Healthcare Compliance

California Healthcare Compliance Information[1]

MRI Interventions is committed to the highest standards of ethical conduct.  As part of our ongoing efforts in the area of compliance, we have developed a Comprehensive Compliance Program that is designed to comply, in all material respects, with applicable federal and state laws and industry standards relating to the marketing and promotion of our products.

DECLARATION OF COMPLIANCE

To our knowledge, and based on our good faith understanding of the regulatory provisions, we have established a Comprehensive Compliance Program, or CCP, consistent with the applicable requirements of California Health and Safety Code §§ 119400 – 119402. 

To our knowledge as of the date of this declaration, MRI Interventions is in compliance, in all material respects, with our CCP, which is described below. 

It should be noted, however, that government standards on compliance, including the compliance program guidance published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”), recognize that no program can completely prevent individual employees from engaging in improper conduct.  Consistent with the HHS-OIG Guidance, our CCP has been tailored to the size, organizational structure, activities and resources of our particular company. 

The Code of Ethics on Interactions with Healthcare Professionals published by the Advanced Medical Technology Association (the “AdvaMed Code”) recognizes that the medical device industry is significantly different from the pharmaceutical industry.  While the California Health and Safety Code §§ 119400 – 119402 makes reference to compliance with the Code on Interactions with Healthcare Professionals published by the  Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”), we manufacture and sell medical devices rather than pharmaceutical products.  Although the PhRMA Code and the AdvaMed Code are substantially similar, we utilize the AdvaMed Code, and not the PhRMA Code, for guidance. 

Recognizing that compliance is a dynamic concept, we intend to reassess our CCP from time to time to determine whether any changes are needed or would be appropriate for a CCP that is tailored for our company.

DATE OF DECLARATION

The foregoing declaration is dated as of June 1, 2014.

OVERVIEW OF CCP

Written Policies and Procedures

MRI Interventions has established written policies that govern our interactions with customers. These policies include:

Policy on Business Meals.  We may provide modest occasional meals that are incidental to the presentation of business, scientific or educational information.  Meals should occur in a setting that is conducive to the business, scientific or educational discussion.  Venues that feature entertainment or recreation are not permitted, and we will not pay for meals of spouses or guests.  In general, the cost of meals with customers should not exceed, on a per person basis, $50 for breakfast, $50 for lunch or $150 for dinner.

Policy on Travel Expense Reimbursement.  We may pay, either directly or through reimbursement, modest travel and lodging expenses for customers to attend business meetings such as facility tours and product demonstrations, as well as training and education programs that we conduct.  Reimbursement of travel and lodging expenses of a spouse or guest accompanying a customer to an MRI Interventions-approved meeting, program or service is not permitted. 

Policy Prohibiting Entertainment.  It is the policy of MRI Interventions to not provide entertainment (e.g. sporting events, theater events, golf outings, concerts, skiing, hunting, etc.) to customers.

Policy on the Provision of Educational and Patient Benefit Items.  On occasion, we may provide customers items that benefit patients or serve a genuine educational function, consistent with the standards of the AdvaMed Code.  Otherwise, gifts to customers are not permitted.  This includes non-educational branded promotional items, regardless of their value.    

Total Annual Promotional Dollar Limit.  We have established an annual limit of $3,500 for meals, travel, lodging and educational or patient benefit items as the aggregate value of the items or activities that may be provided to a California healthcare professional pursuant to the requirements of California Health and Safety Code §§ 119400 – 119402.

Policy on Charitable Contributions.  We may consider charitable contributions when donation benefits society, promotes better healthcare, demonstrates good corporate citizenship and/or serves a genuine educational benefit.

Policy on Educational Grants.  We may provide grants for educational purposes for the advancement of medical education or for the benefit of patients or the public in general.  These may include, but are not limited to, continuing medical and paraprofessional education programs, fellowships provided to teaching institutions and similar organizations with a demonstrated commitment to scientific and technical education, and programs operated by organizations that provide patient education about important healthcare topics. Funding of educational programs will be provided only to organizations and institutions and not to individual practitioners.

Assigned Compliance Officer

MRI Interventions has appointed a compliance officer to oversee our CCP. Our compliance officer has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.

Training

We provide our employees training on the applicable guidelines that govern our CCP.

Communication

We encourage open and candid discussion between management and employees regarding any compliance concerns. MRI Interventions employees are encouraged to report their concerns to their manager or to the compliance officer.  For those who wish to remain anonymous, a toll-free hotline has been established in the US to report suspected violations:  1-877-778-5463. The hotline is managed by an outside vendor, who will log the call and route it to the compliance officer for investigation. 

Auditing and Monitoring

We will self-assess and periodically audit our compliance with our CCP.

Enforcement and Disciplinary Guidelines

MRI Interventions will take appropriate disciplinary actions in response to violations of our CCP. We will conduct a fair and diligent investigation of matters that are brought to our attention in order to ensure the consistent application of the company’s standards.

Responses to Detected Problems and Actions to Correct Issues

We expect a prompt and diligent response to potential violations of our CCP. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.

For a copy of our CCP, please contact MRI Interventions, Inc., Attention: Compliance Officer, One Commerce Square, Suite 2550, Memphis, TN 38103.

 


[1] This information is provided pursuant to California Health and Safety Code §§ 119400 – 119402, which requires certain pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards regulating the marketing and promotion of their products.