(2) The 3 most recent years prior to the start of the ACO's agreement period used in establishing the historical benchmark, when such a benchmark is used to reconcile the ACO for a performance year adjusted in accordance with paragraph (d)(1) of this section
We believe this is appropriate because Section 351(i)(2) of the Public Health Service Act defines the terms biosimilar and biosimilarity to mean that a biosimilar is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the biosimilar and the reference product in terms of the safety, purity, and potency of the product
(3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof
[4] Skoal Bandits were invented by UST's marketing division, the manufacturing process was conceived by Gene Paules of UST, and the process was automated by David Westerman of the Automation Center, Inc., Nashville, Tennessee
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We refer readers to Table H in the Appendix to the CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199), Tables F and G in the Appendix to the CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229), Tables A and B in the Appendix 2 to the CY 2019 PFS final rule (83 FR 60286 through 60303), Tables A, B, and C in the Appendix 2 to the CY 2020 PFS final rule (84 FR 63514 through 63538), Tables A, B, and C in the Appendix 2 to the CY 2021 PFS final rule (85 FR 85370 through 85377), Tables A, B, and C in the Appendix 2 to the CY 2022 PFS final rule (86 FR 65969 through 65997), Tables A, B, and C in the Appendix 2 to the CY 2023 PFS final rule (70633 through 70650), and Tables A, B, and C in the Appendix 2 to the CY 2024 PFS final rule (88 FR 79965 through 79977) for our previously finalized improvement activities Inventories