Notable Quotes from the FY2020 Rule for CAR-T Therapies

• "we stated in the proposed rule that given the relative newness of CAR T-cell therapy and our proposal to continue new technology add-on payments for FY 2020 for the two CAR T-cell therapies that currently have FDA approval (KYMRIAH™ and YESCARTA™), as discussed in section II.G.4.d. of the preamble of the proposed rule and this final rule, at this time we believe it may be premature to consider creation of a new MS-DRG specifically for cases involving CAR T-cell therapy for FY 2020"

• "After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for KYMRIAH® and YESCARTA® and consideration of the public comments we received in response to the FY 2019 IPPS/LTCH PPS proposed rule, we approved new technology add-on payments for KYMRIAH® and YESCARTA® for FY 2019 (83 FR 41299). Cases involving KYMRIAH® or YESCARTA® that are eligible for new technology add-on payments are identified by ICD-10–PCS procedure codes XW033C3 or XW043C3. The applicants for both KYMRIAH® and YESCARTA® estimated that the average cost for an administered dose of KYMRIAH® or YESCARTA® is $373,000. Under existing § 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the technology or 50 percent of the costs in excess of the MS–DRG payment for the case. As a result, for FY 2019, the maximum new technology add-on payment for a case involving the use of KYMRIAH® or YESCARTA® is $186,500"

• "In addition, under the proposed change to the calculation of the new technology add-on payment amount discussed in section II.H.9. of the preamble of the proposed rule (84 FR 19373), we proposed that the maximum new technology add-on payment amount for a case involving the use of KYMRIAH® and YESCARTA® would be increased to $242,450 for FY 2020"

• "Under the revised calculation of the new technology add-on payment amount discussed in section II.H.9. of the preamble of this final rule, the maximum new technology add-on payment amount for a case involving the use of KYMRIAH® and YESCARTA® will be $242,450 for FY 2020; that is, 65 percent of the average cost of the technology"

• "Based on both applicants’ estimates of the average cost for an administered dose for FY 2019, we currently estimate that new technology add-on payments for KYMRIAH® and YESCARTA® will increase overall FY 2020 payments by $93,585,700 (maximum add-on payment of $242,450 * 386 patients)"