The end of the COVID-19 public health emergency (PHE) has signaled relief that the virus responsible for claiming 1.1 million lives nationwide and closing down the U.S. for part of 2020 is at a less threatening stage now. Many laboratory administrative questions come with the end of the PHE – and occasionally, some misinformation.
While the PHE has officially ended, many actions taken during it to protect the public, such as the U.S. Food and Drug Administration (FDA) issuing Emergency Use Authorizations (EUAs) for testing, still continue.
What you need to know: When the FDA announces the EUA termination date, labs may have at least 180 days from the date to continue to use EUA testing for COVID-19. For more details, click here. The FDA has not indicated when the EUA Declaration will be terminated. For now, tests for COVID-19 that received EUAs can continue to be used even after labs are finished with their existing supply. Labs should work with their manufacturer to better understand their path forward for each test they are using.
So, what are some of the real changes laboratories need to consider soon after the end of the public health emergency?
Allison McMullen and Alesia McKeown, scientific partners, Roche Diagnostics U.S., help to sort it out using some questions our customers have asked us.
McMullen, Ph.D., D (ABMM), ran a large lab for several years, including during this PHE. McKeown, Ph.D., has experience leading studies in preparation for in-vitro diagnostics regulatory submissions in addition to spending many years as an academic researcher.
Both say labs should approach the end of the PHE in two phases – what this means most immediately since May 11, 2023, when the PHE officially ended and what it will mean in the future when the FDA terminates the EUA Declaration for COVID-19 tests.
What kind of impact does the end of the PHE have on reimbursement rates – for both individual COVID-19 tests and for combination testing?
Reimbursement rates for Medicare specifically are staying the same for combination testing but will be reduced for standalone high-throughput SARS-CoV-2 tests to about $51.
The U codes created during the pandemic to incent customers to test using high-throughput solutions ($75 reimbursement per test) and to turn results round in a timely manner (additional $25 reimbursement/test) are now retired. That means labs will need to start billing the CPT code, which is reimbursed at a lower rate.
Will asymptomatic testing still be performed for hospital admissions or surgery?
Roche’s own survey of attendees from our recent webinar on the end of the public health emergency showed that about 62% of laboratories will still perform asymptomatic testing, while others will not.
Will asymptomatic testing be reimbursed?
That will be determined by individual payers.
We currently have self-swabbing locations for the public to collect and submit a specimen for COVID testing. We use a blanket order from an in-house provider. Will this still be allowed after May 11 or will patients need to see a provider to get an order for the testing?
Codes for specimen collection for COVID-19 testing from skilled nursing facilities, home health or homebound patients are discontinued after May 11.
If a cytotechnologist is analyzing images remotely and preparing a report that is further reviewed by a pathologist before it is released, do either of them need a CLIA license for working remotely?
No, they don’t currently need a CLIA license for working remotely.The Centers for Medicare and Medicaid is not requiring CLIA certificate requirements for pathologists and other laboratory personnel in remote sites reviewing digital images, results and data.This does not extend to physical slides and laboratory specimens. A private residence may be a remote testing site.
Once the EUA termination date is set, EUA tests can continue to be used and supplied by the manufacturer if the manufacturer has submitted for FDA approval or clearance and that has been accepted by the FDA. If the manufacturer hasn't submitted by the EUA termination date, can labs continue to use the EUA test kits until their expiration?
If the manufacturer has not submitted a marketing submission to the FDA by the EUA Declaration termination date, labs can continue to use the remaining of their existing supply through its expiration date or no more than two years after the EUA termination date, whichever is less.
Roche is fully committed to getting our COVID-19 EUA products De Novo approval or 510(k) cleared. We already have a 510(k)-cleared assay available for use in labs. Several other products have been submitted and are pending approval or clearance and submissions for other products are being prepared.
How will labs know if a manufacturer has submitted?
The best approach is to engage your manufacturer on this issue and continue communication until labs know the submission has been made.
Will we need to revalidate once our kits go from EUA to IVD?
Yes, and that validation will work similarly to how any other IVD is validated by following CLIA and accreditation requirements.
Allison R. McMullen, Ph.D., D (ABMM), has studied viral evolution, directed a clinical microbiology laboratory and worked in public health for the CDC.
Alesia McKeown, Ph.D., is primarily focused on respiratory, virology and transplant areas. She’s driven to combine her expertise in molecular diagnostics and viral evolution to provide innovative solutions for improved patient care.
Disclaimer: This content is provided for educational and informational purposes only and does not constitute providing medical advice or professional services. The information provided should not be used for diagnosing or treating a health problem or disease, and those seeking personal medical advice should consult with a licensed physician. Always seek the advice of your doctor or another qualified health provider regarding a medical condition.