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

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.

Highlights

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.

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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