[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.