(a) File and use. Marketing materials and activities, as defined in §425.20, may be used or conducted five business days following their submission to CMS if—

(1) The ACO certifies compliance with all the marketing requirements under this section; and

(2) CMS does not disapprove the marketing materials or activities.

(b) Deemed approval.

(1) Marketing materials and activities are deemed approved after expiration of the initial 5 day review period specified in paragraph (a) of this section.

(2)

(i) CMS may issue written notice of disapproval of marketing materials and activities at any time, including after the expiration of the initial 5 day review period.

(ii) The ACO, ACO participant, ACO provider/supplier, or another individual or entity performing functions or services related to ACO activities as applicable, must discontinue use of any marketing materials or activities disapproved by CMS.

(c) Marketing requirements. Marketing materials and activities must meet all of the following:

(1) Use template language developed by CMS, if available.

(2) Not be used in a discriminatory manner or for discriminatory purposes.

(3) Comply with §425.304 regarding beneficiary incentives.

(4) Not be materially inaccurate or misleading.

(d) Sanctions. Failure to comply with this section will subject the ACO to the penalties set forth in §425.216, termination under §425.218, or both.

[76 FR 67973, Nov. 2, 2011, as amended at 83 FR 68068, Dec. 31, 2018]