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(ACO) regulations - American Society of Anesthesiologists

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CMS-1345-P 424<br />

<strong>of</strong> care, changes to the quality <strong>of</strong> care, or changes in planned distribution <strong>of</strong> shared savings, the<br />

<strong>ACO</strong> will be required to submit to CMS for review and approval a supplement to its original<br />

application detailing how it will address key changes in processes resulting from these<br />

modifications.<br />

(c) If an <strong>ACO</strong> cannot effectuate the changes needed to adhere to the regulatory<br />

modifications after being given an opportunity to act upon a CAP, the <strong>ACO</strong> would be terminated<br />

from the program.<br />

(d) Nothing in the <strong>regulations</strong> under this part shall be construed to affect the payment,<br />

coverage, program integrity, and other requirements that apply to providers and suppliers under<br />

FFS Medicare.<br />

§ 425.21 Managing significant changes to the <strong>ACO</strong> during the agreement period.<br />

(a)(1) During the 3-year agreement, an <strong>ACO</strong> may remove, but not add, <strong>ACO</strong> participants<br />

(identified by TINs), and it may remove or add <strong>ACO</strong> providers/suppliers (identified by NPI<br />

and/or TIN).<br />

(2) <strong>ACO</strong>s must notify CMS at least 30 days prior to any significant change, as defined in<br />

paragraph (b).<br />

(3) CMS will review the <strong>ACO</strong>'s notification and make one <strong>of</strong> the following<br />

determinations:<br />

(i) The <strong>ACO</strong> may continue to operate under the new structure with savings calculations<br />

for the performance year based upon the updated list <strong>of</strong> <strong>ACO</strong> participant TINs.<br />

(ii) The <strong>ACO</strong> structure is so different from the initially approved <strong>ACO</strong> that it must<br />

submit a new application, and, if applicable, undergo an antitrust review.<br />

(iii) The <strong>ACO</strong> is materially different from the initially approved <strong>ACO</strong> because <strong>of</strong> the

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