[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE UNITED STATES PREVENTIVE SERVICES TASK FORCE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
NOVEMBER 30, 2016
__________
Serial No. 114-176
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
GREG WALDEN, Oregon ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
STEVE SCALISE, Louisiana JANICE D. SCHAKOWSKY, Illinois
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi KATHY CASTOR, Florida
LEONARD LANCE, New Jersey JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky JERRY McNERNEY, California
PETE OLSON, Texas PETER WELCH, Vermont
DAVID B. McKINLEY, West Virginia BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas PAUL TONKO, New York
ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia YVETTE D. CLARKE, New York
GUS M. BILIRAKIS, Florida DAVID LOEBSACK, Iowa
BILL JOHNSON, Ohio KURT SCHRADER, Oregon
BILLY LONG, Missouri JOSEPH P. KENNEDY, III,
RENEE L. ELLMERS, North Carolina Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
LEONARD LANCE, New Jersey JOHN P. SARBANES, Maryland
H. MORGAN GRIFFITH, Virginia DORIS O. MATSUI, California
GUS M. BILIRAKIS, Florida BEN RAY LUJAN, New Mexico
BILLY LONG, Missouri KURT SCHRADER, Oregon
RENEE L. ELLMERS, North Carolina JOSEPH P. KENNEDY, III,
LARRY BUCSHON, Indiana Massachusetts
SUSAN W. BROOKS, Indiana TONY CARDENAS, California
CHRIS COLLINS, New York FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 2
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 4
Witnesses
Kirsten Bibbins-Domingo, M.D., Professor of Medicine and of
Epidemiology and Biostatistics, University of California, San
Francisco, Chairperson, U.S. Preventive Services Task Force.... 5
Prepared statement........................................... 7
John H. Lynch, M.D., Chairman And Professor, Department of
Urology, Georgetown University................................. 36
Prepared statement........................................... 38
John Meigs, Jr., M.D., President, American Academy of Family
Physicians..................................................... 45
Prepared statement........................................... 47
EXAMINING THE UNITED STATES PREVENTIVE SERVICES TASK FORCE
----------
WEDNESDAY, NOVEMBER 30, 2016
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:02 a.m., in
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Present: Representatives Guthrie, Shimkus, Murphy, Burgess,
Blackburn, Lance, Bilirakis, Long, Bucshon, Brooks, Collins,
and Pitts.
Staff Present: Rebecca Card, Assistant Press Secretary; Jay
Gulshen, Legislative Clerk, Health; Dan Schneider, Press
Secretary; Adrianna Simonelli, Professional Staff Member,
Health; Heidi Stirrup, Health Policy Coordinator; Dylan
Vorbach, Deputy Press Secretary; Waverly Gordon, Minority
Professional Staff Member; Samantha Satchell, Minority Policy
Analyst; and Arielle Woronoff, Minority Health Counsel.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. The subcommittee will come to order. I might
note that the Democratic members of the subcommittee are still
at their caucus leadership elections. They will come as soon as
they finish that.
The chairman will recognize himself for an opening
statement.
Today's hearing will be taking a close look at the United
States Preventive Services Task Force created in 1984 as an
independent volunteer panel of 16 national experts in
prevention, primary care, and evidence-based medicine and
tasked with making recommendations about clinical preventive
services which could work to improve the health of all
Americans.
The Affordable Care Act required the Task Force to issue
annual reports to Congress, to include information on gaps in
the evidence-based research related to clinical preventive
services, and recommend areas that need further examination
through targeted research. The Affordable Care Act also tied
some of the Task Force recommendations directly to
reimbursement requirements for private insurance.
Recommendations do not consider cost-effectiveness and are
based solely upon evidence of medical benefit to the patient,
no matter how expensive it is. The Task Force independently
evaluates the medical evidence on clinical preventive services
to inform healthcare professionals, healthcare systems, and the
American people to make careful decisions about their health
and health care. It is believed that by identifying evidence
gaps and highlighting them as priority areas for research will
inspire public and private researchers to collaborate, target
their efforts to generate new knowledge, and address important
health priorities.
However, experience has shown that a number of the Task
Force recommendations have the effect of limiting access to
preventive care. For example, one recommendation was against
screening for prostate cancer in healthy men with a prostate-
specific antigen blood test. Another recommendation was against
routine annual mammogram screenings for women age 40 to 49.
Such recommendations contradict clinical guidelines based on
medical literature and experts in the field. The concerns are
that these recommendations could undermine new models of care
delivery.
Our colleague, vice chair of the full committee,
Representative Marsha Blackburn, has a legislative discussion
draft entitled, ``USPSTF Transparency and Accountability Act of
2016,'' which would require specialists and subspecialists to
be involved in reviewing the preventive services examined by
the Task Force. The legislation would allow a wide range of
patient groups, providers, and Federal agencies to be involved
in the important review process of preventive services.
Furthermore, any evidence reports and recommendations would be
available for public comment. Transparency is further enhanced
by establishing a preventive services stakeholders board to
provide feedback on Task Force activities.
We have before our committee today some of the very
stakeholders who can answer our questions surrounding the
proposed legislation. So I look forward to hearing more about
the work conducted by the Task Force, how it might be improved
with passage of this legislation, and recognize----
Anyone seeking time? Dr. Burgess.
Prepared statement of Hon. Joseph R. Pitts
Today's hearing will be taking a close look at the United
States Preventive Services Task Force, created in 1984 as an
independent, volunteer panel of 16 national experts in
prevention, primary care, and evidence-based medicine and
tasked with making recommendations about clinical preventive
services which could work to improve the health of all
Americans.
The Affordable Care Act required the Task Force to issue
annual reports to Congress to include information on gaps in
the evidence-based research related to clinical preventive
services and recommend areas that need further examination
through targeted research. The Affordable Care Act also tied
some of the Task Force recommendations directly to
reimbursement requirements for private insurance.
Recommendations do not consider cost-effectiveness, and are
based solely upon evidence of medical benefit to the patient,
no matter how expensive it is.
The Task Force independently evaluates the medical evidence
on clinical preventive services to inform health care
professionals, health care systems, and the American people to
make careful decisions about their health and health care. It
is believed that by identifying evidence gaps and highlighting
them as priority areas for research will inspire public and
private researchers to collaborate and target their efforts to
generate new knowledge and address important health priorities.
However, experience has shown that a number of the Task
Force recommendations have the effect of limiting access to
preventive care. For example, one recommendation was against
screening for prostate cancer in healthy men with a prostate-
specific antigen blood test. Another recommendation was against
routine annual mammogram screenings for women ages 40-49.
Such recommendations contradict clinical guidelines based
on medical literature and experts in the field. The concerns
are that these recommendations could undermine new models of
care delivery.
Our colleague, Vice Chairman of the full Committee, Rep.
Marsha Blackburn, has a legislative discussion draft, entitled
``USPSTF Transparency and Accountability Act of 2016'' which
would require specialists and subspecialists to be involved in
reviewing the preventive services examined by the task force.
The legislation would allow a wide range of patient groups,
providers and federal agencies to be involved in the important
review process of preventive services.
Furthermore, any evidence reports and recommendations would
be available for public comment. Transparency is further
enhanced by establishing a preventive services stakeholders
board to provide feedback on Task Force activities.
We have before our committee today some of the very
stakeholders who can answer our questions surrounding the
proposed legislation.
I look forward to hearing more about the work conducted by
the Task Force and how it might be improved with passage of
this legislation.
Mr. Burgess. Thank you, Mr. Chairman.
So people familiar with this subcommittee know I never come
without my copy of the Affordable Care Act, and this morning we
are concerned about section 2713, which by Federal statute
linked preventive service coverage requirements to the
recommendations of the federally appointed United States
Preventive Services Task Force.
Interestingly, this entity is not subject to the Federal
Advisory Committee Act or the Administrative Procedures Act,
providing the public with little opportunity for accountability
and transparency and no review and comment period. So we have
seen from past experiences with the prostate-specific antigen,
the PSA test for prostate cancer, from mammograms for breast
cancer, the Task Force recommendations have consequences and
can deprive patients of lifesaving services.
Last year, the GOP Doctors Caucus wrote a letter to CMS
urging them to withdraw the ``nonrecommended PSA-based
screening'' quality measure that was based on Task Force
recommendations. CMS did withdraw the draft measure, but this
situation clearly demonstrates the danger of the broad
discretion that the USPSTF represents to patients.
Legislation, as Chairman Pitts pointed out, does provide
accountability and transparency for the public. It provides
opportunities for stakeholders to give their input. I
understand the value of identifying preventive services. I
recognize that they can prolong the lives of Americans. I
recognize they can save taxpayer dollars. However, it is
important that a process is in place to ensure providers and
patients that they are involved in the development of
recommendations that carry so much weight and that patients and
their doctor retain a share of the decision-making process.
Thank you, Mr. Chairman. I will yield back the balance of
the time.
Mr. Pitts. The chair thanks the gentleman, and now
recognize the vice chair of the full committee, Mrs. Blackburn,
5 minutes for opening statement.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman.
And I am so appreciative that we are moving forward on this
legislation today. And I wish Mr. Rush were already in the
room. I just want to commend him and his staff for the work
that they have done on this issue. And Mr. Rush had a birthday
last week and he thought having this hearing was a pretty good
birthday present for him, because he does want us to move
forward on this.
And our legislation will address some of the concerns that
have been articulated, the growing concern over a number of the
USPSTF recommendations, and the attempt to control cost by
limiting patient access to preventative care. And I appreciate
that the subcommittee is taking the time to drill down on the
issue and that our witnesses are working with us on this.
We want to make certain that the advice and the guidance
that is there is appropriate. And Mr. Burgess said it well,
that patients and doctors are going to have their say in this
process. Congress must not allow Federal agencies to be making
the individual health choices on behalf of providers. Health
decisions in the country must remain between doctors and
patients.
Currently, there is no congressional appointment process or
oversight mechanism within the USPSTF. Further, I am concerned
that the Task Force members do not always meet with relevant
stakeholders during the review process and often there is no
public dialogue with medical specialists who have years of
expertise on the matters that are under review.
Over the years, we have learned that this insular decision-
making process at times directly conflicts with the informed
views of expert physicians. The USPSTF turned its back on over
20 million women by finalizing erroneous guidelines that would
limit access to mammograms for women between the ages of 40 and
50. Their recommendations have impacted PSA tests and skin
cancer checks. Their reach is broad and can impact each and
every one of us at any time.
Therefore, it is timely that this committee examine the
Task Force to ensure transparency and accountability and make
certain those are embedded in the process. Scientific evidence
should motivate decisions but also support informed decision-
making between physicians and patients. It is important that we
reform the flawed system and ensure informed patient-centered
choices are provided.
Congress does have the oversight responsibility, and
today's hearing will help us to better understand the
implications of recommendations and their impact on access to
health care.
Mr. Chairman, I have got six statements for the record, to
submit for the record. These are all in support of the bill.
They are from the Men's Health Network, Solis Mammography, the
National Business Group on Health, the Urology Policy Forum,
and the HR Policy Association. And, with that, I yield back my
time.
Mr. Pitts. The chair thanks the gentlelady.
Is anyone else seeking time? If not, I will add to the UC
request a letter from the National Association of Pediatric
Nurse Practitioners, a statement from ZERO--The End of Prostate
Cancer. And the Democratic members have asked me to enter into
the record a number of documents, including Ranking Member
Green and Pallone's opening statements, letters to the
committee from a number of parties with statements regarding
the Preventive Services Task Force.
Without objection, so ordered.
[The information was unavailable at the time of printing.]
Mr. Pitts. All right. As usual, the written opening
statements will be made a part of the record.
We will now go to our first panel. We have two panels
today.
The first panel--thank you very much for coming today--is
Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., chairwoman of the
USPSTF, the Task Force. So welcome. Your written opening
statement will be made a part of the record. You will be
recognized for 5 minutes for your summary. The chair recognizes
the gentlelady.
STATEMENT OF KIRSTEN BIBBINS-DOMINGO, M.D., PROFESSOR OF
MEDICINE AND OF EPIDEMIOLOGY AND BIOSTATISTICS, UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO, CHAIRPERSON, U.S. PREVENTIVE
SERVICES TASK FORCE
Dr. Bibbins-Domingo. Thank you very much, Chairman Pitts
and members of the House Energy and Commerce Health
Subcommittee. I am grateful for the opportunity to talk with
you today about the U.S. Preventive Services Task Force.
I am the chair of the Task Force, and I am professor of
medicine and epidemiology at the University of California, San
Francisco. I am also a general internist, and I provide primary
care to a diverse population of adult patients at our public
hospital in San Francisco, Zuckerberg San Francisco General. I
have been in practice for more than 15 years.
Primary care providers specialize in preventing disease
before it starts. Let me tell you a bit about a patient I saw
in clinic several weeks ago. Ruth is a lovely, active 63-year-
old woman. During our visit, she asked me what many of my
patients do. What can I do to make sure I live a long and
healthy life to lower my chance of getting sick in the future?
I take my answers to these questions very seriously. I want
to be clear that the things that Ruth and I decide together
have some chance of preventing disease and prolonging or
improving her life. I also want to make sure I can give Ruth a
complete understanding of the side effects of the tests and
treatments. I want to be sure that she is more likely to
benefit from my recommendations than to be harmed. She has put
her trust in me, and I want to know that my advice and our
shared decisionmaking will help her keep healthy for many years
to come.
This is what we do in primary care. We make recommendations
for people without signs or symptoms of disease about services
aimed at preventing future disease and prolonging healthy life.
And because of this important responsibility, it is crucial
that we know what the science says.
I want to help Ruth prevent breast cancer and cervical
cancer and colorectal cancer. I also want to minimize her
chance of developing a heart attack or stroke, to help prevent
her from falling, and to identify any underlying depression.
For Ruth, and for the many patients like her, we look to the
Task Force for guidelines to tell us about the range of
preventive services that might be applicable and whether they
are likely to be beneficial.
As background, the Task Force was established in 1984 under
the Reagan administration. We are an independent nonpartisan
expert panel that works to improve the health of all Americans
by making evidence-based recommendations about clinical
preventive services, such as screenings, counseling, and
preventive medications. All Task Force members are experts in
evaluating the scientific evidence.
We value the input of subspecialists. We have explicit
procedures for working with subspecialists and for getting
their feedback at every stage in our recommendation process.
For example, we are now working to update our recommendation on
prostate cancer screening, and we have engaged 15 subspecialty
experts with expertise in prostate cancer, including
urologists. We have found that engaging subspecialists on
specific recommendations where they have expertise to offer is
the most effective and efficient approach to our work.
I want to be clear that decisions about insurance coverage
are not in our domain. These are the domains of insurers,
regulators, the State, and the Federal Government. We do
maintain that regardless of how health care is financed,
knowing what the science tells us is critical. This was true
when we were created over 30 years ago and it remains true
today.
One of the joys of primary care is being able to develop a
relationship with our patients over time. I look forward to
continuing to get to know Ruth even better and to working in
partnership with her, armed with the science, to make decisions
that can help keep her healthy. As Ruth ages, we will face
different decisions and we will perhaps make different choices.
I know that I can look to the Task Force to help guide our
conversations.
It is the trust in the Task Force's high-quality, unbiased
recommendations that gives us confidence as primary care
providers to answer Ruth and the many, many patients like her
with assurance when they ask, what can I do to live a long and
healthy life and reduce my chance of getting sick in the
future?
Thank you for inviting me to testify today. I look forward
to our discussion.
[The prepared statement of Dr. Bibbins-Domingo follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The chair thanks the gentlelady.
We will now begin questioning. I will recognize myself 5
minutes for that purpose.
Dr. Bibbins-Domingo, in your testimony you mentioned the
extensive process that the Task Force undertakes to produce
your recommendations. Would you please elaborate a little bit
more, explain the structure of your recommendations?
Dr. Bibbins-Domingo. Sure. We have an explicit process for
and procedures that guide the way we do our work. We have an
open nomination process. We publish in the Federal Register and
solicit nominations from the public. When we take on a topic,
we post our draft research plan for public comment, and we
solicit specific comments from specialty groups and from other
groups that might be concerned about specific populations. We
then incorporate all of that feedback into our fi research
plan. That guides how we review the evidence.
When we get the evidence together, our evidence report that
is conducted by the evidence-based research centers, as well as
our draft recommendation statement, are posted for public
comment. We take the public comment process extremely seriously
and we take the process of getting comments from specific
experts in the field very seriously.
We review all of those comments, and then our response to
those comments and how we have changed our recommendation goes
into the final recommendation, which is then issued. We do
about 12 recommendations a year.
Mr. Pitts. OK. Would you please explain the review process
of the comments that you receive through the recommendation
process?
Dr. Bibbins-Domingo. Sure. So we have a Web site. Anyone
can comment on the Web site. We read every single comment. And
the way we address the comments, we summarize at the end of our
document. We highlight all of the themes that come up in the
comments. And then we also not only list the themes in the
comments, but explicitly how we have addressed those themes, so
that someone can see from beginning to end what we are doing in
response to the comments.
Mr. Pitts. How do you incorporate feedback that you have
received through the comment process? Do individuals who submit
comments receive a response directly?
Dr. Bibbins-Domingo. Individuals don't receive a response
directly, but all of the comments are read, and we take
seriously responding to the major themes that are contained in
the comments. And that is why we publish them in our final
recommendation, so that you could trace our response to that
particular theme.
The range of responses might be sometimes people are
bringing attention to specific studies, other times people are
asking us to clarify sections of our document. It is critical
to us that we found all of the evidence and that we communicate
clearly. And so that is how we use our comments primarily to
make sure we have not missed anything in the evidence and that
our statement is as clear as it can possibly be to as many
people who are interested in our recommendations.
Mr. Pitts. Now that the Affordable Care Act ties your
recommendations directly to insurance reimbursements, do you
feel that the Agency for Healthcare Research and Quality still
meets the needs of the Task Force?
Dr. Bibbins-Domingo. The Agency for Healthcare Research and
Quality has done an outstanding job. We have really expanded
our efforts, in the time I have been on the Task Force, to
increase our transparency, to increase our availability to the
public. We have a Web site with over 10,000 hits a month. We
have an app. We have many products to communicate. And the
logistical support for all of that comes from the Agency for
Healthcare Research and Quality.
Mr. Pitts. Do you believe that there should be a
clearinghouse within HHS to modify the recommendations, if
needed?
Dr. Bibbins-Domingo. I am not commenting on the specific
legislation. We believe that the independence of our Task Force
and having an independent body to evaluate science is
essential. What others do after they receive our reports, I
think, pertains to the other decisions that happen after that.
The decisions about coverage, the decisions about other things
that one might do with the recommendations, that should happen
after our process. The science is what is foundational to our
work, and that is what it has been since the beginning and what
we continue to do.
Mr. Pitts. The chair thanks the gentlelady. My time is
expired.
The chair recognizes the gentleman from Illinois, Mr.
Shimkus, 5 minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman.
I am going to kind of go off script because I am curious
on--I have got a couple questions just for you, Doctor. And I
appreciate you coming here and I appreciate your service.
So you are an internist, right?
Dr. Bibbins-Domingo. Yes.
Mr. Shimkus. And you work for a public hospital. Tell me
about the hospital.
Dr. Bibbins-Domingo. I work for the University of
California, San Francisco. So we have many different sites. We
have a VA, we have a community site, we have a public hospital
site.
Mr. Shimkus. So the public hospital, you named it. What
was----
Dr. Bibbins-Domingo. Zuckerberg San Francisco General.
Mr. Shimkus. Is that financed through San Francisco
government taxes partly? I mean, the funding and compensation
for health care is a big deal in this country, and so I am
always curious when there are publicly funded hospitals, safety
net hospitals, they come probably through property taxes or
sales taxes from different entities. I know you may not know
this, but----
Dr. Bibbins-Domingo. We actually do in part, but we also--
about half of our patients are publicly insured patients
through Medi-Cal or Medicare, so that is about our
distribution. And then, of course, we are part of the city
government. I am paid by the University of California, San
Francisco. We are also a public institution, but that is who
pays my salary. And so I get money from the University of
California, San Francisco. The city contracts with me to
provide care there.
Mr. Shimkus. And then the other question is, the public
hospital, there has always been a challenge of directing
patients to, in essence, more urgent care type operations
versus emergency operations. And that is in-house, so it
doesn't matter if it is a private or not-for-profit.
Does that hospital, especially that public hospital, do
they make some effort to try to do that? M-Cal has a lot of
that--if someone is sick, the emergency room, they have to be
seen, whether it is something really life-threatening.
So that has been a challenge in health care cost, because
it is a higher cost venue to go get the the fishhook cut out of
your hand in an emergency room versus going to an urgent care
facility.
Dr. Bibbins-Domingo. Yes. I would say, it is interesting.
Our hospital is the city and county trauma center, but we also
provide primary care. And so my patients I have seen in clinic
I have seen for over 10 years, for most of them. And I would
say, because all of us are professors at the University of
California, San Francisco, we are committed to delivering
evidence-based primary care, and so we are a combination of
both of those things in our system.
Mr. Shimkus. But you don't know how the hospital may try to
direct people from the emergency room care to an urgent care
setting? You don't know how----
Dr. Bibbins-Domingo. I don't know actually how.
Mr. Shimkus. It is a very tactful dance of how, because
probably some people view that that you can't, by the law, if
people want to go. But I'm just----
Dr. Bibbins-Domingo. I would say, since we are the city and
county's trauma center, most of those patients end up--if other
hospitals are doing that, they end up at our hospital. And I
would say that I am not an emergency physician, so I don't know
how the hospital makes those decisions.
Mr. Shimkus. Very good. Well, I'm sorry to get off topic,
but I just was very curious, based upon your testimony. Thanks
for coming.
And I yield back, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman, now recognizes
Dr. Murphy, 5 minutes for questions.
Mr. Murphy. Thank you.
Doctor, it is great to have you here today. So I want to
ask a little bit about the prevention things. And I like the
legislation that my colleague and friend, Mrs. Blackburn, is
putting through here. But I want to ask you about expanding
this.
So you are talking about prevention and about primary care.
I want to see how we expand this and how those things fit in
too. So you are familiar with the concept of primary,
secondary, and tertiary prevention, right?
Dr. Bibbins-Domingo. Sure.
Mr. Murphy. So primary prevention is populationwide, to
reduce or eliminate risk, et cetera; and secondary prevention
are those things that may be by genetics or family or lifestyle
or environment, history, et cetera, where you minimize the risk
that is already there; and tertiary, the people already have
symptoms, you are going to manage what is there.
I am particularly interested in what direction you see us
going into in looking at this as the integrated care of
behavioral and physical health models. I am astounded when I
see the Medicaid data saying that 5 percent of people are
Medicaid beneficiaries, account for over 50 percent of Medicaid
costs, and virtually all those have concurrent mental illness
with other chronic illnesses, for example, people with diabetes
or heart disease or lung disease. It doubles the risk of
depression and other psychological disorders and, untreated, it
doubles their cost.
And when I have seen studies on whether it is people with
migraine headaches, they have a migraine, they go to the
emergency room, they get the mega workup, MRI, CT scan, et
cetera, or when they have issues too--inflammatory bowel
disease, cancer, just pick it out, lots of visits to physicians
and emergency rooms. But when that primary care physician
manages the case very carefully, so it is not just integrated
care but coordinated care, and then capitated care in the sense
that everybody has a stake in this, doing the right thing, how
that works better.
So I wonder if you could comment on primary care and what
we need to do in the areas of medicine and as we look to reform
the healthcare model for delivery, the role the primary care
physician has in that and how they can integrate that
behavioral medicine and physical medicine together for not just
cost savings but, really, life savings. Can you comment on some
of those things?
Dr. Bibbins-Domingo. I think you are commenting on the very
large role for primary care providers. And I think that that is
an important role and one that, for those of us who were drawn
to primary care as a calling, that is why we went to primary
care, to take care of the whole patient, to think in an
integrative way about how we can care for them.
For me and my role in the Task Force, preventive care is a
big part of that. Trying to prevent disease, primary or
secondary prevention, which is in the purview of the Task
Force, is essential to the work that we do, and it is work
that, really, there is no other specialty in medicine that is
doing that. Primary care is the front line doing that.
I think the large role of primary care providers in the way
we deliver care means that we have to be able to provide the
tools for primary care providers to be able to do their work
most effectively. And our role on the Task Force is to give
them the tools for what the science tells us about prevention
in a way that they can make sure that they are delivering high-
quality, evidence-based care in the midst of all of the things
that they are responsible for doing. And that is what we take
seriously on the Task Force.
Mr. Murphy. So when you said that primary care--and I know
we do not have enough primary care providers, and you refer in
your testimony that is a specialty, along with being a
generalist. A study I saw recently was where doctors working
with inflammatory bowel disease, they give examples of people
who have symptoms. And traditionally, it has been one where,
you know, a physician can bill on a fee-for-service model and
just it is a lot of cash. And they say, you know, this person,
they are always calling my office, I am not going to see them.
But they actually flip that around, and the primary
provider says, we are going to see you as often as you need to,
and you are going to have my direct phone number and you can
text me or email me at any time. And they really find that they
keep those people out of emergency rooms and they get more
directed care.
So this is something that you are seeing as well and how we
can put--and some of them even said, hey, the money we save,
they actually have a psychologist on staff, a psychiatrist on
call. They can Skype them at any time. And these people's
healthimprove dramatically. Part of what you are looking at as
well?
Dr. Bibbins-Domingo. Yes. So I really can't comment on how
we finance health care. That is not my area of specialty or the
focus of the Task Force. I can comment on the fact that we do
take prevention seriously and we take seriously both mental
health and physical health, just the things that you are
talking about.
We have a recommendation on screening for depression. And I
think that that was very important, not just the recommendation
and the evidence base, but that we looked in a variety of
different populations--pregnant and postpartum women, older
adults--to make sure that we can address the mental health
needs, and then that we follow it up to make sure that it is
not just screening but followup.
Mr. Murphy. Right. This is what I want to know, that as you
are looking at your data, are you seeing cost savings that
come? That when you screen that person with heart disease and
you recognize they also have depression, when you treat those
things, does it save money? Are you pulling up that data or no?
Dr. Bibbins-Domingo. So we aren't. The Task Force doesn't
consider cost. It is not an area that is our focus. We are
really focused on effectiveness. And so we are focused
primarily--but we know that it is important to identify people
who have underlying depression who may not have those symptoms
at the surface, because when we do that, treating that is
effective for improving their health.
Mr. Murphy. Thank you. Yield back.
Mr. Pitts. The chair thanks the gentleman, now recognize
the gentlelady from Tennessee, Mrs. Blackburn, 5 minutes for
questions.
Mrs. Blackburn. Thank you, Mr. Chairman.
And, again, thank you for being here and for working with
us, because we do want to move forward on this.
I want to go back into your testimony, because you
mentioned the subspecialists that you had identified and used
and that you value their input. So let's talk about process,
and talk to me about how you identify the subspecialists that
you use. The three urologists, let's take that as kind of our
case study. The urologists that you identified for the study on
prostate cancer, go into how you selected them. What is your
decision-making process?
Dr. Bibbins-Domingo. Yes. So I have to say that I don't
know all of the specifics of the process for identifying them.
I will say it is important to us that we evaluate a few things.
One is our process takes a fair amount of commitment to do, so
it takes a period of time. So commitment to the entire process.
We vet the conflicts of interest very seriously, and so that is
an important feature in how we look at this. And we want people
who are going to be experts in this area. That is probably
fundamental. We are looking for people who have expertise in
screening and treating prostate cancer who can help advise us
for every stage.
I don't exactly know how. I do know, and I learned in the
process here, that our chair of urology at the University of
California, San Francisco is one of the experts that is
consulting with us. He is an outstanding physician. But I would
have to defer to--and I hopefully can get the information back
to you----
Mrs. Blackburn. Yes, that would be----
Dr. Bibbins-Domingo [continuing]. On exactly how we choose
them.
Mrs. Blackburn. That would be great. If you would submit to
us what that process is.
Dr. Bibbins-Domingo. Sure.
Mrs. Blackburn. How you all go about it. I think it would
be helpful to us.
And let me ask you this. Did you seek input from the AUA?
Did you go to any of these groups and seek their input and say,
do you have people to recommend? Or did you go to the clinical
oncology, go to the American Society of Clinical Oncology and
say, do you have people that you want to recommend to us?
Dr. Bibbins-Domingo. So, again, I don't want to be off in
my comments on the very specifics here on prostate cancer. I
would say we routinely engage with the specialty societies that
have expertise in the topics. The American Cancer Society I
know, because we do several cancer topics, is one where we do
that.
And so we engage very specifically and deliberately, not
just to help us identify experts, but also to help give us
feedback on each of our steps in our process.
Mrs. Blackburn. OK. And you mentioned you were surprised to
learn that one of your colleagues was serving on the prostate
task force. So what is the transparency modeling for making the
information public of who is serving on these task forces?
Dr. Bibbins-Domingo. Yes. I guess that is publicly
available. My surprise just reflects that I have not looked at
every single expert for every single topic. I was pleasantly
surprised, and I think it reflects not just that I am
recommending our friends but, rather, that there is an
independent process to really find the experts who really have
expertise in this area and who can devote the time to really
giving us feedback throughout the process. So it just reflects
that we do many topics, as I said, and I don't know the list in
all the topics so----
Mrs. Blackburn. You mentioned that you all do not consider
cost.
Dr. Bibbins-Domingo. That is right.
Mrs. Blackburn. So are you concerned that the Task Force
recommendations affect coverage?
Dr. Bibbins-Domingo. It was the decision of Congress to
link the Task Force recommendations to coverage. We existed
before that linkage. And regardless of how health care is
financed, the science of what works, how do we know what works
is essential. We think that is essential to how doctors and
patients make their decisions together. And we know that people
use that information in these other venues, but our processes
have not changed. They have been the same before the ACA, they
have been the same after the linkage was made. And, really, it
is our process and our evaluation of science that is
foundational. It is other people's jobs to determine the
coverage.
The other thing I would say is that oftentimes Congress has
expanded the coverage. They have decided what is supposed to be
covered. That is exactly what we think should happen. That is
not our domain. And so the example in breast cancer, where we
said women from 40 to 74 benefit from screening, 40 to 74 we
have given a grade that there is benefit from regular
mammography screening, the decision of Congress was to cover
all of those women. And that is somebody else's decision. In my
view as a clinician, it is the appropriate decision. And that
is what we think the process should be. We don't do coverage.
We do the science, and other people should determine the
coverage.
Mrs. Blackburn. Do you think that limiting coverage is
linked to your decisions that it is used as a measure to
control cost? Do you think that is inappropriate?
Dr. Bibbins-Domingo. Again, we don't consider cost. We
don't do coverage. Our processes are really for evaluating the
science.
Mrs. Blackburn. But would you call it inappropriate that
limited access many times gets linked to your decisions?
Dr. Bibbins-Domingo. So I would say, as a clinician, I am
always concerned that patients have access. As a clinician, I
understand the value of access.
Mrs. Blackburn. So that would be of concern to you?
Dr. Bibbins-Domingo. I think that those people who
determine coverage and access should act to assure that there
is access for patients who need it. I would like for the
science to help inform, but the decisions about coverage have
always been made by other people, and science is only one of
the pieces that should play into a coverage decision. We think
it is a piece, an important piece, but it is only one of the
decisions.
Mrs. Blackburn. Excellent. I yield back.
Mr. Pitts. The chair thanks the gentlelady, now recognize
the gentleman from New Jersey, Mr. Lance, 5 minutes for
questions.
Mr. Lance. Thank you very much, Mr. Chairman.
And good morning to you, Doctor, and thank you for being
with us.
In your testimony, you mentioned the 2012 prostate cancer
screening recommendation. As I understand it, only 4 percent of
the clinical trial participants were African Americans. And we
all know that African American men have an extremely high rate
of prostate cancer. And I would like your views on that and how
we might improve the process moving forward.
Dr. Bibbins-Domingo. This is such an important issue, I am
really happy that you brought this to light. As you say,
African Americans suffer from prostate cancer at higher rates
and, unfortunately, they are included in our clinical trials
and the evidence base at much lower numbers.
Our process means we have to use the evidence to arrive at
our recommendations. When we don't have the evidence, we don't
substitute our judgment and what we might do in clinical
practice with a particular patient. We can't substitute that.
What we do do is we make specific language in our
recommendation statements to highlight important evidence gaps,
and we hope that this will prompt the scientific community to
then engage in the process of doing the scientific studies that
we need to generate the guidelines.
This is what we did in 2012 with prostate cancer. We
highlighted the fact that it is really a sad reality that we
have so few African-American men included in the trials. We
called for more studies on African Americans and other high-
risk men. That is very important for our evidence base. We also
gave clinicians some tools. We said, we know that you are going
to continue screening some people, and if you do that, we think
you, doctors and patients together, should understand benefits,
should understand harms, and make informed decisions when
making the decisions about screening, because we know that
doctors still need to act without evidence and we try to give
some guidance for doctors and patients to do that.
Mr. Lance. Thank you, Doctor. Are there other minority
groups where the numbers are not as high as they should be,
based upon percentages in the population?
Dr. Bibbins-Domingo. In prostate cancer, it sticks out in
particular. In other recommendations, we have focused on other
groups. For our diabetes and obesity recommendation, we have
focused on Asian Americans and Pacific Islanders. For every
group we have tried to focus on where the evidence gap is
because, especially if that group is disproportionately
affected by a disease, we need the evidence in order to figure
out whether we should be doing something different.
Mr. Lance. Is there a disproportionate effect regarding
certain minority groups related to diabetes, for example?
Dr. Bibbins-Domingo. I think that diabetes occurs at a
lower body weight in Asian Americans, and I think that is what
we wanted to highlight there. It is occurring at high rates,
but it is at a lower body weight, so sometimes physicians may
not know. That is what it says explicitly in our
recommendations. It is important for doctors and patients to
know that a person from an Asian background who might be not
obese by our current thresholds might still have a risk for
diabetes.
Mr. Lance. Thank you. And in another area, how do morbidity
and mortality rates factor into the current scientific review
analysis and reporting on public health matters?
Dr. Bibbins-Domingo. Great. So we look at the rates of
morbidity and mortality for a condition. That is important
background information for all of our recommendations. If there
is a group, a group by age or by race, ethnicity, or by parts
of the country, or something that is disproportionately
affected, we highlight that and we try to understand whether we
need to tailor a recommendation in some way.
Sometimes we don't have enough information to do that, but
we provide all of the information about morbidity and mortality
rates in our recommendation statement, so that the doctor who
is sitting in their own clinic can make the decision for the
patient in front of them. We want to give them all the tools,
and we write much more than just the top line grade so that a
doctor faced with a patient in front of them can make their own
decisions.
Mr. Lance. Thank you very much for your expertise.
And I yield back half a minute, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman, now recognizes
the gentleman from Indiana, Dr. Bucshon, 5 minutes for
questions.
Mr. Bucshon. Thank you, Mr. Chairman.
Good to see you and thank you for being here. As you know,
the house of medicine changes slowly. I was a physician before
I was in Congress, a surgeon. That said, the level of
skepticism, I think, that you are probably hearing from the
committee is based on the fact that the ACA links what you do
to coverage. And the ACA happens and suddenly recommendations
are less testing in certain areas. And so that, unfortunately,
has brought suspicion on your hard work and all the really
quality work that you do. Because there is interest from
governments, whether that is the United States or others, as
well as private payers in what your recommendations are and how
that may or may not save them money. So that is the lead-in to
my questions.
The biggest question I have is, kind of describe how you
choose studies that you might include because, as you know, in
medicine there are literally tens of thousands of clinical
studies that come out from around the world, many of which they
are paid for by different entities, whether that is government,
whether that is private, and also some that are non-U.S.
studies that could call into question whether or not that is
applicable to the American people.
So can you kind of describe how you might figure out, for
example, on just any issue how you pick and choose what studies
to look at?
Dr. Bibbins-Domingo. Sure. Thank you. So the evidence-based
practice centers that are located at universities around the
country, they conduct the evidence review after we give them
the research plan that we agree on.
They are going to comb through all of the evidence, but
they are going to focus primarily and use the studies that are
done in the U.S. That is going to be a particular focus. And
they are going to be particularly concerned about who is
funding the studies, because we know that the people, the
entities that fund studies, they can perhaps dictate or lead to
bias in those studies.
So a best study for us would be a study that is done in the
U.S., that is not funded by industry, that would be funded by
the NIH. That would be probably our highest quality study, and
then, depending on the study design, would be most likely to
inform our particular decision. We rate the quality of a study,
and the quality of the study includes who is funding it and how
relevant it is to our population.
Mr. Bucshon. Yes. Thank you for that. Because some of the
mammogram recommendations came based on some Canadian data, I
think.
So I want to give you the opportunity on some of the more
controversial areas, prostate screening and mammograms, to
maybe clarify what your recommendations actually said,
including some details that might help us on the committee get
a better idea of what they actually said versus what sometimes
the impression that is created what they have said.
Dr. Bibbins-Domingo. Great. So thank you for the
opportunity to do that.
So for breast cancer, I want to be clear. We recommended
that there is evidence--we said, there is evidence that
mammography works for women between the ages of 40 and 74. That
is what we said. It works--there is a greatly likelihood of
benefit in older women than younger women, but we did say that
many women will choose to screen in their forties, because the
evidence says that it works in the forties, even though the
likelihood of benefit is smaller. It is often miscommunicated
that we said women shouldn't get screened in the forties. That
is absolutely untrue. It is not what we said.
In prostate cancer, there is a mixed bag of evidence. There
is evidence of benefits. There is also evidence of important
harms. We said that on balance, that we didn't think there
should be routine screening in everyone. We did say, if you are
going to engage in screening, you should make an informed
decision and know the benefits and the harms.
I want to speak to the issue that you raise that, since the
Affordable Care Act, we have made decisions that appear to take
away something.
Mr. Bucshon. I just said the appearance of. I didn't say
that you had.
Dr. Bibbins-Domingo. I want to highlight that many things--
because we now have more evidence, we now have more confidence
to recommend actually more things. We have a recommendation for
use of statins to prevent heart disease. We have a
recommendation to screen for lung cancer with CT scans. We have
recommendations to screen for diabetes and to screen for
depression. All of those things that we moved from insufficient
evidence to now a B grade evidence, because scientists have
done the work, we now have the evidence and we can make that
recommendation.
Mr. Bucshon. OK. Thank you very much.
Dr. Bibbins-Domingo. Not at all.
Mr. Bucshon. I yield back.
Mr. Pitts. The chair thanks the gentleman, recognizes the
vice chair of the committee, Mr. Guthrie, 5 minutes for
questions.
Mr. Guthrie. Thanks a lot.
And just, actually, Dr. Bucshon asked a couple questions I
was going to ask, but just kind of piggybacking a little, what
do you say--as you said, the appearance. You know, things
happen, things change in Washington, D.C., then you start
hearing recommendations that, as you have described today, is
not really accurate that you said don't screen, have mammograms
when you are 40, wait till later. That is the kind of stuff
that you hear and so you just tie together. That is why these
hearings are important to flesh this out.
And so just looking at transparency, I guess, within your
group. So one of mine was the Task Force--I understand that you
guys have actually, the Task Force has taken steps over the
past years to improve transparency. Do you agree that more can
be done? And then how would you recommend that if the
information you put out isn't accurate, because it certainly
was portrayed in the public that way, how would you kind of
recommend that that information flows better?
Dr. Bibbins-Domingo. So I would say transparency is core,
it is a core principle to the work that we do. If people don't
trust our recommendations, it is not good for us, because we
want people to use our recommendations. So I would say our
efforts over time have been to improve what others see and hear
about us. That is why we have worked to talk with as many
groups that we can who might have an interest in a particular
population or a particular disease about what the Task Force
does. We urge them to read beyond our top-line recommendation
to understand all of the text that we have written, and to help
them use the text how they might use it in clinical practice or
in other settings.
We have worked on our Web site and other tools for
dissemination, other tools to make it easier for doctors and
patients to make the decisions together, because they have
other tools available to them.
I think an important feature of our work is that the
integrity, our conflicts of interest process, and the integrity
of the Task Force, I think, is essential for allowing many more
groups to feel that they can come to the Task Force and their
recommendations and see something they might be able to use.
And I think it has helped us in our dissemination. But, of
course, we always want to work to improve.
Mr. Guthrie. Thank you. And what Dr. Bucshon asked, I was
going to ask you, is how you determine your research plan, how
you determine how you are going to move forward. If you are in
a research plan and you are looking--and say you see something
that has been brought up that, well, we only have 4 percent
African American men, we know that there are different effects
of these kind of studies, that they would be more susceptible
to prostate cancer; therefore, let's change our plan to--I
mean, how do you react to those kind of things within the
research plan? Do you just put an asterisk to say, this doesn't
really reflect this group of people? I mean, that is pretty
serious when you screen or don't screen, based on your makeup.
Yes.
Dr. Bibbins-Domingo. It is a really great question. I had
this discussion most recently with an advocacy group for
African American men with prostate cancer. They gave a summit
here on Capitol Hill on African American prostate cancer
disparities, this group, Prostate Health Education Network,
PHEN. They provided us comments on our research plan. We posted
the draft. We included a lot of information about African
American men that we hope to be a focus.
They provided us comments that made it clear that we should
include different types of studies. And so based on their
comments, we actually expanded our research plan directly in
response to their comments. And I was really happy to see, when
I went to this particular summit, that they commented that they
could see the changes in our research plan.
I will say in the end, when there are no studies, that is
itself a limitation, because we cannot not make guidelines on
no evidence.
Mr. Guthrie. Right.
Dr. Bibbins-Domingo. So we have to call for more research
when there is no research. But we always provide language that
hopefully helps doctors and patients make decisions even in the
absence. And so the fact that African Americans are
disproportionately affected, they have higher rates, those are
the types of things we include in our recommendations so that
doctors and patients might make that decision, even in the
absence of evidence saying that the screening is effective.
Mr. Guthrie. Well, thanks for that. And the discussion
draft we are looking at today requires collaboration between
other agencies. And I believe collaboration is key, it must be
done to connect all health agencies. How often does your group,
your Task Force work with NIH, DOD, CMS, or the VA?
Dr. Bibbins-Domingo. Oh, we are really fortunate to have
very strong partners. And the National Cancer Institute is one
of our strongest. They come to all of our meetings. They give
their input on what science might be in progress that they have
funded. And they take very seriously when we say we are stuck
here because we don't have enough evidence in this area. That
helps inform how they might prioritize certain types of
research within their agency.
The DOD is present there. I can't remember all of our
partners, but our partners are present at our meeting, and that
has been essential to us, both for providing input to us but
also for helping to disseminate, to get the words out to their
own communities, and to informing other research.
Mr. Guthrie. Well, thank you, and I appreciate your
answers.
And I yield back.
Dr. Bibbins-Domingo. Thank you.
Mr. Pitts. The chair thanks the gentleman, and now
recognizes the gentleman from New York, Mr. Collins, 5 minutes
for questions.
Mr. Collins. Thank you, Mr. Chairman.
Thank you, Doctor, for coming in. I think you have answered
a lot of our concerns, but I guess I would just like to
reiterate on the specialist piece. We do hear from some of our
urologists and others on the specialty care piece that the Task
Force is primarily made up of the primary care type physicians,
but as you have moved into making some recommendations in the
specialty areas.
I think you have answered a lot of those concerns here, but
just to follow on just to make sure that is always top of mind
that these folks are concerned. They are worried. You can
understand why.
Dr. Bibbins-Domingo. Absolutely.
Mr. Collins. But to follow up on something Representative
Blackburn asked you about, the cost piece, I think you said you
don't factor in cost. But if I could just read something to
you, and I just looked up the current law on the Task Force,
and it says directly, ``The Task Force is directed to review
the scientific evidence related to the effectiveness,
appropriateness and cost-effectiveness of clinical preventive
services.'' So really, that is in your charter to take into
account the cost-effectiveness, yet--is there a disconnect here
where you said you don't take into account cost?
Dr. Bibbins-Domingo. You are right that it is in our
charter. We have never in our 32 years considered cost. It is
explicitly on our Web site. It is our policy not to consider
cost. And the main reason is we want people to focus on
effectiveness. We want people to understand what works and not
to get confused that we might be rationing or trying to
withhold something or trying to shift in any other way. We made
our own decision not to consider cost, because we have left it
to other people to make that determination related to coverage.
But you are right, it is in our charter, but we have never
done it in the 32 years we have been in existence.
Mr. Collins. Shouldn't you change your charter then or ask
us to--there is always the issue. It is there for a reason and
you are just ignoring it. I mean, it is not supposed to work
that way.
Dr. Bibbins-Domingo. It is a good question. I personally
think that--and I think that the rationale behind the Task
Force making the decision not to consider cost is because
people get worried that we are withholding things or making
decisions because of cost. We want to start first with what
works. And by not considering cost, we can focus on what works.
Mr. Collins. Well, just a recommendation. If that is on
there, you should perhaps put a disclaimer that says, even
though we were directed to do this, we have, in our own
judgment, decided to ignore that and here's our reason. I know
why you might not want to do that.
Dr. Bibbins-Domingo. Yes.
Mr. Collins. It might make people not realize you are doing
that. But transparency is transparency.
Dr. Bibbins-Domingo. Yes.
Mr. Collins. So you have answered the question. Question
asked, question answered. I would say I think you owe it to put
something like that up there or change the charter or get us to
change it. I mean, you realize you are kind of operating in the
smoke-and-mirror world.
Dr. Bibbins-Domingo. Actually, Congressman, I believe it is
on our Web site.
Mr. Collins. OK.
Dr. Bibbins-Domingo. I appreciate that we might be able to
make it more widely aware that that is the case, but I do
believe it is on our Web site that we don't consider cost.
Mr. Collins. You have answered the question and I brought
it up, and thank you for that.
And with that, Mr. Chairman, I will yield back.
Mr. Pitts. The chair thanks the gentleman.
That concludes the questions of the members who are here.
We will have followup questions. I am sure other members will
have questions. We will send those to you, ask that you please
respond.
Dr. Bibbins-Domingo. OK.
Mr. Pitts. With that, thank you very much, Doctor.
And we will call our second panel to the witness stand. And
there are two members, and I will introduce them in the order
of their presentations. First, Dr. John Lynch, member of the
American Urological Association, Chairman, Professor,
Department of Urology of Georgetown University; and secondly,
Dr. John Meigs, M.D., F.A.A.F.P., President of the American
Academy of Family Physicians.
Thank you very much for coming today. Your written
statements will be made a part of the record. You will each be
recognized for 5 minutes to summarize your testimony.
So I would like to first recognize Dr. Lynch for 5 minutes.
STATEMENTS OF JOHN H. LYNCH, M.D., CHAIRMAN AND PROFESSOR,
DEPARTMENT OF UROLOGY, GEORGETOWN UNIVERSITY; AND JOHN MEIGS,
JR., M.D., PRESIDENT, AMERICAN ACADEMY OF FAMILY PHYSICIANS
STATEMENT OF JOHN H. LYNCH, M.D.
Dr. Lynch. Chairman Pitts, Ranking Member Green, members of
the Energy and Commerce Health Subcommittee, and honored
guests, my name is Dr. John Lynch, and I am testifying today as
a member of the American Urological Association, and as a
practicing urologist, prostate cancer researcher, and professor
and chairman of the Department of Urology at MedStar Georgetown
University Hospital.
Mr. Pitts. Just pull it closer to you a little bit. Yes,
thank you.
Dr. Lynch. I also appear before you today as a prostate
cancer survivor, who feared that if the U.S. Preventive Task
Force recommendations were in existence when I was diagnosed,
my prostate cancer might have been missed. Early detection
saved my life, which is why this hearing today is of utmost
importance.
The AUA would like to thank the subcommittee for taking an
in-depth look at H.R. 1151, the USPSTF Transparency and
Accountability Act. This legislation, spearheaded by
Representatives Marsha Blackburn and Bobby Rush, would make
four key reforms to enhance the transparency and accountability
of the Task Force. First, it would ensure that representation
of the Task Force is balanced, to include practicing specialty
care providers. Second, the bill requires an accountable and
transparent process for comments and considerations related to
research plans and recommendations. Third, the bill would
establish an advisory board to ensure regular input from
interested stakeholders and Federal agencies and payers likely
to be impacted by Task Force recommendations. Fourth and
finally, it would require a process to request review of
previous recommendations when additional peer-reviewed
scientific evidence is available.
These reforms are necessary because the Affordable Care Act
requires coverage without copayment, coinsurance or deductible
when provided by an in-network provider for certain age-
appropriate preventative health services. Those services
include Task Force recommendations with grade A or B. This
change in law shifted the role of the Task Force from a
scientific advisory body to a body with the authority to
influence Federal benefit and coverage requirements.
However, the long-term impacts of these recommendations
aren't always clear. For many patients, the stakes are high.
Earlier this year, the Task Force published a final research
plan to update the PSA screening recommendation. That is a good
thing and something urologists and many patients have been
urging for for the past several years. However, since the
release of the 2012 recommendation, providers face conflicting
recommendations and patients did not know how to determine what
was best for their individual needs.
More accountability and transparency in the Task Force
process would help identify evidence that should be reviewed
and identify any potential issues earlier in the process.
Likewise, it would be helpful for the Task Force to acknowledge
other recommendations or practice guidelines available in the
medical and patient community as well as those issued by
Federal agencies.
The recommendations clearly have an impact on patient care.
Last year, the Journal of the American Medical Association
published two peer-reviewed studies which documented that fewer
men are being screened for prostate cancer and fewer early-
stage cases are being diagnosed and detected. These studies
highlight that the cases have not dropped because the disease
is becoming less common but because there is less effort to
find it.
Because prostate cancer often grows slowly, the Task Force
said, screening finds many tumors that may have never harmed
the patient, resulting in potential overtreatment for some
patients.
As a result, it concluded, testing saves few lives and
leads too many men into unneeded surgery or radiation, which
potentially leaves them impotent and incontinent.
I and many other urologists strongly disagree with the Task
Force's assessment. Rather than issuing a blanket
recommendation that ends screening, it would be better to
screen smarter. These decisions are best made between the
physician and the patient, taking into consideration their
individual risk factors and family history.
The AUA's 2013 guideline emphasizes the importance of
shared decisionmaking as well as a consideration of risk
factors. Representation by urology or other medical specialties
is noticeably absent from the Task Force. By including, in some
manner, those that treat conditions for which recommendations
are being made, the Task Force will ensure appropriate
interpretation of currently available literature and can
benefit from added expertise and input into the diagnosis and
treatment of a disease or condition, as well as ensure the
appropriateness and relevance of recommendations in a clinical
setting.
I understand that every specialty provider cannot be
represented full time on the Task Force, but having a specialty
voice for individual recommendations can improve the outreach
and review process. Likewise, an advisory board would allow
more formal and consistent input and improved engagement of
interested stakeholders.
I hope that Congress will enact USPSTF Transparency and
Accountability Act to improve the process for determining
preventive care coverage and access for patients. I am happy to
answer any questions or follow up with any additional
information.
Thank you, Mr. Chair.
[The prepared statement of Dr. Lynch follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The chair thanks the gentleman.
Now recognizes Dr. Meigs, 5 minutes for your summary.
STATEMENT OF JOHN MEIGS, JR., M.D.
Dr. Meigs. Chairman Pitts, Ranking Member Green, and
members of the Health Subcommittee, thank you for the
opportunity----
Mr. Pitts. Can you poke the button? Yes. That's it.
Dr. Meigs [continuing]. To testify on behalf of the
American Academy of Family Physicians and our 125,000 members.
I am honored to serve as AAFP president, and I proudly
represent physicians who, like myself, provide essential
primary care services and rely on the integrity of the U.S.
Preventive Services Task Force. It is important to note that
the cornerstone of optimal health depends on a robust primary
care and preventive health system.
Decades of studies confirm that States with a higher
concentration of primary care physicians have better health
outcomes, including lower rates of all-cause mortality, even
after controlling for socioeconomic, demographic, and lifestyle
factors. Research also shows that the benefits of primary care
are measurable. An increase of one primary care physician for
10,000 people is associated with an average mortality reduction
of 5.3 percent. In real terms, in real lives, that represents
49 fewer deaths per 100,000 of the population per year.
In addition, high quality primary care is necessary to
achieve the triple aim of better patient care, improve
population health at lower cost. Evidence-based Task Force
recommendations help family physicians frame discussions with
patients who are at risk for disease, guiding them to make
informed decisions based upon timely scientific information and
their personal preferences.
For example, when the Task Force made its 2009 decision
about mammography screenings for women aged 40 to 49, my
patients had questions. We discussed what the recommendations
meant for them as individuals, considering their health status,
family history, and personal preferences. My patients came to
different decisions. Some wanted to screen anyway, others
declined.
Currently, four family physicians serve on the Task Force,
and the AAFP has its own experts who also review the evidence
and Task Force recommendation statements that we adopt and
share with our members. Overall, the AAFP has come to rely on
the Task Force's objective rigorous assessment of scientific
medical evidence. The AAFP believes the current composition of
the Task Force is appropriate and should not change. Thus,
enactment of H.R. 1151, in our opinion, would undermine the
Task Force.
First, H.R. 1151 calls for specialty representation on the
Task Force. Subspecialists already contribute to the Task Force
process, and their expertise is consulted every step along the
way, and the final vote is left to those with expertise in
primary care and evidence-based preventive medicine.
While we respect our specialty and subspecialty colleagues,
their role in treating specific conditions and organ systems is
not the same as developing guidelines to screen for and prevent
such conditions.
Second, the legislation would require input from the
broader healthcare industry. In recent years, Task Force
members and even our AAFP liaisons have been subjected to
intense lobbying from professional societies as well as
pharmaceutical and medical device companies that have
significant economic interest in its recommendations. I have no
doubt that pressure from these groups would only increase if
H.R. 1151 were to be signed into law, and consequently, family
physicians would be unable to trust that the Task Force's
recommendations were completely unbiased.
Third, the legislation would require the Task Force to
assess how its decisions or grades would impact access to
health services, devices, Federal programs, or private health
insurance coverage. The AAFP strongly supports the current
process and function of the Task Force and believes that its
recommendations should be independent of cost and access
considerations.
In conclusion, I want to call your attention to two key
principles. The first is an underlying tenet in all of
medicine: Primum non nocere, first, do no harm.
The second principle, which is not unique to medicine but
certainly seems apropos to today's discussion is if it ain't
broke, don't fix it.
Ladies and gentlemen, the U.S. Preventive Services Task
Force is not broken. It does important good work on behalf of
primary care physicians and our patients. I urge you to
maintain this valuable source of unbiased evidence-based
primary care guidance. Please, do no harm.
Again, I thank you for inviting me to testify, and I would
be happy to answer any questions you might have for me.
[The prepared statement of Dr. Meigs follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The chair thanks the gentleman, and we will now
begin questioning. I recognize myself 5 minutes for that
purpose.
Dr. Meigs, in your testimony, you mention the importance of
the doctor-patient relationship. I agree with that. How do we
ensure the Task Force recommendations still value this
relationship with the insurance tie to the Task Force
recommendations?
Dr. Meigs. The Task Force recommendations apply to the
population, and it is a difficult concept to understand when
you are talking about the population as a whole or an
individual. It still is important, when I have my patient in my
exam room, that she and I or he and I discuss the risk and
benefits, the harms, cost, and concerns about whatever
treatment may be under discussion.
So we use the Task Force recommendations as a starting
point as the basis for a discussion, but that is a
recommendation based on what is best for the population. That
does not change the individual decision that I make with my
patient one-on-one.
Mr. Pitts. All right. Dr. Lynch, as you know, the Task
Force was formed in 1984. What do you think the true impact of
the Task Force has been? Is there a way to measure their
influence on the health of our Nation within the physician
communities?
Dr. Lynch. Well, I can address that specifically to
prostate cancer, which I am far more familiar with and can tell
you that there is now evidence in the literature, following the
2012 recommendations, and I have personal experience with this
as well, that we are seeing a larger percentage of men with
metastatic prostate cancer and higher rate and higher stage
prostate cancer than we did before these recommendations. So I
would say that that has had a deleterious effect on the health
of these men.
Mr. Pitts. As a urologist, would you please speak to the
specific importance of regular PSA test? Why do you think the
Task Force did not recommend routine PSA tests in 2012?
Dr. Lynch. I know the Task Force has excellent intent. They
base their recommendation on 2012 primarily based on two
studies. One was called the PLCO study, which is in the United
States, and the other was the European trial. The PLCO study is
flawed in that actually a report of the New England Journal of
Medicine last year described how there were actually a higher
percentage of men in the arm that was not supposed to be
screened who actually received screening than the men in the
screened arm. So there is really no differences in those two
arms, and one would not expect to show a mortality difference.
So I don't think the literature was there to really support the
recommendations.
Mr. Pitts. So how do you think the Task Force can prevent
something like this from happening in the future?
Dr. Lynch. By involving specialists who treat the disease.
I understand, as I said in my testimony, that not every
specialist can be present on the Task Force, but I think a
specialist has a different skill set, and a lot of them are
experts in evidence-based medicine who would actually add to
the Task Force. And I certainly think the importance of the
advisory board comes through with that when you can have
specialists in open dialogue, just like this is an open
hearing, you can have an open dialogue between an advisory
board and the Task Force to try and look at these issues and
discuss these issues in person.
Mr. Pitts. How often do you think the Task Force should
review recommendations they have previously issued?
Dr. Lynch. I think that depends on the literature, and
there should be access to be able to do that. I think, for
example, if they make a recommendation today, and there is
evidence in the literature next year to support a different
recommendation, they should be able to review that and change
that. Waiting 5 years is too long.
Mr. Pitts. Would you please elaborate on your views of the
grading system the USPSTF uses for recommendations? Do you
believe the discussion draft addresses your concerns?
Dr. Lynch. The grading systems are A, B, C, and D. Right
now, a patient's coverage is tied to A and B. I think that the
draft legislation would help to improve that system by giving
more input, again, to the Task Force and providing more
evidence from specialists.
Mr. Pitts. In your testimony you mention the disconnect
between practicing physicians and the Task Force. Would you
elaborate on that a little bit?
Dr. Lynch. I can elaborate. If you look at the makeup of
the Task Force, for example, there are primary care physicians,
there are internists, there are geriatricians, there are
pediatricians, there are obstetrics and gynecology. There is no
one representing men's issues. Men's health is certainly an
important issue.
Urologists--interestingly enough, in this area, there are a
fair number of my patients who don't have a primary care
physician and don't have an internist. So even yesterday I had
to talk about tobacco cessation, talk about weight reduction
for an obese patient, alcoholism, depression, in addition to
their prostate cancer. So I think adding an additional person
to deal with that would also be very beneficial.
Mr. Pitts. Do you believe the discussion draft before us
today would solve some of this disconnect?
Dr. Lynch. Yes, I do.
Mr. Pitts. Thank you. My time is expired.
The chair recognizes the vice chair of the full committee,
Mrs. Blackburn, 5 minutes for questions.
Mrs. Blackburn. And I will not take all of my 5 minutes. I
do want to thank you all for being here.
And, Dr. Lynch, let's go back to your testimony. The AUA
guidelines differ from the USPSTF guidelines. So I want you
just to walk us through a patient who comes to you and needs
that care, and what does the impact and the difference of those
guidelines have on the care that that patient has access to?
And I appreciate what you just said about timely review. I
think that technology, advances in technology, utilization of
informatics and delivery of health care is something that
changes so rapidly. We never keep pace with that. Government
doesn't keep pace with that. So I think the differences in
these guidelines, how often you all change yours, what you see
or what hesitancy you see from the Task Force, if you will just
speak to that and that relevance to the patient.
Dr. Lynch. Congressman Blackburn, thank you for the
question. If I can give you a specific example----
Mrs. Blackburn. I would love it, yes.
Dr. Lynch [continuing]. Related to a patient. About 8 weeks
ago, I had a African American gentleman walk into my office in
his mid-50s with some urologic symptoms. After a day or two of
testing, I had to sit down with this gentleman and tell him
that he had metastatic prostate cancer that had spread
throughout his skeleton, that he was treatable but certainly
not curable.
I went back and reviewed his records. He had been
receiving, at high risk as an African American male, PSA
testing up through 2012, and then his internist or primary care
physician stopped getting the PSA. He did not have evidence of
prostate cancer in 2012. Now he has widely metastatic prostate
cancer. That was a difficult discussion.
He asked me why, why didn't he do this, why didn't they get
this test? It's a very difficult situation to deal with, and
unfortunately, we are seeing it more and more.
Mrs. Blackburn. OK. Thank you.
And with that, Mr. Chairman, I yield back.
Mr. Pitts. The chair thanks the gentlelady.
I now recognize the gentleman from Pennsylvania, Dr.
Murphy, 5 minutes for questions.
Mr. Murphy. Thank you, Mr. Chairman.
I don't know if you heard some of the questioning I had for
the previous presenter, but I want to raise some of those for
you as well, and then looking at the integrated care model and
noting how, when we are looking at behavioral and physical
medicine together and managing them in terms of primary,
secondary, and tertiary prevention, whether it makes a
difference in terms of quality of care.
Obviously, the patient you just mentioned must have been
dealing with a great deal of psychological issues at that
moment of describing it, and we know a person can be
overwhelmed with anxiety, with panic, with depression,
deterioration of family, other stresses that can come with a
diagnosis or even a risk of a problem. And I have seen studies
where people have actually looked at this, having the primary
care physician work with the specialist and very carefully
managing the psychological and the physical medicine aspects,
and they improve compliance or they reduce errors, medication
compliance, et cetera.
I am wondering if, in your work, you have also looked at
those aspects as well and what you have found in looking at
those parts of prevention and cost savings and better care.
Dr. Lynch. Well, I think that is key, and I think, again,
as the urologist delves into a lot more of men's health and
their urologic issues, a conversation back with their internist
or primary care physician. Because sometimes they will bring
things up to me, as the urologist, that they won't necessarily
bring up to their primary care physician. So the dialogue back
from the specialist to the primary care is getting--the key to
getting that patient the care that he needs and wants and that,
in the long term, is going to reduce costs.
Mr. Murphy. Do you also then, with that, do screening, or
do you recommend the primary care physician also do some
screening for other things like depression, anxiety, and the
impact that may have upon their illness?
Dr. Lynch. Absolutely. And we do that as urologists,
especially in dealing with cancer patients. That is a very
frequent occurrence, and that is something we have to watch
very closely for.
Mr. Murphy. Dr. Meigs, do you do work in this area, too, in
that same--look into behavioral, physical medicine aspects?
Dr. Meigs. In primary care and family medicine, we see
behavioral and psychological problems every day all day long.
That is an extremely important part of our practice, and there
is no way for a good primary care physician to divorce mental
health and behavioral health from physical or other sources of
health care. We treat people. We don't treat organ systems or
diseases. We treat the whole person. And if you ignore that
subset of problems, you have not adequately treated the
individual.
So we are especially in tune to looking for the depressed
patient, the anxious patients, patients with other mental
health issues that need to be addressed because they most
definitely have an effect on their physical health.
Mr. Murphy. In testimony we have heard before this
committee in other parts of Energy and Commerce, we recognize a
person who has a severe mental illness, for example, 75 percent
of the cases have at least one other chronic illness, 50
percent have at least two, a third have at least three, and
that also the person with severe mental illness has triple the
risk for poverty, and the person in poverty has triple the risk
for severe psychological disorder. The list goes on and on as
you have these.
And that we have heard that some practices which actually
employ people to work in behavioral medicine, social worker,
psychologist, or have telemedicine with a psychiatrist there,
they can address those things immediately as opposed to saying,
here is a card, call this person, and let us know what happens.
Because when it is just a referral, compliance drops below 50
percent. When it is in the office, a warm handoff, it is high
level.
So in the practice of primary care and family medicine, is
that something that you are able to do or do you see that,
look, that is not billable hours right now, and so we can't do
that but even though there is a need?
Dr. Meigs. There is a shortage of primary care physicians.
There is just as much a shortage of mental health workers,
psychiatrists, and psychologists. I would love to have one in
my office. I could use them every day.
I practice in a rural community of 2,700 in central
Alabama. There are no mental health professionals. That is a
big area of concern for me and my patients. When I have
patients whose needs exceed my abilities, trying to find
someone to see them or somewhere they can get to, then you get
into the other social determinants of health, they can't afford
the transportation, they have no one to take them, they have
all the other issues that become involved when we are trying to
meet a real critical need for these people.
Mr. Murphy. So that you know, we are going to have a bill
before the House in a couple of hours here to vote on, such
things as providing telemental health consultation for primary
care, and I hope that is something that we can get into
nationwide to really help the rural areas. Over half the
counties in America, as I said before, have no psychologist,
psychiatrist, social worker to deal with these things, but we
know it is a pervasive problem throughout the field of medicine
that is hurting patients.
We want to hear more from you in the future of how we can
do this with secondary and tertiary prevention and help reduce
the problems. Thank you very much.
I yield back.
Mr. Pitts. The chair thanks the gentleman.
I now recognize the gentleman from Indiana, Dr. Bucshon, 5
minutes for questions.
Mr. Bucshon. First of all, thank you both for being here to
testify today.
And, Dr. Meigs, I respectfully disagree that a specialist
might not have more input. I mean, as both of you know, this is
a classic house of medicine battle that starts in the first
year of medical school between--in primary care providers and
specialists, and it is seen here today again, unfortunately.
But it is what it is. We all work together. We all know we have
a specific role in taking care of the patients.
But in this particular instance, just when we are looking
at studies and input to try to decide what the appropriate
screening is, what is the down--what would be the downside of
having more specialist input, other than, from my--as a
specialist, other than as a battle between in the house of
medicine that begins literally in the first year of medical
school? I mean, what would be the potential downside?
Dr. Meigs. I certainly would hope that--and I am sure our
urology colleagues are more than competent to take care of the
urological diseases, but the U.S. Preventive Services Task
Force, their job is to look at the evidence and make
recommendations for primary care on screening for primary
prevention of diseases.
It is a different concept. And as we have already
testified, they bring in the they bring in the consultants,
they bring in the specialists to evaluate the evidence. But
these are physicians and others who are specialists in primary
care, in preventive care, in evaluating evidence, and making
recommendations on the quality of the evidence as to an
unbiased recommendation I can use every day in the exam room
with my patient about what is best for them.
Mr. Bucshon. Yes. I saw a lot of patients with tertiary
care disease and heart disease primarily, right, or lung
cancer. And I have found in my own practice that working
together with my primary care referring doctors, that that kind
of collegial discussion about what my treatment options were of
their patient for this particular thing, whether or not I have
an area of expertise, which I don't claim to have in primary
prevention, it just seems to me that there is not really a
downside to at least having specialists involved in discussing
what the potential treatment options are and what the potential
downsides are of changes in screening recommendations. Because
as Dr. Lynch has pointed out, it does affect specialists if you
change the screening recommendations for prostate cancer or
breast cancer or other things.
To get that, at least followup input maybe later on, like
we are getting from the 2012 recommendation, say, hey, look
here is the result, primary--how would primary care physicians
know that that is the result until their patient comes back to
them with problems that were recognized at a later state? That
is all I am saying.
I just think that the more input you get in healthcare--I
found that to be true as a heart surgeon. If I had an
infectious problem, I would call an ID person. I got as many
minds thinking about a problem as I could get on behalf of the
patient.
So I am just trying to get why there is a potential
downside in having more input on this. As a specialist, I am
having a hard time seeing that.
Dr. Meigs. As you well know, a lot of the diseases that you
treated and that we all treat are preventable.
Mr. Bucshon. They are, yes.
Dr. Meigs. For me, it is a success if my patient needs you
when he is 85 instead of when he is 45 because I treated his
blood pressure----
Mr. Bucshon. I agree.
Dr. Meigs [continuing]. I treated his cholesterol, I got
him to exercise, I got him to lose weight and eat better, then
I think that has been a success. You have a much more dramatic
outcome, but I think the value to the society is just as good
for what I do in that case.
Mr. Bucshon. Absolutely. You are getting no disagreement
from me. In fact, in the last seconds I have, I want to address
the nationwide shortage of primary care physicians, and we are
trying to figure out why that is. And we have to address that
issue in our country.
Southern Indiana, rural Indiana where I live, we have a
critical shortage in our rural counties of primary care
physicians. And to your point, without that success that you
have for your patients, the patients end up seeing me or Dr.
Lynch at a later stage.
So it is critically important. We are adding a medical
school branch of Indiana University Medical School in
Evansville, Indiana, more residency programs. And so as a
Member of Congress, I am doing what I can to get that message
out, that whatever we can do to increase primary care, we
should be doing.
Dr. Meigs. For preventive care and primary care, when I
send a patient to you, I have got a failure.
Mr. Bucshon. I understand.
I yield back.
Mr. Pitts. The chair thanks the gentleman.
That concludes questions of members present. As always----
Mrs. Blackburn. Mr. Chairman----
Mr. Pitts. Yes.
Mrs. Blackburn. May I reclaim a moment of my time just to
make----
Mr. Pitts. All right. Go ahead.
Mrs. Blackburn [continuing]. One clarification for the
record. Going back to what Mr. Collins had said, going to the
USPSTF Web site, I think we do want to note that under the
standards for guidelines and development, in that section, they
absolutely do not list that they don't consider cost or they
don't note that they do not follow their charter. And when you
go to a screen shot or you go to your Web page, and this is a
screen shot of it, and enter the word ``cost,'' nothing comes
up. So we may want to just consider that as we look at changes
for the Task Force.
I yield back.
Mr. Pitts. The chair thanks the gentlelady for her
clarification.
We will have followup questions, other members have
questions, we will send those to you. We ask that you please
respond. I remind members that they have 10 business days to
submit questions for the record. Members should submit their
questions by the close of business on Wednesday, December 14.
So thank you very much for coming, for your expertise, for
sharing in a very important hearing.
Without objection, this hearing is adjourned.
[Whereupon, at 12:26 p.m., the subcommittee was adjourned.]
[all]