The Final Rule published by ONC in May of 2020 provided definitions for Section 4004 of the 21st Century Cures Act. The Final Rule commonly referred to as the Information Blocking Final Rule or the Information Blocking Rule 2020 officially defines information blocking as a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information. In other words, 21st Century Cures Act Information Blocking can be anything that unnaturally prevents access to patient health information.

Starting April 5, 2021, Information Blocking Final Rule requires physicians to respond to any legitimate request to exchange or provide access to electronic health information (EHI) stored in their EHR system. Such a request could come from a patient, another provider, a health plan seeking information for clinical purposes, or a public health agency.

Information Blocking Examples

Practices that restrict authorized access, exchange, or use of such information for treatment and other permitted purposes, changing between health IT systems.

Implementing health IT in ways that intentionally make it more difficult to access, exchange, or use EHI.

Implementing health IT in ways that restrict the access, exchange, or use of EHI when exporting complete information sets or in changing between health IT systems.

Implementing health IT in ways that lead to fraud or abuse, or hinder innovations in health information access, exchange, and use.

The Rule Applies to All

21st Century Cures Act Information Blocking applies to all actors in the healthcare system – physicians and other healthcare providers, hospitals, health IT vendors, and health information exchanges. Health plans may be subject to the Information Blocking Final Rule, depending on their business model. Plans are also subject to a separate information blocking timeline, the CMS Interoperability and Patient Access Rule.

The Eight Exceptions

The Information Blocking Final Rule Summary defines the following as exceptions and not considered to be information blocking:

Preventing harm exception – The physician believes the patient will come to physical harm if the data is released.
Privacy exception – This applies to situations where releasing information could violate HIPAA or state privacy laws.
Security exception – The practice believes that the release of the data would compromise the security of the patient data.
Infeasibility exception – This exception covers natural disasters like floods or earthquakes as well as technical reasons such as the inability of the EHR to separate data from data.
Health IT performance exception - This covers cases where a health IT system is offline for scheduled or unscheduled reasons.
Content and manner exception – Until October 2022, physicians are only required to release data in the USCDI. This exception covers data requests outside of that set. Physicians should discuss this exception with their EHR vendor.
Fees exception – Practices are allowed to charge reasonable fees for providing data. This applies mostly to EHRs and HIEs.
Licensing exception – This exception applies mostly to EHRs. It allows vendors to license technology without it constituting information blocking.

Information Blocking Penalties

There are no penalties, at this time, for physicians who do engage in information blocking. However, the Information Blocking Final Rule does implement a penalty for health IT developers up to $1 million per instance, but not for physicians. The HHS Office of the Inspector General (OIG) is expected to issue a follow up rule with an information blocking timeline sometime this year or next, laying out proposed penalties for physicians.

Steps You Can Take to Be Prepared

The 21st Century Cures Act Information Blocking Rule advances the needs of health care providers, while also being a huge step forward for patients. Understanding your organization’s readiness will help you define the interoperability plan needed to be compliant. Any workflow process that you have that inhibits access to information could potentially violate the information blocking rule 2020 and should be reviewed very carefully.

If your EHR vendor has not proactively informed you of their plans for coming into compliance with the Information Blocking Rule 2020, you should contact them as soon as possible and ask for that information. Once you have done that, you will want to review your internal processes for responding to requests for patient information and identify potential information blocking examples, both from patients and other providers.

Stopping the Blocking and AI

Every one of us is at one time or another a patient. We all want our doctors to learn more about our health conditions and how personalized medicine can improve our lives. Regulation that promotes the free flow of patient data makes it easier for computers using natural language processing in healthcare (NLP) and other artificial intelligence (AI) tools to unlock data in clinical notes. We predict that as these regulations mature, new and important medical data discovery will facilitate better coding, classification and treatment of disease.

At ForeSee Medical, we are tracking all of the latest standards. Our HCC risk adjustment coding software was designed and built ready to exchange data that conforms with the Information Blocking Final Rule mandate.

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