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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
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The safety data for each compound individually is reassuring, but combination safety requires its own evaluation because pharmacological interactions can produce unexpected results even when each agent is well-characterized on its own
