The 21st Century Cures Act, known more simply as the Cures Act, became law in 2016. This bipartisan legislation sought to increase choice and access for patients and providers. To achieve these goals,
the law authorizes funding to help address the opioid epidemic and improve mental health services, and streamlines approval for new drugs, devices, and treatments.
Also included in this law are provisions to prevent information blocking and update requirements for health IT certification. These provisions have major impacts on the regulation of medical practices.
As part of its implementation of the Cures Act, the Office of the National Coordinator for Health IT (ONC) released 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (ONC’s Cures Act Final Rule) in May 2020. One important goal of the Cures Act and the ONC final rule is to prevent information blocking.
ONC’s Cures Act final rule:
• Defines information blocking as any action likely to interfere with access, exchange, or use of electronic health information
• Outlines exceptions to the definition of information blocking, which may be allowed to prevent harm, protect privacy, or other reasons
• Calls on healthcare providers to adopt standardized application programming interfaces (APIs), which enable people to securely access their electronic health information at no cost; for example, by
using apps on their smartphone.
ONC’s Cures Act Final Rule applies to healthcare providers, developers of certified health IT, health information exchanges (HIEs), and health information networks—described by ONC as “information
blocking actors.” The rule includes a knowledge requirement that applies differently to healthcare providers compared to other actors:
• If a healthcare provider knowingly interferes with access, exchange, or use of healthcare information, they are subject to penalties, unless the interference falls under a regulatory exception.
• If the provider doesn’t know their actions are unreasonable and interferes with data exchange, they will not be subject to penalties.
Exactly how regulatory enforcement agencies will interpret and apply the knowledge requirement remains uncertain.That’s not the only uncertainty. Monetary penalties for providers who violate the rules
have not yet been established.
This means that even though these rules went into effect in April 2021, regulatory agencies aren’t enforcing them. However, healthcare providers are urged by the AMA and other stakeholder groups to adopt policies and conduct training within their organizations well in advance of the anticipated release of a rule to enforce information blocking regulations.
Health IT certification
Clinicians participating in CMS quality programs such as the Meritbased Incentive Payment System (MIPS) need to demonstrate meaningful use of certified EHR technology (CEHRT). The Cures Act
and the ONC final rule made several changes to ONC’s existing 2015 Edition Health IT Certification program. These changes are known as the 2015 Edition Cures Update. These changes mean:
• In order to achieve or maintain certification, EHRs must meet the certification criteria set in the 2015 Edition Cures Update
• Clinicians who participate in CMS quality programs must adopt and use technology that meets 2015 Edition Cures Update criteria (CEHRT) by the established deadline to receive full reimbursement.
Quality programs drive the deadline
According to Cures Act regulations, CMS quality programs drive the deadline for healthcare providers to implement or upgrade to CEHRT. MIPS participants won’t need to upgrade until the beginning of the
90-day performance period in 2023 to demonstrate meaningful use of CEHRT (this could be as late as October 2, 2023). Participants in one or more of the programs on the Advanced Alternative Payment
Model (APM) pathway will likely be required to use CEHRT for the entire 2023 performance year.
Note that the 2022 Physician Fee Schedule final rule made no change to the length of the MIPS Promoting Interoperability reporting period; it remains 90 days. It also does not change the requirement
to use CEHRT for the full reporting period.
NextGen® Office EHR has been granted 2015 Edition Cures Update certification from an authorized certification body, the Drummond Group LLC. NextGen Healthcare is the first EHR developer to offer a fully certified, complete EHR solution (CEHRT) that meets 2015 Edition Cures Update criteria.
This approval designates that NextGen Office EHR delivers the required functionality to meet federal government regulations related to use of certified EHR technology. This includes requirements for
CMS quality programs and the information sharing requirements of the 21st Century Cures Act.