Federal Health IT Strategic Plan (2020-2025) Part 1: Health IT Developers, Information Blocking, & Interoperability

On January 15, 2020 the ONC published the 2020-2025 Federal Health IT Strategic Plan. This is the first post of a two-part series that will cover the plan from the perspective of (1) health IT developers, and (2) healthcare provider organizations.

These strategic plans fit a couple of use cases for the federal government. They act as a declaration of high-level policy and organizing principles that help prioritize federal resources. In fact, one of the consumers of these plans is the ONC’s sister agencies, who may look to it for guidance when they are working on initiatives that are adjacent to health IT. This document is an HHS health IT strategic plan that happened to be drafted at ONC.

It’s like a looking glass into how the federal government intends to behave regarding the regulation of health IT. It makes sense to work the Government’s strategic priorities for health IT into your own corporate strategic outlook. So what are those priorities? There are two prongs that stand out to me: (1) the enforcement of 21^st Century Cures’ prohibition of information blocking, and (2) the extensive importance of standards and Application Programming Interfaces and what that means for physician payment programs.

With respect to information blocking, this quote from Dr. Donald Rucker, the National Coordinator for Health IT, says it all:

“[T]he system’s transformation is hindered by entrenched interests looking to prohibit access to that information.”

Enforcing 21^st Century Cures’ prohibition against information blocking is going to be a priority. More than that, the Government is broadcasting that it does not see the lack of interoperability as a result of technical barriers. It sees it as the result of bad actors who are not acting in good faith. This quote is markedly different from how the ONC referred to challenges in interoperability in its last 5 year plan, where it at least spoke of “[c]laimed barriers to interoperability include the use of different technical standards, lack of business incentives that can lead vendors and providers to block the transmission of health information to other vendors and providers, deficits in trust, and differences in state laws and regulations that make it difficult to share information across the stateliness.” There’s no such nuance here.

This means enforcement actions. The plan goes on to claim that developers in the private sector create beneficial technologies when “[s]purred by regulatory actions from ONC and CMS[.]” That’s a pretty clear indication that more regulatory actions are inclement as well. Developers will want to invest heavily in compliance with these 21^st Century Cures regulations: OIG is charged with investigating information blocking allegations and each violation can carry a fine up to $1 million. The proposed ONC rule also integrates the prohibition of information blocking into the ONC Health IT Certification Program. Accordingly, developers’ certifiers (ONC Accredited Certifying Bodies) and the ONC itself will play an enforcement role. This gives the Government additional levers in its enforcement tool kit; including corrective action plans, certification suspensions that essentially prohibit the sale of certified health IT, and certification bans.

Now with respect to interoperable technology itself, ONC stated what standards it wants adopted and advanced : Fast Healthcare Interoperability Resource (“FHIR”) Application Programming Interfaces (“APIs”). The plan also specifically calls out creating a common vocabulary set to improve the quality of data that’s shared, which I see as an oblique nod towards the desire to build upon the United States Core Data for Interoperability (“USCDI”). A few use cases that aren’t currently part of the certification program may see their day soon. A great example is “payer-provider” interoperability, which has been a recent focus of the Da Vinci Project. Broadening the set of use cases subject to certification seems inevitable, especially considering that one of the major goals of the plan is to “Connect Healthcare and Health Data through an Interoperable Health IT Infrastructure.”

From a commercial perspective, this is challenging. You have to make significant compliance investments into a portion of your business where the Government has said that while you are entitled to a “reasonable profit” (a term of art), it sees the private market as engaging in “rent seeking behavior” by charging fees related to data exchange services that are so high they amount to information blocking under 21^st Century Cures (among other allegations of legal and regulatory violations). It comes down to an allegation of price gauging a public good or utility, at least in part. Unfortunately, this creates a mismatch between private incentives to invest a lot into these technologies and the Government’s desired outcome: interoperable health IT across every part of the healthcare system. It’s not a mismatch that is impossible to overcome, and in fact the folks who manage that balance (excelling where the government wants them to while driving profitability through meeting its customers’ demands) will find themselves winning in the post-Cures marketplace. But that requires a lot of talent, ingenuity, and resources.

I think that with these waves of changes to the certification program (and corresponding physician payment programs), we are going to see another wave consolidation, particularly with the certified EHRs. According to ONC’s own estimates, those markets are somewhere between an 80% and 90% penetration rate. There’s not a lot of room for growth; it’s like tax software and companies only buy one. Companies that are not staffed with enough developers and expertise to respond to the Government’s technical demands in a timely way will incur costs in excess of the actual development effort. As a result, these developers will face increased costs of goods sold, a constrained marketplace with marginal room for growth, and a potential downward pressure on revenues if customer dissatisfaction increases.

The reason these developers may see increased customer dissatisfaction is because how these technical standards will be leveraged in hospital and physician reimbursement mechanisms. The previous five year plan talked about advancing “value” to improve health while lowering costs. The way it did that is through a litany of payment programs that required the use of certified EHR technology as a precondition of getting either incentives or avoiding a penalty. Expect FHIR APIs, the USCDI, and other technologies or variants of those to become the new standards for those programs. An early entry point would be making their adoption a precondition of participation for Advanced Alternative Payment Models (the new Primary Care First initiative springs to mind). Another entry point is by making their adoption a requirement of certain government contracts – which can extend to both general contractors and subcontractors. Those steps will increase demand for these technologies because provider organizations will want to realize incentives from those programs as they manage declining revenues from other sources. Eventually, these standards will become a precondition of a mandatory physician and/or hospital reporting program, like the Merit-based Incentive Payment System (“MIPS”).

So what should developers do now? First, review the plan and prepare a comment letter. The more the government hears the same thing, the more likely it will move the needle during the notice and comment period. The last five-year plan had a whole section dedicated to what changed between its draft and final rules. You should evaluate your organization’s unique role in the healthcare system in the introduction. To the extent it is beneficial, size your company and its impact and relay those numbers. Let ONC know who you are and why they should listen to your perspective. Then, in keeping with the document’s high level focus, provide high level feedback on how this could impact your company and its role in the health system. Give praise where praise is due. Avoid being overly negative. But where you see issues that could negatively impact your corporate strategy, or frustrate it entirely, call out those problems and frame the impact around what it means in terms of the ONC’s policy interests (namely, the quality and cost of care). You can submit a comment directly through this link:

https://www.healthit.gov/topic/2020-2025-federal-health-it-strategic-plan

Next, look at this draft strategy plan in context with the ONC and CMS 21^st Century Cures proposed rules, as well as prior guidance. Everything here is signaling aggressive enforcement. On November 21, 2019, the American Health Lawyers Associated (“AHLA”) hosted a podcast with Acting Inspector General Joanne Chiedi, who specifically stated that information blocking will be a major area of focus. Compare this with your strategy. Are you ready for an allegation of information blocking? What does that internal investigation look like? What resources will you leverage internally and externally? How do you report it internally and externally? What kind of liability does it present? Am I staffed appropriately? Do I have the right amount of the right kind of expertise? What’s the delta between where I am and where I need to be to sustain, respond to, and manage multiple allegations of information blocking at any given time (ranging from the frivolous to the serious)?

These are the questions developers, and in a different way, providers, will wrestle with for the next five years. Good luck out there.