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Pennsylvania Keystones of Health Section 1115 Demonstration Approval Period: December 26, 2024 through December 31, 2029 Page 10 of 90 3.14. Administrative Authority. When there are multiple entities involved in the administration of the demonstration, the Single State Medicaid Agency must maintain authority, accountability, and oversight of the program. The State Medicaid Agency must exercise oversight of all delegated functions to operating agencies, MCOs, and any other contracted entities. The Single State Medicaid Agency is responsible for the content and oversight of the quality strategies for the demonstration. 3.15. Common Rule Exemption. The state must ensure that the only involvement of human subjects in research activities that may be authorized and/or required by this demonstration is for projects which are conducted by or subject to the approval of CMS, and that are designed to study, evaluate, or otherwise examine the Medicaid or CHIP program – including public benefit or service programs, procedures for obtaining Medicaid or CHIP benefits or services, possible changes in or alternatives to Medicaid or CHIP programs and procedures, or possible changes in methods or levels of payment for Medicaid benefits or services. CMS has determined that this demonstration as represented in these approved STCs meets the requirements for exemption from the human subject research provisions of the Common Rule set forth in 45 CFR 46.104(d)(5). 4. ELIGIBILITY AND ENROLLMENT 4.1. Eligibility Groups Affected by the Demonstration. Under the demonstration, all eligibility will be defined under the state plan and the demonstration affects all eligibility groups under the state plan through the provision of additional services. In addition, individuals eligible for Medicaid in the state through section 1915(c) waiver programs will be eligible for services under the demonstration when they meet certain clinical and social criteria to qualify for the services as further specified in STC 5.3. The state will require and ensure that these eligible individuals will, to the extent applicable, first receive housing, food, and nutrition services and supports under that section 1915(c) waiver program and then only access Keystones of Health services when unable to access similar services under the section 1915(c) waiver program in which they are enrolled. Keystones of Health eligibility will be determined through existing state plan processes and eligibility. 5. REENTRY DEMONSTRATION INITIATIVE PROGRAM 5.1. Overview of Pre-Release Services and Program Objectives. This component of the demonstration will provide coverage for pre-release services up to 90 days immediately prior to the expected date of release to certain individuals who are inmates residing in prisons and jails (hereinafter “correctional facilities”). To qualify for services covered under this demonstration, individuals residing in correctional facilities must be eligible for Medicaid as determined pursuant to an application filed before or during incarceration and must have an expected release date no later than 90 days as further specified in the STCs below. 5.2. The objective of this component of the demonstration is to facilitate individuals’ access to certain healthcare services and case management, provided by Medicaid participating providers, while individuals are incarcerated and allow them to establish relationships with