HHS Exclusion Becomes A Two-Headed Monster Featuring CMS And OIG

Introduction

On October 14, 2026, the Department of Health and Human Services (HHS) published a notice formally delegating the Secretary’s authority to impose permissive exclusions under section 1128(b) of the Social Security Act to the Centers for Medicare & Medicaid Services (CMS) Administrator. See 91 Fed. Reg. 65,219 (Oct. 14, 2026). A departure from past practice, the delegation gives CMS a direct role in investigating and pursuing exclusions from federal healthcare programs while maintaining the existing delegation to HHS Office of Inspector General (OIG) of mandatory and permissive exclusions under section 1128. This delegation greatly expands CMS’s administrative enforcement tools and may substantially affect the resolution of healthcare and life sciences fraud investigations.