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.
The Advanced Medical Technology Association (AdvaMed) is dedicated to advancing medical technology to achieve healthier lives and healthier economies around the world. As an AdvaMed member, Surgalign recognizes that adherence to ethical standards and compliance with applicable laws are critical to the medical device industry’s ability to continue its collaboration with health care professionals.
Members encourage ethical business practices and socially responsible industry conduct related to their interactions with health care professionals. Members also respect the obligation of health care professionals to make independent decisions regarding Member products.
Surgalign adheres to AdvaMed’s voluntary Code of Ethics to facilitate Members’ ethical interactions with those individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Members’ medical technology products in the United States.
As a member of MedTech Europe, Surgalign is committed to ensuring that our collaboration with healthcare professionals adheres to the highest ethical and professional standards. These standards are encompassed in the MedTech Europe Code of Ethical Business Practice, which is intended to provide the minimum ethical standards and principles for the medical technology industry across Europe. It is designed to supplement, but not replace, any national laws or regulations or other professional or business codes which may apply to MedTech Europe members.
Surgalign Spine Technologies Statement on Slavery and Human Trafficking
California Transparency in Supply Chains Act Disclosure
Surgalign Spine Technologies (including its subsidiaries) (“Surgalign”) is strongly opposed to human trafficking and slavery and supports efforts to eradicate such practices. Surgalign would never knowingly conduct business with contractors or suppliers engaged in such practices.
Given the nature of the types of products, implants and services we provide, it is our assessment that our business activities present little risk of promoting human trafficking and slavery. With respect to these issues, the California Transparency in the Supply Chains Act of 2010 (the “Act”) requires certain manufacturers and retailers, including Surgalign, to disclose their efforts to eradicate human trafficking and slavery from their supply chains. The Act requires disclosure in five (5) areas: audits, verification, certification, training, and internal accountability. At this time, Surgalign does not audit or independently verify its product supply chain or its direct suppliers for risks relating to human trafficking or slavery. According to the Surgalign Code of Conduct and our contractual arrangements with suppliers, our suppliers are required to comply with applicable laws and regulations governing their business practices. Failure to comply with these contractual requirements constitutes breach of contract, but there is no separate certification process specifically for slavery and human trafficking. Surgalign has incorporated information on addressing the potential for human trafficking or slavery in its supply chain into our regular training curriculum for employees and management with direct responsibility for supply chain management. The Surgalign Compliance Program provides internal accountability procedures for these issues.
Visit End Human Trafficking Now for more information about trafficking and the global fight to end it.
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 health care professionals and suspected instances of violations of law or improper conduct in the company. The company has duty to report non-retaliation and confidentiality policies to encourage and protect colleagues who raise a valid concern.
Should you have questions or concerns about an ethics and/or compliance issue, or have questions about our compliance program, please contact any of the following:
Surgalign is committed to the protection of the data privacy of individuals, health care providers and institutions and entities with whom we conduct business. We have appropriate administrative and security policies and procedures that comply with U.S. and international privacy and data protection requirements. If you have any questions about your data privacy, please contact [email protected].
Corporate Citizenship – Payments to Physicians
Physician Payments Sunshine Act
The Physician Payments Sunshine regulation (“Sunshine” or “Open Payments”) requires manufacturers of products reimbursed by Medicare or Medicaid (so-called “covered products”) and certain of their affiliates that operate in the United States to annually report to the Centers for Medicare and Medicaid Services (“CMS”) information about payments or other transfers of value they provide to U.S. physicians and teaching hospitals (collectively, “covered recipients”).
Any payment or transfer of value from a manufacturer operating in the United States to a covered recipient must be reported. Some examples are:
- Meals provided both in and out of the physician’s office
- Physician educational items that do not directly benefit the patient, including textbooks and scientific journal reprints
- Payments for speaking engagements
- The information will be posted on CMS’s Enterprise Portal (https://portal.cms.gov/)
For questions related to information reported on you, send an email to [email protected].
The information provided on this page does not constitute legal advice and is intended for educational purposes only. You should consult with your legal counsel for answers to any specific questions you may have. All information on this page is subject to change as a result of a change in law, regulation or guidance from CMS. For the most up-to-date information on Sunshine, please consult the Open Payments section on the CMS website.
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: [email protected]
- 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: [email protected].
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: [email protected]
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)