Collaboration with Healthcare Professionals and Healthcare Institutions
CSI collaborates with physicians and teaching hospitals in a variety of ways in the development, clinical use and training on the safe and effective uses of CSI products. Examples include (but are not limited to):
- Working with physicians on new product ideas, improvements to existing products and product strategy;
- Having physicians and teaching hospitals serve as study sites in CSI-sponsored clinical studies (many of which are required by the FDA) to show that our products are safe and effective;
- Funding physician-directed studies designed to collect information regarding our products, peripheral artery disease and coronary artery disease;
- Having experienced physician users of our products educate and train other physicians on how to use our products safely and effectively; andHaving experienced physician users of our products conduct seminars and other educational events about our products, peripheral artery disease and coronary artery disease.
These collaborations may result in payments or “transfers of value” to physicians and teaching hospitals that are reportable to the U.S. government under the “Sunshine Act” (a part of the Affordable Care Act) . Examples of transfers of value include, among other things, travel costs associated with programs that require physician’s travel, meals provided in the course of educational programs or other business meetings, compensation for consulting services, compensation for conducting clinical studies, grants to fund clinical studies and royalty payments.
Open Payments is a U.S. government program that collects information about the payments and other “transfers of value” drug and device companies make to physicians and teaching hospitals under the Sunshine Act. This data is then made available to the public each year at www.cms.gov/openpayments.
To find specific data on payments made by CSI, use the search tool located at https://openpaymentsdata.cms.gov/search#company and enter “Cardiovascular Systems Inc.” as the company name.
Contacts for Reporting Violations
If you believe someone may be unintentionally or intentionally violating the law or the principles or standards included in the Code of Conduct document, report the known or suspected violations by contacting:
Chief Compliance Officer
If you would like to notify the board of directors of a suspected violation, contact the Chairman of the Audit Committee:
Chairman of the Audit Committee
Each report of a known or suspected violation will be promptly and thoroughly investigated. If a violation has occurred, CSI will take appropriate actions to prevent similar violations. The Company strictly prohibits retaliation against Representatives for reports made in good faith. Anyone who retaliates against an employee(s) for reporting actual or suspected violations will be subject to appropriate disciplinary action up to, and including, termination.
As an alternative to the contacts described above, you may use the Company’s Compliance Hotline. The Company’s hotline is designed to encourage you to report any concerns you might have about the way we are conducting our business or to identify any workplace behavior that you believe violates laws or our Company’s Code of Ethics. You may also use this line to submit ideas and suggestions to Company management and/or report any other information you might want to share.
What’s most important to know about the hotline is that it’s available for you to use 24 hours a day and if you prefer, you can have anything you communicate over this system be completely confidential and anonymous. This confidentiality is ensured because an independent company, In Touch, operates the program and, if a caller does not identify him/herself, there’s no way for anyone at the Company to identify who might have called and left a message.
Using the hotline is as simple as dialing, toll free, 1-877-344-2714. You will need to write down a five-digit case number that the automated system will assign to you. It’s important that you copy this number down and store it where you can find it because it’s the only way that the Company will be able to request additional information and keep you posted on the progress of its investigation.
After you have been assigned your case number, you will be asked to record a message of any length. When you’ve finished providing what you have to say, either press # or simply hang-up. Within one business day, the message you left will be transcribed by In Touch and then it will be deleted from the system. Only the written transcript of your call will be sent to representatives of the Company’s management and Board of Directors. That way, unless you elect to leave your name or other identifying information, anything you have to say remains confidential and anonymous.
As you will be reminded by In Touch after you leave a message, you should call back in five business days and be prepared to provide your five-digit case number. When you do that, you will receive a message from the Company about the status of your case.
For those that might be more comfortable providing their information by email, you can do so by sending a message to [email protected] Unless you clearly indicate that you wish to be identified, In Touch will remove your name and email address before forwarding the message to representatives of the Company’s management and Board of Directors. Responses from the company to your emailed message will come from In Touch directly.
Although we always prefer that you first try to resolve any questions or concerns with your supervisor or a Human Resources representative, there may be times when you’re not comfortable doing that or you’re not satisfied with the outcome. That’s when you should consider using the hotline.
Management is committed to providing a safe, respectful and ethical working environment. If at any time you don’t feel that’s the case, we encourage you to use the hotline and let us know. In addition, we want to assure you that there will never be any retaliation against any individual for responsibly reporting a workplace related concern.
Public Disclosure of Code and Waivers
The existence and content of this Code of Ethics and Business Conduct is disclosed to shareholders and made available as part of the Company’s filings with the SEC and is also on the Company’s website. It is expected that waivers of this Code rarely, if ever, would be acceptable. Any waiver of a provision of the Code for executive officers or directors may be granted only by the Board of Directors, with only the independent members voting, or an appropriate Board Committee consisting of independent directors, and such waiver must be promptly disclosed to shareholders.
Coordination with Other CSI Policies
The provisions of this Code of Conduct are in addition to, and do not modify, replace or supersede CSI’s other policies or procedures including, but not limited to, those policies and procedures set forth in any employee handbook, or CSI’s other statements of policy or procedure, whether written or oral. Additionally, this Code of Conduct is not intended to be and does not constitute a contract of employment between CSI and its Representatives. If you are an employee and do not have an Employment Agreement with CSI, you are an employee at-will. This means that you have the option of resigning from your employment at any time, for any reason or no reason, with or without prior notice. Conversely, CSI has the same option to terminate your employment at any time, for any reason or no reason, with or without prior notice.
CSI will periodically reaffirm its commitment to compliance with the Code of Ethics and Business Conduct. CSI intends to conduct periodic training sessions regarding the Code. In addition, CSI will periodically distribute copies of the Code and the Certification of Compliance to remind such persons of the contents of the Code as well as to reestablish their commitment to compliance with it.