The 21st Century Cures Act (Cures) was passed by Congress and signed into law by President Barack Obama in December 2016. Cures is a very long and complicated piece of legislation that led to major changes in much of the U.S. healthcare system. One of these changes was a federal prohibition on “information blocking” in healthcare. Almost 5 years have gone by since Cures became law, but the information blocking prohibition is finally taking effect as of April 5, 2021. No doubt, you have heard about the new Information Blocking Rule. Maybe you have already read articles, attended webinars, or watched virtual conferences talking about the rule. If you work in the healthcare industry, it would be hard to not have some awareness of the new federal effort to address information blocking. However, you may still be asking yourself, “What is the big deal?”
Congress included the information blocking prohibition in the Cures Act because Congress determined that there was widespread information blocking happening in the healthcare industry. This information blocking takes many forms and results in individuals being denied access to their own health information, disruption of healthcare delivery, duplication of healthcare services, and impediments in innovation. Congress did not reach these conclusions lightly. In fact, Congress directed the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) to report to it in 2015 on the extent to which electronic health information was being blocked. The ONC report found widespread and systematic evidence of information blocking among healthcare providers, health information networks, health IT developers, and others.
Things were not supposed to work out that way. The advent of electronic medical records was supposed to liberate health information. By digitizing health information, the industry was supposed to not be bound by paper records that were stored in a single place and were not easily shared. Congress allocated hundreds of millions of dollars to accelerate the adoption of electronic medical records by hospitals and physicians by providing financial incentives to implement and use electronic medical records. ONC has repeatedly worked to incentivize the exchange of electronic health information. Despite all the money and incentives, Congress found that electronic health data was captive in silos that were inaccessible to patients and not being shared, even when HIPAA and state laws permitted it.
Cures prohibits information blocking by certain individuals and entities who create, store, transmit, or use electronic health information (or “EHI”). Congress defined “information blocking” as a “practice that interferes with the access, exchange, or use of Electronic Health Information (EHI).” The law is very broad, as we will explain in subsequent posts. It applies to nearly every healthcare provider, every developer of Health IT that is certified by the ONC, and most health information networks (HINs), these individuals and entities are collectively called “Actors.” ONC has created eight “exceptions” that Actors can use to protect them from information blocking violations. The HHS Office of Inspector General (OIG) is charged with enforcing information blocking allegations and can impose Civil Money Penalties of up to $1 million per violation upon HINs and developers of certified health IT, while healthcare providers will be subject to “other disincentives” that are still to-be-determined.
The information blocking prohibitions are broad and many of the exceptions are quite narrow and fact-specific, making generalized approaches difficult.
So, that is what all of the uproar is about.