ON-THE-RECORD PRESS CALL BY SENIOR ADMINISTRATION OFFICIALS ON PRESIDENT DONALD J. TRUMP’S LATEST ACTION TO IMPROVE AMERICAN HEALTHCARE

Office of the Press Secretary FOR IMMEDIATE RELEASE March 9, 2020

ON-THE-RECORD PRESS CALL BY SENIOR ADMINISTRATION OFFICIALS ON PRESIDENT DONALD J. TRUMP’S LATEST ACTION TO IMPROVE AMERICAN HEALTHCARE Via Teleconference   9:05 A.M. EST MR. CANTRELL:  Thank you, Operator.  Good morning, everyone, and thank you for joining today’s briefing by senior administration officials on President Trump’s latest action to improve American healthcare. Today’s briefing will be conducted by Secretary of the Department of Health and Human Services, Alex Azar; Administrator of the Centers for Medicare and Medicaid Services, Seema Verma; National Coordinator for Health Information Technology, Don Rucker; Director of the Domestic Policy Council here at the White House, Joe Grogan; and Special Assistant to the President for Innovation Policy and Initiatives, Matthew Lira. Both opening remarks and the question-and-answer portion to follow will be entirely on the record.  All information is embargoed until the conclusion of the call. And, with that, I’m happy to introduce DPC Director, Joe Grogan. MR. GROGAN:  Thank you, Austin.  Again, my name is Joe Grogan, Assistant to the President and Director of the Domestic Policy Council.  And, this morning, we’re going to be talking about the culmination of a tremendous amount of work on the part of the Department of Health and Human Services, a number of operating divisions within that department, and the White House, to deliver on interoperability for electronic health records. The Trump administration has consistently had a broad view of what needs to be fixed in healthcare and not just focusing on the individual market.  The effort on interoperability is another in a long list of goals to sort out problems that this administration, that this President inherited from previous administrations. Let’s not forget that $36 billion were spent at the beginning of the Obama administration to get Americans to use electronic health records, and this led to a Tower of Babylon inability for physicians, hospitals, medical providers, systems to talk to one another.  It’s led to a tremendous amount of frustration on the part of medical professionals and patients as physicians, interacting with patients, oftentimes spend more time looking at computer screens than they do into the eyes of the people they’re trying to heal. The President, since he’s taken office, has eliminated the Affordable Care Act’s individual mandate penalty, the Cadillac tax, the health insurance tax, and the medical device tax.  Additionally, the double digits and the increases in premiums has stabilized, and we now have premium stability in the individual market. He’s opened up opportunities for people to buy more inexpensive plans, allowed businesses to band together in association health plans, and pushed through the health reimbursement arrangements, which will lead to a vast increase of the number of the people on the individual market without an increase in taxpayer dollars. He has spearheaded initiatives to bring greater options to those suffering from kidney disease.  He’s led the battle against the opioid crisis, leading to a historic marker -- the first drop in opioid deaths in nearly two decades.      He signed a 1-billion-dollar increase in Alzheimer’s research, launched an initiative to end the transmission of HIV/AIDS in America in the next 10 years. He signed Right to Try legislation.  We’re working to revive the Stark and Anti-Kickback rules, which also has taken a tremendous amount of work over many years. And, of course, he’s focused on improving veterans’ healthcare, firing employees who are not delivering for our veterans, eliminating wait times.  And we now have the highest level of favorability for veterans health on record.      His budget demonstrated his commitment to delivering on his vision for a healthy America, with an increase in funding and a fundamental revamp of how we address mental disease in this country.  We’re improving maternal health, access to rural healthcare, and prioritizing critical health research while supporting innovation. With that, there are a number of speakers, so I’m going to turn it over.  But, again, to reiterate, we have spent a lot of time in this administration confronting problems that other administrations have ignored, and fixing problems that we’ve inherited with a very broad view on how to fix healthcare in America. With that, I’ll give my time. SECRETARY AZAR:  Thank you, everyone.  This is Secretary Azar.  Appreciate you joining us for this important announcement.  This announcement is a significant piece of working towards President Trump’s healthcare vision: an affordable, patient-centric system that puts you in control and treats you like a person, not a number.      The driving force behind the President’s healthcare work is to protect what works and make it better.  In more tangible terms, here’s what that means: We’re going to protect your ability to choose the insurance plans and providers that work for you.  We’re going to protect what Americans like about that experience, but deliver that experience with lower costs, less paperwork, more options, and more control. The final rules we’re announcing today will help deliver on all four of those goals.  Today, after tens of billions of dollars invested in digitizing health records, America’s health records system remains balkanized and nearly inacceptable to the patient. We talk a lot about how we love having a choice of doctors, but how can you shop for better options if you can’t practically bring your records with you? Today, Americans’ health records are shackled by a broken system, which means their options are limited too.  Many Americans know how frustrating health records can be today.  I'm the Secretary of Health and Human Services, and even I have struggled to get my health records electronically.  Frankly, the stories we heard in developing the interoperability rules were even more frustrating than we expected. In response to our draft rule, we heard from patients, whose experiences with the broken status quo were not only maddening, they were harmful to their health.  We heard about one woman who was on a trip when she developed a kidney stone for which she needed emergency surgery.  But first she had to obtain her records from her hometown urologist who had to fax them and mail CDs, delaying her surgery for four days. We've heard from patients who are working to get second opinions and more options for challenging cases of cancer or their children with rare diseases, who have to devote huge amounts of their precious energies to pressing doctors for CDs and paper records of their health data. We heard from a physician who helps coordinate care for his 93-year-old mother who lives 200 miles away and visits as many as six different practices in a given year, which are on a variety of EHR -- electronic health record -- systems.  None of those systems keeps track of a single unified list of medications, which of course is a key piece of his mother getting the care she needs. So how are we going to fix this?  Simply put, healthcare providers will be required to provide easy digital access to your records at no cost.  Through what are known as application programming interfaces, or APIs, you will be able to use a smartphone app to have all your health records and your health claims data at hand for use by you and your doctors. Today, all that time patients are spending to assemble hard copies of their records and all that time providers are taking, sending faxes and CDs, can be replaced with the work of an app that seamlessly gathers and retains all that information. We believe that's just the beginning.  We hope to see a whole ecosystem of condition- or disease-specific apps to help patients monitor and improve their health in real time, in part by using data made available from their EHR via an API. We have apps today that can help patients monitor one particular data point, like glucose levels, but they can't easily help the patient understand their whole health picture.  And that's what truly puts the patient in control. This will be accomplished by the Cures Act final rule from the Office of the National Coordinator for Health IT, and an interoperability rule unleashing claims data, from CMS.  I also want to emphasize that we're taking these actions while maintaining and strengthening patient privacy protections.  Patient privacy should never stand in the way of patient control. The wonky term for what we're requiring is “interoperability.”  Practically, from the patient's perspective, these rules mean access and portability.  You will have access to your records, and your records will be portable from doctor to doctor.  Providing patients with access to their data makes it much easier for them to control their own care, and we believe there will be opportunities for other data to be incorporated in the apps patients will use alongside. That's where President Trump's bold actions on price transparency and quality are going to be essential too.  Today's announcement also works to empower your doctors to better coordinate your care, including by requiring that providers send notifications to other relevant providers when you're admitted, transferred, or discharged from a provider. These actions by President Trump are a bold, new way of thinking about government in healthcare.  We're laying down simple rules of the road that will put the patient in control and empower providers to coordinate and pay for outcomes.  Altogether, these steps will dramatically improve American patients’ experience in healthcare.  They'll deliver the American patients lower costs, less paperwork, more options, and more control. On this day, I'd especially like to commend Administrator Seema Verma; Dr. Don Rucker, the head of the Office of the National Coordinator for Health IT; and Will Brady, Chief of Staff to the Deputy Secretary of HHS.  This is truly a major milestone in a long journey begun 15 years ago by my predecessor, Secretary Mike Leavitt.  Truly a historic day in healthcare. With that, I want to hand things over to Dr. Rucker to explain more about ONC's rule and the background behind it. DR. RUCKER:  All right.  Thank you, Mr. Secretary.  First of all, folks, sorry we can't see you in Orlando, which was our original plan here.  But nonetheless, as Secretary Azar has just said, we are announcing what in my 30-plus-year career in healthcare IT is, I think, an unprecedented rule, allowing safe and secure access of health information, giving back to patients. Our rule implements the clinical interoperability provisions of the 21st Century Cures Act.  And as CMS Administrator Verma will tell you in a moment, Americans will now have electronic access to their health information on their smartphone, if they choose. Our rule requires hospitals and doctors to provide software access points -- endpoints, if you will -- to their electronic medical record databases so that patients can download these records to their smartphones.  This download is entirely at the patient's choice.  It is done using modern security provisions and clear communications and choice about privacy. What we want to do here, ultimately, is we're finalizing the policies that we believe will allow patients the ability to manage their healthcare the same way they manage their finances or the travel or other parts of their life on their smartphone. We believe that by giving patients control of the health information -- and it's not just access to the data, it's computable control of the healthcare information -- we're going to see a growth in patient-facing healthcare IT markets from an entirely new app ecosystem that's going to be fueled by transparency about both product and price. We think this health app economy is going to have new services, and we see the smartphone not just as a smartphone, but as a tool to connect other devices to it -- Internet of things type of devices: As the Secretary mentioned, glucometers, blood pressure cuffs, digital scales, peak flow meters, heart rate monitors.  The technology here that we're unleashing is going to democratize healthcare in, I think, powerful ways. How are we doing this?  The Cures Act has two broad provisions that we're implementing here.  One is a requirement about application programming interfaces without special effort, and the second is mandating that patients get their information. So the Cures Act defines a concept known as “information blocking” as practices that interfere with the access, exchange, or use of electronic health information.  The Act requires entities controlling this information to share it with patients and third-party apps the patient chooses, as opposed to apps that are purely under the provider control. Our rule identifies and finalizes the reasonable and necessary activities that do not constitute information blocking, while establishing new rules to prevent information-blocking practices by healthcare providers, developers of certified health IT health information exchanges networks, as required by the Cures Act. The rule also updates certification requirements for health IT developers so that doctors and nurses who are using this health IT are able, if there are safety or usability issues, to discuss those without having to be bound by what has historically been called "gag clauses." Really, again, the theme here is transparency for providers and the American public. How are we doing this with the data?  We have defined the U.S. Core Data for interoperability.  That includes clinical notes, includes things like allergies and medicine.  These are standardized sets of data classes and data elements with the most modern and powerful of data standards to help improve this flow of information. There's a lot more in the rule in making this all happen to start getting us to compare costs and quality and start shopping for care. And so, thank you for joining us this morning.  And I'd like to pass the phone over to CMS Administrator Seema Verma to talk about the CMS rule that is happening at the same time. ADMINISTRATOR VERMA:  Thank you, Don, and thank you for joining the call.  I'd like to begin by sending our thoughts and prayers to everyone that's affected by the coronavirus, especially those who are dealing with the tragic loss of loved ones.  All Americans who are anxiously watching this situation need to know that their government is working around the clock to keep them safe. As you know, we are announcing a major policy change that promises to substantially increase the quality of care of our healthcare system, delivers in times of crisis and always. I'd like to use this time to explain how the CMS rule works, as well as where it fits into our broader efforts to liberate data, lower costs, and improve Americans' healthcare. This particular fix has been a long time coming.  In today's digital age, the vast majority of patients remain unable to obtain easy access to their complete data.  Our healthcare system remains needlessly expensive and inefficient, as repeat tests drive up costs and perhaps, most importantly, doctors are forced to provide care with an incomplete clinical picture. Especially at a time when the healthcare system could be under stress with the handling of the COVID virus, the urgent need for coordinated, integrated care could not be clearer. In a healthcare system characterized by the easy and seamless flow of information, one in which a patient's own data follows them to the provider they choose, care for patients would be drastically improved.  Think of the passengers on the cruise ship, many of whom are seniors -- they may be unaware of the names of all of their prescriptions or the dosage amount -- having simply taken what they needed for the journey.  Under this system envisioned by these rules, they could have access to this critical information and share it with their caregivers. When the Trump administration came into office, we recognized that something needed to change.  Our fragmented system had calcified into a status quo that is profitable for some but doesn't put patients first.  So, in 2018, at the HIMSS Conference, Jared Kushner and myself and others launched the My Healthy Data Initiative to reduce costs and improve care by getting medical record data into the hands of patients and their providers. We started by leaving no room for doubt.  EHR vendors don't own data; patients do.  We overhauled our policies to focus on the electronic exchange of health information between healthcare providers and patients.  And now, under the Trump administration, hospitals are penalized, and clinicians lose their incentive payments if they don't give patients the health data they need to coordinate their care. And then we got our own house in order.  CMS launched Blue Button 2.0, Medicare’s tool that links Medicare claims data to apps on beneficiaries’ phone or other devices.  This allows them to have their data at their fingertips and share it with their caregivers. With thousands of developers in the Blue Button development sandbox and 55 apps now available, Blue Button is getting thousands of Medicare beneficiaries secure access to their health data with the click of a button. In our most recent Medicare open enrollment period, we saw a large increase in the number of beneficiaries using this newfound access to make informed plan choices. Blue Button was the turning point, not only because of the success it had in its own right, but because of how it became the prototype for today's final rule, which has implications for the entire healthcare industry. The personal health records rule, also known as the patient access rule, goes where prior administrations have feared to tread: It finally engages as health insurance plans.  Health plans have significant data on the people they serve, but earlier policies never took that into account.  Our policies now require those payers to step up to the plate and share that wealth of data directly with patients. Specifically, the rule requires, starting in 2021, that all health plans doing business in Medicare, Medicaid, and CHIP, and the federal exchanges, share health data with their patients through a secure standards-based API, which represents the link between the data on various systems and consumers’ phones.  This is where ONC's work comes in, which essentially finalizes the standard that makes that link possible. In effect, the personal health records rule essentially requires that all health plans doing business with the federal government delivers something like Blue Button 2.0 and its private and secure data sharing to the 85 million patients in CMS-regulated health plans. And the rule goes further: By leveraging plans' unique positioning to support patients and providers alike with all the data they have to offer, plans will be required, starting in 2022, to share a patient's health information with each other at the patient's request.  This allows patients to take their data with them when they move from one plan to another and create a cumulative health record as they go. The rule also requires plans to make their provider directory publicly accessible through a provider directory API, starting in 2021.  This will allow innovative third parties to design apps that will help patients evaluate which plan networks are right for them and potentially avoid surprise billing by having a clearer picture of which clinicians are in network. Also, effective six months from today, we are changing the conditions of participation for hospitals to ensure Medicare and Medicaid participating hospitals are supporting care coordination for patients by sending admission, discharge, and transfer notifications so patients receive a timelier follow-up, supporting better care and better health outcomes. In sum, the Trump administration is pushing the healthcare system forward.  We are breaking down barriers to a seamless data-driven healthcare system.  The result of these two rules will be a more intuitive and convenient experience for American patients, better access to data, leading to better research for new treatments and full clinical pictures for doctors -- allowing them to reduce errors that decrease quality and duplications at increased costs. I'd like to pause to emphasize a crucial point: Privacy and security are paramount.  Not a day went by when these rules were in development that we did not consider how to balance the necessity of patients having easy access to their own data with the need for privacy and security.  These two rules ensure plans and developers have the technical tools they need to build secure APIs and apps.  Patients, providers, and plans alike have a responsibility to take an active role in safeguarding patient data.  And we are working with plans to educate patients about what they should look for in terms of privacy when they are selecting an app so they have the tools and the information they need. I want to close by rallying America's developers.  These rules represent an invitation to deliver new and innovative tools for patients to drive higher quality, lower costs, and a more efficient healthcare system in America.  Thank you. MR. LIRA:  Hello, everyone.  This is Matt Lira with the White House Office of American Innovation.  I want to be brief, but I will provide some additional narrative context for how we got to this announcement. Three years ago, at the President's direction, Jared Kushner and Chris Liddell began hosting a series of listening sessions, both at the White House and around the country.  We pulled together executives from the healthcare sector and other sectors of our economy: clinicians, entrepreneurs, researchers, and, most importantly, patients.  And we asked them what are the healthcare priorities and opportunities that are on their minds.  Among the many parts of feedback that we got, we consistently heard about the need for better patient access and control over their own healthcare records. Based on this extensive feedback, Jared Kushner, Seema Verma, and Dr. Rucker, and HHS began an all-hands-on-deck effort to tackle this problem.  It took multiple years.  We issued the rules over one year ago for public comment.  And the central point there is, both before and after we've taken this action, it's been based on listening, engagement with all healthcare stakeholders. And in the best traditions of the policy efforts of this administration, it's a high-impact reform that may not always grab everyday headlines but that is going to dramatically improve the quality of care for Americans across this country. MR. CANTRELL:  Thank you, Matt.  And thank you, everyone.  Operator, we will now take some questions. Q    Good morning.  This is Andrew Feinberg with Breakfast Media.  Thanks for doing this call.  Administrator Verma and Secretary Azar, you’re both on the coronavirus task force, doing this call this morning.  The President, this morning, has tweeted about blaming the media for inflaming the coronavirus situation, Senator Schumer’s comments on two Supreme Court Justices last week; a couple of tweets on the Democratic primary and Bernie Sanders; as well as tweets on the deep state and fake news. He seems to be focused on those things, and you guys are introducing this move, which doesn’t take effect until 2022.  How should Americans have any confidence that your administration is really focusing on this outbreak, which is quickly spiraling into a pandemic, if you guys are doing this and the President is off tweeting in Florida and -- instead of getting ahead of this? MR. CANTRELL:  Yes, sir.  Thank you for your commentary and question.  This is a call about interoperability, and we’re happy to take any more questions we have about interoperability this morning. Next caller. Q    This is Mohana from Politico.  I wanted to know what changes you might have made from the first drafts that were published last year.  I’m wondering if there were any updates with regard to privacy policy. DR. RUCKER:  Yes, we go about 2,000 -- this is Don Rucker of ONC.  We got about 2,000 comments.  And, obviously, as Administrator Verma mentioned, we’re quite concerned about privacy.  This has been a major part of our process here. What we’ve done -- without getting into the specifics of the technical -- is we’ve bound into the patient authentication process the ability of providers to give notice and to let patients know what they’re consenting to, to do that in a very deliberate, straightforward way.  So that is not snuck in on the side, but it is absolutely central to the way that patients allow an app to get access to their information. We’ve also empowered providers to communicate the privacy issues in that process.  We’re using the same secure API technology that is, for example, used in the banking app on your smartphone.  So I think we’ve put in some powerful protections here to make this a reality for patients to get control of their healthcare. ADIMINISTRATOR VERMA:  I think from the CMS side, in terms of the changes from their proposed rule to now, we didn't finalize the requirements around trusted exchange networks and participation in that.  And we also strengthened the privacy and security components of the rule, specifically requiring attestation around privacy for app developers. Q    Hi, Joyce Frieden from MedPage Today.  I wondered if you could talk about a timeline for what providers can expect in terms of when they -- for example, when a doctor's office will know that they have to be required to provide this.  And also, if there are any penalties for them not meeting that deadline. DR. RUCKER:  Yes, Don Rucker again.  So the rule will start with a limited set of data.  We got a lot of feedback from the provider community to start two years from when the rule is in the Federal Register -- so, next week.  So two years downstream from that, with the application programming interfaces allowing patients to get just the U.S. Core Data. There are some provisions, another year after that, for other data.  We've worked extensively with software developers.  Most of the large software developers actually already have built the APIs and versions of the APIs that we are talking about in this rule. The core part of what we wanted to do is to make this as simple and hassle-free for providers.  These are automated endpoints. ADMINISTRATOR VERMA:  The other thing I want to add is that, in 2018, CMS changed the entire Meaningful Use program.  We overhauled that and we now call it “promoting interoperability.”  And so, in 2018, we've changed the rules around that.  So, specifically, hospitals are penalized if they are not sharing patient data with their clients.  So that's already into effect.  And then also, the MACRA program or the MIPS incentive program, all of those incentives are tied to doctors sharing data with their patients. Also, as a requirement -- they’re required to upgrade the software that they were using so that it did have APIs.  And that already went into effect in 2019.  That's already in effect today. Q    Hi all.  This is Blake Burman at Fox Business.  I know you want to keep it on the topic at hand, but, Joe, I would be remiss if I didn't ask you: The market is down 1,900 points right now, down 7 percent.  You guys have been -- the administration has been talking about economic stimulus measures. I'm curious, will you mention -- will you talk at all about what may or may not have occurred over the weekend, what you think people need to know right now, what traders need to know right now, et cetera?  There's a massive sell-off on the street.  Thank you. SECRETARY AZAR:  This is Secretary Azar.  Let me go ahead and address that.  So the Vice President is leading a whole-of -government approach.  We've been very transparent with daily media briefings on all the steps that we're taking. We've taken historic actions to try to prevent the -- to slow the spread of the disease into the United States through restrictions on travel and travel advisories.  We've been making historic advances on therapeutic development as well as vaccine development.  We've been advancing on acquiring additional PPE -- or personal protective equipment -- for healthcare workers.  We had our healthcare providers alerted from day one on this to ensure that our entire public health system and medical professionals were on the alert.  And that's how we identified our first cases in this. We've now got over 2 million tests that have been -- that have been manufactured.  And over a million of those, as of Saturday, have shipped out to public health labs as well as to hospitals, as well as other labs, with availability. We have unleashed, with regulatory reform, our private-sector lab companies so that they can form their own developed tests with direct access into physician offices through their systems.  We are working aggressively on community mitigation efforts in place with Santa Clara County, with Seattle, working with Florida, and New York State, New York City, as they work to contain and mitigate the impacts of cluster outbreaks that they've had in community spreading that’s happened in the United States. We've secured within record time an $8.3 billion emergency supplemental that allows us to advance vaccine therapeutic CPE production, as well as to support state and local public health departments that need to be on the front lines of this to reimburse them and to allow them to add staffing to that. So this whole of government is enacting the action plans for Preparedness and Response that have been in place since the President put them in in 2017.  The American people -- this is a serious issue.  This is a very serious public health issue.  It's a serious issue globally.  The risk to any individual American generally remains low, but we've been very candid that for individuals, in particular the older individuals and in particular those with various elements of medical fragility, to take special precautions.  We've been clear about that over the weekend.  We've also put out guidance around cruise ships.  And we're dealing right now with bringing in individuals off of cruise ships. So it’s been a very aggressive whole-of-government approach at the state, local, and the federal level.  And the notion that we can't do our day jobs and work on this very serious issue is absurd.  We're taking COVID-19 incredibly seriously, and our teams, our public health agencies, are actively working as we sit here and also try to reform the entire healthcare system. ADMINISTRATOR VERMA:  And just to add to that, I think that, you know, as we are working through this whole-of-government approach to responding to the virus, the issues around interoperability are so critical.  Patients have to have access to their health care data. You know, imagine the healthcare system stressed by dealing with coronavirus.  And when patients are coming into the hospital, it helps the doctors and it helps the patients if they have complete medical records.  And when they're leaving the hospital, to be able to have all that data available to them when they go back to their doctors to understand what happened in the hospital, it just makes the system work better. Q    Hi, this is Mike Brady calling from Modern Healthcare.  I was wondering, on the condition of participation for all Medicare and Medicaid participating hospitals, is it a requirement to send electronic notifications to another healthcare facility or community provider?  Can you talk a little bit more about the implementation of that and what hospitals can expect in terms of what those expectations will be? ADMINISTRATOR VERMA:  Yeah, I mean, this goes into effect in six months.  And, essentially, the idea here is they have to provide electronic notification of the discharge.  All of the information related to that hospital stay has to be given to the patient and to their providers.  So, it's really an effort to increase coordination of care to provide a seamless patient experience so that we don't have drops-offs and gaps when people leave the hospital until they get their follow-up care. MR. CANTRELL:  All right.  Thank you, everyone.  This will conclude our call.  Again, both opening remarks and the question-and-answer portion were on the record.  As always, direct all further questions to the White House Press Office.  Thank you, everyone, for joining this morning.                            END                 9:41 A.M. EST