U.S. Business Conduct Policy
INTERACTIONS WITH HEALTHCARE PROFESSIONALS AND HEALTHCARE ORGANIZATIONS
Introduction
Our Mission is to make and sell devices that alleviate pain, restore health and extend life. We recognize that healthcare professionals — those best suited to understand the needs of their patients, the performance of medical devices in the clinical setting and improvements that should be made to medical treatments — are critical partners in our ability to fulfill our Mission. We collaborate with physicians to create new products and therapies and to improve existing products. We provide world-class training and education on the safe and effective use of our products and therapies to healthcare professionals. We sponsor scientific research conducted by healthcare professionals to gather clinical evidence related to our products. All of these interactions are for the ultimate benefit of patients.
In no instance will Medtronic offer or provide a payment to a healthcare professional or healthcare organization as an unlawful inducement to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe a Medtronic product. While physicians are free to decide how to use Medtronic products in treating patients, Medtronic does not promote its commercially released products for unapproved uses. When interacting with healthcare professionals, members of our sales function will not recommend or suggest — or initiate or solicit discussion of — an unapproved use of a Medtronic product or therapy.
II. Commitment to Compliance and Continuous Improvement
III. Medtronic-Conducted Training and Education
IV. Medtronic Support for Third Party Conferences
VII. No Medtronic-Sponsored Entertainment and Recreation
VIII. Modest Meals for Healthcare Professional Business Interactions
IX. Medtronic-Provided Educational Items; Exclusion of Gifts
X. Reimbursement Support Programs
XI. Donations and Research and Educational Grants
XII. Evaluation and Demonstration Products
I. Statement of Principles
Collaboration between healthcare professionals (or healthcare organizations) and industry must be based on solid principles, as it presents the potential for conflicts of interest. These conflicts, both real and perceived, can affect patient and stakeholder confidence in clinicians, products, companies — and the entire industry.
To sustain and enhance medical innovation through principled collaboration so that patients continue to benefit from advances in medical care, Medtronic is guided by two central principles:
Preserve the integrity of the physician-patient relationship
The relationship between physician and patient is a uniquely trusting one because of the special role physicians play in saving and enhancing human life. Appropriate safeguards and regulations are necessary to ensure these relationships are not compromised by collaboration between a physician and industry in the development and testing of new products, or the training and education of other physicians on the safe and effective use of products.
Remain transparent about compensation and policies
To provide patients and physicians with information to make informed treatment decisions, and to develop trust and minimize actual and perceived conflicts, Medtronic is committed to transparency and appropriate disclosure of compensation and policies regarding its relationships with physicians and healthcare organizations. Medtronic will provide transparency into these relationships by making information about them available to the public and governing authorities. We believe that providing greater transparency into the nature of our relationships will help people better understand the critical role that this collaboration plays in advancing patient care, and ultimately, saving and improving lives.
II. Commitment to Compliance and Continuous Improvement
Medtronic is committed to the continuous improvement of our internal processes and procedures around physician collaboration and compensation. At the same time, effectively managing conflicts of interest in healthcare demands a collective dialogue among all stakeholders. As the industry leader, Medtronic will engage interested stakeholders to facilitate dialogue aimed at further evolving best practices to preserve collaboration.
Medtronic has adopted and fully embraces our industry’s code of ethics, the AdvaMed Code of Ethics on Interactions with Health Care Professionals (2009). Each year, our Chief Executive Officer and Chief Ethics & Compliance Officer certify that Medtronic has adopted the AdvaMed Code of Ethics and implemented each of its recommended elements of an effective ethics and compliance program.
Medtronic requires its U.S. employees and agents to follow this policy as implemented through its U.S. Business Conduct Playbook and Processes, as well as all other applicable laws, regulations, company policies and industry standards whenever interacting with healthcare professionals. Medtronic will address violations promptly and with appropriate corrective action.
This policy provides a framework to guide interactions with healthcare professionals and organizations that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Medtronic products in the United States. Because it cannot account for every situation, exceptions to this policy may be approved where the action contemplated does not raise legal, regulatory or ethical concerns.
Questions or concerns regarding the interpretation or application of this policy or its related standards may be directed by any employee or agent to a manager, Medtronic legal counsel or business unit compliance officer or by contacting the Medtronic Voice Your Concern Line at 1-800-488-3125 or visiting www.VoiceYourConcernLine.com.
III. Medtronic-Conducted Training and Education
Medtronic recognizes the importance of educating and training healthcare professionals on the safe and effective use of our products, therapies and related services and support programs. This education and training includes “hands on” product training as well as education on topics associated with the approved or cleared use of our products, therapies and related services and support programs, including related disease states as well as diagnosis, treatment and patient management in the continuum of care. These programs go through a robust approval process that evaluates the agenda, content, faculty and location. Program content must be consistent with the approved use for our products and program faculty must be trained on that approved use. On a fixed fee basis, we compensate healthcare professionals who serve as faculty for these educational programs at the fair market value for their services.
Training and education programs are conducted in appropriate settings — places that are conducive to the program’s educational purpose, convenient for the attendees and reasonable in cost. Where appropriate, we subsidize healthcare professionals’ expenses to travel to Medtronic-conducted training and education programs. Lodging, meals and refreshments provided in conjunction with educational programs must be modest in value and must not overshadow the training and/or educational purpose of the program.
IV. Medtronic Support for Third Party Conferences
Independent educational, scientific and policymaking conferences and meetings promote scientific knowledge, advance the practice of medicine and enhance the delivery of effective healthcare. Medtronic may support these third-party conferences or professional meetings that relate to our products and therapies by providing funding to reduce overall conference costs, defray faculty costs and expenses, support modest meals or receptions and allow attendance by healthcare professionals-in-training. Grants to support third-party conferences and meetings are made after evaluation by qualified representatives, independent of any sales function. We respect the independence of conference sponsors to control the selection of program content, faculty, invitees, educational methods and materials. To that end, Medtronic funding must be consistent with applicable standards established by the conference sponsor and any body accrediting the educational activity, including the disclosure of financial relationships between presenters and Medtronic. Unrelated to grant support, Medtronic may decide to purchase advertisements or lease booth space for displays at conferences. As an efficient locale for interacting with healthcare professionals, we may host receptions for attendees, conduct business meetings with healthcare professionals and, with prior approval and appropriate controls, training and education programs for or consultant meetings with healthcare professionals in connection with conferences.
V. Business Meetings
We conduct business meetings with healthcare professionals to discuss features or other important aspects of Medtronic products or therapies, product-related service concerns, sales terms, contracts, patient access to therapies and other business topics. We do not use business meetings to promote unapproved uses of our products or therapies.
Often, these meetings occur at or close to the healthcare professional’s place of business and require either time away from the clinic or a commitment of the healthcare professional’s non-working time. We host such business meetings only at settings that are conducive to bona fide scientific, educational or business discussions. We may provide occasional modest meals and refreshments in connection with such meetings and, when necessary, pay for reasonable travel costs and modest lodging of meeting attendees.
With regard to business meetings and other interactions with healthcare providers described in this policy, Medtronic does not pay for the meals, travel, lodging or other costs of spouses or guests of healthcare professionals (unless qualified to attend in their own right).
VI. Consulting Arrangements
Medtronic adheres to a needs-based approach to its collaborations with healthcare professionals and organizations. A consistent, well-documented resource planning and approval process precedes implementation of any project. This ensures that each instance of collaboration between Medtronic and a healthcare professional or organization is aligned with a specific, appropriate business need in the areas of training and education; product research and development; advisory services; and clinical research.
We review and approve the selection of each consultant on the basis of the consultant’s qualifications and expertise to meet the defined need. We also take into consideration the consultant’s entire relationship with Medtronic in light of other consulting arrangements. Sales personnel may provide information regarding the interests and qualifications of a healthcare professional, but may not control or unduly influence the decision to engage a particular healthcare professional as a consultant.
Consulting arrangements to obtain services from healthcare professionals or organizations must be in writing, must describe all services to be provided and must be approved in advance. We do not use consulting arrangements to promote unapproved uses of our products or therapies.
Payments to healthcare professionals for consulting services and documented intellectual property contributions may not exceed the fair market value for the services provided or the intellectual property obtained. We monitor all compensation provided to healthcare professionals for consulting services to assure payments to consultants comply with established policies regarding aggregate payment amounts. In the spirit of transparency, once Medtronic has paid a physician $5,000 in aggregate during a calendar year for services related to training and education, product research and development, advisory services or intellectual property contributions, compensation for that physician’s services and contributions will be voluntarily disclosed on our public website for the remainder of that year. Medtronic will of course also comply with any statutory transparency obligations.
Medtronic may pay reasonable and actual expenses incurred by consultants, including travel expenses and modest meals and lodging associated with a consultant meeting. The venue and circumstances of any consultant meeting must be appropriate to the subject matter of the consultation.
VII. No Medtronic-Sponsored Entertainment and Recreation
Medtronic interactions with healthcare professionals are professional in nature, focusing on the exchange of medical or scientific information related to our products and therapies — information that benefits patient care. To underscore this professional focus and avoid the appearance of impropriety, we will not pay for entertainment or recreational events for healthcare professionals.
VIII. Modest Meals for Healthcare Professional Business Interactions
As described previously, Medtronic conducts various business interactions with healthcare professionals where scientific, educational or business information is shared. Often, these interactions are most productive and efficient for healthcare professionals when conducted over a meal. As such, we provide modest meals as an occasional business courtesy so long as the meal is incidental to the purpose of the business interaction, provided in a manner and setting conducive to the exchange of information and attended by a Medtronic representative. We will not pay for meals for a healthcare professional not in attendance at the meeting.
IX. Medtronic-Provided Educational Items; Exclusion of Gifts
To avoid the appearance of impropriety, Medtronic prohibits giving healthcare professionals gifts or other incentives, including all non-educational logo items. We may occasionally provide items that benefit patients or serve a genuine educational function for healthcare professionals. In each case, the value of these items, other than print or electronic medical textbooks or anatomical models used for educational purposes, must be less than $100.
X. Reimbursement Support Programs
Patient access to our products and therapies depends on the availability of timely and complete coverage, reimbursement, and health economic information. Medtronic may provide this information to healthcare professionals, healthcare organizations, payors and/or patients, provided such reimbursement support is accurate, objective and related to Medtronic products, therapies, procedures and services. We may also collaborate with healthcare professionals, healthcare organizations, patients and organizations representing their interests, to achieve government and commercial payor coverage and adequate reimbursement levels that allow patients to access Medtronic products and therapies. In addition, Medtronic facilitates patient access to our products, therapies, procedures and related services by providing assistance to health care professionals and their patients in obtaining favorable coverage decisions, prior authorizations, pre-certifications and appeals of denied claims.
Medtronic-provided reimbursement support may never suggest mechanisms for either billing for services that are not medically necessary or that facilitate fraudulent practices to achieve inappropriate reimbursement.
XI. Donations and Research and Educational Grants
Medtronic may make monetary and product donations for purposes that benefit society and promote better health care or demonstrate good corporate citizenship. Donations are limited to tax-exempt organizations or, in rare instances, individuals engaged in a charitable mission. In addition, Medtronic funds scientific research and education and provides support for educational, scientific and policy making conferences and meetings. Educational grants are provided only to conference sponsors or training institutions, not to individual healthcare professionals. Medtronic may fund general research grants appropriately reviewed and approved to study new therapeutic uses of approved devices. However, Medtronic will not use such research for the purpose of promoting the unapproved use of our products and therapies. When a research grant is used to support publication of clinical study results, Medtronic’s financial support will be disclosed in the publication.
Sales personnel may provide input about the suitability of a proposed grant or donation recipient or program, but may not control or unduly influence the decision to approve donations or grants. Medtronic voluntarily discloses each of our donations and grants on our public website every quarter.
XII. Evaluation and Demonstration Products
Medtronic provides evaluation and demonstration products in compliance with applicable legal and regulatory requirements.