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Despite the Pandemic, It’s Time to Act on the Interoperability Regulations
By Swanand Prabhutendolkar and Shyam Manoj

Over the course of a few short weeks in March, everything in the health care industry turned upside down. The COVID-19 pandemic evolved at an alarming rate, threatening to overwhelm the US health care system. In the thick of it, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) issued their much-anticipated final rules: The CMS Interoperability Rule and the ONC Trusted Exchange Framework, part of the 21st Century Cures Act. While never more daunting, the need to achieve the goals set forth in these final rules has come into sharp focus during the current crisis.

Consider the well-understood roadblocks to interoperability proliferated by EMR systems. As technology changes and health care data becomes digitized, more challenges arise from systems that can’t interact with each other and data that can’t be shared reliably. A simple but telling example from research by the Pew Charitable Trusts reveals that the process of linking the correct medical record to the correct patient—a seemingly basic concept—is a task at which many systems, even when sharing the same EMR vendor, often fail. The research found that at some institutions, such matching was accurate only 50% of the time.

A companion problem is duplicate records. Research by Black Book Market Research showed an average of 18% of patient records within organizations are duplicates. It’s easy to understand how mismatched and duplicate records—and a whole host of additional interoperability issues, especially in a crisis—lead to clinical oversights, medication errors, rehospitalizations, poor patient experiences, and, ultimately, poor outcomes.

While we witnessed increasing consumerism before the pandemic, the shift to remote, self-service workflows arrived swiftly as health care providers mobilized to provide access to services in new ways—telehealth, drive-through testing and assessments, remote registration, and consent. This puts interoperability at the forefront for health care consumers, providers, payers, and IT vendors, not to mention the US government agencies that oversee them.

In the face of growing market pressure as well as aggressive implementation timelines from CMS and ONC, health care organizations are scrambling to implement interoperability milestones as scarce resources are diverted to managing the COVID-19 crisis. While difficult to undertake right now, there are practical steps HIT leaders can take in the short term that will drive interoperability across the health care ecosystem, making it better for consumers, patients, and members.

What Makes Interoperability So Difficult?
The challenges to interoperability are daunting. Historically, HIT solutions emerged independently to support different processes and different health care enterprises. Understanding the following issues will help HIT leaders map out the best approach.

• Multiple standards: Different types of data have distinct and multiple standards. Health Level Seven (HL7), Consolidated Clinical Document Architecture (CCDA), and Quality Reporting Document Architecture are all standards for clinical data. X12 is for claims data, although many custom formats are also used. The next generation standard from HL7, Fast Healthcare Interoperability Resources (FHIR, typically pronounced “fire”), is expected to encompass almost all types of data.

• Standards variability: A fundamental issue with current standards is that they are often highly individualized. For example, EMR vendors customize HL7 and CCDA file formats, thereby requiring organizations that receive the data to have multiple parsers for the same data “standard.”

• Interface and communication technologies: Many well-adopted interface engines, such as Mirth, Rhapsody, and Cloverleaf, communicate file-based data between enterprises. However, the physical communication channels vary greatly, from SFTP and socket connections to API calls and sharing files using folders.

• Multiple patient IDs: Every individual system that manages patient data for a particular purpose, including EMR, lab, radiology, billing, and enrollment systems, has its own patient identifier. Matching these unique identifiers correctly—as highlighted above—is an ongoing challenge.

• Inbound vs outbound data: A well-known issue in the industry is that while EMR vendors have adopted standards, such as HL7, CCDA, and X12, to enable outbound data sharing, complete data sets are not always available, and they are very restrictive about bringing data from other sources back into the EMR.

CMS/ONC Final Rule
Now that the final CMS Interoperability Rule and the ONC Trusted Exchange Framework have been published, it’s time for organizations to move forward, especially in light of the current pandemic and the aggressive implementation timelines.

Five Steps to Drive Interoperability
Despite the current uncertainty and challenging timelines, government regulations are intended to push the health care industry forward to the benefit of patients. Health care organizations are wise to consider the following five practical steps to help them meet interoperability implementation timelines.

• Invest in FHIR 4.0. As FHIR emerges as the de facto standard, organizations should move forward to adopt the current 4.0 version as soon as possible. Organizations can take advantage of resources available, such as the FHIR Interface Guide, to work through the key requirements, including FHIR API gateway and server setup, API development and configuration, USCDI-compliant FHIR profiles, FHIR data mapping and parsing, and security (identity and access management) integration.

• Create a phased plan. Organizations can plan for CMS rule compliance with an incremental approach that incorporates both short-term and long-term objectives, starting with Event Notifications, Public Reporting, and Patient and Provider APIs.

• Organize data. Organizations can prioritize which data structures need to be member- and/or patient centric, in preparation for giving patients more direct access and control.

• Adopt bi-directional data exchange. Organizations can work now to implement more bi-directional data exchange solutions or build their own.

• Participate in industry change. HIT leaders should continue to actively contribute to critical changes in the industry through programs and alliances such as Argonaut, Da Vinci, and CARIN.

Especially considering the role research will play in the aftermath of the pandemic, the shift to enabling more open data exchange and giving patients and insurance plan members better control over their own clinical and claims data is more important than ever. With more widely accepted and robust standards—which typically prevent information blocking between organizations—true bi-directional data exchange between payers and providers will become more prevalent. Further, both payer and provider organizations will have more complete, more timely information available to make decisions that will improve patient outcomes.

With the new rule encouraging data exchange using FHIR, and health care players eager to leverage the many advantages of FHIR infrastructure, the market will soon see more adoption of SMART on FHIR applications. By accepting the new challenge to implement interoperability in incremental steps, HIT leaders drive the interoperability needed to change the health care industry for the better.

— Swanand Prabhutendolkar is senior vice president of data management at CitiusTech. Prabhutendolkar is the leader of CitiusTech’s Healthcare Interoperability/BI-DW/Big Data Practices. With more than 18 years’ experience in IT with companies such as Epic, Polaris, and 3i Infotech, Prabhutendolkar has strong experience in regulatory reporting requirements such as meaningful use and health care standards and frameworks. He has also served as the senior architect for development of CitiusTech’s BI-Clinical product. Prabhutendolkar holds a master’s in IT from IIT Mumbai.

— Shyam Manoj is vice president of health plans at CitiusTech. Manoj has more than 19 years of experience in the US health care industry across payers, providers, pharma/life sciences, and HCIT companies. He has been associated with CitiusTech for the past 10 years and is the consulting head, market business lead for health plans. His primary responsibilities include business development, account management, consulting, P&L, partnership, strategy, and executive responsibilities. His key health care focus areas are HEDIS/quality management, value-based care, health care interoperability, data analytics, and big data.