Preparing for the Rising Tide of Interoperability in Healthcare

Healthcare stakeholders have largely achieved the goal of converting clinical and administrative information into digital formats through the wide-scale implementation of electronic health records (EHRs). However, the ability to share semantically interoperable electronic health information (EHI) among organizations, patients, payers, and other stakeholders has remained limited. Consequently, it is imperative to explore the current state of healthcare interoperability and significant trends that will impact health information management (HIM) professionals, patients, providers, payers, and other stakeholders.

The interoperability landscape is moving quickly. It will be essential to maintain awareness of legislation, standards, and best practices in managing and governing the swelling tsunami of information.

The Health Information Technology for Economic and Clinical Health (HITECH) Act, a component of the American Recovery and Reinvestment Act of 2009 (ARRA), provided incentives and disincentives that led to wide-scale adoption and use of EHRs. As of 2019, 89.9 percent of office-based physicians and essentially all hospitals are using EHRs. However, seamless interoperability has been limited historically by a lack of incentives, insufficient standards, concerns over privacy, and, in some cases, business practices.

The 21st Century Cures Act of 2015 directed the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) to develop policies around “information blocking,” and standards designed to facilitate interoperability. CMS and the ONC released separate final rules in 2020 that provided specific guidance in the form of policies, standards, timelines, and further guidance related to information blocking.

An Overview of Government and Private Sector Interoperability Initiatives

Federal Information Technology Plan

The ONC and other federal agencies are methodically addressing the goals, objectives, and strategies identified in the 2020-2025 Federal Health IT Strategic Plan. In addition to addressing information blocking, the plan promotes data liquidity “to eliminate unnecessarily restrictive data sharing practices,” using endorsed standards, defining implementation specifications, updating certification criteria, and supporting a common agreement for nationwide exchange of health information, as detailed below.

Trusted Exchange Framework and Common Agreement (TEFCA)

TEFCA is a carefully crafted government interoperability framework developed by the ONC, and potentially a major step toward advancing information exchange on a national level. TEFCA will allow for secure nationwide sharing of EHI between regional Qualified Health Information Networks (QHINs). QHINs may connect to health data utilities (HDUs), including health information networks and health information exchanges, as subparticipants. This allows for information exchange among providers, hospitals, payers, and other entities through permitted access to health information. TEFCA is designed to allow QHINs to exchange information with the goal of establishing nationwide interoperability. The Sequoia Project is serving as the “recognized coordinating entity” for TEFCA and will provide oversight to its implementation, including the onboarding and monitoring of QHINs.

The Payer-to-Patient Access Application Provider Interface (API)

As of July 1, 2021, CMS began enforcing support for the payer-to-patient API, one of its policies from the CMS May 2020 Interoperability and Patient Access Final Rule. Certain CMS-covered payer organizations, including Medicare Advantage Organizations, Medicaid, Children’s Health Insurance Program (CHIP), and federal commercial marketplace exchanges are required to offer patients access to their EHI via a Fast Interoperability Healthcare Resources (FHIR®)-enabled API. Payers must release all patient EHI stored within their systems, including but not limited to claims information and medical records (when available).

Release of EHI must be at the request of the patient or potentially a patient proxy. Access must be immediate, and patients must be allowed to use a certified patient access API product of their choosing. The API will then serve as the conduit through which they may access, exchange, consolidate, and store their EHI. Most payers have created technically compliant patient access APIs but, to date, various challenges related to privacy, security, compliance, and usability have emerged that have limited the promotion and utilization of the payer-to-patient access API.

Provider-to-Patient Access API Requirement

Starting on December 21, 2022, provider organizations must use EHRs certified to the 2015 Edition Cures Update Criteria to be compliant with CMS’s Promoting Interoperability initiative. The Cure Update includes a standardized FHIR patient access API and data elements within the US Core Data for Interoperability (USCDI) standard, Version 1.0. For the end of this year, provider organizations have the option of either sharing information through the consolidated Continuity of Care Document (CCD) populated with the required minimum USCDI data elements, or via the FHIR API method. Starting on October 6, 2022, providers will be required to include all EHI within their systems except for psychotherapy notes and certain other documents (e.g., active investigations).

The FHIR methodology of exchanging information has the advantage over other legacy methods, as FHIR allows systems to “push and pull” data between health systems, based on permissions. Information can be set to push data to the receiving destination as new information becomes available, or it can be set up to be pulled by an external system on demand. To meet the patient access API standards, EHI must be accessible on demand in real time via the pull method and available without the need for an intermediary to “approve” or execute the transaction. This gives patients an unprecedented level of control over their health information.

Failure to comply with this requirement (unless certain ONC defined exclusions are met) may be considered information blocking. Information blocking by CMS regulated HINs, HIEs, and certified developers of health information technology may result of penalties of up to $1 million per instance of information blocking. However, civil monetary penalties for provider organizations that engage in information blocking have not been defined, creating an enforcement gap. This has led to challenges with obtaining EHI for legitimate healthcare purposes from some provider organizations.

Lack of enforcement has limited access to the richest source of EHI available, i.e., EHRs. The estimated percentage of health information stored with EHRs went from 46 percent in 2009 to 88 percent in 2019. Once provider information blocking is enforced, EHR data will likely emerge as the primary source of reliable and actionable data in the healthcare ecosystem. In support of gaining access to EHR EHI, the Department of Health and Human Services has stated that enforcement of information blocking by provider organizations is a key near-term objective.

Once this issue is addressed, the most significant remaining challenge to interoperability may be patient reluctance to share their EHI outside of their provider systems. However, the segment of the population that benefits the most from interoperability are patients that have the highest burden of chronic conditions. These patients and their caregivers may be more likely to see the value of having their updated information available in real time as they navigate between settings of care. Payer and provider organizations will play a central role in encouraging patients to allow their EHI to be shared for valid healthcare purposes, primarily through improvements in patient health literacy. Organizations can leverage the AHIMA Foundation’s Health Literacy campaign to advance patient understanding of the potential benefits of health information access, sharing, and use.

Payer-to-Payer EHI Sharing Requirement

The Cures Act also contains a requirement that CMS-covered health plans exchange beneficiary EHI. In 2021, CMS published three FAQs stating that CMS “will not take enforcement action” against affected payers for the payer-to-payer data exchange provision (of the May 2020 Interoperability and Patient Access Final Rule) until future rulemaking is finalized. Once these challenges are resolved, including required standards, it will allow payers to aggregate claims and other information from former payers. This will reduce burden on patients to provide information when on-boarded to a new payer, facilitating a smooth transition to transactions such as referrals or prior authorizations.

Health Level Seven (HL7®) Da Vinci Project

This initiative is a multi-stakeholder, collaborative process engaging providers, payers, health IT vendors, and other stakeholders working to accelerate the adoption of the FHIR standard to support value-based care data exchange across communities in real time. A key focus of the Da Vinci Project has been to improve payer-provider collaboration and allow organizations to implement FHIR in their workflows from a clinical perspective. Numerous use cases have been developed, including clinical data exchange, payer data exchange, data exchange for quality measures/gaps in care, risk adjustment, coverage requirements, prior authorization, and health record exchange.

For example, the first release of the Da Vinci Risk Adjustment FHIR Implementation Guide describes exchanging risk adjustment coding gaps between payers and providers. The Da Vinci Risk Adjustment group is developing “a standard protocol to share and receive clinical data related to risk adjustment and a standard methodology to communicate risk-based coding, documentation and submission status of chronic conditions.” This project has the potential to improve the utilization of gap report information, potentially in real time, allowing for more accurate identification and management of chronic conditions that may not otherwise have been addressed.

CARIN Alliance

The CARIN Alliance is a nonpartisan, multi-sector alliance with the goal of helping patients overcome barriers to accessing their data via consumer-directed exchange. It seeks to advance the ability for consumers and their authorized caregivers to easily access and use health information as needed via nonproprietary APIs that are vetted for their data policies and security practices. CARIN supports allowing patients to retrieve healthcare data from disparate sources, including providers and payers via a secure digital identity.

Interoperability Governance

The interoperability initiatives discussed above share a common goal: facilitate greater access to the EHI stored within EHRs and other systems. As noted previously, enforcement of information blocking by providers may be the principal driver of an anticipated tsunami of health information available to patients, providers, payers, trusted HIT organizations, and other stakeholders. However, the current focus of these efforts is on data exchange and less on how to process and optimize data once it is exchanged. Effective utilization of massive amounts of data from a growing number of disparate sources will inevitably require some form of interoperability governance, which will include directed policies, resources, education, and technologies.

Organizations will have unprecedented access to volumes of encounter documents (e.g., progress notes) transmitted primarily as unstructured text, limiting their clinical and administrative value. A great deal of important clinical and administrative information is stored as free text within these documents. Natural language processing, a form of artificial intelligence, can convert text into actionable codified data elements. Information abstracted should be mapped to a standard reference terminology. This facilitates semantic interoperability and renders data that is fully enabled for analytics. Information can be abstracted as ICD-10-CM, HCPCS, SNOMED CT, LOINC, RxNorm, device nomenclatures, and other code sets. The abstracted data will also need to be harmonized and reconciled with other data sources, another significant information governance challenge.

Once all the pieces are in place, health data exchange will allow for better informed decision-making by patients and their providers. A primary goal of this process is to allow for the automated creation of a fully data enabled and easily updated longitudinal record of care that can be updated in real time. The benefits of achieving a higher level of interoperability, including key data elements abstracted from provider narratives, may finally be realized. Semantic interoperability will benefit a number of healthcare initiatives, including quality, utilization, coordination of care, value-based care, risk adjustment, clinical decision support, disease registries, coordination of care, predictive analytics, population health, and when interventions are needed based on social determinants of health.

Health information management professionals should develop strategies for managing what may be a dramatic increase in the amount of information available to their organizations and patient access. They should advocate for, and participate in, strong data governance programs within their organizations. This includes identifying resources and technical tools needed to validate and reconcile large volumes of structured and unstructured data, and policies related to compliance, privacy, and security practices.

Michael Stearns (michael.stearns@wolterskluwer.com) is a physician informaticist and director at the Health Language/Wolters Kluwer Health.

Susan Clark (sclark@briljent.com) is a health IT consultant with Briljent, advising health information exchanges and state agencies on strategy, funding, and policy.