California 2023 Compliance Policy and Declaration
DECLARATION FOR CALIFORNIA COMPLIANCE LAW
As part of ROUTE 92 MEDICAL, Inc. (“ROUTE 92 MEDICAL” or “Company”) ongoing efforts in the area of compliance, we have developed a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of our products. To our knowledge as of the date of this declaration, Route 92 Medical is in compliance with our Comprehensive Compliance Program, as described here, and with California Health & Safety Code sections 119400-119402.
Copies of our Comprehensive Compliance Program (“CCP”) and our prior year Annual Declaration of Compliance can be obtained by calling us at 650-581-1179 or emailing us at [email protected]
Last updated: February 15, 2023
COMPREHENSIVE COMPLIANCE PROGRAM
ROUTE 92 MEDICAL has established a program designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. Additionally, ROUTE 92 MEDICAL recognizes that adherence to these standards can be furthered through a compliance program that is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG Guidance”). The OIG Guidance advises that effective compliance programs are comprised of seven elements, which are outlined below. As described below, these elements form the basis of ROUTE 92 MEDICAL program for compliance with the standards regulating the marketing and promotion of its products. In addition, ROUTE 92 MEDICAL has implemented and maintains a website (r92m.com) and a compliance hotline to facilitate communication and requests for information related to California State requirements.
Written Policies and Procedures
ROUTE 92 MEDICAL has written policies and procedures to assure substantial compliance with the applicable laws, regulations and standards governing the marketing and promotion of our products. ROUTE 92 MEDICAL follows the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”). ROUTE 92 MEDICAL has established written policies and procedures that govern activities involving communicating with health care professionals about the appropriate use of our products, including appropriate instruction and education required for the safe and effective use of our products. ROUTE 92 MEDICAL also has policies and procedures governing activities involving the advancement of scientific and educational activities supporting medical research and education. These policies and procedures include:
Policy on Travel Expense Reimbursement for CME, Promotional or Product Training Meetings
ROUTE 92 MEDICAL may reimburse attendees for their reasonable travel and lodging expenses associated with attendance at training meetings conducted by ROUTE 92 MEDICAL. Training meetings will be conducted in locations conducive to the exchange of information such as educational or conference settings. Where face-to- face health care professionals training is reasonably necessary for the safe and effective use of ROUTE 92 MEDICAL products, ROUTE 92 MEDICAL may provide training at ROUTE 92 MEDICAL facilities, at independent teaching centers such as medical institutions, or in other appropriate clinical settings.
Policy on Business Meals
ROUTE 92 MEDICAL may occasionally offer a modest meal as part of an educational presentation or a business discussion. Entertainment or recreation at such meetings is not permitted. Attendance by spouses or guests at such meetings is not permitted unless the spouse or guest has a bona fide reason for attending, e.g., they are a health care professional interested in the use of a ROUTE 92 MEDICAL product.
Policy on the Provision of Educational and Practice-Related Items
Subject to approval from the ROUTE 92 MEDICAL Compliance Officer, ROUTE 92 MEDICAL representatives may provide items that benefit patients or serve a genuine educational function for health care professionals.
Total Annual Dollar Limit for California Health Care Professionals
ROUTE 92 MEDICAL has established an annual limit for meals and educational items that may be provided to California health care professionals pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765).
Policy Prohibiting Entertainment
It is the policy of ROUTE 92 MEDICAL not to provide entertainment (e.g. sporting events, golf outings, concerts, etc.) to health care professionals.
Assigned Compliance Officer
ROUTE 92 MEDICAL has a Compliance Officer. Our Compliance Officer is empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management and board of directors. ROUTE 92 MEDICAL has a Compliance Committee. The committee is comprised of the Company’s Compliance Officer and members of the Company’s management team.
ROUTE 92 MEDICAL has an annual Compliance Training process. New employees receive training at the time of hire and sales and marketing employees receive training annually thereafter. The training covers applicable guidelines governing our compliance program. Employees are trained on the consequences of failure to comply with the requirements of the Company’s compliance program.
ROUTE 92 MEDICAL encourages open and candid discussion between management and employees regarding any compliance concern. ROUTE 92 MEDICAL employees are encouraged to report their concerns to their manager or to the Compliance Officer. Employees also have the option to report potential violations anonymously using the ROUTE 92 MEDICAL Compliance Hotline.
Auditing and Monitoring
ROUTE 92 MEDICAL monitors and periodically audits its compliance with its policies and procedures.
Enforcement and Disciplinary Guidelines
ROUTE 92 MEDICAL may take disciplinary action, up to and including discharge/termination, in response to violation of the Company’s compliance policies or procedures. ROUTE 92 MEDICAL may conduct an investigation of matters that are brought to the Company’s attention in order to ensure the consistent application of the Company’s standards.
Responses to Detected Problems and Actions to Correct Issues
ROUTE 92 MEDICAL requires a prompt and diligent response to potential violations of the Company’s compliance program, including its standards regulating the marketing and promotion of our products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.
San Mateo, California, United States of America
Original Date of Issue: 2023-02-15