As the Omicron variant outbreak showed, staying ahead of SARS-CoV-2 can be a challenge. Joyce Gresko of Alston & Bird’s Health Care Group discusses how labs have been meeting the challenge posed by COVID and what they can expect in the next year.

By Chris Wolski

Perhaps the only predictable characteristic of COVID is its unpredictability. As the recent Omicron variant has shown, SARS-CoV-2 can mutate quickly and significantly, necessitating the need to reintroduce various mandates—including mass testing—quickly.

The variant challenge have also exposed the tension between public health priorities and individual health needs. As the COVID pandemic begins to wane, the discussion around the balancing of public and individual health will certainly become more focused—and perhaps heated.

Joyce Gresko, a partner with Alston & Bird, focuses on these issues as a member of the Washington, D.C.-based firm’s Health Care Group and Legislative & Public Policy Team. Gresko’s clients include clinical laboratories and she aids them in understanding and resolving issues related to Medicare and Medicaid payment and coding, federal and state fraud and abuse laws, effective compliance programs, and health care quality.

Gresko recently sat down with CLP to discuss a wide range of topics related to how clinical labs should approach testing, the tension between public and individual health priorities, the overall complexity of meeting the variant challenge, and the role of the Food and Drug Administration (FDA) in regulating laboratory-developed tests.

Her answers have been edited for length and clarity.

CLP: With Omicron and the potentiality of other variant challenges how should clinical labs be approaching testing?

Joyce Gresko: Labs should monitor information on emerging variants that is shared by agencies such as the Food and Drug Administration and Centers for Disease Control and Prevention and validate their test offerings to ensure that their tests are effective at detecting the virus, even with mutations. With Omicron, we found that tests that target multiple sections of the virus’ genome were more likely to be able to detect the virus, even with a mutation in one of the targets. Labs have to evaluate their own tests’ designs in light of information about each variant.

CLP: What’s the biggest challenge variants present to testing and clinical diagnostics?

Gresko: One challenge is expending the resources required to identify the variant, learn about it, validate a test for detecting the virus notwithstanding the mutation, and then communicating to the public and to those who would order the test that it remains effective at detecting the virus and works as intended, even with a new variant.

CLP: Could you outline the distinction between individual testing/results and the bigger picture of mass testing and public health in terms of the importance of understanding the impact of the various variants?

Gresko: When it comes to individual results, knowing which variant is detected is important if there is a change in the resulting treatment for that patient. It may also be important when a clinician is combining test results with symptoms to reach a diagnosis. For example, the Omicron variant caused less severe respiratory issues than Delta did. But when the treatment remains the same for a new variant as for the predominant strain before the new variant emerged, it is less important at the patient level to know which variant caused the illness. When it comes to public health, information about the dominant variant that is circulating may change a community’s response. For example, the fact that Omicron appears to be more easily transmissible than Delta led some localities to reinstitute mask mandates and businesses to delay return-to-office dates.

CLP: What role should the FDA have in regulating laboratory-developed tests? And what does it mean if there is any lag time both from an individual and public health perspective?

Gresko: There has been a discussion about the FDA’s authority to regulate laboratory-developed tests (LDTs) for many years. LDTs are lab processes that are developed and validated within a single laboratory, rather than tangible items that are sold in interstate commerce, like test kits may be. Many of the tests that patients and physicians rely on every day are LDTs, including tests that detect the SARS-CoV-2 virus. It is not the case that LDTs are unregulated if the FDA does not have to approve them. Each laboratory has to be certified pursuant to the federal law called the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and its implementing regulations, which establishes standards for the qualification of the laboratory personnel, the policies and procedures the lab must have in place, and how it ensures that its tests do what the lab says they do.  Additionally, many states require licensure at the state level, and some require state evaluation of specific tests that a laboratory offers. These requirements increase in complexity along with the complexity of a test. In the context of the pandemic, laboratory-developed tests to detect the SARS-CoV-2 virus were evaluated by the FDA only because a public health emergency was declared.

CLP: How do you think COVID testing will evolve in the coming year?

Gresko: Eventually, the public health emergency (PHE) will terminate, and that will have ripple effects on COVID testing overall. The demand for COVID testing will decrease, and so might reimbursement for COVID testing performed by labs. Under current policy, the higher Medicare reimbursement rate for PCR testing that is in effect for the duration of the PHE will be cut nearly in half, and commercial insurers no longer will be required to cover and pay for diagnostic PCR tests without pre-authorization or medical management, another condition that continues only so long as the PHE is in effect. That does not mean there will be no COVID testing at all—but the conditions that were established to encourage more labs to offer COVID testing will no longer be in place. I expect that many labs will get out of the COVID testing business altogether and will repurpose their equipment in service of other testing, while some labs will continue to offer COVID testing as long as there is a need for it. COVID testing may become more like testing for the seasonal flu. 

Chris Wolski is chief editor of CLP.