; or (ii) the amount of additional time required for the submission of the report with respect to such device. (3) Coverage and payment after the transitional period The Secretary may continue to provide for coverage of and payment for a specified breakthrough device after the end of the transitional period of coverage and payment for breakthrough devices through the national coverage determination process if the Secretary determines that the specified breakthrough device— (A) improves the quality of care and patient outcomes; (B) improves the delivery of care