Value-based arrangements
(3) Value-based arrangements. Remuneration paid under a value-based arrangement, as defined at 411.351, if the following conditions are met: (i) The arrangement is set forth in writing and signed by the parties. The writing includes a description of (A) The value-based activities to be undertaken under the arrangement; (B) How the value-based activities are expected to further the value-based purpose(s) of the value-based enterprise; (C) The target patient population for the arrangement; (D) The type or nature of the remuneration; (E) The methodology used to determine the remuneration; and (F) The outcome measures against which the recipient of the remuneration is assessed, if any. (ii) The outcome measures against which the recipient of the remuneration is assessed, if any, are objective, measurable, and selected based on clinical evidence or credible medical support. (iii) Any changes to the outcome measures against which the recipient of the remuneration will be assessed are made prospectively and set forth in writing. (iv) The methodology used to determine the amount of the remuneration is set in advance of the undertaking of value-based activities for which the remuneration is paid. (v) The remuneration is for or results from value-based activities undertaken by the recipient of the remuneration for patients in the target patient population. (vi) The arrangement is commercially reasonable. (vii) (A) No less frequently than annually, or at least once during the term of the arrangement if the arrangement has a duration of less than 1 year, the value-based enterprise or one or more of the parties monitor: