With the proposed Trusted Exchange Framework and Common Agreement (TEFCA), the Office of the National Coordinator for Health IT (ONC) is attempting to provide a single "on-ramp" to nationwide data sharing.
While most industry groups support the goals of this initiative, the timeline for implementation is too aggressive, and the framework is still too broad and does not provide enough clarity as to how it will be rolled out, many organizations say.
ONC released the first draft of the TEFCA back in January 2018 as a framework designed to improve data sharing between health information networks. The framework (PDF), mandated by the 21st Century Cures Act, provides the policies, procedures and technical standards necessary to exchange patient records and health information between providers, state and regional health information exchanges and federal agencies. ONC released the second draft of TEFCA in April and public comments were due June 17.
Because TEFCA was written as a voluntary framework, one of the major issues that ONC will need to wrestle with is how to incentivize participation, many industry leaders say.
A Health Information Technology Advisory Council (HITAC) task force charged with making recommendations about the Trusted Exchange Framework has floated the idea of making participation in TEFCA a condition of participation in Medicare. During a recent meeting, the task force, which reports to the full HITAC committee, recommended that ONC consider a number of “carrots and sticks” to incentivize participation, such as linking participation in TEFCA to ONC’s information blocking rule or enabling the Department of Veterans Affairs (VA) to require participation for providers who want to provide care to veterans under the Mission Act.
“Why would existing health information exchanges, which are functioning reasonably well today, join TEFCA? What is the business motivation or regulatory motivation?” David McCallie Jr., M.D., former senior vice president for medical informatics at Cerner and a task force member, said during the meeting. “This will make or break how the trusted exchange framework will work; it comes down to whether there is an incentive.”
The American Medical Informatics Association (AMIA) and Premier are calling on ONC to develop a more comprehensive plan for TEFCA that includes specific milestones and details about how it will be implemented. This road map should describe what will be required of TEFCA stakeholders for the initial phase, what is being considered for inclusion in subsequent phases and what accountability mechanisms will be in place to gather feedback, AMIA said.
“It will only be through engagement, accountability and transparency that this ‘network of networks’ will successfully emerge and evolve,” AMIA said in its letter to ONC.
Here is a look at some of the themes that emerged from what industry stakeholders had to say:
1. Timeline and provider burden
In TEFCA, ONC has proposed that the first cohort of qualified health information networks (QHINs) will be up and running by August 2020. That is a tight timeline, the American Hospital Association (AHA) said in its comment letter (PDF), and does not provide enough time for networks to update their participation agreements or for hospitals and health systems to update their member agreements.
The Common Agreement includes nearly 30 terms and conditions that need to be incorporated into existing business associate and participation agreements, AHA said.
“We encourage ONC to consider taking a phased approach that will allow QHINs and their participants and members to participate in the TEFCA while their agreements are being updated,” AHA said.
Calling the proposed timeline “overly ambitious,” Premier said in its comments (PDF) that ONC is underestimating the “significant burdens” that will impact providers and other stakeholders who are currently using existing, successful exchange networks and solutions. The burdens will include the costs of TEFCA participation, staffing, contractual changes, privacy and security practices modifications, education and training and other system implementation and administrative costs.
ONC and CMS also need to clarify how and under what circumstances TEFCA participation might be required or incentivized by federal programs, Premier said.
2. Use of standardized APIs and FHIR
The Pew Charitable Trusts recommends ONC take the application programming interface (API) infrastructure the agency is already building in regulation, such as the information blocking rule, and apply it to additional use cases including TEFCA to ensure data can be easily exchanged between providers and with patients, no matter where patients are in the country.
ONC has indicated that TEFCA will initially focus on the document-based exchange processes healthcare facilities currently use. “In addition to documents-based processes, ONC should also examine how to use TEFCA to advance API-based data exchange among providers to enable the transmission of only those data elements that patients and clinicians need,” Pew said.
In its comment letter (PDF), the University of California, San Francisco’s (UCSF's) Center for Digital Health Innovation (CDHI) also is calling for ONC to add a requirement that TEFCA participants use standardized APIs, similar to ONC’s and CMS’ recently proposed regulations. This will ensure interoperability between the two exchange networks, the organization said.
“Without such a requirement, a Trusted Exchange Framework for document-based exchange will never provide the interoperability that Congress, ONC, CMS and the nation all expect with forthcoming standardized APIs,” UCSF’s CDHI said.
In recently proposed interoperability rules, both ONC and CMS are requiring for the first time that the healthcare industry adopts Fast Healthcare Interoperability Resources (FHIR) as the standard for APIs.
The AHA wants to see HL7’s FHIR standard put back into TEFCA.
In its second draft of TEFCA, ONC removed the requirement for QHINs to support FHIR application programming interfaces as an exchange modality, AHA said.
“We recommend that ONC or the recognized coordinating entity include FHIR APIs in the QHIN technical framework as a minimum requirement,” AHA said.
3. Patient access to data
Draft two of TEFCA currently limits patients’ use of the exchange just for Health Insurance Portability and Accountability Act (HIPAA) requests for access to their own medical records and to request copies of the medical record be sent to third parties, according to UCSF CDHI. But patients need and use interoperability for more than just these two rights under HIPAA, the organization said.
Patients want to participate in shared care planning and shared decision-making with their physician, and they want to share remote patient monitoring data and patient-generated health data with their providers. “They want to move beyond piecemeal requests to individual providers to a single, longitudinal health record that is easy to understand, use and update automatically,” the organization said.
The organization is calling for ONC to broaden patients’ individual access services and provide a “full and equal on-ramp for patients’ other core needs.”
4. Patient matching
Pew Charitable Trusts wants ONC to step up efforts to improve patient matching with a focus on broader patient demographic data. ONC should standardize patients’ demographic data, such as using the U.S. Postal Service standard for addresses and including new data elements like email addresses to further improve the accuracy of matches.
“Through TEFCA, ONC has the opportunity to foster the development of an innovative infrastructure for nationwide data exchange that builds on modern approaches to improve patient matching and the effective availability of clinical data,” Pew said.
Members of Congress are trying to move the industry forward with creating a unique patient identifier, an effort long advocated by many health IT leaders. Last week, the U.S. House of Representatives voted in favor of lifting a ban on using federal funding to create patient identifiers.
The effort to overturn the 20-year-old ban now moves to the Senate, although many health IT experts are skeptical about the bill's chances of being enacted.