---
kind: "section"
citation: "42 C.F.R. § 512.456"
title: "42"
number: "512.456"
heading: "Beneficiary incentive: Part B and Part D immunosuppressive drug cost sharing support."
url: "https://uscodex.org/cfr/42/512.456"
---

# §512.456. Beneficiary incentive: Part B and Part D immunosuppressive drug cost sharing support.

- (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](/cfr/42/512.402.md) if all of the following conditions are met:
  - (1) The attributed patient is an eligible attributed patient as defined at [§ 512.402](/cfr/42/512.402.md).
  - (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](/cfr/42/512.460.md).

## Notes

### 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.