§ 425.310 - Marketing requirements.

§ 425.310 Marketing requirements.

Cross Reference

Link to an amendment published at 87 FR 70233, Nov. 18, 2022.

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

(a) File and useRequirements. 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.

must:

(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.

(b) Monitoring.

(1) CMS may request the submission of marketing materials and activities at any time. If CMS determines that the marketing materials and activities do not comply with the requirements of paragraph (a) of this section.

(2)

(i) CMS may

, CMS will 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

to the ACO.

(2) The ACO shall discontinue, and require its ACO

participant

participants, ACO

provider

providers/

supplier

suppliers,

or another individual or entity

and other individuals or entities performing functions or services related to ACO activities

as applicable

to discontinue,

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 87 FR 6797370233, Nov. 2, 2011, as amended at 83 FR 68068, Dec. 31, 201818, 2022]