---
kind: "section"
citation: "42 C.F.R. § 512.450"
title: "42"
number: "512.450"
heading: "Required beneficiary notifications."
url: "https://uscodex.org/cfr/42/512.450"
---

# §512.450. Required beneficiary notifications.

- (a) **General.**
  - (1) IOTA participants must provide notice to attributed patients who are Medicare beneficiaries that they are participating in the IOTA Model.
  - (2) CMS provides a notification template that IOTA participants must use. The template, at minimum does all of the following:
    - (i) Indicates content that the IOTA participant must not change.
    - (ii) Indicates where the IOTA participant may insert its own content.
    - (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) 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:
    - (i) Prominently display informational materials in each of their office or facility locations where attributed patients receive treatment.
    - (ii) **Include this notification in a clear manner on its public facing website.**
    - (iii)
      - (A) Provide the notification described in [paragraph (a)](#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
      - (B) 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)](#a) of this section may be distributed through that agreed upon electronic method.
- (b) **Applicability of general Innovation Center model provisions.**
  - (1) The requirements described in [§ 512.120(c)](/cfr/42/512.120.md?p=c) do not apply to the CMS-provided materials described in [paragraph (a)](#a) of this section.
  - (2) All other IOTA participant communications that are descriptive model materials and activities as defined under [§ 512.110](/cfr/42/512.110.md) must meet the requirements described in [§ 512.120(c)](/cfr/42/512.120.md?p=c).

## Notes

### 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]