July/August 2021

Washington Scene: What the Biden Administration Means for the HIT Industry
By Nick Hatt
For The Record
Vol. 33 No. 4 P. 6

Health care technology policy has historically been apolitical. George W. Bush created the Office of the National Coordinator for Health Information Technology (ONC). Then, Barack Obama expanded the ONC’s powers through the EHR incentive program. And Donald Trump extended the reach of both the ONC and the Centers for Medicare & Medicaid Services (CMS) through the implementation of the 21st Century Cures Act. Now, Joe Biden has entered office with more power than ever to control HIT. Paradoxically, he faces more challenges than his predecessors.

Seema Verma, the former CMS administrator under Trump, declared at the ONC Summit in 2018 that developers should aim to end the fax by 2020. In 2021, the fax lives on, and the pandemic is shining a light on gaps in our public health and interoperability infrastructure. Nationwide interoperability remains a hurdle, and the rollout of patient access requirements in the 21st Century Cures Act will last until 2023.

With such a menu of problems to fix, and four years to get it done, the Biden administration needs to prioritize from among multiple worthy options rather than fiddling with minutia. With several key areas to monitor, Biden’s key appointments will provide a hint of what the next four years will look like.

Early Days
The health care industry is watching intently to see what changes are on the horizon. Thus far, executive orders have reversed some Trump-era initiatives, including commencing an additional open enrollment period. President Biden has also taken action to guide the United States through the pandemic, where his first step was to reestablish a response team.

Biden’s signature public health achievement will likely be promising 100 million shots in 100 days—and delivering 200 million. Perhaps we can expect this “underpromise, overdeliver” style to be a hallmark of his presidency. For example, don’t expect him to declare that the fax has been killed—or even set a date for it—but do expect meaningful progress.

Biden and his team bring experience to Washington. They know that health care evolves slowly and understand the levers to pull to achieve policy objectives.

Focus on Public Health
CMS recently released new rulemaking for the Promoting Interoperability (formerly known as Meaningful Use) program in which it made clear that public health is a priority. Promoting Interoperability is the primary lever that the President has over how hospitals and providers use HIT. Essentially, CMS has the power to adjust its payments to health systems by a few percentage points based on whether those hospitals use certified health care technology.

The new rules have some very notable requirements, including a new and optional bidirectional health information exchange (HIE) item. There are also four public health objectives (each of which were previously optional): syndromic surveillance reporting, immunization registry reporting, electronic case reporting, and electronic reportable laboratory reporting.

Promoting Interoperability works on a points system in which certain thresholds of “menu items” must be met. The move here is powerful in both affirming the role of HIE interoperability and making public health reporting table stakes.

Biden’s request for fiscal year 2022 discretionary funding outlines ambitious goals for health care technology: $8.7 billion for the Centers for Disease Control and Prevention in part to modernize its public health reporting infrastructure, $2.7 billion to the VA’s ongoing EHR modernization program, and $6.5 billion to launch the Advanced Research Projects Agency-Health.

Information Blocking Enforcement and Antitrust
The appointment of Xavier Becerra as the new head of Health and Human Services (HHS) will be interesting to track, especially in regard to anticompetitive and antitrust action. While Becerra has no frontline health care experience, he does know the industry’s business practices. For example, while serving as California attorney general in 2018, Becerra sued Sutter Health, the largest hospital system in northern California, for implementing anticompetitive practices.

As information blocking enforcement begins, Becerra’s Office of the Inspector General (OIG) will be a key area to watch. Information blocking presents some enforcement discretion—should OIG go after EHR vendors with anticompetitive app store practices, or should it go after providers that make it difficult for patients and others to retrieve medical records? Currently, the disincentive for providers (as opposed to EHR vendors) has not been published by HHS. The EHR vendors and HIEs are subject to fines of up to $1 million per infraction.

Generally considered a bipartisan issue, antitrust is another area where HHS may team with the Federal Trade Commission. In fact, antitrust could represent a unique opportunity for politicians to demonstrate a willingness to work together. The ongoing consolidation in all areas of health care is likely to be a prime target. Will the administration’s antitrust theme focus solely on overconsolidated, integrated delivery networks, or will it extend to vendors such as Optum as they acquire providers, startups, and everything in between? Time will tell.

Commitment to Digital Health
The change in ONC leadership from Donald Rucker, MD, to Micky Tripathi, PhD, MPP, suggests a much stronger investment in public health and other infrastructure priorities. Generally speaking, the Trump administration focused on consumerization and enabling patients to access their payer and provider data. Rucker, who has a physician technologist background, was well suited to lead this charge. He knew the needs of physicians and approached matters from the perspective of a practical health care inventor.

Tripathi, on the other hand, has a distinctly different background. As CEO of the Massachusetts eHealth Collaborative and a board member of the Sequoia Project and CommonWell, he was heavily involved in some of the most important projects related to Health Level 7 FHIR (Fast Healthcare Interoperability Resources). Name a large state or national collaborative infrastructure program, and he's probably been involved in it.

With the 21st Century Cures Act Final Rule—which will require advanced interoperability among providers, payers, tech developers, and patients—going into effect later this year, Tripathi is absolutely well suited for the coming period of public health revitalization. And as the country continues to push through the pandemic, having someone with Tripathi’s background and focus is critical.

With $500 million in funding rolling in from Congress to improve public health data and infrastructure, Tripathi is expected to deftly guide state and federal teams. Companies heavily involved in public health response, such as Curative, Carbon Health, and One Medical, stand to benefit as well.

Toward a More Consumer-Oriented Insurance World
The Trump administration issued rules requiring many plans to provide patient access to their information through electronic means. While still being implemented, it’s a set of changes that promises better competition and patient access. The Biden administration must now enforce the existing rules and potentially expand this new direction for CMS. While the rules affect the majority of federally sponsored plans, large insurers are extending the functionality to all members.

Requiring consumer-facing technology is creating new markets. For example, upstart payer Oscar recently announced that it would be selling its technology to other payers as +Oscar.

CMS’s policy direction here resembles that of the ONC’s 10 years ago, which laid the groundwork for a sweeping consolidation of the EHR market. As technology requirements make economies of scale more important, expect a similar occurrence within the payer industry.

Medicaid, Medicare Expansion
Expect the Biden administration to commit to ensuring wider availability of Medicaid, Medicare, and Medicare Advantage. The President has publicly stated that he would like to lower the Medicaid eligibility age from 65 to 60, create a public Medicare option, and roll back state waivers of Accountable Care Act provisions.

Such decisions would represent a massive boon for digital health organizations geared toward those populations. The equation holds for any provider group offering value-based care—the more patients you can cover, the better your economies of scale. Additionally, if members can sign up when they are 60, value-based care can be even more effective by providing earlier interventions.

Final Thoughts
The Biden administration is working quickly to address the most pressing issues related to the pandemic. While beating COVID-19 remains the most urgent initiative, Biden is looking to the future by making the appointments and budget requests necessary to transform HIT for the better. Policy wonks should not necessarily obsess over what new programs are created but rather what tradeoffs are being made in enforcing new programs launched under Trump.

Even while on the campaign trail, Biden made a point of letting voters know how personal health care was to him. His choice of highly qualified administrators and early use of key policy levers demonstrate that he knows how to be effective in making health care changes. Expect a generally “boring” four years in which substantive work gets done without fanfare.

— Nick Hatt is a senior developer at Redox.