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Specifically, the qualifying criteria for low-volume hospitals under section 1886(d)(12)(C)(i) of the Act were amended to specify that, for FYs 2019 through 2022, a subsection (d) hospital qualifies as a low-volume hospital if it is more than 15 road miles from another subsection (d) hospital and has less than 3,800 total discharges during the fiscal year

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In addition, we note that the applicant asserted that omidubicel is not assigned to the same MS-DRG as existing technologies, but also stated that it is assigned to the same MS-DRG as all allogeneic HCT procedures