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Global Life Sciences Update

U.S. Agencies Issue Regulations on No Surprises Act’s Independent Dispute Resolution Process and Good Faith Estimate Requirements

October 11, 2021

On October 7, 2021, the U.S. Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (collectively, the Departments) published an interim final rule with comment to implement provisions of the No Surprises Act (NSA) that concern the federal independent dispute resolution (IDR) process for determining out-of-network reimbursement rates for items and services covered by the NSA1. In addition, HHS issued an interim final rule that addresses the good faith estimates of expected costs that healthcare providers must transmit to uninsured or self-pay patients. HHS also issued implementing regulations for the patient–provider dispute resolution process associated with those good faith estimates. This regulation follows a July interim final rule and a September proposed rule issued by the Departments to implement other provisions of the NSA (as discussed here and here).  

The Departments issued interim final rules by invoking the Administrative Procedure Act’s “good cause” exception to notice-and-comment rulemaking. The provisions in the NSA generally go into effect on January 1, 2022, and the Departments explained that notice-and-comment rulemaking was impracticable and contrary to the public interest because healthcare providers and payors need sufficient time to come into compliance with the implementing regulations. Still, the Departments are soliciting comments, which may inform revisions to the interim final rules. Comments are due December 6, 2021. 

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