Thank you for inviting me today. Let me start by extending special thanks to Dr. Rucker and Matt Lira for organizing this event, and the CMS team Shannon Sartin, and Alex Mugge for their tireless efforts over the last four years. Speaking of four years, this week marks the anniversary of the date that I accepted President Trump’s nomination to become the CMS Administrator. I did so because it was clear to me that this administration wasn’t afraid to disrupt the status quo to make lasting, transformative changes on behalf of the American people.
Such fundamental, structural changes to the healthcare system naturally have not always made us popular with large special interest groups that have made themselves both comfortable and profitable with that status quo. But after four years, I am proud that CMS has not backed down from needed changes when the good of the American patient was on the line. We have advanced a bevy of reforms that promise to usher in a new era in American healthcare, from price transparency to kidney reform to the historic premium price plunges in Medicare Advantage and even the individual market.
But I can think of no more consequential change than our work – taken on CMS’ own initiative without congressional direction, combined with ONC’s new rules – to promote the seamless and secure flow of health information throughout the healthcare system. Over the years, “interoperability” has emerged as the great white whale of healthcare policy – a great prize always seemingly just around the corner but never ultimately realized.
After the previous administration made a massive investment of $36 billion dollars to get health records on electronic systems, the future seemed bright. Patients would no longer shoulder the burden of reconstructing from memory a lifetime of medical information in a moment of crisis – when a quick decision might mean the difference between life and death. Providers would spend less time making and transcribing notes after long shifts and would have complete patient data at their fingertips, allowing them to avoid duplicate tests and unnecessary treatment. And the free flow of information would inaugurate a new era of medical innovation that would transform the face of healthcare.
Unfortunately, that future never materialized. Instead, we’ve found that paper silos have simply become digital silos. Patient data is held hostage in individual electronic systems. Over time, the situation has calcified into a status quo that is profitable for large record companies but bad for patients.
When this administration took over, we understood that in a world where we can communicate instantaneously with someone on the other side of the globe, access our bank account from anywhere, that it wasn’t acceptable that our health information capabilities remain mired in the Stone Age. In 2020, faxes should not be the primary means of records transfer. We are used to a digital experience in every other facet of our lives, and it is high time healthcare caught up.
We announced our plans at the 2018 HIMSS Conference and with the help of ONC’s considerable efforts, this administration has delivered. CMS has overhauled the Meaningful Use Program, which is now known as the Promoting Interoperability Program. Hospitals are now penalized and clinicians lose their incentive payments if they don’t give patients their health data.
Then we got our own house in order. CMS launched Blue Button 2.0, Medicare’s first developer-friendly, FHIR-based API that links Medicare claims data to apps on beneficiaries’ phones or other devices, so they can have it at their fingertips and share it with whoever they choose. With nearly 4,000 developers in the development sandbox and 74 apps now available, Blue Button is giving Medicare beneficiaries secure access to their health claims data with the click of a button. Such vendors and innovators deserve tremendous credit for attempting to deliver simple, innovative solutions to Medicare consumers, and I hope more of their counterparts follow their lead.
Impactful as Blue Button has proven in its own right, we have always viewed it as a model for the broader healthcare system. The CMS Interoperability and Patient Access final rule, finalized earlier this year, requires that all health plans doing business with the federal government deliver something like Blue Button 2.0 to the 85 million patients in CMS-regulated health plans, and that includes Medicare Advantage, Medicaid and CHIP fee-for-serve, and managed care plans and all the insurers offering products on the Exchange. As a result, our policies now require these payers to step up to the plate and share that wealth of claims data directly with patients through a secure, standards-based API.
We hope these insurers making the investment for their public program beneficiaries will also release claims data to all of their beneficiaries. This rule is, without a doubt, our most consequential reform yet and it will be implemented on January 1st of next year.
And the rule goes even further by requiring plans to share patient’s health information with other plans at the patient’s request. This allows people to take their claims data with them when they move from one payer to another and create a cumulative health record as they go.
The rule also requires plans to make their provider directory accessible through a Provider Directory API. 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.
Finally, the rule requires hospitals to support care coordination for patients by sending admission, discharge, and transfer notifications, to the patients’ doctors so patients receive better and timelier follow-up after they leave the hospital.
In sum, the data unleashed through the Interoperability and Patient Access Final rule will create transformation and disruption in ways we have yet to contemplate – but in all cases, providers and patients win by having better access to data.
While Blue Button and the rule have focused on beneficiaries, our Data at the Point of Care pilot that we launched last year gives providers direct access to patient data.
Over 588 provider organizations are participating in the Data at the Point of Care project which is an API that provides Medicare claims data directly to providers to promote better patient care. It is critically important for providers actively engaged in value-based care who can then have their patients’ data readily available. Accessed right in a providers existing workflow, there is no logging into another application or portal required.
But the truth is that efforts such as Data at the Point of Care barely scratch the surface of how dramatically we can drive interoperability.
I am proud of what we have accomplished, but there is more work to be done. To date, our efforts have largely, with some important exceptions, been focused on getting data into the hands of patients. This is appropriate – data belongs to patients first and foremost.
However, we believe the FHIR-based APIs that we have used to expand patient access have significant untapped potential to unleash data and get it directly into the hands of all providers. We need to ensure that patient data from other sources gets incorporated into the health record seamlessly, so that the data can be utilized. Electronic Health Records must finally become truly open and gain the ability to both read and write data in service of better care for patients, so that providers and payers alike – can make use of the data.
And whereas our overhaul of Meaningful Use used penalties and incentives to drive interoperability among providers, the time has come for full-fledged requirements – rigorously enforced – that clinicians provide data in a digital format to patients. Just as we are requiring price transparency of the healthcare system, data transparency should also be required. Look for more from CMS on this issue in the very near future.
Going forward, APIs, FHIR standards, and interoperability must be more than simply a project of CMS and ONC. It must be a priority across HHS, so our entire healthcare system speaks the same language. Consider the possibilities for the healthcare system if medical devices approved by the FDA, were required to be interoperable, so data could flow into EHRs and be captured promptly; or if CDC reporting systems also used FHIR-based standards? The COVID response would have been easier if hospitals could have reported data directly to CDC from their EHRs. As reporting requirements grow to support disease surveillance, we must leverage FHIR and APIs to make this process easier. Further evolution and adoption of FHIR standards across the agency and across the healthcare system is the way forward.
While there is more to be done, a full appraisal of CMS and ONC’s record on interoperability reveals an unsurpassed record of accomplishment. The free and secure flow of health information that patients and providers are soon to enjoy represents a massive transformation of the healthcare system.
I firmly believe the progress we have made was only possible because we came into office with a vision, one that was supported by the White House Office of Innovation run by Chris Liddell and Jared Kushner. As we move toward a competitive healthcare system in which market forces are used to lower prices, increase quality, and boost access, we must make sure patients can be empowered consumers shopping for the best value. That means patients must have access to price and quality data and have their medical data to take wherever they seek care.
But the impact of interoperability goes beyond the individual. In the era of the COVID pandemic, the need for data to move seamlessly is critical for public health surveillance both now and in the future. A truly interoperable system will allow us to rapidly detect emerging infectious diseases and make it easier for providers to share public health data.
I couldn’t be prouder of the work we have accomplished over the last four years on interoperability. I hope the healthcare system at large can unite behind these efforts. Going forward, I hope that the large players in the healthcare system need not wait for government to tell them what to do – they can simply act proactively and voluntarily in order to promote the common good on behalf of the American patient.
This Administration’s efforts on this issue have improved and refined the work of those that came before us. For the sake of the patients that stand to benefit, whatever comes next should take the same approach and build on the unprecedented progress we have made to further advance the system in which data flows with patients at the right time and right place advancing a new era of efficiency and innovation. Thank you and thanks to all of you for the work you do day in and day out to advance this vision.
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