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Additionally, we disagree with commenters that “these changes would discourage the formation of new ACOs and penalize existing ACOs for changes outside their control, undermining the goal of the Shared Savings Program to expand access to coordinated, high quality care.” Conversely, as described in the Regulatory Impact Analysis of the CY 2026 PFS proposed rule (90 FR 32816 and 32817), we estimate that this proposal is expected to marginally increase participation by ACOs that would otherwise been unable to satisfy the 5,000 assigned beneficiary minimum in BY1, BY2, or both

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Freezing the aliquots will prolong the storage life of the peptide