Surgalign’s Corporate Compliance program is integral to bringing our values to life and fulfilling our customer and patient promise by helping ensure we conduct all business activities with integrity and in accordance with applicable guidelines, rules, and regulations.
Message from our Chairman, President and CEO
At Surgalign, our commitment to developing innovative products and services comes with a responsibility to do what is right for the healthcare provider community and their patients. Our values are ingrained in the mindset of each of our team members, representatives, and executives. The foundation of these values is in our Code of Conduct, which guides every action we take with our employees, healthcare customers, their patients, and the communities in which we live and work. Our Code of Conduct provides the foundation for everything we do. Nothing is more essential to our success than doing the right thing.
Our Commitment to Compliance and Ethics
Surgalign is committed to the highest standards of ethical and legal conduct. We have developed a Corporate Compliance and Ethics Program [“CCEP”] to help foster a culture that integrates compliance and ethics into business processes and practices. The CCEP is maintained in the framework of the 2003 OIG Guidance Document on an effective compliance program as well as the 2018 United States Sentencing Commission “Sentencing Guidelines” and the 2020 US Department of Justice “Evaluation of Corporate Compliance Programs” document.
The CCEP is designed to ensure that Surgalign is:
- Creating a culture of honesty and integrity
- Operating in accordance with applicable laws and regulations
- Preventing fraud and abuse
- Detecting compliance issues at an early stage
- Assuring prompt corrective action
- Building employee trust and confidence
The above is accomplished through the following mechanisms:
- Written Standards. We have established and implemented a Code of Conduct and Ethics as well as a Compliance Policy that is consistent with the AdvaMed Code and all aspects of regulatory compliance applicable to our industry.
- Leadership and Structure. We have established effective oversight over the Compliance Program, including selection of a Compliance Officer to develop, operate, and monitor the Compliance Program. This Compliance Officer and his staff are integrated into the business. The Compliance Officer reports regularly to the Nom/Gov committee of our Board of Directors on matters relating to compliance. He helps ensure that the compliance program is reasonably designed, implemented, and enforced so that the program is effective in preventing and detecting unlawful conduct and promotes a corporate culture that encourages ethical conduct and a commitment to compliance with the law.
- Training and Education. All employees receive live or virtual compliance training at orientation, annually, and thereafter on an ad hoc basis when new developments or needs arise. Also, all employees and sales agents receive copies of our Code of Conduct and annually certify that they have read, understood, and agree to abide by these written standards.
- Lines of Communication. To facilitate an open-door environment, we have adopted confidentiality and non-retaliation policies as well as mechanisms to facilitate anonymous reporting. To receive a copy of our Whistleblower Policy, please contact: Compliance@Surgalign.com
- Auditing and Monitoring. Our Compliance Program includes ongoing efforts to monitor, audit, and assess compliance. This includes, but is not limited to, an annual review of healthcare provider interactions as part of its CMS Open Payment report. We also conduct risk assessments at established intervals and more frequently when a need arises. Compliance Risk Assessments are presented to senior leadership and the Nominating and Governance Committee of the independent Board of Directors.
- Investigations and Remediation. Surgalign takes commercially reasonable efforts to quickly and thoroughly investigate and appropriately address compliance issues. Following reviews, an assessment of findings is conducted even if the findings ultimately demonstrate that there was not a compliance issue. Appropriate corrective action may include repairing any gaps in our policies and procedures.
- Disciplinary Policy. Surgalign maintains an unambiguous disciplinary policy that is tiered based upon the seriousness of activity conducted and that includes termination if appropriate.
The Advanced Medical Technology Association (AdvaMed) is dedicated to advancing medical technology to achieve healthier lives and healthier economies around the world. Surgalign recognizes that adherence to ethical standards and compliance with applicable laws are critical to our ability to continue collaboration with healthcare providers. Surgalign respects the obligations of healthcare providers to make independent decisions regarding treatment of their patients.
California Certification of Compliance
To the best of our knowledge, Surgalign is in all material respects in compliance with the requirements of California Health and Safety Code §§ 119400-119402, based on our good faith understanding of the statutory provisions as they may apply to a medical device manufacturer.
View the complete Statement of Compliance with California Law below.
Surgalign respects the privacy of its customers, employees, business partners, and individuals whose personal information with which we are entrusted. Surgalign collects and uses any collected personal health information in accordance with the laws and regulations of the countries in which the information is collected, and in which it does business.
If you have specific questions about Surgalign’s adherence to privacy or security rules when processing personal data on behalf of our customers or the use of Surgalign’s products and services when processing personal data, please contact Surgalign’s Data Protection Officer: DPO@surgalign.com.
California Proposition 65
To the best of our knowledge, Surgalign is in all material respects in compliance with California’s Proposition 65 (also called the Safe Drinking Water and Toxic Enforcement Act). To the best of our knowledge, Surgalign is in all material respects in compliance with the Dodd-Frank Wall Street Reform and Consumer Protection Act, Section 1502, regarding conflict minerals.
View the Certification of Compliance – CA Proposition 65 below.
Effective January 1, 2022, to the best of our knowledge, Surgalign Spine Technology, Inc., [Surgalign] and its subsidiaries are in all material respects in compliance with a Compliance Program that satisfies the requirements of California Health and Safety Code §§119400-119402, based on our good faith and understanding of the statutory provisions as they may apply to a medical device manufacturer.
While California Health and Safety Code §§119400-119402 makes reference to compliance with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (“PhRMA Code”), Surgalign manufactures medical devices rather than pharmaceutical products. Therefore, Surgalign has adopted policies and procedures consistent with the AdvaMed Code of Ethics on Interactions with US Healthcare Professionals.
California’s Proposition 65 (also called the Safe Drinking Water and Toxic Enforcement Act) was enacted in 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm. As part of the law, the state is required to publish a list of chemicals that are “known to the State of California to cause cancer or reproductive toxicity.” The list is updated at least once a year and now contains over 850 different chemicals. The complete list can be found on the California Office of Environmental Health Hazard Assessment (OEHHA) website.
Some of the substances listed by OEHHA can affect the reproductive systems of men and/or women. Others are thought to cause cancer. Scientists classify all of these cancer-related substances at least as probable carcinogens, meaning that they might cause cancer in some people. But not all of them are known carcinogens (known to cause cancer) by groups and experts outside the state of California. This means that not every compound labeled as a possible cancer-causing substance has been proven to the worldwide scientific community to actually cause cancer. The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program.
Surgalign adheres to Proposition 65 in all material respects. For example, required signs are posted in common areas such as break rooms, and we use waste and recycling companies that adhere to the standard. Our waste is segregated into recycling bins such as plastics, e-waste, hazardous waste, general disposal, etc.
Discipline & Zero Tolerance for Retaliation
It is the responsibility of every employee who becomes aware of or has reason to suspect activity that is criminal, potentially criminal, or in violation of this Code or Company policies to report such activity to the Company. Failure to make such a report is a violation of these standards and the Company’s employees may be subject to disciplinary action up to and including termination with the Company.
Any form of retaliation against any of the Company’s personnel or business partner representative(s) who reports an actual or potential compliance matter in good faith is strictly prohibited. Any employee who commits or condones any form of retaliation against a person who has reported an alleged violation or who has participated in an investigation will be subject to disciplinary action up to, and including, termination. Any business partner representative of the Company who commits or condones any form of retaliation against a person who has reported an alleged violation or who has participated in an investigation will be subject to disciplinary action up to, and including, disaffiliation with the Company.
Reporting Questions or Concerns
Surgalign consistently strives to deal with stakeholders in the most fair and ethical manner possible. We provide multiple channels for reporting concerns regarding ethical interactions with healthcare professionals and suspected instances of violations of law or improper conduct in the company.
You can report any questions or concerns directly to the Compliance Department via email at: Compliance@surgalign.com
Additionally, persons have the option of reporting through a third-party hotline 24 hours a day 7 days a week. You can elect for your phone call or online submission to be anonymous.
To report a question or concern through the hotline:
Call: 1-855-231-0609 (United States) or 0800 225 5288 (Germany)