; 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; or (C) reduces spending under this title without reducing the quality of care. . (b) Study of limit on 510 (k) breakthrough devices (1) Study The Secretary of Health and Human Services shall conduct a study on the effect of the limit under section 1899C(a)(2) of the Social Security Act, as added by subsection (a), on the number of devices cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ) that are breakthrough devices for purposes of such section 1899C. (2) Matters examined In conducting the study described in paragraph (1), the Secretary shall— (A) determine the number of medical devices cleared under such section 510(k) during the 5-year period beginning on the date of the enactment of this Act; (B) determine the number of such devices that were not included as breakthrough devices for purposes of such section 1899C by reason of the limitation under subsection (a)(2) of such section