR reviews every allegation of sexual abuse to ensure that 
care providers take appropriate steps to protect the victim, and ensure 
the safety and well-being of children in their care. Care providers 
must use multiple protection measures to ensure the safety and security 
of victims, including housing changes within a facility, transfers to a 
different facility, and emotional support services.

    In all cases of an allegation of sexual abuse, care provider 
facilities must:

          Report the allegation to ORR, State/local child protective 
        services (CPS), State licensing authorities, HHS's Office of 
        Inspector General, and the U.S. Department of Justice's FBI.
          Report allegations of sexual abuse that involve an adult to 
        local law enforcement.
          Cooperate with any investigation of the allegation, 
        including by CPS, licensing or law enforcement.
          Take immediate action to protect the victim and the safety 
        of other children in the program (i.e., separating the victim 
        from the perpetrator, increasing supervision, housing changes, 
        transfers).
          Provide follow-up services, including medical or mental 
        health services.
          Make appropriate notifications to parents, legal guardians 
        and sponsors, attorneys, and child advocates, if applicable.

    If a sexual abuse allegation involves a staff member, the care 
provider facility is required by regulation to suspend the staff member 
from all duties that would provide the staff member with access to UAC 
pending investigation.

    After investigation by an oversight entity substantiates the 
allegation, a care provider facility must take disciplinary action, up 
to and including termination for violating ORR's or the care provider 
facility's sexual abuse-related policies and procedures. Termination is 
the presumptive disciplinary sanction for staff who engaged in sexual 
abuse or sexual harassment.

    In addition to routine monitoring, ORR has an Abuse Review Team 
(ART) that quickly reviews allegations of abuse that are particularly 
serious or egregious in nature. The team is composed of ORR staff with 
the appropriate expertise to assess these allegations, including 
members of ORR's Monitoring Team, the Division of Health for 
Unaccompanied Children, and ORR's Prevention of Sexual Abuse 
Coordinator.

    Question. Table S-6 (on page 124) of the President's budget 
includes a line item stating ``protect the religious liberty of child 
welfare providers.''

    Please describe what this line item is referencing. Is it 
associated with an HHS proposal allowing taxpayer-funded child welfare 
providers to choose which individuals they work with (e.g., qualified 
volunteers, foster parents, and adoptive parents) based on the 
individual's religious identity? If so, please detail the proposed 
policy.

    Answer. The Department believes faith-based providers are the 
bedrock of some of our most difficult placements in terms of children 
with disabilities and, historically, always have been. In the 
President's FY 2020 budget there is a line item entitled ``Protect the 
religious liberty of child welfare providers'' (page 124). This 
proposal is consistent with the Department's grant of an exception to 
the State of South Carolina. In light of the foster care crisis 
resulting from insufficient numbers of foster families, and the 
concurrent moves by some States to close foster providers on the basis 
of the providers' religious beliefs, the administration believes 
Congress should protect adoption and foster care providers from 
discrimination or from burdens imposed on their exercise of their faith 
that may eliminate them from contributing to the number of foster 
placements made in a State. Such an action by Congress would increase 
the scope of available foster and adoption care providers and help 
alleviate the present crisis.

    Question. You and the Department of Health and Human Services (HHS) 
have granted South Carolina an exemption from Federal nondiscrimination 
laws and regulations for State-contracted child welfare agencies in the 
State. You have defended this decision by citing a substantial burden 
to faith-based providers, but you have not addressed how foster youth 
being served by faith-based providers are protected under this waiver 
and whether their religious liberty is protected.

    How will HHS ensure that foster children of a minority religion in 
South Carolina will not be discriminated against, harassed, prohibited 
from exercising their faith, or forced to exercise a faith other than 
their own when being placed by an agency that is devout to a singular 
religious ideology?

    How will HHS assure that the needs of LGBTQ-identified youth in 
foster care in South Carolina will be addressed and protected from 
harassment, discrimination and forms of conversion practices when being 
placed by an agency that professes a deeply held belief against being 
LGBTQ?

    Answer. In light of the request from Governor McMaster, the 
Department granted an exception to the religious nondiscrimination 
provision in 45 CFR Sec. 75.300(c). We determined that requiring 
Miracle Hill Ministries to abandon its use of religious criteria as a 
condition of receiving title IV-E funds would substantially burden the 
free exercise of religion in violation of Religious Freedom Restoration 
Act, 42 U.S.C. Sec. 2000bb, et seq. (RFRA). Our decision to grant an 
exception was also guided by programmatic considerations because 
Miracle Hill Ministries is responsible for up to 15 percent of the 
foster care placements in South Carolina. If it were to cease providing 
services, the State's foster care program would have been substantially 
burdened. Moreover, there are at least nine other agencies in South 
Carolina that may assist foster parents in the event that Miracle Hill 
Ministries is not able to do so as a result of its sincerely held 
religious beliefs.

    The mission of HHS is to enhance and protect the health and well-
being of all Americans. We are committed to providing top quality 
service regardless of race, religion, creed, ethnicity, sexual 
orientation, or any other socio economic identifiers. HHS does not 
condone any form of harassment and discrimination. Our HHS Office for 
Civil Rights investigates and takes appropriate action on matters that 
infringe on civil rights, conscience and religious freedom, privacy, 
and patient safety confidentiality, or violation of the law.

                                 ______
                                 
              Questions Submitted by Hon. Robert Menendez
    Question. During the hearing, you testified that the CDC was not 
conducting research on gun violence because the agency did not have the 
funding to do so. It is my understanding that researchers may apply for 
grants to study gun violence under the Injury Prevention and Control 
program.

    Has the CDC received any grant applications for gun violence 
research under the Injury Prevention and Control program?

    Answer. CDC has not received grant applications specifically for 
gun violence research, but in response to the FY 2019 Notice of Funding 
Opportunity (NOFO) for CE19-001, Injury Control Research Centers, some 
applicants did include proposals for research to develop or evaluate an 
intervention to prevent suicide that included one of the following 
topics related to guns:

          Training for health-care providers to improve their ability 
        to identify at-risk patients and provide education to the 
        patient and caregivers on safe firearm storage and access.
          Evaluate the impact of changing policies on health-care 
        access and firearm laws on mortality.
          Evaluation of secondary data related to firearm laws in the 
        interpretation of surveillance data.

    Question. If yes, why were the applicants not awarded funding?

    Answer. The Notice of Funding Opportunity for the Injury Control 
Research Centers published in FY 2018 and has not yet been awarded. CDC 
expects to make awards this month.

    Question. What resources does the CDC need to begin research on gun 
violence?

    Answer. The FY 2020 President's budget does not include specific 
funding for CDC to conduct research on gun violence. The budget 
includes $24 million for the National Violent Death Reporting System 
(NVDRS), a surveillance system which identifies violence trends at 
national and regional levels by linking data from law enforcement, 
coroners and medical examiners, vital statistics, and crime 
laboratories. NVDRS is a State-based surveillance system that captures 
information on all types of violent deaths-including homicides and 
suicides. Information on firearms is collected as a mechanism of 
injury; the system also collects data on unintentional firearm injury 
deaths. The budget request focuses on public health data collection by 
States--activity that is core to CDC's mission.

    Question. Secretary Azar stated that the HHS IG report 
``speculated'' that there ``may have been thousands not that they found 
them'' in reference to children being separated from their parents 
prior to the June 26, 2018 court order in Ms. L v. ICE. Has ORR 
identified how many children were separated from parents prior to the 
June 26, 2018 court order? If so, what is that number? If not, why not?

    Answer. ORR is presently implementing a court-approved plan to 
identify the separated children of Ms. L. class members for the time 
period of July 1, 2017 through June 25, 2018 (also referred to as the 
expanded class period). The filings by the Government explaining that 
plan are attached.

    Question. Does ORR dispute the findings of the HHS IG report that 
``officials estimated that ORR received and released thousands of 
separated children prior to the June 26, 2018 court order'' and what is 
the basis for disputing the report's findings?

    Answer. OIG did not find that thousands of children were separated 
by DHS and discharged before June 26, 2018. Rather, the OIG reported 
that members of the HHS staff estimated that such children could number 
in the thousands. Our response to the question above addresses our 
estimations with respect to the number of separated children.

    Question. During the hearing, I requested you follow up with my 
office in writing with the exact steps HHS is taking to ensure that the 
families that were separated prior to the June 26, 2018 are identified 
and reunited. The Secretary stated it would be possible for him to do 
so as such information is consistent with the status reports HHS 
provides the courts. My office is still waiting for that information.

    Answer. As noted above, copies of the filings by the Government in 
Ms. L, which explain the Government's plan to identify the separated 
children of Ms. L. class members for the expanded class period, are 
attached. The Court has not yet addressed remedies issues in the 
litigation.

    Question. The budget mentions the troubling upward maternal 
mortality trend in the United States but there are cuts to critical 
programs like title V, Medicaid, and other programs in HRSA that help 
moms and babies. Can you share the administration's strategy to reduce 
maternal mortality and support new moms and babies while cutting 
programs intended to help those groups?

    Answer. The FY 2020 budget Request for the Health Resources and 
Services Administration includes funding specifically targeted to 
addressing maternal mortality by expanding access to safe, high-quality 
health care for women of childbearing age. Specific efforts include 
continued support for State Maternal Health Innovation grants and 
expansion of the Alliance for Innovation on Maternal Health (AIM) 
program's maternal safety bundles to all 50 U.S. States, the District 
of Columbia, U.S. territories, and tribal entities.

          As of late April 2019, AIM is now working with 26 States and 
        has implemented maternal safety bundles in more than 1,300 
        birthing facilities across the country, reaching nearly two 
        million annual births (or around half of all annual births in 
        the United States).
          State Maternal Health Innovation Grants will support State-
        focused demonstrations that implement evidence-based 
        interventions to address critical gaps in maternity care 
        service delivery and reduce disparities in maternal morbidity 
        and mortality.

    In addition, other maternal and child health investments aim to 
improve the overall health and well-being of mothers and babies which 
is also important for reducing maternal mortality. The Healthy Start 
Initiative: Eliminating Disparities in Perinatal Health (Healthy Start) 
will continue to support efforts to address maternal mortality through 
hiring of nurse practitioners, certified nurse midwives, physician 
assistants, and other maternal-child advance practice health 
professionals to provide clinical services, such as well-woman care and 
maternity care services, within program sites nationwide. In 
partnership with the States, the MCH Block grant supports a wide range 
of activities and initiatives reaching 86 percent of all pregnant women 
in the U.S.

    Question. The budget makes significant changes to the way the 
Federal Government funds graduate medical education (GME). Given we are 
in the midst of an ever-growing physician shortage, are there data and 
projections available on how your proposal will address the shortage 
and ensure there are sufficient physician providers to meet America's 
needs today and into the future?

    Answer. Funding for Graduate Medical Education (GME) comes from 
multiple fragmented funding streams, and HHS's GME financing system 
does not target training to the types of physicians needed in the 
United States. The President's FY 2020 budget includes a proposal that 
would consolidate Federal graduate medical education spending from 
Medicare, Medicaid, and the Children's Hospital Graduate Medical 
Education Program into a single grant program for teaching hospitals. 
Total funds available for distribution in FY 2020 would equal the sum 
of Medicare and Medicaid's 2017 payments for graduate medical 
education, plus 2017 spending on Children's Hospital Graduate Medical 
Education, adjusted for inflation. This amount would then grow at the 
CPI-U minus one percentage point each year. Payments would be 
distributed to hospitals based on the number of residents at a hospital 
(up to its existing cap) and the portion of the hospital's inpatient 
days accounted for by Medicare and Medicaid patients. The new grant 
program would be jointly operated by the Administrators of CMS and the 
Health Resources and Services Administration. This grant program would 
be funded out of the general fund of the Treasury. The Secretary would 
have authority to modify the amounts distributed based on the 
proportion of residents training in priority specialties or programs 
(e.g., primary care, geriatrics) and based on other criteria identified 
by the Secretary, including addressing health-care professional 
shortages and educational priorities. These changes modernize graduate 
medical education funding, making it better targeted, transparent, 
accountable, and more sustainable.

    Question. The budget again zeroes out funding for ``Autism and 
Other Developmental Disorders'' at HRSA. How does the administration 
propose to maintain the programs that funding supports and continue to 
invest in autism research, surveillance, and care at a time when the 
autism prevalence rate continues to increase with diminished 
investment?

    Answer. The President's budget prioritizes programs that support 
direct health-care services and give States and communities the 
flexibility to meet local needs. Some of these activities could be 
continued by States using their Maternal and Child Health Block Grant 
awards.

    Question. What investments can we make in Medicare and Medicaid to 
use claims data to flag potential price fixing collusion in the 
prescription drug space?

    Answer. For years, American patients have suffered under a drug-
pricing system that provides generous incentives for innovation, while 
too often failing to deliver important medications at an affordable 
cost. We have access to the greatest medicines in the world, but access 
is meaningless without affordability.

    To address this issue, in May 2018, I joined with President Trump 
to release the American Patients First Blueprint,\9\ a comprehensive 
plan to bring down prescription drug prices and out-of-pocket costs, 
using four key strategies for reform: increased competition, better 
negotiation, incentives for lower list prices, and lowering out-of-
pocket costs.
---------------------------------------------------------------------------
    \9\ https://www.hhs.gov/sites/default/files/
AmericanPatientsFirst.pdf.

    Recognizing that the status quo is indefensible, HHS has rapidly 
taken administrative steps where the Department has authority to turn 
the President's vision into action. These actions include proposals to 
create competition for physician-administered drugs, improve 
competition and negotiation between Medicare's prescription drug plans, 
increase price transparency for drugs advertised on television, end the 
payment of kickbacks that are artificially driving up prices, ensure 
beneficiaries are benefiting from price concessions at the pharmacy 
counter, and address foreign free-riding so that Americans pay prices 
---------------------------------------------------------------------------
closer to what patients in other countries pay for the same drugs.

    CMS also updated its Drug Spending Dashboards with data for 2017. 
This administration's version of the drug dashboards, first released in 
May of last year, adds information on the manufacturers that are 
responsible for price increases and includes pricing and spending data 
for thousands more drugs across Medicare Parts B and D and Medicaid.

    HHS will continue to use all of its administrative tools to achieve 
these goals, and recognizes Congress has the authority to implement 
more sweeping changes. The administration looks forward to working with 
Congress on bipartisan solutions that lower costs, increase 
transparency, and protect patient access and safety.

    The FY 2020 budget legislative proposals complement the many 
successful administrative actions HHS has already taken to lower the 
cost of prescription drugs. These proposals will protect seniors and 
taxpayers by modernizing Medicare Part D, and improving transparency 
and accuracy of payments under Medicare Part B. The budget also 
includes proposals to ensure manufacturers pay their fair share of 
Medicaid rebates covering all price increases.

    Question. The Democratic Republic of Congo is battling the second 
deadliest outbreak of Ebola in history. So far, there have been a 
reported 913 probable cases, with 574 fatalities, and the outbreak is 
not yet under control. Insecurity and community distrust of 
authorities--including health-care workers--have significantly hampered 
the response. Two treatment centers operated by Doctors Without Borders 
were attacked in recent weeks, prompting the organization to close 
them. We withdrew CDC and USAID experts in September of last year due 
to insecurity. While some U.S. experts have returned to Goma, security 
remains an obstacle to the deployment of CDC experts to Ebola 
epicenters to assist with training health-care workers, gathering data 
and lending expertise on contact tracing and building community trust.

    When did the administration last conduct an on the ground 
assessment in eastern Congo to determine what security measures would 
have to be put in place to make it safe for CDC experts to return to 
Ebola epicenters?

    Have there been any recent discussions of what security measures 
the administration might bring to bear to allow CDC and other USG 
personnel to travel to these regions?

    When was the last time you spoke with Secretary of State Mike 
Pompeo about the Ebola response, and what additional USG efforts might 
be brought to bear, and specifically on the issue of provision of 
security?

    To your knowledge, is Secretary Pompeo in active discussions with 
the United Nations about how the United Nations peacekeeping mission 
currently located in eastern Congo might be able to assist with 
security?

    What efforts are we making to overcome community distrust, the 
other major barrier to an effective response?

    Answer. HHS is working closely with other relevant Departments and 
agencies to address the Ebola outbreak. We refer you to the Department 
of State which can answer the other questions pertaining to security 
and peacekeeping.

    Question. Given the risk of the Ebola outbreak spreading across 
borders to South Sudan, Rwanda and Uganda, is there more that we can 
and should do to contain this outbreak?

    Answer. CDC's long-term investments in disease specific work in 
South Sudan, Rwanda, and Uganda have improved each country's ability to 
respond to this complex Ebola outbreak. To assist with screening for 
cases at international borders:

    CPI-UCDC is assisting the DRC Ministry of Health and other partners 
to adapt and train on screening protocols at country-prioritized 
airports and ground crossings; and map population movement into and out 
of the outbreak zone to determine where surveillance should be enhanced 
across borders.

    CPI-UCDC is also working with the Ministries of Health in Uganda, 
Rwanda, and South Sudan to assess and enhance border health capacity 
for surveillance and response, which includes development and 
implementation of border screening protocols. All four countries are 
conducting border screening.

    As of May 4, 2019, over 55 million travelers have been screened at 
priority ports and crossing points in DRC since the outbreak began in 
August 2018. To date, there have been no confirmed cases of Ebola in 
the neighboring countries. CDC and its partners stand ready to provide 
additional assistance to South Sudan, Rwanda, and Uganda as needed.

                                 ______
                                 
             Questions Submitted by Hon. Benjamin L. Cardin
                             public charge
    Question. The Department of Homeland Security has proposed to deny 
green cards and visas to immigrants who have used or might use public 
programs like Medicaid. In comments on this rule, community health 
centers, hospitals, insurance companies, doctors and patient advocates 
all stated that they believed it would lead to families to avoid using 
health care out of fear, and in fact, already has.

    In their comments submitted on Public Charge, the Association of 
Community Affiliated Plans noted the following, ``Well before the 
proposed rule was ever published, one Medicaid health plan in Texas 
found that leaked versions of the proposal contributed to declining 
enrollment in its State; it is thought that nearly 150,000 fewer 
individuals currently access Medicaid in Texas in part due to the 
leaked rule.'' ``Another Medicaid health plan in California -along with 
many of its contracted providers--has already received calls from 
Medicaid enrollees expressing their fear of being considered a public 
charge and requesting information on how to disenroll from the 
program.''

    Can you speak to this proposed rule, the fear it has created in 
immigrant communities, and any action your agency has taken to address 
those fears?

    Answer. HHS defers to the Department of Homeland Security regarding 
its proposed regulations. HHS will continue our work to ensure that 
Medicaid enrollees are truly eligible and are receiving services as 
appropriate.
                        outreach and enrollment
    Question. Over the past 2 years, the Trump administration has made 
dramatic cuts to outreach and enrollment in the Affordable Care Act, 
cutting advertising by 90 percent and cutting the Navigator program by 
80 percent. You and your staff have claimed that these programs are no 
longer needed.

    Have you conducted any research into consumer awareness of open 
enrollment or the Affordable Care Act?

    Have you conducted any research on people who receive in-person 
assistance and whether they are significantly more likely to enroll 
than people who try to enroll by themselves online?

    Answer. Data from the 2019 Open Enrollment Period shows steady plan 
selections through the Federal platform (i.e., HealthCare.gov), with 
more than 8.4 million consumers selecting a plan as of the end of open 
enrollment, December 15, 2018. As was the case last year, CMS remained 
committed to its primary goal of providing a seamless enrollment 
experience for HealthCare.gov consumers, and data show that we achieved 
this goal. Consistent with last year, the consumer satisfaction rate at 
the call center remained at an all-time high--averaging 90 percent--
throughout the entire Open Enrollment Period and, for the second year 
in a row, CMS did not need to deploy an online waiting room during the 
final days of Open Enrollment. As a result, HealthCare.gov consumers 
were able to shop and pick a plan with minimal interruption throughout 
the entire enrollment period.

    When the exchanges were in their infancy, and public awareness and 
understanding of coverage options was low, HHS encouraged Navigators to 
cast a wide net and to provide intensive face-to-face assistance to 
consumers. Since that time, public awareness and education on options 
for private coverage available through the exchanges has increased. 
Certified application counselors, direct enrollment partners, and 
exchange-registered agents and brokers serve as additional resources 
for education on options and outreach to consumers. Enrollment data 
from previous years show that Navigators failed to enroll a meaningful 
number of people through the FFEs, comprising less than 1 percent of 
enrollment in both plan year 2017 and plan year 2018--not nearly enough 
to justify the millions of Federal dollars spent on the program. It was 
appropriate to scale down the Navigator program and other outreach 
activities to reflect the enhanced public awareness of health coverage 
options through the exchanges. Additionally, in the Funding Opportunity 
Announcements (FOA) for the FFE Navigator Program for plan year 2019 
and 2020, Navigator applicants were encouraged to leverage volunteers 
as well as strategic partnerships with public and private organizations 
to target consumers who would benefit from exchange coverage and more 
efficiently meet their enrollment goals. These changes are based on the 
success of private sector-focused programs, such as those within 
Medicare Advantage.

    Question. Last July, GAO released a report deeply critical of your 
agency's management of open enrollment, including the justifications 
for cutting outreach and Navigator funding. GAO found that the cuts, in 
the case of Navigators, were made with incomplete data and failed to 
account for the responsibilities that navigators play beyond patient 
enrollment in qualified health plans. GAO found that navigators 
grantees conducted 68 percent fewer events, laid off staff and 
deprioritized certain populations, such as rural individuals.

    How has your agency responded to the critiques in that report and 
do you plan to use more accurate metrics in determining Navigator 
funding?

    Answer. HHS appreciates the ongoing work of the GAO to study 
critical aspects of our health-care system, including outreach and 
enrollment for the Federally Facilitated Exchange, the subject of the 
report you mention. In that report,\10\ the GAO provided a number of 
recommendations. We concurred with GAO's recommendation to ensure that 
the approach and data we use for determining Navigator award amounts 
accurately and appropriately reflect Navigator performance. We have 
provided guidance to Navigators that their grant funding will be 
explicitly tied to their self-identified goals and their ability to 
meet those goals. We also concurred with the GAO's recommendation to 
assess other aspects of the consumer experience to ensure we have 
quality information to achieve our goals. We have assessed the consumer 
experience through the availability of the two largest customer 
channels supporting exchange operations--the call center and 
HealthCare.gov--as well as customer satisfaction surveys. We believe 
these metrics represent a comprehensive assessment of the consumer 
experience. We are always looking for ways to improve the consumer 
experience and will consider focusing on other aspects of the consumer 
experience as needed. The GAO also recommended that we should establish 
numeric enrollment targets for HealthCare.gov to monitor its 
performance. We did not concur with this recommendation because there 
are numerous external factors that can affect a consumer's decision to 
enroll that are outside our control, such as the state of the economy, 
issuer rates, employment rates, and the number of people who effectuate 
their coverage. These are factors that are wholly unrelated to the 
performance of HealthCare.gov. The Department believes that a more 
informative performance metric is whether everyone who utilized 
HealthCare.gov, who qualified for coverage, and who desired to purchase 
coverage, was able to make a plan selection. HHS does not believe that 
numeric enrollment targets are relevant to assess the performance of 
objectives related to a successful open enrollment period for the 
exchange.
---------------------------------------------------------------------------
    \10\ ``Health Insurance Exchanges: HHS Should Enhance its 
Management of Open Enrollment Performance'' (GAO-18-565), July 2018.

    Question. How do you expect Navigators to fulfill their 
---------------------------------------------------------------------------
responsibilities with such cuts?

    Answer. We take seriously our responsibility to safeguard taxpayer 
dollars and use them effectively to serve the American people. 
Navigator funding was re-
assessed as part of an effort to promote accountability and cost-
effectiveness. When the exchanges were in their infancy, and public 
awareness and understanding of coverage options was low, HHS encouraged 
Navigators to cast a wide net and to provide intensive face-to-face 
assistance to consumers. Since that time, public awareness and 
education on options for private coverage available through the 
exchanges has increased. Certified application counselors, direct 
enrollment partners, and exchange-registered agents and brokers serve 
as additional resources for education on options and outreach to 
consumers. Enrollment data from previous years show that Navigators 
failed to enroll a meaningful number of people through the FFEs, 
comprising less than 1 percent of enrollment in both plan year 2017 and 
plan year 2018--not nearly enough to justify the millions of Federal 
dollars spent on the program. It was appropriate to scale down the 
Navigator program and other outreach activities to reflect the enhanced 
public awareness of health coverage options through the exchanges. 
Additionally, in the Funding Opportunity Announcements (FOA) for the 
FFE Navigator Program for plan year 2019 and 2020, Navigator applicants 
were encouraged to leverage volunteers as well as strategic 
partnerships with public and private organizations to target consumers 
who would benefit from exchange coverage and more efficiently meet 
their enrollment goals. These changes are based on the success of 
private sector-focused programs like those within Medicare Advantage.

    As part of its adjustments in spending, CMS committed resources to 
cost-effective, high-impact outreach during this year's Open Enrollment 
Period and increased outreach efforts as the plan selection deadline 
approached. For instance, CMS sent over 700 million reminder emails and 
text messages to consumers, as well as 3.2 million outreach emails to 
help Navigators, agents and brokers assist consumers. Data from the 
2019 Open Enrollment Period for plan selections through the Federal 
platform shows steady plan selections, with more than 8.4 million 
consumers selecting a plan as of the end of open enrollment, December 
15, 2018. As was the case last year, CMS remained committed to its 
primary goal of providing a seamless enrollment experience for 
HealthCare.gov consumers, and data show that we achieved this goal. 
Consistent with last year, the consumer satisfaction rate at the call 
center remained at an all-time high--averaging 90 percent--throughout 
the entire Open Enrollment Period and, for the second year in a row, 
CMS did not need to deploy an online waiting room during the final days 
of Open Enrollment.
                              disparities
    Question. Health-care disparities continue to be a major problem in 
our country. People of color continue to see lower life expectancy and 
worse health-care outcomes due to systemic and historical barriers, in 
addition to simply the lack of sufficient resources going to their 
communities. Not only are these disparities morally wrong, but they 
also hurt our economy. The W.K. Kellogg Foundation and Altarum found 
that racial disparities cause $93 billion in excess medical care costs 
and $42 billion in untapped productivity, and that, if addressed, could 
boost the economy by $8 trillion in the next 30 years.

    What actions is your agency taking to address disparities in health 
care?

    Answer. At CMS, the Office of Minority Health (OMH) ensures that 
the voices and needs of the populations it represents are present as 
the agency is developing, implementing, and evaluating its programs and 
policies, and is working to ensure that all beneficiaries achieve their 
highest level of health.

    CMS OMH leads the work on the CMS Equity Plan for Improving Quality 
in Medicare. The plan is intended to help Quality Improvement 
Organizations, Hospital Improvement Innovation Networks, and other 
organizations embed health equity throughout their work. The CMS Equity 
Plan for Medicare consists of six priority areas including:

          Expanding the collection, reporting, and analysis of 
        standardized racial and ethnic data;
          Evaluating disparity impacts and integrating equity 
        solutions across CMS programs;
          Developing and disseminating promising approaches to reduce 
        health disparities;
          Increasing the ability of the health-care workforce to meet 
        the needs of vulnerable populations;
          Improving communication and language access for individuals 
        with limited English proficiency and persons with disabilities; 
        and
          Increasing physical accessibility of health-care facilities.

    Many of these areas are also central to the effort throughout HHS 
to reduce health disparities.
                    family separation at the border
    Question. On Friday, March 8th, Judge Dana Sabraw of the District 
Court for the Southern District of California ruled to increase the 
number of families eligible for reunification by including those which 
were separated between July 1, 2017 and June 25, 2018. According Jallyn 
Sualog, Acting Deputy Director for Children's Programs at ORR, every 
case within that period would have to be reviewed to identify which 
children were separated from a parent. In that time, a total of 43,083 
children passed through ORR.

    How are ORR and HHS preparing to take on this new effort?

    Answer. As noted above, copies of the filings by the government in 
Ms. L., which explain the government's plan to identify the separated 
children of Ms. L. class members for the expanded class period, are 
attached.

    Question. It has come to light that there was a large increase in 
unaccompanied minors processed through ORR, well before the class 
action lawsuit Ms. L. v. ICE was filed. Further, ORR had been 
delivering those children to sponsors before Judge Sabraw had issued 
his first injunction on June 26, 2018. Without this information at that 
time, Judge Sabraw limited reunifications to children still in ORR care 
on June 26, 2018.

    Why did ORR and HHS not share this information sooner?

    Answer. Judge Sabraw originally limited the class definition in Ms. 
L. to certain parents of separated children in ORR care as of June 26, 
2018. The numbers of separated children that ORR originally reported to 
the Court were based on that class definition. Judge Sabraw recently 
expanded the class definition to include certain parents of separated 
children in ORR care between July 1, 2017 and June 25, 2018. As a 
result, ORR is now working to identify those class members and report 
information about them to Judge Sabraw.

    Question. What steps will ORR and HHS take to ensure greater 
transparency and communication with the courts and Congress?

    Answer. HHS complies with all statutory authorities and court 
orders that govern the UAC program. HHS is committed to working with 
the courts and court-
appointed monitors in litigation involving the UAC program.

    HHS works diligently to keep Congress continuously updated and 
informed on the ORR/UAC program, reunification efforts, and subsequent 
oversight.

    ORR hosted 99 individual members of Congress at ORR facilities 
across 10 States from June 2018 to the present. In this same time 
frame, ORR managed over 30 tours for members of Congress, their staff, 
and the Congressional Research Service.

    Question. How can HHS, in conjunction with DHS, better determine 
which children should be considered separated and eligible for 
reunification?

    Answer. As noted above, copies of the filings by the government in 
Ms. L, which explain the government's plan to identify the separated 
children of Ms. L. class members for the expanded class period, are 
attached. The Ms. L. Court has not yet made a ruling on remedies for 
the class members for the expanded class period.

    Question. Our Maryland Attorney General, Brian Frosh, has written 
to you and asked for data on the children being held at Maryland 
facilities that are under the custody of the Office of Refugee 
Resettlement, under the Administration for Children and Families, which 
you oversee.

    Can you provide me with the number of children separated from their 
parents that are placed in Maryland under ORR custody, the number of 
locations being used in Maryland, and the timeline for reunification of 
these children with their parents?

    Answer. As of May 5th, there is only one newly separated child in 
ORR care in Maryland, and 26 children have been discharged to sponsors. 
(Some parents were found to be out of class for Ms. L based on further 
review.)

Length of Care                      Count

20-29                               1
40-49                               4
50-59                               3
60-69                               5
70-79                               3
80-89                               1
90-99                               2
100-109                             1
130-139                             2
140-149                             1
150-159                             2
180-189                             1
220-229                             1
Grand Total                         27

    Number of minors placed in a MD ORR funded program (n=27).

------------------------------------------------------------------------
                                                         Total Number of
    Program in MD          Admitted        Discharged     Minors in ORR
                                                            Care in MD
------------------------------------------------------------------------
Bethany Christian                   1               13               14
 Services Maryland
------------------------------------------------------------------------
Board of Child Care                 0               10               10
 Shelter
------------------------------------------------------------------------
Board of Child Care                 0                3                3
 TFC
------------------------------------------------------------------------
Total Number of                     1               26               27
 Minors in ORR Care
 in MD
------------------------------------------------------------------------


    Question. Are parents provided with information on the status of 
their children?

    Answer. All minors in HHS care are assigned case managers. In the 
circumstance of children whose parents are in Federal custody, the case 
managers are in contact with the parents' ICE case managers, ICE 
agents, and other Federal law enforcement officials in order to verify 
their relationship and put the parents and children in communication.

    Within 24 hours of arrival in ORR care, all minors are given the 
opportunity to communicate with a verified parent, guardian or relative 
living in or outside the United States. Every effort is made to ensure 
minors can communicate (via telephone or video) at least twice per 
week.

    Safety precautions are in place to ensure that an adult wishing to 
communicate with a minor is a family member or potential sponsor. 
Attorneys representing minors have unlimited telephone access to such 
minors, and the minor may speak to other appropriate stakeholders, such 
as their consulate, case coordinator, or child advocate.
           medicaid expansion and mental health/sud treatment
    Question. Under the ACA, States are permitted to enroll adults in 
Medicaid with incomes below 138 percent Federal Poverty Level. 
Currently, 36 States and DC have adopted Medicaid expansion, which has 
led to millions of Americans receiving affordable and quality health 
insurance. Included in the coverage they receive is treatment for 
mental health illnesses and substance use disorders.

    The Trump administration supports eliminating the Medicaid 
expansion, which would leave millions without coverage, including those 
who are benefiting from substance use disorder and mental health 
treatments. At a time when the opioid epidemic is devastating parts of 
this country, we need to be working on expanding coverage for these 
essential services.

    Can you explain how the administration plans to provide these 
Americans coverage for treatment of mental health and substance use 
disorders if the Medicaid expansion is repealed?

    Answer. Successful partnership between our leadership at HHS and 
the leaders of every State Medicaid program is vital to delivering on 
the mission of HHS and the mission of the Medicaid program: improving 
the health and well-being of the Americans we serve. This 
administration is committed to granting States more freedom to design 
innovative local solutions. We have followed through on that promise by 
supporting efforts like waiving decades-old restrictions on addiction 
treatment services, allowing States to link working age beneficiaries 
to new opportunities through work and community engagement programs, 
and rolling back overly prescriptive Federal regulations and policies.

    The Medicaid program was designed to serve our most vulnerable 
populations like children and people with disabilities. To strengthen 
the fiscal sustainability of this critical safety net for generations 
to come, this administration is looking at ways to facilitate State 
innovation and increase patient choice.
                        pre-existing conditions
    Question. Because of the Affordable Care Act, health insurance 
companies cannot refuse to cover someone or charge someone more just 
because they have a pre-
existing condition. Among the most common pre-existing conditions are 
high blood pressure, behavioral health disorders, high cholesterol, 
asthma/chronic lung disease, heart conditions, diabetes, and cancer. In 
2017, HHS released a report \11\ stating that as many as 133 million 
non-elderly Americans have a pre-existing condition.
---------------------------------------------------------------------------
    \11\ https://aspe.hhs.gov/system/files/pdf/255396/Pre-
ExistingConditions.pdf.

    In December, a District Court judge in Texas ruled that the ACA is 
unconstitutional. The Trump administration recently filed a brief with 
the 5th Circuit Court of Appeals stating that they support the lower 
court ruling, and that the provisions of the ACA, including protections 
of those with pre-existing conditions, should be invalidated. If the 
5th Circuit agrees with the administration's position and upholds the 
lower court decision, millions of Americans, including those with pre-
---------------------------------------------------------------------------
existing conditions, may lose coverage.

    What is the administration's plan to help those with pre-existing 
conditions get the care they need, including the ability to go to a 
doctor, receive medical tests, and purchase prescription medication?

    Answer. The recent U.S. District Court's declaration regarding the 
Affordable Care Act is a partial final judgment that has been stayed 
pending appeal. Therefore, HHS will continue implementing, 
administering, and enforcing all aspects of the ACA, as it had before 
the court issued its decision. This decision does not require that HHS 
make any changes to any of the ACA programs it implements or 
administers, or its enforcement of any portion of the ACA at this time. 
As always, the Trump administration stands ready to work with Congress 
on policy solutions that will deliver more insurance choices, better 
healthcare, and lower costs while continuing to protect individuals 
with pre-existing conditions.
                     oral health training programs
    Question. In 2000, then-Surgeon General David Satcher reminded the 
Nation that oral health is absolutely essential to general human 
health. Since 2000, we have made some huge strides in ensuring access 
to affordable dental care. Medicaid and CHIP have come together to 
provide dental benefits to 43 million children from economically 
vulnerable families. These kids are the most likely to have tooth 
decay, but now they are able to have the dental check-ups to help stop 
minor oral health issues from becoming something life altering. Key to 
the success of this program is having sufficient dentists in all 
communities across America. Unfortunately, 51 million Americans 
currently live in a designated dental health professional shortage area 
according to the Health Resources and Services administration.

    HRSA's Oral Health Training programs have trained thousands of 
primary care dental residents and oral health-care providers, many of 
whom choose to stay working in underserved communities. Additionally, 
without loan repayment programs to help ease dental school debt, 
dentists are more likely to stay in large cities where the pay is 
higher, rather than open up a new practice somewhere that it's really 
needed. The President's budget proposes to cut the entire $41 million 
budget of these Oral Health Training Programs for 2020.

    If this program was eliminated, do you believe we would still be 
able to attract oral health-care providers to these underserved 
communities?

    What is your agency doing to ensure our country's continued 
progress in oral health?

    Answer. The President's FY 2020 budget prioritizes funding for 
health workforce activities that provide scholarships and loan 
repayment to clinicians, including oral health providers, in exchange 
for their service in areas of the United States where there is a 
shortage of health professionals. The National Health Service Corps 
(NHSC), which supports clinicians who demonstrate a commitment to serve 
our Nation's medically underserved populations at NHSC-approved sites 
located in Health Professional Shortage Areas, currently supports 
dentists and dental hygienists, who make up more than 15 percent of the 
NHSC's field strength.

    Additionally, in FY 2017, the NHSC launched the Dental Students to 
Service Loan Repayment Program, which provides loan repayment up to 
$120,000 to dental students in their last year of school in exchange 
for a 3-year service obligation to practice in communities of greatest 
need.

    Furthermore, the budget also supports the Teaching Health Center 
Graduate Medical Education program, which funds dental residency 
programs. Of the 57 teaching health center sites in AY 2017-2018, three 
are dental residencies.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                        tobacco and e-cigarettes
    Question. Thank you for your commitment to continuing efforts to 
address youth smoking and e-cigarettes and for your dialogue on this 
issue during the hearing on March 14, 2019. I share your goal of 
preventing a new generation of children from becoming addicted to 
nicotine through e-cigarettes and look forward to working with you to 
ensure this issue remains a top priority moving forward.

    As you know, the National Youth Tobacco Survey indicates that 3.6 
million middle school and high school kids are current e-cigarette 
users. As part of the President's budget, you propose to increase the 
Food and Drug Administration (FDA)'s budget by about $6 billion. Some 
of this investment is designed to increase user fees and supplement the 
FDA's work to increase enforcement of age-and identification-
verification requirements (see pg. 27 of the FY 2020 President's HHS 
Budget in Brief).

    However, a review of 2018 compiled statistics available from the 
Compliance Check Inspections Report demonstrates wide variability 
between the States when it comes to age verification and compliance 
checks. This is also true for the most recent report from 2013 on Synar 
Inspections. Given the surge of underage use of e-cigarettes and vaping 
devices such as Juul, I am concerned about the efficacy of the FDA's 
youth-based compliance checks.

    Is there a standard Request for Proposal (RFP) for State 
contractors who would perform youth-based compliance checks? Please 
supply that RFP.

    Answer. In accordance with the Federal Food, Drug, and Cosmetic 
Act, FDA contracts, where feasible, with the States to carry out 
inspections of retailers within that State. Below please find a link to 
the fiscal year (FY) 2018 State Tobacco Retail Compliance Check 
Inspection RFP: https://www.fbo.gov/utils/view?id=3163f5f9
f8240b43836d21cf797637c2.

    Note that not all contracts are awarded on the same cycle and 
therefore only certain States were eligible to apply for this 
particular RFP. FDA also issues similar RFPs for jurisdictions that 
contract with third-party entities and tribes and other jurisdictions 
are inspected by FDA inspectors.

    Question. Are these contracts consistent across States? Please 
supply the standard contract for these contractors.

    Answer. Yes, the contracts are consistent across the States with 
regard to the program requirements for FDA's Tobacco Retail Compliance 
Check Inspection program. Each year, FDA issues a Request for Proposals 
(RFP) for the Compliance Check Inspection contracts to which the States 
and territories submit proposals that detail their respective program 
structure, inspection plan, and cost. FDA reviews the proposal packages 
to determine whether the business and technical plans fulfill the 
requirements established in the RFP.

    A representative tobacco retail compliance check inspection 
contract entered into between FDA and North Carolina in response to the 
FY 2018 RFP is enclosed (see Attachment No. 5).

    Question. Are the detailed instructions for the conduct of 
inspections, including how youths are chosen, and what methods they use 
to attempt to purchase consistent across States? Please supply these 
instructions.

    Answer. FDA's Tobacco Retail Inspection Program contracts outline 
the process and protocols for conducting FDA's tobacco retailer 
compliance check inspections, including how minors are chosen. The 
contractors are responsible for recruiting, hiring, and supervising 
inspectors and minors used in the FDA Tobacco Compliance Check 
Inspection Program.

    Pursuant to the contract, the contractor must only use minors who 
are age 16 or 17 to participate in the program. The contractor must 
ensure that the minors are within the required age range. FDA provides 
training regarding the FDA Tobacco Compliance Check Inspection Program 
to the inspectors and minors. The contractor must ensure that all 
inspectors and minors participating on inspections have taken and 
passed the FDA Tobacco Compliance Check Inspection Program Training 
before beginning initial inspections.

    The Contractor arranges compliance check inspections of retailers 
that sell or advertise tobacco products to determine whether those 
retailers are complying with the FD&C Act, as amended by the Tobacco 
Control Act, and the implementing regulations. Generally, the 
contractor carries out two (2) types of tobacco compliance check 
inspection assignments: (1) undercover buy assignments, to determine a 
retailer's compliance with age and photo identification requirements; 
and (2) advertising and labeling assignments, to cover other provisions 
of the Tobacco Control Act. Please note that minors are not used in 
FDA's advertising and labeling tobacco retail inspections. The 
contractor must assign compliance check inspection assignments to 
inspectors and ensure each inspector conducts and documents each 
assignment according to FDA protocol, which is provided during 
training.

    Question. Thousands of compliance checks are performed each year in 
each State, yet the percentage of retailers that undergo compliance 
checks varies from State to State. Some of this variability may be 
explained by differences in youth and adult tobacco use prevalence 
among the States, and some may be explained by each States' relative 
focus on youth underage sales deterrence. However, it also seems likely 
that variances in methodology and frequency of checks could play a 
role. How are these numbers chosen and what percentage of nicotine and 
tobacco retailers are inspected in each State?

    Question. FDA's Tobacco Retail Inspection Program contracts outline 
the process and protocols for conducting FDA's tobacco retailer 
compliance check inspections. These contracts include requirements that 
contractors ensure inspectors conduct tobacco compliance check 
inspections at a variety of different locations (e.g., urban, suburban, 
rural, and racial and ethnic minority communities) and outlet types 
throughout the jurisdiction. Additionally, contractors are also asked 
to consider geographic factors such as areas located in close proximity 
to middle or high schools or areas with high rates of youth tobacco 
use. FDA directs the contractors to conduct specific follow up 
compliance check inspections at retail establishments where previous 
violations have been observed. The number of inspections each State 
proposes to conduct is based on a variety of factors, including 
historical inspection data and State budgetary and personnel 
considerations.

    Question. Please explain the variability in rates of compliance 
checks and rates of retailer compliance between States?

    Answer. FDA has utilized its authorities to combat the marketing 
and sale of tobacco products to youth. More than a million inspections 
have been conducted under FDA's tobacco retail compliance check 
inspection program. Most retailers have been found to be in compliance 
with the law and even fewer are found to be continuing to violate the 
law upon reinspection. However, there are retailers who continue to 
sell tobacco products to minors. When inspectors observe potential 
violations during compliance check inspections of tobacco retailers, 
FDA may utilize several advisory and enforcement tools provided for in 
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control 
Act) and the Federal Food, Drug, and Cosmetic (FD&C) Act. These actions 
include warning letters, civil money penalties (CMP), no-tobacco-sale 
orders (NTSO), seizures, injunctions, and/or criminal prosecutions.

    We are unable to explain the variability in rates of compliance 
between States; however, we continue to take steps to educate retailers 
to improve compliance rates nationwide. Part of our enforcement work 
also includes ensuring retailers know their responsibilities under the 
law and the consequences for violating them. Toward that end, FDA has 
developed extensive materials to educate industry, including retailers. 
CTP developed guidance documents and multiple webpages that explain 
FDA's tobacco requirements to retailers and provide educational 
resources. Specifically, CTP's Summary of Federal Rules for Tobacco 
Retailers, Retail Sales of Tobacco Products and its Retailer Training 
and Enforcement webpages provide specific information useful to 
retailers, such as fact sheets for retailers, in-store materials, links 
to compliance training webinars, and a diagram of the retail undercover 
purchase inspection and enforcement process.

    Further, FDA does not direct inspections based on statistical 
analysis but rather prioritizes inspections of retailers where 
violations were observed, which could potentially impact a State's 
``compliance rate'' during a period of time.

    Question. What is the approximate cost per compliance check, and 
how is this calculated? Does the cost vary State to State? By how much?

    Answer. Contractor proposals generally account for the cost of 
living, resources available to dedicate to the program, personnel cost, 
number and type of inspectors who are dedicated to the program, travel 
costs depending on the size of the State, geographic distribution of 
retailers within the State, and other circumstances unique to each 
State program. We have a mix of contract types; however, the majority 
of State contracts are cost-reimbursement type contracts.

    Question. Do compliance rates vary by demographic factors such as 
age, gender, and race? Please supply a relative breakdown of the 
demography of the youths used across demographic factors.

    Answer. Contractors only use 16 and 17 year-olds to conduct retail 
compliance check inspections. FDA does not collect information on the 
minors' race and gender. The FY 2018 RFP requires contractors to use 
``[a] representative mix of 16 and 17 year-old Minors who look their 
age. The Minor group should also reflect a representative mix of male 
and female Minors and should reflect the racial/ethnic composition of 
the population where the undercover buy is conducted.''

    Question. Do some youth contractors have much higher buy rates than 
others? Please describe. Are successful buy techniques shared?

    Answer. FDA does not analyze its data for trends in buys made by 
individual minors. Each Minor must complete the required FDA minor 
training prior to conducting any inspections. In addition to this 
training, inspectors review each inspection with the minor and advise 
them of any necessary adjustments prior to moving to the next 
inspection. FDA has held sessions for contractors to share information 
and best practices across States.

    Further, FDA conducts routine training for all inspectors to review 
topics related to inspection procedures, policies, and other 
contractual updates. Before an inspector may begin conducting 
compliance check inspections, inspectors must take an initial required 
training. Additionally, FDA provides quarterly training to contract 
program coordinators and training for all inspectors twice per year. 
Program coordinators and inspectors must also take periodic refresher 
trainings. FDA monitors completion of these training requirements and 
will restrict inspector participation in the program in the event they 
are not met. Program coordinators are also responsible for providing 
additional training to individual inspectors, as needed.

    Question. Do compliance check results vary significantly by type of 
retailer: convenience store, grocery, pharmacy, large discount store, 
tobacco or vape shop, etc.?

    Answer. FDA does not categorize each inspection by type of outlet, 
however, inspections of brick-and mortar retail outlets and 
surveillance of online retailers are separate programs and are 
conducted in different ways. The results of our brick and mortar retail 
inspections are part of FDA retailer compliance check inspection 
program and available to the public in a searchable database online. 
This information includes the names and locations of the retailers 
inspected by FDA. Warning letters issued to other regulated tobacco 
entities, including online retailers are generally the result of other 
FDA tobacco inspection and surveillance programs and may be viewed in 
FDA's Electronic Reading Room.

    Question. Do compliance check rates vary by type of area surveyed 
(such as rural, urban, suburban, racial and ethnic makeup, high or low 
socioeconomic status, high or low tobacco prevalence, etc.)?

    Answer. The Retail Inspection RFP requires the contractor to ensure 
that the commissioned inspectors conduct tobacco compliance check 
inspections at a variety of different locations (e.g., urban, suburban, 
rural, and racial and ethnic minority communities) and outlet types 
throughout the jurisdiction. Additionally, contractors are also asked 
to consider geographic factors such as areas located in close proximity 
to middle or high schools or areas with high rates of youth tobacco 
use. Because of the different geographical and other unique 
circumstances within a State, they may use different criteria to define 
these types of areas. Therefore, FDA cannot reliably analyze compliance 
check rate data based on the type of area. FDA directs the contractors 
to conduct specific follow up compliance check inspections at retail 
establishments where previous violations have been observed.

https://www.accessdata.fda.gov/scripts/oce/inspections/
oce_insp_searching.cfm; https://www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/compliance-actions-and-
activities/warning-letters.

    Question. Do contractors use available information from questions 
above to inform and render compliance checks that are more efficient or 
effective?

    Answer. FDA cannot reliably analyze compliance check rate data 
based on the type of retailer or type of area. As mentioned previously, 
FDA's Tobacco Retail Inspection Program contracts outline the process 
and protocols for conducting FDA's tobacco retailer compliance check 
inspections. These contracts include requirements that contractors 
ensure inspectors conduct tobacco compliance check inspections at a 
variety of different locations (e.g., urban, suburban, rural, and 
racial and ethnic minority communities) and outlet types throughout the 
jurisdiction. Additionally, contractors are also asked to consider 
geographic factors such as areas located in close proximity to middle 
or high schools or areas with high rates of youth tobacco use. FDA 
inspects retail establishments that have previously violated the law 
more frequently in order to assess corrective actions and to verify 
compliance.

    Question. If a youth does make a successful buy, that is to say 
there is a failure in compliance, is there a standard protocol for 
recheck of those particular retailers?

    Answer. Yes. FDA-commissioned inspectors conduct follow up 
compliance check inspections at retail establishments where previous 
violations have been observed to verify compliance following the close-
out of an advisory or enforcement action. FDA may also direct 
contractors to conduct certain inspections to ensure compliance with 
new provisions that go into effect, such as those included in the 
Deeming rule, and/or other enforcement priorities.

    Question. Are compliance checks ``realistic'' in comparison to how 
a typical youth might attempt to buy underage? For example: may the 
youth lie about his or her age; may youths demonstrate to the clerk 
that they are already in possession of a tobacco product or vape 
device; may they engage the clerk in social conversation prior to the 
attempted purchase; may they offer the clerk extra money or other 
compensation?

    Answer. Minors are an integral part of conducting compliance check 
inspections. FDA conducts undercover inspections with minors using 
standard protocols. The protocols include confidential enforcement 
strategy and FDA does not disclose the specific details. However, FDA 
has a number of requirements in the contract regarding the use of 
minors, including a requirement that the contractor ensure that all 
minors follow the chosen protocol consistently. FDA also requires that 
the contractor employ a representative mix of 16- and 17-year-old 
minors who look their age, reflect a representative mix of male and 
female minors, and reflect the racial/ethnic composition of the 
population where the undercover buy is conducted.

    FDA protocol does not require minors to carry photo identification 
for the undercover buy assignments. However, the contractor may 
determine that minors should carry valid photo identification and 
present identification if requested. Such decisions are left to the 
discretion of the contractor.

    Question. How was the FDA fine structure determined, and is there 
scientific evidence or compliance rate data to support that it is 
sufficient?

    Answer. The Tobacco Control Act provides for civil money penalties 
for violations of FD&C Act requirements that relate to tobacco 
products. These violations identified in the statute include the sale 
or distribution of tobacco products in a manner that violates 
regulations addressing the sale or distribution of cigarettes, 
smokeless tobacco, and covered tobacco products in violation of the 
restrictions set forth in 21 CFR part 1140.

    Maximum civil money penalty amounts are set forth in section 
103(q)(2) of the Tobacco Control Act and are adjusted annually for 
inflation. These maximum penalty amounts take into account the 
requirements that are violated, the number of violations, and several 
other factors. If there have been repeated violations (at least 5 
violations of particular requirements over a 36-month period) at the 
outlet and a no-tobacco-sale order would be appropriate, FDA will 
generally seek a no-tobacco-sale order. A no-tobacco-sale order is an 
order prohibiting the sale of tobacco products at a retail outlet 
indefinitely or for a specified period of time.

    Question. If only a fraction of retailers are surveyed each year, 
how likely is it that a violating retailer could reach the threshold of 
five failures in 3 years?

    Answer. Retailers who previously sold to a minor in our inspection 
program are prioritized for re-inspection. FDA's goal is to inspect 
retail establishments that have previously violated the law more 
frequently in order to assess corrective actions and to verify 
compliance. If FDA finds subsequent violations at a retail 
establishment after the issuance of a Warning Letter, it generally 
seeks CMPs in accordance with the schedule published in the Tobacco 
Control Act. If FDA finds a retail establishment committed five or more 
repeated violations in a 36-month period, it may, and generally will, 
seek a No-Tobacco-Sale Order (NTSO) for that retail establishment. FDA 
posts all retailer inspection data on its website, including the 
inspection results.

https://www.accessdata.fda.gov/scripts/oce/inspections/
oce_insp_searching.cfm.

    To date, FDA has issued more than 150 NTSOs. This includes six 6-
month NTSOs to retailers who had already received an initial NTSO.

    Question. The regulations include a two-tiered penalty structure, 
with more lenience granted to those retailers that have completed FDA-
approved training. When and how does the FDA provide such training?

    Answer. The agency does not currently approve any retailer training 
programs. FDA encourages retailers to implement a training program for 
their staff and to tailor their program to meet the needs of their 
employees and business, taking into consideration the size of their 
business and the products that they sell. FDA understands that some 
retailers have established various tobacco retailer training programs.

    The agency has provided retailers with a number of recommendations 
on retailer training, including age verification, to help retailers 
comply with the law. These resources provide retailers with 
recommendations but leave the retailer the flexibility to determine 
which methods of compliance work best for their business. Some of the 
resources FDA has provided to retailers are:

          FDA Age Verification App and This is Our Watch materials: 
        FDA has provided retailers with an FDA Age Calculator app that 
        is available for free in both the Apple App Store and Google 
        Play. The app is a voluntary smartphone application to help 
        retailers comply with Federal, State, and local age 
        restrictions for selling tobacco products. Additionally, FDA 
        has developed a toolkit of voluntary educational resources for 
        retailers through the ``This is Our Watch'' campaign.
          Tobacco Retailer Training Programs Guidance: FDA has 
        developed a guidance document that lays out recommendations for 
        retailers to incorporate into a retailer training program. The 
        guidance document was updated in August 2018.

        https://www.fda.gov/regulatory-information/search-fda-guidance-
        documents
        /tobacco-retailer-training-programs

          Tips for Retailers webinar: FDA has also developed a webinar 
        for retailers to use as a resource to help prevent tobacco 
        sales to minors. The Tips for Retailers: Preventing Sales to 
        Minors webinar is available on the FDA website.

        https://www.fda.gov/regulatory-information/search-fda-guidance-
        documents
        /tobacco-retailer-training-programs.

    Question. In the absence of completed training mentioned in 
question 16 above, is the stricter penalty structure utilized?

    Answer. As you know, the Tobacco Control Act established two 
schedules for the maximum civil money penalties that can be assessed 
for violations of regulations issued under section 906(d) of the FD&C 
Act, including violations of FDA regulations at 21 CFR part 1140--one 
schedule for retailers that do not have an approved training program 
and another schedule, with lower penalties, for retailers with an 
approved training program.

    In determining the amount of penalty the agency will seek, CTP uses 
and will continue to use the lower schedule for all retailers, whether 
or not the retailer has implemented a training program, until 
regulations are developed that establish standards for retailer 
training programs. FDA has issued a guidance entitled ``Guidance for 
Industry: Tobacco Retailer Training Programs,'' which contains examples 
of recommended elements that may be helpful to retailers in designing 
and implementing a training program.

https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/tobac
co-retailer-training-programs.

    Question. After 7 years of FDA compliance checks and over $300 
million in costs attributable to this system, many States still have 
high rates of non-compliance, including Ohio at 21 percent. Does this 
indicate some level of failure of the compliance system? What rate of 
retailer compliance failure does the FDA consider acceptable?

    Answer. The vast majority of retailers are in compliance with FDA's 
tobacco regulations, but a small subset of retailers continue to 
violate the law. Please note that rates calculated using the FDA's data 
are not statistically significant because of repeat inspections of 
violators. To address the subset of retailers who continue to violate 
the law, FDA has taken a multi-prong approach. FDA will continue 
inspecting retailers and issuing warning letters and escalating 
enforcement actions when violations are found. Recently, FDA sent 
letters to thirteen national, corporate-owned chains and franchise 
stores with disturbingly high rates of violations for illegal sales of 
tobacco products to minors, asking each company to submit plans 
describing how they will address and mitigate illegal sales to minors.

    FDA has also developed extensive materials to educate industry, 
including retailers. CTP developed guidance documents, multiple 
webpages, and compliance training webinars that explain FDA's tobacco 
requirements to retailers and provide educational resources. Further, 
FDA continues to utilize our voluntary national retailer education 
program called ``This is Our Watch,'' which includes free resources 
designed to support retailers' efforts to educate their staff on 
enforcing Federal laws and regulations. We hope retailers will protect 
youth in their communities by knowing the law and making use of tools 
that make it easier to prevent underage sales. The FDA has also 
developed a retailer education online platform to provide State and 
territorial officials with educational tools and information on 
retailer regulations. The program also facilitates peer-to-peer 
sharing, and fosters conversations around promising practices, lessons 
learned, and program feedback.

https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/our-
watch.

    Question. The clerk may safely rely on the presentation of 
certified identification that contains a date of birth indicating the 
buyer is of age. However, for those under age 21, almost two thirds 
have used fake IDs to purchase alcohol. How might the FDA work to 
mitigate this problem as more States and localities move their minimum 
sales age to 21?

    Answer. The FDA provides retailers with Guidance Documents and 
webinars on our website, to assist retailers on ways to ensure that the 
identification being presented for the sale of tobacco or covered 
tobacco products is valid and accurate. Current regulations, as 
explained in a guidance entitled ``Guidance for Industry: Tobacco 
Retailer Training Programs,'' States that retailers must verify the age 
of purchasers of tobacco or covered tobacco products under the age of 
27 by means of photographic identification that contains the bearer's 
date of birth. So, while the actual age for the purchase of tobacco 
products may rise in different localities and States, retailers are 
already required to ensure that their stores are checking the 
identification of individuals well over the age of 21.

https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/tobac
co-retailer-training-programs.

    The same Guidance for Industry provides recommendations for 
retailer training programs. The FDA recommends that a training program 
include the ``age that triggers photographic identification 
verification and what constitutes acceptable forms of identification'' 
and lists specific recommendations for the type of identification 
accepted as well as ways to determine the authenticity of a photo 
identification. Specifically, the FDA States that only government-
issued photographic identification containing a date of birth should be 
accepted (such as State-issued drivers' licenses or identification 
cards, military identification cards, immigration cards, or passports). 
Retailers are informed of methods to verify the authenticity of the 
identification, including specific issues to look for that may signify 
an altered or fake identification, such as an expired ID, watermarks or 
State seals and signs of tampering or peeling lamination. Additionally, 
that Guidance for Industry also provides education on alternate means 
of verifying identification that retailers may want to utilize, such as 
electronic age verification devices or scanners. Most importantly, the 
FDA recommends that a training program instruct employees to decline a 
sale when the customer has no photographic identification, the 
photographic identification contains no date of birth, the photographic 
identification has expired, or if the identification does not appear to 
be authentic.

    On its website, FDA provides Retailers Education Materials, 
including webinars discussing Retailer Training and Enforcement. The 
webinar ``Tips for Retailers: Preventing Sales to Minors'' provides 
training and slides that discuss age verification techniques. In this 
webinar, FDA provides ways to identify invalid IDs, such as spelling 
errors, word usage errors, or expired IDs. The webinar also provides 
retailers with the advantages and disadvantages of different age-
verification technologies available from FDA and the marketplace and 
also reminds retailers to check with their States for any online 
trainings or resources to assist with complying with State and Federal 
laws.

https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/
retailer-training-and-enforcement.

    Question. Some complain that States ``game'' the system of Synar 
checks to ensure that risk to their SAMSA moneys is diminished. How 
might the State-based Synar system be strengthened to augment FDA 
compliance efforts?

    Answer. In addition to the Tobacco Control Act, the Department of 
Health and Human Services works to limit youth access to tobacco 
through the Synar Regulation. States can choose to conduct FDA 
compliance check inspections at those outlets randomly selected for the 
Synar sample or for other tobacco enforcement efforts; however, the 
compliance check inspections must follow FDA's protocol and must be 
conducted by FDA commissioned inspectors.

    Question. The current Synar failure percentage threshold is 20 
percent. What effect might there be in reducing that number to 10 
percent or 5 percent?

    Answer. The current Synar maximum retailer violation rate (RVR) is 
20 percent. However, in response to research suggesting that RVRs below 
10 percent are necessary to reduce actual youth access to tobacco 
products, starting in 2009, SAMHSA has encouraged States to strive for 
an RVR below 10 percent. This did not change the regulatory requirement 
that States not exceed 20 percent. In the last year for which SAMHSA 
has final data (FY 2018), 46 States and 5 U.S. territories and Pacific 
Jurisdictions (PJs) reported RVRs lower than 15 percent. Moreover, 33 
States and 4 U.S. territories and PJs reported RVRs below 10 percent. 
However, if the maximum RVR regulatory requirement were to be reduced 
to 10 or 15 percent, several States would likely fall out of 
compliance. The penalties for non-compliance would include a 
requirement that the State appropriate and spend new State tobacco 
prevention funds that can equal millions of dollars. States that have 
exceeded the current maximum of 20 percent have been penalized in this 
way.
                     national institutes of health
    Question. The President's FY 2020 budget proposes 12 percent cuts 
across the National Institutes of Health (NIH). The NIH is the most 
innovative and sophisticated research institution in the world and 
keeps the United States on the forefront of scientific discovery. A cut 
of $4.5 billion would set us back behind countries who continue to ramp 
up their research investment to compete with our brain power.

    In 2018, Ohio had nearly 2,000 active NIH grants. Thousands of my 
constituents are contributing to innovative medical research.

    Prior to proposing this budget, did you or Dr. Collins or anyone at 
the Office of Management and Budget (OMB) do an analysis on how many 
grants this cut of $4.5 billion would impact? If so, what were the 
results of this analysis.

    Answer. NIH analyzed the number of grants supported by the proposed 
NIH funding levels as part of the process of developing the President's 
budget. The congressional justification materials for NIH estimate that 
the FY 2020 funding level would support 38,565 research project grants, 
and a total of 45,964 research grants.

    Question. Did you do any analysis to quantify the job loss that may 
result from these cuts? If so, what were the results of this analysis?

    Answer. I am not aware of any analysis of the specific impact of 
the NIH funding levels on jobs. The NIH funding levels in the 
President's budget were developed to prioritize research in areas of 
public health significance.

    Question. Have you done any analysis on how each State would be 
impacted by these cuts? If so, what were the results of this analysis 
for Ohio?

    Answer. NIH's research plan will assure that the most valuable 
research is funded within this difficult budget environment. NIH 
estimates that the number of new and competing Research Project Grants 
(RPGs) awarded would decrease from about 11,675 in FY 2019 to 7,894 in 
FY 2020. In addition, funding for noncompeting RPGs would be reduced; 
the size of the reduction to specific awards would depend on the 
Institute involved. Similar reductions to other types of research 
grants would also be expected.
      national institute of occupational safety and health (niosh)
    Question. Secretary Azar, you have spoken before about how you 
believe the Centers for Disease Control and Prevention (CDC) is the 
envy of the world when it comes to public health. As you know, the CDC 
is currently working to update and replace two NIOSH facilities in 
Cincinnati, Ohio. The agency is currently undergoing site acquisition 
activities and I understand they anticipate that both the site purchase 
and a design-build contract will be finalized this spring.

    This project is not just about updating the NIOSH buildings--this 
is about improving government efficiency and creating jobs in southwest 
Ohio. We need your commitment that this project will remain on schedule 
and will remain a priority for the administration, despite the FY 2020 
budget's proposed cuts to CDC.

    Will you commit to working with Senator Portman and me to keep this 
project moving forward under your leadership at HHS?

    Answer. CDC is proceeding with acquisition activities related to 
the property in Cincinnati, but there have been some delays, including 
those related to the government shutdown, relocation of a park 
equipment maintenance facility, and ownership of the single residential 
property within the identified site assemblage that did not sell to the 
Uptown Consortium. CDC plans to purchase the site this summer. 
Immediately following the site acquisition, CDC will carry out the 
design and construction of the facility.
                              biosimilars
    Question. One of the proposals in the FY 2020 budget relates to 
encouraging biosimilar development. I support this administration's 
goals in making it easier for biosimilars to enter the marketplace and 
lower costs, but am concerned that we aren't doing enough to ensure 
that we can benefit from a robust biosimilar marketplace.

    What more is HHS doing to ensure a robust biosimilar marketplace?

    Answer. Promoting access to biosimilars and lowering drug prices 
are top administration priorities.

    Since enactment of the Biologics Price Competition and Innovation 
Act of 2009 which established an abbreviated licensure pathway for 
biological products shown to be ``biosimilar to,'' or ``interchangeable 
with,'' an FDA-licensed biological product, FDA has approved 19 
biosimilars and held meetings with biosimilar developers for many more 
products. We've also made substantial progress in developing the 
scientific and regulatory policies needed to implement the licensure 
pathway.

    Recognizing that this is a crucial time in the emergence of 
biosimilars, FDA announced our Biosimilars Action Plan (BAP) last year 
to facilitate access to lower-cost biological products. Under the BAP, 
FDA is focusing its efforts on advancing the science and policies to 
make the development of biosimilars more efficient; increasing the 
acceptance of biosimilars; and taking action against regulatory gaming 
that can deter or delay competition.

    Not only are we making the biosimilar development and review 
process more efficient and predictable, under the BAP, we are also 
taking new steps to communicate with patients, payers, and providers to 
improve the understanding of biosimilar and interchangeable products.

    Of course, the FDA's efforts to improve biosimilar competition will 
be less impactful if rebate walls discourage payers from adding 
biosimilars to their formularies. By proposing to replace rebates with 
up-front discounts, plans will have more incentive to seek drugs with 
lower prices instead of those with higher rebates, which will 
dramatically lower the costs patients face for a number of high-cost 
drugs.

    We continue to evaluate additional steps necessary to strike the 
appropriate balance between encouraging ongoing innovation in biologics 
while also facilitating the robust competition that can reduce costs to 
patients.
                food and drug administration inspections
    Question. The President's FY 2020 budget proposes to eliminate 
funding for the FDA's office of international mail facilities. However, 
the HHS Budget in Brief also details FDA efforts to hire additional 
staff and laboratory support to inspect packages at international mail 
facilities as a way to help fight the opioid epidemic and crack down on 
the illegal sale and shipment of illicit drugs.

    Please explain the President's budget proposal to eliminate $94 
million in funding for the FDA Opioids--International Mail Facilities 
program. Why does the HHS budget propose to cut this funding?

    Page 24 of the HHS Budget in Brief describes investments the 
President's budget would support at the FDA to support its overall 
approach to the opioid epidemic. One of the priorities the FDA has is 
to ``increase enforcement activities to crack down on illegal sale of 
opioids'' by supporting and ``increase of the inspection of packages at 
international mail facilities.'' Please explain how this additional 
support and investment is possible given the cuts to the International 
Mail Facilities program detailed in the previous question. Don't these 
two things contradict one another?

    Answer. As explained above, the FY 2020 budget includes $55 million 
to strengthen FDA's activities in response to the Nation's opioid 
crisis, which may include these activities. The FY 2018 funding for 
Opioid-IMF activities is displayed as a reduction, as the $94 million 
was provided as one-time, no-year funding, to remain available until 
expended. The FY 2020 budget requests the $55 million in FDA's base 
budget and does not request additional no-year funding.
                  area health education centers (ahec)
    Question. Congress created the AHEC program in 1971 to encourage 
medical schools to increase the number of students and residents 
trained in underserved, community-based settings. Today, AHECs act as 
an effective national primary care training network built on committed 
partnerships of 120 medical schools and 600 nursing and allied health 
schools. Additionally, 261 AHEC community-based centers operate in 46 
States, serving over 85 percent of the counties in the United States. 
The AHEC program and its partners have proven to be an effective and 
efficient organization to expand community-based training and ensure 
our health-care workforce has a strong sense of the needs of each 
community and skills that make them stronger practitioners.

    Why does the President's FY 2020 budget propose to eliminate the 
AHEC program, despite its record of success in preparing a diverse, 
culturally competent primary care workforce? What is the justification 
for cutting the AHEC program?

    Answer. The President's Fiscal Year FY 2020 budget request 
prioritizes funding for health workforce activities that provide 
scholarships and loan repayment to clinicians in exchange for their 
service in areas of the United States where there is a shortage of 
health professionals. While funding for the Area Health Education 
Centers (AHEC) Program was eliminated in the FY 2020 President's 
budget, the budget requested funding for the National Health Service 
Corps (NHSC), which supports clinicians who demonstrate a commitment to 
serve our Nation's medically underserved populations at NHSC-approved 
sites located in Health Professional Shortage Areas. In addition, the 
President's budget includes funding for the Teaching Health Center 
Graduate Medical Education (THCGME) program. The THCGME program 
increases healthcare access in underserved communities by supporting 
primary care medical and dental residency programs in community-based 
ambulatory patient care settings. The President's budget includes 
$126.5 million in funding for the THCGME program in each of FY 2020 and 
FY 2021, for a total of $253 million over 2 years.
        children's hospitals graduate medical education (chgme)
    Question. Last year's FY 2019 budget proposed to eliminate the 
CHGME program and combine it with other graduate medical education 
funding streams, while reducing total Federal support for graduate 
medical education by $50 billion over the next decade.

    CHGME was created to fill a gap in the existing GME funding 
streams. I am concerned that the elimination of CHGME would result in 
fewer pediatric specialists and exacerbate the physician shortage in 
this country, especially those who care for our most vulnerable 
children. When I asked you to justify last year's decision to eliminate 
CHGME, you responded that ``the budget proposes to better focus Federal 
spending on GME by consolidating spending into a new capped Federal 
grant program.'' The response failed to answer my questions, which I'm 
repeating in this year's QFRs.

    What caused the President to reverse course on CHGME in this year's 
budget proposal, as compared to his FY 2018 budget proposal?

    If CHGME is eliminated, how will HHS ensure that our pediatric 
workforce pipeline is protected and kids have access to the care we 
need?

    Answer. While the President's FY 2020 budget does not request 
discretionary resources for Children's Hospitals Graduate Medical 
Education (CHGME), it does include funding for children's teaching 
hospitals. The budget proposes to consolidate Federal graduate medical 
education spending from Medicare, Medicaid, and the CHGME program into 
a single grant program for teaching hospitals to equal the sum of 
Medicare and Medicaid's 2017 payments for graduate medical education, 
plus 2017 spending on CHGME, adjusted for inflation. This amount would 
then grow at the CPI-U minus one percentage point each year. 
Pediatricians will continue to be trained under the program structure 
proposed in the President's budget.

    The new grant program would be jointly operated by the 
Administrators of CMS and the Health Resources and Services 
Administration. Payments would be distributed to hospitals based on the 
number of residents at a hospital (up to its existing cap) and the 
portion of the hospital's inpatient days accounted for by Medicare and 
Medicaid patients. The Secretary would have authority to modify the 
amounts distributed based on the proportion of residents training in 
priority specialties or programs and based on other criteria identified 
by the Secretary, including addressing health-care professional 
shortages and educational priorities. This grant program would be 
funded out of the general fund of the Treasury.

    The budget prioritizes funding for health workforce activities that 
provide scholarships and loan repayment to clinicians in exchange for 
their service in areas of the United States where there is a shortage 
of health professionals, as well as training based in community-based 
ambulatory care settings. The President's budget includes funding for 
the Teaching Health Center Graduate Medical Education. The THCGME 
program increases healthcare access in underserved communities by 
supporting primary care medical and dental residency programs in 
community-based ambulatory patient care settings. Of the 57 teaching 
health center sites in AY 2017-2018, three are pediatric residencies. 
The President's budget includes $126.5 million in funding for the 
THCGME program in each of FY 2020 and FY 2021, for a total of $253 
million over 2 years.
                   social service block grant (ssbg)
    Question. The President's FY 2020 budget proposes to eliminate the 
Social Service Block Grant (SSBG), a critical program that allows 
States to meet the needs of their communities. As the addiction 
epidemic continues to devastate our communities and drive more children 
into the foster care system, we must ensure that States have access to 
more support--not less. We know that many States, like Ohio, use SSBG 
funds to support child protective service programs.

    How does the administration plan to support State child welfare 
agencies that rely on SSBG funding? Please provide detail on how the 
administration would do so if the SSBG were eliminated.

    Answer. The President's 2020 budget is focused on improving 
participation in American society by promoting work, shifting resources 
to child welfare prevention, and supporting early childhood education 
and care. The protection and well-being of children is one of the 
Department's top priorities.

    Federal child welfare is provided via multiple programs, the 
largest of which are made available under the Social Security Act 
(SSA).\12\ In particular, title IV-B of the SSA authorizes funding for 
States, territories, and tribes to support a broad range of child 
welfare-related services to children and their families. While child 
welfare services are an allowable expense under the Social Services 
Block Grant (SSBG), the program overall lacks accountability and 
performance measurements, as well as duplicates other Federal funding 
streams. The decision to not include funding for SSBG in the 2020 
budget was not made lightly. However, HHS is committed to reducing 
duplication of effort and better targeting Federal resources.
---------------------------------------------------------------------------
    \12\ The Congressional Research Service provided an informative 
outline of Federal welfare equities in their 2017 report, Child 
Welfare: An Overview of Federal Programs and Their Current Funding.

    The budget continues SSBG's authorization under title XX of the SSA 
as a potential mechanism for rapid response in case of disasters and to 
receive transfer funding from the Temporary Assistance for Needy 
Families program.
                             healthy start
    Question. I appreciate the President's FY 2020 commitment to 
maintaining funding for the Healthy Start program, which helps support 
community-based strategies to reduce disparities in infant mortality 
and improve perinatal outcomes for women and children in high-risk 
areas. Ohio is home to five healthy start sites, which have helped 
combat our State's significant infant mortality problem.

    For the most recent Healthy Start funding cycle, Congress approved 
$122 million for program. After settling aside $12 million for maternal 
mortality and $2 million for Healthy Start performance project support, 
$108 million remained to fund program sites across the country.

    However, when the Health Resources and Services Administration 
(HRSA) announced the Notice of Funding Opportunity (NOFO) in fall 2018, 
the NOFO stated that the estimated awards would total only $95 million.

    Why was there only $95 million available in grants when $108 
million should have been available to fund program sites? How will HRSA 
spend the remaining $13 million?

    Answer. The program received a total of $122.5 million in FY 2019 
appropriated funds, all of which was allocated to the Healthy Start 
program. As noted, the NOFO for the Healthy Start community grants 
indicated that $95 million would be available to support the FY 2019 
competition within the Healthy Start program. In addition to the $95 
million, $12 million is being provided to the new recipients to support 
hiring of clinical service providers to address maternal mortality, per 
the appropriation report language. Funding in the amount of $4.9 
million has also been allocated for 13 Healthy Start community grants 
from the previously funded cohort whose project periods ended March 31, 
2019. Approximately $7.6 million are being used for technical 
assistance to Healthy Start community grantees, a quality improvement 
initiative, and program evaluation. The remaining funds, $3 million, 
will support program administration, information technology, and costs 
associated with operations.

    Question. In addition to the strange discrepancies in funding noted 
above, HRSA also made a significant change to how the funds are 
allocated to various agencies--instead of tiers of funding (as has been 
done in the past), a maximum funding amount was set for each grantee. 
As a result, the medium and large grantees saw significant reductions 
in funding, while smaller grantees saw increases in funding.

    What is the justification for HRSA's change to the way funds are 
allocated across Healthy Start program sites?

    Answer. HRSA routinely adjusts how it allocates funding to grantees 
to ensure it has the greatest impact and meets the needs of the 
population being served. For the FY 2019 Healthy Start NOFO, HRSA 
adjusted the funding level provided per grantee to a single funding 
level with a common set of expectations for all grantees. The 
methodology for this adjustment was based on analysis of performance 
data collected from prior grant recipients over multiple years as well 
as input gathered from prior grant recipients and others during a HRSA 
listening session and open comment period. Some prior grant recipients 
noted that demand for the program exceeded their capacity to serve all 
interested families. Feedback also indicated a desire to increase 
program capacity to serve more pregnant women during the project period 
to promote healthy pregnancy outcomes. Revising the program to a single 
funding level with a common set of expectations for all grantees allows 
grantees to focus on serving infants and families for the first 18 
months after birth and maximize the capacity of recipients to focus on 
service to pregnant women, infants, and families. HRSA expects to see 
more clients served as a result of this redesign.

    Question. How does HRSA plan to support those entities that have 
just seen their funding reduced despite the same workload? How will 
HRSA help ensure the sites that received reduced funding as a result of 
the agency's changes do not have to shrink their programs, cut staff, 
or disenroll clients?

    Answer. Although the FY 2019 redesign reduces funding for a small 
number of prior grant recipients, it also represents a reduced workload 
in meeting new programmatic expectations, roles, and requirements. HRSA 
revised the program to a single funding level with a common set of 
expectations and award amounts for all grant recipients in the FY 2019 
competition. This approach was selected after reviewing performance 
data from prior grant recipients and in consideration of input gathered 
in HRSA listening sessions and other stakeholder feedback. The reduced 
funding is appropriate to the expected workload, based on this 
analysis. The revised approach also provides additional resources to 
the largest number of grant recipients, while also promoting 
efficiencies in overall program operations. The NOFO was published 
several months prior to the project start date, providing an 
opportunity for previously funded grant recipients to start planning 
for this change.
                              tuberculosis
    Question. The President's FY 2020 budget acknowledges that 
``progress to reduce the number of new TB infections has slowed.''

    How will the changes the FY 2020 budget proposes to the TB 
Prevention program help ensure the CDC is able to continue to make 
progress toward eliminating TB in America?

    Answer. To eliminate TB at home, we must reduce the burden of 
disease globally. Nearly 2 billion people are infected with TB 
worldwide, and 10.4 million people become sick with active TB disease 
each year. TB is the leading cause of death from an infectious disease 
globally and claims 1.6 million lives each year, even though there has 
been a cure for more than 70 years. In the United States, a total of 
9,029 new TB cases were reported in 2018. To eliminate TB in the United 
States, we need to reduce the burden of TB disease globally. The U.S. 
TB elimination effort is linked with how well other countries are doing 
in dedicating action and resources to finding and curing active TB 
cases and addressing the reservoir of latent TB infection in their 
populations.

    Question. The FY 2020 President's budget requests $7.2 million for 
Global Tuberculosis activities, which will allow CDC to continue 
efforts to address TB globally. Reflecting a programmatic consolidation 
that occurred within CDC in 2017, the budget proposes to consolidate 
Global TB funding within the Center for Global Health to better 
coordinate Global TB activities across the agency and leverage 
resources for maximum impact. How will the CDC prioritize its global TB 
efforts and sustain partner countries' efforts?

    Answer. To address the global threat posed by Tuberculosis (TB), 
CDC focuses on countries with high TB burden, including countries that 
have strong U.S. business and community ties, resulting in high travel 
volume, are directly connected to the U.S.-based TB epidemic, and that 
are part of the President's Emergency Plan for AIDS Relief (PEPFAR) 
commitment to TB as a key component of a global HIV response. CDC 
continues to address technical and operational challenges in high-
burden TB countries that undermine progress toward achieving global TB 
targets by developing innovative program strategies, leveraging PEPFAR 
platforms, and using proven diagnostic and treatment tools to find, 
cure, and prevent TB.
                     office of refugee resettlement
    Question. The budget justification documents show an increase in 
asylees and unaccompanied minors last year, and we are currently seeing 
an increase in the number of families and unaccompanied minors who are 
presenting and requesting asylum at the southern border. Yet, the 
President's FY 2020 budget proposes a decrease in funding for refugees 
and entrant assistance.

    Please provide specific information that led to the Department 
requesting reduction in this budget line.
Collaboration With the Department of Defense--Immigration
    Answer. The FY 2020 budget request for Transitional and Medical 
Services and Refugee Support Services reflects a reduction of $91 
million from the FY 2019 enacted appropriation level. HHS estimates 
that this level of funding will be sufficient due to lower arrivals in 
recent years of both refugees and other new arrivals eligible for 
refugee benefits. The funding for the UAC program is separate.

    Question. Please provide the details of the Department's request to 
the Department of Defense to house unaccompanied minors on military 
installations.
Collaboration With Department of Homeland Security (DHS)--Immigration
    Answer. ORR works with Federal partners to locate federally owned 
buildings and land that would be suitable to house UAC in the event 
that operational capacity at its State-licensed shelters exceeds 85 
percent. Since 2012, ORR has partnered with the Department of Defense 
(DoD) to locate influx shelters at DoD facilities around the country 
including Lackland Air Force Base, Fort Sill, Holloman Air Force Base, 
and Fort Bliss. HHS and ORR are committed to ensuring that locating 
influx shelters at DoD facilities does not affect military operations 
or impact military readiness.

    Each year, HHS sends a Request for Assistance (RFA) to the Defense, 
requesting that DoD locate facilities that could be used to locate 
influx facilities to shelter UAC. Earlier this year, DoD sent back a 
list of DoD properties that could be used as influx locations to ORR. 
ORR is currently in the process of doing preliminary site visits to 
determine if these locations are viable as influx shelter locations.

    After the preliminary site visit, ORR determines if the site holds 
promise as a potential influx location and, if so, plans and conducts a 
full site assessment. Before a site assessment begins, there is full 
notification process, including notifications to Congress, local 
officials, and the media. If a site is chosen to become an influx site 
to house UAC, the facility is run by a grantee or contractor chosen by 
ORR. Additionally, another notification process is completed to inform 
all relevant stakeholders of ORR's plans.

    ORR does not only look for influx shelter locations at DoD 
facilities, but is constantly working with other Federal partners to 
locate possible sites.

    Question. How will the Department will work with DHS to ensure the 
reunification of any minor separated from a parent during DHS custody? 
Please provide a detailed plan.

    Answer. HHS has completed reunifications for all those Ms. L. class 
members for the original class period who have elected reunification 
under the Ms. L. preliminary injunction. The most recent Joint Status 
Report in Ms. L., which discusses those reunifications, is attached.

    In addition, copies of the filings by the government in Ms. L, 
which explain the government's plan to identify the separated children 
of Ms. L. class members for the expanded class period, are attached. 
The Ms. L. Court has not yet made a ruling on remedies for the class 
members for the expanded class.

    Question. Will the plan detailed in the above question require 
congressional funding?

    Answer. HHS and CBP are working out the amount and sources of 
funding for this plan. While HHS has identified a significant funding 
shortfall for the UAC program, we do not anticipate that this plan will 
significantly exacerbate the funding issues for the program.
     implementation of the support for patients and communities act
    Question. I appreciate the President's FY 2020 budget's commitment 
to combating the addiction crisis and full implementation of the 
SUPPORT for Patients and Communities Act.

    What is CMS's timeline for implementing efforts to increase access 
to care at Institutions of Mental Disease (IMD) facilities, as 
authorized by the SUPPORT Act, for those individuals who need inpatient 
care?

    Answer. The SUPPORT for Patients and Communities Act (Pub. L. 115-
271) included a provision that provides State Medicaid programs with 
the option to cover care in certain IMDs, which may be otherwise 
nonreimbursable under the Federal IMD exclusion, for Medicaid 
beneficiaries aged 21-64 with a substance use disorder for fiscal years 
2019 to 2023. CMS is developing guidance to issue to States regarding 
this option, and CMS hopes to publish a letter to State Medicaid 
Directors this fall. CMS has also been providing technical assistance 
prior to issuing guidance to the few States who have contacted it.

    We believe States are evaluating this provision and CMS's waiver 
options around IMD coverage to determine the best course of action for 
their State.

    Question. What is the administration doing to ensure States and 
communities that are seeing an uptick in the number of overdoses from 
drugs other that opioids (such as meth) are able to benefit from the 
programs Congress has passed to help address addiction?

    Answer. Addressing the opioid epidemic is a top priority of this 
administration, and we appreciate the tools Congress has provided by 
passing legislation such as the SUPPORT for Patients and Communities 
Act (Pub. L. 115-271). HHS is also very concerned about the increasing 
deaths involving cocaine, methamphetamine, and other substances. It is 
often the case that overdose deaths involve multiple substances, and we 
know that fentanyl is being laced into other substances, including 
cocaine and methamphetamine. HHS is committed to increasing access to 
addiction treatment, and we are looking at ways to use the authorities 
Congress has provided in order to accomplish this goal.

    The SUPPORT Act was enacted on October 24, 2018, and CMS is 
implementing a number of new initiatives under that law that aim to 
increase options for treating beneficiaries with opioid use disorder or 
other substance use disorders, ensure prescriber accountability and 
improved safety for patients across CMS programs, and illuminate 
Medicaid prescribing data.

    CMS has issued several Informational Bulletins outlining State 
approaches and effective practices for addressing the opioid epidemic 
within Medicaid. In November 2017, CMS issued guidance to States 
announcing a new policy to allow States to design demonstration 
projects that increase access to treatment for opioid use disorder 
(OUD) and other substance use disorders (SUD). Through this updated 
policy, States will be able to pay for a fuller continuum of care to 
treat SUD, including critical treatment in residential treatment 
facilities that Medicaid is unable to pay for without a waiver.

    The SUPPORT for Patients and Communities Act (Pub. L. 115-271) 
built upon this concept and included a provision that provides State 
Medicaid programs with the option to cover care in certain IMDs, which 
may be otherwise nonreimbursable under the Federal IMD exclusion, for 
Medicaid beneficiaries aged 21-64 with at least one substance use 
disorder (which means patients with substance use disorders other than 
opioid use disorders may participate) for fiscal years 2019 to 2023. 
CMS is developing guidance to issue to States regarding this option, 
and it hopes to publish a letter to State Medicaid Directors this fall. 
CMS has also been providing technical assistance prior to issuing 
guidance to the few States who have contacted it. We believe States are 
evaluating this provision and CMS's waiver options around IMD coverage 
to determine the best course of action for their State. Finally, in 
February 2019, CMS issued guidance \13\ to States on mandatory and 
optional items and services for non-opioid treatment and management of 
pain that may be provided in the State Medicaid program.
---------------------------------------------------------------------------
    \13\ https://www.medicaid.gov/federal-policy-guidance/downloads/
cib022219.pdf?linkId=6393
5089.

    The Substance Abuse and Mental Health Services Administration 
provides support to States through the Substance Abuse Prevention and 
Treatment Block Grant. This funding source allows for flexibility of 
States to determine what their greatest needs are. The $1.9 billion in 
this program serves as a safety net source of funding for substance use 
disorder treatment. These funds are utilized to provide services to 
individuals who may be affected by substances other than opioids, such 
as methamphetamine. In addition, SAMHSA funds the Addiction Technology 
Transfer Centers (ATTCs) who provide training and technical assistance 
on the use of evidence-based practices to treat all substance use 
disorders. These training programs are available to providers, 
communities, and States across the country.
                                adoption
    Question. The President's FY 2020 budget proposal recommends 
cutting adoption incentives by approximately half. In my State, and 
other States across the country, children in need of adoptive parents 
are increasing, partly due to the impacts of opioid crisis.

    Please explain in detail what incentives will be eliminated under 
the President's proposal and what HHS will do to work to increase the 
number of adoptive parents throughout the country.

    Answer. HHS is committed to helping all foster care children 
achieve permanency. When children in foster care cannot be safely 
reunified with their parents, it is important to help them find 
permanent families through adoption or legal guardianship. The Adoption 
and Legal Guardianship Incentive Payments program (formerly called the 
Adoption Incentive Payments program) supports this goal by recognizing 
States' improved performance in helping children and youth in foster 
care find permanent homes through adoption or legal guardianship. 
Incentive payments received by States may be used to provide a broad 
range of child welfare services to children and families, including 
post-adoption services.

    The program was originally established as part of the Adoption and 
Safe Families Act of 1997, and has been reauthorized and revised 
several times. In 2014, the program was renamed to reflect that 
incentives will be paid to jurisdictions for improved performance in 
both adoptions and legal guardianship of children in foster care. 
Current incentive categories recognize improved performance in 
increasing the number of adoptions of children in foster care, the 
number of legal guardianships of children in foster care, the number of 
adoptions and legal guardianships for pre-adolescent children in foster 
care (ages 9-13), and the number of adoptions and legal guardianship 
for older children (ages 14 and older) in foster care.

    Current year funding under the Adoption and Legal Guardianship 
Incentives Program is used to pay for incentives earned based on 
performance in prior years. When the total amount of incentive payments 
earned by a State in any year exceeds the amount of funds available, 
payments are initially pro-rated. However, it has been Administration 
for Children and Families' (ACF) longstanding practice to fully 
recognize positive performance and award all incentive payments. 
Therefore, ACF typically uses each annual appropriation first to payout 
the balance on any previous years' earnings and then, later in the year 
once data become available, to make an initial payment on the earnings 
for the most recent year.

    Historically, funding for the program has been provided at 
approximately $37.9 million annually and that is the level requested in 
the President's FY 2020 budget. However, Congress provided increased 
annual appropriations of $75 million in each of FYs 2018 and 2019. HHS 
is not eliminating incentives, but is requesting funds at the 
traditional $37.9 million.
                       medicaid work requirements
    Question. As part of my questioning on March 14th, I asked you 
about the Department's definition of ``able-bodied adult'' as it 
relates to the work requirements the Department has approved across 
several different States, including my home State of Ohio. You were 
unable to define the term, but instead pointed me toward the approved 
waiver applications for me to see the variations on the term you have 
approved across the different States.

    One of the things I asked you about was a post-partum woman--would 
a woman 3 months after giving birth be considered an ``able-bodied 
adult'' who would be subject to work requirements or risk losing 
Medicaid coverage as she tries to care for her newborn baby.

    Please clarify: does your definition of ``able-bodied adult'' 
include a woman who gave birth less than 3 months ago?

    What is HHS doing to ensure individuals who are kicked off of 
coverage for reasons outside of their control (e.g., information is 
sent to the wrong address, the computer system doesn't work, their 
documentation demonstrating they should be exempt from a work 
requirement isn't properly filed) do not suffer from a lapse in 
coverage?

    How are you ensuring individuals who receive coverage through 
Medicaid are aware of their right to re-enroll in the program if they 
are kicked off?

    Answer. As part of the waivers we've granted, we have set careful 
guardrails that require States to protect their most vulnerable 
beneficiaries (including beneficiaries who are pregnant or post-
partum), and only required community engagement for beneficiaries whose 
circumstances allow them to participate.

    On March 15, 2019, CMS approved Ohio's 1115 demonstration project, 
and that approval is subject to the limitations specified in the waiver 
authorities and special terms and conditions included in the waiver 
approval. With approval of the demonstration, Ohio will require, as a 
condition of continued eligibility, that non-exempt beneficiaries in 
the new adult group at section 1902(a)(10)(A)(i)(VIII) of the Social 
Security Act, ages 19 through 49, engage in qualifying community 
engagement activities for at least 80 hours per month. As part of the 
guardrails to ensure that Ohio protects its most vulnerable residents, 
CMS provided the State with flexibility to exempt various groups that 
the State has determined are unlikely to be able to reasonably comply 
with the requirements, including beneficiaries who are pregnant or 60 
days or less post-partum.

    Under the demonstration, Ohio is required to notify beneficiaries 
of their need to participate in community engagement activities as a 
condition of continued coverage and eligibility. Beneficiaries will 
have 60 days post notification to report their compliance with the work 
and community engagement requirement. Beneficiaries will be allowed to 
report compliance with the work and community engagement requirement in 
person, over the phone, online, or by mail. Once the beneficiary 
reports one time, no further reporting is required unless the 
beneficiary experiences a change in circumstance. If a beneficiary does 
not report within the 60 days that they are completing a qualifying 
activity, meet the criteria for an exemption, or experience a good 
cause circumstance, the beneficiary will be considered non-compliant 
and be disenrolled from Medicaid. The beneficiary will have the option 
of applying to re-enroll in Medicaid. Prior non-compliance will not be 
a factor in any future determination of Medicaid eligibility.

    CMS has also worked with Ohio to include guardrails that will 
protect beneficiaries. The Specific Terms and Conditions (STCs) contain 
a series of assurances, including that the State will: screen 
beneficiaries and determine eligibility for other bases of Medicaid 
eligibility and review for eligibility for insurance affordability 
programs prior to disenrollment; provide full appeal rights prior to 
disenrollment; ensure that there are timely and adequate beneficiary 
notices provided in writing which address community engagement 
requirement features; assess areas within the State that experience 
high rates of unemployment, areas with limited economic and/or 
educational opportunities, and areas with lack of public transportation 
to determine whether there should be further exemptions from the 
community engagement requirements and/or additional mitigation 
strategies, so that the community engagement requirements will not be 
unreasonably burdensome for beneficiaries to meet; monitor the 
application of exemptions to ensure that there is not a disparate 
impact based on race and ethnicity; and maintain a system that provides 
reasonable modifications related to meeting the community engagement 
requirements to beneficiaries with disabilities, among other 
assurances.

                                 ______
                                 
             Questions Submitted by Hon. Michael F. Bennet
    Question. Last spring, the administration announced the ``zero 
tolerance'' policy that resulted in the separation of over 2,800 
children at the southern border. Almost a year later since the 
announcement of this shameful policy, there are still children in HHS 
custody who were separated from their families and have not been 
reunified.

    In January, the HHS Office of Inspector General released a report 
on the separated children placed in the care of the Office of Refugee 
Resettlement (under HHS). The report highlighted that potentially 
thousands of more children may have been separated from their families 
prior to the public announcement of the ``zero tolerance'' policy. A 
Federal judge ruled just last week to recognize the children and 
families that were separated since July 2017.

    Is HHS working to identify the children who were separated from 
their families before the ``zero tolerance'' policy was announced? If 
not, why?

    Answer. Yes. Copies of the filings by the government in Ms. L, 
which explain the government's plan to identify the separated children 
of Ms. L. class members for the expanded class, are attached.

    Question. Will you commit to working on identifying these children 
and reunifying them with their families?

    Answer. HHS is fully committed to implementing the court-approved 
plan for identifying the separated children of Ms. L. class members for 
the expanded class period. The Ms. L. Court has not yet made a ruling 
on remedies for the class members for the expanded class period. HHS 
has created, deployed, and trained a team of USPHS Officers to conduct 
individual case files review as part of a pilot project to implement 
the government's plan to identify substantially all separated children 
referred to and discharged by ORR within the expanded class period. As 
of June 24, 2019, the team has reviewed all of the approximately 33,000 
individual case files. HHS has referred all the cases with a 
preliminary indication of separation to DHS for further assessment and 
reconciliation.

    Question. What steps is your agency taking to implement the 
recommendations from the January OIG report in order to improve program 
operations based on their findings?

    Answer. OIG raised concerns in its report about the inter-agency 
system for sharing information regarding newly separated children (that 
is, children whom DHS separates from a parent or legal guardian for 
cause and in compliance with the Ms. L court's orders, and refers to 
ORR, after June 26, 2018).

    As Assistant Secretary Lynn Johnson explained in her response to 
the OIG report, HHS has implemented changes to the UAC Portal as well 
as the ORR case management process to enhance tracking and automate the 
aggregation of data regarding separated children. HHS still relies on 
DHS to provide us with data on separations. ORR is continually working 
with DHS to try to improve the accuracy and completeness of what DHS 
provides to ORR.

    OIG is conducting additional evaluations of the ORR program and HHS 
is cooperating with the OIG across the board. We are committed to 
continual process improvement and welcome the engagement of the OIG in 
our efforts to improve the UAC program.

                                 ______
                                 
            Questions Submitted by Hon. Robert P. Casey, Jr.
    Question. At a series of Aging Committee hearings in March, the 
shortcomings of the Medicare.gov Plan Finder tool emerged as a 
persistent theme. In February, the Centers for Medicare and Medicaid 
Services (CMS) announced that the agency is actively engaged in a 
redesign of the Plan Finder.

    Will the redesign process include the opportunity for public 
comment and dialogue with benefits counselors (including State Health 
Insurance Assistance Programs or SHIPs) and Medicare beneficiary 
advocates? If so, please describe the stakeholder comment and review 
process CMS will employ.

    Will you commit to providing a preview of the new Medicare Coverage 
Tools for members of Congress and their staff? Please indicate when CMS 
will be prepared to provide a preview of the redesigned Medicare 
Coverage Tools in their entirety.

    Please provide any consumer testing research that CMS is using to 
inform the redesign process. Please indicate how and whether CMS is 
leveraging this research to inform the redesign.

    Please describe any outreach or training that CMS expects to 
provide on the revamped Medicare Coverage Tools to SHIP counselors, 1-
800-MEDICARE call center employees as well as external stakeholders, 
including Medicare beneficiary advocates.

    Answer. As part of CMS's Medicare multi-year initiative to improve 
Medicare service across its customer support channels, CMS is 
undertaking a comprehensive redesign of the Medicare Plan Finder this 
year. In preparation for the fall 2019 Open Enrollment Period, CMS is 
building on its initial investment and focusing on a fulsome redesign 
of the Plan Finder tool to improve usability and address feedback that 
we have received from users and stakeholders. The redesigned Plan 
Finder tool will be an important source for Medicare plan information 
and provide an updated platform and experience for Medicare 
beneficiaries, family members, caregivers, advocates, and healthcare 
providers with one central place to view, compare, and select Medicare 
Part D prescription drug and Medicare Advantage plans.

    CMS has sought feedback on changes to the Plan Finder from key 
stakeholders, including the State Health Insurance Assistance Program 
(SHIP) leadership and Medicare beneficiary advocates. In addition, CMS 
receives continuous feedback from users through consumer testing and 1-
800-MEDICARE Call Center focus groups; CMS is planning similar focus 
groups with SHIP counselors this summer. To ensure user and stakeholder 
needs are met, the redesigned Plan Finder tool will be rolled out in 
phases, including a phase during which CMS will provide a preview to 
and solicit feedback from external stakeholders, including Call Center 
Representatives, SHIPs, and beneficiary advocacy groups. Feedback will 
be incorporated into the redesigned Plan Finder tool, which will be 
launched for the upcoming Medicare Open Enrollment Period.

    In June, CMS provided briefings to congressional staff, including 
staff from the Senate Special Committee on Aging, that previewed 
updates to the Medicare Plan Finder and presented the agency's timeline 
for rolling out the comprehensive redesign of the Medicare Plan Finder 
(Medicare Coverage Tools). The agency anticipates the beta launch for 
the redesigned Medicare Plan Finder to occur in July; at that time, the 
redesigned Medicare Plan Finder will be available in its entirety to 
the public well in advance of the 2019 Open Enrollment period.

    Question. Far too often, people new to Medicare are uniformed or 
misinformed about basic Medicare enrollment rules, including knowing 
how and when to sign up for Medicare (Part A and Part B). The 
consequences of enrollment missteps can be significant, leading to 
lifetime late enrollment penalties, gaps in coverage and barriers to 
accessing needed care.

    Are CMS and SSA engaged in conversations regarding updates to 
existing Medicare enrollment material? This includes, but is not 
limited to, changing or updating written or online material pertaining 
to Social Security statements and Medicare Part A and Part B 
enrollment. If so, please describe the nature of these conversations 
(which agency initiated and why), the updates or changes under 
discussion and any plans that CMS and/or SSA have to make changes based 
on these discussions.

    Answer. The Social Security Administration (SSA) and the Centers 
for Medicare and Medicaid Services (CMS) have enjoyed a long-standing 
partnership helping millions of elderly Americans, and those with 
disabilities, receive the health care they need. With that spirit of 
cooperation in mind, SSA and CMS continue to build on that partnership 
and collaborate on several additional efforts to improve the customer 
experience of our beneficiaries when they enroll in Medicare and 
throughout their time in the program. CMS has reached out to SSA with 
new collaborative opportunities it would like to explore, and some that 
would expand existing work and collaboration. CMS has been working 
together with SSA on areas such as improving Medicare enrollment and 
strengthening the CMS-SSA partnership. Very recently, CMS and SSA 
worked together on the successful effort to remove Social Security 
Numbers from Medicare cards and transactions, which will help protect 
Medicare beneficiaries from identity theft.

    Question. On March 4, 2019, I sent a letter with Senator Toomey to 
the Centers for Medicare and Medicaid (CMS) requesting information 
about the Special Focus Facility program, which is designed to increase 
oversight of nursing home facilities that persistently under perform. 
Will you commit to ensuring that HHS provides a complete and timely 
response to this letter?

    Answer. CMS sent a response to this letter on May 3, 2019.

    Question. Marketplace enrollees nearing Medicare eligibility face 
complicated and time-sensitive enrollment decisions. Without adequate 
and timely information, these individuals can make consequential 
enrollment errors about their coverage. CMS began the Medicare Periodic 
Data Matching Process as a way to identify and notice marketplace 
enrollees found to be dually enrolled in Medicare. Yet, since the 
inception of this process, CMS has failed to bolster their notification 
of marketplace enrollees nearing Medicare eligibility to prevent 
enrollment errors.

    Please describe any outreach to marketplace enrollees nearing 
Medicare eligibility.

    Will you commit to providing additional notification to marketplace 
enrollees nearing Medicare eligibility? If so, please detail CMS's 
intended outreach strategy including email, paper mailing, phone calls, 
and text messages.

    Will you commit to halting plans to terminate coverage for 
marketplace enrollees found to be dully enrolled in Medicare absent 
adequate consumer protections, including sufficient notice and 
education?

    Please detail the administration's decision making process 
regarding extension of Time Limited Equitable Relief for people 
enrolled in marketplace coverage who mistakenly delayed or declined 
Medicare Part B because of misinformation. Will you commit to extending 
this opportunity for relief beyond September 2019?

    Answer. Ensuring that exchange consumers are aware of their 
coverage options and able to make decisions regarding the coverage that 
is appropriate for them is a key priority for CMS. We share your 
concerns regarding the consequences of dual enrollment in Medicare and 
exchange coverage for older Americans, including the potential risk for 
tax liability for advance payments of the premium tax credit (APTC) 
received during months of overlapping coverage or financial penalties 
such as the Medicare Part B late enrollment penalty (LEP) if they delay 
enrolling in Medicare Part B during their initial eligibility period.

    CMS continues to prioritize consumer and stakeholder education 
regarding dual enrollment in Medicare and the exchange and 
transitioning between coverage through various outreach activities. For 
example, CMS provides webinars, newsletters, and fact sheets to 
stakeholders such as assisters, agents, brokers, and issuers. 
Additionally, CMS has developed educational materials to inform 
consumers, including current and future Medicare beneficiaries, of the 
potential consequences of dual enrollment in Medicare and exchange 
coverage, including penalties for not enrolling in Medicare Part B when 
first eligible. This information is now included in the Medicare 
Initial Enrollment Period (IEP) packages (mailed to all beneficiaries 
automatically enrolled in the Medicare program), General Enrollment 
Period (GEP) packages (mailed to all beneficiaries who refused or lost 
Medicare Part B coverage in the last year), the Medicare and You 
Handbook, and on the exchange application.

    Medicare periodic data matching (PDM) is the process by which the 
exchange periodically examines available data sources to identify 
consumers enrolled in exchange health plans with financial help at the 
same time they are determined eligible for, or are enrolled in, 
Medicare. Based on CMS experience performing Medicare PDM, the majority 
of exchange consumers who become dually enrolled have become dually 
enrolled by aging into Medicare and many have likely forgotten to 
terminate their exchange coverage during their Medicare Initial 
Enrollment Period.

    We believe that exchanges can play an important role in mitigating 
the risk for these beneficiaries of tax liability for overlapping 
months of coverage, if they received APTC, and the risk for the 
Medicare Part B late enrollment penalty by proactively terminating 
exchange QHP coverage (if directed to do so by the enrollee) after an 
enrollee is found to be dually enrolled in Medicare and exchange 
coverage. In 2018, the Federally Facilitated Exchange added an 
authorization to the exchange application by which consumers could 
permit or deny the exchange to act on their behalf and end their 
exchange coverage if later found to be enrolled in other qualifying 
coverage such as Medicare. The text of this authorization is as 
follows:

        If anyone on your application enrolls in coverage through a 
        Marketplace plan, but is later found to have other qualifying 
        health coverage (including Medicare, Medicaid, and/or CHIP), 
        you have the option to allow the Marketplace to end their 
        Marketplace coverage if you select ``I agree to this 
        statement'' below.

        If you select ``I disagree to this statement,'' anyone in this 
        situation will stay enrolled in Marketplace coverage and will 
        pay full cost for their Marketplace plan since they'll no 
        longer be eligible for advance payments of the premium tax 
        credit or extra savings.

    This authorization to permit the exchange to end QHP coverage is 
voluntary as consumers can opt in or opt out. Additionally, after 
receiving a Medicare PDM notice, consumers can return to the exchange 
and revoke their authorization for the exchange to terminate their QHP 
coverage if found to be dually enrolled; these consumers will remain 
enrolled in their exchange QHP coverage without APTC.

    In spring 2019, CMS began the process of terminating coverage for 
the first cohort of enrollees who provided this authorization and were 
subsequently determined through PDM to be dually enrolled in Medicare 
and the exchange. Based on stakeholder feedback, CMS intends to conduct 
Medicare PDM more frequently to ensure that newly identified Medicare 
and exchange dual enrollees have sufficient time to sign up for 
Medicare Part B at the appropriate time and without penalty. Responses 
to the updated Medicare PDM notice content has been positive, with many 
dual enrollees proactively ending their QHP coverage after receipt of 
the initial Medicare PDM warning notice. CMS will continue to monitor 
the progress of future rounds of Medicare PDM and will explore ways to 
mitigate any gaps in coverage for the dual enrollee population.

    Regarding time limited equitable relief, CMS is offering this 
relief for certain beneficiaries dually enrolled before September 30, 
2019. These beneficiaries are allowed to enroll in Medicare Part B 
without incurring a LEP or, if these beneficiaries are already paying a 
LEP, they have an opportunity to request a reduction in the penalty. 
CMS is providing this relief because these individuals may not have 
received the information necessary at the time of their Medicare IEP or 
initial enrollment in the exchange to make an informed Medicare Part B 
enrollment decision. As a result, some people with Medicare Part A 
coverage may have enrolled in exchange QHP coverage believing it was an 
alternative to Medicare Part B coverage. These consumers may not have 
known they enrolled in the wrong program prior to the end of their 
Medicare IEP, resulting in either (1) staying in their exchange 
coverage or (2) enrolling in Medicare Part B during the GEP and being 
assessed a Part B LEP.

    We will continue to monitor the transition between Medicare and the 
exchange to improve the overall process as necessary.

    Question. The Center for Medicare and Medicaid Innovation 
(Innovation Center) was designed to support the development and testing 
of innovative health-care payment and service delivery models. The 
Innovation Center's objective to improve quality of care and reduce 
health-care costs functions most efficiently when the process is open 
and thoughtful. Yet, I am concerned that the process by which the 
Innovation Center develops models lacks transparency and that there is 
insufficient detail available on models the Innovation Center is 
currently considering. Please describe the process models go through 
starting from conceptualization to announcement, including the role of 
HHS counsel in this process. What is the current process for 
incorporating stakeholder comments into model development, 
implementation and evaluation processes?

    Answer. Response: We are committed to transparency and stakeholder 
input in Innovation Center models. Since its inception, the Innovation 
Center has consulted and worked with stakeholders across the country, 
other Federal agencies, and other operating divisions within the 
Department of Health and Human Services in order to identify promising 
new payment and service delivery models and help design new models. For 
example, in 2017, in an effort to increase the transparency and 
effectiveness of the Innovation Center's work, CMS issued a Request for 
Information (RFI) seeking feedback on a new direction to promote 
patient-centered care and test market-driven reforms aimed at 
empowering beneficiaries as consumers; providing price transparency; 
and increasing choices and competition to drive quality, reduce costs, 
and improve outcomes. To further transparency, CMS published the 
responses to the RFI in April 2018.\14\ The responses to this RFI and 
other recent RFIs in addition to other public and stakeholder feedback 
that CMS has received, drive the development process for models that 
are under consideration for potential testing.
---------------------------------------------------------------------------
    \14\ The New Direction RFI and the comments received are available 
at: https://innovation.cms.gov/initiatives/direction/.

    The Innovation Center uses a variety of other methods to actively 
seek input from a wide range of stakeholders across the country. The 
Innovation Center holds model-specific listening sessions and focus 
groups, webinars, site visits, summits, and information sharing 
sessions, engaging thousands of innovators from around the country at 
different stages of the model development process. In addition, the 
Innovation Center invites and seeks input on issues in health-care 
payment and delivery through forums that are open to the public, 
including RFIs mentioned above, and notice and comment rulemaking. The 
Innovation Center also interacts with people across the country 
interested in service delivery and payment innovation through its 
---------------------------------------------------------------------------
website, social media outreach, and an email listserv.

    The development and design of Innovation Center models typically 
follows a dynamic lifecycle process that involves several steps. Over a 
period of months, the Innovation Center identifies ideas for new models 
from internal and external stakeholders and then develops ideas into 
model concepts. These concepts are assessed in the context of the 
current portfolio of models, as well as their potential to improve 
quality of care and reduce costs. These concepts are then developed 
into models with specific payment and quality components. From design 
to release of the model can take many months or over a year of work 
depending upon the complexity of the model. Each model must meet the 
statutory requirements to maintain or improve quality and reduce or 
maintain expenditures.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. The President's budget seeks to reduce health-care 
expenditures by repealing the Affordable Care Act and cutting $1.5 
trillion in Medicaid funding over 10 years, proposals that would hurt 
millions of Americans. This approach actually hurts Americans twice: by 
drastically cutting programs on which they depend and leaving in place 
an inefficient health-care delivery system that wastes hundreds of 
billions of dollars a year. There's a better, more responsible way to 
lower health-care spending, and it's through reforms like Accountable 
Care Organizations, bundled payments, and patient-centered medical 
homes.

    Rhode Island has two well-established Medicare Accountable Care 
Organizations: Coastal Medical, which over 5 years has saved Medicare 
$30 million, and Integra Community Care Network, which over 3 years has 
saved Medicare $16 million. These are big numbers in a State as small 
as Rhode Island.

    Do you agree that ACOs and other alternative care models have the 
potential to reduce Federal health expenditures? If yes, how much 
savings would you estimate is possible from these types of delivery 
system reforms?

    Answer. Transforming our health-care system into one that pays for 
value by rewarding outcomes and health instead of procedures and 
sickness is a key Department-wide priority. The Innovation Center is 
developing and testing models that complement HHS's ``four Ps'' of 
driving toward value: Patients as Consumers, Providers as Accountable 
Patient Navigators, Paying for Outcomes, and Prevention of Disease 
Before it Occurs. Getting better value from our health system and 
paying for value requires empowering patients to be engaged and 
informed consumers. In the shift toward value, empowered patients will 
still need physicians to help them navigate the health-care system, and 
HHS needs to give those physicians the right incentives to guide 
patients in making choices that will lead to good outcomes.

    We know that the U.S. health care payment system is overly complex 
and often does not create sufficient incentives for higher-quality, 
lower-cost care. An Alternative Payment Model (APM) is a payment 
approach that creates added incentives to provide high-quality and 
cost-efficient care. APMs can apply to a specific clinical condition, a 
care episode, or a population. Payment for value, as measured through 
outcomes, is the central premise of every model the Innovation Center 
tests. Following the ``four Ps'' we think the current portfolio of 
models will continue to drive the health-care system towards delivering 
value and have the potential to reduce Federal health-care 
expenditures. Additional information on estimated spending effects of 
models is available in the Analytical Perspectives of the FY 2020 
President's budget.

    Question. Why does the President's budget drastically cut Medicaid 
and repeal the Affordable Care Act as its first response to addressing 
health-care spending instead of taking the more responsible and humane 
approach of lowering spending through delivery system reforms?

    Answer. The Medicaid program was designed to serve our most 
vulnerable populations, such as children and people with disabilities. 
To strengthen the fiscal sustainability of this critical safety net for 
generations to come, this administration is looking at ways to 
facilitate State innovation and increase patient choice. Successful 
partnership between our leadership at HHS and the leaders of every 
State Medicaid program is vital to delivering on the mission of HHS and 
the mission of the Medicaid program: improving the health and well-
being of the Americans we serve.

    This administration is committed to granting States more freedom to 
design innovative local solutions. We have followed through on that 
promise by supporting efforts, like waiving decades-old restrictions on 
addiction treatment services and allowing States to link working age 
beneficiaries to new opportunities through work and community 
engagement programs, under authority granted to us under section 1115 
of the Social Security Act. For example, in November 2018, CMS 
published a State Medicaid Director letter discussing strategies under 
existing authorities for States to implement innovative service 
delivery system reforms for adults with serious mental illness, and 
children with serious emotional disturbance. Examples of these 
innovations include improving availability of behavioral health 
screenings and mental health and substance use disorder services in 
schools to identify and engage children with serious emotional 
disturbance sooner. The letter explained a demonstration opportunity 
for States to receive Federal financial support for treating Medicaid 
beneficiaries with these conditions during short-term acute care stays 
in psychiatric hospitals or in residential treatment facilities that 
qualify as an Institution for Mental Diseases.

    Since January 2018, the Innovation Center has launched a number of 
bold, new models designed to provide better care at a lower cost. For 
example, CMS announced the Maternal Opioid Misuse (MOM) Model, which 
aims to improve quality of care for pregnant and postpartum Medicaid 
beneficiaries with opioid use disorder through State delivery system 
innovations. The model tests sustainable coverage and payment 
strategies supporting the coordination of clinical care and the 
integration of services essential for health, well-being, and recovery; 
expands access, service delivery capacity, and infrastructure based on 
State specific needs; and improves quality of care and reduces costs 
for mothers and infants. This model will run from January 1, 2020 
through December 31, 2024.

    Question. With health spending reaching nearly 18 percent of GDP, 
we still spend a larger share of our economy on health care than any 
other OECD nation. The second highest health spender is Switzerland at 
12 percent. For all of the extra money we spend, we don't necessarily 
get better outcomes. [Health Spending Per Capita v. Life Expectancy 
Chart]

    Since 2010, there's been improvement on the budget outlook for 
mandatory Federal spending on health care. [2010 v. 2019 CBO Baseline 
Chart]

    I think the slowdown is evidence that structural changes in the 
delivery of care--many of which were ushered in by the Affordable Care 
Act--have taken hold, and we are seeing lower Federal spending as a 
result.

    Do you believe there is an advantage to reducing health-care 
spending growth through alternative payment and delivery models?

    What is the administration doing to better understand the causes of 
the sustained slowdown in Federal health-care spending?

    Answer. In February 2019, the Office of the Actuary at the Centers 
for Medicare and Medicaid Services (CMS) published a report stating 
that national health expenditure growth is expected to average 5.5 
percent annually from 2018-2027, reaching nearly $6.0 trillion by 2027.

    Growth in national health spending is projected to be faster than 
projected growth in Gross Domestic Product (GDP) by 0.8 percentage 
points over the same period. As a result, the report projects the 
health share of GDP to rise from 17.9 percent in 2017 to 19.4 percent 
by 2027.

    The report found that the outlook for national health spending and 
enrollment over the next decade is expected to be driven primarily by:

          Key economic factors, such as growth in income and 
        employment, and demographic factors, such as the baby-boom 
        generation continuing to age from private insurance into 
        Medicare; and

          Increases in prices for medical goods and services 
        (projected to grow 2.5 percent over 2018-2027 compared to 1.1 
        percent during the period of 2014-2017).

    The report is available at: http://www.cms.gov/Research-Statistics-
Data-and-Systems/Statistics-Trends-and-Reports/
NationalHealthExpendData/NationalHealth
AccountsProjected.html.

    These projections highlight the urgent need to ensure that our 
health-care programs are paying for value, as we are currently on an 
unsustainable trajectory. Transforming our health-care system into one 
that pays for value by rewarding outcomes and health instead of 
procedures and sickness is a key department-wide priority. The 
Innovation Center is developing and testing models that complement 
HHS's ``four Ps'' of driving toward value: Patients as Consumers, 
Providers as Accountable Patient Navigators, Paying for Outcomes, and 
Prevention of Disease Before it Occurs. Following the ``four Ps'' we 
think the current and future portfolio of models will continue to drive 
the health-care system towards delivering value.

    Question. I'm pleased to see the President's budget include a 
number of proposals related to lowering the cost of prescription drugs, 
but the budget does not address the administration's recent proposed 
rule to require rebates from drug companies to PBMs or insurance 
companies to be passed along to consumers that the point of sale. This 
is a proposal that would certainly interact with the administration's 
other drug pricing efforts, and one that would, by CMS's own estimates, 
increase premiums in Medicare Part D. In addition to my concerns about 
increased premiums, I remain skeptical that this proposal will result 
in lower list prices for prescription drugs.

    If the administration's rebate rule was finalized and you were 
still in your previous role as a drug company executive, would you 
support reducing the list prices of the company's drugs?

    If so, by how much relative to the size of the rebates the company 
is currently providing?

    Answer. Subject to the President's executive order \15\ from 
January 28, 2017, I will not participate in any particular matter 
involving my former employer. You may wish to review the responses 
provided to Senate Finance Committee Chairman Chuck Grassley at the 
February 2, 2019, Senate Finance Hearing ``Drug Pricing in America: A 
Prescription for Change, Part II.'' The chairman asked this question of 
the witnesses and all answered that they are supportive of the rule, 
and would consider lowering the list price of their companies' drugs.
---------------------------------------------------------------------------
    \15\ https://www.whitehouse.gov/presidential-actions/executive-
order-ethics-commitments-executive-branch-appointees/.

    Question. If companies are unwilling to reduce list prices by the 
size of the current rebates, doesn't this proposal set drug companies 
---------------------------------------------------------------------------
up to receive a substantial windfall?

    Answer. The current rebate system incentivizes higher list prices. 
If the proposed rule is finalized, pharmaceutical companies will no 
longer participate in rebate schemes to compete for formulary position. 
Such companies would, instead, compete for lower list prices to ensure 
better formulary positions. Pharmaceutical Benefit Managers (PBMs) in 
the current system do a good job of negotiating with the manufactures 
for lower cost; in a system where the proposed rule referenced is 
finalized, PBMs will still be able to extract leverage and drive down 
cost.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                                 ______
                                 
               Questions Submitted by Hon. Maggie Hassan
    Question. This question relates to the HHS OIG's Proposed Rule 
entitled, ``Removal of Safe Harbor Protection for Rebates Involving 
Prescription Pharmaceuticals and Creation of New Safe Harbor Protection 
for Certain Point-of-Sale Reductions in Price on Prescription 
Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.''

    Under the proposed rule, which entity or entities would administer 
and provide the point-of-sale discounts to beneficiaries? Is it the 
administration's intent that that Pharmacy Benefit Managers (PBMs) 
would administer and provide the point-of-sale discounts to the 
beneficiaries? If not, how will the proposed rule's point-of-sale 
discounts be administered?

    Answer. The proposed rule referenced in your question does not 
specify who in the system would administer and provide the point-of-
sale discounts. We solicited common on this important question in the 
proposed rule and have received comment letters on this topic which we 
will consider to help inform the rulemaking process.

    Question. In June of 2018, the Medicaid and CHIP Payment and Access 
Commission (MACPAC) unanimously recommended under Recommendation 1.1 in 
their annual report to Congress that Congress remove the statutory 
requirement that manufacturers blend the average manufacturer price 
(AMP) of a brand drug and its authorized generic.\16\
---------------------------------------------------------------------------
    \16\ MACPAC, ``Improving Operations of the Medicaid Drug Rebate 
Program,'' https://www.macpac.gov/wp-content/uploads/2018/06/Improving-
Operations-of-the-Medicaid-Drug-Rebate-Program.pdf.

    This requirement created an unintended loophole. Rather than use 
the price of the authorized generic, drug companies can sell its 
authorized generic to a corporate subsidiary at an artificially lower 
price, and use that lower price to bring down the AMP, which in turn 
---------------------------------------------------------------------------
lowers the rebate obligation.

    What information have you learned from the Health and Human 
Services Office of the Inspector General report regarding this issue? 
What is the scope of this problem, and how prevalent is this practice 
among drug manufacturers?

    Answer. As part of our overall effort on drug prices, the 
President's FY 2020 budget proposes a legislative fix with which 
Congress could clarify authorized generic drug sales under the Medicaid 
Drug Rebate program. This proposal clarifies that the primary 
manufacturer's average price must exclude the sales of heavily 
discounted authorized generics to secondary manufactures.

    Question. In New Hampshire, our Department of Health and Human 
Services has received about the same level of funding each year for the 
Community Mental Health Block Grant program for the last 20 years.

    Why has funding for the Community Mental Health Block Grant program 
not been increased despite the growing need for mental health services 
across the country?

    Answer. SAMHSA feels strongly that the needs of those with serious 
mental illness are critical. The Community Mental Health Block Grant 
(MHBG) is a major source of SAMHSA funding which supports this effort. 
Though the Block Grant was not proposed for increase this year, this 
does not indicate a lack of priority for this program. The MHBG has 
grown from $533 million in FY 2016 to $733 million in FY 2019. SAMHSA 
maintains this FY 2019 enacted level in the FY 2020 President's budget. 
Overall, the budget provides $1 billion, an increase of $3 million 
above FY 2019, to SAMHSA to improve access to mental health services 
for those with serious mental illness and children with serious 
emotional disturbance, and the budget also proposes $15 million for 
SAMHSA's Assertive Community Treatment program, which is an increase of 
$10 million over the FY 2019 enacted level.

                                 ______
                                 
           Questions Submitted by Hon. Catherine Cortez Masto
    Question. Since 2008, average family premiums for employer 
sponsored plans have increased 55 percent, twice as fast as workers' 
earnings (26 percent) and three times as fast as inflation (17 
percent).\17\ The Kaiser Family Foundation survey from 2018 found that 
``the burden of deductibles on workers continuing to climb over time in 
two ways: a growing share of covered workers face a general annual 
deductible, and the average deductible is rising for those who face 
one.''Do you see this rising share of health-care costs borne by 
employees as problematic?
---------------------------------------------------------------------------
    \17\ Kaiser Family Foundation, https://www.kff.org/health-costs/
press-release/employer-sponsored-family-coverage-premiums-rise-5-
percent-in-2018/.

    We know that providers recover low reimbursements from Federal 
programs through higher charges to commercial plans. What kind of data 
do you have on the impact of your Medicaid cuts on the cost of 
---------------------------------------------------------------------------
employer-sponsored coverage? How about the impact of the hospital cuts?

    Answer. We recognize that serious problems remain with the PPACA. 
Many Americans continue to be priced out of the market and there are 
28.5 million uninsured. As a result, enrollment among unsubsidized 
people continues to decline. In 2019, the average monthly premium for a 
family of four on HealthCare.gov is over $1,500, which can easily 
exceed the family's mortgage.

    The ACA did nothing to address the underlying problems behind 
rising health-care costs in this country. Health-care costs continue to 
be on a trajectory to consume nearly $1 in every $5 of the Nation's 
economy by 2027. At the end of the day, we have to address rising 
health-care costs because that is what is increasing premiums. The 
administration issued rules to expand short-term, limited duration 
insurance plans, which can be far less expensive than exchange plans 
and better suited to peoples' needs. The administration also issued 
rules to expand association health plans and health reimbursement 
accounts, increasing access for small businesses to offer more 
affordable health insurance options for their employees.

    Question. If an individual with a history of cancer is priced out 
of health-care coverage based on their health history--for the purposes 
of this discussion, if their premiums exceed 9.5 percent of their 
income--would you still consider that individual protected from 
discrimination based on their pre-existing condition?

    Answer. Under current law, health insurance issuers cannot refuse 
to cover an individual, or charge that individual a higher price, 
because they have a pre-existing condition (that is, a health problem 
that was present before the date that new health coverage starts). 
These rules went into effect for policy years beginning on or after 
January 1, 2014. Today, we know that the ACA has not delivered on its 
promise to people with pre-existing conditions. In particular, if you 
are ineligible for a premium tax credit, coverage on the individual 
market has likely become unaffordable for you.

    Question. When CBO scored the Graham-Cassidy proposal, they 
determined that ``millions'' would lose coverage under the bill. They 
didn't have enough time to give us specifics; you have had 2 years to 
put together more specific estimates, just as CBO did for other 
versions of ACA repeal. Can you tell me specifically how many Americans 
you expect to lose coverage under this budget over the course of the 
10-year budget window?

    Answer. The budget supports a two-part approach to move away from 
Obamacare, starting with enactment of legislation modeled closely after 
the Graham-Cassidy-Heller-Johnson bill that includes Market-Based 
Health Care Grants. In Medicaid, this includes allowing States a choice 
between a per-capita cap or a block grant, and repealing Obamacare's 
Medicaid expansion, to modernize Medicaid financing and refocus the 
program on those it was originally intended to serve. The second part 
of the budget proposal includes additional reforms to address 
unsustainable health-care spending trends and builds upon the Graham-
Cassidy-Heller-Johnson bill to make the system more efficient. This 
includes proposals to align the growth rates for the Market-Based 
Health Care Grant Program and Medicaid per capita cap and block grant 
with the Consumer Price Index for All Urban Consumers (CPI-U).

    Question. There are a handful of policies in this budget that 
appear to be based on the assumption that consumers are too insulated 
from the true cost of their care to be informed consumers, and are 
thereby driving up the cost of health care (minimum contribution for 
premium tax credits, and increasing copayments in Medicaid). Do you 
think that consumers don't have enough skin in the game? What sort of 
clinical improvement do these policies serve? What data or evidence do 
you have to support that?

    Answer. The President's 2020 budget proposes bold reforms to our 
Nation's safety net and Federal health programs, so that they actually 
work for the people they serve. They aim to empower States to take 
charge of the health-care system and create solutions that will be best 
suited for their citizens. These proposals also empower consumers to 
purchase coverage that best suits their health-care needs.

    These proposals align with the administration's core values. First, 
they rely, to the extent possible, on competition within the private 
sector because that is a key way to drive down costs while improving 
quality. Second, these changes put patients at the center, free to make 
choices that work for them. Third, these reforms defer to States to 
innovate, rather than assuming the Federal Government knows best. 
Finally, these reforms aim to deliver care in an affordable, fiscally 
sustainable way, while maintaining a safety net for those in need.

    Question. The budget proposes to give States the ability to make 
changes to the ten essential health benefits outline in the ACA. Which 
one of those do you see as ``nonessential'' in an insurance product?

    Answer. The President's budget includes a number of proposals to 
improve Federal health programs so they work better for the people they 
serve. These reforms leverage competition within the private sector, 
allow patients to make choices that work for them, and give States the 
freedom to innovate. For 2019, average premiums have dropped for the 
first time since the implementation of the Federally Facilitated 
Exchanges in 2014, suggesting that the numerous actions taken by the 
administration to stabilize the market are working. These actions 
include implementing the market stabilization rule early in the 
administration, granting States flexibility to set their essential 
health benefit benchmark, and using waiver authority to approve 
reinsurance programs in seven States. For example, in the 2019 Payment 
Notice, CMS finalized options for States to select new EHB-benchmark 
plans starting with the 2020 benefit year. Based on this flexibility, 
Illinois made changes to its EHB-benchmark plan for plan year 2020 that 
aim to reduce opioid addiction and overdose by including in its EHB 
benchmark plan alternative therapies for chronic pain, restrictions on 
access to prescription opioids, and expanded coverage of mental health 
and substance use disorder treatment and services.

    Question. Many of the proposals have no revenue or cost estimate. 
That includes proposals for which the fundamental purpose is to 
decrease costs--things like applying insurers' negotiating leverage to 
Part B drugs. Are those cost estimates forthcoming? Do the cost 
estimates from other proposals account for the interactions of these 
proposals? Like for example, the interaction of a Medicaid block grant 
with the Medicare proposals? Do they account for interactions with 
proposed rules like the Rebate rule?

    Answer. The Office of the Actuary (OACT) reviewed proposals in the 
FY 2020 President's budget, but given data and time limitations related 
to certain proposals, cost estimates either could not be generated or 
were not available in time for release of the budget. Cost estimates 
are not anticipated to become available for the remaining proposals. 
OACT will update scores for the Mid-Session Review, scheduled for 
release in July 2019, but will not necessarily have estimates for 
proposals not already scored. Generally, interactions among CMS 
mandatory proposals that were not able to be scored are not accounted 
for; where possible, interactions between scored proposals are 
incorporated. The baseline for the President's budget assumes that 
proposed rules released prior to the budget, including the rule to 
Remove Safe Harbor Protection for Rebates, will be implemented as 
proposed; and the budget proposals are scored in accordance with these 
assumptions.

    Question. The budget includes proposals to cut nearly $50 billion 
from graduate medical education programs. Understanding that there have 
been similar proposals over the years offered by administrations of 
both parties, $50 billion in reduced outlays dwarfs reductions in 
previous proposals, especially in view of the cuts to hospitals through 
other policies in the budget. What in this budget will bring doctors to 
Nevada?

    Answer. Funding for Graduate Medical Education (GME) comes from 
multiple fragmented funding streams, and HHS's GME financing system 
does not target training to the types of physicians needed in the 
United States. The President's FY 2020 budget includes a proposal that 
would consolidate Federal graduate medical education spending from 
Medicare, Medicaid, and the Children's Hospital Graduate Medical 
Education Program into a single grant program for teaching hospitals. 
Total funds available for distribution in FY 2020 would equal the sum 
of Medicare and Medicaid's 2017 payments for graduate medical 
education, plus 2017 spending on Children's Hospital Graduate Medical 
Education, adjusted for inflation. This amount would then grow at the 
CPI-U minus one percentage point each year. Payments would be 
distributed to hospitals based on the number of residents at a hospital 
(up to its existing cap) and the portion of the hospital's inpatient 
days accounted for by Medicare and Medicaid patients. The new grant 
program would be jointly operated by the Administrators of CMS and the 
Health Resources and Services Administration. This grant program would 
be funded out of the general fund of the Treasury. The Secretary would 
have authority to modify the amounts distributed based on the 
proportion of residents training in priority specialties or programs 
(e.g., primary care, geriatrics) and based on other criteria identified 
by the Secretary, including addressing health care professional 
shortages and educational priorities. These changes modernize graduate 
medical education funding, making it better targeted, transparent, 
accountable, and more sustainable.

    Question. How much less money will hospitals receive over the year 
budget window relative to the baseline?

    Answer. The budget includes Medicare proposals designed to improve 
value-based systems of care, exercise fiscal integrity, promote 
competition, and address high drug prices. The package of proposals in 
the President's budget extends the solvency of the Medicare Hospital 
Insurance Trust Fund by 8 years, in part by ensuring Medicare payments 
are directly related to its health care financing role, financing 
certain payments to hospitals outside the Trust Fund and slowing their 
growth rate. The proposals also more closely align Medicare payment 
policy with private insurers.

    Question. When all is said and done, how much more or less money 
will States receive in 2029 relative to the baseline? Nevada 
specifically?

    Answer. Recognizing that States are better positioned to address 
the unique needs of their populations, the budget returns substantial 
control over health care from Washington, DC back to the States. States 
will have the option of choosing between a per-capita cap or a block 
grant for Medicaid, and receive additional funds via the Market-Based 
Health Care Grants in lieu of ACA subsidies to better serve their 
residents. Health-care grant funding for States will be more flexible, 
sustainable, and equitable than under the current Medicaid and ACA 
programs.

    Question. When did you first become aware of the increasing numbers 
of separated children in ORR care? Were you aware of the zero tolerance 
policy or the plan to separate families before it was publicly 
announced in April of 2018?

    Answer. HHS staff maintains that they were told by inter-agency 
partners that there was no family separation policy, and were not told 
about the zero-tolerance policy (ZTP) before DOJ announced it on April 
6, 2018. I take them at their word.

    ZTP was an immigration enforcement policy issued by DOJ on April 6, 
2018. HHS did not issue ZTP. I became aware of the DOJ zero-tolerance 
enforcement policy as a result of then-Attorney General Sessions's 
announcement on April 6, 2018.

    On May 7, 2018, A.G. Sessions announced that DHS and DOJ would 
implement ZTP by having DHS refer 100 percent of illegal southwest 
border crossings to DOJ for prosecution. Neither DOJ nor DHS consulted 
with me before A.G. Sessions made that announcement. I learned about 
the announcement through the news media.

    After the April 6, 2018 announcement, I took no action because 
those implications were not self-evident and I was not informed of the 
policy's implications for the UAC program. It should be noted that I 
was severely ill in April. I was hospitalized in mid-April; I was then 
in home care and on a reduced work schedule.

    On May 7, 2018, then-Attorney General Sessions announced the 100-
percent referral policy. After that announcement, I was not informed 
of, and I did not immediately appreciate, the full implications and 
operational challenges that the zero-
tolerance and 100-percent referral policies could have for our UAC 
program.

    On June 20, 2018, the President issued the executive order, 
``Affording Congress an Opportunity to Address Family Separation.'' On 
June 26, 2018, the court in the Ms. L. litigation entered a class-wide 
preliminary injunction, ordering reunification of class member parents 
with their separated children in ORR care when certain criteria were 
met. From that point, our efforts focused primarily on complying with 
the court's order.

    As the implications of the April 6th and May 7th policies became 
clearer, on June 22, 2018, I activated Robert Kadlec, M.D., Assistant 
Secretary for Preparedness and Response (ASPR), to ensure, inter alia, 
that (1) every child knows where his or her parent is, (2) every parent 
knows where his or her child is, (3) children and parents regularly 
communicate, and (4) reunification occurs as quickly as possible. In 
the UAC program, the term ``reunification'' has historically meant 
discharge to a Category 1 or Category 2 sponsor.

    To comply with the June 26, 2018 order and to accomplish the goals 
discussed above, I asked Dr. Kadlec to lead the reunification efforts. 
The reunification was a resource-intensive and time-sensitive 
obligation. Dr. Kadlec instructed Public Health Commissioned Corps 
Commander Jonathan White to take charge of ASPR's Incident Management 
Team and to oversee the operational dynamics of ASPR's reunification 
mission. Several HHS senior leaders and staff, including myself, worked 
in a secure facility at HHS to manually review thousands of electronic 
case-management records on the UAC portal in order to reunite separated 
children with their separated parents.

    Question. What is HHS doing to identify and reunify the children 
who were separated before the zero tolerance policy was public?

    Answer. HHS is fully committed to implementing the court-approved 
plan for identifying the separated children of Ms. L class members for 
the expanded class period. The Ms. L court has not yet made a ruling on 
remedies for the class members for the expanded class period.

    Question. Family separations continue to occur at the border. What 
are you doing to ensure appropriate child welfare standards are being 
used in making family separation determinations? Does ORR receive the 
information it needs from DHS to make appropriate decision on the care 
of a child who has been separated?

    Answer. HHS has implemented changes to the UAC Portal as well as 
the ORR case management process to enhance tracking and automate the 
aggregation of data regarding separated children. HHS still relies on 
DHS to provide us with data on separations. ORR is continually working 
with DHS to try to improve the accuracy and completeness of what DHS 
provides to ORR.

    Question. What is HHS doing to track newly separated children? Are 
you working with DHS to ensure there is a coordinated tracking system?

    Answer. As noted above, HHS has implemented changes to the UAC 
Portal as well as the ORR case management process to enhance tracking 
and automate the aggregation of data regarding separated children. HHS 
still relies on DHS to provide us with data on separations. ORR is 
continually working with DHS to try to improve the accuracy and 
completeness of the information that DHS provides to ORR.

    Question. Many of the children who are in ORR custody are extremely 
vulnerable and are at heightened risk of sexual abuse. Do your 
requirements and standards for ORR contractors include training on 
trauma and how it manifests in children?

    Answer. Staff are required to complete a number of trainings pre-
employment. These trainings ensure that staff understand their 
obligations under ORR regulations and policies. Care providers must 
tailor trainings to the unique needs, attributes, and sex of the 
unaccompanied alien children in care at the specific care provider 
facility. Staff must complete refresher trainings every year or with 
any policy change. These trainings must include:

          ORR and the care provider facility's zero tolerance policies 
        for all forms of sexual abuse, sexual harassment, and 
        inappropriate sexual behavior;
          The right of unaccompanied alien children and staff to be 
        free from sexual abuse, sexual harassment, and inappropriate 
        sexual behavior;
          Definitions and examples of prohibited and illegal sexual 
        behavior;
          Recognition of situations where sexual abuse, sexual 
        harassment, and inappropriate sexual behavior may occur;
          Recognition of physical, behavioral, and emotional signs of 
        sexual abuse and methods of preventing and responding to such 
        occurrences;
          How to avoid inappropriate relationships with unaccompanied 
        alien children;
          How to communicate effectively and professionally with 
        unaccompanied alien children, including unaccompanied alien 
        children who are lesbian, gay, bisexual, transgender, 
        questioning, or intersex;
          Procedures for reporting knowledge or suspicion of sexual 
        abuse, sexual harassment, or inappropriate behavior as well as 
        how to comply with relevant laws related to mandatory 
        reporting;
          The requirement to limit reporting of sexual abuse, sexual 
        harassment, and inappropriate sexual behavior to staff with a 
        need-to-know in order to make decisions concerning the victim's 
        welfare and for law enforcement, investigative, or 
        prosecutorial purposes;
          Cultural sensitivity toward diverse understanding of 
        acceptable and unacceptable sexual behavior and appropriate 
        terms and concepts to use when discussing sex, sexual abuse, 
        sexual harassment, and inappropriate sexual behavior with a 
        culturally diverse population;
          Sensitivity regarding trauma commonly experienced by 
        unaccompanied alien children;
          Knowledge of existing resources for unaccompanied alien 
        children inside and outside the care provider facility, such as 
        trauma-informed treatment, counseling, and legal advocacy for 
        victims;
          General cultural competency and sensitivity to the culture 
        and age of unaccompanied alien children; and
          Proper procedures for conducting professional pat-down 
        searches, including cross-gender pat-down searches and searches 
        of transgender and intersex unaccompanied alien children in a 
        respectful and least intrusive manner.

    In addition to training staff, care providers must individually 
assess children and youth for risk of being a victim or a perpetrator 
of sexual abuse while in ORR custody and use the results of the 
assessment to inform the minor's housing, education, recreation, and 
other service assignments. If the assessment indicates that the child 
experienced prior sexual victimization or perpetrated sexual abuse, the 
clinician must follow up with any necessary medical or mental health 
services.

    Question. In the President's budget, funding for the Unaccompanied 
Alien Children (UAC) program was held level from FY 2019 at $1.3 
billion. However, the budget also requests increased transfer authority 
as well as requesting a $2 billion contingency fund. Why doesn't your 
budget request the amount of money that the program is actually 
projected to need?

    Answer. It is inherently difficult to project the amount of money 
that the program is actually going to need given the historical, 
significant variability in program needs and the legal requirement that 
ACF take custody of, and provide care for, every unaccompanied alien 
child referred by Federal law enforcement, regardless of the 
availability of funds. The budget proposes two mechanisms to manage 
this variability: (1) the provision of expanded transfer authority, 
which has been included in each Appropriation Act since FY 2015 and has 
afforded the Secretary flexibility to deal with unforeseen increases in 
UAC referrals to the program; and (2) a mandatory contingency fund 
capped at $2 billion over 3 years, which is probabilistically scored at 
$738 million.

    ACF will continue to monitor UAC referrals and all potential 
program impacts, and keep Congress apprised of changes in caseload 
projections and any changes in the UAC population that may alter 
current budget estimates.

                                 ______
                                 

                            Attachment No. 1

JOSEPH H. HUNT
Assistant Attorney General
SCOTT G. STEWART
Deputy Assistant Attorney General
WILLIAM C. PEACHEY
Director
Office of Immigration Litigation
U.S. Department of Justice
WILLIAM C. SILVIS
Assistant Director
Office of Immigration Litigation
SARAH B. FABIAN
Senior Litigation Counsel
Office of Immigration Litigation
U.S. Department of Justice
Box 868, Ben Franklin Station
Washington, DC 20442
Telephone: (202) 532-4824

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L, et al.,                      Case No. 3:18-cv-0428 DMS MDD

          Petitioners-Plaintiffs,   DEFENDANTS' PROPOSED
                                    EXPANDED MS. L CLASS
          vs.                       IDENTIFICATION PLAN SUMMARY

U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al.,

          Respondents-Defendants.
_______________________________________________________________________

    In accordance with the Court's March 28, 2019 Order Setting Further 
Status Conference, ECF No. 391, Defendants hereby submit the attached 
Proposed Expanded Ms. L Class Identification Plan Summary, and 
supporting declarations.
    DATED: April 5, 2019
            Respectfully submitted,

            JOSEPH H. HUNT
            Assistant Attorney General

            SCOTT G. STEWART
            Deputy Assistant Attorney General

            WILLIAM C. PEACHEY
            Director

            WILLIAM C. SILVIS
            Assistant Director

            SARAH B. FABIAN
            Senior Litigation Counsel
            Office of Immigration Litigation
            Civil Division
            U.S. Department of Justice
            P.O. Box 868, Ben Franklin Station
            Washington, DC 20044
            202-532-4824
            (202) 305-7000 (facsimile)
            [email protected]

                                 ______
                                 

                         CERTIFICATE OF SERVICE

IT IS HEREBY CERTIFIED THAT:

    I, the undersigned, am a citizen of the United States and am at 
least eighteen years of age. My business address is Box 868, Ben 
Franklin Station, Washington DC 20044. I am not a party to the above-
entitled action. I have caused service of the accompanying brief on all 
counsel of record, by electronically filing the foregoing with the 
Clerk of the District Court using its ECF System, which electronically 
provides notice.

    I declare under penalty of perjury that the foregoing is true and 
correct.

    DATED: April 5, 2019

            Sarah B. Fabian

                                 ______
                                 

       PROPOSED EXPANDED MS. L CLASS IDENTIFICATION PLAN SUMMARY

On March 8, 2019, the Court expanded the Ms. L class to include adult 
parents who entered the United States at or between ports of entry on 
or after July 1, 2017. The Court has also instructed Defendants to put 
forth a potential plan for identifying the class members within the 
class expansion period of July 1, 2017, through June 25, 2018.

Defendants' proposed plan to identify potential Ms. L class members 
within the class expansion period is explained in the attached 
declarations from Commander Jonathan White of the United States Public 
Health Service and Dr. Barry Graubard of the National Institutes for 
Health.

In short, Defendants would identify potential Ms. L class members by 
identifying their children out of the total population of approximately 
47,000 children discharged by the Office of Refugee Resettlement (ORR) 
during the class expansion period. Defendants would attempt to 
streamline and accelerate identification of children of potential Ms. L 
class members by using programmatic knowledge, data analysis, and 
statistical science to try as best as practicable to segment the 
population based on the probability that the child's parent is a Ms. L 
class member. If successful, segmentation would enable Defendants to 
prioritize children for manual reviews of ORR case management records, 
which would confirm whether the child was, in fact, separated from a 
parent who is a Ms. L class member for the class expansion period.

The operational leads for the work would be: Commander Jonathan White 
for the U.S. Department of Health and Human Services (HHS), Melissa 
Harper for U.S. Immigration and Customs Enforcement (ICE), and Jay 
Visconti for U.S. Customs and Border Protection (CBP). They would 
convene an inter-agency Data Analysis Team. A senior biostatistician 
(likely Dr. Graubard from the NIH) would serve as the lead for the Data 
Analysis Team.

Within approximately four weeks of plan activation, Defendants 
anticipate that the Data Analysis Team would conduct a regression 
analysis of the possible children of potential class members for the 
original class period reported in the most recent Joint Status Report, 
ECF No. 388, using the approximately 12,000 children who were in ORR 
care on June 26, 2018 as a ``training set'' to develop a prediction 
model. The Data Analysis Team would work to validate variables that may 
be predictive of a child having been separated from a parent (e.g., the 
age of the child), and attempt to identify any additional demographic 
features of children separated from parents (as distinct from children 
who entered the United States without a parent). Through validation, 
the team would develop a prediction model correlating relevant 
variables with increased likelihood of parental class membership.

Within approximately eight weeks of plan activation, Defendants 
anticipate that the Data Analysis team would begin using the prediction 
model to rank order the children among the population of approximately 
47,000 for the class expansion period according to their probability of 
being children of potential Ms. L class members. They would then begin 
grouping the children into segments based on statistical probability of 
parental class membership. Using this method, Defendants would begin 
targeting manual case file review on the higher-probability groups. In 
addition, representative samples would be taken from lower-probability 
groups to test them.

As children are identified as possible children of potential Ms. L 
class members, Defendants would validate their status jointly.

Within approximately 12 weeks of plan activation, Defendants would 
begin consolidating information about any newly-identified possible 
child of a potential Ms. L class member with information about the 
potential Ms. L class member known to Defendants. Defendants would 
provide final, rolling lists to Class Counsel. The rolling lists would 
include basic information including the names and alien numbers of the 
children and their class member parents, and the parents' last known 
contact information.

Defendants estimate that identifying all possible children of potential 
Ms. L class members referred to and discharged by ORR during the 
expansion period would take at least 12 months, and possibly up to 24 
months. The time required to complete the work may be affected by at 
least three factors. The first is the efficacy of the initial 
prediction model and the outcomes of sampling of the lower-probability 
groups (which are not known at this juncture). The second is the pace 
of manual record review (which will depend on how many qualified 
contractors Defendants are able to hire and train for the Case File 
Review Team). The third factor is any meet-and-confer process that may 
occur after manual reviews for the initial, higher-probability groups 
are complete.

The primary benefit of Defendants' proposed plan is that, if 
successful, it would front-load the identification of potential Ms. L 
class members and possibly lead to a reduction in the overall time 
required for manual review. For this reason, it is a more rational 
approach than a date-ordered or randomized manual review.

                                 ______
                                 

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L., et al.,                     Case No. 18cv428 DMS MDD

          Petitioners-Plaintiffs,   Hon. Dana M. Sabraw

vs.

U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al.,

          Respondents-Defendents.
_______________________________________________________________________

                     DECLARATION OF JONATHAN WHITE

    I, Jonathan White, declare under penalty of perjury, pursuant to 28 
U.S.C. Sec. 1746, that my testimony below is true and correct:

    1. I am a Commander with the United States Public Health Service 
Commissioned Corps, and have served at the Department of Health and 
Human Services (``HHS'') in three successive presidential 
administrations. I am presently assigned to the 18 Office of the 
Assistant Secretary for Preparedness and Response (``ASPR''), and 
previously served as the Deputy Director of the Office of Refugee 
Resettlement (``ORR'').

    2. The statements in this declaration are based on my personal 
knowledge, information acquired by me in the course of performing my 
official duties, information supplied to me by federal government 
employees, and government records.

    3. I am providing this declaration for use by the Defendants and 
the Court in Ms. L. v. ICE, No. 18-cv-428 (S.D. Cal.).
            Background and Recommended Methodology
    4. My understanding is that on March 8, 2019, this Court expanded 
the class in Ms. L. The class is now defined as: ``All adult parents 
who entered the United States at or between designated ports of entry 
on or after July 1, 2017, who (1) have been, are, or will be detained 
in immigration custody by the DRS, and (2) have a minor child who has 
been, is or will be separated from them by DHS and has been, is or will 
be detained in ORR custody, ORR foster care, or DHS custody, absent a 
determination that the parent is unfit or presents a danger to the 
child.'' ECF No. 386. The same qualifications apply to the original and 
expanded classes. ``[T]he class does not include migrant parents with 
criminal history or communicable disease, or those who are in the 
interior of the United States or subject to the EO.'' ECF No. 82.

    5. The Defendants have previously identified the children of 
potential Ms. L. class members who were in the care of ORR on June 26, 
2018. As I have previously explained, the process of identifying those 
children involved analysis of dozens of data sets from U.S. Customs and 
Border Protection (CBP) and U.S. Immigration and Customs Enforcement 
(ICE), manual review of approximately 12,000 individualized ORR case 
management records, and reconciliation with sworn testimony from the 
ORR grantees caring for the children. ECF No. 347-1. Ultimately, this 
process ``was operationally feasible because the children were still in 
ORR custody, and ORR grantees were able to talk with them about 
separation and share the information with HHS.'' Id.

    6. HHS cannot use the exact same methodology to identify the 
children of potential class members for the class expansion period of 
July 1, 2017 through June 25, 2018 for three reasons. First, ORR has 
discharged the children in its care during the class expansion period, 
and thus lacks access to those children through grantees. Second, my 
current understanding is that CBP is likely not able to produce data 
sets for the time period before April 19, 2018, as CBP did not track 
parental separation data as a separate searchable data point prior to 
that time. Third, the sheer number of ORR case management records, 
covering approximately 47,000 children referred to and discharged by 
ORR during the class expansion period, would overwhelm ORR's existing 
resources were it to attempt a manual review of a1l records in date 
order. See Decl. of Jallyn Sualog, ECF No. 347-2.

    7. I have therefore sought to develop a methodology to try as best 
as practicable to streamline and accelerate the identification of 
potential Ms. L. class members in the class expansion population by 
first identifying their children. To that end, I have consulted with 
Barry Graubard, Ph.D., who is a senior biostatistician for the National 
Institutes of Health (NIH), National Cancer Institute, Division of 
Cancer Epidemiology and Genetics, Biostatistics Branch. NIH is an 
operating division of the U.S. Department of Health and Human Services 
(HHS).

    8. Dr. Graubard has recommended pursuing a methodology that 
combines statistical analysis and manual review of ORR case management 
records. His 8 recommendation is set forth in his declaration, which is 
attached as Exhibit A to the Proposed Expanded Ms. L. Class 
Identification Plan. In my testimony below, I explain how Defendants, 
based on the information known to them today, would likely implement 
Dr. Graubard's recommendation. I would serve as the HHS Operational 
Lead for Reunification for the implementation.
            Plan for Implementing Recommended Methodology
    9. To implement Dr. Graubard's recommended methodology, Defendants 
would likely need to perform approximately 12 weeks of intensive data 
analysis before starting manual reviews. That is, Defendants would 
likely need 12 weeks to format the data, perform a regression analysis, 
and build a prediction model to segment and prioritize manual reviews 
of ORR case management records for the approximately 47,000 possible 
children of potential Ms. L. class members for the class expansion 
period. This approach would involve a series of steps, outlined below, 
that would be informed in real time by the data and would likely evolve 
as implementation progresses and the Defendants refine methods based on 
lessons learned.
            Within Approximately 4 Weeks of Plan Activation
    10. HHS would first prepare a data set encompassing all children 
referred to ORR starting July 1, 2017, and discharged from ORR care 
prior to June 26, 2018.\1\ I understand that set to include 
approximately 47,000 children. See ECF No. 347-1.
---------------------------------------------------------------------------
    \1\ It is possible that some children referred to ORR care in early 
July 2017 would have entered the United States before July 1, 2017. 
Such children would not be potential children of possible Ms. L. class 
members.

    11. Defendants would then convene a Data Analysis Team, reporting 
to the HHS, CBP, and ICE Operational Leads for Reunification, to 
conduct statistical analyses of the data set. A senior biostatistician 
(likely Dr. Graubard of the NIH) would serve as the Data Analysis Team 
---------------------------------------------------------------------------
lead, reporting directly to the Operational Leads for Reunification.

    12. The Data Analysis Team would conduct a regression analysis of 
the possible children of potential class members reported in the most 
recent Joint Status Report, ECF No. 388, using the approximately 12,000 
children who were in ORR care on June 26, 2018 9 as a ``training set'' 
to develop a prediction model. The Data Analysis Team would work to 
validate variables that may be predictive of a child having been 
separated from a parent (e.g., the age of the child), and attempt to 
identify any additional demographic features of children separated from 
parents (as distinct from children who entered the United States 
without a parent). Through validation, the team would develop a 
prediction model correlating relevant variables with increased 
likelihood of parental separation.

    13. We expect that the data will inform the development of the 
prediction model, which will evolve in an iterative, stepwise manner. 
During the process, the Data Analysis Team may request additional data 
from HHS, CBP, or ICE as appropriate.
            Within Approximately 8 Weeks of Plan Activation
    14. Once the Data Analysis Team lead determines that an initial 
version of the prediction model is sufficient for use, the Data 
Analysis Team will apply it to the approximately 47,000 children for 
the class expansion period, and rank order children according to their 
probability of being children of potential Ms. L. class members.

    15. The Data Analysis Team would then stratify the approximately 
47,000 children 24 for the class expansion period into ``bands'' or 
``segments'' based on statistical probability of parental class 
membership. The Defendants would prioritize the highest-probability 
segments for manual review of ORR case management records and any other 
relevant information.

    16. Defendants would build and launch a team of contracted 
administrative staff to conduct manual reviews of ORR case management 
records, which are maintained on the UAC Portal. This ``Case File 
Review Team'' would follow review protocols informed by the work 
conducted during the 2018 reunification. They would report to the HHS 
Operational Lead (who would work with the ORR career staff to train 
them).

    17. Once the manual review of the highest-probability segments 
begins, the Case File Review Team would begin preparing draft lists of 
possible children of potential Ms. L. class members and providing them 
to Defendants on a rolling, weekly basis. HHS, CBP, and ICE would 
review and validate these lists jointly.

    18. While the Case File Review Team conducts manual review of the 
highest-probability segments of children, the Data Analysis Team would 
conduct statistical sampling of the lower-probability bands. The Case 
File Review Team would test the samples through blind, manual review to 
enable the Data Analysis Team to determine whether the sample contains 
any children of potential Ms. L. class members. The outcome of the 
sampling process may result in adjustments to the variables, prediction 
model, or segments. It may also inform the approach to manual case file 
review of the lower-probability bands. If, for example, the samples 
yield no children of potential Ms. L. class members, then it may become 
appropriate for the parties to meet and confer on further streamlining.
            Within Approximately 12 Weeks of Plan Activation
    19. HHS would review the discharge type and sponsor information in 
the UAC Portal to determine: (i) the type of discharge that resulted in 
the child exiting ORR care; (ii) whether a potential Ms. L. class 
member is the child' s sponsor of record; and (iii) the name, address, 
and relationship of the sponsor for each child of a potential Ms. L. 
class member who was discharged to an individual sponsor.

    20. Defendants would consolidate the HHS and DHS information into 
final, rolling lists, which DOJ would provide to Class Counsel. Where 
available, the rolling lists would include the names and alien 
identification numbers for both children and their class member 
parents; their dates of apprehension; the dates children were referred 
to and discharged from ORR care, and the type of discharge; parent 
detention status; and last known parent contact information.
            Total Time for Completion
    21. Jallyn Sualog, the Deputy Director for Children's Programs for 
ORR, testified previously that it would likely take between 235 and 471 
consecutive calendar days for 100 ORR analysts to manually review the 
ORR case management records for the approximately 47,000 children in 
ORR care during the class expansion period. If Defendants were able to 
hire qualified contractors, then I expect it would take at least the 
same number of consecutive calendar days to perform the same work on a 
date-ordered or randomized manual file review.

    22. The goal of pursuing Dr. Graubard's recommended methodology is 
to identify children of potential Ms. L. class members in the class 
expansion population in a faster and more concentrated way than would 
occur through a date-ordered or randomized manual file review. The 
application of the methodology in this context is novel.

    23. The time for completing the process using Dr. Graubard's 
recommended methodology--including manual review of ORR case management 
records prioritized through probabilistic segmentation--may vary for at 
least three reasons. First, the efficacy of the initial prediction 
model, and the outcomes of the sampling of the lower-probability 
segments, are not known at this juncture. They are likely to drive the 
time for completion. Second, the pace of the prioritized manual review 
will depend on the number of qualified contractors that Defendants are 
able to identify and retain for the Case File Review Team, as well as 
the speed with which Defendants are able to scale up the team, and the 
efficiencies that may or may not materialize from having a dedicated 
group of professionals manually reviewing case files over a period of 
months. Third, any meet-and-confer process that occurs after completion 
of the sampling phase could affect the time for completion. Many of 
these considerations are outside Defendants' control.

    24. Given the complexity of the task and the variables and data 
known to Defendants at this time, a reasonable assumption is that it 
will take at least 12 months, and possibly up to 24 months, for 
Defendants to complete the process of identifying potential Ms. L. 
class members in the class expansion population through universal 
manual review. The primary benefit of pursuing Dr. Graubard's 
recommended methodology is that, if successful, it would front-load the 
identification of potential Ms. L. class members and possibly lead to a 
reduction in the overall time required for manual review.

    Executed on April 5, 2019.

            Jonathan White

                                 ______
                                 

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L., et al.,                     Case No. 18cv428 DMS MDD

          Petitioners-Plaintiffs,   Hon. Dana M. Sabraw

          vs.

U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al.,

          Respondents-Defendants.
_______________________________________________________________________

                     DECLARATION OF BARRY GRAUBARD

    I, Barry I. Graubard, declare under penalty of perjury, pursuant to 
28 U.S.C. Sec. 1746, that my testimony below is true and correct:

    1. I am a Senior Investigator in the Biostatistics Branch of the 
National Cancer Institute. See https://dceg.cancer.gov/about/staff-
directory/biographies/A-J/graubard-barry (last visited April 5, 2019). 
A copy of my curriculum vitae is attached as Exhibit 1.

    2. I have more than 40 years of experience conducting statistical 
methods research in biostatistics and survey sampling, and in 
collaborating with scientists on research in cancer epidemiology and 
other areas of epidemiology and public health. For example, I recently 
performed modeling to estimate the one-year probability that an 
individual would get oropharyngeal cancer based on various risk 
factors. The paper reporting this work has been submitted for 
publication to a peer-reviewed journal. The statistical techniques used 
in this study were regression modeling and cross validation.

    3. I have also used other regression methods such as Cox 
proportional hazard regression to predict length of survival (e.g., 
among liver transplant recipients based on patient characteristics and 
clinical risk factors).

    4. The statements in this declaration are based on my personal 
knowledge, information acquired by me in the course of performing my 
official duties, information supplied to me by federal government 
employees, and government records.

    5. I am making this declaration for use in Ms. L. v. U.S. 
Immigration and Customs Enforcement, No. 18cv428 (S.D. Cal.).

    6. I understand that on March 8, 2019, the Court in Ms. L. modified 
the class definition. The class now includes: ``All adult parents who 
entered the United States at or between designated ports of entry on or 
after July 1, 2017, who (1) have been, are, or will be detained in 
immigration custody by the DHS, and (2) have a minor child who has 
been, is or will be separated from them by DHS and has been, is or will 
be detained in ORR custody, ORR foster care, or DHS custody, absent a 
determination that the parent is unfit or presents a danger to the 
child.'' ECF No. 386. I further understand that the modified class is 
subject to the same qualifications as the original certified class, and 
that as a result, it is still the case that ``the class does not 
include migrant parents with criminal history or communicable disease, 
or those who are in the interior of the United States or subject to the 
EO.'' ECF No. 82.

    7. Commander Jonathan White of the United States Public Health 
Services has asked me to recommend a statistical methodology to try to 
streamline and accelerate the identification of the children of Ms. L. 
class members who were referred to and discharged by ORR during the 
class expansion period of July 1, 2017 through June 25, 2018, and to 
advise an inter-agency Data Analysis Team that would seek to implement 
the methodology. My understanding is that approximately 47,000 alien 
children were referred to and discharged by ORR during that period. An 
optimal statistical methodology would enable ORR to prioritize manual 
record reviews for the approximately 47,000 children based on the 
probability that the child's parent is a Ms. L. class member.

    8. I will refer to the approximately 47,000 children who were 
referred to and discharged by ORR during the class expansion period of 
July 1, 2017 and June 25, 2018 as the ``test set.''

    9. I will apply two assumptions to promote an inclusive and through 
review. First, I will assume that any alien child who was apprehended 
by the U.S. Department of Homeland Security (DHS) at the southern 
border together with a parent, and who was referred to ORR care by DHS, 
was possibly separated from the parent by the federal government. 
Second, I will assume that any alien child who was referred to and 
discharged by ORR during the class expansion period is a child of a 
potential Ms. L. class member. These assumptions can be expected to 
include many children who were not separated from their parents, but 
will promote a thorough review.

    10. Based on these assumptions, I recommend using an empirically-
determined model to try to predict the probability for each child that 
a parent accompanied the child before he or she was referred to ORR 
care. These probabilities would be used to group children from the test 
set into strata based on the probability that a parent is a potential 
class member. A separate Case File Review Team would then review the 
ORR case management records for the children in the test set. The 
records of the children in the strata with the highest probabilities 
would be reviewed before strata with lower probabilities, thereby 
identifying more children of class members in the test set in a 
speedier fashion.

    11. I recommend that the Data Analysis Team seek to develop a 
prediction model by analyzing data for the approximately 12,000 
children in ORR care as of June 26, 2018 (the ``training set''). I 
understand that at this point, the government knows which children in 
the training set were children of potential Ms. L. class members. See 
Joint Status Report, ECF No. 388. By analyzing the data associated with 
these children, the Data Analysis Team would seek to identify common 
independent variables that together would provide a framework for rank 
ordering other children by the likelihood that their parent is a Ms. L. 
class member. The list of potentially relevant independent variables 
would include:

      Child age, because tender-age and young children are more 
dependent on parents than older children, and may therefore be more 
likely to travel with parents than with other adults or children;

      The referring U.S. Customs and Border Protection (``CBP'') 
Sector, because I understand that at least one CBP sector is alleged to 
have conducted a pilot program involving increased rates of referrals 
for prosecutions of immigration law violations;

      Sibling information, because younger children who are not in 
sibling groups may have a higher probability of having been separated 
than younger children accompanied by older siblings;

      ORR discharge type, because discharge to a family member other 
than a parent, or discharge type other than release to an individual 
sponsor, might correlate with a higher probability of a child having 
been separated from a parent;

      Appearance of the word ``separated'' or ``separation'' in text 
box data fields on the ORR Portal corresponding with either the initial 
assessment of the child or a Significant Incident Report; and

      Inclusion on any informal tracking list of separated children 
that ORR created during the class expansion period.

    12. To develop a prediction model, the Data Analysis Team would 
analyze the training set data with statistical analysis software. If 
the software proposes multiple models, then the Data Analysis Team 
would apply a statistical method known as cross validation to identify 
the most appropriate model to predict parental class membership within 
a given subset of the training set.

    13. Once the most appropriate model is identified, the Data 
Analysis Team would try to apply it to the available data for the test 
set of approximately 47,000 children referred to and discharged by ORR 
between July 1, 2017 and June 25, 2018. By applying the predictive 
model to the test set, the Data Analysis Team would identify the 
children in the test set who are more likely to have parents who are 
Ms. L. class members. As noted above, the use of the model in this way 
would enable the Data Analysis Team to organize the test set into 
strata according to increasing probability of parental class 
membership, to prioritize manual case file review.

    14. As the Data Analysis Team applies the prediction model to the 
test set, the process may result in refinements to the model and 
segments themselves. For example, if the Case File Review Team 
positively identifies children of potential Ms. L. class members within 
a lower-probability band of the test set, this may result in the Data 
Analysis Team updating the variables it considers as part of its model.

    15. The feasibility of this statistical method may turn on the 
availability, format, and comprehensiveness of the data for the 
children. Assuming, however, that the data is sufficient, the 
statistical method that I have described is a more rational approach 
than a date-ordered or randomized manual record review of the test set. 
If successful, it would front-load the identification of potential Ms. 
L class members. It is possible that it could also reduce the overall 
time required for manual review.

    Executed on April 5, 2019.

            Barry I. Graubard

                                 ______
                                 

                               EXHIBIT 1

                            CURRICULUM VITAE

                                                   January 15, 2019
Name: Barry Ira Graubard
Work Address:  Biostatistics Branch
                Division of Cancer Epidemiology and Genetics,
                National Cancer Institute
                9609 Medical Center Drive RM 7-E140 MSC 9780
                Bethesda, MD 20892-7354
                Phone: (240) 276-7316; Fax: 240-276-7838
                E-mail: [email protected]

Citizenship: United States

Education:

         1968  High School Graduation, Groveton High School, 
Alexandria, VA

    1968-1970  (68 Semester Hours, Major: Chemistry and Mathematics) 
Rensselaer Polytechnic Institute, Troy, New York

         1972  B.S. (Major in Mathematics, Minor in Physics) University 
of Maryland, College Park, MD
         1974  M.A. (Mathematics, Area: Statistics and Probability) 
Department of Mathematics University of Maryland, College Park, MD
         1991  Ph.D. (Mathematical Statistics) Department of 
Mathematics, University of Maryland, College Park, MD

Other Training:

    1977-1979  (12 Semester Hours) Survey Sampling and Biostatistics, 
George Washington University, Washington, DC

Employment:

    1972-1976  Graduate teaching assistant in the Department of 
Mathematics, University of Maryland at College Park

    1977-1980  Mathematical Statistician, National Center for Health 
Statistics

    1980-1981  Mathematical Statistician, Alcohol Drug Abuse and Mental 
Health Administration

    1981-1989  Mathematical Statistician, National Institute of Child 
Health and Human Development, Biometry Branch

    1989-1996  Senior Researcher, National Cancer Institute, Biometry 
Branch, Clinical and Diagnostic Trials Section

    1996-1997  Acting Chief Biostatistical Methodology and Cancer 
Control Section, National Cancer Institute, Biometry Branch

    1997-1999  Senior Associate, Department of Biostatistics, Johns 
Hopkins University, taught a semester course ``Analysis of Health 
Surveys''

    2001-2002  Guest Lecturer, Department of Mathematics, University 
Maryland, taught a one semester workshop entitled ``Analysis of Health 
Surveys''

    1997-pres  Senior Investigator, Title 42, National Cancer 
Institute, Biostatistics Branch.

Membership in Professional Societies:

    1977-pres  American Statistical Association

    1977-pres  Washington Statistical Society

    1980-pres  International Biometric Society Eastern North American 
Region (ENAR)

    2010-pres  American Association for the Advancement of Science

Selected Committee and Board Membership:

    1988-1990  ENAR Biometrics Society Regional Advisory Board

    1991-1994  Washington Statistical Society Public Health and 
Biostatistics Program Chair

    1994-1995  American Statistical Association Biometrics Section 
Program Chair

    1994-1997  American Statistical Association Continuing Education 
Advisory Committee

         1994  American Statistical Association ad hoc committee to 
review candidates for travel awards to 50th Session of the 
International Statistical Institute, 1995

    1997-2001  American Statistical Association, Survey Methods 
Research Section, Chair, Continuing Education Committee

    1998-2001  ENAR Biometrics Society Regional Committee

    1998-1999  NCI Surveillance Implementation Group

    1999-2001  Ad hoc ENAR Biometrics Society Membership Committee

    1999-pres  Federal Committee on Statistical Methodology

         2000  Chair of Search Committee for tenure track/tenure 
research mathematical statistician, Biometry and Mathematical 
Statistics Branch, National Institute of Child Health and Human 
Development, NIH

    2000-pres  Program Committee for Federal Committee on Statistical 
Methods Research Conference

      2001-02  Program Committee for ENAR Biometrics Society 2002 
Spring Meeting

         2001  Chair of Search Committee for tenure track / tenure 
research mathematical statistician, Biometry and Mathematical 
Statistics Branch, National Institute of Child Health and Human 
Development, NIH

      2001-04  United Nations Committee and contributor to UN Technical 
Report on the Analysis of Operating Characteristics of Surveys in 
Developing Countries.

      2003-07  Editorial Board of the JNCI Cancer Spectrum

         2004  Member of the National Children's Study Sampling Design 
Workshop, March 21-22.

         2004  Institute of Medicine Workshop on Estimating the 
Contribution of Lifestyle-Related Factors to Preventable Death Dec. 13-
14; presented ``Calculating the number of deaths attributable to risk 
factor using national survey data.''

      2005-06  Co-Program Chair of Section on General Methodology, 
American Statistical Association, 2006 Joint Statistical Meetings

      2005-10  Advisory Board for the University of Minnesota 
Integrated Health Interview Series Project

         2005  Expert Advisory Group to advise Harvard U on statistical 
methods for combining data from multiple surveys for developing 
measures of the diffusion and use of health information technology

      2006-08 ENAR Education Advisory Committee

      2007-09  Chair of the American Statistical Association Committee 
on the Award of Outstanding Statistical Application

      2007-08  Chair of the Division of Cancer Epidemiology and 
Genetics Committee on Scientists

         2009  Chair Elect of the Biometric Section, American 
Statistical Association

         2009  Member Expert Panel on the Redesign of the National 
Crime Victimization Survey

      2009-10  DCEG Technical Evaluation of Protocols Committee

      2009-10  Member of Selection Committee for Committee of 
Presidents Statistical Societies (COPSS) Snedecor Award

      2010-11  Chair, Selection Committee for COPSS Snedecor Award

      2009-10  Member of Selection Committee for Biometrics Section, 
American Statistical Association, David P Byar Award

         2011  Chair Selection Committee for Biometrics Section, 
American Statistical Association, David P Byar Award

      2009-10  DCEG Technical Evaluation of Protocols Committee

         2011  Chair of Search Committee for tenure track/tenure 
research biostatistician/statistician, Radiation Epidemiology Branch, 
NCI

    2011-2012  DCEG Technical Evaluation of Protocols Committee

    2011-pres  Member of DCEG Promotion and Tenure Review Panel

         2013  Reviewer for the American Statistical Association, 
National Science Foundation and Bureau of Labor Statistics Fellowship 
Program http://www.amstat.org/careers/pdfs/ASANSFBLSFellowshipProgram
.pdf

         2013  Reviewer for proposal to the Luxembourg National 
Research Fund (FNR) INTER MOBILITY programme.

      2014-17  Washington Statistical Society Morris Hansen Lecture 
Committee

      2014-15  Member of the Committee of Presidents of Statistical 
Societies (COPSS) Elizabeth L. Scott Award Committee

      2016-17  Chair, Committee of Presidents of Statistical Societies 
(COPSS) Elizabeth L. Scott Award Committee

      2014-17  Committee of Representatives to American Association for 
the Advancement of Science (AAAS)

         2015  Patient-Centered Outcomes Research Institute (PCORI) 
Obesity Observational Research Initiative Merit Review Panel

         2017  Panel member of FDA Public Workshop on Abuse-Deterrent 
Opioids in Silver Spring, MD, July 10-11, 2017

      2018-20  American Statistical Association Committee on Fellows

Editorial Boards:

    1997-pres  Statistical Editor, Journal of the National Cancer 
Institute

      2008-14  Editorial Board ASA/SIAM Book Series

    2008-pres  Associate Editor, Annals of Applied Statistics

Selected Lectures and Presentations:

         1993  Invited Presentation, The Biometric Society-ENAR Spring 
Meetings, Philadelphia, PA, ``Statistical Validation of Intermediate 
Endpoints for Chronic Diseases.''

         1994  Invited Presentation, The Drug Information Association, 
Washington, DC, ``Regression Analysis of Clustered Data.''

         1995  Invited Presentation, The Joint Statistical Meetings of 
the American Statistical Association, Orlando, FL, ``Analysis of 
Population Based Case-Control Studies with Controls Selected from a 
Survey.''

         1996  Invited Presentation, Bureau of Medical Devices, Food 
and Drug Administration, ``Analysis of Clustered Data.''

         1997  Invited Presentation, Department of Mathematics, 
University of Maryland, ``Variance Estimation for Superpopulation 
Parameters.''

         1999  Invited Presentation, Department of Statistics, Texas 
A&M University, Variance Estimation for Superpopulation Parameters.

    1994-2006  Invited Lecturer Cancer Prevention and Control 
Fellowship Course, NCI, ``Analyzing Health Surveys: Accounting for the 
Sample Design.''

         2000  Keynote Speaker, The 2000 Statistical Science Awards 
Ceremony, Centers for Disease Control and Prevention, Atlanta, GA, 
``Statistical Issues in Analyzing Health Surveys: Applications to 
Cancer Studies.''

         2001  Invited lecturer at the University of Maryland, 
Department of Mathematics, College Park, to teach fall semester 
workshop ``Analysis of Health Survey Data'' (Course: STAT 798A section 
0104); meets one day a week for 1.5 hours.

         2002  Invited presentation Joint Statistical Meetings, 
``Issues in Design-based Weighted Analysis of Survey Data.''

         2002  Invited 1-day course ``Analysis of Complex Survey Data 
with Applications to Health Surveys'' for the Statistics Canada 2002 
Methodology Symposium on Modeling Survey Data for Social and Economic 
Research.

         2003  Invited tutorial at 2003 Spring ENAR Meeting: ``Sample 
Survey Methods for Biostatisticians.''

         2003  Invited discussant at 2003 Spring ENAR Meeting 
``Sampling methods for selecting population controls.''

         2003  Invited speaker at Westat methodology seminar 
``Estimating of Variance Components using Survey Data.''

         2004  Invited Short Course at Eleventh Annual Spring Research 
Conference, ``Analysis of Complex Surveys.''

         2004  Invited presentation Joint Statistical Meetings, 
``Development of statistical methods to analyze complex health surveys 
for epidemiologic studies: Some methods and applications.''

         2004  Invited presentation at Harvard University School of 
Public Health, ``Analyzing Survey Data: Estimation of population 
attributable risk and population variance components.''

         2004  Invited Discussant for Distinguished Lecture by Chris 
Skinner for Joint Program in Survey Methodology, University of 
Maryland, ``Other Issues in Modeling Survey Data.''

         2005  Invited presentation University of Maryland School of 
Medicine, Baltimore, ``Statistical issues in analyzing health surveys: 
application to cancer and mortality studies.''

         2005  Invited Discussant for Distinguished Lecture by Alastair 
Scott for Joint Program in Survey Methodology, University of Maryland, 
``Discussion of population-based case-control studies.''

         2006  Invited presentation Spring ENAR Meeting, Tampa, FL. 
``Using national surveys to estimate the number of deaths attributable 
to a risk factor.''

         2006  Special Contributed Panel Session presentation Joint 
Statistical Meetings, Seattle, WA, ``Finite population vs. 
superpopulation inference in sample surveys: How big is the 
difference?''

         2006  Invited presentation Statistics Canada Symposium 2006, 
Ottawa, Canada, ``Using national surveys to estimate the number of 
deaths attributable to a risk factor.''

         2006  Invited short course for the International Biometrics 
Conference, Montreal, Canada, ``Analysis of Health Survey: Sample 
Survey Methods for Biostatisticians.''

         2007  Invited panel member of ``Role of biostatisticians in 
policy issues'' for the Spring ENAR Meeting, Atlanta, GA.

         2007  Invited presentation at Mathematica, ``To weight or not 
to weight.''

         2008  Invited presentation Joint Statistical Meetings, Denver, 
Colorado ``Application of Peters-Belson to estimation of disparities.''

         2009  Invited presentation for Conference in Honor of Joseph 
Gastwirth, George Washington University, Washington, DC, ``The use of 
the risk percentile curve in the analysis of epidemiologic data.''

         2009  Invited presentation for Joint Statistical Meetings, 
Washington, DC, ``Use of Statistics at the Centers for Disease Control 
and Prevention and National Cancer Institute: Estimation of the numbers 
of all-cause and cause-specific deaths associated with body weight.''

         2011  Invited presentation Department of Statistics, George 
Washington University, ``Conditional logistic regression with survey 
data.''

         2011  Invited presentation National Center for Health 
Statistics, ``Conditional logistic regression with survey data.''

         2013  Invited presentation National Institute of Environmental 
Health Sciences, ``Conditional logistic regression with survey data.''

         2013  Invited presentation, Scholars Summer at Census, U.S. 
Census Bureau, ``Conditional logistic regression with survey data.''

         2013  Invited presentation for Fall Outreach Symposium for the 
International Year of Statistics at the Bureau of Labor Statistics, 
``Estimating sibling recurrence risk in population sample surveys.''

         2014  Invited presentation Statistical Society of Canada 2014 
Annual Meeting, Toronto, ``Estimating sibling recurrence risk in 
population sample surveys.''

         2018  Invited presentation at the 2018 Joint Statistical 
Meetings, ``Population-Based Disease Risk Prediction Modeling Using 
National Survey, Clinical, and Registry Data: Application to Risk 
Prediction for Oropharyngeal Cancer in the U.S. Population,'' 
Vancouver, Canada.

         2018  Invited Talk George Washington University, School of 
Public Health, ``Statistical and Epidemiological Challenges in 
Utilizing the National Health and Nutrition Examination Survey (NHANES) 
Assessment of Oral Human Papillomavirus (HPV) Infection to Study Risk 
of HPV Infection and of Oropharyngeal Cancer in the U.S.,'' Washington, 
DC.

Recent Grants

Unpaid Collaborator
``Trends in Socioeconomic Position and Diet Relationship,'' CA108274 
PI: Kant, Ashima, Queens College, NY July, 2004 to June, 2007.

Unpaid Collaborator
``SNP-based pseudo-semiparametric inference for the case-control 
studies,'' NIH-U01CA159424, National Institutes of Health PI: Li, Yan, 
University of Maryland, College Park, MD, September, 2011 to August, 
2013.

Unpaid Collaborator
``Semiparametric inference for case-control studies with complex 
sampling,'' NIH-8513069, National Institutes of Health PI: Li, Yan 
University of Maryland, College Park, MD, September 24, 2013 to August 
31, 2014.

Teaching Experience:

    1972-76  Graduate Teaching Assistant--Conducted recitation classes 
for undergraduate courses in college algebra, calculus, linear algebra, 
and was a lecturer for introductory statistics course (STAT 100) for 
non-mathematics majors.
       1980  Lecturer for a one semester undergraduate course in 
elementary probability and Stochastic processes for non-mathematics 
majors in Department of Mathematics, University of Maryland.

       1997  Adjunct Professor at Johns Hopkins University Department 
of Biostatistics where I taught a one semester graduate course entitled 
``Analysis of Health Survey Data.''

       2001  Invited lecturer at the University of Maryland, Department 
of Mathematics, College Park, to teach fall semester workshop 
``Analysis of Health Survey Data'' (Course: STAT 798A section 0104); 
met one day a week for about 1.5 hours.

       2002  Invited 1-day course ``Analysis of Complex Survey Data 
with Applications to Health Surveys'' for the Statistics Canada 2002 
Methodology Symposium on Modeling Survey Data for Social and Economic 
Research.

       2003  Invited tutorial at 2003 Spring ENAR Meeting: ``Sample 
Survey Methods for Biostatisticians.''

       2004  Invited Short Course at Eleventh Annual Spring Research 
Conference, ``Analysis of Complex Surveys.''

       2006  Invited short course for the International Biometrics 
Conference, Montreal, Canada, ``Analysis of Health Survey: Sample 
Survey Methods for Biostatisticians.''

       2015  Co-taught ``Statistical Methods for Analysis of Complex 
Samples in Public Health'' at University of Maryland, College Park, MD, 
course number SURV 699N for the Joint Program in Survey Methods.

Primary Mentor:

NCI Post-Doctoral Fellows:

Dr. Sowmya R Rao, 2002-2004, presently Associate Professor at the 
University of Massachusetts Medical School, Worchester, MA and Senior 
Statisticians in the Center for Health Quality, Outcomes and Economic 
Research (CHQOER) in the Veterans Administration Health Services 
Research and Development Service.

Dr. Yan Li, 2006-2008, presently Associate Professor at the Joint 
Program of Survey Methods, University of Maryland, College park, MD.

Dr. Sonya Heltshe 2008-2009, presently Assistant Professor and Senior 
Statistician at Seattle Children's Hospital, Seattle WA Center for 
Clinical and Translational Research.

Dr. Victoria Landsman 2009-2011, presently Scientist and 
Biostatistician at Institute for Work and Health and Adjunct Professor 
at University of Toronto, Assistant Professor.

Dr. Orestis Panagiotou 2015-2016, presently Assistant Professor of 
Health Services, Policy and Practice (Research) at Brown University.

Dr. Noorie Hyun 2016-2017, presently Assistant Professor, Medical 
College of Wisconsin, Institute for Health and Equity, Division: 
Biostatistics Program

Dr. Marlena Maziarz 2017-2018, presently Assistant Professor, Lund 
University, Sweden.

Dr. Gregory Haber 2018-present.

Co-Advisor for Ph.D. Candidates:

Blossom H Patterson, Doctoral Dissertation (1998): ``Latent Class 
Analysis of Sample Surveys,'' College of Education, Department of 
Measurement and Statistics, University of Maryland.

Dewei She, Doctoral Dissertation (2010): ``Genetic Association Studies 
Using Complex Survey Data,'' Department of Statistics, George 
Washington University.

Wenliang Yao, Doctoral Dissertation (2012): ``Estimation of ROC Curve 
With Complex Survey Data,'' Department of Biostatistics, George 
Washington University.

Cong Wang, Doctoral Dissertation (2017): ``Analysis of Familial 
Aggregation Using Recurrence Risk for Complex Survey Data,'' Department 
of Statistics, George Washington University.

April D. Kidd, Doctoral Dissertation (2017): ``Mammography Utilization 
in African American Women,'' School of Nursing, Duquesne University.

Lingxiao Wang, Doctoral Dissertation (currently), Topic: Making cohort 
studies representative of the U.S. population using weighting methods, 
Dept. of Joint Program of Survey Methodology, University of Maryland.

Yan Liu, Doctoral Dissertation (currently), Topic: Generalized Score 
Test for Complex Sample Data, Dept. of Statistics, George Washington 
University.

Ph.D. Dissertation Committees:

Dr. Blossom H Patterson, Dept. of Measurement, Statistics and 
Evaluation, University of Maryland, College Park

Dr. Tara Vogt, Dept Epidemiology, Yale University

Dr. Steven Moore, Dept Epidemiology, Yale University

Dr. Leah M Ferrucci, Dept Epidemiology, Yale University

Dr. Jianzhu Li, Dept. JPSM, University of Maryland, College Park

Dr. Santanu Pramanik, JPSM, University of Maryland, College Park

Dr. Hiroyuki Hikawa, Dept. of Statistics, George Washington University

Dr. Wenliang Yao, Dept. of Biostatistics, George Washington University

Dr. Cong Wang, Dept. of Statistics, George Washington University. 
Title: Analysis of Familial Aggregation Using Recurrence Risk for 
Complex Survey Data, October 2017

Dr. April D. Kidd, School of Nursing, Duquesne University. Title: 
Mammography Utilization in African American Women, November 2017

Dr. Xia Li, Dept. Mathematics, University of Maryland, College Park. 
Title: Misspecified Weights in Weight-Smoothing Methods, January 2018

Research Interests:

Design and Analysis of Complex Surveys and Epidemiologic Studies

Statistical Methods for Design and Analysis of Epidemiological Studies

Analysis and Design of Cluster Randomized/Community Studies and 
Nonrandomized

Evaluation Studies

Classification and Discriminant Analysis

Population Genetics and Genetic Epidemiology

Reviewer for Selected Journals:

American Journal of Clinical Nutrition 

American Journal of Epidemiology

American Journal of Public Health

Annals of Applied Statistics

Biometrics

Biometrika

Controlled Clinical Trials

Epidemiology

Journal of the American Statistical Association

Journal of the American Medical Association

Journal of Clinical Epidemiology

Journal of the National Cancer Institute

Statistics in Medicine

Survey Methodology

Journal of Official Statistics

Journal of the National Cancer Institute

Journal of the American Medical Association

New England Journal of Medicine

Honors and Awards:

1987  Quality Step Award, NICHD.

1990  Snedecor Award--Presented by the American Statistical Association 
and the Biometric Society.

1999  NCI Special Service Award of $5,000 for statistical leadership on 
the ASSIST Evaluation.

1999  NIH Merit Award for fundamental contributions to statistical 
methods for survey studies, and exemplary collaborations in the 
analysis and interpretation of survey data.

2000  NIH Merit Award for extraordinary efforts in developing a 
conceptual framework and evaluation design for the American Stop 
Smoking Intervention Study (ASSIST).

2000  Elected Fellow of the American Statistical Association.

2001  Division of Cancer Epidemiology and Genetics, NCI Mentor of the 
Year Award.

2004  NIH Merit Award for consistent and high-quality effort work on 
the National Health Interview Survey and the California Health 
Interview Survey.

2006  Charles C Shepard Science Award for Assessment and Epidemiology 
presented for scientific excellence by the publication of Excess deaths 
associated with underweight, overweight, and obesity, JAMA 2005; 
293:1861-1867.

2009  NIH Merit Award for excellence in the measurement, analysis, and 
release of nationally representative data concerning serum biomarkers 
from the insulin-like growth factor axis.

2010  NCI Mentor of Merit Award for excellence in mentoring post and 
pre-doctoral fellows.

2013  AAAS Fellow of Statistics Section.

2015  NCI Group Merit Award: NCI Select Agents and Hazardous Biological 
Materials Search.

2018  NCI Mentor Award.

                                 ______
                                 

                              BIBLIOGRAPHY

                           Barry Ira Graubard

  1.  Eckardt MJ, Ryback RS, Rawlings RR, Graubard BI. Biochemical 
diagnosis of alcoholism: a test of the discriminating capabilities of 
gamma-glutamyl transpeptidase and mean corpuscular volume. JAMA. 
1981;246:2707-10.

  2.  Rawlings RR, Rae DS, Graubard BI, Eckardt MJ, Ryback RS. A 
methodology for the construction of a multivariate diagnostic 
instrument: an application to alcohol abuse screening. Comput Biomed 
Res. 1982;15:228-39.

  3.  Eckardt MJ, Graubard BI, Ryback RS, Gottschalk LA. Pretreatment 
consumption as a predictor of post treatment consumption in male 
alcoholics. Psychiatry Res. 1982;982;7:337-44.

  4.  Rawlings RR, Graubard BI, Teper S, Eckardt MJ, Ryback RS. Two-
group classification when both groups are mixtures of normals. 
Biometrical J. 1984;26:923-30.

  5.  Forman MR, Graubard BI, Hoffman HJ, Beren R, Harley EE, Bennett 
P. The Pima infant feeding study: infant feeding and gastroenteritis in 
the first year. Am J Epidemiol. 1984; 119:335-349.

  6.  Forman MR, Graubard BI, Hoffman HJ, Beren R, Harley EE, Bennett 
P. The Pima infant feeding study: breast feeding and respiratory 
infections during the first year of life. Int J Epidemiol. 1984;13:447-
53.

  7.  Klebanoff MA, Graubard BI, Kessel SS, Berendes HW. Low birth 
weight across generations. JAMA. 1984;252:2423-27.

  8.  Mills JL, Graubard BI, Harley EE, Rhoads GG, Berendes HW. 
Maternal alcohol consumption and low birth weight: how much drinking 
during pregnancy is safe? JAMA. 1984;252:1875-79.

  9.  Neale EA, Sher PK, Graubard BI, Habig WH, Fitzgerald SC, Nelson 
PG. Differential toxicity of chronic exposure to phenytoin, 
phenobarbital, or carbamazepine in cerebral cortical cell cultures. 
Pediatr Neurol. 1985;1:143-50.

 10.  Sher PK, Neale EA, Graubard BI, Habig WH, Fitzgerald SC, Nelson 
PG. Differential neurochemical effects of chronic exposure of cerebral 
cortical cell culture to valporic acid, diazepam, or ethosuximide. 
Pediatr Neurol. 1985;1:232-37.

 11.  Forman MR, Fetterly K, Graubard BI, Gaines K. Socio-demographic 
factors associated with breast feeding in the United States: 1969 and 
1980. Am J Clin Nutr. 1985;42:864-69.

 12.  Hemminki E, Graubard BI, Hoffman HJ, Mosher WD, Fetterly K. 
Cesarean section and subsequent fertility: Results from the 1982 
National Survey of Family Growth. Fertil Steril. 1985;43:520-28.

 13.  Shiono PH, Klebanoff M A, Graubard BI, Berendes HW, Rhoads GG. 
Birth weight among women of different ethnic groups. JAMA. 1985;255:48-
52.

 14.  Rawlings RR, Graubard BI, Teper S, Eckardt MJ, Ryback RS. 
Conditional quadratic discrimination in the identification of 
biological markers for disease screening. Biometrical J. 1986;28:957-
64.

 15.  Rawlings RR, Graubard BI, Faden VB, Eckardt MJ. A study on 
discriminant analysis techniques applied to multivariate lognormal 
data. Journal of Statistical Computation and Simulation. 1986;26:79-
100.

 16.  Kurinij N, Klebanoff MA, Graubard BI. Dietary supplement and food 
intake in women of childbearing age. J Am Diet Assoc. 1986;86:1536-40.

 17.  Hemminki E, Myrianthopoulos NC, Pomeroy J, Graubard BI. Cesarean 
section as a risk factor for malformations--a negative finding. Int J 
Epidemiol. 1986;15:360-3.

 18.  Mills JL, Graubard BI. La controversia sugli effetti del bere 
moderatemente durante la gravidanza. La Tutela della Salute della 
Gestantee del Concepito ACTA MEDICA. 1986:123-9.

 19.  Graubard BI, Korn EL. Choice of column scores for testing 
independence in ordered 2xK contingency tables. Biometrics. 
1987;43:471-6.

 20.  Willoughby A, Moss HA, Hubbard VS, Bercus BB, Graubard BI, Vietze 
PM, Berendes HW. Developmental outcome in children exposed to chloride-
deficient formula. Pediatrics. 1987;79:851-57.

 21.  Mills JL, Graubard BI. Is moderate drinking during pregnancy 
associated with increased risk of malformations? Pediatrics. 
1987;80:309-14.

 22.  Mills JL, Graubard BI, Klebanoff MA. Placenta previa is not 
associated with an altered sex ratio at birth. Br Med J. 1987;294:544.

 23.  Korn EL, Graubard BI. Examining neighborhood confounding in a 
survey: an example using the National Health and Nutrition Examination 
Survey II. Stat Med. 1988;7:1087-98.

 24.  Eckardt MJ, Rawlings RR, Graubard BI, Faden VB, Martin PR, 
Gottschalk LA. Neurophychological performances and treatment outcome in 
male alcoholics. Alcoholism: Clinical and Experimental Research. 
1988;12:88-93.

 25.  Davis M K, Savitz DA, Graubard BI. Infant feeding and childhood 
cancer. Lancet. 1988;ii: 365-8.

 26.  Graubard BI, Fears TR, Gail MH. Effects of cluster sampling on 
epidemiologic analysis in population based case-control studies. 
Biometrics. 1989;45:1053-71.

 27.  Forman MR, Hundt GL, Towne D, Graubard B, Sullivan B, Berendes 
HW, Sarov B, Naggan L. The forty-day rest period and infant feeding 
practices among Negev Bedouin Arab women in Israel. Medicl 
Anthropology. 1990;12:207-16.

 28.  Willoughby A, Graubard BI, Hocker A, Storr C, Vietze P, 
Thackaberry JM, Gerry MA, McCarthy M, Gist NF, Magenheim M, Berendes H, 
Rhoads GG. Population-based study of the developmental outcome of 
children exposed to chloride-deficient infant formula. Pediatrics. 
1990;85:485-90.

 29.  Mills JL, Simpson JL, Rhoads GG, Graubard BI, Hoffman H, Conley 
MR, Lasserman M, Cunningham G. Risk of neural tube defects in relation 
to maternal fertility and fertility drug use. Lancet. 1990;336:103-4.

 30.  Malloy MH, Willoughby A, Graubard BI, Lynch J, McCarthy M, Mass 
H, Vietze P, Rhoads G, Berendes H. Exposure to a chloride-deficient 
formula during infancy: effect on outcome at age 9 and 10 years. 
Pediatrics. 1990;86:601-10.

 31.  Klebanoff MA, Shiono PH, Selby JV, Trachtenberg AI, Graubard BI. 
Anemia and spontaneous preterm birth. Am J of Obst and Gyn. 
1990;164:59-63.

 32.  Mills JL, Klebanoff MA, Graubard BI, Carey JC, Berendes HW. 
Barrier contraceptive methods and preeclampsia. JAMA. 1991;265:70-3.

 33.  Korn EL, Graubard BI. Simultaneous testing of regression 
coefficients with complex survey data: use of Bonferroni t-statistics. 
Am Stat. 1990;44:270-6.

 34.  Scheidt PC, Graubard BI, Nelson KB, Hirtz DG, Hoffman HJ, Gartner 
LM, Bryla DA. Intelligence at six years in relation to neonatal 
bilirubin: follow-up of the NICHD trial of phototherapy. Pediatrics. 
1991;87:792-805.

 35.  Malloy MH, Graubard B, Moss H, McCarthy M, Gwyn S, Vietze P, 
Willoughby A, Rhoads GG, Berendes H. Hyperchloremic metabolic alkalosis 
after ingesting a chloride-deficient formula: outcome 9 and 10 years 
later. Pediatrics. 1991;87:811-22.

 36.  Korn EL, Graubard BI. Epidemiologic studies utilizing surveys: 
accounting for the sampling design. Am J Public Health. 1991;81:1166-
73.

 37.  Korn EL, Graubard BI. A note on the large sample properties of 
linearization, jackknife and balanced repeated replication methods for 
stratified samples. Annals of Statistics. 1991;19:2275-79.

 38.  Freedman LS, Graubard BI, Schatzkin A. Statistical validation of 
intermediate endpoints for chronic diseases. Stat Med. 1992;11:167-78.

 39.  Forman MR, Lewando-Hundt G, Graubard BI, Chang D, Sarov B, Naggan 
L, Berendes HW. Factors influencing milk insufficiency and its long-
term health effects: The Bedouin infant feeding study. International 
Journal of Epidemiology. 1992;21:53-8.

 40.  Forman MR, Yao S Graubard BI, Qiao Y, McAdams M, Mao BL, Taylor 
PR. The effect of dietary intake of fruits and vegetables on the odd 
ratio of lung cancer among Yunnan Tin miners. International Journal of 
Epidemiology. 1992;21:437-41.

 41.  Ziegler RG, Subar AF, Craft NE, Ursin G, Patterson BH, Graubard 
BI. Does beta-carotene explain why reduced cancer risk is associated 
with vegetable and fruit intake? Cancer Res (suppl). 1992;52:2060s-6s.

 42.  Graubard BI, Korn EL. Hypothesis testing with complex survey 
data: the use of classical quadratic test statistics with particular 
reference to regression problems. J Am Stat Assoc. 1993;88:629-41.

 43.  Mills JL, Holmes LB, Aarons JH, Simpson JL, Brown ZA, Jovanovic-
Peterson LG, Conley MR, Graubard BI, Knopp RH, Metzger BE. Moderate 
caffeine use and the risk of spontaneous abortion and intrauterine 
growth retardation. JAMA. 1993;269:593-7.

 44.  Cnattingius S, Forman MR, Berendes HW, Graubard BI, Isotalo L. 
Effect of age, parity, and smoking on pregnancy outcome: a population-
based study. Am J Obstet Gynecol. 1993;168:16-21.

 45.  Flegal KM, Launer LJ, Graubard BI, Kestler E, Villar J: Modeling 
maternal weight and height in studies of pregnancy outcome among 
Hispanic women. Am J Clin Nutr. 1993;58:145-51.

 46.  Ursin G, Ziegler RG, Subar AF, Graubard BI, Haile RW, Hoover R.: 
Dietary patterns associated with a low-fat diet in the National Health 
Examination Follow-up Study: identification of potential confounders 
for epidemiologic analyses. Am J Epidemiol. 1993;137:916-27.

 47.  Forman MR, Lanza E, Yong LC, Holden JM, Graubard BI, Beecher GR, 
Melitz M, Brown E D, Smith JC. The correlation between two dietary 
assessments of carotenoid concentrations: Applications of a carotenoid 
food-composition database. Am J Clin Nutr. 1993;58:519-24.

 48.  Yong LC, Forman MR, Beecher GR, Graubard BI, Campell WS, Reichman 
ME, Taylor PR, Lanza E, Holden JM, Judd JT. The relationship between 
dietary intake and plasma levels of carotenoids in premenopausal women: 
Application of the USDA-NCI carotenoid food consumption data base. Am J 
Clin Nutr. 1994;60:223-30.

 49.  Faden VB, Graubard BI. Alcohol consumption during pregnancy and 
infant birth weight. Ann Epidemiol. 1994;4:279-84.

 50.  Graubard BI, Korn EL. Regression analysis with clustered data. 
Stat Med. 1994;13:509-22.

 51.  Murray DM, McKinlay SM, Martin D, Donner AP, Dwyer JH, Raudenbush 
SW, Graubard BI. Design and analysis issues in community trials. 
Evaluation Review. 1994;18:493-514.

 52.  Stevens RG, Graubard BI, Micozzi MS, Neriish K, Blumberg BS. 
Moderate elevation of body iron stores and risk of cancer occurrence 
and death. Int J Cancer. 1994;56:364-69.

 53.  Subar AF, Zeigler RG, Patterson BH, Ursin G, Graubard BI. U.S. 
dietary patterns associated with fat intake: The 1987 National Health 
Interview Survey. Am J Public Health. 1994;84:359-66.

 54.  Ballard-Barbash R, Thompson FE, Graubard BI, Krebs-Smith SM. 
Variability in percent energy from fat throughout the day: Implications 
for application of total diet goals. J Nutr Educ. 1994;26:278-83.

 55.  Kant AK, Graubard BI, Schatzkin A, Ballard-Barbash R. Proportion 
of energy intake from fat and subsequent weight change in the NHANES I 
epidemiologic follow-up study. Am J Clin Nutr. 1995;61:11-17.

 56.  Korn EL, Graubard BI. Analysis of large health surveys: 
Accounting for the sampling design. J R Stat Soc, Ser A. 1995;158:263-
95.

 57.  Kant AK, Schatzkin A, Graubard BI, Ballard-Barbash R. Frequency 
of eating occasions and weight change in the NHANES I Epidemiologic 
Follow-up Study. Int J Cancer. 1995;19:468-74.

 58.  Malloy MH, Graubard BI. Access to home apnea monitoring and its 
impact on rehospitalization among very-low-birth-weight infants. Ach of 
Pediatr and Adolesc Med. 1995;149(3): 326-332.

 59.  Forman MR, Hundt GL, Berendes, HW, Abu-Saad K, Zangwill L, Chang 
D, Bellmaker I, Graubard BI. Undernutrition among Bedouin Arab 
children: A followup of the Bedouin Infant Feeding Study. Am J Clin 
Nutr. 1995;61:495-500.

 60.  Korn EL, Graubard BI. Examples of differing weighted and 
unweighted estimates from a sample survey. Am Stat. 1995;49:291-5.

 61.  Green SB, Corle DK, Gail MH, Mark SD, Pee D, Freedman LS, 
Graubard BI, Lynn WR. Interplay between design and Analysis for 
behavioral intervention trials with community as the unit of 
randomization. Am J Epidemiol. 1995;142(6):587-93.

 62.  Forman MR, Beecher GR, Lanza E, Reichman ME, Graubard BI, 
Campbell WS, Marr T, Yong LC, Judd JT, Taylor PR. Effect of alcohol 
consumption on plasma carotenoid concentrations in premenopausal women: 
a controlled diet study. Am J Clin Nutr. 1995;62(1): 131-135.

 63.  COMMIT Research Group. Community Intervention Trial for Smoking 
Cessation (COMMIT): I. Cohort results from a four-year community 
intervention. Am J Public Health. 1995; 85(2):183-192.

 64.  COMMIT Research Group. Community Intervention Trial for Smoking 
Cessation (COMMIT): II. Changes in adult cigarette smoking prevalence. 
Am J Public Health. 1995; 85(2):193-200.

 65.  Ballard-Barbash R, Graubard BI, Krebs-Smith SM, Schatzkin A, 
Thompson FE. Contribution of dieting to the inverse association between 
energy intake and body mass index. Eur J Clin Nutr. 1996; 50(2): 98-
106.

 66.  Graubard BI, Korn EL. Survey inferences for subpopulations. Am J 
Epidemiol. 1996; 144:102-6.

 67.  Nebeling LC, Forman MR, Graubard BI, Snyder RA. The impact of 
lifestyle characteristics on specific and total carotenoid intake in 
the United States: the 1987 National Health Interview Survey. Eur J 
Clin Nutr. 1997;87:268-271.

 68.  Nebeling LC, Forman MR, Graubard BI, Snyder RA. Specific and 
total carotenoid intake among oral contrceptive and estrogen hormone 
users in the United States. J Am Coll Nutri. 1996;15(6):608-13.

 69.  Faden VB, Graubard BI, Dufour M. The relationship of drinking and 
birth outcome in a U.S. national sample of expectant mothers. Paediatr 
Perinat Epidimol. 1997; 11(2): 167-180.

 70.  Forman MR, Beecher GR, Muesing R, Lanza E, Olson B, Campbell WS, 
McAdam P, Schulman JD, Graubard BI. The fluctuation of plasma 
carotenoid concentrations by phase of the menstrual cycle: a controlled 
diet study. Am J Clin Nutr. 1996;64:559-65.

 71.  Muesing R, Forman MR, Graubard BI, Beecher GR, Lanza E, McAdam P, 
Campbell WS. Changes in lipoprotein and apolipoprotein levels during a 
free-living and two controlled diet cycles in normal premenopausal 
women. J Clin Endocrinol Metab. 1996;81(10):3599-603.

 72.  Graubard BI, Korn EL. Modeling the sampling design in the 
analysis of health surveys. Statistical Methods in Medical Research. 
1996;5:263-81.

 73.  Munoz KA, Ballard-Barbash R, Graubard B, Swanson CA, Schairer C, 
Kahle LL. Recall of body weight and body size estimation in women 
enrolled in the breast cancer detection and demonstration project 
(BCCDP). Int J Obes Relat Metab Disord. 1996;20(9):854-59.

 74.  Korn EL, Graubard BI, Midthune D. Time-to-event analysis of 
longitudinal follow-up of a survey: choice of the time-scale. Am J 
Epidemiol. 1997; 145(1): 72-80.

 75.  Nebeling LC, Forman MR, Graubard BI. Changes in carotenoid intake 
in the United States: the 1987 and 1992 National Health Interview 
Surveys. Journal of American Dietetic Association. 1997;97:991-996.

 76.  Korn, EL, Midthune, D, Graubard, BI. Estimating interpolated 
percentiles from grouped data with large samples. Journal of Official 
Statistics. 1997;13(4):385-400.

 77.  Faden VB, Hanna EH, Graubard BI. The effect of positive and 
negative health behavior on birth outcome. Journal of Substance Abuse. 
1997;9: 63-76.

 78.  Fawzi W, Forman MR, Levy A, Graubard BI, Naggan L, Berendes HW. 
Maternal anthropometry and infant feeding practices in Israel in 
relation to growth in infancy: The North African Infant Feeding Study. 
Am J Clin Nutr. 1997;65:1731-7.

 79.  Korn EL, Graubard BI. Scatter plots with survey data. Am Stat. 
1998; 52(1):58-69.

 80.  Potosky AL, Breen N, Graubard BI, Parsons PE. The association 
between health care coverage and the use of cancer screening tests: 
Results from the 1992 National Health Interview Survey. Medical Care. 
1998;36:257-70.

 81.  Fay MP, Graubard BI, Freedman LS. Conditional logistic regress 
with sandwich estimators: Application to a meta-analysis. Biometrics. 
1998;54:195-208.

 82.  Korn EL and Graubard BI. Variance estimation for superpopulation 
parameters. Statistica Sinica. 1998;8:1131-51.

 83.  Forman MR, Johnson E, Lanza E, Graubard BI, Beecher GR, Muesing 
R. Distribution of individual carotenoids in lipoproteins of 
premenopausal women: A controlled diet study. Am J Clin Nutr. 
1998:67;81-7.

 84.  Lanza E, Forman MR, Johnson E, Graubard BI, Beecher GR, Muesing 
R. Fluctuation and distribution of plasma alpha-tocopherol by phase of 
the menstrual cycle. J Nutr. 1998:128; 1150-55.

 85.  Korn EL, Graubard BI. Confidence intervals for proportions with 
small expected number of positive counts estimated from survey data. 
Survey Methodology. 1998:24, 193-201.

 86.  Graubard BI, Korn EL. Predictive margins with survey data. 
Biometrics. 1999:55;652-9.

 87.  Graubard BI, Korn, EL. Analyzing health surveys for cancer-
related objectives. JNCI. 1999:91; 1005-1016.

 88.  Breslow RA, Wideroff L, Graubard BI, Erwin D, Reichman ME, 
Ziegler RG, Ballard-Barbash R. Alcohol and prostate cancer in the 
NHANES I Epidemiologic Followup Study. Ann Epidemiol. 1999:9;254-61.

 89.  Stillman F, Hartman A, Graubard B, Gilpin E, Chavis D, Garcia J, 
Wun L-P, Lynn W, Manely M. The American Stop Smoking Intervention Study 
(ASSIST): Conceptual framework and evaluation design. Evaluation Rev. 
1999:23;259-80.

 90.  Forman MR, Zhang-J, Nebeling L, Yao S-X, Slesinski MJ, Qiao Y-L, 
Ross S, Keith S, Maher M, Giffin C, Barrett M, Taylor PR, Graubard BI. 
Relative validity of a food frequency questionnaire among tin miners in 
China: 1992-3 and 1995-6 Diet validation studies. Pub Hlth Nutr. 
1999;2(3):301-15.

 91.  Forman MR, Zhang J, Gunter E, Yao S-X, Gross M, Qiao Y-L, 
Graubard BI, Keith S, Maher M, Taylor PR. Season-specific correlation 
between dietary intake of fruits and vegetables and levels of serum 
biomarkers among Chinese tin miners at high risk of lung cancer. Ann NY 
Acad Sci. 1999; 889: 230-239 1999.

 92.  Kant AK, Graubard BI. Variability in selected indexes of overall 
diet quality. Int J Vitam Nutr Res. 2000:69(6);419-27.

 93.  Krebs-Smith SM, Graubard BI, Kahle LL, Subar AF, Cleveland LE, 
Ballard-Barbash R.Low energy reporters vs others: a comparison of 
reported food intakes. Eur J Clin Nutr. 2000:54;281-7.

 94.  Breslow RA, Graubard BI, Sinha R, Subar AF. Diet and lung cancer 
mortality: a 1987 National Health Interview Survey Cohort Study. Cancer 
Causes and Control. 2000: 11(5), 419-31.

 95.  Tziraki C, Graubard BI, Manley M, Kosary C, Moler JE, Edwards BK. 
The effect of training on the adoption of cancer prevention nutrition-
related activities by primary care practices: results of a randomized, 
control study. J Gen Int Med. 2000: 15(3); 155-162.

 96.  Kant AK, Schatzkin A, Graubard BI, Schairer C. A prospective 
study of diet quality and mortality in women. JAMA. 2000: 283(16); 
2109-15.

 97.  Hawk E, Breslow RA, Graubard BI. Male pattern baldness and 
clinical prostate cancer in the Epidemiologic Follow-up of the first 
National Health Interview Examination Survey. Cancer Epi and 
Biomarkers. 2000: 9(5); 523-7.

 98.  Faden VB, Graubard BI. Maternal substance use during pregnancy 
and developmental outcome at three. J Subst Abuse. 2000; 12(4); 329-40.

 99.  Breslow RA, Ballard-Barbash R, Munoz K, Graubard BI. Long-term 
recreational physical activity and breast cancer in NHANES I 
Epidemiologic Follow-up Study. Cancer Epi and Biomarkers. 2001; 10(7); 
805-8.

100.  Fay PM, Graubard BI. Small-Sample adjustments for Wald-type tests 
using sandwich estimators. Biometrics. 2001; 57 (4): 1198-1206.

101.  Chen H, Ward MH, Graubard BI, Heineman EF, Markin RM, Potischman 
NA,Russell RM, Weisenburger DD, Tucker KL. Dietary pattern and 
adenocarcinoma of the esophagus and distal stomach. Am J Clin Nutr. 
2002; 75 (1): 137-144.

102.  Patterson BH, Dayton CM, Graubard BI. Latent class analysis of 
complex sample survey data: Application to dietary data. J Am Stat 
Assoc. 2002; 97 (459); 721-729.

103.  Chen HL, Ward MH, Tucker KL, Graubard BI, McComb RD, Potischman 
NA, Weisenburger DD, Heineman EF. Diet and risk of adult glioma in 
eastern Nebraska, United States. Cancer Cause Control. 2002; 13 (7): 
647-655.

104.  Jemal A, Graubard BI, Devesa SS, Flegal KM. The association of 
blood lead and cancer mortality among whites in the United States. 
Environ Hlth Per. 2002; 10 (4): 325-329.

105.  Chen H, Tucker KL, Graubard BI, Heineman EF, Russell RM, 
Weisenburger DD, Ward MH. Nutrient intakes and ademocarcinoma of the 
esophagus and distal stomach. Nutrition and Cancer. 2002; 42 (1): 33-
40.

106.  Graubard BI, Korn EL. Inference for superpopulation parameters 
using surveys. Statistical Science. 2002; 17 (1): 73-96.

107.  Vogt TM, Mayne ST. Graubard BI, Swanson CA, Sowell AL, Schoenberg 
JB, Swanson GW, Greenberg RS, Hoover RN, Hayes RB, Ziegler RG. Serum 
lycopene, other serum carotenoids, and risk of prostate cancer in U.S. 
blacks and whites. Am J Epid. 2002;155 (11);1023-1032.

108.  Freedman AN, Graubard BI, Rao SR, McCaskill-Stevens W, Ballard-
Barbash R, Gail MH. Estimates of the number of U.S. women who could 
benefit from tamoxifen for breast cancer chemoprevention. JNCI. 2003; 
95 (7); 526-532.

109.  Baker SG, Ko CW, Graubard BI. A sensitivity analysis for 
nonrandomly missing categorical data arising from a national health 
disability survey. Biostatistics. 2003; 4 (1); 41-56.

110.  Stewart PA, Lees PS, Correa A, Breysse P, Gail M, Graubard BI. 
Evaluation of three retrospective exposure assessment methods. Annals 
of Occupation and Hygiene. 2003; 47 (5); 399-411.

111.  Davis WW, Graubard BI, Hartman AM, Stillman FA. Descriptive 
methods for evaluation of state-based intervention programs. Evaluation 
Review. 2003; 27(5); 506-534.

112.  Kant AK, Graubard BI. Predictors of reported consumption of low-
nutrient-density foods in a 24-h recall by 8-16 year old U.S. children 
and adolescents. Appetite. 2003; 41 (2); 175-80.

113.  Stillman FA, Hartman AM, Graubard BI, Gilpin EA, Murray DM, 
Gibson JT. Evaluation of the American Stop Smoking Intervention Study 
(ASSIST): A report of outcomes. JNCI. 2003; 95 (22); 1681-91.

114.  Korn EL, Graubard BI. Estimating variance components using survey 
data. J Roy Stat Soc B. 2003; 65; 175-90.

115.  Sturgeon, SR, Graubard BI, Schairer C, McAdams M, Hoover RN, Gail 
MH. Population density and county level variation in breast cancer 
mortality rates among white women residing n the northeastern and 
southern United States. Cancer Control and Causes. 2003;14 (10): 923-
931.

116.  Vogt TM, Ziegler RG, Graubard BI, Swanson CA, Greenberg RS, 
Schoenberg JB, Swanson GM, Hayes RB, Mayne ST. Serum selenium and risk 
of prostate cancer in U.S. blacks and whites. International Journal of 
Cancer. 2003; 103 (5); 664-670.

117.  Rao RS, Graubard BI, Breen N, Gastwirth JL. Understanding the 
factors underlying disparities in cancer screening rates using the 
Peters-Belson approach: Results from the 1998 National Health Interview 
Survey. Med Care. 2004; 42 (8): 789-800.

118.  Kant, AK Graubard BI. Eating out in America, 1987-2000: Trends 
and nutritional correlates. Preventive Medicine. 2004;38(2):243-9.

119.  Brinton LA, Kruger Kjaer S, Thomsen BL, Sharif HF, Graubard BI, 
Olsen JH, Bock JE. Childhood tumor risk after treatment with ovulation-
stimulating drugs. Fertil Steril. 2004 Apr;81(4):1083-91.

120.  Ratnasinghe LD, Graubard BI, Kahle L, Tangrea JA, Taylor PR, Hawk 
E. Aspirin use and mortality from cancer in a prospective cohort study. 
Anticancer Research. 2004;24(5B): 3177-84.

121.  Flegal KM, Graubard BI, Williamson DF. Methods of calculating 
deaths attributable to obesity. Am J Epi. 2004;160 (4): 331-338.

122.  Kant AK, Graubard BI, Schatzkin A. Dietary patterns predict 
mortality in a national cohort: The National Health Interview Surveys, 
1987 and 1992. J Nutr. 2004; 134 (7): 1793-1799.

123.  Freedman AN, Graubard BI, McCaskill-Stevens W, Ballard-Barbash R. 
How many U.S. women are eligible to use tamoxifen for breast cancer 
prevention? How many women would benefit? The American Journal of 
Oncology Review. 2004; 2(9): 17-18.

124.  Rao RS, Sigurdson AJ, Doody MM, Graubard BI. An Application of a 
Weighting Method to Adjust For Nonresponse In Standardized Incidence 
Ratio Analysis of Cohort Studies. Ann Epidemiol. 2005;15(2): 129-36.

125.  Flegal KA, Graubard BI, Williamson DF, Gail MH. Excess deaths 
associated with underweight, overweight, and obesity. JAMA. 2005; 293 
(15): 1861-67.

126.  Zhang Y, Graubard BI, Klebanoff MA, Ronckers C, Stanczyk FZ, 
Longnecker MP, McGlynn KA. Maternal hormone levels among populations at 
high and low risk of testicular germ cell cancer. Brit J Cancer. 2005; 
92 (9): 1787-1793.

127.  Tseng M, Breslow RA, Graubard BI, Ziegler RG. Dairy, calcium, and 
vitamin D intakes and prostate cancer risk in the national health and 
nutrition examination epidemiologic follow-up study cohort. Am J Clin 
Nutr. 2005; 81 (5): 1147-1154.

128.  Graubard BI, Rao RS, Gastwirth JL. Using the Peters-Belson Method 
to measure health care disparities from complex survey data. Stat Med. 
2005; 24(17):2659-68.

129.  Graubard BI, Fears TR. Standard errors for attributable risk for 
simple and complex sample designs. Biometrics. 2005; 61(3) 847-55.

130.  Sakoda LC, Graubard BI, Evans AA, London WT, Lin W-Y, Shen F-M, 
McGlynn KA. Toenail selenium and risk of hepatocellular carcinoma 
mortality in Haimen, China. International Journal of Cancer. 2005;115 
(4): 618-24..

131.  Colt JS, Wacholder S, Schwartz K, Davis F, Graubard B, Chow W-H. 
Response rates in a case-control study: Effect of disclosure of 
biologic sample connection in the initial contact letter. Annals of 
Epidemiology. 2005; 15(9): 700-704.

132.  Kant AK, Graubard BI. Energy density of diets reported by 
American adults: Association with food group intake, nutrient intake, 
and body weight. International Journal of Obesity. 2005; 29(8): 950-6.

133.  McGlynn KA, Devesa SS, Graubard BI, Castle PE. Increasing 
incidence of testicular germ cell tumors among black men in the United 
States. Journal Clinical Oncology. 2005; 23(24): 5757-61.

134.  McGlynn KA, Graubard BI, Stancyzk FZ, Longnecker MP, Klebanoff 
MA. Maternal hormone levels and risk of cryptorchism among populations 
at high and low risk of testicular germ cell tumors. Cancer Epidem 
Biomarkers and Prevention. 2005; 14 (7): 1732-1737 .

135.  Kant AK, Graubard BI. A comparison of three dietary pattern 
indexes for predicting biomarkers of diet and disease, NHANES III, 
1988-1994. J Amer Coll Nutr. 2005; 24(4): 294-303.

136.  Stolzenberg-Solomon RZ, Graubard BI, Chari S, Limburg P, Taylor 
PR, Albanes D. Insulin, glucose, insulin resistance, and pancreatic 
cancer in male smokers. JAMA. 2005; 294 (22): 2872-2878.

137.  Brinton LA, Sakoda LC, Sherman LE, Frederikse K, Kajaer SK, 
Graubard BI, Olsen JH, Mellemkjaer L. Relationship of benign 
gynecologic diseases to subsequent risk to ovarian and uterine tumors. 
Cancer Epidemiology Biomarkers and Prevention. 2005 14(12) 2929-25.

138.  Zhao F, Forman MR, Belinson J, Shen Y, Graubard BI, Partel AC, 
Rong S, Pretorius RG, Qiao Y. Risk factors for HPV infection and 
cervical cancer among unscreened women in a high-risk rural area of 
China. Int J Cancer. 2006; 118(2):442-8.

139.  Corwin RL, Hartman TJ, Maczuga SA, Graubard BI. Dietary saturated 
fat is inversely associated with bone density in humans: analysis of 
NHANES III. Journal of Nutrition. 2006;136 (1): 159-165.

140.  Schober SE, Mirel LB, Graubard BI, Brody DJ, Flegal KM. Blood 
lead levels and death from all causes, cardiovascular disease, and 
cancer: Results from the NHANES III Mortality Study. Environ Hlth Per. 
2006; 114 (10): 1538-1541.

141.  McGlynn KA, Zhang YW, Sakoda LC, Rubertone MV, Erickson RL, 
Graubard BI.Maternal smoking and testicular germ cell tumors. Cancer 
Epidemiology Biomarkers & Prevention. 2006; 15 (10): 1820-1824.

142.  Chen JB, Pee D, Ayyagari R, Graubard BI, Schairer C, Byrne C, 
Benichou J, Gail MH. Projecting absolute invasive breast cancer risk in 
white women with a model that includes mammographic density. JNCI, 
2006; 98 (17): 1215-1226.

143.  Kant AK, Graubard BI. Secular trends in patterns of self-reported 
food consumption of adult Americans: NHANES 1971-1975 to NHANES 1999-
2002. AJCN. 2006;84 (5): 1215-1223.

144.  Graubard BI, Gilpin EA, Hartman AM, Murray DM, Davis W, Gibson 
JT, Stillman FA. Chapter 9: Analytic methods and results of the ASSIST 
Evaluation. NCI Monograph. 2006.

145.  McGlynn KA, Graubard BI, Klebanoff MA, Longnecker MP. Risk 
factors for cryptorchism among populations at differing risks of 
testicular cancer. Int J Epidemiol. 2006 Jun; 35(3):787-95.

146.  Kant AK, Graubard BI, Kumanyika SK. Trends in black-white 
differentials in dietary intakes of U.S. adults, 1971-2002. American 
Journal of Preventive Medicine. 2007; 32 (4): 264-272.

147.  Graubard BI, Flegal KA, Williamson DF, Gail MH. Estimation of 
attributable number of deaths and standard errors from simple and 
complex sampled cohorts. Stat Med. 2007; 26 (13): 2639-2649.

148.  Meissner HI, Breen N, Taubman ML, Vernon SW, Graubard BI. Which 
women aren't getting mammograms and why? (United States). Cancer Causes 
Control. 2007; 18 (1): 61-70.

149.  Purdue MP, Sakoda LC, Graubard BI, Welch R, Chanock SJ, 
Sesterhenn IA, Rubertone MV, Erickson RL, McGlynn KA. A case-control 
investigation of immune function gene polymorphisms and risk of 
testicular germ cell tumors. CEBP. 2007; 16 (1): 61-70.

150.  Engels EA, Atkinson JO, Graubard BI, Mc Quillan GM, Gamache C, 
Mbisa G, Cohn S., Whitby D, Goedert JJ. Risk factors for human 
herpesvirus 8 infection among adults in the United States and evidence 
for sexual transmission. Journal of Infectious Diseases. 2007;196 (2): 
199-207.

151.  Vogt TM, Ziegler RG, Patterson BH, Graubard BI. Racial 
differences in serum selenium concentration analysis: U.S. population 
data from the Third National Health and Nutrition Examination Survey 
(NHANES III). Am J Epidemiol. 2007; 166 (3): 280-288.

152.  Zhang Y, Graubard BI, Longnecker MP, Stanczyk FZ, Klebanoff MA, 
McGlynn KA. Maternal hormone levels and perinatal characteristics: 
implications for testicular cancer. Ann Epidemiol. 2007 Feb; 17(2):85-
92.

153.  Kant AK, Graubard BI. Secular trends in the association of socio-
economic position with self-reported dietary attributes and biomarkers 
in the U.S. population: National Health and Nutrition Examination 
Survey (NHANES) 1971-1975 to NHANES 1999-2002. Public Health Nutrition. 
2007;10 (2):158-167.

154.  McGlynn KA, Sakoda LC, Rubertone MV, Sesterhenn IA, Liu C, 
Graubard BI., Erickson RL. Body size dairy consumption, puberty and 
risk of germ cell testicular cancer. Am J Epidemiol. 2007; 165 (4):355-
363.

155.  Saydah S, Graubard B, Ballard-Barbash R, Berrigan D. Insulin-like 
growth factors and subsequent risk of mortality in the United States. 
Am J Epidemiol. 2007;166(5):518-26.

156.  Moore SC, Leitzmann MF, Weinstein SJ, Snyder K, Albanes D, 
Virtamo J, Graubard BI, Mayne ST, Yu H, Peters U, Gunter MJ. Insulin 
resistance-
related gene polymorphisms and risk of prostate cancer. CEBP. 2007; 16 
(6): 1315-1317.

157.  Flegal KM, Graubard BI, Williamson DF, Gail MH. Impact of smoking 
and pre-existing illness on estimates of the fraction of deaths 
associated with underweight, overweight, and obesity in the U.S. 
population. Am J Epidemiol. 2007; 166:975-982.

158.  Michels KB, Willett WC, Graubard BI, Vaidya RL, Cantwell MM, 
Sanbury LB, Forman MR. A longitudinal study of infant feeding and 
obesity throughout life Course. Int J Obesity. 2007; 31(7):1078-85.

159.  Welzel TM, Graubard BI, El-Serag HB, Shaib YH, Hsing AW, Davila 
JA, McGlynn KA. Risk Factors for Intrahepatic and Extrahepatic 
Cholangiocarcinoma in the United States: A Population-Based Case-
Control Study. Clin Gastroenterol Hepatol. 2007;5(10):1221-8.

160.  Hunsberger S, Graubard BI, Korn EL.Testing logistic regression 
coefficients with clustered data and few positive outcomes. Stat Med. 
2008; 27(8):1305-24.

161.  Brinton LA, Sakoda LC, Frederiksen K, Sherman ME, Graubard BI, 
Olsen JH, Mellemkjaer L. Relationships of uterine and ovarian tumors to 
pre-existing chronic conditions. Gynecol Oncol. 2007; 107(3):487-94.

162.  Garceau A, Wideroff L, McNeel T, Dunn M, Graubard BI. Population 
estimates of family structure and size. Community Genetics. 2008;11 
(6):331-342.

163.  Millen AE, Subar AF, Graubard BI, Peters U, Hayes RB, Weissfeld 
JL, Yokochi LA, Ziegler RA. Fruit and vegetable intake and prevalence 
of colorectal adenoma in a cancer screening trial. Am J Clinical Nutr. 
2007;86(6):1754-64

164.  Flegal KA, Graubard BI, Williamson DF, Gail MH. Cause-specific 
excess deaths associated with underweight, overweight and obesity. 
JAMA. 2007; 298(17):2028-37.

165.  Freedman DM, Looker AC, Chang S-C, Graubard BI. Prospective study 
of serum vitamin D and cancer mortality in the United States. JNCI. 
2007; 9(21):1594-602.

166.  Kant AK, Graubard BI. Ethnicity is an independent correlate of 
biomarkers of micronutrient intake and status in American adults. J 
Nutr. 2007; 7(11):2456-63.

167.  Graubard BI, Levy PS, Willis GR. A Conversation with Monroe 
Sirken. Stat Sci. 2007; 22 (4):637-650.

168.  Cook MB, Zhang Y, Graubard BI, Rubertone MV, Erickson RL, McGlynn 
KA. Risk of Testicular Germ Cell Tumours in Relation to Childhood 
Physical Activity. Br. J Cancer. 2008; 98:174-8.

169.  Flegal KA, Graubard BI, Williamson DF, Gail MH. Correcting bias, 
or biased corrections? Obesity. 2008; 16(2):229-31.

170.  Breslow RA, Graubard BI. Prospective Study of Alcohol Consumption 
in the United States: Quantity, Frequency, and Cause-Specific 
Mortality. Alcohol-Clin Exp Res. 2008; 32(2): 513-521.

171.  Chia VM, Quraishi SM, Graubard BI, Rubertone MV, Erickson RL, 
Stanczyk FZ, McGlynn KA. Insulin-like growth factor 1, insulin-like 
growth factor-binding protein 3, and testicular germ-cell tumor risk. 
Am J Epidemiol. 2008; 15;167(12):1438-45.

172.  Purdue MP, Graubard BI, Chanock SJ, Rubertone MV, Erickson RL, 
McGlynn KA. Genetic variation in the inhibin pathway and risk of 
testicular germ cell tumors. Cancer Res. 2008;68(8):3043-8.

173.  Figueroa JD, Sakoda LC, Graubard BI, Chanock S, Rubertone MV, 
Erickson RL, McGlynn KA. Genetic variation in hormone metabolizing 
genes and risk of testicular germ cell tumors. Cancer Causes Control. 
2008;19 (9):917-29.

174.  McGlynn KA, Quraishi SM, Graubard BI, Weber JP, Rubertone MV, 
Erickson RL.Persistent organochlorine pesticides and risk of testicular 
germ cell tumors. J Natl Cancer Inst. 2008;100(9):663-71.

175.  Kant AK, Graubard BI. Ethnic and socioeconomic differences in 
variability in nutritional biomarkers. Am J Clin Nutr. 2008;87(5):1464-
71.

176.  Anderson LA, Li Y, Graubard BI, Whitby D, Mbisa G, Tan S, Goedert 
JJ, Engels EA.Human Herpesvirus 8 Seroprevalence Among Children and 
Adolescents in the United States. Pediatr Infect Dis J. 2008;27(7):661-
4.

177.  Chia VM, Sakoda LC, Graubard BI, Rubertone MV, Chanock SJ, 
Erickson RL, McGlynn KA. Risk of testicular germ cell tumors and 
polymorphisms in the insulin-like growth factor genes. Cancer Epidemiol 
Biomarkers Prev. 2008;
17(3):721-6.

178.  Chia VM, Quraishi SM, Graubard BI, Rubertone MV, Erickson RL, 
Stanczyk FZ, McGlynn, KA. Insulin-like growth factor 1, insulin-like 
growth factor-binding protein 3, and testicular germ-cell tumor risk. 
Am J Epidemiol. 2008; 167 (12):1438-1445.

179.  Colbert LH, Graubard BI, Michels KB, Willett WC, Forman MR. 
Physical Activity during Pregnancy and Age at Menarche of the Daughter. 
Cancer Epidemiol Biomarkers Prev. 2008;17 (10):2656-62.

180.  Cook MB, Graubard BI, Rubertone MV, Erickson RL, McGlynn KA. 
Perinatal factors and the risk of testicular germ cell tumors. Intl J 
of Cancer. 2008;122 (11):2600-2606.

181.  Cook MB, Graubard BI, Quraishi SM, Yeager M, Chanock SJ, Crenshaw 
A, Erickson RL, Rubertone MV, Thomas G, McGlynn KA. Genetic variants in 
the 8q24 locus and risk of testicular germ cell tumors. Human Genetics. 
2008;123 (4):409-418.

182.  Rao S, Graubard B, Schmid C, Morton S, Louis T, Zaslavsky A, 
Finkelstein D. Meta-analysis of survey data: application to health 
services research. Health Services and Outcomes Research Methodology. 
2008;8(2): 98-114.

183.  Dunton GF, Berrigan D, Ballard-Barbash R, Graubard BI, Atienza 
AA. Social and physical environments of sports and exercise reported 
among adults in the American Time Use Survey. Prev Med. 2008;47(5): 
519-524.

184.  Anderson LA, Lauria C, Romano N, Brown EE, Whitby D, Graubard BI, 
Li Y, Messina A, Gaffa L, Vitale F, Goedert JJ. Risk factors for 
classical Kaposi sarcoma in a population-based study in Sicily. Cancer 
Epidemiology, Biomarkers and Prevention. 2008 17(12): 3435-3443.

185.  Weinstein SJ, Albanes D, Selhub J, Graubard B, Lim U, Taylor PR, 
Virtamo J, Stolzenberg-Solomon R. One-carbon metabolism biomarkers and 
risk of colon and rectal cancers. Cancer Epidemiol Biomarkers Prev. 
2008;
17(11):3233-40.

186.  Freedman DM, Chang SC, Falk RT, Purdue MP, Huang WY, McCarty CA, 
Hollis BW, Graubard BI, Berg CD, Ziegler RG. Serum levels of vitamin D 
metabolites and breast cancer risk in the prostate, lung, colorectal, 
and ovarian cancer screening trial. Cancer Epidemiol Biomarkers Prev. 
2008;17(4):889-94.

187.  Flegal KM, Graubard BI, Williamson DF, Gail MH. Response to 
``Biased Corrections or Biased About Corrections.'' Obesity. 
2008;17(5):940.

188.  Chia VM, Li Y, Goldin LR, Graubard BI, Greene MH, KordeL, 
Rubertone MV, Erickson RL, McGlynn KA. Risk of cancer in first-and 
second-degree relatives of testicular germ cell tumor cases and 
controls. Int J Cancer. 2009;124(4):952-7.

189.  Jiao L, Mitrou PN, Reedy J, Graubard BI, Hollenbeck AR, Schatzkin 
A, Stolzenberg-Solomon R. A combined healthy lifestyle score and risk 
of pancreatic cancer in a large cohort study. Arch Intern Med. 2009; 
169(8):764-70.

190.  Li Y, Graubard BI. Testing Hardy-Weinberg equilibrium and 
homogeneity of Hardy-Weinberg disequilibrium using complex survey data. 
Biometrics. 2009;32(6):599-606.

191.  Sinha R, Cross AJ, Graubard BI, Leitzmann MF, Schatzkin A. Meat 
intake and mortality: a prospective study of over half a million 
people. Arch Intern Med. 2009;169(6):562-71.

192.  Flegal KM, Shepherd JA, Looker AC, Graubard BI, Borrud LG, Ogden 
CL, Harris TB, Everhart JE, Schenker N. Comparisons of percentage body 
fat, bodymass index, waist circumference, and waist-stature ratio in 
adults. Am J Clin Nutr. 2009 89(2):500-8.

193.  Flegal KM, Graubard BI. Estimates of excess deaths associated 
with bodymass index and other anthropometric variables. Am J Clin Nutr. 
2009 (4):1213-9.

194.  Chatterjee N, Graubard BI, Gastwirth JL. The Use of the Risk 
Percentile Curve in the Analysis of Epidemiologic Data. Statistics and 
Its Interface. 2009; Statistics in the Interface 2 (2): 123-31.

195.  Castle PE, Kreimer AR, Wacholder S, Solomon D, Wheeler CM, 
Koutsky LA, Rydzak G, Buckman DW, Graubard B, Schiffman M. The 
Influence of Loop Electrosurgical Excision Procedure on the Acquisition 
of HPV. 2009; J Infect Dis; 199(11):1612-20.

196.  Ferrucci LM, Sinha R, Graubard BI, Mayne ST, Ma X, Schatzkin A, 
Schoenfeld PS, Cash BD, Flood A, Cross AJ. Dietary Meat Intake in 
Relation to Colorectal Adenoma in Asymptomatic Women. Am J 
Gastroenterol. 2009;104(5):1231-40.

197.  McGlynn KA, Quraishi SM, Graubard BI, Weber JP, Rubertone MV, 
Erickson RL. Polychlorinated biphenyls and risk of testicular germ cell 
tumors. Cancer Res. 2009;69(5):1901-9.

198.  Kedem B, Kim E-Y, Voulgaraki A, Graubard BI. Two-dimensional 
semiparametric density ratio modeling of testicular germ cell data. 
Stat in Med. (2009) 28(16):2147-59.

199.  Cook MB, Sigurdson AJ, Jones IM, Thomas CB, Graubard BI, Korde L, 
Greene MH, McGlynn KA. Endogenous DNA damage and testicular germ cell 
tumors. Int J Androl. 2009;32(6):599-606.

200.  Ferrucci LM, Cross AJ, Graubard BI, Brinton LA, McCarty CA, 
Ziegler RG, Ma X, Mayne ST, Sinha R. Intake of meat, meat mutagens, and 
iron and the risk of breast cancer in the Prostate, Lung, Colorectal, 
and Ovarian Cancer Screening Trial. Br J Cancer. 2009;101(1):178-84.

201.  Pelser C, Dazzi C, Graubard BI, Lauria C, Vitale F, Goedert JJ. 
Risk of classic Kaposi sarcoma with residential exposure to volcanic 
and related soils in Sicily. Ann Epidemiol. 2009; (8):597-601.

202.  Dunton GF, Berrigan D, Ballard-Barbash R, Graubard BI, Atienza 
AA. Environmental Influences on Exercise Intensity and Duration in a 
U.S. Time Use Study. Med Sci Sports Exerc. 2009;41(9):1698-705.

203.  Kant AK, Graubard BI, Atchison EA. Intakes of plain water, 
moisture in foods and beverages, and total water in the adult U.S. 
population--nutritional, meal pattern, and body weight correlates: 
National Health and Nutrition Examination Surveys 1999-2006. Am J Clin 
Nutr. 2009;90(3):655-63.

204.  Chia VM, Li Y, Quraishi SM, Graubard BI, Figueroa JD, Weber JP, 
Chanock SJ, Rubertone MV, Erickson RL, McGlynn KA. Effect modification 
of endocrine disruptors and testicular germ cell tumour risk by 
hormone-metabolizing genes. Int J Androl. 2009;33(4): 588-596.

205.  Pelser C, Vitale F, Whitby D, Graubard BI, Messina A, Gaf` L, 
Brown EE, Anderson LA, Romano N, Lauria C, Goedert JJ. Socio-economic 
and other correlates of Kaposi sarcoma-associated herpesvirus 
seroprevalence among older adults in Sicily. J Med Virol. 2009; 
81(11):1938-44.

206.  McGlynn KA, Guo X, Graubard BI, Brock JW, Klebanoff MA, 
Longnecker MP. Maternal pregnancy levels of polychlorinated biphenyls 
and risk of hypospadias and cryptorchidism in male offspring. Environ 
Health Perspect. 2009;117(9):1472-6.

207.  Sinha R, Park Y, Graubard BI, Leitzmann MF, Hollenbeck A, 
Schatzkin A, Cross AJ. Meat and meat-related compounds and risk of 
prostate cancer in a large prospective cohort study in the United 
States. Am J Epidemiol. 2009;170(9):1165-77.

208.  Dunton GF, Berrigan D, Ballard-Barbash R, Graubard B, Atienza AA. 
Joint associations of physical activity and sedentary behaviors with 
body mass index: results from a time use survey of U.S. adults. Int J 
Obes. 2009;33(12):1427-36.

209.  Graubard BI. Comment on the Sinclair and Pan Paper. Law, 
Probability and Risk. 2009;8:119-122.

210.  Li H, Graubard BI, Gail MH. Covariate adjustment and ranking 
methods to identify regions with high and low mortality rates. 
Biometrics. 2010;66(2): 613-620.

211.  She D, Li Y, Zhang H, Graubard BI, Li Z. Trend tests for genetic 
association using population-based cross-sectional complex survey data. 
Biostatistics. 2010;11(1):48-56.

212.  Katki HA, Sanders CL, Graubard BI, Bergen AW. Using DNA 
fingerprints to infer familial relationships with NHANES III 
households. JASA. 2010;
105(490):552-563.

213.  Breslow RA, Guenther PM, Juan WY, Graubard BI. Alcoholic Beverage 
Consumption, Nutrient Intakes, and Diet Quality in the U.S. Adult 
Population, 1999-2006. JADA. 2010;110(4):551-62.

214.  Li Y, Graubard BI, Korn EL. Application of Nonparametric Quantile 
Regression to Body Mass Index Percentile Curves from Survey Data. Stat 
in Med. 2010;29(5):558-72.

215.  Brock K, Huang W-Y, Fraser D, Ke L, Tseng M, Stolzenberg-Solomon 
R, Peters U, Ahn J, Purdue M, Mason R, McCarty C, Ziegler R, Graubard 
B. Low Vitamin D status is associated with physical inactivity, obesity 
and low vitamin D intake in a large U.S. sample of healthy middle-age 
men and women. Journal of Steroid Biochemistry and Molecular Biology. 
2010; 121: 462-466.

216.  Waters EA, Cronin KA, Graubard BI, Han PK, Freedman AN. 
Prevalence of tamoxifen use for breast cancer chemoprevention among 
U.S. women. Cancer Epidemiology, Biomarkers, and Prevention. 2010; 
19(2): 443-446.

217.  Brock KE, Graubard BI, Fraser DR, Weinstein SJ, Stolzenberg-
Solomon RZ, Lim U, Tangrea JA, Virtamo J, Ke1 L, Snyder K, Albanes D. 
Predictors of vitamin D biochemical status in a large sample of middle-
aged male smokers from Finland. European Journal of Clinical Nutrition. 
2010; 64(3):280-8.

218.  Mai PL, Wideroff L, Greene MH, Graubard BI. Prevalence of family 
history of breast, colorectal, prostate, and lung cancer in a 
population-based study. Public Health Genomics. 2010;13(7-8):497-503.

219.  Olivo-Marston S, Graubard BI, Visvanathan K, Forman MR. Gender 
specific differences in birthweight and the odds of puberty: (NHANES 
III, 1988-1994). Paediatric and Perinatal Epidemiology. 2010;24(3):222-
31.

220.  Flegal KM, Graubard BI, Williamson DF, Gail MH. Sources of 
differences in estimates of obesity-associated deaths from NHANES I 
hazard ratios. Am J Clin Nutr. 2010;91(3):519-27.

221.  Swan J, Breen N, Graubard BI, McNeel TS, Blackman D, Tangka FK, 
Ballard-Barbash R. Recent Data and Trends in Cancer Screening in the 
United States: 1992-2005 National Health Interview Surveys. Cancer. 
2010;116(20):4872-81.

222.  Wideroff L, Garceau AO, Greene MH, Dunn M, McNeel T, Mai P, 
Willis G, Gonsalves L, Martin M, Graubard BI. Coherence and 
Completeness of Family History of Cancer Reports in a General 
Population Survey. Cancer Epidemiology, Biomarkers, and Prevention. 
2010;19(3):799-810.

223.  Flegal KM, Ogden CL, Yanovski JA, Freedman DS, Shepherd JA, 
Graubard BI, Borrud LG. High adiposity and high BMI-for-age in U.S. 
children and adolescents by race-ethnic group. Am J Clin Nutr. 
2010;91(4):1020-6.

224.  Cross AJ, Ferrucci LM, Risch A, Graubard BI, Ward MH, Park Y, 
Hollenbeck AR, Schatzkin A, Sinha R. A large prospective study of meat 
consumption and colorectal cancer risk: an investigation of potential 
mechanisms underlying this association. Cancer Research. 2010; 
70(6):2406-14.

225.  Graubard BI, Freedman AN, Gail MH. Five-Year and Lifetime Risk of 
Breast Cancer among U.S. Subpopulations: Implications for magnetic 
resonance imaging screening. Epidemiol Biomarkers Prev. 
2010;19(10):2430-6.

226.  Dunton GF, Berrigan D, Ballard-Barbash R, Perna F, Graubard BI, 
Atienza AA Adolescents' Sports and Exercise Environments in a U.S. Time 
Use Survey. American Journal of Preventive Medicine. 2010; 39(2): 122-
129.

227.  Ferrucci LM, Sinha R, Ward MH, Graubard BI, Hollenbeck AR, Kilfoy 
BA, Schatzkin A, Michaud DS, Cross AJ. Meat and components of meat and 
the risk of bladder cancer in the NIH-AARP Diet and Health Study. 
Cancer. 2010;116(18):4345-53.

228.  Ferrucci LM, Cross AJ, Gunter MJ, Ahn J, Mayne ST, Ma X, Chanock 
SJ, Yeager M, Graubard BI, Berndt SI, Huang WY, Hayes RB, Sinha R. 
Xenobiotic metabolizing genes, meat-related exposures, and risk of 
advanced colorectal adenoma. World Rev Nutr Diet. 2010;101:34-45.

229.  Gaudet MM, Falk RT, Gierach GL, Lacey JV Jr, Graubard BI, Dorgan 
JF, Brinton LA. Do adipokines underlie the association between known 
risk factors and breast cancer among a cohort of United States women? 
Cancer Epidemiol. 2010;34(5):580-6.

230.  Kim C, McGlynn KA, McCorkle R, Li Y, Erickson RL, Ma S, Zhang G, 
Han X, Zhang Y, Bai Y, Dai L, Graubard BI, Zheng T, Kilfoy B, Hughes K, 
Zhang Y. Sexual functioning among testicular cancer survivors: A case-
control study in the U.S. J Cancer Surviv. 2010;4(3):266-73.

231.  Karami S, Schwartz K, Purdue MP, Davis FG, Ruterbusch JJ, Munuo 
SS, Wacholder S, Graubard BI, Colt JS, Chow WH. Family history of 
cancer and renal cell cancer risk in Caucasians and African Americans. 
Br J Cancer. 2010;102(11):1676-80.

232.  Flegal KM, Graubard BI, Williamson, DF, Cooper, RS. Reverse 
causation and illness-related weight loss in observational studies of 
body weight and mortality. Am J Epidemiol. 2011;173(1):1-9.

233.  Kant AK, Graubard BI. Contributors of water intake in U.S. 
children and adolescents: associations with dietary and meal 
characteristics. NHANES 2005-2006. Am J Cl Nutr. 2010;92(4):887-96.

234.  Freedman DM, Looker AC, Abnet CC, Linet MS, Graubard BI.Serum 25-
hydroxyvitamin D and cancer mortality in the NHANES III study (1988-
2006). Cancer Res. 2010;70(21):8587-97.

235.  Tsai HT, Cross AJ, Graubard BI, Oken M, Schatzkin A, Caporaso NE. 
Dietary factors and risk of chronic lymphocytic leukemia and small 
lymphocytic lymphoma: a pooled analysis of two prospective studies. 
Cancer Epidemiol Biomarkers Prev. 2010;19(10):2680-4.

236.  Major JM, Doubeni CA, Freedman ND, Park Y, Lian M, Hollenbeck AR, 
Schatzkin A, Graubard BI, Sinha R. Neighborhood socioeconomic 
deprivation and mortality: NIH-AARP diet and health study. PLoS One. 
2010; 5(11):.

237.  Goedert JJ, Calamusa G, Dazzi C, Perna A, Pelser C, Anderson LA, 
Madsen C, Preiss LR, Airola M, Graubard BI, Messina A, Lauria C, Romano 
N. Risk of classic Kaposi sarcoma with exposures to plants and soils in 
Sicily. Infect Agent Cancer. 2010;5(1):23.

238.  Douglas JB, Silverman DT, Weinstein SJ, Graubard BI, Pollak MN, 
Tao Y, Jarmo V, Albanes D, Stolzenberg-Solomon R. Serum C-Reactive 
Protein and Risk of Pancreatic Cancer in Two Nested, Case-Control 
Studies. Cancer Epidemiol Biomarkers Prev. 2011;20(2):359-69.

239.  Cook MB, Chia VM, Berndt SI, Graubard BI, Chanock SJ, Rubertone 
MV, Erickson RL, Hayes RB, McGlynn KA. Genetic contributions to the 
association between adult height and testicular germ cell tumors. Int J 
Epidemiol. 2011;40(3):731-9.

240.  Ferrucci LM, Daniel CR, Kapur K, Chadha P, Shetty H, Graubard BI, 
George PS, Osborne W, Yurgalevitch S, Devasenapathy N, Chatterjee N, 
Prabhakaran D, Gupta PC, Mathew A, Sinha R. Measurement of spices and 
seasonings in India: opportunities for cancer epidemiology and 
prevention. Asian Pac J Cancer Prev. 2010;11(6):1621-9.

241.  Trabert B, Longnecker MP, Graubard BI, Klebanoff MA, Stanczyk FZ, 
McGlynn KA. Placental characteristics as a proxy measure of serum 
hormone and protein levels during pregnancy with a male fetus. Cancer 
Causes Control. 2011;22(5):689-95.

242.  van Bemmel DM, Li Y, McLean J, Chang MH, Dowling NF, Graubard B, 
Rajaraman P. Blood Lead Levels, ALAD Gene Polymorphisms, and Mortality. 
Epidemiology. 2011;22(2):273-278.

243.  Li Y, DiGaetano R, Graubard BI. Weighting methods for population-
based case-control studies with complex sampling. JRSS C Applied 
Statistics. 2011;60(2):165-185.

244.  Graubard BI, Korn EL Conditional logistic regression with survey 
data. Statistics in Biopharmaceutical Research. 2011;3(2):398-408.

245.  Daniel CR, Prabhakaran D, Kapur K, Graubard BI, Devasenapathy N, 
Ramakrishnan L, George PS, Shetty H, Ferrucci LM, Yurgalevitch S, 
Chatterjee N, Reddy K, Rastogi T, Gupta PC, Mathew A, Sinha R. A cross-
sectional investigation of regional patterns of diet and cardio-
metabolic risk in India. Nutr J. 2011;10:12.

246.  Valenti RM, Amodio E, Nam JM, Preiss L, Graubard BI, Romano N, 
Goedert JJ. Delayed-type hypersensitivity in classic Kaposi sarcoma 
patients and controls. Br J Cancer. 2011;104(3):433-6.

247.  Chen BE, Graubard BI, Flegal FM, Gail MH. Comparing strategies 
for estimating the association of obesity with mortality via a Markov 
model. Statistics and Its Interface. 2011; 4(4):451-61.

248.  Ruder EH, Laiyemo AO, Graubard BI, Hollenbeck AR, Schatzkin A, 
Cross AJ. Non-Steroidal Anti-Inflammatory Drugs and Colorectal Cancer 
Risk in a Large, Prospective Cohort. Am J Gastroenterol. 
2011;106(7):1340-50.

249.  Kim C, McGlynn KA, McCorkle R, Erickson RL, Niebuhr DW, Ma S, 
Graubard B, Aschebrook-Kilfoy B, Barry KH, Zhang Y. Quality of life 
among testicular cancer survivors: a case-control study in the United 
States. Qual Life Res. 2011; 20(10):1629-37.

250.  Jiao L, Taylor PR, Weinstein S, Graubard BI, Virtamo J, Albanes 
D, Stolzenberg-Solomon R. Advanced Glycation End-Products, Soluble 
Receptor for Advanced Glycation End-Products and Risk of Colorectal 
Cancer. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1430-8.

251.  Freedman AN, Yu B, Gail MH, Costantino JP, Graubard BI, Vogel VG, 
Anderson GL, McCaskill-Stevens W. Benefit/Risk Assessment for Breast 
Cancer Chemoprevention With Raloxifene or Tamoxifen for Women Age 50 
Years or Older. J Clin Oncol. 2011;29(17):2327-33.

252.  Welzel TM, Graubard BI, Zeuzem S, El-Serag HB, Davila JA, McGlynn 
KA. Metabolic syndrome increases the risk of primary liver cancer in 
the United States: A population-based case-control study. Hepatology. 
2011;54(2):463-71.

253.  Jiao L, Weinstein SJ, Albanes D, Taylor PR, Graubard BI, Virtamo 
J, Stolzenberg-Solomon RZ. Evidence that serum levels of the soluble 
receptor for advanced glycation end products are inversely associated 
with pancreatic cancer risk: a prospective study. Cancer Res. 
2011;71(10):3582-9.

254.  Peters JA, Kenen R, Hoskins LM, Koehly LM, Graubard B, Loud JT, 
Greene MH. Unpacking the Blockers: Understanding Perceptions and Social 
Constraints of Health Communication in Hereditary Breast Ovarian Cancer 
(HBOC) Susceptibility Families. J Genet Couns. 2011;20(5):450-64.

255.  Mai PL, Garceau AO, Graubard BI, Dunn M, McNeel TS, Gonsalves L, 
Gail MH, Greene MH, Willis GB, Wideroff L. Confirmation of family 
cancer history reported in a population-based survey. J Natl Cancer 
Inst. 2011;103(10):788-97.

256.  Sinha R, Daniel CR, Devasenapathy N, Shetty H, Yurgalevitch S, 
Ferrucci LM, George PS, Morrissey KG, Ramakrishnan L, Graubard BI, 
Kapur K, Reddy KS, McAdams MJ, Rastogi T, Chatterjee N, Gupta PC, 
Wascholder S, Prabhakaran D, Mathew AA. Multi-center feasibility study 
evaluating recruitment, variability in risk factors, and biomarkers for 
a diet and cancer cohort in India. BMC Public Health. 2011;11(1):405.

257.  Breslow RA, Chen CM, Mukamal KJ, Graubard BI. Prospective Study 
of Alcohol Consumption Quantity, Frequency, and Cancer-Specific 
Mortality in the U.S. Population. Am J Epidemiol. 2011;174(9):1044-53.

258.  Major JM, Cross, AJ, Hollenbeck AR, Graubard BI, Sinha R. 
Patterns of meat intake and risk of prostate cancer among African-
Americans in a large prospective cohort of men. Cancer Causes Control. 
2011;22(12):1691-8.

259.  Shebl FM, Dollard SC, Pfeiffer RM, Biryahwaho B, Amin MM, Munuo 
SS, Hladik W, Parsons R, Graubard BI, Mbulaiteye SM. Human herpesvirus 
8 seropositivity among sexually active adults in Uganda. PLoS One. 
2011;6(6):e21286.

260.  Colt JS, Schwartz K, Graubard BI, Davis F, Ruterbusch J, 
Digaetano R, Purdue M, Rothman N, Wacholder S, Chow WH. Hypertension 
and risk of renal cell carcinoma among white and black Americans. 
Epidemiology. 2011;22(6):797-804.

261.  Li Y, Li Z, Graubard BI. Testing for Hardy Weinberg Equilibrium 
in National Household Surveys that Collect Family-Based Genetic Data. 
Ann Hum Genet. 2011;75(6):732-41.

262.  Major JM, Cross AJ, Doubeni CA, Park Y, Lian M, Hollenbeck AR, 
Schatzkin A, Graubard BI, Sinha R. Socioeconomic deprivation impact on 
meat intake and mortality: NIH-AARP Diet and Health Study. Cancer 
Causes Control. 2012;23(7):1185-91.

263.  Daniel CR, Schwartz KL, Colt JS, Dong LM, Ruterbusch JJ, Purdue 
MP, Cross AJ, Rothman N, Davis FG, Wacholder S, Graubard BI, Chow WH, 
Sinha R. Meat-cooking mutagens and risk of renal cell carcinoma. Br J 
Cancer. 2011;105(7):1096-104.

264.  Gao Y, Katki H, Graubard B, Pollak M, Martin M, Tao Y, Schoen RE, 
Church T, Hayes RB, Greene MH, Berndt SI.Serum IGF1, IGF2, and IGFBP3 
and risk of advanced colorectal adenoma. Int J Cancer. 
2012;131(2):E105-13.

265.  Purdue MP, Colt JS, Graubard B, Davis F, Ruterbusch JJ, Digaetano 
R, Karami S, Wacholder S, Schwartz K, Chow WH. A case-control study of 
reproductive factors and renal cell carcinoma among black and white 
women in the United States. Cancer Causes Control. 2011;22(11):1537-44.

266.  Kant AK, Graubard BI. 20-year trends in dietary and meal 
behaviors were similar in U.S. Children and adolescents of different 
race/ethnicity. J Nutr. 2011;141(10):1880-8.

267.  Daniel CR, Cross AJ, Graubard BI, Hollenbeck A, Park Y, Sinha R. 
Prospective investigation of poultry and fish intake in relation to 
cancer risk. Cancer Prev Res. 2011;4(11):1903-11.

268.  Brock KE, Huang WY, Fraser DR, Ke L, Tseng M, Mason RS, 
Stolzenberg-
Solomon RZ, Freedman DM, Ahn J, Peters U, McCarty C, Hollis BW, Ziegler 
RG, Purdue MP, Graubard BI. Diabetes prevalence is associated with 
serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in U.S. middle-
aged Caucasian men and women: a cross-sectional analysis within the 
Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Br J 
Nutr. 2011;106(3):339-44.

269.  Doubeni CA, Schootman M, Major JM, Torres Stone RA, Laiyemo AO, 
Park Y, Lian M, Messer L, Graubard BI, Sinha R, Hollenbeck AR, 
Schatzkin A. Health Status, Neighborhood Socioeconomic Context, and 
Premature Mortality in the United States: The National Institutes of 
Health-AARP Diet and Health Study. Am J Public Health. 2012;102(4):680-
8.

270.  Lian M, Schootman M, Doubeni CA, Park Y, Major JM, Torres Stone 
RA, Laiyemo AO, Hollenbeck AR, Graubard BI, Schatzkin A. Geographic 
Variation in Colorectal Cancer Survival and the Role of Small-Area 
Socioeconomic Deprivation: A Multilevel Survival Analysis of the NIH-
AARP Diet and Health Study Cohort. Am J Epidemiol. 2011;174(7):828-38.

271.  Hofmann JN, Baccarelli A, Schwartz K, Davis FG, Ruterbusch JJ, 
Hoxha M, McCarthy BJ, Savage SA, Wacholder S, Rothman N, Graubard BI, 
Colt JS, Chow WH, Purdue MP. Risk of renal cell carcinoma in relation 
to blood telomere length in a population-based case-control study. Br J 
Cancer. 2011;105(11):1772-5.

272.  Ruder EH, Thiebaut AC, Thompson FE, Potischman N, Subar AF, Park 
Y, Graubard BI, Hollenbeck AR, Cross AJ. Adolescent and mid-life diet: 
risk of colorectal cancer in the NIH-AARP Diet and Health Study. Am J 
Clin Nutr. 2011;94(6):1607-19.

273.  Zhao FH, Varanasi AP, Cunningham CA, Graubard BI, Hu SY, Chen F, 
Barrett CJ, Qiao YL, Forman MR. Tuberculosis and Oncogenic HPV: 
Potential Co-infections in Women at High-risk of Cervical Cancer in 
Rural China. Asian Pac J Cancer Prev. 2011;12(6):1409-15.

274.  Li Y, Gail MH, Preston DL, Graubard BI, Lubin JH. Piecewise 
exponential survival times and analysis of case-cohort data. Stat in 
Med. 2012;31(13):1361-8.

275.  Nyante SJ, Graubard BI, Li Y, McQuillan GM, Platz EA, Rohrmann S, 
Bradwin G, McGlynn KA. Trends in sex hormone concentrations in U.S. 
males: 1988-1991 to 1999-2004. Int J Androl. 2012;35(3):456-66.

276.  Brock KE, Ke L, Gridley G, Chiu BC, Ershow AG, Lynch CF, Graubard 
BI, Cantor KP. Fruit, vegetables, fibre and micronutrients and risk of 
U.S. renal cell carcinoma. Br J Nutr. 2012;108(6):1077-85.

277.  Daniel CR, Cross AJ, Graubard BI, Park Y, Ward MH, Rothman N, 
Hollenbeck AR, Chow WH, Sinha R. Large prospective investigation of 
meat intake, related mutagens, and risk of renal cell carcinoma. Am J 
Clin Nutr. 2012;95(1):155-62.

278.  Gillison ML, Broutian T, Pickard RK, Tong ZY, Xiao W, Kahle L, 
Graubard BI, Chaturvedi AK. Prevalence of oral HPV infection in the 
United States, 2009-2010. JAMA. 2012 Feb 15;307(7):693-703.

279.  Persson EC, Graubard BI, Evans AA, London WT, Weber JP, Leblanc 
A, Chen G, Lin W, McGlynn KA. Dichlorodiphenyltrichloroethane and risk 
of hepatocellular carcinoma. Int J Cancer. 2012;131(9):2078-84.

280.  Trabert B, Graubard BI, Erickson RL, McGlynn KA. Childhood 
infections, orchitis and testicular germ cell tumours: a report from 
the STEED study and a meta-analysis of existing data. Br J Cancer. 
2012;106(7):1331-4.

281.  Li Y, Graubard BI. Pseudo Semiparametric Maximum Likelihood 
Estimation Exploiting Gene Environment Independence for Population-
Based Case-Control Studies with Complex Samples. Biostatistics. 
2012;13(4):711-23.

282.  Cote ML, Colt JS, Schwartz KL, Wacholder S, Ruterbusch JJ, Davis 
FG, Purdue MP, Graubard BI, Chow WH. Cigarette smoking and renal cell 
carcinoma risk among black and white Americans: effect modification by 
hypertension and obesity. Cancer Epidemiol Biomarkers Prev. 
2012;21(5):770-9.

283.  Voulgaraki A, Kedem B, Graubard BI. Semiparametric regression in 
testicular germ cell data. Annals of Applied Statistics. 
2012;6(3):1185-1208.

284.  Blackwelder WC, Biswas K, Wu Y, Kotloff KL, Farag TH, Nasrin D, 
Graubard BI, Sommerfelt H, Levine MM.Statistical Methods in the Global 
Enteric Multicenter Study (GEMS). Clin Infect Dis. 2012;55 Suppl 
4:S246-53.

285.  Beebe-Dimmer JL, Colt JS, Ruterbusch JJ, Keele GR, Purdue MP, 
Wacholder S, Graubard BI, Davis F, Chow WH, Schwartz KL. Body Mass 
Index and Renal Cell Cancer: The Influence of Race and Sex. 
Epidemiology. 2012;
23(6):821-8.

286.  Dunton GF, Berrigan D, Ballard-Barbash R, Perna F, Graubard BI, 
Atienza AA. Differences in the intensity and duration of adolescents' 
sports and exercise across physical and social environments. Res Q 
Exerc Sport. 2012;
83(3):376-82.

287.  Doubeni CA, Laiyemo AO, Major JM, Schootman M, Lian M, Park Y, 
Graubard BI, Hollenbeck AR, Sinha R. Socioeconomic status and the risk 
of colorectal cancer: An analysis of more than a half million adults in 
the National Institutes of Health-AARP Diet and Health Study. Cancer. 
2012;118(14):3636-44.

288.  Karami S, Colt JS, Schwartz K, Davis FG, Ruterbusch JJ, Munuo SS, 
Wacholder S, Stewart PA, Graubard BI, Rothman N, Chow WH, Purdue MP. A 
case-control study of occupation/industry and renal cell carcinoma 
risk. BMC Cancer. 2012;12(1):344.

289.  Kant AK, Graubard BI. Race-ethnic, family income, and education 
differentials in nutritional and lipid biomarkers in U.S. children and 
adolescents: NHANES 2003-2006. Am J Clin Nutr. 2012;96(3):601-12.

290.  Sinha R, Cross AJ, Daniel CR, Graubard BI, Wu JW, Hollenbeck AR, 
Gunter MJ, Park Y, Freedman ND. Caffeinated and decaffeinated coffee 
and tea intakes and risk of colorectal cancer in a large prospective 
study. Am J Clin Nutr. 2012;96(2):374-81.

291.  Daniel CR, Sinha R, Park Y, Graubard BI, Hollenbeck AR, Morton 
LM, Cross AJ. Meat intake is not associated with risk of non-Hodgkin 
lymphoma in a large prospective cohort of U.S. men and women. J Nutr. 
2012;142(6):1074-80.

292.  Gilsing AM, Berndt SI, Ruder EH, Graubard BI, Ferrucci LM, 
Burdett L, Weissfeld JL, Cross AJ, Sinha R. Meat-related mutagen 
exposure, xenobiotic metabolizing gene polymorphisms and the risk of 
advanced colorectal adenoma and cancer. Carcinogenesis. 2012 
Jul;33(7):1332-9.

293.  Jacobs KB, Yeager M, Zhou W, Wacholder S, Wang Z, Rodriguez-
Santiago B, Hutchinson A, Deng X, Liu C, Horner MJ, Cullen M, Epstein 
CG, Burdett L, Dean MC, Chatterjee N, Sampson J, Chung CC, Kovaks J, 
Gapstur SM, Stevens VL, Teras LT, Gaudet MM, Albanes D, Weinstein SJ, 
Virtamo J, Taylor PR, Freedman ND, Abnet CC, Goldstein AM, Hu N, Yu K, 
Yuan JM, Liao L, Ding T, Qiao YL, Gao YT, Koh WP, Xiang YB, Tang ZZ, 
Fan JH, Aldrich MC, Amos C, Blot WJ, Bock CH, Gillanders EM, Harris CC, 
Haiman CA, Henderson BE, Kolonel LN, Le Marchand L, McNeill LH, Rybicki 
BA, Schwartz AG, Signorello LB, Spitz MR, Wiencke JK, Wrensch M, Wu X, 
Zanetti KA, Ziegler RG, Figueroa JD, Garcia-Closas M, Malats N, Marenne 
G, Prokunina-Olsson L, Baris D, Schwenn M, Johnson A, Landi MT, Goldin 
L, Consonni D, Bertazzi PA, Rotunno M, Rajaraman P, Andersson U, Beane 
Freeman LE, Berg CD, Buring JE, Butler MA, Carreon T, Feychting M, 
Ahlbom A, Gaziano JM, Giles GG, Hallmans G, Hankinson SE, Hartge P, 
Henriksson R, Inskip PD, Johansen C, Landgren A, McKean-Cowdin R, 
Michaud DS, Melin BS, Peters U, Ruder AM, Sesso HD, Severi G, Shu XO, 
Visvanathan K, White E, Wolk A, Zeleniuch-Jacquotte A, Zheng W, 
Silverman DT, Kogevinas M, Gonzalez JR, Villa O, Li D, Duell EJ, Risch 
HA, Olson SH, Kooperberg C, Wolpin BM, Jiao L, Hassan M, Wheeler W, 
Arslan AA, Bueno-de-Mesquita HB, Fuchs CS, Gallinger S, Gross MD, Holly 
EA, Klein AP, LaCroix A, Mandelson MT, Petersen G, Boutron-Ruault MC, 
Bracci PM, Canzian F, Chang K, Cotterchio M, Giovannucci EL, Goggins M, 
Hoffman Bolton JA, Jenab M, Khaw KT, Krogh V, Kurtz RC, McWilliams RR, 
Mendelsohn JB, Rabe KG, Riboli E, Tjneland A, Tobias GS, Trichopoulos 
D, Elena JW, Yu H, Amundadottir L, Stolzenberg-Solomon RZ, Kraft P, 
Schumacher F, Stram D, Savage SA, Mirabello L, Andrulis IL, Wunder JS, 
Patio Garcia A, Sierrasesmaga L, Barkauskas DA, Gorlick RG, Purdue M, 
Chow WH, Moore LE, Schwartz KL, Davis FG, Hsing AW, Berndt SI, Black A, 
Wentzensen N, Brinton LA, Lissowska J, Peplonska B, McGlynn KA, Cook 
MB, Graubard BI, Kratz CP, Greene MH, Erickson RL, Hunter DJ, Thomas G, 
Hoover RN, Real FX, Fraumeni JF Jr, Caporaso NE, Tucker M, Rothman N, 
Perez-Jurado LA, Chanock SJ. Detectable clonal mosaicism and its 
relationship to aging and cancer. Nat Genet. 2012;44(6):651-8.

294.  Persson EC, Quraishi SM, Welzel TM, Carreon JD, Gridley G, 
Graubard BI, McGlynn KA. Risk of liver cancer among U.S. male veterans 
with cirrhosis, 1969-1996. Br J Cancer. 2012;107(1):195-200.

295.  Shebl FM, Capo-Ramos DE, Graubard BI, McGlynn KA, Altekruse SF. 
Socioeconomic status and hepatocellular carcinoma in the United States. 
Cancer Epidemiol Biomarkers Prev. 2012;21(8):1330-5.

296.  Kim C, McGlynn KA, McCorkle R, Li Y, Erickson RL, Ma S, Niebuhr 
DW, Zhang G, Zhang Y, Bai Y, Dai L, Graubard BI, Zheng T, Aschebrook-
Kilfoy B, Barry KH, Zhang Y. Sexual functioning among testicular cancer 
survivors: a case-control study in the U.S. J Psychosom Res. 
2012;73(1):68-73.

297.  Sahasrabuddhe VV, Gunja MZ, Graubard BI, Trabert B, Schwartz LM, 
Park Y, Hollenbeck AR, Freedman ND, McGlynn KA. Nonsteroidal Anti-
inflammatory Drug Use, Chronic Liver Disease, and Hepatocellular 
Carcinoma. J Natl Cancer Inst. 2012;104(23):1808-14.

298.  Kant AK, Graubard BI, Mattes RD. Association of food form with 
self-reported 24-h energy intake and meal patterns in U.S. adults: 
NHANES 2003-2008. Am J Clin Nutr. 2012;96(6):1369-78.

299.  Trabert B, Graubard BI, Nyante SJ, Rifai N, Bradwin G, Platz EA, 
McQuillan GM, McGlynn KA. Relationship of sex steroid hormones with 
body size and with body composition measured by dual-energy X-ray 
absorptiometry in U.S. men. Cancer Causes Control. 2012;23(12):1881-91.

300.  Wang YC, Graubard BI, Rosenberg MA, Kuntz KM, Zauber A, Kahle L, 
Schechter CB, Feuer EJ. Derivation of background mortality by smoking 
and obesity in cancer simulation models. Medical Decision Making. 
2013;33(2):176-97.

301.  Hofmann JN, Schwartz K, Chow WH, Ruterbusch JJ, Shuch BM, Karami 
S, Rothman N, Wacholder S, Graubard BI, Colt JS, Purdue MP.The 
association between chronic renal failure and renal cell carcinoma may 
differ between black and white Americans. Cancer Causes Control. 
2013;24(1):167-74.

302.  Major JM, Graubard BI, Dodd KW, Iwan A, Alexander BH, Linet MS, 
Freedman DM. Variability and Reproducibility of Circulating Vitamin D 
in a Nationwide U.S. Population. J Clin Endocrinol Metab. 
2013;98(1):97-104.

303.  Purdue MP, Moore LE, Merino MJ, Boffetta P, Colt JS, Schwartz KL, 
Bencko V, Davis FG, Graubard BI, Janout V, Ruterbusch JJ, Beebe-Dimmer 
J, Cote ML, Shuch B, Mates D, Hofmann JN, Foretova L, Rothman N, 
Szeszenia-Dabrowska N, Matveev V, Wacholder S, Zaridze D, Linehan WM, 
Brennan P, Chow WH. An investigation of risk factors for renal cell 
carcinoma by histologic subtype in two case-control studies. Int J 
Cancer. 2013;132(11):2640-7.

304.  Banegas MP, Leng M, Graubard BI, Morales LS.The risk of 
developing invasive breast cancer in Hispanic women : A look across 
Hispanic subgroups. Cancer. 2013;119(7):1373-80.

305.  Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-
cause mortality with overweight and obesity using standard body mass 
index categories: a systematic review and meta-analysis. JAMA. 2013 
2;309(1):71-82.

306.  Freedman DM, Cahoon EK, Rajaraman P, Major JM, Doody MM, 
Alexander BH, Hoffbeck RW, Kimlin MG, Graubard BI, Linet MS. Sunlight 
and Other Determinants of Circulating 25-Hydroxyvitamin D Levels in 
Black and White Participants in a Nationwide U.S. Study. Am J 
Epidemiol. 2013;177(2):180-92.

307.  Persson EC, Schwartz LM, Park Y, Trabert B, Hollenbeck AR, 
Graubard BI, Freedman ND, McGlynn KA. Alcohol consumption, folate 
intake, hepatocellular carcinoma incidence and liver disease mortality. 
Cancer Epidemiol Biomarkers Prev. 2013;22(3):415-21.

308.  Chang JT, Shebl FM, Pfeiffer RM, Biryahwaho B, Graubard BI, 
Mbulaiteye SM. A population-based study of Kaposi Sarcoma-associated 
herpesvirus seropositivity in Uganda using principal components 
analysis. Infect Agent Cancer. 2013;8(1):3.

309.  Landsman V, Graubard BI. Efficient analysis of case-control 
studies with sample weights. Stat in Med. 2013;32(2):347-60.

310.  Daniel CR, Park Y, Chow WH, Graubard BI, Hollenbeck AR, Sinha R. 
Intake of fiber and fiber-rich plant foods is associated with a lower 
risk of renal cell carcinoma in a large U.S. cohort. Am J Clin Nutr. 
2013;97(5):1036-43.

311.  Breslow RA, Chen CM, Graubard BI, Jacobovits T, Kant AK. Diets of 
drinkers on drinking and nondrinking days: NHANES 2003-2008. Am J Clin 
Nutr. 2013;97(5):1068-75.

312.  Kant AK, Graubard BI. Family income and education were related 
with 30-year time trends in dietary and meal behaviors of American 
children and adolescents. J Nutr. 2013;143(5):690-700.

313.  Graubard BI, Sirken MG. Estimating sibling recurrence risk in 
population sample surveys. Human Heredity. 2013; 76(1):18-27.

314.  Welzel TM, Graubard BI, Quraishi S, Zeuzem S, Davila JA, El-Serag 
HB, McGlynn KA. Population-Attributable Fractions of Risk Factors for 
Hepatocellular Carcinoma in the United States. Am J Gastroenterol. 
2013;
108(8):1314-21.

315.  Trabert B, Graubard BI, Erickson RL, Zhang Y, McGlynn KA. Second 
to fourth digit ratio, handedness and testicular germ cell tumors. 
Early Hum Dev. 2013;89(7):463-6.

316.  Liao LM, Schwartz K, Pollak M, Graubard BI, Li Z, Ruterbusch J, 
Rothman N, Davis F, Wacholder S, Colt J, Chow WH, Purdue MP. Serum 
leptin and adiponectin levels and risk of renal cell carcinoma. 
Obesity. 2013;21(7):1478-85.

317.  Ke L, Graubard BI, Albanes D, Fraser DR, Weinstein SJ, Virtamo J, 
Brock KE. Hypertension, pulse, and other cardiovascular risk factors 
and vitamin D status in Finnish men. Am J Hypertens. 2013;26(8):951-6.

318.  Schairer C, Li Y, Frawley P, Graubard BI, Wellman RD, Buist DS, 
Kerlikowske K, Onega TL, Anderson WF, Miglioretti DL. Risk factors for 
inflammatory breast cancer and other invasive breast cancers. J Natl 
Cancer Inst. 2013;105(18):1373-84.

319.  Schwartz LM, Persson EC, Weinstein SJ, Graubard BI, Freedman ND, 
Mannisto S, Albanes D, McGlynn KA. Alcohol consumption, one-carbon 
metabolites, liver cancer and liver disease mortality. PLoS One. 2013; 
28;8(10).

320.  Major JM, Norman Oliver M, Doubeni CA, Hollenbeck AR, Graubard 
BI, Sinha R. Socioeconomic status, healthcare density, and risk of 
prostate cancer among African American and Caucasian men in a large 
prospective study. Cancer Causes Control. 2012;23(7):1185-91.

321.  Lubin JH, De Stefani E, Abnet CC, Acosta G, Boffetta P, Victora 
CG, Graubard BI, Munoz N, Deneo-Pellegrini H, Franceschi S, 
Castellsague X, Ronco AL, Dawsey SM. Mate drinking and esophageal 
squamous cell carcinoma in South America: pooled results from two large 
multi-center case-
control studies. Cancer Epidemiol Biomarkers Prev. 2014;23(1):107-16.

322.  Major JM, Sargent JD, Graubard BI, Carlos HA, Hollenbeck AR, 
Altekruse SF, Freedman ND, McGlynn KA. Local geographic variation in 
chronic liver disease and hepatocellular carcinoma: contributions of 
socioeconomic deprivation, alcohol retail outlets, and lifestyle. Ann 
Epidemiol. 2014;24(2):104-10.

323.  Mai PL, Vadaparampil ST, Breen N, McNeel TS, Wideroff L, Graubard 
BI. Awareness of Cancer Susceptibility Genetic Testing: the 2000, 2005, 
2010 National Health Interview Surveys. American Journal of Preventive 
Medicine. 2014;46(5):440-8.

324.  She D, Zhang H, Li Y, Graubard BI, Li Z. Family Based Association 
Study with Complex Survey Data. Statistics and Its Interface. 2014; 
7(2), pp.167-176.

325.  Landgren O, Graubard BI, Katzmann JA, Kyle RA, Ahmadizadeh I, 
Clark R, Kumar SK, Dispenzieri A, Therneau TM, Melton III L, Caporaso 
N, Korde N, Roschewski M, Costello R, McQuillan GM, Rajkumar SV. Racial 
Disparities in the Prevalence of Monoclonal Gammopathies: A population-
based study of 12,482 persons from the National Health and Nutritional 
Examination Survey. Leukemia. 2014;28(7):1537-42.

326.  Dinse GE, Jusko TA, Ho LA, Annam K, Graubard BI, Hertz-Picciotto 
I, Miller FW, Gillespie BW, Weinberg CR. Accommodating Measurements 
Below a Limit of Detection: A Novel Application of Cox Regression. Am J 
Epidemiol. 2014;179(8):1018-24.

327.  Li Y, Safaeian M, Robbins H, Graubard BI. Logistic analysis of 
epidemiologic studies with augmentation sampling involving re-
stratification and population expansion. Biostatistics. 2015;16(1):169-
78.

328.  Flegal KM, Kit BK, Graubard BI. Body Mass Index Categories in 
Observational Studies of Weight and Risk of Death. Am J Epidemiol. 
2014;180(3):288-96.

329.  Chaturvedi AK, Graubard BI, Pickard RK, Xiao W, Gillison ML. 
High-Risk Oral Human Papillomavirus Load in the U.S. Population, 
National Health and Nutrition Examination Survey 2009-2010. J Infect 
Dis. 2014;210(3):441-7.

330.  Ruder EH, Berndt SI, Gilsing AM, Graubard BI, Burdett L, Hayes 
RB, Weissfeld JL, Ferrucci LM, Sinha R, Cross AJ. Dietary iron, iron 
homeostatic gene polymorphisms and the risk of advanced colorectal 
adenoma and cancer. Carcinogenesis. 2014;35(6):1276-83.

331.  Kant AK, Graubard BI. Association of self-reported sleep duration 
with eating behaviors of American adults: NHANES 2005-2010. Am J Clin 
Nutr. 2014;100(3):938-47.

332.  Kant AK, Graubard BI.40-Year Trends in Meal and Snack Eating 
Behaviors of American Adults. J Acad Nutr Diet. 2015;115(1):50-63.

333.  Xiao Q, Sinha R, Graubard BI, Freedman ND. Inverse associations 
of total and decaffeinated coffee with liver enzyme levels in NHANES 
1999-2010. Hepatology. 2014;60(6):2091-8.

334.  Koh DH, Nam JM, Graubard BI, Chen YC, Locke S, Friesen M. 
Evaluating temporal trends from occupational lead exposure data 
reported in the published literature using meta-regression. Annals of 
Occupational Hygiene. 2014; 58(9):1111-25.

335.  Kant AK, Whitley MI, Graubard BI. Away from home meals: 
associations with biomarkers of chronic disease and dietary intake in 
American adults, NHANES 2005-2010. Int J Obes (Lond). 2015;39(5):820-7.

336.  Trabert B, Falk RT, Figueroa JD, Graubard BI, Garcia-Closas M, 
Lissowska J, Peplonska B, Fox SD, Brinton LA. Urinary bisphenol A-
glucuronide and postmenopausal breast cancer in Poland. Cancer Causes 
Control. 2014; 25(12):1587-93.

337.  Li Y, Graubard BI, Huang P, Gastwirth JL. Extension of the 
Peters-Belson method to estimate health disparities among multiple 
groups using logistic regression with survey data. Stat Med. 
2015;34(4):595-612.

338.  Wentzensen N, Walker JL, Gold MA, Smith KM, Zuna RE, Mathews C, 
Dunn ST, Zhang R, Moxley K, Bishop E, Tenney M, Nugent E, Graubard BI, 
Wacholder S, Schiffman M. Multiple biopsies and detection of cervical 
cancer precursors at colposcopy. J Clin Oncol. 2015;33(1):83-9.

339.  Fuhrman BJ, Xu X, Falk RT, Dallal CM, Veenstra TD, Keefer LK, 
Graubard BI, Brinton LA, Ziegler RG, Gierach GL. Assay reproducibility 
and interindividual variation for 15 serum estrogens and estrogen 
metabolites measured by liquid chromatography-tandem mass spectrometry. 
Cancer Epidemiol Biomarkers Prev. 2014;23(12):2649-57.

340.  Flegal KM, Panagiotou OA, Graubard BI. Estimating population 
attributable fractions to quantify the health burden of obesity. Ann 
Epidemiol. 2015; 25(3):201-7.

341.  Yao W, Li Z, Graubard BI. Estimation of ROC curve with complex 
survey data. Stat in Med. 2015;34(8):1293-303.

342.  Landsman V, Lou WY, Graubard BI. Estimating survival 
probabilities by exposure levels: utilizing vital statistics and 
complex survey data with mortality follow-up. Stat in Med. 
2015;39(5):820-7.

343.  Loftfield E, Freedman ND, Graubard BI, Guertin KA, Black A, Huang 
W-Y, Shebl FM, Mayne ST, Sinha R. Coffee drinking and cutaneous 
melanoma risk in the NIH-AARP diet and health study. JNCI. 2015;107(2):

344.  Kant AK, Graubard BI. Within-person comparison of eating 
behaviors, time of eating, and dietary intake on days with and without 
breakfast: NHANES 2005-2010. Am J Clin Nutr. 2015;102(3):661-70.

345.  Petrick JL, Freedman ND, Graubard BI, Sahasrabuddhe VV, Lai GY, 
Alavanja MC, Beane Freeman LE, Boggs DA, Buring JE, Chan AT, Chong DQ, 
Fuchs CS, Gapstur SM, Gaziano JM, Giovannucci EL, Hollenbeck AR, King 
LY, Koshiol J, Lee IM, Linet MS, Palmer JR, Poynter JN, Purdue MP, 
Robien K, Schairer C, Sesso HD, Sigurdson AJ, Zeleniuch-Jacquotte A, 
Wactawski-Wende J, Campbell PT, McGlynn KA. Coffee consumption and risk 
of hepatocellular carcinoma and intrahepatic cholangiocarcinoma by sex: 
The Liver Cancer Pooling Project. Cancer Epidemiol Biomarkers Prev. 
2015;24(9):1398-1406.

346.  Guertin KA, Freedman ND, Loftfield E, Graubard BI, Caporaso NE, 
Sinha R. Coffee consumption and incidence of lung cancer in the NIH-
AARP Diet and Health Study. Int J Epidemiol. 2016;45(3):929-39.

347.  Loftfield E, Shiels MS, Graubard BI, Katki HA, Chaturvedi AK, 
Trabert B, Pinto LA, Kemp TJ, Shebl FM, Mayne ST, Wentzensen N, Purdue 
MP, Hildesheim A, Sinha R, Freedman ND. Associations of Coffee Drinking 
with Systemic Immune and Inflammatory Markers. Cancer Epidemiol 
Biomarkers Prev. 2015;24(7):1052-60.

348.  Chaturvedi AK, Graubard BI, Broutian T, Pickard RK, Tong ZY, Xiao 
W, Kahle L, Gillison ML. NHANES 2009-2012 Findings: Association of 
Sexual Behaviors with Higher Prevalence of Oral Oncogenic Human 
Papillomavirus Infections in U.S. Men. Cancer Res. 2015;75(12):2468-77.

349.  McGlynn KA, Sahasrabuddhe VV, Campbell PT, Graubard BI, Chen J, 
Schwartz LM, Petrick JL, Alavanja MC, Andreotti G, Boggs DA, Buring JE, 
Chan AT, Freedman ND, Gapstur SM, Hollenbeck AR, Hou L, King LY, 
Koshiol J, Linet M, Palmer JR, Poynter JN, Purdue M, Robien K, Schairer 
C, Sesso HD, Sigurdson A, Wactawski-Wende J, Zeleniuch-Jacquotte A. 
Reproductive factors, exogenous hormone use and risk of hepatocellular 
carcinoma among U.S. women: results from the Liver Cancer Pooling 
Project. Br J Cancer. 2015;112(7):1266-72.

350.  McGlynn KA, Hagberg K, Chen J, Graubard BI, London WT, Jick S, 
Sahasrabuddhe VV. Statin use and risk of primary liver cancer in the 
Clinical Practice Research Datalink. JNCI. 2015;107(4).

351.  Gastwirth JL, Graubard BI. Comment on Cochran's ``Observational 
Studies.'' Observational Studies. 2015; 173-181.

352.  Petrick JL, Sahasrabuddhe VV, Chan AT, Alavanja MC, Beane Freeman 
LE, Buring JE, Chen J, Chong DQ, Freedman ND, Fuchs CS, Gaziano JM, 
Giovannucci EL, Graubard BI, Hollenbeck AR, Hou L, Jacobs EJ, King LY, 
Koshiol J, Lee IM, Linet MS, Palmer JR, Purdue MP, Rosenberg L, 
Schairer C, Sesso HD, Sigurdson AJ, Wactawski-Wende J, Zeleniuch-
Jacquotte A, Campbell PT, McGlynn KA. NSAID use and risk of 
hepatocellular carcinoma and intrahepatic cholangiocarcinoma: The Liver 
Cancer Pooling Project. Cancer Prev Res (Phila). 2015;8(12):1156-62.

353.  Ghazarian AA, Trabert B, Graubard BI, Schwartz SM, Altekruse SF, 
McGlynn KA. Incidence of testicular germ cell tumors among U.S. men by 
census region. Cancer. 2015;121(23):4181-89.

354.  Guertin KA, Freedman ND, Vogtman E, Stolzenberg-Solomon RZ, 
Graubard BI, Sinha R. A prospective study of coffee intake and 
pancreatic cancer: results from the NIH-AARP Diet and Health Study. Br 
J Cancer. 2015;113(7):1081-5.

355.  Rao SR, Breen N, Graubard BI. Trends in Black-White Disparities 
in Breast and Colorectal Cancer Screening Rates in a Changing Screening 
Environment: The Peters-Belson Approach Using United States National 
Health Interview Surveys 2000-2010. Med Care. 2016;54(2):133-9.

356.  Loftfield E, Freedman ND, Graubard BI, Guertin KA, Black A, Huang 
WY, Shebl FM, Mayne ST, Sinha R. Association of Coffee Consumption With 
Overall and Cause-Specific Mortality in a Large U.S. Prospective Cohort 
Study. Am J Epidemiol. 2015;182(12):1010-22.

357.  McGlynn KA, Hagberg K, Chen J, Braunlin M, Graubard BI, Sunaya N, 
Jick S, Sahasrabuddhe VV. Menopausal hormone therapy use and risk of 
primary liver cancer in the Clinical Practice Research Datalink. Int J 
Cancer. 2016;138(9):2146-53.

358.  Karami S, Colt JS, Stewart PA, Schwartz K, Davis FG, Ruterbusch 
JJ, Chow WH, Wacholder S, Graubard BI, Purdue MP, Moore LE. A case-
control study of occupational sunlight exposure and renal cancer risk. 
Int J Cancer. 2016;138(7):1626-33.

359.  Zhou CK, Levine PH, Cleary SD, Hoffman HJ, Graubard BI, Cook MB. 
Male Pattern Baldness in Relation to Prostate Cancer-Specific 
Mortality: A Prospective Analysis in the NHANES I Epidemiologic Follow-
up Study. Am J Epidemiol. 2016;183(3):210-7.

360.  Vogtmann E, Graubard B, Loftfield E, Chaturvedi A, Dye BA, Abnet 
CC, Freedman ND. Contemporary impact of tobacco use on periodontal 
disease in the USA. Tob Control. 2017;26(2):237-238.

361.  Makarova-Rusher OV, Altekruse SF, McNeel TS, Ulahannan S, Duffy 
AG, Graubard BI, Greten TF, McGlynn KA. Population attributable 
fractions of risk factors for hepatocellular carcinoma in the United 
States. Cancer. 2016;122(11):1757-65.

362.  Karami S, Daughtery SE, Schwartz K, Davis FG, Ruterbusch JJ, 
Wacholder S, Graubard BI, Berndt SI, Hofmann JN, Purdue MP, Moore LE, 
Colt JS. Analgesic use and risk of renal cell carcinoma: A case-
control, cohort and meta-analytic assessment. Int J Cancer. 
2016;139(3):584-92.

363.  Keadle SK, McKinnon R, Graubard BI, Troiano RP. Prevalence and 
trends in physical activity among older adults in the United States: A 
comparison across three national surveys. Prev Med. 2016;89:37-43.

364.  Yang B, Hagberg KW, Chen J, Sahasrabuddhe VV, Graubard BI, Jick 
S, McGlynn KA. Associations of antibiotic use with risk of primary 
liver cancer in the Clinical Practice Research Datalink. Br J Cancer. 
2016;115(1):85-9.

365.  Maas P, Barrdahl M, Joshi AD, Auer PL, Gaudet MM, Milne RL, 
Schumacher FR, Anderson WF, Check D, Chattopadhyay S, Baglietto L, Berg 
CD, Chanock SJ, Cox DG, Figueroa JD, Gail MH, Graubard BI, Haiman CA, 
Hankinson SE, Hoover RN, Isaacs C, Kolonel LN, Le Marchand L, Lee IM, 
Lindstrm S, Overvad K, Romieu I, Sanchez MJ, Southey MC, Stram DO, 
Tumino R, VanderWeele TJ, Willett WC, Zhang S, Buring JE, Canzian F, 
Gapstur SM, Henderson BE, Hunter DJ, Giles GG, Prentice RL, Ziegler RG, 
Kraft P, 
Garcia-Closas M, Chatterjee N. Breast Cancer Risk From Modifiable and 
Nonmodifiable Risk Factors Among White Women in the United States. JAMA 
Oncol. 2016;2(10):1295-1302.

366.  Yang B, Petrick JL, Chen J, Hagberg KW, Sahasrabuddhe VV, 
Graubard BI, Jick S, McGlynn KA. Associations of NSAID and paracetamol 
use with risk of primary liver cancer in the Clinical Practice Research 
Datalink. Cancer Epidemiol. 2016;43:105-11.

367.  Berrigan D, Troiano RP, Graubard BI. BMI and mortality: the 
limits of epidemiological evidence. (Commentary) Lancet. 2016; 
388(10046):734-36.

368.  Deziel NC, Beane Freeman LE, Graubard BI, Jones RR, Hoppin JA, 
Thomas K, Hines CJ, Blair A, Sandler DP, Chen H, Lubin JH, Andreotti G, 
Alavanja MC, Friesen MC. Relative Contributions of Agricultural Drift, 
Para-Occupational, and Residential Use Exposure Pathways to House Dust 
Pesticide Concentrations: Meta-Regression of Published Data. Environ 
Health Perspect. 2017;125(3):296-305.

369.  Liu B, Yu M, Graubard BI, Troiano RP, Schenker N. Multiple 
imputation of completely missing repeated measures data within persons 
from a complex sample: application to accelerometer data in the 
National Health and Nutrition Examination Survey. Stat in Med. 
2016;35(28):5170-5188.

370.  Loftfield E, Freedman ND, Dodd KW, Vogtmann E, Xiao Q, Sinha R, 
Graubard BI. Coffee Drinking Is Widespread in the United States, but 
Usual Intake Varies by Key Demographic and Lifestyle Factors. J Nutr. 
2016;146(9):1762-8.

371.  Wang L, Graubard BI, Li Y. A composite likelihood approach in 
testing for Hardy Weinberg Equilibrium using family-based genetic 
survey data. Stat in Med. 2016;35(27):5040-5050.

372.  Keadle SK, McKinnon R, Graubard BI, Troiano RP. Combining 
activity-related behaviors and attributes improves prediction of health 
status in NHANES. J Phys Act Health. 2017;14(8): 626-35.

373.  Campbell PT, Newton CC, Freedman ND, Koshiol J, Alavanja MC, 
Beane Freeman LE, Buring, JE,Chan AT, Chong DQ, Datta M, Gaudet MM, 
Gaziano JM, Giovannucci EL, Graubard BI, Hollenbeck AR, King L, Lee IM, 
Linet MS, Palmer JR, Petrick JL, Poynter JN, Purdue MP, Robien K, 
Rosenberg L, Vasrabuddhe VV, Schairer C, Sesso HD, Sigurdson AJ, 
Stevens VL, Wactawski-Wende J, Zeleniuch-Jacquotte A, Renehan AG, 
McGlynn KA. Body Mass Index,Waist Circumference, Diabetes, and Risk of 
Liver Cancer for U.S. Adults. Cancer Res. 2016;76(20):6076-6083.

374.  Purdue MP, Stewart PA, Friesen MC, Colt JS, Locke SJ, Hein MJ, 
Waters MA, Graubard BI, Davis F, Ruterbusch J, Schwartz K, Chow WH, 
Rothman N, Hofmann JN. Occupational exposure to chlorinated solvents 
and kidney cancer: a case-control study. Occup Environ Med. 
2017;74(4):268-274.

375.  Ke L, Mason RS, Mpofu E, Vingren JL, Li Y, Graubard BI, Brock K. 
Hypertension and other cardiovascular risk factors are associated with 
vitamin D deficiency in an urban Chinese population: A short report. J 
Steroid Biochem Mol Biol. 2017; 173:281-91.

376.  Kant AK, Graubard BI. A prospective study of water intake and 
subsequent risk of all-cause mortality in a national cohort. Am J Clin 
Nutr. 2017; 105(1):212-220.

377.  Deziel NC, Nuckols JR, Jones RR, Graubard BI, De Roos AJ, Pronk 
A, Gourley C, Colt JS, Ward MH. Comparison of industrial emissions and 
carpet dust concentrations of polychlorinated dibenzo-p-dioxins and 
polychlorinated dibenzofurans in a multi-center U.S. study. Sci Total 
Environ. 2017;580:1276-1286.

378.  Guertin KA, Li XS, Graubard BI, Albanes D, Weinstein SJ, Goedert 
JJ, Wang Z, Hazen SL, Sinha R. Serum Trimethylamine N-oxide, Carnitine, 
Choline and Betaine in Relation to Colorectal Cancer Risk in the Alpha 
Tocopherol and Beta Carotene Study. Cancer Epidemiol Biomarkers Prev. 
2017; 26(6):945-52.

379.  Locke SJ, Deziel NC, Koh DH, Graubard BI, Purdue MP, Friesen MC. 
Evaluating predictors of lead exposure for activities disturbing 
materials painted with or containing lead using historic published data 
from U.S. workplaces. Am J Ind Med. 2017;60(2):189-197.

380.  Petrick JL, Kelly SP, Liao LM, Freedman ND, Graubard BI, Cook MB. 
Body weight trajectories and risk of oesophageal and gastric cardia 
adenocarcinomas: a pooled analysis of NIH-AARP and PLCO Studies. Br J 
Cancer. 201728;116(7):951-959.

381.  Colt JS, Hofmann JN, Schwartz K, Chow WH, Graubard BI, Davis F, 
Ruterbusch J, Berndt S, Purdue MP. Antihypertensive medication use and 
risk of renal cell carcinoma. Cancer Causes Control. 2017 
Apr;28(4):289-297.

382.  Breslow RA, Castle IP, Chen CM, Graubard BI. Trends in Alcohol 
Consumption Among Older Americans: National Health Interview Surveys, 
1997 to 2014. Alcohol Clin Exp Res. 2017;41(5):976-986.

383.  Layne TM, Weinstein SJ, Graubard BI, Ma X, Mayne ST, Albanes D. 
Serum 25-hydroxyvitamin D, vitamin D binding protein, and prostate 
cancer risk in black men. Cancer. 2017;123(14):2698-2704.

384.  Kelly SP, Graubard BI, Andreotti G, Younes N, Cleary SD, Cook MB. 
Prediagnostic Body Mass Index Trajectories in Relation to Prostate 
Cancer Incidence and Mortality in the PLCO Cancer Screening Trial. 
JNCI. 2016;109(3):1-9.

385.  Flegal KM, Graubard BI, Yi SW. Comparative effects of the 
restriction method in two large observational studies of body mass 
index and mortality among adults. Eur J Clin Invest. 2017;47(6):415-
421.

386.  Thistle JE, Graubard BI, Braunlin M, Vesper H, Trabert B, Cook 
MB, McGlynn KA. Marijuana use and serum testosterone concentrations 
among U.S. males. Andrology. 2017;5(4):732-738.

387.  Yang B, Petrick JL, Kelly SP, Graubard BI, Freedman ND, McGlynn 
KA. Adiposity across the adult life course and incidence of primary 
liver cancer: The NIH-AARP cohort. Int J Cancer. 2017;141(2):271-278.

388.  Gu F, Xu S, Devesa SS, Zhang F, Klerman EB, Graubard BI, Caporaso 
NE. Longitude Position in a Time Zone and Cancer Risk in the United 
States. Cancer Epidemiol Biomarkers Prev. 2017;26(8):1306-1311.

389.  Etemadi A, Sinha R, Ward MH, Graubard BI, Inoue-Choi M, Dawsey 
SM, Abnet CC. Mortality from different causes associated with meat, 
heme iron, nitrates, and nitrites in the NIH-AARP Diet and Health 
Study: population based cohort study. BMJ. 2017;357.

390.  Yang B, Petrick JL, Abnet CC, Graubard BI, Murphy G, Weinstein 
SJ, Mannisto S, Albanes D, McGlynn KA. Tooth loss and liver cancer 
incidence in a Finnish cohort. Cancer Causes Control. 2017;28(8):899-
904.

391.  Sun L, Subar AF, Bosire C, Dawsey SM, Kahle LL, Zimmerman TP, 
Abnet CC, Heller R, Graubard BI, Cook MB, Petrick JL. Dietary Flavonoid 
Intake Reduces the Risk of Head and Neck but Not Esophageal or Gastric 
Cancer in U.S. Men and Women. J Nutr. 2017;147(9):1729-1738.

392.  Callahan CL, Schwartz K, Ruterbusch JJ, Shuch B, Graubard BI, Lan 
Q, Cawthon R, Baccarelli AA, Chow WH, Rothman N, Hofmann JN, Purdue MP. 
Leukocyte telomere length and renal cell carcinoma survival in two 
studies. Br J Cancer. 2017;117(5):752-755.

393.  Loftfield E, Freedman ND, Inoue-Choi M, Graubard BI, Sinha R. A 
Prospective Investigation of Coffee Drinking and Bladder Cancer 
Incidence in the United States. Epidemiology. 2017;28(5):685-693.

394.  Petrick JL, Yang B, Altekruse SF, Van Dyke AL, Koshiol J, 
Graubard BI, McGlynn KA. Risk factors for intrahepatic and extrahepatic 
cholangiocarcinoma in the United States: A population-based study in 
SEER-Medicare. PLoS One. 2017;12(10):e0186643.

395.  Landgren O, Graubard BI, Kumar S, Kyle RA, Katzmann JA, Murata K, 
Costello R, Dispenzieri A, Caporaso N, Mailankody S, Korde N, 
Hultcrantz M, Therneau TM, Larson DR, Cerhan JR, Rajkumar SV. 
Prevalence of myeloma precursor state monoclonal gammopathy of 
undetermined significance in 12372 individuals 10-49 years old: a 
population-based study from the National Health and Nutrition 
Examination Survey. Blood Cancer J. 2017;7(10).

396.  Dultz G, Graubard BI, Martin P, Welker MW, Vermehren J, Zeuzem S, 
McGlynn KA, Welzel TM. Liver transplantation for chronic hepatitis C 
virus infection in the United States 2002-2014: An analysis of the 
UNOS/OPTN registry. PLoS One. 2017;12(10):e0186898.

397.  Chaturvedi AK *, Graubard BI *, Broutian T, Pickard RKL, Tong ZY, 
Xiao W, Kahle L, Gillison ML. Effect of Prophylactic Human 
Papillomavirus (HPV) Vaccination on Oral HPV Infections Among Young 
Adults in the United States. J Clin Oncol. 2018;36(3):262-267. 
(*contributed equally).

398.  Ghazarian AA, Trabert B, Graubard BI, Longnecker MP, Klebanoff 
MA, McGlynn KA. Placental weight and risk of cryptorchidism and 
hypospadias in the Collaborative Perinatal Project. Am J Epidemiol. 
2018 Jul 1;187(7):1354-1361.

399.  Flegal KM, Kit BK, Graubard BI. Bias in Hazard Ratios Arising 
from Misclassification According to Self-Reported Weight and Height in 
Observational Studies of Body Mass Index and Mortality. Am J Epidemiol. 
2018;187(1):125-134.

400.  Kant AK, Graubard BI. Secular trends in regional differences in 
nutritional biomarkers and self-reported dietary intakes of American 
adults: NHANES 1988-1994 to 2009-2010. Public Health Nutr. 2018;10:1-
13.

401.  Kant AK, Graubard BI. A prospective study of frequency of eating 
restaurant prepared meals and subsequent 9-year risk of all-cause and 
cardiometabolic mortality in U.S. adults. PLoS One. 2018;13(1).

402.  Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess Deaths 
Associated with Underweight, Overweight, and Obesity: An Evaluation of 
Potential Bias. National Center for Health Statistics. Ser 3 (42). 
2018.

403.  Hyun N, Gaswirth JL, Graubard BI. Grouping Methods for Estimating 
the Prevalences of Rare Traits from Complex Survey Data that Preserve 
Confidentiality of Respondents. Stat in Med. In press.

404.  Ghazarian AA, Trabert B, Robien K, Graubard BI, McGlynn KA. 
Maternal use of personal care products during pregnancy and risk of 
testicular germ cell tumors in sons. Environmental Research. 164:109-
113.

405.  Hall IJ, Tangka FKL, Sabatino SA, Thompson TD, Graubard BI, Breen 
N. Patterns and Trends in Cancer Screening in the United States: 
Results from the 2000-2015 National Health Interview Surveys. Prev 
Chronic Dis. 2018 Jul 26;15:E97.

406.  Inoue-Choi M, McNeel TS, Hartge P, Caporaso NE, Graubard BI, 
Freedman ND. Non-Daily Cigarette Smokers: Mortality Risks in the U.S. 
Am J Prev Med. 2019 Jan;56(1):27-37.

407.  Thistle JE, Petrick JL, Yang B, Graubard BI, McGlynn KA. 
Domperidone use and risk of primary liver cancer. Cancer Epidemiol. 
2018:170-175.

408.  Kant AK, Graubard BI. Complementary and compensatory dietary 
changes associated with consumption or omission of plain water by U.S. 
adults. Appetite. 2018 Sep 1;128:255-262.

409.  Jeffries N, Zaslavsky A, Creswell JW, Palmer R, Gregorich S, 
Reschovsky J, Graubard BI, Choi K, Pfeiffer RM, Zhang X, Breen N, Diez-
Roux A. Methodological challenges to understanding causes of health 
disparities. AJPH (in press).

410.  Bock CH, Ruterbusch JJ, Holowatyj AN, Steck SE, Van Dyke AL, Ho 
WJ, Cote ML, Hofmann JN, Davis F, Graubard BI, Schwartz KL, Purdue MP. 
Renal cell carcinoma risk associated with lower intake of 
micronutrients. Cancer Med. 2018 Aug;7(8):4087-4097.

411.  Layne TM, Graubard BI, Ma X, Mayne ST, Albanes D. Prostate cancer 
risk factors in black and white men in the NIH-AARP Diet and Health 
Study. Prostate Cancer Prostatic Dis. 2018. (In press)

412.  Loftfield E, Zhou W, Graubard BI, Yeager M, Chanock SJ, Freedman 
ND, Machiela MJ. Predictors of mosaic chromosome Y loss and 
associations with mortality in the UK Biobank. Sci Rep. 2018 Aug 
17;8(1):12316.

413.  Petrick JL, Thistle JE, Zeleniuch-Jacquotte A, Zhang X, 
Wactawski-Wende J, Van Dyke AL, Stampfer MJ, Sinha R, Sesso HD, 
Schairer C, Rosenberg L, Rohan TE, Robien K, Purdue MP, Poynter JN, 
Palmer JR, Newton CC, Linet MS, Liao LM, Lee IM, Koshiol J, Kitahara 
CM, Hofmann JN, Graubard BI, Giovannucci E, Gaziano JM, Gapstur SM, 
Freedman ND, Chong DQ, Chan AT, Buring JE, Beane Freeman LE, Campbell 
PT, McGlynn KA.Body Mass Index, Diabetes and Intrahepatic 
Cholangiocarcinoma Risk: The Liver Cancer Pooling Project and Meta-
analysis. Am J Gastroenterol. 2018 Oct;113(10):1494-1505.

414.  Caporaso NE, Gu F, Klerman EB, Devesa SS, Jones RR, Zhang F, 
Cahoon EK, Graubard BI. Longitude Position in a Time Zone and Cancer 
Risk-Response. Cancer Epidemiol Biomarkers Prev. 2018 Sep;27(9):1111-
1112.

415.  Callahan CL, Locke SJ, Dopart PJ, Stewart PA, Schwartz K, 
Ruterbusch JJ, Graubard BI, Rothman N, Hofmann JN, Purdue MP, Friesen 
MC. Decision rule approach applied to estimate occupational lead 
exposure in a case-control study of kidney cancer. Am J Ind Med. 2018 
Nov;61(11):901-910.

416.  Deziel NC, Beane Freeman LE, Hoppin JA, Thomas K, Lerro CC, Jones 
RR, Hines CJ, Blair A, Graubard BI, Lubin JH, Sandler DP, Chen H, 
Andreotti G, Alavanja MC, Friesen MC. An algorithm for quantitatively 
estimating non-occupational pesticide exposure intensity for spouses in 
the Agricultural Health Study. J Expo Sci Environ Epidemiol. (In press)

417.  Groh EM, Hyun N, Check D, Heller T, Ripley RT, Hernandez JM, 
Graubard BI, Davis JL. Trends in Major Gastrectomy for Cancer: 
Frequency and Outcomes. J Gastrointest Surg. (In press)

418.  Yang B, Petrick JL, Thistle JE, Pinto L, Kemp TJ, Tran HQ, 
Gewirtz AT, Waterboer T, Fedirko V, Jenab M, Graubard BI, Weinstein SJ, 
Albanes D, McGlynn KA.Bacterial translocation and risk of liver cancer 
in a Finnish cohort. Cancer Epidemiol Biomarkers Prev. 2019. (In press)

419.  Tota JE, Gillison ML, Katki HA, Kahle L, Pickard RK, Xiao W, 
Jiang B, Graubard BI*, Chaturvedi AK*. Individualized risk-prediction 
model for oropharynx cancer in the U.S. population. (Submitted). 
(*contributed equally)

420.  Wang L, Graubard BI, Katki HA, Li Y. Improving External Validity 
of Epidemiologic Cohort Analyses: A Kernel Weighting Approach. 
(Submitted).

421.  Ghazarian AA, Trabert B, Graubard BI, Gunja MZ, Longnecker MP, 
Stanczyk FZ, Klebanoff MA, McGlynn KA. Human chorionic gonadotropin 
(hCG) levels and risk of cryptorchidism in sons of white and black 
mothers. (Submitted).

422.  Thistle JE, Yang B, Petrick JL, Qiao YL, Fan JH, Abnet CC, Taylor 
PR, McGlynn KA. Association of tooth loss with incident liver cancer 
and chronic liver disease mortality in a rural Chinese population. 
(Submitted).

Book chapters, letters, or other non-peer-reviewed publications

Sirken MG, Graubard BI, and McDaniel M. National network surveys of 
diabetes. In: 1978 Proceedings of the American Statistical Association 
of the Section on Survey Research Methods. American Statistical 
Association, 1978;631-35.

Sirken MG, Graubard BI, LaValley RW. Evaluation of census population 
coverage by network surveys. In: 1978 Proceedings of the American 
Statistical Association of the Section on Survey Research Methods. 
American Statistical Association, 1978; 
239-44.

Graubard BI, Casady RJ. An application of Goodman's method for 
estimating classes in a population. In: 1980 Proceedings of the 
American Statistical Association of the Section on Survey Research 
Methods. American Statistical Association, 1980;
757-60.

Shimizu IM, Graubard BI. Methodology for obtaining national counts of 
health professionals. In: 1980 Proceedings of the 18th National Meeting 
of the Public Health Conference on Records and Statistics, 1980;103-6.

Eckardt MJ, Ryback RS, Rawlings RR, Graubard BI. Selection of controls 
in testing for alcoholism.(letter). JAMA 1982;247:2496-7.

Forman MR, Fetterly K, Graubard BI. Racial and educational factors 
associated with breast-feeding--United States, 1969 and 1980. MMWR 
March 23, 1984;33:153-4.

Rawlings RR, Graubard BI, Faden VB, Eckardt MJ. A Monte-Carlo study of 
the effects of nonsphericity and non-normality on repeated measures 
tests. In Johnson, G. C. and Brown, R.C. (Eds.): Quantity and Quality 
of Statistical Research in Business Economics, vol. 3. Santa Rosa, 
California: G. Thronkoff Press 1988;297-313.

Graubard B, Gail M. Cluster sampling of controls in population-based 
case-control studies. In: Fortner JG, Rhoads JE, eds. Accomplishments 
in cancer research 1991. Philadelphia: JB Lippincott. 1992;366-7.

Ziegler RG, Ursin G, Craft NE, Subar AF, Graubard BI, Patterson BH. 
Does beta-carotene explain why reduced cancer risk is associated with 
vegetable and fruit intake? New research directions. In: Bray, G. A., 
Ryan, D. H. eds. Pennington Center Nutrition Series, Vol 3. Vitamins 
and Cancer Prevention. Baton Rouge: LSU Press: 1993;352-71.

Graubard BI, Korn EL, Midthune D. Testing goodness-of-fit for logistic 
regression with survey data. American Statistical Association 1997 
Proceedings of the Section on Survey Research Methods. 1997; 170-174.

Midthune DN, Korn EL, Graubard BI. Variance estimation for truncated 
logistic regression. (Letter). Biometrics. 1998:54;1193-95.

Korn EL, Graubard BI. Weighting for unequal selection probabilities in 
multilevel models Discussion on paper by Pfeffermann et al. J R Stat 
Soc, Ser B Part 1. 1998: 60.

Kulldorff H, Graubard B, Velie E. The P-value and P-value function. 
(Letter). Epidemiology.1999:10;345-6.

Rizzo L, Graubard BI, DiGaetano R, Wideroff L. Establishing sampling 
rates for the Family History of Cancer Validation Study. American 
Statistical Association 2000 Proceedings of the Section on Survey 
Research Methods. 2000.

Smith PJ, Srinath KP, Battaglia, MP, Graubard BI, Barker L, Hoaglin DC, 
Frankel M, Khare M. Issues relating to the use of jackknife methods in 
the National Immunization Survey. American Statistical Association 2000 
Proceedings of the Section on Survey Research Methods. 2000.

Patterson BH, Dayton CM, Graubard BI. Latent class analysis of complex 
sample survey data: Application to dietary data-Rejoiner. J Am Stat 
Assoc. 2002; 97 (459): 738-741.

Flegal KM, Williamson DF, Graubard BI. Obesity and cancer. Letter. New 
England Journal of Medicine. 2003;349 (5): 502-502.

Rutter JL, Rao RS, Bouchelet I, Dores G, Green H, Gulley J, Koblinski 
J, Lundberg M Stolzenberg-Soloman R, Wheelock R, Williams W, Wolfsberg 
T, Graubard B, Hartge P, Sholom Wacholder, and Joan P. Schwartz. Survey 
of Mentoring Experiences of NIH Postdoctoral Fellows. Short report in 
Nature 2003, http://felcom.nih.gov/Mentoring/Survey.html.

Flegal KM, Williamson DF, Graubard BI. Letter: Overweight and obesity 
mortality trends in Canada, 1985-2000. Can J Public Health. 2004; 95 
(3): 235-235.

DiGaetano R, Graubard B, Rao S, Severynse J, Wacholder S. Case control 
studies after RDD: New sample designs and analytic strategies. 
Proceedings of the Section on Statistics in Epidemiology, American 
Statistical Association. 2004: 3045-3049.

Flegal KM, Graubard BI, Williamson DF, Gail MH. Letter. Weight and 
mortality. Hypertension. 2006; 47 (2): 398.

Flegal KM, Williamson DF, Graubard BI. Letter. Using adjusted relative 
risks to calculate attributable fractions. Am J Pub Hlth. 2006; 96 (3): 
398.

Flegal KA, Graubard BI, Williamson DF, Gail MH. Weight-Associated 
Deaths in the United States (Letter). J of Women's Health. 
2007;16(9):1368-1370.

Flegal KA, Graubard BI, Williamson DF, Gail MH. Simple examples should 
not be extrapolated to the U.S. population (Letter). Int J Obes. 2008; 
32(5):87.

Graubard BI, Korn EL. Edited CR Rao and D Pfeffermann. Handbook of 
Statistics No. 29 Sample Surveys: Theory, Methods and Inference. 
Chapter 37. Scatter plots with survey data. Elsevier. 2009.

Freedman DM, Fuhrman B, Graubard BI, Chang SC. Vitamin D and cancer 
mortality. Cancer Epidemiol Biomarkers Prev. Letter. 2009;18(1):359.

Gail MH, Graubard B, Williamson DF, Flegal KM. Comments on 'Choice of 
time scale and its effect on significance of predictors in longitudinal 
studies' by Michael J. Pencina, Martin G. Larson and Ralph B. 
D'Agostino, Statistics in Medicine 2007; 26:1343-1359. Stat in Med. 
2009;28(8):1315-7.

Flegal KM, Graubard BI, Williamson DF, Gail MH. Response to ``Biased 
Corrections or Biased About Corrections.'' Obesity. (In press)

Wu LC, Graubard BI, Gail MH. Tipping the balance of benefits and harms 
to favor screening mammography starting at age 40 years. Ann Intern 
Med. 2012;157: 597-598.

Kant AK, Graubard BI. Reply to J Cedernaes and C Benedict. Am J Clin 
Nutr. 2014 Nov;100(5):1403-4.

Flegal KM, Kit BK, Graubard BI. Reply. Am J Epidemiol. 
2014;180(11):1129-30.

Kant AK, Graubard BI. Reply. Am J Clin Nutr. 2017;105(4):1019-1020.

BOOK

Korn EL and Graubard BI. Analysis of Health Surveys. New York: John 
Wiley and Sons. 1999.

                                 ______
                                 

                            Attachment No. 2

JOSEPH H. HUNT
Assistant Attorney General
SCOTT G. STEWART
Deputy Assistant Attorney General
WILLIAM C. PEACHEY
Director
Office of Immigration Litigation
U.S. Department of Justice
WILLIAM C. SILVIS
Assistant Director
Office of Immigration Litigation
SARAH B. FABIAN
Senior Litigation Counsel
Office of Immigration Litigation
U.S. Department of Justice
Box 868, Ben Franklin Station
Washington, DC 20442
Telephone: (202) 532-4824

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L, et al.,                      Case No. 3:18-cv-0428 DMS MDD

          Petitioners-Plaintiffs,   DEFENDANTS' STATUS REPORT
                                    RE: EXPANDED MS. L CLASS
    vs.                             IDENTIFICATION PLAN

U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al,

          Respondents-Defendants.

    Defendants submit this status report on their Expanded Ms. L. Class 
Identification Plan. Defendants appreciate the Court's observations 
about the Plan and the opportunity to respond to those observations. To 
that end, Defendants have attached two declarations to aid the Court by 
addressing: (1) Plaintiffs' April 15 filing about the Plan, ECF No. 
397; (2) the Court's observations and questions about the Plan, made at 
the April 16 status conference; and (3) a meeting about the Plan held 
between the parties on April 22, which included (among other agency 
representatives) Commander Jonathan White (HHS's operational lead for 
the Plan) and Jay Visconti (CBP's operational lead for the Plan). Among 
other things, the attached declarations serve to highlight the 
following points:

      Timeline for Completion: Commander White believes that the Plan 
proposed by the government will identify the vast majority of the 
expanded Ms. L class members within 6 months. Commander White cannot be 
certain of this, however, because the Plan rests on a new process that 
he has not previously conducted or tested and because unknown variables 
could cause the process to take longer if certain variables do not 
proceed as Commander White anticipates. Thus, the 1-2 year timeframe 
noted in the government's plan serves as a cautious outside estimate 
that applies only if the variables developed by Commander White to 
speed up the process do not proceed as he expects that they should. A 
hard deadline is accordingly inapt in this circumstance, particularly 
because the Plan relies on the assessment and expertise of an 
operational lead--Commander White--who has been unable to pin down a 
deadline with certainty but who has repeatedly demonstrated to this 
Court strong results, good faith, and great dispatch. Defendants thus 
propose that, rather than setting a hard deadline, Defendants would 
submit a status report every 30 days informing the Court about the 
status of the Plan and its execution, based on the reports of Commander 
White. If, upon reviewing these reports, the Court believes that a 
deadline or different approach is warranted, the Court can make that 
judgment based on the information before it at that time.

      Review of Portal vs. Paper Files: Review of the UAC Portal, as 
opposed to paper files, is the fastest and most efficient way to 
proceed with this review. The UAC Portal contains information that is 
electronically input from a variety of sources, including from DHS, as 
well as pdf documents from the case manager's paper files that are 
uploaded into the portal. The data and documents in the UAC Portal 
include all sources of information held by HHS that are most likely to 
answer the question of whether any minor was separated from a parent. 
Moreover, the UAC Portal is a database that can immediately be reviewed 
by contract reviewers working together in a centralized location under 
the oversight of Commander White as soon as the contract for hiring 
those reviewers is finalized and Commander White can train them 
regarding the review process. Conversely, case manager paper files are 
scattered among more than 100 locations and would need to be located 
and shipped to a centralized location, and they also are not likely to 
contain all of the information that would inform a reviewer about 
whether a child was separated from a parent.

      April-June 2018 List: Plaintiffs have stated that they believe 
that a list exists of children separated between April and June 2018 
that has already been reconciled between DHS and HHS. Defendants have 
inquired extensively about such a list, but have not located any list 
that meets the description of the list provided by Plaintiffs at the 
parties' meeting. Moreover, if any such list existed that had been 
reconciled between CBP and HHS, then Jay Visconti and Commander White 
likely would be aware of that list. In any event, the government's Plan 
includes the use of separation data kept by CBP for the time period 
from April through June 2018. Initial lists reflecting that data have 
already been sent from CBP to HHS. As discussed below, HHS intends to 
use this information as part of its first wave of file review in the 
UAC Portal. Defendants hope that this information and these efforts put 
to rest any concern about an April-June 2018 list.

      Defendants Will Review Files During the Initial 12-Week Plan 
Period: As the Court is aware, Commander White estimates that it will 
take approximately 12 weeks to develop its statistical prediction model 
and apply it to the approximately 47,000 relevant records. Defendants 
assure the Court that they will review files in the UAC Portal during 
that 12-week period--that review will not be delayed by any ``ramp up'' 
period. In particular, during that 12-week period, Defendants will 
undertake UAC portal case-file review with prioritized groups of 
files--such as those identified by the CBP data from the April to June 
2018 time period and unofficial ORR lists that were kept during the 
relevant time period. The government anticipates that this initial case 
file review effort will be underway within 10 days.

      Defendants Will Review DHS Files, Not Just HHS Files: Plaintiffs 
have said that the Plan should include review of DHS files. Defendants 
agree--and indeed, review of DHS files has always been part of the 
government's Plan. On a regular basis, CBP will receive information 
from HHS about children whose file revealed some indicia of separation. 
CBP will then search its electronic systems of record to determine 
whether there is a record of the child being encountered with a parent, 
whether there is a record of the child being separated from that 
parent, and the reason for such a separation. CBP will send relevant 
information about the parent and the reason for the separation to both 
HHS and ICE for further review and an ultimate determination of class 
membership. Once this coordinated review has been completed and a 
determination of class membership has been made, the government intends 
to provide the lists of potential expanded class members to Plaintiffs 
on a rolling basis.

Commander White and Jay Visconti will both be present at today's 
hearing. Defendants intend to provide information about the 
government's Plan, expand on the matters described above, and respond 
to any questions the Court may have.

DATED: April 25, 2019

            Respectfully submitted,

            JOSEPH H. HUNT
            Assistant Attorney General

            SCOTT G. STEWART
            Deputy Assistant Attorney General

            WILLIAM C. PEACHEY
            Director

            WILLIAM C. SILVIS
            Assistant Director

            SARAH B. FABIAN
            Senior Litigation Counsel
            Office of Immigration Litigation
            Civil Division
            U.S. Department of Justice
            P.O. Box 868, Ben Franklin Station
            Washington, DC 20044
            202-532-4824
            (202) 305-7000 (facsimile)
            [email protected]

                         CERTIFICATE OF SERVICE

IT IS HEREBY CERTIFIED THAT:

    I, the undersigned, am a citizen of the United States and am at 
least eighteen years of age. My business address is Box 868, Ben 
Franklin Station, Washington DC 20044. I am not a party to the above-
entitled action. I have caused service of the accompanying brief on all 
counsel of record, by electronically filing the foregoing with the 
Clerk of the District Court using its ECF System, which electronically 
provides notice.

    I declare under penalty of perjury that the foregoing is true and 
correct.

DATED: April 25, 2019

            Sarah B. Fabian

                                 ______
                                 

                      UNITED STATES DISTRICT COURT

_______________________________________________________________________

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L., et al.,                     Case No. 18cv428 DMS MDD

          Petitioners-Plaintiffs,     
                                    Hon. Dana M. Sabraw
    vs.

U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al.,

          Respondents-Defendants

               SUPPLEMENTAL DECLARATION OF JONATHAN WHITE

    I, Jonathan White, declare under penalty of perjury, pursuant to 28 
U.S.C. Sec. 1746, 13 that my testimony below is true and correct:

    1. The statements in this declaration are based on my personal 
knowledge, information acquired by me in the course of performing my 
official duties, information supplied to me by federal government 
employees, and government records.

    2. This declaration supplements the declaration that I executed on 
April 5, 2019, which is attached here as Exhibit 1. The purposes of 
this declaration are to summarize the case management information that 
ORR keeps on the UAC Portal, provide additional details about the 
Government's Proposed Plan to identify members of the expanded class 
(which would rely on the UAC Portal), and share my concerns about 
Plaintiffs' proposed plan.

           Individualized Case Management and the UAC Portal

    3. ORR administers the Unaccompanied Alien Children (UAC) program 
through a network of approximately 115 care providers located in 17 
states. The care providers are ORR grantees. They help ORR conduct 
individualized case management of UAC.

    4. ORR uses an information system called ``the UAC Portal'' to 
administer the 27 UAC program across the ORR care provider network. The 
main purpose of the UAC Portal 28 is to enable individualized case 
management of UACs, not population-level analysis of all the most 
relevant information that HHS possesses for each child.

    5. The case management process begins when ORR receives a referral 
of the 4 unaccompanied child from DHS through the UAC Portal. Upon 
receiving the referral, the ORR Intakes Team uses the UAC Portal to 
designate a bed for the child at a facility in the ORR care provider 
network. Once the child arrives at the facility, the care provider 
staff documents in the UAC Portal all aspects of the UAC's care while 
in ORR custody. This includes comprehensive assessments of the child's 
history and family systems, as well as any child needs assessments, 
youth care services, health care and behavioral health care, 
significant incident reporting, child protection, and discharge 
planning for the UAC.

    6. The information about the UAC that DHS provides to ORR at the 
time of 12 referral is captured in the Portal. This would include any 
information derived from the I-213 or other law enforcement 
apprehension records which DHS shares with ORR. Any 14 such information 
conveyed by DHS is included in the Referral section of the Portal and, 
in 15 that way, becomes part of the child's case management record.

    7. The case management record for an individual child on the UAC 
Portal also includes information entered directly by care provider 
staff-including case managers (professionals who coordinate discharge 
planning and family connection services for children), youth care 
workers (state-certified individuals who provide individual line-of-
sight supervision and care to children), clinicians (licensed 
behavioral health professionals who provide mental health care to 
children), health care personnel such as doctors and nurses who conduct 
children's initial medical evaluation and subsequent medical care, 
teachers who provide classroom educational services to the child, and 
any other professionals who interact with the child.

    8. Additionally, the case management record for an individual child 
on the UAC. Portal includes uploaded documents in portable document 
format (PDF) for relevant information which was originally on paper 
(and was not entered directly into the UAC 28 Portal). This includes 
paper records of health care services delivered, legal documents 
related to the child, as well as documents provided by the family 
relevant for sponsor vetting and discharge, such as birth certificates, 
printouts related to background checks, employment verification. 
Significant paper documents related to the child are uploaded into the 
UAC Portal so as to be available to ORR Federal staff as well as care 
provider staff.

    9. Separate from the case management record for the child, which is 
entirely contained in the UAC Portal, individual care providers may 
maintain paper files on each child. In my experience, the paper files 
kept by care providers are usually duplicative of the uploaded PDFs and 
other contents of the UAC Portal. In those instances where the paper 
files contain information beyond what appears on the UAC Portal, such 
additional information is typically immaterial to the case management 
process. That is, the additional information is not material to the 
child's welfare while in ORR care, or the process of identifying and 
vetting family members to serve as sponsors for the child.

    10. In addition, the paper files do not contain critical 
information that is maintained on the UAC Portal, such as the referral 
information from DHS.

 The Government's Proposal to Identify Potential Expanded Class Members

    11. On April 5, 2019, the Government submitted a Proposed Expanded 
Ms. L. Class Identification Plan that is designed to identify 
substantially all class members within 6 months. The Government 
recognized that the identification process might take longer to 
complete, possibly up to 1 to 2 years, if the Government were to 
instead conduct a randomized or date-ordered manual review of all HHS 
and DHS records for all of the approximately 47,000 children from the 
class expansion period. See ECF No. 394.

    12. The Government seeks to streamline and accelerate the record 
review--and condense the time period for identifying substantially all 
class members from 1 to 2 years down to 6 months--by applying a 
statistical prediction model to the records in the UAC Portal, as 
developed from an analysis of variables associated with the children of 
original class members. See ECF No. 394. The purpose of the model would 
be to prioritize the record review based on the likelihood of parental 
class membership, and front-load the identification of potential class 
members.

    13. To accomplish the Plan, the Government would hire and train a 
team of data scientists and scalable teams of record reviewers on a 
contract basis. Ordinarily, Federal procurements for services of this 
type would require approximately three to four months for the Federal 
acquisition process and an additional thirty days for recruitment of 
staff. Here, the Government seeks to complete the procurement within 
six weeks. The contract personnel for record review would arrive with 
cleared background checks, and would work full-time reviewing and 
reconciling case management records and other information for the 
population of children discharged from ORR care during the expansion 
period.

    14. The Government estimates it would take approximately 12 weeks 
to develop its statistical prediction model and apply it to the 
approximately 47,000 relevant records. During that time, the Government 
would conduct concurrent record review for prioritized populations such 
as the list produced by Customs and Border Protection (CBP) of children 
separated after April 19, 2018, as well as the informal tracking list 
of children identified as separated by ORR beginning in 2017. My 
preliminary assessment is that those two lists combined are likely to 
yield between 500 and 1,000 children for record review, after the lists 
are compared against the children who were in ORR care as of June 26, 
2018.

    15. My professional opinion is that the statistical analysis is 
essential to the rapid and accurate identification of possible children 
of potential class members for the expanded class period. Nevertheless, 
the process of record review can be initiated with prioritized 
populations prior to the completion of the statistical analysis 
process.

    16. I anticipate that record review of the two prioritized 
populations would begin on a limited basis within 10 days. While 
finalizing the procurement of contract personnel, the Government would 
deploy specialized Federal personnel from the U.S. Public Health 
Service Commissioned Corps to conduct record review. The Federal 
personnel would be trained by ORR subject matter experts and overseen 
directly by me.

    17. The initial focus of the record review would be on factual 
indicia of separation. If the record review team were to find an 
indicator of separation, then it would reconcile 28 that indicator with 
the other information in the child's case management record. If the 
record review team were to conclude that the child was likely 
separated, it would obtain any additional, available information about 
the child's parent from DHS. Such information would be used to 
determine potential class membership. The Government would provide 
lists of potential class members to Plaintiffs on a rolling basis.

    18. The Government used a similar process to identify possible 
children of potential class members in 2018. The key difference is that 
the Government does not have custody of the children for the expansion 
class period and cannot speak with them directly. The information that 
the Government obtained from children in ORR care in 2018 was critical 
to identifying separations on an expedited basis. Without that 
information, the reconciliation of indicia of separation becomes all 
the more critical.

                   Concerns With Plaintiffs' Proposal

    19. On April 15, 2019, Plaintiffs objected to the Government's 
proposal, and claimed that U.S. Immigration and Customs Enforcement 
(``ICE'') already had a list of children separated from their parents 
and released from ORR custody between April and June 2018. (ECF No. 
397). I have no knowledge of such a list. Since April 15, CBP has 
produced to me a list of children who were potentially separated 
between April and June 2018. We are in the process of comparing that 
list against the children who were in ORR care as of June 26, 2018, to 
determine which children should undergo record review.

    20. Plaintiffs also made recommendations on how to identify class 
members for the expansion period. Some of those recommendations--such 
as reviewing records during the first 90 days of the work--are part of 
the Government's plan. Other recommendations would decrease the 
accuracy or speed of the process, or possibly harm ORR's current 
operations and ability to care for the UACs presently in custody.

    21. For example, Plaintiffs recommended that case managers review 
ORR care providers' paper files to identify class members during the 
expansion period. This would require a redeployment of case managers 
from 115 facilities to search for, retrieve, and review the paper files 
at a time when ORR is operating at approximately 97% of its bed 
capacity, and facing an influx of UACs across the Southern Border. ORR 
needs all case managers fully engaged in day-to-day case management to 
achieve a discharge rate that keeps pace with the rate of UAC 
referrals. If discharges were to fall below referrals due to a 
redeployment of case managers to paper file reviews, ORR might exhaust 
its bed capacity. The result would be backups of UACs at CBP border 
stations, which are short-term holding facilities not suitable for 
children for stays of longer than 72 hours.

    22. My professional opinion is that pulling even a few case 
managers away from their normal duties to conduct or support a paper 
file review would slow the discharge rate for all UACs, and create a 
risk of a backup at CBP Border Stations. As the person who led the UAC 
Program's emergency operations in past influx events in 2012, 2014, 
2016, and 2017, I am deeply opposed to any proposal to take case 
managers away from their urgent mission of safe and timely discharge of 
children currently in care.

    23. Plaintiffs' approach is also problematic because the UAC Portal 
is a better tool for quickly identifying possible children of potential 
class members.The UAC Portal contains the information from the paper 
files that the case managers themselves deemed material to the case 
management process. Plus, it contains highly relevant information that 
does not appear in the paper files, such as the referral information 
from DHS. The UAC Portal is the natural starting point for any review 
because it already aggregates the most relevant information available 
to the Government. Plaintiffs' proposal to review all paper records at 
all care providers' facilities across the country would result in a 
duplicative, wasteful, and slower process than review of the UAC Portal 
online. The far better approach is to review the UAC Portal, and expand 
the analysis to paper records on a case-by-case basis when there is a 
specific, identified reason to do so.

    24. Plaintiffs request that the Government review DHS I-213s and 
Event ID numbers. As indicated in my previous declaration, see ECF No. 
394-2, at  20, the Government plans to review available DHS records 
that bear on class membership. I envision that the record review team 
will identify children who were likely separated. The names and Alien 
Numbers of the children will be conveyed on a rolling basis to CBP and 
ICE, which will conduct reviews within their own information systems on 
those Alien Numbers, including the DHS I-213s and information 
corresponding to the Event ID. This DHS analytic process would inform 
the development of the lists of potential class members which will be 
provided to the Plaintiffs on a rolling basis.

    25. Plaintiff's proposed three-month timeframe for the Government 
to complete the identification of potential class members is 
unrealistic. Plaintiff's proposal assumes the Government could simply 
replicate its extraordinary mobilization of resources from last summer. 
But, at that time, the children were in ORR custody, and the Government 
was able to reconcile its records quickly by asking the children 
whether they were separated from their parents. Plus, a similar 
mobilization would jeopardize current ORR operations given the influx 
of UACs across the Southern Border.

                               Conclusion

    26.  It is my belief based upon my experience that it is possible 
to accelerate the accurate identification of potential class members. 
The timeframe of 1 to 2 years is accurate as an outer bound, and the 
plan proposed by the Government is intended to compress that timeframe 
to 6 months. Because this effort would be unprecedented, I cannot 
guarantee a specific timeframe, but it is my firm belief that the 
Government's plan is the fastest means available to identify potential 
class members for the expansion period. I am fully committed to working 
in good faith with the Court and Plaintiffs to implement the plan.

Executed on April 24, 2019.

            Jonathan White

                                 ______
                                 

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

Ms. L., et al.,
          Plaintiffs,

v.                                  No. 3:18-cv-00428-DMS-MDD

U.S. Immigration and Customs
Enforcement, et al.,
          Defendants.

                      DECLARATION OF JAY VISCONTI

    I, Jay Visconti, pursuant to 28 U.S.C. Sec. 1746, and based upon my 
personal knowledge and information made known to me from official 
records and reasonably relied upon in the course of my employment, 
hereby declare as follows, relating to the above-captioned matter:

    1.  I am an Assistant Chief with the United States Border Patrol 
(USBP) currently serving in the capacity as a Senior Advisor to the 
Chief Operating Officer and Senior Official Performing the Functions 
and Duties of the Commissioner, U.S. Customs and Border Protection 
(CBP), Department of Homeland Security. I have been in this role since 
July 2016. In this role, I am responsible for directly supporting and 
advising the Chief Operating Officer and Senior Official Performing the 
Functions and Duties of the Commissioner, as well as the Deputy 
Commissioner, on issues such as USBP's strategic, operational and 
tactical plans, and policies and procedures governing threats, such as: 
terrorist organizations, criminal organizations, illegal immigration/
human smuggling, narcotics and contraband smuggling, transnational 
gangs, threats to legitimate trade and travel, and imported consumer 
products jeopardizing public safety. An additional role that I perform 
is as the Director of the CBP Statistical Tracking and Analysis Team 
(STAT), which provides high-level analysis and reporting into CBP's 
immigration and seizure data. Because of my work with the CBP STAT, and 
my previous position as the Assistant Chief over the USBP's Statistics 
and Data Integrity (SDI) Branch, I was involved in the previous Ms. L 
reunification efforts, and was again called upon to be the CBP 
Operational Lead for the government's plan to account for the members 
of the expanded Ms. L class.

    2.  Prior to serving in this position, I was the Assistant Chief 
over the USBP SDI Branch, where I provided day to day statistics and 
analysis to USBP senior leadership and worked to ensure data quality 
within the USBP data. I have been a U.S. Border Patrol agent since 
January 2, 1996. The U.S. Border Patrol (USBP) is the operational 
component of CBP with the responsibility of, among other things, 
apprehending individuals who enter between the ports of entry. USBP 
maintains information about individuals in its custody in a system of 
records known as e3. E3, which is a suite of applications containing 
multiple modules, contains information that USBP collects and maintains 
to prevent the illegal entry of people, terrorists, terrorist weapons, 
and contraband from entering the United States between ports of entry. 
This information includes, among other things, biographic, biometric, 
and other enforcement and detention data associated with encounters of 
individuals between the ports of entry. I am familiar with the 
development, capabilities and updates to the e3 system. Prior to 
serving as the Assistant Chief over the USBP SDI Branch, I was the 
program manager for the requirements gathering, design and development 
of the e3 suite of applications (Processing, Prosecutions, Biometrics, 
Assaults, and Detention modules).

    3.  The Office of Field Operations (OFO) is the operational 
component of CBP which has responsibility for, among other things, 
inspecting individuals who present themselves at ports of entry seeking 
admission. OFO uses a system which is in many way similar to e3, known 
as SIGMA. I have general familiarity with SIGMA and its capabilities.

    4.  I am familiar with the Ms. L litigation, and have personally 
participated in CBP efforts related to this litigation. In July 2018, I 
served as CBP's main point of contact in the interagency effort to 
identify and reunify the children of Ms. L class members. During this 
role, I worked closely with the Department of Health and Human Services 
(HHS) and U.S. Immigration and Customs Enforcement (ICE). I worked with 
the HHS ASPR Data team to reconcile unaccompanied alien children file 
records identified by HHS as possible separations with the relevant 
data in CBP's electronic systems of records.

    5.  I am also familiar with CBP's efforts to record and track 
family separations in CBP's electronic systems of records, and work 
closely with relevant individuals in both USBP and OFO on such efforts. 
I also communicate regularly with my colleagues at ICE Enforcement and 
Removal Operations (ERO).

    6.  I am CBP's Operational Lead for the government's plan to 
identify members of the expanded Ms. L class, as identified in the 
filing submitted to the Court on April 5, 2019. In this role, I am 
working closely with a team of data experts to review relevant CBP 
files and provide relevant information to the Data Analysis Team for 
further review. I provide more detail about this process below.

    7.  I make this declaration in order to explain the efforts that 
CBP has already undertaken as part of the government's plan to identify 
the members of the expanded class, and to explain CBP's role in the 
process.

Identifying Children Separated between April 19 and June 26, 2018

    8.  Following the expansion of the Ms. L class on March 8, 2019, I 
became CBP's Operational Lead for the government's plan to identify 
members of the expanded class.

    9.  CBP's USBP began tracking separations in our electronic systems 
of record starting on April 19, 2018. I understand that OFO took steps 
to identify separations prior to June 29, 2018, when the system was 
updated. Thus, I determined that CBP would provide Commander White and 
his team with the data reflecting all separations documented by CBP 
between April 19 and June 26, 2018. This information is not a final 
list of class members, but it is important data that can be used in the 
process of identifying the children of potential expanded Ms. L class 
members. CBP maintained this information in USBP and OFO's electronic 
system of records.

    10.  In the past week, using the separations data from this time 
period, USBP and OFO have pulled the relevant cases out of their 
electronic systems of records, as well as information that was manually 
tracked, and compiled that data into lists contained in spreadsheets. 
These lists included all separations of children from their parents or 
legal guardians recorded from April 19, 2018 through June 26, 2018, 
regardless of the reasons for the separation. I provided Commander 
White with the OFO list on April 17, 2019 and with the USBP list on 
April 19, 2019. The OFO list reflected data retrieved through June 28, 
2018, but no separations were recorded after June 26, 2018.

    11.  It is my understanding that Commander White and his team will 
use this and other data to prioritize HHS case files for review to 
identify possible children of potential class members. Once Commander 
White and his team have finished their review of their own case files 
and identified these possible children of potential class members, both 
CBP and ICE will review its own data to make a determination regarding 
the circumstances of any separation and to assess class membership. The 
Data Analysis Team expects that this review will be an iterative, 
collaborative process.

CBP's General Role in the Government's Identification Plan

    12.  In general, as described in the government's April 5th filing, 
the government's plan is intended to be a collaborative, interagency 
review process, with each agency reviewing their own respective data 
and exchanging relevant data on a rolling basis. The government's 
ultimate goal is to identify members of the Ms. L class with as much 
accuracy as possible.

    13.  Specifically, I expect that CBP will regularly receive 
information from HHS about children whose file revealed some indicia of 
separation. CBP will then search its electronic systems of record to 
determine whether there is a record of the child being encountered with 
a parent, whether there is a record of the child being separated from 
that parent, and the reason for such a separation. CBP will generally 
conduct this review by searching for the child's Alien File number (A-
number), and then reviewing all relevant records relating to that 
particular child's encounter.

    14.  For instance, CBP may search a child's A-number and find that 
the child was encountered as part of a group of individuals. It would 
then be possible for CBP to look through other members of this group to 
determine whether the child's parent was also part of that group, or 
whether the child entered the country unaccompanied. CBP will also 
review the child's documentation in its systems of records, as well as 
the documentation of any accompanying parent, to attempt to determine 
the reason for any separation. CBP will then send relevant information 
about the parent, and the reason for the separation, to both HHS and 
ICE for further review and an ultimate determination of class 
membership.

    15.  Without having information from HHS about which children to 
search for, however, it would not be practical to simply review every 
file in a particular event. Some events may reflect the apprehension of 
hundreds of individuals at one time, all of whom would have the same 
event number. Thus, without knowing whether there is some indicia that 
a child in that group was separated from a parent, such a search would 
not, in my opinion, be likely to lead to information about potential 
family separations.

    16.  This is particularly true given the number of individuals that 
CBP encounters at the southwest border. In FY 2018, for instance, CBP 
apprehended or deemed inadmissible more than 520,000 individuals at the 
southwest border. In FY 2019 to date (through the end of March), CBP 
has apprehended or deemed inadmissible over 422,000 individuals. The 
records for all of these encountered are contained in two different 
systems of records, e3 for USBP and SIGMA for OFO, and there are 
multiple records related to each individual. Thus, without some method 
of targeting CBP's review, such as HHS' determination that there is 
indicia of separation, manual review of these records would require 
extensive time, resources, and effort, which would dramatically 
increase the time it would take for the government to complete its 
complete accounting of the expanded Ms. L class.

    17.  I declare that the foregoing is true and correct to the best 
of my knowledge, information, and belief.

Executed this 25th day of April, 2019.

            Jay, Visconti
            Senior Advisor
            U.S. Customs and Border Protection

                                 ______
                                 

                            Attachment No. 3

JOSEPH H. HUNT
Assistant Attorney General
SCOTT G. STEWART
Deputy Assistant Attorney General
WILLIAM C. PEACHEY
Director
Office of Immigration Litigation
U.S. Department of Justice
WILLIAM C. SILVIS
Assistant Director
Office of Immigration Litigation
SARAH B. FABIAN
Senior Litigation Counsel
Office of Immigration Litigation
U.S. Department of Justice
Box 868, Ben Franklin Station
Washington, DC 20442
Telephone: (202) 532-4824

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L, et al.,                      Case No. 3:18-cv-0428 DMS MDD

          Petitioners-Plaintiffs,   STATUS REPORT REGARDING
                                    EXPANDED MS. L CLASS
    vs.                             IDENTIFICATION PLAN

U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al.,

          Respondents-Defendants.

    In accordance with the Court's April 25, 2019 Order Following 
Status Conference, ECF No. 405, Defendants hereby submit this Status 
Report Regarding Expanded Ms. L. Class Identification Plan, which 
consists of the attached declaration from Commander Jonathan White. 
Commander White will be available during the May 17, 2019 telephonic 
status conference to answer any questions the Court may have.

DATED: May 16, 2019

            Respectfully submitted,

            JOSEPH H. HUNT
            Assistant Attorney General

            SCOTT G. STEWART
            Deputy Assistant Attorney General

            WILLIAM C. PEACHEY
            Director

            WILLIAM C. SILVIS
            Assistant Director

            SARAH B. FABIAN
            Senior Litigation Counsel
            Office of Immigration Litigation
            Civil Division
            U.S. Department of Justice
            P.O. Box 868, Ben Franklin Station
            Washington, DC 20044
            202-532-4824
            (202) 305-7000 (facsimile)
            [email protected]

                         CERTIFICATE OF SERVICE

IT IS HEREBY CERTIFIED THAT:

    I, the undersigned, am a citizen of the United States and am at 
least eighteen years of age. My business address is Box 868, Ben 
Franklin Station, Washington DC 20044. I am not a party to the above-
entitled action. I have caused service of the accompanying brief on all 
counsel of record, by electronically filing the foregoing with the 
Clerk of the District Court using its ECF System, which electronically 
provides notice.

    I declare under penalty of perjury that the foregoing is true and 
correct.

    DATED: May 16, 2019

            Sarah B. Fabian

                                 ______
                                 

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

Ms. L., et al.                      Case No. l8cv428 DMS MDD
          Petitioners-Plaintiffs,     
                                    Hon. Dana M. Sabraw
    vs.
U.S. IMMIGRATION AND CUSTOMS
ENFORCEMENT, et al.,

Respondents-Defendants.

                     DECLARATION OF JONATHAN WHITE

    I, Jonathan White, declare under penalty of perjury, pursuant to 28 
U.S.C. Sec. 1746, that my testimony below is true and correct:

    1.  The statements in this declaration are based on my personal 
knowledge, information acquired by me in the course of performing my 
official duties, information supplied to me by federal government 
employees, and government records.

    2.  The purpose of this declaration is to update the Court on the 
Government's implementation of its Plan for identifying possible 
children of potential members of the expanded class of parents in this 
case.

    3.  On April 25, 2019, the Court approved the Government's Proposed 
Plan that is designed to identify substantially all class members 
within 6 months.

    4.  Since April 25, 2019, the Department of Health and Human 
Services (``HHS''), U.S. Customs and Border Protection (``CBP''), and 
U.S. Immigration and Customs Enforcement (``ICE'') Operational Leads 
have consulted and developed a work-flow process to optimize 
interagency validation and consolidation of information.

    5.  In addition, a team of U.S. Public Health Service Commissioned 
Corps (``USPHS'') Officers has been created, deployed and trained to 
conduct case file review asbpart of a pilot project. As of May 13, the 
USPHS case file review pilot team had conducted preliminary UAC Portal 
case file review of 4,108 cases. These cases are for the prioritized 
populations such as the list produced by CBP of children separated 
after April 19, 2018; the informal tracking list of children identified 
as separated by ORR beginning in 2017; and children referred to ORR 
during the class expansion period who were 12 years of age or younger 
on the date of referral.

    6.  On May 6 and 13, HHS transmitted data sets on minors with some 
preliminary indication of separation to CBP and ICE for further 
assessment, reconciliation with CBP and ICE information, and 
determination of potential parental class membership. The data sets are 
currently under review at CBP and, as CBP review is completed, will 
move to ICE.

    7.  HHS is expediting the procurement to hire and train a team of 
data scientists and scalable teams of record reviewers. HHS is in the 
process of engaging a Federally Funded Research and Development Center 
to provide this skilled labor and support. The procurement is 
proceeding rapidly toward finalization. Ordinarily, Federal 
procurements for services of this type would require a minimum of four 
months, but this process is being expedited.

    8.  Once DHS has completed its reconciliation process and potential 
class membership is determined, the Government will provide lists of 
potential class members to Plaintiffs on a rolling basis.

Executed on May 16, 2019.

            Jonathan White

                                 ______
                                 

                            Attachment No. 4

JOSEPH H. HUNT                      Lee Gelernt*
Assistant Attorney General          Judy Rabinovitz*
SCOTT G. STEWART                    Anand Balakrishnan*
Deputy Assistant Attorney General   AMERICAN CIVIL LIBERTIES
WILLIAM C. PEACHEY                  UNION FOUNDATION
Director                            125 Broad St., 18th Floor
Office of Immigration Litigation    New York, NY 10004
WILLIAM C. SILVIS                   T: (212) 549-2660
Assistant Director                  F: (212) 549-2654
Office of Immigration Litigation    [email protected]
SARAH B. FABIAN                     [email protected]
Senior Litigation Counsel           [email protected]
NICOLE MURLEY                         
Trial Attorney                      Bardis Vakili (SBN 247783)
Office of Immigration Litigation    ACLU FOUNDATION OF
U.S. Department of Justice          SAN DIEGO AND IMPERIAL
Box 868, Ben Franklin Station       COUNTIES
Washington, DC 20442                P.O. Box 87131
Telephone: (202) 532-4824           San Diego, CA 92138-7131
Fax: (202) 616-8962                 T: (619) 398-4485
                                    F: (619) 232-0036
ADAM L. BRAVERMAN                   [email protected]
United States Attorney                
SAMUEL W. BETTWY                    Stephen B. Kang (SBN 292280)
Assistant U.S. Attorney             Spencer E. Amdur (SBN 320069)
California Bar No. 94918            AMERICAN CIVIL LIBERTIES
Office of the U.S. Attorney         UNION FOUNDATION
880 Front Street, Room 6293         39 Drumm Street
San Diego, CA 92101-8893            San Francisco, CA 94111
619-546-7125                        T: (415) 343-1198
619-546-7751 (fax)                  F: (415) 395-0950
                                    [email protected]
Attorneys for Federal Respondents-   [email protected]
Defendants                            
                                    Attorneys for Petitioners-
                                    Plaintiffs
                                    *Admitted Pro Hac Vice

                      UNITED STATES DISTRICT COURT

                    SOUTHERN DISTRICT OF CALIFORNIA

MS. L, et al.,                      Case No. 18cv428 DMS MDD

          Petitioners-Plaintiffs,     
                                    JOINT STATUS REPORT
    vs.                               

U.S. IMMIGRATION AND CUSTOMS          
ENFORCEMENT, et al.,                  

          Respondents-Defendants.     

    The Court ordered the parties to file a joint status report 
(``JSR'') by 3:00pm on May 7, 2019, in anticipation of the status 
conference scheduled at 1:00pm on May 8, 2019. The parties submit this 
joint status report in accordance with the Court's instruction.

I. DEFENDANTS' POSITIONS

    A.  Update on Reunifications for the Original Class Period

    As of May 6, 2019, Defendants have discharged 2,766 of 2,814 
possible children of potential class members for the original class 
period. That is, Defendants have discharged 2,766 of the 2,814 possible 
children of potential class members who were in the care of the Office 
of Refugee Resettlement (ORR) as of June 26, 2018. See Table 1: 
Reunification Update. This is an increase of seven discharges reported 
in Table 1 since the JSR filed on April 12, 2019. See ECF No. 396. Four 
of the seven children were reunified with the separated parent; the 
remaining three were discharged under other appropriate circumstances, 
such as discharges to other appropriate sponsors.

    Currently, there is one child of a class member from the original 
class period who remains in ORR care and is proceeding towards 
reunification or other appropriate discharge. This child has a parent 
who departed from the United States, but the Steering Committee has 
advised that resolution of parental preference will be delayed. 
Defendants are supporting the efforts of the Steering Committee to 
obtain a statement of intent from the parent. Once Defendants receive 
notice from the Steering Committee, Defendants will either reunify the 
child or move him into the TVPRA sponsorship process, consistent with 
the intent of the parent.

    The current reunification status for the 2,814 children ages 0 
through 17 for the original class period, who have been the focus of 
Defendants' reporting to date, is further summarized in Table 1. The 
data in Table 1 reflects approximate numbers on these children 
maintained by ORR at least as of May 6, 2019. These numbers are dynamic 
and continue to change as more reunifications, determinations on class 
membership, or discharges occur.


                     Table 1: Reunification Update
------------------------------------------------------------------------
                                   Phase 1   Phase 2  (5 and
          Description             (Under 5)       above)         Total
------------------------------------------------------------------------
Total number of possible               107            2,707       2,814
 children of potential class
 members
------------------------------------------------------------------------
                           Discharged Children
------------------------------------------------------------------------
Total children discharged from         106            2,660       2,766
 ORR care:
------------------------------------------------------------------------
 Children discharged by being          82            2,084       2,166
 reunified with separated
 parent
------------------------------------------------------------------------
 Children discharged under             24              576         600
 other appropriate
 circumstances (these include
 discharges to other sponsors
 [such as situations where the
 child's separated parent is
 not eligible for
 reunification] or children
 that turned 18)
------------------------------------------------------------------------
                  Children in ORR Care, Parent in Class
------------------------------------------------------------------------
Children in care where the               0                1           1
 parent is not eligible for
 reunification or is not
 available for discharge at
 this time:
------------------------------------------------------------------------
 Parent presently outside the           0                1           1
 U.S.
------------------------------------------------------------------------
     Steering Committee has              0                1           1
     advised that resolution
     will be delayed
------------------------------------------------------------------------
 Parent presently inside the            0                0           0
 U.S.
------------------------------------------------------------------------
     Parent in other federal,            0                0           0
     state, or local custody
------------------------------------------------------------------------
     Parent red flag case                0                0           0
     review ongoing--safety and
     well being
------------------------------------------------------------------------
                Children in ORR Care, Parent out of Class
------------------------------------------------------------------------
Children in care where further           1                8           9
 review shows they were not
 separated from parents by DHS
------------------------------------------------------------------------
Children in care where a final           0               15          15
 determination has been made
 they cannot be reunified
 because the parent is unfit or
 presents a danger to the child
------------------------------------------------------------------------
Children in care with parent             0               21          21
 presently departed from the
 U.S. whose intent not to
 reunify has been confirmed by
 the ACLU
------------------------------------------------------------------------
Children in care with parent in          0                1           1
 the U.S. who has indicated an
 intent not to reunify
------------------------------------------------------------------------
Children in care for whom the            0                1           1
 Steering Committee could not
 obtain parental preference
------------------------------------------------------------------------

    B.  Update on Removed Class Members for the Original Class Period
    The current reunification status of removed class members for the 
original class period is set forth in Table 2 below. The data presented 
in this Table 2 reflects approximate numbers maintained by ORR as of at 
least May 6, 2019. These numbers are dynamic and continue to change as 
the reunification process moves forward.


             Table 2: Reunification of Removed Class Members
------------------------------------------------------------------------
    REUNIFICATION
       PROCESS             REPORTING METRIC        NO.   REPORTING PARTY
------------------------------------------------------------------------
STARTING POPULATION   Children in ORR care with      23  Defs.
                       parents presently
                       departed from the U.S.
-------------------------------------------------------------------------
PROCESS 1: Identify   Children with no ``red         23  Defs.
 and Resolve Safety/   flags'' for safety or
 Parentage Concerns    parentage
-------------------------------------------------------------------------
PROCESS 2: Establish  Children with parent           23  Defs.
 Contact with          contact information
 Parents in Country    identified
 of Origin
                     ---------------------------------------------------
                      Children with no contact       23  Defs. & Pls.
                       issues identified by
                       plaintiff or defendant
                     ---------------------------------------------------
                      Children with parent           23  Defs.
                       contact information
                       provided to ACLU by
                       Government
------------------------------------------------------------------------
PROCESS 3: Determine  Children for whom ACLU has     21  Pls.
 Parental Intention    communicated parental
 for Minor             intent for minor:
                     ---------------------------------------------------
                         Children whose parents     21  Pls.
                       waived reunification
                     ---------------------------------------------------
                         Children whose parents      0  Pls.
                       chose reunification in
                       country of origin
                     ---------------------------------------------------
                         Children proceeding         0  Pls.
                       outside the reunification
                       plan
                     ---------------------------------------------------
                      Children for whom ACLU has      1  Pls.
                       not yet communicated
                       parental intent for
                       minor:
                     ---------------------------------------------------
                         Children with               0  Defs.
                       voluntary departure
                       orders awaiting execution
                     ---------------------------------------------------
                         Children with parental      0  Defs.
                       intent to waive
                       reunification documented
                       by ORR
                     ---------------------------------------------------
                         Children whose parents      0  Pls.
                       ACLU has been in contact
                       with for 28 or more days
                       without intent determined
------------------------------------------------------------------------
                      Children whose parents          1  PIs
                       steering committee could
                       not obtain parental
                       preference
------------------------------------------------------------------------
PROCESS 4: Resolve    Total children cleared          0  Pls.
 Immigration Status    Processes 1-3 with
 of Minors to Allow    confirmed intent for
 Reunification         reunification in country
                       of origin
                     ---------------------------------------------------
                         Children in ORR care        0  Defs.
                       with orders of voluntary
                       departure
                     ---------------------------------------------------
                         Children in ORR care w/     0  Defs.
                       o orders of voluntary
                       departure
                     ---------------------------------------------------
                             Children in ORR          0  Defs.
                       care whose immigration
                       cases were dismissed
------------------------------------------------------------------------


    C.  Update Regarding Government's Implementation of Settlement 
Agreement


------------------------------------------------------------------------
   SETTLEMENT PROCESS           DESCRIPTION                NUMBER
------------------------------------------------------------------------
Election Forms\1\        Total number of executed  353 (225 Parents/128
                          election forms received   Children) \2\
                          by the Government
------------------------------------------------------------------------
                            Number who elect to   195 (124 Parents/71
                          receive settlement        Children)
                          procedures
------------------------------------------------------------------------
                            Number who waive      158 (101 Parents/57
                          settlement procedures     Children) \3\
------------------------------------------------------------------------
Interviews               Total number of class     139 \4\
                          members who received
                          interviews
------------------------------------------------------------------------
                            Parents who received  73
                          interviews
------------------------------------------------------------------------
                            Children who          66
                          received interviews
------------------------------------------------------------------------
Decisions                Total number of CFI/RFI   66 \5\
                          decisions issued for
                          parents by USCIS
------------------------------------------------------------------------
                            Number of parents     66 \6\
                          determined to establish
                          CF or RF upon review by
                          USCIS
------------------------------------------------------------------------
                            Number of parents     0
                          whose CF or RF finding
                          remains negative upon
                          review by USCIS
------------------------------------------------------------------------
                         Total number of CFI       73 \7\
                          decisions issued for
                          children by USCIS
------------------------------------------------------------------------
                            Number of children    73 \8\
                          determined to establish
                          CF by USCIS
------------------------------------------------------------------------
                            Number of children    0
                          determined not to
                          establish CF by USCIS
------------------------------------------------------------------------
Removals                 Number of class members   100 Parents \9\
                          who have been returned
                          to their country of
                          origin as a result of
                          waiving the settlement
                          procedures
------------------------------------------------------------------------
\1\ The number of election forms reported here is the number received by
  the Government as of April 30, 2019.
\2\ The number of children's election forms is lower than the number of
  parent election forms because in many instances a parent electing
  settlement procedures submitted an election form on his or her own
  behalf or opposing counsel e-mailed requesting settlement
  implementation for the entire family, but no separate form was
  submitted on behalf of the child.
\3\ The number of children's waivers is lower because some parents have
  submitted waivers only for themselves and some parents who have waived
  reunification also waived settlement procedures and have therefore not
  provided a form for the child.
\4\ Some individuals could not be interviewed because of rare languages;
  these individuals were placed in Section 240 proceedings.
\5\ This number is the aggregate of the number of parents whose negative
  CFI/RFI determinations were reconsidered, number of parents whose
  negative CFI/RFI determination was unchanged, and individuals who were
  referred to 240 proceedings without interview because of a rare
  language. This number excludes 12 cases where a parent already had an
  NTA from ICE or was already ordered removed by an IJ (which are
  included in the interview totals).
\6\ This number includes parents who received positive CF/RF
  determinations upon reconsideration, parents who received a Notice to
  Appear based on their child's positive CF determination, and parents
  who were placed in Section 240 proceedings due to a rare language.
\7\ This number is the aggregate of the number of children who received
  a positive CF determination, the number of children who received a
  negative CF determination, and children who were referred to 240
  proceedings without interview because of a rare language.
\8\ This number includes children who received a positive CF
  determination, children who received a Notice to Appear as a dependent
  on their parent's positive CF determination, and children who were
  placed in Section 240 proceedings due to a rare language.
\9\ This number is as of April 27, 2019.


    D.  Parents Who ICE Records Reflect Have Absconded After Being 
Released


------------------------------------------------------------------------
 
------------------------------------------------------------------------
Absconders               Number of Parents who    153 \10\
                          absconded from
                          enrollment in ATD
                          (Alternatives To
                          Detention)
------------------------------------------------------------------------
\10\ Data from time period of May 4, 2018 to April 30, 2019.


    E.  March 8, 2019 Order Regarding Class Definition

    On April 25, 2019, the Court approved Defendants' Plan for 
identifying members of the expanded class, and ordered the parties to 
provide a status report regarding implementation of this plan on May 
16, 2019, ECF No. 405. In accordance with that order Defendants will 
separately update the Court regarding Plan implementation in the May 16 
status report.

    F.  Pending Motion Regarding Released Settlement Class Members

    The parties met and conferred regarding this issue on March 27, 
2019. On April 3, 2019, Plaintiffs sent a list of questions regarding 
the information provided by Defendants. Defendants responded to these 
inquiries on April 12, 2019. Plaintiffs sent some follow up inquiries 
regarding the information provided by Defendants on May 3, 2019, and 
the parties spoke again on May 6, 2019 regarding these inquiries. 
Defendants are following up on a couple of issues discussed on that 
call, but otherwise understand that Plaintiffs are satisfied with the 
information that Defendants have provided and have no further requests 
at this time.

    G.  Children Awaiting Placement

    On April 3, 2019, Plaintiffs sent an email requesting information 
regarding the status of 17 children who remain in ORR custody, and 
whose parents were removed and waived reunification. Defendants 
provided information in response to this inquiry in the last JSR, and 
also concurrently provided additional information to Plaintiffs. 
Defendants have received no further inquiries on this topic and believe 
the matter to be resolved.

    H.  Settlement Agreement Related to Removed Parents

    In the April 12, 2019 JSR, Plaintiffs stated that they ``expect[ed] 
that [this] issue will need to be addressed in the next JSR and status 
conference.'' Despite this statement, Plaintiffs have not raised the 
issue with Defendants in advance of this filing. If Plaintiffs make any 
assertions about this issue in this JSR, at tomorrow's status 
conference Defendants will be prepared to propose how the Court should 
proceed.

    I.  Government Processes, Procedures, and Tracking, for Separations 
Since June 26, 2018
            1. Data Requested by Plaintiffs
    Defendants will provide Plaintiffs updated reports containing 
information regarding parents and children separated since the Court's 
June 26, 2018 preliminary-
injunction order on the Friday following the filing of each JSR.
            2. Processes and Procedures
    Defendants have provided a summary outline memorializing the 
processes, procedures, tracking, and communication between the agencies 
that have been adopted by the agencies since June 26, 2018. The outline 
also included an overview of the options for separated parents and 
children to obtain information about reunification options. Defendants 
also have reached out to representatives for the Bureau of Prisons and 
the U.S. Marshals Service to ensure that those entities are included in 
discussions regarding these processes and procedures.

    On March 4, 2019, Plaintiffs and lawyers for the children's legal 
service providers sent comments and questions in response to the 
government's proposals. Defendants have reviewed those comments and 
questions, and the parties met and conferred on April 15, 2019, 
regarding those inquiries. Defendants have received no follow-up 
comments or inquiries from Plaintiffs since that meet and confer.

II. MS. L. PLAINTIFFS' POSITION

1.  Centralized Database and Procedures and Standards to Govern Further 
Separations

    The parties continue to meet and confer on how to address the 
continuing separations.

2.  Deported Parents and Settlement

    The parties continue to confer on this issue. Plaintiffs expect, 
however, that the issue will need to be addressed in the next JSR.

3.  Information Regarding Parents Separated from Children After June 26

    Plaintiffs have requested rolling disclosures of separations, as 
the last government disclosure, on April 12, included only separations 
between June 26, 2018 and March 16, 2019. The parties continue to meet 
and confer on this issue, and on the level of detail that the 
government discloses for the basis of a separation.

4.  Additional Information Requests

    Plaintiffs have made requests for additional information about 
class members, including as to parents who have been treated as if they 
were class members while in ICE detention (e.g., the government 
identifies them as having ``waived reunification'') but who have yet to 
appear on class lists. The parties continue to meet and confer on these 
issues.

5.  Steering Committee Progress

    The Steering Committee has successfully contacted and confirmed the 
preferences of nearly all removed parents with respect to 
reunifications. On April 12, the government reported that, as of April 
11, 30 children with removed parents remained in ORR custody. The 
Committee has advised the government that no preference will be 
forthcoming for one of those parents due to complex and individualized 
family circumstances, leaving 29 children with removed parents in the 
operative group. The Committee has delivered preferences for the 
parents of 28 of those children. The parent of the remaining child is 
seeking to return to the United States under the Settlement Agreement, 
and the Steering Committee has advised the government that the delivery 
of a parental reunification election in this case will therefore be 
delayed.

    The status of efforts based on the operative group of 29 children 
in ORR custody with removed parents appears in the table immediately 
below.\11\
---------------------------------------------------------------------------
    \11\ As discussed at the October 25 Status Conference, Plaintiffs 
are reporting a set of detailed numbers based on the government's most 
recent list of children in ORR custody with removed parents. The 
numbers presented in this Joint Status Report are based on the numbers 
provided by the government in the April 12 Joint Status Report, 
excluding the one child for which no preference will be forthcoming.


------------------------------------------------------------------------
 
------------------------------------------------------------------------
Removed parents identified by the government to the                29
 Steering Committee as of 4/12/2019
Parent's final preference has been communicated to the        28 \12\
 government
------------------------------------------------------------------------
     Parent has elected reunification in Country of Origin         0
------------------------------------------------------------------------
     Parent has elected to waive reunification in Country         28
     of Origin
------------------------------------------------------------------------
Total number of cases where the parent seeks to return to          1
 the U.S.
------------------------------------------------------------------------
\12\ The Steering Committee determined that for one child it was
  appropriate to report the preference of a non-removed parent because
  the Steering Committee was unable to reach the removed parent.


F.  Children Whose Parents Have Submitted Preferences and Are Still 
Detained

    On February 12, the Steering Committee provided to the government 
information regarding 22 children who had been in ORR custody for at 
least five months following the submission of a final reunification 
election. The government provided detailed information regarding these 
children most recently on April 12, which the Steering Committee 
appreciates. According to the government's April 12 data, 13 children 
in ORR custody as of that date remained separated from their parents 
for more than six months following the submission of a final 
reunification election, with seven children having been in ORR custody 
for more than eight months following the submission of a final 
reunification election. The Steering Committee will continue to meet 
and confer with the Government regarding the remaining children.

III.  MMM-Dora Plaintiffs' Report Regarding Settlement Implementation

    The parties continue to work together to implement the settlement 
agreement approved on November 15, 2018. Counsel for Plaintiffs are 
providing the government with signed waiver forms as they are received 
from class members. The parties are meeting and conferring on 
settlement implementation issues as they arise (including a productive 
meeting earlier this week), and are working together to resolve various 
issues regarding implementation, interviews for class members, 
statistical reporting, and various individualized issues as they arise. 
The parties will alert the Court of any issues that require the Court's 
guidance.

    As reported in the prior JSR, and per the Court's February 22, 2019 
Order (ECF No. 362), the Government provided Dora and M.M.M. counsel 
with a list of class members with removal orders, which includes 
individuals with either expedited removal orders or final removal 
orders. The parties are continuing to meet and confer about the data 
and the best way to identify class members who may be in need of 
settlement relief. The Government has recently provided Plaintiff's 
counsel with additional address information to facilitate outreach to 
class members.

DATED: May 7, 2019

            Respectfully submitted,

            Lee Gelernt *
            Judy Rabinovitz *
            Anand Balakrishnan *
            AMERICAN CIVIL LIBERTIES UNION
            FOUNDATION
            125 Broad St., 18th Floor
            New York, NY 10004
            T: (212) 549-2660
            F: (212) 549-2654
            [email protected]
            [email protected]
            [email protected]

            Bardis Vakili (SBN 247783)
            ACLU FOUNDATION OF SAN DIEGO
            AND IMPERIAL COUNTIES
            P.O. Box 87131
            San Diego, CA 92138-7131
            T: (619) 398-4485
            F: (619) 232-0036
            [email protected]

            Stephen B. Kang (SBN 292280)
            Spencer E. Amdur (SBN 320069)
            AMERICAN CIVIL LIBERTIES UNION
            FOUNDATION
            39 Drumm Street
            San Francisco, CA 94111
            T: (415) 343-1198
            F: (415) 395-0950
            [email protected]
            [email protected]

            Attorneys for Petitioners-Plaintiffs
            *Admitted Pro Hac Vice

            JOSEPH H. HUNT
            Assistant Attorney General
            SCOTT G. STEWART
            Deputy Assistant Attorney General
            WILLIAM C. PEACHEY
            Director
            WILLIAM C. SILVIS
            Assistant Director

            SARAH B. FABIAN
            Senior Litigation Counsel
            NICOLE MURLEY
            Trial Attorney
            Office of Immigration Litigation
            Civil Division
            U.S. Department of Justice
            P.O. Box 868, Ben Franklin Station
            Washington, DC 20044
            (202) 532-4824
            (202) 616-8962 (facsimile)
            [email protected]

            ADAM L. BRAVERMAN
            United States Attorney
            SAMUEL W. BETTWY
            Assistant U.S. Attorney

            Attorneys for Respondents-Defendants

                                 ______
                                 

                            Attachment No. 5
                            
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                            
                            
                                 ______
                                 
              Prepared Statement of Hon. Chuck Grassley, 
                        a U.S. Senator From Iowa
    Good morning. This hearing will come to order.

    I want to welcome our witness, the Secretary of the Department of 
Health and Human Services, Mr. Alex Azar.

    I appreciate Secretary Azar coming before the committee to talk 
about the health and human services proposals in President Trump's 
budget for fiscal year 2020.

    Congress decides how much the government spends and how to allocate 
those resources. But the President gets to have a say, and it's our 
duty to consider those recommendations.

    We're here today to discuss the Trump administration's 
recommendations for HHS programs.

    These programs impact the day-to-day lives of many people in Iowa 
and throughout the country. Medicare and Medicaid cover health care for 
over 130 million people. Human services programs administered by HHS 
help millions of families in need while promoting upward mobility. The 
programs this committee oversees spend over $1 trillion and take 
hundreds of millions of dollars to administer.

    The President's budget proposal aims to tackle a number of pressing 
challenges. It looks to get a better handle on the opioid epidemic and 
improve child welfare outcomes. This committee has been active on these 
issues and has a role in overseeing HHS's implementation of laws that 
Congress has passed in these areas.

    The budget also strives to lower the high cost of prescription 
drugs. I share that goal and look forward to working with my colleagues 
on this committee to find ways to make medications more affordable in 
Medicare and Medicaid while protecting taxpayers who fund these 
programs.

    President Trump and Secretary Azar deserve tremendous credit for 
highlighting the need to reduce drug costs for patients. Their 
sustained efforts have helped to make big drug pricing policy changes 
possible.

    The budget serves as a reminder that Congress needs to act to make 
sure Medicare and Medicaid are around for future generations. Putting 
these programs on a sustainable financial path while ensuring patients 
can get the care they need is hard work.

    As I've said many times, regardless of the issue, the legislative 
heavy lifting needs to be done in a bipartisan manner to achieve a 
lasting solution.

    This hearing provides an opportunity to talk about issues important 
to our constituents and country. So whether you agree or disagree with 
specific policy proposals in the budget, it's important that we engage 
with Secretary Azar on the issues.

    I appreciate that Secretary Azar is here to perform the time-
honored tradition of testifying on the budget, which enables us to 
execute our duty to consider the President's proposals. I look forward 
to a robust discussion.

    With that, I recognize Ranking Member Wyden for his opening 
statement.

                                 ______
                                 
                 Prepared Statement of Hon. Ron Wyden, 
                       a U.S. Senator From Oregon
    It's budget week on Capitol Hill. There's a lot to discuss this 
morning, so I'll get right to it.

    The Trump administration seems to have an inexhaustible supply of 
destructive health-care ideas that would harm vulnerable Americans.

    Let's start with the Arkansas paperwork requirements. With the 
Trump administration's blessing, Arkansas went ahead inflicting a 
right-wing experiment onto people enrolled in Medicaid. They say it's 
all about work requirements, not about reducing coverage. They're 
wrong. Eighteen thousand people in Arkansas have lost their health 
care. They're people who want to work, and they're people who are 
working.

    Secretary Azar was asked on Tuesday why so many people in Arkansas 
have lost coverage. He answered that the administration was basically 
clueless. The Trump budget takes this experiment national. In fact, it 
makes it mandatory--in every State.

    Bottom line, this doesn't make people healthier. It's not about 
promoting work. This is a back-door scheme to kick people off their 
Medicaid coverage by putting mountains of paperwork between patients 
and their doctors.

    Next issue, another hare-brained right-wing experiment. A cadre of 
Republican Governors and Attorneys General recently sued HHS in an 
attempt to get the entire Affordable Care Act ruled unconstitutional. 
Their legal argument wouldn't get a passing grade in Con. Law 101. But 
instead of defending the law of the land against this lawsuit, as is 
the longstanding bipartisan practice, the Trump Justice Department 
decided it would jump on board.

    And in fact, the Justice Department focused its attack on key 
protections for pre-existing conditions. It wants them ruled 
unconstitutional. The legal brief involved is so absurd, three career 
officials refused to put their names on it. One even resigned. After a 
political appointee agreed that he would be the public face of this 
attack, he was rewarded with a nomination to the Sixth Circuit Court of 
Appeals.

    On the topic of hurting those with pre-existing conditions, let's 
turn to junk insurance. The fight against junk insurance goes back 
decades. I was part of the effort to crack down on Medigap supplemental 
plans targeting seniors. More recently there was a similar effort in 
the private insurance market. The Trump administration said, ``Enough 
cracking down, let's bring junk insurance back.'' Once again, scam 
artists are free to sell bargain-basement plans on the individual 
market that don't cover the health care people actually need.

    Next, the Trump administration wants to fillet Medicaid by block-
granting and capping the program. That's an idea so destructive it 
couldn't pass when the Congress was under unified Republican control. 
Not only would it put essential care on the chopping block for 
millions, including children and people with disabilities, it's a 
surefire way to create a nationwide crisis of nursing home closures. 
Despite those dangers, the administration is now reportedly exploring 
how to block-grant Medicaid through administrative fiat.

    The administration cut open-season for health insurance in half. It 
also slashed funding for the advertising and in-person assistance that 
helps people sign up for coverage under the ACA. The budget would take 
away middle-class tax credits for health care. The list of health-care 
sabotage goes on. Bottom line, it's stunning how creative the Trump 
administration has been at making health care worse in America.

    Now let's turn to the pharmaceutical checklist. Donald Trump made 
the skyrocketing costs of prescription drugs a core issue on the 
campaign trail. He's talked a lot about it in office, even criticized a 
few companies on Twitter. He famously said in early 2017 that drug 
makers are ``getting away with murder.''

    Two years later, he gets a failing grade on doing anything about 
it. The President once said he wanted to let Medicare negotiate to 
bring down drug prices, but that's nowhere to be found in his budget. 
There's nothing in the budget that would force drug manufacturers to 
lower their prices. So far, there's been no concrete action to back up 
the President's promises.

    I'll close with two final issues. First, on the separation of 
migrant children from their parents: last year, Secretary Azar came 
before this committee and told us that HHS had everything under 
control, the kids were accounted for, and reunification would proceed 
smoothly. He said the Department and parents, I quote, ``With just 
basic keystrokes, within seconds, could find any child in our care.''

    Based on available evidence, it now appears that was dead wrong. 
Reports suggest the government cannot account for the whereabouts of 
potentially thousands of children who were in its care. HHS documents 
that were recently released also show that there were thousands of 
allegations of sexual abuse inflicted on children in government 
custody. So while Secretaries Azar, Nielsen, and other Trump officials 
tried to send reassuring messages, behind the scenes these kids were 
subjected to chaos and abuse. This is an ongoing, horrifying scandal at 
the border, and now there's evidence the Trump administration is 
working to intimidate and silence the journalists trying to expose it.

    Finally, I need to address an issue dealing with foster care. In 
January, the Trump administration gave South Carolina a green light for 
religious discrimination in its foster care program. That announcement 
came with the assurance that it was only one State, it was a very 
particular set of circumstances, and there wouldn't be any 
discrimination. Then the President got up at the National Prayer 
Breakfast and suggested that this policy could become national.

    In my view, this road heads directly toward taxpayer-funded 
discrimination on religious grounds. The first victims of that 
discrimination will be people who want to step up and provide safe and 
loving homes for foster kids. People who are Jewish, who are Catholic, 
who are Muslim, who choose to practice no religion, LGBTQ Americans, 
potentially others. The next victims will be vulnerable youngsters, 
since this policy would limit the number of foster homes available to 
them. There are also alarming questions about what this would mean for 
Jewish kids and Catholic kids who wind up in settings that are hostile 
to their faiths. What would it mean for LGBTQ kids, or children who are 
struggling with their sexual orientation?

    I'm extremely troubled by what the administration is doing in this 
area. So I'm going to have more questions about that, as well as the 
other issues I've discussed today, and more.

                                 ______
                                 

Gallup

January 23, 2019

U.S. Uninsured Rate Rises to Four-Year High

By Dan Witters

  The U.S. uninsured rate has risen steadily since 2016

  Women, younger adults, the lower-income have the greatest increases

  All regions except for the East reported increases
_______________________________________________________________________

WASHINGTON, DC--The U.S. adult uninsured rate stood at 13.7% in the 
fourth quarter of 2018, according to Americans' reports of their own 
health insurance coverage, its highest level since the first quarter of 
2014. While still below the 18% high point recorded before 
implementation of the Affordable Care Act's individual health insurance 
mandate in 2014, today's level is the highest in more than four years, 
and well above the low point of 10.9% reached in 2016. The 2.8-
percentage-point increase since that low represents a net increase of 
about seven million adults without health insurance.

[[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


Nationwide, the uninsured rate climbed from 10.9% in the third and 
fourth quarters of 2016 to 12.2% by the final quarter of 2017; it has 
risen steadily each quarter since that time. Since Gallup's measurement 
began in 2008, the national uninsured rate reached its highest point in 
the third quarter of 2013 at 18.0%, and thus, the current rate of 
13.7%--although it continues a rising trend--remains well below the 
peak level.

These data, collected as part of the Gallup National Health and Well-
Being Index, are based on Americans' answers to the question, ``Do you 
have health insurance coverage?'' Sample sizes of randomly selected 
adults in 2018 were around 28,000 per quarter.

The ACA marketplace exchanges opened on October 1, 2013, and most new 
insurance plans purchased during the last quarter of that year began 
their coverage on Jan. 1, 2014. Medicaid expansion among 24 states (and 
the District of Columbia) also began at the beginning of 2014, with 12 
more states expanding Medicaid since that time. Expanded Medicaid 
coverage as a part of the ACA broadens the number of low-income 
Americans who qualify for it to those earning up to 138% of the federal 
poverty level. The onset of these two major mechanisms of the ACA at 
the beginning of 2014 makes the uninsured rate in the third quarter of 
2013 the natural benchmark for comparison to measure the effects of 
that policy.

Uninsured Rates Increase Most Among Women, Young Adults, the Lower-
                    Income

The uninsured rate rose for most subgroups in the fourth quarter of 
2018 compared with the same quarter in 2016, when the uninsured rate 
was lowest. Women, those living in households with annual incomes of 
less than $48,000 per year, and young adults under the age of 35 
reported the greatest increases. Those younger than 35 reported an 
uninsured rate of over 21%, a 4.8-point increase from two years 
earlier. And the rate among women--while still below that of men--is 
among the fastest rising, increasing from 8.9% in late 2016 to 12.8% at 
the end of 2018.

At 7.1%, the East region, which has in recent years maintained the 
lowest uninsured rate in the nation, is the only one of the four 
regions nationally whose rate is effectively unchanged since the end of 
2016. Respondents from the West, Midwest and South regions all reported 
uninsured rates for the fourth quarter of 2018 that represent increases 
of over 3.0 points. The South, which has always had the highest 
uninsured rate in the U.S. but has seen some of the greatest declines 
at the state level, has had a 3.8-point increase to 19.6%.


            Percentage of Uninsured U.S. Adults, by Subgroup
                               % Uninsured
------------------------------------------------------------------------
                                                                Change
                                    Q4 2016  %   Q4 2018  %   pct. pts.
------------------------------------------------------------------------
Age
 
18-34                                     16.8         21.6         +4.8
35-64                                     11.0         13.7         +2.7
65+                                        2.3          3.7         +1.4
18-64                                     13.1         16.3         +3.2
 
Gender
 
Men                                       12.9         14.5         +1.6
Women                                      8.9         12.8         +3.9
 
Annual household income
 
Under $24,000                             22.6         25.4         +2.8
$24,000-<$48,000                          16.1         19.1         +3.0
$48,000-<$90,000                           7.8          9.1         +1.3
$90,000-<$120,000                          3.2          5.9         +2.7
$120,000 or more                           2.4          3.6         +1.2
 
Region
 
East                                       7.5          7.1         -0.4
West                                       9.6         13.2         +3.6
Midwest                                    7.7         10.9         +3.2
South                                     15.8         19.6         +3.8
------------------------------------------------------------------------
Gallup National Health and Well-Being Index

Implications

A number of factors have likely played a role in the steady increase in 
the uninsured rate over the past two years. One may be an increase in 
the rates of insurance premiums in many states for some of the more 
popular ACA insurance plans in 2018 (although most states saw premiums 
stabilize for 2019). For enrollees with incomes that do not qualify for 
government subsidies, the resulting hike in rates could have had the 
effect of driving them out of the marketplace. Insurers have also 
increasingly withdrawn from the ACA exchanges altogether, resulting in 
fewer choices and less competition in many states.

Other factors could be a result of policy decisions. The open 
enrollment periods since 2018 have been characterized by a significant 
reduction in public marketing and shortened enrollment periods of under 
seven weeks, about half of previous periods. Funding for ACA 
``navigators'' who assist consumers in ACA enrollment has also been 
reduced in 2018 to $10 million, compared with $63 million in 2016. 
Overall, after open enrollment in the ACA federal insurance marketplace 
(i.e., healthcare.gov) peaked in 2016 at 9.6 million consumers, it 
declined by approximately 12.5%, to 8.4 million in 2019, based on 
recently released figures.

Other potential factors include political forces that may have 
increased uncertainty surrounding the ACA marketplace. Early in his 
presidency, for example, President Donald Trump announced, ``I want 
people to know Obamacare is dead; it's a dead healthcare plan.'' 
Congressional Republicans made numerous high-profile attempts in 2017 
to repeal and replace the plan. Although none fully succeeded 
legislatively, the elimination of the ACA's individual mandate penalty 
as part of the December 2017 Republican tax reform law may have reduced 
participation in the insurance marketplace in the most recent open 
enrollment period.

Trump's decision in October 2017 to end cost-sharing reduction could 
also potentially have affected the uninsured rate. The cost-sharing 
payments were made to insurers in the marketplace exchanges to offset 
some of their costs for offering lower-cost plans to lower-income 
Americans. The Trump administration had previously renewed the payments 
on a month-by-month basis but later concluded that such payments were 
unlawful. In April 2018, a federal court granted a request for a class-
action lawsuit by health insurers to sue the federal government for 
failing to make the payments. Such lawsuits continue to be litigated.

                                 ______
                                 
              Miracle Hill Ministries Foster Care Program

                           117 Drummond Lane

                           Pickens, SC 29671

                          www.miraclehill.org

Miracle Hill Ministries, Inc. has been approved to license individual 
foster homes. The foster homes can be licensed to care for a specific 
age or gender child. Among the requirements for becoming foster 
parents, one would have to be fingerprinted and pass SLED and DSS 
background checks for criminal activity and child abuse. Also, any 
prospective home would need to pass a health and fire inspection to 
assure a healthy and safe environment for the child. Fourteen hours of 
training are also required of each foster parent and is provided by 
Miracle Hill staff. When the licensing process is complete, Miracle 
Hill foster parents are qualified to receive foster children through 
our agency. These children have been referred by local DSS offices.

A foster parent for Miracle Hill must: (1) be a born-again believer in 
the Lord Jesus Christ as expressed by a personal testimony and 
Christian conduct; (2) be in agreement without reservation with the 
doctrinal statement of Miracle Hill Ministries; (3) be an active 
participant in, and in good standing with, a Protestant church; (4) 
have a genuine concern for the spiritual welfare of children entrusted 
to their care; (5) have a lifestyle that is free of sexual sin (to 
include pornographic materials, homosexuality, and extramarital 
relationships); (6) abstain from activities or addictions that have a 
detrimental effect on clients * including: undiscerning choices related 
to literature and entertainment; excessive or imprudent use of alcohol; 
use of illegal drugs; abuse of prescription medications; and the use of 
tobacco in the presence of foster children and inside the foster home 
or foster parent's vehicle.
---------------------------------------------------------------------------
    * According to the teachings of Romans 14:13-23, we are to keep 
from becoming a stumbling block to others. It is important to exercise 
biblical discretion by restricting your freedom and demonstrating sound 
judgment based on biblical principles that displays evidence of 
spiritual growth and maturity. This is especially important considering 
\2/3\ of children in foster care come from homes with a substance 
abusing adult and individuals that have been in foster care are 50% 
more likely to abuse substances in their lifetime. (Titus 2:11-12)

In accordance with Title VI of the Civil Rights Act of 1964, the 
Multiethnic Placement Act of 1994 and Section 1808 of the Small 
Business Job Protection Act of 1996, 42 U.S.C. 622(b)(9), 671(a)(18), 
674(d) and 1996b, Miracle Hill is prohibited from discriminating on the 
basis of race, color and/or national origin when making foster care 
---------------------------------------------------------------------------
decisions.

If you are interested in becoming a foster parent and feel that you 
meet the requirements, please complete the information in the ``Getting 
Started'' section of the website. The Miracle Hill foster home staff 
will review the information. If you have met the requirements, a 
licensing worker will contact you to make an appointment to meet your 
family and aid you in the licensing process.

How can I learn more? If you would like to know more about Miracle Hill 
Ministries, Inc., have a tour of our facilities, or set up an 
appointment regarding your needs, please call us at 864-878-9987, or 
write to us at:

            Miracle Hill Ministries, Foster Home Program
            117 Drummond Lane
            Pickens, SC 29671

You can also visit our web site at www.miraclehill.org.

                                 ______
                                 
                Administration for Children and Families

                   Office of the Assistant Secretary

                      330 C Street, SW, Suite 4034

                          Washington, DC 20201

                            www.acf.hhs.gov

                            January 23, 2019

Governor Henry McMaster
State House
1100 Gervais Street
Columbia, SC 29201

Re: Request for Deviation or Exception from HHS Regulations 45 CFR 
Sec. 75.300(c)

Dear Governor McMaster:

This correspondence responds to your letter of February 27, 2018, to 
the Acting Assistant Secretary for Children and Families, written ``on 
behalf of South Carolina and faith-based organizations'' operating 
under South Carolina's Title IV-E Foster Care Program (``the SC Foster 
Care Program''). As clarified through follow-up telephone calls, your 
letter requested that the SC Foster Care Program be granted an 
exception from U.S. Department of Health and Human Services' (``HHS'' 
or the ``Department'') regulations at 45 CFR Sec. 75.300(c), 
prohibiting subgrantees from selecting among prospective foster parents 
on the basis of religion, to the extent that such prohibition conflicts 
with a subgrantee's religious exercise. We understand that one such 
faith-based subgrantee, Miracle Hill Ministries (``Miracle Hill''), 
exclusively recruits foster parents of a particular religion and 
accounts for up to 15% of your total foster care placements. We also 
understand that you believe that there are other participating faith-
based organizations with similar religious exercise concerns and that 
other entities in the SC Foster Care Program do not have the same 
conflicts with Sec. 75.300(c) and would work with prospective foster 
parents of different faiths or no faith.

Section 75.300(c) says:

        (c) It is a public policy requirement of HHS that no person 
        otherwise eligible will be excluded from participation in, 
        denied the benefits of, or subjected to discrimination in the 
        administration of HHS programs and services based on non-merit 
        factors such as age, disability, sex, race, color, national 
        origin, religion, gender identity, or sexual orientation. 
        Recipients must comply with this public policy requirement in 
        the administration of programs supported by HHS awards.

These requirements are broader than the nondiscrimination requirements 
specified in the Foster Care Program Statute, 42 U.S.C. 
Sec. 671(a)(18), which says:

        (a) Requisite features of State plan. In order for a State to 
        be eligible for payments under this part, it shall have a plan 
        approved by the Secretary which--(18) not later than January 1, 
        1997, provides that neither the State nor any other entity in 
        the State that receives funds from the Federal Government and 
        is involved in adoption or foster care placements may--(A) deny 
        to any person the opportunity to become an adoptive or a foster 
        parent, on the basis of the race, color, or national origin of 
        the person, or of the child, involved; or (B) delay or deny the 
        placement of a child for adoption or into foster care, on the 
        basis of the race, color, or national origin of the adoptive or 
        foster parent, or the child, involved.

The statutory requirements of Sec. 671(a)(18) are incorporated into the 
grant for the SC Foster Care Program through 45 CFR Sec. 75.300(a), 
which requires ``that Federal funding is expended and associated 
programs are implemented in full accordance with U.S. statutory and 
public policy requirements.'' Other federal civil rights statutes may 
likewise apply to the SC Foster Care Program directly, as a recipient 
of federal financial assistance, or through 45 CFR Sec. 5.300(a). Your 
letter did not request an exception from Sec. 75.300(a).

In support of your exception request, you state that South Carolina has 
more than 4,000 children in foster care, that South Carolina needs more 
child placing agencies, and that faith-based organizations ``are 
essential'' to recruiting more families for child placement. You 
specifically cite Miracle Hill, a faith-based organization that 
recruits 15% of the foster care families in the SC Foster Care Program, 
and you state that, without the participation of such faith-based 
organizations, South Carolina would have difficulty continuing to place 
all children in need of foster care. You make the case that, if the SC 
Foster Care Program is not provided an exception from Sec. 75.300(c) in 
this regard, certain faith-based organizations operating under your 
grant would have to abandon their religious beliefs or forego licensure 
and funding. You contend this would cause hardship to faith-based 
organizations and to the SC Foster Care Program. Your letter seeking 
the exception argued that certain requirements in Sec. 75.300(c) and 
(d) exceed any nondiscrimination requirements or authority imposed by 
statute, and that Sec. 75.300(c) and (d) limit the free exercise of 
religion of faith-based organizations in violation of the Religious 
Freedom Restoration Act, 42 U.S.C. Sec. 2000bb, et seq. (``RFRA''). In 
follow-up telephone conversations with your chief legal counsel, the 
request for an exception was narrowed to the religious 
nondiscrimination provision in Sec. 75.300(c).

On December 18, 2018, Miracle Hill wrote to HHS stating that, in 
prohibiting Miracle Hill's use of religious criteria in selecting 
prospective foster parents under the SC Foster Care Program, HHS's 
regulations substantially burden Miracle Hill's free exercise of 
religion (including under RFRA), and are also ultra vires because they 
exceed the scope of the relevant statutes. Miracle Hill notes that the 
South Carolina Department of Social Services, pursuant to the 
requirements imposed on it through its grants from HHS, declined to 
renew Miracle Hill's license to provide foster services and ``instead 
granted [Miracle Hill] a provisional license that would be revoked if 
[Miracle Hill] continued [its] ministry consistent with [its] religious 
beliefs.'' It is HHS's understanding that this provisional license will 
be revoked in January 2019 unless Miracle Hill agrees to partner with 
foster parents in accordance with Sec. 75.300(c), which Miracle Hill 
cannot do, because Miracle Hill ``believe[s] those who hold certain 
positions of spiritual influence and leadership--including foster 
parents--should share [Miracle Hill's] religious mission and beliefs.''

The HHS Office for Civil Rights (``OCR'') is the HHS component with 
delegated authority to ensure compliance with RFRA by the Department, 
its programs, and the recipients of HHS federal financial assistance. 
OCR has reviewed Miracle Hill's letter as part of an ongoing 
investigation and has determined that subjecting Miracle Hill to the 
religious nondiscrimination requirement in Sec. 75.300(c) (by requiring 
South Carolina to require Miracle Hill to comply with Sec. 75.300(c) as 
a condition of receiving funding) would be inconsistent with RFRA.

OCR specifically found that Miracle Hill's sincere religious exercise 
would be substantially burdened by application of the religious 
nondiscrimination requirement of Sec. 75.300(c), and that subjecting 
Miracle Hill to that requirement, by denying South Carolina's exception 
request, is not the least restrictive means of advancing a compelling 
government interest on the part of HHS. Relevant to this determination 
is the fact that the religious nondiscrimination provision in 
Sec. 75.300(c) exceeds the scope of the nondiscrimination provisions 
found in the federal statutes applicable to the SC Foster Care Program, 
and provides no exceptions for religious organizations as are found in 
other statutes prohibiting religious discrimination. See, e.g., 42 
U.S.C. Sec. 2000e-1(a) (Title VII); 42 U.S.C. Sec. 3607(a) (Fair 
Housing Act). In addition, the interest of allowing potential foster 
parents into the SC Foster Care Program appears capable of being served 
by other providers in the program, since at least nine other foster 
care providers in Miracle Hill's area appear available to assist 
potential foster parents in the event Miracle Hill is unable to partner 
with certain potential foster parents because of Miracle Hill's 
religious beliefs. Of additional relevance is the fact that the OMB 
Uniform Administrative Requirements, located at 2 CFR Sec. 200.300, do 
not contain provisions analogous to the broad religious 
nondiscrimination provision in 45 CFR Sec. 75.300(c). As the Supreme 
Court recognized in Holt v. Hobbs, 135 S. Ct. 853, 866 (2015); 
consideration of analogous programs operated by other governmental 
entities is relevant in determining whether the government has a 
compelling interest ``of the highest order'' in requiring such a burden 
on religious exercise. Finally, 45 CFR Part 75 provides a mechanism for 
granting an exception from requirements of that part, including 
Sec. 75.300(c): namely, as applicable here, case-by-case exceptions 
available under 45 CFR Sec. 75.102(b). The Supreme Court has emphasized 
that, where exceptions are available, the government has a difficult 
burden to meet before refusing an exception under RFRA. See, e.g., 
Gonzales v. O Centro Espirita Beneficenfe Uniao do Vegetal, 546 U.S. 
418, 434 (2006). Accordingly, OCR concluded that Miracle Hill (and any 
other similarly situated religious organization in the SC Foster Care 
Program) is entitled under RFRA to an exception from the religious 
nondiscrimination requirements of 45 CFR Sec. 75.300.

Section 75.102(b) of 45 CFR states that ``[e]xceptions on a case-by 
case basis for individual non-Federal entities may be authorized by the 
HHS awarding agency or cognizant agency for indirect costs, except 
where otherwise required by law or where OMB or other approval is 
expressly required by this part.'' This provision permits the HHS 
awarding agency (or the ``cognizant agency for indirect costs'') to 
grant exceptions on a case-by-case basis.

After reviewing all of the information you have provided, we have 
determined that requiring your subgrantee Miracle Hill to comply with 
the religious non-discrimination provision of 45 CFR Sec. 75.300(c) 
would cause a burden to religious beliefs that is unacceptable under 
RFRA. While this determination is sufficient to require the granting of 
your request for an exception from such provision of the regulation, we 
also note that the application of the regulatory requirement would also 
cause a significant programmatic burden for the SC Foster Care Program 
by impeding the placement of children into foster care.

For these reasons, under 45 CFR Sec. 75.102(b), HHS is hereby 
conditionally granting the requested exception from the religious non-
discrimination requirement of 45 CFR Sec. 75.300(c). The exception 
applies with respect to Miracle Hill or any other subgrantee in the SC 
Foster Care Program that uses similar religious criteria in selecting 
among prospective foster care parents. The exception applies on the 
condition that Miracle Hill, or any other subgrantee making use of this 
exception, be required to refer potential foster parents that do not 
adhere to the subgrantee's religious beliefs to other subgrantees in 
the SC Foster Care Program, or to refer them to the SC Foster Care 
Program staff themselves, if the SC Foster Care Program staff is 
equipped to refer those persons to other willing subgrantees. This 
condition is added on the understanding that Miracle Hill, and any 
other subgrantee making use of this exception, does not object on 
religious grounds to making such referrals and, therefore, the 
condition does not implicate additional RFRA concerns.

Please note that this exception does not relieve the SC Foster Care 
Program of its obligation to comply with any other requirements of 45 
CFR Part 75.300(c), of other paragraphs of 45 CFR Part 75.300, of 42 
U.S.C. Sec. 671(a)(18), or of any provisions of civil rights statutes, 
including Title VI of the Civil Rights Act of 1964, Title IX of the 
Education Amendments of 1972, the Age Discrimination Act of 1975, and 
section 504 of the Rehabilitation Act of 1973 that may apply.\1\
---------------------------------------------------------------------------
    \1\ 42 U.S.C. Sec. 2000d et seq., 20 U.S.C. Sec. 1681 et seq., 42 
U.S.C. Sec. 6101 et seq., and 29 U.S.C. Sec. 794, respectively.

If you require any additional information, please contact me at 
---------------------------------------------------------------------------
202.205.7747.

            Sincerely,

Steven Wagner
Principal Deputy Assistant Secretary
Administration for Children and Families

                                 ______
                                 

                             Communications

                              ----------                              


                        Center for Fiscal Equity

                      14448 Parkvale Road, Suite 6

                          Rockville, MD 20853

                      [email protected]

                    Statement of Michael G. Bindner

Chairman Grassley and Ranking Member Wyden, thank you for the 
opportunity to submit these comments for the record to the Committee on 
Finance on the HHS FY 2020 Budget Request.

The federal budget process is broken. The solution must include 
incentives to keep the process moving. Automatic appropriations would 
occur at Joint Budget Resolution marks, and if no resolution is passed, 
revised Budget Control Act spending caps would end this difficulty and 
spur action by both parties. Because BCA levels are too low, the marks 
in the Act could be increased by the legislation amending the process 
itself. These marks should be realistic rather than punitive. Part of 
any reform must include new caps be set through 2025, when parts of the 
TCJA expire as well.

We have added a Carbon Value-Added Tax to the first bullet of our 
comprehensive four part approach to tax reform. An 25% Asset Value-
Added Tax will be added to the second bullet so that capital gains 
taxes can be repealed, making automatic filing possible based on 
submissions to the IRS from federal NBRT income and tax credit data 
provided by state revenue agencies (see bullet four). Aside from these 
changes, our proposals are identical to what we have stated previously, 
and can be found in Attachment One.

Thank you for the opportunity to address the committee. We are, of 
course, available for direct testimony or to answer questions by 
members and staff.

Attachment One: Center for Fiscal Equity Detailed Proposals

Most of our proposals are about tax and entitlement policy and the 
process of estimating discretionary spending, rather than specific 
recommendations for departmental budgets. As a reminder and to 
education new members, here is our four-part approach to tax reform:

      A Value-Added Tax (VAT) to fund domestic military spending and 
domestic discretionary spending with a rate between 10% and 13%, which 
makes sure very American pays something. A Carbon VAT is included.
      Personal income surtaxes on joint and widowed filers with net 
annual incomes of $100,000 and single filers earning $50,000 per year 
to fund net interest payments, debt retirement and overseas and 
strategic military spending and other international spending, with 
graduated rates between 5% and 25%. Capital Gains Taxes will be 
replaced by a 25% VAT on Asset Sales, making automatic filing possible.
      Employee contributions to Old-Age and Survivors Insurance (OASI) 
with a lower income cap, which allows for lower payment levels to 
wealthier retirees without making bend points more progressive.
      A VAT-like Net Business Receipts Tax (NBRT), which is 
essentially a subtraction VAT with additional tax expenditures for 
family support, health care and the private delivery of governmental 
services, to fund entitlement spending and replace income tax filing 
for most people (including people who file without paying), the 
corporate income tax, business tax filing through individual income 
taxes and the employer contribution to OASI, all payroll taxes for 
hospital insurance, disability insurance, unemployment insurance and 
survivors under age 60. Collection would be accomplished by the states, 
who would forward data to the IRS.

Discretionary activities of the Department of Health and Human Services 
would be funded by the VAT. While some of our VAT proposals call for 
regional breakdowns of taxing and spending, they do not for this 
department. While some activities, such as the Centers for Disease 
Control, exist outside the Washington, DC metro area, even these are 
site specific rather than spread out on a nation-wide basis to serve 
the public at large. While some government activities benefit from 
national and regional distribution, health research will not.

The one reform that might eventually be considered in this area is to 
more explicitly link government funded research with ownership of the 
results, so that the Department might fund some of their operations 
with license agreements for some of the resulting research, enabling an 
expanded research agenda without demanding a higher budget allocation.

Of course, regionalization is possible if the Uniformed Public Health 
Service is put into the role of seeing more patients, particularly 
elderly patients and lower income patients who are less than well 
served by cost containment strategies limiting doctor fees. Medicaid is 
notoriously bad because so few doctors accept these patients due to the 
lower compensation levels, although we are encouraged the health care 
reform is attempting to reduce that trend. Medicare will head down that 
road shortly if something is not done about the Doc Fix. It may become 
inevitable that we expand the UPHS in order to treat patients who may 
no longer be able to find any other medical care. If that were to 
happen, such care could be organized regionally and funded with 
regionally based taxes, such as a VAT.

The other possible area of cost savings has to do with care, now 
provided for free, on the NIH campus. While patients without insurance 
should be able to continue to receive free care, patients with 
insurance likely could be required to make some type of payment for 
care and hospitalization, thus allowing an expansion of care, greater 
assistance to patients who still face financial hardship in association 
with their illnesses and a restoration of some care that has been 
discontinued due to budget cuts to NIH. This budget contains even more 
cuts. These should not be allowed. Rather, previous cuts must be 
restored.

The bulk of our comments have to do with health and retirement 
security.

One of the most oft-cited reforms for dealing with the long-term 
deficit in Social Security is increasing the income cap to cover more 
income while increasing bend points in the calculation of benefits, the 
taxability of Social Security benefits or even means testing all 
benefits, in order to actually increase revenue rather than simply 
making the program more generous to higher income earners. Lowering the 
income cap on employee contributions, while eliminating it from 
employer contributions and crediting the employer contribution equally 
removes the need for any kind of bend points at all, while the 
increased floor for filing the income surtax effectively removes this 
income from taxation. Means testing all payments is not advisable given 
the movement of retirement income to defined contribution programs, 
which may collapse with the stock market--making some basic benefit 
essential to everyone.

Moving the majority of Old-Age and Survivors Tax collection to a 
consumption tax, such as the NBRT, effectively expands the tax base to 
collect both wage and non-wage income while removing the cap from that 
income. This allows for a lower tax rate than would otherwise be 
possible while also increasing the basic benefit so that Medicare Part 
B and Part D premiums may also be increased without decreasing the 
income to beneficiaries. Increasing these premiums essentially solves 
their long term financial problems while allowing repeal of the Doc 
Fix.

If personal accounts are added to the system, a higher rate could be 
collected, however recent economic history shows that such investments 
are better made in insured employer voting stock rather than in 
unaccountable index funds, which give the Wall Street Quants too much 
power over the economy while further insulating ownership from 
management. Too much separation gives CEOs a free hand to divert income 
from shareholders to their own compensation through cronyism in 
compensation committees, as well as giving them an incentive to cut 
labor costs more than the economy can sustain for consumption in order 
to realize even greater bonuses.

Employee-ownership ends the incentive to enact job-killing tax cuts on 
dividends and capital gains, which leads to an unsustainable demand for 
credit and money supply growth and eventually to economic collapse 
similar to the one most recently experienced.

Congress just adopted a Chained CPI, but no additional fund has been 
proposed for poor seniors or the disabled, which means there will be 
suffering. This should not be allowed without some readjustment of base 
benefit levels, possibly by increasing the employer contribution and 
grandfathering in all retirees. This is easily done using our proposed 
NBRT, which replaces the Employer Contribution to OASI and all of DI 
and should be credited equally to all workers rather than being a 
function of income.

The NBRT base is similar to a Value-Added Tax (VAT), but not identical. 
Unlike a VAT, an NBRT would not be visible on receipts and should not 
be zero rated at the border--nor should it be applied to imports. While 
both collect from consumers, the unit of analysis for the NBRT should 
be the business rather than the transaction. As such, its application 
should be universal--covering both public companies who currently file 
business income taxes and private companies who currently file their 
business expenses on individual returns.

A key provision of our proposal is consolidation of existing child and 
household benefits, including the Mortgage Interest and Property Tax 
Deductions, into a single refundable Child Tax Credit of at least $500 
per month, per child, payable with wages and credited against the NBRT 
rather than individual taxes. Ending benefits for families through the 
welfare system could easily boost the credit to $1,000 per month for 
every family, although the difference would also be made up by lowering 
gross and net incomes in transition, even for the childless.

Assistance at this level, especially if matched by state governments 
may very well trigger another baby boom, especially since adding 
children will add the additional income now added by buying a bigger 
house. Such a baby boom is the only real long-term solution to the 
demographic problems facing Social Security, Medicare and Medicaid, 
which are more demographic than fiscal. Fixing that problem in the 
right way adds value to tax reform. Adopting this should be scored as a 
pro-life vote, voting no should be a down check to any pro-life voting 
record.

The NBRT should fund services to families, including education at all 
levels, mental health care, disability benefits, Temporary Aid to Needy 
Families, Supplemental Nutrition Assistance, Medicare and Medicaid. 
Such a shift would radically reduce the budget needs of HHS, while 
improving services to vulnerable populations, although some of these 
benefits could be transferred to the Child Tax Credit.

The NBRT could also be used to shift governmental spending from public 
agencies to private providers without any involvement by the 
government--especially if the several states adopted an identical tax 
structure. Either employers as donors or workers as recipients could 
designate that revenues that would otherwise be collected for public 
schools would instead fund the public or private school of their 
choice. Private mental health providers could be preferred on the same 
basis over public mental health institutions. This is a feature that is 
impossible with the FairTax or a VAT alone.

To extract cost savings under the NERT, allow companies to offer 
services privately to both employees and retirees in exchange for a 
substantial tax benefit, provided that services are at least as 
generous as the current programs. Employers who fund catastrophic care 
would get an even higher benefit, with the proviso that any care so 
provided be superior to the care available through Medicaid. Making 
employers responsible for most costs and for all cost savings allows 
them to use some market power to get lower rates, but not so much that 
the free market is destroyed. Increasing Part E and Part D premiums 
also makes it more likely that an employer-based system will be 
supported by retirees.

Enacting the NBRT is probably the most promising way to decrease health 
care costs from their current upward spiral--as employers who would be 
financially responsible for this care through taxes would have a real 
incentive to limit spending in a way that individual taxpayers simply 
do not have the means or incentive to exercise. While not all employers 
would participate, those who do would dramatically alter the market. In 
addition, a kind of beneficiary exchange could be established so that 
participating employers might trade credits for the funding of former 
employees who retired elsewhere, so that no one must pay unduly for the 
medical costs of workers who spent the majority of their careers in the 
service of other employers. Conceivably, NBRT offsets could exceed 
revenue. In this case, employers would receive a VAT credit.

The Administration believes that the Affordable Care Act is failing. It 
was not, but it will soon with the end of mandates. Rates will soon 
start going up as incentives for the uninsured are not adequate in the 
light of pre-existing condition reform to make them less risk averse 
than investors in the private insurance market, the whole house of 
cards may collapse--leading to either single payer or the enactment of 
a subsidized public option (which, given the nature of capitalism, will 
evolve into single payer). While no one knows how the uninsured will 
react over time, the investment markets will likely go south at the 
first sign of trouble.

We suggest to the Secretary that he have an option ready when this 
occurs. Enactment of a tax like the NBRT will likely be necessary in 
the unlikely event the ACA collapses. It could also be used to offset 
non-wage income tax cuts proposed by the House, rather than cutting 
coverage for older, poorer and sicker Americans. Single-payer is 
inevitable unless the President is simply blowing smoke about the ACA 
failing.

                                 ______
                                 
           National Association of Chain Drug Stores (NACDS)

                      1776 Wilson Blvd., Suite 200

                          Arlington, VA 22209

                              703-549-3001

                             www.nacds.org

Introduction

The National Association of Chain Drug Stores (NACDS) thanks Chairman 
Grassley, Ranking Member Wyden, and the Members of the United States 
Committee on Finance for the opportunity to submit a statement on ``The 
President's Fiscal Year 2020 Budget.''

NACDS and the chain pharmacy industry are committed to partnering with 
Congress, HHS, patients, and other healthcare providers to improve 
access to quality, affordable healthcare services. NACDS represents 
traditional drug stores, supermarkets and mass merchants with 
pharmacies. Chains operate over 40,000 pharmacies, and NACDS' over 80 
chain member companies include regional chains, with a minimum of four 
stores, and national companies. Chains employ nearly 3 million 
individuals, including 157,000 pharmacists. They fill over 3 billion 
prescriptions yearly, and help patients use medicines correctly and 
safely, while offering innovative services that improve patient health 
and healthcare affordability. NACDS members also include more than 900 
supplier partners and over 70 international members representing 21 
countries. Please visit nacds.org.

As this Committee examines the President's Fiscal Year 2020 Budget, we 
offer the following for your consideration, with a specific focus on 
the FY 2020 Department of Health and Human Services (HHS) Budget 
Request.

Lowering Costs Through Pharmacy DIR Reform

The FY 2020 HHS Budget Request notes steps the Department took in the 
past year aimed at lowering the cost of prescription drugs, including 
ensuring beneficiaries are benefiting from price concessions at the 
pharmacy counter. We urge HHS to continue these actions in FY 2020 by 
finalizing provisions in the November 2018 Centers for Medicare and 
Medicaid Services (CMS) proposed rule ``Modernizing Part D and Medicare 
Advantage to Lower Prices and Reduce Out-of-Pocket Expenses'' that 
would increase competition in the Medicare Part D program and lower 
beneficiary out-of-pocket costs by reforming pharmacy direct and 
indirect remuneration (DIR) fees. CMS has proposed to reform pharmacy 
DIR by requiring that pharmacy price concessions are passed on to 
patients.\1\ Specifically, these reforms include:
---------------------------------------------------------------------------
    \1\ 83 Fed. Reg. 62152, 62190-92 (Nov. 30, 2018).

      Redefining the ```negotiated price'' to include all pharmacy 
price concessions. Including all pharmacy price concessions in the 
negotiated price would reduce its amount and result in lower 
---------------------------------------------------------------------------
beneficiary cost sharing;

      Developing a broad definition of ``price concession'' to include 
all forms of discounts, direct or indirect subsidies, or rebates that 
serve to reduce costs incurred by Part D sponsors. Again, this would 
help ensure the lowest negotiated price and thus, lower beneficiary 
cost-sharing; and

      Developing standardized pharmacy performance metrics for 2020 as 
the first step toward the development of Medicare Part D pharmacy 
quality incentive program. HHS needs to develop a pharmacy quality 
incentive program to align incentives between plans, pharmacies and 
beneficiaries. Pharmacy incentive payments would support higher quality 
and health outcomes. Examples are medication optimization and improved 
medication adherence, which would improve patient outcomes and reduce 
downstream healthcare costs.

The use of pharmacy DIR fees grew an astonishing 45,000 percent between 
2010 and 2017.\2\ Because of this, Medicare beneficiaries are paying 
more out-of-pocket, the federal government is not fully understanding 
what it is paying for prescription drugs, and retail pharmacies are 
conducting business in an environment where they are unsure whether a 
payment will be clawed back at some later date as ``DIR.''
---------------------------------------------------------------------------
    \2\ Id. at 62147.

As CMS has thoroughly documented, pharmacy DIR fees increase 
beneficiary drug costs and increase taxpayer costs for catastrophic 
coverage and low-income cost-sharing subsidies.\3\ CMS also recognizes 
that pharmacy DIR fees harm pharmacies by reducing transparency and 
predictability of reimbursement.\4\ More broadly, pharmacy DIR fees 
undermine drug price transparency, which is necessary for efficient 
market competition that would reduce prescription drug costs.\5\ CMS 
has recognized the harms caused by pharmacy DIR fees for years.\6\
---------------------------------------------------------------------------
    \3\ Id. at 62190-92.
    \4\ Id. at 62191.
    \5\ Id. at 62176.
    \6\ See, e.g., 82 Fed. Reg. 56336, 56420-21 (Nov. 28, 2017) 
(explaining how pharmacy DIR fees increase beneficiary costs and 
decrease drug price transparency necessary for competition among 
plans); CMS, Medicare Part D--Direct and Indirect Remuneration (DIR) 
(Jan. 19, 2017) (noting the negative impact of pharmacy DIR fees on 
beneficiary drug costs, taxpayer subsidies and plan cost-avoidance); 
CMS, ``Fact Sheet--Medicare Part D--Direct and Indirect Remuneration 
(DIR)'' (Jan. 19, 2017), available at https://www.cms.gov/newsroom/
fact-sheets/medicare-part-d-direct-and-indirect-remuneration-dir.

Pharmacy DIR fees obfuscate true drug prices, thus undermining the 
transparency needed to allow all stakeholders, notably patients and 
providers, to make informed decisions about how to best meet healthcare 
needs. As CMS also points out, ``consumers cannot efficiently minimize 
both their costs and costs to the taxpayers by seeking and finding the 
lowest-cost drug or a plan that offers them the lowest-cost drug and 
pharmacy combinations.''\7\
---------------------------------------------------------------------------
    \7\ Id. at 62176.

Beneficiaries are likely unaware that the increasing use of pharmacy 
DIR fees has led to inflated drug costs, and thus higher cost-sharing. 
The impact of higher cost-sharing for beneficiaries also negatively 
impacts medication adherence, leading to increased total cost of care 
---------------------------------------------------------------------------
and poorer health outcomes.

Better Medication Adherence and Medication Optimization Reduce 
Healthcare Costs

Finalizing pharmacy DIR reform needs to be coupled with the development 
of standardized pharmacy quality metrics and a pharmacy quality 
incentive program. Without a standard set of metrics, beneficiaries, 
pharmacies, and plans are unable to make comparisons of pharmacy 
quality. As a result, there is not an effective means for consumers to 
compare plans and pharmacies within the Part D program, undercutting 
market competition.

Pharmacy DIR fee reform and the development of a standardized pharmacy 
quality incentive program will save taxpayers billions of dollars by 
aligning incentives for the entire Medicare program, which will 
encourage a more systematic investment in pharmacy quality programs 
designed to facilitate care coordination, reduce medical errors, 
advance population health, and empower and motivate beneficiaries to 
achieve better health outcomes through medication optimization services 
and improved medication adherence.

Medication optimization services encompass patient-centered activities 
that improve health outcomes by addressing medication appropriateness, 
effectiveness, safety, adherence, and access. Medication optimization 
services delivered by community pharmacies are central to the care of 
beneficiaries. Nearly all Americans (91.7 percent) live within 5 miles 
of a community retail pharmacy and in 2017 nearly 73 percent of 
prescriptions dispensed in theU.S. were filled at retail pharmacies. 
Face-to-face interactions with beneficiaries at the point-of-dispensing 
allow the pharmacist to counsel and educate the patient and are 
critical to achieving national-scale improvements in health outcomes 
and lowered costs.\8\
---------------------------------------------------------------------------
    \8\ Patients who participated in brief face-to-face counseling 
sessions with a community pharmacist at the beginning of statin therapy 
demonstrated greater medication adherence and persistency than a 
comparison group who did not receive face-to-face counseling. The 
intervention group had statistically greater Medication Possession 
Ratio (MPR) than the control group every month measured. Taitel, M., 
Jiang, J., Rudkin, K., Ewing, S., and Duncan, I.; ``The impact of 
pharmacist face-to-face counseling to improve medication adherence 
among patients initiating statin therapy;'' Patient Prefer Adherence; 
2012;6:323-9; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3340117/. 
Likewise, a systematic review was conducted using 51 studies 
determining the optimal modes of delivery for interventions to improve 
adherence to cardiovascular medications. Among person-dependent 
interventions (nonautomated phone calls, in-person interventions), 
phone calls showed low success rates (38%). In-person pharmacist 
interventions were effective when held in a pharmacy (83% successful) 
but were less effective in clinics (38%). Cutrona, S.L., and Chaudhry, 
N.K., et al.; ``Modes of Delivery for Interventions to Improve 
Cardiovascular Medication Adherence;'' AJMC; December 2010; https://
www.ajmc.com/journals/issue/2010/2010-12-vol16-n12/
ajmc_10dec_cutrona929to942?p=1.

The better use of medicines will also reduce medication non-adherence--
that is, patients not taking their medications as prescribed by their 
healthcare provider. Medication non adherence contributes to $100-$290 
billion in unnecessary healthcare expenditures every year as a result 
of increased hospitalizations and other avoidable, expensive medical 
services.\9\, \10\, \11\ Numerous studies have 
shown that reducing patient drug costs increases medication adherence, 
which, in turn, reduces overall healthcare costs. For example, a recent 
study found that medication nonadherence for diabetes, heart failure, 
hyperlipidemia, and hypertension resulted in billions of dollars in 
Medicare fee-for-service expenditures, millions of hospital days, and 
thousands of emergency department visits that could have been 
avoided.\12\ Specifically, the study estimated that avoidable costs 
from medication nonadherence of four chronic conditions is $28.9 
billion, representing 8 percent of the total expenditures. A 2017 white 
paper found that the direct medical costs and consequences related to 
not taking medication as prescribed is estimated to be 7 to 13 percent 
of national health spending annually--approximately $250 billion to 
$460 billion in 2017, translated to a potential cost to taxpayers of $6 
trillion over 10 years.\13\ And a 2016 cost-benefit analysis concluded 
that between one and two thirds of medication-related hospitalizations 
are caused by poor adherence. Improving adherence could result in 
annual per-person savings ranging from $1,000 to $7,000, depending on 
the disease state.\14\ Multiple, credible sources have drawn the same 
conclusion: medication non-adherence is a costly, preventable problem 
that dramatically affects total cost of care.
---------------------------------------------------------------------------
    \9\ Rosenbaum, L. and Shrank, W.H.; ``Taking Our Medicine--
Improving Adherence in the Accountability Era;'' New England Journal of 
Medicine; Aug. 22, 2013.
    \10\ Network for Excellence in Health Innovation; ``Bend the Curve: 
A Health Care Leader's Guide to High Value Health Care;'' 2011.
    \11\ The NCPIE Coalition; ``Enhancing Prescription Medicine 
Adherence: A National Action Plan;'' 2007.
    \12\ Lloyd, Jennifer T., Maresh, Sha, Powers, Christopher, Shrank, 
W.H., and Alley, Dawn E.; ``How Much Does Medication Nonadherence Cost 
the Medicare Fee-for-Service Program?''; Medical Care, January 2019.
    \13\ ``A Treatable Problem: Addressing Medication Nonadherence by 
Reforming Government Barriers to Care Coordination;'' Prescriptions for 
a Healthy America; October 2017.
    \14\ Patterson, J.A., et al.; ``Cost-Benefit of Appointment-based 
Medication Synchronization in Community Pharmacies;'' American Journal 
of Managed Care; 2016.
---------------------------------------------------------------------------

Value of Pharmacy

NACDS urges Congress and HHS to explore opportunities to utilize 
pharmacists to their fullest extent in improving access to high-
quality, affordable healthcare and improving overall health outcomes. 
For generations, Americans have relied on their local, community 
pharmacists to meet their healthcare needs--trusted, highly accessible 
healthcare providers deeply committed to providing accurate 
prescriptions and helping patients take medications as prescribed.
Pharmacist Provider Status
The full value of pharmacy is broader in scope, however. Pharmacies and 
pharmacists are being recognized for their abilities to provide high-
quality healthcare services at an overall lower cost.

Millions of Medicare beneficiaries lack adequate access to primary 
healthcare services, and this is only expected to increase as the 
number of enrollees grows. According to the American Association of 
Medical Colleges (AAMC), by 2030, we will face a shortage of more than 
120,000 doctors.\15\ Pharmacists are uniquely positioned to help 
address this anticipated shortage by playing a greater role in the 
delivery of healthcare services in collaboration with other healthcare 
team providers.
---------------------------------------------------------------------------
    \15\ HIS Markit, LTD; ``The Complexities of Physician Supply and 
Demand: Projections from 2016 to 2030;'' Prepared for Association of 
American Medical Colleges, March 2018.

NACDS' member chain community pharmacies are accessible, patient-
centered healthcare destinations. One study of a high-risk Medicaid 
population found that patients visited their pharmacies 35 times per 
year, compared to seeing their primary care doctors 4 times per year, 
and specialists 9 times per year.\16\ Voters agree:
---------------------------------------------------------------------------
    \16\ Moose, J. and Branham, A.; ``Pharmacists as Influencers of 
Patient Adherence;'' Pharmacy Times, August 21, 2014.

      83% of voters say that pharmacies are easy to access.\17\
---------------------------------------------------------------------------
    \17\ Poll conducted by Morning Consult from January 4-6, 2019, 
among a national sample of 1995 registered voters.

      80% of voters have visited a pharmacy in the past twelve 
months.\18\
---------------------------------------------------------------------------
    \18\ Id.

Community pharmacists are among the advanced healthcare professionals 
with doctorate level education and years of clinical training. 
Pharmacists' education and training equips them to provide many 
services in addition to dispensing and educating patients on their 
medications. Such services include health tests and screenings, 
management of chronic conditions and related medications, point of care 
testing (e.g., flu, strep) and immunization screening and 
administration. Pharmacists have been recognized by numerous states 
through their scope of practice laws to provide these and other 
services to patient populations. However, while physicians and certain 
other providers are already reimbursed under Medicare Part B for 
---------------------------------------------------------------------------
providing similar services, pharmacists are not.

Community pharmacists reduce the costs of health care by improving 
patient care and collaboration among providers, optimizing medication 
use for improved patient outcomes, contributing to medication error 
prevention, and preventing hospital readmissions cost avoidance, which 
cost Medicare $26 billion annually.\19\
---------------------------------------------------------------------------
    \19\ Agency for Healthcare Research and Quality. Statistical Brief 
#172, April 2014. Available from: http://www.hcup-us.ahrq.gov/reports/
statbriefs/sb172-Conditions-Readmissions-Payer.
pdf (accessed Dec. 9, 2014).

Pharmacists can also be better utilized to respond to immediate public 
health needs. For example, in the battle against the opioid crisis 
pharmacists can help identify and treat those with opioid addiction or 
who may be prone to addiction. This includes providing services such 
opioid antagonist counseling or opioid risk factor intervention 
---------------------------------------------------------------------------
services.

We urge members of the Committee to support soon-to-be introduced 
legislation that will recognize pharmacists as Medicare providers, 
allowing them to offer a greater role in the delivery of healthcare 
services and work in collaboration with other providers in addressing 
opioid abuse and misuse.
Addressing the Opioid Epidemic
In addition to recognizing pharmacists as key providers in the battle 
against the opioid epidemic, NACDS supports additional policy solutions 
to reduce the incidence of opioid addiction and abuse, including:

      Requiring that all prescriptions be issued electronically with 
limited exceptions;
      Legislate a 7-day supply limit for the prescribers of initial 
opioid prescriptions issued for acute pain;
      Collaboration with stakeholders on a nationwide prescription 
drug monitoring program (PDMP) database; and
      Providing manufacturer-funded mail-back envelopes for unused 
opioid drugs, available to patients at pharmacies upon request.

NACDS seeks to partner with lawmakers to advance these key policy 
initiatives. NACDS seeks the support of members of the 116th Congress 
to enact legislation establishing a 7-day supply limit for initial 
opioid prescriptions written for acute pain.

Per the Centers for Disease Control and Prevention (CDC), a greater 
amount of opioid exposure increases the risk of long-term use and 
addiction. Notably, the average day supply per opioid prescription has 
increased in recent years, from 13.3 to 18.1 days per prescription 
between 2006 and 2016. Considering this trend and the risk of exposure 
to higher amounts of opioids, lawmakers must adopt policies to promote 
careful prescribing practices for prescription opioids.

Enactment of 7-day supply limits for acute opioid prescriptions is 
supported by the CDC prescribing guidelines, as it helps reduce the 
incidence of misuse, abuse, and overdose of these drugs. So far, over 
30 states have adopted laws or other policies limiting the maximum day 
supply that can be authorized on an initial opioid prescription for 
acute pain.

NACDS encourages members of the Committee to support legislation that 
is standardized nationwide to promote consistent patient care and 
implementation that limits initial opioid prescriptions for acute pain 
to no more than a 7-day supply. If pain continues, the prescriber may 
issue any appropriate new prescription.

When addressing our nation's opioid epidemic, voters are most likely to 
understand that pharmacists are part of the solution, rather than the 
problem. This is a distinction that pharmacists share with law 
enforcement. For example:

      65% of voters support allowing pharmacists to work with Medicare 
patients to help prevent, detect or treat potential opioid abuse (17% 
oppose; 28% don't know/no opinion).\20\
---------------------------------------------------------------------------
    \20\ Poll conducted by Morning Consult from January 4-6, 2019, 
among a national sample of 1995 registered voters.
---------------------------------------------------------------------------
      61% of voters support requiring that all prescriptions be issued 
and handled electronically to reduce fraud and abuse (19% oppose; 20% 
don't know/no opinion).\21\
---------------------------------------------------------------------------
    \21\ Id.
---------------------------------------------------------------------------
      58% of voters support limiting the initial fill of certain 
opioid prescriptions to a seven-day supply to reduce the incidence of 
addition and abuse (24% oppose; 28% don't know/no opinion).\22\
---------------------------------------------------------------------------
    \22\ Id.

Pharmacies and pharmacists are integral to our nation's healthcare 
system. They are among the most accessible healthcare providers and 
provide high-quality healthcare services that are not only lower cost, 
but also prevent more costly downstream healthcare services.

Specific Medicare Part D Concerns

Beyond our concerns that HHS address DIR reform, we also ask the 
Committee to raise the following issues with HHS:
Broader Use of Prior Authorization and Step Therapy, New Formulation 
        and Drug Price Increases Exceptions
In the November 2018 Part D Rule, CMS proposed providing Part D plans 
with a number of utilization management tools designed to drive the 
utilization of lower cost drugs.\23\ Specifically, CMS is proposing to 
allow plans: (1) to use prior authorization for protected class drugs 
or to determine use for protected class indications or both, (2) to 
exclude from their formularies a protected class single-source drug or 
biological product for which the manufacturer introduces a new 
formulation with the same active ingredient or moiety that does not 
provide a unique route of administration, and (3) to exclude from their 
formularies any single-source drug or biological product that is a 
protected class drug whose price increases, relative to the price in a 
baseline month and year, beyond the rate of inflation.
---------------------------------------------------------------------------
    \23\ 83 Fed. Reg. 62152 (Nov. 30, 2018).

NACDS supports efforts to curb the rising costs of prescription drugs 
but cautions that any action that HHS takes must be balanced with 
ensuring access to needed prescriptions drugs for Medicare 
beneficiaries. Plans should only be allowed flexibility to make changes 
to the treatment of protected class drugs and manage drugs through 
exception processes to the extent that doing so does not reduce drug 
coverage. Limiting access to prescription drugs can have unintended 
consequences, including decreased medication adherence, which further 
---------------------------------------------------------------------------
leads to poorer health and increased costs down the road.

In order to ensure beneficiary access and adherence is not jeopardized, 
NACDS recommends that any policies making changes in utilization 
management of protected classes be based on clinical parameters focused 
on the best treatment for the patient. Specifically, we recommend the 
following parameters be considered in allowing plans more flexibility 
with respect to utilization management tools:

      Only apply to new starts and only if guided by drug-selection 
assay criteria (e.g., genotypic assay),
      Not apply to products that show improved adherence, convenience, 
or tolerability profile, and
      Apply only to non-protected class indications.

We believe implementing such protections will help ensure beneficiaries 
will continue to have access to the treatments they need to best 
address their healthcare needs.

Ensuring access to needed medications is particularly crucial for the 
most vulnerable beneficiaries, such as those being treated with 
antiretrovirals (ARVs) and antineoplastics. The treatment of those with 
HIV and cancer involves unique challenges not present with other 
patients and therapies within the Part D program. For example, patients 
with HIV are now living longer than ever before due to advances in 
clinically superior treatment options, however, challenges such as 
evolving HIV population demographics and increases in costs for HIV 
treatment contribute to suboptimal adherence to drug regimens and risk 
of ARV resistance.

Similarly, the use of individualized and targeted therapy, tumor-
agnostic therapy, CAR T-cell, gene and other therapies for cancer 
patients have greatly improved the specificity of treatment as well as 
long-term outcomes and survival. This has only increased the importance 
of immediate access to a wide array of therapies, as any delay can have 
catastrophic effects. Traditional utilization management tools are of 
limited usefulness due to the individualized and targeted nature of 
modern cancer treatments that do not have other clinically 
interchangeable options.

The unique challenges that patients living with HIV/AIDS and cancer 
face must be balanced with traditional utilization management tools and 
approached in a manner that ensures access to a broad array of 
treatment options. These challenges require that effective treatment 
options be available among the six protected drug classes. We ask that 
the Committee members communicate to HHS that the agency must ensure 
that any changes to drug management or drug formularies do not come at 
the cost of patient access and medication adherence, and especially so 
for vulnerable patient populations.
Prohibition Against Gag Clauses in Pharmacy Contracts
NACDS applauds Congress for passing the ``Know the Lowest Price Act of 
2018'' (Pub. L. 115-262) that prohibits plans from restricting their 
network pharmacies from informing their plan enrollees of the 
availability of prescription drugs at a cash price that is below what 
that the enrollee would be charged (either the cost sharing amount or 
the negotiated price when it is less than the enrollee's cost sharing 
amount) for the same drug under the enrollee's plan. We are encouraged 
that CMS states that the measure will become effective with the plan 
year starting January 1, 2020. The prohibition of gag clauses in 
contracts among plans, Medicare Advantage plans, PBMs, and pharmacies 
will enhance patient access to medications, enable pharmacists to have 
improved relationships with patients, and keep healthcare costs for 
patients to a minimum. We look forward to working with you to implement 
this important requirement.
Part D Explanation of Benefits
CMS also proposed to require that plans include the cumulative 
percentage change in the negotiated price since the first day of the 
current benefit year for each prescription drug claim in the 
explanation of benefits (EOB). NACDS agrees that providing 
beneficiaries with necessary information to make informed choices about 
their health care, including making determinations about whether a 
prescription is covered under their plan is a valuable goal and could 
help reduce costs and lead to better health. However, the usefulness of 
the information is time sensitive and providing this information after 
a prescription has been filled, such as through the EOB or through an 
end-of-the-year annual statement, may allow a beneficiary to make a 
more informed choice going forward, but misses the opportunity to make 
an immediate change, as could be done if the information were provided 
at the point of prescribing.

To this end, we ask members of the Committee to communicate to HHS that 
the agency should adopt provisions that allow the prescriber to make a 
coverage determination and access cost information at the point of 
prescribing. Providing information at the point of prescribing will 
allow the beneficiary to work with his or her prescriber to find 
alternative or lower cost solutions and avoid unnecessary delay and 
potential lapses in therapy.
Electronic Prescribing and the Part D Prescription Drug Plan
NACDS strongly supports patient-centered policies and legislation that 
lower patient costs, including the efforts of HHS and CMS in 
integrating a patient-specific real-time benefit tool (RTBT) into the 
Part D benefit to drive lower prescription drug spending and minimize 
beneficiary out-of-pocket costs. Beneficiaries often arrive at the 
pharmacy counter with little or no insight as to what a medication will 
cost them, which can lead to overuse of unnecessarily expensive 
medications and the underuse of essential medications. We strongly 
agree with CMS that ``reducing medication cost also yields benefits in 
patients' medication adherence'' and that ``increasing patient cost-
share for a medication [is] associated with a significant decrease in 
medication adherence.''\24\ The integration of a RTBT into the Part D 
benefit will give providers and beneficiaries the information needed to 
make better informed choices on their healthcare treatment.
---------------------------------------------------------------------------
    \24\ Id. at 62165.

While appreciating CMS' efforts to improve access to clinically 
appropriate and cost information, NACDS cautions policies utilizing 
RTBTs must be designed to provide information in a manner that allows 
the prescriber to make a determination about whether a prescribed drug 
is covered by the beneficiary's insurance plan without fear of 
``steering'' a beneficiary to certain pharmacies or to mail order. This 
could be accomplished by requiring the beneficiary to select his or her 
pharmacy of choice prior to the prescriber utilizing the RTBT to access 
the enrollee cost-sharing information. Moreover, we believe that the 
RTBT must provide sufficient information to the prescriber and pharmacy 
to facilitate clinical decision making that will inform prescribers and 
pharmacists to assist in determining optimal patient medication 
---------------------------------------------------------------------------
regimens.

RTBTs must also be able to take into consideration pharmacy-level cost-
containment programs, such as $4.00 generic programs, or patient 
assistance programs. Moreover, absent system safeguards, RTBTs can 
inadvertently drive physician prescribing of expensive, therapeutically 
alternatives that are subject to high rebate arrangements between PBMs 
and manufacturers. Such results would needlessly drive up the overall 
spending of the Part D program. Policies utilizing RTBTs must:

    1.  Preserve patient's right to pharmacy selection at the outset;
    2.  Ensure accurate and complete patient's out-of-pocket costs at 
formulary and pharmacy levels;
    3.  Avoid unintended economic costs to taxpayers and beneficiaries 
associated with steering patients to therapeutic alternatives that are 
subject to ``spread pricing'' due to excessive list prices and rebates;
    4.  Not allow commercial messaging within RTBT transmissions; and
    5.  Ensure information integrity, fairness and accuracy among 
others.

Again, we ask members of the Committee to communicate to HHS the need 
for RTBTs to be implemented in a way that serves its goals of providing 
timely information that would lower prescription drug costs.

Conclusion

NACDS thanks the Committee for your consideration of our comments. We 
urge members of the Committee to ask HHS to use their authority to 
include pharmacy DIR fee reform, the development of standardized 
pharmacy quality metrics, and the development of a pharmacy quality 
incentive program in the Final Part D Rule for FY 2020. Additionally, 
we encourage the Committee to support policy solutions that recognize 
the value pharmacy provides in helping combat the opioid epidemic and 
helping reduce patient costs while improving overall health.

                                   