Health Law Advisor

On August 3, 2023, the U.S. Department of Health & Human Services (“HHS”), the Department of Labor, and the Department of Treasury (collectively, the “Departments”) temporarily suspended the federal Independent Dispute Resolution (“IDR”) process immediately following the issuance of a decision by the U.S. District Court for the Eastern District of Texas (the “Court”) that vacated certain regulations and guidance the Departments issued to implement the No Surprises Act (“NSA”).

The Court’s ruling in Texas Medical Association, et al. v. HHS (“TMA IV”)—which addressed claim “batching” and the $350 administrative fee required to initiate the IDR process—represents the Department’s third significant loss in legal challenges against the Departments’ implementation of the NSA’s IDR process that providers, facilities, air ambulance providers, and plans may use to determine the correct payment amounts for certain out-of-network services. On August 11, 2023, the Departments issued a “Frequently Asked Questions” guidance document to detail their intended approach to address the administrative fee. The Departments plan to issue additional updates on the NSA IDR process after further analysis of the TMA IV decision.

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices.[1]

As described in the notice with comment period (the “Procedural Notice”), the voluntary TCET pathway aims to streamline efforts between CMS, the FDA, and manufacturers of certain FDA-designated breakthrough devices to more efficiently advance breakthrough devices through the CMS coverage determination processes using a “coverage with evidence development” (CED) approach.

Under the proposed three-phase framework, manufacturers of breakthrough devices accepted into the TCET pathway would enter a period of transitional coverage through a TCET national coverage determination (NCD), during which the device’s manufacturer would be able to generate evidence for CMS to use to determine the breakthrough devices’ post-TCET final coverage status.

Notably, CMS stated that the agency only anticipates accepting five candidates to participate in the TCET pathway each year.[2] Stakeholders must submit comments on the TCET pathway by August 28, 2023.