Section 425.216 - Actions prior to termination(a)Pre-termination actions.(1) If CMS concludes that termination of an ACO from the Shared Savings Program is warranted, CMS may take one or more of the following actions prior to termination of the ACO from the Shared Savings Program. (i) Provide a warning notice to the ACO regarding noncompliance with one or more program requirements.(ii) Request a CAP from the ACO.(iii) Place the ACO on a special monitoring plan.(2) Nothing in this part, including the actions set forth in paragraph (a)(1) of this section, negates, diminishes, or otherwise alters the applicability of other laws, rules, or regulations, including, but not limited to, the Sherman Act (15 U.S.C. 1 et seq.), the Clayton Act (15 U.S.C. 12 ), and the Federal Trade Commission Act (15 U.S.C. 45 et seq.).(b)Corrective action plans.(1) The ACO must submit a CAP for CMS approval by the deadline indicated on the notice of violation.(i) The CAP must address what actions the ACO will take to ensure that the ACO, ACO participants, ACO providers/suppliers or other individuals or entities performing functions or services related to the ACO's activities or both correct any deficiencies and comply with all applicable Shared Savings Program requirements.(ii) The ACO's performance will be monitored and evaluated during and after the CAP process.(2) CMS may terminate the participation agreement if the ACO fails to submit, obtain approval for, or implement a CAP, or fails to demonstrate improved performance upon completion of the CAP. 76 FR 67973 , Nov. 2, 2011, as amended at 80 FR 32839 , June 9, 2015