With the release of complementary proposed rules by CMS and the Office of the National Coordinator for Health IT (ONC) a couple of months ago, health care organizations and their health IT vendors will have to comply with practice changes and updates aimed at promoting greater interoperability for the health care industry, improving patient access to their health information, and implementing key provisions of the 21st Century Cures Act.
Cheat sheet: Our key takeaways from the big new ONC, CMS health IT proposals
CMS proposed rule
CMS' proposed rule aims to help improve patient access to data, aid implementation of application programming interfaces (APIs), and increase electronic data exchange and digital delivery. CMS proposes enhanced care coordination and health information exchange requirements, specifically in the form of APIs, which must be enabled to provide patients with access to their health information using an application of their choice. This includes access to clinical, encounter, claims, and other types of data that can be shared among patients, plans, and federal agencies. The goal is to make a variety of data accessible beginning in 2020.
Finally, CMS addresses information blocking by proposing to publicly list the clinicians, eligible hospitals (EHs), or critical access hospitals (CAHs) in the Promoting Interoperability (PI, formerly Meaningful Use) programs that attest "no" in the CMS reporting system (i.e., QualityNet) to prevent information blocking.
ONC proposed rule
ONC's proposed rule implements key provisions of the 21st Century Cures Act, which became law in 2016. The rule updates the ONC health IT certification program and clarifies how the health care industry can prevent information blocking.
While the rule contains significant implications for all health care providers, the majority of the proposal relates to developers of certified electronic health record technology (CEHRT). Specifically, CEHRT criteria are slated to be added or removed, replaced, or revised to support evolving health IT standards and bolster interoperability. For example, health IT developers would need to re-configure their systems and deploy updates for end users to collect data according to the U.S. Core Data for Interoperability (USCDI) standard, which replaces the existing Common Clinical Data Set (CCDS). Health IT developers would have 24 months from the final rule effective date to re-certify their product(s) and release updated software to end users. ONC also proposes to formally adopt the API standard, the Fast Healthcare Interoperability Resources (FHIR).
Finally, ONC's proposed rule further defines information blocking and specifies which activities would not constitute information blocking, known as "exceptions" to the definition. There are seven proposed exceptions to information blocking: preventing harm, promoting the privacy and security of electronic health information (EHI), recovering costs reasonably incurred, responding to infeasible requests, licensing interoperability elements on reasonable and non-discriminatory terms, and maintaining and improving health IT performance. The penalty for IT developers that engage in information blocking is up to $1 million per offense.
Your next steps
Provider organizations and health IT vendors can submit public comment on both proposed rules until June 3, 2019 at 5 P.M. EST (see here for the CMS and here for the ONC comment submission instructions). The comment period is an important time for all stakeholders to voice their opinions, concerns, and questions regarding the proposed rules.
Providers may wish to provide detailed comment on:
- The prevention of information blocking exception types proposed. For example, the language ONC proposes is more limited than previous CMS regulations. ONC narrowly focuses on restricting information when it could cause physical harm, while the CMS allowance in its PI rules is broader, permitting restriction of sensitive data if the clinician determines it could cause any type of harm.
- The speed at which EHR vendors must comply with the new technology requirements. Many organizations are still in stabilization mode for their 2015 Edition CEHRT and adding yet another lift may be daunting. Additionally, the unstated implication is that organizations would have to pay for another upgrade for this functionality, which was not addressed in the ONC rule.
- The feasibility of sharing admission, discharge, and transfer information with other care settings that have yet to fully adopt health IT capabilities. Providers may propose that CMS more specifically address exceptions where care settings are not able to receive this information electronically.
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