Could the Trusted Exchange Framework be Discriminatory or Misused?

First, let me say I fully support the objectives of the Trusted Exchange Framework and Cooperative Agreement (TEFCA) that the 21st Century Cures Act directs the Office of the National Coordinator (ONC) of Health and Human Services (HHS) to create. However, I have always had some concerns that it could be discriminatory or, based on ONC's proposed TEFCA exception condition to their renamed Manner Exception (currently called "Content and Manner"), premature in its effect on other manners of health information exchange that already exist. These other manners of exchange may be ones that providers, Health Information Exchanges (HIEs), payers and health information technology developers already participate robustly and securely. Some of these types of exchanges are required by law such as state-based health information exchanges, and some are ubiquitous due to the course of time, (even legal) convention, and industry adoption such as those used for electronic prescribing or the transacting through intermediaries that operate under HIPAA. But I have been nagged by the possible confusion and displacing effect of TEFCA on currently functioning exchanges. Three main reasons:

• What TEFCA calls a "participant" or "sub-participant" (the individuals and entities who are the actual parties that facilitate or directly participate in health information exchange within a Qualified Health Information Network (QHIN)) already may be engaging in a regional, state or local HIE that does the sort of exchange that TEFCA would support in the present or at some future time.
• The HIE that such an individual or entity already uses may not seek TEFCA participation status itself leading its participating individuals and entities to consider the possible redundancy of time, effort, and resource to participate in both that HIE and TEFCA. Would the individual or entity be compelled to make a choice of which to continue to participate in?
• TEFCA requires a participant or sub-participant to be a part of one and only one QHIN due to the way that the directory of all TEFCA participating entities would be structured at the level of the Recognized Coordinating Entity (RCE) whereby a participant can be a member of one and only one QHIN. This seems like it might drive out participation in a non-TEFCA participating HIE where there is redundancy between it and TEFCA or reduce participation in TEFCA if the current HIE in use works for the participating entity's purpose, is robust and secure or even required by state or local jurisdictions to be used. This would exacerbate the issue highlighted by my second concern.

Maybe these things are red herrings or maybe I am wrong. I will submit to what time proves out. If I am right especially on the last one, that could have the effect of disenfranchising some HIEs and some types of exchange that currently occur suitably at present. It at least forces decisions on individuals and entities about their interoperability strategy. Hence, my concerns for TEFCA being potentially discriminatory.

We now have the proposed TEFCA exception condition under ONC's recent "HTI-1" proposed rule that would update certification criteria most significantly for predictive decision support and patient requested conditions/restrictions of consent, adopt Version 3 of the USCDI along with supporting updates to both C-CDA and FHIR based interoperability standards and specifications, expand some Information Blocking Exceptions for certain new conditions, and update Conditions of Certification for the EHR Reporting Program (the "Insights" Condition). In the Information Blocking Exception condition proposals, ONC proposes a condition under the Manner Exception for TEFCA to give safe harbor to health information exchange sought by one party from another for a TEFCA permitted purpose of exchange that is not currently required when both parties participate in TEFCA otherwise. Such exchange would use the modalities and scope of information approved under TEFCA for a purpose permitted by TEFCA. For example, a payer might seek Electronic Health Information (EHI) from a provider for a payment purpose using the C-CDA standard to support obtaining medical information for supporting prior authorization. Such would be permitted under TEFCA but is not currently required based on how TEFCA is initially being launched.

Here is my concern, and I am not the only one calling it out. To provide such a safe harbor exception condition could work to be discriminatory against current functioning health information exchanges or be used for coercion to exchange EHI where the necessary supporting modalities do not yet exist under TEFCA. In the example I give, providers do currently make available EHI in many ways to payers. Now granted, many of them are inefficient, semi-automated and based on non-standard means of providing EHI from provider to payer. One could construct other examples under other TEFCA permitted purposes of exchange. My point is that if a party sought to obtain EHI from another party using the TEFCA exception condition, and it represents new and novel demand for the recipient of the request, it could be in duplication, contradiction, or competition to the current means by which that recipient is used to making EHI available. Such an exchange purpose also may be one that does not yet have standards defined or adopted under TEFCA for the use case that is the basis of a request for access, exchange, or use. This creates potential for the requesting party to coerce implementation of something not yet recognized under TEFCA at the expense of a currently serviceable means of exchange. Further, ONC essentially pronounces non-TEFCA based exchange inferior when they say in the preamble discussion of their proposed TEFCA exception condition that non-TEFCA means of exchange "are potentially less interoperable, less secure, or less scalable" when TEFCA has not even been launched as a production exchange yet. This seems an unnecessary aspersion cast on current means of exchange that do their job serviceably.

I could name other entities who feel similarly but only need point to the Health Information Technology Advisory Committee's (HITAC) Proposed Rule Task Force's report to the full HITAC on the proposed TEFCA exception condition. To quote the report under recommendation 56, "If the TEFCA Manner Proposal goes forward, (we) recommend that ONC limit the requirement to utilize TEFCA exchange when offered to apply only to those use cases for which a TEFCA SOP has been finalized and published by the Recognized Coordinating Entity (RCE), and for which responses are required and operational under TEFCA. This change is necessary because to require the use of TEFCA exchange before the relevant use cases and technical requirements have been finalized may inadvertently disincentivize TEFCA participation."

Clearly, ONC has a policy (and statutory) imperative to make TEFCA work. However, may it be for its own merits and performance, and not in a discriminatory way on what works. HIEs that preceded TEFCA that remain in use have a legitimate place and must remain in use when TEFCA has not yet addressed the purpose of exchange (and may not) especially when HIEs are of long-standing use. ONC should also not be premature on incenting use of TEFCA for exchange purposes through an exception condition that would encourage use cases that, while permitted, are not yet supported by the necessary underlying recognized interoperability modalities, standards and specifications. ONC has an adoption challenge on its hands with TEFCA, and along with the RCE, should encourage adoption and help sell the business case for adoption to participants by helping them understand what its value proposition is, how participants and sub-participants can develop the roadmap to balance what they currently participate in with moving to using TEFCA, and how there legitimately remains a complement between the two even if what that is changes over time. I know it has taken a long time to get TEFCA where it now is on the verge of production launch perhaps by the end of 2023 and there is growing impatience for it to get underway. However, ONC, your duty is to help adopters see the path rather than getting ahead of yourself. Do so by positively selling the value and not by even inadvertently discriminating against current state health information exchange, much of which must remain in complement with TEFCA by necessity.