I. Version History
Revision A - released June 30, 2011
Revision B - released March 28, 2013
U.S. Healthcare Compliance Plan (the "Compliance Plan").
III. Purpose and Scope
Maquet Cardiovascular, LLC, Maquet Cardiovascular U.S. Sales, LLC d/b/a Maquet Medical Systems USA, Atrium Medical Corp. and Datascope Corp. (collectively "Maquet") are subsidiaries of the publicly listed Swedish group of global medical device companies Getinge AB. Maquet is committed to working collaboratively with the clinical community to improve care at a reasonable cost. As part of this mission, Maquet recognizes that adherence to ethical standards and compliance with applicable laws and regulations is critical to ensure that interactions with Healthcare Providers (HCPs) in the United States and internationally are responsible and within legal and regulatory requirements.
This Compliance Plan defines the process used at Maquet to promote honest, ethical and lawful conduct by all employees of Maquet (as defined below) in their interactions with HCPs and in the provision of healthcare items and services reimbursable by third party payers. It is intended to (a) raise the awareness of Employees of the ethical and legal issues that may be encountered in interacting with HCPs and in providing items and services reimbursable by federal and state healthcare programs, and (b) describe the process to address these issues.
For purposes of this Compliance Plan, the terms "Healthcare Provider" or "HCP" include any person or entity in a position to purchase, lease, recommend, use or arrange for the purchase or lease of Maquet products. This includes both clinical and non-clinical personnel who make decisions related to product purchasing. It also includes decision-makers within group purchasing organizations. Doctors, nurses, physician assistants, respiratory therapists, surgical technologists, hospital staff (including the contracts office), perfusionists etc. should be treated as Healthcare Providers under this Compliance Plan.
The Compliance Plan applies to all U.S. based Maquet Employees (full-time or part-time) whether working within or outside of the U.S. on applicable U.S.-related Maquet business.
The sections of this Compliance Plan are listed in the following Table of Contents. You are expected to consult the relevant sections of the Compliance Plan with the understanding that more than one section may be applicable to the issue at hand.
IV. Questions regarding the Compliance Plan
Not every situation which may arise can be anticipated. Maquet's Compliance Counsel, is available to assist you with any questions regarding the Compliance Plan or other Compliance-related issues. Compliance receives the reports from the information sources below and conducts Compliance-related investigations. Compliance can be reached at (201) 995-8985 or UScompliance@maquet.com.
Compliance Plan violations will be addressed vigorously and will result in appropriate corrective action, up to and including termination.
VI. Reporting Violations
Should you become aware of any violations of the Compliance Plan such as an outright bribe or a questionable gift to a HCP, you must report the incident.
Maquet encourages you to communicate concerns regarding any inappropriate or illegal behavior to your immediate supervisor or your supervisor's manager. If you are not able to report your concern to your immediate management, we also encourage you to discuss your concerns with the Human Resources department, or contact the HR Helpline at 973-709-7878 or email HRHELPLINE@maquet.com. However, we recognize that there may be times, due to the serious nature of the concern, that you may decide to report the concern to our Compliance Hotline at 1-800-247-1656 or via our Compliance Website https://Reportlineweb.com/GetingeHoldingsUSA.
Reporting to the Compliance Hotline and Website is anonymous. However, as you may expect, investigations based on an anonymous report are more difficult than those based on an in-person report where we can have a continuous dialogue. Thus, to facilitate our investigations, we encourage you to report in person. If you must use the Compliance Hotline or Website, we encourage you to provide your name and contact information. We will ensure no retaliation occurs against employees who report truthfully and in good faith.
VII. Compliance Training
New employees who may be expected to interface with HCPs must complete Compliance training within 90 days of their start date. Employees who may be expected to interface with HCPs will be retrained in Compliance annually.
1. Prohibition on Kickbacks
U.S. law prohibits you from offering or providing any remuneration in the form of cash or other value (e.g., bribe, rebate, gift) to any person, directly or indirectly, in order to induce that person to (1) purchase, lease, order, or arrange for or recommend the purchasing, leasing, or ordering of an item or service reimbursed under a federal healthcare program, or (2) refer an individual for an item or service reimbursed under a federal healthcare program (e.g., Medicare, Medicaid, or the Department of Veterans Affairs health facility network). U.S. and international laws prohibit you from offering a kickback to individuals, even non-U.S. HCPs, around the world.
For example, you cannot offer a physician a research grant in exchange for the physician's recommendation that a product be added to a hospital's approved product listing. You may not make this offer even if you had a real bona fide desire to support the research, which may be directed to cancer research or another noteworthy cause. As long as one purpose of the arrangement is to induce a referral or purchase, the offer is illegal.
Notwithstanding the above, you are permitted to (i) discount the price of our products if the discounts are fully documented and disclosed, and (ii) enter into legitimate fee-for-service agreements (e.g., for consulting or training) with physicians and other Healthcare Providers.
2. Evaluation, Demonstration and Free Products
A. Evaluation and Demonstration Products
You may not give products to Healthcare Providers (HCPs) for free, even on a short-term or free-sample basis, to induce a purchase of any product, including Maquet products. However, under certain circumstances described below, you may provide a reasonable quantity of products to HCPs at no charge for evaluation and demonstration purposes to allow HCPs to assess the appropriate use and functionality of the product and determine whether and when to use, order, purchase, or recommend the product in the future. Maquet's products provided for evaluation are expected to be used in patient care.
Volume. The number of single use products provided at no charge will not exceed the amount reasonably necessary for the adequate evaluation of the products under the circumstances.
Duration of Use. Multiple use products may be provided without transfer of title for evaluation purposes but only for a period of time that is reasonable under the circumstances to allow an adequate evaluation, which is usually less than 90 days.
Demonstration Products. Demonstration products are typically unsterilized single use products or mockups of such products that are used for HCP and patient awareness, education, and training. For example, a HCP may use a demonstration product to show a patient the type of device that will be implanted in the patient. Demonstration products typically are not used in patient care. Demonstration products not intended for patient use are identified by such designations as "Sample," "Not for Human Use," or other suitable designation on the product, the product packaging, and/or documentation that accompanies products or technologies.
B. Limitations on Free Products
Free products are no-charge products including medical devices and software. Giving free products to a HCP can be viewed as a kickback unless it is for an allowable purpose. Free products should not be given to HCPs, even as a form of apology. However, free products may be given to HCPs if they fall into one of several categories: evaluation (discussed above), demonstration (discussed above), research, warranty/repair/replacement, as part of a legitimate dispute settlement, and validation or marketing in connection with a non-free product sale. HCPs should not be billing their patients for products they have not paid for. If you have any questions about free products, please consult the Compliance Department.
Validation Studies; Research. Free products are allowed for validation studies or conducting research. You must disclose the value of the free products relative to its no-charge status to HCPs. The free products and their value should be disclosed in written study or research agreements. At the conclusion of the study or research, unused free products must be returned to Maquet.
Service. Should a valid warranty, service or performance issue arise, free replacement products or credits may be given to HCPs as part of the warranty or service. The value of any free products should be documented in the invoice, contract and/or service documents.
Evaluation and demonstration products can only be provided pursuant to Legal Department-approved documentation. Multiple use products can only be provided under a contract.
If Maquet provides evaluation and demonstration products to HCPs, Maquet will furnish such HCPs with documentation and disclosure regarding the no-charge status of such evaluation and demonstration products. Maquet can market a product as a free product, e.g., "buy 3, get 1 free." In this case, the purchase contract or invoice should show a 25% discount.
3. Discounts, Rebates and Other Price Concessions
Improperly structured discounts, rebates and other price concessions have the potential to improperly influence a customer's decision-making regarding Maquet's products. You must properly structure any discounts, rebates and price concessions that are given to customers to avoid possible violations of the Anti-Kickback Statute, the False Claims Act and other Federal and state laws and regulations.
Providing Discounts to Customers. You may only provide discounts contemporaneously at the time of the product purchase or retrospectively in the form of a rebate. The basis of determining the discount must be established prior to the first sale of the product to which the discount applies. You may not offer or make an up-front payment to a customer in lieu of a discount or rebate.
Disclosure of Discounts. To comply with Federal guidelines, all discounts and rebates will be appropriately disclosed to customers as follows:
- You must provide written disclosure to the customer which appropriately reports the discount.
- You must ensure discounts are reflected on product invoices or statements where the amount of the discount is known at the time of the sale.
- For arrangements where the amount of the discount is not known at the time of the sale (e.g., rebate arrangements or bundled pricing arrangements), you must ensure the existence of the discount program is reported on product invoices or statements, and provide the buyer with documentation of the calculation of the discount, including identification of the specific goods or services purchased to which the discount will be applied, once such details become known, but in no event later than one year after the year in which the discount is earned.
You must retain discount documentation and make it available to state or Federal healthcare program officials upon request.
4. All Payments to Healthcare Providers Must Be Fair Market Value or Less
An overpayment for a good or service could be viewed as an inducement to have Healthcare Providers (HCPs) purchase more of Maquet's products or services. Maquet must not overpay HCPs to avoid the appearance of a kickback. All payments to HCPs should be fair market value or less. Your manager will have guidelines about acceptable pre-approved payment rates for HCPs.
A HCP may ask for a higher rate than the pre-approved rates. The higher rate may still be fair market value based on certain factors. To get the higher rate approved, you must fill out a Payment Review Request Form and review it with your manager. Compliance will rely on the information in the Payment Review Request Form, and you will be held accountable for the falsity of any information. You must send the Payment Review Request Form to Compliance, who will conduct and document a fair market value analysis and respond in writing about the acceptability of the payment.
In certain cases, Maquet may need to send the proposed rates to an independent third party valuation expert. Please plan accordingly and keep the HCP informed.
5. Limitations on Meals
Maquet's business interactions with Healthcare Providers (HCPs) often involve the presentation of scientific, educational, and business information. Such exchanges may be productive and efficient when conducted in conjunction with meals. Reasonable meals may be provided as an occasional business courtesy consistent with the limitations in this section. All meals you provide must comply with applicable state laws and regulations. Meal limits and expense reimbursement are detailed in Maquet's Travel & Expense Management Policy.
Some states may have more restrictive limitations on the provision of meals to HCPs. In these states, you are required to act in accordance with applicable state laws.
Purpose. The meal will be incidental to the bona fide discussion of scientific, educational, or business information and provided in a manner conducive to the discussion of such information. The meal will not be part of an entertainment or recreational event.
Setting and Location. Meals will be in a setting that is conducive to bona fide scientific, educational, or business discussions. Meals may occur at the HCP's place of business. However, in some cases the place of business may be a patient care setting that is not available for, or conducive to, such scientific, educational or business discussions. In other cases, it may be impractical or inappropriate to provide meals at the HCP's place of business, for example, (a) where the medical product or technology cannot easily be transported to the HCP's location, (b) when it is necessary to discuss confidential product development or improvement information, © where a private space cannot be obtained onsite, or (d) where the demands of a HCP's practice dictate limited opportunities for interactions or meetings at other than offsite locations (e.g., during non-business hours or non-work days). In such cases, meals may be provided in an off-site location that is conducive to bona fide scientific, educational or business discussions to the extent permissible under applicable state laws and regulations.
Participants. You can only provide meals to participants in the business interaction. For example, when you host an instructional presentation at an HCP's office, you may not provide a meal for an entire office staff if the entire staff did not attend and have a bona fide interest in the presentation. In addition, you cannot provide a meal to a HCP unless a Maquet representative is present at the meal (such as a "dine & dash" program). You cannot invite spouses or guests of HCPs or any other person who does not have a bona fide professional interest in the information being shared at the meeting and will not provide meals to such persons.
Government Employees. You may not provide a meal to Federal or State Government employees except for modest meals related to a consulting or training agreement. This prohibition includes business meetings and conferences, except for "widely attended gatherings."
HCPs Licensed in Massachusetts. Occasional and modest meals are allowed in a doctor's office or a "hospital setting" if there is an informational presentation. Otherwise, meals given directly to a Massachusetts HCP are forbidden. CME Providers may provide meals to Massachusetts HCPs.
HCPs Who Practice in Vermont. You are prohibited from providing meals to Vermont HCPs who regularly practice in Vermont in regular business interaction. Always consult with Compliance before providing a meal to a Vermont HCP.
Key Criteria for Compliance
- Meals should be modest and only for a legitimate purpose.
- If the HCP practices in Massachusetts or Vermont or is a government employee, consult with the Compliance Department about whether a meal can be provided.
Arrangements involving the payment of royalties to a Healthcare Provider (HCP) must meet the contractual standards set forth in the Consulting Arrangement Section of this Compliance Plan. HCPs, acting individually or as part of a group that they are an active participant, may make valuable contributions that improve Maquet products or technologies. They may develop intellectual property, for example, patents, trade secrets, or know-how, under a product or technology development or intellectual property licensing agreement. Maquet may enter into a royalty arrangement with a HCP only where the HCP is expected to make or has made a novel, significant, or innovative contribution to, for example, the development of a product, technology, process, or method. A significant contribution by an individual or group, if it is the basis for compensation, should be appropriately documented.
The calculation of royalties payable to a HCP in exchange for Intellectual Property should be based on factors that preserve the objectivity of medical decision-making and avoid the potential for improper influence. For example, royalties paid in exchange for Intellectual Property may not be conditioned on: (1) a requirement that the HCP purchase, order or recommend any Maquet product or medical technology or any product or technology produced as a result of the development project; or (2) a requirement that the HCP market the product or medical technology upon commercialization. Maquet may, however, elect to enter into separate consulting agreements with HCPs for marketing services. Please consult the Compliance Department before entering into consulting agreements with a Massachusetts-licensed HCP for sales and marketing activities.
7. Prohibition on Gifts
Non-Educational Gifts Are Prohibited
Generally, you should not be providing gifts to Healthcare Providers (HCPs), including items that are for personal use by the HCPs (or their family members, office staff or friends), such as a DVD player, computer or digital music player or personal gifts such as cookies, wine, flowers, chocolates, gift baskets, holiday gifts or cash or cash equivalents. Further, you should not give HCPs any type of non-educational branded promotional items, even if the item is of minimal value and related to the HCP's work or for the benefit of patients. Examples of non-educational branded promotional items include pens, notepads, mugs and other items that have Maquet's name, logo, or the name of one of its medical technologies. This restriction extends to your own personal funds, which also should not be used to provide gifts or items to HCPs that would otherwise be prohibited.
Educational Gifts are Sometimes Allowed
However, you may occasionally provide items to HCPs that benefit patients or serve a genuine medically-relevant function for HCPs. Other than medical textbooks, anatomical models or other similar medically relevant items useful to the advancement of medical care, any such item should have a fair market value of less than $100. Any educational gifts must be approved by your manager and the Compliance Department, and paid for out of the Marketing or Training Departments.
States have laws regulating gifts to HCPs. You may not give gifts to Vermont HCPs who regularly work in Vermont. This is in contrast to the gift laws of Massachusetts, which are aligned with the guidance provided in this section (applies to non-government employee Massachusetts HCPs).
Beware of gifts to government employees. You must not give educational gifts such as medical textbooks to federal government employees (e.g., Department of Veterans Affairs). State-specific laws often apply to state government employees such as HCPs that work at state or county hospitals. You and your manager should consult the Compliance Department before giving educational gifts to state government employees.
Key Compliance Criteria. Avoid all promotional gifts. Avoid even educational gifts to county, state or federal government employees or Vermont HCPs.
8. Supporting Third-Party Educational Conferences
Bona fide independent, educational, scientific, and policymaking conferences promote scientific knowledge, medical advancement and the delivery of effective healthcare. These typically include conferences sponsored by national, regional, or specialty medical associations and conferences sponsored by accredited continuing medical education (CME) or continuing education (CE) providers. Compliance with Accreditation Council for Continuing Medical Education (ACCME) Guidelines satisfies these guidelines. Maquet may support these conferences in various ways, but may not control the content of the program or the selection of program content, conference materials, speakers, or selection of attendees.
This Section does not cover promotional programs. Promotional programs are those that are either (1) organized and conducted by Maquet itself, or (2) organized and conducted by a third-party with funding from Maquet where Maquet controls or influences the program content or other aspects of the program (e.g., attendees, venue).
Conference Grants. Provision of an educational grant to a conference sponsor or training institution may be appropriate (i) to reduce conference costs, (ii) to allow attendance by medical students, residents, fellows, and others who are HCPs in training, provided the selection of these individuals is made by their academic institutions and not by Maquet, (iii) for reasonable speaker fees, travel, lodging, and modest meals for Healthcare Providers (HCPs) who are bona fide conference faculty members, and (iv) to support the provision of meals and refreshments for HCP attendees, provided such meals and refreshments satisfy all compliance principles related to meals. Meals and refreshments must be modest in value, subordinate in time and focus to the purpose of the conference, and clearly separate from the CME/CE portion of the conference.
Funding to support conferences is only appropriate when:
- The gathering is primarily dedicated to promoting objective scientific and educational activities and discourse;
- The program has a genuine educational function;
- The sponsor independently controls and is responsible for the selection of program content, faculty, educational methods, and materials;
- The funding is used to reimburse only the legitimate expenses for bona fide educational activities; and
- The funding is consistent with applicable standards established by the conference sponsor and the entity accrediting the educational activity.
Advertisements and Demonstration. Maquet may purchase advertisements and lease booth space for product displays at conferences where the program includes, or is reasonably expected to include, information on approved uses of Maquet products. Maquet may display in the areas designated by the conference sponsor but may not conduct any promotional activity in the same room as the CME/CE program.
Grant Requests. All CME/CE grant requests must be submitted to the Grant Review Committee at http://www.maquetgrantsusa.com/. The initial request must describe the purpose or intended use of the grant or reference other documents attached (e.g., brochure, flyer), confirm that the grant will be to support a medical education program, and confirm that the grant will not be used for general overhead or for expenses of attendees.
9. Corporate Sponsorships
Maquet may provide general funding to sponsor patient groups, medical or professional societies, or other organizations that work to increase the understanding of scientific, clinical, or healthcare issues that contribute to the improvement of patient care or continuing education of professionals. Sponsorship funds may not be paid to Maquet customers or entities controlled by Maquet customers, private physician practices, or individual Healthcare Providers (HCPs).
Sponsorship may be recognized by the recipient organization, including the level of sponsorship (e.g., platinum, gold, silver), on its meeting brochures, banners, website, or other materials. Sponsorship of meetings or activities that will be attended primarily by HCPs must be open to other medical device or pharmaceutical companies. Maquet must pay the same fee as other corporate sponsors for the same level or type of sponsorship.
Examples of Permissible Sponsorships
- "Gold" level annual sponsorship of the American Heart Association (AHA) for general educational programs regarding coronary artery disease prevention and awareness
- Sponsorship funding of appropriate, non-educational activities, such as a modest hospitality suite or Wi-Fi Café at the national meeting of the Society for Vascular Surgery (SVS)
Examples of Impermissible Sponsorships
- Sponsorship of a hospitality suite at a disease-state awareness program sponsored by the Transcatheter Cardiovascular Therapeutics (TCT) that is intended specifically for a discussion of a disease state for which Maquet products are not indicated
- Sponsorship funding for the American College of Surgeons (ACS) members to attend a Broadway show one evening during the ACS meeting. This is impermissible because Maquet may not provide funding for entertainment, social, cultural, or recreational activities
Sponsorship funding must not be used to reimburse the travel, lodging, or other personal expenses of attendees, to compensate attendees for their time, or to provide any type of gift to the attendees or presenters. Sponsorship funding also may not be provided on behalf of any customer, patient, or other individual.
All requests for sponsorship funds must be made in writing from the requesting organization on its letterhead and must include a completed W-9 form. The Compliance Department reviews all documentation to ensure the request is consistent with Maquet's policies and that the requested fee is reasonable. If appropriate, the Legal Department approves the request and generates a written agreement to be signed by all parties.
10. Studies and Clinical Research
Maquet can support clinical research and clinical studies (collectively "research") provided (1) the research is directed to developing clinical information for a valid purpose necessary to accomplish Maquet's business goals, (2) the terms of the support are memorialized in a contract approved by the Legal and Compliance Departments, and (3) only Maquet employees who have no role in selling products to the research institution are involved in evaluating, negotiating and managing the research agreements and the resulting research on behalf of Maquet.
Support by Maquet. Maquet may provide a research grant in the form of equipment, services, software, supplies, and/or monetary/non-capital support. Upon the conclusion of the research or study, equipment, software and unused supplies must be returned to Maquet. Support or Investigator compensation for any research (1) must not be conditioned upon an expectation that the support will induce or encourage the purchase of Maquet products, (2) must not be based on the volume or value of business generated, and (3) must not reward the Investigator or their Institution for past purchases.
Research Grants. Research provides valuable scientific and clinical information, improves clinical care, leads to promising new treatments, and promotes improved delivery of healthcare and otherwise benefits patients. In furtherance of these objectives, Maquet may provide research grants to support independent medical research with scientific merit. Such activities should have well-defined objectives and milestones and may not be linked directly or indirectly to the purchase of Maquet products or technologies. All such grants must be approved by the Compliance Department.
Investigators' Meetings. Maquet often brings investigators together to discuss the status of their research. These meetings must not be promotional in nature. Sales representatives must not attend such meetings.
Non-US HCPs. Non-US HCPs may be subject to other laws. Consult the Compliance Department.
11. Educational Grants and Charitable Donations
Educational Grants. Educational grants may be provided for legitimate purposes, including, but not limited to, the examples below. Maquet will not make educational grants as an unlawful inducement.
- Continuing Medical Education. Maquet may support conferences sponsored by accredited continuing medical educational providers in various ways, as detailed in the Supporting Third-Party Educational Conferences section.
- Graduate and Post-Graduate Medical Education. Maquet may make grants to support the genuine medical education of physicians, medical students, residents, and fellows participating in fellowship programs that are charitable or have an academic affiliation, or to support the health education of other medical personnel.
- Public Education. Maquet may make grants for the purpose of supporting education of patients or the public about important healthcare topics.
Charitable Donations. Maquet may make monetary or product donations for charitable purposes, such as supporting indigent care, patient education, public education, or the sponsorship of events where the proceeds are intended for charitable purposes. Donations will be motivated by bona fide charitable purposes and should be made only to bona fide charitable organizations or, in other instances, to individuals engaged in genuine charitable activities for the support of a bona fide charitable mission. Maquet will exercise diligence to ensure the bona fide nature of the charitable organization or charitable mission.
Grant Requests. All grant requests must be submitted for approval to the Grant Review Committee at http://www.maquetgrantsusa.com. In the event you receive any request from a Healthcare Provider for an educational grant, or a charitable donation, please direct them here.
If you are in sales or marketing function, you may not provide input about the suitability of a proposed grant or charitable donation recipient or program, and may not control or influence the decision of whether a particular HCP or institution will receive a grant or donation or the amount of such grant or donation. To reduce the risks that a grant program or charitable donation is used improperly to induce or reward product purchases or to market product inappropriately, Maquet separates its grant making and charitable donations functions from its sales and marketing functions.
12. Consulting Arrangements
Maquet engages Healthcare Providers (HCPs) to provide a wide-range of valuable, bona fide consulting services through various types of arrangements, such as contracts for research, product development, transfer and/or development of intellectual property, marketing, participation on advisory boards, presentations at Maquet-sponsored training and other services. Consulting agreements must be in writing and describe all services to be provided. Research protocols should be in writing.
You may engage consultants for the above services provided (i) you do not pay more than fair market value compensation for their services, (ii) the services are intended to fulfill a legitimate business need and do not constitute an unlawful inducement, and (iii) the services are rendered. A legitimate business need is a need for information, services, or advice to Maquet that can be met by entering into a consulting or service agreement with an individual. The business need for each agreement must be identified before entering into the agreement. A legitimate need for the services is identified in advance and documented. The number of consultants retained by Maquet should not be greater than the number reasonably necessary to achieve the legitimate business need.
Selection. Selection of a consultant must be made on the basis of the consultant's qualifications and expertise to meet the defined need. The agreement may not be used to encourage the HCP to purchase, order, or recommend the purchasing or prescribing of Maquet products and should state that it is not being used for such purposes. Maquet's sales personnel may provide input about the suitability of a proposed consultant, but sales personnel should not control or influence the decision to engage a particular HCP as a consultant.
Location. The venue and circumstances for Maquet meetings with consultants must be appropriate for the subject matter of the consultation. These meetings must 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 may not be held at a resort location, unless the consultant is participating in and contributing to Maquet's annual sales meeting, which typically takes place at a resort location.
Compensation. Compensation to be paid to the consultant over the term of the agreement must be specified in the agreement. Compensation must represent fair market value in an arm's length transaction for the services provided and may not be based on the volume or value of the consultant's past, present or anticipated business. Consultants are required to keep adequate records of, and periodically report to Maquet on the time, personnel and resources used in performance of the agreement. If the consultant is compensated based on an hourly rate, the consultant must submit to Maquet records showing the number of hours spent performing work required under the agreement. In appropriate cases where Maquet does not have other means of assessing the progress of work performed by a consultant, consultants should submit to Maquet periodic (at least quarterly) reports on the progress of the work.
Expenses. Consulting agreements may provide for reimbursement of documented, reasonable and actual expenses incurred by a consultant that are necessary to carry out the consulting arrangement, such as costs for travel, modest meals, and lodging.
Meetings. You may invite HCPs to participate in a consulting/advisory role to provide feedback on product ideas or to speak to Maquet employees on clinical, medical, or marketing issues. The appropriate uses of consultant meetings are to obtain assistance with the design of Maquet's clinical programs, or to gain an understanding of clinical practice or the marketplace relative to Maquet's products and services. Consultants must be informed when the product or use under discussion is investigational. Confer with Compliance before organizing a sales or marketing-focused consultant meeting with Vermont or Massachusetts HCPs.
Disclosure. Consultants who sits on a clinical practice guideline committee or is a member or employee of or affiliated with an educational or not-for-profit institution should disclose the existence and nature of his or her relationship with Maquet to the committee(s) or institution and agree to follow any procedures set forth by such committee(s) or institution. Consultants should disclose all other potential conflicts of interest.
Meals. Maquet sponsored meals and refreshments provided in conjunction with a consultant meeting must be modest in value and subordinate in time and focus to the primary purpose of the meeting. Maquet may not provide recreation or entertainment in conjunction with these meetings.
Approvals. All Maquet Consulting Agreements and/or Clinical Study Agreements with HCPs, for new and renewal agreements or relationships, must be authorized by, and require the signature of, a Maquet Vice President. All consulting agreements must be submitted to the Legal Department for prior review and approval.
Key Criteria for Compliance
- All consultant arrangements must be specified in a specific contract.
- Consultants may only be hired for a legitimate business need.
13. Payment Information
Maquet, as a medical device manufacturer, is required to report to the Federal Government and certain states payments to HCPs and hospitals. You must notify Compliance and Accounts Payable when invoices from HCPs contain charges that are inconsistent with this Compliance Plan. You are responsible for the completion and accuracy of expense reports. Compliance will provide additional information and training related to payment reporting.
14. Massachusetts Healthcare Providers
Massachusetts has additional laws that you need to follow. Full-time and part-time employees of Maquet are excluded.
Meals. Occasional and modest meals are allowed in a "hospital setting" if there is an informational presentation. Otherwise, meals given directly to a HCP are forbidden. CME Providers may provide meals to Massachusetts HCPs.
Seek help. Ask the Compliance Department before making grants or donations, preparing consultant or speaker agreements, supporting third-party conferences or providing faculty support directed to Massachusetts HCPs. As these are often fact-intensive inquiries, please provide the Compliance Department with the details of the situation.
15. Vermont Healthcare Providers
Vermont has additional laws that you need to follow. Full-time and part-time employees of Maquet are excluded.
Meals. Vermont has a meal ban for Vermont HCPs. In certain cases, you may be able to provide a meal in conjunction with technical training when it involves travel. You must get the permission of Compliance prior to providing any meals to a Vermont HCP.
Refreshments. Due to recent changes in the law, you may provide Refreshments, including coffee or other snacks, when at a booth at a conference or seminar.
No-charge Items. No-charge equipment loans must be less than 120 days in duration. No-charge items given to HCPs are reported annually.
Seek help. Ask the Compliance Department before making grants or donations, preparing consultant or speaker agreements, supporting third-party conferences or providing faculty support directed to Vermont HCPs. As these are often fact-intensive inquiries, please provide the Compliance Department with the details of the situation.
16. Lawful Promotion of FDA Regulated Products
The U.S. Food and Drug Administration (FDA) oversees the public health by assuring the safety and effectiveness of drugs and medical devices marketed in the United States. In fulfilling this responsibility, the FDA regulates how these products are labeled and promoted.
Healthcare companies are bound by federal law to secure the approval or clearance of certain products by the FDA. Prior to marketing or promoting a product, the manufacturer provides the FDA with evidence of the safety and effectiveness of the product for a specific use or uses. The product receives FDA approval or clearance on the basis of this evidence, and the approved uses (indications) are listed in the product labeling.
Although physicians can lawfully prescribe or use products for unapproved ("off-label") indications, companies cannot promote products for "off-label" indications and are restricted in how they communicate with Healthcare Providers (HCPs) and other customers about these uses.
All labeling, advertising, and promotional materials for Maquet products must comply with the Federal Food, Drug, and Cosmetic Act, FDA regulations and policies, and other applicable federal and state regulations and pertinent Maquet's SOPs.
A. Promotional Activities
Maquet's employees, including sales personnel and engineering, distribution providers and/or third party sales agents of the firm, must ensure appropriate and accurate promotion of all company products. No Maquet employee may promote any unapproved or uncleared Maquet product or promote any product use that has not been approved or cleared by FDA.
Sales representatives and other commercial personnel may not engage in any discussions with customers or potential customers on unapproved or uncleared products, or unapproved uses of currently marketed Maquet products. A sales representative who receives a request for off-label information must refer the inquiry to the Chief Medical Officer, as described below, and copy his or her manager.
Sales representatives and marketing personnel also may not distribute articles or other materials discussing off-label uses. Similarly, they may not encourage off-label talk at events such as physician speaker events or "plant" questions in the audience that are likely to lead to off-label discussion. U.S. sales representatives are bound by United States promotional rules when interacting with U.S. HCPs anywhere in the world (e.g., if you are attending a conference in Sweden).
Maquet employees also may not make comparative or superiority clinical claims (e.g., claims that Maquet's product is more effective than a competitor product) without substantial supporting clinical evidence approved by the Legal and Regulatory Affairs Departments.
B. Promotional Materials
All labeling, advertising, and promotional materials, including but not limited to detailing pieces, reprints, slides, computer presentations, audiovisual materials, reimbursement materials, materials for distribution at programs, and branded press materials must be submitted for review and approval by the Regulatory Department and the Vice President of Marketing in accordance with applicable labeling and advertising Standard Operating Procedures. This includes materials that describe, refer to, or promote any Maquet product created and/or intended to be distributed by sales or marketing personnel outside of Maquet.
Certain materials used as sales training aids or background information are intended for internal educational purposes only and are identified as such by Maquet. Employees may not distribute or show these materials to HCPs or customers.
Key Criteria for Compliance
- Promotional discussions and materials pertaining to Maquet products must be consistent with product labeling.
- All promotional, marketing and sales-training materials must be reviewed and approved in accordance with applicable labeling and advertising Standard Operating Procedures prior to distribution
- Sales representatives and other commercial field-based staff, including third-party agents contracted for these roles, must undergo training in appropriate promotional practices consistent with labeling and advertising SOPs.
17. Responding to Unsolicited Requests about "Off-Label" Product Uses
If anyone (such as a physician, pharmacist, nurse, individual from a buying group or other Healthcare Provider (HCP)) poses an unsolicited question about an off-label use of a Maquet product, or about a Maquet product that has not yet been cleared or approved by FDA, you must advise the requestor that Maquet policy prohibits you from discussing off-label uses and direct that person to the Chief Medical Officer.
- Refer the inquiry to the Chief Medical Officer by providing to the requestor the telephone number (973) 709-7570 or fax number (973) 709-6505 of the Chief Medical Officer. Copy your manager on the communication. The HCP requestor will need to provide a description of the off-label use being requested and the method by which the HCP wishes to receive the information (e.g., email or phone call).
The Chief Medical Officer can provide appropriate information directly to the requestor consistent with FDA guidelines. Failure to follow this policy can be cause for employee disciplinary action including, but not limited to, termination of employment.
18. Sales, Promotional, and Other Business Meetings
Maquet may conduct sales, promotional and other business meetings with Healthcare Providers (HCPs) to discuss, for example, features of Maquet's products, sales terms, or contracts. Often, these meetings occur close to the HCP's place of business. It is appropriate to pay for reasonable travel costs of attendees when necessary (e.g., for plant tours or demonstrations of non-portable equipment) and/or to provide occasional modest meals and refreshments in connection with such meetings.
Employees cannot use a plant tour or demonstration to justify reimbursing a HCP for expenses unrelated to education about Maquet's products, e.g., a third-party conference or a personal trip. Maquet may not reimburse HCPs for their time during a plant tour or other sales, promotional or non-consultant business meetings.
You may not pay for meals, refreshments, travel, or lodging of guests of HCPs or any other person who does not have a bona fide professional interest in the information being shared at the meeting.
Where discussion of unapproved products or uses is necessary to obtain the advice or services of a consultant, any discussion of such products or uses by Maquet employees must be pre-approved by Compliance and be non-promotional, objective, balanced, and scientifically rigorous.
19. Maquet Conducted Product Training and Education
Maquet has a responsibility to make training and education on their products available to Healthcare Providers (HCPs). "Training" means instruction on the safe and effective use of Maquet's products. "Education" means communicating information directly concerning or associated with the use of Maquet's products, e.g., information about disease states and the uses of products in certain patient populations. Training and education programs include, but are not limited to, "hands on" training sessions, cadaver workshops, lectures and presentations, and grand rounds. Training should not include topics such as Billing and Coding. All Maquet employees must adhere to the following principles when conducting training and education programs concerning Maquet's products for HCPs:
- Training must be consistent with approved product labeling.
- Programs and events must 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 limited cases, it may be appropriate for a Maquet representative to provide training and education at the HCP's location.
- Programs providing "hands on" training on Maquet's products must be held at training facilities, medical institutions, laboratories, or other appropriate facilities. The training staff used by Maquet must have the proper qualifications and expertise to conduct such training.
- Maquet may provide HCP attendees with modest meals and refreshments in connection with these programs, but may not provide an honorarium or other compensation for time spent in training. 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. Entertainment is not permitted.
- Where there are objective reasons to support the need for out-of-town travel to efficiently deliver training and education on Maquet's products, Maquet may pay for reasonable travel and modest lodging costs of the attending HCPs. Maquet may not pay for the meals, refreshments, travel, or other expenses for guests of HCPs or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.
- Maquet representatives must not touch or make contact with the patient or, during the procedure, touch or operate instruments or equipment that delivers or regulates therapy to the patient.
- CME credits should not be issued for Maquet sponsored and controlled training.
Key Criteria for Compliance
- Maquet representatives providing technical support may not promote the device for uses outside the approved product labeling.
- If a physician elects to use a device in a manner not described in the product labeling, Maquet representatives must limit the discussion of product related information to the device's labeled instructions for use, its operating principles, its performance specifications and other technical aspects of the product.
20. Providing Reimbursement Information
You may only promote our products based solely on their efficacy, safety, and cost.
You may not offer unsolicited comments regarding the amount a customer might receive in reimbursement from Medicare or Medicaid for a Maquet product or a competitor's product. You may not provide personal opinions or interpretations of coding, coverage, or reimbursement information, nor should you offer unsolicited comments about such topics. If you are asked about reimbursement issues not related to specific coding, coverage, and payment by a customer or other individual, you should respectfully refer the customer to Maquet's third-party reimbursement information provider. If you have any questions regarding promotion of products that are reimbursed by Medicare or Medicaid, contact your supervisor or the Regulatory Affairs Department.
21. Patient Information
You may encounter Patient's protected health information ("PHI") while at a customer site. PHI is identifiable patient health information and protected in certain situations under the Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH). HIPAA and HITECH restrict how "covered entities" (e.g., physicians, hospitals and health insurance carriers) and their "business associates" can disclose and use this information. Although Maquet cannot usually be considered a "covered entity" or a "business associate" to a covered entity, Maquet is committed to cooperating with customers in their efforts to protect the confidentiality and security of patient information. You must keep confidential all PHI, even if incidentally or electronically received.
Should PHI come onto Maquet's premises in any form for any reason or if you are aware of breach of privacy related to PHI, you must immediately notify the Compliance Department.