Su Chen, M.D., is both an emergency medicine physician and clinical science principal at MITRE, as well as the program manager for CodeX, an HL7 FHIR Accelerator optimizing data and API standards for patient care and research in cancer, genomics, and cardiovascular health.
Speaking at the Aug. 23 meeting of the Da Vinci Project, another FHIR Accelerator with a focus on payer-provider interoperability and prior authorization use cases, Chen spoke with optimism about the progress she is seeing.
“Not only in the area of prior authorization for general purposes, but for health data exchange at large, the time for FHIR in health interoperability is now,” she said. Even in areas where there hasn't been a significant federal mandate, the progress is real, Chen added. “The secret sauce to addressing these key data-sharing pain points and getting this progress done is really the community and the collaboration not only within these accelerators but across accelerators, across workgroups.”
A key question, Chen said, is how real is this progress? “A year ago, if you'd asked me is there really adoption of CodeX FHIR standards for routine use or for vendor adoption or have CodeX initiatives demonstrated real-world takeaways or early impacts to patient care or research, I would have had to answer no.” But just a year later, she says the answer is yes.
She explained that CodeX is focused on advancing data standards in the area of complex health, so we can represent diseases like cancer and communicate to represent that true picture of complex cancer disease across healthcare, so that patients can have the care and research journeys that they deserve and really expect.
CodeX began with a focus on radiation oncology, and now it has expanded to other clinical complex clinical terminology areas, such as cardiovascular health and genomics. “We are advancing the development and doing implementation-focused initiatives around clinical terminology standards, such as mCODE, which is a FHIR data standard for cancer,” she said.
Chen used a hypothetical example of a patient “M.,” who is 70 years old and has prostate cancer that has spread with metastasis to the bone. To represent that prostate cancer with the level of detail needed to guide research and treatment options for M with detail such as cancer stage or related genomic biomarkers requires a level of granularity of detail.
“At CodeX, our strategy is really to begin with the end in mind to drive adoption and implementation success at the point of care,” Chen said. “Implement is our end mission here. It's not just the development of FHIR standards, but really advancing these standards to improve and transform real-world health processes and outcomes.”
In other words, what might this mean to you? If you're a patient with prostate cancer that spread to the bone, and you need prior authorization for radiation treatment, usually when you go for care, you spend a lot of time catching your doctor up with what's been going on or explaining what another doctor or another specialist has done, Chen added. “But these FHIR standards like mCODE allow us to speak via a common language to support all parts of a patient's care journey, including the care you receive, or even how you communicate from patient provider to payer to get a treatment approved for payment by insurance. Without these data standards, it's pretty hard to share this important health information. I think we've all had frustration or delays in either trying to get medical records from one doctor to another or struggling with entering that needed information to get treatments approved for payment. These are the kinds of struggles that we hope to alleviate by automating a world where FHIR standards really enable us to not only do payer and value-based care transactions, but allow us to leverage things like mCODE to speak about cancer genomics, vascular health, across the healthcare ecosystem.”
One of the key questions in CodeX’s prior authorization for cancer use case is: is it possible to leverage FHIR standards to automate prior authorization so that at least 80 percent of them do not need manual checks in in regards to the complex area of cancer? Can this reduce the burden and reduce delays so that patients have more timely access to care? “We've already finished proof of concept 2.0 and validated with synthetic patient data, testing end-to-end connectivity across the different folks for the anticipated pilot in spring of 2024,” Chen said. “And like all CodeX use case pilots, the primary goals here are whenever possible, to be able to facilitate a phased development cycle that involves live patients, patient data and clinical data with actual production environments at the table. With these real-world requirements in play, we are really stress-testing what these FHIR standards can do in clinical spaces with significant learnings and takeaways, she added.
Chen noted that direct federal support for requiring healthcare data exchange in the area of complex disease has been more gradual to develop than in some other areas. “So any progress made with CodeX has really been where federal onus and mandate has not directly applied. We've really engaged our community to successfully garner voluntary buy-in and de facto adoption. Unlike a year ago, we can now point to a growing real-world footprint. What that has meant is that cancer FHIR standards are now adopted by the largest EHR vendor in the U.S. acute care space, and available as of their November 2022 release version. In radiation oncology, those standards are in production or on release roadmaps for specialty EHR platforms, which support greater than 80 percent of North American health sites. And the use of CodeX-related FHIR standards for active for routine care is actually active and being rolled out internationally in places such as Brazil and Germany. Our membership has been growing rapidly and represents diverse perspectives across healthcare. It's their real-world vision and their expertise that is steering our course. We do this so that any progress we make really has the robustness and maturity needed to fly in actual healthcare environments.”
“I hope that you can see how this momentum has really built up, and core to this has been the development and the really amazing progress made by our prior authorization community.”
In March 2023, CodeX expanded its steering committee to include the following stakeholders:
• Adam Dicker, M.D., Ph.D., FASTRO, FASCO, chair and professor of Radiation Oncology, Pharmacology, and Experimental Therapeutics, Thomas Jefferson University; affiliated with CodeX member ASTRO
• Charles Mayo, Ph.D. FAAPM, FASTRO professor and director of Radiation Oncology Informatics & Analytics, University of Michigan; vice chair, AAPM Data Science Committee; and chair, AAPM Big Data Subcommittee; affiliated with CodeX member AAPM
• Sorena Nadaf, M.S., MMI, chief data & informatics officer for Alliance Data Innovation Lab; affiliated with CodeX member ACTO
• Heather Trimble, vice president, Product Strategy & Growth, eviCore healthcare; affiliated with CodeX member Evernorth Health Services
• Wanmei Ou, Ph.D., vice president of Product, Ontada; affiliated with CodeX member Ontada
The new representatives began their term in January of 2023, joining the two existing members: Chen and HL7 CEO Chuck Jaffe, M.D., Ph.D.