On June 1, 2022, updates to the AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code) became effective, centered around value-based care considerations and best practices for meetings with health care professionals in light of recent concerns by the Department of Health and Human Services Office of Inspector General (HHS OIG).
Value-Based Care
For one, the AdvaMed Code revision addresses arrangements focused on advancing value-based care, including value-based safe harbors that protect specific arrangements that deliver more value to patients by improving quality, reducing cost, or both.
Available safe harbors have a set of specific requirements and limitations that must be met in order for the safe harbor protection to apply. Additionally, medical device manufacturers do not benefit from value-based safe harbors the same way providers and payors of health care do, though medical device manufacturers and durable medical equipment companies can participate in protected care coordination arrangements involving digital health technology (as long as the requirements are met). These participants are known as “limited technology participants” and this special pathway recognizes the important role medical device and durable medical equipment companies have in patient care coordination and management.
Importantly, the AdvaMed Code notes that even if a certain arrangement is not eligible for protection under the value-based safe harbor, that does not mean that the arrangement automatically violates the anti-kickback statute. Instead, arrangements that do not fit in safe harbor should be reviewed for compliance with the Federal anti-kickback statute based on the totality of facts and circumstances, including the parties’ intent.
In the revised AdvaMed Code, medical technology companies are now advised of the following regarding interactions with health care providers, related to arrangements that promote outcomes or value-based care. They should:
- Provide customers with accurate and objective information about coverage, reimbursement, and health economics of medical technologies, including in the context of value-based reimbursement arrangements with payors
- Retain health care professionals as consultants to help in the development, evaluation, or implantation of protocols, procedures, and solutions to improve outcomes, quality, and efficiency
- Conduct sales, promotional, and other business meetings with health care providers to discuss value-based solutions, services, or arrangements.
Fraud and Abuse Concerns
The updated Code also provides additional guidance with respect to educational and other health care provider meetings, in light of concerns from the Special Fraud Alert: Speaker Programs issued by HHS OIG in November 2020.
Some of these changes to the AdvaMed Code include advising members to consider specific documentation regarding not only their legitimate need for certain consultants but also the fair market value of their compensation.
Additionally, the Code notes that the common use of virtual meeting software may impact the findings of a legitimate need for in-person meetings.
Finally, the revised Code notes that companies might consider certain controls when it comes to entertainment-based engagements with healthcare professionals, including drink limits, spending caps, and prohibiting alcohol at certain events to ensure compliance with generally applicable rules for meals and refreshments.
Conclusion and Further Reading
While the AdvaMed Code does not carry the force of law, several states have adopted its provisions as mandatory, and it therefore must be followed in those specific states. To further encourage compliance, AdvaMed also makes public the companies that have attested to compliance with the Code.
For a more in-depth review of these changes and the impact they may have on the pharmaceutical industry, read the June 2022 issue of our monthly sister publication, Policy & Medicine Compliance Update.