; (II) the 40 covered part D drugs that are utilized by at least 1,000 Medicare part D beneficiaries with respect to whom the total annual spending per such a beneficiary under this part for coverage of such a drug is at least $10,000; or (III) the 20 covered part D drugs that are utilized by at least 1,000 Medicare part D beneficiaries and with respect to which there are unit cost increases at or above the 95th percentile of overall covered part D drug unit cost increases during the most recent 12-month period prior to the beginning of such negotiation year for which data is available; (ii) with respect to which the cost of such a drug to the part D eligible individual involved would exceed the annual out-of-pocket threshold applicable under section 1860D–2(b)(4)(B) for such negotiation year, if the drug were prescribed to the individual for the period of the year or with respect to which a single treatment regimen is priced above such annual out-of-pocket threshold applicable under such section 1860D–2(b)(4)(B) for the year; 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) Annual report to Congress Not later than 30 days after the date on which the Secretary completes negotiations under this paragraph for the first negotiation year and each year thereafter, the Secretary shall submit to Congress and make available to the public a report describing the negotiations during the preceding negotiation year, including— (i) the number of applicable covered part D drug prices negotiated; (ii) the magnitude of savings achieved as a result of such negotiations; (iii) the number of times price negotiations failed (based on the criteria included in the guidance issued pursuant to clause (ii) of subparagraph (B)) and resulted in the use of fallback prices under clause (i) of such subparagraph, and the rationale for any such decisions