The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The organization is also an industry “go-to” source for understanding complex compliance and regulations. AdvaMed has revised its Code of Ethics on Interactions with Health Care Professionals. Revisions will be in effect as of June 1, 2022, and medical technology companies may want to consider revising their compliance policies to reflect the changes.
The updates address the recent alterations in the Anti-Kickback Statute’s (AKS) value-based safe harbor rules. The safe harbor rules outline the types of “payment and business practices that will not be considered kickbacks, bribes, or rebates that unlawfully induce payment by Medicare or Medicaid programs.” Effective as of January 19, 2021, the US Department of Health and Human Services Office of Inspector General (HHS-OIG) does not permit medical device companies to use the safe-harbor rule. There is an exception made for those medical device companies with digital health technology. The updates also address how to best conduct meetings, trainings, and communication with healthcare professionals. The updated code expands upon definitions to better explain the new Anti-Kickback Statute (AKS) Value-Based Enterprise (VBE) safe harbor terms. It enumerates on permissible arrangements under the new AKS, acceptable interactions with healthcare providers, and it addresses restrictions related to providing alcohol at company-conducted programs and meetings. Additionally, the Code provides a thorough list of FAQs to aid in better understanding how these changes might impact your company.
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