HR4441-119

2. Increasing adoption of and access to breakthrough devices Section 1886(d)(5)(K) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)) is amended by adding at the end the following new clause: A breakthrough device that is not approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act by the deadline specified in section 412.87(f)(2) of title 42, Code of Federal Regulations (or a successor regulation) may be conditionally approved for the new technology add-on payment under this subparagraph for a particular fiscal year, effective for discharges beginning in the first quarter after receiving such approval, clearance, or authorization, provided that the approval, clearance, or authorization is granted before July 1 of the fiscal year for which the applicant applied for new technology add-on payments. For purposes of this clause, the term breakthrough device means a medical device that— is designated for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act; and has been approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act for the indication for which the designation described in item (aa) was made. This clause shall not be considered an adjustment and shall be implemented in a budget neutral manner. This section, and the amendments made by this section, shall take effect on the enactment of this Act and shall apply to a breakthrough device (as defined in section 1886(d)(5)(K)(x)(II) of the Social Security Act, as added by subsection (a)) that is approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e) on or after July 1, 2023. (x) (I)A breakthrough device that is not approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act by the deadline specified in section 412.87(f)(2) of title 42, Code of Federal Regulations (or a successor regulation) may be conditionally approved for the new technology add-on payment under this subparagraph for a particular fiscal year, effective for discharges beginning in the first quarter after receiving such approval, clearance, or authorization, provided that the approval, clearance, or authorization is granted before July 1 of the fiscal year for which the applicant applied for new technology add-on payments. (II)For purposes of this clause, the term breakthrough device means a medical device that— (aa)is designated for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act; and (bb)has been approved, cleared, or authorized under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act for the indication for which the designation described in item (aa) was made. (III)This clause shall not be considered an adjustment and shall be implemented in a budget neutral manner..