Management Certifications Contract Clauses (10)

Management Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain CSI employees (Certifying Employees) are expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable CSI department is in compliance with applicable Federal health care program requirements, FDA requirements, and 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, General Counsel, Compliance Officer, Senior Vice President of Operations, and all Senior Vice Presidents, Vice Presidents, and Senior Directors. For each Reporting Period, each Certifying Employee shall sign a certification that states: Cardiovascular Systems, Inc. Corporate Integrity Agreement5 "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 CSI policies, and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department] of 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, 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). B.Written Standards Within 90 days after the Effective Date, CSI shall develop and implement written policies and procedures regarding the operation of its Compliance Program, including the compliance program requirements outlined in this CIA and CSI's compliance with Federal health care program requirements and FDA requirements (Policies and Procedures). The Policies and Procedures shall, at a minimum, address appropriate ways to conduct Covered Functions in compliance with (i) all applicable Federal healthcare program requirements, including, but not limited to the Federal Anti-Kickback Statute (42 U.S.C. §1320a-7b((b)) and the False Claims Act (31 U.S.C. §§ 3729-3733) and (ii) all applicable FDA requirements. Throughout the term of this CIA, CSI shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element of evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At least annually (and more frequently, if appropriate), CSI shall assess and update, as necessary, the Policies and Procedures. Any new or revised Policies and Procedures shall be made available to all Covered Persons. Cardiovascular Systems, Inc. Corporate Integrity Agreement6 All Policies and Procedures shall be made available to OIG upon request. C.Training and Education 1. Covered Persons Training. Within 90 days after the Effective Date, CSI shall develop a written plan (Training Plan) that outlines the steps CSI will take to ensure that all Covered Persons receive at least annual training regarding CSI's CIA requirements and Compliance Program, the applicable Federal health care program requirements, including but not limited to the requirements of the Anti-Kickback Statute and the Stark Law, and FDA requirements. The Training Plan shall include information regarding the following: training topics, categories of Covered Persons required to attend each training session, length of the training session(s), schedule for training, and format of the training. CSI shall furnish training to its Covered Persons pursuant to the Training Plan during each Reporting Period. View More