Sec. 2. Expedited coding of novel medical products

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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: 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. 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) ). The Secretary shall— 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; and not later than 30 calendar days after making such determination, notify the manufacturer of the determination.

A HCPCS code assigned under this clause shall allow for the reliable monitoring of utilization and outcomes of the novel medical product as described in clause (vi). If the Secretary makes a determination to assign a HCPCS code to a product under subclause (II), such code— may be assigned within the first quarter after the manufacturer files, with respect to such product, a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ), a biological product license application under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ), a premarket application under section 515(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e(c) ), a report under section 510(k) of such Act ( 21 U.S.C. 360k ), or a request for classification under section 513(f)(2) of such Act ( 21 U.S.C. 360c(f)(2) ); and may not take effect before the date the product is approved, cleared, or licensed by the Food and Drug Administration.

No information submitted under subclause

(II)shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code. For purposes of this subparagraph, the term novel medical product means a drug, biological product, or medical device— that has not been assigned a HCPCS code; and that has been designated 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) ). For purposes of this subparagraph, the term HCPCS means the Healthcare Common Procedure Coding System. The Secretary shall establish a code modifier within the hospital inpatient prospective payment system under section 1886(d) to track the utilization and outcomes of novel medical products that are assigned a HCPCS code pursuant to the expedited coding process under clause

(iii)and are furnished by hospitals in inpatient settings. .

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