Several key questions remain open. The notice does not give CMS independent authority to conduct hearings or issue regulations. Commentators argue this could raise Fifth Amendment due process concerns, because the statute guarantees excluded parties reasonable notice and an opportunity for a hearing. The notice also does not define the scope of the delegated authority, explain how CMS and HHS-OIG will divide responsibilities, or describe how the two agencies could act jointly. Its effect on False Claims Act cases is unaddressed.
Attorneys should watch for the first exclusions CMS issues under the delegation, along with any guidance on how the agencies will allocate cases and handle hearings. For drugmakers and device makers, the notice means CMS and HHS-OIG hold co-equal permissive exclusion authority over participation in Medicare and Medicaid. Exclusion is broader than CMS's existing power to revoke enrollment and billing privileges, because it removes a provider from all federal health care programs. CMS had proposed new grounds to deny or revoke Medicare enrollment for physicians, ambulatory surgery centers, and other providers three months before this delegation, so the two tools may be used together.