§512.450. Required beneficiary notifications.
42 C.F.R. § 512.450
General.
IOTA participants must provide notice to attributed patients who are Medicare beneficiaries that they are participating in the IOTA Model.
CMS provides a notification template that IOTA participants must use. The template, at minimum does all of the following:
Indicates content that the IOTA participant must not change.
Indicates where the IOTA participant may insert its own content.
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.
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:
Prominently display informational materials in each of their office or facility locations where attributed patients receive treatment.
Include this notification in a clear manner on its public facing website.
Provide the notification described in paragraph (a) of this section to each applicable attributed patient in a paper format at their first office visit or other outpatient visit after the start of the IOTA Model; or
If the applicable attributed patient has affirmatively opted out of receiving paper communication or has chosen to receive communication through electronic methods, the notification described in paragraph (a) of this section may be distributed through that agreed upon electronic method.
Applicability of general Innovation Center model provisions.
The requirements described in § 512.120(c) do not apply to the CMS-provided materials described in paragraph (a) of this section.
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).
Notes, amendments, and revision history
Amendments
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32872, June 1, 2026]
Source
Source: 89 FR 96445, Dec. 4, 2024, unless otherwise noted.
Authority
Authority: 42 U.S.C. 1302, 1315a, and 1395hh.
Source
Source: 85 FR 61362, Sept. 29, 2020, unless otherwise noted.
Amendments
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32872, June 1, 2026]