Commitment to the Highest Standards
Consistent with our commitment to demonstrate the highest ethical behavior possible in our business conduct with our customers, competitors, suppliers, and governmental agencies, and to operate with integrity and in compliance with all applicable laws, Aesculap, Inc., Aesculap Implant Systems, LLC, and Aesculap Biologics, LLC (collectively “Aesculap” or “Company”) have established a comprehensive compliance program in accordance with the guidelines published by the Office of Inspector General, U.S. Department of Health and Human Services (the “OIG Guidance”). Our Compliance Program, established by our Board of Directors, is one of the key components of our commitment to the highest standards of corporate conduct.
The purpose of our Compliance Program is to prevent and detect violations of law or company policy. As the OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is Aesculap’s expectation that employees will comply with our Code of Business Conduct, and the policies established in support thereof. In the event that Aesculap becomes aware of violations of law or company policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
Aesculap has described below the fundamental elements of our Compliance Program. In accordance with the voluntary standards established by the OIG Guidance and as explicitly recognized in the OIG Guidance, we have tailored our Compliance Program to fit the unique environment and size of our company.
Moreover, this is a description of our Compliance Program. A Compliance Program is dynamic, involving not only multiple policies, procedures, and programmatic activities, but also the commitment of senior management, and the support of all employees, vendors, and agents to make the program effective. Our policies have taken into consideration the nature of our business as a medical device manufacturer, and are consistent with the voluntary AdvaMed Code of Ethics on Interactions with Healthcare Professionals, adopted by the Advanced Medical Technology Association (the “AdvaMed Code”).
We regularly review and enhance our Compliance Program and policies and procedures to meet our evolving compliance needs. If you would like to receive a copy of our Compliance Program, please call toll-free 800-258-1946.
Overview of Compliance Program
1. Written standards
- Aesculap’s Code of Business Conduct is our statement of ethical and compliance principles that guide our daily operations. The Code establishes that we expect management, employees, vendors and agents of the Company to act in accordance with law and applicable Company policy. The Code articulates our fundamental principles, values and framework for action within our organization.
- The OIG Guidance has identified several potential risk areas for manufacturers, and called on companies to develop compliance policies in these risk areas. These risk areas include (1) data integrity pertaining to government reimbursement practices, (2) kickbacks and other illegal remuneration, and (3) compliance with laws regulating drug samples. Aesculap’s policies and procedures address these and other risk areas.
- In accordance with the AdvaMed Code, the Company does not provide any items of a personal nature to healthcare professionals, including without limitation, company logo items such as pens, pads, etc. The Company may only provide items solely of an educational nature to educate healthcare professionals and patients, and modest meals or food items in compliance with state laws and consistent with the AdvaMed Code. Aesculap’s policy is consistent with California’s Health and Safety Code §§ 119400-119402, effective July 1, 2005. In accordance with California requirements, Aesculap has established a specific annual aggregate dollar limit of $2,000 on reportable items or activities that we may provide to an individual medical or health care professional in California. This limit represents a spending cap, not a goal or average; in most cases, the amount spent per physician will be substantially less than the cap amount.
2. Leadership and Structure
- Compliance Officer: We have designated a senior-level official to serve as our Chief Compliance Officer. We are committed to ensuring that the Chief Compliance Officer has the ability to effectuate change within the organization as necessary and to exercise independent judgment. The Chief Compliance Officer is charged with the responsibility for developing, operating and monitoring the comprehensive Compliance Program.
- Compliance Committee: Aesculap has established a Compliance Committee to advise the Chief Compliance Officer and assist in the implementation of the Compliance Program. The members of the Compliance Committee are represented by senior-level officials in the finance, human resources, marketing, and sales departments.
3. Education and Training
A critical element of our Compliance Program is the education and training of our employees and agents on their legal and ethical obligations under applicable federal health care program requirements, and on our Code of Business Conduct and compliance policies and procedures. Aesculap is committed to taking all necessary steps to effectively communicate our standards and procedures to all affected personnel. Moreover, Aesculap regularly reviews and updates its training programs, as well as identifies additional areas of training on an “as needed” basis.
4. Internal Lines of Communication
Aesculap is committed to fostering dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of violations of law or our policies, should know who to turn to for a meaningful response and should be able to do so without fear of retribution. To that end, we have adopted open-door policies, as well as confidentiality and non-retaliation policies. In order to further encourage open lines of communication regarding potential violations, we have established procedures to allow individuals who want to report anonymously to do so. Aesculap’s anonymous hotline number is 800-931-0620.
5. Auditing and Monitoring
Aesculap’s Compliance Program includes efforts to monitor, audit, and evaluate compliance with the Company’s compliance policies and procedures, including efforts to monitor the activities of sales force personnel. We note that in accordance with the OIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations. We will utilize ongoing assessment of compliance programs to identify new and emerging risk areas and address these risks.
6. Responding to Past and Potential Violations
Aesculap’s Compliance Program includes procedures to screen potential employees, vendors, and agents, and Aesculap will not do business with persons or organizations that have been excluded, debarred, suspended, or are otherwise ineligible to participate in Federal healthcare programs. Aesculap’s Compliance Program also includes the imposition of disciplinary action for employees that violate the law or Company policy. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address inappropriate conduct and to deter future violations.
7. Corrective Action Procedures
A Compliance Program increases the likelihood of preventing, or at least identifying unlawful and unethical behavior. However, HHS-OIG recognizes that even an effective Compliance Program may not prevent all violations. As such, our compliance program requires Aesculap to respond promptly to potential violations of law or Company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations.
Open Payments and Other Transparency Programs
Section 6002 of the Patient Protection and Affordable Care Act, commonly referred to as the Physicians Payment “Sunshine Act” and now known as the National Physician Payment Transparency Program ‘OPENPAYMENTS’, requires annual disclosure to the Centers for Medicare and Medicaid Services (CMS) of payments or other value provided to physicians and teaching hospitals (‘covered recipients’) by certain manufacturers (‘applicable manufacturers’) of drugs, devices, biological, and medical supplies that are covered by Medicare, Medicaid or the Children’s Health Insurance Program. State laws in VT, MA, and CT may also place disclosure requirements around certain items of value provided by pharmaceutical and medical device manufacturers to health care professionals. Aesculap complies with all federal and state disclosure requirements.
Aesculap Implant Systems LLC is committed to the highest standard of ethical practice in our business conduct with our customers, competitors, suppliers and governmental agencies. As part of our Compliance Program, we have adopted a Code of Business Conduct and Company Compliance Policies that are modeled off of, among other things, (i) guidance documents published by the Office of Inspector General, U.S. Department of Health and Human Services (the “OIG Guidance”) and (ii) the voluntary AdvaMed Code of Ethics on Interactions with Health Care Professionals, adopted by the Advanced Medical Technology Association *the “AdvaMed Code”). Consistent with the OIG Guidance, we have tailored our Compliance Program to the nature of our business as a medical device manufacturer, considering our size, organizational structure and resources, and have implemented policies that are consistent with the AdvaMed Code.
To the best of our knowledge, and based upon our good faith understanding of the statutory requirements, Aesculap’s Compliance Program meets the requirements set forth in the California Health and Safety Code §§ 119400-119402, This declaration is not intended and should not be construed to imply that Aesculap has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situation, we take reasonable and appropriate remedial or corrective action in a manner consistent with our Compliance Program.
Recognizing that compliance is a dynamic concept that must be adapted to the characteristics of a particular company, we are constantly reassessing our comprehensive Compliance Program to improve it. As such, we will be making modifications to our policies and procedures to address any changes in, or interpretations of, the laws, regulations, advisory opinions, case law, OIG Guidances, AdvaMed Code, or other guidances that may become known to us from time to time. The description of our Compliance Program, provided above, reflects our program. Policies and procedures have been implemented to ensure compliance with our Code of Business Conduct.
This Declaration is made as of July 1, 2022, and as noted above, we will be updating our Compliance Program on an ongoing basis. Copies of our Compliance Program and this Declaration may be obtained by calling the toll-free number listed above in the description of our Compliance Program. In accordance with the California Code, Aesculap has made a Declaration annually since July 1, 2005.