This author discusses the AdvaMed Code of Ethics and the Physician Payment Sunshine Act, and how they affect medical product sales representatives when they visit your podiatry practice.
The medical product sales reps who visit your podiatry office every now and then are good people to know. They’re there to show you medical advances that can help save lives, improve treatments and enhance the quality of life for your patients. They often have the training and expertise to stand beside you for technical support during procedures when you use their companies’ technologies.
These routine and important interactions with industry reps can present risks of a conflict of interest. Accordingly, it is important to you and your patients that you take a reasonable approach to avoid a conflict of interest, or even the appearance of such a conflict, including inappropriate gifts.
Too often, we misunderstand critical relationships between industry representatives and doctors. That’s why the Advanced Medical Technology Association (AdvaMed) developed its Code of Ethics on Interactions with Health Care Professionals. AdvaMed, the largest American medical technology association representing medical device and diagnostics companies, strongly encourages both industry and physicians to commit to openness and high ethical standards in the conduct of their business interactions.
The AdvaMed Code provides clarity and rigor in areas such as company-conducted training and education for physicians. Since the successful use of medical technologies often depends on the skill and training of the clinician using them, the industry has a responsibility to make education and training available to physicians on the safe and effective use of its products.
According to the AdvaMed Code, educational programs for healthcare providers should occur in settings that are conducive to the exchange of information. “Hands-on” training should take place at facilities suitable for the type of training to occur. Instructors should be qualified and have the technical expertise to conduct the training.
However, if you think the sales rep should show up at your podiatry practice with pizza or doughnuts for your entire office staff to compensate for the time it takes to showcase the latest innovations, or you expect a bouquet of flowers to mark the occasion, you are going down the wrong path.
While a company or its representative may provide modest meals or refreshments to healthcare professionals in conjunction with a presentation of scientific, educational or business information, companies may provide these only to healthcare professionals who actually attend such meetings, according to the AdvaMed Code. A sales rep may also provide certain items to healthcare professionals that benefit patients or serve a legitimate educational function, but other than medical textbooks or anatomical models, any such item should be under $100 in value.
A company or its representative may not otherwise provide gifts, such as meals, snacks, wine, flowers, gift baskets, branded promotional items or cash to a healthcare professional or a healthcare professional’s office or staff members as the code does not consider them educational items or for the benefit of patients.
The AdvaMed Code’s chief goal is to ensure that decisions relating to medical treatment are always based on the best interests of patients. The safeguards included in the code are also intended to mitigate the risk of government enforcement, which can follow if decisions relating to medical treatment happen for the wrong reasons. It is important to remember that the risk of investigation and enforcement exists not just for companies but for doctors as well, and the consequences can be severe.
Complementing the AdvaMed Code is the Physician Payment Sunshine Act, which was included as part of the 2010 Affordable Care Act. The main purpose of the Physician Payment Sunshine Act is to provide patients with enhanced transparency into the legitimate relationships their healthcare providers have with manufacturers, including medical technology companies and their representatives.
The Physician Payment Sunshine Act does not restrict industry-physician interactions or collaborations. Indeed, these are essential to the unique innovation model for developing advanced medical technologies and the safe and effective use of such products. Nor does the Physician Payment Sunshine Act prohibit payments or transfers of value related to legitimate industry-physician interactions or collaborations. Rather, the law requires manufacturers and their representatives to track and report payments and transfers of value made to healthcare providers and teaching hospitals that result from these interactions.
Reportable items under the Physician Payment Sunshine Act include not only payments for consulting and honoraria but also gifts, food and beverages, entertainment, travel or any other transfers of value worth $10 or more (or even items worth less than $10 if the total for a doctor adds up to $100 in a given year). The law also requires reporting of ownership/investment interests.
Patients will be able to see these reported payments and transfers of value when the data is published on a searchable public website by the Centers for Medicare and Medicaid Services (CMS) in September 2014. Related data collection by manufacturers began in the summer of 2013. The information patients will be able to see may include brief contextual statements for specific payments or transfers of value provided by manufacturers to help patients understand the purpose of these transactions.
AdvaMed and its members have actively supported passage and effective implementation of the Sunshine Law to help ensure that healthcare professionals like podiatrists continue to make independent decisions regarding the healthcare and treatment of patients, and the collaborative development of advanced medical technologies.
Healthcare providers can work hand-in-glove with AdvaMed as well as individual medtech companies and company reps that may follow the AdvaMed Code. Doing so promotes strong standards and helps educate colleagues and patients about the requirements of the code and the Physician Payment Sunshine Act to help meet their mutually important goals.
Van Haute is an Associate General Counsel at AdvaMed.