42 CFR §512.450

1. (a)General.
   1. (1)IOTA participants must provide notice to attributed patients that they are participating in the IOTA Model.
   2. (2)CMS provides a notification template that IOTA participants must use. The template, at minimum does all of the following:
      1. (i)Indicates content that the IOTA participant must not change.
      2. (ii)Indicates where the IOTA participant may insert its own content.
      3. (iii)Includes information regarding the attributed patient's opportunity to opt-out of data sharing with IOTA participants and how they may opt out if they choose to do so.
   3. (3)To notify attributed patients of their rights and protections and that the IOTA participant is participating in the IOTA Model, the IOTA participant must do all of the following:
      1. (i)Prominently display informational materials in each of their office or facility locations where attributed patients receive treatment.
      2. (ii)Include this notification in a clear manner on its public facing website.
      3. (iii)Provide this notification to each attributed patient in a paper format.
2. (b)Applicability of general Innovation Center model provisions.
   1. (1)The requirements described in § 512.120(c) do not apply to the CMS-provided materials described in paragraph (a) of this section.
   2. (2)All other IOTA participant communications that are descriptive model materials and activities as defined under § 512.110 must meet the requirements described in § 512.120(c).