Corporate Compliance

Paradigm Spine, LLC desires to ensure that its operations continue to be conducted in accordance with all national, state and local laws and regulations. To underscore and enhance our commitment to ethical behavior in all that we do, we have implemented a Corporate Compliance Program. Our Corporate Compliance Program is intended to establish a framework for legal compliance by the company and our personnel. 

We strive to provide surgeons with the products, services and information they need to provide the best for their patients. We have established a reputation of trust that must be preserved and strengthened. We are committed to fostering an environment that encourages all Paradigm Spine, LLC personnel to actively participate in accomplishing effective compliance with all laws and regulations. We are proud to demonstrate our commitment to following all legal requirements and ethical principles in providing our products and services. 

Paradigm Spine, LLC has been, and continues to be, committed to conducting its business in full compliance with all national, state and local laws and regulations. We are particularly committed to preventing, detecting and resolving non-compliance with these requirements. The Corporate Compliance Program aids Paradigm Spine in this prevention, detection and resolution. We require that all compliance issues encountered be raised, thoroughly investigated and resolved in a timely manner in accordance with this Compliance Program. The Compliance Program is designed to assist Paradigm Spine in protecting the excellent reputation and high levels of trust that we have established in the market. 

AdvaMed Code of Ethics Certification

Paradigm has submitted a valid certification to the AdvaMed Code of Ethics on Interactions with Health Care Professionals

 

California Certification

Declaration of Adoption of Comprehensive Compliance Program Pursuant to California Health and Safety Code Section 119400-119402

Paradigm Spine, LLC designs, manufactures and sells orthopedic medical devices. As a medical device manufacturer with a strong commitment to ethical behavior, Paradigm Spine, LLC has adopted a Comprehensive Compliance Program in accordance with the Compliance Program Guidance developed by the United States Department of Health and Human Services Office of Inspector General.

This Comprehensive Compliance Program includes: (1) A Code of Business Conduct and written policies; (2) A Compliance Officer and Compliance Committee; (3) An anonymous compliance hotline; (4) Employee training; (5) A process to respond to reports of suspected non-compliance, including appropriate disciplinary action; (6) Auditing and monitoring; and (7) Protocols for investigation and remediation of identified non-compliance, including a sanction screening process.  As an organization we strive to conduct all of our business interactions with healthcare professionals in a compliant and ethical manner.

Our Code of Business Conduct sets out the expectation of behavior expected of all employees and specific sections of the Code of Business Conduct summarize Paradigm Spine, LLC policies regarding interactions with medical or health care professionals.

Paradigm Spine, LLC has adopted Compliance Policies for interactions with health care professionals that are based on the AdvaMed Code of Ethics on Interactions with Health Care Professionals (effective July 1, 2009). Paradigm Spine, LLC has supplemented its Compliance Policies with certain provisions from the PhRMA Code on Interactions with Healthcare Professionals (effective January, 2009) as necessary to comply with state laws governing interactions with health care professionals.

Our policies on interacting with Healthcare Professionals establishes an Annual Spending Limit on meals, promotional materials or items or activities that Paradigm Spine, LLC or its representatives may give or otherwise provide to an individual medical or health care professional ($2,000 per surgeon annual limit).  The exceptions to the Annual Spending Limit include: 1) the value of samples; 2) financial support for continuing medical education conferences or health education scholarships if provided in accordance with Company policy; 3) fair market value payments, meals, and expenditures made in connection with approved consulting relationships or for healthcare professionals who speak on behalf of the company; 4) food and beverages incidental to programs offered through hospitals and other institutions designed to train healthcare professionals on the use of Paradigm Spine, LLC products; 5) Training programs necessary for the safe and effective use of Paradigm Spine, LLC products, consistent with the AdvaMed Code.

To the best of our knowledge, Paradigm Spine, LLC is in all material respects in compliance with a Comprehensive Compliance Program (“CCP”) that satisfies 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.

Questions on the Code of Business Conduct, our Comprehensive Compliance Program, requests for materials or any addition questions can be directed to our Compliance Officer at (860) 904-4451 or toll-free at 866-460-9408.  –  Updated as of April 7, 2015.