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A Change Is Gonna Come: AdvaMed Revises Its Code Of Ethics On Interactions With Health Care Professionals – Healthcare

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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


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

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

  • 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

  • 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

AGG Observations

  • 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.

Originally published 4 April 2022

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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