ONC head Micky Tripathi on info-blocking complaints, provider penalties and future of TEFCA
Interoperability was a central focus at the annual HIMSS conference in Orlando, with a slew of companies from large EHR vendors like Cerner to interoperability startups such as Health Gorilla peddling their data-sharing solutions last week. Their goal: to help coordinate care across thousands of miles and between disparate providers and health IT systems.
The federal government has been especially active in this space as well, even before the pandemic highlighted the nation's lack of unfettered health-data sharing.
The Biden administration recently released its framework for countrywide data exchange, called TEFCA, and is also beginning to see information-blocking complaints trickle in, measures that stem from the 21st Century Cures Act passed in 2016.
National Coordinator for Health IT Micky Tripathi, in an interview on the sidelines of HIMSS last week, shared his thoughts on the scope and content of the interoperability complaints, when industry can expect penalties for providers found information blocking and how the government plans to build on TEFCA moving forward.
Here are five takeaways from the interview.
In early 2020, the HHS finalized interoperability rules requiring providers, health information exchanges and health IT developers certified by ONC to share data with patients and with each other.
Since April last year, when the information-blocking regulations came into effect, the HHS has received 299 claims of information blocking.
"I had no idea what to expect, actually, both in terms of volume and the composition. It's funny, because I certainly hear both sides," said Tripathi, a long-time veteran of health IT. "I definitely hear some people saying, 'Whoa, there's way more of this going on than there's reporting around the complaints.' But then on the other side, I definitely hear people saying, 'Wow, that's a lot. That's significant.'"
Tripathi said the number of complaints illustrates the importance of moving forward with further education and enforcement, so wronged parties know there's a system in place to flag concerns.
"There's always sort of a balance of, how many complaints would you like to see? I would actually like to see zero real complaints, because that means it's actually not happening. But on the other hand, knowing that there are issues out there, I would like for everyone who believes they are in a situation where they're experiencing the effects of that interference to feel they can file a complaint," he said.
The majority of complaints — 211 — have been filed against healthcare providers. Forty-six allege information blocking specifically by a health IT developer, while just two are against health information networks or exchanges.
Meanwhile, patients have registered the majority of claims.
"I had no idea what the composition was going to be," Tripathi said. "I think that's really interesting. Especially because the individuals arguably in some ways might have been the hardest to reach."
The head of the ONC noted it's harder for individuals to be aware of the reporting process, while vendors pay strict attention to it because they've got "real, no-kidding" civil monetary penalties of $1 million per incident if they're found to be in violation.
"So in that sense, it was somewhat surprising that there was that much awareness, that we had that many individuals coming forward. I see that as a good thing," he added.
Despite some appeals from patient advocates, the government isn't considering releasing the names of the actors accused of information blocking.
It's uncertain what number of the claims are substantiated, though regulators have sent all credible claims to HHS' Office of the Inspector General for investigation. Tripathi stressed that the ONC has just been receiving complaints and that no violation has been found so far.
"We absolutely wouldn't release the name of either party. For something that's just a complaint, hasn't been investigated," Tripathi said, adding that he "can't even speak to what OIG is going to do" when the enforcement agency begins investigating complaints.
An OIG rule outlining financial penalties for health information exchanges and health IT developers found to be information blocking is expected to be finalized in March. The HHS has yet to propose appropriate disincentives on providers, though 21st Century Cures said regulators could fine as much as $1 million per information-blocking incident.
There are some concerns that the information-blocking regulations are toothless without penalties for providers found guilty of blocking the free flow of electronic information — especially since the large majority of complaints so far have been lodged against providers.
HHS Secretary Xavier Becerra highlighted this as a major enforcement gap in remarks he made virtually at HIMSS.
Tripathi said criticisms of the delay are fair.
"We're working really hard on it, but it's complicated," Tripathi noted. "I can definitely assure you that we are spending a lot of time figuring out how to get that policy out the door. We need to fix it as soon as we can."
TEFCA publication is 'amazing'
In January, the Biden administration released its governance framework for health information exchange, called the Trusted Exchange Framework and the Common Agreement (TEFCA). The goal of TEFCA is to create legal and technical requirements to enable secure information sharing across different entities.
Soon, the application process will open for health information networks, exchanges and other companies to become qualified health information networks (QHINs), or groupings of organizations whose participants can exchange health information across the U.S.
Tripathi said having TEFCA published feels "amazing," partially due to how long it took to be published.
"It had kind of gone underground for a while. I was in the industry until just 14 months ago, and I literally had just assumed that it was dead. And so it's pretty exciting to be able to come in and take stock of where it is, and do a little bit of a reset, and confirm that it's going to be something that's going to be valuable," he said.
Tripathi said the ONC and its private partners, including the Sequoia Project, have started working with stakeholders to iron out wrinkles with the framework. The community response has largely been positive and there are a number of organizations that seem interested in joining.
In order to become a QHIN, entities have to sign onto the Common Agreement, which establishes the infrastructure model and governing approach to help users in different networks share information with each other. The government anticipates initial QHINs will onboard the network this year.
"There are definitely a number of potential QHINs who are starting to look at stuff and will hopefully come forward and go through the process," Tripathi said.
Still, it doesn't mean concerns haven't been raised, including clarifying issues around how individual access works, identity proofing and patient matching, minimum necessary data sharing with public health, aligning different laws and jurisdictions and more, he added.
"It isn't as if we've waved the magic wand, and those go away. But now we have a forum to be able to start to surface those," Tripathi said.
Tripathi noted it's too early to speculate on how many entities will apply, and it's important that ONC not be too prescriptive about what constitutes a viable QHIN. But it could take only a small number of networks joining to achieve widespread interoperability.
For example, if interoperability frameworks Carequality and CommonWell Health Alliance joined TEFCA, that would result in almost blanket coverage of the hospital acute market and ambulatory providers, as the vendors that participate in those networks make up "something like 80% to 90% of the providers in the country," Tripathi said.
Additionally, there are different ways other organizations could participate as well, he added. For example, health insurers could let QHINs form and join different networks, or get together to form their own payer-specific health insurance QHIN.
"From an ONC perspective, and from a TEFCA perspective, we're sort of agnostic to that. And that's what I mean about the market forming," Tripathi said.
Federal agency participation
The ONC is collaborating with a number of federal agency partners in what use cases they'd like to be enabled through TEFCA, including CMS, the Centers for Disease Control and Prevention, the Social Security Administration and the Departments of Defense and Veterans Affairs, which provide medical services to military service members and veterans.
To start, QHINs participating in TEFCA will have to respond to requests for data for treatment and individual access purposes. Then, over time, the ONC and Sequoia plan to phase in other exchange purposes of payment, healthcare operations, public health and government benefits determination.
The CMS in particular is very interested in TEFCA use cases, Tripathi said.
"We're having discussions about, are there possibilities for — to the extent that CMS participates in networks, like through Medicare, Medicaid, or CMMI — are there other opportunities for them to participate in TEFCA as being a more efficient way of doing the things that they already do today? And that would be a big benefit to the taxpayers at large, since that would lower the cost of their operations," he added.
Other use cases the CMS may be interested in include quality measurement pathways, when information is needed for claims attachments. This is a place where CMS is already getting data, but TEFCA may be a more effective way to do that, Tripathi said.
Similarly, the SSA already participates in some networks for the purpose of government benefits determination, while TEFCA offers the opportunity for scalability.
Carrots and sticks?
Some in the industry are concerned that TEFCA's voluntary nature could threaten future adoption, despite the competitive advantages to joining. Tripathi said that's something the ONC plans to continuously monitor, given that there are no direct carrots or sticks for uptake.
Tripathi noted that with the government standing behind TEFCA, it offers the framework a degree of solidity and trust which is hopefully a benefit, and that private companies will be able to benefit from it standing up these use cases that are hard for the commercial market to do by itself.
"Hopefully, the TEFCA model can help to make those real," Tripathi said.
The ONC is waiting to see what happens on adoption before reconsidering any additional measures to incentivize participation, such as requiring entities to participate in TEFCA if they also want to participate in other federal programs like Medicare or Medicaid.
"I don't know that there is a, 'We are now opening the discussion of federal incentives for this,' so much as it be more, as things grow and develop, you start to see more opportunities to say there's real value here for the taxpayers," Tripathi said.