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22 | Page <br /> <br />Recipient and its subrecipients are encouraged to review internally “required by law” <br />disclosures under the HIPAA Privacy Rule prior to applying for or drawing down funds <br />under this Cooperative Agreement. For more details on identifying parties as subrecipients <br />or contractors for the purposes of receiving award funds, see 45 CFR §75.351 Subrec ipient <br />and Contractor Determinations , and Section 39 of the Standard Terms and Conditions (Pass <br />Through Entities, Subrecipients, and Contractors ). <br /> <br />Subrecipients are bound by all Terms and Conditions of Award under the guidance of the <br />Recipient. The Recipient shall plan for, and carry out, the collection and reporting of any PII <br />and PHI that may be required for the evaluation of the InCK Model, and shall ensure that its <br />subrecipients have planned for and do the same. The Recipient must also ensure that any <br />other individuals or entities (i.e., not subrecipients) involved in capturing or providing <br />model data do so at the time and in the form and manner specified by the Recipient. In <br />preparing to participate in the model, the Recipient and subrecipients shall ensure that any <br />institutional requirements (e.g., review by an Institutional Review Boa rd (IRB)) are <br />completed in time to ensure that the data collection and reporting obligations under 42 CFR <br />§ 403.1110(b) are met at the time and in the form and manner specified by CMS. All IRB <br />materials (if applicable), including any consent forms, must contain an explicit statement <br />that allows PII and PHI collected under this award to be shared with and submitted to CMS <br />and its contractors for the purpose of carrying out the evaluation of the InCK Model. Should <br />an institutional requirement present a barrier that delays or prevents the Recipient or a <br />subrecipient from meeting these data collection and reporting obligations, the Recipient <br />could be subject to corrective action pursuant to Section 23 of this document (Corrective <br />Action and Termination). <br />In ensur ing conformance with this section, CMS encourages the Recipient and its <br />subrecipients to discuss their obligations under 42 CFR § 403.1110(b) with any approving <br />bodies (such as an IRB). Failure to obtain IRB approval, if applicable, for the requisite <br />reporting to CMS and its contractors under 42 CFR § 403.1110(b) will not relieve the <br />Recipient and its subrecipients’ obligations under 42 CFR § 403.1110(b). <br />The Recipient shall accurately collect and submit all required data elements in the form and <br />manner requested by CMS or its contractor s. Such data will include, but are not limited to, <br />quality measures , person-level screening, referral information , Medicaid and CHIP (if <br />applicable) claims and encounter data, community service data , medical records or charts, <br />information on contacts or communications with beneficiaries, and other data generated by <br />the Recipient’s subr ecipients that CMS determines is necessary to evaluate this model. CMS <br />will determine whether information regarding an attributed beneficiary is duplicated by <br />comparing that beneficiary’s Medicaid or CHIP ID number or Social Security number . CMS <br />will count only information regarding beneficiaries with a valid Medicaid or CHIP ID <br />toward milestones. <br /> <br />DocuSign Envelope ID: 7832B0E4-F34E-430E-A3C2-1A6A14F29307