Health Law Advisor

The Second Circuit dealt a blow to the dietary supplement industry last month as it affirmed a lower court’s decision not to temporarily pause enforcement of New York’s new restrictions on sales of certain dietary supplements to minors as legal challenges continue to proceed through the court system.

The federal government is back in business, and those who may be scrambling to comply with the January 20, 2026, deadline for the Food and Drug Administration’s (“FDA” or the “Agency”)  Food Traceability Rule (“FTR” or “Final Rule”) will be pleased with the likely possibility of a generous extension from the agency—to July 20, 2028.

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.