HEALTH CARE COMPLIANCE PROGRAM
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 herein to refer to any individual or entity that purchases, leases, uses, recommends or prescribes ConMed’s products: 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 revised and restated Code of Ethics issued by the Advanced Medical Technology Association (AdvaMed), an organization representing companies such as ConMed that develop, produce, manufacture and market medical products, technologies and related services. This Health Care Compliance Program also incorporates 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 setting forth the standards on interactions with Health Care Professionals, this Health Care Compliance Program also describes the rules regarding the mandatory 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”). Currently, only the United States has passed a payment act, the Physician Payment Sunshine Act (the “Sunshine Act”). Under the Sunshine Act, ConMed and its subsidiaries must report annually to the U.S. federal government the total payments and transfers of value made to all physicians and teaching hospitals. 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 doctors 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. Other Payment Acts have been proposed and are pending, most notably in the United Kingdom and the Netherlands. ConMed will comply with the requirements of all Physician Payment Acts in the jurisdictions where it conducts business.
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 Institution 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 866-838-0850. 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, 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. Other jurisdictions have enacted similar legislation.
If it is determined that ConMed violated the anti-kickback statute, our customers and potential customers could be barred from seeking Medicare or other governmental reimbursement 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.
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 the anti-kickback and similar statutes.
III. COMPANY-CONDUCTED PRODUCT TRAINING AND EDUCATION
ConMed recognizes the importance of providing training to Health Care Professionals on the safe and effective use of our products. Such programs often 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 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 products should be held at training facilities, medical institutions, laboratories, or other appropriate facilities. All training staff should have the proper qualifications and expertise to conduct such training. Training staff may include qualified field sales employees who have the technical expertise necessary to perform the training.
- 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.
- Where there are objective 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 travel and modest lodging costs of the attending Health Care Professionals. 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 at the meeting.
IV. SUPPORTING THIRD-PARTY EDUCATIONAL CONFERENCES
CONMED may contribute to or sponsor the cost of third party national, regional, or specialty medical associations and conferences, and continuing medical education conferences and professional meetings, provided such conferences or meetings are primarily dedicated to promoting objective scientific, medical, surgical or other educational activities or discourse. Control over the selection of content of presentations, faculty, educational methods and materials must remain with the organizer of the conference.
- Out-of-Pocket Expenses. Except as provided below with regard to faculty expenses, CONMED may not reimburse out-of-pocket expenses or make educational grants directly to attendees in connection with attendance at third party educational conferences, without the express approval of the HCCC.
- Educational Grants. CONMED may provide grants only to organizations with a genuine educational function, including conference sponsors and training institutions. Grants must be consistent with the standards established by the conference sponsor and any body accrediting 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, except with the express approval of the HCCC.
- Conference Meals and Refreshments. CONMED may provide funding to the conference sponsor to support the provision of 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 State-specific restrictions, refer to Exhibit A.)
- Faculty Expenses. 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 (see Arrangements with Consultants, below), 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.
- Advertisements and Demonstration. CONMED may purchase advertisements and lease booth space for company displays at conferences.
V. SALES, PROMOTIONAL, AND OTHER BUSINESS MEETINGS
Product Promotional Meetings Generally
It is appropriate for CONMED to meet with Health Care Professionals to discuss product features, contract negotiations, and sales terms. The locations of such meetings should be conducive to the discussion of patient care or product features. Such locations should be reasonably priced; it is not appropriate to conduct these meetings at lavish hotels or resort locations unless the location is justified by a legitimate business purpose.
CONMED may pay for occasional modest meals and refreshments for Health Care Professionals attending such meetings, provided a CONMED representative is present. CONMED is not permitted to provide meals or refreshments for those who are not attending the meeting, such as for office staff. CONMED will not pay for any other entertainment in connection with such meetings, except in accordance with Section VII below.
CONMED may pay for reasonable travel costs of attendees when necessary (e.g., for plant tours or equipment demonstrations). However, CONMED will not pay for meals, refreshments, travel, or lodging of guests of Health Care Professionals or any other person who does not have a bona fide professional interest in the information being shared at the meeting. (For State-specific restrictions, if any, refer to Exhibit A.)
Focus groups can provide CONMED with significant and valuable feedback on our products, proposed products, or other plans. Any payments made to Health Care Professionals for participation in a focus group, or otherwise to provide feedback on a product, discuss a research project, or explore a collaborative opportunity, must be in accordance with the following:
- CONMED may reimburse the participating Health Care Professional for reasonable out-of-pocket expenses for meals and travel.
- CONMED may pay reasonable compensation for time spent. The amount of compensation must not exceed fair market value for the participant’s time.
- The services provided by the participant must be genuine and not token.
- The purpose of the focus group must not be to promote a product. Participants must be selected based on their expertise in the field. CONMED may not require participants to use or promote the product.
- Any payment to a Health Care Professional in connection with a focus group must be made in accordance with a written agreement signed by both the Health Care Professional and CONMED.
VI. CONSULTING ARRANGEMENTS WITH HEALTH CARE PROFESSIONALS
Consultants 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. It is appropriate to pay consultants fair market value compensation for performing these services intended to fulfill a legitimate business need. However, consulting agreements must not be disguised programs to 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, approved by the HCCC, 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. 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 on the basis of the consultant’s qualifications and expertise to address the identified purpose, and should not be on the basis of volume or value of the consultant’s past, present or anticipated business.
- 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 of purchases or referrals or other business with CONMED.
- 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 travel, and modest meals and lodging costs 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. 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 to the primary purpose of the meeting. CONMED may not provide recreation or entertainment in conjunction with these meetings, except in accordance with Section VII.
- Records of the services provided by the consultants should be maintained by CONMED.
- CONMED’s sales personnel may provide input about the suitability of a proposed consultant, but sales personnel may not control the decision to engage a particular consultant.
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 by the consultant must be novel, significant and innovative, and must be appropriately documented.
- Royalties 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.
VII. ENTERTAINMENT AND RECREATION
This section relates only to entertainment and recreational activities, as opposed to meals and refreshments, which are addressed in Section VIII below. Entertainment and recreational activities provided to Health Care Professionals are increasingly subject to state-specific restrictions, such as disclosure obligations or outright prohibition. Accordingly, it is CONMED’s policy to require pre-approval from the appropriate HCCC before paying, directly or indirectly, for any entertainment or recreational event or activity for any Health Care Professional, unless such Health Care Professional is an employee or director of the Company participating in the entertainment or recreational activity on the same terms as other Company employees. Providing unapproved entertainment and recreation to Health Care Professionals is prohibited, even if the CONMED employee or agent pays for such activities and is not reimbursed by CONMED. If you wish to engage in an entertainment or recreational activity with a Health Care Professional, you must obtain the approval of the appropriate HCCC in advance, or you may attend the event with each party paying his or her own way.
VIII. MODEST MEALS ASSOCIATED WITH HEALTH CARE PROFESSIONAL BUSINESS INTERACTIONS
In connection with product training, conferences, business meetings, and other interactions with Health Care Professionals described herein, CONMED may provide modest meals to Health Care Professionals as an occasional business courtesy consistent with the limitations in this section. (For State-specific restrictions, refer to Exhibit A.)
- Purpose. The meal should be incidental to the bona fide presentation of scientific, educational, or business information and provided in a manner conducive to the presentation of such information. The meal cannot be part of an entertainment or recreational event, unless approved in accordance with Section VII above.
- 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, 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. 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 (such 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.
ConMed is restricted from giving gifts to Health Care Professionals, except in accordance with this section. A “gift” is anything of value provided to a Health Care Professional for free and not otherwise permitted under this Health Care Compliance Program.
Specifically, 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 a DVD player or MP3 player/I-Pod, except as compensation for bona fide services.
A limited exception is that, except where prohibited by 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.
This section is not intended to address the legitimate practice of providing products for evaluation and demonstration purposes, which is addressed in Section XII.
X. PROVISION OF COVERAGE, REIMBURSEMENT AND HEALTH ECONOMICS INFORMATION
CONMED may provide Health Care Professionals with coverage, reimbursement and health economic 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 not interfere with a Health Care Professional’s independent clinical decision-making or provide coverage, reimbursement and health economics support as an unlawful inducement. 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. 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.
XI. RESEARCH AND EDUCATIONAL GRANTS AND CHARITABLE DONATIONS
CONMED may provide research and educational grants and charitable donations as follows:
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. Such activities must have well-defined 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.
Educational grants may be provided for legitimate purposes, including but not limited to the examples below. As noted in Section IV above, CONMED may make educational grants to conference sponsors or training institutions. CONMED may not make educational grants directly to individual Health Care Professionals.
- Advancement of Medical Education. CONMED may make grants to support the genuine medical education of medical students, residents, fellows or other medical personnel participating in fellowship programs that are charitable or have an academic affiliation. (For additional considerations regarding educational grants, see Section IV.)
- Public Education. CONMED may make grants for the purpose of supporting education of patients or the public about important health care topics.
CONMED may make monetary and/or product donations 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 the Health Care Professional (e.g., the Health Care Professional’s charitable foundation).
- 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.
- 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, unless (1) the Health Care Professional is a charitable organization, (2) the purpose of the donation is charitable, and (3) the donation is not an unlawful inducement.
- 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 such personnel may not approve requests for charitable donations.
- Examples of acceptable donations are purchasing a foursome at a golf tournament sponsored by a charitable foundation to benefit social service programs and holiday gift giving to low income families, or grants for the purpose of supporting education of medical students, patients or the public about important health topics. An example of an unacceptable donation is a donation to a hospital (whether or not for profit) with no specified charitable cause.
- Donations must be approved through the established processes through the use of the approved donation form.
XII. EVALUATION AND DEMONSTRATION PRODUCTS
CONMED may provide reasonable quantities of products to Health Care Professionals at no charge for evaluation and demonstration purposes under the following circumstances:
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. The terms of an evaluation of such products must be set in advance in writing, and the contract must 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.
Appropriate documentation and disclosure should be provided to Health Care Professionals regarding the no-charge status of evaluation and demonstration products.
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 the Program, but also its 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”. 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.
Revised: August 31, 2014
When interacting with a Massachusetts Health Care Professional, you must adhere to the following standards in addition to the requirements set forth in the Health Care Compliance Program. It is important to note that these restrictions apply to all interactions with Health Care Professionals licensed in Massachusetts, regardless of whether those interactions occur in Massachusetts or outside of Massachusetts. For further guidance, please contact the Compliance Committee or the Legal Department.
- No company may provide payment for meals directly to a Health Care Professional 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 Professional.
- 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 Professionals 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 Professional, 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 Professional 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 Professionals 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 Professional and the company for the purchase of the device.
When interacting with a Vermont Health Care Professional, you must adhere to the following standards in addition to the requirements set forth 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. 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 in certain specified instances.
- 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 Accreditation Council for Continuing Medical Education 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.
- 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 90 days, to permit evaluation of the device by a Health Care Professional or patient.