; and (ii) complete such negotiations not less than 30 days before the first day of the application review process for the first plan year during the applicable period for new contracts or expanding existing contracts with PDP sponsors and MA organizations to offer prescription drug plans or MA–PD plans, respectively. (B) Use of fallback if negotiations fail (i) In general If, after negotiations under subparagraph (A) with respect to an applicable period, the Secretary is not successful in obtaining an appropriate price for applicable covered part D drugs in accordance with clause (ii), the price that may be charged to PDP sponsors and MA organizations for applicable covered part D drugs furnished to enrollees during such period shall be the lowest of the following: (I) The contract price applied pursuant to section 8126 of title 38, United States Code, for such drug for the contract year (as defined in such section 8126). (II) The average of the prices available, during the most recent 12-month period for which data is available from the manufacturer to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity in Canada, the United Kingdom, Germany, France, and Japan. (III) The best price determined under section 1927(c)(1)(C) for such drug for the most recent rebate period (as defined in section 1927(k)(8)) applicable to such first plan year of the applicable period. (ii) Guidance Not later than 6 months before the Secretary begins negotiations under subparagraph (A) with respect to the first applicable period, the Secretary shall issue guidance on criteria to be considered for purposes of determining under clause (i) whether or not the Secretary is successful in obtaining an appropriate price for an applicable covered part D drug. Such criteria shall include at least the following: (I) The comparative clinical effectiveness and cost effectiveness, if available, of such covered part D drug. (II) The budgetary impact of providing coverage under this part for