Last February, ONC and CMS issued two new proposed rules that will affect health IT stakeholders nationwide. The combined proposals seek to further push healthcare towards true interoperability by enforcing new information blocking penalities, and as February 2020 approaches, the public comment period has officially closed. The rule from ONC, titled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, should be published in the near future. The proposal implements the information blocking provisions of the Act. Violators can be subjected up to a $1 million fine per violation. Read on to discover what you need to know about information blocking as we anticipate the rule’s passage.
Together, the proposed rules from ONC and CMS implement the information blocking provisions of the 21st Century Cures Act. One of the most talked about aspects of the legislation, the announcement on information blocking had many stakeholders scratching their heads. What constitutes information blocking? Who can be found guilty of it, and what would happen to the guilty parties? In response, ONC has held several public webinar sessions over the last few months in order to encourage stakeholder involvement and further educate the public on the implications of their rule.
Last March, ONC provided the background of how the rule came about. The ONC provided technical research to Congress to inform the 21st Century Cures Act’s passage, and was subsequently charged with implementing a complaint process for reporting information blocking violations. Since the Cures Act has been passed, the ONC has held multiple stakeholder engagements for about 2 years, and a temporary way of submitting complaints is already live on the ONC website.
For an action to be considered information blocking, all of the following must be true:
According to the current proposal, the definition of information blocking is a practice by a healthcare provider, health IT developer, health information exchange, or health information network that except as required by law or specified by the Secretary as a reasonable and necessary activity, is likely to interfere with, prevent, or materially discourage the access, exchange or use of electronic health information. The most important part of this definition is that information does not, in reality, need to be blocked in order to be penalized – the action only needs to have a reasonable likelihood of interference with the movement of electronic health information (EHI).
- Must be undertaken by a covered actor.
- Must involve EHI.
- Action interferes with, prevents or materially discourages the access, exchange or use of EHI.
- Must have requisite knowledge.
- Action is not required by law.
- Action is not covered by an exception.
The consequences of information blocking include penalties for health IT developers, networks and exchanges, who are subject to civil monetary penalties up to 1 million dollars per violation. Additionally, ONC has proposed a certification ban for health IT developers found in violation of information blocking, and for these developers to be publicly listed. Penalties for individual providers found guilty of information blocking are still under discussion.