Compliance

Comprehensive Compliance Program Description

I. Introduction

We are committed to conducting our business in compliance with all applicable laws, rules, and regulations and the highest standards of ethical conduct. To this end, we have established and will maintain a Comprehensive Compliance Program (“Compliance Program”) in accordance Department of Health and Human Services Office of Inspector General (OIG). Our Compliance Program is a key component of our commitment to adhering to the highest standards of corporate responsibility and fostering a culture of compliance that places a premium on doing business with integrity.

The purpose of our Compliance Program is to (1) prevent, detect, and remediate violations of laws, rules, regulations, as well as our codes, policies, and procedures and (2) promote a culture of the highest ethics within the organization. It is our expectation that employees will comply with our Company Code of Conduct and Ethics and the policies and procedures established in support of such Code. As the OIG Guidance recognizes, however, the implementation of a Compliance Program cannot guarantee the elimination of improper employee conduct.

Below are the fundamental elements of our Compliance Program. As recognized in the OIG Guidance, we have tailored our Compliance Program to fit the unique environment of our company. Moreover, our Compliance Program is dynamic, and we regularly review and enhance our Compliance Program to meet our evolving compliance needs.

II. Overview of Compliance Program

Compliance Governance

Compliance Committee. We have established an Ethics & Compliance Committee made up of the Chief Medical Officers of Claris Vision and Prairie Eye Center, Executive Leadership Team Members including Process Improvement, Human Resources, Information Technology, Finance, and Billing. Executive Council will be present to provide legal guidance as appropriate and will record minutes for the meeting. The Ethics & Compliance Committee shares overall responsibility for our compliance efforts globally and for informing senior management and the Audit Committee of the Board of Directors about compliance matters. The Ethics & Compliance Committee is responsible for providing regular and comprehensive information on compliance activities and issues to the Chief Executive Officer and Executive Team. The Compliance Committee meets on quarterly basis and manage areas of risk and areas of critical focus for the Compliance Program. Our Chief Compliance/Operations Officer serves as the Committee’s chairperson.

Written Policies and Procedures

We have established policies and procedures, including our Company Code of Conduct and Ethics, which articulate our fundamental principles and values and provide a framework for ethical conduct within our organization. The Company Code of Conduct and Ethics establishes our expectation that management, employees, and our agents act in accordance with all applicable laws, rules, regulations, and our policies and procedures, as well as the highest standards of ethics.

It is our policy to not provide any item of value to any healthcare professional with the intent of influencing that healthcare professional’s prescribing habits.

Education and Training

A crucial element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable laws, rules, regulations, and company codes, policies and procedures. We annually provide education to all staff and providers on our policies and procedures to ensure a thorough understanding of the company’s expectations, highlighting any changes from the previous year. In addition, staff and providers are assigned annual mandatory education including, but not limited to, Fraud, Waste and Abuse, HIPAA, OSHA, Anti-Harassment and Diversity. “Teams” communication may be used for news blasts or updates, allowing for real time sharing of information. A compliance scorecard is maintained by the department.

Lines of Communication

We actively foster dialogue between management and employees. Our goal is that all employees should know to whom to turn when seeking answers to questions or reporting possible violations of company policies or procedures and understand that they can make such reports without fear of retaliation. To that end, we have implemented “see something, say something” and open-door policies, as well as confidentiality and non-retaliation policies. We have a confidential, toll-free compliance hotline to which employees and persons outside of our teams may anonymously report any concerns or suspected violations of applicable laws, rules, regulations, or our policies or procedures (see “How to Report a Compliance Concern” below).

Auditing and Monitoring

Our Compliance Program includes monitoring and auditing to evaluate adherence to our policies and procedures. We note that, in accordance with the OIG Guidance, the nature, extent, and frequency of our compliance monitoring and auditing may vary according to new regulatory requirements, changes in business practices, and other considerations.

Responding to Potential Violations

When we become aware of potential violations of applicable laws, rules, regulations or company policies or procedures, the company will promptly investigate such matters and determine as to whether the facts substantiate the existence of a violation. We will document the conduct of such investigations and develop a Corrective Action Plan, where warranted.

Disciplinary and Corrective Action

While each substantiated violation will be considered on a case-by-case basis, where appropriate we will utilize disciplinary action consistent with company policy to address misconduct and to deter future violations. We will also work to determine the root cause of the violation and assess whether the violation is due to gaps in company policies or procedures and take appropriate corrective action designed to prevent future violations.

III. Declaration of Compliance

We hereby declare, to the best of our knowledge, information, and belief, and based upon our good faith understanding of the statutory requirements, we have, as of the date of this declaration, established a Comprehensive Compliance Program.

While our Comprehensive Compliance Program cannot completely eliminate the possibility that an individual employee will engage in improper conduct, our program is reasonably designed to prevent and detect violations of applicable laws, rules, and regulations, as well as our own internal policies and procedures.

IV. How to Report a Compliance Concern

We are committed to, always conducting business consistent with the highest standards of ethical conduct, fairness, integrity and respect for the law and our corporate values. We agree to maintain a third-party confidential reporting system for the receipt, retention, and treatment of complaints regarding compliance concerns, whether reported or discovered during audits.  

You may report a problem or concern by making a report via the Company’s web-based reporting tool at [email protected]  (effective 1-1-2023) calling the Company’s Compliance Concern Hotline at 1-866-562-4393. Calls and submission are anonymous (unless the caller self-identifies) and will be directed to the appropriate individuals on our team.

Transparency Reporting

We are committed to full transparency under the US Physician Payment Sunshine Act and US State-level disclosure laws.

Over the past several years, there have been an increased number of Federal and State laws that require transparency into the relationships between pharmaceutical and medical device companies with healthcare providers. These laws impose various combinations of tracking and reporting of payments, transfers of value, compliance with the law, and compliance with our own internal policies and procedures. 

The Sunshine Act

Payments and “transfers of value” are defined as cash or cash equivalent, in-kind items or services, stock, stock options, ownership interest, dividend, profit, or other return on investment. In addition, manufacturers must specify the nature of the payment that is made either directly or indirectly to a physician. Examples of such are consulting fees, honoraria, gifts, entertainment, food and beverage, travel and lodging, education, etc.

Annual education on the Sunshine Act is available to all providers on an annual basis.

For additional information about this Compliance Program, please contact our office and request to speak with the Chief Compliance Officer or Executive Legal Counsel

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