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(ACO) regulations - American Society of Anesthesiologists

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CMS-1345-P 135<br />

ensure that <strong>ACO</strong>s understand the dynamic nature <strong>of</strong> this part <strong>of</strong> the program and what<br />

specific programmatic changes would be incorporated into the agreement. We further<br />

propose that in those instances where regulatory modifications effectuate changes in the<br />

processes associated with an <strong>ACO</strong> pertaining to design, delivery, and quality <strong>of</strong> care that<br />

the <strong>ACO</strong> will be required to submit to us for review and approval, as a supplement to<br />

their original application, an explanation <strong>of</strong> how they will address key changes in<br />

processes resulting from these modifications. If an <strong>ACO</strong> fails to effectuate the changes<br />

needed to adhere to the regulatory modifications, we propose that the <strong>ACO</strong> would be<br />

placed on a corrective action plan, and if after being given an opportunity to act upon the<br />

corrective action plan, the <strong>ACO</strong> still fails to come into compliance, it would be<br />

terminated from the program. For a more detailed discussion <strong>of</strong> the process for requiring<br />

and implementing a corrective action plan, please refer to the section II. H. <strong>of</strong> this<br />

proposed rule. We propose that <strong>ACO</strong> participants shall continue to be subject to all<br />

requirements applicable to FFS Medicare, such as routine CMS business operations<br />

updates and changes in FFS coverage decisions, as they may be amended from time to<br />

time. In other words, nothing in the Shared Savings Program shall be construed to affect<br />

the payment, coverage, program integrity, and other requirements that apply to providers<br />

and suppliers under FFS Medicare.<br />

8. Managing Significant Changes to the <strong>ACO</strong> During the Agreement Period.<br />

Aside from changes that an <strong>ACO</strong> may experience as a result <strong>of</strong> regulatory<br />

changes, the <strong>ACO</strong> itself may also experience significant changes within the course <strong>of</strong> its<br />

3-year agreement period due to such events as: the following:<br />

• Deviations from approved application for reasons such as the drop out <strong>of</strong> an

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