A change is coming: AdvaMed is revising its code of ethics on interactions with healthcare professionals | Arnall Golden Gregory LLP
In 1964 Sam Cooke sang “A Change is Gonna Come”. In March 2022, Advanced Medical Technology (AdvaMed) said the same thing when it announced revisions to its Code of Ethics for Interactions with Healthcare Professionals (the Code). As its name suggests, the Code provides guidelines and recommendations to its member (and non-member) medical device and technology companies on how companies should interact with healthcare professionals in order to minimize possible ethical and federal compliances (e.g..Anti-bribery law).
This bulletin reviews the recent amendments, which come into effect on June 1, 2022. We have already discussed the contents of the Code here.
The Code is not legally binding, but many device companies, including non-AdvaMed members, have adopted the Code as best practices and some states have recommended that medical device companies follow it.
- The 2022 revisions cover topics relating to:
- innovative business models;
- recent value-based safe harbor modernizations; and
- best practices for companies running training and education programs.
The revised Code also includes updated frequently asked questions (FAQs), additional information and key concepts.
Specifically, the 2022 Code:
- Recognizes that medical technology companies:
- leverage health care data and technology innovation to enable new knowledge, support health and well-being, improve interventions and patient outcomes, and improve the quality and efficiency of service delivery Health care ;
- develop data-driven devices and solutions that can operate independently or as part of a larger ecosystem to enable data collection, aggregation and analysis;
- can be uniquely positioned with a data hub, analytics capabilities and clinical solutions to improve health outcomes and provide business solutions to improve efficiency; and
- provide a combination of technologies and services designed to deliver targeted results.
- Recognizes and seeks to address the new reality of businesses interacting more with healthcare practitioners through virtual means: “An interaction that involves participants participating in a virtual environment typically enabled by digital technology rather than meeting in a physical location”.
- Updates definitions, including:
- Expand the definition of “medical technology” to include digital technology and software platforms that help “coordinate patient care”.
- Add the term “value-based care”, which is defined as “a model of health care delivery in which contributors to care are paid based on individual patient health outcomes, population health outcomes, improving access to health care for underserved populations, managing costs, and/or improving efficiency . . . may include payer-based reimbursement agreements for providers, agreements between providers, and agreements between providers and manufacturers or other participants in the healthcare system.
- Removes suggestion that certification occurs annually, indicating change to single certification. Previously, the Code “strongly encouraged” companies to submit annual certification, confirming the implementation of an effective compliance program.
- Regarding the engagement of healthcare professionals to provide consulting services, states that “developing, evaluating, or implementing an agreement to advance value-based care” may be a legitimate counseling service and businesses can train healthcare professionals as long as the agreement is structured in a way that minimizes the risk of abuse, such as meeting a legitimate need and in line with a compensation at fair market value.
- Provides advice regarding alcohol at live corporate programs and meetings (for example, trainings, educational programs, or business meetings), including that:
- refreshments, including alcohol, should be modest, provided for a legitimate purpose, in an appropriate setting and to appropriate participants; and
- businesses must establish controls around the supply of alcohol, such as consumption limits per person, spending limits per drink, limitations on the type of alcohol allowed, or the prohibition of alcohol at certain events .
- Clarifies that companies can provide modest meals or refreshments during virtual meetings, but recommends companies develop processes to monitor orders and delivery, track attendance to ensure only appropriate attendees receive refreshments and/or or prohibit home delivery.
- Updates FAQs on scholarships and business sponsorships, with a framework on how companies should assess applications for these activities.
- Provides guidance on how companies should consider reviewing the request for third-party program support, which includes a number of factors, such as whether the request is reasonable and reflects the educational purpose and whether the agenda reflects legitimate educational, medical or scientific proposals. Of the reunion.
- Enables companies to provide accurate and objective information relating to the economically efficient use of its medical technologies (e.g.., reimbursement and intervention in health economics, including when negotiating contracts based on value and results) economic information; however, the companies may not interfere with independent clinical decision-making by a healthcare professional or provide the information as an incentive.
- Medical device companies, whether AdvaMed members or not, should review the revisions and modify internal policies to reflect the recommendations, as appropriate.
- The Code reflects the new reality of our world with an emphasis on virtual meetings and new technologies.
- Legends, such as FAQs, additional information, and key concepts, provide useful information to better understand the Code’s objectives.
- A change is coming, but it may not be bad.