At Sorin Group, we believe that medical equipment and device manufacturers have a responsibility to deliver the highest quality products, while adhering to the highest ethical standards and practices in the industry.
This philosophy is reflected in both our day-to-day business practices, as well as in the relationships we maintain with customers, shareholders, coworkers, clinicians, partners, and suppliers, and professional associations including healthcare, financial and regulatory institutions.
In recent years, our industry has changed drastically. Increasingly, the government is more closely examining relationships between sales representatives and providers and other referral sourcres as they have done in the pharmaceutical industry for quite some time. Hospitals now require our representatives to have additional background screening and training, including HIPAA education, before they can even walk through the door.
Sorin is committed to addressing these changes and remaining compliant with the letter and spirit of any and all applicable laws wherever we do business. Sorin has implemented compliance policies to provide practical guidance on several issues that arise while transacting Sorin Group business.
To learn more about how Sorin is responding to recent changes in the regulatory environment, click on any of the links below:
 How is the regulatory environment changing and how does this affect relationships between sales representatives and providers?
In addition to developing the best medical innovation and technology available, Sorin's continued success is dependent on solid interaction and long-standing relationships with physicians and other healthcare providers. Yet, our industry has changed drastically in recent years and we continue to work in an environment where our relationships with providers are under increased scrutiny. It is impossible to pick up an industry publication, without learning that the government has initiated another investigation into the sales and marketing practices of device manufacturers. In recent years there has been an increasing number of cases in the pipeline, most of them initiated by whistleblowers. A series of large settlements followed, each with an accompanying Corporate Integrity Agreement (CIA) requiring the organization to allow an outside entity a microscopic view of its business, contracting, consulting and marketing practices. There are several laws and codes of conduct which affect how individuals conduct themselves at Sorin. However, from a sales perspective, the Anti-Kickback statute is the most important law. It is a federal statute which criminalizes the “knowing and willful” offer, payment, solicitation or receipt of “any remuneration (including any kickback, bribe or rebate)” “in return for” or “to induce” the referral of or arranging for business paid for by a federal health care program. The government has taken a wide view of what can be considered a kickback, and it has become immensely important for companies like Sorin to provide a greater emphasis on compliance procedures and policies in order to ensure no one in the organization violates the law.
What is Sorin Group doing to ensure compliance with the changing regulatory environment?
To help navigate the complex compliance environment we operate in, Sorin Group is a member of AdvaMed. AdvaMed is a U.S. based medical device manufacturer and distributor trade association. As a member, Sorin Group has adopted the AdvaMed Code of Ethics for Interaction with Healthcare Professionals. In addition, Sorin Group has established a set of compliance policies and procedures to help translate AdvaMed into actual practice. All Sorin representatives (employees and contracted agents) are expected to adhere to the AdvaMed Code and Sorin Group's compliance policies and procedures. In addition, Sorin Group has a full-time Chief Compliance Officer, Bill Huron. In conjunction with the Compliance Committee, the Chief Compliance Officer develops and maintains Sorin Group's comprehensive set of compliance policies and procedures to help ensure Sorin Group successfully navigates the complex medical device regulatory environment. The policies and procedures address everyday issues such as meals and entertainment, physician consulting arrangements, non-retaliation for reporting compliance issues, compliance training and charitable donations. Another large initiative Sorin has undertaken is to develop an on-line series of compliance training courses and set the goal for 100% participation in the training. Currently there are four training modules which cover the Sorin Code of Conduct, HIPAA Privacy, AdvaMed Code of Ethics, and the Principles of Global Competition. 
Visit the AdvaMed Website
Read the AdvaMed Code of Ethics
What is the Code of Conduct practiced by Sorin Group?
The Sorin Group Code of Conduct sets forth internal guidelines for management practices and business ethics.
Read the Sorin Group Code of Conduct
Sorin has several key policies of which employees, contracted agents and our customers should be aware:
- Compliance Committee
Sorin has formed a Sorin North America Compliance Committee made up of key managers from several functions. The goal of the Committee is to ensure Sorin’s compliance with relevant laws, regulations, and other industry standards. The Committee is responsible for adopting all compliance policies and monitoring overall adherence to Sorin compliance policies and procedures.
- Compliance Hotline
A mechanism for employees, contracted agents or interested parties (such as: vendors or former employees, etc.) to report suspected unethical conduct or compliance violations of any kind. The hotline can be reached at 1-888-259-8571 or by clicking here.
- Meals and Entertainment Policy
The Committee has established guidelines on when providing meals is appropriate and set a maximum limit of $150 per individual excluding tax and tip. In addition, the policy limits the frequency of providing meals to any one healthcare provider.
- Gifts
Gifts, formally a mainstay in many industries including the device industry are no longer permitted, unless several conditions are met. The gift must not exceed a retail value of $100 and it must relate to patient care, serve a genuine educational function (e.g., textbooks, educational materials), or relate to the health care providers work (e.g., pens, mouse pads, laser pointers, clip boards). Items for personal benefit, such as t-shirts and golf balls, are not related to the health care provider’s work or patient benefit and are prohibited. In addition, the gift must not take into account the actual or potential volume of referrals or other business generated by the healthcare provider.
- Charitable Donations/Donated Product Policies
Sorin has established an independent committee which meets monthly to evaluate requests for charitable donations and donated products. The goal of this committee is to ensure that donations to charitable entities or events will, in no way, be economically motivated or influenced by either the maintenance of current customers, employees or contracted agents or to encourage agreements with potential customers, employees or contracted agents. The charitable donation policy can be found on the Sorin North America Intranet and questions about the policy and what types of donations will be considered can be directed to Rebecca Hellman at 303-467-6529.
- Other Policies
Sorin has also established other policies covering basic compliance program elements, including compliance training requirements, non-retaliation policy and a sanction policy. The compliance training policy establishes compliance training requirements for employees and contracted sales agents. The non-retaliation policy states that employees or contracted agents who report a potential compliance violation will not be retaliated against by the company. The sanction policy establishes the procedure for both instituting and documenting sanctions against both Sorin employees and contracted agents who violate compliance policies.
Sorin’s Compliance Policies and Procedures can be found on the intranet or by sending an e-mail to soringroupethics@sorin.com.
What are your other professional compliance affiliations?
I have a compliance-related question.
Compliance related questions can be directed to Bill Huron, Chief Compliance Officer for Sorin Group North America. He can be reached at 303-467-6479.
In addition, Sorin has established a Compliance Hotline which is both phone and internet-based, which allows people to report issues or concerns they may have in an anonymous and confidential manner. The Hotline can be reached through 1-888-259-8571 or click here.
My organization would like to request educational or charitable support for one of its events. How should this donation request be made?
Sorin Group has established a Charitable Donations Committee to review all requests for charitable support.
The Charitable Donations Committee is made of representatives from Sorin’s compliance, legal, finance and clinical areas.
All requests for charitable donations including requests to sponsor educational and/or scientific conferences should be made on the “Application for Educational, Research, or Charitable Donations from Sorin Group” form and will be reviewed by the Charitable Donations Committee. The Chief Compliance Officer or a member of the Compliance Department will communicate all decisions on charitable donation requests including requests to sponsor educational and/or scientific conferences.
The Application may be submitted to the Charitable Donations Committee via completion and submission through this website Donation Form, or by completing and faxing the Application to 303-467-6163.
Any questions concerning the charitable donations request and/or review process may be sent via e-mail to soringroupethics@sorin.com.
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