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These compounds remain without approved clinical trial evidence of safety and effectiveness

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As described in the CY 2026 PFS proposed rule (90 FR 32666), we proposed changes to the Shared Savings Program eligibility requirements to allow for participation by ACOs with a minimum of 5,000 assigned beneficiaries in their third benchmark year, even if the ACO has fewer than 5,000 assigned beneficiaries in benchmark year (BY) 1, BY2, or both