In January, the Advanced Medical Technology Association (AdvaMed), the U.S. medical device industry’s largest trade and lobbying group, released an updated “Code of Ethics on Interactions with U.S. Health Care Professionals” (HCPs).
The Code of Ethics originally appeared as the Health Industry Manufacturers Association Code in 1993. It was later updated and relaunched as the AdvaMed Code in 2003 and revised in 2008.
The last time AdvaMed updated its Code of Ethics was in the immediate aftermath of the U.S. Attorney deferred prosecution agreement era in 2008. Then U.S. Attorney Chris Christie most famously accused device companies of rampant abuse of payments to physicians and other healthcare providers in exchange for recommending the use of company devices in violation of the federal Anti-Kickback Statute.
Among other things, Christie cited payments for unnecessary consulting agreements, questionable payments for speaking engagements and royalty payments where surgeons contributed little, if any, intellectual property. Without admitting guilt, the major orthopedic industry players paid over$300 million in fines and entered into extensive deferred prosecution agreements requiring third-party review of industry/physician contracts.
Nearly one decade after those “bad-old-days,” AdvaMed updated Code of Ethics will go into effect on January 1, 2020.
Why update now?
Scott Whitaker, the Association’s CEO, said the updates “reflect evolving legal standards, care delivery models and best practices of the last decade.” He added the Code is designed to “ensure the Code’s continued effectiveness as a premier foundational document for ethics and compliance across the medtech industry.”
Kevin Lobo, Stryker Corporation’s chairman and CEO, is the association’s Chair-Elect. He said by helping to ensure companies continue to focus on ethical business practices, “The refreshed Code reinforces the industry’s commitment to delivering expert care and building products that make a difference for health care professionals and patients.”
What’s New?
While the Code also adds new Code values such as “Innovation; Education; Integrity’ Respect; Responsibility; & Transparency,” Matt Wetzel, AdvaMed’s vice president and deputy general, said the most important change is that the Code is now more readable, accessible, and usable for field service representatives.
We scoured the 38-page document looking for any new and significant updates or new rules guiding physician/industry relationships. The updated Code basically repackages the existing Codes and we were left wondering, “Where’s the Beef?”
What we found was that the Code does not focus on “ethics” as much as it focuses on clarifying rules that will help companies and surgeons steer clear of federal Anti-Kickback Statute violations.
The only hint of ethics is the industry association’s description of the physician and other providers’ “highest duty to act in the best interest of their patients.” Industry helps providers meet this duty “through necessary, collaborative interactions.”
Defining what is “necessary” and navigating the legal requirements governing industry and physicians’ interactions, of course, helps publicly traded companies meet their fiduciary responsibility to shareholders.
