When the COVID-19 public health emergency (PHE) began two years ago, the Department of Health and Human Services issued temporary waivers to relax the Anti-Kickback Statute, Stark Law, and other regulations to clear the way for health care arrangements that would be problematic in times of normalcy. Telehealth is the most significant example. Last week, the agency began the process of restoring the normal regulations when the Centers for Medicare & Medicaid Services (CMS) announced that it was eliminating certain waivers and regulatory flexibility it provided for skilled nursing facilities, inpatient hospices, intermediate care facilities, and end-stage renal disease (ERSD) facilities when the COVID-19 pandemic began two years ago.
This is a clear signal that PHE regulatory flexibility is coming to an end and labs should prepare accordingly. Technically, the PHE is due to expire on April 16. HHS has previously indicated that it would give 60 days’ notice before announcing the PHE. However, labs, hospitals, and other providers don’t think that’s enough lead time and have asked for a 90-day extension that would result in the PHE’s coming to an end in July.
But while the exact end date remains to be determined, with cases stabilizing and national COVID-19 fatigue growing, it seems pretty clear that the end of the PHE is coming soon. And that means labs will need to regear their compliance programs for pre-pandemic conditions.