LIBRARY GUIDE: Medical Device Sales & Marketing

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1 LIBRARY GUIDE: Medical Device Sales & Marketing

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3 Table of Contents Overview... 2 About Our Health Care Compliance Solution... 2 Our Relationship With AdvaMed... 2 Course Descriptions: Basics of the AdvaMed Code (MDSM01)...3 Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (MDSM03)...4 Best Practices: Educational Grants (ADVAMED-MINI-03)...4 Best Practices: Educational Items and Prohibition on Gifts (ADVAMED-MINI-04)...5 Best Practices: Grand Rounds (ADVAMED-MINI-06)...5 Best Practices: Modest Meals (ADVAMED-MINI-02)...5 Best Practices: Plant Tours (ADVAMED-MINI-05)...5 Best Practices: Supporting Third-Party Educational Conferences (ADVAMED-MINI-01)...6 Ethhical Third party Sales & Marketing Intermediary (SMI) Relationships (MDSM06)...6 EucoMed Guidelines on Interactions with Healthcare Professionals (MDSM04)...6 HIPAA and Privacy Guidelines for Medical Device Sales Representatives (PRIVACY01)...6 Introduction to Medical Device Health Care Compliance (MDSM05)...7 OIG Compliance Program Guidance for Medical Device Manufacturers Field Force (OIG03)...7 Operating Room Conduct (PHA68)...7 Physician Payment Sunshine Act (PHSM11)... 8 Reporting Adverse Events for Medical Devices (MDMS02)...8 Environmental, Health and Safety Topics: Basic Radiation Awareness (EHS05)...9 Bloodborne Pathogens Health Care Workers (EHS09)...9 Page 1

4 Overview: UL EduNeering s Medical Device Sales and Marketing Library is specifically designed for the (promotional) regulatory, legal, communications, compliance and other industry professionals who daily interact with the marketing, advertising, promotional and communication issues regulated by the FDA. The Privacy Guidelines course includes a short summary of the Health Insurance Portability and Accountability Act (HIPPA) Privacy Rule and describes how the regulations affect the detailing and customer-support activities of Medical Device sales representatives. Third Party Oversight Risk Assessment Policy Tracking UL HEALTH CARE COMPLIANCE LEARNING SOLUTION Audit Inquiries Employee Training and Content Conduct Code of About our Health Care Compliance Suite This Library is part of the Health Care Compliance Suite (HCCS) which helps Life Science companies strip the complexity from compliance learning programs. Our solution shifts compliance learning from a reactive to a proactive process, as it enables you to automate learner risk profiling, establish well-defined certification roles, streamline delivery of training to employees and third parties and generate real-time audit reports that answer detailed compliance questions. As regulatory requirements grow more complex, your training content must be crafted in a way that ensures proper retention and improves employee and contractor performance. Our highly-engaging compliance course Libraries, when aligned with organization-specific training content, form the backbone of our customers ethics and compliance programs. Our courses are designed by experts in adult learning. The courses employ proven instructional design methodology and mastery, fostering deep processing and understanding of the material and actually resulting in behavior change the goal of effective training. UL works with leading subject-matter experts to update our courses as regulations and guidelines change. Our Relationship with AdvaMed Under a multi-year agreement, UL serves as the online partner for compliance solutions to AdvaMed, the world s largest medical technology trade association, and the Medical Technology Learning Institute (MTLI). UL s extensive Library of online resources for medical technology companies has been independently reviewed by AdvaMed. The AdvaMed Code course in this Library represents the only online course on the Code that s been approved by AdvaMed. In addition, this Library contains six AdvaMed Code mini-modules that only take about 10 minutes to complete and can be used throughout the year to help reinforce AdvaMed Code guidelines to employees, resellers and contractors. LEGEND: Learners have the option to take this course via a mobile device, such as an ipad. Page 2

5 Course Descriptions: Listed Alphabetically Basics of the AdvaMed Code (MDSM01) The Advanced Medical Technology Association (AdvaMed) represents companies that develop, produce, manufacture and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities (Medical Technologies) in order to enable patients to live longer and healthier lives. AdvaMed recently approved a major update of its Code of Ethics on Interactions with Health Care Professionals (the Code). It is crucial for all Medical Technology companies to understand the guidelines and how they impact interactions with Health Care Professionals (HCPs). The term Health Care Professional is defined broadly in the Code and includes persons and entities involved in the provision of patient care and in the decisions to purchase, lease or recommend a medical technology. These individuals may include purchasing agents, physician practice managers and management within group purchasing organizations. AdvaMed Code Company-Conducted Product Training and Education Third Party Educational Conferences and Business Meetings Consulting Arrangements Evaluation and Demonstration Products Modest Meals, Prohibition on Entertainment and Gifts Coverage and Reimbursement Grants and Donations Note: Learners have the option to take this course via a mobile device, such as an ipad. It is important to remember that some HCPs are also government employees. More restrictive legal restrictions may apply to such individuals. After completing this course you will understand how the AdvaMed Code guides your interactions with HCPs. This updated Code contains important revisions and new provisions that include: Further clarification and distinguishing of appropriate and inappropriate interactions between HCPs and representatives of Medical Technology companies; A new Code compliance section listing companies that certify their adoption of the Code (available on the AdvaMed website); A prohibition on providing entertainment or recreation to HCPs, as well as a prohibition on gifts; Guidelines for entering into royalty arrangements with HCPs; Parameters for the provision of evaluation and demonstration products; An expanded section addressing the provision of objective reimbursement, coverage and health economics information to HCPs. Page 3

6 Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (MDSM03) The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation,105 CMR , helps ensure that the relationship between life science manufacturers and health care practitioners (HCPs) does not interfere with the independent judgment of the HCPs. This course explains the MA Regulation, which has similar provisions to the AdvaMed and PhRMA Codes of Ethics, and imposes a number of additional restrictions on how sales and service personnel interact with health care practitioners. For example, your company may be required to have a Code of Conduct in place. Who is subject to the MA Regulation? What are the general requirements of the MA Regulation? Can companies use non-patient identified prescriber data? Can Companies engage Massachusetts-licensed health care practioners as consultants and can they provide meals? Are companies permitted to support Continuing Medical Education (CME) programs under the MA Regulation? Are there other acceptable or restricted activities relating to payments to Massachusetts-licensed health care practitioners? Are there disclosure requirements under the MA Regulation? After completing this course, you will be able to recognize how to comply with the new restrictions and understand the critical differences between the MA Regulation and the AdvaMed and PhRMA Codes of Ethics. Best Practices: Educational Grants (ADVAMED-MINI-03) Medical Device companies have to base their decision on whether to provide an educational grant based on several key factors (accreditation, faculty qualifications, etc.) After completing this course, you will know the basic requirements for providing grants for educational programs and fellowships. Best Practices: Educational Items and Prohibition on Gifts (ADVAMED-MINI-04) Whether you provide an educational item or gift depends on a few key questions, such as whether the item is for patient use. This course describes the AdvaMed Code s guidance on providing items to Health Care Professionals (HCPs), emphasizing the need for these items to be educational or for the benefit of patients. Page 4

7 Best Practices: Grand Rounds (ADVAMED-MINI-06) If your company is asked for a grant to support a Grand Rounds session, the first thing to determine is whether or not the institution will have control over the program. This course describes appropriate support for Grand Rounds sessions under the AdvaMed Code. Best Practices: Modest Meals (ADVAMED-MINI-02) Determining whether a meal you want to provide is considered modest and allowable under the AdvaMed Code requires your company to answer a series of questions regarding the purpose and structure of the meal. This course describes the best practices and requirements under the AdvaMed Code for providing modest meals to Health Care Professionals (HCPs) as a part of medical device sales presentations. Best Practices: Plant Tours (ADVAMED-MINI-05) This course describes the appropriate circumstances under the AdvaMed Code for providing plant tours to Health Care Professionals (HCPs). It also describes compliance requirements for these tours and provides real-world examples of situations in which the AdvaMed Code s guidance for plant tours may apply. Best Practices: Supporting Third-Party Educational Conferences (ADVAMED-MINI-01) Educational support includes funds granted to a third-party conference sponsor with the intent of reducing conference costs. These costs are legitimate educational expenses and bona fide educational activities. This course describes the AdvaMed Code s guidance for corporate support of third-party educational conferences. Page 5

8 Ethical Third Party Sales and Marketing Intermediary ( SMI ) Relationships (MDMS06) This course explores third party sales and marketing intermediary relationships. It discusses the key regulatory risks associated with sales and marketing with third parties, depicts how an effective compliance program can assist a company in mitigating regulatory risks, and describes essential elements of an effective compliance program. Topics Include: Definition Compliance Program Risk Areas Scenarios Conclusion Challenge EucoMed Guidelines on Interactions with Healthcare Professionals (MDSM04) This course focuses on the EucoMed Guidelines on Interactions with Health Care Professionals (HCPs). The mission of EucoMed is to improve patient and clinician access to modern, innovative, and reliable medical technology. The goal of this course is to familiarize EucoMed members with the guidelines of their many interactions with HCPs. Key Principles Education and Meetings Consulting, Arrangements, Gifts and Billing Donations and Grants HIPAA and Privacy Guidelines for Medical Device Sales Representatives (PRIVACY01) This course provides a short summary of the HIPAA Privacy Rule and describes how HIPAA affects the detailing and customer support activities of medical device sales representatives. Definition Effects of HIPAA Products & Software Assistance & Training Patient Issues Introduction to Medical Device Health Care Compliance (MDSM05) This course provides high-level introduction and background regarding the compliance environment affecting the Medical Device industry. These topics are especially important in the industry, as the development of medical device products involves a close collaboration between the industry and Health Care Professionals (HCPs), and their use may require the interaction and skill of medically-trained personnel. This course is designed to make employees aware of pertinent laws, regulations and industry guidance that regulate the Medical Device industry. FDA Regulations The Federal Anti-Kickback Statute The Office of the Inspector General (OIG) Compliance Program Guidance AdvaMed Code of Ethics Foreign Corrupt Practices Act (FCPA) False Claims Act State Ethics and Compliance Legislation Note: MOB version is available for this course. Page 6

9 OIG Compliance Program Guidance for Medical Device Manufacturers Field Force (OIG03) This course has been prepared to assist Medical Device manufacturers in identifying practices that present a potential risk of liability under the three major risk areas identified in the Office of the Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers. Risk areas the OIG identified for Medical Device manufacturers When common arrangements can be considered kickbacks How consulting agreements raise fraud and abuse issues How off-label promotion can raise concerns under fraud and abuse laws Operating Room Conduct (PHA68) This course addresses all aspects of Operating Room (OR) conduct. The course will cover important, general information about the hospital environment and staff, how to behave prior to and upon arrival at the hospital and how to dress for the OR. The course also covers the OR setting, protocols and restrictions for entering patient care areas, the roles of company representatives and hazards that are present in a hospital and in the operating room. Protocols OR Attire Representatives Procedure Support Hazards Aseptic Technique Note: This course has been approved by the Association of Operating Room Nurses (AORN) Continuing Education Approval Committee for 2.5 Contact Hours Physician Payment Sunshine Act (PHSM11) This course provides the basics of the Physician Payment Sunshine Act ( Sunshine Law ), which was passed in 2010 as part of comprehensive health reform legislation. The law requires certain businesses to comply with specific transparency requirements. Specifically, those businesses must report payments to physicians and teaching hospitals as well as ownership interests by those physicians. The main purpose of the law is to provide patients with enhanced transparency into the relationships their Health Care Providers have with Life Science and Medical Technology manufacturers. Companies Required to Report Payment and Other Transfer of Value Information Required on the Transparency Report Physician Ownership Reporting Exclusions Penalties After taking this course, learners will understand which companies are required to report, what is a covered recipient, and what types of payments need to be reported. Page 7

10 Reporting Adverse Events for Medical Devices (MDMS02) The FDA has the authority to oversee the manufacture of medical devices. The FDA requires manufacturers, importers and user facilities to file Medical Device Reports (MDRs) so that adverse events can be detected and corrected quickly. Congress enacted legislation requiring manufacturers to report to the FDA all device-related deaths, serious injuries, and certain malfunctions because numerous reports over the years have shown there is widespread underreporting. This underreporting resulted in injuries affecting public health which could not be traced by the FDA. Topics Include: Defining an Adverse Event Types of Reports Internal Procedures Documentation/Recordkeeping Filling Out an MDR After completing this course, you will be able to identify what a MDR is and the types of reports that exist. You will also recognize a company s requirements for reporting adverse events for medical devices. Page 8

11 Environmental, Health and Safety Topics: Basic Radiation Awareness (EHS05) The general public often thinks radiation exposure only occurs in areas displaying Caution: Radiation or Danger: Radiation signs. Actually, in addition to exposure in certain work places, each of us is exposed to natural radiation each day of the year. This course presents information about the types of natural and manmade (ionizing) radiation, as well as where radiation originates, its health effects, principles of protection and components of an effective Radiation Protection Program. References: NRC 10 CFR, Part 20 Standards for Protection against Radiation OSHA 29 CFR Part Ionizing Radiation This course incorporates materials from The HSE Group, Inc. Bloodborne Pathogens Health Care Workers (EHS09) Health Care workers face the risk of exposure to bloodborne pathogens every day. These pathogens include hepatitis, AIDS and other infectious diseases. In this course, participants will learn the sources of bio-hazardous substances and the routes of transmission and symptoms of bloodborne diseases. This course also covers the proper techniques and equipment for personal protection, the actions to be taken following a possible exposure and the components of an effective Exposure Control Plan. References: OSHA 29 CFR Part Bloodborne Pathogens This course incorporates materials from The HSE Group, Inc. and J. Fleming. Page 9

12 About UL EduNeering UL EduNeering is a business line within UL Life & Health s Business Unit. UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute. 202 Carnegie Center Suite 301 Princeton, NJ UL and the UL logo are trademarks of UL LLC uleduneering.com LG/100114/MD