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Deciding what issues to address when training reps

Device Regulation Alert: Safety, Compliance and Reimbursement News, July 30, 2007

PART III: In this issue we'll give you some tips on how to identify what compliance topics to tackle when training staff.

Medical device company representatives confront unique compliance problems not encountered by other sectors of healthcare. These concerns affect the type of training device companies must give their representatives.

Device representatives maintain a unique relationship with those using or prescribing the devices they sell. These highly experienced and well-trained professionals often accompany the physicians, and the equipment or devices, into the treatment environment, notes Michael Manthei, a healthcare lawyer and partner with Holland & Knight LLP. While physicians and device representatives engage in significant interaction this raises potential compliance concerns, says Manthei.

In addition to kickbacks and self-referral prohibitions, device representatives also must understand other regulatory provisions that affect their presence in a treatment environment. Concerns include patient privacy, OSHA compliance, among others. (For more, read the special report "Hospitals and rep credentialing programs," in the May 28, 2007 Device Regulation Alert.)

Additionally, companies frequently provide education regarding their equipment. Many representatives think education represents an area safe from compliance worries-but that is not the case, warns Manthei.

"There is a line between legitimate training, the accoutrements which go with that, and crossing the line into illegal remuneration," he says.

For example, it may be legitimate to bring physicians to a location, provide meals, and some entertainment as long as it is incidental to the main purpose-to train them on the equipment, he says. It's a different thing to bring the highest users and their families, to an expensive or exotic location such as Hawaii and arrange for them to play golf-in which case the primary focus is entertainment not education. Under such circumstances the trip could easily be misconstrued as a reward or kickback in exchange for their business.

Other compliance issues require training, too. Make sure to include the following items in your training tool kit:

• AdvaMed's Code of Ethics on Interactions with Health Care Professionals.
  
• OIG's Compliance Program Guidance for Pharmaceutical Manufacturers. Notably, no specific program guidance for the medical device industry exists of yet, but the OIG told medical device companies to look to the pharmaceutical guidance for help.
  
• OIG advisory opinions, fraud alerts and bulletins.
  
• American Medical Association's (AMA) Ethical Opinion E-8.061 Gifts to Physicians from Industry. The opinion addresses physician interaction with industry representatives and reveals what the AMA expects from its members. Examining this document provides tools you can use to help your staff respond to pressure from medical practitioners seeking incentives.
  
• Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support. The document provides guidelines for sponsorship of continuing education from the medical industry. The guidelines focus on issues of independence and provide important information on best practices, says Manthei.
  
• Department of Justice press releases and coverage of high profile settlements. Reviewing current enforcement actions or investigations can reveal patterns and indicate what the government is really looking at. "Press releases show what the government sees as crossing the line," says Manthei.

Editor's Note: Next week, we'll explain how to follow-up and make sure your representatives took your training message to heart.

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