The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ health IT office are tackling the nation’s data exchange infrastructure, which they say isn’t working for Americans.
The CMS and the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator of Health IT (ASTP/ONC) are seeking public comment on how to ease data exchange among the healthcare ecosystem for patients, providers, payers, vendors and value-based care organizations through a request for information published May 13. The RFI also asks questions related to information blocking, price transparency, prior authorization and quality measurement policies.
“Although the building blocks for a patient-centric digital health ecosystem are in place, the experience of most patients, caregivers, and providers is neither seamless nor simple,” the RFI says.
Stakeholders say the RFI could have a profound impact and change the ecosystem. While it’s not clear how the Trump administration will implement feedback, stakeholders say the outcome could be transformational for interoperability and data access.
The RFI had a sprawling thematic reach. It asks stakeholders how current programs like the Trusted Exchange Framework and Common Agreement (TEFCA), CMS APIs and health data exchanges are—and aren’t—working. The RFI asks fundamental questions about the ONC initiatives of the last two decades.
The RFI zeroes in on the experiences of patients’ and caregivers’ access to their health record data. Tom Leary, senior vice president and head of government relations at the Health Information and Management Systems Society (HIMSS), said data access for patients and caregivers has been largely neglected in the regulatory implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act and the 21st Century Cures Act.
Leary referenced the Trump administration's AI RFI from the Office of Science Technology Policy from February and noted that the administration provided clarification on a framework for federal AI procurement within 60 days. “Hopefully that’s the pattern that the administration starts to demonstrate is, we’re going to ask the question, but then we’re going to give you some guidance,” he said.
Stakeholders including Jennifer Goldsack, CEO of the Digital Medicine Society, think focusing on data infrastructure is the right way to address challenges across health IT.
“My big takeaway was there is a realization that flows of data, the ability to use and reuse with the appropriate permissions, health data and information, is the key that unlocks a sustainable health care system,” Goldsack said in an interview. “When we get back to TEFCA, and when we get back to interoperability, and we get back to sort of standardized APIs for data exchange, all that's driving towards is a recognition that data is currency … they've actually got down to brass tacks and recognize that it's all about the data.”
A focus on the patient and original health IT legislation
The first section of the RFI is dedicated to the experience that patients and caregivers have had accessing their personal health information electronically, how they are digitally managing their health records and using technology to navigate care.
The CMS and the ASTP want to know how patients and caregivers are accessing their health information digitally and whether any data are missing. It asks what obstacles patients and caregivers face to accessing all of their health data.
The RFI focuses on stimulating developer interest in digital health technologies and how the government can encourage providers to adopt them.
The RFI seeks to understand what health management or care navigation apps patients are using to manage their health needs and to identify the next steps in their care journey.
“CMS and ASTP/ONC would like to continue to build on the existing policy framework to drive large-scale adoption of health management and care navigation applications, reduce barriers to data access and exchange, realize the potential of recent innovations in healthcare that promote better health outcomes, and accelerate progress towards a patient-centric learning health system,” the introduction to the RFI says.
The CMS asks how it could incentivize the use of these apps by patients and caregivers and what accessibility features make digital health products easy to use for Medicare beneficiaries.
The agency is considering whether it should review and approve digital health products for purposes other than coverage determinations. The CMS asks how it could collect real-world data on digital health products’ impact on health outcomes and related costs once they are in the market.
“It's going to come down to making the juice worth the squeeze to adopt these technologies. So whatever incentive is placed on the table has to outweigh the costs and logistical burden of implementation,” Goldsack said.
Leary said the RFI is getting back to the foundations of the HITECH Act and the 21st Century Cures Act. The executive branch has not yet fully addressed the patient and caregiver data access mandate in the laws, he noted.
“The CMS RFI brings the topics of what data points do you need? What has been your experience with personal health records, or your MyChart, or whatever your patient portal is? What has been your experience, what is missing?” Leary said. “For the average person, the current portals might be perfect, but for someone dealing with a chronic illness, or they're caring for someone with a chronic illness, there might be other data elements, or there might be capabilities that they wish they had in their patient portal. I think that having that kind of query out to the patient and caregiver community is a very healthy discussion for us to be having.
He continued: “It fits very well with the overall MAHA theme of getting the patient involved [in their care].”
HIEs, TEFCA, certifying APIs
The RFI asks stakeholders about the real-world impacts of TEFCA. The offices ask whether TEFCA is performing unique interoperability functions, whether there are adequate TEFCA alternatives to achieve patient access to health information and whether there are use cases that TEFCA is not currently supporting.
In the payer-specific section of the RFI, the CMS and the ASTP ask what policy-level or technical limitations payers can identify with TEFCA and if they hinder adoption.
The RFI also probes health information exchanges. The agencies ask how the exchanges are helping patients with availability, value and accuracy of health data. Leary said health information exchanges will likely be a big topic of the responses to the Trump administration RFI.
“I think that proper funding for health information exchange, the verb, at both the state and federal level, is something that is … continually being discussed, and the viability of health information exchanges, the noun, is a critical component of making sure that we continue to deliver on the expectations that the American public has come to have around healthcare,” Leary said. “Then you're going to layer on some pretty sophisticated expectations around artificial intelligence. It's a very important dialogue for us all to have to make sure that the data is useful.”
HIMSS will be focusing part of its response to the CMS and the ASTP on the debate between certifying EHRs or whether the industry can move to only certifying APIs.
“That's really one area that we'll be focusing on, that certification of APIs, and ultimately, does it mean that we only need to certify APIs, or do we need to continue to provide that level of certification for the providers in the community?” Leary said.
Leavitt Partners released a paper (PDF) in March arguing that “limited efforts have been done to advance non EHR solutions and application programming interfaces required by Congress.” Certification of certain APIs could also help encourage their adoption, Leary added.
There are still parts of the health tech ecosystem that the federal government has yet to significantly aid, according to Aaron Neiderhiser, CEO and co-founder of Tuva Health, a common data model for aggregating claims and clinical data.
From a population health perspective, the CMS and the ASTP still have a long way to go to incentivize data analytics at a population level, like some of the initiatives it seemingly seeks to do with answering why American children have chronic diseases or what the root cause of autism is.
“We have this problem where interoperability and taking an API approach to transactions has been helpful for exchanging information on a single patient, or often even at a level below that, like, one encounter. It's been completely useless in making the data ready to actually generate meaningful insights at a population level, and that's why we're building.”
Aggregating and enriching population-level data could also be important for the development of novel AI algorithms. Goldsack described the need for system-level change to be able to deliver on the promises of AI.
“This is the infrastructure play that we need to see in order to actually bring to fruition all of the conversations and, frankly, investments in AI,” Goldsack said. “When I think about the digitization of healthcare, it's all going to run on flows of data … in order to actually find efficiencies, to do precision medicine, to actually drive towards things like value-based care. Absent access to high-quality data, none of that happens.”