Corporate Compliance
OUR COMMITMENT
Neuronetics is a publicly traded medical device company that focuses on designing, developing, and commercializing products that improve the quality of life for patients who suffer from psychiatric disorders. We actively collaborate with the clinical community and regulatory agencies to improve care for the many patients suffering from these disorders.
​
CORPORATE COMPLIANCE
Neuronetics is a member of the Medical Device Manufacturers Association (“MDMA”) and complies with the MDMA Revised Code of Conduct on Interactions with Healthcare Providers (“MDMA Code”). The MDMA Code is fundamentally equivalent to the Advanced Medical Technology Association (“AdvaMed”) Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”).
​
Neuronetics created a compliance program (“Compliance Program”) to implement its Code for Interactions with Healthcare Providers (“Code”). The Code is based on guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG”), specifically the seven elements of an effective compliance program. Neuronetics also has policies and processes in place to address each of the seven elements and other related topics involving interactions with healthcare providers.
​
Neuronetics Compliance Program promotes honest, ethical and lawful conduct by all Neuronetics employees in their interactions with Healthcare Providers and in the provision of healthcare items and services to Healthcare Providers. The Neuronetics Compliance Program is intended to raise the awareness of Neuronetics employees to the ethical and legal issues that may be encountered when interacting with Healthcare Providers, and to define Neuronetics processes that employees should follow to address these issues.
​
COMPREHENSIVE COMPLIANCE PROGRAM SUMMARY
​
1. Written Policies and Procedures: The Code is the primary policy that governs interactions between Neuronetics and healthcare providers. Neuronetics also has related policies and procedures to provide guidance on how employees are expected to interact with healthcare providers.
​
2. Compliance Leadership: Neuronetics has a Compliance Officer and Compliance Committee and both are empowered to lead the company and guide employees in all activities related to our Code
​
3. Education and Training: Neuronetics provides periodic training to ensure that employees are familiar with the requirements of our Code and these related policies and procedures.
​
4. Communication: Developing effective lines of communication is essential and Neuronetics has several options for employees to report possible acts of non-compliance. Employees may seek the advice of their supervisors, the Compliance Officer, or may report a concern by calling Neuronetics’ anonymous reporting hotline at 877-472-2110.
​
5. Auditing and Monitoring: The company performs auditing and monitoring of activities – _both based on an audit schedule and ad hoc, as appropriate. Auditing and monitoring efforts, through and including implementation of corrective actions, are collaborative efforts between the Compliance Officer and the business.
​
6. Enforcement and Appropriate Disciplinary Action: If an employee fails to comply with our Code, or associated policies and procedures, the Compliance Committee is empowered to determine the appropriate type of sanction required and works with the relevant supervisor for implementation.​​
​
7. Corrective Action Procedures: Neuronetics has corrective action procedures in place to address deficiencies in its compliance program. Human Resources, in conjunction with the Compliance Committee, monitor corrective actions taken related to our Code and related policies and procedures, including any sanctions taken in response to instances of non-compliance.
​
ANNUAL LIMIT ON GIFTS, PROMOTIONAL MATERIALS, OR ITEMS OR ACTIVITIES
Neuronetics has established a $3,500.00 limit on items provided to HCPs on an annual basis. This limit applies to gifts and items provided to healthcare providers but does not include: items provided at no charge to patients; financial support for continuing medical education forums; financial support for health educational scholarships; or payments made for legitimate professional services provided by a healthcare or medical provider, including, but not limited to, consulting fees. The following items and activities are examples of items subject to the limit: samples for demonstration purposes; journal article reprints; business and training meals with healthcare providers; and promotional materials. Any items provided to healthcare providers are for educational and training purposes, are provided in accordance with our Code, and are never provided as incentives.
​
DECLARATION OF COMPLIANCE WITH CALIFORNIA LAW
As such, to the best of its knowledge, Neuronetics is in compliance with California Health & Safety Code § 119400- 194002 and Neuronetics’ Code and Compliance Program meet the requirements of the MDMA Code and the MDMA Code requirements are substantially similar to: (1) the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers; (2) the PhRMA Code on Interactions with Health Care Professionals, that are specified in § 119400-194002; and (3) the AdvaMed Code.
​
A copy of this Compliance Program can be obtained by calling Neuronetics’ Customer Service at 877-600-7555.
Date: December 2019
14-00024-002 Rev E