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ONC and CMS Release Final Interoperability Regulations

A man wearing scrubs sits at a desk in a hospital setting. He is looking at a computer monitor.

Earlier today, the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS) publicly released their final regulations related to driving more interoperability and data exchange across the entire healthcare ecosystem. According to the government, the combined regulations are intended to provide patients with timely access to their health data to make informed healthcare decisions and better manage their care. The government expects the regulations to place patients at the center of care delivery and provide them more control is the centerpiece of the Trump Administration’s work toward a value-based healthcare system.

The ONC Interoperability and Information Blocking Final Regulation implements key provisions of the 21st Century Cures Act focused on advancing interoperability; supporting the access, exchange, and use of electronic health information (EHI); and, addressing occurrences of information blocking. ONC’s regulation also establishes application programming interface (API) requirements using the FHIR standard, including for patients to use APIs to be able to electronically access all of their EHI, structured and/or unstructured, at no cost.

The ONC Final Rule also outlines eight exceptions to the definition of information blocking that would apply when one of the designated actors meets the conditions of one or more exceptions—in such an instance, that actor would not be considered an information blocker. It is important to note that an actor’s practice that does not meet the conditions of an exception will not automatically constitute information blocking, as these practices will be evaluated on a case-by-case basis to determine whether information blocking has occurred.

The CMS Interoperability and Patient Access Final Regulation builds on ONC’s Final Regulation as well as the MyHealthEData Initiative, which was originally announced at HIMSS18. The CMS Regulation is focused on liberating patient claims data so patients can be more informed decision makers leading to better-informed treatment. Beginning January 1, 2021, CMS is requiring Medicare Advantage, Medicaid, Children’s Health Insurance Program, and Qualified Health Plan (QHP) issuers on the federal exchanges to share claims and other health information with patients in a safe, secure, understandable, user-friendly electronic format through its Patient Access API.

CMS is enabling patients to access their data through any third party application they choose to connect to the API and better integrate a health plan’s information to a patient’s EHR. The idea underlying the CMS Regulation is that patients can take this information with them as they move from plan to plan, and provider to provider throughout the healthcare system. In addition, CMS is establishing a new Condition of Participation (CoP) for all Medicare and Medicaid participating hospitals that requires them to send electronic notifications to another healthcare facility or community practitioner when a patient is admitted, discharged, or transferred.

Stay connected to HIMSS over the coming days as we provide in depth analysis on the impact of the Final ONC and CMS Interoperability Regulations.

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