CORONAVIRUS

HHS Puts Information Blocking and EHI Operability on Hold Due to COVID-19 Crisis

On March 9, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) and CMS issued but didn’t publish final rules designed to improve patient access to their own electronic health information (EHI) by banning providers, IT developers and health information networks from engaging in information blocking. The distinction between issuing and publishing is important because final rules don’t take effect until 60 days after they’re published in the Federal Register. But then the COVID-19 crisis intervened and publication of the final rule was delayed. And after 6 weeks of silence, the ONC, CMS and OIG officially confirmed what most suspected: Enforcement and implementation of information blocking rules is on hold for the time being.

OIG Delays Enforcement
On April 22, the OIG issued an unpublished proposed rule laying the groundwork for enforcement by amending the civil monetary penalty (CMP) regulations allowing the issuance of CMPs against providers that violate the ONC information blocking requirements (set out in the March 9 rules). But the agency also made it clear that it’s not a question of if but rather when enforcement should begin. At a minimum, the OIG proposed to delay enforcement until November 2, 2020.

CMS Delays Implementation
But the November 2 deadline got pushed even further back when CMS announced that it was extending by six more months the implementation timeline of certain parts of its own final rule affecting interoperability, including requirements admission, discharge and transfer notification Conditions of Participation (CoPs), which were originally supposed to take effect six months after the final rule was published. Translation: Those interoperability requirements will now take effect one year after publication of the final rule. Meanwhile, it remains unclear when the final rule will actually be published.

ONC Reissues Final Rule
On May 1, the ONC published the final rule, starting the 60-day effective date clock (i.e., June 30, 2020. But while the publication date triggers multiple compliance dates for various components of the interoperability and information blocking provisions (set at 60 days, 6 months, and 24 months following publication), the agency is changing that timeline for certain requirements in light of the COVID-19 crisis. Here’s a summary of some of the key new enforcement discretion dates and implementation timelines.

Revised ONC Information Blocking & Interoperability Timelines

Step(s) Original Compliance Date Revised Compliance Date
Condition of Certification (CoC) assurances June 30, 2020 September 30, 2020
*CoC: Information Blocking
*CoC: Assurances – Information Blocking
*CoC: Assurances – EHI Export Rollout
*CoC: Application Programing Interface (API) – Compliance by Certified API Developers with health IT certified
November 2, 2020 February 2, 2021
*CoC: API – Rollout of new standardized API functionality
*ONC-Authorized Certification Bodies (ONC-ACBs): Certification to Common Clinical Data Set/USCDI Criteria
*ONC-ACBs: Certification to Application Access – Data Category Request Criterion
May 2, 2022 August 2, 2022
*CoC: Assurances – EHI Export Rollout
*ONC-ACBs: Certification to Data Export Criterion
May 1, 2023 August 1, 2023
Information Blocking November 2, 2020 November 2, 2020
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