Organogenesis is committed to conducting its business ethically and in compliance with all applicable laws, regulations, guidelines, and policies. In keeping with that commitment, we have developed and implemented a rigorous and comprehensive compliance program which governs our entire business operations.
A. Compliance Officer
The Company's Compliance Officer is responsible for overseeing the implementation and administration of the Compliance Program and reports at least quarterly to the Company's Compliance Committee. The Compliance Officer's core responsibility is to direct and implement compliance-related changes in the organization, and exercise independent judgment in assessing and implementing compliance-related matters. The Compliance Officer is also charged with reporting compliance-related issues directly to the organization's senior management.
B. Compliance Committee
The Company has established a Compliance Committee which meets at least quarterly. The mission of the Compliance Committee includes, among other things:
C. Compliance-Related Policies
The Company has implemented compliance-related policies that are consistent with the evolving business and strict regulatory environment. Organogenesis enforces compliance-related policies and expects its employees to fully comply with its Compliance Program. Any employee who violates these standards is subject to appropriate disciplinary action, up to and including termination. The Company's compliance policy expressly prohibits retaliation or retribution against any employee who reports or makes a good faith effort to report a suspected misconduct or improper behavior.
The organization's compliance policies and procedures are designed to ensure that interactions with Healthcare Professionals are appropriate, ethical, and consistent with all applicable laws, regulations, guidelines, policies and standards. The Compliance program is designed following the framework laid out by the U.S. Department of Health and Human Services Office of Inspector General's April 2003 publication "Compliance Program Guidance for Pharmaceutical Manufacturers" ("OIG Compliance Guidance") the Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on Interactions with Healthcare Professionals," revised effective January 2009 ("PhRMA Code"), and the AdvaMed Code of Ethics on Interactions with Health Care Professionals, revised effective July 1, 2009 ("AdvaMed Code"). For a statement regarding compliance with California Health & Safety Code § 119402, click here.
D. Training and Educational Programs
The Company's Compliance Program includes training and educating employees regarding their general ethical obligations and their specific obligations to comply with Company policies and procedures and with all applicable laws and regulations. The training programs also involve educating employees on new and existing Corporate Policies, and on the standards and procedures applicable to their job functions. New employees receive compliance training as part of their initial training. Also, employees whose job functions involve interactions with Health Care Professionals receive on-going compliance training on a routine and periodic basis. Regularly scheduled update-training and tests are scheduled after the initial training to provide necessary reinforcement on compliance.
To ensure that the Company's culture remains compliance-focused, management is involved in training and assessment in order to assure a consistent understanding of compliance throughout the organization. High-level personnel in the Department of Regulatory Affairs are constantly assessing and re-assessing the training programs to ensure that any updates in the applicable laws/regulations are included and also to address any real or perceived short-comings in order to strengthen the overall effectiveness of the training programs.
E. Communicating Compliance Issues and Concerns
Organogenesis is committed to fostering an environment where open communication regarding the Company's Compliance Program's policies and procedures is encouraged. This includes, in particular, the airing of concerns and reporting of suspected improper practices. Any employee who has concerns about a particular activity that the employee feels may violate policies or the law is required to report such concerns. The Company is committed to open communication regarding compliance issues and employees are encouraged to ask questions about compliance matters. Employees may either report their concerns to their managers or to any member of the Regulatory Affairs Department, including the Organization's Compliance Officer. The Company has also established a toll free number (800) 598-6936) and email at firstname.lastname@example.org, available 24 hours a day and 7 days a week, which allows confidential anonymous reporting of suspected compliance violations. Employees may also email the Compliance Officer directly.
F. Monitoring, Auditing, and Investigations
The Compliance Program includes activities designed to monitor, audit and ensure compliance with the Company's policies and procedures. The Compliance Officer oversees and/or coordinates periodic monitoring and auditing to ensure adherence to applicable policies. The Compliance Officer (or designee) is charged with developing an annual audit plan which is subject to re-assessment and refinement in the course of the year to address unforeseen issues. A variety of internal and external auditing resources are used to conduct periodic monitoring and auditing. The Compliance Officer (or designee) works with relevant internal and external experts and management to evaluate auditing and monitoring findings and ensure the implementation of any corrective action deemed necessary as a result of audits or routine monitoring activities.
The Compliance Officer (or designee) reviews and evaluates concerns communicated to the Regulatory Affairs Department to determine whether further investigation is required of activities that may be inconsistent with the policies and procedures of the Compliance Program or applicable law(s). The Compliance Officer may, as necessary, request assistance from the members of the Compliance Committee or outside experts to conduct an investigation, depending on the nature of the alleged misconduct. Investigations are and shall be conducted confidentially to the greatest extent possible and with every effort to respect the rights of all concerned.
G. Corrective Action and Discipline
If after investigation it is determined that noncompliant conduct occurred, the matter is forwarded to the appropriate parties for corrective and/or disciplinary action. Such response and disciplinary action may include (but is not limited to): terminating or otherwise disciplining the employee(s) involved; disciplining supervisors in accordance with the facts for failure to supervise adequately and control the behavior of the employee(s); revising guidelines, policies, and procedures or any function of the Compliance Program to prevent the reoccurrence of misconduct in the area; increasing auditing and monitoring procedures; or retraining.
H. Updating the Compliance Program The Company amends its Compliance Program periodically to reflect changes in regulations and the overall regulatory environment. The Regulatory Affairs Department reviews all changes suggested by the Compliance Officer, members of the Compliance Committee, or other Company personnel. The Compliance Officer is responsible for communicating changes in the Compliance Program to Company employees in a timely manner.
Effective February 1, 2019, to the best of our knowledge and based on our good faith understanding of the statutory provisions as they may apply to medical device and pharmaceutical product manufacturers, Organogenesis Inc. ("Organogenesis") is in material compliance with the California Health and Safety Code §§ 119400-119402 requirements for Comprehensive Compliance Program ("CCP"), including satisfying the requirements of California Health and Safety Code §§ 119400-119402. The requirements of the CCP are encapsulated in Organogenesis' Healthcare and Regulatory Compliance Policy ("Policy").
To remain consistent with the Department of Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers ("HHS-OIG Guidance"), Organogenesis adapted its Policy to the nature of its business as a manufacturer of medical devices and mixed products as defined under 21 CFR 3.2(e).
California Health and Safety Code §§ 119400-119402 dictates compliance with the Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals ("PhRMA Code"). As a manufacturer of medical devices, Organogenesis has also adopted policies and procedures consistent with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals ("AdvaMed Code"). The spirit of AdvaMed Code is substantially similar to the spirit of PhRMA Code. However, there are certain non-conflicting significant differences applicable to the medical device industry.
Organogenesis' Policy contains annual spending limit for certain promotional activities directed toward healthcare professionals practicing in California ("Annual Spending Limit"). The Annual Spending Limit is set at $3,000 per year for each applicable California healthcare professional. The Annual Spending Limit applies to gifts, promotional materials, and other items or activities that are provided to an individual California healthcare professional. In accordance with relevant law, the only exceptions to the Annual Spending Limit are: 1) the value of samples or evaluation product; 2) financial support for continuing medical education forums or health educational scholarships or fellowship grants; 3) payments made for legitimate professional services provided by a California healthcare professional, including reimbursement for reasonable expenses; 4) research grants; and 5) patient education materials and health-related items provided for the patient's benefit.
Organogenesis is committed to the highest practices of ethical and legal conduct. The Policy is designed to prevent and detect violations, and includes the following:
To obtain a print version of our Policy or this declaration, please call Customer Support at 1-800-598-6936.
For a written copy of the Compliance Program description, email email@example.com