Compliance

Compliance

Compliance and Transparency Reporting


Compliance

Comprehensive Compliance Program Description


I. Introduction

Lantheus is committed to conducting its 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 with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”) published by the Office of Inspector General, U.S. Department of Health and Human Services. 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 Lantheus codes, policies and procedures and (2) promote a culture of the highest ethics within the organization. It is Lantheus’ 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.

Lantheus has described below 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. Lantheus has established an Ethics & Compliance Committee made up of Lantheus senior management. The Ethics & Compliance Committee shares overall responsibility for Lantheus’ 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 a regular basis to identify and manage areas of risk and areas of critical focus for the Compliance Program. Lantheus’ Vice President, Internal Audit, serves as the Committee’s chairperson.

Written Policies and Procedures

Lantheus has 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 agents of Lantheus act in accordance with all applicable laws, rules, regulations, and Lantheus policies and procedures, as well as the highest standards of ethics.

It is Lantheus’ 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 policies and procedures. Lantheus regularly communicates our policies and procedures to ensure a thorough understanding of the company’s expectations and regularly reviews and updates these training programs.

Lines of Communication

Lantheus actively fosters 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 Lantheus may anonymously report any concerns or suspected violations of applicable laws, rules, regulations, or Lantheus policies or procedures (see “How to Report a Compliance Concern” below).

Auditing and Monitoring

Lantheus’ Compliance Program includes monitoring and auditing to evaluate adherence to Lantheus’ 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 Lantheus becomes aware of potential violations of applicable laws, rules, or regulations or company policies or procedures, the company will promptly investigate such matters and make a determination as to whether the facts substantiate the existence of a violation. Lantheus will document the conduct of such investigations.

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

Lantheus Holdings, Inc. hereby declares on behalf of itself and its subsidiaries that, 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 that is in material compliance with the requirements of California Health and Safety Code §§ 119400-119402.] While Lantheus’ 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

Lantheus is committed to conducting its business on a daily basis consistent with the highest standards of ethical conduct, fairness, integrity and respect for the law and its corporate values.  Lantheus maintains a third-party confidential reporting system for the receipt, retention and treatment of complaints regarding Lantheus’ accounting, internal accounting controls, auditing matters, policy, safety, human resource matters, violation (or possible violation) of laws and other compliance concerns.  You may report a problem or concern by making a report via the Company’s web-based reporting tool at www.lantheus.ethicspoint.com or by calling the Company’s Compliance Concern Hotline at 1-877-472-6272 for calls placed within the United States, or 1-503-747-1848 for calls placed outside the United States. Calls and submission are anonymous (unless the caller self-identifies) and will be directed to the appropriate individuals at Lantheus.

 

Transparency Reporting

Lantheus is 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 PhRMA Code, and compliance with our own internal policies and procedures.  Lantheus complies with all applicable laws, including the federal Sunshine Act and state regulations in Massachusetts, California, Minnesota, Nevada, District of Columbia, Vermont, West Virginia and Connecticut.

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.

Learn More/Related Links:

https://www.cms.gov/openpayments/index.html
http://www.medicalimaging.org/policy-and-positions/sunshine/

All questions related to transparency reporting should be sent to the Commercial Compliance Team at sunshineteam@lantheus.com.