CMS Sponsored Model Arrangements and Patient Incentives – Current as of March 2021
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Stark
[No comparable exception]
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Anti-Kickback
Safe harbor for CMS sponsored model arrangements and patient incentives 42 CFR 1001.952(ii)
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“Remuneration” does not include an exchange of anything of value between or among CMS–sponsored model parties under a CMS–sponsored model arrangement for which CMS has determined that this safe harbor is available if all of the following conditions are met:
(i) The CMS–sponsored model parties reasonably determine that the CMS–sponsored model arrangement will advance one or more goals of the CMS–sponsored model;
(ii) The exchange of value does not induce CMS–sponsored model parties or other providers or suppliers to furnish medically unnecessary items or services, or reduce or limit medically necessary items or services furnished to any patient;
(iii) The CMS–sponsored model parties do not offer, pay, solicit, or receive remuneration in return for, or to induce or reward, any Federal health care program referrals or other Federal health care program business generated outside of the CMS–sponsored model;
(iv) The CMS–sponsored model parties in advance of or contemporaneous with the commencement of the CMS–sponsored model arrangement set forth the terms of the CMS–sponsored model arrangement in a signed writing. The writing must specify at a minimum the activities to be undertaken by the CMS–sponsored model parties and the nature of the remuneration to be exchanged under the CMS–sponsored model arrangement;
(v) The parties to the CMS–sponsored model arrangement make available to the Secretary, upon request, all materials and records sufficient to establish whether the remuneration was exchanged in a manner that meets the conditions of this safe harbor; and
(vi) The CMS–sponsored model parties satisfy such programmatic requirements as may be imposed by CMS in connection with the use of this safe harbor.
For purposes of remuneration that satisfies this safe harbor, the safe harbor protects:
(i) For a CMS–sponsored model governed by participation documentation other than the legal instrument setting forth the terms and conditions of a grant or a cooperative agreement, the exchange of remuneration between CMS–sponsored model parties that occurs on or after the first day on which services under the CMS–sponsored model begin and no later than 6 months after the final payment determination made by CMS under the model;
(ii) For a CMS–sponsored model governed by the legal instrument setting forth the terms and conditions of a grant or cooperative agreement, the exchange of remuneration between CMS–sponsored model parties that occurs on or after the first day of the period of performance or such other date specified in the participation documentation and no later than 6 months after closeout occurs; and
(iii) For a CMS–sponsored model patient incentive, an incentive given on or after the first day on which patient care services may be furnished under the CMS–sponsored model as specified by CMS in the participation documentation and no later than the last day on which patient care services may be furnished under the CMS–sponsored model, unless a different timeframe is established in the participation documentation. A patient may retain any incentives furnished in compliance with this safe harbor.
(v)
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“Remuneration” does not include a CMS–sponsored model patient incentive for which CMS has determined that this safe harbor is available if all of the following conditions are met:
(i) The CMS–sponsored model participant reasonably determines that the CMS–sponsored model patient incentive will advance one or more goals of the CMS–sponsored model;
(ii) The CMS–sponsored model patient incentive has a direct connection to the patient's health care unless the participation documentation expressly specifies a different standard;
(iii) The CMS–sponsored model patient incentive is furnished by a CMS–sponsored model participant (or by an agent of the CMS–sponsored model participant under the CMS–sponsored model participant's direction and control), unless otherwise specified by the participation documentation;
(iv) The CMS–sponsored model participant makes available to the Secretary, upon request, all materials and records sufficient to establish whether the CMS–sponsored model patient incentive was distributed in a manner that meets the conditions of this safe harbor; and
(v) The CMS–sponsored model patient incentive is furnished consistent with the CMS–sponsored model and satisfies such programmatic requirements as may be imposed by CMS in connection with the use of this safe harbor.
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For purposes of this safe harbor , the following definitions apply:
(i) CMS–sponsored model means:
(A) A model being tested under section 1115A(b) of the Act or a model expanded under section 1115A(c) of the Act; or
(B) The Medicare shared savings program under section 1899 of the Act.
(ii) CMS–sponsored model arrangement means a financial arrangement between or among CMS–sponsored model parties to engage in activities under the CMS–sponsored model that is consistent with, and is not a type of arrangement prohibited by, the participation documentation.
(iii) CMS–sponsored model participant means an individual or entity that is subject to and is operating under participation documentation with CMS to participate in a CMS–sponsored model.
(iv) CMS–sponsored model party means:
(A) A CMS–sponsored model participant; or
(B) Another individual or entity whom the participation documentation specifies may enter into a CMS–sponsored model arrangement.
(v) CMS–sponsored model patient incentive means remuneration not of a type prohibited by the participation documentation that is furnished to a patient under the terms of a CMS–sponsored model.
(vi) Participation documentation means the participation agreement, legal instrument setting forth the terms and conditions of a grant or cooperative agreement, regulations, or model-specific addendum to an existing contract with CMS that specifies the terms of a CMS–sponsored model.
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