ONC and CMS Propose Extensive Interoperability-related Regulations

ONC and CMS Propose Extensive Interoperability-related Regulations

On Monday, February 11, the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health IT (ONC) released proposed regulations that focus on ensuring that health information is shared across the entire care continuum, including with patients. The CMS Proposed Regulation is attempting to advance interoperability from the patient perspective, by putting patients at the center of their health care and confirming that they can access their health information electronically without special effort. ONC’s regulation calls on the community to adopt standardized application programming interfaces (APIs) and presents seven reasonable and necessary conditions that do not constitute information blocking.

CMS is proposing to require that payers, such as Medicare Advantage Plans, Medicaid, Children’s Health Insurance Programs, and qualified health insurance plans in Federally-facilitated exchanges deploy standardized, open APIs to make certain information available to enrollees. In addition, CMS is using this rule to revise the Medicare and Medicaid Conditions of Participation (CoPs) for participating hospitals by adding a new standard that would require hospitals to send electronic patient event notifications of a patient’s admission, discharge, and/or transfer to another health care facility or to another community provider.

The ONC Rule proposes to update the existing 2015 Edition Certification Criteria to ensure certified health IT systems can: send and receive electronic health information (EHI) in a structured format; make EHI available without special eff¬ort through the use of APIs; and, export a single patient’s or multiple patients’ EHI from the health IT system to a location designated by the patient. In addition, the rule identifies where the actions of a healthcare provider, developer of certified health IT, health information network, or health information exchange would not be considered information blocking if they were to interfere with the access, exchange, or use of EHI. The rule proposes the exceptions for these entities as:

  • Engaging in practices to prevent patient harm.
  • Engaging in consistent, non-discriminatory practices to protect the privacy of electronic health information.
  • Implementing practices to promote the security of electronic health information.
  • Performing maintenance or improvements to health IT performance with the agreement of the user.
  • Recovering reasonable costs to allow for the access, exchange, and use of electronic health information.
  • Receiving a request to provide access, exchange, or use of electronic health information that is infeasible because the request would impose a substantial burden that is unreasonable under the circumstances.
  • Allowing for the licensing of technical artifacts to support the interoperability of EHI on reasonable and non-discriminatory terms.

HIMSS is continuing to review both the ONC and CMS proposed regulations and will provide a more extensive analysis in the coming days.

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