; and (B) develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A). (2) Report October 1, 2025, the Comptroller General shall submit to Congress a report containing the preliminary results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. 4414. Novel medical products (a) Expedited coding of novel medical products Section 1174(b)(2)(B) of the Social Security Act ( 42 U.S.C. 1320d–3(b)(2)(B) ) is amended by adding at the end the following new clauses: (iii) Expedited coding of novel medical products (I) In general Notwithstanding paragraph (1), in the case of a novel medical product (as defined in clause (iv)), the Secretary shall make modifications to the HCPCS code set at least once every quarter. (II) Request Upon the written confidential request of a manufacturer of a novel medical product, the Secretary shall make a determination whether to assign a HCPCS code to such product. Such request may occur on or after the date on which the product receives a designation as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a) ), a breakthrough device under section 515B of such Act ( 21 U.S.C. 360e–3 ), or a regenerative advanced therapy under section 506(g) of such Act ( 21 U.S.C. 356(g) ). (III) Deadline for determination; notification The Secretary shall— (aa) not later than 180 calendar days after receiving the request of a manufacturer under subclause (II), make a determination under such subclause with respect to the request