The 21st Century Cures Act is a multiphase, multidomain piece of legislation whose requirements for healthcare providers are in effect now, and increase over time. Between pushing for electronic health record (EHR) interoperability and funding vast, ambitious research and data-collection initiatives, the act attempts to harness our collective data-gathering power for medical good. However, this noble goal imposes many administrative burdens and costs on healthcare practices.
For example, healthcare providers have many concerns now that the prohibition against information blocking, referred to as the “open notes” provision, is in place. Under this requirement, patients must be able to access information in their EHRs “without delay.” Healthcare providers may be relieved to learn of the positive effects that open notes can have on patient understanding, patient adherence to care plans, and patient-physician relationships.
Still, the open notes requirement presents healthcare providers with immediate practical needs to understand the good, the bad, and the ugly of the requirement, exceptions to the requirement, and strategies for success when composing open notes.
Once healthcare providers achieve compliance with the current requirements of the Cures Act, they should start preparing for what comes next: Notes that are required to be even more open, the potential for EHR vendor issues, and the possibility to see practice benefits from research outcomes.
Notes That Are Even More Open
One new forthcoming development is that by 2023, according to the timeline of the Cures Act, patients will be able to see task notes from staff members, as well as clinical notes from their provider. Task notes include items like reminders from staff members to the provider to return a call from the patient. Starting now, if they are not doing so already, staff members should begin composing task notes as if the patient can see them—because soon, that will be the reality.
New Interoperability Standards
Interoperability has been a goal since the digitization of health records began, and by 2023, EHRs must meet a higher standard of interoperability under the Cures Act than many are prepared to meet. They must be ready to function within what Robert Wachter, MD, has called “the digital ecosystem,” meaning EHRs must be able to safely exchange personal health information (PHI) not only with other EHRs, but also with third-party applications such as Apple Health, patient-facing systems, and enterprise systems.
The data sets that define interoperability requirements are derived from United States Core Data for Interoperability (USCDI), governed by the Office of the National Coordinator for Health Information Technology (ONC). According to the ONC, the USCDI “sets a foundation for broader sharing of electronic health information to support patient care.”
Some EHRs are not currently compatible with the digital ecosystem, so meeting the 2023 standard of interoperability is not only a matter of healthcare providers and staff members learning to use new EHR technologies—it’s a matter, in many cases, of EHR vendors innovating to alter their technology itself. Because many vendors may not make the current deadline, some speculate that the deadline may be extended.
That said, some EHR vendors already offer a patient portal that meets interoperability requirements to the 2023 standard. However, many healthcare practices have been using their EHR with certain interoperability-related features turned off—and they may face staggering financial burdens in their attempt to access the version of their EHR that meets the new standard. The burden is so extreme that some older physicians are considering retiring in 2023 and some practices are even contemplating returning to paper medical records. Despite losing reimbursement from the Centers for Medicare and Medicaid Services over time for reverting to paper medical records, some practices calculate that this will entail less of a financial hit than investing in a new EHR that meets Cures Act requirements.
One of the biggest obstacles to reaching true interoperability to date has been EHR vendors that closely guard the data contained in their software, leading to much displeasure among healthcare providers and patients. The ultimate goal of the Cures Act is to support patient care by addressing health information technology hurdles across the continuum of care, and information blocking is strongly discouraged.
It’s imperative that each healthcare provider has a technology plan in place well in front of the deadline. For many, this may mean anything from a simple upgrade of their EHR to moving to a completely different EHR. Here are steps healthcare providers should take to meet the deadline:
- Reach out to your EHR vendor to ensure they are prepared to support the requirements. These requirements include both the 21st Century Cures 2015 certification and the API-based certification with a deadline of December 2022.
- If the vendor has everything in place and you are satisfied with the progression, move on to policies and procedures to prepare your staff. However, if you find that your vendor is behind or their path is not meeting your expectations, you may need to look for a new partner.
Legislators put these rules in place to increase collaboration between healthcare providers and their patients, allowing for better quality healthcare, but it could come at a cost to those who have outdated technology. Many healthcare technology companies, including EHR vendors, have gone to a subscription model, which allows providers to purchase their software and training packages with no money down. However, the learning curve should not be overlooked. Each time a new program or rule comes about, the practice must adopt it in an efficient manner.
Potential Beneficial Research
The Cures Act allocates funding totaling $4.8 billion over 10 years to four innovation projects:
- The Precision Medicine Initiative: The National Institutes of Health (NIH) operates this long-term research effort to understand how the intersection of genetics, lifestyle, and environment impacts an individual’s disease prevention and treatment options. One aspect of the Precision Medicine Initiative is the “All of Us” project, which is “inviting one million people across the U.S. to help build one of the most diverse health databases in history.”
- The Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative: Using innovative technologies, researchers will create a dynamic new map of the brain that will show how individual cells and complex neural networks interact. The BRAIN Initiative aims to increase understanding of how the brain encodes, stores, and retrieves information, informing transformations in how neurological disorders are diagnosed and treated.
- The Beau Biden Cancer Moonshot: This “bold effort to accelerate progress in cancer research” is investigating how to overcome cancer’s resistance to therapy and working to build a national cancer data ecosystem.
- Regenerative Medicine Innovation Project: To further the field of regenerative medicine, which aims to repair or replace damaged cells, tissues, or organs using stem cells and/or other therapeutic technologies, the NIH and the Food and Drug Administration will award grants and contracts to facilitate research using stem cells, including autologous stem cells. Some specialties will find themselves putting new knowledge generated by Cures Act research initiatives into practice sooner than others, but these initiatives are intended to benefit all patients and providers.