Last week, the Office of the National Coordinator for Health Information Technology (ONC) published an Interim Final Rule: Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency (Interim Final Rule) providing needed relief to entities working toward compliance. In the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Rule), issued on May 1, 2020, ONC defines the entities that are subject to the rule’s provisions. ONC refers to these entities as Actors. Actors include health care providers, health IT developers of certified health IT, Health Information Exchanges (HIEs), and Health Information Networks (HINs). The Interim Final Rule provides these Actors with “additional flexibilities” to implement the provisions of the ONC Rule including updated compliance dates. ONC explained that the extension is due to the outbreak of COVID-19 public health emergency; however, this will also provide ONC with additional time to provide answers to the numerous questions that the agency has received as Actors work toward compliance. ONC is accepting comments on this rule, as is typical for an interim final rule. These comments must be submitted to regulations.gov by January 4, 2021.
The Interim Final Rule extends “the applicability date for the information blocking provisions and compliance dates and timeframes for certain Program requirements, including compliance dates for certain 2015 Edition health IT certification criteria and Conditions and Maintenance of Certification requirements.” See CMS and ONC Enforcement Deadlines Chart for more information about compliance dates for the ONC Rule.
Information Blocking
The Interim Final Rule extends the compliance date for the Information Blocking provisions of the ONC Rule. Actors subject to the Information Blocking provisions now have until April 5, 2021, to comply with these provisions.
The Interim Final Rule specifically calls out the ONC Rule’s “Content and Manner Exception.” In the ONC Rule, Actors would be prohibited from engaging in Information Blocking of Electronic Health Information (EHI). The Exception narrowed the scope of the EHI definition, however, to only include elements in the United States Core Data for Interoperability (USCDI) for the first 18 months after the compliance date. After that date, Actors would be required to exchange the full scope of date within the EHI definition. In the Interim Final Rule, ONC extended the date for compliance with the full definition of EHI to October 6, 2022.
Conditions of Certification
The extensions for the various Conditions of Certification (CoC) differ from April 5, 2021 to December 31, 2023. As a result, developers of certified health IT should refer to the compliance table linked above to determine the required compliance date for CoCs that apply to their business
Other Changes
The Interim Final Rule makes several technical changes. These changes include the adoption and incorporation by reference of the USCDI v1 (July 2020 Errata)[1], the adoption of the latest version of the US Core Implementation Guide 3.1.1 to support standardization across the healthcare IT industry.
The Interim Final Rule also identifies many technical corrections and other errors that ONC identified in the ONC Rule. The Interim Final Rule corrects these errors and provides additional clarification in the preamble for stakeholders to consider as they implement the ONC Rule provisions. Notably, ONC states that it was their “explicit intent that the definition of information blocking would only apply to developers of certified health IT, not all health IT developers” and corrected the regulatory text to include the full phrase “health IT developer of certified health IT.”
Enforcement
While Actors should comply with the provisions in the ONC Rule by the new, extended dates, Office of Inspector General (OIG) has stated that it will not begin enforcement of the information blocking provisions until the it finalizes its rules related to penalties. This likely will be before compliance is required, but could lead to additional delays. In addition, HHS must also publish regulation that establishes the “disincentives” for health care providers subject to the information blocking provisions before providers will be subject to government enforcement. Stakeholders will have the opportunity to comment on the health care provider disincentive rule.
What it All Means
While ONC and OIG remain committed to the improvement of interoperability, we believe that the delay was, in part, a response to the challenges that actors have had with compliance and the desire for ONC to provide guidance on numerous questions that actors have had about the applicability of the ONC Rule. ONC has begun to post guidance and we anticipate it will publish more over the coming weeks and months. In the meantime, the compliance extension provides some needed relief for actors that have worked hard to comply and need more time and for those that have been delayed in focusing on compliance efforts.
For more information, please contact Jodi Daniel (jdaniel@crowell.com).
[1] https://www.healthit.gov/isa/sites/isa/files/2020-07/USCDI-Version-1-July-2020-Errata-Final.pdf.