Do the Cures Act and Information Blocking Rules apply differently depending upon the type of actor? The Cures Act and Information Blocking Rules apply differently depending upon which category an actor falls into: HIE/ HIN, Developer of Certified Health IT or HCP. They establish different intent requirements depending upon the category of actor. For HIEs/HINs and Developers of Certified Health IT, the actor must have known or should have known that a practice is likely to interfere with the access, exchange that participate in the Medicare and Medicaid programs (the “CMS Patient Access and Interoperability Rule”)6, and (ii) a 2020 ONC final rule implementing the information blocking provisions and applicable exceptions, interoperability and certification criteria requirements of the Cures Act (the “ONC Cures Act and Information Blocking Rule”);7 and (iii) the July 2023 OIG final rule implementing the Cures Act’s penalties for HIEs/HINs and Developers of Certified Health IT that engaged in information blocking (the “ONC CMP Enforcement Rule”).8 Collectively, these rules are referred to hereinafter as the “Information Blocking Rules”. Cures Act to mean practices which are likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information3 (“EHI”) unless the practice is required by law or permitted through rulemaking established by the Secretary of the US Department of Health and Human Services (“HHS”).4 Different types of activities taken by an actor may constitute information blocking under the Cures Act, including: - Practices that restrict authorized access, exchange or use under applicable state or Federal law of information for treatment and other permitted purposes under such applicable law(s), including transitions between certified health IT; - Implementing health IT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging or using EHI; and - Implementing health IT in ways that are likely to restrict the access, exchange or use of EHI with respect to exporting complete information sets or in transitioning between health IT systems, or leading to fraud, waste or abuse, or impede innovations and advancements in health information access, exchange and use, including care delivery enabled by health IT.5 Within HHS, the Office of the National Coordinator for Health Information Technology (“ONC”) is tasked with implementing the Cures Act’s interoperability, patient access and information blocking provisions through rulemaking, with additional rule-making obligations tasked to the HHS Centers for Medicare & Medicaid Services (“CMS”) and the OIG. Three distinct but related key rules were previously promulgated under the Cures Act: (i) a 2020 CMS final rule implementing interoperability and information sharing provisions for payers and health care providers WWW.LAWYER-MONTHLY.COM 39 Krystyna Monticello Attorneys at Oscislawski LLC
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