On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First NSA Rule”) fleshing out portions of the No Surprises Act (“NSA”), which was enacted at the end of 2020. Congress passed the NSA to protect patients from receiving surprise medical bills arising from covered treatment rendered by nonparticipating providers that the patients did not have the opportunity to choose. Specifically, the NSA applies primarily to surprise bills patients receive from nonparticipating providers of emergency services and from nonparticipating providers—like consulting specialists, radiology departments, and clinical laboratories—that provide services to a patient while receiving care for non-emergency services at a participating facility, such as a hospital. The sweeping provisions of the NSA will levelize patient cost-sharing obligations between participating and nonparticipating providers in the foregoing care settings and will prohibit nonparticipating providers from balance billing patients for a cost-sharing amount higher than they would be charged by a participating provider or facility.

This Client Alert focuses on the unique operational and billing impacts clinical laboratories face under the NSA, the implications of which far surpass hurdles laboratories currently face under most state law surprise billing frameworks. Laboratory providers’ early understanding of the potential implications of the NSA and First NSA Rule is crucial both for submitting comments to the Departments during continued NSA rule development and refinement and for timely complying with the NSA and related rules, which go into effect on January 1, 2022. The First NSA Rule expressly seeks comments on a significant nu Comments to the First NSA Rule are due September 7, 2021.