Common use of Compliance with Contract Provisions and Applicable Laws Clause in Contracts

Compliance with Contract Provisions and Applicable Laws. The CICO must, to the satisfaction of CMS and SCDHHS: Comply with all provisions set forth in this Contract; Comply with all applicable provisions of federal and state laws, regulations, guidance, waivers, Demonstration terms, and conditions, including the implementation of a compliance plan. The CICO must comply with the Medicare Advantage and Prescription Drug Plan requirements in Part C and D of Title XVIII, and 42 C.F.R. Part 422 and Part 423, and 42 C.F.R. Part 438 except to the extent that waivers from these requirements are provided in the Memorandum of Understanding (MOU) signed by CMS and SCDHHS for this initiative; and Comply with other laws. No obligation imposed herein on the CICO shall relieve the CICO of any other obligation imposed by law or regulation, including, but not limited to, the federal Balanced Budget Act of 1997 (Public Law 105-33), and regulations promulgated by SCDHHS or CMS. SCDHHS and CMS shall report to the appropriate agency any information it receives that indicates a violation of a law or regulation. SCDHHS or CMS will inform the CICO of any such report unless the appropriate agency to which SCDHHS or CMS has reported requests that SCDHHS or CMS not inform the CICO. Adopt and implement an effective compliance program that aligns with the approved South Carolina Medicaid managed care requirements to prevent, detect, and correct Fraud, waste, and Abuse. In addition, the compliance program must, at a minimum, include written policies, procedures, and standards of conduct that: Articulate the CICO's commitment to comply with all applicable federal and state standards, including, but not limited to: Fraud detection and investigation; Procedures to guard against Fraud and Abuse; Prohibitions on certain relationships as required by 42 C.F.R. § 438.610; Obligation to suspend payments to Providers consistent with 42 CFR § 438.608(a)(8); Disclosure of ownership and control of CICO; Disclosure of business transactions; Disclosure of information on persons convicted of health care crimes; Reporting an Adverse Benefit Determination taken for Fraud, Integrity, and quality; and Appointment of a Medicare Compliance Officer who acts as the compliance program point of contact for both internal staff and CMS representatives. Describe compliance expectations as embodied in the CICO’s standards of conduct; Implement the operation of the compliance program; Provide guidance to employees and others on addressing potential compliance issues; Identify how to communicate compliance issues to appropriate compliance personnel; Describe how potential compliance issues are investigated and resolved by the CICO; Include a policy of non-intimidation and non-retaliation for good faith participation in the compliance program, including, but not limited to, reporting potential issues, investigating issues, conducting self-evaluations, audits and remedial actions, and reporting to appropriate officials, including the State Attorney General’s Medicaid Fraud Control Unit; and Develop and implement an effective compliance program that applies to its operations, consistent with 42 C.F.R. § 420, et seq, 42 C.F.R. § 422.503, 42 C.F.R. § 423.504, and 42 C.F.R. §§ 438.600-610, 42 C.F.R. § 455. Comply with all aspects of the joint Readiness Review. Provide False Claims Education for all employees and First Tier, Downstream and Related Entities as required in 42 U.S.C. § 1396(a)(68).

Compliance with Contract Provisions and Applicable Laws. The CICO ICO must, to the satisfaction of CMS and SCDHHSMDHHS: Comply with all provisions set forth in this Contract; and Comply with all applicable provisions of federal and state State laws, policies, regulations, guidanceguidance waivers and standards, waivers, and Demonstration terms, terms and conditions, including the implementation of a compliance plan. The CICO ICO must comply with the Medicare Advantage and Prescription Drug Plan requirements in Part C and D of Title XVIII, and 42 C.F.R. Part 422 and Part 423, and 42 C.F.R. Part 438 except to the extent that waivers from these requirements are provided in the Memorandum of Understanding (MOU) MOU signed by CMS and SCDHHS MDHHS for this initiative; and . Comply with other lawsOther Laws. No obligation imposed herein on the CICO ICO shall relieve the CICO ICO of any other obligation imposed by law or regulation, including, but not limited to, to the federal Balanced Budget Act of 1997 (Public Law 105-33), and regulations promulgated by SCDHHS MDHHS or CMS. SCDHHS MDHHS and CMS shall report to the appropriate agency any information it receives that indicates a violation of a law or regulation. SCDHHS MDHHS or CMS will inform the CICO ICO of any such report unless the appropriate agency to which SCDHHS MDHHS or CMS has reported requests that SCDHHS MDHHS or CMS not inform the CICO. ICO. Adopt and implement an effective compliance program that aligns with the approved South Carolina Medicaid managed care requirements to prevent, detect, detect and correct Fraud, waste, and Abuse. In addition, the The compliance program must, at a minimum, include written policies, procedures, and standards of conduct that: Articulate the CICOICO's commitment to comply with all applicable federal and state State standards, including, including but not limited to: Fraud detection and investigation; Procedures to guard against Fraud and Abuse; Prohibitions on certain relationships as required by 42 C.F.R. § 438.610; Obligation to suspend payments to Providers consistent with 42 CFR § 438.608(a)(8)providers; Disclosure of ownership and control of CICOICO; Disclosure of business transactions; Disclosure of information on persons convicted of health care crimes; Reporting an Adverse Benefit Determination Determinations taken for Fraud, Integrityintegrity, and quality; and Appointment of a Medicare Compliance Officer who acts as the compliance program point of contact for both internal staff and CMS representatives. Describe compliance expectations as embodied in the CICOICO’s standards of conduct; Implement the operation of the compliance program; Provide guidance to employees and others on addressing dealing with potential compliance issues; Identify how to communicate compliance issues to appropriate compliance personnel; Describe how potential . Develop and implement an effective compliance issues are investigated program that applies to its operations, consistent with 42 C.F.R. § 420, et seq., 42 C.F.R. § 422.503, and resolved 42 C.F.R. §§ 438.600-610, 42 C.F.R. 455. The ICO must report all employees, providers, and Enrollees suspected of Fraud, waste, and/or Abuse that warrant investigation to MDHHS – Office of Inspector General (DCH-OIG), the Medicaid Fraud Control Unit and CMS. The ICO must provide the number of complaints warranting a preliminary investigation each year. Further, for each complaint warranting full investigation, the ICO must provide MDHHS-OIG the following information: The name of the provider, individuals, and/or entity, including their address, phone number and Medicaid identification number, and any other identifying information. Source of the complaint. Type of provider (if applicable). Nature of the complaint. Approximate range of dollars involved. Legal and administrative disposition of the case, including actions taken by law enforcement officials to whom the CICO; case has been referred. Include a policy of non-intimidation and non-retaliation for good faith participation in the compliance program, including, including but not limited to, to reporting potential issues, investigating issues, conducting self-evaluations, audits and remedial actions, and reporting to appropriate officials. For ICOs that make or receive payments under the contract of at least $5,000,000, the ICO must adopt and implement written policies for all employees of the ICO, and of any contractor or agent of the ICO, that provide detailed information about the False Claims Act and other federal and State laws described in section 1902(a)(68) of the Social Security Act, including information about rights of employees to be protected as whistleblowers. The ICO must inform MDHHS of actions taken to investigate or resolve the State Attorney General’s Medicaid Fraud Control Unit; reported suspicion, knowledge, or action. The ICO must also cooperate fully in any investigation by MDHHS and Develop and implement an effective compliance program any subsequent legal action that applies may result from such investigation. In some circumstances, the ICO is permitted to its operationsdisclose protected health information, consistent with (PHI) as defined by 42 C.F.R. § 420160.103 to MDHHS without first obtaining authorization from the Enrollee to disclose such information. MDHHS must ensure that such disclosures meet the requirements for disclosures made as part of the ICO’s treatment, et seqpayment, 42 or health care operations as defined in 45 C.F.R. § 422.503164.50, 42 or any other exceptions provided for under 45 C.F.R. § 423.504164 et. seq.1. Disclosure of Litigation, or Other Proceeding. The ICO must notify MDHHS and CMS within fourteen (14) calendar days of receiving notice of the following types of litigation, investigation, arbitration, or other proceeding (collectively, “Proceeding”) involving the ICO, a First Tier, Downstream, or Related Entity, or an officer or director of the ICO or First Tier, Downstream, or Related Entity, that arises during the term of the ICO, including: A criminal Proceeding; A parole or probation Proceeding; A Proceeding under the Xxxxxxxx-Xxxxx Act; A civil Proceeding involving A Claim that might reasonably be expected to adversely affect the ICO’s viability or financial stability; or A governmental or public entity’s Claim or written allegation of Fraud; or A Proceeding involving any license that the ICO is required to possess in order to perform under this Contract. Contract Management and Readiness Review Requirements Contract Readiness Review Requirements CMS and MDHHS, or their designee, will conduct a Readiness Review of each ICO, which must be completed successfully, as determined by CMS and MDHHS, prior to the Contract Operational Start Date. CMS and MDHHS Readiness Review Responsibilities CMS and MDHHS or its designee will conduct a Readiness Review of each ICO that will include, at a minimum, one on-site review. This review shall be conducted prior to marketing to and Enrollment of Potential Enrollees into the ICO’s plan. CMS and MDHHS or its designee will conduct the Readiness Review to verify the ICO’s assurances that the ICO is ready and able to meet its obligations under the Contract. The scope of the Readiness Review will include, but is not limited to, a review of the following elements: Network provider composition and access, in accordance with Section 2.7; Staffing, including key personnel and functions directly impacting Enrollees (e.g., adequacy of Enrollee services staffing, in accordance with Section 2.9); Capabilities of First Tier, Downstream and Related Entities, in accordance with Appendix C; Care management capabilities, in accordance with Section 2.5; Content of provider contracts, including any provider performance incentives, in accordance with Section 5.1.7; Enrollee Services capability (materials, processes and infrastructure, e.g., call center capabilities), in accordance with Section 2.9; Comprehensiveness of quality management/quality improvement and Utilization Management strategies, in accordance with Section 2.8.6; Internal Grievance and Appeal policies and procedures, in accordance with Section 2.10 and Section 2.11; Fraud and Abuse and program integrity policies and procedures, in accordance with Section 2.1.2.1.4; Financial solvency, in accordance with Section 2.15; Information systems, including Claims payment system performance, interfacing and reporting capabilities and validity testing of Encounter Data, in accordance with Section 2.17, including IT testing and security assurances. No individual shall be enrolled into the ICO unless and until CMS and MDHHS determine that the ICO is ready and able to perform its obligations under the Contract as demonstrated during the Readiness Review. CMS and MDHHS or its designee will identify to the ICO all areas where the ICO is not ready and able to meet its obligations under the Contract and provide an opportunity for the ICO to correct such areas to remedy all identified deficiencies prior to the Contract Operational Start Date. CMS or MDHHS may, at its discretion, postpone the Contract Operational Start Date for the ICO that fails to satisfy all Readiness Review requirements. If, for any reason, the ICO does not fully satisfy CMS or MDHHS that it is ready and able to perform its obligations under the Contract prior to the Contract Operational Start Date, and CMS or MDHHS do not agree to postpone the Contract Operational Start Date, or extend the date for full compliance with the applicable Contract requirement, then CMS or MDHHS may terminate the Contract. ICO Readiness Review Responsibilities The ICO must demonstrate to CMS’ and MDHHS’s satisfaction that the ICO is ready and able to meet all Contract requirements identified in the Readiness Review prior to the Contract Operational Start Date, and prior to the ICO engaging in marketing of its Demonstration product; The ICO must provide CMS and MDHHS, or their designee, with corrections requested by the Readiness Review. Contract Management The ICO shall employ a qualified individual to serve as the MI Health Link Program Liaison (Program Liaison) of its Capitated Financial Alignment Model. The Program Liaison shall be dedicated to the ICO’s participation in the Demonstration and be authorized and empowered to represent the ICO in all matters pertaining to the ICO’s program, such as rate negotiations for the ICO program, Claims payment, and provider relations/contracting. The Program Liaison may serve as the Compliance Officer but the ICO may select a separate individual to serve in such a role. In no instance, do the roles of the Program Liaison circumvent the requirements of a Compliance Officer under 42 C.F.R. §§ 438.600-610422.503(b)(4)(vi)(B), 42 C.F.R. § 455423.504(b)(4)(vi)(B), and 438.608(a)(1)(ii). Comply The Program Liaison shall be able to make decisions about the program and policy issues. The Program Liaison or the Medicare Compliance Officer shall act as liaison between the ICO, CMS, and MDHHS, and has responsibilities that include but, are not limited to, the following: Ensure the ICO’s compliance with all aspects the terms of the joint Readiness ReviewContract, including securing and coordinating resources necessary for such compliance; Oversee all activities by the ICO and its First Tier, Downstream and Related Entities, including but not limited to coordinating with the ICO’s quality management director, medical director, and behavioral health clinician; Ensure that Enrollees receive written Notice of any significant change in the manner in which services are rendered to Enrollees at least thirty (30) calendar days before the intended effective date of the change, such as a retail pharmacy chain leaving the Provider Network; Receive and respond to all inquiries and requests made by CMS, MDHHS or both in time frames and formats specified by CMS and MDHHS; Meet with representatives of CMS or MDHHS, or both, on a periodic or as-needed basis to resolve issues within specified timeframes; Ensure the availability to CMS and MDHHS, upon their request, of those members of the ICO’s staff who have appropriate expertise in administration, operations, finance, management information systems, Claims processing and payment, clinical service provision, quality management, Enrollee services, Utilization Management, Provider Network management, and benefit coordination; Represent the ICO at MDHHS and CMS meetings; Coordinate requests and activities among the ICO, the PIHP, all other First Tier, Downstream and Related Entities, CMS, and MDHHS; Make best efforts to promptly resolve any issues related to the Contract identified either by the ICO, CMS, or MDHHS; and Meet with CMS and MDHHS at the time and place requested by CMS and MDHHS if either CMS or MDHHS or both, determine that the ICO is not in compliance with the requirements of the Contract. Provide False Claims Education Implement all action plans, strategies, and timelines, including but not limited to those described in the ICO’s response to the Request for all employees Proposal (RFP) to the extent such responses do not conflict with the MOU or this Contract. Assure billing and payment issues identified by First Tier, Downstream and Related Entities are resolved within thirty (30) calendar days of learning about the issue; Assure timely and appropriate coordination with Adult Protective Services (APS) when referrals are made by the ICO; Assure timely and appropriate coordination with the MI Health Link Ombudsman (MHLO) Program when resolving beneficiary issues. Organizational Structure The ICO shall establish and maintain the interdepartmental structures and processes to support the operation and management of its Demonstration line of business in a manner that fosters integration of physical health, behavioral health, and community-based and facility-based LTSS service provisions. The provision of all services shall be based on prevailing clinical knowledge and the study of data on the efficacy of treatment, when such data is available. The ICO shall describe the interdepartmental structures and processes to support the operation and management of its Demonstration line of business. On an annual basis, and on an ad hoc basis, when changes occur or as required in 42 U.S.C. § 1396(a)(68)directed by MDHHS, CMS or both, the ICO shall submit to the CMT an overall organizational chart that includes senior and mid-level managers. For all employees, by functional area, the ICO shall establish and maintain policies and procedures for managing staff retention and employee turnover. Such policies and procedures shall be provided to the CMT upon request. If any Demonstration specific services and activities are provided by a First Tier, Downstream or Related Entity, the ICO may require submission of the organizational chart of the First Tier, Downstream or Related Entity which clearly demonstrates the relationship with the First Tier, Downstream or Related Entity and the ICO’s oversight of the First Tier, Downstream or Related Entity. The ICO shall immediately notify the CMT whenever positions held by key personnel become vacant and shall notify the CMT when the position is filled and by whom. Key personnel positions include, but are not limited to The ICO’s Executive with oversight of the Demonstration, MI Health Link Program Liaison. Chief executive officer, if applicable, Chief financial officer, Chief operating officer or director of Operations, Chief medical officer/medical director, Pharmacy director, Quality improvement director, Utilization Management director, Care coordination/care management/disease management program manager, Director of LTSS, Nursing Facility Care Coordinator Liaison, Community liaison, ADA compliance director or point of contact for reasonable accommodations, Claims director, Management information system (MIS) director, IT director, if different from MIS director, Medicare/Medicaid compliance officer, Grievance/Appeals coordinator, and Privacy and security officer.

Compliance with Contract Provisions and Applicable Laws. ‌ The CICO CICO must, to the satisfaction of CMS and SCDHHSSCDHHS: Comply with all provisions set forth in this Contract; Comply with all applicable provisions of federal and state laws, regulations, guidance, waivers, Demonstration terms, and conditions, including the implementation of a compliance plan. The CICO CICO must comply with the Medicare Advantage and Prescription Drug Plan requirements in Part C and D of Title XVIII, and 42 C.F.R. Part 422 and Part 423, and 42 C.F.R. Part 438 except to the extent that waivers from these requirements are provided in the Memorandum of Understanding (MOU) signed by CMS and SCDHHS SCDHHS for this initiative; and Comply with other laws. No obligation imposed herein on the CICO CICO shall relieve the CICO CICO of any other obligation imposed by law or regulation, including, but not limited to, the federal Balanced Budget Act of 1997 (Public Law 105-33), and regulations promulgated by SCDHHS SCDHHS or CMS. SCDHHS SCDHHS and CMS shall report to the appropriate agency any information it receives that indicates a violation of a law or regulation. SCDHHS SCDHHS or CMS will inform the CICO CICO of any such report unless the appropriate agency to which SCDHHS SCDHHS or CMS has reported requests that SCDHHS SCDHHS or CMS not inform the CICO. CICO. Adopt and implement an effective compliance program that aligns with the approved South Carolina Medicaid managed care requirements to prevent, detect, and correct Fraud, waste, and Abuse. In addition, the compliance program must, at a minimum, include written policies, procedures, and standards of conduct that: Articulate the CICOCICO's commitment to comply with all applicable federal and state standards, including, but not limited to: Fraud detection and investigation; Procedures to guard against Fraud and Abuse; Prohibitions on certain relationships as required by 42 C.F.R. § 438.610; Obligation to suspend payments to Providers consistent with 42 CFR § 438.608(a)(8)Providers; Disclosure of ownership and control of CICOCICO; Disclosure of business transactions; Disclosure of information on persons convicted of health care crimes; Reporting adverse actions or, effective July 1, 2017, an Adverse Benefit Determination taken for Fraud, Integrityintegrity, and quality; and Appointment of a Medicare Compliance Officer who acts as the compliance program point of contact for both internal staff and CMS representatives. Describe compliance expectations as embodied in the CICOCICO’s standards of conduct; Implement the operation of the compliance program; Provide guidance to employees and others on addressing potential compliance issues; Identify how to communicate compliance issues to appropriate compliance personnel; Describe how potential compliance issues are investigated and resolved by the CICOCICO; Include a policy of non-intimidation and non-retaliation for good faith participation in the compliance program, including, but not limited to, reporting potential issues, investigating issues, conducting self-self- evaluations, audits and remedial actions, and reporting to appropriate officials, including the State Attorney General’s Medicaid Fraud Control Unit; and Develop and implement an effective compliance program that applies to its operations, consistent with 42 C.F.R. § 420, et seq, 42 C.F.R. § 422.503, 42 C.F.R. § 423.504, and 42 C.F.R. §§ 438.600-610, 42 C.F.R. § 455. Comply with all aspects of the joint Readiness Review. Provide False Claims Education for all employees and First Tier, Downstream and Related Entities as required in 42 U.S.C. § 1396(a)(68).

Compliance with Contract Provisions and Applicable Laws. The CICO ICO must, to the satisfaction of CMS and SCDHHSMDHHS: Comply with all provisions set forth in this Contract; and Comply with all applicable provisions of federal and state State laws, policies, regulations, guidanceguidance waivers and standards, waivers, and Demonstration terms, terms and conditions, including the implementation of a compliance plan. The CICO ICO must comply with the Medicare Advantage and Prescription Drug Plan requirements in Part C and D of Title XVIII, and 42 C.F.R. Part 422 and Part 423, and 42 C.F.R. Part 438 except to the extent that waivers from these requirements are provided in the Memorandum of Understanding (MOU) MOU signed by CMS and SCDHHS MDHHS for this initiative; and . Comply with other lawsOther Laws. No obligation imposed herein on the CICO ICO shall relieve the CICO ICO of any other obligation imposed by law or regulation, including, but not limited to, to the federal Balanced Budget Act of 1997 (Public Law 105-33), and regulations promulgated by SCDHHS MDHHS or CMS. SCDHHS MDHHS and CMS shall report to the appropriate agency any information it receives that indicates a violation of a law or regulation. SCDHHS MDHHS or CMS will inform the CICO ICO of any such report unless the appropriate agency to which SCDHHS MDHHS or CMS has reported requests that SCDHHS MDHHS or CMS not inform the CICO. ICO. Adopt and implement an effective compliance program that aligns with the approved South Carolina Medicaid managed care requirements to prevent, detect, detect and correct Fraud, waste, and AbuseXxxxx. In addition, the The compliance program must, at a minimum, include written policies, procedures, and standards of conduct that: Articulate the CICOICO's commitment to comply with all applicable federal and state State standards, including, including but not limited to: Fraud detection and investigation; Procedures to guard against Fraud and Abuse; Prohibitions on certain relationships as required by 42 C.F.R. § 438.610; Obligation to suspend payments to Providers consistent with 42 CFR § 438.608(a)(8)providers; Disclosure of ownership and control of CICOICO; Disclosure of business transactions; Disclosure of information on persons convicted of health care crimes; Reporting an Adverse Benefit Determination Determinations taken for Fraud, Integrityintegrity, and quality; and Appointment of a Medicare Compliance Officer who acts as the compliance program point of contact for both internal staff and CMS representatives. Describe compliance expectations as embodied in the CICOICO’s standards of conduct; Implement the operation of the compliance program; Provide guidance to employees and others on addressing dealing with potential compliance issues; Identify how to communicate compliance issues to appropriate compliance personnel; Describe how potential . Develop and implement an effective compliance issues are investigated program that applies to its operations, consistent with 42 C.F.R. § 420, et seq., 42 C.F.R. § 422.503, and resolved 42 C.F.R. §§ 438.600-610, 42 C.F.R. 455. The ICO must report all employees, providers, and Enrollees suspected of Fraud, waste, and/or Abuse that warrant investigation to MDHHS – Office of Inspector General (DCH-OIG), the Medicaid Fraud Control Unit and CMS. The ICO must provide the number of complaints warranting a preliminary investigation each year. Further, for each complaint warranting full investigation, the ICO must provide MDHHS-OIG the following information: The name of the provider, individuals, and/or entity, including their address, phone number and Medicaid identification number, and any other identifying information. Source of the complaint. Type of provider (if applicable). Nature of the complaint. Approximate range of dollars involved. Legal and administrative disposition of the case, including actions taken by law enforcement officials to whom the CICO; case has been referred. Include a policy of non-intimidation and non-retaliation for good faith participation in the compliance program, including, including but not limited to, to reporting potential issues, investigating issues, conducting self-evaluations, audits and remedial actions, and reporting to appropriate officials. For ICOs that make or receive payments under the contract of at least $5,000,000, the ICO must adopt and implement written policies for all employees of the ICO, and of any contractor or agent of the ICO, that provide detailed information about the False Claims Act and other federal and State laws described in section 1902(a)(68) of the Social Security Act, including information about rights of employees to be protected as whistleblowers. The ICO must inform MDHHS of actions taken to investigate or resolve the State Attorney General’s Medicaid Fraud Control Unit; reported suspicion, knowledge, or action. The ICO must also cooperate fully in any investigation by MDHHS and Develop and implement an effective compliance program any subsequent legal action that applies may result from such investigation. In some circumstances, the ICO is permitted to its operationsdisclose protected health information, consistent with (PHI) as defined by 42 C.F.R. § 420160.103 to MDHHS without first obtaining authorization from the Enrollee to disclose such information. MDHHS must ensure that such disclosures meet the requirements for disclosures made as part of the ICO’s treatment, et seqpayment, 42 or health care operations as defined in 45 C.F.R. § 422.503164.50, 42 or any other exceptions provided for under 45 C.F.R. § 423.504164 et. seq.1. Disclosure of Litigation, or Other Proceeding. The ICO must notify MDHHS and CMS within fourteen (14) calendar days of receiving notice of the following types of litigation, investigation, arbitration, or other proceeding (collectively, “Proceeding”) involving the ICO, a First Tier, Downstream, or Related Entity, or an officer or director of the ICO or First Tier, Downstream, or Related Entity, that arises during the term of the ICO, including: A criminal Proceeding; A parole or probation Proceeding; A Proceeding under the Xxxxxxxx-Xxxxx Act; A civil Proceeding involving A Claim that might reasonably be expected to adversely affect the ICO’s viability or financial stability; or A governmental or public entity’s Claim or written allegation of Fraud; or A Proceeding involving any license that the ICO is required to possess in order to perform under this Contract. Contract Management and Readiness Review Requirements Contract Readiness Review Requirements CMS and MDHHS, or their designee, will conduct a Readiness Review of each ICO, which must be completed successfully, as determined by CMS and MDHHS, prior to the Contract Operational Start Date. CMS and MDHHS Readiness Review Responsibilities CMS and MDHHS or its designee will conduct a Readiness Review of each ICO that will include, at a minimum, one on-site review. This review shall be conducted prior to marketing to and Enrollment of Potential Enrollees into the ICO’s plan. CMS and MDHHS or its designee will conduct the Readiness Review to verify the ICO’s assurances that the ICO is ready and able to meet its obligations under the Contract. The scope of the Readiness Review will include, but is not limited to, a review of the following elements: Network provider composition and access, in accordance with Section 2.7; Staffing, including key personnel and functions directly impacting Enrollees (e.g., adequacy of Enrollee services staffing, in accordance with Section 2.9); Capabilities of First Tier, Downstream and Related Entities, in accordance with Appendix C; Care management capabilities, in accordance with Section 2.5; Content of provider contracts, including any provider performance incentives, in accordance with Section 5.1.7; Enrollee Services capability (materials, processes and infrastructure, e.g., call center capabilities), in accordance with Section 2.9; Comprehensiveness of quality management/quality improvement and Utilization Management strategies, in accordance with Section 2.8.6; Internal Grievance and Appeal policies and procedures, in accordance with Section 2.10 and Section 2.11; Fraud and Abuse and program integrity policies and procedures, in accordance with Section 2.1.2.1.4; Financial solvency, in accordance with Section 2.15; Information systems, including Claims payment system performance, interfacing and reporting capabilities and validity testing of Encounter Data, in accordance with Section 2.17, including IT testing and security assurances. No individual shall be enrolled into the ICO unless and until CMS and MDHHS determine that the ICO is ready and able to perform its obligations under the Contract as demonstrated during the Readiness Review. CMS and MDHHS or its designee will identify to the ICO all areas where the ICO is not ready and able to meet its obligations under the Contract and provide an opportunity for the ICO to correct such areas to remedy all identified deficiencies prior to the Contract Operational Start Date. CMS or MDHHS may, at its discretion, postpone the Contract Operational Start Date for the ICO that fails to satisfy all Readiness Review requirements. If, for any reason, the ICO does not fully satisfy CMS or MDHHS that it is ready and able to perform its obligations under the Contract prior to the Contract Operational Start Date, and CMS or MDHHS do not agree to postpone the Contract Operational Start Date, or extend the date for full compliance with the applicable Contract requirement, then CMS or MDHHS may terminate the Contract. ICO Readiness Review Responsibilities The ICO must demonstrate to CMS’ and MDHHS’s satisfaction that the ICO is ready and able to meet all Contract requirements identified in the Readiness Review prior to the Contract Operational Start Date, and prior to the ICO engaging in marketing of its Demonstration product; The ICO must provide CMS and MDHHS, or their designee, with corrections requested by the Readiness Review. Contract Management The ICO shall employ a qualified individual to serve as the MI Health Link Program Liaison (Program Liaison) of its Capitated Financial Alignment Model. The Program Liaison shall be dedicated to the ICO’s participation in the Demonstration and be authorized and empowered to represent the ICO in all matters pertaining to the ICO’s program, such as rate negotiations for the ICO program, Claims payment, and provider relations/contracting. The Program Liaison may serve as the Compliance Officer but the ICO may select a separate individual to serve in such a role. In no instance, do the roles of the Program Liaison circumvent the requirements of a Compliance Officer under 42 C.F.R. §§ 438.600-610422.503(b)(4)(vi)(B), 42 C.F.R. § 455423.504(b)(4)(vi)(B), and 438.608(a)(1)(ii). Comply The Program Liaison shall be able to make decisions about the program and policy issues. The Program Liaison or the Medicare Compliance Officer shall act as liaison between the ICO, CMS, and MDHHS, and has responsibilities that include but, are not limited to, the following: Ensure the ICO’s compliance with all aspects the terms of the joint Readiness ReviewContract, including securing and coordinating resources necessary for such compliance; Oversee all activities by the ICO and its First Tier, Downstream and Related Entities, including but not limited to coordinating with the ICO’s quality management director, medical director, and behavioral health clinician; Ensure that Enrollees receive written Notice of any significant change in the manner in which services are rendered to Enrollees at least thirty (30) calendar days before the intended effective date of the change, such as a retail pharmacy chain leaving the Provider Network; Receive and respond to all inquiries and requests made by CMS, MDHHS or both in time frames and formats specified by CMS and MDHHS; Meet with representatives of CMS or MDHHS, or both, on a periodic or as-needed basis to resolve issues within specified timeframes; Ensure the availability to CMS and MDHHS, upon their request, of those members of the ICO’s staff who have appropriate expertise in administration, operations, finance, management information systems, Claims processing and payment, clinical service provision, quality management, Enrollee services, Utilization Management, Provider Network management, and benefit coordination; Represent the ICO at MDHHS and CMS meetings; Coordinate requests and activities among the ICO, the PIHP, all other First Tier, Downstream and Related Entities, CMS, and MDHHS; Make best efforts to promptly resolve any issues related to the Contract identified either by the ICO, CMS, or MDHHS; and Meet with CMS and MDHHS at the time and place requested by CMS and MDHHS if either CMS or MDHHS or both, determine that the ICO is not in compliance with the requirements of the Contract. Provide False Claims Education Implement all action plans, strategies, and timelines, including but not limited to those described in the ICO’s response to the Request for all employees Proposal (RFP) to the extent such responses do not conflict with the MOU or this Contract. Assure billing and payment issues identified by First Tier, Downstream and Related Entities are resolved within thirty (30) calendar days of learning about the issue; Assure timely and appropriate coordination with Adult Protective Services (APS) when referrals are made by the ICO; Assure timely and appropriate coordination with the MI Health Link Ombudsman (MHLO) Program when resolving beneficiary issues. Organizational Structure The ICO shall establish and maintain the interdepartmental structures and processes to support the operation and management of its Demonstration line of business in a manner that fosters integration of physical health, behavioral health, and community-based and facility-based LTSS service provisions. The provision of all services shall be based on prevailing clinical knowledge and the study of data on the efficacy of treatment, when such data is available. The ICO shall describe the interdepartmental structures and processes to support the operation and management of its Demonstration line of business. On an annual basis, and on an ad hoc basis, when changes occur or as required in 42 U.S.C. § 1396(a)(68)directed by MDHHS, CMS or both, the ICO shall submit to the CMT an overall organizational chart that includes senior and mid-level managers. For all employees, by functional area, the ICO shall establish and maintain policies and procedures for managing staff retention and employee turnover. Such policies and procedures shall be provided to the CMT upon request. If any Demonstration specific services and activities are provided by a First Tier, Downstream or Related Entity, the ICO may require submission of the organizational chart of the First Tier, Downstream or Related Entity which clearly demonstrates the relationship with the First Tier, Downstream or Related Entity and the ICO’s oversight of the First Tier, Downstream or Related Entity. The ICO shall immediately notify the CMT whenever positions held by key personnel become vacant and shall notify the CMT when the position is filled and by whom. Key personnel positions include, but are not limited to The ICO’s Executive with oversight of the Demonstration, MI Health Link Program Liaison. Chief executive officer, if applicable, Chief financial officer, Chief operating officer or director of Operations, Chief medical officer/medical director, Pharmacy director, Quality improvement director, Utilization Management director, Care coordination/care management/disease management program manager, Director of LTSS, Nursing Facility Care Coordinator Liaison, Community liaison, ADA compliance director or point of contact for reasonable accommodations, Claims director, Management information system (MIS) director, IT director, if different from MIS director, Medicare/Medicaid compliance officer, Grievance/Appeals coordinator, and Xxxxxxx and security officer.