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Compliance Program

stethescopeI.  INTRODUCTION


Hemosphere is committed to establishing and maintaining an effective compliance program in accordance with the compliance program guidance published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”).  Our comprehensive compliance program (the “Compliance Program”) is one of the key components of our commitment to the highest standards of corporate conduct.

The purpose of our Compliance Program is to seek to prevent and detect violations of law and company policy.  As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated.  Nonetheless, it is Hemosphere’s expectation that employees will comply with the Codes of Conduct we have adopted and with all applicable laws and regulations.  In the event that Hemosphere becomes aware of violations of law or company policy, we will investigate the matter and, as appropriate, take disciplinary action and implement corrective measures designed to prevent future violations.

Hemosphere has described below the fundamental elements of our Compliance Program.  In accordance with the voluntary standards established by the HHS-OIG Guidance and as explicitly recognized in the Guidance, we have tailored our Compliance Program to fit the unique environment and size of our company.

Moreover, this document 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.

We regularly review and enhance our Compliance Program to meet our evolving compliance needs.


II.  OVERVIEW OF COMPLIANCE PROGRAM


1.  Written Standards

  • The AdvaMed Code Code of Ethics on Interactions with Health Care Professionals is our statement of essential ethical and compliance principles that guide our daily operations.  The Code makes it clear that we expect management, employees, vendors and agents of the company to act in accordance with law and applicable company policy.  The Code, as adopted by Hemosphere, Inc., is the Code of Conduct on Interactions with Health Care Professionals and Frequently Asked Questions as written and adopted by AdvaMed (Advanced Medical Technology Association) dated July 1, 2009.

  • The HHS-OIG Guidance has identified several potential risk areas for manufacturers, and called on companies to develop compliance policies in these risk areas.  As relevant to device and pharmaceutical manufacturers, these risks include (1) data integrity pertaining to government reimbursement policies and (2) kickbacks and other illegal remuneration.

2.  Leadership and Structure.

We have selected a Compliance Officer at the Hemosphere corporate level to serve as focal point for compliance activities.  We are committed to ensuring that our Compliance Officer has the ability to effect change within the organization as necessary and to exercise independent judgment.  This Officer is charged with the responsibility for developing, operating and monitoring the Compliance Program.

3.  Education and Training.

A critical element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal health care program requirements.  Hemosphere is committed to taking all necessary and appropriate steps to effectively communicate our standards and procedures to all affected personnel.  Ongoing training programs include live meetings of attorneys from our Legal Counsel with top management, sales trainees, sales and marketing employees and other personnel; on-line training from qualified third party vendors; and regular refresher courses.  The Compliance Program’s role in this education and training is to set and enforce minimum training requirements for employees by function and to ensure that all training received by employees is adequately documented.  Moreover, Hemosphere, through its Compliance Program, will regularly review and update its training programs, as well as identify additional areas of training on an “as needed” basis.

4.  Internal Lines of Communication.

Hemosphere 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 fraud and abuse, 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.  Employees may report matters confidentially to the Hemosphere Integrity Helpline or directly to the Audit Committee of Hemosphere, or to the Corporate Compliance Officer.

5.  Auditing and Monitoring.

Hemosphere’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 HHS-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 an ongoing assessment of compliance programs to identify new and emerging risk areas and address these risks.

6.  Responding to Past and Potential Violations.

Hemosphere’s Compliance Program includes a policy that Hemosphere will not do business with persons or organizations that have been excluded, debarred, suspended, or are otherwise ineligible to participate in Federal healthcare programs.  Although each situation is considered on a case by case basis, Hemosphere will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations by its employees and third parties with whom it does business.

7.  Corrective Action Procedures.

A compliance program increases the likelihood of preventing 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 the company to respond promptly by investigating potential violations of law or company policy, taking appropriate disciplinary action when necessary, and taking action to prevent future violations including assessing whether the violation is in part due to gaps in our policies, practices or internal controls, and repairing such gaps, if any.

Members of the public may request a copy or copies of this document and Hemosphere's annual written declaration of compliance by sending an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it or by calling the following toll-free telephone number:  888.313.8233.



Last Updated ( Sunday, 06 June 2010 18:59 )