That’s because CMS requires genome-sequencing tests to be federally approved, a process that lab scientists say is too costly and time consuming to be done for every patient.
There are 50 public labs in the U.S. that can sequence COVID-19 samples, but Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories, told Insider that she doesn’t know of any labs that have completed the validation process to get federal approval.
“The process of validating a next-generation sequencing test is burdensome,” Ms. Wroblewski said. “It takes a lot of time. It takes a lot of data. It takes a lot of resources. And the thing about the variants is that variants of concern and of interest are constantly changing, so you would have to do a whole validation every time you have a variant.”
The one exception, Ms. Wroblewski said, is if epidemiologists need to disclose a patient’s variant information during contact tracing.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.