(a) Cost sharing support for Part B and Part D immunosuppressive drugs. For immunosuppressive drugs covered under Medicare Part B or Medicare Part D and prescribed to an attributed patient, the IOTA participant may subsidize, in whole or in part, the cost sharing associated with the immunosuppressive drugs under Part B and Part D immunosuppressive drug cost sharing support defined at § 512.402 if all of the following conditions are met:

(1) The attributed patient is an eligible attributed patient as defined at § 512.402.

(2) The IOTA participant must provide a written policy in a form and manner specified by CMS for the provision of Part B and Part D immunosuppressive drug cost sharing support that is approved by CMS before the PY in which the cost sharing support is made available.

(i) The IOTA participant must revalidate the written policy with CMS and in a form and manner specified by CMS for the provision of Part B and Part D immunosuppressive drug cost sharing support before its provision in a subsequent PY.

(ii) The IOTA participant's initial written policy and the revalidation of the written policy must establish and justify the criteria that qualify an eligible attributed patient to receive Part B and Part D immunosuppressive drug cost sharing support.

(iii) The IOTA participant's written policy and the revalidation of the written policy must include an attestation that the IOTA participant will not, in providing Part B and Part D immunosuppressive drug cost sharing support, take into consideration the type, cost, generic status, or manufacturer of the immunosuppressive drug(s) or limit an eligible attributed patients' choice of pharmacy.

(b) Restrictions. (1) An IOTA participant must not take into consideration the type, cost, generic status, or manufacturer of the immunosuppressive drug(s) or limit an eligible attributed patients' choice of pharmacy when providing Part B and Part D immunosuppressive drug cost sharing support.

(2) An IOTA participant may not receive financial or operational support for Part B and Part D immunosuppressive drug cost sharing support from pharmacies and pharmaceutical manufacturers.

(c) Documentation. (1) An IOTA participant must maintain contemporaneous documentation that includes all of the following:

(i) The identity of the eligible attributed patient to whom Part B and Part D immunosuppressive drug cost sharing support was provided.

(ii) The date or dates on which Part B and Part D immunosuppressive drug cost sharing support was provided.

(iii) The amount or amounts of Part B and Part B immunosuppressive drug cost sharing support that was provided.

(2) An IOTA participant must retain and make available records pertaining to Part B and Part D immunosuppressive drug cost sharing support to the Federal Government in accordance with § 512.460.