Am I an Information Blocker: A $1,000,000 Question

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Since the 21st Century Cures Act final rule was released earlier this year, there has been a lot of confusion around one specific regulation in the rule - “Information Blocking”. Information Blocking can be viewed as the inverse of interoperability. The Cures Act Rule is designed to give patients and their healthcare providers secure access to health information. It ensures that patients can electronically access all their Electronic Health Information (EHI), structured and/or unstructured, at no cost. The Information Blocking provision establishes certain requirements for healthcare providers, EHR developers and Health Information Exchanges (HIEs), the “Actors”, to prevent actions that interferes with, prevents, or materially discourages access, exchange, or use of EHI. Any violations by any of these aforementioned “Actors” may be investigated by Health and Human Services (HHS) Office of the Inspector General (OIG) and are subject to penalties. EHR developers and HIEs may face civil penalties up to $1 million per violation. The appropriate disincentives for healthcare providers have been not finalized. However, it is also important to note that healthcare providers are subjected to the regulation even if they do not use an EHR. Providers must attest to the Information Blocking statement as a part of the Promoting Interoperability (PI) category under the Merit-Based Incentive Payment System (MIPS) in order to submit data for the 2020 Performance Year.

Actors Covered by Information Blocking

Information Blocking Deadline Shift

The Information Blocking provisions were initially scheduled to go into effect on November 2nd, 2020. On October 29th, 2020, ONC announced an Interim Final Rule to extend compliance for some of the provisions due to the COVID-19 pandemic. In this blog, we will discuss what changed in the Interim Final Rule and how it impacts providers and EHR vendors.

Evolution of the USCDI

A short history lesson before we dig deeper into the new requirements. More than a decade ago, ONC defined the “Meaningful Use data set” as a list of the minimum required fields that had be supported by certified EHRs for reporting summary of care records as a part of care transitions or to be accessed by a patient. This dataset included patient demographics, medications, problems, allergies, procedures, labs, vital signs, smoking status, care plans and care team members. In the 2015 EHR certification, this requirement was expanded to include the Common Clinical Data Set (CCDS). Under the Cures Act rule, a new data set was defined, referred to as United State Data for Interoperability (USCDI v1). USCDI further expands on the CCDS with some additional data types. More importantly, USCDI aligns very nicely with APIs developed under the most current HL7® FHIR® standard, which is one of the key requirements under the Cures Act. The US Core Profile Implementation Guide that has been adopted by ONC for testing the API requirements under the Cures Act Rule is based on the initial version of USCDI.

Minimum Requirement to Prevent Information Blocking

Based on the Interim Final Rule, an EHR vendor must support a mechanism to respond to a request to access, exchange or use EHI with, at a minimum, the data elements represented in the USCDI v1 standard starting April 5th, 2021. It is interesting to note that the information blocking is not directly related to EHR certification. Therefore, EHR developers do NOT need to update their certification to support the USCDI dependent certification criteria till December 31st, 2022. However, as most EHRs currently support data-sharing through CCDA as part of their certification, this translates to the following task items for most EHR vendors:

Update their current CCDA to include the additional data elements included in the USCDI v1
Make the updated CCDA available to patients through a patient portal and/or the API
Make the updated CCDA available to other providers through the use of the Direct Method (Edge Protocol)

An Easy Solution to Address Information Blocking Requirements

“Darena Solutions became the first (and is still the only) organization in the country to be certified to support the most current Patient Access API as defined in the ONC Cures Update requirements.”

Our team has been working with many of our EHR partners to help them get ready to support these requirements through their CCDA. We have developed a set of guidelines to help identify and map the additional data elements for updating the CCDAs to meet the USCDI standard, and most importantly, satisfy the Information Blocking requirements. Although, updating the CCDA meets the requirements for now, the EHR vendors will have to start supporting the USCDI elements through a FHIR® API as part of the other Cures Act requirements. The USCDI equivalent requirement in FHIR® translates to supporting the US Core Profile. To ensure that the CCDA updates align with the future requirements for supporting US Core Profile, we have developed a set of mapping guidelines based on the feedback received from many of our EHR partners. Based on those mapping guidelines, we have developed a free app that can help you validate CCDAs against the US Core Profile rules. We are open sourcing this mapping library so that we can collaborate with all our partners to further improve this.

Contact us to learn how you can participate in this collaboration to not just meet the Information Blocking requirements, but to get prepared for all the Cures Act requirements on or before the fast approaching deadline. In August this year, Darena Solutions became the first (and is still the only) organization in the country to be certified to support the upcoming Patient Access API as defined in the ONC Cures Update requirements. We have plug-and-play solutions that can help you not just avoid the Information Blocking penalties, but to be ahead of the mandates for all the upcoming Cures Act requirements over the next few years.