21st Century Cures Act

The 21st Century Cures Act (Cures Act), designed to speed up the process of medical advances, was signed into law on December 13, 2016. Expanding on the FDA’s commitment to incorporate patient perspectives into the development of devices, biological products, and drugs, the Cures Act allows for clinical trial designs to be modernized in order to make the development and review of new products more efficient by allowing for the inclusion of real-world evidence and clinical outcome assessments.

While the Cures Act has been law for four years now, there are still developments taking place and questions with regard to the specifics of the Act and how they will affect daily operations across the healthcare industry. Let’s look at how the Cures Act affects healthcare technology, as well as where the current timeline stands for these new regulations, particularly in light of the COVID-19 pandemic.

The Cures Act and EMR Certification

Part of the strategy behind the Cures Act was to address the ongoing challenges with regard to data interoperability and EHRs. Under the Cures Act, the Secretary of Health & Human Services (HHS) was directed to create workable processes for many of the provisions in the law, leading to two proposed rules being published in 2019.

One of the proposed rules was from the Office of the National Coordinator for Health Information Technology (ONC), which was targeted at providers, practices, patients, and technology developers. Under this proposed rule there are a number of provisions that directly affect Electronic Medical Record (EMR) and Electronic Health Record (EHR) vendors. These provisions are as follows:

• Significant upgrades are required to the approximately 680 EMR/EHR products that currently carry 2015 Edition certification through ONC in order to maintain certification. It’s expected that CMS will require providers to use software that is certified at this more robust level in order to participate in quality reporting programs moving forward.
• Certified EHRs will be required to support application programming interfaces (APIs) in order to increase data access across different EHR vendors and third-party applications, allowing for increased transparency and greater interoperability.
• EHRs will be required to replace the existing standard of the Continuity of Care Document with the United States Core Data for Interoperability (USCDI) standard as their minimum set of patient data elements that is shared between EHRs.
• Health IT developers will be limited in the fees they can charge for development of and ongoing upgrades to APIs.

Again, the focus of each of these provisions is to encourage and enable interoperability in order to bring about better access to patient health data and, ultimately, improved patient outcomes.

What will EMRs need to develop?

In order to support the increased focus on interoperability, EMRs will need to develop their systems subject to the HL7 (Health Level Seven) FHIR (Fast Healthcare Interoperability Resources)  standard to allow for healthcare information, whether clinical or administrative, to be securely available to the each of the individuals who have a right to access that data for the purpose of patient care, regardless of the software program they utilize.

For practices, the use of FHIR means the ability for the experience of exchanging healthcare data to more closely mirror similar experiences in other industries where such transactions are more streamlined. It’s also likely to allow for more integrated use of Patient Generated Health Data (PGHD) that is created through the use of wearable devices and monitoring gadgets by serving as the missing link that patients and providers have been looking for to easily streamline and integrate data into their EHR systems.

Another piece of the puzzle for EMRs is the (USCDI), which is a standardized set of data elements and classes that will allow for interoperable health information exchange, nationwide. USCDI replaces the Common Clinical Data Set that was required as part of 2015 Edition health IT certification, so EMR developers will need to be aware and adjust their software accordingly in order to maintain certification.

What will EMRs need to do in addition to development?

There are other pieces that health IT companies will have to attend to in addition to the changes they will need to make in their development process. The first of these pieces is Real World Testing. This testing requires that the health IT developer test their certified health IT in every clinical setting for which its use is intended and if, through this testing, the developer discovers any issues with their product’s conformity to the certification criterion at all, that developer is required to report those issues to the ONC-ACB within 30 days of when the issue was first identified. Additionally, any developer who plans to update its certified Health IT under the Standards Version Advancement Process is required to provide all of its affected customers as well as its ONC-ACB with advance notice.

The next piece that EMRs need to be aware of is information blocking. Generally speaking, information blocking is the interference in the access, exchange, or use of electronic health information (EHI) by some entity in any situation except that in which such interference is required by law or specified as a necessary and reasonable activity by the Secretary of Health & Human Services. Information blocking includes:

• Restricting authorized access, exchange, or use of electronic health information including during transitions between certified health IT
• Increasing the complexity of accessing, exchanging, or using EHI by implementing health IT in ways that aren’t standard
• Restricting access, exchange, or use of EHI with regard to exporting complete information sets or leading to waste, fraud, or abuse, or impeding advancements in the access, exchange, and use of EHI through the way health IT is implemented

While there are exceptions to information blocking for reasons of privacy, security, preventing harm, and infeasibility, along with a few others, EMRs must be careful to ensure that they are indeed within those parameters if there is any indication of information blocking within their system.

It’s important to note that due to the COVID-19 pandemic there have been some delays with the implementation of these new pieces. Initially health IT developers were going to be required to submit their plans for Real World Testing no later than December 15, 2020, however, that date has been delayed by one year making the new deadline for initial plans December 15, 2021. Per Drummond, testing plans are not being accepted currently, but there are plans in the works to release additional guidance documents in the early months of 2021 prior to that submission process being opened in order to give health IT vendors more information.

Timing for Having all Pieces in Place and Certified

As we mentioned, there has been some delay in these pieces in response to the current public health crisis, so it’s important to note the changes between the pertinent dates from the final rule as compared to those in the interim final rule.

As you can tell, there are a number of changes to be mindful of as a result of the 21st Century Cures Act, all of which are intended to increase interoperability between health IT and so improve patient health outcomes. You can rest assured that MicroMD is staying on top of all of the regulations and changes and will be ready to serve your practice as always. For more information visit our website at micromd.com or call 1-800-624-8832.