Cath Lab Digest

Our readers may remember fondly (or perhaps not so fondly) the days when there were frequent requests from all forms of DME suppliers, home health agencies, infusion providers, and product manufacturers to visit our clinics. This is usually during the lunch hour to provide lunch and talk to the staff about their products or services, or simply to say “thank-you” for the business. Along with the lunch, left behind were piles of pens, pads, mouse pads, can drink covers, and other “reminders”. Additionally there were the boxes of donuts, bagels, and candy passed through the front window with the company logo on a sticker proudly letting the recipients know who brought them. In more distant years there were trips, golf games, sporting events and all sorts of “perks” that came with close relationships to coveted vendors whose products were used frequently and with whom a close relationship had developed.

For many, our hospitals may have placed limits on the free goods, especially meals, unless there was legitimate education being presented during work hours. But there certainly seemed no harm in a few pens and pads.

But then with the arrival of January 2009, it all seemed to come to a screeching halt. Most of our vendors gave us a heads up that it was coming, that the rules were changing, and apologetically announced that even the wall calendar that they had always provided would be no more.
Note: (Check out the December 2009 issue of Ostomy Wound Management for a free wall calendar provided by HMP Communications.)

Most just accepted the changes, as “somebody’s” rules, but this issue of Today’s Wound Clinic seemed the obvious forum for providing the details.
Many state and national medical device and pharmaceutical associations have developed over the years codes of ethics—the ones we will address in this article were conceived and written by two national associations who represent—the Advanced Medical Technology Association (AdvaMed) and the Pharmaceutical Researcher and Manufacturers of America (PhRMA). AdvaMed (www.advamed.org) is the world’s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. AdvaMed members and subsidiaries manufacture nearly 90 percent of the healthcare technology products purchased annually in the United States and more than 50 percent of the healthcare technologies purchased annually around the world. PhRMA (www.pharma.org) represents the country’s leading pharmaceutical research and biotechnology companies. AdvaMed originally published its Code of Ethics on Interactions with Health Care Professionals in 2003, with an update in 2005. The ‘Code of Ethics’ was revised in 2008 and implemented in July 2009 but many companies began implementing the provisions at the beginning of this year. The goal of the new Code was to find a balance between productive interactions with healthcare professionals and ethical behavior consistent with fraud and abuse authorities.

Although many of us are not familiar with the medical device and pharmaceutical trade associations, we are appreciative that there are organizations that place a ‘Code of Ethics’ at the forefront of their industry. To help us understand the position of AdvaMed and PhRMA, the effect on our industry and clinics, and the role that we in the clinics can play in assuring compliance with the guidelines, TWC solicited the help of Marcia Nusgart, R.Ph, Nusgart is the executive director of the Alliance of Wound Care Stakeholders, a multidisciplinary consortium of over 15 physician, clinician, provider, manufacturer and patient organizations that addresses regulatory and legislative issues impacting wound care. She also serves as executive director for the Coalition of Wound Care Manufacturers and President of Nusgart Consulting, LLC. She previously served as associate vice president, Home Care for the Advanced Medical Technology Association (AdvaMed). The authors also solicited the help of Lynn Shapiro Snyder and Ben Martin, health lawyers from the national health law firm, Epstein, Becker & Green, P.C. (EBG). The law firm has one of the largest health industry law practices in the United States. For more information about EBG, visit their website at www.ebglaw.com.

Set forth below are questions and answers related to the purpose of the Codes, the evolution of the changes, and what our role should be in connection with industry compliance.

Q: Isn’t the restriction of pads and pens extreme? If I’m making a treatment decision, I don’t look down at my pen for guidance.
A: Both Codes were revised to prohibit the provision of branded items, including those of nominal value, such as pads and pens. This eliminated one of those “gray areas” mentioned above. The government enforcement community has been particularly vocal about its concerns that a vendor’s provision of branded items can improperly influence a prescriber’s choice of product, especially when the branded items have no relationship to patient care or patient education. These items are considered by the enforcement community to be a form of subsidization of a prescriber’s overhead. This would include not only pads and pens, but also coffee mugs, clocks, calendars, and novelty items. Of course, pharmaceutical and medical device manufacturers may still provide truthful and non-misleading information about their products to prescribers (in compliance with FDA requirements).