By Stephanie Jamison (Greenway Health) and Leigh Burchell (Altera Digital Health), Chair and Vice Chair, EHR Association Executive Committee, and Greg Thole (Oracle), Chair, EHR Association Certification Workgroup
Following an in-depth analysis of HTI-2 and the process of drafting comments (available here), the EHR Association has identified several overarching issues, as well as specific concerns related to Insights measures within the proposed rule.
Highlighting the Positives
Before we delve into the negatives, however, it is important to note that we are highly supportive of several of ASTP’s recommendations. One is the proposal to expand the Certification Program to include criteria focused on the adoption and use of certified health IT by both payers and public health agencies (PHAs) to supplement criteria for healthcare providers. Holding all parties to specific and consistent standards and procedures is critical to achieving real end-to-end interoperability.
Another is the way ASTP has structured the numerous new proposed FHIR API-based required features (e.g., dynamic registration, SMART Health Cards, CDS Hooks, Subscriptions) in a manner that allows developers to re-use the same capability for multiple different use-case-focused criteria. This is a helpful format that allows developers to streamline and avoid duplicating work effort.
Finally, in the context of the Insights requirements, many of ASTP’s proposals demonstrate attentiveness to the questions and concerns raised by the Association and its member companies since the measures were originally finalized in HTI-1 rulemaking. Some of these tweaks to measurement specifications will reduce the burden and make for more consistent and valuable reporting data.
Overarching Concerns
While we do support many elements of HTI-2, there are also several areas of real concern. We’ve raised many of them previously in comments, but they have yet to be adequately addressed by ASTP and other regulatory agencies.
For example, a common refrain in the Association’s comment letters and RFI responses is that compliance timelines and the scope of work in ASTP regulations create significant burdens for all health IT developers, as well as our healthcare provider customers. We delivered this message related to HTI-1, and our members are now devoting extensive resources to compliance—sometimes at the cost of innovation clients have requested.
Yet, as evidenced by the extensive scope of the HTI-2 proposals, ASTP and CMS continue to ignore the significant and serious timeline concerns we’ve voiced for years. CMS programs, such as the Medicare Promoting Interoperability program and Merit-based Incentive Payment System (MIPS), require healthcare providers to use upgraded certified EHR technology effective essentially on the same deadlines set by ASTP for vendors to deliver those updates. This forces developers to deliver compliant solutions significantly earlier than the deadlines officially listed by ASTP and does not allow adequate runway after the deadline for healthcare providers to adopt the updates, potentially compromising a safe and effective implementation process.
The recently released CMS Interoperability and Prior Authorization final rule is a pivotal measure to reshape the industry. By laying the groundwork for expanded access to health information and streamlined prior authorization processes by mandating the use of FHIR APIs, this regulation takes a critical step toward using comprehensive, timely data to support value-based care initiatives, reduce costs, and improve outcomes.
As stakeholders navigate the ever-changing interoperability landscape, the first step is tapping FHIR APIs to ensure compliance and adaptation to shifting tides. From there, organizations can look beyond compliance to see how FHIR APIs can open the door to next-level innovation and usher in a future where efficiency, collaboration, and patient-centric care take center stage.
What are three ways the new CMS interoperability and prior auth rules will impact healthcare organizations?
Overall, the new rules serve as a critical foundation for expanding access to health information and improving the prior auth process in healthcare.
For all stakeholders, the collective FHIR APIs provide the ability to use comprehensive, timely claims and clinical data to support value-based care programs by implementing a common data approach to leverage historical patient data to maximize quality outcomes for patients. These initiatives are critical to reducing healthcare delivery costs while maximizing patient quality in real time. Additionally, as acutely acknowledged by CMS in its rule commentary, while many patients over the course of a year can have a significant number of providers, it is likely that they will only have one or two payers, thus making the making payer the prime hub in a hub-and-spoke style data sharing model.
For payers, if the FHIR APIs are implemented and utilized as advised by CMS, the respective APIs will not only have the ability to materially improve the ability to share relevant data in a more timely manner, it will also significantly reduce the cost and administrative burden of such data sharing. Today, many payers have entire departments that are focused on packaging and sending data to relevant provider partners. By automating the data sharing process with FHIR APIs, not just for CMS compliance but for all other interoperability use cases, payers can ‘kill two birds with one stone’ and meet regulatory requirements while also creating internal efficiency and significantly improving access to data, as outlined above.
For providers, using interoperable data for prior authorization can help make patient care decisions more quickly, improving patient, provider, and payer alignment and ultimately improving outcomes.
By Jason Warrelmann, vice president global services and process industries, UiPath.
FHIR, or Fast Healthcare Interoperability Resources, are quickly being adopted on a massive scale. While only 24% of healthcare companies currently utilize application programming interfaces (APIs) at scale, according to recent data, FHIR APIs will become widespread by 2024.
The data also shows that more than 50% of providers (out of 400 surveyed stakeholders) said they are consuming and producing a large number of APIs. However, some players lag behind, with 43% and 37% saying they consume and build APIs, respectively. That being said, however, 67% of providers and 61% of players expect their respective organizations to utilize APIs at scale as soon as 2023.
But what exactly does FHIR do?
Developed by Health Level 7, or HL7, FHIR has quickly become the standard for representing and exchanging health information. FHIR enables how healthcare information can be exchanged between different computer systems regardless of how it is stored. It allows this information, including clinical and administrative data, to be available securely to those who need access to it and who have the right to do so for the benefit of a patient receiving care. However, FHIR APIs are not easy for businesses to adopt, as it is mostly driven by the need for compliance with interoperability rules today. For healthcare providers, this means several steps of preparation before they can be fully FHIR-ready.
FHIR-enabled automation can help make this adoption easier, leaving the preparation to software robots. Automation software makes sharing data and information between teams more seamless, ensuring everyone is on the same page when it comes to FHIR APIs. FHIR-enabled automation also ensures compliance and streamlines important processes, reducing the cost of FHIR adoption and making it faster and more efficient.
Here are the three ways FHIR-enabled automation can simplify the FHIR adoption process:
By Angela Kennedy, director of strategic operations, medical specialty societies, IQVIA.
In 2016, the 21st Century Cures Act (Cures Act) resulted in new regulations that fundamentally changed the way deidentified patient data is accessed and utilized. However, data quality and interoperability between the various healthcare stakeholders has been a major hurdle.
When it comes to implementing the Cures Act, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) each must administer the law’s requirements. Therefore, each agency has released a final rule over their respective jurisdiction.
Information blocking is a primary focus of the ONC final rule, which also requires that developers certified by the ONC Health IT Certification Program must have standardized Application Programming Interfaces (APIs) and implement Fast Healthcare Interoperability Resources (FHIR) technology, enabling individuals to access structured electronic health information securely and easily.
These advancements will only make information sharing easier. The CMS Interoperability and Patient Access final rule also focuses on API interoperability, requiring federal payers to make provider directory information publicly available. Specifically, it encourages interoperability and patient access to health information.
In a major step to ensure open sharing of information, the ONC introduced the US Core Data for Interoperability (USCDI). Since ONC is the certifying body for EHRs, providers must be prepared to transition to a new “Cures Edition” version of its software before the end of 2022.
What is USCDI?
USCDI encompasses a standard for data creation, a set of defined data classes and elements that Electronic Health Record (EHR) vendors must be able to provide. This creates an expectation for open and free access to healthcare data by industry stakeholders, including physicians, insurers, labs, registries, and the patients themselves. CMS requires that payers share the USCDI data they maintain with patients via the Patient Access API and with other payers via the Payer-to-Payer Data Exchange.
While some organizations have used APIs to aid the exchange of data, experts in the healthcare industry have been aware that for a truly free and open data exchange to work, modern technology and standards need to be put in place. This is where FHIR comes in.
What is FHIR?
FHIR is based on a new iteration of Representational State Transfer (REST) designs, which uses HTTP to enable the exchange of information between applications. That means if two applications adhere to the standards outlined for REST technologies, it makes it easier for two applications to exchange and manage healthcare data regardless of how it is stored. Not only do these applications now speak the same language, but FHIR has also created categories for certain healthcare interactions to further refine the data exchange by making it easily identifiable within each system.
Health Level Seven International (HL7) announces the Office of the National Coordinator for Health Information Technology’s (ONC’s) FHIR at Scale Taskforce (FAST) will transition into an HL7 FHIR Accelerator.
The FAST project was originally founded to identify Fast Healthcare Interoperability Resources (FHIR) scalability barriers and define a common set of infrastructure standards for scalable FHIR solutions. As an Accelerator, FAST will continue its work under the purview of HL7 with a broad range of stakeholders informing and participating in the initiative.
“As a widely adopted standard supported by many of the most notable stakeholders in the health IT community, FHIR is making rapid, real-world progress toward addressing the biggest challenges of health data interoperability,” said HL7 International chief executive officer Charles Jaffe, M.D., Ph.D. “The FAST Accelerator will bring us closer to defining a consistent and scalable approach to deploying FHIR across high-value use cases and disseminating these best practices to the industry.”
FAST will complement and support the work of HL7’s other accelerators. While groups such as Vulcan, the Da Vinci Project, and CodeX develop standards to support specific functional use cases, FAST focuses on scalability approaches that implementers can leverage across use cases to simplify deployment and use of FHIR in disparate environments.
In early 2022, FAST formed a cross-stakeholder team to begin the transition from an ONC-convened initiative to an HL7 FHIR Accelerator. The team has been working to develop a framework for the accelerator’s scope of work, governance principles, and operating and funding models.
By John Kelly, chief technology officer, PatientKeeper, Inc.
If there’s a topic in healthcare IT that has absorbed more ink over the past decade than “interoperability,” I can’t imagine what it would be. (Well, going back to 2009, “meaningful use” may rank a close second.)
The federal government has taken a significant interest in advancing health IT interoperability. For instance, Title IV of the 21st Century Cures Act is all about it, and in 2020 ONC promulgated rules designed to push the industry along to make interoperability a practical reality. One specific way is through an application programming interface (API) approach that “supports health care providers’ independence to choose the ‘provider-facing’ third-party services they want to use to interact with the certified API technology they have acquired.”
But, generally speaking, government mandates have paved a slow and bumpy road to any health IT goal. They focus on rules and regulations rather than incentives (admittedly, meaningful use was a different case). And thus far, that has been the fate of interoperability.
The metaphor our parent company, Commure, uses to describe healthcare today is a city without roads. We built the “city” of healthcare, populated with over 3,000 healthcare IT companies, without considering the pathways that would connect them. Healthcare lacks the proper infrastructure and connectivity to collect and serve up data in ways that will meaningfully transform the way care is accessed, coordinated, delivered, and experienced.
I believe healthcare IT is, at long last, on the cusp of finally realizing the much-hyped, yet elusive promise of true interoperability. Why now? Because of the cloud, and cloud vendors’ embrace of open standards in their APIs, notably FHIR.
A new initiative launched by Health Level Seven International (HL7) and jointly supported by the Centers for Disease Control and Prevention (CDC) and the Office of the National Coordinator for Health IT (ONC) seeks to use widely recognized data exchange standards to help advance public health. The effort, called Helios, intends to strengthen the capacity and streamline data sharing across all levels of public health using the HL7 Fast Healthcare Interoperability (FHIR) standard.
“Public health has risen in urgency and importance over the last 18 months,” said the ONC’s National Coordinator for Health IT Micky Tripathi, Ph.D., M.P.P., “FHIR accelerators have had great success in engaging implementers as early as possible to help identify and overcome longstanding barriers to interoperability. The Helios alliance is a market-based implementation collaboration that will help to ensure FHIR development is coordinated and focused on real world public health needs.”
The initiative is the latest to use HL7’s FHIR Accelerator program, which seeks to speed the development and availability of FHIR to deliver better data that leads to better health outcomes. The Helios alliance represents an ambitious new use of the FHIR Accelerator Program, pulling together a diverse group of state, tribal, local, territorial, and Federal public health agencies, private and philanthropic sector partners, and other groups interested in the equitable and effective use of data for the advancement of public health.
“Helios is expected to become an integral component of the HL7 FHIR Accelerator Program and comprise a cornerstone to the newly announced HL7 Implementation Division,” said Charles Jaffe, M.D., Ph.D., the CEO of Health Level Seven International. “The Helios Public Health Accelerator will provide a critical step toward the direct access to data needed for public health.”
As the FHIR standard matures, there is a clear path to utilize FHIR and other existing standards to execute the interoperable exchange of data for public health. Helios members will help demonstrate the utility of FHIR and ensure public health needs are at the forefront as FHIR-based implementations evolve and rollout nationwide.
As the FHIR standard matures, there is a clear path to utilize FHIR and other existing standards to execute the interoperable exchange of data for public health. Helios members will help demonstrate the utility of FHIR and ensure public health needs are at the forefront as FHIR-based implementations evolve and rollout nationwide.
“Standardizing and automating our data flows will help us accelerate data into action,” said Daniel Jernigan, M.D., M.P.H., CDC’s deputy director for public health science and surveillance. “Organizing in this way will help ensure FHIR-based solutions are integrated, aligned, and are a complement to everything else that’s going on in the public health community.”
Organizers of Helios are encouraging other entities to participate in the effort. More information about Helios and the project’s goals can be found on HL7’s website, www.hl7.org/helios/.
The COVID-19 pandemic has served as an innovation catalyst for many healthcare delivery organizations. Within a short period of time, health systems had to find ways to perform tasks they previously did not execute, such as scheduling thousands of vaccination appointments online with people that are not regular patients and delivering healthcare visits between patients and doctors electronically.
Let’s pause for a moment and acknowledge what a great achievement this burst of innovation and implementation was in an industry that chronically underfunds IT and rolls-out projects over years, not months.
However, this accelerated innovation can also present a problem – there is no going back. Patients expect online services. Patients want to book appointments like they book services for their car or food delivery: online. Patients want the option to have phone or video visits instead of waiting weeks for face-to-face visits. There is a myriad of options for new applications that promise remote patient monitoring or improved diagnostics, workflows, etc. How can a CIO in Healthcare possibly cater to all the demands for innovation when they must shell out the majority of their budget to maintain a behemoth EHR Mega suite from one of the three main vendors in the U.S. at the same time?
Fortunately, there are interoperability standards that enable just this – connecting new applications that augment the functionality of core systems and let information flow between all of them. HL7 v2 was designed for this and has been around since the 1990s. It was developed along with other EDI standards, such as X11, in an age when files where exchanges in batches or real-time when a connection was available – in other words, before the Internet age. While HL7 v2 is focused on transacting clinical data, X11 was developed to transact claims.
Much has changed in the world since the 1990s, and HL7 v2 is still the reliable de-facto standard that our healthcare system and interoperability across providers runs on in 2021. But it is not a great standard in the age of web services and mobile applications. To ensure interoperability flourishes in today’s digital age, we now have HL7 FHIR (Fast Healthcare Interoperability Resources). Many of the new and promising applications that allow innovative functions and workflows are based on FHIR. The introduction of FHIR creates the following set of questions for a CIO at a healthcare delivery organization that is considering his or her innovation agenda: