1. Short title This Act may be cited as the Ensuring Patient Access to Critical Breakthrough Products Act of 2018 . 2. Coverage and payment for breakthrough devices under the Medicare program (a) In general Part E of title XVIII of the Social Security Act ( 42 U.S.C. 1395x et seq.) is amended by adding at the end the following new section: 1899C. Coverage of breakthrough devices (a) Breakthrough devices (1) In general For purposes of this section, the term breakthrough device means a medical device that is a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and that is— (A) provided with review priority by the Secretary under subsection (d)(5) of section 515 of such Act; and (B) approved or cleared pursuant to section 510(k), 513(f), or 515 of such Act for use in treating an indication. (2) Limitation on number of 510(k) devices With respect to a 5-year period, in no case may more than five medical devices described in paragraph (1) that are classified under section 510(k) of the Federal Food, Drug, and Cosmetic Act be covered and paid for under this title by reason of this section during each such 5-year period. (b) Coverage (1) Transitional coverage (A) In general During the transitional coverage period (as defined in subparagraph (B)) a breakthrough device shall be— (i) deemed to be reasonable and necessary for purposes of section 1862(a)(1)(A); (ii) deemed to be approved for an additional payment under section 1886(d)(5)(K); (iii) deemed to be approved for pass-through payment under section 1833(t)(6) and section 1833(i)