Health Information Compliance Alert

The pandemic shined a spotlight on the importance of interoperability in healthcare — and how lackluster data sharing can impede care. Now, the feds are taking what they learned, harnessing the provisions of the 21st Century Cures Act, and aiming to bolster health information exchanges across the country.

Details: On Jan. 18, the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Sequoia Project released the first official edition of the Trusted Exchange Framework Common Agreement (TEFCA). Among the highlights of the agreement is establishing a Recognized Coordinating Entity (RCE) to develop, update, implement, and maintain the Common Agreement, while Qualified Health Information Networks (QHINs) connect to establish a nationwide sharing of health information.

Read on for a breakdown of this significant advancement in healthcare data sharing.

COVID-19 Exposed the Need For TEFCA

While an official version of the agreement was released in recent months, TEFCA has been in development for several years. The agreement was originally part of the 21st Century Cures Act that was signed into law on Dec. 13, 2016. “[T] he National Coordinator shall convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks,” Section 4003(b) of the law states,

The idea behind TEFCA is that the agreement will make sharing health data simpler. TEFCA “is intended as a network of networks for healthcare. It provides the legal and technical sharing frameworks for health information exchanges (HIEs) to transfer patient data to one another,” says Drew Ivan, chief strategy officer of Lyniate in Boston, Massachusetts.

Currently, several national and regional Health Information Networks (HINs) exist, but many HINs don’t share data. As evidenced by the COVID-19 Public Health Emergency (PHE), there is a definitive need to share health information between providers and facilities — for both care and public health reasons.

Dissect the Components of TEFCA

The two main components of TEFCA include the Trusted Exchange Framework (the “TEF”) and the Common Agreement (the “CA”).

“The ‘Trusted Exchange Framework’ can be thought of as the ‘governance’ portion of TEFCA,” says Daniel T. Golder, DDS, MBA, principal of Impact Advisors in Naperville, Illinois. The TEF creates a common set of non-binding, foundational principles for practices and policies that help enable data sharing between HINs. Essentially, the TEF establishes the standards that networks need to comply with when sharing data.

The TEF also defines seven principles that act as safety measures for organizations exchanging health information. These principles include:

1. Standardization
2. Openness and transparency
3. Cooperation and non-discrimination
4. Privacy, security, and safety
5. Access
6. Equity
7. Public health

By agreeing to these principles, entities will “enter into more uniform contractual relationships” that help improve the digital exchange of health information, indicates the TEFCA User’s Guide.

How will users in different HINs safely and securely share information? That’s where the CA comes into play. “The Common Agreement is a legal contract that both the RCE and a prospective QHIN will sign and can therefore be thought of as the ‘legal’ side of TEFCA,” says Dr. Golder. In other words, the CA are the terms and conditions that regulate the QHINs’ activities. Dr. Golder adds that some provisions of the CA will flow down to entities “within a QHIN’s network via other agreements.”

Simplify Collecting Patient Histories

Provider organizations that want to participate in TEFCA won’t have a direct connection to the agreement, but rather they’ll participate through their HIE. “Providers should be understanding the benefits and requirements of participating in TEFCA and starting to understand which interoperability tools and services they’ll want to be using,” says Ivan. For providers participating in one or more HIEs, they should check with their HIE about TEFCA plans, but providers who aren’t participating in the program, “they should identify the predominant one in their geography and get connected,” Ivan adds.

In the TEFCA hierarchical structure, providers are participants of an individual QHIN. Other examples of participants include HIEs, health system electronic health records (EHRs), pharmacy health IT systems, and consumer apps.

From top to bottom, TEFCA is organized as follows:

• ONC: Sets certain governance requirements and the overall policy.
• RCE: Supervises and provides a governing approach for QHINs.
• QHINs: Directly connect and expedite national interoperability.
• Participants: Parts of an individual QHIN.
• Subparticipants: Members of an HIE (such as a provider or consumer app) and the pharmacy health IT system.

Consider this scenario: Why should providers join TEFCA? Imagine a 54-year-old patient visiting Arizona sprains their ankle. They are originally from Virginia but present to a local urgent care clinic to have their ankle evaluated. All their medical records are back home with their primary care provider. Now, what if the urgent care clinic could access the patient’s medical records and health information with a couple of keystrokes or mouse clicks, so the clinicians could immediately provide care?

That interoperability is the end goal of TEFCA. Ideally, the sharing of data between QHINs will allow providers and health systems to gather a more informed care picture across multiple settings via fewer connection points. This collection of data will help providers coordinate and improve the type of and quality of care for their patients. The nationwide accrual of information could help reduce costs, improve care quality, and expand public health interoperability.

Plus, when the patient in the scenario above returns home to Virginia, their primary care provider can easily access any X-rays and clinical documentation from the encounters in Arizona. The provider can then offer efficient, informed follow-up care to the patient.

Figure Out the Financials

With most policy changes and agreements, the question most businesses ask is, “What’s the cost?” This is an important question to address since a provider organization looking to join the agreement may require an IT infrastructure upgrade and more staff to handle the demands of the network.

At the same time, member organizations will pay a fee to their regional QHIN. These fees allow the organization to access the national network. When you examine this aspect, TEFCA can be a winning scenario for both parties. The sharing of data will provide clinically relevant data about patients, which can help reduce healthcare costs. At the same time, the QHINs receive a steady and stable income stream from the fees, which they can use to plan capital expenditures.

Will TEFCA Take Full Effect in 2022?

With the first edition of the agreement released in January, TEFCA is still in the development stages. The agreement is anticipated to be operational at some point in 2022, but “realistically it will be 2023 before most participants and subparticipants will be fully online with TEFCA,” Dr. Golder explains.

Some of the steps that need to be accomplished before TEFCA is fully operational include:

• Application and approval of QHINs by the RCE
• Approved QHINs need to implement technical and governance requirements, as specified by the CA
• Approved QHINS must become fully operational
• QHINs need to sign participants to contracts and start exchanging information

“[The agreement] is still in development, so be on the lookout for fast progress over the next 12 months,” Ivan says.

Stay tuned: Health Information Compliance Alert will continue to monitor TEFCA updates and report accordingly as changes are introduced.

Resources: Review the 21st Century Cures Act at www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf and find the TEFCA User’s Guide at https://rce.sequoiaproject.org/wp-content/uploads/2022/01/Common-Agreement-Users-Guide.pdf.