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Additional Third Party Meeting Information at Compliance on MSD's MySpineTools Website
This information about Medtronic Sofamor Danek's (MSD) sponsorship of Third Party Meetings is being provided at its www.MedtronicSofamorDanek.com website so it can be accessed by anyone who may be interested in requesting a financial support for a Third Party Meeting.

MSD also maintains a www.MySpineTools.com website for its Customers, sales representatives and other employees that has additional information about MSD's financial support for Third Party Meetings. MySpineTools.com requires a user ID and password - which are only granted to Customers, sales representatives and employees. Throughout this website, we identify additional information that is available to users with MySpineTools.com access. Customers are not able to access the MySpineTools.com pages that are restricted to sales representatives and employees.

MSD sales representatives and other employees should go to Rep/Employee Resources at Compliance at www.myspinetools.com for additional information relevant to them about MSD's financial support for Third Party Meetings.

Glossary of Terms
Defined words and terms are used throughout this website and the documents you can access and download from this website. Go to Glossary of Terms for the definition.

MSD's Third Party Meeting Administrator
MSD's Third Party Meeting Administrator is responsible for receiving, reviewing, and administering all Third Party Meeting support and Scholarship requests. The current Third Party Meeting Administrator is:

Stephanie Elkins
Medical Education Department
1800 Pyramid Place
Memphis, TN 38132
stephanie.elkins@medtronic.com
901.344.0654

What Are Third Party Meetings
Under the AdvaMed Code of Ethics and Medtronic's Business Conduct Standard #8, MSD is permitted to provide financial support for education and/or scientific meetings, congresses, conferences, roundtables, and other forums for health care professionals that are not organized by MSD and address medical conditions, disease states and/or therapies for which MSD Products can be used.

There are three types of Third Party Meetings that MSD can financially support under BCS #8. Each type of meeting has specific criteria that must be satisfied.

Third Party Meeting Type Requirements

Nationally or Regionally Recognized Meetings

Bona fide independence from MSD

Educational, scientific or policy making topics

Conference, congress, or professional meeting

Have a relationship to MSD's business or products

Grand Rounds

A written agreement that specifies the topics to be addressed.

The topics are related to therapies, uses or indications for MSD products, and

The subsidy does not exceed normal and customary expenses

Scientifically Valuable Roundtables or Discussion Groups

High caliber and scientifically valuable, and

Directed towards advancing the state of medical knowledge about MSD's therapies, or

Meaningfully addresses disease states or technology of interest to MSD.

What this means is that MSD can provide financial support for meetings sponsored by the professional associations our Customers belong to, grand rounds organized by Customers, as well as other types of educational and/or scientific forums.

To request MSD financial support for a Third Party Meeting, go to Meeting Support.

What Are Not Third Party Meetings
The following are not Third Party Meetings and, as a result, are not eligible for Third Party Meeting financial support:

MSD Training and Education Program. If a MSD Training and Education Program is scheduled to take place at the same place as a Third Party Meeting before, during or after the Third Party Meeting, review Third Party Meeting Locations below.
Referral dinners and other Co-Marketing Activities where a Customer is promoting his practice to patients or possible referral sources, including CME-credited conferences sponsored by a Customer when Customer staff is all or most of the faculty and the invitees are primarily potential referral sources rather than peer surgeons.
Casual meetings among customers that lack an organized agenda and/or clear educational or scientific purpose.

Although there are exceptions, a general rule of thumb is that if no CME/CEU credits are offered, it does not qualify as a Third Party Meeting.

Customer Sponsored Third Party Meetings for Referral Sources
A Customer Sponsored Third Party Meeting where the Customer's staff are all or most of the faculty for the Third Party Meeting and the intended audience is patients or primarily potential referral sources, rather than other surgeons who perform the same types of spine-related procedures the sponsoring Customer performs, are not eligible for funding as a Third Party Meeting, even when CME or CEU credits are available to attendees. Since they are not eligible for funding as a Third Party Meeting, they are also not eligible for a charitable contribution. This restriction does not apply to Grand Rounds.

These types of Customer-sponsored conferences are not eligible for support as a Third Party Meeting because they are considered promotional activities that have an educational component. Such Customer-sponsored conferences may qualify as a Co-Marketing Activity that MSD can help fund as long as all of MSD's Co-Marketing Activity criteria are satisfied. Additional information about financial support for Co-Marketing Activities is available to MSD's sales representatives and employees at the Compliance site at www.myspinetools.com, by selecting "Rep/Employee Resources" and then selecting "Business Colleague Arrangements (BCS #6)" from the "Rep/Employee Information and Tools" drop down menu at the top of the page.

Permissible Types of Financial Support for Third Party Meetings
MSD's financial support, which may be referred to as an "Educational Grant" can take a variety of forms, including:

Meeting sponsorship to pay for and/or reduce overall program costs.
Meal and/or reception sponsorship. The meal or reception must comply with the General Provisions: Meals and Other Hospitality Requirements and Limitations Policy.
Speaker costs (payable to the Third Party Meeting sponsor, not directly to the speaker)
Scholarships for health care professionals in training, payable to the Third Party Meeting organizer or the professional's academic institution, not directly to the professional.

Such sponsorship may include different types of recognition, for example, reference in a brochure, name and logo on a book bag, a sign recognizing sponsorship of a meal or reception.

Prohibited Types of Financial Support for Third Party Meetings
MSD can only provide financial support to the Third Party Meeting sponsor, it cannot provide financial support directly to faculty or attendees. Consequently, MSD does not pay:

Customers to attend a Third Party Meeting.
Faculty to attend or speak or any other fees directly to the faculty.
For any costs related to a Customer's spouse or other quest.
Scholarships for health care professionals who are not in training.
A Customer's meals, hospitality, recreation or entertainment, unless it qualifies as a Customer Business Meeting under BCS #5 or Business Colleague Meeting under BCS #6 and complies with the General Provisions: Meals and Other Hospitality Requirements and Limitations Policy.

MSD may grant a BCS Exception and directly pay a faculty member's travel expenses when the conference sponsor does not pay for a faculty member's international travel.

Scholarships for Third Party Meetings
Under the AdvaMed Code of Ethics and BCS #8 MSD may provide Scholarships only for health care professionals in training, such as students, residents, and fellows. They are not permitted for health care professionals who have completed their training.

MSD helps health care professionals who are not in training to attend Third Party Meetings by providing various financial support, to lower the costs for those attending. For example, MSD's sponsorship may result in lower registration fees.

MSD provides a limited number of Scholarships to major society or instructional courses with robust agendas that are directly or indirectly related to spinal deformity, deterioration, or trauma or associated neurological disease states and conditions or the appropriate use of biologic products that are located in the United States in non-resort locations.

The following is a non-exhaustive list of Third Party Meetings for which MSD will not provide Scholarships:

Surgical Management of Spine Disorders (Beaver Creek, Colorado)
Innovative Techniques in Spine Surgery (Cabo San Lucas, Mexico)
OSTAR Spine Study Group (Palm Beach, Florida)
Emerging Technology Spine Education Summit (Telluride, Colorado)
Mayfield Winter Clinics (Snowmass, Colorado)
Selby Spine Conference (Park City, Utah)
Ricard Lende Winter Neurosurgery Conference (Snowbird, Utah)
Ski with the Spine Center (Whistler, Canada)

To request a scholarship for a health care professional in training, go to Scholarships.

Exhibit-Only Sponsorships
If the only sponsorship MSD will be providing is to pay $1500 or less for exhibit space, then the Third Party Meeting Sponsorship Request Form does not have to be submitted. Sales Personnel, with appropriate approval by their managers, can decide to pay $1500 or less for exhibit space. However, the payment must be only for exhibit space - it cannot be to pay another type of sponsorship. Also, it must be legitimate exhibit space and not a sham in order to avoid complying with requirements for requesting financial support for a Third Party Meeting. For example, if MSD is the only exhibitor, we would consider any payments to be a sponsorship that requires review and approval, not an exhibit space payment.

MSD's Third Party Meeting Administrator must approve any exhibit space purchases that cost more than $1500.

Typically, the sponsor has a form or application that needs to be completed. Instead of requiring the sponsor complete the Third Party Meeting Sponsorship Request Form, the meeting sponsor or MSD's sales personnel can complete and send the sponsor's exhibit space form to MSD's Third Party Meeting Administrator for review. The Third Party Meeting Administrator will let you know if he needs any other information and whether the exhibit space purchase is approved. Sales Personnel are permitted to complete and submit exhibit space applications.

Third Party Meeting Locations
Generally, Third Party Meetings can be at locations that MSD cannot use for its own meetings and training - such as resort locations. The only time when we will be concerned about where a Third Party Meeting takes place is if:

MSD has a meeting or training program of its own before, during, or after the Third Party Meeting at the same location and we pay for Customers' travel and/or lodging.
MSD pays for more than 30% of the Third Party Meeting expenses.
More than 25% of the attendees are also faculty.

If any of these criteria apply, the Third Party Meeting will have to be at a location MSD can approve, i.e., not a resort location, or the location will have to be approved as a BCS Exception.

Sales Involvement in Third Party Meeting Support and Scholarships
MSD's Sales Personnel, including employees, Distributors, and Independent Sales Representatives, may not be involved in requesting or granting Third Party Meeting support for a Scholarship.

Often, MSD Customers chair Third Party Meetings, or, in the case of Grand Rounds, are conducted by Customers. MSD's Third Party Meeting Administrator may contact Sales Personnel for insight about the content and quality of the Third Party Meeting. However, Sales Personnel should not comment on whether the financial support would be important to Customer's business with MSD or try to influence a decision on the basis of a Customer's past or future business with MSD.

We have to make sure Sales Personnel do not influence the decision on the basis of a Customer's past or future business with MSD, because then the government may consider MSD's financial support to be an illegal kickback.

Business Conduct Standard Brochures
MSD has created a brochure regarding educational grants, subsidies and scholarships for Third Party Meetings that provide answers to common BCS questions.

Third Party Meeting Support and Scholarships (LITEGTPBR4A)

MSD Employees and Sales Representatives can order the brochure at www.myspinetools.com. Select "Resources" from the top navigation bar and then, from the Overview page, select "Click here to order available literature and video for customer use." The brochures are under the Sales Division category. The Item # for each brochure is provided in parentheses in the above listing.

Third Party Meeting Q&As

Why is there so much concern about whether MSD subsidizes Third Party Meetings?

Because the federal government is aggressively investigating the types of payments and benefits that pharmaceutical and medical device companies give their Customers. The government believes companies use Third Party Meetings subsidies - often referred to as "Education Grants" - to reward Customers for purchasing their products in the past and to encourage Customers to purchase more of their products in the future. When the federal government ultimately pays for these products - typically through Medicare or Medicaid - then these types of incentives are considered an illegal kickback.

The federal government is investigating medical device companies and their Customers for these types of illegal kickbacks and they expect to enter into big settlements like they have with pharmaceutical companies.

What laws apply to financially supporting Third Party Meetings?

There are not laws that apply specifically to MSD's financial support of Third Party Meetings. The laws that affect MSD's financial support of these meetings are the state and federal anti-kickback laws that prohibit giving or receiving anything of value in exchange for purchasing something that is paid for by tax dollars - typically by Medicare or Medicaid. If a company like MSD provides financial support - like a Scholarship - and only one purpose of that contribution is the expectation that a Customer will continue or start buying our products - the federal government believes there has been an illegal kickback and MSD could be prosecuted.

In addition, a Customer who benefits from MSD's financial support could be prosecuted because it is also illegal to receive something of value. That means, for example, that if MSD's Scholarship for a Customer is considered an illegal kickback, then the Customer could also be prosecuted.

What does the AdvaMed Code of Ethics say about financially supporting Third Party Meetings?

Section III of AdvaMed's Code, entitled "Supporting Third Party Educational Conferences" deals with these issues. It requires the meeting to be an actual and legitimate "educational, scientific, or policymaking conference promot[ing] scientific knowledge, medical advancement and the delivery of effective health care."

What does Medtronic's U.S. Business Conduct Standards say about Third Party Meetings?

Business Conduct Standard #8, "Medical Conferences, Congresses & Professional Meetings Sponsored by Organizations Other than Medtronic" states: "Medtronic has an interest in building awareness and understanding of its products and related disease states through support for third-party scientific forums. For these purposes, Medtronic may underwrite the cost of such third-party conferences or meetings and may subsidize the attendance of health care professionals-in-training. Such payments must comply with local Business Conduct Standards."

What types of Third Party Meetings can MSD support?

BCS #8 identifies threes types of Third Party Meetings that MSD can financially support. Each type of meeting has specific criteria that must be satisfied.

Third Party Meeting Type	Requirements
Nationally or Regionally Recognized Meetings	Bona fide independence from MSD Educational, scientific or policy making topics Conference, congress, or professional meeting Have a relationship to MSD's business or products
Grand Rounds	A written agreement that specifies the topics to be addressed. The topics are related to therapies, uses or indications for MSD products, and The subsidy does not exceed normal and customary expenses
Scientifically Valuable Roundtables or Discussion Groups	High caliber and scientifically valuable, and Directed towards advancing the state of medical knowledge about MSD's therapies, or Meaningfully addresses disease states or technology of interest to MSD.

How can MSD's financial support for a Third Party Meeting be used?

There are several permitted uses of MSD's subsidy, but there are also some prohibited uses as well:

Permitted Uses Prohibited Uses

Reducing overall conference costs, which may reduce attendee registration fees.

Giving Scholarships for health care professionals-in-training

Helping fund the compensation paid for faculty selected by the sponsor.

Hosting modest meals and receptions during the conference that do not compete or take precedence over the educational aspects

Directly pay faculty.

Paying any expenses for spouses or other guests of attendees.

Giving scholarships to health care professionals who are not in training.

Can MSD provide Scholarships to a Customer to help them attend a Third Party Meeting?

Maybe. Scholarships can be provided only for health care professionals-in-training to attend Third Party Conferences. If the Customer is not "in-training," then we cannot provide a scholarship. By sponsoring Third Party Meetings the overall costs, including registration, are lower. By helping to lower the overall costs, we are helping Customers who are not in-training because they will pay less than if we did not provide sponsorship.

Why doesn't MSD financial support some Customer-organized conferences when CME credits are available to the people who attend?

Because these are often promotional events - not Third Party Meetings that qualify under BCS #8. It is not difficult for a conference to qualify for CME credits. The issue is whether the primary purpose of the conference is to educate peer surgeons or promote the Customer's practice to potential referral sources.
If the conference faculty is almost completely composed of members of the Customer's staff and the invitees are primarily potential referral sources - such as primary care physicians, non-spine surgeon orthopedists, and pediatricians - rather than other spine surgeons who perform surgical procedures similar to the sponsoring Customer, then we believe the primary purpose of the conference is to promote the Customer's practice. If we sponsored such events, we would be paying the Customer's marketing and promotion expenses - which are operating expenses -- and it is not appropriate under the AdvaMed Code of Ethics or Medtronic's Business Conduct Standards for MSD to pay a Customer's operating expenses. So, for the same reason we cannot pay for a Customer's furniture, software, computers, and other capital and operating expenses, we cannot pay for their marketing and promotional expenses.

If MSD decides to help fund faculty compensation or honoraria, can MSD select some of the faculty?

No. MSD cannot select faculty for the Third Party Meeting. MSD can provide faculty recommendations. But the meeting sponsor must retain full discretion to select the faculty.

Since someone else is planning the Third Party Meeting, does MSD have to worry about the type of location and how much meals cost?

Generally, Third Party Meetings can be at locations that MSD cannot use for its own meetings and training - such as resort locations. The only time when we will be concerned about where a Third Party Meeting takes place is if:

MSD has a meeting or training program of its own before, during, or after the Third Party Meeting at the same location and we pay for Customers' travel and/or lodging.

MSD pays for more than 30% of the Third Party Meeting expenses.

More than 25% of the attendees are also faculty.

If any of these criteria apply, the Third Party Meeting will have to be at a location MSD can approve or an exception must be granted according to MSD's General Provisions: Business Conduct Standards Exception Policy, which is available at the BCS Policies section of the Compliance site at www.myspinetools.com.

Regardless of the location, any meals, receptions or other hospitality that MSD sponsors must still be modest.

I'm a MSD sales representative and the doctors in my area get together once a month to discuss cases and learn from each other. Is that a Third Party Meeting that MSD can subsidize by helping to pay for the food?

Probably not, but we would need more information to know whether it could qualify as one of the three types of Third Party Meetings described above. If it does not, then you would not be able to help subsidize the meeting unless an exception is approved before the meeting.

It is unlikely the meeting would qualify as a Business Courtesy under BCS #5 because it would not qualify as a Customer Business Meeting- an MSD representative does not have to be present for the meeting and the meeting is not for purposes of conducting MSD-related business, such as negotiating sale terms.

A Customer wants us to conduct a MSD Education and Training Program regarding our products during their regularly scheduled Grand Rounds. Should this be handled under BCS #7 or BCS #8?

BCS #7 applies. The fact that the Customer wants you to conduct the MSD Education and Training Program during the time period they reserve for Grand Rounds does not change the nature of what you are doing - you are sill training health care professionals on the proper use of MSD Products. As a result, it is not a Third Party Meeting under BCS #8, it is a MSD Education and Training Program under BCS #7. This response is unique to Grand Rounds since the Customer controls how that time is used. It is not possible to have MSD Education and Training Programs part of the agenda of another type of Third Party Meeting unless a BCS Exception is approved.

Does a referral dinner a Customer wants to have for local physicians who may refer patients to him qualify as a Third Party Meeting?

No. This type of referral dinner would not qualify as one of the Third Party Meetings described above but it may qualify as a CO-Marketing Activity. More information is available to sales representatives and MSD employees about Co-Marketing Activities by selecting "Business Colleague Arrangements" from Rep/Employee Information and Tools drop down menu at the Compliance site at www.mypsinetools.com.

Can we pay for exhibit space at a Third Party Meeting?

Yes. Purchasing exhibit space at a Third Party Meeting is a sales expense and if the cost of the exhibit space is $1500 or less it does not need to be reviewed by MSD's Third Party Meeting Administrator. If the exhibit space will cost more than $1500, then complete the sponsor's exhibit space form or application and send it to MSD's Third Party Meeting Administrator for review and approval.

Can sales representatives buy meals for their Customers while they are attending a Third Party Meeting?

Yes, in fact, we realize it is likely this will happen. But, remember, any such meals must comply with BCS #5 regarding Business Courtesies and with the General Provisions: Meals and Other Hospitality Requirements and Limitations Policy, which is available at the BCS Policies section of the Compliance site at www.myspineetools.com.

What should a sales representative say if a Customer says MSD better subsidize a Third Party Meeting, or a specific Scholarship or he won't do business with us?

Explain that the federal and state anti-kickback laws make it illegal to tie financial support for a Third Party Meeting, including a Scholarship, to past or future business with MSD. Also explain that MSD has implemented a Compliance Program to help make sure that both the Customer and MSD comply with the anti-kickback laws. And, give them the information provided on this page on how to request financial support or a Scholarship that won't violate the anti-kickback laws.

If the Customer continues to insist that the financial support is necessary to reward past business or receive future business, immediately notify MSD's Compliance Office by sending an email to MSDCompliance@medtronic.com.

How can requests for MSD's support for a Third Party Meeting be submitted?

For meeting sponsorship, complete the Third Party Meeting Support Request Form. Go to Meeting Support.

For Scholarships, complete the Health Care Professional in Training Scholarship Request Form. Go to Scholarships.

Who do I contact if I have any questions?

If you have any questions, contact MSD's Compliance Office (MSDCompliance@medtronic.com).

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Published: May 13, 2005	Updated: November 21, 2008
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