Corporate compliance

Spineart 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 implemented 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 send an email to compliance-us@spineart.com.

Spineart 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 send an email to compliance-us@spineart.com.

For More Information

• Data Privacy
• California Consumer Privacy 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
• Royalty payments associated with product development

The information will be posted on CMS’s Open Payments Portal.

For questions related to information reported on you, send an email to compliance-us@spineart.com.

As part of our continued efforts in the area of compliance, we have developed a Comprehensive compliance Program (CCP) that is reasonably
designed to prevent and detect violations of our business principles. To the best of our knowledge, and based on our good faith understanding of the statutory requirements, we have established a CCP compliant with requirements of Chapter 8 to Part 15 of Division 105 of California’s Health and Safety Code. We have developed a CCP tailored to the size, organizational structure and resources of the company, and implemented our CCP to meet the compliance goals set forth by the State of California. We regularly reassess the program to improve it, and it is possible that we will make further adjustments aimed at improving the effectiveness of our CCP in the coming year.

While California Health and Safety Code §§ 119400‐119402 makes reference to compliance with the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals (“PhRMA Code”), Spineart manufactures medical devices rather than pharmaceutical products. Therefore, Spineart determined that it was more appropriate for the company instead to adopt policies and procedures consistent with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”).

Elements of the Spineart Compliance Program

• Written Standards
• Annual Aggregate Promotional Spending Limit of $2,500 that excludes permissible items specified in statute such as educational materials that benefit patients.
• Compliance Program Infrastructure with a Designated Compliance Professional
• Education & Training
• Open, Internal Lines of Communication for the Reporting of Issues
• Auditing & Monitoring
• Corrective Action Procedures