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As discussed previously, it is important to avoid distribution of excessive prepaid shared savings because doing so could result in several undesirable outcomes, such as ACOs accruing debt to CMS that they are unable to repay, which could disruption the ACOs' operations and participation in the Shared Savings Program

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Although RCTs are required to determine the effectiveness or safety of nicotine products as smoking cessation tools, outcomes related to latency, such as oral cancer, require long-term observational studies

As amended by section 502(b) of the FCAOEA, 2024, section 1834A(a)(1)(B) of the Act now provides that in the case of reporting ( with respect to CDLTs that are not ADLTs, the Secretary shall revise the reporting period under subparagraph (A) such that(i) no reporting is required during the period beginning January 1, 2020, and ending December 31, 2024

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