For a lot of epidemiological and health economic research, that time lag is not a major problem. But for vaccine surveillance, we need that data much sooner.
Another difficulty comes from people getting vaccinated without filing an insurance claim. For example, the millions of people who have gotten their shots at mass vaccination sites.
In terms of public health, mass vaccination, regardless of insurance status, is a great thing. But the absence of those insurance claims makes it harder to match vaccinated individuals with any adverse events they report — at least for the purposes of large-scale safety studies.
Much of our analysis depends on having access to the claims data that are generated after a health care encounter.
Those are two big challenges. How does your team deal with them?
I’ll start with the data lag. Reducing this lag is a large part of the Optum initiative with the FDA. We’ve been able to set up a data feed that is not dependent on the adjudication process, shortening that lag significantly.
For the "missing claim" problem, state registries should capture anyone who got a shot at those public vaccination sites, so we are working with the states to access that information and further improve the accuracy of any inferences drawn from our analysis.
Where do you see the Optum work with the FDA’s BEST program going from here?
Our host, Dr. Mark McClellan from the Duke-Margolis Center for Health Policy, called this surveillance capability “a foundation that has many applications going forward,” including the continued analysis of our nation’s response to COVID-19 and any future public health emergencies.
We take pride in our ability to contribute to these efforts, and we stand ready to continue to play our part to help ensure the safety and well-being of all populations across the country.
Tracking the safety and effectiveness of drug treatments and vaccines has always been important, but the pandemic showed us how vital these information pathways that inform the analyses are — and how much they can still improve. The innovation created by Dr. Seeger’s team can provide new levels of insight that just weren’t accessible before.