OVERVIEW

Codman is committed to promoting a culture of ethical business practices and obeying all laws, regulations, industry standards, and Johnson & Johnson corporate policies that govern our interactions with health care providers. Collectively we refer to this as Health Care Compliance (“HCC”).

HCC applies to many aspects of our business, and this site is designed to provide you with information about our HCC program, as well as some useful information about our company processes. This site provides information on the following topics:

• Education Grants, Charitable Contributions, and Product Donations
• Research Funding
• Fee for Service Consulting Activities
• Meals, Entertainment, Gifts and Travel
• Information Regarding Off Label Use of Company Products
• Reimbursement Support
• Inventory Exchanges
• Reporting Suspected Violations

   

The company interacts with a variety of health care professionals, many of which are in a position to influence the purchase or recommendation of Codman 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.

 Codman 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 Codman.

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, Codman 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 Codman 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 Codman.

“Seven Elements”

Codman’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 Codman’s management.
 
 

EDUCATION GRANTS, CHARITABLE CONTRIBUTIONS, AND PRODUCT DONATIONS

Education Grants

Codman supports a variety of educational programs that are of interest to the Company, including continuing medical education (CME) events hosted by providers accredited by the Accreditation Council for Continuing Medical Education (“ACCME”); non-CME events that avoid “off-label” discussion of Codman products; fellowship grants; travel grants for spine fellows and qualifying residents; grand rounds; and other programs. Each request is evaluated on the individual program’s merits, and all requests must be reviewed by the Codman Education Grant Committee for approval.
 
Requests for funding must be submitted by an accredited CME provider or a not-for-profit institution, outlining the amount requested, the proposed use of funding and a detailed budget. The requests should provide details about the program, indicate whether it will be CME-eligible, and include an agenda of topics to be covered and any other relevant information. Requests should be submitted to the company at least six weeks before the program and may be submitted via our online application.

All requests for funding are reviewed by the Codman 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. Company associates from Sales and Marketing may provide input and background information on submitted requests but do not have a vote in award decisions. No employee or independent sales representative is authorized to commit grant funding without the approval of the Education Grant Committee.
Factors our committee considers as part of the review process include the following:
 

• Content – The company looks to support high quality events that are in line with our strategic objectives. Programs that are unrelated to Neurosurgical, Neurovascular, Neurological disorder or NeuroCritical Care, may be denied. Programs that are not of significant educational value, or that are duplicative of other programs funded by the company may also be denied. 
• Scope – Programs that serve a larger audience or which have a greater impact on the medical community may receive greater consideration than those of limited scope.
• Location – The event’s venue must be appropriate and conducive to achieving its educational objectives. The company reserves the right to reject a request if the venue appears inappropriate.
• Budget – The company will assess the reasonableness of the event’s detailed budget provided by the requestor, ensuring components appear in line with fair market value. The company may reject a request or award a lesser amount based on the event’s budget or due to internal education grant budget constraints.

All approved awards are made via a restricted grant from Codman 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. Grant decisions are contingent upon review of the appropriate state laws (e.g VT and MA).

If an award is rejected, a written response will be provided to the requestor with an appropriate explanation for the decision.
Codman has partnered with an independent foundation to administer fellowship support from the company beginning with the 2010-2011 academic year. The Neurosurgery Research and Education Foundation (NREF) accepts funding requests for clinical neurosurgery fellowship programs in the U.S.. The foundation has outlined an application and selection process that is independent of Codman, including the application due dates, and our company plays no role in the request or approval process at the organization. For more information on how to apply for funding, please visit the foundation’s respective website at www.aans.org/Research/. Codman is still accepting requests for NeuroEndovascular fellowships and the following fellowship application must be completed for these fellowship grants.
Education grants can be submitted via our online application. For more information on our education grants, please see our FAQs or Quick Reference Guide.

Charitable Contributions

Codman 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

Codman may provide a donation to an IRS 501(c)(3) not-for-profit organization in alignment with its charitable objectives. A request for funding must be made in writing on the organization’s letterhead, outlining the amount requested, the proposed use of funds and other relevant information about the request and/or the requesting organization. The request should be submitted to the Codman Worldwide Director of Human Resources, 325 Paramount Drive, Raynham, MA 02767.

No company employee or independent sales representative is authorized to commit charitable funding to a health care provider without the approval of Human Resources.

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. Internal budget considerations may impact the availability of charitable funding.

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

Codman 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. Please consult with your Codman sales representative who can provide additional information on how to request product donations.

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 product(s), and any unused product must be returned to the company.

If a request is rejected, a written response will be provided to the requestor with an appropriate explanation for the decision.

No employee or independent sales representative is authorized to commit free product.

RESEARCH FUNDING

Codman 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.

Clinical Studies

Codman funds clinical studies that are required to document the safety and efficacy of products prior to approval of those devices. After approval, the company may fund either company-initiated or investigator-initiated clinical research studies that are of interest to the company. Investigator-initiated studies are clinical research study protocols proposed by a health care provider who requests company assistance in funding the study. Under company-initiated studies, Codman will proactively seek and sponsor outcome studies to evaluate the cleared or approved use of a company’s device.

Studies that involve unapproved (i.e., off-label) use of marketed Medical Device Company products may be supported if the goal is to advance medical knowledge and the studies conform to applicable regulations. Investigator-initiated prospective studies related to "off label" uses of Codman product will require the institution to obtain an Investigational Device Exemption (IDE) from the US Food & Drug Administration in the USA or appropriate regulatory authorization in other countries. Investigator requests for funding for clinical studies should be made in writing on the institution’s letterhead to the Codman Clinical Research Committee (VP or Director of Clinical Research and Medical Affairs), 325 Paramount Drive, Raynham, MA 02767. The company will assess each funding request on a case-by-case basis. The following information is generally required as part of an institution’s or investigator’s request:

• Study proposal or premise, including:
  • Study design (e.g., retrospective or prospective, randomized or not, etc.)
  • Length of study
  • Number of subjects with statistical justification if relevant, and duration of follow-up
  • Study endpoints
• Study budget which addresses the following:
  • Direct costs related to research/clinical staff on study-related activities
  • Initial start-up costs prior to first enrolled subject
  • Study specific fees
  • Indirect costs
• Site’s qualifications to successfully perform the study

Requests for such funding must be presented to the company’s Clinical Research Committee, whose members include representatives 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:

• Area of study
• Scientific merit (e.g., study hypothesis)
• Scope of study
• Ethical considerations
• Budget (including the fair market value of budget components)

  No company employee or independent sales representative is authorized to commit clinical research funding to an investigator or institution.

  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.
  Protocol is of scientific worthiness and the concept is complete and adequate, addressing: 1) background and scientific rationale, 2) objectiveness, 3) study design, 4) study procedures, 5) clear endpoints, and 6) data analysis plan;

  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 Codman Clinical Research Committee (VP or Director of Clinical Research and Medical Affairs) or VP/Director of R&D (in-vitro studies), 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 Clinical Research Committee. The following factors are considered in deciding whether to fund the request:

  • Protocol is of scientific worthiness and the concept is complete and adequate, addressing: 1) background and scientific rationale, 2) objectiveness, 3) study design, 4) study procedures, 5) clear endpoints, and 6) data analysis plan;
  • Proposed budget is limited to fair market value relative to the proposed research;
  • Research facility and lab are appropriately qualified to conduct the research and have the capacity to achieve the study’s objectives; and
  • The researcher has been properly trained, is qualified to conduct or supervise the research, and has prior experience and/or has published in medical literature.

  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. 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

  Codman believes that formal engagement with health care providers is essential to further advances in safe and effective neurological treatment for patients. The company engages a number of appropriately qualified health care providers, primarily Neurosurgeons, Interventional Neuro-Radiologists and Endovascular Neurosurgeons, 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.”

  The company outlines necessary Consulting services in advance during its annual Needs Assessment process. The Needs Assessment outlines the nature and quantity of these necessary and planned services and must be approved by senior management. The Needs Assessment is closely tied to the company’s annual budget for such activities.

  All approved Consulting activities must be covered under a written contract with the Consultant. The agreement 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 in exchange for the services being performed. The company encourages the Consultant to disclose the existence of the agreement with his/her patients and institution, if not already mandated. In accordance with Johnson & Johnson’s commitment to transparency, the company will disclose payments made under consulting activities (and royalties) to U.S. physicians on its website by July 2011.

  No Codman 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 from the company. Professionals in Codman’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. 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.

  MEALS, ENTERTAINMENT, GIFTS AND TRAVEL

  Meals It is permissible for a company associate to conduct business-related discussions over a meal with a health care professional. Such meals are generally part of a sales call or company-sponsored training event or meeting. In all such instances the meal must be modest in nature and held at an appropriate venue for business discussions. Company associates must also abide by any policies established at a customer location if applicable. Individual institution policies and/ or state legislation may impose stricter limits. The stricter policy applies.

  The company has established the following modest per-person meal limits for its employees and independent sales representatives when interacting with an health care professional:

  • Breakfast: $25
  • Lunch: $50
  • Dinner: $125

  Government employees are subject to more stringent guidelines related to where and when meals are provided and the amount allowed.

  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.

  Gifts & Entertainment

  As a member of AdvaMed, Codman fully supports the “AdvaMed Code of Ethics on Interaction with Health Care Professionals.”

  In line with this Code of Ethics, entertainment is prohibited, 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.

  Gifts are also prohibited including branded and unbranded items.  However, educational items to HCPs may be provided occasionally and must benefit patients or serve a genuine educational function for the HCP.

  Travel
  
  The company generally provides travel arrangements for health care providers who participate in Codman Medical Education events, including training courses on company products. Registrants will be contacted by Medical Education with information related to travel for such events.

  Codman 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 Codman’s travel policy include the following:

  ·  Hotel accommodations must be modest and appropriate for the specific event. The company may not host events with health care providers at resort locations.
  ·  Air travel must generally be in coach class, except transoceanic flights over six (6) hours may be in business class which must be approved in advance or outlined in a Consulting agreement.
  ·  The company will not reimburse the travel expenses of a spouse or guest unless there is a bona fide reason for their participation, which must be approved by the company in advance of the trip.
  ·  Non-business related expenses, such as movie rental fees or personal items, will not be reimbursed by the company.

  ·  Reimbursement to a Consultant for allowable items will be made if accompanied by a detailed receipt. Photocopies are acceptable.

   

  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 Codman Professional Education event.

  Separate guidelines are in place for Government employees, who require an ethics officer letter of authorization to attend a company product training event. The letter, which outlines a complete description of the training to be offered, must be sent to the company for review 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.
   

  However, in accordance with ACCME, the company does offer educational grants to interns, residents, fellows and others who are health care professionals in training to attend major educational conferences (refer to Education Grants section of the page for further information).

   

  WORLDWIDE HEADQUARTER (WWHQ) VISITS

  A health care provider may be invited to the Codman worldwide headquarters facility in Raynham, Massachusetts, to meet with company personnel, attend product training, and tour the manufacturing and research facilities. Such visits can be an effective way for a health care provider to learn more about the company and its products.

  WWHQ visits generally are initiated by a sales representative after hearing of a health care provider’s interest in learning more about the company. The sales representative should contact the Medical Education Department to schedule the meeting, and often the sales representative will accompany the health care provider to Raynham during the visit.

  The health care provider’s travel expenses will be covered either by the company or the independent sales representative. In either case the company’s travel policies apply.

  Because such visits generally are initiated by a sales associate and do not involve the rendering of bona fide services to the company by the visiting health care provider, they are not considered billable Consulting activities. Accordingly, the company will not pay a fee or honorarium to the health care provider for the visit, and no Consulting services are expected from the health care provider during the visit. If confidential information is to be exchanged or offered by either party, an appropriate confidentiality agreement must be entered into before the date of the visit. Questions regarding such agreements should be discussed with the company’s Medical Education Department during the planning phase of the visit.

  INFORMATION REGARDING OFF LABEL USE OF COMPANY PRODUCTS

  As a manufacturer of health care products sold in the United States, Codman’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.

  Codman employees and independent sales representatives may not promote company products for use outside the scope of their FDA approval (commonly referred to as “off label”), nor may the company engage other parties, such as Consultants, to promote such off label use. The Government views such promotion as “misbranding” of the products and not permissible under the law.

  During an operating room procedure, a sales representative may respond to an unsolicited request for technical support related to the preparation and operation of the company’s medical device from a physician who, solely within his or her professional judgment, has elected to use that medical device for a use not described in the product labeling. The representative may answer questions only related to the labeled instructions of the device, its operating principles, its performance specifications, and similar technical information about the device.

  Because health care providers are not subject to the same restrictions and for purposes of patient safety, there may be occasions when a health care provider wishes to consult with the company about an unapproved use. Requests for off label information about Codman products, which must be unsolicited and not prompted by any company associate, may be directed to the Codman Regulatory Affairs Department (tel. 508-880-8100).

  REIMBURSEMENT SUPPORT

  Codman’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.

  Regardless of the components of the reimbursement, the health care provider has the sole responsibility for billing the third party insurer, including the complete and accurate preparation of “cost reports” and selection of the appropriate diagnosis related group (DRG) which often drives the amount reimbursed.

  The responsibility of Codman is to provide complete and accurate information on our invoices to customers who rely on this information to bill insurers. Invoices provided by the company will clearly outline the individual products actually purchased and the price paid for each. Any applicable discounts will be prorated to all products on the invoice, and if a rebate is subsequently paid the customer will receive a complete listing of the resulting net price paid for all products during the applicable period.

  Codman associates generally are not experts in the complex area of third party reimbursement. Given the roles and responsibilities described above, our company associates are not authorized to provide any guarantees about product reimbursement or profit to a health care provider, nor may they become involved in patient-specific insurance claims or appeals.

  The company may provide reimbursement-related materials on its products for informational purposes only, and Codman makes no representation, promise or guarantee concerning levels of reimbursement, payment or charge. Health care providers are advised to consult their local payer organizations with regard to local reimbursement policies.

  INVENTORY EXCHANGES

  Codman may provide new inventory to a customer in exchange for a customer’s own, existing Codman 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 Codman’s Finance Department and must be of equal value to the new inventory issued using the customer’s existing pricing.

  The customer must relinquish its existing, owned inventory to Codman in exchange for the replacement inventory. A credit memo will be issued for the products received by the company, offset by an invoice for the new products issued. The customer is under no obligation to purchase additional products from Codman as a direct result of the exchange. However, minimum purchase commitments, enabling a customer to earn certain volume discounts, may be in effect pursuant to a separate pricing agreement.

  A health care provider should contact the local Codman sales representative for more information on inventory exchanges.

  REPORTING SUSPECTED VIOLATIONS

  Conducting our business in an ethical manner, consistent with all applicable laws and regulations, is the responsibility of every Codman 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.

  Suspected violations of Codman’s HCC policies, as well as any other allegation of impropriety (such as threats and physical violence, financial fraud, workplace discrimination, environmental or safety concerns, alleged off label promotion, conflicts of interest, sexual harassment, anti-trust, Sarbanes Oxley exceptions, patient privacy concerns, other ethical violations, etc.) may be reported to the company’s Director of Health Care Compliance HCCDPYUS@its.jnj.com. or other appropriate senior manager of the company (tel. 508-880-8100).

  For those who wish to remain anonymous, a toll-free hotline has been established in the US to report suspected violations: 1-800-371-2029. The hotline is managed by an outside vendor, who will log the call and route it to the appropriate member of company management for investigation. The caller may be provided with a case number to check on the status at a future date.

  A website also has been established for those who wish to report a suspected violation online. Please visit: https://www.credohotline.com for more information on how an alleged incident may be reported to the company online.

   Questions and comments about these and other HCC policies may be directed to the Director of Health Care Compliance, Codman’s chief compliance officer, at (508) 880-8100 or HCCDPYUS@its.jnj.com.