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All the preclinical studies (such as humanized animal models) and observational studies were excluded

This refinement also ensures that ASM participants who introduce a financial component to their CCAs continue to comply with all applicable statutes, regulations, and guidance, as stated in proposed 512.771(a)(5).Per OIG's rationale for the creation of the CMS-sponsored model safe harbors at 1001.952(ii) at 84 FR 55694 the significant flexibility of the safe harbor relied upon the Innovation Center's ability to oversee, monitor, and embed program integrity protections in the models

doi: 10.1002/micr.20722

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