As part of Cala Health, Inc. (“Cala Health” 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, Cala Health 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 Annual Declaration of Compliance can be obtained by contacting us at Compliance@CalaHealth.com
Last updated: May 2021
COMPREHENSIVE COMPLIANCE PROGRAM
Cala Health Medical, Inc. (“Cala Health” or “Company”) 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, Cala Health 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 Cala Health program for compliance with the standards regulating the marketing and promotion of its products. In addition, Cala Health has implemented and maintains a website (calahealth.com) and a compliance email to facilitate communication and requests for information related to California State requirements.
Written Policies and Procedures
Cala Health has written policies and procedures to assure substantial compliance with the applicable laws, regulations and standards governing the marketing and promotion of our products. Cala Health follows the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”). Cala Health 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. Cala Health 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 Educational Grants and Research Grants
- Policy on Charitable Contributions and Patient Assistance
- Policy on Travel Expense Reimbursement for CME, Promotional or Product Training Meetings
- Policy on Business Meals
- Policy on the Provision of Educational and Practice-Related Items
- Total Annual Dollar Limit for California Health Care Professionals
- Policy Prohibiting Entertainment
Assigned Compliance Officer
Cala Health has a Compliance Officer. The Compliance Officer serves as the focal point for compliance activities. We are committed to ensuring that the Compliance Officer can effectuate change within the organization as necessary and to exercise independent judgment. The Compliance Officer is charged with the responsibility for developing, operating, and monitoring the Compliance Program.
A critical element of our compliance program is the education and training of relevant personnel on their legal and ethical compliance-related obligations. New employees receive training at the time of hire and 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.
Cala Health encourages open and candid discussion between management and employees regarding any compliance concern. Cala Health employees are encouraged to report their concerns to their manager or to the Compliance Officer. Employees also have the option to report potential violations using Compliance@CalaHealth.com.
Auditing and Monitoring
Cala Health self-assesses and periodically audits its compliance with its policies and procedures.
Corrective Action Procedures
A compliance program increases the likelihood of preventing or at least identifying unlawful and unethical behavior. However, even an effective compliance program may not prevent all violations. Cala Health may investigate matters that are brought to the Company’s attention in order to ensure the consistent application of the Company’s standards. Cala Health may take disciplinary action, up to and including discharge/termination, in response to violation of the Company’s compliance policies or procedures.
Responses to Past and Potential Violations
Cala Health 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.