(a) General. An IOTA participant may choose to provide any or all of the following types of attributed patient engagement incentives to an attributed patient under the conditions described in paragraph (b) of this section:

(1) Communication devices and related communication services directly pertaining to communication with an IOTA participant or IOTA collaborator to improve communication between an attributed patient and an IOTA participant or IOTA collaborator.

(2) Transportation to and from an IOTA participant and between other providers and suppliers involved in the provision of ESRD care.

(3) Mental health services to address an attributed patient's behavioral health symptoms pre- and post-transplant.

(4) In-home care to support the health of the attributed patient or the kidney transplant in the post-transplant period.

(b) Conditions. An IOTA participant may provide attributed patient engagement incentives of the type described in paragraphs (a)(1) through (4) of this section when all of the following conditions are met:

(1) An IOTA participant provides a written policy, in a form and manner specified by CMS, for the provision of attributed patient engagement incentives.

(2) CMS approves an IOTA participants written policy before the first PY in which an attributed patient engagement incentive is first made available.

(3) CMS revalidates the IOTA participant's written policy in a form and manner specified by CMS prior to each PY in which an attributed patient engagement incentive is offered subsequently.

(4) The IOTA participant includes in its written policy:

(i) A description of the items or services that will be provided as attributed patient engagement incentives.

(ii) An explanation of how each item or service that will be an attributed patient engagement incentive has a reasonable connection to any of the following:

(A) An attributed patient achieving and maintaining active status on a kidney transplant waitlist.

(B) An attributed patient accessing the kidney transplant procedure.

(C) The health of the attributed patient or the kidney transplant in the post-transplant period.

(D) A justification for the need for the attributed patient engagement incentives that is specific to the IOTA participant's attributed patient population.

(iii) An attestation that items that are attributed patient engagement incentives will be provided directly to an attributed patient.

(iv) An attestation that the IOTA participant will pay service providers directly for services that are attributed patient engagement incentives.

(v) An attestation that any items or services acquired by the IOTA participant that will be furnished as attributed patient engagement incentives will be acquired for the minimum amount necessary for an attributed patient to achieve the goals described in paragraphs (3)(ii)(A) through (C) of this paragraph.

(c) Restrictions. (1) An IOTA participant must provide items that are attributed patient engagement incentives directly to an attributed patient.

(2) An IOTA participant must pay service providers directly for any services that are offered as attributed patient engagement incentive.

(3) An IOTA participant must not offer an attributed patient engagement incentive that is tied to the receipt of items or services from a particular provider or supplier.

(4) An IOTA participant must not advertise or promote an item or service that is an attributed patient engagement incentive, except to make an attributed patient aware of the availability of the items or services at the time an attributed patient could reasonably benefit from them.

(5) An IOTA participant must not receive donations directly or indirectly to purchase attributed patient engagement incentives.

(6) An IOTA participant must retrieve items that that are attributed patient engagement incentives from the attributed patient when the attributed patient is no longer eligible for the that item or at the conclusion of the IOTA Model, whichever is earlier.

(i) Documented, diligent, good faith attempts to retrieve items that are attributed patient engagement incentives are deemed to meet the retrieval requirement.

(ii) [Reserved]

(7) Items that are communication devices:

(i) May not exceed $1,000 in retail value for any one attributed patient in any one PY;

(ii) Must remain the property of the IOTA participant;

(iii) Must be retrieved from the attributed patient by the IOTA participant—

(A) When the attributed patient is no longer eligible for the communication device or at the conclusion of the IOTA Model, whichever is earlier; and

(B) Before another communication device may be made available to the same attributed patient.

(d) Documentation. The IOTA participant must do all of the following:

(1) Maintain contemporaneous documentation of items and services furnished as attributed patient engagement incentives that includes, at minimum all of the following:

(i) The date the attributed patient engagement incentive is provided.

(ii) The identity of the attributed patient to whom the item or service was provided.

(2) Document all retrieval attempts of items that are attributed patient engagement incentives, including the ultimate date of retrieval.

(3)(i) Retain records pertaining to furnished attributed patient engagement incentives.

(ii) Make the records available to the Federal Government in accordance with § 512.460.