21st Century Cures Act: 5 years later
Here’s a rundown of the many items on the ‘to-do’ list that are essential to fully implement the IT provisions of the law.
In December 2016, the 21st Century Cures Act was signed into law, making national headlines for creating new programs and advancing regulatory reforms to speed the development and approval of new drugs and medical devices. Other provisions in the bipartisan law sought to address the opioid crisis, support precision medicine and increase access to behavioral health services.
Still, the most important part of the Cures Act for the IT industry and healthcare providers focused on advancing health data interoperability through a combination of new and/or revised programs, mandates and rules.
Now that it’s been over five years since the law was enacted, let’s check in on the status of the key health IT provisions of the 21st Century Cures Act.
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Finally, a final rule
The Cures Act required the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology to write new health IT regulations. ONC took its first shot at doing so by issuing a proposed rule in 2019. Then, following an extended public comment period, in March 2020, ONC released a 1,244-page final rule aptly titled, “21st Century Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program.”
The ONC regulation established compliance or implementation deadlines for most of the rule’s major provisions at six, 24 and 36 months from the rule’s initial effective date – June 30, 2020. However, ONC later delayed most of those deadlines in response to the COVID-19 pandemic.
As it stands now, some of the health IT rules called for by the Cures Act are in effect; others are in effect but are not being enforced; and others still have yet to be written. Thus, it is fair to say that the Cures Act is definitely still a work in progress.
Let’s consider the status of three critical parts of the law: EHR certification updates, information blocking and the trusted exchange interoperability framework.
EHR certification updates
You may remember that the “meaningful use” EHR incentive program came in three stages. For each stage, EHR vendors were required to demonstrate that their products met a list of certification criteria (product functions) to obtain federal certification status. In turn, physicians were required to “upgrade” their EHR software to the next level of certified edition and then meet the reporting objectives required for each stage.
The meaningful use program ended several years ago, but many of its compliance obligations – including the use of certified EHR technology – were rolled into the Medicare Access and CHIP Reauthorization Act law’s Quality Payment Program. Individual clinicians and group practices subject to the Quality Payment Program, Merit-Based Incentive Payment System or Advanced Alternative Payment Models are still required to use certified EHR technology.
The Cures Act included a long list of new EHR certification criteria (product functions) and program requirements (specific business practices and actions) that EHR companies must meet to maintain federal certification. EHR products that pass the government-sponsored test that demonstrates they meet the new requirements earn the designation of being certified for the 2015 Edition Cures Update.
Under the ONC final rule, this 2015 Edition Cures Update will be the only certified EHR technology accepted in the Quality Payment Program and other federal programs as of Jan. 1, 2023. This means that many affected providers will have to implement the 2015 Edition Cures Update version of an EHR before the end of this year. (Note: Some federal programs, such as the Merit Based Incentive Payment System, only require 90 days of certified EHR technology use per calendar year, so the upgrade deadline will be as late as Oct. 2, 2023, in many cases.)
The Cures Act EHR update is the equivalent of a stage four for the meaningful use program. That’s because even though that program ended years ago, this will be the fourth time since 2011 that some physicians will have to upgrade their EHRs to a new edition to keep pace with federal regulations.
As defined under Section 4004 of the Cures Act, information blocking is generally a practice by a certified EHR company, health information network, health information exchange or healthcare provider that, except as required by law or specified by HHS as a reasonable and necessary activity, is likely to interfere with access, exchange or use of electronic health information. ONC’s 2020 final rule defined each of these terms in detail and identified eight categories of reasonable and necessary activities – exceptions – that generally do not constitute information blocking.
In the final rule and through subsequent sub-regulatory guidance documents, ONC also described several scenarios that likely would trigger information blocking. Perhaps the most controversial of those requires healthcare providers to immediately release lab or test results to patients through patient portals without allowing time for consultation or provider communication of the results.
The ONC final rule originally set the “applicability” date for the information blocking regulations as Nov. 2, 2020, but that was later moved to April 5, 2021, and then Oct. 6, 2022. And the regulations are limited in scope, only pertaining to electronic health information as identified by the data elements represented in the United States Core Data for Interoperability standard.
Even though the information blocking regulations are expected to soon be applicable, actual enforcement of compliance is still a ways off. That’s because the HHS Office of the Inspector General has yet to issue a final rule to establish enforcement dates and policies pertaining to the civil monetary penalties that health IT developers, networks and exchanges will be subject to, and HHS has yet to establish “appropriate disincentives” for healthcare providers.
Until these enforcement and disincentive rules are finalized, the information blocking provision will technically remain in effect, but for practical purposes remain unenforced.
Trusted Exchange Framework and Common Agreement
In an effort to nudge national health information networks, such as Carequality and CommonWell, to connect with one another, Section 4003(b) of the Cures Act required ONC to publish a Trusted Exchange Framework and Common Agreement, or TEFCA, for voluntary industry participation.
As intended under the law, The Trusted Exchange Framework would describe a common set of non-binding, foundational policies and practices that could help facilitate exchange among networks, while the Common Agreement would establish the infrastructure model and governing approach for users in different networks to share clinical information under a set of mutually agreed-to rules.
ONC released draft TEFCA documents for public comment in both 2018 and 2019. In 2019, ONC awarded a government contract to The Sequoia Project to serve as the recognized coordinating entity that would develop, update, implement and maintain the Common Agreement. Then, following an extensive review of public comments, in January 2022, ONC published the first final version of TEFCA.
With this release, The Sequoia Project also took steps to begin implementing TEFCA.
The application process for organizations seeking Qualified Health Information Network designation under the agreement is now slated to begin in late summer or early fall, according to a recent blog post issued by ONC and the Sequoia Project.
Thus, TEFCA is in the early stages of implementation and seems poised to soon be in the operational phase.
The key IT provisions of the 21st Century Cures Act are still a work in progress. We’ll have to wait and see whether the law delivers on its promise of advancing interoperability and data exchange.
Chris Emper is president of Emper Healthcare Advisors and government affairs advisor at NextGen Healthcare.