Common use of Management Certifications Clause in Contracts

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek department is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President/Chief Executive Officer; Chief Financial Officer; Vice President of Quality, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory Supervisor; and Director of Human Resources & Risk Management. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Envision employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Envision department is in compliance with applicable Federal health care program requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, all members of senior management and the following: President/leaders of all divisions, business units or departments with operations that relate to the Federal health care programs (e.g., (i) Chief Executive Officer; , Chief Financial Officer, Chief Operating Officer, Chief Accounting Officer and Chief Strategy Officer for Envision Healthcare Corporation; (ii) Chief Executive Officer, Chief Financial Officer, Chief Operating Officer for Envision Physician Services; and (iii) President, Executive Vice President of QualityPresidents, Acute CareSenior Vice Presidents, Regional Medical Directors, and Behavioral Health Site Medical Directors for Envision Physician Services; Director of Patient ’ Emergency Medicine, Hospitalist, and Critical Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory Supervisor; and Director of Human Resources & Risk ManagementService Line). For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Envision policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek Envision is in compliance with all applicable Federal health care Envision Corporate Integrity Agreement program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Greenway employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Greenway department is has adhered to the Software Standards and Practices; timely and effectively identified and addressed Patient Safety Issues and Certification Issues; performed the Obligations to Existing and Future Customers; and complied in compliance full with the Anti-Kickback Statute, applicable laws and regulations, Federal health care program requirements, including the requirements of payment programs involving the use of health information technology and the regulations and other guidance related to these programs, the ONC Health IT Certification Program requirements, Greenway’s own Policies and Procedures, and all reporting obligations of and other requirements created under this CIA. These Certifying Employees shall include, at a minimum, the following: the President/, the Chief Executive Officer; , the Chief Financial Officer; Vice President of Quality, Acute Carethe Chief Operations Officer, the Chief Medical Officer, the Compliance Officer, the Chief Technology Officer, the Chief Revenue Officer, the senior executive over human resources, software development and product management, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and the lead individual responsible for Patient Safety Officer; Radiology Manager; Laboratory Supervisor; Issues and Director of Human Resources & Risk ManagementCertification Issues. For each Reporting Period, each Certifying Employee shall sign a certification that states: states:‌ “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to that the [insert name of department] of Greenway: (1) complies with all applicable laws and regulations, including, to the extent applicable, Federal health care program requirements, including the requirements of payment programs involving the use of health information technology and the regulations and other guidance related to these programs, and ONC Health IT Certification Program requirements; (2) complies with all obligations and reporting requirements of the Corporate Integrity Agreement, ; and Millcreek policies, (3) complies with Greenway’s Policies and Procedures. I have taken reasonable steps to promote such compliance, adherence, and performance. To the best of my knowledge, except as otherwise described herein, the [insert name of department] of Millcreek Greenway is in compliance with all applicable laws and regulations; applicable Federal health care program requirements, including the requirements of payment programs involving the use of health information technology and the regulations and other guidance related to these programs, and ONC Health IT Certification Program requirements; obligations and reporting requirements of the Corporate Integrity Agreement; Greenway’s Policies and Procedures; and all other applicable requirements and obligations. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.above.‌

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Sutter employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek department is Covered Functions within their areas of responsibility are in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President/the Xxxxxx Health Chief Executive Officer; Officer (CEO), the Xxxxxx Health Chief Financial Officer (CFO), the Xxxxxx Health Chief Compliance Officer; , Xxxxxx Health Senior Vice President of QualityPresidents leading clinical, Acute Carehuman resources, operations, and Behavioral revenue cycle functions; Foundation CEOs, CFOs, and the senior leaders from each Foundation leading human resources, operations, and revenue cycle, respectively; the Comprehensive Health Services; Director of Patient Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory SupervisorAssessment Program Executive Director; and Director each Compliance Officer or Senior Compliance Officer with oversight of Human Resources & Risk Managementa Foundation or the Comprehensive Health Assessment Program. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to the Covered Functions associated with [insert name of department], an area under my supervision. My job responsibilities include ensuring the Covered Functions under my supervisions are in compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Sutter policies, and I have taken steps to promote such compliance. To the best of my knowledge, the Covered Functions associated with [insert name of department] of Millcreek is are in compliance with all applicable Federal health Xxxxxx Health Corporate Integrity Agreement care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.. Within 90 days after the Effective Date, Sutter shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).‌

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Mallinckrodt employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek department Mallinckrodt division or business unit is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President/Chief Executive Officer; Vice President & Chief Financial Officer; Vice President, Government Affairs & Patient Advocacy; Senior Director, Patient Services and Reimbursement; Executive Vice-President of Quality, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing Commercial & Operations Officer; Executive Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Chief Scientific Officer; Radiology Manager; Laboratory Supervisor; and Director of Human Resources & Risk Management. For each Reporting Period, each Certifying Employee shall sign a certification that states: Mallinckrodt plc Corporate Integrity Agreement “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of departmentdepartment or functional area], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of departmentthe department or functional area] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Mallinckrodt policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of departmentdepartment or functional area] of Millcreek Mallinckrodt is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above. Within 90 days after the Effective Date, Mallinckrodt shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Envision employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Envision department is in compliance with applicable Federal health care program requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, all members of senior management and the following: President/leaders of all divisions, business units or departments with operations that relate to the Federal health care programs (e.g., (i) Chief Executive Officer; , Chief Financial Officer, Chief Operating Office, Chief Accounting Officer and Chief Strategy Officer for Envision Healthcare Corporation; (ii) Chief Executive Officer, Chief Financial Officer, Chief Operating Office for Envision Physician Services; and (iii) President, Executive Vice President of QualityPresidents, Acute CareSenior Vice Presidents, Regional Medical Directors, and Behavioral Health Site Envision Corporate Integrity Agreement 6 Medical Directors for Envision Physician Services; Director of Patient ’ Emergency Medicine, Hospitalist, and Critical Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory Supervisor; and Director of Human Resources & Risk ManagementService Line. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Envision policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek Envision is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above. B. Written Standards 1.

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Vascular Access Centers employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Vascular Access Centers department is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President/Chief Executive Officer; , Chief Financial Medical Officer; , General Partner, Controller, Director of Finance, Senior Vice President of QualityMarketing and Business Development, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy Clinical Operations and Patient Safety Officer; Radiology Manager; Laboratory Supervisor; and Compliance, Director of Human Resources & Risk ManagementResources, Regional Director, Manager of Reimbursement Services, Team Lead of Coding Department, Area Manager of New Jersey locations, and Area Manager of Maryland locations. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Vascular Access Centers policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name Vascular Access Centers Corporate Integrity Agreement of department] of Millcreek Vascular Access Centers is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.. Within 90 days after the Effective Date, Vascular Access Centers shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).‌

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek employees ofBeaumont Health and other entities identified herein (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority ofauthority and shall annually certify that the applicable Millcreek WBH department is in compliance with applicable Federal health care program requirements and with the obligations of this ofthis CIA. These Certifying Employees shall include, at a minimum, the followingfollowing Beaumont Health employees: President/Chief Executive President and ChiefExecutive Officer; Chief Financial ChiefFinancial Officer; Vice President of Quality, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing ChiefOperating Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety ChiefMedical Officer; Radiology ManagerChiefNursing Officer; Laboratory SupervisorChiefQuality Officer; ChiefInformation Officer; President, Beaumont Medical Group; Executive Director, Beaumont Medical Group; ChiefHuman Resources Officer; ChiefInformation Officer; and Director of Human Resources & Risk ManagementEVP for Post-Acute Care Division and Diversified Services. The Certifying Employees shall also include the: EVP for Post-Acute Care Division and Diversified Services,2 who is responsible for monitoring and overseeing WBH for purposes ofthis CIA. For each Reporting Period, each Certifying Employee shall sign a certification that states: “"I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of departmentofdepartment], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of departmentofdepartment] with all applicable Federal health care program requirementsrequ_irements, obligations of the ofthe Corporate Integrity Agreement, and Millcreek WBH policies, and I have taken steps to promote such compliance. To the best of my ofmy knowledge, the [insert name of departmentofdepartment] of Millcreek ofWBH is in compliance with all applicable Federal health care program requirements and the obligations of the ofthe Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ If any " Ifany Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the ofthe reasons why he or she is unable to provide the certification outlined above.. 2 Presently employed by Xxxxxxxx Health Inc.‌

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Novartis and Novartis Affiliate employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek department Novartis business unit is in compliance with applicable Federal health care program and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: Head, Novartis Pharma USA (NPC); Executive Vice President/, US Novartis Oncology (NPC); Executive Director, Patient Assistance Programs (Novartis); US Head, Business Planning & Analysis (Novartis); US NBS Country Lead (Novartis Services, Inc.); SVP, Chief Executive OfficerBusiness Officer (AveXis); SVP, Chief Medical Officer (AveXis); SVP, Chief Regulatory Officer (AveXis); SVP, Chief Financial Officer; Vice President of Quality, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory SupervisorOfficer (AveXis); and Director of Human Resources & Risk ManagementAAA General Manager, USA (AAA). For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of the department] with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and Millcreek Novartis policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek Novartis is in compliance with all applicable Federal health care program requirements requirements, FDA requirements, and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above. Within 120 days after the Effective Date, Novartis shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the Novartis Corporate Integrity Agreement certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Apria employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Apria department is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President/Chief Executive Officer; Chief Financial Officer; Vice President of Quality, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing Compliance Officer; VP of Billing and Reimbursement; Executive Vice President, Division President of Senior Services– East Division; Executive Vice President, Division President of Surgical Services– West Division; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory Supervisor; and Director of Human Resources & Risk ManagementExecutive Vice President, Division President – Central Division. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Apria policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek Apria is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above. Within 90 days after the Effective Date, Apria shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Envision employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Envision department is in compliance with applicable Federal health care program requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, all members of senior management and the following: President/leaders of all divisions, business units or departments with operations that relate to the Federal health care programs (e.g., (i) Chief Executive Officer; , Chief Financial Officer, Chief Operating Office, Chief Accounting Officer and Chief Strategy Officer for Envision Healthcare Corporation; (ii) Chief Executive Officer, Chief Financial Officer, Chief Operating Office for Envision Physician Services; and (iii) President, Executive Vice President of QualityPresidents, Acute CareSenior Vice Presidents, Regional Medical Directors, and Behavioral Health Site Envision Corporate Integrity Agreement 6 Medical Directors for Envision Physician Services; Director of Patient ’ Emergency Medicine, Hospitalist, and Critical Care Services/Chief Nursing Officer; Vice President of Senior Services; Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory Supervisor; and Director of Human Resources & Risk ManagementService Line. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Envision policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek Envision is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Astellas employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek department Astellas division or business unit is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: Senior Vice President/Chief Executive Officer, Oncology Sales & Marketing (APUS); Chief Financial OfficerSenior Vice President, Urology & Hospital Sales & Marketing (APUS); Senior Vice President Health Systems (APUS); Vice President of QualityPresident, Acute Care, and Behavioral Health Services; Director of Patient Care Services/Chief Nursing OfficerCommercial Operations; Vice President of Senior ServicesPresident, Corporate Communications (AUS); Vice President of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory SupervisorPresident, US Regulatory (APGD); and Director of Human Resources & Risk ManagementSenior Vice President, Medical Affairs Americas (APGD). For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of departmentdepartment or functional area], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of departmentthe department or functional area] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Astellas policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of departmentdepartment or functional area] of Millcreek Astellas is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ ” If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.. Within 120 days after the Effective Date, Astellas shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).‌ Corporate Integrity Agreement Astellas Pharma US, Inc.

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Millcreek Guardian employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Millcreek Guardian department is in compliance with applicable Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall includeinclude all members of senior management and the leaders of all business units, divisions or departments with operations that relate to the Federal health care programs, including, at a minimum, the following: President/Chief Executive OfficerOfficer (CEO); Chief Financial OfficerOfficer (CFO); Chief Compliance Officer (CCO); Vice President of Quality, Acute Care, and Behavioral Health ServicesRevenue Cycle; Senior Vice President for Operations (SVPO); Market Directors of Operations; Senior Vice President for Clinical Operations (SVPCO); Vice President for Care Management; Director of Patient Care Services/Chief Nursing OfficerInformation Technology; Vice President of Senior ServicesHuman Resources; Vice President Facility Administrators; Directors of Surgical Services; Director of Outpatient Services; Physical Therapy Manager; Director of Pharmacy and Patient Safety Officer; Radiology Manager; Laboratory SupervisorNursing; and Director of Human Resources & Risk ManagementRehab Managers. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Millcreek Guardian policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Millcreek Guardian is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”‌ If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.. Within 90 days after the Effective Date, Guardian shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).‌