; or (iii) that are single-source drugs or biologicals (as defined in section 1847A(c)(6)(D)) and that satisfy at least one other criterion described in a previous clause of this subparagraph. (E) Guidance Not later than 6 months before the Secretary begins negotiations under subparagraph (A) for the first negotiation year, the Secretary shall issue guidance on criteria to be considered for purposes of determining under subparagraph (B) whether or not the Secretary is successful in obtaining an appropriate price for a 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 such covered part D drug. (iii) The number of similarly effective drug or alternative treatment regimens for each approved use of such covered part D drug. (iv) Associated unmet need or severity of illness. (F) Public explanation on negotiations outcomes Not later than 30 days after the date on which the Secretary completes negotiations under this section during a negotiation year with a pharmaceutical manufacturer, with respect to the price for a covered part D drug for a negotiated price period, with respect to such year, the Secretary shall make publicly available an explanation of the outcome of such negotiations, based on the criteria included in the guidance issued pursuant to subparagraph (E). (G) MedPAC report (i) Study The Medicare Payment Advisory Commission shall conduct a study on the price negotiations conducted by the Secretary under this paragraph, including an analysis of— (I) the extent to which such price negotiations are achieving lower prices for covered part D drugs for part D eligible individuals who are enrolled under a prescription drug plan or under an MA–PD plan