By Rebecca Mayo, J.D.
HHS and CMS have issued final rules aimed to advance interoperability in the health care ecosystem and improve patient accessibility of information needed to make informed health care decisions.
Although more than 95 percent of hospitals and 75 percent of office-based clinicians are utilizing certified health IT, there are still challenges in creating a comprehensive, longitudinal view of a patient’s health history. CMS believes that patients should have the ability to move from payer to payer, provider to provider, and have both their clinical and administration information travel with them throughout their journey. According to an HHS press release, the two final rules, issued by the HHS Office of National Coordinator for Health Information Technology (ONC) and CMS, mark the most extensive health care data sharing policies the federal government has implemented. The rules work hand-in-hand by setting technical data standards and preventing anticompetitive information blocking practices, and setting requirements for payers and hospitals to make that information available.
Interoperability and patient access. CMS is adopting policies for the Medicare and Medicaid programs, the Children’s Health Insurance Program (CHIP), and qualified health plan (QHP) issuers on the individual market Federally-facilitated Exchanges (FFEs) established by the Patient Protection and Affordable Care Act. The final rule requires hospitals, psychiatric hospitals, and critical access hospitals that utilize an electronic medical records system or other electronic administrative system to demonstrate that it can accomplish certain tasks. The system’s notification capacity must be fully operational, it must be able to send notifications that include the minimum patient health information specified in the final rule, and the system must be able to send notifications at the time of a patient’s registration in the emergency department or inpatient services and at the time of discharge to all applicable post-acute care services providers and primary care practitioners.
The final rule requires Medicare Advantage (MA) organizations, Medicaid and CHIP FFS programs, Medicaid managed care plans, CHIP managed care entities, and QHP issuers on the FFEs to implement and maintain a standards-based Patient Access application programming interface (API). The Patient Access API must, at a minimum, make available adjudicated claims, encounters with capitated providers, and clinical data, no later than one business day after a claim is adjudicated or encounter data received. Payers are also required to coordinate care between payers by exchanging, at a minimum, the data elements specified in the current content and vocabulary standard finalized by the ONC 21st Century Cures Act final rule.
Cures Act. In an effort to reduce burden, ONC has finalized five deregulatory actions, including the removal of a requirement to conduct randomized surveillance on a set percentage of certified products and removal of certain program requirements. The Common Clinical Data Set (CCDS) definition that was adopted in 2015 has been removed and replaced with the United States Core Data for Interoperability (USCDI). Adopting the USCDI as a standard will establish a set of data classes and constitute data elements required to support interoperability nationwide.
The final rule includes a Condition of Certification requirement that prohibits any health IT developer under the Program from taking any action that constitutes information blocking. Further, health IT developers are required to publish APIs that allow health information from such technology to be accessed, exchanged, and used without special effort through the use of APIs or successor technology or standards, as provided for under applicable law.
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