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 Progenity employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. 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 Progenity policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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, Progenity 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).

Appears in 3 contracts

Sources: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement, Corporate Integrity Agreement (Progenity, Inc.)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Friendship Entities employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Friendship Entities 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, the following: Chief Executive Officer; , Chief Financial Officer; , Chief Operating Officer; Chief Commercial , Compliance Officer; Chief Scientific Officer; Chief Medical Officer; , Director of Nursing, Human Resources Director, and Chief Information OfficerRegional Administrator. 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 Progenity the Friendship Entities’ policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity the Friendship Entities 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, Progenity 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Indivior employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Indivior 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: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Medical Officer; Chief Scientific Officer; Chief Medical Commercial and Strategy Officer; Chief Financial Officer; Senior Vice President of Regulatory Affairs; Senior Vice President Global Medicines Development; Senior Director and Chief Information OfficerHead, MSL and Medical Outcomes and Value Team; Senior Vice President for US Sales and Marketing; and Senior Vice President for US Treatment Access, Support Programs and Business Insights. 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, FDA requirements, obligations of the Corporate Integrity Agreement, and Progenity Indivior 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 Progenity Indivior 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 90 days after the Effective Date, Progenity Indivior 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Genova employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Genova 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, the following: Chief Executive Officer; Officer Chief Financial Officer; Chief Operating Officer; Officer Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Officer Chief Information Officer. Officer Vice President of Business Development Director of Human Resources and Corporate Compliance Director of Marketing Chief Science Officer Client Services Manager Controller International Business Development Senior Information Technology Manager Information Technology Manager, Statistical Science Information Technology Manager, Software Development Information Technology Manager, Clinical Laboratory Information and Financial Systems Human Resources Manager Senior Quality Manager Marketing Team Lead Production Design Marketing Manager Lab Director Development Manager Technical Manager Medical Education Product Manager Medical Education Content Manager states: 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 Progenity Genova policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Genova 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, Progenity Genova 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Indivior employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Indivior 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: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Medical Officer; Chief Scientific Officer; Chief Medical Commercial and Strategy Officer; Chief Financial Officer; Senior Vice President of Regulatory Affairs; Senior Vice President Global Medicines Development; Senior Director and Chief Information OfficerHead, MSL and Medical Outcomes and Value Team; Senior Vice President for US Sales and Marketing; and Senior Vice President for US Treatment Access, Support Programs and Business Insights. 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, FDA requirements, obligations of the Corporate Integrity Agreement, and Progenity Indivior 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 Progenity Indivior 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 90 days after the Effective Date, Progenity Indivior 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity employees for the U.S. Healthcare Supply DMEPOS Companies (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department for the U.S. Healthcare Supply DMEPOS Companies 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, the followingfollowing individuals at U.S. Healthcare Supply, LLC, Spectrum Diabetic Services, LLC, Heritage Diabetic Supply, Inc, and Dependable Diabetic Supply, LLC: any Covered Person with the title and job responsibilities of Chief Executive Officer; , President, Compliance Officer, Chief Operating Officer, Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer, director, or manager. 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 Progenity [insert name of applicable entity] policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity [insert name of applicable entity] 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, Progenity the U.S. Healthcare Supply DMEPOS Companies 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity UHS employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity UHS department is in compliance with applicable Federal health care program requirements and requirements, with the obligations of this CIA, and with professionally recognized standards of healthcare. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; , President, Chief Financial Officer; , Senior Vice Presidents of the Behavioral Health Division, and at each Facility, the Facility’s Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Executive Officer. 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 departmentUHS division, department or facility], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of departmentUHS division, department or facility] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Progenity UHS policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of departmentUHS division, department or facility] of Progenity is in compliance with all applicable Federal health care program requirements 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, Progenity UHS 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement (Universal Health Services Inc)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Envision employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity 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: 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 Commercial Financial Officer; , Chief Scientific Officer; Chief Medical OfficerOperating Office for Envision Physician Services; and Chief Information Officer(iii) President, Executive Vice Presidents, Senior Vice Presidents, Regional Medical Directors, and Site Envision Corporate Integrity Agreement 6 Medical Directors for Envision Physician Services’ Emergency Medicine, Hospitalist, and Critical Care Service 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 Progenity Envision policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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. Within 90 days after the Effective Date, Progenity 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement (Envision Healthcare Corp)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Rehab employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Rehab 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, the following: Chief Executive Officer; Chief Financial Officer; President, National Sales Director, Chief Operating Officer; Chief Commercial , Director of Complex Rehab, Insurance and Reimbursement Manager, Compliance Officer; Chief Scientific Officer; Chief Medical Officer; , Director of Human Resources, and Chief Information Financial Officer. 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 Progenity Rehab policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [insert name of department] of Progenity Rehab 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, Progenity 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement, Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity employees of CCH (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity CCH Group or CCH of New York 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, the followingindividuals who serve in the following capacities for CCH Group or CCH of New York: the Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Quality Officer; Chief Scientific Officer; Chief Medical Officerany other Covered Person who is an officer or director; and Chief Information Officerany Program Director, Clinical Director, or Medical Director. 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 Progenity CCH policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [insert name of department] of Progenity CCH Group [or CCH of New York] 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, Progenity CCH Group and CCH of New York shall develop and implement a written process for their respective 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).

Appears in 2 contracts

Sources: Corporate Integrity Agreement (Amedisys Inc), Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity ▇▇▇▇▇ employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity ▇▇▇▇▇ 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, the following: the Chief Executive Officer; , the Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , the Senior Vice President of Operations, any employee with the title Product Manager, and Chief Information Officerany other employees of ▇▇▇▇▇ with a title of Vice President or higher, including, but not limited, to Area Vice Presidents. 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 Progenity ▇▇▇▇▇ policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity ▇▇▇▇▇ 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, Progenity ▇▇▇▇▇ 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Lundbeck employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Lundbeck division or business unit 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific OfficerVice President, Market Access; Chief Medical Officer; Vice President, U.S. Medical, Vice President, Public Affairs, and Chief Information Officer. Vice President, Business Effectiveness 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 Progenity Lundbeck 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 Progenity Lundbeck 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 90 120 days after the Effective Date, Progenity Lundbeck 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Sava employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Sava 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, the following: Chief Executive Officer; , Chief Operating Officer, Chief Financial Officer; , Chief Operating Integrity Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and , Chief Information Officer, Senior Vice Presidents of Care Management, Senior Vice Presidents of Clinical Operations and Division Presidents. 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 Progenity Sava policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Sava 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, Progenity SavaSeniorCare Administrative and Consulting, LLC, 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-sub- certifications that must be obtained, etc. ., prior to the Certifying Employee making the required certification).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Jazz employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Jazz division or business unit 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, the following: Chief Executive OfficerBusiness Unit Head, Sleep; Chief Financial OfficerBusiness Unit Head, Hematology and Oncology; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical OfficerVice President, Market Access; and Chief Information OfficerVice President, Corporate Affairs and Government Relations. 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 Progenity Jazz 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 Progenity Jazz 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 90 120 days after the Effective Date, Progenity Jazz 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement (Jazz Pharmaceuticals PLC)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Northwell employees with their primary worksites at Lenox Hill (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Lenox Hill 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, the following: Chief Executive Officer; Director, Regional Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief , and Medical Officer; and Chief Information OfficerDirector. 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 Progenity Lenox Hill Hospital’s policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Lenox Hill Hospital 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, Progenity ▇▇▇▇▇▇▇▇▇ 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity CareMed employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity CareMed 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, the following: Chief Executive Officer; , Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , Senior Vice President of Sales and Chief Information OfficerMarketing, Director of Training, Intake Coordinator, Senior Clinical Registered Pharmacist, Claims Processing Manager, Coding and Billing Managers, and Director of the Call Center (Patient Referrals and Orders). 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] _______________ department with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Progenity CareMed policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [insert name _______________ department of department] of Progenity CareMed 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 90 120 days after the Effective Date, Progenity CareMed 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement (PharMerica CORP)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity TPRC employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity TPRC 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, the following: Chief Executive Officer; Chief Financial Officer; Officer Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. Officer Vice President of Operations 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 Progenity TPRC policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity TPRC 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, Progenity TPRC 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity GSMC employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity GSMC department is in compliance with applicable Federal health care program requirements and with the obligations requirements of this CIA. These Certifying Employees shall include, at a minimum, the following: (1) the Vice President of Patient Care Services and Chief Executive Nursing Officer; (2) the Chief Medical Officer; (3) the Human Resources Director; (4) the Chief Financial Officer; and (5) the Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. 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 including the requirements of 42 U.S.C. § 1320a-7b(b) (Anti-Kickback Statute) and the ▇▇▇▇▇ Law, and the regulations and other guidance documents related to these statutes, requirements of the Corporate Integrity Agreement, and Progenity GSMC’s policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity GSMC is in compliance with all applicable Federal health care program requirements, including the requirements of 42 U.S.C. § 1320a-7b(b) (Anti-Kickback Statute) and the obligations ▇▇▇▇▇ Law, and the regulations and other guidance documents related to these statutes, and the requirements 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. above.‌‌ Within 90 days after the Effective Date, Progenity GSMC 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Life Spine employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Life Spine 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: the Chief Executive Officer; the Chief Operating Officer; the Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officerthe Senior Vice President of Sales and Marketing. 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 Progenity Life Spine, Inc.’s policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Life Spine, Inc. 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 90 120 days after the Effective Date, Progenity Life Spine 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity RMS employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity RMS department 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: Chief Executive Officer; Chief Financial Officer; Chief Operating OfficerVice President of Operations; Chief Commercial OfficerDirector of Marketing; Chief Scientific Officer; Chief Medical Officer; and Chief Information OfficerHead of Sales for Dermatology. 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 Progenity RMS policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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, Progenity RMS 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).certification).‌‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Hebrew Homes employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Hebrew Homes 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; all members of senior management, and Chief Information Officeroperations leaders of all divisions, business units and/or departments with operations that relate to the Federal health care programs. 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 Progenity Hebrew Homes’ policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Hebrew Homes 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 90 120 days after the Effective Date, Progenity Hebrew Homes 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Greenway employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity 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 with 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; , the Chief Operating Operations Officer; Chief Commercial Officer; Chief Scientific 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 Chief Information Officerproduct management, and the lead individual responsible for Patient Safety Issues and Certification 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 Progenity 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 Progenity 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. Within 90 days after the Effective Date, Progenity 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).above.‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity CRMC employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity CRMC 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Financial Officer; Chief Scientific OfficerMedical Staff President; Chief Medical OfficerLegal Counsel; and Chief Information Nursing Officer. 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 Progenity CRMC policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity CRMC 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, Progenity CRMC 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity HealthNet employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity HealthNet 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, the following: Chief Executive Officer; , Chief Financial Officer; , Chief Operating Quality Officer; , Chief Commercial Compliance Officer; Chief Scientific Officer; , Chief Medical Officer; , Associate Medical Director, Chief Operations Officer, Chief Development and Chief Information Communications Officer. 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 Progenity HealthNet policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity HealthNet 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, Progenity 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity PharMerica employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity PharMerica 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, the following: Chief Executive Officer; , Chief Financial Officer; , Senior Vice President of Business Development, Senior Vice President of Sales and Client Services, Executive Vice President of Pharmacy Operations, Chief Operating Pharmacy Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , and Chief Information Officerthe Vice Presidents of Operations. 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 functional responsibility or name of department, as applicable], 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 and Controlled Substances Act requirements, obligations of the Corporate Integrity Agreement, and Progenity PharMerica policies, and I have taken steps to promote such compliance. Option 1 Use if a potential issue is identified: I have identified potential issues of noncompliance with these requirements and I have referred those issues consistent with PharMerica’s processes for reporting potential misconduct for further review and follow-up, including at a minimum to the Compliance Department. To Apart from those referred issues, I am not currently aware of any violations of the best of my knowledge, the [insert name of department] of Progenity is in compliance with all applicable Federal health care program and Controlled Substance Act requirements and or the obligations of the Corporate Integrity AgreementCIA. I understand that this certification is being provided to and relied upon by the United States.” Option 2 – Use if no potential issue is identified: I have not identified potential issues of noncompliance with these requirements and have therefore not referred such issues for further review and follow-up. I am not currently aware of any violations of Federal health care program and Controlled Substance Act requirements or the obligations of the CIA. 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, Progenity PharMerica 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Mallinckrodt employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Mallinckrodt division or business unit 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, the following: Chief Executive Officer; Vice President & Chief Financial Officer; Vice President, Government Affairs & Patient Advocacy; Senior Director, Patient Services and Reimbursement; Executive Vice-President and Chief Operating Commercial & Operations Officer; Chief Commercial Officer; Executive Vice President and Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. 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 Progenity 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 Progenity 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, Progenity 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Insys employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Insys 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 leaders of all business units/divisions that perform Covered Functions, including the following: Chief Vice President (VP) – Corporate Development and Strategy; Senior VP – Research & Development & Regulatory; Executive OfficerDirector of Commercial; Chief Financial OfficerVP, Clinical Development; Chief Operating OfficerExecutive Director of Sales; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and, to the extent that a business unit or division performs Covered Functions and Chief Information Officer. is not covered by the certification of one of the above-listed individuals, other such executives, vice-presidents, and directors of business units or divisions as would be necessary to ensure that there is a Certifying Employee from each such business unit or 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 the department] with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and Progenity Insys policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Insys 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 90 120 days after the Effective Date, Progenity Insys 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity APM, Park Center, and ▇▇▇▇▇▇ employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity APM or, Park Center 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief following:‌  Principal(s)  Vice President(s) of Human Resources  Clinical and Nurse Manager(s)  Billing Director(s)  Operations Director(s)  IT Director(s)  Lab Director(s)  Compliance Coordinator(s)  Front Office Supervisor(s)  Medical Officer; Records Supervisor(s)  Payroll and Chief Information Officer. Benefits Manager(s)  Facilities Manager 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 Progenity [APM or Park Center] policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity [APM or Park Center] 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, Progenity 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Flower Mound employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Flower Mound department is in compliance with applicable Federal health care program requirements and with the obligations requirements of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; Chief Financial Officer; , Chief Operating of Medical Staff, THP’s Group Financial Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , and Chief Information OfficerTHR’s Hospital Channel COO. 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 the [insert name of department] with all applicable Federal health care program requirements, obligations requirements of the Corporate Integrity Agreement, and Progenity Flower Mound policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Flower Mound is in compliance with all applicable Federal health care program requirements and the obligations requirements 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, Progenity Flower Mound 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Amgen employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Amgen division or business unit 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, the following: Chief Executive OfficerVice President (EVP), Global Commercial Operations; Chief Financial OfficerSenior Vice President (SVP), Corporate Affairs; Chief Operating OfficerSVP, Global Strategy, Commercialization, and Innovation; Chief Commercial OfficerSVP, General Manager (GM), U.S. General Medicine; Chief Scientific OfficerVice President (VP), GM, U.S. Oncology Business Unit; Chief Medical OfficerVP, GM, U.S. Inflammation and Nephrology Business Unit; VP, GM, Neurology Business Unit; VP, GM Bone and Cardiovascular Business Unit; and Chief Information OfficerVP, Value & Access. 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 Progenity Amgen 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 Progenity Amgen 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 90 120 days after the Effective Date, Progenity Amgen 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity CHN employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity CHN 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, the following: President and Chief Executive Officer; , Regional Presidents, Chief Financial Officer; , Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , and Chief Information Officerall other members of senior management and the leaders of all business units, divisions or departments with operations that relate to the requirements of this CIA and the CHN operations described herein. 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 Progenity CHN policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [insert name of department] of Progenity CHN 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, Progenity CHN 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity ION employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity ION 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, the following: Chief Executive Officer; , President, Chief Operating Officer, Chief Development Officer, Chief Financial Officer; Chief Operating , Director of Compliance, Arrangements Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , Director of Operations, Director of Business Development, Vice President of Revenue Cycle, Billing and Chief Information OfficerCollections Manager, and Controller. 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 Progenity ION policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity ION 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. Additionally, for each Reporting Period, the Chief Executive Officer, Chief Operating Officer, Director of Compliance, and Arrangements Officer shall include in his/her certification the following statements in addition to the above language for all Certifying Employees: “My responsibilities include ensuring that ▇▇▇’s Arrangements (as that term is defined in the Corporate Integrity Agreement), and the manner in which ION negotiates, implements, and enforces its Arrangements, and performs under its Arrangements, comply with all applicable Federal health care program requirements, including the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and the ▇▇▇▇▇ Law (42 U.S.C. § 1395nn). During the current Reporting Period, I have monitored the negotiation, implementation, and enforcement of, and performance under, ▇▇▇’s Arrangements on behalf of ION. I have taken steps to ensure that ▇▇▇’s Arrangements and the manner in which ION negotiates, implements, and enforces, and performs under its Arrangements comply with all applicable Federal health care program requirements. During the current Reporting Period, I have taken steps and exercised due diligence to ensure that: (1) The terms of every ION Physician-Investor’s investment do not take into account the volume or value of that ION Physician-Investor’s referrals to ION, any Health Care Provider, any Cancer Center, or any individual or entity with which ▇▇▇ has a Leasing Arrangement, Management Arrangement, or Ownership Arrangement; (2) ION does not use any means to pressure or influence ION Physician- Investors to refer or influence referrals to ION, any Health Care Provider, any Cancer Center, or any individual or entity with which ION has a Leasing Arrangement, Management Arrangement, or Ownership Arrangement; (3) ▇▇▇ has no role in medical decision-making related to individual patients of ION Physician-Investors or individual patients of any Health Care Provider or Cancer Center, including, but not limited to, not recommending treatments, procedures, or other medical courses of action related to individual patients; (4) ION does not provide to any ION Physician-Investor information about the volume or value of any other ION Physician-Investor’s referrals to ION or to any entity with which ION has a Leasing Arrangement, Management Arrangement, or Ownership Arrangement; (5) ▇▇▇ has implemented policies and procedures to ensure that ION does not engage in the conduct described in (1) through (4), above, and Covered Persons have been trained on their individual and collective obligation to comply with these policies and procedures; (6) All ION Leasing Arrangements: (a) have rates fixed in advance; (b) are at fair market value; (c) do not include “Additional Time Blocks” or additional payments or compensation that vary with the value or volume of referrals or the value or volume of any item or service for which payment may be made in whole or in part under a Federal health care program; and (d) do not function in a manner that takes into account the value or volume of items, services, or referrals generated by ION or ION Physician-Investors; (7) The rental amounts, fees, charges, compensation, or other payment amounts enumerated in all Leasing Arrangements and Management Arrangements are supported by and consistent with fair market valuation reports conducted by independent, objective, and qualified individuals or entities with fair market valuation expertise, in accordance with requirements of Section III.E, below; (8) All Ownership Agreements or other agreements between ION and ION Physician-Investors do not include, or were amended within 60 days of the Effective Date so that they do not include, any explicit or implicit provision that ties an ION Physician-Investor’s qualification to be an investor to the ION Physician-Investor’s ability to refer or induce referrals to any entity with which ION has a Leasing Arrangement or Management Arrangement, including, but not limited to, provisions that strip an ION Physician-Investor of ownership or reduce their ownership interest in the event that the ION Physician- Investor moves out of the geographic area of the Leasing Company in which they are invested or no longer practices medicine; (9) ▇▇▇ has made reasonable efforts to diversify the ownership of each Leasing Company to decrease the percentage of investors who are Health Care Providers in a position to make referrals to a Cancer Center and to decrease the percentage of referrals or business generated by investors in the Leasing Company; and (10) ▇.▇. ▇▇▇▇▇▇▇▇▇▇ is neither an employee or officer of ION and he did not participate in the management of ION in such capacities and, other than in his capacity as (i) a member of SightLine Health, LLC or (ii) a director of SightLine Health, LLC in which capacity ▇.▇. ▇▇▇▇▇▇▇▇▇▇ does not exert affirmative control of SightLine Health, LLC, ▇.▇. ▇▇▇▇▇▇▇▇▇▇ was not entitled to participate in an advisory, management, or decision-making role with ▇▇▇. I understand that ▇▇▇ has a duty to comply with the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the ▇▇▇▇▇ Law (42 U.S.C. § 1395nn), the regulations, and other guidance documents related to these statutes, and other Federal law independent of the obligations and responsibilities described in the above certification. I further understand that the above certification is not an exclusive list of actions that ION must undertake to comply with the Anti-Kickback Statute, ▇▇▇▇▇ Law, and other Federal laws. To the best of my knowledge, I believe that ▇▇▇ has complied at all times during the Reporting Period with the Anti-Kickback Statute, ▇▇▇▇▇ Law, and other Federal laws. Furthermore, I understand that this certification is being provided to and relied upon by the United States.” If the Chief Executive Officer, Chief Operating Officer, Director of Compliance, or Arrangements Officer is unable to provide such a certification the Chief Executive Officer, Chief Operating Officer, Director of Compliance, or Arrangements Officer shall provide a written explanation of the reasons why he/she is unable to provide the certification outlined above. Within 90 days after the Effective Date, Progenity ION shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification certifications required by this section 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Providence employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Providence department is in compliance with applicable Federal health care program requirements and requirements, with the obligations requirements of this CIA, and with professionally recognized standards of healthcare and patient safety. These Certifying Employees shall include, at a minimum, the following: Providence’s Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; , Chief Medical Officer; Officers, and Chief Information OfficerNursing Officers. 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 requirements of the Corporate Integrity Agreement, and Progenity Providence policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Providence is in compliance with all applicable Federal health care program requirements, the requirements and the obligations of the Corporate Integrity Agreement, and all professionally recognized standards of care and patient safety. 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 he/she/they is/are unable to provide the certification outlined above. Within 90 days after the Effective Date, Progenity Providence 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Essilor employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Essilor business unit is in compliance with applicable Federal health care program and FDA requirements and with the obligations requirements of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; President of Essilor North America, President of Distributor Channels, Chief Financial Officer; , Chief Operating Marketing Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , Senior Vice President of Customer Development, and Chief Information OfficerSenior Vice President of Sales. 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, obligations FDA requirements, requirements of the Corporate Integrity Agreement, and Progenity Essilor policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity is in compliance Essilor complies with all applicable Federal health care program requirements requirements, FDA requirements, and the obligations requirements 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 90 120 days after the Effective Date, Progenity Essilor 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).certification).‌‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Sandoz employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Sandoz division or business unit 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, the following: Chief Executive OfficerVice President, CFO; Chief Financial OfficerVice President, Revenue Finance; Chief Operating Officer; Vice President, Chief Commercial OfficerOfficer U.S.; Chief Scientific Officer; Chief Medical OfficerVice President People & Organization; and Chief Information OfficerExecutive Director, Contracts and Pricing. 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 Progenity Sandoz 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 Progenity Sandoz 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, Progenity Sandoz 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Cordant employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Cordant 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, the following: • President • Chief Executive Officer; Officer • Chief Human Resources Officer • Chief Financial Officer; Officer • Chief Operating Officer; of Staff • Chief Commercial Officer; Information Officer • All Senior Vice Presidents • All General Managers • Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. Technical Officer 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 Progenity Cordant policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Cordant 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, Progenity Cordant 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA Agreement for all Covered Persons, certain Progenity LDH employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity LDH department is in compliance with applicable Federal health care program requirements and with the obligations of this CIAAgreement. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; members of Leadership and Chief Information Officerthe managers of LDH’s Office of Management and Finance, Bureau of Health Services Financing, and Division of Fiscal 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 Progenity LDH policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity LDH 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, Progenity LDH 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).certification).‌

Appears in 1 contract

Sources: State Agency Compliance Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Respironics employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Respironics business unit is in compliance with applicable Federal health care program requirements and with the obligations requirements of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive OfficerBusiness Leader, Sleep & Respiratory Care (SRC); Chief Financial OfficerNational Business Leader, SRC; Chief Operating OfficerSenior Director – Marketing; Chief Commercial OfficerGlobal Marketing Leader; Chief Scientific OfficerBusiness Sales Leader, Sleep and Home Respiratory; Chief Medical OfficerCustomer Solutions Leader; and Chief Information OfficerDirector of Clinical Affairs. 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, obligations requirements of the Corporate Integrity Agreement, and Progenity Respironics policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity is in compliance Respironics complies with all applicable Federal health care program requirements requirements, and the obligations requirements 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, Progenity Respironics 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).certification).‌‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Vibra employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Vibra 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, the following: following employees (or their functional equivalents): Chief Executive Officer; Chief Information Officer; Chief Strategy Officer; Chief Financial Officer; Chief Operating Administrative Officer; Chief Commercial OfficerEVP, Business Development and Strategic Market Expansion; Chief Scientific OfficerEVP, Clinical Operations; Division Senior Vice Presidents; EVP, Chief Medical Officer; Division Presidents; SVP, New Market Development; EVP, Case Management; and facility Chief Information OfficerExecutive Officers. 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 Progenity Vibra policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Vibra 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, Progenity Vibra 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity CSI employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity CSI department is in compliance with applicable Federal health care program requirements requirements, FDA requirements, and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President, Chief Executive Officer; , Chief Financial Officer; , the principal Human Resources executive, Chief Operating Officer; Chief Commercial , General Counsel, Compliance Officer; Chief Scientific Officer; Chief Medical Officer; , Senior Vice President of Operations, and Chief Information Officerall Senior Vice Presidents, Vice Presidents, and Senior Directors. 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, FDA requirements, obligations of the Corporate Integrity Agreement, and Progenity CSI policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity CSI 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, Progenity CSI 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement (Cardiovascular Systems Inc)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity employees (The Certifying Employees) are specifically expected to Employees shall monitor and oversee activities compliance within their areas of authority the divisions or departments for which they are responsible and shall annually certify that the applicable Progenity BioReference division or department is in compliance with applicable Federal health care program requirements and with the obligations requirements of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. For each Reporting Period, each Certifying Employee shall sign a certification that statescertify as follows: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of division or department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of division or department] ]’s compliance with all applicable Federal health care program requirements, obligations requirements of the Corporate Integrity Agreement, and Progenity policies, BioReference’s policies and I have taken steps to promote such complianceprocedures. To the best of my knowledge, the [insert name of division or department] of Progenity is in compliance with all applicable Federal health care program requirements and the obligations requirements 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 this certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined abovecertification. Within 90 days after the Effective Date, Progenity BioReference 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Avanti employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Avanti 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, the followingfollowing for Gardena Hospital, L.P.: Chief Executive Officer; , Chief Financial Officer; , Patient Care Services Director/Manager, Chief Operating Nursing Officer; , and Associate Administrator. These Certifying Employees shall also include, at a minimum, the following for Avanti Hospitals, LLC: Chief Commercial Executive Officer; , Chief Scientific Financial Officer; , Chief Medical Officer; , and Chief Information Compliance Officer. 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 Progenity Avanti policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Avanti 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 Within 90 days after the Effective Date, Progenity Avanti shall develop and implement a written process for Certifying Employees policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Avanti's compliance with Federal health care program requirements (Policies and Procedures). The Policies and Procedures also shall address:‌ a. 42 U.S.C. § 1320a-7b(b) (Anti-Kickback Statute) and the ▇▇▇▇▇ Law, and the regulations and other guidance documents related to follow for these statutes, and business or financial arrangements or contracts that generate unlawful Federal health care program business in violation of the purpose Anti­‌ Kickback Statute or the ▇▇▇▇▇ Law; and b. the requirements set forth in Section III.D(Compliance with the Anti-Kickback Statute and ▇▇▇▇▇ Law).‌ The Policies and Procedures shall be made available to all Covered Persons. Throughout the term of completing this CIA, Avanti shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the certification required by this section performance of all employees. At least annually (e.g.and more frequently, reports that must if appropriate), Avanti shall assess and update, as necessary, the Policies and Procedures. Any revised or new Policies and Procedures shall be reviewed, assessments that must made available to all Covered Persons. All Policies and Procedures shall be completed, sub-certifications that must be obtained, etc. prior made available to the Certifying Employee making the required certification)OIG upon request. C. Training and Education

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Health Quest employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Health Quest 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, the following: President/Chief Executive Officer; , Chief Operations Officer, Chief Medical Operations Officer, Chief Financial Officer; , Chief Operating Administrative Officer; , Chief Commercial Compliance Officer; , Chief Scientific Information Officer; Chief Medical Officer; , and Chief Information Human Resources Officer. 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 Progenity Health Quest policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Health Quest 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 90 120 days after the Effective Date, Progenity Health Quest 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Memorial Health employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Memorial Health 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, the following: Chief Executive Officer; Chief Financial Officer; , Chief Operating Officer; , Chief Commercial Nursing Officer; Chief Scientific Officer; , Chief Medical Officer; , Vice President of Finance, and Chief Information OfficerVice President of Revenue Cycle and Physician Services. 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 Progenity Memorial Health policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Memorial Health 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 90 120 days after the Effective Date, Progenity Memorial Health 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Walgreens employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Walgreens 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, the following: Chief Executive OfficerSenior Vice President, Pharmacy; Senior Vice President, Pharmacy and Retail Operations; Senior Vice President, Operations; Senior Vice President, Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical OfficerOfficer Retail Pharmacy; and Senior Vice President, Chief Information Human Resources Officer. 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 Progenity Walgreens policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Walgreens 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, Progenity Walgreens 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity SUN employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department SUN 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: Chief Executive Officer; Chief Financial Officer; , Chief Operating Compliance Officer; Chief , business unit leader of Specialty Dermatology I, head of Medical Affairs, and head of Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information OfficerOperations. 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 Progenity Sun Pharmaceutical Industries policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity [Sun Pharmaceutical Industries, Inc. or DUSA Pharmaceuticals, Inc.] 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.” SUN Corporate Integrity Agreement 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, Progenity SUN 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Taro employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Taro division or business unit 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical OfficerHead of U.S. Generics, Rx; and Chief Information OfficerDirector, Pricing, Contracts, and Chargebacks. 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 Progenity Taro 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 Progenity Taro 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, Progenity Taro 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Apria employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Apria 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Compliance Officer; Chief Commercial OfficerVP of Billing and Reimbursement; Chief Scientific OfficerExecutive Vice President, Division President – East Division; Chief Medical OfficerExecutive Vice President, Division President – West Division; and Chief Information OfficerExecutive Vice President, Division President – Central Division. For each Reporting Period, each Certifying Employee shall sign a certification that states: Apria - Corporate Integrity Agreement “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 Progenity Apria policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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, Progenity 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement (Apria, Inc.)

Management Certifications. In addition to The Certifying Covered Persons shall monitor compliance within the responsibilities set forth in this CIA divisions or departments for all Covered Persons, certain Progenity employees (Certifying Employees) which they are specifically expected to monitor responsible and oversee activities within their areas of authority and shall annually certify that the applicable Progenity McKinsey division or department is in compliance with applicable Federal health care program requirements, Regulated Industry Requirements, and the requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer. For each Reporting Period, each Certifying Employee Covered Person shall sign a certification that statescertify as follows: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of division or department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of division or department] ]’s compliance with all applicable Federal health care program requirements, obligations of the Regulated Industry Requirements, Corporate Integrity AgreementAgreement requirements, and Progenity policies, McKinsey’s policies and I have taken steps to promote such complianceprocedures. To the best of my knowledge, the [insert name of division or department] of Progenity is in compliance with all applicable Federal health care program requirements requirements, Regulated Industry Requirements, and the obligations of the Corporate Integrity AgreementAgreement requirements. I understand that this certification is being provided to and relied upon by the United States.” If any Certifying Employee Covered Person is unable to provide such a this certification, the Certifying Employee Covered Person shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined abovecertification. Within 90 days after the Effective Date, Progenity ▇▇▇▇▇▇▇▇ shall develop and implement a written process for Certifying Employees Covered Persons 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 Covered Person making the required certification).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity 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 Progenity 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; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical OfficerOfficer (AveXis); and Chief Information OfficerAAA 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 Progenity Novartis policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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 90 120 days after the Effective Date, Progenity Novartis 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity VITAS employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity VITAS 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, the following: Chief Executive Officer; , President, Chief Financial Officer; , Chief Operating Officer; , Chief Commercial Information Officer; , Chief Scientific Compliance Officer; , all Senior Vice Presidents with operations field responsibility, National Medical Director, Chief Medical Officer; Officer and Chief Information Nursing Officer. 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 Progenity VITAS policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity VITAS 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." Vitas Corporate Integrity Agreement 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, Progenity VITAS 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement (Chemed Corp)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Pfizer employees (Certifying Employees) are specifically expected to monitor supervise and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Pfizer business unit is in compliance compliant with applicable Federal health care program requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive OfficerVice President, Corporate Responsibility; Chief Financial OfficerRegional President North America, Vaccines; Chief Operating OfficerRegional President North America, Oncology; Chief Commercial OfficerRegional President North America, Inflammation & Immunology; Chief Scientific OfficerRegional President North America, Rare Disease; Chief Medical OfficerRegional President North America, Internal Medicine; US President, Retail; US President, Institutions; and Chief Information OfficerVice President, US Payer Channel & Access Lead. 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 Progenity Pfizer 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 Progenity Pfizer 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 90 120 days after the Effective Date, Progenity Pfizer 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity USWM employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department USWM 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 followingall relevant business units/divisions that perform Covered Functions, including: Chief Executive OfficerSenior Vice President; Chief Financial OfficerManager, Sales Operations; Chief Operating OfficerDirector, Marketing; Chief Commercial OfficerDirector, Brand Management; Chief Scientific Officer; Chief Medical OfficerNational Sales Director; and Chief Information OfficerSenior Director, Quality. 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 Corporate Integrity Agreement – USWM of the Corporate Integrity Agreement, and Progenity USWM policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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 90 120 days after the Effective Date, Progenity USWM 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity IHS employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity IHS 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, the following: the Chairman and Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information OfficerExecutive Vice President of Physician Services. 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 Progenity IHS policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [insert name of department] of Progenity IHS 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, Progenity IHS shall develop and implement a written process for Certifying Employees to follow for the purpose of in connection with completing the certification certifications 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Prime employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Prime 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, the following: ▇▇▇▇ ▇▇▇▇▇, M.D. (Chairman, President and CEO of Prime Healthcare Services, Inc.); Chair of the Board of Prime Healthcare Foundation, Inc.; all Corporate Regional Chief Executive OfficerOfficers; all Corporate and Regional Chief Medical Officers; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical OfficerVice President(s) of Clinical Integration or Coding; and Chief Information OfficerVice President of Human Resources. 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 the [insert name of department] with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Progenity Prime policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Prime 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, Progenity Prime 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Merit employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Merit 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: Chief Executive Officer; the Chief Financial Officer; , the Executive Vice President – Commercial, the Chief Operating Regulatory Affairs Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; , and Chief Information Officerthe Vice President – US Sales. 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 Progenity Merit policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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 90 days after the Effective Date, Progenity Merit 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity ResMed employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity ResMed 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, the following: Chief Executive Officer; President of Sleep Business, President of Respiratory Care Business, Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; and Chief Information Officer, Vice President of Sales Management, Vice President of Operations, Vice President of Marketing, Vice President of Corporate Compliance. 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 Progenity ResMed policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity ResMed 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. above.‌ Within 90 days after the Effective Date, Progenity ResMed 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Mercy or MHM employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Mercy 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, the following: Chief Executive Officer; the President, the Chief Financial Officer; , the Chief Operating Officer; , and the Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; Physician Officer of each of Mercy Hospital Springfield and Chief Information OfficerMercy Clinic Springfield Communities. 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 Progenity Mercy policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described in this certification, the [insert name of department] of Progenity Mercy 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. above.‌‌ Within 90 days after the Effective Date, Progenity Mercy 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Apria employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Apria 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, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Compliance Officer; Chief Commercial OfficerVP of Billing and Reimbursement; Chief Scientific OfficerExecutive Vice President, Division President – East Division; Chief Medical OfficerExecutive Vice President, Division President – West Division; and Chief Information OfficerExecutive 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 Progenity Apria policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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, Progenity 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Astellas employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Astellas division or business unit 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, the following: Chief Executive OfficerSenior Vice President, Oncology Sales & Marketing (APUS); Chief Financial OfficerSenior Vice President, Urology & Hospital Sales & Marketing (APUS); Chief Operating OfficerSenior Vice President Health Systems (APUS); Chief Vice President, Commercial OfficerOperations; Chief Scientific OfficerVice President, Corporate Communications (AUS); Chief Medical OfficerVice President, US Regulatory (APGD); and Chief Information OfficerSenior 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 Progenity 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 Progenity 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 90 120 days after the Effective Date, Progenity 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Avanir employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity department Avanir 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: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; the Chief Medical Officer; Senior Vice President (SVP), Sales & Marketing; Vice President, Regulatory; Director, Procurement; and Chief Information OfficerSVP, Commercial Operations. 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 Progenity Avanir policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity 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, Progenity Avanir 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).certification).‌

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity GIS Parties employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity GIS Party’s 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, include the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief the GIS Medical Officer; Director, the GIS Secretary, the GIS Managing Partner, the GIS Practice Administrator, the GIS Human Resources and Chief Information OfficerPayroll Director, the GIS Accounts Payable Director, the GIS Billing Supervisor, the GIS Clinical Manager, the GIDE and DCAD Managing Partner(s), and the GIDE and DCAD Clinical Director(s). 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 Progenity the GIS Parties’ policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity [GIS/GIDE/DCAD] 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, Progenity 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Hope Hospice employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Hope Hospice 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, the following: Chief Executive Officer; , Chief Financial Officer; , Billing Manager, Chief Operating Human Resources Officer; Chief Commercial Officer; Chief Scientific Officer; , Chief Medical Officer; , and Chief Information Operations Officer. 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 Progenity Hope Hospice policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Hope Hospice 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, Progenity Hope Hospice 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Progenity Radeas employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Progenity Radeas department is in compliance with applicable Federal health care program requirements and with the obligations requirements of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer; Chief Financial Officer; Chief Operating Officer; Chief Commercial Officer; Chief Scientific Officer; Chief Medical Officer; Business Director, President of Sales, Production Director, Business Team Manager, Controller, Vice President of Sales, and Chief Information OfficerDirector of Sales. 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 requirements of the Corporate Integrity Agreement, and Progenity Radeas’s policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of Progenity Radeas is in compliance with all applicable Federal health care program requirements and the obligations requirements 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, Progenity Radeas 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).

Appears in 1 contract

Sources: Corporate Integrity Agreement