breakthrough device means a breakthrough device with respect to which no Medicare benefit category exists. (2) Period of transitional coverage (A) In general Subject to subparagraph (C), the provisions of subsection (b)(1) (relating to the transitional coverage period and payment for breakthrough devices, including the use of the most recently available data and information on costs) shall apply to a specified breakthrough device in the same manner as such provisions apply to a breakthrough device. The Secretary may use methodologies under existing payment systems established under this title, may provide for appropriate adjustments to such methodologies, or may establish a new payment methodology under this title, to provide for payment for a specified breakthrough device to ensure the payment basis for such payment covers costs of the specified breakthrough device are covered by such payment. (B) Report (i) In general With respect to each specified breakthrough device, the Secretary shall submit to Congress a report on the coverage of and payment for such specified breakthrough device under this section that includes the following information: (I) The manner in which coverage is provided and payment is made for the specified breakthrough device, including how such device was classified (such as an item of durable medical equipment or otherwise) and the payment methodology the Secretary applied with respect to such device. (II) The impact of the availability of the specified breakthrough device to Medicare beneficiaries, including impacts on the quality of patient care, patient outcomes, and patient experience. (III) The impact of the availability of the specified breakthrough device to Medicare beneficiaries on program expenditures under this title. (IV) Such other information as the Secretary determines to be appropriate. (ii) Deadline (I) In general Except as provided in subclause (II), the Secretary shall submit a report required under this subparagraph no later than the end of the transitional period of