15.03.420 Duration of Price Determination

(a) The Authority's approved price shall be in effect for the entire period of the registered entity's registration; provided, however, that at the conclusion of the first year of the registration period, or prior to that time based upon documented exceptional circumstances, the registered entity may request that the price be modified based upon a material change in the registered entity's costs. The registered entity shall fully support its request with sufficient information and documentation, in a manner and format determined by the Authority, to justify its request. If the Authority denies such request, the registered entity shall only charge prices previously approved by the Authority.

(b) If the Authority has approved a price, the registered entity shall immediately notify the Authority of any cost or pricing data submitted that it determines was inaccurate, incomplete, or noncurrent as of the date of the Authority's approval of the price. If the registered entity provides such notice, or if the Authority independently learns of such inaccurate, incomplete or noncurrent data, the Authority may require the registered entity to provide new data to correct the deficiency, or consider the inaccuracy, incompleteness, or noncurrency of the data. The Authority may adjust the price per dose if the defective data significantly increased the price approved by the Authority.