42 CFR § 493.1807
Additional sanctions: Laboratories that participate in Medicare
June 11, 2020
The following additional sanctions are available for laboratories that are out of compliance with one or more CLIA conditions and that have approval to receive Medicare payment for their services.
(a) Principal sanction. Cancellation of the laboratory's approval to receive Medicare payment for its services.
(b) Alternative sanctions.
(1) Suspension of payment for tests in one or more specific specialties or subspecialties, performed on or after the effective date of sanction.
(2) Suspension of payment for all tests in all specialties and subspecialties performed on or after the effective date of sanction.