In 1964, Sam Cooke sang “A Change is Gonna Come.” In March 2022, the Advanced Medical Technology (AdvaMed) said the same when it announced revisions to its Code of Ethics on Interactions with Health Care Professionals (the Code). As the Code’s name indicates, it provides guidelines and recommendations to its medical device and technology company members (and non-members) about how companies should interact with health care professionals to minimize potential ethical and federal compliance (e.g., Anti-Kickback Statute) risks.
This Bulletin reviews the recent changes, which go into effect on June 1, 2022. We have previously 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 focus on topics concerning:
- innovative business models;
- recent value-based safe harbor modernizations; and
- best practices for companies hosting training and education programs.
The revised Code also includes updated frequently asked questions (FAQs), additional insights, and key concepts.
Specifically, the 2022 Code:
- Recognizes that medical technology companies:
- leverage health care data and technology innovation to enable new insights, support health and wellness, improve patient interventions and outcomes, and enhance the quality and efficiency of health care delivery;
- develop data-driven devices and solutions can work independently or as a part of a larger ecosystem to enable data collection, aggregation, and analysis;
- may be uniquely positioned with data hub, analytics capabilities, and clinical solutions to improve health outcomes, and provide business solutions to improve efficiency; and
- provide a combination of technology and services designed to deliver targeted outcomes.
- Recognizes and seeks to address the new reality of companies interacting more with health care practitioners through virtual means: “An interaction that involves attendees participating in a virtual environment that is generally enabled by digital technology rather than meeting in a physical location.”
- Updates definitions, including:
- Expanding the definition of “medical technology” to include digital technology and software platforms that assist in “coordinating patient care.”
- Adding the term “Value-Based Care,” which is defined as “a health care delivery model in which contributors to care are paid based on individual patient health outcomes, population health outcomes, increasing access to health care for underserved populations, managing costs, and/or improving efficiency . . . may include payor-driven reimbursement arrangements for providers, arrangements between providers, and arrangements between providers and manufacturers or other participants in the health care system.”
- Removes the suggestion that the certification occur annually, indicating a shift in favor of a one-time certification. Previously, the Code “strongly encouraged” companies to submit an annual certification, affirming implementation of an effective compliance program.
- Regarding engaging health care professionals to provide consulting services, states the “development, evaluation, or implementation of an arrangement to advance value-based care” can be a legitimate consulting service and companies can train health care professionals so long as the arrangement is structured in a way that minimizes risk of abuse, such as being in response to a legitimate need and consistent with fair market value compensation.
- Provides guidance regarding alcohol at live company programs and meetings (e.g., training, 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
- companies should establish controls around the provision of alcohol, such as per-person drink limits, per-drink spend limits, limitations on the type of alcohol permitted, or prohibiting alcohol at certain events.
- Clarifies that companies can provide modest meals or refreshments during virtual meetings, but recommends that companies develop processes to control ordering and delivery, track attendance to ensure that only appropriate participants receive the refreshments, and/or prohibit home delivery.
- Updates the FAQs on educational grants and commercial sponsorships, with a framework for how companies should assess requests for these activities.
- Provides guidance on how companies should consider reviewing request to support third-party programs, which include a number of factors, such as whether the request is reasonable and reflective of the educational purpose and whether the agenda reflects the legitimate educational, medical, or scientific proposes of the meeting.
- Permits companies to provide accurate and objective information relating to the economically efficient use of its medical technologies (e.g., reimbursement and health economics intervention, including when negotiating value-and-outcomes-based contracting) economic information; however, companies may not interfere with a health care professional’s independent clinical decision-making or provide the information as an inducement.
- 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 our world’s new reality with a focus on virtual meetings and newer technologies.
- The callouts, such as FAQs, additional insights, and key concepts, provide useful insights to better understand the Code’s objectives.
- A change is gonna come, but it may not be bad.