1. (a) Publication of selection criteria.

   1. (1) The IOTA participant must publicly post on its website the criteria used by the IOTA participant for evaluating and selecting patients for addition to their kidney transplant waitlist by the end of PY 1.
   2. (2) For all subsequent PYs, the IOTA participant must review its publicly posted criteria used for evaluating and selecting patients for addition to its kidney transplant waitlist and ensure that the information is up to date on its website by the end of each relevant PY.

   3. (3) IOTA participants performing living donor kidney transplants must—

      1. (i) Publicly post on its website its living donor selection criteria for evaluating potential living donors for kidney transplant waitlist patients by the end of PY 2; and
      2. (ii) For all subsequent PYs, review its living donor selection criteria for evaluating potential living donors for kidney transplant waitlist patients and ensure that the information on its website is correct by the end of each relevant PY.
2. (b) [Reserved]

3. (c) Review of acceptance criteria. IOTA participants must review transplant organ offer acceptance criteria (as defined at § 512.402) with their IOTA waitlist patients who are Medicare beneficiaries at least once every 6 months that the Medicare beneficiary is on their waitlist.

   1. (1) The IOTA participant must conduct this review via patient visit, phone, email or mail on an individual basis, unless the Medicare beneficiary declines this review.

      1. (i) Prior to reviewing transplant organ offer acceptance criteria, as defined at § 512.402, with IOTA waitlist patients who are Medicare beneficiaries, IOTA participants must give these beneficiaries an opportunity to decline this review.

      2. (ii) If an IOTA waitlist patient who is a Medicare beneficiary declines this review, the IOTA participant must do both of the following:

         1. (A) Record in the IOTA waitlist patient who is a Medicare beneficiary's medical record all of the following:

            (1) The date on which this review was declined.

            (2) The method by which this review was declined.

         2. (B) Offer the IOTA waitlist patient who is a Medicare beneficiary the opportunity to review transplant organ offer acceptance criteria once every 6 months at which time the IOTA waitlist patient who is a Medicare beneficiary will have the opportunity to decline this review again.

   2. (2) The IOTA participant must record in the IOTA waitlist patient who is a Medicare beneficiary's medical record all of the following:

      1. (i) The information specified in paragraph (c) of this section was reviewed with the IOTA waitlist patient who is a Medicare beneficiary.
      2. (ii) The date in which this review took place.
      3. (iii) The method by which this review was delivered.

4. (d) Change in waitlist status notification.

   1. (1) The IOTA participant must do the following for all IOTA waitlist patients who are Medicare beneficiaries during the model performance period:

      1. (i) Inform IOTA waitlist patients who are Medicare beneficiaries any time their status on the waitlist is changed that would impact their ability to receive an organ offer (that is, from active to inactive).

      2. (ii) When there is a change in waitlist status, provide notifications to each IOTA waitlist patient who is a Medicare beneficiary that includes all of the following:

         1. (A) The most recent date the IOTA waitlist patient who is a Medicare beneficiary became inactive.
         2. (B) The reason for the change in waitlist status.
         3. (C) That the IOTA waitlist patient who is a Medicare beneficiary cannot receive organ offers while inactive.
         4. (D) Information on how the IOTA waitlist patient who is a Medicare beneficiary may become active on its waitlist again.
         5. (E) How the IOTA waitlist patient who is a Medicare beneficiary may contact the IOTA participant for more information or with any questions.

      3. (iii) The IOTA participant must provide this notification (as described in paragraph (d)(1)(i) of this section), and the information specified in paragraph (d)(1)(ii) of this section as follows:

         1. (A) Electronically or by mail on an individual basis.
         2. (B) Within 10 days of the IOTA waitlist patient who is a Medicare beneficiary's change in waitlist status.
         3. (C) Annually, thereafter, for as long as the IOTA waitlist patient who is a Medicare beneficiary remains inactive (that is, 365 consecutive days).

   2. (2) Record in the IOTA waitlist patient who is a Medicare beneficiary's medical record a copy of the notification that includes all of the following:

      1. (i) The method by which the notification was delivered.
      2. (ii) The date of when the notification was delivered.

   3. (3) For IOTA waitlist patients who are Medicare beneficiaries and—

      1. (i) ESRD patients, the IOTA participant must also notify the dialysis facility (as defined at 42 CFR 494.10) and managing clinician (as defined at § 512.310) or nephrologist.
      2. (ii) Non-ESRD patients, the IOTA participant must also notify the referring provider or practitioner providing care to the IOTA waitlist patient who is a Medicare beneficiary.

[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32871, June 1, 2026]