Written by: David Raths | Healthcare Innovation
Even after hundreds of comments have been submitted, health IT stakeholders are still considering the implications of the Request for Information put out by CMS and ASTP/ONC about value-based care, data standards, and interoperability. Two influential speakers in the digital health sphere are the executives of b.well Connected Health, a company that helps patients gather and use their longitudinal health data. Kristen Valdes, the company’s CEO, and Jill DeGraff, b.well’s head of regulatory, recently spoke with Healthcare Innovation.
HCI: Do you think the questions posed in the request for information (RFI) from CMS and ASTP/ONC signal that big changes are coming to the digital health ecosystem?
Valdes: Yes. The questions are exactly aligned with our beliefs and premise of why we started the business in the first place, around creating a transparent, shoppable consumer experience in healthcare that is built on an open innovation ecosystem. I signaled that we’re at this inflection point, where we are either going to allow natural monopolies to emerge in healthcare, or we are going to try to build ecosystems. And this administration is very big on creating markets, and I think they’ve signaled the exact right things.
HCI: I recently spoke with Premier policy folks about this, and my take was that typically you don’t see Republican administrations wanting to impose more regulations and fines on business. But Premier was recommending much stronger enforcement of information blocking regulations. I thought that seemed like kind of a shift in thinking for a Republican administration.
DeGraff: The interesting thing is that the first Trump administration was remarkably pro-transparency, pro-standards, pro-competition, and one of the first things that this current Trump administration did was bring back an executive order that had been part of the first administration that had been rescinded during the Biden administration, which basically said you needed to support this more competitive ecosystem in order to curb market abuses. So that’s why we have the cost transparency rules for hospitals.
Also, earlier transparency regulations only called for some tools to be made available to consumers and for data to be presented in machine-readable format. Well, now we have much more mature infrastructure to support real-time streamable data through APIs, so they’re going to accelerate standards for transparency-oriented data to be shared through APIs, too, and that’s also going to drive that consumer experience that Kristen led off with.
Another theme that this administration has talked about since they started talking to the healthcare stakeholder groups is the emergence of generative AI and LLMs in the market. The only way to realize that advancement is to unlock the data. If the data continues to remain siloed and locked up in these proprietary walled gardens, we’re not going to be able to realize the future from a healthcare perspective. They see it as a real opportunity to finally solve for this runaway freight train of a pricing problem that we have in this country that also delivers poorer outcomes.
HCI: Kristen, you spoke on a panel at the HHS listening session about the RFI. One of the suggestions you made was shifting certification from EHRs to APIs. Is that something that was hinted at in the RFI?
Valdes: It wasn’t. But it is something that has been discussed at the CARIN Alliance. We believe that the definition of Meaningful Use, which is the certification of the operational workflows inside of an EHR, should be moved to the APIs that surround that EHR, because that would create a level playing field for both incumbents, EHRs included, and new entrants and healthcare innovators to access the point of care from a data access perspective. That way, real competition emerges.
HCI: Well, if we had someone from Epic on the call, wouldn’t they say that they have lots of APIs. But are those more proprietary than open?
Valdes: Quite frankly, Epic is the most advanced in their interoperability. But there are 2,000 EHRs in this country today. Think about something like access to care and scheduling. One of the biggest pain points for consumers today is wait times and being able to find care when they need it, right? That’s why provider directory rules came about. It’s very, very difficult for people to find new doctors, and especially those accepting new patients, and then oftentimes they wait. So when you think about all EHRs, including virtual care and digital health companies, there needs to be a standard that emerges, like a FHIR implementation guide for scheduling that mandates the types of information and the workflows.
What is the minimum viable product from an API perspective so that you could create something like a Google Flights or an Amazon that allows for a consumer to see all of their options, irrespective of the EHR, so that they can compare with an informed knowledge base: What is convenient for me? What am I willing to pay? Who can see me the earliest? Can this be done virtually vs. in person? Is there a prior authorization?
The overwhelming majority of EHRs today have APIs that will show you what availability exists for an appointment. But unlike Epic, which is much further along, they don’t allow you to actually book the appointment through that API. So we need that regulatory approach that says everyone can compete on a level playing field, which is where innovation is going to emerge, but we need to standardize it so that consumers can have a more holistic picture of what they’re after.
HCI: If ONC did start certifying on the API level, could the EHR certification work that they’re doing now go by the wayside, or should that continue?
Valdes: I think it can go by the wayside. I mean, even Epic in their letter in response to the CMS RFI, talked about the fact that Meaningful Use certification was made for a different day and time. And that’s always true, right? Regulation is just like technology. It’s stale over time, because we live in a different technological era, a different regulatory era than what we saw prior. So it’s time for change.
HCI: Another thing you mentioned was the need to eliminate “portalitis,” adding that portal overload is a symptom of a broken identity infrastructure. Can you talk about what that means?
Valdes: Being the mom of a child with a rare disease — you know, Bailey has 26 different clinical patient portals. None of them are accurate. None of them talk to each other. But she also just recently went from pediatric care to adult care. If she wanted to collect her longitudinal record, which she is legally entitled to do, to any trusted third-party app of her choosing, she would have to call some of those pediatric offices who she’s not able to see for care and ask for a portal credential to even access her data. They’re not going to give it to her unless she has an appointment, and they’re not going to book her an appointment because she no longer qualifies to be seen. That’s just one of about 100 examples of why it is very difficult for people to use portals as the privacy or identity solution for trusting that people do, in fact, want their data.
You can use your retina to go through TSA and board an airplane. You should be able to use your retina to collect your medical record. There are many more secure ways and more private ways that are more advanced than a portal login and password.
HCI: Jill, after the listening session, you wrote about some CMS announcements and initiatives.The first one was about a national healthcare directory. Why do we not already have one?
DeGraff: We’ve been going after it in piecemeal through legislation and regulation, but no real initiative. At the same time when the No Surprises Act was established, there was a congressional mandate for provider directories by all health plans to get cleaned up, and if they don’t get cleaned up, and you have providers listed in it that are actually out of network, then you’re not going to be able to go balance-bill. For those, you’re going to have to to eat whatever that balance bill is, but there’s no enforcement behind it.
Provider directories, at the network level, at the health plan level, have been notoriously problematic for years, but to Kristen’s point, people need to be able to make intelligent decisions involving their finances as well as their ability to find care, and have an easy way to figure out where their data is. You have doctors who move around; practices close; they have privileges and see patients at multiple systems. So you need a way for there to be an authoritative source of truth, recognizing that there must be a multitude of different sources of data in order to get that roll-up to an authoritative directory.
HCI: Another thing you mentioned was that a Data at the Point of Care API will move into production. Can you describe that briefly?
DeGraff: It has to do with being able to create a real-time, streamable longitudinal health summary to power applications, so that you can get to the right information at the right time. If you’re CMS, and you’re getting all the claims data, you may be able to identify the care gaps, or where care gaps have been closed. But if you can’t get that information into the EMR to influence population health analytics or at the point of care during a clinical encounter, then it’s like a tree falling in the forest that no one hears.
HCI: Another thing you mentioned is that CMS said it will exchange information over networks. The folks at Premier mentioned to me that at the listening session, the people from CMS said that they are interested in participating in a trusted exchange. But the Premier execs said it seemed like CMS purposefully did not mention TEFCA at all. So are people trying to read the tea leaves to see if they’re going to continue to support TEFCA or not?
DeGraff: Oh, absolutely. I think the actual language is that they reinforce their commitment to participate in trusted exchange. That might mean being a node for trusted exchange. It could be through this API-oriented ecosystem. It could also be through HIEs. It could be through just one information network, such as eHealth Exchange. I think what they want to do is actually establish a bit of a race to the top and not necessarily put all their chips on one solution.
Valdes: There’s a large percentage of healthcare stakeholders, myself included, who don’t feel that EHRs should have been approved to be QHINs. There’s an inherent conflict of interest.
TEFCA holds the promise of a single onramp to nationwide interoperability. We know that technologically these things are possible, but because of who got in and was influential early, we didn’t meet the goal marker. TEFCA was supposed to launch on FHIR, not on CCDA; it was supposed to launch with six permitted use cases, but it only launched on treatment. So I think right now it’s being perceived as a much less complete national network. I don’t think that it’s going to deliver up to its promise unless some very clear issues are resolved.
