Sterile water lacks the bacteriostatic agent, meaning bacteria can begin to grow after the first use, contaminating the entire vial

Specifically, under new 425.308(b)(10), we proposed that, for each performance year, an ACO would be required to report (in a standardized format specified by CMS) its spend plan, the total amount of prepaid shared savings received from CMS, and an itemization of how any prepaid shared savings were actually spent during each year, including expenditure categories, the dollar amounts spent on the various categories, information about which groups of beneficiaries received direct beneficiary services that were purchased with prepaid shared savings and investments that were made in the ACO with prepaid shared savings, how these direct beneficiary services were provided to beneficiaries and how the direct beneficiary services and investments supported the care of beneficiaries, any changes to the spend plan as submitted under 425.640(d)(2), and such other information as may be specified by CMS
However, walking into that conversation prepared with good information makes a world of difference
Request for additional data: PCAC may ask for more safety or efficacy information before making a final recommendation, potentially delaying the timeline
After that, they are given once a month to keep levels up