ONC and CMS Announce Enforcement Discretion for Interoperability Regulations to Allow the Community Time to Address COVID-19

On Tuesday, April 21, 2020, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) announced a period for enforcement discretion around implementation of the final interoperability regulations to provide all health system stakeholders with additional time to focus on addressing the COVID-19 pandemic. The agencies are allowing compliance flexibilities for many of the provisions in the final interoperability regulations, to ensure that the community can direct the appropriate resources toward COVID-19 services. ONC and CMS will be publishing the final regulations in the Federal Register on May 1, 2020, which officially starts the implementation timetable around each regulation.

According to Don Rucker, MD, National Coordinator for Health Information Technology, “ONC remains committed to ensuring that patients and providers can access electronic health information, when and where it matters most. During this critical time, we understand that resources need to be focused on fighting the COVID-19 pandemic.” CMS Administrator Seema Verma described the extensive steps that her agency has taken to ease burden on the healthcare industry as it fights the virus. “Now more than ever, patients need secure access to their healthcare data, observed Administrator Verma, “nevertheless, in a pandemic of this magnitude, flexibility is paramount for a healthcare system under siege by COVID-19.”

For CMS, enforcement discretion covers only certain parts of its Interoperability Regulation. With hospitals on the front lines of the COVID-19 public health emergency, CMS is extending the implementation timeline for the admission, discharge, and transfer notification Conditions of Participation by an additional six months, to become effective May 3, 2021. CMS is going to use a period of enforcement discretion for the Patient Access Application Programming Interfaces (APIs) and Provider Directory API policies for Medicare Advantage, Medicaid, and the Children’s Health Insurance Program, extending the requirements to begin July 1, 2021. CMS also announced that it would not enforce the new requirements for the Patient Access API for Qualified Health Plan issuers on the individual market Federally-Facilitated Exchanges until July 1, 2021. Other policies included in CMS’s Final Regulation will be implemented and enforced on schedule.

With ONC’s May 1, 2020, publication of its Interoperability Regulation, the effective date for many of the provisions in its regulation comes 60 days later, or June 30, 2020. For example, the effective date for the certification portion of the Regulation, the 2015 Edition Cures Update Certification Criteria, and certain Conditions of Certification will be June 30.

Compliance for these as well as other components of the Final Regulation occurs six months from its publication, or November 2, 2020. This date is when specific compliance requirements start for several Conditions of Certification, including related to information blocking and APIs. However, to provide the community with more flexibility to implement the regulations, ONC is instituting an additional three-month period of enforcement discretion, meaning that February 1, 2021, would be the earliest date for enforcement around many of the provisions in the Final Regulation. More information from ONC on the Enforcement Discretion Dates and Timeframes is available online.

In related news, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) also released a proposed regulation April 21 that describes the parameters around enforcement of information blocking civil money penalties (CMPs). OIG is proposing that enforcement of information blocking will not begin until 60 days after its regulation becomes final. In addition, OIG is emphasizing that it will exercise enforcement discretion on imposing CMPs against actors who have engaged in information blocking after the effective date of this final regulation. Moreover, conduct that occurs before the effective date of their final regulation will not be subject to information blocking CMPs.

It is important to note that ONC and CMS pledged to continue to monitor the implementation landscape to determine if further action is needed related to the Interoperability Regulations to allow the community to respond to the COVID-19 Pandemic.

If you have questions, or need more information, about HIMSS’s efforts around the ONC and CMS Interoperability Regulations, please reach out to policy@himss.org.