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Under the proposed revisions, if a beneficiary voluntarily aligns to a Shared Savings Program ACO under 425.402(e), we would not assign the beneficiary to that Shared Savings Program ACO when the beneficiary is also eligible for claims-based assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on (1) claims for primary care and/or other services related to treatment of one or more specific diseases or conditions targeted by the model or (2) claims for services other than primary care service, and for which there has been a determination by the Secretary that waiver of the requirement in section 1899(c)(2)(B) of the Act is necessary for purposes of testing the model

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however, clinical trials in humans are very limited