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The company interacts with a variety of health care professionals, many of which are in a position to influence the purchase or recommendation of DePuy Spine products. Such professionals may include surgeons, nurses, allied health professionals, hospital administrators, purchasing agents, and third party payors, to name a few. Our dealings with them must be lawful and consistent with all applicable regulations and customer policies, and they must avoid actual and perceived conflicts of interest. The company also abides by a set of Principles of Collaboration to guide us in our formal interactions with health care providers.  DePuy Spine is a member of the Advanced Medical Technology Association (“AdvaMed”), an association of health care manufacturers which produces nearly 90% of the medical devices sold in the United States, and we have adopted the AdvaMed “Code of Ethics on Interaction with Health Care Providers.” The Code outlines the standards of ethical business practices applicable to those who have adopted it, and it serves as a foundation for many of the HCC policies in place at DePuy Spine. Applicability The HCC policies on this site apply to our business practices in the United States – whether with a US or a non-US health care provider – as well as interactions we may have outside the US with health care providers. Regardless of where a transaction may occur, DePuy Spine must adhere to the more restrictive of either local laws and customs or the policies outlined on this site. The company’s HCC policies apply equally to DePuy Spine employees, independent contracted sales representatives, and other entities or individuals engaged by the company to interact with health care providers on the company’s behalf (collectively referred to as “company associates” on this site). Employees are governed by these policies as part of their employment with the company, and non-employees agree to abide by our HCC policies under their contractual obligations with DePuy Spine. “Seven Elements” DePuy Spine’s HCC program encompasses the recommendations of the US Department of Health and Human Services’ Office of the Inspector General (“OIG”), which has identified the “Seven Elements of an Effective Health Care Compliance Program”: 1. Written Policies & Procedures have been created to address all applicable categories of transactions. 2. Assigned Compliance Officer and Committees are in place. 3. Training is conducted with new hires and existing associates at least once per year. 4. Communication is a key part of our program to share the “tone at the top” and promote a culture that embraces health care compliance. 5. Auditing and Monitoring efforts are conducted to verify whether there is actual adherence to our HCC policies. 6. Enforcement and disciplinary measures are taken against those who violate any HCC policies. 7. Response to detected problems and actions to correct issues are considered a high a priority of DePuy Spine’s management. EDUCATION GRANTS, CHARITABLE CONTRIBUTIONS, AND PRODUCT DONATIONS All approved awards are made via a restricted grant from DePuy Spine to a CME provider or an appropriate not-for-profit institution, which must sign a grant letter of agreement outlining the terms of the award before payment will be remitted. Education grants may not be funded directly by a sales representative. Awards cannot be granted to an individual, and the company does not approve multi-year commitments. If an award is rejected, a written response will be provided to the requestor with an appropriate explanation for the decision. Fellowships The company provides support to a limited number of spine fellowship programs in the US. Fellowship applications are generally provided once per year to qualifying programs. Approved awards are capped at an annual maximum, and the company generally provides support for one fellow per program. Medical professionals outside the US who are interested in financial support for a visitation to a US site are encouraged to contact their own country’s Johnson & Johnson or DePuy affiliate. For more information on the company’s fellowship support, please email SpineMedicalAffairs@dpyus.jnj.com. Travel Grants A travel grant up to $2,000 may be provided for a spine fellow or qualifying resident (in his/her last or second-to-last year of neuro or ortho residency) to attend one appropriate CME-eligible meeting held in the US each year. The request must be submitted by the institution’s program director at least eight weeks prior to the meeting; the company will not provide a retroactive award for a meeting that already has passed. Requests are evaluated on a case-by-case basis and should be submitted as per the education grant process outlined above. Charitable Contributions DePuy Spine is committed to being a good corporate citizen, doing our part to give back to the community. As part of this commitment the company may provide donations in the form of a cash contribution or free product for indigent patient care. Cash Contributions
All requests for contributions from health care providers are reviewed by the DePuy Spine Education Grant Committee, which generally meets once per month. Voting members of the committee include senior management from Medical Affairs, Regulatory Affairs, Health Care Compliance, and the Law Department. No company employee or independent sales representative is authorized to commit charitable funding to a heath care provider without the approval of the Education Grant Committee. The committee considers the nature of the donation and assesses the request for health care compliance. Internal budget considerations may impact the availability of charitable funding. The company generally will not provide funding for capital campaigns or endowments and will not consider requests for multi-year commitments. Depending on the circumstances, the company also may apply more stringent criteria when considering a charitable contribution to an entity controlled by, or at the direction of, a surgeon customer. If the request is approved, the Human Resources department will work with the requestor to obtain a copy of its “IRS Determination Letter”, confirming its tax-exempt status. The requestor must sign a contribution agreement prior to receipt of the funding, and an IRS OBRA Form also will be required. If a request is rejected, a written response will be provided to the requestor with an appropriate explanation for the decision. Product Donations DePuy Spine may provide free product for indigent patient care to US patients who lack any insurance coverage or as part of an overseas “missionary” trip. A qualifying not-for-profit institution must submit a written request at least eight weeks before the planned surgery or trip, outlining the nature of the surgery to be performed, information about the requesting institution, and a detailed listing of the specific product(s) requested. The request should be submitted to DePuy Spine’s Marketing Administrative Assistant, 325 Paramount Drive, Raynham, MA 02767. Requests for free product are considered on a case-by-case basis by the company’s Education Grant Committee as per the approval process outlined under Charitable Contributions above. The company will not consider requests for multi-year commitments or for multiple overseas trips, nor will free product be provided for underinsured patients. If the request is approved, the company will request a copy of the
organization’s “IRS Determination Letter”, confirming its tax-exempt
status. The requestor must sign a contribution agreement prior to receipt
of the donated product, and an IRS OBRA Form also will be required. The
surgeon and institution must certify in writing that they will not seek
third party reimbursement for the procedure(s), and any unused product
must be returned to the company.
DePuy Spine funds a variety of
investigator-initiated and company-initiated clinical and scientific
research studies that promote the generation or analysis of data in
furtherance of patient care. Such funding may be either for Clinical
studies or Pre-Clinical Research studies.
Requests for such funding must be presented to the company’s Clinical Research Committee, whose members include senior management from Clinical Affairs, Regulatory Affairs, and Health Care Compliance. Other functional groups provide input as necessary but do not have decision-making authority. Requests will be evaluated by the committee based upon relevant criteria, including: No company employee or independent sales representative is authorized to commit clinical research funding to an investigator or institution without the approval of the Clinical Research Committee. If the study is approved, the institution and investigator will be required to sign a research agreement outlining the terms of the research award before the study commences. Funding will be limited to an amount covering reasonable, study-associated costs. Overhead costs associated with the study are carefully considered to determine whether they are reasonable and in accordance with company policies. The company will structure the disbursement of funds in accordance with the completion of study-related milestones as outlined in the written agreement. If the request for funding is not approved, a written response will be provided to the requestor with an appropriate explanation for the decision. Pre-Clinical Research Studies The company provides limited funding for pre-clinical studies. Requests for such funding should be made in writing on the institution’s letterhead to the DePuy Spine Director of Research, 325 Paramount Drive, Raynham, MA 02767. The request should be accompanied by a study protocol, including all relevant aspects of the proposed study, and a budget detailing the specific costs associated with the study. All requests for funding must be reviewed by the DePuy Spine Research Advisory Board, which meets periodically as necessary. This committee is overseen by senior management in the Research & Development department and considers the following factors in deciding whether to fund the request: Funding may be denied for research that is duplicative of studies already performed or work already in process, unless such work is deemed necessary. No company employee or independent sales representative is authorized to commit research funding to a researcher or institution without the approval of the Research Advisory Board. If approved, the institution and researcher will be required to sign an agreement outlining the terms of the research before the study commences or funds are disbursed. Funding will be limited to an amount covering reasonable, study-associated costs. The company will structure the disbursement of funds in accordance with the completion of study-related milestones as defined in the written agreement. If a request is rejected, a written response will be provided to the institution and/or researcher with an appropriate explanation for the decision. FEE FOR SERVICE CONSULTING
ACTIVITIES
Consistent with its Principles of
Collaboration, DePuy Spine believes that formal engagement with health
care providers is essential to further advances in safe and effective
spine treatment for patients. The company engages a number of
appropriately qualified health care providers, primarily spine surgeons,
to perform a variety of necessary and bona fide services, including new
product development, professional education, sales training, and
activities relating to clinical studies and market research. In this
formal capacity such health care providers are generally termed
“Consultants.” All approved Consulting activities are covered under a written contract with the Consultant. The agreement is generally for a one-year term (except for approved one-time honoraria), identifies the specific activities to be performed, specifies compensation for the services to be performed by the Consultant, and includes other terms and conditions as appropriate. Compensation must represent a fair market value exchange for the services being performed. In certain instances – primarily new product development, assessing new technologies, and medical writing where intellectual property or copyrightable material will be created – the Consultant must obtain the express written consent of his/her institution (e.g., a hospital or university) prior to entering into the agreement. The company encourages the Consultant to disclose the existence of the agreement with his/her patients and institution, if not already mandated. No DePuy Spine employee may engage a health care professional to participate in a billable Consulting activity before a fully executed contract is in place to cover such activity, and no company associate is authorized to commit that a contract is forthcoming without the express approval of the appropriate committee. Professionals in DePuy Spine’s field sales organization are not authorized to engage a Consultant without approval or remit a Consulting fee to a health care provider. All Consulting payments are initiated by a written invoice, signed by the Consultant and submitted to the company’s Medical Affairs Department (SpineMedicalAffairs@dpyus.jnj.com). Medical Affairs verifies all aspects of the invoice and independently confirms the activity with the appropriate company employee prior to payment. In addition to receiving fair compensation for services rendered, the company reimburses the Consultant for necessary travel expenses associated with the consulting work. Such reimbursement must be in accordance with the company’s Travel Policy. Product development agreements with Consultants generally involve the creation or contribution of intellectual property (“IP”), whether patented or not (unpatented “know how”), featured in the newly developed products. In exchange for the Consultant’s assignment or contribution of IP to the company, DePuy Spine may pay a royalty on sales of the new product(s) covered by the IP. Represented as a percentage of the net sales of the products developed, such royalty payments are limited to the fair market value of the IP, as estimated by DePuy Spine, and are paid over a limited number of years. Royalties are not paid to a US Consultant on his/her own purchases of the royalty-bearing products or the purchases of other surgeons at the same institution.
Meals These same limits apply to Consultants seeking reimbursement of their own meals while traveling on company business. A photocopy of the meal receipt must accompany the Consultant’s invoice. Different guidelines are in effect for Government employees, and DePuy Spine associates must limit each meal with a Government employee to $20, not to exceed $50 per year, or any other limit imposed by the Government agency. A company associate may not pay the cost of health care provider’s spouse or guest unless they have a bona fide business reason for participating in the meal. Entertainment As a member of AdvaMed, DePuy Spine fully supports the “AdvaMed Code of Ethics on Interaction with Health Care Professionals.” In line with this Code of Ethics, the company does not permit entertainment at sales calls or promotional meetings, including golf outings, theater or ball park tickets, and the like. Such events are not generally conducive to appropriate business discussions and can lead to a perceived conflict of interest. Modest entertainment with a Consultant may be hosted by a member of senior management of DePuy Spine, so long as the entertainment is of limited scope, occurs adjacent to a bona fide Consulting activity, and does not interfere with the services performed by the Consultant. Gifts An occasional gift of less than $25 may be offered to a health care provider so long as it is modest in nature and directly related to patient care. Company employees and independent sales representatives must also abide by any policies established at a customer location if applicable. Gifts to Government employees are generally prohibited, and in no instance may a gift be offered as an attempt to influence the purchase of DePuy Spine products. A medical textbook made be provided by the company’s Medical Education Department to a fellow or qualifying resident (in his/her last or second-to-last year of neuro or ortho residency). Please contact MedicalEducation@dpyus.jnj.com for more information. Travel The company generally provides travel arrangements for health care providers who participate in DePuy Spine Medical Education events, including training courses on company products. Registrants will be contacted by Medical Education with information related to travel for such events. DePuy Spine will cover the necessary travel expenses of Consultants who perform services for the company. Consultants’ travel expenses may be arranged directly by the company, though it is more common for the Consultant to invoice the company for his/her out-of-pocket travel expenses. Regardless of the method of payment or the nature of the activity, highlights of DePuy Spine’s travel policy include the following: The company authorizes its independent sales representatives to fund the travel expenses of a health care provider who attends a DePuy Spine Medical Education course or WWHQ visit. Sales associates are not permitted to fund directly or indirectly the travel expenses of a Consultant whose travel relates to services being rendered for the company, such as the faculty at a DePuy Spine Medical Education event. Separate guidelines are generally in place for Government employees, who may require a “letter of proffer” to attend a company training event. The letter, which outlines a complete description of the training to be offered, must be sent to the company’s Medical Education Department for review prior to the training. The Government employee’s base commander or Ethics Officer must give written approval prior to the training. In accordance with the standards of the Accreditation Council for Continuing Medical Education (ACCME), neither the company nor its independent sales representatives may fund travel expenses or registration fees for a surgeon to attend a continuing medical education (CME) event. The company chooses to apply the same policy to other health care professionals’ continuing education events (e.g., nurses, OR technicians, etc.), even though they may not be governed by the ACCME. WORLDWIDE HEADQUARTER (WWHQ) VISITS
As a manufacturer of health care products sold in the United States,
DePuy Spine’s products must be approved for their intended use by the US
Food and Drug Administration. The FDA prohibits a manufacturer from
promoting its product for unapproved uses, even though a health care
provider may, in his or her judgment, use the products in any manner that
he/she sees fit for the patient. DePuy Spine’s products are generally purchased by a health care
institution (such as a hospital), which then may seek reimbursement from
third party payors, including private insurance companies and Government
health programs (such as Medicare and Medicaid). The hospital’s
reimbursement may or may not include the surgeon’s professional service
component, as the surgeon may separately bill the third party payor in
some instances. DePuy Spine may provide new inventory to a customer in exchange for a
customer’s own, existing DePuy Spine products or a competitor’s inventory
owned by the customer. Such exchanges typically arise from upgrades of
company product or competitive conversions. The value of the inventory
returned will be assessed by DePuy Spine’s Finance Department and must be
of equal value to the new inventory issued using the customer’s existing
pricing. REPORTING SUSPECTED VIOLATIONS Conducting our business in an ethical manner, consistent with all
applicable laws and regulations, is the responsibility of every DePuy
Spine employee and contracted party. Training on our policies is provided
to our associates, and appropriate disciplinary action is taken against
those who violate the company’s HCC policies.
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