With a flurry of dropped regulations at the end of 2020 and now in the early days of the new Biden Administration, you may be expecting a wholesale change in a new Administration’s approach to health information technology (health IT). I’m not.
Now, it goes without saying that policy, in general, is going to change dramatically under a Biden Administration. Democrats and Republicans have VERY different philosophies and core principles. However, one thing I’ve observed over the years is that both Democrats and Republicans tend to agree that health IT is part of the solution, not part of the problem.
While it’s impossible to know what will happen, I think there are some areas of potential change or continuity with implications for health IT. Let’s take a look in three key areas: policy focus, personnel and the role of government in health care.
Policy focus. Where will federal agencies spend their time and capital under the Biden administration? Early reading of the tea leaves suggests that while major changes obviously will be on deck down the road, there also is likely to be continuity.
- Building on current initiatives. Under the previous administration, health IT was a key element to accelerate the shift to value-based care (VBC), address burden reduction and increase transparency. I don’t expect a lot to change. First, they are all bipartisan issues and will give the new Congress something to coalesce around and continue health IT-related work begun in the last session. Further, President Biden is likely to build on initiatives concerning price transparency and prescription drug pricing, according to Chris Jennings, who was an Obama White House Advisor.
I also expect the new administration to support use of application programming interfaces (APIs) to collect and share data, as well as standards, particularly HL7’s FHIR (Fast Healthcare Interoperable Resources).
And let’s not forget about health IT and the COVID-19 pandemic. Efforts were begun under the Trump Administration to use health IT to mitigate of the effects of the pandemic and to develop innovative solutions. I expect to see continued efforts to build on this foundation and, again, health IT can be part of the solution. Vaccine tracking can be done using health IT. Therapies are being prescribed via the ePrescribing or ordering components of electronic health records (EHRs). And EHRs are being used to document encounters and inform caregivers. Health information exchanges are supporting providers. Broader efforts leveraging health IT include modernizing the public health infrastructure; expanding telehealth and remote patient monitoring; and using health IT to support a national testing strategy.
Regulations. There was a whirlwind of rules and regulations that were dropped near the end of the Trump administration. Many of these were specifically health IT oriented. Two come to mind, both related to prior authorization. The first is the final rule concerning the use of an electronic prior authorization standard in Medicare Part D plans, which was published on December 31, 2020. Specifically, the rule provides that prescription drug plans are required to support the electronic prior authorization transaction standard in NCPDP’s SCRIPT Standard Version 2017071.
The second is a final rule, which dropped on January 15, 2021. It is aimed at reducing burden as well as standardizing and speeding up the prior authorization process. This regulation requires payers, not including plans on the federal exchanges, to make prior authorization decisions within 72 hours for urgent cases and seven days for standard requests. It also requires public payers—and those on federal exchanges–to implement application programing interfaces (APIs) that will give providers better access to data about their patients and streamline the process of prior authorization.
I think that was less about differing philosophies than expediency. More specifically, the Centers for Medicare and Medicaid Services (CMS) has been working diligently in the last year and wants to get its hard work implemented before a change of administration.
Research. We know that President Biden led the Cancer Moonshot. I’m not aware of any Republicans that aren’t supportive of accelerating cancer research to develop more therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage. Health IT supports this.
And, of course, this year’s equivalent is accelerating bio-medical research related to COVID-19. We can expect to see a lot of continued and expanded activities at the National Institutes of Health, and public-private partnerships, to better understand the virus; how it interacts in various demographic groups; and develop vaccination and treatment strategies for the virus, its variants and among various demographic groups. Health IT will play an integral role in gathering and sharing patient and administrative data in those efforts, as well as in identifying and reporting adverse events.
Personnel. Top-level positions always change in a new administration. Of course, the most important person to health IT is, well, the most important person in the Biden Administration and that would be President Joseph Robinette Biden, Jr., himself. Health IT is a bit of a subset of healthcare, in general. What do we know so far?
- HHS Secretary. Arguably, the second most important person to health IT is the Secretary of the Department of Health and Human Services (HHS). President Biden’s nominee for this role is California Attorney General, Xavier Becerra. If approved by the Senate, addressing the COVID-19-caused pandemic will be a priority. This then will be a front-and-center issue in the HHS agencies (which is where the rubber really hits the road, policy wise).
- ONC. One of the key HHS appointments affecting our world is the head of the Office of the Coordinator for Health Information Technology (ONC). And one has been named right off the bat: Micky Tripathi, Ph.D. His appointment is significant in several ways.
First, it signals the importance of health IT in the new administration. Second, this is not Tripathi’s first rodeo when it comes to health IT and getting things done while navigating sometimes difficult policy and organizational waters. He has a long-standing background in standards and interoperability from various industry and stakeholder perspectives. For example, he currently serves on the board of directors of the Sequoia Project, the CommonWell Health Alliance, the CARIN Alliance, HL7 International, the HL7 FHIR Foundation, and Datica. Tripathi also is the project manager of the Argonaut Project, an “accelerator” of HL7 standards.
Finally, Tripathi has operational experience (a plus in running an agency in the HHS bureaucracy). Tripathi recently served as chief alliance officer for a population health management solutions company called Arcadi. This followed a merger with the Massachusetts eHealth Collaborative (MAeHC), a non-profit health IT advisory and clinical data analytics company of which Tripathi was president and CEO. This means that Tripathi will be an informed advocate for health information exchanges, having run one, and will be an expert in using them for public health (something sorely needed as we struggle through COVID-19 and its aftermath). He certainly understands the provider and provider system perspective, having worked in the Boston area with scores of them. We all know that sometimes that “mile”— either the first or last, depending on where you sit — is the hardest.
In short, I think Tripathi is an excellent pick.
- I had an inkling of the potential importance of health IT in the Biden administration in the transition. Although few health IT people were visible, an exception was Aneesh Chopra, who served on the US Postal Service (USPS) Review Team. His inclusion seems a little incongruous until you recognize that his deep IT expertise was leveraged as part of a push to standardize USPS addresses to support more consistent patient matching. The former Chief Technology Officer for the Obama Administration, Aneesh is very much a healthcare IT guy, currently serving as the co-founder and president of CareJourney, a clinical analytics and insights company. When he was a member of the Obama Administration, he launched the Blue Button program to give military veterans a tool to download their individual health records from the Veterans’ Administration. Since leaving, he has been active in a number of health IT initiatives, including the CARIN Alliance.
The role of government in health care. While both Democrats and Republicans view health IT as part of the solution, there are disagreements between the parties on the role that government should play in healthcare. This view was affirmed in a recent conversation with Catherine Pugh, who is the eHealth Initiative’s Assistant Vice President for Policy. This Washington, DC-based independent nonprofit organization is known as eHI. It engages multiple stakeholders in health care to develop and drive the implementation of a common set of principles, policies, and best practices for improving healthcare.
One example that stood out in our conversations is differing party views on policy implementation. On one hand, Democrats tend to be a little more prescriptive about how policies are implemented — in healthcare, think Meaningful Use. On the other hand, Republicans are a little more about incentives to encourage adoption.
Interestingly, Catherine and I agree that a lot of what the Trump Administration did relative to health IT stemmed from the passage of the 21st Century Cures Act, a bi-partisan bill signed into law by President Obama on one of his last days. More specifically, under President Trump and his appointee to head ONC, Donald Rucker, MD, the ONC emphasized interoperability and removing information blocking, improving price transparency, reducing provider burden and encouraging patients to take control of their health records. I don’t expect a Biden Administration will oppose any of these philosophies.
Under Dr. Rucker, ONC encouraged the industry to create solutions that they agreed would be reasonable to implement, and then put those into regulations. While not everyone agrees with regulations – see opposition to the “Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients’ Electronic Access to Health Information” Rule here – a lot of industry stakeholders put a lot of time into creating the standards.
Started by the Obama Administration, the Trump Administration also attempted to leverage the entire administration – HHS, FDA, CMS, VA, etc. – to encourage the adoption of health IT. I expect that the Biden Administration will do the same.
My advice to stakeholders. In summary, while there may be some delays as high-level Biden Administration nominees get appointed, I don’t think very much in health IT will change as we transition from a Trump to a Biden administration. My advice to stakeholders: it’s time to act. Don’t procrastinate thinking that you’ll have time.
Edited by Maurice Nagle