§ 423.2728 — Recalculation of phase-in eligibility determination.

§ 423.2728 Recalculation of phase-in eligibility determination.

(a) Right to request a recalculation. A manufacturer that has received a phase-in eligibility determination notice, as described at § 423.2720(c), may request a recalculation of such determination in accordance with the requirements of this section.

(b) Timeframe and method of filing. A manufacturer that seeks a recalculation of its phase-in eligibility determination must file the request, in the manner specified by CMS, no later than 30 calendar days from the date the phase-in eligibility determination notice is electronically sent to the manufacturer. In order to receive consideration, the recalculation request must clearly describe the issue(s) forming the basis of the request and must include supporting documentation.

(c) Disposition and notification. After consideration of the issues raised, CMS will decide whether to perform the recalculation, and will issue a written decision to the manufacturer that will include CMS's decision about whether to perform the requested recalculation and, if such recalculation is performed, the resulting eligibility determination. The decision is final and binding, subject to the requirements of the Manufacturer Discount Program under section 1860D-14C of the Act, this subpart, and the Manufacturer Discount Program agreement.

(d) Limitation. The recalculation process cannot be used to request or be granted an exception to the requirements set forth in statute that determine eligibility for the specified manufacturer or specified small manufacturer phase-in.