- AdvaMed’s Code of Ethics on Interactions with Health Care Professionals has been overhauled, its first revision in 10 years, Jonathan Turner, vice president of ethics and compliance at Smith & Nephew, said Monday at The MedTech Conference. The revised code takes effect Jan. 1, 2020.
- The updated code includes four new topics: jointly conducted education and marketing programs; communicating for the safe and effective use of medical technology; consigned products (products to which the company retains title until the product is used); and company representatives providing technical support in the clinical setting. It also addresses value-based care and artificial intelligence — topics that did not feature on the industry's radar during the last revision a decade ago.
- Some key changes in the redo include expanding the section on the Physician Payment Sunshine Act to include nurses, nurse practitioners and physician assistants. That act mandates public reporting of payments to physicians by makers of medical devices and supplies, drugs and biologics if they are covered by Medicare, Medicaid or the Children's Health Insurance Program.
With government scrutiny of life sciences companies increasing, industry codes of ethics are a way manufacturers can argue they are already monitoring themselves.
“It’s a demonstration of self-regulation and gives the industry that much more credibility as the government looks at these arrangements,” said Matt Wetzel, senior counsel with Akin Gump Strauss Hauer & Feld, who spearheaded the Code’s revision. Wetzel spoke Monday at a session at the AdvaMed-sponsored MedTech Conference in Boston.
Device companies' relationships with healthcare providers can be tricky, especially in areas such as educational programs. The government has stepped up scrutiny of education and co-marketing programs over the past decade. Those relationships can create risk under the federal Anti-Kickback Statute and other fraud and abuse laws.
Companies need to be careful to institute "independent controls to help ensure such arrangements are not made as unlawful inducements," Wetzel said.
If educational programming includes the healthcare practitioner and a guest and is conducted at a resort-type location, the line between a business meeting and a junket could become blurred, Nancy Travis, AdvaMed's vice president of international compliance and governance, said.
Under the revised code, written documentation of any arrangements is required and the healthcare practitioners must make fair and equitable contributions toward the activity and payment of costs.
"Already this [code update] has been helpful," said Kristi Schrode Travers, assistant general counsel at Johnson & Johnson. "Doctors are hearing about it and know companies need to split the costs with the healthcare provider."
Another area that has come under fire from the government has been company representatives providing technical support in clinical settings and the updated code addresses this, too.
Any company representative who's allowed to be in the clinical setting — for example, in the operating room — must be there at the direction and under the supervision of the healthcare provider. In addition, the representative must be transparent that they are there on behalf of the company, must comply with patient privacy and hospital credentialing, and must not interfere with the clinician's autonomy.
The guidelines are aimed at creating consistency across the industry by providing a compliance guide that multiple stakeholders can use.
"This is plain English," panelist Avi Spira, chief compliance, risk and privacy officer of Fujifilm said. "This is something you can give to your sales leadership and they can understand it and don't have to come to us so frequently."