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As described in the Regulatory Impact Analysis of the CY 2026 PFS proposed rule (90 FR 32816 and 32817) and reiterated in the related analysis in section VI of this final rule, we anticipate the changes we are finalizing to allow for additional flexibility in eligibility requirements, in combination with the alternative caps on shared savings or shared losses, will marginally increase Shared Savings Program participation over the 10 year projection window from 2026 to 2035

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None of it has been confirmed as clinically operative in humans, and current research remains mechanistic and preclinical rather than clinically confirmed