AdvaMed Code of Ethics Case Studies

Transcription

1 AdvaMed Code of Ethics Case Studies Health Care Compliance Association 2006 Compliance Institute Vickie McCormick

2 Approaching the Case Studies Approach Review common requests to medical device companies provide sponsorships, contributions and other funding that involve or affect customers. Discuss how such situations can be evaluated and should be resolved under the AdvaMed Code of Ethics for Interactions with Health Care Professionals Identify: Relevant provisions Gaps in the Code Solutions and options Can request electronic copy of presentation to access Notes Page feature with my comments and analysis 2

3 Referral Source Dinners Sales personnel want to sponsor a dinner for a customer s current and potential referral sources. The dinner would be at a local restaurant and physicians who do or may refer patients to the customer would be invited. There will be a presentation. Is the non-profit or for-profit status of the customer relevant? Is Member-Sponsored Product Training and Education under Section II available to support the dinner? Can the sponsorship be treated as a gift? Would it matter if the presentation included information about the Device Company s products? 3

4 Customer Sponsored Newsletters Customer requests sponsorship for a newsletter that is sent to patients and possible referral sources. The newsletter includes information about various disease states and treatments. It also contains information about the customer s practice, facilities, and treatment capabilities. Can the sponsorship take the form of advertising? Does it matter whether the customer is non- or for-profit? Does it matter whether the Device Company is referenced or its products are marketed in the newsletter? What if the request is to sponsor a series of newsletters, not all of which will address disease states using your products? 4

5 Customer-Sponsored Conference A hospital customer has requested funding to help support a CME-credited conference that it will be conducting at its facility. Most of the speakers will be hospital-staff physicians. The attendees will be primary care physicians in the area. Can this be treated like a Third Party Educational Conference? Do the CME credits matter? Does this qualify for Third Party Educational Conference support under Section III? Does it matter whether the customer is non- or for-profit? What if the presentations will include discussions about how the Device Company s products are used in treatment? 5

6 Device Company Products Embedded in an Anatomical Model A sales representative wants to give a physician an anatomical model with the Device Company s products embedded so the physician can show patients what that part of their body will look like after surgery. Are there any limitations? How should the embedded products be treated under the Code? Anatomical models Embedded products Value and limits 6

7 Genuine Personal Friendships A sales representative has known one of his customers since college. They have stayed close and their family members interact with each other without the sales rep or customer. The customer s daughter is graduating from high school. Can the sales rep give her a gift? Code Section VI Gifts Significant life events Dealing with genuine personal friendships between sales reps and customers. 7

8 Training and Education at Third Party Educational Conferences Many of Device Company s customers will be attending a Third Party Educational Conference. It also recently introduced a new product. It would be a great time to have training and education on using the new product. Can Device Company arrange for training and education at the Third Party Educational Conference? Third Party Educational Conference restrictions Off-Agenda Device Company-Sponsored Training and Education 8

9 Receptions during Third Party Educational Conferences Dealing with Attendees Guests Device Company has decided to sponsor a reception during a Third Party Educational Conference. Because of the Conference location, it is expected that spouses and other guests will be traveling with Health Care Professionals to the conference. Can attendees guests be invited to the reception? Third Party Educational Conference hospitality sponsorship What if it is a by Device Company invitation only reception Ideas for dealing with attendees guests 9

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11 Additional Issues for Consideration Process for requesting exceptions to the AdvaMed Code or Device Company Code. Sales rep wants to make personal contribution to local charity hospital that is also his customer for fundraiser related to Alzheimer's, which his father and uncle have Paying a customer to write a journal article is it the same or different from paying a customer to present at a Third Party Educational Conference Responsibility for re-seller compliance with the AdvaMed Code 11

12 Additional Issues for Consideration Taking customer s to the sales representatives private country club for golfing Customers paying for things that exceed Device Company limits, i.e., meals, travel, lodging, gifts, etc. or that are prohibited, i.e., sporting events, theatrical events, concerts, etc. Giving customers tickets the sales rep received for free. Having customers pay face value of season tickets purchased by the Device Company 12

13 Additional Issues for Consideration Determining fair market value for consulting services. Requiring Customer-Consultants to comply with the AdvaMed Code and/or Device Company Code Fellowships at non-academic learning institutions, i.e., Mayo Clinic and Cleveland Clinic Sponsoring a customer s charitable activities that have no relationship to Device Company s business, i.e., cardiac rhythm company sponsoring Alzheimer s fundraiser. 13