Compliance

U.S. Compliance

 

Spinal Simplicity is committed to conducting business with strong ethical values and patient well-being at the forefront. Our commitment to ethical conduct and compliance are the foundation of Spinal Simplicity’s business practices.

Spinal Simplicity’s Compliance Program is intended as a guide for employees and others conduct so that Spinal Simplicity may fulfill its obligations to observe federal, state, and local laws and regulations applicable to the business. The standards of conduct described in this Program are intended to define the scope of conduct that the Program covers. The standards of conduct described in this Program offer guidance on Spinal Simplicity’s policies. Spinal Simplicity’s employees are urged to seek the guidance of, or report violations to the Director of Compliance who may be reached at (913) 553-4514. In addition, reports may be made to the Spinal Simplicity Compliance Phonemail Reporting Line (913) 800-8863 at any time. Reports will be treated confidentially to the extent reasonably possible. 

Compliance Complaint Reporting

Spinal Simplicity has established a complaint reporting process for the receipt of compliance-related complaints. If you have a compliance-related concern or complaint, please contact the Director of Compliance at 913-553-4514. In the event a complaint is received, Spinal Simplicity is committed to promptly investigating and taking appropriate corrective action, if necessary, to address the concern and prevent any further problematic conduct.

Business Code of Conduct

Spinal Simplicity is committed to conducting business with strong ethical values and patient well being at the forefront. Our commitment to ethical conduct and compliance are the foundation of Spinal Simplicity’s business practices.

Spinal Simplicity has adopted a Code of Conduct, along with a comprehensive compliance program to facilitate a corporate culture that places the utmost value on ethical, compliant behavior in every aspect of our business. All Spinal Simplicity team members, along with distributors and related parties, are expected to abide by the ethical and legal standards set forth in these policies and programs, as well as abiding by the applicable laws and regulations in every country where we conduct business.

Spinal Simplicity has also adopted and is committed to the principles and practices set forth in the AdvaMed Code of Ethics.

Any questions or concerns regarding Spinal Simplicity’s Compliance Program, including reports of potentially problematic conduct, may be directed to the Company’s Director of Compliance at internalreporting@spinalsimplicity.com or 913-553-4514.

Spinal Simplicity’s Code of Business Conduct provides an overview of the Company’s compliance program requirements which are based on a commitment to ethical business practices and abiding by applicable laws and regulations.

The principles set forth in the Code of Business Conduct are set forth in furtherance of the Company’s Compliance Program. It is expected that every Spinal Simplicity Employee, Contractor, Distributor, Agent, Member, Manager, Officer, and Director engage in business practices that are ethically sound and legally compliant.

By way of example, Spinal Simplicity identifies prohibited conduct below that is not acceptable and would require reporting through the Company’s Compliance Program Reporting Procedure.

  • Actions that could harm Spinal Simplicity’s reputation as an ethical company
  • Creation of financial records that don’t accurately reflect the financial transaction
  • Avoidance of the Company’s standard review and control processes
  • Failure to properly administer Company record retention practices
  • Failure to appropriately carry out job duties as required by law
  • Funds or transactions that have not been reported and/or accurately recorded
  • Transactions that lack the proper supporting documentation
  • Falsification of any reports
  • Engaging in any unethical act to entice a customer, potential customer, or other third party to do business with the Company
  • Acceptance of kickbacks or similar payments
  • Authorization for payment of goods and services not received, or over payment for goods actually received or valid services performed
  • Misuse of Company resources
  • Unauthorized or improper access, misuse, modification, destruction or disclosure of Company data
  • Theft of Company equipment/resources
  • Using “workarounds” or schemes to avoid complying with domestic and/or international rules and regulations or Company policies

Any inappropriate relationship that could create a conflict of interest or potential conflict of interest. Spinal Simplicity’s goal is to set forth the standards for appropriate and ethical business conduct, to monitor compliance with the Company’s Compliance Programs, to respond to reports of unauthorized conduct, and to take actions to address any such conduct and prevent its occurrence in the future.

Physician Payment Sunshine Act Compliance

Medical drug, device, biological, and supply manufacturers operating in the United States are required to track and report all payments and other transfers of anything of value to physicians and teaching hospitals, pursuant to a law passed in 2010 called the Physician Payment Sunshine Act (the “PPSA”). Spinal Simplicity has adopted policies and procedures that are consistent with the requirements of the PPSA to comply with the law. Please contact Compliance at (913) 553-4514 to request a form.

Quality Event Reporting

The Spinal Simplicity Quality Assurance team is committed to promptly responding to all reported product events. If you feel an event* has occurred, please contact Spinal Simplicity immediately by emailing productcomplaints@spinalsimplicity.com, or calling (913) 451-4414.

To facilitate event review, you may wish to download the Field Contact Report form below. Complete and e-mail to productcomplaints@spinalsimplicity.com.

*Alleged deficiency relating to identity, quality, durability, reliability, safety, effectiveness, or performance of a marketed device.

California Comprehensive Compliance Program Declaration

I.         INTRODUCTION

Spinal Simplicity, LLC (“Spinal Simplicity”) is committed to establishing and maintaining an effective compliance program in accordance with the Compliance Program Guidance published by the Office of Inspector General, U.S Department of Health and Human Services (the “HHS-OIG Guidance”).  Our Compliance Program is one of the key components of our commitment to the highest standards of ethical practice.

The purpose of our Compliance Program is to prevent and detect violations of law or company policy.  As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated.  Nonetheless, it is Spinal Simplicity’s expectation that employees will comply with Compliance Program and the policies established in support of the Compliance Program.  In the event that Spinal Simplicity becomes aware of potential violations of law or company policy, the company will, where appropriate, investigate the matter and take disciplinary action and implement corrective measures to prevent future violations.

Spinal Simplicity has described below the fundamental elements of our Compliance Program.  In accordance with the voluntary standards established by the HHS-OIG Guidance and as explicitly recognized in the Guidance, we have tailored our Compliance Program to fit the unique environment and size of Spinal Simplicity.

This document is a description of our Compliance Program.  A Compliance Program is dynamic, involving not only multiple policies, procedures, and programmatic activities, but also the commitment of senior management, and the support of all employees, contractors, and agents to make the program effective.

We regularly review and enhance our Compliance Program to meet our evolving compliance needs.

II.        OVERVIEW OF COMPLIANCE PROGRAM

1. Written standards.

  • Spinal Simplicity’s Compliance Program is our statement of ethical and compliance principles that guide our daily operations. The Compliance Program articulates our fundamental principles, values and framework for action within our organization.
  • The HHS-OIG Guidance has identified several potential risk areas for manufacturers, and called on companies to develop compliance policies in these risk areas. Spinal Simplicity’s Compliance Program speaks to key-risk areas.  A specific annual dollar limit of $2,500 per recipient has been imposed on gifts, promotional materials, items or activities provided by a Spinal Simplicity employee or agent to covered recipients in California.

2. Leadership and Structure.  Spinal Simplicity has designated a Compliance Officer.  The Compliance Officer serves as the focal point for compliance activities.  We are committed to ensuring that the Compliance Officer has the ability to effectuate change within the organization as necessary and to exercise independent judgment.  The Compliance Officer is charged with the responsibility for developing, operating, and monitoring the Compliance Program.

3. Education and Training.  A critical element of our Compliance Program is the education and training of relevant personnel on their legal and ethical compliance-related obligations.  Spinal Simplicity will regularly review and update its training programs, as well as identify additional areas of training on an “as-needed” basis.

4. Internal Lines of Communication.  Spinal Simplicity is committed to fostering dialogue between management and employees.  Spinal Simplicity has adopted open-door and non-retaliation policies.

5. Auditing and Monitoring.  Spinal Simplicity’s Compliance Program includes efforts to monitor, audit, and evaluate compliance with the company’s compliance policies and procedures, including efforts to monitor the activities of salesforce personnel.  We will utilize ongoing assessment of compliance programs to identify new and emerging risk areas and address these risks.

6. Responding to Past and Potential Violations.  Spinal Simplicity’s Compliance Program includes disciplinary and other policies for violation of the law or company policy.  Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations.

7. Corrective Action Procedures.  A compliance program increases the likelihood of preventing, or at least identifying unlawful and unethical behavior.  However, HHS-OIG recognizes that even an effective compliance program may not prevent all violations.  As such, Spinal Simplicity is committed to responding promptly to potential violations of law or company policy, taking appropriate disciplinary action, assessing whether the violation is in part due to gaps in our policies, practices, or internal controls, and taking action to prevent future violations.

SPINAL SIMPLICITY, LLC 2020 DECLARATION OF COMPLIANCE

As part of our continued efforts in the area of compliance, we have developed a Comprehensive Compliance Program that is reasonably designed to prevent and detect violations.  Consistent with the HHS-OIG Compliance Program Guidance for Pharmaceutical Manufacturers, we have tailored our Comprehensive Compliance Program to the nature of our business as a medical device manufacturer.  The medical device industry has established, and Spinal Simplicity’s Comprehensive Compliance Program is designed in accordance with, a voluntary ethical code called the AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code).  The AdvaMed Code is substantially equivalent to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (PhRMA Code), but reflects the unique interactions between medical technology companies and health care professionals.

Government standards on compliance programs recognize that no program can completely prevent individual employees from improper conduct.  Recognizing that compliance is a dynamic concept, Spinal Simplicity continuously reviews and updates its Comprehensive Compliance Program to improve it.  As a result, the Comprehensive Compliance Program periodically incorporates changes in policy and approach that require the subsequent development of new and upgraded systems and processes.

Spinal Simplicity has developed a Comprehensive Compliance Program that we believe meets the compliance goals set forth by the State of California.  The description of our Comprehensive Compliance Program, provided above, reflects the plan we have implemented.  To our knowledge, we are, in all material respects, in compliance with our Compliance Program and applicable law.

A copy of this document or the Compliance Program may be obtained by calling (844) 774-6304.Click here to view / print the form.