With the breakneck pace at which new health information technology reports and regulations are released, last week’s report from the Office of the National Coordinator for Health Information Technology (“ONC”)—on health information blocking—may have failed to hit the radar. But it should have, because of the key message it contains:
“[…] some business practices, though they may arguably advance legitimate individual economic interests, interfere with the exchange of electronic health information in ways that raise serious information blocking concerns. At some point, ONC believes that decisions to engage in such practices are unreasonable as against public policy […]”
Said more succinctly, when it comes to sharing electronic patient health information, public good should trump private gain. While it may seem like an obvious statement, it represents a tectonic shift in the narrative surrounding health information exchange (“HIE” – the electronic sharing of patient data across unaffiliated provider organizations).
For more than a decade, our federal strategy has largely left HIE to the market under the assumption that, if there is benefit to be created (and estimates suggest that there is), we should see the emergence of ways to capture that benefit. In practice, this means that HIE efforts have sprung up in various health care markets across the country, and where public money has been spent on HIE (largely at state and community levels), it has come in the form of one-time start-up funding, not a commitment of ongoing support or regulatory mandates for HIE participation.
What has been substantially underappreciated, however, is the fact that, for the key actors needed to enable HIE to occur—provider organizations and vendors—there might be more benefit, or at least more certain benefit, from not doing so. And as a result, these actors may behave in ways that interfere with the free-flow of patient information that is needed to improve health and health care.
With the release of the information blocking report, which was produced in response to a 2015 Omnibus bill request that introduced the term “information blocking,” ONC makes plain that this behavior will no longer be tolerated. This enormously exciting development means we might see real progress after decades of investment that has failed to convert into sustainable approaches to robust HIE. The key to such progress, however, lies in how well we can identify when information blocking is occurring. This will not be easy.
According to the report, if the behavior of provider organizations or vendors meets the following three criteria, they are considered to be engaging in information blocking:
- Interference. There must be “an act or course of conduct that interferes with the ability of authorized persons or entities to access, exchange, or use electronic health information.”
- Knowledge. “The decision to engage in information blocking [must be] made knowingly.”
- No Reasonable Justification. Conduct must be “objectively unreasonable in light of public policy.”
Health Information Blocking: In Concept And In Practice
In concept these are good criteria, and they should capture the two key types of problematic behavior. The first is the actions taken by provider organizations to selectively share information based on what is in their competitive best interest. The second is the actions taken by vendors to maximize revenue by making it difficult for providers to access or share information and then charging for solving those problems.
In practice, these criteria are progressively harder to prove. Without being able to definitively identify whether or not something is occurring, it is extremely difficult to create effective policy remedies to combat it. The particularly tricky dimension is “reasonable” justification. There is no question that the CEO of a large electronic health record vendor would have quite a different definition of “reasonable” than would our National Coordinator for Health IT.
However, even among those seeking to maximize public benefit, there is likely to be disagreement on what constitutes “reasonable.” There are hard tradeoffs to be made when trying to balance the need to further the availability of electronic health information for better care, and maintaining the privacy and security of electronic health information. And reasonable people can disagree about what constitutes a reasonable tradeoff.
There is clearly a subset of behavior that will incontrovertibly represent information blocking. The appendix of the ONC report presents scenarios that illustrate how the criteria might be applied. Perhaps the most extreme scenario involves an electronic health record vendor that activates a “kill switch” that “encrypts all patient health records stored on Provider’s computer systems and renders the data inaccessible to Provider and its patients.”
This is in response to an unresolved billing dispute between the vendor and the provider, and even when the provider requests temporary access so that it can retrieve its patients’ records, the vendor does not allow it. It would be hard to find anyone who could argue that the vendor had a reasonable justification for refusing the temporary access, and so this offers up a textbook case of information blocking. However, clear-cut cases like this one are likely to be more the exception than the rule.
Indeed, the report acknowledges that “whether any reasonable justification exists will depend on the attendant facts and circumstances and require a careful consideration of the objective reasons for the practice; its likely impact on health information exchange; the extent to which it could have been reasonably avoided; and the extent to which it advances any countervailing interest.” This sounds like lawsuit-level evidence, evidence that is going to be complex and costly to generate. In addition, a line will have to be drawn in terms of just how much public benefit there would have to be to compensate for what could be real losses to providers and vendors.
Yet without a definitive verdict, it will be much harder to take effective action. And to begin with, there is no statutory basis on which to investigate and go after information blocking; today, these practices are, for the most part, completely legal. How to navigate these intertwined challenges is a critical unresolved issue, particularly so given the fact that ONC has the ability to take some actions to curb information blocking, but stronger action would require collaboration among a broader set of federal agencies and even new legislation.
A Policy Framework To Combat Health Information Blocking
The report does propose a multi-faceted policy framework to limit information blocking, comprised of targeted actions (four of which are highlighted here) and an additional set of broader strategies to foster an environment that discourages information blocking. The first targeted action is the use of the current “certification” process for electronic health record products to assess whether information blocking is occurring, and as a way to take corrective action against vendors found to be engaging in this activity (by suspending certification or decertifying products).
The second action is to increase transparency of information about vendor behavior. Better availability of information about vendors’ business practices (and costs) could motivate better behavior through public shaming, impacting vendors’ ability to attract new customers. Increasing transparency is also the strategy most likely to garner bi-partisan support.
Third, the report suggests a set of governance “rules of the road” that would discourage information blocking practices, and entities would be recognized (likely by ONC) for complying with the rules. This is the least well-developed of the strategies, particularly given the limited options for ONC to enforce compliance, and so it is hard to evaluate the likely effectiveness.
Fourth, clarifying HIPAA and other health information privacy laws will help remove the potential that exists today for provider organizations and vendors to use these laws as a cover to engage in information blocking. Such clarifications are long-overdue in general, and will be critical to resolving many of the “reasonable justification” debates.
The additional dimensions of the framework propose coordination with other federal entities (Office of the Inspector General, Centers for Medicare and Medicaid Services [CMS], Department of Justice, and Federal Trade Commission) to create stronger incentives for avoiding information blocking, and to create stronger investigation and enforcement mechanisms (beyond ONC core competencies). It is clear that information blocking is an issue of concern to multiple federal agencies, and they are likely to be willing to work with ONC on combating it.
However, doing so will require making some bets about the best path forward for health care delivery system reform efforts more generally. For example, ONC argues that working with CMS to spread value-based alternative payment models (such as accountable care organizations, or “ACOs”) should help to combat information blocking because these models create the need to “exchange data across the care continuum.” However, in the appendix, the first scenario describes an ACO that refuses to share information electronically with a competitor ACO, and the blocking ACO argues that its behavior is justified because “it is advancing the broader interests of competition and consumers.” Achieving the right balance between competition and information-sharing has remained an elusive goal, and federal agencies may need to decide to err on one side versus the other.
The Potential For A New Era
While these challenges are difficult, and much work remains to convert the ONC report’s ideas into meaningful action, we should not discount the enormous step the report represents. There has long been recognition that current market conditions create incentives for providers and vendors to establish business practices that interfere with sharing and use of electronic health information. But there has been no term for these practices, and no framework for addressing them.
While not sufficient to ensure that we achieve broad-based interoperability of health IT systems (and realize the substantial potential value from the $28 billion public investment in these systems), reducing information blocking is not only a necessary step, it is perhaps the most critical step. Now that we have a clear statement that public benefit and public policy goals take precedent, and there is serious talk about enforcement mechanisms, providers and vendors may finally be convinced to shift their business practices and business models to deliver on these.
When the C-suite truly believes that they can be most successful by competing on the basis of sharing and using data, rather than hoarding and controlling data, we will know that we have succeeded.
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