On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020. This joint announcement was made by the Office of the National Coordinator for Health IT (“ONC”), the Centers for Medicare & Medicaid Services (“CMS”), and the HHS Office of Inspector General (“OIG”).
As we previously discussed, the final rules are intended to improve patient access to electronic health information (“EHI”) and to standardize the modes of exchanging EHI. These rules greatly affect hospitals and other healthcare stakeholders, who are working at the forefront of the COVID-19 pandemic. HHS considers the decision to exercise enforcement discretion as one of many steps “taken to ease [the] burden on the healthcare industry as it fights COVID-19.” HHS will continue monitoring implementation of the rules to decide if additional actions are necessary.
CMS’s Enforcement Discretion
CMS announced that it will be extending by six months the time periods for implementing certain aspects of the Interoperability and Patient Access Final Rule. Accordingly, the admission, discharge, and transfer notification Conditions of Participation rules, which were initially scheduled to take effect six months after the publication of the final rule, will now be effective 12 months after publication.
CMS will also exercise discretion for six months regarding the Patient Access API and Provider Directory API requirements for Medicare Advantage, Medicaid, and the Children’s Health Insurance Program (“CHIP”) under 42 C.F.R. Parts 422, 431, 438, and 457. The requirements, which were to become effective on January 1, 2021, will not be enforced until July 1, 2021. CMS will similarly defer enforcement of the new requirements for the Patient Access API for Qualified Health Plan (“QHP”) issuers under 45 C.F.R. Part 156 until July 1, 2021.
These are the only requirements for which CMS has announced it will exercise enforcement discretion. Other policies and requirements must be implemented as set out in the final rule, including the payer-to-payer data exchange deadline of January 1, 2022.
ONC’s Enforcement Discretion
ONC announced that it will exercise enforcement discretion for three months following the original compliance date for all new requirements in the ONC Final Rule. Therefore, ONC will not enforce such requirements, found at 45 C.F.R. Part 170, for three months after the initial date or time period provided in the final rule. A detailed list of the requirements and new compliance deadlines can be found here.