Deputy Secretary Hargan Speech at AMA’s National Advocacy Conference
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Deputy Secretary Hargan Speech at AMA’s National Advocacy Conference


Good morning, everyone, and thank you for
having me to speak to all of you today. I apologize that, due to a last minute issue,
Secretary Azar was not able to join you all today. I know he wishes he could have been here,
and greatly enjoyed addressing this meeting last year. Today, before I talk a bit about President
Trump’s and HHS’s vision for healthcare and the role physicians play in it, I want to
provide an update on our efforts to combat the China coronavirus. As we respond to the evolving outbreak, the
attention and dedication of America’s physicians have been vital. Our sympathies go out to everyone in the United
States, in China, and elsewhere who have been sickened by the virus or seen loved ones fall
ill. We were saddened to learn of the death of
the first American citizen recently, a 60-year-old woman in Wuhan. Our gratitude goes out to those responding
to the outbreak in China, here in the U.S., and around the world. Physicians and other healthcare professionals
are the backbone of our public health system, which is the best in the world, so thank you
for the work that many of you have done already. There have now been 13 confirmed cases of
the China coronavirus in the United States, including two cases of transmission to people
who had not recently been to China. There are many unanswered questions about
the virus, and we’re working as quickly as possible to answer them. These questions include exactly how rapidly
it spreads, how deadly it is, whether it is commonly transmitted by patients who are not
yet displaying symptoms, and other issues. Right now, our scientists and public health
experts are trying to resolve these questions using the data we have from China and the
cases we have here. In the very near future, we hope, they will
be able to work with their Chinese counterparts and other international experts on the ground
in China. We can expect to see more cases here in the
United States in all likelihood, identified by an American physician or other healthcare
provider, which is the way we’ve identified the vast majority of the cases here so far. The immediate risk to the American public
at this time is low, and we are acting swiftly to keep that risk low. But, as Secretary Azar has emphasized, the
situation has the potential to change very rapidly, and we are constantly preparing mitigation
strategies that would be necessary if the situation does change. I want to give you a sense of the coordinated
work that’s going on across the government. The State Department, HHS, and other agencies
have been working to help Americans return to the U.S. from Wuhan if they so desire. Here at home, physicians, hospitals, and state
and local health departments are working with CDC to follow the playbook for infectious
disease response: identify, diagnose, isolate, treat, contact-trace. Last week, FDA issued an Emergency Use Authorization
for the CDC’s diagnostic test for the virus. The CDC’s test kits are now available for
order by U.S. state and local public health laboratories, Department of Defense laboratories,
and select international laboratories all told, 191 international laboratories and 115
labs here at home. The FDA is also assessing the risks that the
outbreak could present to American medical supply chains. For years, we’ve been aware of the potential
for outbreaks to impact and possibly disrupt supply chains, and that has been a focus for
some time at FDA and HHS’s emergency response arm, the Assistant Secretary for Preparedness
and Response. Since the start of the outbreak, the FDA has
established direct communications and provided direct points of contact for manufacturers
of finished drug products and active pharmaceutical ingredients. Our Biomedical Advanced Research and Development
Authority, or BARDA, has expanded its work with a pharmaceutical company around a candidate
therapeutic for the virus. The National Institute for Allergy and Infectious
Diseases, under Dr. Tony Fauci’s leadership, is collaborating with a biotechnology company
and the Coalition for Epidemic Preparedness Innovation, or CEPI, to develop a messenger
RNA candidate vaccine. A vaccine is a long-term project, but if all
goes well, this candidate vaccine is expected to enter Phase 1 trials within two to three
months an incredible tribute to American scientists and physicians. Our longstanding offer to send world-class
experts to China to assist their response remains on the table, and the State Department
recently helped deliver nearly 18 tons of relief supplies to Hubei, the epicenter of
the outbreak. Meanwhile, we are working on the ground in
countries around the world in Africa, Asia, and elsewhere to assist them with detection
and prevention, through CDC offices, State Department personnel, and partnerships we’ve
built through years of preparedness work. Finally, we’ve been implementing the prudent
policies that the President announced to reduce the risk of transmission by travelers. That means temporary required quarantines
of U.S. citizens and permanent residents who have recently been to Hubei, and voluntary,
self-monitoring quarantines for those who have recently been elsewhere in mainland China. We’ve required that all other individuals
who have recently been to mainland China wait 14 days before coming to the United States. These targeted steps aim to slow the virus’s
spread to and within the U.S. and give our government and other countries more time to
build preparedness, understand the virus, and develop countermeasures. These policies are consistent with those of
many of our peer governments, like Italy and South Korea, and they are in line with accepted
best practices and the International Health Regulations. To some, at first glance, such measures may
not match the initial instincts of physicians who are devoted to patient care. But these measures are what we believe is
necessary to put you, and our healthcare system, in the best position to care for your patients
and to protect public health. We made these decisions with not only the
input but also the strong support of our public health leaders across HHS. These steps complement the generous help we’re
offering at home and around the world. Every arm of the federal government that can
help to protect the American people has been engaged, and we’re thankful that the private
sector, including hospitals and physicians, have been equally active in responding. We’re continuing to take new steps to adjust
our posture as needed every day, Secretary Azar will continue coordinating work through
the President’s Coronavirus Task Force, and all of HHS leadership will continue to be
closely engaged. While the China coronavirus is a huge challenge,
we’ve spent years investing in state and local public health departments, to help them prepare
for outbreaks and other public health emergencies. We’re working with these public and private
partners, so that, if necessary, we can begin to mitigate the spread of the virus if it
reaches our shores in larger numbers. We have always known that the next major infectious
disease outbreak is a matter of when, not if, and we’re grateful for the contributions
many physicians have made in preparedness efforts. So thank you for your attention to preparedness,
thank you for your commitment to addressing this outbreak, and please continue to look
for updates from CDC and other parts of HHS on the situation. The way we’ve responded to the China coronavirus
reflects, in part, the strength of the American healthcare system, public health infrastructure,
and biomedical research enterprise, which are each the finest in the world. President Trump has an exciting vision for
how we can build on the successes of our current healthcare system, and make it better. He’s promised Americans a system with affordable,
personalized care, a system that puts you in control, provides peace of mind, and treats
you like a human being, not a number. I want to give you just one small example
of what that can look like, and how we’ve been working to make it possible for America’s
patients and physicians. Last year, as part of CMS’s Patients over
Paperwork initiative, which has relied on the input of so many physicians like you,
we heard from an organ transplant surgeon at Johns Hopkins. He liked to set up his patients with their
medicines in an organized pillbox, and talk them through the medications, before they’re
discharged from the hospital following a transplant. But, due to a Medicare policy, he couldn’t
personally set them up with their immunosuppressant medications. Those had to be shipped to the patient’s home
address or home pharmacy. So we looked into this, and made a change
so that patients could receive these medications before heading home from the hospital. Here’s what one of the surgeon’s patients
said about the change: I don’t know how I could have handled going to a pharmacy and
filling all of these medications that I need to take this evening after all I’ve been through. Thank you so much for making sure I have my
medications this is one less thing to worry about. As it happens, that’s not all we’re trying
to do to make this patient and her physician’s experience better. Under our proposed changes to the Stark Law
and the Anti-Kickback Statute, part of the Deputy Secretary’s Sprint to Regulated Care,
the doctor could be able to give the patient a free smart pillbox, which could provide
reminders to the patient and alert the physician about missed doses. The physician could even be able to provide
a home health aide to go home with the patient, talking her through her medicines as needed. These changes demonstrate how we can help
physicians drive patient-centered innovation innovation that focuses on quality and outcomes,
rather than reams of paperwork or volumes of procedures. Another place we aim to do that is through
our work around interoperability and patient control of health records. In the days since Secretary Azar and I were
talking about this issue in the 2000s, in the HHS general counsel’s office, we’ve seen
massive advances in technology. The ubiquity of smartphones, apps, cloud-based
storage and computing power, and near-universal access to high-speed internet has completely
changed so many aspects of American life, but not, unfortunately, so much of healthcare. We have made huge progress on digitizing records,
and we’re grateful for the effort and investments that many physicians have put into making
that possible. But we’re not getting the return we should
on all the investments you have made because records aren’t easily transferrable among
physicians and they aren’t easily accessible to the patient. This can be a source of tremendous frustration
for patients and physicians no matter how well-versed these patients may be in the inner
workings of the health system. Secretary Azar has his stories about electronic
records snafus, I have mine, Administrator Verma has had hers. We’ve joked that, at this point, HHS senior
staff meetings could become impromptu roundtables about EHR frustrations. I’m sure many of you have had your share of
frustrations not just on the provider side, but as a patient too. Health records today are stored in a segmented,
balkanized system, and it’s not just affecting the patient and provider experience it’s affecting
care. This has to change, and it has to change soon. That is why, last year, we proposed ONC’s
bold interoperability rule, which will finally put patients in charge of their own data. Patients should be able to access their electronic
medical record at no cost, period. Physicians should be able to use the IT tools
that allow them to provide the best care for patients, without excessive costs or technical
barriers. In an interoperable system, these records
can also become much more than just records. They can be highly valuable tools for delivering
Americans better, more affordable healthcare. That thinking helped motivate the historic
reforms we recently made to E and M codes, which aim to make those records more than
just cumbersome billing systems, into actually useful clinical records. Seamless health IT systems, and patient use
of smartphone apps, also hold huge potential for delivering affordability and quality through
price transparency and competition, all as part of a drive toward a value-based system. Starting in January 2021, thanks to President
Trump’s executive order on price transparency, hospitals will be required to make their actual
prices available, in an easily usable format, to patients. We’ve also proposed to require that insurers
make public the prices that they negotiate with providers, and what patients cost-sharing
will be on a given plan. Now, imagine having that information seamlessly
integrated with patients clinical information so your patients can be aware of what services
they’re receiving and how much they’re paying for them, in the same place. That is an opportunity for important conversations
that don’t happen today and it’s quite possible with the right work on harmonization of data
standards. This could not only transform the experience
of shopping for care, but also the experience of receiving care: We know how frustrating
the process of prior authorization can be, for both physicians and patients, but it could
be greatly accelerated if clinical and financial data streams were integrated. Cost information isn’t the only key piece
of empowering patients and physicians. Quality information is also essential, which
is why the President’s transparency executive order asked HHS to work with the Department
of Defense and the Department of Veterans Affairs to develop a roadmap of all the health
quality measures that we collect, an issue I’ve been working on closely. The thousands of quality measures administered
by HHS, VA, and DOD are important. But we have gone too long without examining
what we, as a government, are doing in this space. We need to ask whether we’re using the right
metrics, whether the process for picking these metrics is appropriate, and how we can make
these metrics more meaningful and useful for both patients and physicians. We’re grateful for the AMA’s input on this
effort so far, and the perspective of America’s physicians will continue to be essential. The President’s vision for healthcare is also
reflected in some commonsense reforms proposed by his annual budget that we released this
week: proposals that aim to make American healthcare better, more affordable, and more
patient-centered. The President’s budget also puts a priority
on responding to a number of serious public health challenges we face as a country. We’re going to continue combating our country’s
crisis of addiction and overdose, not just from opioids but psychostimulants such as
meth as well. We propose the necessary investments for widespread
implementation of the President’s plan to end the HIV epidemic by 2030. The Budget also puts a new focus on maternal
health and maternal mortality, where our country’s outcomes have been unacceptable for far too
long. We also lay out a vision for investing in
rural health, by thinking creatively about how care is delivered and financed. This is an issue that is especially important
to me, as someone who grew up in a rural area, in southern Illinois, and have a long history
of rural health providers in my family. I believe you’re hearing next from Senator
Barrasso, who has been a leader on rural health issues and a source of advice for us. I look forward to working with Congress and
with physicians on this challenge. Many of you in this room undoubtedly have
interactions in your work with some of the health challenges I just mentioned many of
you may be working on several of these challenges. I want you to know that these issues are priorities
for Secretary Azar, for me, and for the entire Trump Administration, so come to us with your
ideas on them. Through the reforms I’ve discussed today,
we’re giving you the tools you need to make an impact on your patients health and to build
an even better healthcare system for all Americans. Together, we can deliver the kind of system
President Trump envisions: one that’s affordable, personalized, puts the patient in control,
and treats every patient like a human being, not a number. Thank you for the work many of you have done
toward that end already, and thank you again for having me here today. It’s been a pleasure.

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