Section 493.1842 - Cancellation of Medicare approval(a)Basis for cancellation.(1) CMS always cancels a laboratory's approval to receive Medicare payment for its services if CMS suspends or revokes the laboratory's CLIA certificate.(2) CMS may cancel the laboratory's approval under any of the following circumstances: (i) The laboratory is out of compliance with a condition level requirement.(ii) The laboratory fails to submit a plan of correction satisfactory to CMS.(iii) The laboratory fails to correct all its deficiencies within the time frames specified in the plan of correction.(b)Notice and opportunity to respond. Before canceling a laboratory's approval to receive Medicare payment for its services, CMS gives the laboratory-(1) Written notice of the rationale for, effective date, and effect of, cancellation;(2) Opportunity to submit written evidence or other information against cancellation of the laboratory's approval. This sanction may be imposed before the hearing that may be requested by a laboratory, in accordance with the appeals procedures set forth in § 493.1844 .
(c)Effect of cancellation. Cancellation of Medicare approval terminates any Medicare payment sanctions regardless of the time frames originally specified.