APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year.
For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges come and go, as well as changes to the No Surprises Act’s out-of-network billing procedures. At the same time, supply chain issues continue and the acute shortage of medical technologists, pathologists, and lab staff is ongoing. That’s just for the first half of 2022. More significant changes are coming—and The Dark Report guides you through them in this issue.
A change in how federal prosecutors enforce lab fraud statutes has caused certain lab executives and sales managers to find themselves named as defendants in federal court cases. In this article, we describe how the U.S. Department of Justice (DOJ) is more aggressively targeting individuals accused of Medicare fraud and abuse. As you will read, in one large civil suit, executives have been taken to court even after corporate settlements with their lab company were reached. This is a one-two anti-fraud punch that has not been seen before from the DOJ. Anyone responsible for lab compliance will want to note this shift.
Meanwhile, changes may be imminent to allow the federal Food and Drug Administration (FDA) to regulate laboratory-developed tests (LDTs). We’ve discussed the Verifying Accurate Leading-edge IVCT Development (VALID) Act in past issues. As you will read here, observers believe Congress is poised to pass this legislation as part of a larger FDA authorization bill. If the VALID Act goes forward, oversight of LDTs will shift from the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and move to the FDA. Once the VALID Act becomes law, it is expected that the process of obtaining FDA clearance for an LDT will become expensive and time-consuming. Many pathologists believe this will discourage academic medical centers and researchers from developing and validating new biomarkers that could diagnose disease earlier and more accurately.
For the remainder of 2022, this collective list of changes will continue to affect clinical labs and the healthcare systems of which they are part. Ironically, the one change that is of greatest importance—to improve quality of patient care—will probably not be advanced by these developments.