; and (II) 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) ). (v) HCPCS defined For purposes of this subparagraph, the term HCPCS means the Healthcare Common Procedure Coding System. (vi) Inpatient products 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. . 3. Coverage determinations for novel medical products Section 1862(l) of the Social Security Act ( 42 U.S.C. 1395y(l) ) is amended by adding at the end the following new paragraph: (7) Coverage pathway for novel medical products (A) In general The Secretary shall facilitate an efficient coverage pathway to expedite a national coverage decision for coverage with evidence development process under this title for novel medical products described in subparagraph (D). The Secretary shall review such novel medical products for the coverage process on an expedited basis, beginning as soon as the Secretary assigns a HCPCS code to the product under clause (iii)(V)(aa) of section 1174(b)(2)(B). (B) Determination of coverage with evidence development Such coverage pathway shall include, with respect to such novel medical products, if the Secretary determines coverage with evidence development is appropriate, issuance of a national coverage determination of coverage with evidence development for a period up to, but not to exceed, 4 years from the date of such determination. (C) Modernizing payment options for novel medical products Not later than 4 years after issuing such national coverage determination, the Secretary shall submit to Congress