- Days into 2018, ONC released the first draft of the Trusted Exchange Framework and Common Agreement (TEFCA) designed to streamline health data exchange and advance interoperability per provisions of the 21st Century Cures Act.
While most stakeholders have voiced overall support for the framework, some have pointed to specific areas of the current draft that are still in need of improvement. To put it briefly, the framework is a necessary step in enabling true interoperability across the healthcare industry but needs to be fine-tuned before implementation.
General Counsel Steve Gravely has represented the non-profit Sequoia Project since its formation in 2012 and has seen interoperability advance significantly in recent years. He concurs with the sentiments put forward by AHA, DirectTrust, and the Electronic Healthcare Network Accreditation Commission (to name a few) that the goals of TEFCA are well-intentioned.
“I’m really happy that ONC expressly recognizes the importance of the private sector in the TEFCA guidance,” Gravely told EHRIntelligence.com. “ONC recognizes that the private sector is critical to promoting interoperability.”
The ONC decision to create qualified health information networks (QHINs) to address the industry’s need for large organizations to serve as overarching facilitators of health data exchange warrants merit, according to Gravely. QHINs will ensure interoperability for the networks they represent to create a nationwide network-of-networks.
“That’s a good idea — that we have a limited number of organizations that take on the burden of operationalizing the common agreement and really being the backbone of interoperability,” said Gravely. “Then other organizations work with this finite set. I like the idea of QHINs — conceptually they make a lot of sense.”
In keeping with the opinions of several health information exchange (HIE) leaders, Gravely also sees the framework’s voluntary nature as a positive.
“That’s the right approach as opposed to a heavy mandated approach,” he said.
However, Gravely predicts all organizations within the HIE community — HIEs, HINs, and interoperability initiatives including the Sequoia Project’s own Carequality — will feel TEFCA’s effects.
“This is going to drive change,” Gravely emphasized. “I am concerned TEFCA is going to be disruptive. I think ONC embraced that. In the webinars they have held they have been candid that TEFCA is going to require change. It is going to disrupt the status quo.”
While change is often necessary to spurring progress, some smaller HIEs facing financial uncertainty may be forced out of business. TEFCA — as well as the forthcoming regulations related to information blocking — may put overwhelming financial strain on organizations unable to keep up with mounting requirements.
Changing Business Models Under New Regulations
In addition to drafting and operationalizing TEFCA, ONC also plans to streamline the flow of health data by releasing new rules related to information blocking later this year. Gravely anticipates these new information blocking regulations will significantly change the nature of health data exchange.
“Information blocking regulations will be generally applicable to the whole industry,” said Gravely. “The combination of TEFCA and information blocking rules means nobody has the luxury of sitting this out and saying, ‘this doesn’t apply to me.’ Even though TEFCA is voluntary, no one can sit out the fact that this ecosystem is fundamentally changing.”
Though these new regulations may improve health data exchange in the long run, some HIEs may struggle to stay afloat in a new world that limits or altogether prohibits HIEs from charging healthcare organizations to share data.
“There will be HIEs that close up shop,” cautioned Gravely. “Is that really what we want? I don’t know. That will be a consequence because they may simply say they cannot operate in this kind of world.”
“There are HIEs that survive solely on what they charge for the data that they transact,” he continued. “I’m not sure that’s a sound business model but there are HIEs that do that.”
Whether reducing the number of HIEs nationwide will be a positive or negative development remains to be seen. Regardless, those organizations that are willing to voluntarily participate in TEFCA will need to make significant changes to become QHINs or QHIN participants.
The requirements to become a QHIN are necessarily lofty — the number of QHINs should not exceed 10, Gravely stated. However, Gravely expressed concern QHIN requirements as written in the current TEFCA draft may be so prescriptive and demanding that ONC runs the risk of scaring off all but one or two organizations willing to step up to the task.
Reducing the Prescriptive Nature of QHIN Requirements
The prescriptive nature of QHIN requirements will pose a significant challenge to the HIE community, Gravely predicts.
“I know that Sequoia said this and others have said it too — I doubt there’s any organizations that would actually meet QHIN requirements as drafted,” said Gravely.
While raising the bar high could motivate some HIE and interoperability networks to make substantial improvements, it is likely to also slow or deter widespread framework adoption.
“We need to move this process forward, and having requirements no one can meet right now is just going to take longer and add costs and make it more difficult,” Gravely said. “One of the big concerns I have is that ONC is trying to raise the bar and I support that — but I’m worried the draft guidance sets the bar so high that it’s really counterproductive.”
Gravely recommends ONC take a multi-pronged approach to encouraging organizations to become QHINs.
“First, ONC can dial back the rigorous requirements for QHINs,” said Gravely. “One of the clear areas where they should do that is for the requirement related to connectivity brokers.”
Connectivity brokers provide services including record locator services, patient identification services, and other kinds of centralized data repository tools. Requiring that QHINs include connectivity brokers necessitates that networks adopt a centralized data repository model rather than a federated model. Federated networks operate using a decentralized model in which data is stored at individual organizations and shared upon request rather than being stored in a central repository.
“I would say most networks are federated,” stated Gravely. “That’s the way the market has evolved. I don’t think there’s anything wrong with federated networks. But TEFCA seems to say you have to be centralized. Automatically you’ve ruled out almost every network from being a QHIN.”
To ensure capable, willing organizations are not deterred from attempting to become QHINs, ONC should consider relaxing some of the framework’s more challenging requirements related to connectivity brokers.
“I’m also worried about the restrictive financial rules ONC has put in TEFCA for QHINs about what they can charge, what costs they can recoup, etc.,” said Gravely. “Loosening up the requirements is part one.”
The other half is finding a way to incentivize organizations to become QHINs, Gravely advised.
Incentivizing Organizations to Become QHINs
With new information blocking rules coming later this year, Gravely sees an opportunity for ONC to leverage organizations’ concerns about being non-compliant or penalized for information blocking as incentive to become QHINs.
“ONC could say, if you voluntarily pick up the baton to become a QHIN, you will be deemed to be in compliance with the information blocking rules,” suggested Gravely. “You’ll have been signed off on by ONC, you’ll have a contract with an RCE, and therefore you’ll be deemed to be in compliance.”
Granting QHINs a seal of approval indicating they are in compliance with certain regulations may incentivize some to step up to the challenge. Additionally, ONC will need to simply and efficiently assist QHINs with the financial burden of investing in the necessary changes to meet requirements.
“It’s not clear to me how the QHINs can recoup the cost of that investment,” said Gravely. “TEFCA goes into a lot of granular detail about how QHINs can charge each other fees that are based on their incremental cost of changing.”
“They say if you have to revise your agreement, then your legal fees can be charged,” he continued. “If you have to adopt new policies, procedures, the incremental costs will be charged — for me that’s really going create an accounting nightmare in terms of what are your costs are today versus your marginal costs to comply with TEFCA. A lot more thought needs to be put into that whole financial piece.”
The amount of time and money QHINs could spend accounting for these costs and reimbursements could be overwhelming for organizations.
“The amount of change that TEFCA is going to require is a challenge — but coupled with the very strict and granular financial rules — that’s a real barrier,” he said.
Though stakeholders agree the framework needs to be modified substantially before implementation, Gravely suspects his client — the Sequoia Project — will participate in TEFCA in whatever capacity it can.
“Anyone who is involved in any part of electronic health data exchange — vendor, health system, or HIN — anyone that’s involved in transacting electronic health data will have to participate in some way with TEFCA.” He said. “And EMR vendors and HINs are going to have to comply with information blocking regulations that OIG promulgates because those won’t be limited to just TEFCA participants.”
The Sequoia Project submitted extensive comments to ONC recommending potential changes to TEFCA. The organization suggested ONC reduce the prescriptive nature of the framework, enhance framework flexibility, and clarify qualifications for the recognized coordinating entity (RCE), among other recommendations.
Despite TEFCA’s remaining problem areas, Gravely and others working with the Sequoia Project support ONC’s ultimate mission of improving interoperability through cross-industry collaboration.
“We support where ONC is headed here,” said Gravely. “They did a good job generally speaking and we support the overall framework.”