This Health Care Compliance Program sets forth CONMED Corporation’s principles and rules underlying our interactions and relations with Health Care Professionals. Additional, more specific rules relating to consulting and other arrangements with Health Care Professionals are contained in CONMED’s Corporate Policy “Consulting and Other Arrangements with Health Care Practitioners and Institutions,” which is available from the Legal Department and on the Company’s Intranet. The term “Health Care Professional” is used in this document to refer to any individual or entity that is authorized or licensed to provide health care services or items to patients (e.g., physicians, nurses, pharmacists, hospitals, and ambulatory surgical centers) or is involved in the decision to purchase, order, lease, use, recommend or prescribe CONMED’s medical devices (e.g., in addition to the parties and entities above, administrative personnel at provider entities such as hospital purchasing agents),1 in other words, our customers and potential customers. This Health Care Compliance Program applies to all employees of CONMED and its subsidiaries, as well as the sales representatives and distributors who operate as CONMED’s sales agents or representatives (who are collectively referred to herein as simply “CONMED”).
At CONMED, we recognize that Health Care Professionals play an essential role in the development, testing and training involved in producing safe and effective medical devices. We also recognize that the best interests of the patient can be well served by a collaborative relationship with Health Care Professionals. Our goal in developing this Health Care Compliance Program is to ensure that our collaborative relationships do more than merely comply with applicable laws, regulations and government guidance—we aim to meet the highest ethical standards and achieve appropriate transparency so as to surpass the minimum standards of compliance.
To that end, we have adopted this Health Care Compliance Program, which is modeled on the Advanced Medical Technology Association (AdvaMed) Revised and Restated Code of Ethics on Interactions with U.S. Healthcare Professionals (most recently updated effective January 1, 2020 (the “AdvaMed Code”). AdvaMed is an organization representing companies such as CONMED that develop, produce, manufacture and market Medical Technologies (medical devices and products, technologies, digital and software platforms, and related services, solutions, and therapies used to diagnose, treat, monitor, manage, and alleviate health conditions and disabilities).2 “This Health Care Compliance Program also incorporates certain standards mandated by law or regulation. In some cases, local jurisdictions have adopted unique regulations for dealing with Health Care Professionals in their jurisdiction. Because CONMED is committed to complying with all laws and regulations in every jurisdiction where it does business, those regulations are set forth in Exhibit A hereto and are incorporated by reference.
In addition to the standards on interactions with Health Care Professionals, CONMED’s Health Care Compliance Program includes compliance with requirements for reporting of payments and other transfers of value made to certain Health Care Professionals, as required by the various physician payment acts (“Physician Payment Acts”). Under the Physician Payments Sunshine Act, CONMED and its subsidiaries must report annually to the U.S. Centers for Medicare and Medicaid Services (“CMS”) the payments and transfers of value made to physicians and teaching hospitals, as well as direct and indirect ownership and investment interests held by physicians. Transfers of value include, among other things, meals and lodging associated with medical education and training, compensation for consulting services, royalty payments and licensing fees, research and clinical trial-related expenditures, grants and charitable donations, and other lawful courtesies provided to Health Care Professionals in the course of doing business. Reports for each calendar year are due by March 31st of the following year, and the data reported will be posted on a searchable and publicly available website in an effort to promote transparency between physicians and the drug and device industries. Note that the Sunshine Act applies to interactions with U.S. physicians regardless of the country where those interactions occur. In addition, due to revisions to the Sunshine Act, in 2021 we will begin tracking payments and other transfers of value made to nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, certified nurse midwives, physician assistants, and other mid-level practitioners. Reporting requirements take effect in 2022 for payments and other transfers of value made in 2021. CONMED will comply with the requirements of all Physician Payment Acts in the jurisdictions where it conducts business.
CONMED has also implemented elements designed to support an effective compliance program, informed by government guidance and the AdvaMed Code. CONMED has addressed the seven following areas of compliance as recommended by the U.S. Department of Health and Human Service Office of Inspector General (“HHS-OIG”):
- Designating a Compliance Officer/Compliance Committee
- Implementing Written Standards
- Developing Effective Lines of Communication
- Conducting Effective Education and Training
- Conducting Internal Auditing and Monitoring
- Enforcing Standards through Well-Publicized Disciplinary Guidelines
- Responding Promptly to Detected Offenses and Undertaking Corrective Action
CONMED has established a Compliance Committee, whose duties include, among other things, the administration, interpretation and application of the Health Care Compliance Program. The Compliance Committee shall report any alleged violations of the Health Care Compliance Program and the Corporate Policy on Consulting and Other Arrangements with Health Care Practitioners and Institutions to the Audit Committee of CONMED’s Board of Directors.
Employees who have any questions relating to this Health Care Compliance Program, or who become aware of a situation that is or may potentially be a violation, should contact any member of the Compliance Committee or the Legal Department. They may also report a violation or suspected violation to their supervisor, or to CONMED’s Company Hotline at 844-238-8430 or https://conmed.ethicspoint.com.3 All reports made through the Hotline may be made anonymously. The Company will not allow retaliation against any employee for reports made in good faith.
Violations of this Health Care Compliance Program will lead to disciplinary action, up to and including termination of employment.
The principal law in the United States governing CONMED’s relations with Health Care Professionals is the federal Anti-Kickback Statute (“AKS”), which establishes severe civil and criminal penalties for anyone who knowingly and willfully offers or pays (or solicits or receives) any “remuneration” in cash or in kind, directly or indirectly, to induce someone (e.g., a doctor or hospital) to purchase, lease, recommend or prescribe any item for which payment may be made under any federal or state health care program. Under current judicial and administrative decisions, a violation may be found even if only one purpose of the “remuneration” is to induce the purchase of products; it does not matter if there are other legitimate purposes for the payment. In addition, there does not have to be an agreement to purchase in exchange for the remuneration, and there is no requirement that the remuneration result in an increase in state or federal health care expenditures. There are established regulatory safe harbors that if fully satisfied will relieve companies of potential exposure under the AKS. Actions that do not fit into a regulatory safe harbor under AKS are not per se violations of the statute but will be evaluated in terms of all facts and circumstances.
If it were to be determined that CONMED violated the AKS, our customers and potential customers could be barred from seeking Medicare or other governmental reimbursement from government health care programs for their purchases of CONMED’s products. In addition, CONMED and/or our officers and employees could face stiff fines and exclusion/debarment from all federal and state health care programs. Individuals, moreover, could face potential jail sentences for violations of this statute.
There is additional potential exposure under other healthcare laws. For example, under the AKS a claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim under the False Claims Act.
Many states have similar anti-kickback laws, and in some cases these laws apply regardless of the payor (i.e., whether government or commercial, or self-pay).
The AdvaMed Code refers to the concept of an “unlawful inducement” to reflect the prohibitions found in the AKS.
This Health Care Compliance Program is designed to ensure, to the maximum extent possible, that payments to Health Care Professionals do not run afoul of anti-kickback and similar laws.
III. CONSULTING ARRANGEMENTS WITH HEALTH CARE PROFESSIONALS
Health Care Professionals can provide valuable bona fide services, including research, product development and/or transfer of intellectual property, marketing, participation on advisory boards, presentations at CONMED-sponsored training, and product collaboration. Arrangements of this nature and involving these services are referred to for purposes of this policy as consulting arrangements. It is appropriate to pay Health Care Professionals fair market value compensation for performing these services intended to fulfill a legitimate business need. However, consulting arrangements must be bona fide and not be used to incentivize or reward or pay Health Care Professionals for purchasing CONMED products or services or to influence such purchasing decisions. The following are required for any arrangement between CONMED and consultants:
- Consulting arrangements must be in writing, in a form and in an amount approved by the Compliance Committee, signed by the parties and specify all services to be provided. If the contract is for clinical research services, there must also be a written research protocol.
- Consulting arrangements should be entered into only where a legitimate need and purpose for the services is identified in advance and documented. A legitimate need arises when CONMED requires the services of a Health Care Professional to achieve a specific objective, such as the need to train Health Care Professionals on the technical components of safely and effectively using a product; the need for clinical expertise in conducting product research and development; or the need for a physician’s expert judgment on clinical issues associated with a product. The number of Health Care Professionals retained must not be greater than the number reasonably necessary to achieve the identified purpose.
- Selection of a consultant should be based on the consultant’s qualifications and expertise to address the identified CONMED purpose. Qualifications to consider include the consultant’s specialty, years of experience, practice setting, speaking and publication experience, or experience with, usage of, or familiarity with a specific CONMED Medical Technology. Subjective factors, such as recognition as a thought leader or the ability to effectively deliver training content, may also be taken into consideration. The volume or value of the Health Care Professional’s past, present or anticipated business should not be a factor in selection. Consultants are only selected from among Health Care Professionals who have been duly vetted by CONMED.
- Compensation paid to a consultant should be consistent with fair market value in an arm’s-length transaction for the services provided, and may not be tied to the volume or value of purchases or referrals or other business with CONMED. Fair market value should incorporate objective criteria in its analysis.
- CONMED may pay for documented, reasonable and actual expenses incurred by a consultant in carrying out the subject of the consulting arrangement, including reasonable and actual costs for travel and lodging, and modest meals incurred by consultants attending meetings with, or on behalf of, CONMED. CONMED may not reimburse meals or travel expenses for the consultant’s guests.
- The place and circumstances for meetings with consultants should be appropriate to the subject matter of the consultation and there must be objective, legitimate reasons that support the need for out-of-town travel and lodging. Any legitimate need for travel will be documented by CONMED. These meetings should be conducted in clinical, educational, conference, or other settings, including hotel or other commercially available meeting facilities, conducive to the effective exchange of information. Meetings with consultants at lavish hotels or resort locations are not appropriate.
- Any meals and refreshments provided in conjunction with a consultant meeting should be modest in value and should be subordinate in time and focus on the bona fide discussion and presentation of scientific, educational, or business information. CONMED may not provide recreation or entertainment in conjunction with these meetings.CONMED should confirm the services provided by a Health Care Professional are in accordance with the written consulting agreement. Records of the services provided by the consultants should be maintained in accordance with legal requirements and Company policy.
- CONMED’s sales personnel may provide input about the suitability of a proposed consultant, but are not to control or unduly influence the selection. The ultimate decision and authority to engage a particular consultant resides with the head of the particular business unit (Vice President and General Manager or President).
- If the consultant has developed or contributed to the development or improvement of a product, it may be appropriate to pay the consultant a royalty. Any such royalty arrangement must be in writing, comply with the standards set forth above, and meet the following additional requirements:
- The contribution to the development of any CONMED product, technology, process, or method by the consultant must be novel, significant and innovative, and must be appropriately documented if it is the basis for compensation.
- The calculation for royalties payable to a consultant in exchange for Intellectual Property must be based on factors that preserve the objectivity of medical decision-making and may not be conditioned on a requirement that the consultant purchase, order or recommend any of CONMED’s products or any product produced as a result of the development project.
- Royalties may not be conditioned on a requirement to market the product upon commercialization. However, CONMED may elect to enter into a separate consulting agreement with the consultant for marketing services if such services meet the requirements set forth above.
- CONMED should be mindful of potential conflict of interest considerations that may exist relative to Health Care Professionals, based on other positions held or roles with other organizations or entities.
IV. COMPANY-CONDUCTED PROGRAMS & MEETINGS WITH HEALTH CARE PROFESSIONALS
CONMED recognizes the importance of providing training to Health Care Professionals on the safe and effective use of our medical devices. Such programs may occur at centralized locations (requiring out-of-town travel for some participants), and may extend more than one day. For local and State-specific restrictions in this area, if any, please refer to Exhibit A. With regard to CONMED product training and education for purchasers:
- Programs and events should be conducted in settings, whether live or virtual, that are conducive to the effective transmission of information. These may include clinical, educational, conference, or other settings, such as hotels or other commercially available meeting facilities. In some cases, it may be appropriate for a CONMED representative to provide training and education at the Health Care Professional’s location.
- Programs providing “hands on” training on CONMED’s medical devices should be held at training facilities, medical institutions, laboratories, or other appropriate facilities.
- All faculty and training staff should have the proper qualifications and expertise to conduct such training. Training staff may include Health Care Professionals or qualified Company personnel (e.g., field sales employees who have the technical expertise necessary to perform the training).
- Health Care Professionals must have a legitimate need to attend any training programs.
- Where there are objective, legitimate reasons to support the need for out-of-town travel to efficiently deliver training and education on the Company’s products, CONMED may pay for reasonable and modest travel and lodging costs of the attending Health Care Professionals. Travel and lodging are addressed further in Section VII.
- CONMED may provide Health Care Professional attendees with modest meals and refreshments in connection with these programs. Any such meals and refreshments should be modest in value and subordinate in time and focus to the training and/or educational purpose of the meeting. The meal or refreshments should not be part of any entertainment or recreational event. Meals and refreshments are addressed further in Section VIII.
- It is not appropriate for CONMED to pay for the meals, refreshments, travel, or other expenses for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared or for whom there is no legitimate need for their attendance at the meeting.
CONMED may identify a legitimate need to conduct other types of business meetings with Health Care Professionals to discuss, for example, Medical Technology features, sales terms, Company service offerings and their impact on health care delivery, product line offerings, health economics information, or purchase contract arrangements. Other examples could include plant or facility tours, meetings to demonstrate equipment, or meetings to explore product development or clinical testing needs. In addition to ensuring there is a legitimate need for a potential business meeting, the setting should be appropriate in terms of location (e.g., at or close to a Health Care Professional’s place of business, another centralized location, or a Company facility, as appropriate to the topics to be discussed), and in all instances conducive to the discussion of relevant information. Health Care Professional attendees should be limited to those with an objective, legitimate need to attend the business meeting. Travel and lodging, and meals and refreshments, are subject to Sections VII and VIII.
V. EDUCATIONAL & RESEARCH GRANTS, CHARITABLE DONATIONS, AND COMMERCIAL SPONSORSHIPS
CONMED may provide monetary, in-kind, and other contributions to third parties in support of their educational, charitable, and research programs as described in this section.
A “Third-Party Organizer” is a third-party entity that organizes and/or oversees the development of the Third-Party Program, including the selection of presenters, attendees, topics, materials, and methods. A Third-Party Program Organizer could include, for example, a health care professional society, institution, and association, medical trust fund, continuing medical education provider, or hospital or other health care entity.
A “Third-Party Program” is a bona fide, independent health care-related educational, scientific, business, and/or policymaking conference, meeting, or event put on by a third party other than the Company. This term includes programs that are accredited to provide continuing education credits and programs that are not accredited.
A “Satellite Symposium” is a Company-organized and funded program that is appended to a Third-Party Program agenda but that the Third-Party Organizer does not control. These programs often take place during meal breaks at the Third-Party Program and may address education and training topics that coincide with the Third-Party Program’s focus. A Satellite Symposium does not include a Company-organized meeting, training, or educational session (such as an advisory board, consultant meeting, or product education session) that (a) may be held in close physical and temporal proximity to a Third-Party Program and (b) is not appended to or included in the Third-Party Program’s official agenda.
An “Educational Grant” is a payment or in-kind support to a third-party entity (e.g., a Third-Party Program Organizer or a training institution) to reduce the costs of providing education. An Educational Grant is not offered for Commercial Sponsorship opportunities.
A “Commercial Sponsorship” is a payment or in-kind support provided to a third party in exchange for advertising or promotional opportunities for the Company (e.g., a Company exhibit at a Third-Party Program).
Additional key principles are addressed below, and additional examples and Frequently Asked Questions about appropriate practices are provided in the AdvaMed Code.
A. Supporting Third-Party Programs Through Educational Grants and Commercial Sponsorship
CONMED will adhere to all standards established by the Third-Party Program Organizer or the body accrediting the Third-Party Program, as applicable. If permitted by applicable standards, CONMED can: (a) recommend knowledgeable faculty or appropriate categories of attendees; or (b) select and send faculty to the Third-Party Program to speak on CONMED’s behalf, provided that CONMED contracts with the faculty subject to the AdvaMed Code and an appropriate disclosure is made to the Program attendees that the faculty is presenting on behalf of and paid by CONMED. CONMED will not pass along to any Health Care Professional any of the benefits that CONMED receives in exchange for its final support to a Third-Party Program (e.g., golf foursome).
1. Educational Grants
Educational grants may be provided for legitimate purposes, including but not limited to the examples below. CONMED may not make educational grants directly to individual Health Care Professionals. CONMED may provide education grants to or sponsor the cost of Third Party Programs.
- CONMED may make grants for the purpose of supporting education of patients or the public about important health care topics.
- Except as provided below with regard to faculty expenses for CONMED-sponsored Satellite Symposia, CONMED will not provide any contribution (whether monetary or in-kind) directly to an individual Health Care Professional or pay directly for an individual Health Care Professional’s registration, fees, or travel or lodging expenses to attend a Third-Party Program. This prohibition does not preclude CONMED from paying for a Health Care Professional’s modest and reasonable travel and lodging expenses to attend a separate, unrelated CONMED-organized training or educational session or consultant meeting (for example an advisory board). (See Section IV Company Conducted Programs & Meetings with Health Care Professionals)
- CONMED may provide grants only to organizations with a genuine educational function, including third-party conference sponsors and training institutions. Grants must be consistent with the standards established by the conference sponsor and any accrediting body for the educational activity. CONMED may provide a grant to the conference sponsor to reduce conference costs. CONMED may also provide grants to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows, and others who are in training (except as limited by state law, see Exhibit A). Grants must be paid directly to the conference sponsor, not an attendee, and cannot be used to reduce the registration expenses for designated participants.
- CONMED may provide funding to the conference sponsor to support the provision of modest meals and refreshments to conference attendees. Also, CONMED itself may provide meals and refreshments for all attendees, but only if it is provided in a manner that is also consistent with the guidelines of the conference sponsor and the body accrediting the educational activity. Any meals and refreshments should be modest in value, subordinate in time and focus to the purpose of the conference, and clearly separate from the continuing medical education portion of the conference. For local and State-specific restrictions, refer to Exhibit A.
- CONMED may make grants to conference sponsors for reasonable speaking or teaching fees, travel, lodging, and modest meals for bona fide conference faculty members. CONMED may not make the grant directly to the faculty member unless the faculty member is subject to a written CONMED consulting agreement entered into in accordance with this Health Care Compliance Program (refer to Section III, “Consulting Arrangements with Health Care Professionals”), the speaking arrangement is part of the services being provided to CONMED under that agreement, and the faculty member discloses to the conference sponsor that his/her expenses and/or fees are being paid by CONMED under a consulting agreement.
2. Commercial Sponsorships
CONMED may provide payment or in-kind support, or commercial sponsorships, of a Third-Party Program, for a commercially reasonable fee, in exchange for marketing and promotional benefits such as advertising, signage, display/exhibit space or other promotional opportunities.
3. Satellite Symposia
- The opportunity to host a Satellite Symposium may be offered to CONMED if it provides a Commercial Sponsorship in support of a Third-Party Program. A Satellite Symposium is a Company-organized and funded program that is appended to a Third-Party Program agenda but that the Third-Party Organizer does not control. These programs often take place during meal breaks at the Third-Party Program and may address education and training topics that coincide with the Third-Party Program’s focus. If CONMED hosts a Satellite Symposium it will clearly disclose that it is a Company-conducted event.
- If CONMED has engaged a Health Care Professional to serve as a bona fide faculty member on its behalf consistent with Section III, including at a Satellite Symposium, it may cover the Health Care Professional’s relevant registration fees (limited, as appropriate, to the time necessary to speak at the Satellite Symposium) as well as modest and reasonable travel and lodging expenses, subject to Section VII.
B. Supporting Other Third-Party Programs through Educational Grants
CONMED may provide Educational Grants to training institutions (such as medical schools and teaching hospitals) and to other third-party entities in support of their legitimate educational and training programs and activities. This includes, but is not limited to, Educational Grants to support the education and training of health care and medical personnel (for example, physicians, medical students, residents, fellows, or other Health Care Professionals-in-training), patients, and the public about important health care topics.
C. Supporting Independent Third-Party Research
Research provides valuable scientific and clinical information, improves clinical care, leads to promising new treatments, promotes improved delivery of health care, and otherwise benefits patients. In furtherance of these objectives, CONMED may provide research grants to support independent medical research with scientific merit and has established controls for reviewing requests for research grants. Such activities must have well-defined goals, objectives, and milestones set forth in a written contract, and may not be linked directly or indirectly to the purchase of CONMED’s products. Unrestricted research grants are not permitted.
- Research requests should be accompanied by clinical protocols that outline objectives and milestones; requests should also document the nature and scope of research activity, budget, duration of research, and requirements for independent authorizations or approvals.
- Research grants may include in-kind or monetary support for legitimate, study-related, documented expenses or services and/or reasonable quantities of no-charge product for the limited duration of the research.
- The recipient of CONMED monetary or in-kind research support will retain independent control over the research.
- CONMED’s sales personnel may provide input about the proposed research program or recipient, but will not control or unduly influence the decision of who will receive support or the amount of the support.
D. Supporting Charitable Programs through Charitable Donations and Commercial Sponsorship
CONMED may make monetary and/or in-kind charitable donations of product or equipment for a bona fide charitable purpose, such as supporting indigent care, patient education, public education, community support, or the sponsorship of events where proceeds are intended for charitable purposes. Donations should be made only to charitable organizations that are separate from, and not related to, a Health Care Professional (e.g., donations should not be made to the Health Care Professional’s own charitable foundation). CONMED may also provide Commercial Sponsorships in support of events where the proceeds are intended for charitable purposes.
- All requests for charitable contributions must be supported by a letter from the entity requesting the contribution. The letter must describe the purpose of the contribution and confirm that the requesting party is a charitable entity. The letter should have as much supporting information as possible in order that CONMED may conduct its due diligence on the request including, for example, the entity’s tax status, the corporate status under relevant state law, and the charitable mission or purpose.
- No donation may be made in exchange for a purpose of inducing a Health Care Professional to purchase or lease or to recommend the purchase or lease of CONMED products or services. CONMED should not fund a charitable request from a Health Care Professional in which that Health Care Professional describes its past or future purchases of CONMED products as a reason for CONMED to provide charitable funds.
- Charitable donations may only be made to charitable organizations, which may include charitable foundations affiliated with Health Care Professionals as long as the foundation is truly a separate entity from the Health Care Professional. No donation may be made directly to a Health Care Professional.
- CONMED employees may not make charitable donations on behalf of CONMED.
- Sales, marketing or service personnel may provide input about the suitability of a proposed charitable donation recipient or program, but they will not control or unduly influence the decision of whether a particular entity will receive support or the amount of support received. All charitable donations must be approved by the head (Vice President and General Manager or President) of the particular business unit.
- CONMED will not pay for or provide tickets to Health Care Professionals or their spouses or guests to attend charitable events such as galas and golf outings.
- Donations must be pre-approved by the Compliance Committee through the established processes and use of the approved donation form.
- CONMED may also provide a commercial sponsorship in support of a charitable fundraising event, separate from any charitable donations, and should reflect a commercially reasonable fee in exchange for any marketing and promotional benefits and also comply with applicable laws related to marketing and promotion of the Company products.
VI. JOINTLY CONDUCTED EDUCATION AND MARKETING PROGRAM
CONMED is permitted to partner with Health Care Professionals to jointly conduct education and marketing programs in relation to its medical devices. These programs serve an important purpose by allowing CONMED and Health Care Professionals to educate patients and other Health Care Professionals on medical conditions and the range of testing or treatment options available, including the availability of CONMED’s products and the Health Care Professional’s ability to diagnose or treat related medical conditions.
In conducting joint education and marketing programs with Health Care Professions, CONMED adheres to the following principles:
- CONMED must identify a bona fide, legitimate need to engage in the activity for its own educational or marketing benefit.
- CONMED has established controls to help ensure that decisions to engage in these arrangements are not made as an unlawful inducement, and CONMED will require Health Care Professionals participating in these arrangements to comply with its guidelines on, for example, providing information related to CONMED’s product labeling and guidelines for furnishing appropriate health economics information, among other controls.
- Jointly conducted education and marketing programs should be balanced and promote both CONMED and its medical devices, and the Health Care Professional and the range of services offered for the diagnosis and treatment of related medical conditions.
- CONMED and the Health Care Professional should serve as bona fide partners in the program and should make equitable contributions towards the activity and costs (e.g., developing content, invitations, space rental, AV needs, and other production costs).
- The arrangement with the Health Care Professional will be documented in a written agreement that describes the purpose of the jointly conducted education and marketing program, and the roles, responsibilities, and contributions of each party.
VII. TRAVEL AND LODGING; VENUE
CONMED may pay for modest and reasonable travel and lodging costs for Health Care Professionals to attend Company-conducted programs or meetings under certain circumstances. In all instances, CONMED must identify objective, legitimate reasons to support the need for travel and lodging for Health Care Professionals. CONMED will follow all applicable state and federal laws and regulations related to paying for Health Care Professional travel and lodging, and will also apply the following principles:
- There must be objective, legitimate reasons that support the need for out-of-town travel, such as the need to deliver training and education, the inability to effectively deliver the content of the program through means other than an in-person meeting, or the need to demonstrate CONMED’s products. Legitimate need for travel will be appropriately documented by CONMED.
- Travel and lodging accommodations and costs must be modest and reasonable under the circumstances. CONMED has established controls on the appropriate class of travel service, the appropriate level of lodging accommodations, and the timing and location of travel arrangements for Health Care Professionals.
- CONMED may not pay for or otherwise subsidize the travel or lodging of spouses or guests of Health Care Professionals or any other person who does not have a bona fide professional interest in the information being shared at any CONMED meetings, nor will CONMED pay for a Health Care Professional’s personal travel or lodging.
- The setting for any CONMED program or meeting with Health Care Professionals should be conducive to the exchange of information and should not be the main attraction of the event. The setting should be centrally located and easily accessible in relation to the place of origin of the invited participants; the setting should not be selected because of its entertainment or recreational facilities; and CONMED will not host any program or meeting at top category or luxury hotels or resort facilities without an appropriate justification.
VIII. PROVIDING MODEST MEALS AND REFRESHMENTS TO HEALTH CARE PROFESSIONALS
In connection with product training, conferences, business meetings, and other interactions with Health Care Professionals described herein, CONMED may provide modest meals and refreshments to Health Care Professionals as an occasional business courtesy consistent with the limitations in this section. For local and State-specific restrictions, refer to Exhibit A.
- Purpose. The meal should be subordinate in time and in focus to the discussion and presentation of scientific, educational, or business information and provided in a manner and place conducive to the presentation of such information. The meal cannot be part of an entertainment or recreational event.
- Setting and Location. Meals should be in a setting that is conducive to bona fide scientific, educational, or business discussions, which may include the Health Care Professional’s place of business or an outside location if the place of business is not available for (e.g., a restaurant), or conducive to, such scientific, educational, or business discussions. Examples of when it may be appropriate to provide meals outside the Health Care Professional’s place of business include (1) where the products cannot easily be transferred to the Health Care Professional’s location, (2) when it is necessary to discuss confidential product development or improvement information, or (3) where a private space cannot be obtained on site.
Notwithstanding the foregoing, under no circumstances may meals be provided to a Health Care Professional in violation of state law. For example, Massachusetts prohibits companies from providing or paying for meals for a Health Care Professional in certain settings, and Vermont prohibits companies from providing meals directly to Health Care Professionals altogether. Because state laws vary, all requests for reimbursement of a meal provided to a Health Care Professional must be on a Company-approved form available on the Company intranet.
- Participants. CONMED may provide a meal only to Health Care Professionals who actually attend the meeting and have a bona fide purpose for attending the meeting. CONMED may not provide a meal for an entire office staff where everyone does not attend the meeting. CONMED also may not provide a meal where its representative is not present for the educational portion of the program (sometimes referred to as a “dine and dash” program). CONMED may not pay for meals for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.
IX. EDUCATIONAL & PATIENT BENEFIT ITEMS; PROHIBITION ON GIFTS
CONMED may not provide branded, promotional items or gifts to Health Care Professionals. A limited exception is that, except where prohibited by local or state law (see Exhibit A), CONMED may occasionally provide items to Health Care Professionals that benefit patients or serve a genuine educational function. Examples of such items include medical textbooks, anatomical models, and short-term subscriptions to scientific, industry or peer-related publications. Any other educational items should have a fair market value of less than $100.
CONMED may not give Health Care Professionals any type of complimentary non-educational branded promotional items, even if the item is of minimal value and related to the Health Care Professional’s work or for the benefit of patients. Examples of non-educational branded promotional items include pens, notepads, mugs, and/or other items that have a company name or logo, or the name or logo of a company product. CONMED also may not give a Health Care Professional gifts such as cookies, wine, flowers, chocolates, gift baskets, holiday gifts or cash or cash equivalents, regardless of the occasion. Finally, CONMED may not provide items that are capable of use by the Health Care Professional (or his or her family members, office staff or friends) for non-educational or non-patient-related purposes, such as office supplies, scrubs, a tablet, Smart Phone, laptop, or other mobile device capable of personal use.
This section is not intended to address the legitimate practice of providing products for evaluation and demonstration purposes, which is addressed in Section XIII.
X. PROHIBITION ON ENTERTAINMENT AND RECREATION
CONMED does not provide entertainment or recreation to Health Care Professionals in any form. Some examples of entertainment and recreational activities (which are prohibited) include, among others, theater, sporting events, golf, skiing, hunting, or vacation trips. This prohibition applies regardless of : (1) the value of the activity; (2) whether CONMED engages the Health Care Professional as a consultant; or (3) whether the entertainment or recreation is secondary to an educational purpose.
XI. COMMUNICATING FOR THE SAFE AND EFFECTIVE USE OF MEDICAL TECHNOLOGY
CONMED recognizes that ensuring access to truthful and non-misleading information relating to its products is critical to Health Care Professionals’ ability to exercise medical judgment, to provide high-quality care, and to safely use available Medical Technology. Health Care Professionals may use a product for any use that they determine is in the best medical interests of their patients. This includes uses that are contained in CONMED’s product labeling or otherwise consistent with such labeling, but it could also include uses that are not approved or cleared (i.e. “off-label” uses). As recognized under U.S. law and by the FDA, off-label use of these medical devices can be an important part of medical practice and may even constitute a medically recognized standard of care.
CONMED has developed policies and controls that incorporate principles of applicable law and guidance relative to communications about its medical devices.
CONMED may engage in industry-appropriate communications of information, which can include, among other activities:
- Proper dissemination of peer-reviewed scientific and medical journal articles, reference texts, and clinical practice guidelines;
- Presentations at educational and medical meetings regarding clinical trial results or research and development data for an investigational use (taking care that no claims are made regarding safety and effectiveness); and
- Discussions with consultants and Health Care Professionals to obtain advice or feedback relating to topics such as unmet patient needs, product research and development, and the like.
CONMED has a responsibility to communicate about medical and scientific information to assist in achieving positive patient outcomes and support of the public health, and will do so by ensuring that: (1) only authorized Company personnel provide responses about unapproved or uncleared uses of its medical devices; (2) communications about medical devices are truthful and non-misleading; and (3) information related to unapproved or uncleared uses of its Medical Technology is identified as such.
XII. PROVISION OF HEALTH ECONOMICS AND REIMBURSEMENT INFORMATION
CONMED may provide Health Care Professionals with timely and complete coverage, reimbursement and health economics information regarding its products if such information is accurate, objective, and readily available. CONMED may also collaborate with Health Care Professionals, patients and organizations representing their interests, to achieve government and commercial payor coverage decisions, guidelines, policies, and adequate reimbursement levels that allow patients to access CONMED’s products. CONMED may, at the request of a Health Care Professional to facilitate patient access to its products and subject to the appropriate privacy safeguards, assist the patient by facilitating the preparation and submission of requests for coverage determinations, prior authorizations, pre-certifications and appeals of denied claims; however, such assistance may not be provided as an unlawful inducement.
CONMED may not interfere with a Health Care Professional’s independent clinical decision-making or provide coverage, reimbursement and health economics support as an unlawful inducement to purchase, lease, recommend or prescribe any CONMED product or service. For example, CONMED may not provide free services that eliminate an overhead or other expense that a Health Care Professional would otherwise of business prudence or necessity have incurred as part of its business operations if doing so would amount to an unlawful inducement to purchase, lease, recommend or prescribe any CONMED product or service. Furthermore, CONMED may not suggest a mechanism for billing for services that are not medically necessary, or for engaging in fraudulent practices to achieve inappropriate payment.
XIII. EVALUATION, DEMONSTRATION, AND CONSIGNED PRODUCTS
CONMED may provide reasonable quantities of products to Health Care Professionals at no charge for evaluation and assessment, and to determine whether to purchase the product. CONMED may also provide Health Care Professionals with non-sterile demonstration units to use in educating patients about the product and its use.
These products may be provided at no charge to allow Health Care Professionals to assess the appropriate use and functionality of the product and determine whether and when to use, order, or recommend the product in the future. CONMED products provided for evaluation are typically expected to be used in patient care.
- Single Use/Consumables/Disposables. The number of single use products provided at no charge may not exceed the amount reasonably necessary for the adequate evaluation of the products under the circumstances.
- Multiple Use Products/Capital Equipment. Such products provided without transfer of title for evaluation purposes may be furnished only for a period of time that is reasonable under the circumstances to allow an adequate evaluation and consistent with any applicable transparency reporting requirements. The length of time may depend, for example, on the type of products, frequency of anticipated use, and the duration of required training, among other things. The terms of an evaluation of such products must be set in advance in writing specifying the length of the evaluation period, and the contract must also provide that CONMED will retain title to such products during the evaluation period and that the products must be returned to CONMED at the conclusion of the evaluation period unless the Health Care Professional chooses to purchase or lease the products. For State-specific restrictions, if any, refer to Exhibit A.
- Demonstration. Demonstration products are typically unsterilized single-use products or mock-ups of such products that are used for Health Care Professional and patient awareness, education, and training. For example, a Health Care Professional may use a demonstration product to show a patient the type of device that will be implanted in the patient. Demonstration products are not intended to be used in patient care and should be identified as not intended for patient use by use of such designations as “Sample”, “Not for Human Use”, or other suitable designation on the product, the product packaging, and/or documentation that accompanies the product.
- Consigned Products. Consigned products are medical devices that: CONMED provides to a Health Care Professional for use in a patient care setting and which CONMED retains title until the product is used. Consigned products should be subject to contractual arrangements that address the terms of, for example, the number of products, any requirements to segregate the consigned products from other products, and, if applicable, any space rental terms. CONMED will establish appropriate controls for consigned products for purposes such as billing and restocking, reconciling record discrepancies between the number of products used or verified during inventory, and removal of expired product.
Appropriate documentation and disclosure should be provided to Health Care Professionals regarding the no-charge status of evaluation and demonstration products.
XIV. TECHNICAL SUPPORT PROVIDED IN THE CLINICAL SETTING
CONMED sales representatives may play an important role in the clinical setting by providing technical support on the safe and effective use of Medical Technology. For example, a CONMED sales representative may need to explain the unique settings and technical controls functions of our products, and may also make recommendations. CONMED sales representatives may also assist the clinical/operating room team to ensure that the appropriate range of necessary devices and accessories are available during a procedure, especially when dealing with Medical Technology that involves multiple devices and/or accessories.
CONMED will adhere to the following principles when providing technical support in clinical settings:
- Company representatives should enter and be present in the clinical setting only at the request of, and under the supervision of, a Health Care Professional.
- Company representatives should be transparent that they are acting on behalf of CONMED in a technical support capacity.
- Company representatives should not interfere with a Health Care Professional’s independent clinical decision-making.
- Company representatives should comply with applicable hospital or facility policies and requirements, including patient privacy and credentialing requirements.
- A Company’s technical support should not eliminate an overhead or other expense that the Health Care Professional should otherwise incur while providing patient care.
This Health Care Compliance Program does not and cannot answer every question or address every possible situation. It is important to follow not only the letter of applicable law and guidance, the AdvaMed Code, and the Program, but also the spirit. Additionally, specific rules and regulations regarding consulting and other arrangements with Heath Care Professionals are contained in the CONMED Corporate Policy “Consulting and Other Arrangements with Health Care Practitioners and Institutions,” and other CONMED policies and procedures (including those relating to product promotion and non-promotional communication).
If you have any concerns that any proposed payments may be questionable, don’t make or commit to make the payment without first consulting the Legal Department or the Compliance Committee.
Please note that any payments that are forbidden to be made by CONMED are also forbidden to be made by CONMED employees, sales representatives and distributors working for CONMED, including their immediate family members. You may not make any payments individually to any Health Care Professionals on CONMED’s behalf. No payments permitted hereunder may be made by personal checks.
Revised: December 2019
EXHIBIT A - STATE-SPECIFIC STANDARDS
In addition to federal requirements and guidelines, and the AdvaMed Code, certain states have also established requirements for life science industry interactions with health care professionals and related entities.
In some instances states impose a specific requirement that regulated companies put in place a Health Care Compliance Program. CONMED has developed a Health Care Compliance Program that is reasonably designed to prevent and detect violations, consistent with federal guidelines and the AdvaMed Code, and to be consistent with expectations of California, Connecticut, Massachusetts, Nevada, and Vermont.
While many state provisions mirror federal law and guidelines and the AdvaMed Code, in some instances the states establish additional or more expansive requirements, in some cases requiring state-level tracking, reporting and/or certifications.
These state requirements are highlighted below in the following sections of this Exhibit A to CONMED’s Health Care Compliance Program:
I. Health Care Compliance Program Requirements
II. Limitations or Bans on Specific Expenditures
III. Tracking, Reporting and/or Certification Requirements
I. Health Care Compliance Program Requirements
California law requires companies subject to the law to adopt and maintain a “Comprehensive Compliance Program,” developed in accordance with the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers,” developed by the U.S. Department of Health and Human Services, Office of the Inspector General (the “HHS-OIG Guidance”), and the PhRMA “Code on Interactions with Health Care Professionals” (or “PhRMA Code”).
CONMED’s policy is to adhere to the California law, but to orient its Health Care Compliance Program around the AdvaMed Code, given the AdvaMed Code’s applicability to device companies. The AdvaMed Code is considered substantially equivalent to the PhRMA Code but reflects the unique interactions between medical technology companies and Heath Care Professionals.
Connecticut requires medical device manufacturing companies to adopt and maintain a Comprehensive Compliance Program. The Comprehensive Compliance Program must be developed in accordance with the HHS-OIG Guidance and the AdvaMed Code.
Massachusetts has, by law, established a “Pharmaceutical and Medical Device Manufacturer Code of Conduct” (also referred to as the “Marketing Code of Conduct”) and requires subject companies to adopt a code of conduct consistent with this law.
Nevada requires device manufacturers to implement a compliance program relevant to interactions with Nevada-Licensed Practitioners,4 and consistent with the AdvaMed Code as adopted by the Nevada Board of Pharmacy (the “Nevada Board”).
Vermont requires device manufacturers to designate an individual who is responsible for compliance and reporting activities of the company.
II. Limitations or Bans on Specific Expenditures
Maine prohibits providing gifts of any kind to health care Practitioners5 including cash gifts in any amount or a gift for which reciprocity is expected or implied.
There are, however, exceptions for certain items and expenditures:
Non-cash Items of Direct Benefit to Patients
- Companies are permitted to give non-cash items of minimal value that will directly benefit health care Practitioners’ patients including:
- Educational materials; and
- Modest meals and refreshments provided to health care Practitioners in connection with a meeting or presentation about the benefits, risks and appropriate uses of medical devices, disease states or other scientific information, as long as the meeting or presentation occurs in a venue and manner conducive to informational communication.
- Companies may give funding to Maine academic institutions and residency and fellowship programs to support the participation of medical, nursing, physician assistant, and pharmacy students, residents and fellows in professional meetings, including educational meetings. The program, however, must identify the funding recipients based on independent institutional criteria and the funds must be distributed to recipients without
specific attribution to CONMED or any other industry sponsors.
Honoraria and Expenses
- Companies are permitted to provide reasonable honoraria and make payments of reasonable expenses to health care Practitioners at a professional or educational conference or meeting.
Massachusetts has imposed requirements on interactions with Health Care Practitioners6 licensed in Massachusetts, regardless of whether those interactions occur in Massachusetts or outside of Massachusetts. Key aspects of the law are summarized below, and you should also review and adhere to the full content of the Massachusetts Marketing Code of Conduct. For further guidance, please contact the Compliance Committee or the Legal Department.
- No company may provide payment for meals directly to a Health Care Practitioner at any Continuing Medical Education (“CME”) event or educational conference, although a CME provider or conference organizer may, at its own discretion, apply any financial support provided by the company for the event to provide meals for all participants.
- No company may provide sponsorship or payment for CME that does not meet the standards established by the Accreditation Council for Continuing Medical Education (“ACCME”) or equivalent commercial support standards of the relevant continuing education accrediting body, or that provides payment directly to a Health Care Practitioner.
- No company may provide financial assistance directly to medical students, residents, fellows and other Health Care Professionals in training to permit them to attend educational conferences. However, this does not prohibit CONMED from supporting conferences where medical students, residents, fellows or other Health Care Professionals in training are to attend.
- No company may provide or pay for meals for Health Care Practitioners unless they are of modest value and in a setting conducive to informational communication.
- No meals may be offered without an informational presentation made by a CONMED representative or without such a representative being present.
- No company may provide direct or indirect payments of any kind including cash, cash equivalents, equity, or other tangible items, to a Health Care Practitioner, except as compensation for bona fide services.
Expense Reimbursement by Written Agreement Only
- Companies may reimburse for reasonable out-of-pocket costs incurred by a Health Care Practitioner directly as a result of the performance of bona fide services, but only where the reimbursement is specified in, and paid for under, a written agreement.
- Companies may pay or reimburse for reasonable expenses, including travel- and lodging-related expenses necessary for technical training of Health Care Practitioners on the use of a medical device, if the commitment to provide such expenses, and the amounts or categories of reasonable expenses to be paid, are described in the written agreement between the Health Care Practitioner and the company.
When interacting with a Vermont Health Care Professional,7 you must adhere to the following standards in addition to the requirements set forth generally in the Health Care Compliance Program. These restrictions apply to interactions with Health Care Professionals who are licensed in Vermont and who practice there regularly. Key aspects of the these requirements are set forth below, and you should also review the Vermont Prescribed Products Gift Ban Guide, which is updated annually by the Vermont Office of the Attorney General, and the Vermont Office of the Attorney General webpage providing up-to-date information on Disclosures by Manufacturers of Prescription Drugs, Biological Products and Medical Devices. For further guidance, please contact the Compliance Committee or the Legal Department.
- “Gift” is broadly defined as (i) anything of value provided to a Health Care Professional for free or (ii) any payment, food, entertainment, travel, subscription, advance, service, or anything else of value provided to a Health Care Professional, except for certain defined allowable expenditures. It is unlawful for any company to offer or give any gift to a Health Care Professional, unless the Health Care Professional reimburses the cost of the gift at fair market value.
- Food is included in the definition of “gift” and is therefore prohibited to be given to a Health Care Professional, except if a Health Care Professional reimburses the cost at fair market value.
- A company may pay an honoraria and/or expenses of a Health Care Professional who serves on the faculty of an educational conference or seminar only if:
- there is an explicit contract with specific deliverables, which are restricted to medical issues, not marketing activities; and
- the content of the presentation, including slides and written materials, is determined by the Health Care Professional.
- Any conference sponsored by the company must:
- be accredited by the ACCME or a comparable organization; and
- offer continuing medical education credit, feature multiple presenters on scientific research, or be authorized by the sponsoring association to recommend or make policy.
- Any conference sponsored by the company must:A company may pay or reimburse for the reasonable expenses, including travel- and lodging-related expenses, necessary for technical training of Health Care Professionals on the use of a medical device, but only if the commitment to provide such expenses and the amounts or categories of reasonable expenses to be paid are described in a written agreement between the Health Care Professional and the company.
Evaluation and Demonstration Products
- A company may loan a medical device to a Health Care Professional for a short-term trial period, not to exceed 120 days,8 to permit evaluation of the device by a Health Care Professional or patient. Reasonable quantities of a medical device demonstration or evaluation unit may be provided to a Health Care Professional to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future.
III. Tracking, Reporting and/or Certification Requirements
A. California Annual Spending Limit; Annual Statement of Compliance
California law requires that a specific maximum annual dollar limit be set on any gifts, promotional materials, or items or activities that a company may give or otherwise provide to an individual California medical or health professional (i.e., permissible items under law), with certain items excepted from the annual limit.9
California also requires an annual written declaration by the company of their adherence to the requirement to have a Comprehensive Compliance Program.
B. Connecticut Advanced Practice Registered Nurse Transparency Reporting
Connecticut requires an annual transparency report for any payments or transfers of value to Advanced Practice Registered Nurses not practicing in collaboration with a physician in the state.
C. Massachusetts Annual Disclosure Reporting
Massachusetts requires annual disclosure reports on all fees, payments, subsidies, items for value or any other economic benefits with at least a value of $50 provided to any Massachusetts-Licensed Health Care Professional or other Covered Recipients under Massachusetts law, but disclosure is not required if the payment or transfer of value is otherwise reported under the federal Sunshine Act.
D. Nevada Code of Conduct and Related Reporting
Nevada requires regulated companies to annually provide copies of their marketing code of conduct; a description of their training program; a description of their investigation policy and procedures concerning noncompliance with the marketing code of conduct; the name, title, and contact information of their compliance officer. Nevada also requires the certification of an annual audit to monitor its compliance with the marketing code of conduct.
E. Vermont Expense Tracking and Disclosure Requirement; Compliance Officer Reporting
Vermont requires tracking and annual reports on all fees, payments, subsidies, items or economic benefits provided to Vermont Health Care Professionals as well as other health care entities if they are not otherwise reported under the federal Sunshine Act. Annually on January 1, the designated compliance officer must complete the Compliance Officer form which will include disclosure of the individual’s name and contact information, the intent to submit disclosures of expenditures and/or samples to the Vermont Office of the Attorney General, and whether data was submitted to the federal government in accordance with the Sunshine Act requirements.
1 Health Care Professionals as used in this document does not include persons who are bona fide employees of a Company, while acting in that capacity.
2 As a global company with operations and sales around the world, CONMED is also a member of other trade associations representing medical device manufacturers, such as Canada’s Medical Technology Companies (“MEDEC”), the Medical Technology Association of Australia (“MTAA”) and others. These Associations all have adopted Codes of Conduct and Codes of Practice substantially similar to AdvaMed’s Code of Ethics, and as such their principles are included in this Health Care Compliance Program as well.
3 For hotline reports from outside the United States, please check on the web site for the appropriate local phone number to call.
4 Nevada law defines a “Practitioner” as a physician, dentist, veterinarian or podiatric physician who holds a license to practice in the State of Nevada; a hospital, pharmacy or other institution licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or administer drugs in the course of professional practice or research; an advanced practice registered nurse who is authorized to prescribe dangerous drugs and devices, and physician assistant who is licensed by the State Board of Osteopathic Medicine and has the ability to prescribe dangerous drugs and devices under the supervision of an osteopathic physician.
5 “Practitioner” means an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice.
6 Under Massachusetts law “Health Care Practitioner” means “a person who prescribes prescription drugs for any person and is licensed to provide health care in Massachusetts, or a partnership or corporation comprised of such persons, or an officer, employee, agent or contractor of such person acting in the course and scope of his or her employment, agency or contract related to or in support of the provision of health care to individuals. Hospitals are not healthcare practitioners. Additionally, full time employees and board members of pharmaceutical or medical device manufacturers are not health care practitioners.”
7 “Health care professional” for Vermont purposes means: (i) a person who is authorized by law to prescribe or to recommend prescribed products, who regularly practices in this State, and who either is licensed by this State to provide or is otherwise lawfully providing health care in this State; or (ii) a partnership or corporation made up of the persons described in subdivision (i) of this subdivision (7)(A); or (iii) an officer, employee, agent, or contractor of a person described in subdivision (i) of this subdivision (7)(A) who is acting in the course and scope of employment, of an agency, or of a contract related to or supportive of the provision of health care to individuals. The term shall not include a person described in subdivision (A) of this subdivision (7) who is employed solely by a manufacturer. “Regularly practices” means to practice at least periodically under contract with, as an employee of, or as the owner of, a medical practice, health care facility, nursing home, hospital, or university located in Vermont.
8 Note that any loan beyond 90 days will be subject to the federal Sunshine Act reporting requirements.
9 “Medical or health professional” means any of the following: (1) A person licensed by state law to prescribe drugs for human patients; (2) A medical student; (3) A member of a drug formulary committee.