LiDCO Ltd has established a corporate compliance program designed to materially comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products in accordance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals. The AdvaMed Code is substantially similar to the PhRMA Code referenced in California Health and Safety Code, sections 119400 -119402, but specifically addresses the unique nature of interactions between medical device manufacturers and Health Care Professionals.
The LiDCO program was developed to comply with the Compliance Program guidance published by the Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services. The OIG Guide advises that effective compliance programs are comprised of seven elements, including written policies and procedures, assigned Compliance Officer, training, communication, auditing and monitoring, enforcement and disciplinary guidelines, and responses to detected problems and actions to correct issues.
In addition to our compliance program, LiDCO has established an annual spending limit for certain promotional activities directed toward healthcare professionals practicing in California (“Annual Spending Limit”). The Annual Spending Limit is set at $2,000 per year for each applicable California healthcare professional. The Annual Spending Limit applies to promotional materials or activities that are provided to an individual California healthcare professional. The exceptions to this Annual Spending Limit are: i) financial support for continuing medical education forums or fellowship grants, ii) the value of evaluation product, iii) payments made for legitimate professional services provided by a California healthcare professional, including reimbursement for reasonable expenses, iv) research grants, and v) patient education materials and health-‐related items provided for the patient’s benefit.
As of May 16, 2017, LiDCO declares that to our knowledge, we are in all material aspects, in compliance with the Compliance Plan as well as California Health and Safety Code § 119402.